If you look at the published side effects of statins, arrhythmia is certainly listed. Of course the statin makers also claim to have studies showing that this drug class can treat a-fib. For me, among the other painful side effects, my heart rate and rhythm was, indeed affected adversely with the only 3 doses I was able to tolerate.
I am not surprised. Over the course of a few months, my wife was spoke with three people who were having problems with muscles. They all radiated from the neck down in to the back. My wife asked each of them if they were on statins and they were. The pain stopped when statins were discontinued.
Most egregiously, there was an 86 year old neighbor who complained of the neck pains and was put on pain relievers. Turns out that she had been put on statins too. Why would a doctor put an 86 year old on statins?
I was told by my doctor to take them, but I declined.
Statins impair mitochondrial metabolism and therefore only people who have healthy mitochondrial functioning can tolerate them. Carnitine, (which is also available by prescription as Carnitor) has been shown in the medical literature to be of benefit, sometimes highly beneficial (search PubMed with the terms carnitine and statin and you will also find plenty of good full length free articles). All the antioxidants and vitamins, such as the group included in the “Mitochondrial Cocktail” as compiled by the Cleveland Clinic, will help support mitochondrial functioning. Some of the nutrients will benefit some people more than others since everyone has their own biochemical uniqueness. Mitochondria are less capable of self-repair by the time a person survives to age 40 (years). There will be no outward sign that you are over the hill after that, at least over the hill at the intracellular level. However, you will be becoming increasingly vulnerable to toxins, impaired healing, ageing, all the things you wish to never experience.
Dan, so sorry for your experience. I was considering ablating, but will not after I read your article. Question: I’ve been reading about a new ablation procedure called HIFU (high intensity frequency ultrasound or something like that) which is supposed to be more effective and safer than regular ablation because a balloon type mechanism wraps around the outside of the vein. Have you heard of this? Also, does your wife still have afib?
A good source of information is Hans Larsen’s Afib Forum. And here is a recent article in The Washington Post
I do not know much about HIFU — and I am not telling anyone to avoid a procedure if their Afib is so difficult to live with that you are considering it.
I am saying that if you do consider it, you need to do your research, you need to avoid teaching/research hospitals.
You need to find an experienced physician whom who trust and who you know will not hand the job off to a trainee without your knowledge.
After you are unconscious in the OR, sometimes even the notes made in the medical record may not enable you to know who really did what, as I found out the hard way when I became a surgical patient at Hopkins. What might ward off highly disturbing discoveries after it is too late is a true “Informed Consent” that clearly spells out who will do what when you are having surgery and no family or friends are allowed in the room to be watching out for you. Of course, you must keep a copy of that consent form from the time your signature is given so that subsequent alterations are more obvious. Hindsight reveals so much!!
I just recently was an employee on the that floor – Halsted 5, which is the adjacent floor to the CCU and I am all too familiar with catheter tip afib ablation. I know all of the MDs you speak about – with the exception of the fellow. I have to say, working on that floor as a Nurse Practitioner was the worst experience of my life. I am thinking of starting my own blog detailing the hostile work environment and the workplace bullying that went on (All the time I was thinking “Is this how employees are treated in the # 1 Hospital in the world?”).I am shocked by what I read, and so incredible sorry. I had never even heard about this case (no one ever spoke of it) until I found it on the web, and did not know that mitral valve tearing was a possible complication. All of that being said I was not an employee at the time your wife was there. I applaud you for getting your message out. I will pray for you and your wife.
Dan, I wish you and your wife the best. I hope each and everyone of those individuals who were responsible for your nightmare, and there are quite a few, experience your pain ten fold.
I too have been told I am a perfect candidate for ablation.
After reading your story, I am rethinking my options.
Question: In the recent trials on ablation devices such as Thermocool and Arctic Front, there were exclusion of patients having taken Amiodarone for 6 months prior to enrollment and also not used in the drug arm. What is the reasoning behind that since Amiodarone is one of the more effective drugs?
2010-04-20 Answered by Dr. Moussa Mansour
The two studies you mentioned were randomized clinical trials comparing medical treatment versus ablation for paroxysmal atrial fibrillation. The use of Amiodarone was allowed in the medical treatment arm. Amiodarone however carries some risk of adverse effects, such as pulmonary fibrosis, liver toxicity,thyroid gland dysfunction and others. According to the guidelines of the American College of Cardiology/American Heart Association, Amiodarone is not recommended as a first line of therapy in patients with atrial fibrillation and structurally normal heart. As a result many patients and physicians are reluctant to use this medication in young patients.
Researcher,
I don’t understand. You ask Dr. Mansour about the exclusion of Amiodarone. (I refer specifically to the J&J trial.)
He says ” …The use of Amiodarone was allowed in the medical treatment arm.”
However, the J&J study says: “Amiodarone was not allowed per study protocol.”
Some patients on the drug arm were put on amio at their doctor’s discretion. The 6 months amio exclusion prior to time zero applies as per protocol. So that comparison between patients who failed AAD without amio followed by ablation(s) and patients who failed AAD without amio followed with additional AAD plus amio is fair.
Hopefully, that clarifies why it was done the way it was. I noticed other ablation trials (with cryo balloons for example) had exactly the same protocol.
Wilber must be too busy to respond. Mansour is a well known EP at Mass. General involved in many trials so his answer should be trustworthy.
Think in terms of comparing second line ablation compared to second line AAD with Amio. Who needs to be excluded for the comparison to be fair? That is the question that NIH wanted to be answered for all new devices.
By the way, you will probably find the following presentation interesting. The doctor stated that many more patients are being killed by AAD medication than ablation. It is pretty hard to argue with the complication data comparison he shows for drugs vs ablation.
Dan
I feel for you and Pam. I guess the “kangaroo” court is really trying to wallop you both with their lawyers. In cases like this the ins. co. is usually sitting in the back room – pulling the puppet strings. They play very dirty – so the court must have an odor of sorts?
Just thought I’d drop by because I do allot of research on clinical trials – and happened on this one recently — Looks like the notorious Hugh Calkins is at it once again~ http://clinicaltrials.gov/ct2/show/NCT00964392
Curiously – think about it – WILL Calkins disclose the experimental nature of THIS PROCEDURE to the patients signing on the dotted line as we speak???
So this got me wondering……..How many other patients
did he “a-hem” forget to mention that the same procedure done on Pam was still in the experimental stage?
If I was a juror I would think, hmmmm there HAD to be more patients he didn’t tell – adid they NOT know that they were secretly passed on to other drs. for their ablation also?
Geez, it’s like Calkins was running a Tanning Salon – Book em and Cook em!
If your lawyer doesn’t allude to deception of other patients – then the jury will most likely figure that out – Believe me it is a NO brainer.
Take heart – the appeal will be very appealing in Pam’s favor!
Blessings to you both.
Thanks for the link. I have learned so much from your site, particularly how to read study data with a more jaundiced eye. No, I have not failed anti-arrhythmic drugs yet, and no the risks of the procedure have not been discussed in any great detail. My cardiologist suggested it as an alternative to oral meds. Until reading your website I thought it was a relatively benign procedure that was well understood. My symptoms would have to become soooooooooo much worse before I would consider this. Thank you for taking the time to write this. You’ve performed a significant public service.
Allison, Your post distresses me because my husband was a very fit athlete who was also led to believe this was a simple procedure. He was well controlled on the medication, but had an ablation. Bottom line – he died. Please consider having a very frank discussion with your cardiologist. If it were me, I would consider going somewhere else. Doctors who are so flippant about this procedure should have their licenses revoked. Just my humble opinion.
I’ve read this with horror. Am I correct in deducing that there is no, none, NOT ANY safe ablation procedure for atrial fib? I was recently diagnosed with lone paroxysmal afib and am already being encouraged to have the procedure. After reading this I am now more terrified than I previously was.
Afib is terrible to live with, and I can understand why someone would want to have the procedure done, to want to have something done. I would urge people to become fully informed before making that decision. Your doctor is often not the best source of unbiased information.
Recently diagnosed, you are being “encouraged” to have the procedure. Encouraged by whom? Why? Have you truly failed anti-arrhythmic drugs? Are your symptoms so terrible that you would risk an invasive procedure?
Were you informed that the risk of death is 1 in 1,000? Did they tell you that they have no idea what the long-term efficacy of the procedure is? Did they tell you that you may well need to have the procedure performed twice or maybe even three times for it to be initially successful and that even then you will still have to be on anti-arrhythmic drugs and coumadin? Did they tell you that safety and success is highly dependent on operator experience? Were you told that if you go to a teaching hospital that your physician will likely have a fellow in training do the job?
There are many on Hans Larsen’s Afib forum, to which I linked above, who have had ablations and are glad they did. If your symptoms are severe and you choose to go ahead with it, that is a good place to get reassurance — and more information.
sorry to interject an opinion again but…
allison, if you have drug refractory symptomatic AF, ablation has to be considered, in addition to the 2nd or 3rd anti-arrhythmic drug as alternatives. most doctors are ethical and care for their patients as they would a family member; something that is incontrovertible to even the most cynical and well read lay people. despite what is out there on the blogosphere, the truth of the matter is this has to be considered. another reasonable website is http://www.a-fib.com where patients present both good and bad stories about ablation. i honestly cannot allow you to get a one-sided view here. this website is a good thing for patients, but honestly, even dan takes a reasonable view. he acknowledges both good and bad outcomes, and it would be hard to sleep at night knowing that a tragic personal tale would stand in the way of another person benefitting from a therapy that is available and that can potentially help. you represent the moral hazard in trashing a procedure which may help people. perhaps this is the panacea for all your ills, but unfortunately this website may be the vehicle which shapes your opinion on a potentially beneficial option.
Your opinion is welcome here. I believe in the free and open exchange of ideas. I cannot say the same for the site that you recommend http://www.a-fib.com/
My wife was banned first. They have a section called “patient experiences” or something and Pam just posted the facts of what happened to her at Hopkins. No opinion, just bare bones facts of her case.
they should include pam’s story on the website. i provide that site, HRS website, and your site to the patients who see me for AF ablation consults.
it certainly helps foster the discussion for the second pre-ablation visit in the office.
Calkins “has been the most important person in bringing some reality to prior outrageous claims of success rates made by some centers.”
To which I reply:
Calkins was also one of the persons making those very outrageous claims of success rates. Early on, like when he was experimenting on people like my wife, he used to talk of ablation being the “cure” for AF. He famously claimed in 2003 that “Target the active pulmonary vein and the success rate jumps to 90 percent,”… “The procedure is ready for prime-time,” “Physicians and their patients should know about it.”
That’s before he figured out in 2005 that he had a success rate of 52% and a complication rate of 12%. That’s when he started turning down the hype — after he mauled at least 35 people — that we know of.
KC Says:
March 18, 2010 at 7:28 pm
“And it was about time, too. But he was the first. The first to learn from his mistakes and talk about it at national meetings. Prior to that it was near impossible to talk patients down from their expectations. From my perspective, it was the patients that were pushing very hard to have this procedure done and seemed surprised when my vociferous warnings about the complexity and risk became apparent. Many patients hear what they want to hear and won’t listen to what they don’t want to hear.”
Dan Walter Says:
The first to learn from his mistakes? He made a huge mistake by nearly killing my wife – that’s for sure – but this discussion has nothing to do with honest mistakes. It’s about deception and betrayal of trust.
What he “learned from” was experimenting on people and realizing late in the game that this procedure does not work as advertised — as HE advertised it.
He was dreaming of catheter ablation as the big cure for Afib with no more Coumadin. What he and the others learned was that this is a very risky elective procedure which offers only palliative treatment – and that’s not proven to last more than three or four years.
As I say, they learned that by duping people into the procedure and injuring and killing more than a few.
Dan
I have alot of catching up to do here- but find the comments interesting and poignant It doesn’t matter that they include for/against/whoknows/sourgrapes/ types of remarks –
So be it-
What I believe matters is that the readers are so very fortunate that you have the writing talent backed with intensive research to present Pam’s horrible experience with ablation.
I’ve read this one and many clinical trials – and this procedure was clearly not ready for “prime time” as Calkins spouted.
When a patient has faith in a doctor and that faith is broken – by misrepresentation- or garnishment of the success rate of a procedure that is in itself legally actionable if it fails. But when not told of certain harms in advance – that is clearly lack of informed consent.
What I find most unconscionable is the dr’s casual manner and unprofessional conduct in leaving Pam to a less experienced dr. by leaving her unattended. That in itself increased the material facts of the risks he withheld in the first place.
Pam was permanently damaged and suffers to this day and Calkins wants to defend his actions and walk away from it. Let’s pray he must pay for such arrogance!
What a terrible ordeal. I think you have helped bring to the surface the mafia of the new millenium. So much money to be made, so many looking to make it. The attempt to cover up at Hopkins in my mind is a criminal act and should be handled accordingly.
You are a better man than I. I would be in jail by now.
On a side note, why is it that Johnson & Johnson always seems to be in the “mix” when it comes to unethical or outright illegal activities? I’m not singling them out, other than to say I’ve had my own issues with them. Perhaps illegal and device manufacturer always belong in the same sentence.
It used to be said about the French, but we have certainly trumped them as we have truly become “the nation of whores.”
Dan Walter says: We could never trump the French in that department.
The trial design was biased in favor of ablation. According to Hugh G. Calkins, MD, when you compare ablation to drug therapy in people who have already failed an anti-arrhythmic drug,“What we’re doing is sort of guaranteeing the drug arm’s not going to work, you know, in virtually anyone.”
Let’s think for ourselves for a minute and not listen to calkins. Read the trial description and tell me what the problem is. I haven’t trusted what calkins has to say for a long while and I am not about to start now.
The problem is that it’s not only Calkins who says in essence that the study was bogus. From what I can gather, Bayesian statistical analysis is a long way from hard science and can be manipulated.
They were comparing drug therapy to a procedure. “After the initial procedure, patients in the catheter ablation group were allowed up to 2 repeat ablation procedures within 80 days. At the discretion of the investigator, a previously ineffective drug could be continued during the effectiveness evaluation period.”
The patients in the trial underwent up to three ablation procedures, could take anti-arrhythmic drugs, and were called successes if there was a decrease in afib symptoms. The headlines read “Ablation Better than Drugs for Afib”
These quotes are from transcripts of FDA trial design hearings:
Dr. Cynthia Tracy: “To me, it doesn’t make any sense to compare the risk of anti-arrhythmic drug therapy with the risk of catheter ablation… you are comparing apples and oranges….”
Dr. Simmons: “trying to randomize them to drugs is just not going to work, right? We all agree to that. There is certainly enough historical data on drug therapy for atrial fibrillation to establish criteria on drug therapy, plus it is not a comparable control. So doing a randomized study comparing some ablation technique to drug therapy for atrial fibrillation is kind of a meaningless study.”
Dr. Anne Curtis: “I agree… It is comparing apples to oranges. I’m not sure you can compare ablation in patient A, whose got their own pattern of afib, to how patient B does with drug therapy.
Dr. Tracy: “I agree with all those comments.”
Dr. Vetrovec: “I just don’t want you stopping the drug and then ablating them and then starting the drug again and calling it a success…”
” …we sought input from a significant number of E.P.s. We were told by many of them that a study comparing A.F. ablation and medication did not make for strong clinical science because patients that failed a drug are being randomized to additional drug therapy as the control.”….. Burke Barett, vice president of regulatory and clinical affairs for CardioFocus.
The bad thing is that there are these financially incestuous relationships involving the Universities, the doctors, the FDA, big pharma or big device companies.
You would think that an institution would want to keep itself clean…look closely at what is done or how it is done. They should want to know every aspect about how a patient is cared for.
The fact is that the institution doesn’t know anything about how procedures are performed and who does them…and what the incentives are to the doc.
Ablation should be an experimental procedure until it is DOCUMENTED to be effective and the risks are well quantified.
I look at the trial differently. The control are the people on drugs that want to remain on drugs (this is real world because drugs are first line therapy for AF). If the patient fails drug, he is eligible for ablation and there are additional exclusion items as stated in the paper.
You also don’t need Bayesian analysis to tell ablation worked better. All you have to do is to take the worse results of the ablation group and compare it to the drug arm. The worse ablation results were still better than the drug arm, and by a significant margin. So significant that they had to stop enrollment for the trial because it was unethical to randomize patients to the drug arm and not give them a choice. It wasn’t even close.
When you said “rigged”, I thought you had issues with the way they picked patients. I looked at it and to me, they were going with real world and that is patients are ALWAYS put on drugs first despite the toxicity of available AF drugs and often very bad side effects. It is only after the patients either fail drugs or can’t handle the complications of drugs that they are candidates for ablation or surgery. The other aspect of the trial that is real is that not everyone that choses ablation has access to the best experts so there were top experts involved as well as mediocre centers with so-so EPs and there was a big spread in success rates amongst the centers.
It is very ironic that even Calkins is better than drugs for this group of patients as I surely would not want him or his trainees near my heart.
Regarding the amio question, one part of the paper talked about exclusion of Amio. Then another part talked about Amio being used. I emailed the lead author to get the reasoning and a clarification. I will write more when I get the reply.
From what I can tell, there are two (official) reasons amiodarone was excluded — and they seem reasonable. Firstly, amiodarone apparently has an almost unknowable half-life, so you wouldn’t really know the effects the drug is having in the context of drugs/ablation in the study. Secondly, I understand that amio is a harsh drug over the long haul, so many docs are reluctant to start a younger person on it because of possible effects on organs like the lungs down the road.
But, I’m curious as to how the study can be justified when 2/3 of the potential subjects were excluded. Dr. Waldo says that “at least two thirds of the people being treated for atrial fibrillation with drug therapy are on amiodarone.”
Add to that the general agreement that Amio is the most effective AAD out there – and you’ve essentially crippled the study. You are excluding the most effective drug that ablation can be compared to. How does that make sense?
I haven’t heard from Wilber yet. As to your comments, it is true that Amio is very toxic and takes the body about 6 months to excrete. There is also the issue that some top expert EPs think (based on what data I don’t know) that Amio modifies ectopic substrate and that AF ablation when Amio in the body is useless because the ablation needs to be done on substrate that has not been altered by drug(s) like Amio (unless a patient is to be on Amio life long). The whole panel agreed to the protocol with NIH concurrence before hand so there has to be some reasoning behind not wanting Amio 6 months prior to enrollment. I will wait for Wilber to clarify.
Question: In the recent trials on ablation devices such as Thermocool and Arctic Front, there were exclusion of patients having taken Amiodarone for 6 months prior to enrollment and also not used in the drug arm. What is the reasoning behind that since Amiodarone is one of the more effective drugs?
2010-04-20 Answered By: Dr. Moussa Mansour
The two studies you mentioned were randomized clinical trials comparing medical treatment versus ablation for paroxysmal atrial fibrillation. The use of Amiodarone was allowed in the medical treatment arm. Amiodarone however carries some risk of adverse effects, such as pulmonary fibrosis, liver toxicity,thyroid gland dysfunction and others. According to the guidelines of the American College of Cardiology/American Heart Association, Amiodarone is not recommended as a first line of therapy in patients with atrial fibrillation and structurally normal heart. As a result many patients and physicians are reluctant to use this medication in young patients.
Floyd, When you say “Johnson & Johnson always seems to be in the “mix” when it comes to unethical or outright illegal activities?” – what are you referring to?
My opinion has been that JJ has been one of the more diligent companies when reporting device failures or adverse complications and doing subsequent voluntary recalls. Do you have some specific examples of JJ misconduct?
Hah! Just Google Johnson & Johnson and Justice Department.
Jim Edwards at BNet is about the only journalist out there covering this stuff in a serious way. Here’s just one example: “J&J Nursing Home Kickback Scheme”
How about heart related devices as that is what I was referring to and more interested in.
Dan you referred to rigged Navistar J&J trial. I looked at the NIH clinical trials site and there are more than one. Can you provide the link to the one you are referring? Thanks.
Tip of the iceberg. Looks like a culture of deceit/arrogance. It’s not just devices, but all aspects of the company. They are not alone, but they are in the mix at several levels.
The problem involves allegations that a J&J unit called Scios marketed the heart drug Natrecor for “off label” uses, or for treatment of conditions for which federal regulators have not yet approved the drug. The U.S. Food and Drug Administration approved Natrecor in 2001 for patients experiencing acute heart failure. But according to Law.com, the government could be ready to pursue charges that Scios also marketed the drug for chronic heart problems, for which it didn’t have FDA approval
Stryker, Biomet, DePuy Orthopedics, Zimmer, and Smith & Nephew Settle, Agree to Deferred Prosecution It’s fall, the season for settlements, deferred prosecution agreements, and federal monitors. Reported by numerous reporters was a large settlement made by five companies that manufacture orthopedic devices, Stryker Orthopedics (a unit of Stryker Inc), Biomet, DePuy Orthopaedics (a unit of Johnson & Johnson), Zimmer Holdings, and Smith & Nephew. As reported by Barnaby Feder in the New York Times,
Of the five companies involved in the agreement, all but one will be paying hefty fines, which add up to $310 million. The companies include Zimmer Holdings Inc. (fined $169.5 million), Biomet Orthopedics (fined $26.9 million), DePuy Orthopaedics (fined $84.7 million), Smith & Nephew (fined $28.9 million). The fifth company, Stryker Corp., was not required to pay any money since the company voluntarily cooperated with investigators before any other company did and was able to enter into a Non-Prosecution Agreement with the government.
How bad could that Texas lawsuit against Johnson & Johnson for mismarketing Risperdal be? Try $5,000 per visit of a sales rep to a doctor.
That was the formula used in a West Virginia state court case in which the state attorney general sued J&J and its Janssen Pharmaceutica unit over false or misleading statements about Risperdal and Duragesic. The West Virginia judge assessed only $4.4 million in fines, but the formula he used — $5,000 per visit of a rep to a doctor plus $500 per letter or brochure — could have resulted in $22 million in fines.
The court noted in its order,
The defendants were twice put on notice by previous [FDA] warning letters that its promotional materials for Duragesic contained false or misleading statements; however … the defendants then willfully sent the false or misleading Duragesic [brochure] to West Virginia health care providers to make its medication Duragesic more appealing for sale.
The wording of [the] November 2003 Risperdal letter was intentionally constructed to modify the FDA’s warning language and mislead healthcare professionals, who rely on this information when prescribing medication for their patients.
J&J faces a much bigger suit in Texas, where it has been accused of Medicaid fraud, kickbacks and improper marketing of Risperdal to children and the poor in that state
The rigged Navistar study showing ablation is better than drugs got the big PR rollout, but when J&J had less heartening news to report, it didn’t do the full court press. This from a Reuters dispatch in 2005:
“Johnson & Johnson has revised the label of its Natrecor heart failure medicine to include data that suggest it may increase the risk of death, following two widely publicized medical journal articles that questioned its safety.
J&J did not issue a press release to announce the label change.
Instead, a company Web site, Sciosinc.com, published the lengthy label without pointing out which section of it had been added. “The label was quietly changed by Johnson & Johnson, which apparently doesn’t want to attract much attention to the new mortality language,” said Dr. Steven Nissen, a cardiologist at the Cleveland Clinic who in 2001 advised U.S. regulators not to approve Natrecor.”
Some people never developed far enough, at a psychological level, to have even the start of a conscience. It would be so welcome if they could become healthy enough to start to have a conscience. And even better if they could then have a profound ability to recall all that they have done to others. When I am face to face with such persons, I pray that they may experience such a miracle as psychological growth in this realm where they are so deficient. Doing so helps me keep my language and tone of voice closer to what is acceptable out in public.
Johnson & Johnson Charged With Kickback Scheme
8 Comments
By Ed Silverman // January 15th, 2010 // 12:33 pm
The US Attorney in Boston says Johnson & Johnson paid tens of millions of dollars in kickbacks – in the form of special rebates and other payments – so Omnicare, the nation’s biggest provider of pharmacy services to nursing homes, would put more patients on its Risperdal schizophrenia med (the Justice Department statement).
Dan, I think we were separated at birth. I am in total agreement with you.
We could obviously go on with the likes of Pfizer, Merck, Astra Zeneca, Lilly, etc., not to mention the Ranbaxy’s and other foreign interests that blatantly lie, misinform, and on and on. Let s not forget the huge buckets of money going to those top-tier hospitals we always see in USN&WR. Sure, they do good work, but let’s not sacrifice people in the “interest of science” plus we get a few million to add to the budget.
The government needs to start taking criminal action as people are dying because of a need to make the annual report look good for Wall Street.
Not sure what you’re looking for. J&J and most device manufacturers (Medtronic, Guidant, etc.)have the common thread of paying for endorsements, fudging the numbers, etc. If it’s found throughout the organization (different divisions), is it fair to assume that corporate governance is tainted? There is so much money involved, the fines that are levied is mere pocket change. Probably goes into the annual marketing budget.
I would look deeper into Thermocool. It’s all public record.
It’s disturbing because who can we trust to give us honest, accurate information these days. The marketing spin that companies put on their products/services are telling you all is fine, just don’t pay attention to the people that are dying, experiencing extensive morbidity or the fact that we changed our protocols mid study. Everything should be ok as soon as my Golden parachute is packed and ready.
How can anyone possibly use the word “Cure” when referring to ablation therapy for AF when patients are required to undergo additional procedures, continute taking their meds and still have breakthrough episodes. Those are the lucky ones. How about those that never make it off the OR table?
Please don’t get me wrong, this is not a personal attack at your question. I just wonder when the great unwashed will wake up and realize they are being killed or maimed so the inner circle of executives can line their pockets with blood money?
My heart felt empathy for what Pam and you went through and still dealing with. As I said in the other forum, it seems complications are being under reported and you have uncovered an example of it. I have seen the same thing recently when I compared the complications reported in a recent journal publication about a new piece of equipment to what was actually filed with the FDA. There is an inherent conflict of interest since the doctor(s) are paid consultants. It is scandalous especially since this latest and greatest is still being marketed as “safe”.
I am sorry that you and your wife experienced this tragedy. It is important to remember that there is only one road to becoming an experienced surgeon, and that is by being an inexperienced surgeon (albeit under close, experienced supervision). You may be interested in reading the novel House of God by Shem, or the factual writings by Atul Gawande. The overwhelming majority of people on the other end of the stethoscope are disturbed many aspects of the health care system, and we are working hard to fix them. However, as you have experienced, there are very few easy answers.
I am very sorry for what you and you’re wife have been through. I confess that I have put patients and their families through similar ordeals. Every physician has, and most of us are doing our best to make sure patients who decide to have relatively elective procedures understand what they are getting themselves into while doing our best to prevent any complications.
I perform ablations for atrial fibrillation and successfully convince most patients not to undergo the procedure. It is very difficult to adequately explain to patients the complexity of this procedure, the uncertainties regarding success and the myriad of complications that can occur.
I will recommend this website to every patient considering this procedure from now on.
I do not know Hugh Calkins personally. As pointed out, he is a well known figure. I do not defend his actions but I can say that he has been the most important person in bringing some reality to prior outrageous claims of success rates made by some centers. Between his call for more rigor in follow up to support claims of success rates, Dr. Cappato’s registry publications and this website, it is easier to give patients a more accurate picture of what to expect.
You write that Calkins “has been the most important person in bringing some reality to prior outrageous claims of success rates made by some centers.”
Calkins was also one of the persons making those very outrageous claims of success rates.
Early on, like when he was experimenting on people like my wife, he used to talk of ablation being the “cure” for AF. He famously claimed in 2003 that “Target the active pulmonary vein and the success rate jumps to 90 percent,”… “The procedure is ready for prime-time,” “Physicians and their patients should know about it.”
That’s before he figured out in 2005 that he had a success rate of 52% and a complication rate of 12%.
That’s when he started turning down the hype — after he mauled about 35 people.
And it was about time, too. But he was the first. The first to learn from his mistakes and talk about it at national meetings. Prior to that it was near impossible to talk patients down from their expectations. From my perspective, it was the patients that were pushing very hard to have this procedure done and seemed surprised when my vociferous warnings about the complexity and risk became apparent. Many patients hear what they want to hear and won’t listen to what they don’t want to hear.
“…Marketing has moved into the breach… New technology has sometimes led to big advances, which can justify extra costs. But often, technology spreads long before investigators know whether it is worthwhile.”
The technology is incredible. The issue is…again…are the results believable when its sponsored by a company…when there are major marketing and financial forces that are driving the technique.
This equipment becomes obsolete so fast…the costs are so high…again, I plead for data – not hype.
High technology has enamored all of us…it’s just got to be better – and some of it is…and some of it isn’t.
Cardiology may be the worst…everyone wants stents or procedures or the lastest and best. Unfortunately, when you critically look at the data, in the vast majority of patients, invasive interventions or bypass surgeries pale in comparison to old fashioned medical therapy – not always – but most of the time. It is a fascinating phenomena. I was hoping that health care reform would evolve so that evidence based medicine would become more the norm and less the exception.
This is a high risk procedure and even 1-2% mortality rate is expected from this procedure. If the doctors have to been taken to the court for every complication, no one will do the high-risk procedures. Certainly, these risk should be minimized at their best effort.
I do have sympathy for the family. However, on the other hand, I doubt that it is appropriate to post their names and photos in the internet. It is sort of an extreme action to get even with the doctors.
Dan:
As I was reading the local paper about the successful Thermocool AF trial (for interested readers see Journal of the American Medical Association 1/27/2010 on catheter ablation for patients with paroxysmal atrial fibrillation who have failed one anti-arrhythmic drug) in the Philadelphia Inquirer, I was saddened to see your comments below the article online. Have you resorted now to smear tactics based upon your personal tragedy?
It is laudable to tell your wife’s story to caution patients and families alike. Certainly to spend your time preventing others from being helped by a procedure (that overall does help alot of people despite an overall low percentage chance of serious risk) is reprehensible.
lynn makes wonderful points. again it is a tragic story that i cannot even imagine happening to my spouse.
regardless, informed consent discussion for AF ablation should be a lengthy discussion. When I undertake this discussion with patients (I am happy to give my bias as you do yours) it often occurs over many visits in the office and I encourage spouses and families to be present. I mention death, and the described serious complications as quoted in the literature and tell patients my serious complications as well. i also provide them the success rate in elimination of atrial fibrillation in my hands and in the published literature (being careful not to mention the word “cure”) which is approximately 70-80% for paroxysmal patients and 60-70% for persistent AF patients. I do mention that they may require more than one procedure to achieve success. i provide internet websites which present a balanced view of the procedure. many of my EP colleagues take a similar approach.
informed consent should always be given, and it is one of our most sacred jobs to provide this truthfully. not every physician does this unfortunately as evidenced by posts on your website.
however, as the medical literature has born out in the last 10 years, and will continue to do in the future as we perform larger and larger randomized trials on AF ablation, your cautionary tale will hopefully provide pause to all patients seeking ablation as a counterpoint to the clear benefits it provides to most.
providing a forum for patients and loved ones to cope with their complications as you do is commendable. to “put yourself out there” with such a personal tragedy is again laudable and I am not sure I would have the strength to do so. how you choose to prevent many patients who can be helped by this procedure is your First Amendment right. I cannot walk in your shoes and can only imagine that you view this as a way to prevent another tragedy such as your wife’s.
At a certain point though, you do harm people who can be helped by this procedure. You cannot escape that truth whether you agree or not. It will not help you or your wife cope with her tragedy, nor bring Lynn’s husband back. that is the sad truth.
Let’s look at the disclosure for the study:
Funding/Support: This study was funded by Biosense Webster, who provided the catheters used.
Financial Disclosures: Dr Wilber reported receiving grants from Biosense Webster, Boston Scientific, Medtronic, and St Jude Medical; consulting fees from Biosense Webster, Medtronic, and Sanofi-Aventis; honoraria from Biosense Webster, Boston Scientific, Medtronic, and St Jude Medical; and royalties from Blackwell/Futura. Dr Pappone reported receiving grants and consulting fees from St Jude Medical and Johnson & Johnson, and honorarium from Biosense Webster. Dr Neuzil reported receiving grants from Biosense Webster, Cardiofocus, Cyrocath Technologies, Hansen Medical, NIH BARI 2D, and St Jude Medical; consulting fees from Stereotaxis; and honorarium from Biosense Webster. Dr De Paola reported receiving a grant from Bristol-Myers Squibb. Dr Marchlinski reported receiving grants and honoraria from Biosense Webster, Boston Scientific, and St Jude Medical; consulting fees from Biosense Webster, Boston Scientific, GE Healthcare, Medtronic, and St Jude Medical; and speakers’ bureau fees from Biosense Webster. Dr Natale reported receiving grants from Biosense Webster and St Jude Medical, and speakers’ bureau fees from Biosense Webster, Boston Scientific, Medtronic, and St Jude Medical. Dr Macle reported receiving consulting fees and honorarium from Biosense Webster. Dr Daoud reported receiving consulting fees from BARD and Biosense Webster, and honorarium from Biosense Webster. Dr Calkins reported receiving consulting fees from Ablation Frontiers, Atricure, BARD, Biosense Webster, Boston Scientific, CryoCor, CyberHeart, Medtronic, ProRhythm, Sanofi-Aventis, and TASER International; a grant and honorarium from Biosense Webster; speakers’ bureau fees from Atricure, BARD, Biosense Webster, Boston Scientific, Medtronic, and Reliant; and fellowship fees from BARD, Boston Scientific, and Medtronic. Dr Hall reported receiving consulting fees from Biosense Webster. Dr Reddy reported receiving grants from Atritech, Boston Scientific, Biosense Webster, Cardiofocus, CryoCath Technologies, Endosense Hansen Medical, St Jude Medical, and Stereotaxis; consulting fees from Biosense Webster and St Jude Medical; and honoraria from Boston Scientific, Biosense Webster, Medtronic, and St Jude Medical. Dr Augello reported receiving honoraria from BARD, Biosense Webster, and St Jude Medical. Dr Reynolds reported receiving consulting fees from Biosense Webster, Cardiome Pharma Corp, and Sanofi-Aventis. Mr Vinekar and Ms Liu are employees of Biosense Webster. Drs S. Berry and D. Berry reported receiving consulting fees from Biosense Webster, Veridex LLC, Boston Scientific, Endologix, R.R. Bard, W.L. Gore, Medtronic, Bristol-Myers Squibb, Pfizer, and Teva Pharmaceuticals.
industry funding has always played a role in medical development. only now we have rules to at least disclose publicly industry funded support. i agree fully with this. the medicines and devices used in all medical specialties are largely developed by industry and their collaboration with physicians and nurses.
many of the life saving breakthroughs we take for granted (and some of your bloggers have probably benefited from)are as a result of the process you delineate above.
it is important for people to debate you, as it will only highlight both sides of the issue. as the crushing weight of positive evidence consumes more and more of your time, you will need others to help in your cause. you also probably know that we are currently undertaking the CABANA trial, a 3000 pt randomized NIH sponsored trial to demonstrate whether there is a lifesaving benefit to AF ablation over anti-arrhythmic drugs. Smaller single center trials as well as recent JAMA article on Thermocool AF have demonstrated the advantages of ablation in smaller pt populations.
your wife’s story speaks for itself and is very powerful. it certainly has changed how I talk to patients. taking your message off the blog though will be a tougher job. no one is going to give you a free ride…
jdh – I would tell everyone to run, as quickly as they can. Living with AF is so much better than the consequences can be. My husband is DEAD because we believed doctors who mislead us as to the safety of this procedure. If we had known the real risk, we might still have gone forward, but it would have been a truly informed decision. So, I find myself 48 years old and a widow because we believed the lofty promises that are not true.
Nobody is preventing anyone from having this procedure, but people need to be informed of the true statistics. The chance of major complications is much higher than is presented to the average patient. Please don’t insult with your assumption that there is some kind of smear campaign going on. People should have a healthy fear and do the research before they allow themselves to be led down this awful path.
Just for a moment imagine that your wife or husband has an issue that they can live with, but they are promised a cure. Then they are told that this is a relatively simple procedure with some risks, sure, but they are young and healthy and the risks are mostly associated with the anesthetic anyway. Who wouldn’t do it? If it meant they were cured? Now, imagine that that same person never comes home from the hospital and you are left wondering why you didn’t research this sooner? As hard as you try to imagine you’ll never get it and you should be grateful for that.
Lynn, So sorry for the tragic outcome on your husband.
I am catching up on my reading at this blog and would like to find out more about your story. Where do I go to find a more detailed account of what happened during your husband’s procedure?
If not available, perhaps you can share here or on afibbers.net under something like “ablation horror stories”
Researcher – thanks for the kind thoughts and words. I haven’t written an accounting, it’s still too raw and fresh for me. I will keep the website in mind and when I’m ready I might do that. I think the idea of having this and other sites that tell the truth about the statistics are vital for those considering it.
thanks for clarifying the purpose of your website.
to answer a question with a statement on “smear tactics”: show me reasonable examples that you provide of positive research data on AF ablation in your website. you provide a one-sided view. you must know (as you have done a significant amount of reading) and must acquiesce to the fact that there is a positive side here. you just choose to ignore it in your website. without some sort of balance you do a disservice to many. as you “advertise” your website after newspaper articles, you will need to prepare for more of this.
turning doctors damaging words on themselves is quite an effective tool. thankfully you are protected by malpractice law and awards and your effective writing must have helped your malpractice attorney win the case. but that doesn’t reverse or fix the permanent damage to your loved one.
because these are your “beliefs”, and certainly even if incorrect at times do not rise or meet the criteria for slander, you can continue with this. as the law on internet content leaves much ambiguity about false claims or character assassination as you conduct with Dr. Calkins, you are protected to do what you do. i get the feeling someday you may cross that line, which will be unfortunate. you are right to suspect that once people with resources are threatened enough, you will be bear the brunt of the monied interests. I neither agree with it as a liberal politically, or a physician professionally. But it probably will happen.
i provide help to patients who suffer from AF on a daily basis with a variety of options including lifestyle changes, medications, and yes catheter ablation.
i hope my patients read your website. most will come back to me for help after spending time navigating it….
“After the initial procedure, patients in the catheter ablation group were allowed up to 2 repeat ablation procedures within 80 days. At the discretion of the investigator, a previously ineffective drug could be continued during the effectiveness evaluation period.”
So the patients in the trial underwent up to three ablation procedures and could take anti-arrhythmic drugs? And this is s successful study?
this was the specified design of the trial. i’ll bet your website that this was part of the informed consent process for each and every patient in this trial and they were told that they may require more than one procedure(i consented a few myself). they all knowingly and willingly signed informed consent and the study physicians were practicing the standard of care.
when you analyze the kaplan meier curves in results section, demonstrating a 66% freedom from AF in the ablation arm, vs a 16% freedom from AF in the drug arm during 9 month effectiveness period, the results clearly favor ablation for patients with drug refractory PAF. these results cannot be extrapolated to persistent AF or patients with low ejection fraction. but for younger patients with symptomatic PAF who have failed one drug, this strategy clearly wins. at least the JAMA editors and most cardiologists and EP’s think so.
for those interested in taking an unbiased look for themselves please see JAMA 1/27/2010. also see the live AF ablation procedure on the Today Show from this morning at the Cleveland Clinic on NBC website. the more proper publicity for this procedure, the better.
Did you see that they never talked about the specific risks involved in the procedure. “oh, she’s completely awake and not in pain at all”. She will be “cured” after this zapping (she might have to come back, but then we’ll “fix” her for good).
Please understand I don’t mean to be flippant and I know that people have been helped, but they make things sound relatively risk free. (MY heart almost stopped when she talked about a video game).
My point all along is “informed consent” and doctors who tell the truth. It was somewhat comforting to see that the doctor didn’t stop what he was doing INSIDE that woman’s heart to talk to the reporter. What a stupid thing to do to sit next to him and distract him. Also, how would he react to a complication? Would he get up and go into the room with the actual patient or would someone else handle it? I’m sorry – I digress – you must understand how upsetting that segment was for me.
The only thing I got out of this is that it is a new “miracle cure” and it is sooooo safe and also it is now even easier for the doctor to hand off the controls to someone else – how would you ever know which doctor is working on you as they aren’t even in the same room?
You know, I’m sure that for this particular woman, cardiac ablation was a “miracle”. IF it works, she will be much better off and it will seem like she has been given a new lease on life. I get it…my husband would probably have been the same way. If he could have lived the life he wanted to; it would have been a dream. Instead; without informed consent, it is a nightmare. My only intent is to make sure that people know the TRUE risk involved. Don’t candy coat this or any other procedure. People are smart; they can take the truth. Arrogant doctors who believe we only need to hear what we can “handle” are just plain wrong. This procedure has a high complication rate – you might die or worse live out your days severely brain damaged from lack of oxygen – it might be worth it to you to take that risk, but understand it does happen.
Please jdh, the next time you walk into the cardiac cath lab, think about your patient – who are they? What are their hopes and dreams? They have value. You took on this profession with your eyes wide open and I hope they continue to stay open. Expect to be held accountable and stop making excuses for those who are not doing their patients justice.
JDH – Please do me a favor and stick to the topic…and not speculate on what I do or don’t do about cardiology and its attendant procedures. Don’t excuse your proclivity to do invasive procedures because you RATIONALIZE that I said patients for unnecessary invasive procedures.
Incidentally, I have (as mentioned to Dan on a number of occasions in private conversations) an equally jaundiced view about coronary interventions and stents for patients with chronic (not acute) coronary syndromes. Please don’t lump me with all of the other lemmings in cardiology. Indeed, I agree with you that there are far far too many coronary interventions…a whole different topic…maybe a whole different website – but nothing to do with ablation which is the purpose of this website.
You know NOTHING about how I practice medicine…and you are telling me what I do and who I send to the cath lab?!? Tell me something…where do you get your information about me – the same place that documents atrial fibrillation ablation statistics?!? How ignorant and arrogant of you.
I try to take care of my patients based on the best available information and a considered evaluation of the patients condition, age, comorbidities and any number of other factors that are individually appropriate. I don’t scan, echo, or test relentlessly. I evaluate each individual personally and I keep up with the literature.
Show me the data….long term data…because right now for atrial fibrillation, the best information for management of most (not all) atrial fibrillation patients can be derived from conclusions from AFFIRM!
I have seen surgery for atrial fibrillation…I watched Cox do some of his early work…never, would I subject a patient to that procedure – but don’t use that as a rational or justification that you should keep on ablating…right now, there is absolutely no long term data about the consequences of the procedure…yet I hear ads on the radio for several hospitals trolling for victims – all in the name of dollars. There are analogies here…I’ll try not to be blatant, pornographic or indiscreet…but maybe you should practice a bit of intense self-examination and not speculation about what I do in my practice of medicine.
i provided a short list below for you to check out, but i am sure you have read all of these articles anyway. i hope you feel better after your venting.
if you practice a rhythm control strategy as AFFIRM would suggest(although of course we can argue the substudies that demonstrate mortality benefit in patients who actually maintained SR), are all of your patients happy with this “strategy”?
jdh – your arrogance is amazing. This is what is wrong with the overall profession of cardiology. You are right no matter what – your view is the “right” way and there is no swaying you from your path. You have decided the literature is skewed, but because it is the best you have, you will follow it. You have decided to make a “game” out of having a discussion with someone who might disagree with your view of the world.
Tell me, jdh, how many patients have you sent to the cath lab for ablation who died because of it? Can you remember their names, what about their faces, what about the faces of their loved ones? I’m just curious if you keep those patients in your memory and learn from their loss or do you go back to the literature and start spouting the statistics, flawed as they are?
lynn
i am not right all the time, in fact i make mistakes and errors every day, just like you. and this is no game. we are arguing over a procedure that has ramifications (both bad and good) for tens of thousands of people. i think disagreement is good and have answered frank and dan with counterpoints which obviously have drawn strong reaction. it means that I am making a successful counterpoint here. most of my debators now call me arrogant. that’s ok.
i have not had a death during an ablation but i could go over each and every one (which is thankfully a small number) where a patient had a complication. i could tell you their each of their names, faces, (of course I won’t to protect privacy) and their spouses names. i can tell you what they do for a living, and how many kids they have. that isn’t anything special, that’s my job.
i faced their loved ones with empathy and compassion. i have and will continue to spend hours at their bedsides while they get better. your last paragraph couldn’t be farther from the truth. you or dan or frank can demonize me, but unfortunately, in real life I am one of the most compassionate, empathetic and skilled people you will come across. my patients will tell you that. my practice grows larger each day due to the skill and personal care I provide. i dont want or expect any gratitude or special treatment because of it, again it’s my job.
no one can fill the hole left by the death of your loved one during the ablation procedure. i don’t expect you or dan to ever ever agree with anything that I say. regardless, i feel empathy for your loss and for dan’s wife’s tragedy, whether you think I do or not.
i wish you the best lynn. i hope with each day your grief diminishes and you find peace. you and dan and frank should have the last word in the debate. as this is a website about medical negligence as dan would put it. it is not a website to discuss ideas on both sides of the fence here. that is clear.
i look forward to the book dan and to see how the story ends…..
Thank you jdh, I do appreciate the kind thoughts. It would appear that my grief and my anger are deep and it is true they are. I rarely am cruel, and after going back over my posts, I made generalizations about you that may or may not be true. If I’ve learned anything through this experience it is that I am quite capable of being cruel and have been on several occasions.
Peace will be a long time coming for me because both myself and my husband were lied to about this procedure. Because he was in such great physical shape (an athlete), we were led to believe that the only risks were from the anesthetic. This, of course, proved to be untrue as it appears that the catheter punched a hole in his heart. Then to compound the error, it wasn’t recognized soon enough and by the time they reacted, his brain was severely damaged. That is why the video with the doctor in another room altogether affected me so strongly. The doctors involved did not intend to injure anyone and, in fact, were trying to help, but without the truth, we did not make an “informed decision”. This is where my argument lies. I made a generalization that you lie to your patients and there is no way for me to know that – it was fueled by grief and anger and for that I am sorry.
Please do me a favor and don’t ever lose your humanity in a profession that sometimes causes one to do it.
For anyone thinking about having cardiac ablation – please research the risks – do not rely on your doctor to tell you everything. Be your own advocate and make an informed decision. Please do hold your loved ones tight and make sure your house is in order because the risks are there and they are real as I’m sure the rewards are.
JDH – I do think that industry supported studies are generally suspect with respect to devices especially – see recent “mess” in England about septal occlusion devices.
In general drug studies have had their results reviewed and tabulated by a blinded independent group…this is not the standard for devices.
I have not insulted you…I have not told you how to practice medicine…I have tried to give you an insight into how I practice medicine. I have told you that I disagree with the widespread use of an intervention that does not have long term data for safety and efficacy. If the studies are still being performed to assess these issues…how can this be considered anything but an experimental procedure? Why is ablation being used as a clinical tool at this point in time?
I thank you for the references…and yes, I have read them. I do not concur with your assessment that these results warrant the use of the technique in patients with atrial fibrillation.
We have a woman whose husband was killed by this procedure.
We have a man whose wife was terribly injured by the procedure.
We have a cardiologist who believes the procedure is unsafe and unproven.
We have a cardiologist who believes the procedure is safe and effective.
I want to know from you, JDH, what kind of complications you have seen, and how many?
I want to know if you have any conflicts of interest. I want to know if you have received any inducement or encouragement, backing or reward of any kind from the device industry.
I want to know if you truly believe that performing multiple invasive procedures – which carry a proven death rate of one in a thousand each time the procedure is performed – is safer for your patients than drug therapy.
How can you defend this industry sponsored study, which Hugh Calkins has said was doomed to fail because “it sort of guarantees that the drug arm’s not going to work.”
Why, exactly, are you so enamored of catheter ablation for atrial fibrillation?
dan
i have done approximately 500 AF ablations. i have had one tamponade which was drained during the procedure and patient discharged next day.
i have had one stroke with permanent arm motor deficit. patient is in sinus off coumadin although of little comfort to that person i am sure.
no significant groin complications from access, PV stenosis, AE fistula, MV damage or death etc.
i have not personally taken a dollar from device or ablation industry for consulting, speaking or research. i have participated in industry funded trials (like thermocool AF) as well as NIH sponsored trials at no personal financial gain.
i have no financial conflict of interest.
drug therapy is no free lunch. each drug has issues. if patient has coronary disease, and a class 1 drug is used, higher incidence of fatal MI and arrhtyhmias (see cast). if amiodarone used, toxic to most organs. if patient develops occult kidney disease possibly a 2-4% risk (which may be conservative estimate) of torsades de pointes which can be fatal on tikosyn and sotalol. many interactions with tikosyn and sotalol that may go unrecognized in our age of polypharmacy, and I can go on and on. in younger patients some studies suggest 25-50% patients (25% of the amiodarone pts in Affirm) had to stop the drug due to intolerance.
I have done 500 ablations. I keep a database on my patients and my success rate is approximately 80% for PAF and 70% with persistent’s from one procedure. i monitor patients with 30 day event monitor post ablation and 7 day monitor at 6 months, one year, and with symptoms. I have taken back ~10% to the lab for a second or third procedure.
I think my patient’s success rate is comparable to the better AF centers but I cannot compare myself to Natale, he is a world expert. I am not.
Certainly a small percentage of (about 25% of patients that I follow require AAD post ablation, and the goal of ablation is not primarily get patients off drug, it is to control AF) patients are still taking AAD’s post ablation. But if you ask them how life is without AF anymore, they will tell you it has given them a new life.
You have resorted to the above comments, it is truly sad that this is what you have devolved into in this debate. it speaks volumes about you. You can mock me or whatever you are trying to do with the above comment, but in the end it becomes pointless to debate the above nonsense.
I agree with Dan you must have a gift! You should publish those results. Your results are beyond compare. No one in any journal, in any series has published results as fantastic as yours. Your complication results are better than any other reported series. You should be teaching this technique down at Hopkins, or Penn, or Harvard. You should report this at the upcoming ACC – why don’t you do an abstract or poster?
I am a practicing cardiologist who did electrophysiology training. Your story is honest, true and a very apt and telling description of a horror story. I do believe that the entire concept of atrial fibrillation…indeed of catheter ablation of most (not all) cardiac structures is frought with danger and quite honestly should not be performed except under the most dire of circumstances. I can’t defend the medical community’s blatent advertising of the technique on television, radio, and news articles.
It is reprehensible that dishonest statistics and assurances are made to the general public. I truly believe that an audit of Dr. Calkin’s statistics for success – I mean permanent, long-term success of the technique should be insisted upon. This data needs to be available for Hopkins and for all hospitals in our country. There is absolutely no chance that any ablation technique (for the atria or the ventricle) is capable of the success rates that are being described over the long term.
Please keep up the story – if you wish someone to review or comment on additional pieces of information, please feel free to contact me.
It is interesting to see your reply here because my husband died during an ablation procedure in October. He was perfectly healthy, but had atrial fibrillation and hated taking the medication. We were led to believe the statistics surrounding the procedure (this was NOT done at Hopkins). So, at 53 he drove himself to the hospital and his heart stopped during the procedure. They brought him back (with mixed messages as to how long he was “down”), but he was dramatically brain damaged and died 8 days later. After extensive research between October and now I can see that the statistical information is seriously flawed. These procedures are not as “safe” as patients are led to believe and the complications can be extremely serious including death. The comments below that reflect “hey, mistakes get made” wouldn’t be made if one of their own family had actually died during this “relatively minor – safe procedure”.
I believe that if an audit was performed of all patients who were treated with ablation alone (no additional medications) and followed over a 5 year period of time – the rate of recurrence of the arrhythmia would be 70-75% (failure rate)! These centers that are advertising a cure are selling snake oil. Dr. Calkins sold and bottled the snake oil in Baltimore…and he is trying to sell it nationally as well.
frank, as a practicing cardiologist, do you prescribe anti-arrhythmic medications? what are their long term successes in controlling AF?
are there downsides to AAD therapy, even fatal side effects? (for the laymen see CAST trial) is there literature out there to suggest that ablation may actually be better then AAD therapy in smaller trials? what does Affirm trial and other trials tell us about long term mortality in patients with AF?
I didn’t train or practice at Hopkins. certainly there is some “snake oil” peddled out there about ablation procedures by some, but certainly not the majority. unfortunately your snake oil is just as slick. there are many alternatives to catheter ablation. leave patients in AF and live with the symptoms, try drugs, insert a pacemaker, or surgical ablation. let the data decide. the day catheter ablation loses out, I will happily move on to a better alternative.
Review the latest article in JAMA and tell me that this was an honest comparison of the technique/therapy. Let’s be honest here!@!
Clearly the patient population with atrial fibrillation is a very diverse group of patients…I really think that it is impossible to “lump” all patients with AF into a group study looking at any intervention. Clearly there are groups that are at high risk for complications from AAD and patients that are at extremely low risk. I’m not trying to promote anything-I’m asking for long term data for CURES at a reasonable interval of time from the start of an intervention.
How can you accuse me of snake oil? – I’m not selling anything…I’m not promoting anything…I want clear data that shows that I should or should not recommend a specific therapy. Should I subject a patient to an invasive 4 hour procedure that has a 25% or 50% chance of long term success. Finally, of the patients that are “cured” – how many are on some drug – supposedly the drugs that the procedure is designed to eliminate?
You give me that data – and I will raise the white flag – It isn’t available…no one reports it! Please tell me I’m wrong – I’m not stubborn – I’m not bullheaded – I just want honest, non-tainted data that is not supported by drug companies or by device or catheter companies.
you send patients for invasive heart catheterizations to treat angina I’m sure every day, so you can’t have it both ways. stents treat symptoms in patients with angina and have questionable if any mortality benefit in the long run except for acute MI pts. cath procedure has similar if not greater risks. what is the long term chance of success of not needing another stenting procedure in patients in real life?
they are analogous issues, one is a plumbing problem and one is an electrical problem, both medical problems can have dire consequences if left untreated. there are procedures to treat both that can help but some patients require medications in the long term to help control the problem.
i’ll attach a list of articles for you to peruse when i get the time in the next few weeks. you can decide for yourself. to communicate your belief that there is 25-50% long term success rate for AF ablation suggests that the articles i send will help improve your education on the matter….
i’m not here to sell ablation. but realistically it is another option for people that didn’t exist 15 yrs ago. surgical ablation has been done for a little over 20 yrs in the mainstream and when you actually read those articles (like the original Cox3-Maze paper in Journal of Thoracic and CV Surgery Damiano et al 2003) the percentage of complications and how they measured success if horrific.
and to answer your question on not including amiodarone in Thermocool AF trial, i would argue two points, long term success of any drug in pts who have failed on one drug is 20-30% in the literature. Even amiodarone as an initial strategy at best has been 50-66% success at one year in the literature. Using that drug in young patients has long term effects as you know. If you start all your 50 yo patients on it, alot will have thyroid or liver issues or show up with stiff lungs in their 60′s or 70′s, so realistically not a viable long term strategy. for dronedarone, still can’t use in HF patients, and probably a little less effective but better tolerated than amio without the long term side effects (we think!). once the pill comes out that it equivalent efficacy to ablation without the side effects, I am happy to stop ablating AF….
a list for frank:
to save typing we’ll include a short list of the citations from Thermocool AF trial (JAMA 1/27) as they provide an adequate summary:
citations 2-4 summarize long term effects of AF longitudinally
citation 10, calkins et al, expert consensus on catheter and surgical ablation
citations 13, 15, 16 trials comparing AAD vs ablation (Wazni et al, Pappone et al, Jais et al)
citation 24 circ 2005 worldwide survey on AF abl, second worldwide survey data presented at Af symposium 2009
f/u studies on success of ablation:
citation 28, pappone et al Heart Rhythm 2008, 5 yr f/u study on PAF pts
not in citations but another article on late recurrence:
Mainigi et al JCE 18(1) 2006 69-74
Thermocool AF trial JAMA 1/27/2010
And to hopefully further answer unanswered questions is CABANA which is currently enrolling 3000 pts, NIH sponsored trial
So a building body of literature over the last 5-6 years showing efficacy. Some industry funded and some not.
The industry funding issue is tricky, because if these studies are tainted, should we believe that the industry funded statin trials are tainted as well? i prescribe statins every day as i am sure you do. just because zocor(4S) lipitor and crestor trials(Miracl, Jupiter) have some industry backing doesn’t mean we ignore the results, just as you cannot ignore and must heed this growing body of literature.
I am sorry about what has happened to your wife. However, every doctor has made some mistakes and there is not a single one who has never had any complication during his/her career. I am sorry your wife has been so unlucky but nobody wanted to hurt her. I am really looking forward to the end of story. Martin
From: Mary Gall [mailto:marygall@dhmh.state.md.us]
Sent: Friday, November 13, 2009 9:24 AM
To: nmurphy@cminc.com
Subject: Re: Complaint MD00046402 2of 3
Hello Mr. Murphy,
I have received your three emails. Thank you for the information. As we discussed, the investigation is underway, and I will apprise you of my findings within the 45 day period we discussed.
There is no time limit on filling a complaint, so I encourage people to help future patients by letting others know to consider avoiding Johns Hopkins. And NEVER stay overnight, especially on the floor called Nelson 6.
Outstanding piece of living medical history! I had been considering this same procedure to cure my atrial fibrillation! My first cardiologist Dr Perla whom I went to while living in the Syracuse area once told me that; “anything we give you is only a patch job and that the parts you’re born with are usually much better than anything we can gave you, we are only human. “Unfortunately, we are not perfect; doctors are not perfect and hospitals are not perfect. They are subject to the same flaws and weaknesses as every other human being and institution. Thanks you for your honesty and bravery; just be careful not to get arrested for exercising your first amendment right to free speech…
I am a heart attack survivor who last year was misdiagnosed with acid reflux and sent home from the E.R. despite presenting with textbook symptoms like crushing chest pain, nausea, sweating and pain radiating down my left arm.
Two weeks of increasingly debilitating symptoms later – but hey! at least I knew it wasn’t my heart! – I finally returned to the E.R. but this time to a revised diagnosis of “significant heart disease” and a 99% blockage in my left anterior descending artery.
I was told that I was very lucky to have survived those two weeks, but because a man with the letters M.D. after his name had told me quite emphatically that my symptoms were NOT cardiac, I was too willing to trust his judgement.
Bad doctoring – or bad diagnostics? All my cardiac tests (cardiac enzymes, EKG, treadmill stress test) had come back “normal”. Given that, until recently, most cardiac research over the past three decades has been done either exclusively on male subjects, or with females represented in statistically insignificant numbers, these “normal” test results leading to often-fatal misdiagnoses are tragically common.
We know that women are under-diagnosed with heart disease – and even when accurately diagnosed, are under-treated compared to their male counterparts.
Women (especially younger women) with heart disease are much more likely than men to be misdiagnosed. Research on cardiac misdiagnoses reported in the New England Journal of Medicine looked at more than 10,000 patients (48% women) who went to their hospital Emergency Rooms with chest pain or other heart attack symptoms. Investigators found that one in every 50 people who had suffered a heart attack was misdiagnosed and sent home from hospital.
But women younger than 55 were seven times more likely to be misdiagnosed than men of the same age. The consequences of this were enormous: being sent away from the hospital doubled the chances of dying.
In 2005, the American Heart Association surveyed U.S. physicians to determine how many knew that heart disease kills more women each year than men. Only 8% of primary care (family)doctors were aware of this fact. Even more appalling, however: only 17% of cardiologists knew this. CARDIOLOGISTS! This is their business. It is all they do. HOw is it possible that they did not know this important fact?
Dan, Thanks for your comment on http://www.MDWhistleblower.blogspot.com.
Yes, I’m okay with suing ‘bad faith’ MD. The point I wanted to raise in the post is that physicians who have done everything right are routinely ensnared in the legal system, where we can dangle for months or years until we are (hopefully) cut loose. I think that many of the reasons for providing some occupations with immunity, could apply to us as well.
Dan, I am a recent grad jumping into the medical field with eyes wide open. I am a radiological technologist working in a cath lab/ep lab in southern california. I enjoy my job very much and enjoy the ability/opportunity to help others.
First I would like to address LRR’s comment about the mitral valve not being torn out. I don’t understand how he can argue. It is clearly seen on the TEE. I am not an ultrasound technologist and can’t positively interpret the images…they kind of speak for themselves. The valve while still in place and still operating, appear to be critically damaged!
My second point is more touchy. First please allow me to express my greatest regard and best of wishes for your wife, you, and all of your family. I have to disagree with your overall criticism of “trainees”. Everyone starts somewhere, and by the time any “trainee” flies solo they have undergone many years of training. They didn’t just walk in off the street. Even myself, after four years of schooling, one of those spent 100% in clinical rotations and 6 months of working for my hospital have yet to scrub in with the doctor by myself. And my only job in the procedure is to hand off the catheters! I am not taking away from the fact that you should be FULLY aware of ALL physicians AND “trainees” in the room during the procedure.
This is getting long winded and I apologize. One last point is that Ablation procedures are successful. They do have a high recurrent rate, I have read studies varying from 35% to 60% recurrency rates. But even if you take the high side at 60, I believe the value of coming of warfarin, or coumadin are very well worth the recurrency rate! Blood thiners are not…NOT…something to be on. They definately place your body at a limited capability. Preventing your body from clotting is like playing Russian Roulette!
Dan I could go on for ever. I am deeply invested in this topic and I would probably bore you over time.
Your wife experienced numerous failures of the medical system. I believe the horrendous parts surround the procedure…not the procedure itseld. Dr. C’s failure to communicate with you, his failure to inform you of others involvement, and his audacity at ‘showing up for the burn’ show a doctor who has clearly lost sight of the forest for the trees. Also, finding a hemostat under your wife after RT also shows lack of pt care. I believe it’s these things that make the safe and effective stay.
The other important thing I wanted to promise you Dan, as well as everyone else reading this article, is that I promise to uphold your loved ones as my own. I enjoy the opportunity given to me every day to help heal our patients. Nothing is more satisfying that answering a midnight page and rushing to the hospital and saving someone from an MI. I recognize the importance of patient safety, patient care, and patient/family communication and promise to uphold the highest standards in these regards.
My brother-in-law was killed in a local hospital a year ago. He was admitted with pancreatitis and put in a double occupancy room. He was out of his head in a matter of a few days as the sepsis had invaded his whole body while nobody watched. He was left dirty in his bed, unable to communicate properly, and severely congested. The doctor kept saying he had dementia and COPD which I can attest to that he never had. We talked on a regular basis. He was sent home after two weeks of hell in critical condition. After two days an ambulance was summoned and bypassed the hospital that had released him in critical condition. The second hospital took immediately to ICU and was astonished that he had been released to go home by the first slaughter house. He was found to have MIRSA in his lungs and it was too late to do anything for him other than make him comfortable. I am still in shock at losing a vibrant, healthy brother-in-law.
There are many horror stories and this is just one of them. I myself have had some very bad experiences but for the grace of God, I’m still alive. We for the most part, live in spite of the doctors. A degree in medicine, a God does not make.
Good grief. The valve was not torn out. You don’t know if the catheter would have gone where it went if Dr. C was driving. An anatomical predisposition would not necessarily have shown up on echo.
You get dealt a bad hand, despite the best intentions of a highly competent group of doctors. Collect your settlement and move on with your lives. Play the hand you’ve got now and don’t worry about what might have been.
I am done with your wheedling.
By the way, your repeated statements that Dr. C committed malpractice open you up to legal liability. If a trial finds that HE did not commit malpractice, then your statements are libelous. You could pay a financial cost. That would be irony.
*Is there another way to print the man’s name? It is Hugh G. Calkins, MD
*Hugh Calkins told us that HE would be performing the procedure, so yes, that’s what we thought was going to be the case.
*According to a pre-procedure echo performed by Hugh Calkins, there is nothing out of the ordinary about my wife’s cardiovascular anatomy.
* If she was “destined to have her chest cracked” as soon as the catheter got tangled in the mitral valve, then why didn’t they take her to surgery and untangle the catheter from the valve? That way, she would not have a prosthetic mitral valve and be dependent on warfarin for the rest of her life.
*”He told you the part of the procedure for which he’d be there. You just didn’t listen.” How do you know? I was there. He said HE would be doing the procedure.
*I doubt that if Dr. Calkins were driving the catheter that he would have snaked the catheter into the left ventricle. Which is what happened.
Go back an reread it – not in the defensive posture of a medical person – but through the eyes of a patient who trusted her doctor.
> Would you say that continuing with the ablation
> procedure on a patient who is in congestive heart
> failure secondary to having her mitral valve torn out
> is “medically the right thing?”
See, this is what I mean. Her valve wasn’t “torn out.” When you’re that willfully inaccurate it makes it hard to take you seriously.
Also realize, as Hippocrates did 2500 years ago, that judgment is difficult. I don’t know if the decision to proceed was right or wrong, and neither do you, because we weren’t there, and because Dr. C did not have the perfect knowledge of the future that you do. I doubt Dr. C is a stupid man or a evil man, despite your cartoonish portrayal of him.
Your wife was in a world of hurt as soon as the chordae became entangled. She was destined to have her chest cracked at that point. You have no idea whether the same thing would have happened if Dr. C had been driving the catheter. Perhaps there is something about your wife’s cardiovascular anatomy that predisposed her to this complication.
You also don’t address the point that having the trainee perform part of the procedure is (I presume) standard operating procedure in every case at Hopkins. Your suppose that someone looked at her and said “Hey, she’s trailer trash, let Dr. Killwoman do the procedure.” If she were the Queen of Denmark, yeah, Dr. C probably would have done the whole procedure, but that’s a silly point to argue. He told you the part of the procedure for which he’d be there. You just didn’t listen.
And by the way, nice job on search engine optimization techniques by always spelling Dr. C’s name in full. Vendetta, no?
Example 1:”Physicians would love to stop prescribing warfarin, but there is nothing better.” My wife would love to be able to stop taking warfarin, but she can’t. This is relevant because her need to take it is the direct result of a doctor’s malpractice.
Example 2: “You complain about getting consent from your wife while she is critically ill. What’s the alternative?”
If you re-read that section you will see that I am commenting on the irony of waiting for her to wake up from a procedure in which she nearly died because of a lack of informed consent — so that they can obtain informed consent for a procedure for which there is no alternative.
Again, this is the direct result of malpractice on the part of Hugh G. Calkins, MD.
“… at every step people were medically trying to do the right thing, and trying very hard.” Wrong. If at the first step, Hugh G. Calkins had performed the procedure, as we were led to believe, instead of letting a trainee preform the most dangerous part of a high risk procedure, this would not have happened.
Would you say that continuing with the ablation procedure on a patient who is in congestive heart failure secondary to having her mitral valve torn out is “medically the right thing?”
You’re outraged, and you let it show, but it damages your credibility as an accurate observer. Example 1: you act as if warfarin being used as rat poison is somehow relevant — it is not. Physicians would love to stop prescribing warfarin, but there is nothing better. Example 2: You complain about getting consent from your wife while she is critically ill. What’s the alternative? She’s going into emergency surgery because nothing else is going to stop her from being critically ill. One does the best one can under the circumstances.
So, as a result of things like this, I’m not ready to trust what you say, and stopped reading after awhile. I think one reason you are so mad is that you apparently went to a TEACHING hospital (of your own free will) and apparently did not ask what the TEACHING bounds were for your wife. You guys have been around. Kind of an obvious question, no? I think part of your rage is guilt.
It was a horrendous outcome, no question about that. But understand that at every step people were medically trying to do the right thing, and trying very hard.
A surgeon with a very high complication rate at Johns Hopkins?
From all the research that I’ve done, it seems that the specialists are good enough at their jobs, but when they slip your case to a trainee — or once the surgery is over and you get thrown into the general population for recovery, that’s when the trouble starts.
This is very unfortunate to read. I now know which hospital I should avoid if I ever have to go to one in the future. Thank you for sharing this story.
I recently became an RN, but have also had family in the hospital a lot recently. I have had the experiences of previous posters who have had their input disregarded by healthcare professionals, have been treated with annoyance for asking questions, and have been given inaccurate or poor explanations. I did have some healthcare professionals who listened and treated my family and I with respect, but that was more the exception than the rule.
Unfortunately the situation of doctors admitting errors is not an easy change since it is embedded in the culture. In an ethics class I took, I read Errors in Medicine: Nurturing Truthfulness by Francoise Baylis which calls for the entire profession of medical doctors to work toward acknowledging errors. Baylis also points out barriers to this goal. I thought you would find other advocates of your cause encouraging. Also, The Jewish Chronic Disease Hospital Case by John D. Arras directly addresses the ethical issues surrounding informed consent that you have raised.
There are also many other writings I found valuable that pertain to healthcare in Ethical Issues In Modern Medicine: Contemporary Readings In Bioethics (7th ed.) edited by Steinbock, Arras, and London.
In order to work toward error disclosure, I think that it will take both leaders in the medical profession working collectively and the public to support a mechanism for acknowledging errors appropriately. There will be the whole spectrum of errors from minor to egregious and so the consequences will also need to be on a continuum. Additionally, it seems stricter requirements are needed for informed consent for new and/or experimental treatments which would require the number of total treatments performed (with a comparison of the number of alternative treatments performed), the success rate (with a comparison of the success rate of alternative treatments), rate of complications (with a comparison of the rate of complications for alternative treatments), and an opposing view from a medical professional detailing disadvantages in relation to the alternative treatment. This information should be in bold at the top of the informed consent. Also, proponents of new and/or experimental treatments should not be allowed to tell patients and family experimental treatments are a cure or possibly a cure. Doctors should clearly state that at this point it is unknown if the treatment has the potential to cure and it is not fully tested. Using the same statements for new/experimental treatments and robustly tested treatments backed by evidence is misleading. The two must be clearly distinct from one another. Just as when I was in nursing school it was against the law for me to claim I was an RN, it should be against the law for new/experimental treatments to be discussed with patients as if they are well-tested treatments.
I had this same discussion with an ethics classmate regarding experimental cancer treatments. Doctors told many women with breast cancer they might benefit from HDC-ABMT, but patients are also told that they might benefit from standard chemotherapy which has solid evidence behind it. The difference is that in experimental treatments we do not know whether the treatment even has the to potential to cure. With standard effective treatments, there is a defined probability of getting cured. This distinction tends to be muddled time and again. The essay Bone Marrow Transplants For Advanced Breast Cancer: The Story Of Christine DeMeurers by Alex John London from the ethics book catalyzed my discussion with my classmate.
My heart goes out to your wife. Many stand with you in your call for better informed consent and stricter regulation of new/experimental treatments.
Your wife was an unfortunate statistic and I’m sorry it happened. The surgeon in question has helped too many people live better longer lives to have his career negated because of this one incident. He won’t lose his license because of it. The sooner you realize that the sooner you can get on with you lives.
If your goal really were to help prevent this from happening again you’d devote your energy to continued research.
I don’t have to be in the medical field to disagree with such a lopsided discussion. No defense and no independent 3rd party review.
So what do you want? Money.
Or the surgeon should have his license revoked? At the cost of innumerable other people that will be saved? Slander his name like this becuase your wife was a statistic. That’s a slap to the hundreds of other people people he’s helped.
I guess the real question will be; can you prove that your wife wasn’t more than a statistical complication? Have any experts in the field come to your defense? Or are you just going to say “they’ll protect themselves no matter what”
I see that you are quite critical of this doctor. Have you interviewed the hudreds if not thousands of patients lives he’s improved, or just your wife?
I assume that your are a medical person. Maybe you should go back and read it with a less defensive posture.
I don’t care how many thousands of other people the Doc has no doubt helped. I care about what he did to my wife, about how he almost killed her and how he lied to us about it from the beginning.
These are Dr. Calkins’ words – not mine or anyone else’s: “the safety and efficacy of pulmonary vein isolation was unknown then and it is unknown now,” it is “a high risk procedure,” and “associated with a risk of serious complications,” and “anyone who is doing this procedure realizes there is a learning curve and the learning curve is very rocky as you go up on it and the complications are like no other procedure that’s ever been done in an EP lab… We don’t know where this procedure is going. It’s evolving rapidly, a procedure with high risks that’s in evolution.”
He made that statement the year AFTER he handed off the procedure to a trainee without our knowledge.
That’s more than “just a statistical complication.”
That’s arrogance and deceit and betrayal of a patient’s trust.
I am so sorry for your wife’s suffering. I have a comparable story I will write a blog or book about as soon as my lawsuit is settled. I was diagnosed with a sigmoidocele (descent of sigmoid colon into recto vaginal septum) supposedly hindering my ability to move my bowels efficiently. I was told at 3 top hospitals I needed my sigmoid colon removed. Incomplete rectal emptying was taking too much time in the morning even with a laxative. I had my sigmoid removed. The docs I went to then did 3 unconsented procedures and 4 addtiional ones that they TOLD me I needed (which I did not.) As a result of this overly invasive surgery, I lost the function of my rectum, pelvic floor muscles, and my colon. My bladder function has also been damaged. I developed a severe narrowing of my colon at the area where the top of the rectum was attached to my descending colon. It narrowed in to a 3 millimeter diameter and the surgeon did not address it nor did he refer me on for help. I also developed small bowel obstructions and was unable to eat for 7 months due to 2 loops of small intestine that had been trapped in concrete like scar tissue. After 7 months of treatments and evals at 7 top major medical centers, only 1 doctor was willing to step over the political boundaries and do what needed to be done to save my life. My weight had dropped to 99 lbs from 125 because I was unable to eat or move stool through the damaged colon and rectum. This one doc had to lyse severe adhesions off of my distal ileum and create a permanent ileostomy. I now pass waste into a bag from my small intestine but am lucky to be doing so. I still face risk of small bowel adhesion obstruction but thankfully have been OK since the lysis and ileostomy. The worst part of this whole thing is upon medical review of my case, I did not have a sigmoidocele in the first place. The RESIDENT who read my defecogram mistook a look of small intestine (an enterocele) for a loop of sigmoid colon (sigmoidocele.) The loop of small intestine that descended temporarily into the space between the top of my rectum and top of my vagina did not hinder rectal emptying. All I really had was a rectocele which could have been fixed vaginally. I was healthy otherwise. Lost my professional career. Am on borrowed time. Because I was so severely scarred internally, if I get another adhesion reobstruction I will likely die as they can’t keep going in again to free more bowel loops because each time they do, more scar tissue can form. I have been traveling a lot and learning what is important in life: family, friends, sunsets, travel, pets, relaxation and so on. As a child I always worried about getting some awful disease. Instead, my death may ultimately be caused by the misread of a scan by a resident unchecked by her supervisor, the surgery performed based on that erroneous scan report, then multi-procedures performed (for the money) that were unconsented and non-indicated. My advise to anyone, never have elective surgery. Only what you have to have to save your life. Even then, I say “Good luck.” Sincerely, Evelyn
Great work, Dan!
Johns Hopkins should be shut down and “Bad Huey” should be arrested and cuffed.
I hope you will sue them for big bucks. You and your wife deserve that as a minimum.
I had an ablation at U.Pa and the night before the procedure, two swarthy looking characters from Bagdad or Teheran came into my room and shoved a paper in front of me and yelled “Sign It”.
I will NEVER go to a teaching hospital again.
I learned from my mistake and traveled to the Cleveland Clinic where my treatment was superb. Dr Schweikert performed 2 ablations and each one of them put me in NSR for 3 years. I cannot praise him enough. His supervisor was the famous Andrea Natale. I don’t think that “Bad Huey” had anyone to teach him.
By the way, you have Hans Larsen’s website linked to your site. Maybe you should remove the link since I posted your marvelous website on Larsen’s message board and within 2 hours he had removed it.
Best wishes to you and your long-suffering wife.
Henry
This was painful to read in that I am also working on a book about the murder (and that’s what is was) of my mother at the hands of an ER attending and 3 residents.
We definitely need a better way to communicate in the hospital and track the patients.
Also, while a resident is a doctor, they so enjoy passing themselves off as “the doctor”. In our case, the result was 75 days of intractable pain and suffering and then death. None of which was necessary if they had listened.
By the way….did you know they will lie under oath?
Amazing.
I’m sorry to hear what happened with your wife’s surgery. I understand the frustration with coming across medical error. My dad died of brain cancer and at one point one major medical center had found a mass in the brain that another major medical center missed.
Despite my own medical needs, I have thus far refused to see doctors at the institution that made the error. However, there are many errors that have been made at the one I trust. It’s simply too painful to visit the other one, despite the fact that there are very many good doctors and treatments being performed there.
The blatant truth is that every hospital experiences medical errors. Some are true mistakes, some are negligent. It happens everywhere.
If I read correctly, and this happened 7 years ago, I would hope for your sake that this would turn into something positive – like giving advice on choosing doctors or how to be your own health care coordinator.
I know these things can change lives forever. Some of the things you said concern me for your own emotional health. Some of them sound like Post Traumatic Stress Disorder, which would be understandable considering the circumstances. I do hope that you can find solace.
How important are the voices of those who have been there. The medical community at large failed my daughter fourteen years. When the true identity
of her illness/condition was finally revealed, we were lead astray once again.
Promised by one surgeon that she would be well after her surgery, only to find her in worse condition only two days later. Promised again (by same surgeon) she would be “better” if we allowed her to be injected (monthly) with an expensive drug that would alleviate her “symptoms.” (Later the drug company came under fire for giving doctors expensive gifts-vacations-in return for their commitment to persuade ailing women to take the drug).
Promised later by another surgeon that HE was the answer to our daughter’s pain. We spent hours on the phone with him, sent cash-in-advance, as he is a highly acclaimed surgeon who has patients fly in from all over the world, thus he needs a portion of his money “up-front,” only to realize while my daughter is IN surgery with him that he had lied to us and was not providing the critical component of surgery that we were adamant, and promised: a bowel surgeon.
This lie, this surgery, once again, left my daughter in increased pain. Yet this time her pain was completely intolerable. After suffering over a month, she finally said: “Mom, let’s stop praying for an answer…let’s pray God will take me.”
Thankfully, we persevered. A third USA surgeon finally gave us the truth: “she can’t be helped in the USA, take her to Europe”. We did. After a mere 4-hour surgery by a brilliant surgeon and a unique method of surgery, she became totally and completely whole!
But, rest not your heart; our saga was only beginning. My blissful, ecstatic
exuberance to help others who suffer from this same (hushed) medical condition came at a cost: I am now slandered to smithereens by a so-termed internet “group” who wish to discredit the doctor who literally saved our daughter’s life. Since our story tells of this doctor, I am defamed and cyber-bullied by “professional” men who are determined to keep a stronghold on this lucrative malady of American medicine. Those men remain safely hidden behind the skirts of women who have nothing to lose; thus they do their evil bidding.
These men have managed to monopolize this illness, killing the threat of competition by character assassination of any person who dare share a story of hope and answer.
To all who find themselves in similar situations, I say: press on.
I read every word…couldn’t stop reading about your very unfortunately experience. Am telling all my nurse and Dr friends about this one. JH should be so ashamed and be doing every thing possible to rectify any/all mistakes. Scary!!!!!! My husband had an ablation by an EP in Green Bay in 2001..to date he has had no further spells of fib…but the arrhythmia continues….he takes warfarin . It prevents strokes when your rhythms are irregular…safer than lots of modern meds they have for heart arrhythmias, don’t think of it as rat poison in such little doses and regular monitering) You can die from too much salt…and you need a little.
I laughed to read the name of the Face book group..Be Kind to Nurses, We Keep Drs From Accidentally Killing You ! It isn’t funny but very true as any old nurse will tell you. As a nurse (now retired).. I have saved many patients from inattentive doctors….yes they are busy, yes they are tired etc etc…no excuses. Nurses are tired and overworked too and go home to families and more work.. Don’t accept any of their whining about overwork. That is not professional behavior. If you take the job you are obigated to be responsible for all your actions( and if you can’t you should refuse to work , demand more help, protest whatever) but never endanger your patients!!! Nurses were taught that. We took oaths to do that…don’t Drs do that? They should lose their license if the things you say are true..and the hospital should be checked out too and reprimanded like nursing homes are when patients don’t get good care. Professionals all should know their limits and fight for their patients, clients etc. No excuses !!! Medicine is serious business…..no place for coverups…excuses…you need a good lawyer !!!
Here is an aside for any who read this and have atrial fib….. I spent days after my husbands ablation surfing the web for better answers for atrial fib triggers etc…and found some that have worked for him. It is not easy to find but there is alot of research literature on magnesium and calcium levels and heart arrhythmias…. an amazing amount to be found and ongoing all over the world. We printed out reams and his Dr helped us get these ratios right. He has taken these supplements in a carefully balanced ratio daily and there have been no incidents for nearly 8 years.
Please write on your blog and tell us how your wife is doing now…..wishing you both some happy days your deserve all things good.
I do a lot of writing and think your style is good….the truth is what people want….don’t stretch it or candy coat it for anyone. If you are thinking of publishing this story…I would not put in the stories of the other peoples problems with jH as it changes the flow…maybe another article with multiple shorter stories. Wishing you all the success possible to get justice. It is tough work to fight the “big guys”……. I am reminded of a Tshirt one of my sons frequently wore as a college student that read…Subvert the Dominant Paradigm. He is still doing that in his field of forest research. We have a duty to challenge all the “big organizations” whoever they are. You have a cause that is worthy…..stay strong. There really are good lawyers out there and I hope you find the best one. One of my daughters is a lawyer and is fighting for parents who lose babies due to defective baby equiptment made often by top companies and I am so proud of her…the facts in these cases is just heart breaking too…it disturbs her sleep often. But it is noble work to fight the ‘giants’ for all the other people who could be hurt if you do nothing. Best wishes to both of you…. Chris
As an attending electrophysiologist, your story hits home.
Your wife’s story and your blog about the experience is truly captivating and I have learned alot from reading it. Thank you for sharing it.
After 4 years of medical school, 4 years of internal medicine, and 4 years of cardiology training, (including 2 years of an electrophysiology fellowship) at “one of the top ten best hospitals’; I agree that communication often needs to be improved at teaching hospitals (and community hospitals too) and a realistic picture of a procedure needs to be given.
After having finished two Afib ablations today in two highly symtomatic patients who are doing well post procedure, and after seeing a half dozen patients in the office yesterday who are truly better for the procedure, I think it is important to say that the procedure does indeed work in a majority of(but not all) patients. I am open and honest about this up front.
The catheter based procedure also compares quite favorably to surgical ablation (you might be curious how “success” is defined in both the EP and surgical literature from the “early days”, including data on the COX Maze and other subsequent iterations of the MAZE procedure. often a phone call to a patient who said they were in sinus rhythm or a snapshot ECG of that same rhythm defined success. Now evidence based literature is more rigorous and requires more monitoring for a longer period of time to define success. I have done about a dozen catheter based ablations in patients with recurrent arrhythmias who have had prior MAZE procedure so it happens both ways.
Two balanced articles on the worldwide experience of catheter based ablation of afib are published or on their way: Cappato et al Circulation, 2005; and a follow up survey on the the current worldwide experience by Cappato which I believe is in press.
The procedure does have risks and despite my reasonable experience I never stop worrying about the “bad things” that might happen until the patient is safely through the procedure and is on there way home. For many of us who give our lives to this job, which often comes at the expense of our loved one’s lives, our worst fears come to light when something so tragic as what happened to your wife happens.
Thanks for taking the time to post. I’m glad you brought up how the standards for success are ever changing. I hadn’t thought about that. Also, thanks for pointing out that the ablation procedure sometimes works for patients when Maze procedures don’t. I also appreciate the reference to a scholarly article; I am going to read it.
Excellent website,although horrific experiences. You may want to read the blogging of a nursing administrator who did blow the whistle, and after being attacked, resorted to blogging. There are lots of on point blog posts about empowering and protecting yourselves and your loved ones.
I don’t get your point here, and it’s the opening paragraph of your book…!
“If, for example, you catch a bullet on a Baltimore street corner, or your mother presents you at the ER as a feverish welfare child, then it’s open season for the med students, well meaning as they may be. They can practice on you because if your procedure results in an adverse outcome — which is to say that if you are mangled or killed — nobody will question said outcome, precisely because… you are a nobody.
At the other end of the spectrum are wealthy and prominent patients, who get treated by doctors who have already learned what not to do from the mistakes inflicted upon the lower classes.
This was a very well written, thought provoking story that I think you are doing a huge service by sharing! The truth is sometimes hard to swallow, none the less it is something that patients AND caregivers should not avoid, we should tell it, seek it and gleen from it.
As patients we all deserve and want to be treated right. We sometimes go blindly handing our lives over to others assuming that they will treat it as valuable, precious and worthy of their best effort. We should be able to EXPECT at the VERY LEAST honesty and a good attitude. However, more often than not it just doesn’t happen that way. Should caregivers take offense to this? YES- All the knowledge and know how in the world is worthless if you are incapable of giving your best effort, are dishonest or have a bad attitude. These are peoples lives you are dealing with! Their is a huge amount of pressure to be in this line of work, but you’ve agreed to it, if its too much you need to seek a new career.
We need to be a society where its ok to do what is right, without fear, as patients, as nurses, as Doctors, and as administrators, how did we get soo far off track? How is it that this story isnt unique, it is all to common, I myself have my own story(s) of healthcare ineptness, and who is to blame? Its time for accountability, and an expectance of higher standards. Doctors and Administrators get sick to and when it comes down to it every single person in healthcare should be treating their patients EXACTLY as they themselves would like to be treated PERIOD.
Best wishes to you and your wife! the pen IS mightier than the sword so keep it coming!
I’m so very sorry Pam, you, and your families were treated with such cold indifference during such a prolonged period of great suffering for Pam.
It must have been heartbreaking to observe this chain of events unfold, day after day, week after week, powerless to do anything but observe, and provide support as best you could.
Thank you for sharing Pam’s and your experience with others. You may never hear of it, but I’m sure it will help someone avoid the same level of suffering.
Some time ago I created the Case Health website for just that purpose – sharing. I’ve also produced a book collection of case studies. It’s free to anyone who wants it – and the book can also be freely shared forward.
All patient experiences are valuable, and through the work I do, I’m focussed on building recognition of that value in the interests of making the path to health success shorter for others who follow.
I sincerely hope Pam’s future, and hence yours, is now looking much brighter than the tortuous period you summarized in these chapters,
my best wishes and hopes for happier days ahead,
Cris
ICU nursing (which is where I began my nursing career) is my favorite for many reasons. I take great pride in saying that I am an ICU/cath lab nurse. It is our goal to make and achieve goals for our patient and their families. A plan of care should be developed by the nurse each shift when caring for the ICU patient (any patient for that matter). Many goals that are set for the patient will not or cannot be met for a plethera of reasons, but the most important and simply vital piece is that there are effective transitions to get to where the patient and family need to go next. Anything less than that just aids in wasted time, and ICU patients do not have time to waste. In my opinion, it seems as if those transitions were missing from your wife’s care. Pam was on detours from hell and that to me is not acceptable. “The Best Hospital” should have top notch critical care nurses taking care if its patients. My perception is that there was a serious lack of nursing leadership when Pam needed it most and that makes me very, very sad. All the more reason why each critical care nurse needs to read this. Your story defines “Murphy’s Law” (where if anything can go wrong it will/does) and I feel confident in saying that almost every nurse has experienced it with at least one patient in their career. I have several patients in my memory who were effected by it and secondary to it are the scars that are left in my mind. It is from situations like this that we should become a smarter and stronger nurse and patient advocate. After safety, compassion, advocacy and family education/empowerment are second. Sure sounds like you could have used just that.
Their are great doctors and nurses all over the world. Rest assured. Doctors need direction. The good ones know it and rely on the nurses and continuing education they trust to help them. That team effort gives each patient the best care possbile and details do not go un-noticed. The system failed you and Pam and I am so sorry. Sorries don’t buy back time though, do they?
I hope you win your case. I hope your story sends shock waves to doctors, nurses and hospital administrators everywhere. I hope it reaches the medical and nursing school deans. This is a problem in every city in the US. I hope Pam’s hard fight helps others to “do the right thing”. Good luck.
Thank you for your courage to write this. I cannot imagine the can of worms that you have opened by doing this. My husband, (now an elementary school principal) with exceptional moral fiber once said to me when I had encountered a dilemma wherein I needed to speak up for the greater good said to me, ” You can do things right, or you can do the right thing”. Words to live by.
I feel conflicted about some of the things in your writings. The first part of me is full of compassion for you and your wife. Catastrophic events took place in her care, or lack thereof. Overlookings, errors, the very basics of medicine. Unacceptable in any facet. If it was the physician in your shoes and it was his wife on the table, I can assure you that things would have not gone the way they did for you. I don’t care which hospital in anycity or state. Her care would have not been so “lack luster”. The inital complication could or would have occured but then subsequent events would not have been. The alternative-life long atrial fibrillation and SVT if not controlled can and do cause a significant quality of life change for most people. I think your wife must have felt poorly for her to have gotten the diagnosis of female hysteria (which is the most ridiculous diagnosis ever) and to have you both to consider the ablation in the first place. The doctors are fueled by the patients constant complaints (of their persistant symptoms) that push them to the next step in remedies for the ailment. Everyone wants to be fixed. Right? I know I do for my own medical issues and I would want that for my own family. The doctors are only attempting to do what they know is right. And for that I am grateful. Extended periods of time of atrial fibrillation and SVT will cause heart failure. As I am sure you know, heart failure has systemic manefestations that depending on how severe the heart failure, will determine the length of life expectancy. Which ultimately means feeling worse and worse and losing quality of life. So in a nut shell, ablation (if successfull woo! If not, then why the hell bother) or slowly succumb to heart failure or its secondary killers? Talk about your ultimate catch-22. That defines my conflict. I feel badly for all involved. I am a critical care/cath lab/EP RN. I love being a nurse, it is an amazingly rewarding profession. I cannot imagine ever doing anything else except for medical malpractice law to defend patients and their families who have gone through situations such as yours. I plan on giving your writings to fellow nurses, nursing VP’s, risk management RN’s and the MD’s that I know. I think all cricial care professionals should read this for many reasons.
Informed consent. The only physicians that I know that have fully done this are few, and they were not the cardiologists that I have worked with. It is a nauseating truth. I constantly struggle with the physicians inability to accept “NO” for an answer. It is okay for people to understand the complete process of what they will or will not decide to undergo. If “no” is what someone wants, then “no” is what should be honored. At the time of decline, all other options of treatment should be discussed with the patient and family so that the best possible outcome by the patients wants can be achieved. It is the patients decision to know what is best for themselves if the doctor has discussed all options. Plain and simple, that is what we are employing them for. It is in the hippocratic oath that they take to do just that. I feel in my heart that docotrs believe the oath as principle doctrine and try to live and conduct their daily practices by that. However and unfortunately, it gets intermittantly lost, a costly human defect. Becoming desensitized is a deplorable process that medical professionals are infected with at times during their careers. It happens to mosat all people. However, in medicine, it can and does alter or potentially end patients lives.
We went to the the best doctor in the field at “The Best Hospital in America.” We were told we were in the best of hands. At no point were we told that a trainee was going to perform vital aspects of the procedure. At no point did Doc Calkins tell us what we later found out — that he “shows up to be there during the burn.” Calkins never told us that he considers this procedure the riskiest, most technically challenging procedure ever performed in the EP Lab – and that he was going to turn it over to a trainee.
When the trainee screwed up, my wife went through hell and almost died — and Hugh Calkins looked me in the eye and lied about it. If you think my anger is excessive I can only assume that you are a physician or med student and therefore defensive as a matter of course.
MP .. true, the fine print is there. But according to the author it seems that “students” were involved.. what it was, was a fellow – a cardioloigts traing in the procedure. I feel bad for what they went through, but lets face it Hopkins has saved many patients. His anger while understandable is excessive.
Why didn’t they go to a non-teaching private hospital…
WPW. I agree with your number one. It comes across as biased and vengeful, but I think he and his wife(who was an ICCU nurse for years) did research the surgery, the doctor and the hospital. What they didn’t research was the small print on the consent form. Unfortunately, most people forget that a teaching hospital allows interns, residents and fellows to participate in surgery. What most people don’t realize is that what they’re told doesn’t necessarily correlate with the documents they sign.
Dude – sorry about your wife.. but
1. you are way biased and vengeful and simply not credible
2. since you crank out a website aimed at the destruction of a hospital.. you can’t possibly be that dumb not to have researched the surgery before agreeing to it
3. your wife’s a nurse, right? well, what’s her problem in not being bale to understand.
don’t buy it…. pffttt
I am very sorry to hear about your wife and your experience. Dr. Calkins performed a ventricular ablation on me several years ago. I specifically went to him, because the cardiologists in NY did not do a thing for me.
Comment:
Deana: what we call what you are is a “TROLL”. Stop trying to hijack Dan’s website and get your own up & running again – and don’t abuse this one attempting to advertise it.
Dan: Thank you so much.
While my dad was dying of Amyloidosis in a celebrated Canadian hospital, I regularly saw petty humiliations and agonies perpetrated by un-empathetic, senseless stupidity. While dad and I were chatting in a common area one evening, a resident walked up, introduced himself, and asked dad how he felt. On being calmly told, “my hands feel like they’re on fire” the resident grabbed him by the hands and held on to them, commenting “they don’t feel hot to the touch” – I still shake, wishing I’d kicked that boy in the face.
My dad was from Buffalo, NY, worked at Bethlehem Steel like his dad before him, and served his time in the Army. My dad didn’t cry out and didn’t screm. His jaw went rock hard. The pain was blinding.
And that fool held on, not having seen dad’s chart, not having asked permission to touch him, not noticing he’d gone stark white – babbling nonsense until my dad could politely interrupt him and take his hands back.
Dad was surprised. I wasn’t.
I went in for annual checkups and always told the nurse and doctor I was a virgin. Unfortunately, I’m pretty. I’ve been stabbed by more cucumber-sized speculums than I care to admit, because nobody, inall the times from 16 to 26 that I visited the doctor, ever believed me. The small speculum was *every single time* the second one they used on me. I will admit, I’m loud, and on at least one occasion, I believe I bit a “caregiver” in the room.
Too many people don’t understand the *critical nature* of the mistakes that are made, and are too polite to speak up for themselves until they’re a bewildered “victim”.
Thank you for writing this – it’s necessary that patients become aware, and that caregivers realize there’s a reason that patients must protect themselves from caregivers with the best intentions.
According to Dan’s statements, it must be remembered that Dan’s website only concerns the doctors he dealt with. He does not take on the medical system which he believes to be good. I also misunderstood the point of the site. Basically, it appears he is chagrined that his wife didn’t get the care he believed she deserved having made sure to take extra steps to get it. It’s the bad care after the extra steps taken that he seems to address.
Having been at our mother’s side for eight months after she contracted MRSA after surgery, and then a whole series of other (preventable) complications, we can personally attest to the very dangerous healthcare delivery system we are all at the mercy of. The bottom line is…the longer you are a patient in a U.S. hospital, the more at risk you are of facing an untimely death.
Our mother died four years ago, and we found out after the fact, that the circumstances of her death were never revealed to us. (We were simply told that she had a stroke from a massive brain hemmorrhage. What they neglected to tell us was they had given her the antidote for antigcoaulant overdose—and it was given 9 hours too late.) Blatant lying and lying by ommission are accepted behaviors in hospitals.
One crucial piece of bloodwork is missing from our mother’srecord: her CBC for that day (she had a CBC every single day for 2 weeks in this ICU—the only one missing is the one for the day she hemmorrhaged.) We also found out that her platelet count was so low 2 days prior to this hemmorrhage that she needed a blood transfusion. But no CBC was done 2 days later? …and we’re supposed to believe this?
After four years of dealing with the hubris, arrogance, and ‘there’s nothing you can do to us’ attitude of hospital administrators and risk managers, we have come to realize that hefty profits and complete lack of regulatory oversight/accountabiliy have led to corruption in our hospitals.
The Joint Commission is toothless.” They told us that “because we are not a regulatory agency, you should file a report with your state dept. of hospital licensing.” The Joint Commission is nothing more than a paid membership organization that hospitals use to market themselves as “SAFE.”
I believe every word of your 18 chapters—because we’ve been there. All we can do is continue to speak the truth until we have our last breath. One thing they can’t do is silence us.
Thanks very much for your comment.
1. “Would it have been ok if Dr. Wu be introduced as assistant?”
I don’t know how to answer that. Seeing as how Dr. Calkins has said this: it is a “a high risk procedure,” and “associated with a risk of serious complications,” and “anyone who is doing this procedure realizes there is a learning curve and the learning curve is very rocky as you go up on it and the complications are like no other procedure that’s ever been done in an EP lab… a procedure with high risks that’s in evolution… there has never been a procedure in the field of electrophysiology with such a high complication rate. There have been more than a handful of deaths from this procedure, and as more and more people start doing it and are on that learning curve, it could be a bit of a mess… having an experienced operator is critical to safety end efficacy.”
If he had told us all that, and then said I’m going to let a trainee do it because I “show up to be there during the burn,” my guess is we would have said “I don’t don’t think so, Doc.”
Since, however, we were told by Dr. Calkins that he had done lots of these procedures and that he was comfortable and confident in doing it, and that he was going to be the primary operator, I suppose it would have been OK if he said “I’ll be closely supervising Dr. Wu, while I teach him certain aspects of the procedure.” But what happened was a bait and switch – pure and simple. A betrayal of the patient’s trust.
2. “Is it possible that their maneuvering the catheter was the standard of care?”
EP’s would say the standard of care was not violated based on improper catheter manipulation. I would of course disagree. If you’re paying close attention to the position of the catheter, you would keep it from becoming tangled up in the mitral valve muscles. It’s not like like Dr. Wu was paying close attention and taking great care to keep the catheter away from the entrance to the mitral valve – and then all of a sudden, the catheter sprang toward the left ventricle of it’s own volition. He SCREWED UP, pure and simple.
3. Their report makes no mention of being in the left ventricle. Of course it would not, it would be too embarrassing. It says right on the box to not let the catheter enter the left ventricle. What the report does say is this: “.. the posterior leaflet was completely flail due to severing of two chordae tendineae and avulsion of the posteromedial papillary muscle near its base.” The papillary muscle is located in the base of the left ventricle, not in the left atrium. For a catheter to get trapped at the base of papillary muscle at the base of the left ventricle, it would have to be in the left ventricle, would it not?
4. The distinction in the procedure report “appears to be the reason for the procedure (your wife’s was for a-fib, while others were not).” Again, mitral valve damage is listed as a complication for ANY cardiac catheterization, and to me their report is akin to warning lathe operators about the dangers of wearing a necktie on the job. Their distinction would be that this is the first time this particular brand of necktie got tangled in a lathe – or this is the first time a necktie got caught in a lathe while making an umbrella stand instead of a table lamp. It is ridiculous.
5. There are many reports questioning whether this catheter, indeed this whole procedure, is useful (Hugh Calkins himself says “the safety and efficacy of pulmonary vein isolation is unknown) and this came out just last year: “Catheter ablation of atrial fibrillation: do we know what we are doing?” Europace.2007; 9: 1002-1005
6. Better techniques? Apparently yes. That is what the “learning curve” is all about. Every time someone’s heart gets ripped up, or dies from a stroke or a perforated esophagus or pulmonary vein stenosis, the Docs learn something and the procedure is then presumably improved.
7. Complication rates vary wildly. If Hugh Calkins is trying to steer patients toward the procedure in order to advance the learning curve, he says “the procedure is ready for prime time” with a complication rate of 3%. If Hugh Calkins is talking to fellow researchers, the complication rate is anywhere from 6 to 12%.
8. “It does sound fishy that the note suddenly appeared. May I reasonably argue that it was poor handling of medical records, and not ‘tampering’?” No, you may not reasonably argue that is was poor handling of the records that lead the chart note revealing Dr. Wu’s involvement to be withheld for four years. Every time I made a request to Johns Hopkins fro Pam’s records, the records person would contact Dr. Calkins would confirm that he had delivered all the notes and records in his possession. On at least seven occasions, he was asked to provide ALL the records and seven times he left out that one chart note — except to in house lawyers. We got it by mistake, when it was finally added to the record AFTER the statute of limitations had expired.
9. As for other EP’s, I get many comments. About half are appalled that I would make such accusations, while the other half encourage me to keep writing.
Again, thank you for reading and for your comments.
Thanks for sharing your story, which I am sure has taken quite a mental toll on your
family’s life. I am sorry to hear about all the mistakes made.
I am a physician ‘in training’ as a 4th yr fellow. I feel that I read other’s stories, in order to re-connect with that ‘perspective’ you discuss so often. I do gain some insight as well, about doctors, patients, and medical care
Although, I also feel attacked as well. “Great doctors” everywhere start somewhere as a trainee. Some of your commenters would not prefer any ‘trainees’ when it comes to them. To be fair, would have been ok if Dr. Wu be introduced as assistant? Do have any numbers to know how many of these procedures Dr. Wu has done? How about Dr. Calkins? What if you had heard that Dr. Wu had done 10 procedures in the past 1 month, Dr. Calkins has done 50, but his last one was 2 years ago, b/c now his fellows do the procedures? how about with this specific catheter?
Of course, I am making up numbers, and being somewhat ridiculous, although during my training, I have found that some procedures I do, I did it more often, and I was better at it than my superiors, since they leave those procedures to residents/fellows.
I read the case report. I am not a cardiologist. Is it possible that their maneuvering the catheter was the standard of care? (I don’t know that answer). If so, then how could they be blamed for this? Could you include where you found that the docs were in in the left ventricle? Their case report makes no mention of it.
You also make a point of saying that in the case report, they report that it is an unknown complication, but then reference 2 other cases. Its a little cheesy, but the distinction appears to be the reason for the procedure (your wife’s was for a-fib, while others were not).
I agree the medical notes disparity is maddeningly frustrating. It does sound fishy that the note suddenly appeared. May I reasonably argue that it was poor handling of medical records, and not ‘tampering’? Is it possible that the missing document was really written in ’02 but never got to the chart? the cynic will say ‘no way’ but the believer will say its possible. I think its easier to argue the missing chest tubes notes. In handling patient charts, I have often come across some that have easily >400 notes. It is very easy to find some of them missing for any reason. I have accidently dropped these charts, b/c the sheer nature of their size. Papers fly everywhere. Also, moving from one room to another causes things to get misplaced. I will bet some get missed. That is unfortunate.
Have you discussed your case with another EP specialist? I think their perspective would be interesting as well.
other questions that I don’t have answers for but would be interesting to know
1) are there conflicting reports that state this catheter is useful?
2) are there better techniques now for AF within interventional cardiology field?
3) complication rates for this procedure?
4) has techniques changed for the better?
Its a shame to hear that people lied to you and your wife, and the subsequent ordeal. Good luck in your endeavors..
Please do not change your account to ease the feelings of those who consider it inflammatory. The situation deserves emotional response. Readers need emotional response in order to have the interest to read the entire story, otherwise they will miss out on other important information.
My husband has atrial fib and has had the ablation therapy described to him in glowing terms. I am sending him a link to this blog.
I think your story is perfect as published. It is truth, and truth is what all of us need to see, and act upon. Medical incompetence is bad enough, but coverups and lying when medical imcompetence occurs, make the situation even more intolerable and hurtful and ANGER-MAKING. If a man makes a mistake, it is his ethical duty to admit it and attempt his very best to make amends — at the very least, in the case of your wife, all her surgical costs should be ERASED, and medical care to treat all complications of this BOTCHED PROCEDURE should be provided FREE FOR THE REST OF HER LIFE, and furthermore such care should be provided by ANYONEOF HER CHOOSING and then paid for by Johns Hopkins Medical School.
Someone asked me the other day, “Whydon’t you get a liver transplant” (to make it possible for me to be around fragrance chemicalsafter having experienced liver damage — primarily from chemicals in a lab I worked in and a building-in-renovation I worked in — that has made my liver incompetent to properly process/excrete chemicals ranging from air “fresheners” to perfumes to…). At the time I replied, “I would not want to be subject to being dependent upon a lifelong supply of immune-suppressing drugs.” And then, too, there is also the fact that “body harvesting” of spare parts for transplants, is not always characterized by the degree of quality control one would think should be fundamental to medical practice (in other words, the chance of getting a liver damaged in some way other than mine — perhaps even to the point of carrying nodes of cancer — seems a likely danger). Now, after reading your and your wife’s story, I am reminded of the third reason I attempt to stay out of the clutches of the medical system: incompetence and damage (much of which I’ve experienced, but not to the degree of your wife) and lying about said incompetence and damage. Oh, yes, there are some good doctors (I have had at least one in my family). But how does one know that the one s/he has consulted, is one of them?
Best of luck to you and yours.
We’re a medical family, and the partner of the doctor that made the huge mistake is a very good friend (Not the one who messed up, the partner). They still sent us bills and such though and my mom threw a fit, then the CEO told us they wouldn’t bill us for it anymore because he knew what happened (Essentially admitted guilt- probably aren’t supposed to do that), but yeah its cause the partner is a good friend and we’re all medical. I sure hope the guy isn’t doing that to anyone else though- he had no idea what he was doing! Our insurance still paid their portion, but we did notify them of what happened. We’re just not the “suing” type either I guess; we don’t really care about money, just want me to be okay. I have to have an ablation now though; it never ends, all byproducts of that. Not to mention that I went 4 years before someone read my echo correctly and diagnosed my CHD correctly. This stuff can happen anywhere, not just Hopkins.
I had a CardioSEAL ASD closure device placed at a Toledo hospital but the cardio oversized it by 2x and it punctured two holes in my atrium (So instead of closing the ASD, it created two more!) I had to have open heart surgery to remove it but one leg of the device is still lodged in my heart. We should have sued. Super scary.
Welcome to the body of brave and eloquent souls who write about these things. I too express my tale in this way. My website is temporarily down for updates and improvements but it will be up again shortly. I have some thoughts to send your way.
People in general have swallowed the myth that hospitals are wonderful places. It’s weird that advertizements for all other products are questioned and regarded with skepticism except for medical care. There is this absurd perception that doctors are closer to God than anyone except perhaps Santa Claus.
My solution to the problem is demystification. The public absolutely MUST let go of the easy belief that prayer is the last ingredient in survival and that the doctor is never a dubious component when illness comes your way.
Doctors are flawed people almost to a perosn. First, they have the idea that they “suffer” the schooling process. I see a homeless or handicapped person as suffering more of a “schooling” process. He has to learn how to live on the street or with his disability. Med students have a lot of fun learning and they are given the best opportunities and facilities. Also if they don’t like it they can always quit!
I could go on at length but sum it up as follows. There is a massive amount of brainwashing going on here. Everyone is suffering except a few at the top of the heap. These top managers of the global human population epidemic have chosen to hide the culling process rather than promote birth control. Hospitals are the places of choice. Jails and mental institutions as well. Organ harvesting is growing as a “holy” way to kill disposables rather than save them.
A hospital is not a holy place. It is at best a garage for humans. The more of us there are the greater the panic to pretend they care; the greater the disrespect for patients and the need to conceal the limitations.
Doctors are horribly manipulated by healthcare “controllers.” They are told they are great so that they will perfom. The trickle-down effect is their goal. Membership in that elite club they can smell in the wings is so tantalizingly close. They do the most awful things to try to get there.
Because they are characteristically overachievers and have been so since childhood they are essentially infantile and naive. They are excellent tools.
The solution is to realize we need to prevent healthcare. First, we reduce population by not having children in this ill-equipped environment called earth and wait it out. At the same we tell our stories regardless of stupid comments like “if you hate doctors so much I’d like to see what you will do after a car accident…”
We need to go back to square one and look after ourselves as much as possible. This way we can at least elicit a bit of respect when we go to hospital. They will want to see US rather than the other way around.
If you go back and look you will see that everything that Hopkins would consider to be defamatory is either my opinion or is fully documented, e.g. “the attending shows up to be there during the burn,” and “the safety and efficacy of pulmonary vein isolation was unknown then and it is unknown now,” are quotes by Hugh Calkins from this transcript: http://www.fda.gov/ohrms/dockets/ac/03/transcripts/3954t1.htm. Hugh Calkins IS a TASER salesman: http://www.policeone.com/police-products/press-releases/99272/.
I’ve been following this case with interest. I’m sure your family has gone through a lot but something bothers me and I wonder if it bothers your attorney.
You say you can prove everything that happened, but if you lose your appeal most courts would view the appellate decision as proof of your inability to prove your case. How will that work for John Hopkins and the two doctors involved? After everything you’ve written about them can they sue you for attempting to ruin their reputations?
Thanks very much for your comments. You are insightful as to the inflammatory parts in the beginning, because I have been struggling with how to tone it down without losing the edge that makes you want to read on. It is difficult to do because, as you can see, my version of events is very well documented. In other words, it’s inflammatory precisely because it is true!
As far as the physicians involved not meaning to do harm and feeling guilty about it, well, I’ve understood perfectly well from the beginning that doctors are only human and therefore make mistakes like the rest of us. That does not however, give them the right to deceive and conceal their mistakes – at the expense of the patient. If they feel so badly about it now, they can still come clean and acknowledge what the documentation shows – that they put their careers and reputations above the welfare of their patient. Until such time their reputations are fair game to be compared to the documented record.
You are right that it needs to be couched more in terms of raising awareness of patient safety issues and I am working to do that, but as it develops you will see that it also serves as a cautionary tale to physicians and med students that when mistakes are made, they need to own up to them and come clean right away. It is in everyone’s best interest to do so.
I get a lot of comments from doctors, and it is interesting that half are angry and indignant, while half say keep up the good work. Thanks again for your comments and best to you in your career. I think that you will make a fine physician.
Good Writing! Intriguing style. I would encourage you to put this into print,
I found it interesting to see how your tone kind of changes from the early chapters to later..and I would encourage you to “tone down” some of the inflammatory parts in the beginning, however, this may have been what captivated me.
I am starting a cardiology fellowship this fall. I am 30 years old and I have now reached the point in my life where I have spent more time beyond high school “in training” than the the entire point up to high school. Of the past 30 years of my life, I have spent 25 years as a student, and I have 4 more years to go before I am an attending. I can relate to doctors and fellows in your case. I guess, I don’t really know what to take as I read your story other than the twinges of guilt, from things that have gone wrong in the various parts of my clinical experiences.
My only thoughts are that these doctors involved in your experience did (not) intend to cause harm and I can only imagine how they feel now, and I worry that your purpose is to cause publicity (bad) about them more than to improve the culture of safety in medicine.
With how much of this written, my take is that your number one goal or purpose is to have these doctors run out of the business. If you are to publish this, you need to change the theme to more about raising awareness of the need to improve the culture of safety in healthcare.
I am saddened to hear about your wife and your story. I work at Hopkins and unfortunately have experienced a similar situation. Your voice is important. Thank you for publishing this. We need to look at ourselves and understand if we’re really performing as the BEST hospital. We have a long way to go. Your story needs to be heard by all. Continue publishing.
Aside from not being informed that the attending would not be a primary operator, to me the real transgression here is that the attending knew full well that this procedure was far more difficult and dangerous than he led us to believe.
And then for him to repeatedly state to colleagues that this procedure is highly risky with “complications like no other he’s seen in the EP lab,” and that it is by far “the most dangerous any cardiologist would ever perform”, and to state that it should be performed by highly experienced personnel – to then to let a physician in training perform vital parts of the procedure – without telling us – and then to lie to us about it – to me that is a betrayal of patient trust of the highest order.
I appreciate that you as a cardiologist took the time to read the story and to comment on it. I know it may seem that I am unfairly painting all cardiologists as insensitive and incompetent, which of course is not the case. I am working to present a more balanced picture. But the facts are such that it can be a difficult task.
I do not think this Dr. is a bad guy. I think he lost his perspective, and I think this story needs to be told so as to remind other physicians to not lose theirs.
Thank you gain for taking the time to read the story and to comment and I am glad that you do not take offense.(It is interesting to me that of the physicians who contact me, roughly half are defensive and angry – while the other half tell me to keep up the good work.)
tragic to see what has happened. HOWEVER, as a practitioner (and dare I say, a cardiologist *aghast*!) I must argue that you and the team taking care of your wife would not be in this predicament had they spent the time to properly take informed consent from you. I know how teaching hospitals work. Often the most junior person gets consent. However, this does not let the attending physician “wash his hands free” of any responsibilty. Every attending I worked under whom I respected, would go into the room after I just walked out with the consent form signed and explain the procedure themselves. The patient damn well knew my role as the cardiology fellow and my attendings role as the man (or woman) in charge.
That being said, I have seen situations like yours arise precisely because there was poor communication between the treatment team (attending and fellow or resident) and the patient and his or her family. cries of, “I didnt know so and so was going to scrub and actually do the procedure. I thought Dr. Chief of Section was actually doing it” are all too common.
of course, they should not be. informed consent should really be informed.
All that being said, this was an inadvertent (albeit an incredibly awful) complication. When you have lasso catheters in the LA being manuevered it’s not surprising they get stuck on the MV apparatus. I’ve gotten a Swan Ganz catheter stuck on someones pacer wire in the RV. And this was a procedure done under proper supervision as a trainee! (the outcome was fine).
take home point: dont believe the hype of USNEWS. Always question question question your doctors and realise that teaching hospitals are called TEACHING hospitals for a reason.
since you all seem to have so much distrust for doctors, nurses, and hospitals, please by all means avoid them! the next time you get sick, take your care into your own hands. clearly you know better than the so-called experts.
You commented on my site linking here on an essentially unrelated post. I did not approve the comment, because it’s unrelated and is therefore spam. In the future, perhaps an email would be more appropriate.
Let me first clear the air: I am certainly biased. I do simulation research on heart attacks at Johns Hopkins University, and am working on my degree there. That said, I can’t speak in any official capacity for the institution, and my words are strictly my own.
I have worked with some of the physicians in the EP lab at JHH. I have observed several procedures, and I can tell you that in all cases the nurses were compassionate and very concerned for the comfort of the patients. They were very careful to maintain the correct level of sedation and quick to offer reassurance to patients.
EP fellows and other cardiologists don’t look to see how much you can afford to pay when they come in to do a procedure. They review the problem and set about trying to solve it as carefully and thoroughly as they can. Please keep in mind that they are human, and all humans make mistakes, including doctors. From what I could tell, EP fellows are allowed to do procedures. They are by no means complete rookies, and have had extensive training in their specialty. They are supervised by attendings, and if there’s any question about the abilities of the fellow in a given situation, the attending steps in.
By the way, the checklists Christine mentions have vastly improved the reliability of medicine at Hopkins and elsewhere. I just finished reading a New Yorker article about the vast improvements Hopkins’ checklists have produced in Michigan hospitals, and the country of Spain has requested help setting up checklists in their hospitals as well. In my time at Hopkins, I’ve seen a constant effort to improve patient care. You don’t like checklists? How do you think the “arrogant” doctors feel? And yet, they’re slowly conceding to them in the interest of patient care. The numbers show that they make a substantial difference.
Now, none of this is meant to dismiss the charges that are leveled in this blog. I’ve only read this side of the story, but for all I know it may be entirely and precisely true. I hope that it’s not, but I won’t say it isn’t. If that’s the case, then as others have suggested a malpractice lawyer is probably warranted, and I hope Hopkins makes an effort to curtail such problems in the future.
However, please don’t generalize this to all patient care, or all cardiologists, at Hopkins or elsewhere. Most physicians really try to make a difference for the better.
this whole thing is ridiculous–from the attending being in the dr’s lounge, to your sedated wife signing the consent(they would have had you do that) to drs owning the apts around the hospital and jacking up prices to take advantage of poor patient families–boo hoo you didn’t get to know the cardiac surgeon before he rearranged his schedule to perform life saving surgery–your wife would have died immediately anywhere else! and your quotes are completely irrelevant–the charges against JHH overworking residents occurred in august when the new guidelines were first in place, NOT in april when your wife was there. i’m surprised you didn’t somehow find hopkins doctors responsible for your wife’s car accident! maybe the drs were tired and scared because they work exceedingly hard hours and actually care and medicine is an inexact science with all kinds of complications and unpredictable outcomes. go find a shaman and avoid doctors all together if they are all so evil.
ps i am not a hopkins employee i just hate people who try to blame everything on someone, clearly the appeal of a lawsuit with big $$ is the underlying theme here
What a horrible story. What a horrible experience to have to go through. I am a cert. med-surg. nurse and have seen hospitals cover up many things. Patients have complications caused by error. The nurses I have worked with are the best and have the knowledge and compassion to take the best care of the patient and of the family. The problems is we are all over worked. On a daily basis I have talked to my superiors about the dangers of high nurse to patient ratios. We nurses have no authority to change this problem, especially in areas where the facility company owns all of the health care facilities in the area. They have a monopoly on everything, staff are afraid of being blacklisted. My prior supervisor and vice-president of nursing told me I had a bad attitude when I went to them about my concerns for patient and employee safety issues. I assure you I spoke to them with great respect at the time. Facilities in some areas(Virginia) set their own staff to patient ratios. Although what they set may be good, in practice with the nursing shortage we have to take care of too many patients at a time and it is impossible to provide good care to all patients. If we stay late to complete all of our work we are told no overtime hours. It is scary to work in health care these days. When a family member of mine is in the hospital, I have stayed with them to make sure they get what they need, and I am not afraid to speak up and demand what they need.
I read it all feeling increasingly horrified as the nightmare unfolded, I’m feeling stunned now but, sadly, not surprised. We are meant to trust them, see them as our saviours and never question them. Sadly my family have also suffered in the hands of the medical profession, we went to court, we won, but we didn’t really win, we lost, a precious child, through the incompetence and neglect of our white-coated experts.
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* Posted today at 1:21 pm
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More people are killed/maimed in hospitals and in the hands of doctors than from car accidents. I am so sorry what you both have been through. My parents were both Health Care Professionals. They knew who the good ones were and who to avoid. But, with them both being gone now…and spoiled by great physicans from the past, I am on my own always researching doctors for various problems. Going to top notch hospitals and even what appears to be top notch doctors isn’t always as it seems. One must always be on their toes….for everything. You need eyes behind your back and a mouth to speak up. Too many people worry about hurting a doctor’s feelings if something does not seem right.
Recently, I had surgery. It was not heart surgery. I knew something was not right. I sounded like a broken record and still was not heard. I was treated poorly and ignored with my concerns. I even requested to see another doctor in the same group and my hands were slapped as how unethical this was. I spoke up again (not nicely) and was banned from ever seeing another doctor in the practice.
Two outside physicians confirmed what was suspected. I was not crazy.
The Banning was done by a well known/America’s Best!~! The post op problems were diagnosed by not one..but by two different outside groups that are not as well known at the Ban Group.
So, America’s Best/World’s Best, Cream of the Crop, Who’s Who in America’s Doctor’s/Best Hospitals, do not mean anything to me anymore. We are at their Mercy and have to pray and pray hard for our lives every time we seek medical help. Sad but too often, true.
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* Posted today at 1:37 pm
Thank you for sharing this story. Each of us in this community can relate on some level. Dealing with the medical community is a hit and miss situation. I am amazed each and every day by things that go on that we never hear about. I had a stent placed in 2006 and saw no problem with having a fellow observe the procedure. However, the intern actually was allowed to perform part of the procedure which resulted in my having 5 puncture sites in my groin. I was bruised from my stomach to my knee for weeks. The doctor insisted the intern had assisted on not worked on me, but my IV malfunctioned during the procedure and I didn’t get most of the “groggy med”. I clearly saw the intern at my right hip (he had on a turban – no offense to anyone, but no one else in that room had on a navy turban that day) I also heard the doctor giving him instructions from way across the room like “keep going – no that’s too far – start again”. Doctor was nowhere close enough to me to be doing the procedure. No one believed my IV was messed up until a nurse checked it and everyone panicked since not only was I not getting my groggy med, I was not getting my blood thinners. This happened at The Heart Institute at St. Luke’s in Houston, TX.
I had triple bypass 12/30/07 after being dismissed as having “hysterical woman” syndrome. A nurse told someone I was there for “preventative cardiology” because no one believed my symptoms were cardiac at 41 even after 2 stents. The heart cath I had to lie to get resulted in my emergency triple bypass (told them I went off Plavix knowing they would have to cath.) I was taken off Plavix since my stents were bypassed. 18 days later I had a heart attack caused by a blood clot in one of my new bypasses, which had to be stented resulting in me going back on Plavix. Had I not been taken off of it, I would probably not have had the heart attack.
I love your signs for the ICU – especially “You are not in Hell your are in the ICU”. When I had my heart attack, I begged not to go back to ICU. I got no rest and was allowed hardly any visitors. Since I had my bypass so recently, I had no choice. I now suffer from post traumatic stress disorder from everything I have been through, yet it is nothing compared to what your family went through. Your wife and family are in my thoughts and prayers. I am anxious to read the rest of your story. Thank you again for sharing.
I think that your wife’s story is a perfect example of what is wrong with our heath care system as a whole. We have health care professionals who are overworked and under appreciated. It seems that the lower you are on the totem pole as a health care worker (i.e. techs and nurses) or as a patient (i.e. from the lower and middle classes) then all of the flaws of the “best health care system in the world” are truly exposed. In my opinion we need to do a revamp on the way we approach health care, we need to put more effort into preventative care and providing coverage for all. While developing new techniques and equipment for complicated medical procedures is necessary and using it is being on the cutting edge, we have largely neglected the basics of preventative care and overall wellness. Why, because there isn’t anything glamorous or exciting about preventative care and wellness, it’s not flashy and the subject of cutting edge research, its just common sense. I mean look at health insurance, it’s not about providing affordable coverage for doctors and nurses to treat their patients its about providing incentives to cut corners on care and to avoid anything deemed unnecessary. The time that doctors and nurses spend on the phone fighting insurance companies for the funds to doing necessary testing and procedures on their patients has taken up time that used to be spent treating patients. Rather then paying our health care workers respectable wages with decent hours, we have implemented mandatory overtime and tried to cut corners wherever possible. Thus we arrive back to what has happened to your wife, its clear that many people have dropped the ball with you, your wife and the rest of your family; you have been deceived, ignored, patronized and neglected and sadly I am sure that there are others who have been in a similar situation. It’s reading stories like this that make me even more determined to become a nurse and to fight for my patients no matter what the cost is, I truly hope that your wife does not suffer anymore at the dangerous hands of our “first class health care system.”
For some-one working in Medicine this is an eye-opener! I’m still a junior doctor, and have done a lot of procedures on my own, but in the beginning always under the supervision of my consultant.
Unfortunately we still have to learn, and sometimes the curve is “steep and rocky”, but remember the professor who heads the unit, and is world-wide recignised as a leader in a certain field, also had to start from the beginning, under supervision.
It’s like flying. Sooner or later you have to solo, with no-one to hold your hand.
But the one thing that we have to keep in mind is part of the Hippocratic Oath :FIRST DO NO HARM!!
Doctors need to ask themselves firstly: What is the best for this patient? And then, Am I able to provide this for the patient? If we are unable then we need to refer to a colleague who will be able to provide that option that is best for the patient.
I wonder how these Pompous male doctor’s would like to have just a small washcloth covering their penis and balls and laying like this for everyone to see them from the gallery. There might be a lot of laughter. Hmmmm The doctor may not be the stud, he thinks he is, after all. LOL and the whole world would know.
Signed: I am Woman…Hear Me Roar!
All these arrongant SOB doctors have to face their Maker. Bad things happened to me via the hands of doctors. I have suffered physically and emotionally from uncaring doctors. I asked God to handle this. Every single doctor that has hurt me has had a tragedy strike them. Hmmm! God does work in mysterious ways! Almost like placing a voo doo on them. Watch out doctors. Walk the straight line and do what is right for your patients and admit to fault and error quickly so help can be forthcoming ASAP!
That scared the *&#% out of me! I’ve had more bad experiences than good (involving Emergency care) not inpatient as your wife had. I realize how vulnerable we all are and pray that the person holding my heart (literally and figuratively) will treat me as that they would their own wife, mother, daughter or sister.
So Lauren it sounds like it was more important to get the kid trained than your well being. Thanks for sharing this. I will pay more attention now to details. Perhaps these teaching hospitals are not the answers to a patient’s prayer unless of course you are the King of Siam! Perhaps we all can add Ph.D after our name for times like this. Would that impress them? LOL
I am soo sorry your wife went through this nightmare. BUT, I am not surprised that some of these so called top notch (loosely said) hospitals treat patients in this manner. You are so right about the rich and the not so rich. The rich even has a private door they can go through and even a private cath lab offered to them. They are treated with respect and with full class dignity. The chiefs hover around them.
I had a heart cath in Houston. Suppose to be a top notch place. We spoke to the cath doctor prior and was assured he would be doing the heart cath and if I needed a stent, he would notify my husband (sitting close by) before placing it in. Ha Ha. I did not even have a nurse in the room. I was given IV sedation and must of zonked out quickly. I awoke to loud frigtened talking and saw a stranger sitting to my right side working in my heart. To the back of him (about 3-4 ft behind this kid) was standing the doctor we thought was going to do all the work. I asked what was hapeening while the kid was still talking loudly and the head guy walked over to me and got in my face 9 I smelled his breath as that is how close he was to me) and said, “SHUT YOUR &%^&(,
*&%^%*, Mouth and act like an adult!~! He turned around an looked toward another door and started yelling for someone to give him more Fentynal. I awoke in my room
andf told my husband what had happened. he was agahst that this could happen in So and So Hospital. The doctor never came out and to9ld my husband that he was inserting two stents. The procedure was 2 hours long and no work from the cath lab all the while. I asked the main cath doctor whay he yelled at me. he denied it and said I was hallucinating. I asked to see the Cath report on dismissal and saw tewo names listed in attendance. I also noted that the “kid in trainining” had a difficult time deploying the “Taxus stent” in the RCA. I was livid b y then. I proceeded to call the stent makers and gave them a copy of the report and they verified that yes, there was some difficulty noted in the deployment. What this meant was if this kid could not deploy the stent….they would have to call for a surgeon to do by-pass. Ah ha! This is why the “kid in training” was talking loudly–he was in trouble. I called the CEO and discussed this with him and yes…I did not dream any of this up….All this happened. I was treated like a menial. When I saw the Cath doctor two week later, he was upset with me that I called him in on the carpet. He said, “this is a teaching hospital” and you sign papers allowing us to do this and that and I should know better”! I got in his face and told him how the cow ate the cabbage. Needless to say, I was not going to return to that place, again. I wrote again to the CEO and asked that everyone who has a heart cath that can see and understand, be asked verbally in front of witnesses and family, to allow or not allow a “trainee” to work in your heart”!
The head cath doctor said, “well how are these kids going to learn”…My response, “not on my heart, they don’t” and if one does allow this…the patient should be compensated for this or not charged a dime for his procedure…The CEO did say, all patients have a right to say NO with no backlash! This CEO needs to enforce this with all doctors. Yes, the rich and dignitaries have the best of all worlds…money, fame and fortune and great medical care. Patients need to be aware of their surroundings and not take a back seat to pompous, holier than thou, doctors. Some of these doctors need their bare bottoms spanked. I will be in line first, thank you.
Lauren.
Hmm sounds a little like when I had my gall bladder out. I spent 2 weeks talking to this doctor who had “done hundreds of these”. When I woke up some kid walks in and starts talking to me about how my surgery went. I looked at him and said “Who the F*** are you?” He replied. “Im Dr So-and-so, I did your surgery” Turns out he was a resident. Fortunately, I didnt get nearly as torn up as your poor wife did. But compared to what I was told to expect, it was definitely the job of an inexperienced surgeon.
Thank you for publishing your medical nightmare so that others perhaps learn something which will spare someone else the
tragedy your wife and you have suffered.
I would like to bring to your attention that there have been several formal medical experiments taking place in regards to the various methods of catheter ablation for atrial fibrillation. They are registered with the US government by the way. I have reviewed these studies and found a significant number of them were *terminated*. Various reasons were given. Some of the procedures were using microwave and other radio frequencies to destroy tissue. The reasons for clinical trial termination was listed as vague reasons such as “lack of participant recruitment.” etc.
I was a Coronary and Coronary Surgical ICU Nurse Specialist for part of my career. I didn’t work in teaching hospitals for reasons you identified, and I worked at facilities regarded as the best in their field. I can tell you that surgeons often did not perform all of the work in surgery. However, because cardiac surgery statistics of outcomes are very important in ranking of the facility, there was more than a concerted effort to have a desired outcome. It was so important that some cardiac hospitals would literally wheel a patient out of the operating room into the recovery room if they were crashing and death was imminent. They didn’t want any stats showing anyone actually died on the table during surgery.
People are not aware of the FAILURE IN THE INFORMED CONSENT PROCESS. Forgive me for the capitals, which I even consider obnoxious. However, my major political effort at this time is to try to restore the concept of informed consent which has been severely eroded more than you can imagine. This extend to powers the executive branch has unilaterally taken during this present administration. Patients – even just citizens -are being subjected to non-consensual human experimentation everyday. Literally.
Please feel free to contact me at the unpublished email address I left with you should you wish to. I can only sympathize, but if that would help, I’m available.
By the way, if the blood thinners are managed properly, they won’t
cause any problems. I took them myself for a few years after developing blood clots from standing on my feet for so many hours in these ICU’s without a break for even a drink of water for 8-12 hours at at time, day after day, year after year.
I sincerely wish your family the absolute best restoration of your lives.
I’m assuming you are obtaining a medical malpractice attorney.
The legal profession is even worse in terms of work ethic. I hope you obtain several legal opinions and interview many attorneys before choosing one to handle your case. There are more nightmare stories in the follow up legal handling of medical malpractice cases
than you could imagine. There is less disclosure of what goes on behind closed door in that industry than any other besides politics.
Pam’s story sounds very similar to my third ablation done at Mayo Clinic Rochester, MN. I thought that I was going to the “best facility” with the best Dcotors available, if it was good enough for the kings and Presidents, it must be the best.
Being that this was my third attempt at ablation, I requested and thought I was assured of the most senior EP. I too was given the consent after initial sedation, back in the anti room prior to ablation.
My wife met a very nice woman while waiting for my ablation. It seems she and her husband flew in from Arizona on a “rush” basis being referred by a DR. at Mayo’s Arizona facility. In talking with her it appeared that this couple was very “well off”. My wife still had no clue that there might be a problem in being assured of the Doctor we had requested to perform the procedure.
After what seemed like an eternity, a Dr. we had never met nor knew of came in saying he had good news and bad news! He felt they had erradicated all the errant signals but that when they started to remove the catheters,one had punctured his ventricle and they were taking him to ICU. My wife was in schock.
While waiting in the ICU waiting area she overheard another family being told that during pacemaker placement, there had been a problem, also making her feel even more fearful of what kind of care was I receiving.
After another couple of hours, My wife had about had it and luckily my daughter was with her, she asked her to ask the nurse how much longer before we could see me, and if it wasn’t soon my wife was about to make a scene. I was very lucky to have survived with no permanent damage, that we know of. I went on to have a Cox maze in 2005 and feel better than I have in years. only wish I had done it a lot sooner, even though it is major surgery, there is less risk than with ablation.
Having read a shorter version of Pam’s experience on affibers.org, you have my best wishes for the best possible outcome, only sorry you did not have better luck with your court case. Where is the justice?
Best regards
Tate
That is a horrific story and I hope the nurses involved had the courage to report the doctor. Unfortunately things like that happen all over the world. In the UK, nurses seem more able to report doctors bad practice. If we see one doctor’s name on the consent form and that doctor is present during the procedure, we are supposed to report. Note that the consenting doctor should be present, not necessarily doing the procedure. It is generally recognised that a patient has the right to know exactly who will be performing a procedure and has the right to question how often they do this and what there success rate is. And if they are savvy, they can also get this information using the freedom of information act.
My husband went into Johns Hopkins Hospital with signs of liver failure but poor nursing and physician care and hospital acquired infections kept him from getting the liver transplant he needed resulting in his death seven weeks later.
The hepatologist kept insisting he was the healthiest of her liver patients, was not in liver failure and did not need a transplant. An endoscopy they performed and stated was normal missed an ulcer that five days later almost caused him to bleed to death.
He was not given proper nourishment. The physicians kept insisting he was eating when I knew he could not eat because of his illness. When his medical condition finally deteriorated to the point he could be considered for a transplant I was told he was too malnourished to survive a transplant.
The most distressing part of the hospitalization was the lack communication and family centered care. The staff treated me with distain for asking questions, nurses gave vague and patronizing answers, the physicians communicated only when directly confronted and were often armed with incorrect facts. The attending physician flat out lied about several issues.
The ICU nurses refused to offer a portable phone or let my husband use his cell phone to have contact with his children.
The JHH physicians are very arrogant, lack any compassion, and have no communication skills. They treat the patients as isolated organs or diseases and not human beings that have families depending on them.
When it was clear my husband was going to die these doctors dissappeared into the wooodwork, not one offered any condolences or asked if there was anything they could do.
I am a health care provider myself and would not treat any of my patients or their families the way my husband and I were treated.
Every day thousands of people are subjected to substandard care and arrogant doctors and nurses at supposedly one of this countries premier health institutions.
I used to work in the EP lab. I can tell you that no one in a teaching hospital is allowed to perform such procedures without the attending being by their side. If a student is extremely competent, the attending might allow them to do some of the work, but only after lots of proof that they know what they are doing, but the attending is still at their side. Also, there is no reason that I can think of where a person had to lie on a table without being covered. I am so sorry that this had to happen.
Thank you for publishing your horror story. As a chronically ill citizen of Baltimore, I have – for a decade – described that I live in the land of Johns Hopkins gods. From personal experience, I can say that the Hopkins trained/employed physicians that I’ve had the good fortune to see are accountants with little practice in clinical observation.
Who needs the skill of clinician when you have checklists? Barf.
I had a HopkinsAss (TM) prescribe Zyprexa for interrupted sleep, because I too am a woman, and suffer female hysteria (it’s a conspiracy. we’re here to take over the world with our “hysterics” which is why our uteri must be removed at all costs!)
“What about my family history of type 2 diabetes?” I asked. He insisted that I was “too smart” and therefore had “too much to worry about.” I have to give him credit though. He was right about the “too smart” part – I never filled the prescription and never went back.
Keep up the good work. And wishing Pam (and you) quick healing and recovery.
Before medical negligence rendered me barely capable of keeping up with ADL’s – the activities of daily living – I was frequently working with lawyers as an expert witness. I found that I preferred working on homicide cases because most, usually all, the killing of another person or persons had already been done. Civil cases, in contrast, meant watching people being tortured to some degree, perhaps severely tortured, and I just did not want to be involved in that process for plaintiff or defense. Way back in time, when I was in medical school, we were taught to “First of all, do no harm”. Family and friends visiting patients provided social and emotional support, sometimes were urgently needed for assisting patients in eating, and sometimes would spend the night with patients, especially when children were admitted. There was no concept of needing someone to be constantly at the patient’s side in order to try to protect the patient from being harmed by the healthcare staff. Isn’t it amazing how far we have come with all the medical advances that could hardly have been imagined in the 60′s!
How many of you were taking a STATIN before you were diagnosed with AFIB, or had your AFIB worsen after beginning a STATIN?
I have seen no information on statins and arrhythmia.
If you look at the published side effects of statins, arrhythmia is certainly listed. Of course the statin makers also claim to have studies showing that this drug class can treat a-fib. For me, among the other painful side effects, my heart rate and rhythm was, indeed affected adversely with the only 3 doses I was able to tolerate.
I am not surprised. Over the course of a few months, my wife was spoke with three people who were having problems with muscles. They all radiated from the neck down in to the back. My wife asked each of them if they were on statins and they were. The pain stopped when statins were discontinued.
Most egregiously, there was an 86 year old neighbor who complained of the neck pains and was put on pain relievers. Turns out that she had been put on statins too. Why would a doctor put an 86 year old on statins?
I was told by my doctor to take them, but I declined.
Statins impair mitochondrial metabolism and therefore only people who have healthy mitochondrial functioning can tolerate them. Carnitine, (which is also available by prescription as Carnitor) has been shown in the medical literature to be of benefit, sometimes highly beneficial (search PubMed with the terms carnitine and statin and you will also find plenty of good full length free articles). All the antioxidants and vitamins, such as the group included in the “Mitochondrial Cocktail” as compiled by the Cleveland Clinic, will help support mitochondrial functioning. Some of the nutrients will benefit some people more than others since everyone has their own biochemical uniqueness. Mitochondria are less capable of self-repair by the time a person survives to age 40 (years). There will be no outward sign that you are over the hill after that, at least over the hill at the intracellular level. However, you will be becoming increasingly vulnerable to toxins, impaired healing, ageing, all the things you wish to never experience.
Dan, so sorry for your experience. I was considering ablating, but will not after I read your article. Question: I’ve been reading about a new ablation procedure called HIFU (high intensity frequency ultrasound or something like that) which is supposed to be more effective and safer than regular ablation because a balloon type mechanism wraps around the outside of the vein. Have you heard of this? Also, does your wife still have afib?
A good source of information is Hans Larsen’s Afib Forum. And here is a recent article in The Washington Post
I do not know much about HIFU — and I am not telling anyone to avoid a procedure if their Afib is so difficult to live with that you are considering it.
I am saying that if you do consider it, you need to do your research, you need to avoid teaching/research hospitals.
You need to find an experienced physician whom who trust and who you know will not hand the job off to a trainee without your knowledge.
Thank you for your comment.
A good source of information is Hans Larsen’s Afib Forum. And here is a recent article in The Washington Post
I do not know much about HIFU — and I am not telling anyone to avoid a procedure if the Afib is so difficult to live with that you are considering it.
I am saying that if you do consider it, you need to do your research, you need to avoid teaching/research hospitals.
You need to find an experienced physician whom who trust and who you know will not hand the job off to a trainee without your knowledge.
After you are unconscious in the OR, sometimes even the notes made in the medical record may not enable you to know who really did what, as I found out the hard way when I became a surgical patient at Hopkins. What might ward off highly disturbing discoveries after it is too late is a true “Informed Consent” that clearly spells out who will do what when you are having surgery and no family or friends are allowed in the room to be watching out for you. Of course, you must keep a copy of that consent form from the time your signature is given so that subsequent alterations are more obvious. Hindsight reveals so much!!
I just recently was an employee on the that floor – Halsted 5, which is the adjacent floor to the CCU and I am all too familiar with catheter tip afib ablation. I know all of the MDs you speak about – with the exception of the fellow. I have to say, working on that floor as a Nurse Practitioner was the worst experience of my life. I am thinking of starting my own blog detailing the hostile work environment and the workplace bullying that went on (All the time I was thinking “Is this how employees are treated in the # 1 Hospital in the world?”).I am shocked by what I read, and so incredible sorry. I had never even heard about this case (no one ever spoke of it) until I found it on the web, and did not know that mitral valve tearing was a possible complication. All of that being said I was not an employee at the time your wife was there. I applaud you for getting your message out. I will pray for you and your wife.
Dan, I wish you and your wife the best. I hope each and everyone of those individuals who were responsible for your nightmare, and there are quite a few, experience your pain ten fold.
I too have been told I am a perfect candidate for ablation.
After reading your story, I am rethinking my options.
Take care and God Bless
Chuck
Researcher says:
Researcher,
I don’t understand. You ask Dr. Mansour about the exclusion of Amiodarone. (I refer specifically to the J&J trial.)
He says ” …The use of Amiodarone was allowed in the medical treatment arm.”
However, the J&J study says: “Amiodarone was not allowed per study protocol.”
Some patients on the drug arm were put on amio at their doctor’s discretion. The 6 months amio exclusion prior to time zero applies as per protocol. So that comparison between patients who failed AAD without amio followed by ablation(s) and patients who failed AAD without amio followed with additional AAD plus amio is fair.
Hopefully, that clarifies why it was done the way it was. I noticed other ablation trials (with cryo balloons for example) had exactly the same protocol.
Wilber must be too busy to respond. Mansour is a well known EP at Mass. General involved in many trials so his answer should be trustworthy.
I still do not understand. I’ve read Mansour’s answer to your question several times and I don’t see where he answered it.
Think in terms of comparing second line ablation compared to second line AAD with Amio. Who needs to be excluded for the comparison to be fair? That is the question that NIH wanted to be answered for all new devices.
By the way, you will probably find the following presentation interesting. The doctor stated that many more patients are being killed by AAD medication than ablation. It is pretty hard to argue with the complication data comparison he shows for drugs vs ablation.
http://www.venicearrhythmias.org/2009/swf/0597.html
That was me.
Dan
I feel for you and Pam. I guess the “kangaroo” court is really trying to wallop you both with their lawyers. In cases like this the ins. co. is usually sitting in the back room – pulling the puppet strings. They play very dirty – so the court must have an odor of sorts?
Just thought I’d drop by because I do allot of research on clinical trials – and happened on this one recently — Looks like the notorious Hugh Calkins is at it once again~
http://clinicaltrials.gov/ct2/show/NCT00964392
Curiously – think about it – WILL Calkins disclose the experimental nature of THIS PROCEDURE to the patients signing on the dotted line as we speak???
So this got me wondering……..How many other patients
did he “a-hem” forget to mention that the same procedure done on Pam was still in the experimental stage?
If I was a juror I would think, hmmmm there HAD to be more patients he didn’t tell – adid they NOT know that they were secretly passed on to other drs. for their ablation also?
Geez, it’s like Calkins was running a Tanning Salon – Book em and Cook em!
If your lawyer doesn’t allude to deception of other patients – then the jury will most likely figure that out – Believe me it is a NO brainer.
Take heart – the appeal will be very appealing in Pam’s favor!
Blessings to you both.
Thanks for the link. I have learned so much from your site, particularly how to read study data with a more jaundiced eye. No, I have not failed anti-arrhythmic drugs yet, and no the risks of the procedure have not been discussed in any great detail. My cardiologist suggested it as an alternative to oral meds. Until reading your website I thought it was a relatively benign procedure that was well understood. My symptoms would have to become soooooooooo much worse before I would consider this. Thank you for taking the time to write this. You’ve performed a significant public service.
Allison, Your post distresses me because my husband was a very fit athlete who was also led to believe this was a simple procedure. He was well controlled on the medication, but had an ablation. Bottom line – he died. Please consider having a very frank discussion with your cardiologist. If it were me, I would consider going somewhere else. Doctors who are so flippant about this procedure should have their licenses revoked. Just my humble opinion.
Lynn
Allison,
Do you mean to tell me that this doctor offered ablation to you as a first-line therapy?
Dan
Allison said that she hasn’t failed meds.
I’ve read this with horror. Am I correct in deducing that there is no, none, NOT ANY safe ablation procedure for atrial fib? I was recently diagnosed with lone paroxysmal afib and am already being encouraged to have the procedure. After reading this I am now more terrified than I previously was.
Here is a good source for information: http://www.afibbers.net/forum/
Afib is terrible to live with, and I can understand why someone would want to have the procedure done, to want to have something done. I would urge people to become fully informed before making that decision. Your doctor is often not the best source of unbiased information.
Recently diagnosed, you are being “encouraged” to have the procedure. Encouraged by whom? Why? Have you truly failed anti-arrhythmic drugs? Are your symptoms so terrible that you would risk an invasive procedure?
Were you informed that the risk of death is 1 in 1,000? Did they tell you that they have no idea what the long-term efficacy of the procedure is? Did they tell you that you may well need to have the procedure performed twice or maybe even three times for it to be initially successful and that even then you will still have to be on anti-arrhythmic drugs and coumadin? Did they tell you that safety and success is highly dependent on operator experience? Were you told that if you go to a teaching hospital that your physician will likely have a fellow in training do the job?
There are many on Hans Larsen’s Afib forum, to which I linked above, who have had ablations and are glad they did. If your symptoms are severe and you choose to go ahead with it, that is a good place to get reassurance — and more information.
sorry to interject an opinion again but…
allison, if you have drug refractory symptomatic AF, ablation has to be considered, in addition to the 2nd or 3rd anti-arrhythmic drug as alternatives. most doctors are ethical and care for their patients as they would a family member; something that is incontrovertible to even the most cynical and well read lay people. despite what is out there on the blogosphere, the truth of the matter is this has to be considered. another reasonable website is http://www.a-fib.com where patients present both good and bad stories about ablation. i honestly cannot allow you to get a one-sided view here. this website is a good thing for patients, but honestly, even dan takes a reasonable view. he acknowledges both good and bad outcomes, and it would be hard to sleep at night knowing that a tragic personal tale would stand in the way of another person benefitting from a therapy that is available and that can potentially help. you represent the moral hazard in trashing a procedure which may help people. perhaps this is the panacea for all your ills, but unfortunately this website may be the vehicle which shapes your opinion on a potentially beneficial option.
JDH,
“…sorry to interject an opinion again but.”
Your opinion is welcome here. I believe in the free and open exchange of ideas. I cannot say the same for the site that you recommend http://www.a-fib.com/
I have been banned from that forum.
That should tell you something.
why were you banned?
My wife was banned first. They have a section called “patient experiences” or something and Pam just posted the facts of what happened to her at Hopkins. No opinion, just bare bones facts of her case.
I was banned for posting links to this site.
they should include pam’s story on the website. i provide that site, HRS website, and your site to the patients who see me for AF ablation consults.
it certainly helps foster the discussion for the second pre-ablation visit in the office.
That is a commendable attitude JDH. No one should be afraid of information.
Calkins “has been the most important person in bringing some reality to prior outrageous claims of success rates made by some centers.”
To which I reply:
Calkins was also one of the persons making those very outrageous claims of success rates. Early on, like when he was experimenting on people like my wife, he used to talk of ablation being the “cure” for AF. He famously claimed in 2003 that “Target the active pulmonary vein and the success rate jumps to 90 percent,”… “The procedure is ready for prime-time,” “Physicians and their patients should know about it.”
That’s before he figured out in 2005 that he had a success rate of 52% and a complication rate of 12%. That’s when he started turning down the hype — after he mauled at least 35 people — that we know of.
March 18, 2010 at 7:28 pm
“And it was about time, too. But he was the first. The first to learn from his mistakes and talk about it at national meetings. Prior to that it was near impossible to talk patients down from their expectations. From my perspective, it was the patients that were pushing very hard to have this procedure done and seemed surprised when my vociferous warnings about the complexity and risk became apparent. Many patients hear what they want to hear and won’t listen to what they don’t want to hear.”
The first to learn from his mistakes? He made a huge mistake by nearly killing my wife – that’s for sure – but this discussion has nothing to do with honest mistakes. It’s about deception and betrayal of trust.
What he “learned from” was experimenting on people and realizing late in the game that this procedure does not work as advertised — as HE advertised it.
He was dreaming of catheter ablation as the big cure for Afib with no more Coumadin. What he and the others learned was that this is a very risky elective procedure which offers only palliative treatment – and that’s not proven to last more than three or four years.
As I say, they learned that by duping people into the procedure and injuring and killing more than a few.
Dan
I have alot of catching up to do here- but find the comments interesting and poignant It doesn’t matter that they include for/against/whoknows/sourgrapes/ types of remarks –
So be it-
What I believe matters is that the readers are so very fortunate that you have the writing talent backed with intensive research to present Pam’s horrible experience with ablation.
I’ve read this one and many clinical trials – and this procedure was clearly not ready for “prime time” as Calkins spouted.
When a patient has faith in a doctor and that faith is broken – by misrepresentation- or garnishment of the success rate of a procedure that is in itself legally actionable if it fails. But when not told of certain harms in advance – that is clearly lack of informed consent.
What I find most unconscionable is the dr’s casual manner and unprofessional conduct in leaving Pam to a less experienced dr. by leaving her unattended. That in itself increased the material facts of the risks he withheld in the first place.
Pam was permanently damaged and suffers to this day and Calkins wants to defend his actions and walk away from it. Let’s pray he must pay for such arrogance!
Dan,
Wow. Can you email me offline.
JMM
Dan,
What a terrible ordeal. I think you have helped bring to the surface the mafia of the new millenium. So much money to be made, so many looking to make it. The attempt to cover up at Hopkins in my mind is a criminal act and should be handled accordingly.
You are a better man than I. I would be in jail by now.
On a side note, why is it that Johnson & Johnson always seems to be in the “mix” when it comes to unethical or outright illegal activities? I’m not singling them out, other than to say I’ve had my own issues with them. Perhaps illegal and device manufacturer always belong in the same sentence.
It used to be said about the French, but we have certainly trumped them as we have truly become “the nation of whores.”
Dan Walter says: We could never trump the French in that department.
The best coverage of corruption in medicine that I can find on the net is by Jim Edwards on BNET
I think I found the NIH Navistar file you are referring to.
http://clinicaltrials-lhc.nlm.nih.gov/ct2/show/NCT00116428
Can you please expand on your “rigged” comment with regard to the trial’s description? Thanks.
http://adventuresincardiology.com/chapter-next/
The trial design was biased in favor of ablation. According to Hugh G. Calkins, MD, when you compare ablation to drug therapy in people who have already failed an anti-arrhythmic drug,“What we’re doing is sort of guaranteeing the drug arm’s not going to work, you know, in virtually anyone.”
Let’s think for ourselves for a minute and not listen to calkins. Read the trial description and tell me what the problem is. I haven’t trusted what calkins has to say for a long while and I am not about to start now.
The problem is that it’s not only Calkins who says in essence that the study was bogus. From what I can gather, Bayesian statistical analysis is a long way from hard science and can be manipulated.
They were comparing drug therapy to a procedure. “After the initial procedure, patients in the catheter ablation group were allowed up to 2 repeat ablation procedures within 80 days. At the discretion of the investigator, a previously ineffective drug could be continued during the effectiveness evaluation period.”
The patients in the trial underwent up to three ablation procedures, could take anti-arrhythmic drugs, and were called successes if there was a decrease in afib symptoms. The headlines read “Ablation Better than Drugs for Afib”
These quotes are from transcripts of FDA trial design hearings:
Dr. Cynthia Tracy: “To me, it doesn’t make any sense to compare the risk of anti-arrhythmic drug therapy with the risk of catheter ablation… you are comparing apples and oranges….”
Dr. Simmons: “trying to randomize them to drugs is just not going to work, right? We all agree to that. There is certainly enough historical data on drug therapy for atrial fibrillation to establish criteria on drug therapy, plus it is not a comparable control. So doing a randomized study comparing some ablation technique to drug therapy for atrial fibrillation is kind of a meaningless study.”
Dr. Anne Curtis: “I agree… It is comparing apples to oranges. I’m not sure you can compare ablation in patient A, whose got their own pattern of afib, to how patient B does with drug therapy.
Dr. Tracy: “I agree with all those comments.”
Dr. Vetrovec: “I just don’t want you stopping the drug and then ablating them and then starting the drug again and calling it a success…”
” …we sought input from a significant number of E.P.s. We were told by many of them that a study comparing A.F. ablation and medication did not make for strong clinical science because patients that failed a drug are being randomized to additional drug therapy as the control.”….. Burke Barett, vice president of regulatory and clinical affairs for CardioFocus.
The bad thing is that there are these financially incestuous relationships involving the Universities, the doctors, the FDA, big pharma or big device companies.
You would think that an institution would want to keep itself clean…look closely at what is done or how it is done. They should want to know every aspect about how a patient is cared for.
The fact is that the institution doesn’t know anything about how procedures are performed and who does them…and what the incentives are to the doc.
Ablation should be an experimental procedure until it is DOCUMENTED to be effective and the risks are well quantified.
Amen, Frank.
I look at the trial differently. The control are the people on drugs that want to remain on drugs (this is real world because drugs are first line therapy for AF). If the patient fails drug, he is eligible for ablation and there are additional exclusion items as stated in the paper.
You also don’t need Bayesian analysis to tell ablation worked better. All you have to do is to take the worse results of the ablation group and compare it to the drug arm. The worse ablation results were still better than the drug arm, and by a significant margin. So significant that they had to stop enrollment for the trial because it was unethical to randomize patients to the drug arm and not give them a choice. It wasn’t even close.
When you said “rigged”, I thought you had issues with the way they picked patients. I looked at it and to me, they were going with real world and that is patients are ALWAYS put on drugs first despite the toxicity of available AF drugs and often very bad side effects. It is only after the patients either fail drugs or can’t handle the complications of drugs that they are candidates for ablation or surgery. The other aspect of the trial that is real is that not everyone that choses ablation has access to the best experts so there were top experts involved as well as mediocre centers with so-so EPs and there was a big spread in success rates amongst the centers.
It is very ironic that even Calkins is better than drugs for this group of patients as I surely would not want him or his trainees near my heart.
Researcher,
Frank says:
“The problem was that they excluded amiodarone/dronedarone and used second tier drugs.”
What about that?
Regarding the amio question, one part of the paper talked about exclusion of Amio. Then another part talked about Amio being used. I emailed the lead author to get the reasoning and a clarification. I will write more when I get the reply.
From what I can tell, there are two (official) reasons amiodarone was excluded — and they seem reasonable. Firstly, amiodarone apparently has an almost unknowable half-life, so you wouldn’t really know the effects the drug is having in the context of drugs/ablation in the study. Secondly, I understand that amio is a harsh drug over the long haul, so many docs are reluctant to start a younger person on it because of possible effects on organs like the lungs down the road.
But, I’m curious as to how the study can be justified when 2/3 of the potential subjects were excluded. Dr. Waldo says that “at least two thirds of the people being treated for atrial fibrillation with drug therapy are on amiodarone.”
Add to that the general agreement that Amio is the most effective AAD out there – and you’ve essentially crippled the study. You are excluding the most effective drug that ablation can be compared to. How does that make sense?
I haven’t heard from Wilber yet. As to your comments, it is true that Amio is very toxic and takes the body about 6 months to excrete. There is also the issue that some top expert EPs think (based on what data I don’t know) that Amio modifies ectopic substrate and that AF ablation when Amio in the body is useless because the ablation needs to be done on substrate that has not been altered by drug(s) like Amio (unless a patient is to be on Amio life long). The whole panel agreed to the protocol with NIH concurrence before hand so there has to be some reasoning behind not wanting Amio 6 months prior to enrollment. I will wait for Wilber to clarify.
Question: In the recent trials on ablation devices such as Thermocool and Arctic Front, there were exclusion of patients having taken Amiodarone for 6 months prior to enrollment and also not used in the drug arm. What is the reasoning behind that since Amiodarone is one of the more effective drugs?
2010-04-20 Answered By: Dr. Moussa Mansour
The two studies you mentioned were randomized clinical trials comparing medical treatment versus ablation for paroxysmal atrial fibrillation. The use of Amiodarone was allowed in the medical treatment arm. Amiodarone however carries some risk of adverse effects, such as pulmonary fibrosis, liver toxicity,thyroid gland dysfunction and others. According to the guidelines of the American College of Cardiology/American Heart Association, Amiodarone is not recommended as a first line of therapy in patients with atrial fibrillation and structurally normal heart. As a result many patients and physicians are reluctant to use this medication in young patients.
Floyd, When you say “Johnson & Johnson always seems to be in the “mix” when it comes to unethical or outright illegal activities?” – what are you referring to?
My opinion has been that JJ has been one of the more diligent companies when reporting device failures or adverse complications and doing subsequent voluntary recalls. Do you have some specific examples of JJ misconduct?
Hah! Just Google Johnson & Johnson and Justice Department.
Jim Edwards at BNet is about the only journalist out there covering this stuff in a serious way. Here’s just one example: “J&J Nursing Home Kickback Scheme”
http://industry.bnet.com/pharma/10006128/jj-nursing-home-kickback-scheme-tripled-risperdal-sales-doj-alleges/
How about heart related devices as that is what I was referring to and more interested in.
Dan you referred to rigged Navistar J&J trial. I looked at the NIH clinical trials site and there are more than one. Can you provide the link to the one you are referring? Thanks.
The problem was that they excluded amiodarone/dronedarone and used second tier drugs.
Tip of the iceberg. Looks like a culture of deceit/arrogance. It’s not just devices, but all aspects of the company. They are not alone, but they are in the mix at several levels.
The problem involves allegations that a J&J unit called Scios marketed the heart drug Natrecor for “off label” uses, or for treatment of conditions for which federal regulators have not yet approved the drug. The U.S. Food and Drug Administration approved Natrecor in 2001 for patients experiencing acute heart failure. But according to Law.com, the government could be ready to pursue charges that Scios also marketed the drug for chronic heart problems, for which it didn’t have FDA approval
Stryker, Biomet, DePuy Orthopedics, Zimmer, and Smith & Nephew Settle, Agree to Deferred Prosecution It’s fall, the season for settlements, deferred prosecution agreements, and federal monitors. Reported by numerous reporters was a large settlement made by five companies that manufacture orthopedic devices, Stryker Orthopedics (a unit of Stryker Inc), Biomet, DePuy Orthopaedics (a unit of Johnson & Johnson), Zimmer Holdings, and Smith & Nephew. As reported by Barnaby Feder in the New York Times,
Of the five companies involved in the agreement, all but one will be paying hefty fines, which add up to $310 million. The companies include Zimmer Holdings Inc. (fined $169.5 million), Biomet Orthopedics (fined $26.9 million), DePuy Orthopaedics (fined $84.7 million), Smith & Nephew (fined $28.9 million). The fifth company, Stryker Corp., was not required to pay any money since the company voluntarily cooperated with investigators before any other company did and was able to enter into a Non-Prosecution Agreement with the government.
How bad could that Texas lawsuit against Johnson & Johnson for mismarketing Risperdal be? Try $5,000 per visit of a sales rep to a doctor.
That was the formula used in a West Virginia state court case in which the state attorney general sued J&J and its Janssen Pharmaceutica unit over false or misleading statements about Risperdal and Duragesic. The West Virginia judge assessed only $4.4 million in fines, but the formula he used — $5,000 per visit of a rep to a doctor plus $500 per letter or brochure — could have resulted in $22 million in fines.
The court noted in its order,
The defendants were twice put on notice by previous [FDA] warning letters that its promotional materials for Duragesic contained false or misleading statements; however … the defendants then willfully sent the false or misleading Duragesic [brochure] to West Virginia health care providers to make its medication Duragesic more appealing for sale.
The wording of [the] November 2003 Risperdal letter was intentionally constructed to modify the FDA’s warning language and mislead healthcare professionals, who rely on this information when prescribing medication for their patients.
J&J faces a much bigger suit in Texas, where it has been accused of Medicaid fraud, kickbacks and improper marketing of Risperdal to children and the poor in that state
The rigged Navistar study showing ablation is better than drugs got the big PR rollout, but when J&J had less heartening news to report, it didn’t do the full court press. This from a Reuters dispatch in 2005:
“Johnson & Johnson has revised the label of its Natrecor heart failure medicine to include data that suggest it may increase the risk of death, following two widely publicized medical journal articles that questioned its safety.
J&J did not issue a press release to announce the label change.
Instead, a company Web site, Sciosinc.com, published the lengthy label without pointing out which section of it had been added. “The label was quietly changed by Johnson & Johnson, which apparently doesn’t want to attract much attention to the new mortality language,” said Dr. Steven Nissen, a cardiologist at the Cleveland Clinic who in 2001 advised U.S. regulators not to approve Natrecor.”
How do these people sleep at night?
Some people never developed far enough, at a psychological level, to have even the start of a conscience. It would be so welcome if they could become healthy enough to start to have a conscience. And even better if they could then have a profound ability to recall all that they have done to others. When I am face to face with such persons, I pray that they may experience such a miracle as psychological growth in this realm where they are so deficient. Doing so helps me keep my language and tone of voice closer to what is acceptable out in public.
How about this year……so far.
Johnson & Johnson Charged With Kickback Scheme
8 Comments
By Ed Silverman // January 15th, 2010 // 12:33 pm
The US Attorney in Boston says Johnson & Johnson paid tens of millions of dollars in kickbacks – in the form of special rebates and other payments – so Omnicare, the nation’s biggest provider of pharmacy services to nursing homes, would put more patients on its Risperdal schizophrenia med (the Justice Department statement).
Dan, I think we were separated at birth. I am in total agreement with you.
We could obviously go on with the likes of Pfizer, Merck, Astra Zeneca, Lilly, etc., not to mention the Ranbaxy’s and other foreign interests that blatantly lie, misinform, and on and on. Let s not forget the huge buckets of money going to those top-tier hospitals we always see in USN&WR. Sure, they do good work, but let’s not sacrifice people in the “interest of science” plus we get a few million to add to the budget.
The government needs to start taking criminal action as people are dying because of a need to make the annual report look good for Wall Street.
researcher,
Not sure what you’re looking for. J&J and most device manufacturers (Medtronic, Guidant, etc.)have the common thread of paying for endorsements, fudging the numbers, etc. If it’s found throughout the organization (different divisions), is it fair to assume that corporate governance is tainted? There is so much money involved, the fines that are levied is mere pocket change. Probably goes into the annual marketing budget.
I would look deeper into Thermocool. It’s all public record.
It’s disturbing because who can we trust to give us honest, accurate information these days. The marketing spin that companies put on their products/services are telling you all is fine, just don’t pay attention to the people that are dying, experiencing extensive morbidity or the fact that we changed our protocols mid study. Everything should be ok as soon as my Golden parachute is packed and ready.
How can anyone possibly use the word “Cure” when referring to ablation therapy for AF when patients are required to undergo additional procedures, continute taking their meds and still have breakthrough episodes. Those are the lucky ones. How about those that never make it off the OR table?
Please don’t get me wrong, this is not a personal attack at your question. I just wonder when the great unwashed will wake up and realize they are being killed or maimed so the inner circle of executives can line their pockets with blood money?
My heart felt empathy for what Pam and you went through and still dealing with. As I said in the other forum, it seems complications are being under reported and you have uncovered an example of it. I have seen the same thing recently when I compared the complications reported in a recent journal publication about a new piece of equipment to what was actually filed with the FDA. There is an inherent conflict of interest since the doctor(s) are paid consultants. It is scandalous especially since this latest and greatest is still being marketed as “safe”.
I am sorry that you and your wife experienced this tragedy. It is important to remember that there is only one road to becoming an experienced surgeon, and that is by being an inexperienced surgeon (albeit under close, experienced supervision). You may be interested in reading the novel House of God by Shem, or the factual writings by Atul Gawande. The overwhelming majority of people on the other end of the stethoscope are disturbed many aspects of the health care system, and we are working hard to fix them. However, as you have experienced, there are very few easy answers.
Thanks. “House of God” is one of Pam’s favorite books.
It is important for you as a medical student to remember that betraying a patient’s trust is the worst sin a doctor can commit.
I am very sorry for what you and you’re wife have been through. I confess that I have put patients and their families through similar ordeals. Every physician has, and most of us are doing our best to make sure patients who decide to have relatively elective procedures understand what they are getting themselves into while doing our best to prevent any complications.
I perform ablations for atrial fibrillation and successfully convince most patients not to undergo the procedure. It is very difficult to adequately explain to patients the complexity of this procedure, the uncertainties regarding success and the myriad of complications that can occur.
I will recommend this website to every patient considering this procedure from now on.
I do not know Hugh Calkins personally. As pointed out, he is a well known figure. I do not defend his actions but I can say that he has been the most important person in bringing some reality to prior outrageous claims of success rates made by some centers. Between his call for more rigor in follow up to support claims of success rates, Dr. Cappato’s registry publications and this website, it is easier to give patients a more accurate picture of what to expect.
You write that Calkins “has been the most important person in bringing some reality to prior outrageous claims of success rates made by some centers.”
Calkins was also one of the persons making those very outrageous claims of success rates.
Early on, like when he was experimenting on people like my wife, he used to talk of ablation being the “cure” for AF. He famously claimed in 2003 that “Target the active pulmonary vein and the success rate jumps to 90 percent,”… “The procedure is ready for prime-time,” “Physicians and their patients should know about it.”
That’s before he figured out in 2005 that he had a success rate of 52% and a complication rate of 12%.
That’s when he started turning down the hype — after he mauled about 35 people.
And it was about time, too. But he was the first. The first to learn from his mistakes and talk about it at national meetings. Prior to that it was near impossible to talk patients down from their expectations. From my perspective, it was the patients that were pushing very hard to have this procedure done and seemed surprised when my vociferous warnings about the complexity and risk became apparent. Many patients hear what they want to hear and won’t listen to what they don’t want to hear.
This certainly looks familiar: http://www.nytimes.com/2010/02/14/health/14robot.html?ref=todayspaper
Results Unproven, Robotic Surgery Wins Converts
“…Marketing has moved into the breach… New technology has sometimes led to big advances, which can justify extra costs. But often, technology spreads long before investigators know whether it is worthwhile.”
The technology is incredible. The issue is…again…are the results believable when its sponsored by a company…when there are major marketing and financial forces that are driving the technique.
This equipment becomes obsolete so fast…the costs are so high…again, I plead for data – not hype.
High technology has enamored all of us…it’s just got to be better – and some of it is…and some of it isn’t.
Cardiology may be the worst…everyone wants stents or procedures or the lastest and best. Unfortunately, when you critically look at the data, in the vast majority of patients, invasive interventions or bypass surgeries pale in comparison to old fashioned medical therapy – not always – but most of the time. It is a fascinating phenomena. I was hoping that health care reform would evolve so that evidence based medicine would become more the norm and less the exception.
This is a high risk procedure and even 1-2% mortality rate is expected from this procedure. If the doctors have to been taken to the court for every complication, no one will do the high-risk procedures. Certainly, these risk should be minimized at their best effort.
I do have sympathy for the family. However, on the other hand, I doubt that it is appropriate to post their names and photos in the internet. It is sort of an extreme action to get even with the doctors.
Maybe you should read the story.
Dan:
As I was reading the local paper about the successful Thermocool AF trial (for interested readers see Journal of the American Medical Association 1/27/2010 on catheter ablation for patients with paroxysmal atrial fibrillation who have failed one anti-arrhythmic drug) in the Philadelphia Inquirer, I was saddened to see your comments below the article online. Have you resorted now to smear tactics based upon your personal tragedy?
It is laudable to tell your wife’s story to caution patients and families alike. Certainly to spend your time preventing others from being helped by a procedure (that overall does help alot of people despite an overall low percentage chance of serious risk) is reprehensible.
Read the posts below after Henry’s.
lynn makes wonderful points. again it is a tragic story that i cannot even imagine happening to my spouse.
regardless, informed consent discussion for AF ablation should be a lengthy discussion. When I undertake this discussion with patients (I am happy to give my bias as you do yours) it often occurs over many visits in the office and I encourage spouses and families to be present. I mention death, and the described serious complications as quoted in the literature and tell patients my serious complications as well. i also provide them the success rate in elimination of atrial fibrillation in my hands and in the published literature (being careful not to mention the word “cure”) which is approximately 70-80% for paroxysmal patients and 60-70% for persistent AF patients. I do mention that they may require more than one procedure to achieve success. i provide internet websites which present a balanced view of the procedure. many of my EP colleagues take a similar approach.
informed consent should always be given, and it is one of our most sacred jobs to provide this truthfully. not every physician does this unfortunately as evidenced by posts on your website.
however, as the medical literature has born out in the last 10 years, and will continue to do in the future as we perform larger and larger randomized trials on AF ablation, your cautionary tale will hopefully provide pause to all patients seeking ablation as a counterpoint to the clear benefits it provides to most.
providing a forum for patients and loved ones to cope with their complications as you do is commendable. to “put yourself out there” with such a personal tragedy is again laudable and I am not sure I would have the strength to do so. how you choose to prevent many patients who can be helped by this procedure is your First Amendment right. I cannot walk in your shoes and can only imagine that you view this as a way to prevent another tragedy such as your wife’s.
At a certain point though, you do harm people who can be helped by this procedure. You cannot escape that truth whether you agree or not. It will not help you or your wife cope with her tragedy, nor bring Lynn’s husband back. that is the sad truth.
Let’s look at the disclosure for the study:
Funding/Support: This study was funded by Biosense Webster, who provided the catheters used.
Financial Disclosures: Dr Wilber reported receiving grants from Biosense Webster, Boston Scientific, Medtronic, and St Jude Medical; consulting fees from Biosense Webster, Medtronic, and Sanofi-Aventis; honoraria from Biosense Webster, Boston Scientific, Medtronic, and St Jude Medical; and royalties from Blackwell/Futura. Dr Pappone reported receiving grants and consulting fees from St Jude Medical and Johnson & Johnson, and honorarium from Biosense Webster. Dr Neuzil reported receiving grants from Biosense Webster, Cardiofocus, Cyrocath Technologies, Hansen Medical, NIH BARI 2D, and St Jude Medical; consulting fees from Stereotaxis; and honorarium from Biosense Webster. Dr De Paola reported receiving a grant from Bristol-Myers Squibb. Dr Marchlinski reported receiving grants and honoraria from Biosense Webster, Boston Scientific, and St Jude Medical; consulting fees from Biosense Webster, Boston Scientific, GE Healthcare, Medtronic, and St Jude Medical; and speakers’ bureau fees from Biosense Webster. Dr Natale reported receiving grants from Biosense Webster and St Jude Medical, and speakers’ bureau fees from Biosense Webster, Boston Scientific, Medtronic, and St Jude Medical. Dr Macle reported receiving consulting fees and honorarium from Biosense Webster. Dr Daoud reported receiving consulting fees from BARD and Biosense Webster, and honorarium from Biosense Webster. Dr Calkins reported receiving consulting fees from Ablation Frontiers, Atricure, BARD, Biosense Webster, Boston Scientific, CryoCor, CyberHeart, Medtronic, ProRhythm, Sanofi-Aventis, and TASER International; a grant and honorarium from Biosense Webster; speakers’ bureau fees from Atricure, BARD, Biosense Webster, Boston Scientific, Medtronic, and Reliant; and fellowship fees from BARD, Boston Scientific, and Medtronic. Dr Hall reported receiving consulting fees from Biosense Webster. Dr Reddy reported receiving grants from Atritech, Boston Scientific, Biosense Webster, Cardiofocus, CryoCath Technologies, Endosense Hansen Medical, St Jude Medical, and Stereotaxis; consulting fees from Biosense Webster and St Jude Medical; and honoraria from Boston Scientific, Biosense Webster, Medtronic, and St Jude Medical. Dr Augello reported receiving honoraria from BARD, Biosense Webster, and St Jude Medical. Dr Reynolds reported receiving consulting fees from Biosense Webster, Cardiome Pharma Corp, and Sanofi-Aventis. Mr Vinekar and Ms Liu are employees of Biosense Webster. Drs S. Berry and D. Berry reported receiving consulting fees from Biosense Webster, Veridex LLC, Boston Scientific, Endologix, R.R. Bard, W.L. Gore, Medtronic, Bristol-Myers Squibb, Pfizer, and Teva Pharmaceuticals.
industry funding has always played a role in medical development. only now we have rules to at least disclose publicly industry funded support. i agree fully with this. the medicines and devices used in all medical specialties are largely developed by industry and their collaboration with physicians and nurses.
many of the life saving breakthroughs we take for granted (and some of your bloggers have probably benefited from)are as a result of the process you delineate above.
it is important for people to debate you, as it will only highlight both sides of the issue. as the crushing weight of positive evidence consumes more and more of your time, you will need others to help in your cause. you also probably know that we are currently undertaking the CABANA trial, a 3000 pt randomized NIH sponsored trial to demonstrate whether there is a lifesaving benefit to AF ablation over anti-arrhythmic drugs. Smaller single center trials as well as recent JAMA article on Thermocool AF have demonstrated the advantages of ablation in smaller pt populations.
your wife’s story speaks for itself and is very powerful. it certainly has changed how I talk to patients. taking your message off the blog though will be a tougher job. no one is going to give you a free ride…
jdh – I would tell everyone to run, as quickly as they can. Living with AF is so much better than the consequences can be. My husband is DEAD because we believed doctors who mislead us as to the safety of this procedure. If we had known the real risk, we might still have gone forward, but it would have been a truly informed decision. So, I find myself 48 years old and a widow because we believed the lofty promises that are not true.
Nobody is preventing anyone from having this procedure, but people need to be informed of the true statistics. The chance of major complications is much higher than is presented to the average patient. Please don’t insult with your assumption that there is some kind of smear campaign going on. People should have a healthy fear and do the research before they allow themselves to be led down this awful path.
Just for a moment imagine that your wife or husband has an issue that they can live with, but they are promised a cure. Then they are told that this is a relatively simple procedure with some risks, sure, but they are young and healthy and the risks are mostly associated with the anesthetic anyway. Who wouldn’t do it? If it meant they were cured? Now, imagine that that same person never comes home from the hospital and you are left wondering why you didn’t research this sooner? As hard as you try to imagine you’ll never get it and you should be grateful for that.
Lynee
Lynn, So sorry for the tragic outcome on your husband.
I am catching up on my reading at this blog and would like to find out more about your story. Where do I go to find a more detailed account of what happened during your husband’s procedure?
If not available, perhaps you can share here or on afibbers.net under something like “ablation horror stories”
Thanks.
Researcher – thanks for the kind thoughts and words. I haven’t written an accounting, it’s still too raw and fresh for me. I will keep the website in mind and when I’m ready I might do that. I think the idea of having this and other sites that tell the truth about the statistics are vital for those considering it.
Lynn
“Providing a forum for patients and loved ones to cope with their complications as you do is commendable…”
Commendation refused.
I am not providing a forum in which patients and loved ones can cope with their complications.
I am providing an outlet for victims of medical negligence.
thanks for clarifying the purpose of your website.
to answer a question with a statement on “smear tactics”: show me reasonable examples that you provide of positive research data on AF ablation in your website. you provide a one-sided view. you must know (as you have done a significant amount of reading) and must acquiesce to the fact that there is a positive side here. you just choose to ignore it in your website. without some sort of balance you do a disservice to many. as you “advertise” your website after newspaper articles, you will need to prepare for more of this.
turning doctors damaging words on themselves is quite an effective tool. thankfully you are protected by malpractice law and awards and your effective writing must have helped your malpractice attorney win the case. but that doesn’t reverse or fix the permanent damage to your loved one.
because these are your “beliefs”, and certainly even if incorrect at times do not rise or meet the criteria for slander, you can continue with this. as the law on internet content leaves much ambiguity about false claims or character assassination as you conduct with Dr. Calkins, you are protected to do what you do. i get the feeling someday you may cross that line, which will be unfortunate. you are right to suspect that once people with resources are threatened enough, you will be bear the brunt of the monied interests. I neither agree with it as a liberal politically, or a physician professionally. But it probably will happen.
i provide help to patients who suffer from AF on a daily basis with a variety of options including lifestyle changes, medications, and yes catheter ablation.
i hope my patients read your website. most will come back to me for help after spending time navigating it….
good luck dan, i’ll let you have the last word.
The “successful Thermocool AF trial”
Doc,
Please explain this section:
“After the initial procedure, patients in the catheter ablation group were allowed up to 2 repeat ablation procedures within 80 days. At the discretion of the investigator, a previously ineffective drug could be continued during the effectiveness evaluation period.”
So the patients in the trial underwent up to three ablation procedures and could take anti-arrhythmic drugs? And this is s successful study?
this was the specified design of the trial. i’ll bet your website that this was part of the informed consent process for each and every patient in this trial and they were told that they may require more than one procedure(i consented a few myself). they all knowingly and willingly signed informed consent and the study physicians were practicing the standard of care.
when you analyze the kaplan meier curves in results section, demonstrating a 66% freedom from AF in the ablation arm, vs a 16% freedom from AF in the drug arm during 9 month effectiveness period, the results clearly favor ablation for patients with drug refractory PAF. these results cannot be extrapolated to persistent AF or patients with low ejection fraction. but for younger patients with symptomatic PAF who have failed one drug, this strategy clearly wins. at least the JAMA editors and most cardiologists and EP’s think so.
for those interested in taking an unbiased look for themselves please see JAMA 1/27/2010. also see the live AF ablation procedure on the Today Show from this morning at the Cleveland Clinic on NBC website. the more proper publicity for this procedure, the better.
Did you see that they never talked about the specific risks involved in the procedure. “oh, she’s completely awake and not in pain at all”. She will be “cured” after this zapping (she might have to come back, but then we’ll “fix” her for good).
Please understand I don’t mean to be flippant and I know that people have been helped, but they make things sound relatively risk free. (MY heart almost stopped when she talked about a video game).
My point all along is “informed consent” and doctors who tell the truth. It was somewhat comforting to see that the doctor didn’t stop what he was doing INSIDE that woman’s heart to talk to the reporter. What a stupid thing to do to sit next to him and distract him. Also, how would he react to a complication? Would he get up and go into the room with the actual patient or would someone else handle it? I’m sorry – I digress – you must understand how upsetting that segment was for me.
The only thing I got out of this is that it is a new “miracle cure” and it is sooooo safe and also it is now even easier for the doctor to hand off the controls to someone else – how would you ever know which doctor is working on you as they aren’t even in the same room?
You know, I’m sure that for this particular woman, cardiac ablation was a “miracle”. IF it works, she will be much better off and it will seem like she has been given a new lease on life. I get it…my husband would probably have been the same way. If he could have lived the life he wanted to; it would have been a dream. Instead; without informed consent, it is a nightmare. My only intent is to make sure that people know the TRUE risk involved. Don’t candy coat this or any other procedure. People are smart; they can take the truth. Arrogant doctors who believe we only need to hear what we can “handle” are just plain wrong. This procedure has a high complication rate – you might die or worse live out your days severely brain damaged from lack of oxygen – it might be worth it to you to take that risk, but understand it does happen.
Please jdh, the next time you walk into the cardiac cath lab, think about your patient – who are they? What are their hopes and dreams? They have value. You took on this profession with your eyes wide open and I hope they continue to stay open. Expect to be held accountable and stop making excuses for those who are not doing their patients justice.
Lynn
Why was the most effective drug eliminated from the study apriori?
I’m not trying to defend the drug…I just want to know why the most effective drug wasn’t studied in the protocol?
Why wasn’t it’s successor studied?
This was a study that was designed to make ablation look good.
Kinda stacking the deck don’t you think?
JDH – Please do me a favor and stick to the topic…and not speculate on what I do or don’t do about cardiology and its attendant procedures. Don’t excuse your proclivity to do invasive procedures because you RATIONALIZE that I said patients for unnecessary invasive procedures.
Incidentally, I have (as mentioned to Dan on a number of occasions in private conversations) an equally jaundiced view about coronary interventions and stents for patients with chronic (not acute) coronary syndromes. Please don’t lump me with all of the other lemmings in cardiology. Indeed, I agree with you that there are far far too many coronary interventions…a whole different topic…maybe a whole different website – but nothing to do with ablation which is the purpose of this website.
You know NOTHING about how I practice medicine…and you are telling me what I do and who I send to the cath lab?!? Tell me something…where do you get your information about me – the same place that documents atrial fibrillation ablation statistics?!? How ignorant and arrogant of you.
I try to take care of my patients based on the best available information and a considered evaluation of the patients condition, age, comorbidities and any number of other factors that are individually appropriate. I don’t scan, echo, or test relentlessly. I evaluate each individual personally and I keep up with the literature.
Show me the data….long term data…because right now for atrial fibrillation, the best information for management of most (not all) atrial fibrillation patients can be derived from conclusions from AFFIRM!
I have seen surgery for atrial fibrillation…I watched Cox do some of his early work…never, would I subject a patient to that procedure – but don’t use that as a rational or justification that you should keep on ablating…right now, there is absolutely no long term data about the consequences of the procedure…yet I hear ads on the radio for several hospitals trolling for victims – all in the name of dollars. There are analogies here…I’ll try not to be blatant, pornographic or indiscreet…but maybe you should practice a bit of intense self-examination and not speculation about what I do in my practice of medicine.
i provided a short list below for you to check out, but i am sure you have read all of these articles anyway. i hope you feel better after your venting.
if you practice a rhythm control strategy as AFFIRM would suggest(although of course we can argue the substudies that demonstrate mortality benefit in patients who actually maintained SR), are all of your patients happy with this “strategy”?
pardon the typo, i meant rate control strategy in paragraph two first sentence.
keep the insults coming frank. i find them rather enjoyable.
jdh – your arrogance is amazing. This is what is wrong with the overall profession of cardiology. You are right no matter what – your view is the “right” way and there is no swaying you from your path. You have decided the literature is skewed, but because it is the best you have, you will follow it. You have decided to make a “game” out of having a discussion with someone who might disagree with your view of the world.
Tell me, jdh, how many patients have you sent to the cath lab for ablation who died because of it? Can you remember their names, what about their faces, what about the faces of their loved ones? I’m just curious if you keep those patients in your memory and learn from their loss or do you go back to the literature and start spouting the statistics, flawed as they are?
Lynn
lynn
i am not right all the time, in fact i make mistakes and errors every day, just like you. and this is no game. we are arguing over a procedure that has ramifications (both bad and good) for tens of thousands of people. i think disagreement is good and have answered frank and dan with counterpoints which obviously have drawn strong reaction. it means that I am making a successful counterpoint here. most of my debators now call me arrogant. that’s ok.
i have not had a death during an ablation but i could go over each and every one (which is thankfully a small number) where a patient had a complication. i could tell you their each of their names, faces, (of course I won’t to protect privacy) and their spouses names. i can tell you what they do for a living, and how many kids they have. that isn’t anything special, that’s my job.
i faced their loved ones with empathy and compassion. i have and will continue to spend hours at their bedsides while they get better. your last paragraph couldn’t be farther from the truth. you or dan or frank can demonize me, but unfortunately, in real life I am one of the most compassionate, empathetic and skilled people you will come across. my patients will tell you that. my practice grows larger each day due to the skill and personal care I provide. i dont want or expect any gratitude or special treatment because of it, again it’s my job.
no one can fill the hole left by the death of your loved one during the ablation procedure. i don’t expect you or dan to ever ever agree with anything that I say. regardless, i feel empathy for your loss and for dan’s wife’s tragedy, whether you think I do or not.
i wish you the best lynn. i hope with each day your grief diminishes and you find peace. you and dan and frank should have the last word in the debate. as this is a website about medical negligence as dan would put it. it is not a website to discuss ideas on both sides of the fence here. that is clear.
i look forward to the book dan and to see how the story ends…..
Thank you jdh, I do appreciate the kind thoughts. It would appear that my grief and my anger are deep and it is true they are. I rarely am cruel, and after going back over my posts, I made generalizations about you that may or may not be true. If I’ve learned anything through this experience it is that I am quite capable of being cruel and have been on several occasions.
Peace will be a long time coming for me because both myself and my husband were lied to about this procedure. Because he was in such great physical shape (an athlete), we were led to believe that the only risks were from the anesthetic. This, of course, proved to be untrue as it appears that the catheter punched a hole in his heart. Then to compound the error, it wasn’t recognized soon enough and by the time they reacted, his brain was severely damaged. That is why the video with the doctor in another room altogether affected me so strongly. The doctors involved did not intend to injure anyone and, in fact, were trying to help, but without the truth, we did not make an “informed decision”. This is where my argument lies. I made a generalization that you lie to your patients and there is no way for me to know that – it was fueled by grief and anger and for that I am sorry.
Please do me a favor and don’t ever lose your humanity in a profession that sometimes causes one to do it.
For anyone thinking about having cardiac ablation – please research the risks – do not rely on your doctor to tell you everything. Be your own advocate and make an informed decision. Please do hold your loved ones tight and make sure your house is in order because the risks are there and they are real as I’m sure the rewards are.
Lynn
JDH – I do think that industry supported studies are generally suspect with respect to devices especially – see recent “mess” in England about septal occlusion devices.
In general drug studies have had their results reviewed and tabulated by a blinded independent group…this is not the standard for devices.
I have not insulted you…I have not told you how to practice medicine…I have tried to give you an insight into how I practice medicine. I have told you that I disagree with the widespread use of an intervention that does not have long term data for safety and efficacy. If the studies are still being performed to assess these issues…how can this be considered anything but an experimental procedure? Why is ablation being used as a clinical tool at this point in time?
I thank you for the references…and yes, I have read them. I do not concur with your assessment that these results warrant the use of the technique in patients with atrial fibrillation.
JDH:
I don’t think anyone intends insult.
We have a woman whose husband was killed by this procedure.
We have a man whose wife was terribly injured by the procedure.
We have a cardiologist who believes the procedure is unsafe and unproven.
We have a cardiologist who believes the procedure is safe and effective.
I want to know from you, JDH, what kind of complications you have seen, and how many?
I want to know if you have any conflicts of interest. I want to know if you have received any inducement or encouragement, backing or reward of any kind from the device industry.
I want to know if you truly believe that performing multiple invasive procedures – which carry a proven death rate of one in a thousand each time the procedure is performed – is safer for your patients than drug therapy.
How can you defend this industry sponsored study, which Hugh Calkins has said was doomed to fail because “it sort of guarantees that the drug arm’s not going to work.”
Why, exactly, are you so enamored of catheter ablation for atrial fibrillation?
dan
i have done approximately 500 AF ablations. i have had one tamponade which was drained during the procedure and patient discharged next day.
i have had one stroke with permanent arm motor deficit. patient is in sinus off coumadin although of little comfort to that person i am sure.
no significant groin complications from access, PV stenosis, AE fistula, MV damage or death etc.
i have not personally taken a dollar from device or ablation industry for consulting, speaking or research. i have participated in industry funded trials (like thermocool AF) as well as NIH sponsored trials at no personal financial gain.
i have no financial conflict of interest.
drug therapy is no free lunch. each drug has issues. if patient has coronary disease, and a class 1 drug is used, higher incidence of fatal MI and arrhtyhmias (see cast). if amiodarone used, toxic to most organs. if patient develops occult kidney disease possibly a 2-4% risk (which may be conservative estimate) of torsades de pointes which can be fatal on tikosyn and sotalol. many interactions with tikosyn and sotalol that may go unrecognized in our age of polypharmacy, and I can go on and on. in younger patients some studies suggest 25-50% patients (25% of the amiodarone pts in Affirm) had to stop the drug due to intolerance.
i believe in the procedure because it works.
Five hundred successful procedures with only two complications! You are better than Natale. You are better than anybody.
And all these patients in NSR with no AADs.
Remarkable.
I have done 500 ablations. I keep a database on my patients and my success rate is approximately 80% for PAF and 70% with persistent’s from one procedure. i monitor patients with 30 day event monitor post ablation and 7 day monitor at 6 months, one year, and with symptoms. I have taken back ~10% to the lab for a second or third procedure.
I think my patient’s success rate is comparable to the better AF centers but I cannot compare myself to Natale, he is a world expert. I am not.
Certainly a small percentage of (about 25% of patients that I follow require AAD post ablation, and the goal of ablation is not primarily get patients off drug, it is to control AF) patients are still taking AAD’s post ablation. But if you ask them how life is without AF anymore, they will tell you it has given them a new life.
You have resorted to the above comments, it is truly sad that this is what you have devolved into in this debate. it speaks volumes about you. You can mock me or whatever you are trying to do with the above comment, but in the end it becomes pointless to debate the above nonsense.
JDH
I agree with Dan you must have a gift! You should publish those results. Your results are beyond compare. No one in any journal, in any series has published results as fantastic as yours. Your complication results are better than any other reported series. You should be teaching this technique down at Hopkins, or Penn, or Harvard. You should report this at the upcoming ACC – why don’t you do an abstract or poster?
i publish papers and abstracts every year.
there is nothing relevant in my results. they are comparable to most centers.
i would have thought better of an MD Frank….
I am a practicing cardiologist who did electrophysiology training. Your story is honest, true and a very apt and telling description of a horror story. I do believe that the entire concept of atrial fibrillation…indeed of catheter ablation of most (not all) cardiac structures is frought with danger and quite honestly should not be performed except under the most dire of circumstances. I can’t defend the medical community’s blatent advertising of the technique on television, radio, and news articles.
It is reprehensible that dishonest statistics and assurances are made to the general public. I truly believe that an audit of Dr. Calkin’s statistics for success – I mean permanent, long-term success of the technique should be insisted upon. This data needs to be available for Hopkins and for all hospitals in our country. There is absolutely no chance that any ablation technique (for the atria or the ventricle) is capable of the success rates that are being described over the long term.
Please keep up the story – if you wish someone to review or comment on additional pieces of information, please feel free to contact me.
It is interesting to see your reply here because my husband died during an ablation procedure in October. He was perfectly healthy, but had atrial fibrillation and hated taking the medication. We were led to believe the statistics surrounding the procedure (this was NOT done at Hopkins). So, at 53 he drove himself to the hospital and his heart stopped during the procedure. They brought him back (with mixed messages as to how long he was “down”), but he was dramatically brain damaged and died 8 days later. After extensive research between October and now I can see that the statistical information is seriously flawed. These procedures are not as “safe” as patients are led to believe and the complications can be extremely serious including death. The comments below that reflect “hey, mistakes get made” wouldn’t be made if one of their own family had actually died during this “relatively minor – safe procedure”.
I believe that if an audit was performed of all patients who were treated with ablation alone (no additional medications) and followed over a 5 year period of time – the rate of recurrence of the arrhythmia would be 70-75% (failure rate)! These centers that are advertising a cure are selling snake oil. Dr. Calkins sold and bottled the snake oil in Baltimore…and he is trying to sell it nationally as well.
frank, as a practicing cardiologist, do you prescribe anti-arrhythmic medications? what are their long term successes in controlling AF?
are there downsides to AAD therapy, even fatal side effects? (for the laymen see CAST trial) is there literature out there to suggest that ablation may actually be better then AAD therapy in smaller trials? what does Affirm trial and other trials tell us about long term mortality in patients with AF?
I didn’t train or practice at Hopkins. certainly there is some “snake oil” peddled out there about ablation procedures by some, but certainly not the majority. unfortunately your snake oil is just as slick. there are many alternatives to catheter ablation. leave patients in AF and live with the symptoms, try drugs, insert a pacemaker, or surgical ablation. let the data decide. the day catheter ablation loses out, I will happily move on to a better alternative.
Review the latest article in JAMA and tell me that this was an honest comparison of the technique/therapy. Let’s be honest here!@!
Clearly the patient population with atrial fibrillation is a very diverse group of patients…I really think that it is impossible to “lump” all patients with AF into a group study looking at any intervention. Clearly there are groups that are at high risk for complications from AAD and patients that are at extremely low risk. I’m not trying to promote anything-I’m asking for long term data for CURES at a reasonable interval of time from the start of an intervention.
How can you accuse me of snake oil? – I’m not selling anything…I’m not promoting anything…I want clear data that shows that I should or should not recommend a specific therapy. Should I subject a patient to an invasive 4 hour procedure that has a 25% or 50% chance of long term success. Finally, of the patients that are “cured” – how many are on some drug – supposedly the drugs that the procedure is designed to eliminate?
You give me that data – and I will raise the white flag – It isn’t available…no one reports it! Please tell me I’m wrong – I’m not stubborn – I’m not bullheaded – I just want honest, non-tainted data that is not supported by drug companies or by device or catheter companies.
I’m waiting…
you send patients for invasive heart catheterizations to treat angina I’m sure every day, so you can’t have it both ways. stents treat symptoms in patients with angina and have questionable if any mortality benefit in the long run except for acute MI pts. cath procedure has similar if not greater risks. what is the long term chance of success of not needing another stenting procedure in patients in real life?
they are analogous issues, one is a plumbing problem and one is an electrical problem, both medical problems can have dire consequences if left untreated. there are procedures to treat both that can help but some patients require medications in the long term to help control the problem.
i’ll attach a list of articles for you to peruse when i get the time in the next few weeks. you can decide for yourself. to communicate your belief that there is 25-50% long term success rate for AF ablation suggests that the articles i send will help improve your education on the matter….
i’m not here to sell ablation. but realistically it is another option for people that didn’t exist 15 yrs ago. surgical ablation has been done for a little over 20 yrs in the mainstream and when you actually read those articles (like the original Cox3-Maze paper in Journal of Thoracic and CV Surgery Damiano et al 2003) the percentage of complications and how they measured success if horrific.
and to answer your question on not including amiodarone in Thermocool AF trial, i would argue two points, long term success of any drug in pts who have failed on one drug is 20-30% in the literature. Even amiodarone as an initial strategy at best has been 50-66% success at one year in the literature. Using that drug in young patients has long term effects as you know. If you start all your 50 yo patients on it, alot will have thyroid or liver issues or show up with stiff lungs in their 60′s or 70′s, so realistically not a viable long term strategy. for dronedarone, still can’t use in HF patients, and probably a little less effective but better tolerated than amio without the long term side effects (we think!). once the pill comes out that it equivalent efficacy to ablation without the side effects, I am happy to stop ablating AF….
a list for frank:
to save typing we’ll include a short list of the citations from Thermocool AF trial (JAMA 1/27) as they provide an adequate summary:
citations 2-4 summarize long term effects of AF longitudinally
citation 10, calkins et al, expert consensus on catheter and surgical ablation
citations 13, 15, 16 trials comparing AAD vs ablation (Wazni et al, Pappone et al, Jais et al)
citation 24 circ 2005 worldwide survey on AF abl, second worldwide survey data presented at Af symposium 2009
f/u studies on success of ablation:
citation 28, pappone et al Heart Rhythm 2008, 5 yr f/u study on PAF pts
not in citations but another article on late recurrence:
Mainigi et al JCE 18(1) 2006 69-74
Thermocool AF trial JAMA 1/27/2010
And to hopefully further answer unanswered questions is CABANA which is currently enrolling 3000 pts, NIH sponsored trial
So a building body of literature over the last 5-6 years showing efficacy. Some industry funded and some not.
The industry funding issue is tricky, because if these studies are tainted, should we believe that the industry funded statin trials are tainted as well? i prescribe statins every day as i am sure you do. just because zocor(4S) lipitor and crestor trials(Miracl, Jupiter) have some industry backing doesn’t mean we ignore the results, just as you cannot ignore and must heed this growing body of literature.
I am sorry about what has happened to your wife. However, every doctor has made some mistakes and there is not a single one who has never had any complication during his/her career. I am sorry your wife has been so unlucky but nobody wanted to hurt her. I am really looking forward to the end of story. Martin
A place to enter a formal complaint is
Mary Gall
From: Mary Gall [mailto:marygall@dhmh.state.md.us]
Sent: Friday, November 13, 2009 9:24 AM
To: nmurphy@cminc.com
Subject: Re: Complaint MD00046402 2of 3
Hello Mr. Murphy,
I have received your three emails. Thank you for the information. As we discussed, the investigation is underway, and I will apprise you of my findings within the 45 day period we discussed.
Sincerely,
Mary Gall, RN, Surveyor
http://dhmh.md.gov/ohcq/faq_help/file_a_complaint.htm
call 877-402-8218
I’ll keep everyone informed as to the results of this investigation at
http://complaintsjohnshopkins.wordpress.com/
There is no time limit on filling a complaint, so I encourage people to help future patients by letting others know to consider avoiding Johns Hopkins. And NEVER stay overnight, especially on the floor called Nelson 6.
Neil Murphy
Outstanding piece of living medical history! I had been considering this same procedure to cure my atrial fibrillation! My first cardiologist Dr Perla whom I went to while living in the Syracuse area once told me that; “anything we give you is only a patch job and that the parts you’re born with are usually much better than anything we can gave you, we are only human. “Unfortunately, we are not perfect; doctors are not perfect and hospitals are not perfect. They are subject to the same flaws and weaknesses as every other human being and institution. Thanks you for your honesty and bravery; just be careful not to get arrested for exercising your first amendment right to free speech…
I am a heart attack survivor who last year was misdiagnosed with acid reflux and sent home from the E.R. despite presenting with textbook symptoms like crushing chest pain, nausea, sweating and pain radiating down my left arm.
Two weeks of increasingly debilitating symptoms later – but hey! at least I knew it wasn’t my heart! – I finally returned to the E.R. but this time to a revised diagnosis of “significant heart disease” and a 99% blockage in my left anterior descending artery.
I was told that I was very lucky to have survived those two weeks, but because a man with the letters M.D. after his name had told me quite emphatically that my symptoms were NOT cardiac, I was too willing to trust his judgement.
Bad doctoring – or bad diagnostics? All my cardiac tests (cardiac enzymes, EKG, treadmill stress test) had come back “normal”. Given that, until recently, most cardiac research over the past three decades has been done either exclusively on male subjects, or with females represented in statistically insignificant numbers, these “normal” test results leading to often-fatal misdiagnoses are tragically common.
We know that women are under-diagnosed with heart disease – and even when accurately diagnosed, are under-treated compared to their male counterparts.
Women (especially younger women) with heart disease are much more likely than men to be misdiagnosed. Research on cardiac misdiagnoses reported in the New England Journal of Medicine looked at more than 10,000 patients (48% women) who went to their hospital Emergency Rooms with chest pain or other heart attack symptoms. Investigators found that one in every 50 people who had suffered a heart attack was misdiagnosed and sent home from hospital.
But women younger than 55 were seven times more likely to be misdiagnosed than men of the same age. The consequences of this were enormous: being sent away from the hospital doubled the chances of dying.
In 2005, the American Heart Association surveyed U.S. physicians to determine how many knew that heart disease kills more women each year than men. Only 8% of primary care (family)doctors were aware of this fact. Even more appalling, however: only 17% of cardiologists knew this. CARDIOLOGISTS! This is their business. It is all they do. HOw is it possible that they did not know this important fact?
My particular interest since surviving my own heart attack has been on diagnosis and misdiagnosis in women heart patients. More on this at:
http://myheartsisters.org/2009/05/28/heart-attack-misdiagnosis-women/
Dan, Thanks for your comment on http://www.MDWhistleblower.blogspot.com.
Yes, I’m okay with suing ‘bad faith’ MD. The point I wanted to raise in the post is that physicians who have done everything right are routinely ensnared in the legal system, where we can dangle for months or years until we are (hopefully) cut loose. I think that many of the reasons for providing some occupations with immunity, could apply to us as well.
Dan, I am a recent grad jumping into the medical field with eyes wide open. I am a radiological technologist working in a cath lab/ep lab in southern california. I enjoy my job very much and enjoy the ability/opportunity to help others.
First I would like to address LRR’s comment about the mitral valve not being torn out. I don’t understand how he can argue. It is clearly seen on the TEE. I am not an ultrasound technologist and can’t positively interpret the images…they kind of speak for themselves. The valve while still in place and still operating, appear to be critically damaged!
My second point is more touchy. First please allow me to express my greatest regard and best of wishes for your wife, you, and all of your family. I have to disagree with your overall criticism of “trainees”. Everyone starts somewhere, and by the time any “trainee” flies solo they have undergone many years of training. They didn’t just walk in off the street. Even myself, after four years of schooling, one of those spent 100% in clinical rotations and 6 months of working for my hospital have yet to scrub in with the doctor by myself. And my only job in the procedure is to hand off the catheters! I am not taking away from the fact that you should be FULLY aware of ALL physicians AND “trainees” in the room during the procedure.
This is getting long winded and I apologize. One last point is that Ablation procedures are successful. They do have a high recurrent rate, I have read studies varying from 35% to 60% recurrency rates. But even if you take the high side at 60, I believe the value of coming of warfarin, or coumadin are very well worth the recurrency rate! Blood thiners are not…NOT…something to be on. They definately place your body at a limited capability. Preventing your body from clotting is like playing Russian Roulette!
Dan I could go on for ever. I am deeply invested in this topic and I would probably bore you over time.
Your wife experienced numerous failures of the medical system. I believe the horrendous parts surround the procedure…not the procedure itseld. Dr. C’s failure to communicate with you, his failure to inform you of others involvement, and his audacity at ‘showing up for the burn’ show a doctor who has clearly lost sight of the forest for the trees. Also, finding a hemostat under your wife after RT also shows lack of pt care. I believe it’s these things that make the safe and effective stay.
The other important thing I wanted to promise you Dan, as well as everyone else reading this article, is that I promise to uphold your loved ones as my own. I enjoy the opportunity given to me every day to help heal our patients. Nothing is more satisfying that answering a midnight page and rushing to the hospital and saving someone from an MI. I recognize the importance of patient safety, patient care, and patient/family communication and promise to uphold the highest standards in these regards.
Thank you very much for the kind words.
My brother-in-law was killed in a local hospital a year ago. He was admitted with pancreatitis and put in a double occupancy room. He was out of his head in a matter of a few days as the sepsis had invaded his whole body while nobody watched. He was left dirty in his bed, unable to communicate properly, and severely congested. The doctor kept saying he had dementia and COPD which I can attest to that he never had. We talked on a regular basis. He was sent home after two weeks of hell in critical condition. After two days an ambulance was summoned and bypassed the hospital that had released him in critical condition. The second hospital took immediately to ICU and was astonished that he had been released to go home by the first slaughter house. He was found to have MIRSA in his lungs and it was too late to do anything for him other than make him comfortable. I am still in shock at losing a vibrant, healthy brother-in-law.
There are many horror stories and this is just one of them. I myself have had some very bad experiences but for the grace of God, I’m still alive. We for the most part, live in spite of the doctors. A degree in medicine, a God does not make.
And what more can Dr. Hugh Calkins take from me?
Good grief. The valve was not torn out. You don’t know if the catheter would have gone where it went if Dr. C was driving. An anatomical predisposition would not necessarily have shown up on echo.
You get dealt a bad hand, despite the best intentions of a highly competent group of doctors. Collect your settlement and move on with your lives. Play the hand you’ve got now and don’t worry about what might have been.
I am done with your wheedling.
By the way, your repeated statements that Dr. C committed malpractice open you up to legal liability. If a trial finds that HE did not commit malpractice, then your statements are libelous. You could pay a financial cost. That would be irony.
*Well, you go back and look at this echo film (http://www.youtube.com/watch?v=QztHmYLXhMA) and tell me if “having her valve torn out” is overstating the case.
*Is there another way to print the man’s name? It is Hugh G. Calkins, MD
*Hugh Calkins told us that HE would be performing the procedure, so yes, that’s what we thought was going to be the case.
*According to a pre-procedure echo performed by Hugh Calkins, there is nothing out of the ordinary about my wife’s cardiovascular anatomy.
* If she was “destined to have her chest cracked” as soon as the catheter got tangled in the mitral valve, then why didn’t they take her to surgery and untangle the catheter from the valve? That way, she would not have a prosthetic mitral valve and be dependent on warfarin for the rest of her life.
*”He told you the part of the procedure for which he’d be there. You just didn’t listen.” How do you know? I was there. He said HE would be doing the procedure.
*I doubt that if Dr. Calkins were driving the catheter that he would have snaked the catheter into the left ventricle. Which is what happened.
Go back an reread it – not in the defensive posture of a medical person – but through the eyes of a patient who trusted her doctor.
> Would you say that continuing with the ablation
> procedure on a patient who is in congestive heart
> failure secondary to having her mitral valve torn out
> is “medically the right thing?”
See, this is what I mean. Her valve wasn’t “torn out.” When you’re that willfully inaccurate it makes it hard to take you seriously.
Also realize, as Hippocrates did 2500 years ago, that judgment is difficult. I don’t know if the decision to proceed was right or wrong, and neither do you, because we weren’t there, and because Dr. C did not have the perfect knowledge of the future that you do. I doubt Dr. C is a stupid man or a evil man, despite your cartoonish portrayal of him.
Your wife was in a world of hurt as soon as the chordae became entangled. She was destined to have her chest cracked at that point. You have no idea whether the same thing would have happened if Dr. C had been driving the catheter. Perhaps there is something about your wife’s cardiovascular anatomy that predisposed her to this complication.
You also don’t address the point that having the trainee perform part of the procedure is (I presume) standard operating procedure in every case at Hopkins. Your suppose that someone looked at her and said “Hey, she’s trailer trash, let Dr. Killwoman do the procedure.” If she were the Queen of Denmark, yeah, Dr. C probably would have done the whole procedure, but that’s a silly point to argue. He told you the part of the procedure for which he’d be there. You just didn’t listen.
And by the way, nice job on search engine optimization techniques by always spelling Dr. C’s name in full. Vendetta, no?
Example 1:”Physicians would love to stop prescribing warfarin, but there is nothing better.” My wife would love to be able to stop taking warfarin, but she can’t. This is relevant because her need to take it is the direct result of a doctor’s malpractice.
Example 2: “You complain about getting consent from your wife while she is critically ill. What’s the alternative?”
If you re-read that section you will see that I am commenting on the irony of waiting for her to wake up from a procedure in which she nearly died because of a lack of informed consent — so that they can obtain informed consent for a procedure for which there is no alternative.
Again, this is the direct result of malpractice on the part of Hugh G. Calkins, MD.
“… at every step people were medically trying to do the right thing, and trying very hard.” Wrong. If at the first step, Hugh G. Calkins had performed the procedure, as we were led to believe, instead of letting a trainee preform the most dangerous part of a high risk procedure, this would not have happened.
Would you say that continuing with the ablation procedure on a patient who is in congestive heart failure secondary to having her mitral valve torn out is “medically the right thing?”
I could go on.
You’re outraged, and you let it show, but it damages your credibility as an accurate observer. Example 1: you act as if warfarin being used as rat poison is somehow relevant — it is not. Physicians would love to stop prescribing warfarin, but there is nothing better. Example 2: You complain about getting consent from your wife while she is critically ill. What’s the alternative? She’s going into emergency surgery because nothing else is going to stop her from being critically ill. One does the best one can under the circumstances.
So, as a result of things like this, I’m not ready to trust what you say, and stopped reading after awhile. I think one reason you are so mad is that you apparently went to a TEACHING hospital (of your own free will) and apparently did not ask what the TEACHING bounds were for your wife. You guys have been around. Kind of an obvious question, no? I think part of your rage is guilt.
It was a horrendous outcome, no question about that. But understand that at every step people were medically trying to do the right thing, and trying very hard.
Yes, he is the surgeon with very high complication rate
A surgeon with a very high complication rate at Johns Hopkins?
From all the research that I’ve done, it seems that the specialists are good enough at their jobs, but when they slip your case to a trainee — or once the surgery is over and you get thrown into the general population for recovery, that’s when the trouble starts.
Ashish Shah
No.
Do you know the name of the surgeon mentioned in WSJ by Peter Pronovost?
This is very unfortunate to read. I now know which hospital I should avoid if I ever have to go to one in the future. Thank you for sharing this story.
I recently became an RN, but have also had family in the hospital a lot recently. I have had the experiences of previous posters who have had their input disregarded by healthcare professionals, have been treated with annoyance for asking questions, and have been given inaccurate or poor explanations. I did have some healthcare professionals who listened and treated my family and I with respect, but that was more the exception than the rule.
Unfortunately the situation of doctors admitting errors is not an easy change since it is embedded in the culture. In an ethics class I took, I read Errors in Medicine: Nurturing Truthfulness by Francoise Baylis which calls for the entire profession of medical doctors to work toward acknowledging errors. Baylis also points out barriers to this goal. I thought you would find other advocates of your cause encouraging. Also, The Jewish Chronic Disease Hospital Case by John D. Arras directly addresses the ethical issues surrounding informed consent that you have raised.
There are also many other writings I found valuable that pertain to healthcare in Ethical Issues In Modern Medicine: Contemporary Readings In Bioethics (7th ed.) edited by Steinbock, Arras, and London.
In order to work toward error disclosure, I think that it will take both leaders in the medical profession working collectively and the public to support a mechanism for acknowledging errors appropriately. There will be the whole spectrum of errors from minor to egregious and so the consequences will also need to be on a continuum. Additionally, it seems stricter requirements are needed for informed consent for new and/or experimental treatments which would require the number of total treatments performed (with a comparison of the number of alternative treatments performed), the success rate (with a comparison of the success rate of alternative treatments), rate of complications (with a comparison of the rate of complications for alternative treatments), and an opposing view from a medical professional detailing disadvantages in relation to the alternative treatment. This information should be in bold at the top of the informed consent. Also, proponents of new and/or experimental treatments should not be allowed to tell patients and family experimental treatments are a cure or possibly a cure. Doctors should clearly state that at this point it is unknown if the treatment has the potential to cure and it is not fully tested. Using the same statements for new/experimental treatments and robustly tested treatments backed by evidence is misleading. The two must be clearly distinct from one another. Just as when I was in nursing school it was against the law for me to claim I was an RN, it should be against the law for new/experimental treatments to be discussed with patients as if they are well-tested treatments.
I had this same discussion with an ethics classmate regarding experimental cancer treatments. Doctors told many women with breast cancer they might benefit from HDC-ABMT, but patients are also told that they might benefit from standard chemotherapy which has solid evidence behind it. The difference is that in experimental treatments we do not know whether the treatment even has the to potential to cure. With standard effective treatments, there is a defined probability of getting cured. This distinction tends to be muddled time and again. The essay Bone Marrow Transplants For Advanced Breast Cancer: The Story Of Christine DeMeurers by Alex John London from the ethics book catalyzed my discussion with my classmate.
My heart goes out to your wife. Many stand with you in your call for better informed consent and stricter regulation of new/experimental treatments.
Thank you very much for the thoughtful message.
scary stuff man. best of luck.
Thanks.
Your wife was an unfortunate statistic and I’m sorry it happened. The surgeon in question has helped too many people live better longer lives to have his career negated because of this one incident. He won’t lose his license because of it. The sooner you realize that the sooner you can get on with you lives.
If your goal really were to help prevent this from happening again you’d devote your energy to continued research.
OK Doc.
Hugh Calkins is not a surgeon. He is a cardiologist.
I’d be pleased for you to point out some slander here. The most damaging words against him are his own words.
It’s all fully documented.
License revoked? At the very least.
My goal? To prevent this from happening to some other trusting soul.
I don’t have to be in the medical field to disagree with such a lopsided discussion. No defense and no independent 3rd party review.
So what do you want? Money.
Or the surgeon should have his license revoked? At the cost of innumerable other people that will be saved? Slander his name like this becuase your wife was a statistic. That’s a slap to the hundreds of other people people he’s helped.
What is your goal?
What exactly is your goal?
I guess the real question will be; can you prove that your wife wasn’t more than a statistical complication? Have any experts in the field come to your defense? Or are you just going to say “they’ll protect themselves no matter what”
I see that you are quite critical of this doctor. Have you interviewed the hudreds if not thousands of patients lives he’s improved, or just your wife?
Steve Timmons,
I assume that your are a medical person. Maybe you should go back and read it with a less defensive posture.
I don’t care how many thousands of other people the Doc has no doubt helped. I care about what he did to my wife, about how he almost killed her and how he lied to us about it from the beginning.
These are Dr. Calkins’ words – not mine or anyone else’s: “the safety and efficacy of pulmonary vein isolation was unknown then and it is unknown now,” it is “a high risk procedure,” and “associated with a risk of serious complications,” and “anyone who is doing this procedure realizes there is a learning curve and the learning curve is very rocky as you go up on it and the complications are like no other procedure that’s ever been done in an EP lab… We don’t know where this procedure is going. It’s evolving rapidly, a procedure with high risks that’s in evolution.”
He made that statement the year AFTER he handed off the procedure to a trainee without our knowledge.
That’s more than “just a statistical complication.”
That’s arrogance and deceit and betrayal of a patient’s trust.
I am so sorry for your wife’s suffering. I have a comparable story I will write a blog or book about as soon as my lawsuit is settled. I was diagnosed with a sigmoidocele (descent of sigmoid colon into recto vaginal septum) supposedly hindering my ability to move my bowels efficiently. I was told at 3 top hospitals I needed my sigmoid colon removed. Incomplete rectal emptying was taking too much time in the morning even with a laxative. I had my sigmoid removed. The docs I went to then did 3 unconsented procedures and 4 addtiional ones that they TOLD me I needed (which I did not.) As a result of this overly invasive surgery, I lost the function of my rectum, pelvic floor muscles, and my colon. My bladder function has also been damaged. I developed a severe narrowing of my colon at the area where the top of the rectum was attached to my descending colon. It narrowed in to a 3 millimeter diameter and the surgeon did not address it nor did he refer me on for help. I also developed small bowel obstructions and was unable to eat for 7 months due to 2 loops of small intestine that had been trapped in concrete like scar tissue. After 7 months of treatments and evals at 7 top major medical centers, only 1 doctor was willing to step over the political boundaries and do what needed to be done to save my life. My weight had dropped to 99 lbs from 125 because I was unable to eat or move stool through the damaged colon and rectum. This one doc had to lyse severe adhesions off of my distal ileum and create a permanent ileostomy. I now pass waste into a bag from my small intestine but am lucky to be doing so. I still face risk of small bowel adhesion obstruction but thankfully have been OK since the lysis and ileostomy. The worst part of this whole thing is upon medical review of my case, I did not have a sigmoidocele in the first place. The RESIDENT who read my defecogram mistook a look of small intestine (an enterocele) for a loop of sigmoid colon (sigmoidocele.) The loop of small intestine that descended temporarily into the space between the top of my rectum and top of my vagina did not hinder rectal emptying. All I really had was a rectocele which could have been fixed vaginally. I was healthy otherwise. Lost my professional career. Am on borrowed time. Because I was so severely scarred internally, if I get another adhesion reobstruction I will likely die as they can’t keep going in again to free more bowel loops because each time they do, more scar tissue can form. I have been traveling a lot and learning what is important in life: family, friends, sunsets, travel, pets, relaxation and so on. As a child I always worried about getting some awful disease. Instead, my death may ultimately be caused by the misread of a scan by a resident unchecked by her supervisor, the surgery performed based on that erroneous scan report, then multi-procedures performed (for the money) that were unconsented and non-indicated. My advise to anyone, never have elective surgery. Only what you have to have to save your life. Even then, I say “Good luck.” Sincerely, Evelyn
Great work, Dan!
Johns Hopkins should be shut down and “Bad Huey” should be arrested and cuffed.
I hope you will sue them for big bucks. You and your wife deserve that as a minimum.
I had an ablation at U.Pa and the night before the procedure, two swarthy looking characters from Bagdad or Teheran came into my room and shoved a paper in front of me and yelled “Sign It”.
I will NEVER go to a teaching hospital again.
I learned from my mistake and traveled to the Cleveland Clinic where my treatment was superb. Dr Schweikert performed 2 ablations and each one of them put me in NSR for 3 years. I cannot praise him enough. His supervisor was the famous Andrea Natale. I don’t think that “Bad Huey” had anyone to teach him.
By the way, you have Hans Larsen’s website linked to your site. Maybe you should remove the link since I posted your marvelous website on Larsen’s message board and within 2 hours he had removed it.
Best wishes to you and your long-suffering wife.
Henry
“… did you know they will lie under oath?”
I do now.
This was painful to read in that I am also working on a book about the murder (and that’s what is was) of my mother at the hands of an ER attending and 3 residents.
We definitely need a better way to communicate in the hospital and track the patients.
Also, while a resident is a doctor, they so enjoy passing themselves off as “the doctor”. In our case, the result was 75 days of intractable pain and suffering and then death. None of which was necessary if they had listened.
By the way….did you know they will lie under oath?
Amazing.
I’m sorry to hear what happened with your wife’s surgery. I understand the frustration with coming across medical error. My dad died of brain cancer and at one point one major medical center had found a mass in the brain that another major medical center missed.
Despite my own medical needs, I have thus far refused to see doctors at the institution that made the error. However, there are many errors that have been made at the one I trust. It’s simply too painful to visit the other one, despite the fact that there are very many good doctors and treatments being performed there.
The blatant truth is that every hospital experiences medical errors. Some are true mistakes, some are negligent. It happens everywhere.
If I read correctly, and this happened 7 years ago, I would hope for your sake that this would turn into something positive – like giving advice on choosing doctors or how to be your own health care coordinator.
I know these things can change lives forever. Some of the things you said concern me for your own emotional health. Some of them sound like Post Traumatic Stress Disorder, which would be understandable considering the circumstances. I do hope that you can find solace.
Yes, when it is finished. (Another 4-6 months)
Thanks.
Will you provide a printer-friendly version?
How important are the voices of those who have been there. The medical community at large failed my daughter fourteen years. When the true identity
of her illness/condition was finally revealed, we were lead astray once again.
Promised by one surgeon that she would be well after her surgery, only to find her in worse condition only two days later. Promised again (by same surgeon) she would be “better” if we allowed her to be injected (monthly) with an expensive drug that would alleviate her “symptoms.” (Later the drug company came under fire for giving doctors expensive gifts-vacations-in return for their commitment to persuade ailing women to take the drug).
Promised later by another surgeon that HE was the answer to our daughter’s pain. We spent hours on the phone with him, sent cash-in-advance, as he is a highly acclaimed surgeon who has patients fly in from all over the world, thus he needs a portion of his money “up-front,” only to realize while my daughter is IN surgery with him that he had lied to us and was not providing the critical component of surgery that we were adamant, and promised: a bowel surgeon.
This lie, this surgery, once again, left my daughter in increased pain. Yet this time her pain was completely intolerable. After suffering over a month, she finally said: “Mom, let’s stop praying for an answer…let’s pray God will take me.”
Thankfully, we persevered. A third USA surgeon finally gave us the truth: “she can’t be helped in the USA, take her to Europe”. We did. After a mere 4-hour surgery by a brilliant surgeon and a unique method of surgery, she became totally and completely whole!
But, rest not your heart; our saga was only beginning. My blissful, ecstatic
exuberance to help others who suffer from this same (hushed) medical condition came at a cost: I am now slandered to smithereens by a so-termed internet “group” who wish to discredit the doctor who literally saved our daughter’s life. Since our story tells of this doctor, I am defamed and cyber-bullied by “professional” men who are determined to keep a stronghold on this lucrative malady of American medicine. Those men remain safely hidden behind the skirts of women who have nothing to lose; thus they do their evil bidding.
These men have managed to monopolize this illness, killing the threat of competition by character assassination of any person who dare share a story of hope and answer.
To all who find themselves in similar situations, I say: press on.
I read every word…couldn’t stop reading about your very unfortunately experience. Am telling all my nurse and Dr friends about this one. JH should be so ashamed and be doing every thing possible to rectify any/all mistakes. Scary!!!!!! My husband had an ablation by an EP in Green Bay in 2001..to date he has had no further spells of fib…but the arrhythmia continues….he takes warfarin . It prevents strokes when your rhythms are irregular…safer than lots of modern meds they have for heart arrhythmias, don’t think of it as rat poison in such little doses and regular monitering) You can die from too much salt…and you need a little.
I laughed to read the name of the Face book group..Be Kind to Nurses, We Keep Drs From Accidentally Killing You ! It isn’t funny but very true as any old nurse will tell you. As a nurse (now retired).. I have saved many patients from inattentive doctors….yes they are busy, yes they are tired etc etc…no excuses. Nurses are tired and overworked too and go home to families and more work.. Don’t accept any of their whining about overwork. That is not professional behavior. If you take the job you are obigated to be responsible for all your actions( and if you can’t you should refuse to work , demand more help, protest whatever) but never endanger your patients!!! Nurses were taught that. We took oaths to do that…don’t Drs do that? They should lose their license if the things you say are true..and the hospital should be checked out too and reprimanded like nursing homes are when patients don’t get good care. Professionals all should know their limits and fight for their patients, clients etc. No excuses !!! Medicine is serious business…..no place for coverups…excuses…you need a good lawyer !!!
Here is an aside for any who read this and have atrial fib….. I spent days after my husbands ablation surfing the web for better answers for atrial fib triggers etc…and found some that have worked for him. It is not easy to find but there is alot of research literature on magnesium and calcium levels and heart arrhythmias…. an amazing amount to be found and ongoing all over the world. We printed out reams and his Dr helped us get these ratios right. He has taken these supplements in a carefully balanced ratio daily and there have been no incidents for nearly 8 years.
Please write on your blog and tell us how your wife is doing now…..wishing you both some happy days your deserve all things good.
I do a lot of writing and think your style is good….the truth is what people want….don’t stretch it or candy coat it for anyone. If you are thinking of publishing this story…I would not put in the stories of the other peoples problems with jH as it changes the flow…maybe another article with multiple shorter stories. Wishing you all the success possible to get justice. It is tough work to fight the “big guys”……. I am reminded of a Tshirt one of my sons frequently wore as a college student that read…Subvert the Dominant Paradigm. He is still doing that in his field of forest research. We have a duty to challenge all the “big organizations” whoever they are. You have a cause that is worthy…..stay strong. There really are good lawyers out there and I hope you find the best one. One of my daughters is a lawyer and is fighting for parents who lose babies due to defective baby equiptment made often by top companies and I am so proud of her…the facts in these cases is just heart breaking too…it disturbs her sleep often. But it is noble work to fight the ‘giants’ for all the other people who could be hurt if you do nothing. Best wishes to both of you…. Chris
Dan,
As an attending electrophysiologist, your story hits home.
Your wife’s story and your blog about the experience is truly captivating and I have learned alot from reading it. Thank you for sharing it.
After 4 years of medical school, 4 years of internal medicine, and 4 years of cardiology training, (including 2 years of an electrophysiology fellowship) at “one of the top ten best hospitals’; I agree that communication often needs to be improved at teaching hospitals (and community hospitals too) and a realistic picture of a procedure needs to be given.
After having finished two Afib ablations today in two highly symtomatic patients who are doing well post procedure, and after seeing a half dozen patients in the office yesterday who are truly better for the procedure, I think it is important to say that the procedure does indeed work in a majority of(but not all) patients. I am open and honest about this up front.
The catheter based procedure also compares quite favorably to surgical ablation (you might be curious how “success” is defined in both the EP and surgical literature from the “early days”, including data on the COX Maze and other subsequent iterations of the MAZE procedure. often a phone call to a patient who said they were in sinus rhythm or a snapshot ECG of that same rhythm defined success. Now evidence based literature is more rigorous and requires more monitoring for a longer period of time to define success. I have done about a dozen catheter based ablations in patients with recurrent arrhythmias who have had prior MAZE procedure so it happens both ways.
Two balanced articles on the worldwide experience of catheter based ablation of afib are published or on their way: Cappato et al Circulation, 2005; and a follow up survey on the the current worldwide experience by Cappato which I believe is in press.
The procedure does have risks and despite my reasonable experience I never stop worrying about the “bad things” that might happen until the patient is safely through the procedure and is on there way home. For many of us who give our lives to this job, which often comes at the expense of our loved one’s lives, our worst fears come to light when something so tragic as what happened to your wife happens.
Best wishes to you and your wife.
Thanks for taking the time to post. I’m glad you brought up how the standards for success are ever changing. I hadn’t thought about that. Also, thanks for pointing out that the ablation procedure sometimes works for patients when Maze procedures don’t. I also appreciate the reference to a scholarly article; I am going to read it.
Excellent website,although horrific experiences. You may want to read the blogging of a nursing administrator who did blow the whistle, and after being attacked, resorted to blogging. There are lots of on point blog posts about empowering and protecting yourselves and your loved ones.
One more tool in your tool kit.
I don’t get your point here, and it’s the opening paragraph of your book…!
“If, for example, you catch a bullet on a Baltimore street corner, or your mother presents you at the ER as a feverish welfare child, then it’s open season for the med students, well meaning as they may be. They can practice on you because if your procedure results in an adverse outcome — which is to say that if you are mangled or killed — nobody will question said outcome, precisely because… you are a nobody.
At the other end of the spectrum are wealthy and prominent patients, who get treated by doctors who have already learned what not to do from the mistakes inflicted upon the lower classes.
My wife landed somewhere in the middle.”
This was a very well written, thought provoking story that I think you are doing a huge service by sharing! The truth is sometimes hard to swallow, none the less it is something that patients AND caregivers should not avoid, we should tell it, seek it and gleen from it.
As patients we all deserve and want to be treated right. We sometimes go blindly handing our lives over to others assuming that they will treat it as valuable, precious and worthy of their best effort. We should be able to EXPECT at the VERY LEAST honesty and a good attitude. However, more often than not it just doesn’t happen that way. Should caregivers take offense to this? YES- All the knowledge and know how in the world is worthless if you are incapable of giving your best effort, are dishonest or have a bad attitude. These are peoples lives you are dealing with! Their is a huge amount of pressure to be in this line of work, but you’ve agreed to it, if its too much you need to seek a new career.
We need to be a society where its ok to do what is right, without fear, as patients, as nurses, as Doctors, and as administrators, how did we get soo far off track? How is it that this story isnt unique, it is all to common, I myself have my own story(s) of healthcare ineptness, and who is to blame? Its time for accountability, and an expectance of higher standards. Doctors and Administrators get sick to and when it comes down to it every single person in healthcare should be treating their patients EXACTLY as they themselves would like to be treated PERIOD.
Best wishes to you and your wife! the pen IS mightier than the sword so keep it coming!
Michele
Dear Dan,
I’m so very sorry Pam, you, and your families were treated with such cold indifference during such a prolonged period of great suffering for Pam.
It must have been heartbreaking to observe this chain of events unfold, day after day, week after week, powerless to do anything but observe, and provide support as best you could.
Thank you for sharing Pam’s and your experience with others. You may never hear of it, but I’m sure it will help someone avoid the same level of suffering.
Some time ago I created the Case Health website for just that purpose – sharing. I’ve also produced a book collection of case studies. It’s free to anyone who wants it – and the book can also be freely shared forward.
All patient experiences are valuable, and through the work I do, I’m focussed on building recognition of that value in the interests of making the path to health success shorter for others who follow.
I sincerely hope Pam’s future, and hence yours, is now looking much brighter than the tortuous period you summarized in these chapters,
my best wishes and hopes for happier days ahead,
Cris
ICU nursing (which is where I began my nursing career) is my favorite for many reasons. I take great pride in saying that I am an ICU/cath lab nurse. It is our goal to make and achieve goals for our patient and their families. A plan of care should be developed by the nurse each shift when caring for the ICU patient (any patient for that matter). Many goals that are set for the patient will not or cannot be met for a plethera of reasons, but the most important and simply vital piece is that there are effective transitions to get to where the patient and family need to go next. Anything less than that just aids in wasted time, and ICU patients do not have time to waste. In my opinion, it seems as if those transitions were missing from your wife’s care. Pam was on detours from hell and that to me is not acceptable. “The Best Hospital” should have top notch critical care nurses taking care if its patients. My perception is that there was a serious lack of nursing leadership when Pam needed it most and that makes me very, very sad. All the more reason why each critical care nurse needs to read this. Your story defines “Murphy’s Law” (where if anything can go wrong it will/does) and I feel confident in saying that almost every nurse has experienced it with at least one patient in their career. I have several patients in my memory who were effected by it and secondary to it are the scars that are left in my mind. It is from situations like this that we should become a smarter and stronger nurse and patient advocate. After safety, compassion, advocacy and family education/empowerment are second. Sure sounds like you could have used just that.
Their are great doctors and nurses all over the world. Rest assured. Doctors need direction. The good ones know it and rely on the nurses and continuing education they trust to help them. That team effort gives each patient the best care possbile and details do not go un-noticed. The system failed you and Pam and I am so sorry. Sorries don’t buy back time though, do they?
I hope you win your case. I hope your story sends shock waves to doctors, nurses and hospital administrators everywhere. I hope it reaches the medical and nursing school deans. This is a problem in every city in the US. I hope Pam’s hard fight helps others to “do the right thing”. Good luck.
Thank you for your courage to write this. I cannot imagine the can of worms that you have opened by doing this. My husband, (now an elementary school principal) with exceptional moral fiber once said to me when I had encountered a dilemma wherein I needed to speak up for the greater good said to me, ” You can do things right, or you can do the right thing”. Words to live by.
I feel conflicted about some of the things in your writings. The first part of me is full of compassion for you and your wife. Catastrophic events took place in her care, or lack thereof. Overlookings, errors, the very basics of medicine. Unacceptable in any facet. If it was the physician in your shoes and it was his wife on the table, I can assure you that things would have not gone the way they did for you. I don’t care which hospital in anycity or state. Her care would have not been so “lack luster”. The inital complication could or would have occured but then subsequent events would not have been. The alternative-life long atrial fibrillation and SVT if not controlled can and do cause a significant quality of life change for most people. I think your wife must have felt poorly for her to have gotten the diagnosis of female hysteria (which is the most ridiculous diagnosis ever) and to have you both to consider the ablation in the first place. The doctors are fueled by the patients constant complaints (of their persistant symptoms) that push them to the next step in remedies for the ailment. Everyone wants to be fixed. Right? I know I do for my own medical issues and I would want that for my own family. The doctors are only attempting to do what they know is right. And for that I am grateful. Extended periods of time of atrial fibrillation and SVT will cause heart failure. As I am sure you know, heart failure has systemic manefestations that depending on how severe the heart failure, will determine the length of life expectancy. Which ultimately means feeling worse and worse and losing quality of life. So in a nut shell, ablation (if successfull woo! If not, then why the hell bother) or slowly succumb to heart failure or its secondary killers? Talk about your ultimate catch-22. That defines my conflict. I feel badly for all involved. I am a critical care/cath lab/EP RN. I love being a nurse, it is an amazingly rewarding profession. I cannot imagine ever doing anything else except for medical malpractice law to defend patients and their families who have gone through situations such as yours. I plan on giving your writings to fellow nurses, nursing VP’s, risk management RN’s and the MD’s that I know. I think all cricial care professionals should read this for many reasons.
Informed consent. The only physicians that I know that have fully done this are few, and they were not the cardiologists that I have worked with. It is a nauseating truth. I constantly struggle with the physicians inability to accept “NO” for an answer. It is okay for people to understand the complete process of what they will or will not decide to undergo. If “no” is what someone wants, then “no” is what should be honored. At the time of decline, all other options of treatment should be discussed with the patient and family so that the best possible outcome by the patients wants can be achieved. It is the patients decision to know what is best for themselves if the doctor has discussed all options. Plain and simple, that is what we are employing them for. It is in the hippocratic oath that they take to do just that. I feel in my heart that docotrs believe the oath as principle doctrine and try to live and conduct their daily practices by that. However and unfortunately, it gets intermittantly lost, a costly human defect. Becoming desensitized is a deplorable process that medical professionals are infected with at times during their careers. It happens to mosat all people. However, in medicine, it can and does alter or potentially end patients lives.
We went to the the best doctor in the field at “The Best Hospital in America.” We were told we were in the best of hands. At no point were we told that a trainee was going to perform vital aspects of the procedure. At no point did Doc Calkins tell us what we later found out — that he “shows up to be there during the burn.” Calkins never told us that he considers this procedure the riskiest, most technically challenging procedure ever performed in the EP Lab – and that he was going to turn it over to a trainee.
When the trainee screwed up, my wife went through hell and almost died — and Hugh Calkins looked me in the eye and lied about it. If you think my anger is excessive I can only assume that you are a physician or med student and therefore defensive as a matter of course.
MP .. true, the fine print is there. But according to the author it seems that “students” were involved.. what it was, was a fellow – a cardioloigts traing in the procedure. I feel bad for what they went through, but lets face it Hopkins has saved many patients. His anger while understandable is excessive.
Why didn’t they go to a non-teaching private hospital…
WPW. I agree with your number one. It comes across as biased and vengeful, but I think he and his wife(who was an ICCU nurse for years) did research the surgery, the doctor and the hospital. What they didn’t research was the small print on the consent form. Unfortunately, most people forget that a teaching hospital allows interns, residents and fellows to participate in surgery. What most people don’t realize is that what they’re told doesn’t necessarily correlate with the documents they sign.
Dude – sorry about your wife.. but
1. you are way biased and vengeful and simply not credible
2. since you crank out a website aimed at the destruction of a hospital.. you can’t possibly be that dumb not to have researched the surgery before agreeing to it
3. your wife’s a nurse, right? well, what’s her problem in not being bale to understand.
don’t buy it…. pffttt
Some parts of the story get boring.
I am very sorry to hear about your wife and your experience. Dr. Calkins performed a ventricular ablation on me several years ago. I specifically went to him, because the cardiologists in NY did not do a thing for me.
Dr. Calkins is a fine doctor.
Comment:
Deana: what we call what you are is a “TROLL”. Stop trying to hijack Dan’s website and get your own up & running again – and don’t abuse this one attempting to advertise it.
Dan: Thank you so much.
While my dad was dying of Amyloidosis in a celebrated Canadian hospital, I regularly saw petty humiliations and agonies perpetrated by un-empathetic, senseless stupidity. While dad and I were chatting in a common area one evening, a resident walked up, introduced himself, and asked dad how he felt. On being calmly told, “my hands feel like they’re on fire” the resident grabbed him by the hands and held on to them, commenting “they don’t feel hot to the touch” – I still shake, wishing I’d kicked that boy in the face.
My dad was from Buffalo, NY, worked at Bethlehem Steel like his dad before him, and served his time in the Army. My dad didn’t cry out and didn’t screm. His jaw went rock hard. The pain was blinding.
And that fool held on, not having seen dad’s chart, not having asked permission to touch him, not noticing he’d gone stark white – babbling nonsense until my dad could politely interrupt him and take his hands back.
Dad was surprised. I wasn’t.
I went in for annual checkups and always told the nurse and doctor I was a virgin. Unfortunately, I’m pretty. I’ve been stabbed by more cucumber-sized speculums than I care to admit, because nobody, inall the times from 16 to 26 that I visited the doctor, ever believed me. The small speculum was *every single time* the second one they used on me. I will admit, I’m loud, and on at least one occasion, I believe I bit a “caregiver” in the room.
Too many people don’t understand the *critical nature* of the mistakes that are made, and are too polite to speak up for themselves until they’re a bewildered “victim”.
Thank you for writing this – it’s necessary that patients become aware, and that caregivers realize there’s a reason that patients must protect themselves from caregivers with the best intentions.
Lori:
According to Dan’s statements, it must be remembered that Dan’s website only concerns the doctors he dealt with. He does not take on the medical system which he believes to be good. I also misunderstood the point of the site. Basically, it appears he is chagrined that his wife didn’t get the care he believed she deserved having made sure to take extra steps to get it. It’s the bad care after the extra steps taken that he seems to address.
Having been at our mother’s side for eight months after she contracted MRSA after surgery, and then a whole series of other (preventable) complications, we can personally attest to the very dangerous healthcare delivery system we are all at the mercy of. The bottom line is…the longer you are a patient in a U.S. hospital, the more at risk you are of facing an untimely death.
Our mother died four years ago, and we found out after the fact, that the circumstances of her death were never revealed to us. (We were simply told that she had a stroke from a massive brain hemmorrhage. What they neglected to tell us was they had given her the antidote for antigcoaulant overdose—and it was given 9 hours too late.) Blatant lying and lying by ommission are accepted behaviors in hospitals.
One crucial piece of bloodwork is missing from our mother’srecord: her CBC for that day (she had a CBC every single day for 2 weeks in this ICU—the only one missing is the one for the day she hemmorrhaged.) We also found out that her platelet count was so low 2 days prior to this hemmorrhage that she needed a blood transfusion. But no CBC was done 2 days later? …and we’re supposed to believe this?
After four years of dealing with the hubris, arrogance, and ‘there’s nothing you can do to us’ attitude of hospital administrators and risk managers, we have come to realize that hefty profits and complete lack of regulatory oversight/accountabiliy have led to corruption in our hospitals.
The Joint Commission is toothless.” They told us that “because we are not a regulatory agency, you should file a report with your state dept. of hospital licensing.” The Joint Commission is nothing more than a paid membership organization that hospitals use to market themselves as “SAFE.”
I believe every word of your 18 chapters—because we’ve been there. All we can do is continue to speak the truth until we have our last breath. One thing they can’t do is silence us.
Keep Writing Dan,
Another RN who advocates for patients rights.
Thanks very much for your comment.
1. “Would it have been ok if Dr. Wu be introduced as assistant?”
I don’t know how to answer that. Seeing as how Dr. Calkins has said this: it is a “a high risk procedure,” and “associated with a risk of serious complications,” and “anyone who is doing this procedure realizes there is a learning curve and the learning curve is very rocky as you go up on it and the complications are like no other procedure that’s ever been done in an EP lab… a procedure with high risks that’s in evolution… there has never been a procedure in the field of electrophysiology with such a high complication rate. There have been more than a handful of deaths from this procedure, and as more and more people start doing it and are on that learning curve, it could be a bit of a mess… having an experienced operator is critical to safety end efficacy.”
If he had told us all that, and then said I’m going to let a trainee do it because I “show up to be there during the burn,” my guess is we would have said “I don’t don’t think so, Doc.”
Since, however, we were told by Dr. Calkins that he had done lots of these procedures and that he was comfortable and confident in doing it, and that he was going to be the primary operator, I suppose it would have been OK if he said “I’ll be closely supervising Dr. Wu, while I teach him certain aspects of the procedure.” But what happened was a bait and switch – pure and simple. A betrayal of the patient’s trust.
2. “Is it possible that their maneuvering the catheter was the standard of care?”
EP’s would say the standard of care was not violated based on improper catheter manipulation. I would of course disagree. If you’re paying close attention to the position of the catheter, you would keep it from becoming tangled up in the mitral valve muscles. It’s not like like Dr. Wu was paying close attention and taking great care to keep the catheter away from the entrance to the mitral valve – and then all of a sudden, the catheter sprang toward the left ventricle of it’s own volition. He SCREWED UP, pure and simple.
3. Their report makes no mention of being in the left ventricle. Of course it would not, it would be too embarrassing. It says right on the box to not let the catheter enter the left ventricle. What the report does say is this: “.. the posterior leaflet was completely flail due to severing of two chordae tendineae and avulsion of the posteromedial papillary muscle near its base.” The papillary muscle is located in the base of the left ventricle, not in the left atrium. For a catheter to get trapped at the base of papillary muscle at the base of the left ventricle, it would have to be in the left ventricle, would it not?
4. The distinction in the procedure report “appears to be the reason for the procedure (your wife’s was for a-fib, while others were not).” Again, mitral valve damage is listed as a complication for ANY cardiac catheterization, and to me their report is akin to warning lathe operators about the dangers of wearing a necktie on the job. Their distinction would be that this is the first time this particular brand of necktie got tangled in a lathe – or this is the first time a necktie got caught in a lathe while making an umbrella stand instead of a table lamp. It is ridiculous.
5. There are many reports questioning whether this catheter, indeed this whole procedure, is useful (Hugh Calkins himself says “the safety and efficacy of pulmonary vein isolation is unknown) and this came out just last year: “Catheter ablation of atrial fibrillation: do we know what we are doing?” Europace.2007; 9: 1002-1005
6. Better techniques? Apparently yes. That is what the “learning curve” is all about. Every time someone’s heart gets ripped up, or dies from a stroke or a perforated esophagus or pulmonary vein stenosis, the Docs learn something and the procedure is then presumably improved.
7. Complication rates vary wildly. If Hugh Calkins is trying to steer patients toward the procedure in order to advance the learning curve, he says “the procedure is ready for prime time” with a complication rate of 3%. If Hugh Calkins is talking to fellow researchers, the complication rate is anywhere from 6 to 12%.
8. “It does sound fishy that the note suddenly appeared. May I reasonably argue that it was poor handling of medical records, and not ‘tampering’?” No, you may not reasonably argue that is was poor handling of the records that lead the chart note revealing Dr. Wu’s involvement to be withheld for four years. Every time I made a request to Johns Hopkins fro Pam’s records, the records person would contact Dr. Calkins would confirm that he had delivered all the notes and records in his possession. On at least seven occasions, he was asked to provide ALL the records and seven times he left out that one chart note — except to in house lawyers. We got it by mistake, when it was finally added to the record AFTER the statute of limitations had expired.
9. As for other EP’s, I get many comments. About half are appalled that I would make such accusations, while the other half encourage me to keep writing.
Again, thank you for reading and for your comments.
-Dan
Thanks for sharing your story, which I am sure has taken quite a mental toll on your
family’s life. I am sorry to hear about all the mistakes made.
I am a physician ‘in training’ as a 4th yr fellow. I feel that I read other’s stories, in order to re-connect with that ‘perspective’ you discuss so often. I do gain some insight as well, about doctors, patients, and medical care
Although, I also feel attacked as well. “Great doctors” everywhere start somewhere as a trainee. Some of your commenters would not prefer any ‘trainees’ when it comes to them. To be fair, would have been ok if Dr. Wu be introduced as assistant? Do have any numbers to know how many of these procedures Dr. Wu has done? How about Dr. Calkins? What if you had heard that Dr. Wu had done 10 procedures in the past 1 month, Dr. Calkins has done 50, but his last one was 2 years ago, b/c now his fellows do the procedures? how about with this specific catheter?
Of course, I am making up numbers, and being somewhat ridiculous, although during my training, I have found that some procedures I do, I did it more often, and I was better at it than my superiors, since they leave those procedures to residents/fellows.
I read the case report. I am not a cardiologist. Is it possible that their maneuvering the catheter was the standard of care? (I don’t know that answer). If so, then how could they be blamed for this? Could you include where you found that the docs were in in the left ventricle? Their case report makes no mention of it.
You also make a point of saying that in the case report, they report that it is an unknown complication, but then reference 2 other cases. Its a little cheesy, but the distinction appears to be the reason for the procedure (your wife’s was for a-fib, while others were not).
I agree the medical notes disparity is maddeningly frustrating. It does sound fishy that the note suddenly appeared. May I reasonably argue that it was poor handling of medical records, and not ‘tampering’? Is it possible that the missing document was really written in ’02 but never got to the chart? the cynic will say ‘no way’ but the believer will say its possible. I think its easier to argue the missing chest tubes notes. In handling patient charts, I have often come across some that have easily >400 notes. It is very easy to find some of them missing for any reason. I have accidently dropped these charts, b/c the sheer nature of their size. Papers fly everywhere. Also, moving from one room to another causes things to get misplaced. I will bet some get missed. That is unfortunate.
Have you discussed your case with another EP specialist? I think their perspective would be interesting as well.
It is unfair to characterize warfarin as rat poison. In medical management, its not the same. http://en.wikipedia.org/wiki/Warfarin
other questions that I don’t have answers for but would be interesting to know
1) are there conflicting reports that state this catheter is useful?
2) are there better techniques now for AF within interventional cardiology field?
3) complication rates for this procedure?
4) has techniques changed for the better?
Its a shame to hear that people lied to you and your wife, and the subsequent ordeal. Good luck in your endeavors..
Please do not change your account to ease the feelings of those who consider it inflammatory. The situation deserves emotional response. Readers need emotional response in order to have the interest to read the entire story, otherwise they will miss out on other important information.
My husband has atrial fib and has had the ablation therapy described to him in glowing terms. I am sending him a link to this blog.
I think your story is perfect as published. It is truth, and truth is what all of us need to see, and act upon. Medical incompetence is bad enough, but coverups and lying when medical imcompetence occurs, make the situation even more intolerable and hurtful and ANGER-MAKING. If a man makes a mistake, it is his ethical duty to admit it and attempt his very best to make amends — at the very least, in the case of your wife, all her surgical costs should be ERASED, and medical care to treat all complications of this BOTCHED PROCEDURE should be provided FREE FOR THE REST OF HER LIFE, and furthermore such care should be provided by ANYONEOF HER CHOOSING and then paid for by Johns Hopkins Medical School.
Someone asked me the other day, “Whydon’t you get a liver transplant” (to make it possible for me to be around fragrance chemicalsafter having experienced liver damage — primarily from chemicals in a lab I worked in and a building-in-renovation I worked in — that has made my liver incompetent to properly process/excrete chemicals ranging from air “fresheners” to perfumes to…). At the time I replied, “I would not want to be subject to being dependent upon a lifelong supply of immune-suppressing drugs.” And then, too, there is also the fact that “body harvesting” of spare parts for transplants, is not always characterized by the degree of quality control one would think should be fundamental to medical practice (in other words, the chance of getting a liver damaged in some way other than mine — perhaps even to the point of carrying nodes of cancer — seems a likely danger). Now, after reading your and your wife’s story, I am reminded of the third reason I attempt to stay out of the clutches of the medical system: incompetence and damage (much of which I’ve experienced, but not to the degree of your wife) and lying about said incompetence and damage. Oh, yes, there are some good doctors (I have had at least one in my family). But how does one know that the one s/he has consulted, is one of them?
Best of luck to you and yours.
We’re a medical family, and the partner of the doctor that made the huge mistake is a very good friend (Not the one who messed up, the partner). They still sent us bills and such though and my mom threw a fit, then the CEO told us they wouldn’t bill us for it anymore because he knew what happened (Essentially admitted guilt- probably aren’t supposed to do that), but yeah its cause the partner is a good friend and we’re all medical. I sure hope the guy isn’t doing that to anyone else though- he had no idea what he was doing! Our insurance still paid their portion, but we did notify them of what happened. We’re just not the “suing” type either I guess; we don’t really care about money, just want me to be okay. I have to have an ablation now though; it never ends, all byproducts of that. Not to mention that I went 4 years before someone read my echo correctly and diagnosed my CHD correctly. This stuff can happen anywhere, not just Hopkins.
I had a CardioSEAL ASD closure device placed at a Toledo hospital but the cardio oversized it by 2x and it punctured two holes in my atrium (So instead of closing the ASD, it created two more!) I had to have open heart surgery to remove it but one leg of the device is still lodged in my heart. We should have sued. Super scary.
Hi Dan,
Focus=understanding and the strength of the communication process. What is the point of your website again?
Well thanks. I can’t agree that most Docs are flawed people – except in the sense that the phrase “flawed people” is redundant.
I think most Docs are decent people. Sometimes they lose perspective.
Hi Dan,
Welcome to the body of brave and eloquent souls who write about these things. I too express my tale in this way. My website is temporarily down for updates and improvements but it will be up again shortly. I have some thoughts to send your way.
People in general have swallowed the myth that hospitals are wonderful places. It’s weird that advertizements for all other products are questioned and regarded with skepticism except for medical care. There is this absurd perception that doctors are closer to God than anyone except perhaps Santa Claus.
My solution to the problem is demystification. The public absolutely MUST let go of the easy belief that prayer is the last ingredient in survival and that the doctor is never a dubious component when illness comes your way.
Doctors are flawed people almost to a perosn. First, they have the idea that they “suffer” the schooling process. I see a homeless or handicapped person as suffering more of a “schooling” process. He has to learn how to live on the street or with his disability. Med students have a lot of fun learning and they are given the best opportunities and facilities. Also if they don’t like it they can always quit!
I could go on at length but sum it up as follows. There is a massive amount of brainwashing going on here. Everyone is suffering except a few at the top of the heap. These top managers of the global human population epidemic have chosen to hide the culling process rather than promote birth control. Hospitals are the places of choice. Jails and mental institutions as well. Organ harvesting is growing as a “holy” way to kill disposables rather than save them.
A hospital is not a holy place. It is at best a garage for humans. The more of us there are the greater the panic to pretend they care; the greater the disrespect for patients and the need to conceal the limitations.
Doctors are horribly manipulated by healthcare “controllers.” They are told they are great so that they will perfom. The trickle-down effect is their goal. Membership in that elite club they can smell in the wings is so tantalizingly close. They do the most awful things to try to get there.
Because they are characteristically overachievers and have been so since childhood they are essentially infantile and naive. They are excellent tools.
The solution is to realize we need to prevent healthcare. First, we reduce population by not having children in this ill-equipped environment called earth and wait it out. At the same we tell our stories regardless of stupid comments like “if you hate doctors so much I’d like to see what you will do after a car accident…”
We need to go back to square one and look after ourselves as much as possible. This way we can at least elicit a bit of respect when we go to hospital. They will want to see US rather than the other way around.
The time is now. Thank you for your work.
If you go back and look you will see that everything that Hopkins would consider to be defamatory is either my opinion or is fully documented, e.g. “the attending shows up to be there during the burn,” and “the safety and efficacy of pulmonary vein isolation was unknown then and it is unknown now,” are quotes by Hugh Calkins from this transcript: http://www.fda.gov/ohrms/dockets/ac/03/transcripts/3954t1.htm. Hugh Calkins IS a TASER salesman: http://www.policeone.com/police-products/press-releases/99272/.
On what grounds could Johns Hopkins sue me?
I’ve been following this case with interest. I’m sure your family has gone through a lot but something bothers me and I wonder if it bothers your attorney.
You say you can prove everything that happened, but if you lose your appeal most courts would view the appellate decision as proof of your inability to prove your case. How will that work for John Hopkins and the two doctors involved? After everything you’ve written about them can they sue you for attempting to ruin their reputations?
Thanks very much for your comments. You are insightful as to the inflammatory parts in the beginning, because I have been struggling with how to tone it down without losing the edge that makes you want to read on. It is difficult to do because, as you can see, my version of events is very well documented. In other words, it’s inflammatory precisely because it is true!
As far as the physicians involved not meaning to do harm and feeling guilty about it, well, I’ve understood perfectly well from the beginning that doctors are only human and therefore make mistakes like the rest of us. That does not however, give them the right to deceive and conceal their mistakes – at the expense of the patient. If they feel so badly about it now, they can still come clean and acknowledge what the documentation shows – that they put their careers and reputations above the welfare of their patient. Until such time their reputations are fair game to be compared to the documented record.
You are right that it needs to be couched more in terms of raising awareness of patient safety issues and I am working to do that, but as it develops you will see that it also serves as a cautionary tale to physicians and med students that when mistakes are made, they need to own up to them and come clean right away. It is in everyone’s best interest to do so.
I get a lot of comments from doctors, and it is interesting that half are angry and indignant, while half say keep up the good work. Thanks again for your comments and best to you in your career. I think that you will make a fine physician.
Dan
Good Writing! Intriguing style. I would encourage you to put this into print,
I found it interesting to see how your tone kind of changes from the early chapters to later..and I would encourage you to “tone down” some of the inflammatory parts in the beginning, however, this may have been what captivated me.
I am starting a cardiology fellowship this fall. I am 30 years old and I have now reached the point in my life where I have spent more time beyond high school “in training” than the the entire point up to high school. Of the past 30 years of my life, I have spent 25 years as a student, and I have 4 more years to go before I am an attending. I can relate to doctors and fellows in your case. I guess, I don’t really know what to take as I read your story other than the twinges of guilt, from things that have gone wrong in the various parts of my clinical experiences.
My only thoughts are that these doctors involved in your experience did (not) intend to cause harm and I can only imagine how they feel now, and I worry that your purpose is to cause publicity (bad) about them more than to improve the culture of safety in medicine.
With how much of this written, my take is that your number one goal or purpose is to have these doctors run out of the business. If you are to publish this, you need to change the theme to more about raising awareness of the need to improve the culture of safety in healthcare.
Thanks very much. That means a lot to me and my wife.
I am saddened to hear about your wife and your story. I work at Hopkins and unfortunately have experienced a similar situation. Your voice is important. Thank you for publishing this. We need to look at ourselves and understand if we’re really performing as the BEST hospital. We have a long way to go. Your story needs to be heard by all. Continue publishing.
Thank you very much for your comments.
Aside from not being informed that the attending would not be a primary operator, to me the real transgression here is that the attending knew full well that this procedure was far more difficult and dangerous than he led us to believe.
And then for him to repeatedly state to colleagues that this procedure is highly risky with “complications like no other he’s seen in the EP lab,” and that it is by far “the most dangerous any cardiologist would ever perform”, and to state that it should be performed by highly experienced personnel – to then to let a physician in training perform vital parts of the procedure – without telling us – and then to lie to us about it – to me that is a betrayal of patient trust of the highest order.
I appreciate that you as a cardiologist took the time to read the story and to comment on it. I know it may seem that I am unfairly painting all cardiologists as insensitive and incompetent, which of course is not the case. I am working to present a more balanced picture. But the facts are such that it can be a difficult task.
I do not think this Dr. is a bad guy. I think he lost his perspective, and I think this story needs to be told so as to remind other physicians to not lose theirs.
Thank you gain for taking the time to read the story and to comment and I am glad that you do not take offense.(It is interesting to me that of the physicians who contact me, roughly half are defensive and angry – while the other half tell me to keep up the good work.)
tragic to see what has happened. HOWEVER, as a practitioner (and dare I say, a cardiologist *aghast*!) I must argue that you and the team taking care of your wife would not be in this predicament had they spent the time to properly take informed consent from you. I know how teaching hospitals work. Often the most junior person gets consent. However, this does not let the attending physician “wash his hands free” of any responsibilty. Every attending I worked under whom I respected, would go into the room after I just walked out with the consent form signed and explain the procedure themselves. The patient damn well knew my role as the cardiology fellow and my attendings role as the man (or woman) in charge.
That being said, I have seen situations like yours arise precisely because there was poor communication between the treatment team (attending and fellow or resident) and the patient and his or her family. cries of, “I didnt know so and so was going to scrub and actually do the procedure. I thought Dr. Chief of Section was actually doing it” are all too common.
of course, they should not be. informed consent should really be informed.
All that being said, this was an inadvertent (albeit an incredibly awful) complication. When you have lasso catheters in the LA being manuevered it’s not surprising they get stuck on the MV apparatus. I’ve gotten a Swan Ganz catheter stuck on someones pacer wire in the RV. And this was a procedure done under proper supervision as a trainee! (the outcome was fine).
take home point: dont believe the hype of USNEWS. Always question question question your doctors and realise that teaching hospitals are called TEACHING hospitals for a reason.
since you all seem to have so much distrust for doctors, nurses, and hospitals, please by all means avoid them! the next time you get sick, take your care into your own hands. clearly you know better than the so-called experts.
I copied this from “Critic’s Corner” – dw
Brock Tice Says:
June 8, 2008 at 5:15 pm edit
You commented on my site linking here on an essentially unrelated post. I did not approve the comment, because it’s unrelated and is therefore spam. In the future, perhaps an email would be more appropriate.
Let me first clear the air: I am certainly biased. I do simulation research on heart attacks at Johns Hopkins University, and am working on my degree there. That said, I can’t speak in any official capacity for the institution, and my words are strictly my own.
I have worked with some of the physicians in the EP lab at JHH. I have observed several procedures, and I can tell you that in all cases the nurses were compassionate and very concerned for the comfort of the patients. They were very careful to maintain the correct level of sedation and quick to offer reassurance to patients.
EP fellows and other cardiologists don’t look to see how much you can afford to pay when they come in to do a procedure. They review the problem and set about trying to solve it as carefully and thoroughly as they can. Please keep in mind that they are human, and all humans make mistakes, including doctors. From what I could tell, EP fellows are allowed to do procedures. They are by no means complete rookies, and have had extensive training in their specialty. They are supervised by attendings, and if there’s any question about the abilities of the fellow in a given situation, the attending steps in.
By the way, the checklists Christine mentions have vastly improved the reliability of medicine at Hopkins and elsewhere. I just finished reading a New Yorker article about the vast improvements Hopkins’ checklists have produced in Michigan hospitals, and the country of Spain has requested help setting up checklists in their hospitals as well. In my time at Hopkins, I’ve seen a constant effort to improve patient care. You don’t like checklists? How do you think the “arrogant” doctors feel? And yet, they’re slowly conceding to them in the interest of patient care. The numbers show that they make a substantial difference.
Now, none of this is meant to dismiss the charges that are leveled in this blog. I’ve only read this side of the story, but for all I know it may be entirely and precisely true. I hope that it’s not, but I won’t say it isn’t. If that’s the case, then as others have suggested a malpractice lawyer is probably warranted, and I hope Hopkins makes an effort to curtail such problems in the future.
However, please don’t generalize this to all patient care, or all cardiologists, at Hopkins or elsewhere. Most physicians really try to make a difference for the better.
As much as I am aware of things like this, I am truly speechless and so sorry! Thank you for sharing the story. It is such an important one.
I’m passing it along…
Now, now. Hate is an ugly word.
this whole thing is ridiculous–from the attending being in the dr’s lounge, to your sedated wife signing the consent(they would have had you do that) to drs owning the apts around the hospital and jacking up prices to take advantage of poor patient families–boo hoo you didn’t get to know the cardiac surgeon before he rearranged his schedule to perform life saving surgery–your wife would have died immediately anywhere else! and your quotes are completely irrelevant–the charges against JHH overworking residents occurred in august when the new guidelines were first in place, NOT in april when your wife was there. i’m surprised you didn’t somehow find hopkins doctors responsible for your wife’s car accident! maybe the drs were tired and scared because they work exceedingly hard hours and actually care and medicine is an inexact science with all kinds of complications and unpredictable outcomes. go find a shaman and avoid doctors all together if they are all so evil.
ps i am not a hopkins employee i just hate people who try to blame everything on someone, clearly the appeal of a lawsuit with big $$ is the underlying theme here
You’re right. They’ll just keep piling it on and on and then when something happens it’s your fault.
It’s amazing to me how everyone knows this — but it is not part of the public discussion.
Thanks for the reply
What a horrible story. What a horrible experience to have to go through. I am a cert. med-surg. nurse and have seen hospitals cover up many things. Patients have complications caused by error. The nurses I have worked with are the best and have the knowledge and compassion to take the best care of the patient and of the family. The problems is we are all over worked. On a daily basis I have talked to my superiors about the dangers of high nurse to patient ratios. We nurses have no authority to change this problem, especially in areas where the facility company owns all of the health care facilities in the area. They have a monopoly on everything, staff are afraid of being blacklisted. My prior supervisor and vice-president of nursing told me I had a bad attitude when I went to them about my concerns for patient and employee safety issues. I assure you I spoke to them with great respect at the time. Facilities in some areas(Virginia) set their own staff to patient ratios. Although what they set may be good, in practice with the nursing shortage we have to take care of too many patients at a time and it is impossible to provide good care to all patients. If we stay late to complete all of our work we are told no overtime hours. It is scary to work in health care these days. When a family member of mine is in the hospital, I have stayed with them to make sure they get what they need, and I am not afraid to speak up and demand what they need.
These posts from: Women’s Heart Support
* Posted today at 12:35 pm
I read it all feeling increasingly horrified as the nightmare unfolded, I’m feeling stunned now but, sadly, not surprised. We are meant to trust them, see them as our saviours and never question them. Sadly my family have also suffered in the hands of the medical profession, we went to court, we won, but we didn’t really win, we lost, a precious child, through the incompetence and neglect of our white-coated experts.
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* Posted today at 1:21 pm
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More people are killed/maimed in hospitals and in the hands of doctors than from car accidents. I am so sorry what you both have been through. My parents were both Health Care Professionals. They knew who the good ones were and who to avoid. But, with them both being gone now…and spoiled by great physicans from the past, I am on my own always researching doctors for various problems. Going to top notch hospitals and even what appears to be top notch doctors isn’t always as it seems. One must always be on their toes….for everything. You need eyes behind your back and a mouth to speak up. Too many people worry about hurting a doctor’s feelings if something does not seem right.
Recently, I had surgery. It was not heart surgery. I knew something was not right. I sounded like a broken record and still was not heard. I was treated poorly and ignored with my concerns. I even requested to see another doctor in the same group and my hands were slapped as how unethical this was. I spoke up again (not nicely) and was banned from ever seeing another doctor in the practice.
Two outside physicians confirmed what was suspected. I was not crazy.
The Banning was done by a well known/America’s Best!~! The post op problems were diagnosed by not one..but by two different outside groups that are not as well known at the Ban Group.
So, America’s Best/World’s Best, Cream of the Crop, Who’s Who in America’s Doctor’s/Best Hospitals, do not mean anything to me anymore. We are at their Mercy and have to pray and pray hard for our lives every time we seek medical help. Sad but too often, true.
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* Posted today at 1:37 pm
Thank you for sharing this story. Each of us in this community can relate on some level. Dealing with the medical community is a hit and miss situation. I am amazed each and every day by things that go on that we never hear about. I had a stent placed in 2006 and saw no problem with having a fellow observe the procedure. However, the intern actually was allowed to perform part of the procedure which resulted in my having 5 puncture sites in my groin. I was bruised from my stomach to my knee for weeks. The doctor insisted the intern had assisted on not worked on me, but my IV malfunctioned during the procedure and I didn’t get most of the “groggy med”. I clearly saw the intern at my right hip (he had on a turban – no offense to anyone, but no one else in that room had on a navy turban that day) I also heard the doctor giving him instructions from way across the room like “keep going – no that’s too far – start again”. Doctor was nowhere close enough to me to be doing the procedure. No one believed my IV was messed up until a nurse checked it and everyone panicked since not only was I not getting my groggy med, I was not getting my blood thinners. This happened at The Heart Institute at St. Luke’s in Houston, TX.
I had triple bypass 12/30/07 after being dismissed as having “hysterical woman” syndrome. A nurse told someone I was there for “preventative cardiology” because no one believed my symptoms were cardiac at 41 even after 2 stents. The heart cath I had to lie to get resulted in my emergency triple bypass (told them I went off Plavix knowing they would have to cath.) I was taken off Plavix since my stents were bypassed. 18 days later I had a heart attack caused by a blood clot in one of my new bypasses, which had to be stented resulting in me going back on Plavix. Had I not been taken off of it, I would probably not have had the heart attack.
I love your signs for the ICU – especially “You are not in Hell your are in the ICU”. When I had my heart attack, I begged not to go back to ICU. I got no rest and was allowed hardly any visitors. Since I had my bypass so recently, I had no choice. I now suffer from post traumatic stress disorder from everything I have been through, yet it is nothing compared to what your family went through. Your wife and family are in my thoughts and prayers. I am anxious to read the rest of your story. Thank you again for sharing.
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This story reminds me of Upton Sinclairs’s story of the meat packing industry “The Jungle.” Let’s hope it has the same dramatic effect!
I think that your wife’s story is a perfect example of what is wrong with our heath care system as a whole. We have health care professionals who are overworked and under appreciated. It seems that the lower you are on the totem pole as a health care worker (i.e. techs and nurses) or as a patient (i.e. from the lower and middle classes) then all of the flaws of the “best health care system in the world” are truly exposed. In my opinion we need to do a revamp on the way we approach health care, we need to put more effort into preventative care and providing coverage for all. While developing new techniques and equipment for complicated medical procedures is necessary and using it is being on the cutting edge, we have largely neglected the basics of preventative care and overall wellness. Why, because there isn’t anything glamorous or exciting about preventative care and wellness, it’s not flashy and the subject of cutting edge research, its just common sense. I mean look at health insurance, it’s not about providing affordable coverage for doctors and nurses to treat their patients its about providing incentives to cut corners on care and to avoid anything deemed unnecessary. The time that doctors and nurses spend on the phone fighting insurance companies for the funds to doing necessary testing and procedures on their patients has taken up time that used to be spent treating patients. Rather then paying our health care workers respectable wages with decent hours, we have implemented mandatory overtime and tried to cut corners wherever possible. Thus we arrive back to what has happened to your wife, its clear that many people have dropped the ball with you, your wife and the rest of your family; you have been deceived, ignored, patronized and neglected and sadly I am sure that there are others who have been in a similar situation. It’s reading stories like this that make me even more determined to become a nurse and to fight for my patients no matter what the cost is, I truly hope that your wife does not suffer anymore at the dangerous hands of our “first class health care system.”
There is wisdom in that.
You are obviously very upset but truth never lies in the extremes.
For some-one working in Medicine this is an eye-opener! I’m still a junior doctor, and have done a lot of procedures on my own, but in the beginning always under the supervision of my consultant.
Unfortunately we still have to learn, and sometimes the curve is “steep and rocky”, but remember the professor who heads the unit, and is world-wide recignised as a leader in a certain field, also had to start from the beginning, under supervision.
It’s like flying. Sooner or later you have to solo, with no-one to hold your hand.
But the one thing that we have to keep in mind is part of the Hippocratic Oath :FIRST DO NO HARM!!
Doctors need to ask themselves firstly: What is the best for this patient? And then, Am I able to provide this for the patient? If we are unable then we need to refer to a colleague who will be able to provide that option that is best for the patient.
I wonder how these Pompous male doctor’s would like to have just a small washcloth covering their penis and balls and laying like this for everyone to see them from the gallery. There might be a lot of laughter. Hmmmm The doctor may not be the stud, he thinks he is, after all. LOL and the whole world would know.
Signed: I am Woman…Hear Me Roar!
All these arrongant SOB doctors have to face their Maker. Bad things happened to me via the hands of doctors. I have suffered physically and emotionally from uncaring doctors. I asked God to handle this. Every single doctor that has hurt me has had a tragedy strike them. Hmmm! God does work in mysterious ways! Almost like placing a voo doo on them. Watch out doctors. Walk the straight line and do what is right for your patients and admit to fault and error quickly so help can be forthcoming ASAP!
That scared the *&#% out of me! I’ve had more bad experiences than good (involving Emergency care) not inpatient as your wife had. I realize how vulnerable we all are and pray that the person holding my heart (literally and figuratively) will treat me as that they would their own wife, mother, daughter or sister.
So Lauren it sounds like it was more important to get the kid trained than your well being. Thanks for sharing this. I will pay more attention now to details. Perhaps these teaching hospitals are not the answers to a patient’s prayer unless of course you are the King of Siam! Perhaps we all can add Ph.D after our name for times like this. Would that impress them? LOL
I am soo sorry your wife went through this nightmare. BUT, I am not surprised that some of these so called top notch (loosely said) hospitals treat patients in this manner. You are so right about the rich and the not so rich. The rich even has a private door they can go through and even a private cath lab offered to them. They are treated with respect and with full class dignity. The chiefs hover around them.
I had a heart cath in Houston. Suppose to be a top notch place. We spoke to the cath doctor prior and was assured he would be doing the heart cath and if I needed a stent, he would notify my husband (sitting close by) before placing it in. Ha Ha. I did not even have a nurse in the room. I was given IV sedation and must of zonked out quickly. I awoke to loud frigtened talking and saw a stranger sitting to my right side working in my heart. To the back of him (about 3-4 ft behind this kid) was standing the doctor we thought was going to do all the work. I asked what was hapeening while the kid was still talking loudly and the head guy walked over to me and got in my face 9 I smelled his breath as that is how close he was to me) and said, “SHUT YOUR &%^&(,
*&%^%*, Mouth and act like an adult!~! He turned around an looked toward another door and started yelling for someone to give him more Fentynal. I awoke in my room
andf told my husband what had happened. he was agahst that this could happen in So and So Hospital. The doctor never came out and to9ld my husband that he was inserting two stents. The procedure was 2 hours long and no work from the cath lab all the while. I asked the main cath doctor whay he yelled at me. he denied it and said I was hallucinating. I asked to see the Cath report on dismissal and saw tewo names listed in attendance. I also noted that the “kid in trainining” had a difficult time deploying the “Taxus stent” in the RCA. I was livid b y then. I proceeded to call the stent makers and gave them a copy of the report and they verified that yes, there was some difficulty noted in the deployment. What this meant was if this kid could not deploy the stent….they would have to call for a surgeon to do by-pass. Ah ha! This is why the “kid in training” was talking loudly–he was in trouble. I called the CEO and discussed this with him and yes…I did not dream any of this up….All this happened. I was treated like a menial. When I saw the Cath doctor two week later, he was upset with me that I called him in on the carpet. He said, “this is a teaching hospital” and you sign papers allowing us to do this and that and I should know better”! I got in his face and told him how the cow ate the cabbage. Needless to say, I was not going to return to that place, again. I wrote again to the CEO and asked that everyone who has a heart cath that can see and understand, be asked verbally in front of witnesses and family, to allow or not allow a “trainee” to work in your heart”!
The head cath doctor said, “well how are these kids going to learn”…My response, “not on my heart, they don’t” and if one does allow this…the patient should be compensated for this or not charged a dime for his procedure…The CEO did say, all patients have a right to say NO with no backlash! This CEO needs to enforce this with all doctors. Yes, the rich and dignitaries have the best of all worlds…money, fame and fortune and great medical care. Patients need to be aware of their surroundings and not take a back seat to pompous, holier than thou, doctors. Some of these doctors need their bare bottoms spanked. I will be in line first, thank you.
Lauren.
Hmm sounds a little like when I had my gall bladder out. I spent 2 weeks talking to this doctor who had “done hundreds of these”. When I woke up some kid walks in and starts talking to me about how my surgery went. I looked at him and said “Who the F*** are you?” He replied. “Im Dr So-and-so, I did your surgery” Turns out he was a resident. Fortunately, I didnt get nearly as torn up as your poor wife did. But compared to what I was told to expect, it was definitely the job of an inexperienced surgeon.
Thank you for publishing your medical nightmare so that others perhaps learn something which will spare someone else the
tragedy your wife and you have suffered.
I would like to bring to your attention that there have been several formal medical experiments taking place in regards to the various methods of catheter ablation for atrial fibrillation. They are registered with the US government by the way. I have reviewed these studies and found a significant number of them were *terminated*. Various reasons were given. Some of the procedures were using microwave and other radio frequencies to destroy tissue. The reasons for clinical trial termination was listed as vague reasons such as “lack of participant recruitment.” etc.
I was a Coronary and Coronary Surgical ICU Nurse Specialist for part of my career. I didn’t work in teaching hospitals for reasons you identified, and I worked at facilities regarded as the best in their field. I can tell you that surgeons often did not perform all of the work in surgery. However, because cardiac surgery statistics of outcomes are very important in ranking of the facility, there was more than a concerted effort to have a desired outcome. It was so important that some cardiac hospitals would literally wheel a patient out of the operating room into the recovery room if they were crashing and death was imminent. They didn’t want any stats showing anyone actually died on the table during surgery.
People are not aware of the FAILURE IN THE INFORMED CONSENT PROCESS. Forgive me for the capitals, which I even consider obnoxious. However, my major political effort at this time is to try to restore the concept of informed consent which has been severely eroded more than you can imagine. This extend to powers the executive branch has unilaterally taken during this present administration. Patients – even just citizens -are being subjected to non-consensual human experimentation everyday. Literally.
Please feel free to contact me at the unpublished email address I left with you should you wish to. I can only sympathize, but if that would help, I’m available.
By the way, if the blood thinners are managed properly, they won’t
cause any problems. I took them myself for a few years after developing blood clots from standing on my feet for so many hours in these ICU’s without a break for even a drink of water for 8-12 hours at at time, day after day, year after year.
I sincerely wish your family the absolute best restoration of your lives.
I’m assuming you are obtaining a medical malpractice attorney.
The legal profession is even worse in terms of work ethic. I hope you obtain several legal opinions and interview many attorneys before choosing one to handle your case. There are more nightmare stories in the follow up legal handling of medical malpractice cases
than you could imagine. There is less disclosure of what goes on behind closed door in that industry than any other besides politics.
Take care.
Beth
Pam’s story sounds very similar to my third ablation done at Mayo Clinic Rochester, MN. I thought that I was going to the “best facility” with the best Dcotors available, if it was good enough for the kings and Presidents, it must be the best.
Being that this was my third attempt at ablation, I requested and thought I was assured of the most senior EP. I too was given the consent after initial sedation, back in the anti room prior to ablation.
My wife met a very nice woman while waiting for my ablation. It seems she and her husband flew in from Arizona on a “rush” basis being referred by a DR. at Mayo’s Arizona facility. In talking with her it appeared that this couple was very “well off”. My wife still had no clue that there might be a problem in being assured of the Doctor we had requested to perform the procedure.
After what seemed like an eternity, a Dr. we had never met nor knew of came in saying he had good news and bad news! He felt they had erradicated all the errant signals but that when they started to remove the catheters,one had punctured his ventricle and they were taking him to ICU. My wife was in schock.
While waiting in the ICU waiting area she overheard another family being told that during pacemaker placement, there had been a problem, also making her feel even more fearful of what kind of care was I receiving.
After another couple of hours, My wife had about had it and luckily my daughter was with her, she asked her to ask the nurse how much longer before we could see me, and if it wasn’t soon my wife was about to make a scene. I was very lucky to have survived with no permanent damage, that we know of. I went on to have a Cox maze in 2005 and feel better than I have in years. only wish I had done it a lot sooner, even though it is major surgery, there is less risk than with ablation.
Having read a shorter version of Pam’s experience on affibers.org, you have my best wishes for the best possible outcome, only sorry you did not have better luck with your court case. Where is the justice?
Best regards
Tate
That is a horrific story and I hope the nurses involved had the courage to report the doctor. Unfortunately things like that happen all over the world. In the UK, nurses seem more able to report doctors bad practice. If we see one doctor’s name on the consent form and that doctor is present during the procedure, we are supposed to report. Note that the consenting doctor should be present, not necessarily doing the procedure. It is generally recognised that a patient has the right to know exactly who will be performing a procedure and has the right to question how often they do this and what there success rate is. And if they are savvy, they can also get this information using the freedom of information act.
My husband went into Johns Hopkins Hospital with signs of liver failure but poor nursing and physician care and hospital acquired infections kept him from getting the liver transplant he needed resulting in his death seven weeks later.
The hepatologist kept insisting he was the healthiest of her liver patients, was not in liver failure and did not need a transplant. An endoscopy they performed and stated was normal missed an ulcer that five days later almost caused him to bleed to death.
He was not given proper nourishment. The physicians kept insisting he was eating when I knew he could not eat because of his illness. When his medical condition finally deteriorated to the point he could be considered for a transplant I was told he was too malnourished to survive a transplant.
The most distressing part of the hospitalization was the lack communication and family centered care. The staff treated me with distain for asking questions, nurses gave vague and patronizing answers, the physicians communicated only when directly confronted and were often armed with incorrect facts. The attending physician flat out lied about several issues.
The ICU nurses refused to offer a portable phone or let my husband use his cell phone to have contact with his children.
The JHH physicians are very arrogant, lack any compassion, and have no communication skills. They treat the patients as isolated organs or diseases and not human beings that have families depending on them.
When it was clear my husband was going to die these doctors dissappeared into the wooodwork, not one offered any condolences or asked if there was anything they could do.
I am a health care provider myself and would not treat any of my patients or their families the way my husband and I were treated.
Every day thousands of people are subjected to substandard care and arrogant doctors and nurses at supposedly one of this countries premier health institutions.
I used to work in the EP lab. I can tell you that no one in a teaching hospital is allowed to perform such procedures without the attending being by their side. If a student is extremely competent, the attending might allow them to do some of the work, but only after lots of proof that they know what they are doing, but the attending is still at their side. Also, there is no reason that I can think of where a person had to lie on a table without being covered. I am so sorry that this had to happen.
Thank you for publishing your horror story. As a chronically ill citizen of Baltimore, I have – for a decade – described that I live in the land of Johns Hopkins gods. From personal experience, I can say that the Hopkins trained/employed physicians that I’ve had the good fortune to see are accountants with little practice in clinical observation.
Who needs the skill of clinician when you have checklists? Barf.
I had a HopkinsAss (TM) prescribe Zyprexa for interrupted sleep, because I too am a woman, and suffer female hysteria (it’s a conspiracy. we’re here to take over the world with our “hysterics” which is why our uteri must be removed at all costs!)
“What about my family history of type 2 diabetes?” I asked. He insisted that I was “too smart” and therefore had “too much to worry about.” I have to give him credit though. He was right about the “too smart” part – I never filled the prescription and never went back.
Keep up the good work. And wishing Pam (and you) quick healing and recovery.
Before medical negligence rendered me barely capable of keeping up with ADL’s – the activities of daily living – I was frequently working with lawyers as an expert witness. I found that I preferred working on homicide cases because most, usually all, the killing of another person or persons had already been done. Civil cases, in contrast, meant watching people being tortured to some degree, perhaps severely tortured, and I just did not want to be involved in that process for plaintiff or defense. Way back in time, when I was in medical school, we were taught to “First of all, do no harm”. Family and friends visiting patients provided social and emotional support, sometimes were urgently needed for assisting patients in eating, and sometimes would spend the night with patients, especially when children were admitted. There was no concept of needing someone to be constantly at the patient’s side in order to try to protect the patient from being harmed by the healthcare staff. Isn’t it amazing how far we have come with all the medical advances that could hardly have been imagined in the 60′s!