AA“Just one of Those Things…”
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AAProfessor Hugh Calkins went through the notes for his presentation one more time. Others read the Wall Street Journal or looked through their information packets. It was a little before 9AM on a rainy Thursday in May, 2003. The Food and Drug Administration’s Circulatory System Devices Panel was convening in the Walker/Whetstone Room of the Gaithersburg, Maryland, Holiday Inn. The panel’s main order of business was approval of a medical device made by the Cardima corporation. Dr. Calkins was there with his slide presentation to persuade his friends and colleagues on the panel to approve Cardima’s REVELATION Tx cardiac catheter ablation system.
On the street out front, first responders were in full swing at the scene of a gory head-on collision that tied up traffic and made a couple of sales reps from Medtronic late for the meeting. At 9:18, Warren K. Laskey, M.D. looked at his Rolex. He tapped his microphone. The doctors put their danishes down and the meeting came to order.
Before Hugh Calkins could get in there and pitch for Cardima, there was other business to be dealt with. The panel’s Executive Secretary, Garretta Wood of the FDA, appointed the seven cardiologists at the head table to be voting members, and proclaimed Warren Laskey to be Chairman. She then gave the mandatory reading of the conflict of interest statement, noting that sometimes a member’s value to the panel outweighed any perceived conflicts, and these people get waivers.
Out of the seven voting members, conflict of interest waivers had been granted to four of them, so the perceived intercourse between the docs and companies with business before the panel was officially overlooked. And to be fair, they have to do that as a practical matter. Most cardiologists who consult for the FDA get speaking fees, grants, consultation fees and medical advisory fees from all the big companies. If we excluded candidates from regulatory panels based upon their financial arrangements with medical device manufacturers, you’d never get a quorum.
Not to say there is anything unseemly going on.
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Chairman Laskey kicked off the meeting with a grim bit of business. “Before we commence with the topic of the day, there will be a brief presentation by Marian Kroen of the FDA … ”
Marian had been dispatched from the Issues Management Staff at the ominous sounding Office of Surveillance and Biometrics to alert the cardiology world to a potential danger. Two people had died, or, in the parlance of the trade, “there had been adverse events” involving Medtronic products.
Medtronic makes some sophisticated gadgets. They make implantable medicine pumps, and stents for clogged arteries. They make neurostimulators, which are electrodes buried deep in the brain to help Parkinson’s disease patients. For stubborn muscle pain, there is diathermy, which is basically a way to warm up your muscles via microwave.
A couple of people who had both brain stimulators and sore backs went to get their muscles microwaved. They fell asleep and never woke up. Medtronic and the FDA had done some tests to figure out what exactly had felled the victims, and an autopsy had been performed on one of the dead medical consumers. Conclusion: A deadly interaction of the two devices.
It seems that sometimes the electromagnetic field from the heating pad can cause the electrode tips in a person’s brain to turn red hot, which cooks the brain from the inside out. The good news is that because the brain has no pain receptors, the victims don’t feel a thing, which I suppose would count as a victory in the eyes of the director of the pain clinic.
“So what did FDA do?” posed Marian, “We reached into our toolbox and took some actions.” Bold actions. The FDA made Medtronic put bigger warning labels on the packages of both devices, so that both brain and pain physicians could beware the broiled brain.
Some of the cardiologists seemed impatient, What’s this got to do with us?
“As you all know,” Marian said, “Cardiac ablation happens at around 50 to 55 degrees Celsius… ” The cardiologists did indeed know that when a wire inserted into the heart raises nearby tissue to about 130° F it kills that tissue, which creates scar tissue, which blocks the pathway of rogue electrical beats that cause your heart to quiver.
That’s the idea anyway.
There may have been adverse interactions between pacemakers, defibrillators and diathermy, and as a matter of fact there should have been, but there were no reports. Why? “There have been warning labels about pacemakers on diathermy equipment for a long time,” said Marian, “but, as we all know, who reads the labeling?” Doctors are apparently no different from husbands and fathers in their scorn for directions. Just rip open the package and start figuring it out.
After advancing various theories as to why brains were getting cooked while hearts seemingly remained unscathed, she invited comment from the group. Perked up and prepared for questions, she was met with a strong showing of apathy. Warren Laskey broke the spell.
He didn’t think it was a big deal. “For openers,” Laskey said, “I don’t know if any of it makes sense, and it’s not a trivial exercise to reposition pacemaker lead. I think if it were really more than a curiosity, you would hear more about it. Do my colleagues have any thoughts?” A doctor asked what it was that made some diathermy/brain patients more vulnerable to injury than others. Marian deferred to Paul Rejarica, a representative from the FDA’s Office of Science and Technology, which had performed some tests.
“I don’t know,” he said. “It’s just one of those things.”
Dr. Laskey looked up and peered out over nearly invisible reading glasses. “All right, thank you. We’re puzzled as well. Let’s move on …” With that, the FDA Office of Surveillance and Biometrics contingent was dismissed and it was time for the main event. It was show time for Hugh Calkins and Cardima, and there was a lot on the line.
