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VERITAS

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The motto at Harvard, where Hugh Calkins attended medical school, is Veritas.  As a serious and determined young physician in the making, the future Professor of  Medicine at  Johns Hopkins University (Veritas vos liberabit), must have laid eyes on that motto thousands of times—so often that he probably stopped seeing it after a while, its impact literally diminished by degrees until it became intellectual white noise. What likely did stick in his mind was  the Statue of  Three Lies. It is a bronze sculpture of a founding father type  looking out over Harvard Yard.

One supposes it to be a likeness and tribute to the founder of  all things statshoe of three liesCrimson, John Harvard, since that is what is engraved on the base of the statue: John Harvard, Founder, 1638.  But the nickname has it right. Each finely chiseled line is a lie.  The likeness is not that of  John Harvard, who did not found the institution, which was not founded in 1638. And it would have been there in Harvard Yard at the the Statue of  Three Lies  where, as is the custom, a young Hugh Grosvenor Calkins rubbed his hand on the bogus founder’s shoe for luck before turning to take on the world.

The narrative presented by Johns Hopkins via their muscular stable of attorneys goes something like this: Pam Walter grabbed Hugh Calkins by the lapels one day and demanded a catheter ablation procedure.

He discouraged the idea, telling her that he didn’t know if the procedure was safe. In fact, he didn’t even know if it worked, and he warned her that  catheter ablation for atrial fibrillation is the most dangerous  EP procedure  he knows of.

According to Hopkins, the myriad conflicts of interest at the country’s largest medical research center were disclosed to the patient. Calkins told her that what he was really doing was conducting a de facto medical trial. He was experimenting with two new ablation techniques and testing out a couple of new mapping catheters. He was trying out the new Biosense Webster Lasso® mapping Catheter and the new basket catheter put out by EP Technologies, a division of Boston Scientific. He was also collecting performance data on  the new Chilli® ablation catheter from Cardiac Pathways, and he told her that she should be aware that Ron Brody, president of the university, was on the board of directors for a major medical device manufacturer.

He told Pam that he was getting paid in one way or another by all of these outfits, but that Johnson & Johnson was kicking down the salary for the Fellow who would be working on her, so her body would probably be used to experiment with the Lasso® catheter, and that these procedures are  sort of like shake-out cruises for new medical devices and their operators. They had done this procedure on dogs, and now they were going to try it out on people, and Pam would be one of the first.

He was not running any of this by the FDA, which he considered to be irrelevant, and he was not running any of it by the  Hopkins Internal Review Board either, because they’d rather not know what went on in his EP Lab.

He told Pam that contrary to public perception, going to Hopkins for an ablation was akin to going to the barber college for a haircut—except you don’t get the discount. And since it is a teaching hospital, he would hand the job to a trainee whom she would never meet who would be using a new type of catheter, one he had never seen before. The most Calkins could promise was that he would try to stop by at some point during the procedure.

According to Johns Hopkins, all this was made very clear to Pam and she was advised that the smart play for her would be to stick with drug therapy.

But she had the temerity to insist, and they acceded to her wishes.  And when things didn’t turn out so well for her, she had the gall to blame Johns Hopkins.

When he’s out on the circuit, giving talks at various cardiology gatherings around the country, Calkins presents his findings—the results from the studies he performs on people—with the air of a storied combat vet at the local  American Legion hall.  “I learned a lot of things the hard way about the Lasso® catheter,” he tells colleagues. “One thing is you can lasso a lot of things with it, including the mitral valve and if you happen to lasso the mitral valve it’s hard to untangle the valve. When we tried to untangle the valve we wound up ripping the valve and having to replace the valve, and I can tell you that was one memorable lasso experience…”

Of course, even the most vivid memories can fade in the fog of litigation. The lawyer here might as well have been deposing the Magic 8-Ball: Did you tell Pam Walter that you did not know if the benefits of the procedure outweighed the risks? 

Reply hazy, try again.

Nevertheless, thanks to court ordered depositions, we have a permanent and public record of how Richard Wu and Hugh Calkins recall the unfolding events of March 25, 2002—and on the subject of who was actually performing the procedure, Calkins puts forth fuzzy scenarios. Contrary to his customary  “showing up to be there during the burn,” as he confided to colleagues at an FDA hearing, on this particular day he would have scrubbed out after the procedure was set in motion, leaving the trainee at the wheel.

But he is insistent on the point that he was doing the critical part of the procedure. “I would de-scrub when it’s time to analyze the figures to find out if the vein was isolated. This isn’t just looking at something. It’s very tricky to do this. This is the critical part of the procedure. That’s the part I was performing. That’s what I was doing and then the catheter got entrapped.”

He is trying to downplay the fact that he was not the primary operator for the procedure. That task had been delegated—without the patient’s knowledge—to a trainee named Richard C. WU.

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