Collateral Damage: A Patient, a New Procedure and the Learning Curve

VERITAS

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 Crimson, 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 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.

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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 in 2001 and demanded a catheter ablation procedure because she could no longer stand living with atrial fibrillation and she wanted something done short of open heart surgery.

Hugh Calkins discouraged the idea, telling Pam that he didn’t know if the procedure was safe. Hell, he didn’t even know if it worked, and he warned her that catheter ablation for atrial fibrillation is the most dangerous EP procedure there is. He advised her that contrary to public perception, going to Hopkins for a procedure is 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 and who would be using new and unfamiliar instruments.

According to Hopkins, the myriad conflicts of interest that infest the country’s largest health sciences research center were fully disclosed. 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 for Cardiac Pathways.

Calkins disclosed that he was getting paid in one way or another by all of these outfits, but 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. He told Pam that she should be aware that William R. Brody, president of the university, was on the board of directors for a major medical device manufacturer that did business with the hospital.

Pam Walter was made aware in no uncertain terms that these procedures are sort of like shakeout cruises for new medical devices and their operators. Cardiologists 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 customers for the trial-and-error phase.

Calkins was not running any of this by the FDA, which he considered to be irrelevant, nor was he running any of it by the Hopkins Internal Review Board, because they’d rather not know what went on in his EP Lab…