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Choirboy Defense: Could these lads do anything wrong?

 I realize that many Medtronics employees are heart sick over this situation. I extend my sympathies to them. I once had the honor of visiting with Earl Bakken in my lab  on a snowy morning when we were the only ones who made it into work. I took the bus, and he crossed the street from the Radisson.   Medtronic is a wonderful company and this situation is disgraceful. My bet is that the people responsible for this will soon be gone. Live long and prosper, Medtronic. Our state depends on innovative companies like yours.

Earlier published in the Chonicle of HIgher Education. and used with permission.

Something remarkable has happened. A whole issue—June—of a prominent journal, The Spine Journal, is devoted to destroying industry-funded research supporting the use of a bio-therapeutic agent for spinal fusion, so-called  recombinant human bone morphogenetic protein form 2 (rhBMP-2) in the Medtronic product, Infuse.

This remarkable issue features an editorial that is available for download as a pdf: “A challenge to integrity in spine publications: years of living dangerously with the promotion of bone growth factors.”  It initially cites seven research publications for scrutiny. Altogether these studies report zero, nada, side effects in 780 protocol patients. The authors dryly add another citation (from Hemingway’s The Sun Also Rises)  to the list: “Yes, isn’t it pretty to think so.”

Since then the side-effects of rhBMP-2 have become widely known. These include conditions related to unregulated bone growth as well as other disorders including sterility in males and cancer.

And what did these criticized studies have in common: Megabucks for the investigators from, primarily, Medtronic. Some of the authors of these studies have financial involvements with Medtronic that run in the tens of millions of dollars.

Sadly, this story is nothing really new to those who have been following the medical-industrial complex for years.  At our own place one of the docs got in trouble for testifying in favor of Infuse® research before Congress without letting his audience know that he was a consultant for Medtronic. Senator Grassley was annoyed.  I’d also point out that Dr. Carl Elliott (against type if one of my Brainstorm colleagues is correct in her aspersions against the cowardly tenured) has been valiantly crusading against using clinical trials for marketing exercises and other unethical practices in clinical trials.  Various administrative attempts to discredit him have been unsuccessful,  but he is being criticized even to this day by a flack for the Academic Health Center at the University of Minnesota.

The writers of this piece were really on their game. They point out that one of the openings often used by these shills is the choirboy defense: “We are an honest profession; our integrity is unimpeachable; our ethical standards are not in doubt; potential conflicts of interest are only ‘potential’…”  I’ve heard these same arguments used by three medical-school deans so far.

The editorial ends with the primum non nocere statement of the Hippocratic Oath. First do no harm.  It admits that harm has been done.  At first I was a little disappointed in this argument, but on reflection it really is that simple.  I’ve heard a medical school dean justify behavior based on the fact that something was not illegal.

Is ethical behavior too much to ask of the medical profession?

ps. Since the first draft, the matter has gone viral. Paul Thacker—who until recently rode shotgun for Grassley—writes “War Breaks Out Over Medtronic’s Infuse®” and The New York Times chips in with: “Spine Experts Repudiate Medtronic Studies.” The Chronicle now has: “Researchers Paid by Medical Company Missed Flaws in Its Spinal Implant, Study Finds.”


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