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Greg Webb
Greg Webb
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Unauthorized Medical Device Testing and the Physicians Who Participate

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Just when I think I’ve heard, read or seen it all I’m struck, yet again, by the arrogance of the medical manufacturing industry. Not only the medical industrial complex, but also the doctors who work closely with, endorse, and profit from these corporations.

It’s reassuring to know that the FDA has an Office of Criminal Investigations (OCI) tasked to "conduct and coordinate investigations of suspected criminal violations of the Federal Food, Drug, and Cosmetic Act (FDCA) and other related Acts; the Federal Anti-Tampering Act (FATA); and other statutes including applicable Title 18 violations of the United States Code (USC); and to collect evidence to support successful prosecutions through the federal or state court systems as appropriate".

The Director of OCI, John Roth, writes a blog where he shares information about the work of the FDA’s investigative unit. A recent story recounts events dating back to 2004 but the story is as relevant today as it was then. It speaks to the ongoing work of the FDA and the continuing issues with regulation, enforcement and noncompliant corporations.

Medical device maker, Synthes, made a product that was given limited approval by the FDA but not for one specific use: injection into the spine. The drug was Norian, a sort of bone cement used to treat "vertebral compression fractures" of the vertebrae. Synthes ignored the FDA warning about the medication’s use in the injectable form. It had the option to engage in scientifically validated clinical trials, a process that would have taken about three years and close to one million dollars. Instead it found doctors who were wiling to try out the drug, presumably knowing of the FDA nonapproval and warning of the risks. The FDA had already issued its severest level of warning, the Black Box warning, but Synthes went ahead pushing its product.

And, it found doctors who agreed to be part of this ‘study’. Doctors who were willing to perform operations on their patients—using a drug the FDA found to be highly dangerous.

Three people died on the operating table.

"Despite this, the company did not recall the product from the market, an action which would have required them to disclose details of the three deaths to the FDA. Equally egregious, Synthes officials deliberately misled the FDA during an official inspection in May and June 2004." (Roth’s blog, 6/05/2013)

To summarize, the FDA’s Office of Criminal Investigation and other FDA groups were successful in prosecuting the medical manufacturing company. In 2010, "Synthes pled guilty and paid the maximum fine allowable by law — in excess of $23 million for the company and its corporate parent. In 2011, four executives were convicted and sentenced to prison terms."

We are not told what happened to the doctors who participated in the Synthes studies. So we’re left to wonder what led these doctors to risk their patients’ lives. Was money involved? Or was it an honest attempt to save lives when nothing else would work? We are talking vertebrae fractures, so it does not seem as if death was eminent.

What about the Doctor’s role participating in medical equipment and drug trials? Any clinical trial, even with FDA approval, presents risks. Are most doctors able to balance the risks with the chances of recovery and the larger goal of creating new and safe treatments for illnesses? It would seem to me that if the FDA is suspicious of a treatment, then the doctor should be wary, at a minimum. In the case of Synthes the FDA position was clear. A Black Box warning is the most severe warning used by the FDA.

The Hippocratic oath has long been seen as the guideline for doctors in how they practice medicine, treat patients and strive to embody the ethical and moral standards we expect from the medical profession. What happens when doctors fail to comply, in fact or spirit? They have pledged in that oath:

"I will remember that I remain a member of society, with special obligations to all my fellow human beings, those sound of mind and body as well as the infirm."

Is this not a more eloquent version of "Do no harm"?

When I read The Hippocratic Oath, and this section in particular, I find the doctors who were in collusion with Synthes to in gross violation of the spirit of the oath, possibly worse.

For more on The Hippocratic Oath visit: http://www.pbs.org/wgbh/nova/body/hippocratic-oath-today.html