Saturday, December 13, 2008

Ethics: Epic Fail

When I was studying for the ethics portion of the California State Bar Examination, there was a phrase that really struck me. It had to do with the Judicial Code of Ethics and stated that a judge must not only avoid impropriety, but also the appearance of impropriety. That concept has stuck with me for over thirty years, primarily because it made perfect sense to me. It has to do with being in a position of trust. That position must not only be earned, it must also be maintained. The concept applies to more than judges and lawyers. It also applies to all those other "professions" involving trust: clergy, bankers, politicians, and doctors, to name just a few.

That's why this article in the Minneapolis Star Tribune really curdled my blood this morning. It has to do with doctors and a medical technology company.

Documents filed this week in a federal whistleblower lawsuit against some of the nation's top spine surgeons hint at a lucrative financial relationship between Medtronic Inc. and several doctors at Twin Cities Spine Center, a Minneapolis practice that is one of the largest of its kind in the country.

The whistleblower suit alleges that the Fridley-based medical technology company offered consulting and royalty agreements to induce doctors to use its innovative bone-graft product, Infuse, in ways not approved by the U.S. Food and Drug Administration (FDA)."

For those not familiar with the medical procedures involved, Medtronic has come up with a product to facilitate bone grafts used in spinal fusions, a surgical procedure used to stabilize a weakened portion of the spine. The product in question has been approved for use in the low back region (the lumbar spine), but has not been approved for the neck region (the cervical spine). The law suit alleges that various doctors were paid by the company to use the product for "off label" use.

The company and the various doctors have responded that the contracts the doctors admittedly entered into did not involve "off label" use:

Lundquist said consulting and royalty agreements between Medtronic and the doctors at Twin Cities Spine have "no bearing on the promotion of off-label uses of devices." All payments, which he did not specify, are "carefully linked to the fair market value of the surgeon's time and intellectual property," he said.

This comment by one of the defense lawyers is in fact an admission that the doctors did accept money from Medtronics. That, for me, is the problem.

If the product is indeed the best medical breakthrough since x-rays and penicillin, then doctors should be thrilled enough to use it without being party to kick-backs (make no mistake, that is what in fact those payments are). And that, at the very least, is the appearance of impropriety.

Health care costs is one of the biggest and one of the most complicated issues facing the next administration. It would be better for the medical profession and for the nation if this kind of problem were addressed by the American Medical Association head on. But if the AMA won't take that lead, then we're going to have to insist that Congress does.

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Anonymous Anonymous said...

According to Dr. Andrew Weil, the ama came into existence for the purpose of putting Homeopaths out of business. I wouldn't expect ethics or patient wellfare to be on their agenda.

7:38 AM  

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