5/25/2011

Med school starts formal investigation of prof who warned generic drug might not work, after pocketing hidden $260,000 from brand name manufacturer

✔✔✔✔✔UPDATE - Duke Medical School launches formal investigation.

✔✔✔✔ The Wall St Journal reported Wednesday that the maker of the very expensive blood-thinning medicine Lovenox paid two professional societies and Duke's Dr. Victor Tapson millions of dollars to warn against approving a much cheaper generic version.

The payments were not disclosed during testimony against the generic before U-S regulators at the Food and Drug Administration.

It is not clear if Congressional investigators who issued a report on this, found that Tapson or the societies were influenced by the payments to render anything other than their professional judgment that the generic equivalent did not work as well. There is e-mail, however, that one of the societies did not feel it should offer any opinion at all, saying it had never done so. But money talked and there is a stench.

Tapson, a thrombosis expert who is director of pulmonary medicine at Duke, got more than $260,000. It is not clear if this is a personal fee, or if it paid for research.

The other recipients -- of far larger amounts -- are the Society of Hospital Medicine and the North American Thrombosis Forum. In all $5 million changed hands, paid by Sanofi SA, which holds the patent.

While the generic equivalent drug has been approved for years and used safely in European countries and elsewhere, without US approval Sanofi had a firm grip on a $4 billion a year world-wide market.

Ultimately the FDA did approve the generic version of the drug in the US -- and Sanofi's brand name sales plummeted.

These details are from an investigation by the Senate Finance Committee. Sen. Max Baucus (D., Mont.), chairman of the committee said, "Pharmaceutical companies simply cannot be allowed to spend millions of dollars to buy medical opinions that claim objectivity but instead favor their products."

Before Lovenox, some people -- for example those with episodes of an irregular heartbeat called atrial fibrillation -- had to use blood thinning drugs all the time. The reason: the blood thinning (anti-clogging) drugs before Lovenox took so long to work, they would not prevent strokes that can arise during an episode.

These drugs -- the same as rat poison!! -- were very cheap. They were also very dangerous because other drugs and foods could make them act unpredictably, easily causing blood to thin so much it could seep and cause a stroke. People taking these blood thinners have to have repeated blood tests to monitor their condition.

Lovenox resolved these problems -- at a very very fancy price. The drug could be injected during an episode and it worked rapidly. And the drug was tolerated better, removing some of the risks of a dosage too high.

✔✔ The medical professional has been struggling with consultant's fees for some time, and various ethical codes have been enacted to address the issue. We do not know at this moment if Duke has any policies that may have been violated.

Loyal Readers will recall how the cancer quack Dr. Anil Potti collected $100,000 over two years from Eli Lilly and GlaxoSmithKline to speak favorably about their drugs at so-called education meetings. Potti typically traveled to meet other doctors at breakfast -- before coming to Duke for his "cancer research." Other Duke doctors got even larger amounts.

Even local doctors have come under the drug companies's grip, being offered first class vacations if they write enough prescriptions for a company's expensive drugs.

The investigative journalists at http://www.propublica.org/ have done an outstanding job defining the dimensions of this. On their home page, on the right, see Major Investigations. There is a searchable database where you can check your doctor!

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