In-House Investigators

Posted by Mark Abramowicz, M.D.

The recent Medical Letter article on the new erythropoiesis-stimulating agent peginesatide (Omontys – Affymax-Takeda) did something unusual. It drew attention to the fact that some of the investigators who conducted the clinical trials that led to the drug’s approval by the FDA are employees of the manufacturer of the drug. That is often the case, but we generally don’t mention it. The company develops the drug and pays for the studies. It has to pay the FDA to review the drug. That is the system we have. It is not surprising that the company participates in the studies. It has a lot at stake here. In 2005, spending for an erythropoiesis-stimulating drug was the largest single Medicare drug expenditure ($1.75 billion).

The FDA usually requires for approval only that a new drug be more effective than a placebo. In this case, the company did something more: it compared its new drug to epoetin (the $1.75 billion drug). Good for them. But when a company sponsors a study, participates in it (which can mean designing it, implementing it, analyzing the results and writing them up for publication), and publishes it, there will be no surprises. So we mentioned it.

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