lunes, 12 de septiembre de 2011

FDA: Juez y...parte. O de los conflictos de intereses en asuntos de bifosfonatos

So how should we interpret the presence of at least four members of a joint panel of the Reproductive Health Drugs Advisory Committee and the Drug Safety and Risk Management Advisory Committee who have had financial ties to different drugmakers whose products are being reviewed today? The meeting is being held to decide whether women who use osteoporosis meds should take so-called drug holidays due to worries about unusual side effects associated with long-term use.

Among the drugs being reviewed - Fosamax, which is sold by Merck; Reclast, which is sold by Novartis; Boniva, which is sold by Roche; and Actonel, which is sold by Warner-Chilcott. Known as bisphosphonates, the widely used meds have also generated reports concerning thigh-bone fractures (look here), jaw-bone damage (read here) and, in some cases, esophageal cancer (see this).

A search of the names of the panel members, however, turned up a few connections to different drugmakers. For instance, Bart Clarke, an associate professor of medicine at the Mayo Clinic College of Medicine whose expertise is endocrinology has been a consultant for Merck (read this). And Sonia Hernandez-Diaz, an associate professor in the Department of Epidemiology at the Harvard School of Public Health, has been a consultant to Novartis (see here).

Also, Maria Suarez-Almazor, a distinguished professor at the University of Texas MD Anderson Cancer Center whose expertise is epidemiology, has been a speaker for Roche (read this). And Elaine Morrato, an assistant pediatrics professor at the University of Colorado in Denver whose expertise is epidemiology and risk communications, was an instructor for a RiskMAP program developed for Merck (see here). (You can read the committee rosters here and here).

Their presence irks one government watchdog, who says having experts with financial ties can poison the well. “The FDA makes sure that these panels are balanced with one industry and one consumer representative. But you lose this balance when you have these professors who serve as proxies for industry,” says Paul Thacker, an investigator with the Project On Government Oversight and a former US Senate investigator. “And it’s an insult to American researchers to think that FDA can’t find people without conflicts, because the data from Eric Campbell doesn’t support such a finding.”


Ver también:

FDA Committee to Review Osteoporosis Drugs - ABC News

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