September 9th, 2011

FDA Panel On Bone Drugs And Conflicted Members

Pharmalot

The controversy over conflicts of interest among FDA advisory committee members shows no sign of abating. Three years after enacting tougher standards over concerns that financial ties to drugmakers were potentially corrosive, the agency is now considering loosening its rules because some officials say it has become harder to find qualified experts who are not conflicted (read here).

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.”

He was referring to a study that Campbell, who is an associate professor of medicine at Harvard Medical School, published two years ago that found nearly 53 percent of academic researchers have some type of relationship with industry (read the abstract). However, another way to view this finding is that about 47 percent do not have ties and, presumably, may also be qualified to serve on FDA advisory committees without causing concern about conflicts.

“They found 22 people who they deemed to experts and only a few had relationships with industry and I think that refutes the commonly held perception that it is impossible to find experts who don’t have conflicts,” Campbell tells us. “I’m actually stunned it’s a small number. I would have predicted that a lot more (would have relationships with the drugmakers).”

And what did the FDA have to say about this? An FDA spokeswoman did not address our question about the number of people with ties to the drugmakers and how that squares with recent concerns that finding experts without connections is becoming increasingly difficult. However, the spokeswoman did write to say that conflict of interest waivers were not issued for any of the panelists.

Read more: http://www.pharmalot.com/2011/09/fda-panel-on-bone-drugs-and-conflicted-members/

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