Goozner and the Integrity in Science Project on Conflicts at the FDA

Like the National Academies, the Food and Drug Administration recently reviewed its conflict of interest policies. And once again, the Integrity in Science Project at the Center for Science in the Public Interest offered a useful take on the findings:

When the original 2001 Vioxx study appeared in the New England Journal of Medicine, its industry-funded authors dismissed data showing the drug raised the risk of heart attack by suggesting the comparison drug in the trial had been cardio-protective. Last month, the Food and Drug Administration did something similar with a study [PDF] of conflicts of interest on its advisory committees. The agency's press release said it would be difficult to create advisory committees free from conflicts of interest. The study, which cost taxpayers $60,000, according to FedSpending.org, also claimed the advisors granted conflict-of-interest waivers had greater expertise than those without conflicts serving on the committees.

In fact, a Center for Science in the Public Interest reanalysis of the data contained in the report revealed that the FDA and the report should have drawn the opposite conclusions. The report examined four committees created during 2006 that granted 17 waivers. It took just 88 person-hours to identify 30 independent experts with all the expertise needed to fill those slots. Each of the 30 affirmatively declared in the medical literature that they had no conflicts of interest. Moreover, the expertise of those potential candidates, according to the report's own methodology, was greater than either the conflicted or unconflicted experts chosen to serve on the committees.

In a letter [Word Doc] sent today to Commissioner Andrew von Eschenbach, a coalition of consumer groups called on the FDA to reopen consideration of an agency proposal made last March that would forbid anyone who has financial ties with industry worth more than $50,000 from serving on advisory committees. It would also deny voting rights to advisers with lesser conflicts. "While the FDA's proposed guidance doesn't go far enough, this study shows that those barred or restricted under its limited provisions could be easily replaced," said Merrill Goozner, director of CSPI's Integrity in Science Project. Recently passed legislation only requires the agency to reduce total waivers by 20 percent over the next five years, which is well short of the total ban on conflicts of interest sought by consumer groups.

Merrill not only directs the project but has written a widely-praised book on the costs of drug development, and maintains his own blog, Gooznews. Both come recommended.