Bad Medicine: If FDA Lets Drug Company Docs Advise It, Safety Will Suffer

Last Updated Jul 26, 2011 1:44 PM EDT

FDA commissioner Margaret Hamburg may relax conflict-of-interest rules next year, thus allowing more doctors with ties to drug companies onto the advisory panels that recommend new drugs for approval. What would happen next is no mystery: Safety and efficacy standards for new drugs would go down, and more drugs would be approved.

Here's an excellent case study of the way scientists can view science differently depending on who pays them. The FDA recently voted to withdraw its approval of the use of the drug Avastin for breast cancer, after its advisory panel gave Avastin the thumbs down by a vote of 12-1. That panel was populated by cancer specialists with no financial ties to Roche (RHHBY), the drug's maker.

But the oncologists who advise the non-profit National Comprehensive Cancer Network, a group that gives guidance to cancer-treatment centers, voted 24-0 to keep using Avastin for breast cancer. Ten of the 33 members on that panel have been on the Roche payroll, according to Pharmalot. (The numbers don't add up because not all of them participated in the vote, but one or two of them must have voted in favor of Avastin.)

Hamburg has a laudable goal: 23 percent of FDA advisory committee panel seats are vacant, and the FDA can't act either way on a drug if it doesn't have enough butts in seats. In fact, inaction is the same thing as non-approval from companies' point of view -- they can't sell the drug.

But even under the current, stricter standards, there have been too many examples of drugs getting to market that have turned out to be more dangerous that researchers on drug-company payrolls said they would be. GlaxoSmithKline has all but withdrawn its diabetes treatment Avandia after it turned out to cause heart attacks. The FDA launched a criminal investigation into whether the company misled the agency after it argued robustly that its product's risks were no different from competing brands.

And Sanofi's (SNY) atrial fibrillation drug Multaq was expected to be a blockbuster but has since been sharply restricted in its use because it causes heart flutters in some patients -- the very defect it is supposed to prevent. Back in 2008, Sanofi's research showed it reduced hospital stays. That was from a post-hoc "cherry picking" analysis; later data showed it to be more risky for some AF patients.

Surely there's another way to find the few dozen doctors needed to make the most important decisions the FDA can possibly make?

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