The numbers are small but the implications significant. A pair of academic researchers has tossed a conflict-of-interest grenade in the laps of the leaders of the federal Food and Drug Administration. Is there too much of a revolving door between Big Pharma and many of the top experts who play vital roles in giving the regulatory thumbs-up or thumbs-down to our medicines?
In a letter published in the prestigious British Medical Journal (now known as “thebmj”), two doctors on the faculty at the Oregon Health and Science University say they studied FDA experts who approved cancer and hematology drugs from 2001 through 2010, finding that a quarter of them since have left the agency and now work or consult for Big Pharma firms. They chose these specialists to scrutinize because their own expertise is in blood cancers, and because they’d heard a lot about the revolving door but had seen no documentation of its actual extent.
“If you know in the back of your mind that your career goal may be to someday work on the other side of the table, I wonder whether that changes the way you regulate,”Dr. Vinay Prasad, a hematologist-oncologist and assistant professor at Oregon Health and Science University, told National Public Radio, adding, “Are you more likely to give [companies] the benefit of the doubt? Are you less likely to beat them up hard over [issues like using bad comparisons in drug studies]?”
He said his own experience tells him that there is great subjectivity in difficult decisions about cancer medications and whether they should advance to public use. He said he and other experts hope the FDA can be a firewall against harmful drugs, and that its experts need independence to make this so.
The researchers said they looked via publicly available sources at FDA experts only if they participated in significant reviews of cancer and hematology drugs, and they did not try to back-track to see specific recommendations by given experts, especially those who went to Big Pharma employ.
Other researchers and the FDA itself downplayed the Oregon data. They said the process is sufficiently complex and involves multiple parties such that, combined with tough agency personnel regulations, no single individual can disproportionally affect drug decisions. An FDA spokesman also noted that agency rules protect confidential discussions and data, there are required “cooling off” periods before federal experts can go to private industry, and that, among elite scientists, the job options would be select, including as a regulator or in an industry.
As someone who has represented many clients harmed by dangerous drugs that inexplicably made it to the market, often with insufficient warnings on them or with apparent lack of due diligence about their injurious qualities, I am skeptical of the FDA’s dismissal of the Oregon researchers’ work. It is admittedly not as deep or as solid as it could be. But it sends up a troubling warning, and it would be calamitous to the American people to learn later that FDA experts, indeed, are in a revolving relationship with the industry they’re supposed to regulate─to the detriment of patients and the public. As a former president remarked often, trust but verify. The FDA is big and sufficiently well-funded by taxpayers that it should be providing the transparency and buttressing its credibility by having open, published data on this issue.