We Found Independent Experts—the FDA Can Too

June 18, 2012 | 3:38 pm
Michael Halpern
Former Contributor

Pharmaceutical and medical device companies, and some in Congress, argue that it’s difficult to find independent experts to serve on FDA’s scientific advisory committees due to strong financial conflict of interest standards.

Our experience proves otherwise.

More than 100 of the 620 positions on FDA advisory committees are vacant. but with one email to our scientist network, the Union of Concerned Scientists was able to find enough candidates to fill more than half of the vacant positions with experts who have no declared conflicts of interest.

Congress Prepares to Give Industry More Influence

Congress is expected to vote this week on legislation that will govern how the FDA evaluates prescription drugs and medical devices for health and safety. Unfortunately, Congress is under immense lobbying pressure from the pharmaceutical and medical device industries to give it more influence over the drug and medical device approval process.

We expect the legislation will reflect major industry priorities, including allowing more experts who have financial ties to drug and device companies to serve on FDA advisory panels.

This is not a trivial exercise. FDA advisory committees provide science-based recommendations to the FDA on the safety and efficacy of a wide-range of products, including pharmaceutical drugs, vaccines and biological supplies, tobacco products, medical devices, and food safety.

Testing the Industry’s Argument

The medical device and drug industries claim that there just aren’t enough non-conflicted qualified experts out there. So we decided to put their theory to a test. We sent an email to some of the medical doctors and public health scientists on the UCS Science Network and asked anyone who was interested in serving on an FDA advisory committee to get in touch.

Word spread, and the response was astounding. Sixty-one qualified experts responded, and each expert confirmed that he or she does not have any conflicts of interest.

Today, we nominated these 61 experts to demonstrate that the FDA can ensure that its panels are free from inappropriate financial influence.

“It is crucial that the FDA make its decisions based on solid scientific evidence, unaffected by politics,” said nominee Dr. Lisa Plymate, a geriatric physician at Providence ElderPlace in Seattle, Washington. “The FDA is charged with serving as the primary regulatory agency for the public, and they must act based on scientific analysis of the data before them.”

Let me say it again: with one email, we were able to fill nearly ten percent of all advisory committee positions, and more than half of all vacant positions. Imagine what we could do with a more aggressive campaign.

A Large Pool of Talent

Our success is not entirely surprising, given the fact that there are tens of thousands of qualified medical, pharmacological and other experts in the United States.  Our experience shows that it is possible to reach these experts, and many of them are willing to take the time to participate on an advisory panel.

“Patients depend on physicians to make correct decisions, and we physicians depend on the FDA to thoroughly assess drugs for efficacy and safety,” said nominee Dr. William Beckett, an internist at Mount Auburn Hospital in Cambridge, Massachusetts.  “Being a panelist would be a service to my fellow citizens, most of whom will ultimately rely on FDA reviewed medications.”

The Path Forward

Even if Congress relaxes conflict-of-interest rules, the FDA can and should aspire to select as few conflicted experts as possible. Financial ties should never play a role when evaluating the safety of pharmaceutical drugs, medical devices, food, and tobacco products.

To be sure, serving on an advisory committee is a commitment. Terms last up to four years, and advisory committee members must travel to Washington, D.C. up to four times per year to meet (The agency covers travel costs and provides a small salary for each meeting day).

If you’re a scientist who wants to learn more, please email me. We’ll continue to recruit independent scientists throughout the year to help create a more independent FDA.

We also hope that the FDA will be receptive to our efforts.  The FDA has a lot on its plate and limited resources.  If UCS can help, our scientists have shown they are interested in lending a hand.