COMMENTARY

FDA Approvals: Is Pharma Buying Testimonies?

F. Perry Wilson, MD, MSCE

Disclosures

February 05, 2020

Welcome to Impact Factor, your weekly dose of commentary on a new medical study. I'm Dr F. Perry Wilson.

On March 27, 2018, in a nondescript room at the US Food and Drug Administration (FDA), a woman stood before a panel of FDA advisors and told the heartbreaking story of how her son died of a fentanyl overdose. She spoke of his struggles with withdrawal symptoms, and how fear of withdrawal kept him from getting adequate treatment. She closed with this statement: "I encourage you to consider approval of lofexidine for the purpose of alleviating and easing opioid withdrawal symptoms."

She was one of six speakers at the open public hearing before the FDA Psychopharmacologic Drugs Advisory Committee. Her travel and accommodations, she noted, were paid for by US WorldMeds, the makers of lofexidine, which was being considered for FDA approval. It was formally approved for treatment of opioid withdrawal a few months later.

What's going on?

This scene—patients, advocates, and drug companies presenting their comments to an FDA approval panel—is repeated every time a new drug is up for consideration. The "open public hearing" portion of the advisory panel meeting typically lasts an hour.

Anyone can petition to speak, and if too many petitions are received, the FDA engages in a lottery. This seems good; the public should have a voice in these decisions.

But this isn't what happens in practice, as this paper appearing in BMJ Evidence-Based Medicine makes clear. It turns out that individuals presenting at these open public hearings are often handpicked by the pharmaceutical company seeking approval, who may pay for travel, accommodations, and time. Individuals who speak are encouraged but not required to disclose these conflicts of interest.

The paper examined the public transcripts of 14 meetings of the Psychopharmacologic Drugs Advisory Committee, which included 145 individual testimonies.

Of those, around 40% reported a financial conflict of interest (COI), another 40% reported no COIs, and 20% didn't mention COIs at all.


 

Not surprisingly, those disclosing a COI were much more likely to recommend that the drug be approved compared with those without a COI.


 

Eighty-two percent of those with a COI recommended the drug, compared with just 32% of those without.

Of course, the FDA panel doesn't need to listen to these recommendations, but it's hard to imagine that the emotional appeals from patients and patient advocates don't make a difference. Of the 14 drugs examined, 11 are now FDA approved.

One thing to make clear: I don't think the interpretation here is that people are changing their testimony because they are getting paid. Rather, pharma is identifying individuals who are already predisposed to be favorable toward the drug—and paying them. They know how to navigate the system, but the rest of us would be hard-pressed to figure out how to speak at one of these meetings. (But here's a link if you want.)

Is there a better way? The authors suggest that the panels be presented with random video diaries from individuals who participated in the phase 3 trials. I'm not sure how workable that is. To me, it seems that pharma should simply be prevented from paying people to testify, even if they are just covering travel expenses. The open public hearing was designed to let Americans have a say in the drug approval process. It would be more democratic without the corporate sponsorship.

F. Perry Wilson, MD, MSCE, is an associate professor of medicine and director of Yale's Program of Applied Translational Research. His science communication work can be found in the Huffington Post, on NPR, and here on Medscape. He tweets @methodsmanmd and hosts a repository of his communication work at www.methodsman.com.

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