“Open Public Hearings” at FDA Co-Opted by Big Pharma

Conflicts of interest abound when the public weighs in on drug approvals.

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On March 27th, 2018 in a nondescript room at the FDA, a woman stood before a panel of FDA advisors and told the heartbreaking story of how her son had 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:

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She was one of six speakers at the open public hearing before the FDA Psychopharmacologic Drug 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, 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 in theory 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 the BMJ makes clear.

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It turns out that individuals presenting at these open public hearings are often hand-picked 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 examines 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, another 40% reported no conflict of interest, and 20% didn’t mention COI at all.

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Not surprisingly, those disclosing a conflict of interest were much more likely to recommend the drug be approved compared to those without a conflict of interest.

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82% of those with a COI recommended the drug, compared to just 32% 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 the panels be presented with random video diaries from individuals who participated in the phase 3 trials. I’m not sure how workable this 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.

This commentary first appeared on medscape.com

Writing about medicine, science, statistics, and the abuses thereof. Commentator at Medscape. Associate Professor of Medicine at Yale University.

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