Drugs

Companies Pay for Some Panel Testimony: Study

A Medscape commentary says that some of the public speakers addressing an FDA advisory committee have had their expenses and time paid for by the drug companies whose products are being considered. The commentary (free membership required) references a study in BMJ Evidence-Based Medicine that makes clear 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 study examined transcripts of 14 meetings of the Psychopharmacologic Drugs Advisory Committee that included 145 individual testimonies. Of those, some 40% reported a financial conflict of interest, another 40% reported no conflict of interest, and 20% did not mention conflicts of interest.

“Of course,” the commentary says, “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 [in the study], 11 are now FDA approved.

The Medscape commentary makes clear there is no thought that people are changing their testimony because they are being paid. Rather, drug companies are identifying individuals who they believe are already predisposed to be favorable toward their drug and then paying them. “They know how to navigate the system,” it says, “but the rest of us would be hard-pressed to figure out how to speak at one of these meetings.”

The study authors recommended that advisors be shown random video diaries from individuals who participated in Phase 3 trials. The commentary author questions how workable that would be and suggests simply preventing drug companies from paying people to testify, even if it is only for travel expenses.

“The open public hearing was designed to let Americans have a say in the drug approval process,” the commentary concludes. “It would be more democratic without the corporate sponsorship.”

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Gupta Raises Concerns About Overton’s Independence, Ideology

Overton Confirmation Remains Uncertain After Senate Hearing

FDA Classifies Boston Scientific Imager II Catheter Recall as Class I

FDA Approves Gazyva for Childhood-Onset Idiopathic Nephrotic Syndrome