Many FDA Advisory Speakers Found with Industry Funding

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2 February 2016. A review of an FDA advisory committee on cancer drugs finds nearly one-third of speakers at its meetings receive financial support from companies making the drugs under review. The analysis by Vinay Prasad at Oregon Health and Science University and Matthew Abola, a medical student at Case Western Reserve University, is reported in yesterday’s (1 February) issue of the journal JAMA Internal Medicine (paid subscription required).

Prasad is a  a hematologist-oncologist at OHSU, as well as a scholar at the school’s Center for Health Care Ethics. He and Abola examined transcripts of 28 meetings of the Food and Drug Administration’s Oncologic Drugs Advisory Committee that reviews and evaluates data on drug products for treating cancer, from 2009 to 2014. The study excluded 21 meetings during that time without public hearings, or where cancer drugs were not discussed.

FDA’s advisory committees seek independent outside guidance on new therapies and medical devices. The Oncologic Drugs Advisory Committee has 13 members mainly with a background in cancer care as well as biostatistics. One consumer representative is also authorized among the voting members, in addition to a non-voting industry representative. As with other advisory committees, its recommendations are not binding, but often predict the FDA’s decision.

Prasad and Abola identified 103 speakers at the 28 committee hearings. Of those speakers, 3 in 10 (30%) had some financial connection with the companies making the drugs being reviewed, either from funding of travel to attend the meeting or as representatives of organizations supported by the companies. Two of the speakers revealed their organizational affiliations, but not the financial support received by the companies making the drugs, which the research team discovered later on.

Among all 103 speakers, nearly half (45%) experienced the type of cancer which the drug under review addresses, while about 3 in 10 (31%) actually used the drug being reviewed. In addition, 2 speakers were principal investigators of key clinical trials testing the drugs being discussed. The researchers examined comments made by speakers in the meeting transcripts, and nearly all speakers (92%) spoke favorably about the drugs in question. Only 6 of the 103 speakers did not support FDA approval of the drugs, with none having a financial connection to the drug’s developer.

Because such a large percentage of the speakers are cancer patients, say the authors, they can offer unique perspectives and deserve to be heard. “Some of the stories are really compelling,” notes Prasad in a university statement, “but it’s a mistake to assume that people who speak at these hearings represent the average patient or express what the average patient wants.” Prasad adds, “Patients who suffered real side effects, they are not the ones able to travel to these meetings.”

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