Testimony from public speakers at FDA advisory committee meetings under increased scrutiny.
Some public advocates for the approval of certain cancer drugs may have a little extra motivation for their support.
An analysis that examined speakers who attend FDA advisory meetings found speakers who represent cancer patients have financial ties with the company seeking marketing approval, ties that are not always disclosed.
"The industry has hijacked that microphone -- they're using it as their second presentation at advisory committee meetings," said study senior author Vinay Prasad, MD, MPH, senior scholar in the Center for Ethics in Health Care.
Researchers examined data from 2009 to 2014 about the speakers who attended 49 meetings of the FDA Oncologic Drug Advisory Committee.
A tally was taken of the amount of public speakers at the meetings who were cancer patients -- and took the drug under consideration — and how many represented an organization or had a financial association with the drug manufacturer.
The analysis, published in JAMA Internal Medicine, classified speaker comments as favorable, neutral, or negative toward FDA approval.
The results showed that out of 103 speakers, more than 90% supported the marketing approval. Approximately 30% reported that they had financial ties with the drug manufacturer, while 2 speakers reported they were principal investigators of pivotal trials.
Researchers found 2 instances where the speakers did not disclose their financial ties in representing organizations that had previously received money from the manufacturer.
Out of all the speakers, almost half were patients with the type of cancer under evaluation, with 31% having used the drug. Speakers at FDA hearings are ideally able to provide unbiased and unique perspective of the drug. However, hearing testimonies do not always represent all patients who have used the drug.
"Some of the stories are really compelling, 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," Dr. Prasad said. "We're likely hearing more of the upsides. Patients who suffered real side effects, they are not the ones able to travel to these meetings."