Are FDA Panel Votes on Psych Drugs Tainted by Speakers’ COIs?
Members of the public who receive travel and other expenses from pharmaceutical study sponsors to attend US Food and Drug Administration (FDA) advisory panel meetings and provide testimony about the efficacy of a new psychiatric drug are highly likely to deliver a positive opinion, new research shows.
Such individuals, investigators say, have the potential to skew outcomes of FDA advisory panel votes, potentially leading to psychiatric drug approvals that are not exclusively based on objective scientific evidence.
“The implications of these findings are concerning since COIs have the potential to skew public speakers’ testimonies at these meetings and persuade committee members to look beyond the evidence and approve a drug through the acquisition of non–evidence-based information,” study investigator William Roberts, a medical student at Oklahoma State University (OSU) College of Osteopathic Medicine in Tulsa, told Medscape Medical News.
The study was published online February 4 in BMJ Evidence-Based Medicine.
First Look at Psychiatry Drugs
The Psychopharmacologic Drug Advisory Committee (PDAC) is one of 33 FDA advisory committees responsible for reviewing safety and efficacy data for human and investigational psychiatric drugs and make recommendations for or against FDA approval.
Prior to providing testimony, speakers are asked about potential COIs, but not required to publicly disclose them at the meeting.
Although previous research has shown a relationship between the COIs of these public speakers and their likelihood of providing positive testimony, little is known about their effect in the field of psychiatry.
To learn more, the researchers analyzed the transcripts from 14 meetings of the PDAC between April 2009 and March 2019. Over the 10-year period, there were 145 public speakers. About one quarter were from the general public, 20% from nonprofit organizations, 17% of speakers were patients, 14% industry representatives, 12% representatives from medical organizations, 10% were friends or relatives of the patient, and less than 1% were patient advocates.
Nearly half (49%) of the speakers made a positive statement about the drug under review, 23% made a negative statement, and 28% made a neutral statement.
About 36% of these public speakers reported a COI, 48% reported no COIs, and 16.5% didn’t mention COIs at all. Most COI disclosures were related to travel expenses or the speakers were paid consultants by the pharmaceutical company.
Among those speakers who disclosed a COI, 82% provided a positive statement on the drug. Among the speakers who either did not reveal a COI or did not mention a COI, 32% provided a positive statement.
Speakers who had previously or were currently taking the drug in question provided a positive statement in 11 of 12 (92%) instances and speakers who had the condition in question provided a positive statement in 16 of 29 (55%) instances.
“Guise of Neutrality”
“This study confirms what we’ve seen in the context of many other FDA advisory committee meetings, which is that a substantial number of public speakers have financial ties to the product sponsor and that, unsurprisingly, these speakers are likely to support product approval,” Matthew McCoy, PhD, Department of Medical Ethics and Health Policy, University of Pennsylvania Perelman School of Medicine, Philadelphia, told Medscape Medical News.
“In principle,” said McCoy, who was not involved with the study, “public comment periods have the potential to enhance deliberations by providing patient and other perspectives that aren’t represented on the advisory committee. These findings are concerning because they provide further evidence that public comment periods are actually being leveraged to reinforce the sponsor’s message under the guise of neutrality suggested by the word ‘public.’ “
The investigators recommend that pharmaceutical companies not be allowed to handpick the patients they want to speak during open public hearings, but rather random video diaries from patients involved in the drug’s clinical trial phases be played at these hearings instead to promote transparency and validity of the approval process.
“Essentially,” said Roberts, “patients involved in the drug’s clinical trials would be required to record video updates regarding their experience and viewpoint of the drug throughout the clinical trial phase. A random selection of these video diaries [not picked by the pharmaceutical company] would be played for the panel during committee meetings to provide an accurate representation of the patient testimonies.
“This implemented process may help ensure non-emotionally charged testimonies are presented to the committee and potentially reduce the risk of bias regarding the approval of psychiatric drugs,” Roberts said.
The authors also suggest limiting the number of public speakers who have COIs — or prohibiting their testimony altogether.
The study had no specific funding. Roberts and McCoy have disclosed no relevant financial relationships.
BMJ Evid Based Med. Published online February 4, 2020. Abstract