Drug approval bodies must tighten rules on conflicts of interest
Author: Louise Prime
Public speakers who disclosed a conflict of interest (COI) were more likely than those who didn’t, to give a positive testimony about the effectiveness of a psychiatric drug in committee meetings of the US Food and Drug Administration (FDA), an investigation has revealed. Furthermore, almost one in six speakers did not even mention their COI – and of these, almost half gave a positive testimony regarding drug approval.
In open public hearings at the FDA’s Psychopharmacologic Drug Advisory Committee (PDAC) meetings, speakers who provide testimonies about the drug in question are invited but not compelled to disclose any COI before they start to speak. The authors of this new study* argued in BMJ Evidence-Based Medicine that pharmaceutical companies could carefully select public speakers and train them to use emotional tactics to persuade committee members to look beyond the evidence and recommend approval of a drug; and they cited initial evidence that has demonstrated a relationship between COIs of these public speakers and their likelihood for providing a positive testimony.
The researchers analysed (blinded) transcripts from 145 speakers at 14 PDAC meetings from April 2009 to March 2019. They categorised the speakers (patient advocate, friend or relative of the patient, general public, industry representative, medical organisation representative, non- profit and patient); recorded whether or not the speaker reported having the condition in question, were taking or had previously taken the drug in question or disclosed a COI (and, if yes, the nature of the COI); and classified each testimony as positive, negative or neutral concerning drug approval.
They found that more than a third (52) of the public speakers disclosed a COI – with travel and lodging being the most common – of whom 42 provided a positive testimony regarding the psychiatric drug under discussion. They calculated that speakers who disclosed a COI were three times as likely to give a positive testimony as speakers who did not. Speakers who had the condition in question were not more likely to provide a positive statement than those who did not.
The study authors also reported that 24 out of the 145 (16.6%) of the public speakers did not disclose that they did have a COI – and among these speakers, nearly half gave a positive testimony.
They concluded: “Our results showed that disclosing a COI was associated with increased odds of public speakers providing a favourable testimony for the recommendation of psychiatric drugs. The implications of these findings are concerning since COIs have the potential to skew public speakers’ testimonies and persuade committee members to recommend a drug through emotionally charged tactics.”
They backed previous calls for pharmaceutical companies to be prevented from handpicking the patients they want to speak during open public hearings, and instead for random video diaries from patients involved in the drug’s clinical trial phases to be played at the hearings “to promote transparency and validity regarding the approval process”. And they called for stronger disclosure rules for public speakers, and for the FDA to implement stricter procedures regarding COIs, or eliminating public speakers with COIs altogether.
*Roberts W, Jellison S, Wayant C, et al. Characteristics and conflicts of interests of public speakers at the Psychopharmacologic Drug and Advisory Committee meetings regarding psychiatric drugs. BMJ Evidence-Based Medicine Epub ahead of print: 4 February 2020. doi:10.1136/bmjebm-2019-111299