Public opinion of drugs effectiveness may be too biased
People asked by experts to comment on the effectiveness of new psychiatric drug treatments appear to be unfairly biased even though they declare a conflict of interest, suggests research published online in the journal BMJ Evidence-Based Medicine today.
US researchers found potential positive bias among people who were meant to be giving objective opinion on drugs to experts before they decide to approve them for wider public use.
In the US, the Psychopharmacologic Drug Advisory Committee is one of 33 advisory committees of the Food and Drug Administration (FDA) - the agency that ensures medicines and medical devices work and are safe—that is responsible for reviewing safety and efficacy data for human and investigational psychiatric drug products.
During committee meetings, an open public hearing takes place where speakers provide testimonies regarding the drug in question and are asked, but do not have to, mention a conflict of interest when speaking.
Previous studies have found a relationship between conflicts of interest of these public speakers and their likelihood for providing a positive testimony, but little is known about their effect in the field of psychiatry.
Medical student Will Roberts and colleagues from Oklahoma State University's Center for Health Sciences in the US therefore studied data on transcripts from 18 meetings of the Psychopharmacologic Drug Advisory Committee between April 2009 and March 2019.
During the 10-year period, there were 145 public speakers, the most common being from the general public (24.8%), non-profit organisations (20%), patients (17.2%), industry representatives (13.8%), medical organisation representatives (12.4%), friend or relative of the patient (10.3%) and patient advocate (less than 1%).
Of the 145 speakers, 52 disclosed a conflict of interest (COI).
Such conflicts can include reimbursement for travel and lodging by the pharmaceutical company to attend the meeting, previous or current payments for consulting from the pharmaceutical company, and compensation as a paid investigator in previously conducted clinical trials for the drug under review.
Among these 52 speakers, 82% provided a positive testimony about the psychiatric drug in question.
Those speakers who had the condition in question were not more likely to provide a positive statement than those who did not.
In addition, 24 out of the 145 public speakers did not mention their COI, and among these speakers, nearly half of them provided a positive testimony.
This is an observational study, so can't establish cause. Nevertheless, the authors concluded that the 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 speaker's testimonies and persuade committee members to recommend a drug through emotionally charged tactics," they conclude.
The authors recommend that pharmaceutical companies should not be allowed to handpick the patients they want to speak during open public hearings, and instead that random video diaries from patients involved in the drug's clinical trial phases be played at these hearings to promote transparency and validity regarding the approval process.
They also recommend the FDA implement additional procedures regarding conflicts of interest, specifically stricter management of such conflicts or prohibition.
More information: Characteristics and conflicts of interests of public speakers at the Psychopharmacologic Drug and Advisory Committee meetings regarding psychiatric drugs, DOI: 10.1136/bmjebm-2019-111299