Researchers from the United States have found that public may be under a mistaken belief regarding the efficacy of commercially available drugs and drug promotions and bias may be the reason behind this.
The new study titled, “Characteristics and conflicts of interests of public speakers at the Psychopharmacologic Drug and Advisory Committee meetings regarding psychiatric drugs,” was published in the latest issue of the British Medical Journal Evidence-Based Medicine.
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This study was conducted by a team of researchers who function as the Psychopharmacologic Drug Advisory Committee which is one of the 33 committees that works as advisory to the US Food and Drug Administration (FDA). They found that 82 percent of the public speakers who sing praises of a drug’s efficacy may have conflicts of interest with the drug makers. This committee works to find out the exact data on efficacy of new and investigational psychiatric drugs.
The team wrote that during meetings of the committee, an open public hearing takes place and each of the speakers were asked to provide their views and testimonies regarding the new drug that was being tried. Results of this review found that these speakers who spoke well about the drug were usually ones who had conflicts of interest with the drug’s makers. This study also showed that disclosing such conflicts of interests would mean that these same speakers were less likely to provide a favorable review of the drug in terms of efficacy.
The data was looked at by Will Roberts and colleagues from Oklahoma State University's Center for Health Sciences in the US. Roberts is a medical student at the institute. They looked at transcripts from 18 meetings of the Psychopharmacologic Drug Advisory Committee. The meetings took place between 2009 April and 2019 March.
The team found that, there were 145 such public speakers and of these over one third of them disclosed their conflicts of interest with the pharmaceutical companies making the drugs. The other three fourths, who did not disclose their interests, were more likely to provide a positive review of the drugs. Of the 145 speakers, 24.8 percent were non scientific and belonged to the general public, 20 percent belonged to non-profit organizations, 17.2 percent were patients, 13.8 percent were industry sales representatives, 12.4 percent were medical organization representatives, 10.3 percent were patient family and friends and less than 1 percent were patient advocates. A total of 52 had disclosed conflicts of interest, they wrote. These included reimbursement of travel and lodging to meetings and conferences most frequently. Some also received payments for consultation and some received compensations for conducting clinical trials. Of these 52, 82 percent had provided a positive drug review when asked to testify. Patients with the psychiatric condition were most likely to say positive things about the drug. They noted that 24 of the 145 speakers did not disclose their conflicts of interest and of these nearly a dozen provided a positive review of the medications.
From these results the team speculated the effects it could have on the clinical practice in future. They wrote that the impact of these results could be long term because these public speakers and their positive testimonies were biased and thus the actual scientific evidence might be overlooked when committee members consider these drugs for FDA approval. They added that if these “non-evidence-based information”, or anecdotal information remained the mainstay from these individuals with vested interests, drugs with doubtful efficacy may get approval.
The team wrote, “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 suggested that patient and public testimonies in the form of random video diaries could be played at the committee hearings instead of pharmaceutical companies bringing in patients and family members to the meetings. They called for more transparency in the whole process of approval based on public and patient opinion. They wrote that this would validate the whole process and make it more scientific. They also said that the FDA needs to be stricter when it comes to pharmaceutical companies making these psychiatric drugs, to be allowed to bring in testimonials where there are conflicts of interest. The called for stricter management of these conflicts of interest and their prohibition from the drug approval process. This would ensure a clear and transparent drug approval process and also ensure that only safe and effective drugs are approved for market use, the team explained.
Roberts W, Jellison S, Wayant C, et alCharacteristics and conflicts of interests of public speakers at the Psychopharmacologic Drug and Advisory Committee meetings regarding psychiatric drugsBMJ Evidence-Based Medicine Published Online First: 04 February 2020. doi: 10.1136/bmjebm-2019-111299, https://ebm.bmj.com/content/early/2020/01/05/bmjebm-2019-111299