Drug Companies Need Greater Transparency in Reporting. A new report in BMJ Open raises concerns about the lack of public reporting on many of the drug trials used as the basis for new drug approval.
The researchers say about one third of such trials are not published and they are pushing for all trial results to be made public to give physicians more information for their prescribing decisions. In the new study, the researchers graded drug companies on their transparency, the Washington Post reports.
The research team examined thousands of pages of regulatory documents, and totaled the number of trials Food and Drug Administration (FDA) regulators reviewed, versus how many trials were published or otherwise publicly reported.
This first transparency report card showed how much evidence was made publicly available about how 15 drugs that were approved in 2012 work in people. Jennifer Miller, an assistant professor of medical ethics at New York University School of Medicine, oversaw the research, the Post reports.
Miller said all evidence from trials is important in the practice of evidence-based medicine. “If the public evidence is partial or biased you risk having partial or biased [prescribing] guidelines,” she said.
The report card in the new study gave the companies a transparency grade
The report card in the new study gave the companies a transparency grade, based on what percentage of all trial results, not just the ones required to be reported, were made publicly available. Gilead’s HIV drug Stribild, a combination medication, received a grade of 21 percent. Of 34 trials presented to the FDA, 26 were never made public, according to the Post.
Stivarga, Bayer’s colorectal cancer drug, got a grade of 47 percent. Seven of 12 trials not made public. Pfizer made public all 28 trials it presented to the FDA for its kidney cancer drug, Inlyta. And received a score of 100 percent.
The researchers acknowledge the limitations of their study. They analyzed only a subset of drugs approved in 2012, and they researchers did not look at evidence of how the drugs worked (or didn’t work). The research was confined to whether clinical trials were registered with the FDA and reported, the Post says.
Clinical trials usually are conducted in three phases, with different goals in each. Phase III trials, the last step before approval, are the largest and most authoritative. Phase III trials test the safety and effectiveness of the drug. Later-stage trials that meet certain requirements are required to be registered and reported to the FDA.
Only a small fraction of the trials identified in the BMJ Open study were among those required to be disclosed, but five drugs made by three companies were rated as zero percent compliant. Three of the 15 drugs studied had at least one publicly unavailable late-stage phase III trial.
Jennifer Miller’s non-profit organization, Bioethics International
Jennifer Miller’s non-profit organization, Bioethics International, which has funding from foundations and universities but not pharmaceutical companies, plans to issue drug company transparency report cards every year. The researchers hope the “Good Pharma Scorecard” will act as an incentive for companies to be more transparent.
The researchers say when evidence is withheld it is more difficult for physicians to know how a drug works on patients. Unreported trials—usually the ones with mediocre or negative findings—may contain information useful to physicians in their treatment decisions.
Sometimes a failed drug in fact works well for a portion of the population. In a 2008 study in the New England Journal of Medicine, researchers examined evidence provided to the FDA in support of a dozen antidepressants. More than 20 studies that showed the drugs did not work were not published, the Post reports. Eleven others were “published in a way that, in our opinion, conveyed a positive outcome,” the authors wrote.
Only three studies showing negative results were published. Overall, nearly a third of the studies submitted to the FDA were not published, keeping potentially valuable information out of the hands of doctors and the public.
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