When it comes to disclosing clinical trial data, some drug makers are still keeping secrets, according to a new study.
Thirty-five percent of all trial results for 15 drugs that were approved in 2012 by the Food and Drug Administration were not publicly disclosed. And nearly 30 percent of the trials conducted for those drugs failed to meet legal disclosure requirements.
“This confirms that pharmaceutical companies often fall below legal and ethical standards,” said Jennifer Miller, an assistant professor in the Division of Medical Ethics at the NYU School of Medicine and a co-author of the study, which was published in BMJ. The study examined 318 clinical trials involving almost 100,000 participants.
The findings come amid growing clamor from academics and consumer groups to press drug and device makers to release trial data. If research is not published or reported in accessible registries, physicians and patients are prevented from having a complete picture of the risks and benefits of medicines.
At issue is the ability for researchers to independently verify study results and, consequently, improve patient treatments that can lead to better health and lower costs.
Such concerns have been heightened following various safety scandals that revealed trial data for some products was never fully published or disclosed. A few notable examples include the Vioxx painkiller, which was withdrawn by Merck, and the Paxil antidepressant sold by GlaxoSmithKline. A recent independent analysis of Paxil trial data reported results that contradicted initial safety claims.
Over the past year, regulators in the US and Europe responded to concerns by releasing new rules designed to widen access. The World Health Organization has released a new position statement calling for companies to publish all research studies.
And several drug makers, in varying degrees, have taken steps to release trial data. Notably, Glaxo created a web site where data requests are made to 10 different drug makers. And Johnson & Johnson is working with Yale University to provide access to data.
Nonetheless, more than 50 physicians and academics sent letters this week to each of the US presidential candidates asking whether they support access to clinical trial data held by federal agencies and what they will do to ensure reporting requirements are met.
And Sense About Science, a UK nonprofit that launched the AllTrials campaign to widen access to data, is working with 85 asset managers and pension funds to assess steps taken by drug makers to provide trial information. A report is expected in coming months.
Despite the grim findings in the BMJ study, Miller noted there are signs that the industry is gradually adopting what she called ‘best practices’ toward greater transparency. But to prod drug makers, she plans to publish an annual scorecard that ranks disclosure of trial data.
A version of this scorecard, in fact, appears in the BMJ study and found that Glaxo, J&J and Pfizer released all of the trial data for the drugs that were approved by the FDA in 2012. “We seek to publish results of all our clinical trials, regardless of whether the results might be perceived as positive or negative,” a Glaxo spokeswoman wrote us.
However, Miller’s scorecard also found that some drug makers fared poorly. For instance, Gilead Sciences publicly disclosed only 21 percent of trials for its Stribild HIV drug and Sanofi disclosed just 22 percent of the trials conducted for its Aubagio multiple sclerosis treatment.
A Sanofi spokeswoman wrote us that the company registers its clinical trials on public registries, including clinicaltrials.gov, and study results included in these registries are published on the company web site, peer-reviewed medical journals and at medical congresses. A Gilead spokeswoman declined to comment.Print This Post