When it comes to disclosing clinical trial data, some drug makers are still keeping secrets, according to new research published in the journal BMJ Open.
According to the study, 35 percent of all trial results for 15 drugs that were approved by the Food and Drug Administration in 2012 were not disclosed. Additionally, 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 New York University School of Medicine and a co-author of the study, which looked at 318 clinical trials involving almost 100,000 participants.
In recent years academics and consumer groups have pressed drug makers and medical device manufacturers to release their trial data, saying without access to such data, doctors and patients have an incomplete 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 were underscored by safety scandals in which trial data for some products were never fully published or disclosed. Notable examples include the painkiller Vioxx, which has been withdrawn by its manufacturer Merck, and GlaxoSmithKline’s antidepressant Paxil. A recent independent analysis of Paxil trial data reported results that contradicted initial safety claims.
Regulators in the United States and Europe have responded by releasing new rules during the past year to increase access to trial data, while some drug firms have implemented steps to release more of their trial 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 that reporting requirements are met.
Miller said that there are signs that the drug 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 the scorecard appears in the BMJ study.
Some firms performed better on the scorecard than others: GlaxoSmithKline, Johnson & Johnson, and Pfizer released all of the trial data for the drugs that were approved by the FDA in 2012. But others can do better. 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 said 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 and in peer-reviewed medical journals, and are presented at medical meetings. A Gilead spokeswoman declined to comment.