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When it comes to disclosing clinical trial data, some drug makers still keep secrets, according to a new study.
Thirty-five percent of all test results from 15 drugs approved in 2012 by the Food and Drug Administration were not made public. And nearly 30% of the trials conducted for these drugs did not meet the 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 co-author of the study which was published in BMJ. The study examined 318 clinical trials involving nearly 100,000 participants.
The results come amid growing clamor from academics and consumer groups to urge drug and device manufacturers to publish test data. If the research is not published or reported in accessible registers, doctors and patients are prevented from having a complete picture of the risks and benefits of drugs.
The issue is the possibility for researchers to independently verify the results of the study and, therefore, improve patient treatments that can improve health and reduce costs. .
Such concerns have been exacerbated as a result of various security scandals that have revealed that test data for some products have never been fully published or disclosed. Some notable examples include the pain reliever Vioxx, which was removed by Merck, and the antidepressant Paxil sold by GlaxoSmithKline. A recent independent analysis of the Paxil trial data reported results contradicting the initial security claims.
In the past year, regulators in the United States and Europe have responded to concerns by issuing new rules to expand access. The World Health Organization has issued a new position statement asking companies to publish all research studies.
And several drug manufacturers, to varying degrees, have taken steps to publish test data. Glaxo has created a website where requests for data are sent to 10 different drug manufacturers. And Johnson & Johnson works with Yale University to provide access to the data.
Nevertheless, more than 50 doctors and academics sent this week letters to each of the US presidential candidates to ask them if they agree to access data from the US. clinical trials held by federal agencies. are reached.
Sense About Science, a British organization that launched the AllTrials campaign to expand access to data, is working with 85 asset managers and pension funds to evaluate actions taken by the drug manufacturers. A report is expected in the coming months.
Despite the ominous findings of the BMJ study, Miller noted that some signs show that the industry is gradually adopting what it calls "best practices" towards greater transparency. But to encourage drug manufacturers, she intends to publish an annual dashboard that ranks the disclosure of test data.
A version of this dashboard, in fact, appears in the BMJ study and revealed that Glaxo, J & J and Pfizer have released all test data for drugs approved by the FDA in 2012. "We are looking to publish all of our clinical trials, whether the results can be seen as positive or negative," wrote a Glaxo spokesperson.
However, Miller's dashboard also found that some drug makers were struggling with it. For example, Gilead Sciences publicly disclosed only 21 percent of the trials of its HIV drug Stribild and Sanofi only disclosed 22 percent of the trials conducted for its treatment against multiple sclerosis Aubagio.
A Sanofi spokesperson wrote to us that the company is registering its clinical trials on public registries, including clinicaltrials.gov, and the results of studies included in these registries are published on the website of the company. Company, peer-reviewed medical journals and medical conferences. A spokeswoman for Gilead declined to comment.
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