Drugmakers Kept One-Third of Trial Results Secret, Study Findsby
Only 65% of clinical results on 2012 drugs have been disclosed
Gilead released 21% on HIV drug Stribild; Glaxo scores 100%
Pharmaceutical companies including Gilead Sciences Inc. and Sanofi kept secret more than a third of all clinical trial results for 15 drugs approved in 2012, according to a study, failing to publish data that could tip off doctors and patients to potentially dangerous side effects.
Twelve drugmakers released a median of 65 percent of relevant clinical trial findings for the selected treatments, according to the study, published Thursday in the medical journal BMJ Open. All of the drugs were approved by the U.S. Food and Drug Administration, which saw all of the human trials before granting clearance.
Not all companies were the same: GlaxoSmithKline Plc pre-registered and published every human study of its meningitis vaccine MenHibrix. Johnson & Johnson reported or published all its studies for the tuberculosis treatment Sirturo, and Pfizer Inc. did the same for its kidney cancer drug Inlyta. J&J and Glaxo are among some drugmakers that have publicly committed to giving more public access to data than required under the law.
For Gilead’s HIV drug Stribild, by contrast, only 21 percent of the clinical trial are publicly available, and Sanofi reported or published 22 percent of trials for its multiple sclerosis treatment Aubagio.
“It’s impossible to have evidence-based medicine without the evidence,” Jennifer Miller, a study co-author and assistant professor of medical ethics at New York University School of Medicine, said Monday. Miller is also president of a nonprofit, Bioethics International. “People are worried that companies are hiding critical information about new medicines and vaccines -- their safety and efficacy information -- for the sake of profit.”
Sanofi said in an e-mailed statement that it looks forward “to reviewing the study to understand the authors’ methodology and results,” adding that it is “committed to the timely, effective sharing of clinical trial data” and publishes results of clinical trials on its website and in medical journals and conferences.
A representative for Gilead had no immediate comment on the study.
The full extent of the companies’ discretion to hide clinical information came to the fore more than a decade ago when Eliot Spitzer, then the attorney general of New York state, sued Glaxo in 2004, accusing it of suppressing research that showed links between its antidepressant Paxil and increased risk of suicide in young people.
In later court cases, it came to light that Glaxo executives talked about burying studies that seemed to link Paxil to birth defects. Glaxo settled with Spitzer and agreed to publish its research online, and industry groups rushed to say that other drug companies would follow. Yet that hasn’t happened across the board, according to Miller.
The U.S. Congress acted in 2007 to expand a 1997 law preventing drugmakers from hiding clinical trials by requiring companies to publicly register some of them. Yet those that had to be disclosed amounted to a small fraction of the total conducted for the 15 drugs. A median of three clinical trials per drug were subject to the law, compared with a median of 17 trials conducted per drug. And even for those studies, a median of almost 30 percent of trials per drug didn’t comply with the law, according to the researchers, failing to register or report results in a timely fashion.
Going forward, the rankings will be updated and expanded to include smaller companies and more types of drugs, Miller said. She hopes they’ll push drug companies to improve their standing.
“There have been major ethics failures by pharmaceutical companies and the industry as a whole in the area of clinical trial disclosure,” Miller said. “It’s driving a massive amount of distrust.”