November 12, 2015
By Alex Keown, BioSpace.com Breaking News Staff
NEW YORK – A study published in BMJ Open by not-for-profit group Bioethics International alleges Gilead Sciences, Inc. and Sanofi as among the worst industry offenders when it comes to transparency of its clinical drug trials.
The report’s authors evaluated data of 15 drugs approved by the U.S. Food and Drug Administration (FDA) in 2012. The authors said there were wide variations of how much information was made public. According to the report, Gilead had the lowest scores of the companies reviewed. Researchers said Gilead disclosed 21 percent of the trial results for its HIV medicine Stribild. Sanofi‘s multiple sclerosis drug Aubagio also ranked low for publicly available information.
Sanofi told FierceBiotech it planned on reviewing the study’s methodology and that the company “is committed to the timely, effective sharing of clinical trial data in an effort to help patients, healthcare professionals, patient advocacy organizations and the research community.” The company said its trials are registered with the FDA and results are published on its website.
But the report from the industry watchdogs is not flattering to the industry as a whole. Citing data from 2012, the report authors said only two-thirds of clinical trials supporting new drugs were disclosed “falling below legal and ethical standards.” Additionally, the report said almost half of all reviewed drugs had at least one undisclosed Phase II or Phase III trial.
“Incomplete disclosure of clinical trial results impacts the ability of healthcare decision-makers, including physicians, prescription guideline writers, payers and formulary committees, to effectively evaluate the appropriate use of a drug,” the researchers said in a statement. Joseph S. Ross, associate professor of medicine and public health at Yale University School Of Medicine and an author on the paper, said medical decisions should be made based on all trial information, not only the information made public by drug companies.
Jennifer E. Miller, president of Bioethics International, said a loss of public trust is a critical issue facing the pharmaceutical industry.
“Only 17 years ago, the pharmaceutical industry was among the most admired business sector in the world, and today only 12 percent of Americans believe that pharmaceutical companies are honest and ethical,” Miller said in a
It wasn’t all bad news though. The report said three of 10 companies, GlaxoSmithKline , Johnson & Johnson , and Pfizer Inc. , publicly disclosed all clinical trial results for at least one of their reviewed drugs.
Joanne Waldstreicher, chief medical officer of Johnson & Johnson, said the company believes sharing clinical trial data advances the science that is the foundation of medical care.
“Clinical trial data transparency is in the best interest of the patients who use our products and the providers who prescribe them,” Waldstreicher said in a statement.
In addition to the criticism of the lack of transparency in the trials, Bioethics International launched a new scorecard system to “independently rank biopharmaceutical companies and new drugs based on key ethics, human rights, and public health criteria, beginning with R&D and clinical trial transparency.” Bioethics International said it is expanding the rankings to include drugs approved in other years, as well as additional trial sponsors. The group said it will release the rankings annually with a goal of “improving biopharmaceutical company compliance with legal and ethical standards and the quality of medical knowledge.”
