Only two-thirds of clinical trials for new drugs were disclosed in 2012, according to a new study in BMJ Open by Bioethics International, a non-profit group. In addition, almost half of all reviewed drugs had at least one undisclosed Phase 2 or 3 trial. This lack of transparency breaches legal and ethical standards.
Three of ten companies reviewed in the study—GlaxoSmithKline, Johnson & Johnson, and Pfizer—publicly disclosed all clinical trial results for at least one of their reviewed drugs. But the lowest scoring company, Gilead, disclosed 21% of the trial results for its HIV medicine Stribild. Sanofi’s multiple sclerosis drug Aubagio also ranked low for publicly available information.
Incomplete disclosure of clinical trial results impacts the ability of healthcare decision-makers, including physicians, prescription guideline writers, payers and formulary committees, to evaluate the appropriate use of a drug effectively.
Bioethics International has also launched a Good Pharma Scorecard, 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. The organization plans to release these rankings annually.
“A critical issue facing the biopharmaceutical industry today is the loss of public trust,” said Jennifer E. Miller, president of Bioethics International and assistant professor of medical at NYU Langone Medical Center. “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.”
“It’s impossible to have evidence-based medicine without the evidence,” says Dr Miller, the lead author on the study.
The views, opinions and positions expressed by these authors and blogs are theirs and do not necessarily represent that of the Bioethics Research Library and Kennedy Institute of Ethics or Georgetown University.