Report: Mixed Results for Drugmakers’ Clinical Trials Disclosure
Results were mixed for drugmakers’ disclosure of clinical trial results, according to a recent study from Bioethics International.
The study evaluated 15 drugs approved by the FDA in 2012, and found that only two-thirds of clinical trials per drug were disclosed. Almost half of the reviewed drugs had at least one undisclosed Phase 2 or 3 trial.
Some companies were better than others at reporting full trial results. GlaxoSmithKline, Johnson & Johnson and Pfizer all shared full trial results for at least one of their drug candidates, the report says. Their meningitis vaccine, tuberculosis drug and two cancer drugs respectively fell among the top of the pile.
Which companies were the worst offenders? According to the study, Gilead Sciences only reported 21 percent of trial results for its HIV treatment Stribild (elvitegravir, cobicistat, emtricitabine, tenofovir disoproxil fumarate). Sanofi’s multiple sclerosis drug Aubagio (teriflunomide) also ranked low for transparency at 22 percent.
Gilead published 21 percent of its 34 trials of Stribild, and Sanofi a mere 16 percent for 32 analyzed trials of Aubagio.
Sanofi defended its record of registering trials — including those for Aubagio and Zaltrap (ziv-aflibercept) — on public databases, as well as publishing results on its website, in medical journals and at medical congresses. The company tells CTA that it supports the Pharmaceutical Research and Manufacturers of America’s Principles for the Responsible Sharing of Clinical Trial Data.
“A critical issue facing the biopharmaceutical industry today is the loss of public trust,” said Jennifer Miller, the nonprofit’s president and lead author of the report, in its release. “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.”
Bioethics now is expanding its look at clinical trials transparency into an annual, ranked Good Pharma Scorecard, which will evaluate firms and new drugs based on clinical trial disclosure, human rights and other ethical practices related to R&D. — Victoria Pelham
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