When it comes to publishing a full set of trial data on new drugs, the biopharma industry overall has a poor record on transparency, according to a new report from a bioethics watchdog group. And some companies--like Sanofi ($SNY) and Gilead ($GILD)--fall well below the "legal and ethical" standards on this score.
The not-for-profit Bioethics International reported in BMJ Open that a third of the trial data that supported new drug approvals in 2012 never saw the light of day. And nearly half of the reviewed drugs that came up for approval in 2012 cleared the finish line with an undisclosed Phase II or Phase III study.
A group of top bioethicists, including Arthur Caplan at NYU Langone Medical Center, noted that a lack of transparency on key safety and efficacy data for these drugs contributed to the steady erosion of the pharma industry's reputation around the world. And without all the data on a new drug, they add, neither doctors nor patients can truly evaluate the risk/benefit profile of new therapies.
Gilead was singled out as one of the worst offenders, providing only 21% of the data on its HIV cocktail Stribild. Sanofi's Aubagio was also cited.
But not all big pharma companies did poorly. The group also noted that GlaxoSmithKline ($GSK), J&J ($JNJ) and Pfizer ($PFE) disclosed all the trial results for at least one of their reviewed drugs that year.
The group also announced that it had created a new scorecard that would be used to grade the company's performance on their transparency standard. And there were some clear signs that many of the top players were eager to do better.
|Harvard's David Korn|
"Notably, all companies responded to our requests for input," noted Harvard's David Korn. "Many companies scoring lower on our ranking scale were interested in ascertaining where and how they were not transparent with the intention of improving, and those who scored highly offered recommendations for maintaining best practices."
Gilead did not respond immediately to FierceBiotech, which isn't surprising as it rarely responds at all to criticism. Sanofi provided this statement:
"We look forward to reviewing the study to understand the authors' methodology and results. Sanofi 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, and we are fully supportive of the PhRMA-EFPIA Principles for the Responsible Sharing of Clinical Trial Data. Sanofi registers its clinical trials on public registries including the FDA's clinicaltrials.gov, and results of clinical trials included in these registries are published on Sanofi.com (including Aubagio and Zaltrap), in peer-reviewed medical journals and at medical congresses."
- here's the release