Making Available All Clinical Trial Data: A First by GSK

In an announcement last week, which has been described as “a genuine historic milestone”, by Ben Goldacre, author of ‘Bad Pharma’, the British pharmaceutical major GlaxoSmithKline has committed itself to publishing the results of all clinical trials, without holding back any of the results no matter how adverse the results may be to the success of the drug.

In an op-ed in the NYT, a few days before GSK’s announcement, Goldacre, had slammed the pharmaceutical industry for allegedly cherry picking only the best data from the clinical trials for the purposes of publishing, while holding back on information about possible adverse events.. Gouldacre describes how pharmaceutical companies have allegedly been violating the reporting requirements of the Food and Drug Administration Amendments Act of 2007 by not disclosing all data from clinical trials. The lack of access to all such data from all clinical trials, especially trials that demonstrate adverse effects of a drug, seriously impedes, the ability of the medical community to treat patients safely with them. It is hoped that with greater access to clinical trial data the medical community will be better empowered to make the best decision for patients.

So, what made GSK commit itself to this path-breaking move of disclosing all clinical data?

The answer probably lies in the massive  $3 billion dollar fine that GSK had to pay to U.S. regulators to settle criminal and civil liability for falsely promoting drugs for off-label uses, bribing doctors etc. By agreeing to publish all clinical data,  GSK may not only reduce its liability arising from any future lawsuits alleging suppression of critical clinical trial data, but the company will also gain precious moral ground over its competitors. For a company which has suffered adverse publicity, a move like this may just help restore some of the lost sheen. As per the report in the Guardian, GSK has committed to publishing “CSRs for clinical outcomes trials for all approved medicines dating back to the formation of the company in 2000.” Given that GSK is releasing clinical trial data from more than a decade ago, there is the possibility that the company may be opening itself up to further claims – unless of course it is confident of its track record on safety.

It remains to be seen whether these commitments translate into firm action on the ground but assuming that things go according to plan, GSK’s action will be a vindication of the efforts by drug regulators and the medical community to force pharmaceutical companies to disclose more information.

Prashant Reddy Thikkavarapu, CLB Student Fellow, Stanford Law School LLM candidate