As I See It: Transparency and clinical trial data
Just like Pharma dug in against the Physician Payments Sunshine Act—which now requires them to disclose payments to doctors—they are once again opposing the latest transparency issue: clinical trial data. Fortunately, they are once again swimming against the current.
Earlier this year, the BMJ began requiring authors to share study data when requested. In an editorial that accompanied the new policy, BMJ's editor-in-chief wrote that the data should not remain secret and that transparency will strengthen patient safety.
Multiple other groups, including GlaxoSmithKline, have come out in favor of the policy. And then, there's PhRMA and its European cousin, the EFPIA. While both have paid mouth service to transparency, they oppose Europe's draft policy to make data public. And get this, they oppose transparency, in part, because they are worried making data public might harm patient safety. It's a laughable argument.
The thrust of the matter is that medicine needs to enter the modern era of science. In some fields, you can't even publish a study unless you upload your data and algorithm. Why should medicine be held to a separate standard? Especially, since we've seen so many scandals involving clinical trials for billion-dollar super drugs that turned out to be super duds.
Attempts to delay this latest transparency movement will, of course, fail. We will eventually get to the point where it will seem unethical for corporations to experiment on humans and hide the data from the public. It's just too bad that fewer companies are unwilling to join GlaxoSmithKline to make this possible sooner.
Paul Thacker is a consultant to several nonprofits and a fellow at the Safra Center on Ethics at Harvard University.