Unlocking the Gates: GlaxoSmithKline to Open Drug Trial Data

Last week, a pharmaceutical company made a novel and potentially groundbreaking decision: GlaxoSmithKline (GSK), announced that it would release the data from all of its clinical trials to researchers, who could use the information from GSK’s successes and failures in drug development to independently make new medical and pharmaceutical discoveries. This is the first time a major pharmaceutical company has opened its files in this manner.

Citing a desire to demonstrate transparency in a notoriously opaque industry, GSK Chief Executive Andrew Witty said: “People have to really believe they are looking at the whole picture … We will make available the raw data at patient level from all our trials—you can’t get anything more granular than that.” Along with allowing approved researchers the ability to review data from its trials, GSK will also open its proprietary “compound library” of drugs that have shown positive  effects against tuberculosis—which it did for its malaria compounds in 2009. Reuters points out that malaria, TB, and other neglected diseases have “little commercial upside for drugmakers.” At the same time, making available its drug compounds for neglected diseases that disproportionately effect the developing world is a laudable decision.

This move comes in the wake of GSK’s record-breaking US$3 billion settlement with the U.S. government for ethical breaches, including hiding or misrepresenting negative trial findings. The New York Times details skepticism among researchers and pharma activists, including concerns that GSK’s limitations on who can access the data, including an independent panel that will approve each researcher applying to review the database, could stymie anyone who might have a negative opinion about the company. At the same time, many believe that GSK should be celebrated for its unprecedented decision, which could force other drug companies to do the same.

Bringing this information to the public sphere, and influencing other companies to follow suit, could result in major breakthroughs in health. The Wall Street Journal quoted Witty about this very issue:

“As a truly global health-care company, I believe we have a responsibility to do all we can at GSK to use our resources, knowledge and expertise to help tackle serious global health challenges … However, the complexity of the science and the scale of the challenge mean that we can’t solve these problems alone.”

Opening up this information so that researchers and experts can see how GSK’s successes and failures have worked could save scientists from duplicating efforts and could flesh out current thinking and approaches, leading to innovation and discoveries.

The Guardian reports that Witty believes this is not corporate social responsibility (CSR) but rather a “[fundamental challenge to]  the business model that we operated,” but I can’t see how it’s not. At the root of many experts’ thinking on CSR is the notion that responsible practices should be built into the business model, not set aside as a special program or philanthropic endeavor. GSK’s decision to open its proprietary, patented drug compounds and the full scope of its clinical trial research is a bold one. The company should be recognized for its responsible actions in this matter, even as it has been censured for its ethical lapses (and paid quite a bit for them, I might add). Sharing clinical trial data could pave the way to the next major medical breakthrough, and we cannot criticize GSK for contributing to such a worthy cause, and for pioneering responsibility of this type in its industry.

Photo credit:  jaYmE del Rosario, via Flickr, CC BY 2.0.