May 8, 2013 / 2:21 PM / 4 years ago

Drugmakers split as demands for open data mount

4 Min Read

Margaret Hamburg, Commissioner of the U.S. Food and Drug Administration (FDA), speaks during the 2013 Reuters Health Summit in New York, May 6, 2013.Shannon Stapleton

NEW YORK (Reuters) - Big data is emerging as a big headache for the drug industry as regulators and advocates push for greater transparency on information from clinical trials, leaving companies split over how to respond.

GlaxoSmithKline Plc (GSK.L) this week set up a new online system to provide researchers with access to clinical data about its medicines, but some rivals have turned to their lawyers instead.

The issue has triggered a court battle in Europe, where the European Medicines Agency (EMA) has set alarm bells ringing with plans to release previously secret trial data submitted as part of the new drug application process.

Margaret Hamburg, head of the Food and Drug Administration (FDA), told the Reuters Health Summit this week that U.S. laws prevented similar disclosure in the United States but the agency was nonetheless looking to increase transparency.

"I do think there are some ways in which we should do more," she said. "It would be beneficial if we could shine a bit more light on why we don't approve a product because at the present time that information is not posted in the same way as when we do an approval."

The EMA's plans to release clinical trial data have been slammed as irresponsible by the Pharmaceutical Research and Manufacturers of America lobby group, which fears it could harm business and undermine incentives for research.

That position chimes with U.S. drugmakers AbbVie Inc (ABBV.N) and InterMune Inc ITMN.O, both of which have challenged the release of data about their drugs, and last week won a temporary injunction against the EMA. [ID:nL6N0DH3A5]

Still, many drug companies reckon the clamor for greater openness won't go away, given past drug safety scares and the demands from independent researchers for access to data that allows them to stress-test industry claims about medicines.

Public Distrust

"I think society will demand it of us, so we might as well get on and find a way of doing it," Lars Sorensen, chief executive of Denmark's Novo Nordisk A/S (NOVOb.CO), told the summit meeting this week.

"We will be well advised as an industry to go down this route because, after all, our science and our drug development is based on academic science that is often publicly funded, and people in society at large participate in our clinical trials."

Public distrust of both the drug companies and the regulatory authorities that police them has grown following a series of scandals over the safety of drugs such as Merck & Co Inc's (MRK.N) now-withdrawn painkiller Vioxx and GlaxoSmithKline's (GSK) diabetes pill Avandia.

GSK is the first drug company to announce plans to release detailed data from its clinical trials, including patient-level results made anonymous that sit behind studies of approved and failed drugs.

The British drugmaker is establishing a panel of independent experts to review research proposals to make sure data is used for bona fide scientific research. The EMA also plans to draw up a system to stop inappropriate use of data.

"We see more value from transparency and openness than not," GSK CEO Andrew Witty told Reuters last week. "I guess not everybody necessarily shares that view."

Follow Reuters Summits on Twitter @Reuters_Summits

Editing by Jeffrey Benkoe

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