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The Push for More Accountability

The drive for open-access data is making rapid headway.

Julia Yellow, New York Times
Source: Julia Yellow, New York Times

“For years,” reporter Katie Thomas noted in yesterday’s New York Times, “researchers have talked about the problem of publication bias, or selectively publishing results of trials.” “Time and again," she added, "positive results were published while negative ones were not. Taken together, studies have shown that results of only about half of clinical trials make their way into medical journals.”

The selective reporting and under-reporting of such trials not only creates a misleading picture about the efficacy of a whole range of prescription medications. It also results in peculiar anomalies, where even researchers working on blockbluster drugs—so-named because their revenue generates more than a billion dollars—can’t reliably answer such basic questions as: Do they actually work?

Researchers and doctors make highly consequential decisions for patients, based on trust and faith that what is published about a prescription drug is accurate and reliable. Yet the information a drug-maker chooses to disclose about its product invariably is selective, occasionally ghostwritten, and frequently cherry-picked “by authors with financial ties to the companies whose drugs they are writing about.” Far from presenting a neutral and exhaustive picture of the medication itself, including its side effects and performance relative to placebo, such information instead points to an inbuilt bias and a major conflict of interest.

Still in the top 5 on the Times’ most-emailed list, Thomas’s article, “Breaking the Seal on Drug Research,” details the fascinating, ultimately cheering story of Peter Doshi, a postdoctoral fellow at Johns Hopkins, whose dogged attempt to determine whether the anti-flu drug Tamiflu actually works led to a showdown with its manufacturer, Roche, that resulted in the drug-maker releasing thousands of pages of data on the drug—essentially before Dr. Doshi and his colleagues published the information themselves.

In a bid to reject such a ludicrous, potentially dangerous gaming of the system, the European Medicines Agency—as Thomas notes and this blog reported back in April—last week “released a draft policy, expected to take effect next year, in which it would release clinical trial data whenever it approved a new drug."

Although the Pharmaceutical Research and Manufacturers of America (PhRMA), a major industry group, and several drug companies so far have opposed that policy, claiming it would reveal too many trade secrets to competitors, the focus on greater transparency and reliable data has already had a significant effect, as Thomas’s article helps underscore.

“Until recently,” she notes, “the idea that companies should routinely hand over detailed data about their clinical trials might have sounded far-fetched. Now, the onus is on the industry to explain why it shouldn’t.” Follow me on Twitter @christophlane

Update, July 4, 2013: Editorial, New York Times: "Full Disclosure Needed for Clinical Drug Data."