Breaking the Seal on Drug Studies ; Activists by Accident, Doctors Help Open Trove of Clinical Trial Research

Article excerpt

Researchers are pushing Big Pharma to disclose all clinical results -- and not just those that make the industry look good.

Peter Doshi walked across the campus of Johns Hopkins University in a rumpled polo shirt and stone-washed jeans, a backpack slung over one shoulder. He's 32, and not sure where he will be working come August, when his postdoctoral fellowship ends. On a campus filled with backpack-toters, he was an unremarkable presence. And yet, even without a medical degree, he is one of the most influential voices in medical research today.

Dr. Doshi's renown comes not from solving the puzzles of cancer or discovering the next blockbuster drug, but from pushing the world's biggest pharmaceutical companies to open their records to outsiders in an effort to better understand the benefits and potential harms of the drugs that billions of people take every day. Together with a band of far-flung researchers and activists, he is trying to unearth data from clinical trials -- complex studies that last for years and often involve thousands of patients across many countries -- and make it public.

The current system, the activists say, is one in which the meager details of clinical trials published in medical journals, often by authors with financial ties to the companies whose drugs they are writing about, is insufficient to the point of being misleading.

There is an underdog feel to this fight, with postdocs and academics flinging stones at well-fortified corporations. But they are making headway. Last autumn, after prodding by Dr. Doshi and others, the drug giant GlaxoSmithKline announced that it would share detailed data from all global clinical trials conducted since 2007, a pledge it later expanded to all products dating to 2000. Though that data has have not yet been produced, it would amount to more than 1,000 clinical trials involving more than 90 drugs, a remarkable first for a major drug maker.

The European Medicines Agency, which oversees drug approvals for the European Union, is considering a policy to make trial data public whenever a drug is approved. And on June 17, the medical world saw how valuable such transparency could be, as outside researchers published a review of a spinal treatment from the device maker Medtronic. The review, which concluded that the treatment was no better than an older one, relied on detailed data the company provided to the researchers.

For years, researchers have talked about the problem of publication bias, or selectively publishing results of trials. Concern about such bias gathered force in the 1990s and early 2000s, when researchers documented how, time and again, 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. Problems with data about high- profile drugs have led to scandals over the past decade, like one involving contentions that the number of heart attacks was underreported in research about the painkiller Vioxx. Another involved accusations of misleading data about links between the antidepressant Paxil and the risk of suicide among teenagers.

To those who have followed this issue for years, the moves toward openness are unfolding with surprising speed.

"This problem has been very well documented for at least three decades now in medicine, with no substantive fix," said Dr. Ben Goldacre, a British author and an ally of Dr. Doshi. "Things have changed almost unimaginably fast over the past six months."

Much of that change is happening because of what Dr. Goldacre calls an "accident of history." In 2009, Dr. Doshi and his colleagues set out to answer a simple question about the anti-flu drug Tamiflu: Does it work?

Resolving that question has been far harder than they ever envisioned, and, four years later, there is still no definitive answer. But the quest to determine Tamiflu's efficacy transformed Dr. …