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