By Hester Plumridge
Drug companies and researchers will no longer be able to
withhold the results of unfavorable clinical trials, if changes to
European law are passed as expected next month.
The new law would require the results of all trials plus a full
clinical-study report to be published within a year of the trial
ending. The European Parliament is to vote on the new legislation
April 3, and it would come into force in 2016.
Around half of all trial results go unpublished, according to
current estimates, including a 2009 paper that looked at 677
studies conducted in different countries. A 2012 paper found just
45% of 635 U.S. National Institutes of Health-sponsored trials were
published within 30 months of completion.
Academics, physicians and organizations like the Cochrane
Collaboration--which carries out in-depth analyses into drugs'
safety--have been fighting for years to make trial data more widely
available.
Such groups fear that some companies play down or even conceal
data that doesn't support their drugs, skewing the evidence of a
drug's effectiveness.
"Withholding trial results means we are misled about the
benefits and risks of treatments," says doctor, author and
transparency campaigner Ben Goldacre. "Patients are harmed and
money is wasted."
Glenis Willmott, the member of the European Parliament who
drafted the bill, calls the current situation "outrageous" and the
fact that trials could be needlessly repeated "bad for science and
public trust in medical research."
Pharmaceutical companies have become more open about releasing
drug data in recent years, pushed by U.S. legal settlements and
growing public pressure in Europe after a 2009 scandal involving
unpublished trial data for Roche's antiviral treatment Tamiflu.
But the publication of clinical-study reports--documents that
can run to hundreds or thousands of pages and contain all the
trial's data and findings--is proving controversial for some
companies.
Rare-disease specialists worry publishing them might compromise
patient confidentiality, especially for diseases where there are
fewer than 100 patients across the continent.
Others have commercial concerns. "These CSRs are prepared for
one purpose and one purpose only--and it's to gain regulatory
approval of a drug," says Pfizer Inc.'s associate general counsel,
Justin McCarthy.
"The thing we're worried about is someone taking our CSR to an
emerging-market country, putting their own letterhead on it and
seeking approval in a way that would circumvent our intellectual
property."
Drug companies AbbVie Inc. and InterMune Inc. sued the European
Medicines Agency last year for attempting to publish CSRs. Both
filed legal actions to prevent data on their drugs that they
consider commercially confidential being released to competitors.
The court cases are ongoing.
Ms. Willmott says the new legislation should help the agency's
case for disclosing information. "We're saying a clinical-study
report isn't commercially confidential," she says.
Transparency campaigners lament the fact that the new rules
would cover only drugs approved from 2014 onward, omitting most
treatments currently in use.
"I would like to have applied it retrospectively, but we didn't
have that option," Ms. Willmott says .
Still, many companies are moving toward greater openness.
Johnson & Johnson has given all trial data on its approved
drugs to Yale University to decide what to release. GlaxoSmithKline
PLC is publishing CSRs for its drugs online; reports for 10 of its
drugs and some combination products are now available on its
website.
"The requests for data have increased over the years," says
Roche Holding AG's chief operating officer for pharmaceuticals,
Daniel O'Day. "A year ago, we expanded our data-sharing policy to
make all clinical-study reports for Roche medicines available to
researchers."
The industry's hope is that more transparency will feed through
to more patients volunteering for trials.
"Even in areas like cancer, where there is a very active patient
community, you still have a very low percentage of cancer patients
enrolling in clinical trials," Pfizer's Mr. McCarthy says.
"If this helps build trust and credibility, I would hope that
would help increase participation rates, because that will only
help bring new medicines to market that much faster."
Write to Hester Plumridge at Hester.Plumridge@wsj.com
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