July 15 2012
"It will make a huge difference to public health. The pharmaceutical industry routinely exaggerates the benefits of its drugs and plays down the harms or hides them. By getting access to material held by drug regulators we may discover that many drugs are less effective than we thought they were and also more harmful."
LONDON (Reuters) - Europe's
medicines regulator, criticised in the past for excessive secrecy, is opening
its data vaults to systematic scrutiny in a move that will let independent
researchers trawl through millions of pages of clinical trial information.
The change is a landmark in
transparency that puts Europe ahead of the United States, according to critics
of the $1 trillion-a-year global drugs industry, who have long argued for full
access to trial data.
Such information is a treasure
trove for scientists wanting to test drug company claims and potentially expose
product deficiencies.
As part of a process of opening
up, the European Medicines Agency (EMA) plans to hold a conference in November
to consider ways of making large data sets available rapidly and routinely to
outside investigators.
The shift chimes with a widespread
push in many fields to treat scientific data as a public rather than a private
resource as the world grapples with a growing flood of information.
It is blow for the pharmaceutical
industry, which guards its commercial secrets fiercely and has not before been
required to share its data with independent researchers or academics. Companies
however have little choice in the matter since they must submit their data to
the regulator to get drugs approved.
"It's a sea-change in attitude,"
said EMA senior medical officer Hans-Georg Eichler, who admits regulators and
drug companies have been tarnished by past scandals.
The EMA, like the Food and Drug
Administration (FDA) in the United States, was criticised for failing to spot
problems with drugs such as Merck & Co's now withdrawn painkiller Vioxx and
GlaxoSmithKline's diabetes pill Avandia.
FRAUD SETTLEMENT
Access to data was important in
both cases. GSK's failure to give the FDA safety information about Avandia was
one factor behind its record $3 billion healthcare fraud settlement in the
United States on July 2.
"This industry has certainly done
a disservice to itself," Eichler said in an interview at the agency's
headquarters in east London.
"I hope everybody will learn that
daylight is the best disinfectant and this will be a contributing step in
rebuilding trust in the regulator and in the industry."
The EMA's change of heart has not
been entirely voluntary.
Its position used to be that data
from clinical trials paid for by industry was commercially confidential, but it
was jolted from that stance after the European Ombudsman ruled such
confidentiality was not compatible with the public interest.
There has also been a cultural
shift at the agency and transparency has been put at the top of the agenda by
the EMA's new executive director, Guido Rasi. Rasi took over in January from
Thomas Lonngren, who controversially became a consultant for the pharmaceutical
industry within weeks of leaving.
Peter Gotzsche, director of the
nonprofit Nordic Cochrane Centre in Denmark, which carries out systematic
healthcare reviews, is one of those who battled the EMA and successfully
appealed to the ombudsman to get access to data. He is convinced the about-turn
will make a major difference.
"It's very good news. Europe used
to be behind the FDA in terms of openness and transparency but now Europe is
ahead," he said.
"It will make a huge difference to
public health. The pharmaceutical industry routinely exaggerates the benefits of
its drugs and plays down the harms or hides them. By getting access to material
held by drug regulators we may discover that many drugs are less effective than
we thought they were and also more harmful."
In the last 18 months, the EMA has
released around 1.5 million pages of clinical trial data - an increase of more
than a hundred-fold compared to 2010 and 2009.
RAW DATA
But providing that information at
the moment is laborious and time-consuming, since patient-level data must be
redacted by staff to protect patient confidentiality.
In future, Eichler hopes
standardised systems can be agreed for anonymising data, although the devil will
be in the detail of setting the parameters for this procedure.
In addition to uncovering new
facts about drugs through secondary analysis, giving researchers access to raw
data might one day open up new methods for treatment - perhaps using machine
learning systems that could marry a patient's health record directly to data
from appropriate clinical trials.
Getting access to large
patient-level data sets will be central to developing the computer science and
artificial intelligence systems needed for such tools.
Europe's drugs watchdog, however,
does not envisage a complete free-for-all for data, which would only be released
after the agency has finished reviewing a new drug.
"We don't want to be blind-sided
by studies of poor quality that create a public health scare," Eichler said.
"What the debate now is about is finding the right conditions to minimise the
potential for false findings."
One way to achieve that would be
to make researchers spell out upfront how data will be used by establishing a
clear protocol that cannot be revised after the event.
That idea is backed by GSK, which
has gone further than some companies in providing access to data following past
rows.
A spokesman for Britain's biggest
drugmaker said it already provided patient-level data to external researchers,
on a case by case basis, on condition protocols were peer reviewed ahead of time
and there was a commitment to publish results.
http://www.cnbc.com/id/48188038?__source=RSS*tag*&par=RSS
http://www.cnbc.com/id/48188038?__source=RSS*tag*&par=RSS
(Editing by Chris Wickham and
Giles Elgood)
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