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drugs such as Merck & Co’s now withdrawn painkiller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.
