* Pledge to provide access to patient-level data from trials
* Independent panel to assess requests for data
* Move follows record fraud fine in United States
* GSK also to make TB compound library freely available
By Ben Hirschler
LONDON, Oct 11 GlaxoSmithKline,
criticised in the past for keeping important information about
its medicines to itself, is to lift the lid on more of its drug
Three months after GSK was fined $3 billion for fraud in the
United States, where prosecutors accused it of concealing safety
issues, chief executive Andrew Witty said on Thursday detailed
data from its clinical trials would be made available to other
researchers. That would include anonymised patient-level results
that sit behind clinical trials of approved and failed drugs.
The move, a first for a major pharmaceutical company, may
prompt others to follow suit. GSK believes opening its data
stores to outsiders will help in the hunt for new drugs, as well
as ending suspicions that the industry has secrets to hide.
"I'd be a bit surprised if, in two years, we were the only
company doing this. Whether or not you are going to see other
companies act in six weeks, I have no idea," Witty said.
Britain's biggest drugmaker will set up an independent panel
of experts to review requests submitted by researchers, which
will then be vetted for scientific merit. The new system will
start at the beginning of next year.
In July, GSK reached a record $3-billion settlement with the
U.S. government, pleading guilty to charges that it had provided
misleading information on some drugs, including antidepressant
Paxil and diabetes pill Avandia.
Other companies have reached similar but smaller settlement
deals, fuelling demands from groups such as the Cochrane
Collaboration, which carries out systematic healthcare reviews,
for them to release all clinical trials data.
Such information is a treasure trove for scientists wanting
to test drug company claims and expose product deficiencies.
Witty acknowledged some researchers would use company data
to look for problems with its medicines but said he would rather
learn about genuine problems sooner. Overall, he said there was
more upside than risk from the move.
Mark Walport, director of the Wellcome Trust medical
charity, said GSK had set an important precedent by showing how
the drug industry must adapt to drive forward medical advances.
Fiona Godlee, editor of the British Medical Journal and a
frequent industry critic, said GSK's move "promises a real step
change in how academics and the industry work together".
To some extent, GSK is bowing to the inevitable, given the
growing trend for greater openness across all areas of science.
Drug regulators, too, are pushing companies in the same
direction. The European Medicines Agency recently decided to
make its own data vaults containing drug company trial results
available for systematic scrutiny.
The industry's failure to provide full access to such data
was blasted in a recent book which received widespread public
attention in Britain; "Patients are harmed when data is
withheld," said Ben Goldacre, author of "Bad Pharma".
"It is great that GSK has made further promises of greater
transparency, but promises are not enough, because they have
been broken in the past. We will only see if this promise is
different in the years to come."
Witty reaffirmed a commitment to seek publication of results
of all clinical trials evaluating its medicines - regardless of
whether the results were positive or negative for the company -
in peer-reviewed scientific journals.
LIBRARY FOR NEW TB DRUGS
He also said he would make GSK's library of compounds with
potential activity against tuberculosis (TB) freely available to
outside research groups, matching a similar move in 2009 to put
malaria compounds in the public domain.
The company has screened its pharmaceutical library of more
than 2 million compounds to find any that might be effective
against TB and has found just over 200 "hits" that will be made
available to outside researchers wanting to study them further.
TB, like malaria, is a disease that offers little commercial
upside for drugmakers and Witty said GSK was also looking at
similar initiatives for other neglected illnesses.