* 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 (Reuters) - GlaxoSmithKline, criticised in the past for keeping important information about its medicines to itself, is to lift the lid on more of its drug data secrets.
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.
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.