GlaxoSmithKline plans to open up much of its drug research in an apparent effort to deflect criticism that important information gathered in clinical trials often does not see the light of day.
The move, a first for a major pharmaceutical company, was announced Thursday by its chief executive, Andrew Witty, in London.
Researchers contacted about the plan Wednesday expressed a mix of enthusiasm and skepticism, citing the recent $3 billion settlement by GlaxoSmithKline with the U.S. government over charges that the company had misrepresented trial data for popular drugs like Avandia and Paxil.
Still, the company is taking a step in the right direction, the researchers said, and might set a precedent in an industry that could use more transparency.
“This is a reason to celebrate: a company stepping forward to make a public commitment to sharing their data at the individual patient level and fostering open science,” said Dr. Harlan M. Krumholz, a cardiologist at Yale School of Medicine who has been an advocate for more open sharing of data. “The hope is that it would make it untenable for other companies not to follow suit.”
Headquarters in RTP
GlaxoSmithKline, a British drug concern, will open its clinical trial data to other researchers once a drug has completed the approval process or been abandoned. The company has 3,800 workers at its U.S. headquarters in Research Triangle Park and 600 more employees in Zebulon.
“We’re increasingly realizing that the more you can make this an open enterprise, the more likely you are to be able to get an advance which allows you to make a medicine,” Dr. Patrick Vallance, president of pharmaceuticals research and development at GlaxoSmithKline, said in an interview.
The new policy applies to global clinical trials since 2007 (notably, that excludes Avandia and some other drugs now on the market) and all clinical trials starting in 2013.
‘A deficit of trust’
Critics have long called on drug companies to release the full results of clinical trials, arguing that public health would benefit from a better exchange of information about a drug’s benefits and risks.
Some researchers said they would need to hear more before giving the plan their support.
“There is a deficit of trust,” said Dr. Steven Woloshin, a professor of medicine at the Dartmouth Institute for Health Policy and Clinical Practice, who frequently analyzes clinical trial results. “That’s why it’s totally essential that they publish not just results but also the protocol – the complete program.”
Staff writer David Bracken contributed.