GSK opens its doors to help tackle global health challenges

In what many have called an effort to deflect criticism that important information gathered in clinical trials often does not see the light of day, GSK are setting out new steps to build on the progress resulting from GSK’s ‘open innovation’ approach to R&D.

In recent years, GSK has been making fundamental changes to its business model, becoming more open to sharing its intellectual property and knowledge.

Building on that progress, GSK will set out new measures to help develop new and faster-acting treatments for tuberculosis.

GSK will also outline new commitments to share detailed clinical trial data to enable additional scientific inquiry and analyses to further scientific knowledge and help bring benefit to patients.

The move is a first for a major pharmaceutical company and the announcement is scheduled for today, when chief executive, Andrew Witty, will unveil the plans in London.

Researchers contacted about the plan on Wednesday expressed a mix of enthusiasm and skepticism, citing the recent $3 billion settlement by GlaxoSmithKline with the US federal government over charges that the company had misrepresented trial data for popular drugs like Avandia and Paxil.

“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 the 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.”

In addition, the company plans to release information about 200 of its experimental drug compounds that have shown signs of fighting tuberculosis.

“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.

“I think we recognize that you learn as much about the medicine after it’s launched as you knew before.”

The comapany will put together a group of independent experts who will receive and review requests for the data. These requests will then be reviewed for scientific merit, where approved, access will be granted via a secure web site.

This will enable researchers to examine the data more closely or to combine data from different studies in order to conduct further research, to learn more about how medicines work in different patient populations and to help optimise the use of medicines with the aim of improving patient care.

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.”

Dr. Vallance said that the panel would be composed of experts respected internationally, and researchers’ proposals would be accepted even if the release would cast the drugs in a negative light.

“We’ve been caught by some things in the past — I think we want to be clear on this,” he said.