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NYT – Glaxo Opens Door to Data on Research

NYT – Glaxo Opens Door to Data on Research


GlaxoSmithKline plans to open up much of its drug research in an apparent effort todeflect 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, is scheduled to be announced on Thursday by its chief executive, Andrew Witty, 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 federal 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 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.”

Whether more disclosure might lead to safer, more effective drugs remains to be seen. 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.

Glaxo is taking the step after experimenting with disclosure for treatments for tropical diseases like malaria and finding those efforts successful, according to company officials.

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 company intends to name an independent panel of experts to review requests submitted by researchers. If the requests are deemed to have scientific merit, the company’s data will be made available to scientists on a secure Web site. 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.

“Making data available, particularly on the products that didn’t succeed, could avoid others having to learn the same lessons,” said Joshua M. Sharfstein, Maryland’s health secretary and the former principal deputy commissioner of the Food and Drug Administration.

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.

Although drug companies collect voluminous amounts of data during the trials, which involve thousands of patients in many countries and sometimes last for years, only a sliver of that information is typically made public, and often in formats — as in articles in medical journals — that can present the drugs in the best light.

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 of GlaxoSmithKline said the data would include the complete trial protocol. A company spokeswoman, Sarah G. Alspach, said in an e-mail that some other supporting documents would be provided to allow researchers to “understand and navigate the data so they can conduct their research.”

Dr. Steven Nissen, a cardiologist at the Cleveland Clinic, wondered about the objectivity of the disclosure process, asking, “Would someone who wants to take a critical look at an existing drug on the market be granted access?”

In 2007, Dr. Nissen raised concerns about the heart attack risks of the diabetes drug Avandia after analyzing data from clinical trials that GlaxoSmithKline was required to make public after a legal settlement. In 2010, the F.D.A. severely limited access to Avandia, and its use has been suspended in Europe.

In July, the company agreed to pay $3 billion in fines, in part to settle claims that it failed to report on Avandia’s safety risks. Federal prosecutors also accused GlaxoSmithKline of withholding data about the antidepressant Paxil that raised concerns about an increased risk of suicide in teenagers.

In the case of Avandia, the company acknowledged that it did not disclose details of clinical trials to the F.D.A. in some reports but said it did disclose it in others. It did not admit any wrongdoing related to reporting clinical trial data in Paxil.

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.