Drug makers create U.S. database for trial results

The drug industry, fighting off criticism for hiding data from negative studies, unveiled on Tuesday a database for firms to voluntarily provide summarized results of most clinical trials of medicines sold in the United States.

The Web-based clearinghouse will contain summaries of findings, both positive and negative, of studies completed since October 2002, according to the Pharmaceutical Research and Manufacturers of America, the drug industry’s lobbying group known as PhRMA.

The effort comes amid mounting calls from physicians, medical journal editors and lawmakers for more disclosure of unfavorable study results, which manufacturers usually do not publicize. Some companies, including Eli Lilly and Co., recently have pledged to make all research findings public.

Only “hypothesis-testing” trials of drugs on the U.S. market, which are usually late-stage studies, will be included in PhRMA’s database. Earlier “exploratory” studies are being excluded from the database.

Summaries written by the manufacturers will be provided for studies not published in medical journals. The full data will not be made available.

Dr. David Fassler, a child and adolescent psychiatrist who has pushed for full disclosure of study results, called PhRMA’s plan “a step in the right direction.” Fassler said he would prefer a registry of all clinical trials, including those by academic researchers and private foundations, and independent oversight of the information.

DEBATE OVER PEDIATRIC ANTIDEPRESSANTS

“The public needs to be assured the data is consistent, accurate and complete,” said Fassler, who practices in Burlington, Vermont.

Calls for better disclosure intensified recently amid a debate about antidepressant use by children. Manufacturers did not publicize studies that raised safety questions and failed to show most of the drugs were effective for treating pediatric depression.

Last month, GlaxoSmithKline Plc agreed to release information on all its clinical studies to settle a lawsuit filed by New York Attorney General Eliot Spitzer, who had accused the firm of suppressing data on antidepressant Paxil.

Forest Laboratories Inc. made a similar promise on Tuesday to disclose trial data on antidepressants Lexapro and Celexa, as well as summaries of other study results, Spitzer’s office said in a statement.

The controversy over disclosure of information from antidepressant trials is the subject of a congressional hearing set for Thursday. Drug company executives and medical journal editors are scheduled to testify.

Caroline Loew, PhRMA’s vice president for scientific and regulatory affairs, said the new database was part of industry efforts to make study results “as transparent and accessible as possible.” The group plans to turn the registry over to a third party to manage it, she said.

The database is slated to start operating Oct. 1 at [url=http://www.clinicalstudyresults.org]http://www.clinicalstudyresults.org[/url] PhRMA officials said they expect most of their members, which include the world’s biggest drug makers, to participate.

Provided by ArmMed Media
Revision date: July 3, 2011
Last revised: by Sebastian Scheller, MD, ScD