Drug firms disclose more clinical trial data
Responding to public criticism and increased pressure from prestigious medical journals, pharmaceutical companies are publicly disclosing more information about clinical trials they sponsor.
The number of trials with incomplete information listed on clinicaltrials.gov, the National Institutes of Health's registration website, plunged to 8 percent in the first 11 months of 2006, from 26 percent prior to 2006, said an editorial published today in the New England Journal of Medicine .
"Although more can be done, this improvement in registration quality is to be praised," said the editorial's authors, Journal editor Dr. Jeffrey Drazen and Dr. Deborah Zarin , head of clinicaltrials.gov.
The increase in the voluntary disclosure of clinical-trial information is primarily a response to a requirement by medical-journal editors, who in 2005 began rejecting articles about trial results if the studies were not registered in a public database. About 20 percent of all articles submitted to the New England Journal of Medicine should be registered because they meet criteria for public disclosure set by the International Committee of Medical Journal Editors, said Karen Pedersen, spokeswoman for the journal. About 10 percent of those articles are rejected because they have not been registered.
Drug companies are eager to have articles showing benefits of drugs published because they inform doctors about potential new uses for treatments, which can lead to increased sales.
Critics say drug makers sometimes attempt to bury negative trial results.
The long-standing issue of clinical-trial disclosure came to a head in 2004 following accusations that British drug maker GlaxoSmithKline suppressed trial results suggesting its antidepressant Paxil provided little benefit to adolescents and may have led some to contemplate suicide. GlaxoSmithKline agreed to pay $2.5 million to settle a lawsuit brought by New York Attorney General Eliot Spitzer over the company's failure to disclose the information.
The New England Journal of Medicine today details a Pfizer Inc. trial of a renal cancer treatment. The editors were prepared to reject an article about the trial because Pfizer didn't disclose what health effects it would measure based on "commercial sensitivity." The journal agreed to publish the manuscript after learning a trial investigator independently registered the study, including information about the health effects to be measured. Pfizer said it is investing millions of dollars in an effort to make sure required information about its drug trials is disclosed.
Even with the improved track record, Democrats in Congress, including Senator Edward M. Kennedy and Representative Edward J. Markey of Massachusetts, are expected to renew their push for a federal law mandating that clinical trials be registered and their results reported. In response to the New England Journal of Medicine editorial, Markey said the current reporting system remains inadequate.
"A voluntary registry is like allowing a student to pick which grades he wants to include on his report card and which ones he wants to leave out," he said.
But the Pharmaceutical Research and Manufacturers of America , the Washington lobbying and trade group, said mandatory registries are not needed. "The way the system's working right now seems to be meeting the goals of providing information to patients," said Alan Goldhammer , PhRMA's associate vice president for regulatory affairs.
Christopher Rowland can be reached at crowland@globe.com. 
