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Journals Insist Drug Manufacturers Register All Trials

"Registration in and of itself is a very big step," Curfman said. "Even if there aren't results out there, the very fact it is known this trial was conducted is a very big step forward -- it becomes much harder to bury a trial away."

Christine Laine, senior deputy editor of the Annals of Internal Medicine, said the requirement would apply to any trial begun after July 1, 2005. For trials already in progress, she said, companies would have to register them before seeking publication.

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A number of initiatives are also underway in Congress to enforce registration of trials. The federal Food and Drug Administration Modernization Act of 1997 established a database called ClinicalTrials.gov and required companies to register trials, but many companies have evaded the requirement or filed incomplete information. FDA officials said there has been no enforcement, in part because Congress was vague about who would wield the stick.

Democrats in the House and Senate are expected to introduce legislation soon that would impose penalties on companies that do not register their trials with the government-run database before recruiting patients. Unlike the 1997 law, proposals would require registrants to list not only when a trial began, how many patients were recruited and what yardsticks of performance were used, but also what the study found.

"I understand the concern of some companies that if they report an adverse result their stock might suffer," said Rep. Edward J. Markey (D-Mass.), who said he and Rep. Henry A. Waxman (D-Calif.) would introduce a bill in the next two weeks. "But consider the alternative -- patients suffer as doctors prescribe in the dark."

The ClinicalTrials.gov database, which was a party to the journal editors' new initiative, recently expanded its format to include the primary and secondary outcome measures of a trial and details of when trials end. While journal editors will encourage the use of ClinicalTrials.gov, Laine said other databases could also be used, so long as they are maintained by nonprofit entities and abide by the rules laid down by the editors.

In today's congressional hearing, executives from GlaxoSmithKline, Wyeth Pharmaceuticals, Forest Laboratories Inc., Eli Lilly & Co., Bristol-Myers Squibb Co., Organon USA and Pfizer Inc. are expected to be asked about the controversy over suppressed studies information and the use of antidepressants among children.

Last year, British authorities warned doctors not to prescribe a number of antidepressants to children, citing an increased risk of suicidal behavior. The FDA has declined to take a similar step, citing the need for more careful evaluations. Today's hearing will also question FDA officials. In February, an internal agency report found that the medications were associated with an increased risk of suicidal behavior. Top FDA officials played down the report at the time and refused to make it public until recently.

A second internal agency analysis, undertaken after researchers from Columbia University reclassified suicidal cases reported in company trials, recently produced statistical findings that appeared to confirm the February assessment.

Last week, the author of the new report, FDA scientist Tarek Hammad, told investigators working for Senate Finance Committee Chairman Charles E. Grassley (R-Iowa) that his analysis agreed with the earlier finding -- and that he favored stronger warning labels on the drugs. The first internal report had recommended that the agency discourage the use of antidepressants other than Prozac for depressed children.

Grassley's investigators said Hammad went further this week and told them, "I can no longer say that Prozac is okay for children."


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