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Medical Journals Tighten Rules on Clinical Trials

Will force drug researchers to make all studies public

WEDNESDAY, Sept. 8, 2004 (HealthDayNews) -- In an attempt to lift the veil of secrecy shrouding clinical trials, several of the world's leading medical journals announced Wednesday that researchers must publicly register all trials if they want any of them published.

In an 11th-hour declaration that it was policing itself, the pharmaceutical industry said Tuesday it was launching its own Web database that would publicize the results of its trials, both positive and negative. Still, some political leaders said they would introduce legislation making such registrations mandatory.

The moves are aimed at ending what one editor called "research hide-and-seek," in which drugmakers have been accused of squelching results of clinical trials that reflect badly on their medications, while at the same going full-bore in publishing only the positive results.

Sens. Christopher Dodd (D-Conn.), Tim Johnson (D-S.D.) and Edward Kennedy (D-Mass.) said they will be introducing legislation that would make such registration mandatory. The legislation will be introduced this week or next, said Jim Manley, a spokesman for Kennedy.

The Pharmaceutical Research and Manufacturers of America (PhRMA), which represents the industry, announced Tuesday in a statement that it was starting a central database to "better communicate the results of clinical studies of marketed drugs" completed since October 2002. The database, which appears to be mandatory, will be available as of Oct. 1.

That announcement, which Drazen told the Associated Press was "too little, too late," came as Congressional hearings on the issue of trials with negative results are scheduled to begin.

It also was made a day before the International Committee of Medical Journal Editors (ICMJE), the umbrella organization representing 11 medical journals around the world, said it would consider for publication only trials that had been publicly registered. An editorial laying out the change in policy will appear in all member journals, including the Journal of the American Medical Association, the New England Journal of Medicine, the British Medical Journal, the Annals of Internal Medicine and The Lancet.

Jeff Trewhitt, a spokesman for PhRMA, said the group's announcement was not timed as a last-minute attempt to forestall more drastic measures from the outside. "This is something that has been evolving for a couple of years," he said. "In July 2002, PhRMA put in place clinical trial guidelines for member companies, and this is the next step in that process. We provided the guidelines two years ago, now we've taken it a step further in providing a registry."

"This game of what we call research hide-and-seek has been an issue among the editors for some time," said Dr. Jeffrey Drazen, editor-in-chief of the New England Journal of Medicine. "But we didn't think that we had any likelihood of success in dealing with the drug companies because every time you brought up something like this, you got 20 reasons why it couldn't happen. We owe a lot to Eliot Spitzer."

This summer, Spitzer, the New York State Attorney General, sued GlaxoSmithKline, alleging that the company had withheld negative information and misrepresented data involving the use of its popular antidepressant Paxil in children. Among other things, the drug giant was accused of withholding several studies that did not show positive results among children and adolescents. Glaxo settled the lawsuit in August, agreeing to release data.

"This really brought the issue to public awareness and, since that time, Merck and Glaxo and others have decided to post a lot of data online, [but] we think there's more to it than that," Drazen said.

According to the Washington Post, a little-known law does require pharmaceutical companies to disclose clinical trials, but the U.S. Food and Drug Administration has been lax in enforcing the regulation. The Post reported that, in 2002, only 48 percent of cancer drugs had registered. Some companies had no studies listed at all.

"The pharmaceutical industry is supposed to have [registered] through one of the FDA Modernization Acts, but their degree of compliance has been quite low," Drazen said. "This way, we think we may be able to enhance compliance."

The new journal stipulations require registration for any clinical trails starting patient enrollment after July 1, 2005. Trials that began enrollment before this date will have to register by Sept. 13, 2005. Although the editors did not advocate any specific registry, they pointed out that only the National Library of Medicine's clinical trials site meets their requirements, including being available to the public at no charge.

By contrast, the PhRMA registry will not list trials that are still enrolling patients and will not necessarily include all details about a trial, the AP reported.

The move by the editors and by members of Congress is supposed to enhance the quality and quantity of information available to physicians and patients.

"Long-term, it'll result in better patient care because physicians will have more information upon which to base their decisions," said Dr. Catherine DeAngelis, editor-in-chief of the Journal of the American Medical Association. "If you only have positive studies, then you don't know if there are others where it didn't look so good."

"We think that it will help with the issue of full disclosure," Drazen added. "When we publish now, if a drug company has a real nice positive trial and reports that trial, we don't know if they have done three others that were negative. With an open database like this, when we have a paper in for review, we will search the database to make sure we're getting the complete story."

For now, though, editors have no way of knowing how distorted information has been up to this moment. "I wish I had a way to quantify that," Drazen said. "That's actually the question."

More information

Visit the National Library of Medicine's existing registry,

SOURCES: Catherine DeAngelis, M.D., editor-in-chief, Journal of the American Medical Association, Chicago; Jeffrey M. Drazen, M.D., editor-in-chief, New England Journal of Medicine, Boston; Jim Manley, spokesman, Sen. Edward Kennedy (D-Mass.), Washington, D.C.; Jeff Trewhitt, spokesman, Pharmaceutical Research and Manufacturers of America, Washington, D.C.; PhRMA statement; Sept. 16, 2004, New England Journal of Medicine; July 6, 2004, Washington Post; Sept. 7, 2004, Associated Press
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