NIH backs disclosure of all drug research

The head of the National Institutes of Health, the federal government's biomedical research agency, said yesterday that there was a "very high" likelihood the government would soon require the nation's drug companies to publicly report results from all research experiments.

In recent weeks, a chorus of physicians and politicians have called for an end to the occasional practice by some drug firms of suppressing in-house research studies that reflect poorly on their drugs.

These critics argue that doctors lack a full picture of prescription medications without access to this data, and have asked the government to create a public research database that would list results from every medical experiment conducted in the United States, regardless of the outcome.

Dr. Elias A. Zerhouni, director of the National Institutes of Health, said in an interview yesterday that drug makers would probably agree to participate if such a database were created.

"I don't really see why [drug companies] wouldn't do it," he said. "They'll probably go along."

Zerhouni said NIH analysts recently informed him there was "no impediment" to creating a public government-run research database, but he said he was unsure when the effort would begin.

Zerhouni, in Boston to meet with physicians at Massachusetts General Hospital, is the highest-ranking government health official to weigh in on a controversy that has roiled the medical research establishment for the last month, though complaints about companies suppressing research have circulated for years.

In the last week, several major drug makers, including Merck & Co. and GlaxoSmithKline, said they would support a government-run database. Advocates of disclosure, led by the American Medical Association and several prominent medical journals, have insisted that a government database would be the only way to ensure all research is released.

Court Rosen, a spokesman for Pharmaceutical Research and Manufacturers of America, the drug industry's Washington lobbying arm, said, "Obviously, we think this is a serious matter."

"We look forward to sitting down with the AMA and talking about clinical trial registries."

Rosen said the industry had reservations about the proposal, particularly the possibility that disclosure of certain studies could give away trade secrets to competitors.

Currently, the Food and Drug Administration collects the results of all medical experiments, using the data to assess the safety and effectiveness of drugs. But the data, by law, are not released. To create a public registry, Congress would probably have to pass laws authorizing the agency to disclose data, as well as provide money to run the database.

"The FDA doesn't have the authority or funding to maintain a public listing of all clinical trials," said agency spokesman Jason Brodsky. "We do recognize that a public listing could be invaluable to physicians."

New York Attorney General Eliot Spitzer set off the controversy when he filed a lawsuit June 2 against GlaxoSmithKline, alleging the firm suppressed research that reflected poorly on the antidepressant Paxil.

But Zerhouni, appointed to run the NIH by President Bush in May 2002, yesterday took a dim view of Spitzer's case.

"I don't think there was any willful" wrongdoing by GlaxoSmithKline, he said.

One Mass. General staffer raised the issue of research suppression during a question-and-answer period, and Zerhouni responded by emphatically endorsing disclosure by drug firms.

"We need to publish these results, make them available," he said. "The more we do it, the more likely we are to succeed.

"At pharmaceutical companies, you can find tons of data that's not being exploited" for treatments, Zerhouni said. "Negative findings are as important as positive findings."

Raja Mishra can be reached at rmishra@globe.com.