State May Require Details of Drug Clinical Trials

Maine could become the first state that requires drug companies to share the results of clinical trials with the public.

The bill, expected to be signed today by Gov. John Baldacci, is a response by lawmakers to national cases in which companies did not reveal to physicians and leading medical journals a drug’s potential risks.

Companies would have to make more information available online, which would not only be accessible to Maine residents, but to anyone with a computer.

Backers said the legislation is part of a larger movement to end secrecy and selective reporting by the pharmaceutical industry. Disclosure, they argue, might have prevented thousands of deaths attributed to the 1999 release of the drug Vioxx by Merck & Co.

"We learned from past experience from cigarette companies. We learned from past experience with paint companies," said state Rep. Arthur Lerman, D-Augusta, a sponsor of the bill. "Corporations are not always forthcoming with the complete picture."

But even as Baldacci prepares to sign the bill, drug companies and many lawmakers remain skeptical. They say information on clinical trials is already available online, through a voluntary manufacturers’ Web site and also through the U.S. Food and Drug Administration. Some opponents say that trying to act like the FDA could expose the state to lawsuits from drug companies.

"This is not the solution," said state Sen. Richard Rosen, R- Bucksport. "The idea that a state with a small population and limited resources is going to take this on – it is a romantic idea, but it is just not practical."

The Legislature narrowly passed the bill this month. It will require drug makers to post clear information on trials, including positive and negative findings.

The legislation also authorizes the state to levy a $1,000 fee on each drug company that does business in Maine, generating about $300,000 annually. Part of that money would help develop the Web site, and part would fund other public information programs. On the site, visitors will likely be directed through links to trial information posted by the companies.

"It would be difficult for private citizens to go out and do this homework," said Jude Walsh, state director of pharmacy affairs.

Information over the years has generally been available only to FDA regulators, who didn’t release much to the public because of trade laws. Companies released public versions of their studies as drugs moved toward the shelves, but the picture wasn’t always complete, critics say.

"If the results were negative or confusing, there would be no way for the public to know if the study even took place," said Dr. Kenneth Ault, director of the Maine Medical Center Research Institute in Scarborough. Disclosure has become more widespread since 2000, Ault said, but more needs to be done.

"As physicians and scientists," Ault said, "we are interested in having full access to the data and seeing all the results." Walsh said the state just wants to make it easier for doctors and patients to make informed health decisions.

Everyone agrees the state is stepping into an area where the stakes are high. Drug companies often spend more than a decade and nearly $1 billion to bring a new drug to market. Critics of the industry say that means companies have zero room for failure, leading to a code of silence when drug trials don’t go as expected.

"The data is parceled out by the drug companies. They don’t even have to share their information with the authors who write for the medical journals," said John Abramson, who teaches at Harvard Medical School. "We don’t have . . . places where doctors can get unbiased information."

Abramson, who criticizes the industry in his book "Overdosed America," supports legislative measures like the one in Maine. But there needs to be independent interpretation of the trials, not just the release of data, he said.

The industry responded Tuesday with a statement from the Pharmaceutical Research and Manufacturers of America. That group’s new disclosure policy, which takes effect July 1, asks companies to volunteer information about all clinical trials. "The federal government already has access to the clinical trial information and posts the appropriate information on a Web site," said Ken Johnson, PhRMA senior vice president.

The bill also gives the Maine attorney general the power to sue companies that don’t comply. The state also would have the power to pull television or Internet ads that are judged to be deceptive.