A new state law in Maine promises to increase disclosure of clinical trials sponsored by drug companies, providing a first-in-the-nation look at all clinical trial data for every drug on the market.
The law, which goes into effect in mid-October, will provide patients and doctors with unprecedented access to the data resulting from drug clinical trials, including harmful side effects that often remain hidden from public view.
"Responses have been very positive," said Arthur Lerman, the Maine state representative who sponsored the bill. "People are eager to have access to the information. The idea that drug companies are now going to be held accountable and [that] there will be more transparency should make a difference."
Under the law, a drug may not be advertised in the state of Maine unless the manufacturer has disclosed the name of the entity that has conducted or is conducting clinical trials, a summary of the purpose of the trials, the dates during which the trials have taken place, and information concerning the results of the trials, including potential or actual adverse effects of the drug.
As such, the law stands to disclose potential side effects, such as those revealed in the infamous cases of drugs like the painkillers Vioxx (rofecoxib) and Bextra (valdecoxib).
"Giving doctors and researchers access to these studies is one way consumers can be assured that the medicines they take each day are as safe as possible," said Rob Schneider, manager of PrescriptionforChange.org, a project of Consumers Union, publisher of Consumer Reports.
Implementing the Law
The state's Department of Health and Human Services will be responsible for implementing the law, and the state attorney general's office will handle enforcement. "I hope it will change the way drug companies do business," said Lerman.
At least 15 states are considering similar legislation, and a federal bill sponsored by Senators Charles Grassley (R-Iowa) and Christopher Dodd (D-Conn.) would require all drug study results be registered and made public on a federal government Web site. Current federal law does not require all drug company clinical trials to be registered, although some are done so on a voluntary basis. (See News, Vol. 97, No. 6, p. 410, "Clinical Trials Registration Efforts Gain Some Ground.")
Under the new Maine law, drug manufacturers who do business in the state will be required to post on a publicly accessible Web site any clinical trial conducted or sponsored after October 15, 2002. As the law covers any company that sells drugs in Maine, it is expected that the bulk of drug company studies will be made public under the law. "This law ultimately will help improve drug safety for all Americans," Schneider said.
Duplication of Effort?
But drug companies remain skeptical, saying the data already exist in voluntary releases. Ken Johnson, senior vice president of communications for the Pharmaceutical Research and Manufacturers of America (PhRMA), said that the law "would require a duplicative Web site of information already available elsewhere. The federal government already has access to the clinical trial information and posts the appropriate information on a Web site, www.clinicaltrials.gov."
But the new Maine law requires only that the clinical trial data exist somewhere, not necessarily on the Maine Web site, said Jude Walsh, Maine director of pharmacy affairs. The data may be a simple link on the Maine Department of Health and Human Services Web site listed with only summary information about the results. By going beyond existing federal law, it will provide a unique look at clinical trial data for pharmaceuticals, including potential or actual adverse effects of the drug in question. In fact, that's how Walsh envisions the early stages of the project, admitting that the implementation stage of the project is still being worked out with the state attorney general's office.
Said the bill's sponsor Lerman, "We're simply saying that the companies need to let the state DHHS know where the information is available on the Internet."
Under an existing Maine state law passed a few years ago, pharmaceutical companies are already required to disclose information about the amount of money they spend to market medications. This information will serve as a trigger for the new law, requiring clinical trial data for each drug marketed in the state.
"We've tried to make this administratively simple," said Lerman. "We've tried to be creative to ensure there is no duplication of effort."
The new legislation also allows the state to impose an annual fee of $1,000 on each drug company that does business in the state of Maine. This fee should generate about $300,000 a year, which will be used both to build the DHHS Web site and to create public service announcements directing the public to the Web site.
The bill gives the Maine attorney general the power to bring suit against companies that don't comply, and the state also has the power to discontinue public ads it judges to be deceptive.
"This legislation is part of a growing trend across the country," said David Fassler, M.D., a clinical professor of psychiatry at the University of Vermont's College of Medicine. "Physicians and patients need and deserve access to data from clinical trials in order to make fully informed decisions about treatment options."
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