Veil of secrecy to lift on drug tests

The industry has begun to make some moves to address the concerns about drug trials. Drug companies have agreed to set up a voluntary system of posting their drug trials on the Internet. But that seems unlikely to satisfy some members of Congress, who are expected to introduce legislation to establish a mandatory drug registry.

Last week, editors of a dozen influential medical journals announced that they would begin requiring drug companies to post a drug trial in a public database prior to accepting an article about it. Doctors rely on these articles to make treatment choices. The editors hope that the registry will force unfavorable drug studies, before kept secret, into the open.

Medical journals already had been tightening up on the authorship of their articles, insisting that authors declare if they had any conflicts of interest, such as any financial or other ties to the drug company, says Daniel Callahan, a director at the Hastings Center, a nonprofit bioethics research institute in Garrison, N.Y.

"The most fundamental complaint [has been that pharmaceutical companies] function as a kind of 'black box,' " he says, because the results that were published could not be put in a context of other results, which were hidden from doctors, researchers, and journal editors. One benefit of a registry will be to head off "dead end" research, as other researchers are able to see what approaches have not worked, he adds.

Drug companies have an ethical obligation to report all their findings, says Arthur Caplan, director of the Center for Bioethics at the University of Pennsylvania in Philadelphia. When a company signs up subjects to take experimental drugs, it often promises to use the tests to generate knowledge, he says. But "if you don't publish and make public what you find, it's not honoring your contract."

Information from previously undisclosed clinical trials could lower prices, reduce the number of badly designed trials, and help doctors considering the use of a drug for a nonapproved purpose to know why it hasn't been approved for that use. "We give a lot of freedom to doctors to 'muck around,' " - try various remedies - "but they'd do a lot less of that if they knew that the drug companies had already tried to do it," Mr. Caplan says.

Antidepressant drugs "have some serious side effects ... that seem to be much more common than people realize ... much more common than you might think from seeing drug ads and from reports on drug studies," says Joel Gurin, executive vice president of Consumer Reports. His magazine just finished a survey of readers showing a "dramatic shift from talk therapy to drug therapy for mental health problems" during the past decade. In 1995, less than half of people getting mental health treatment - 40 percent - got drug therapy. Today 68 percent receive drug treatment, Mr. Gurin says.

Some studies coming to light show that antidepressants work no better than placebos. Even better than merely registering drug trials, Caplan suggests, would be to require that a new drug not only be "safe and do what it's supposed to do," but that it do it as well or better than other drugs already on the market. That, he says, would help push research into new areas and save money.

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