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Growing concerns over the safety and efficacy of anti-depressant drugs prescribed to children have caught the eye of Congress and the New York state attorney general. Now they’re becoming the catalyst for calls to reform the way clinical trials of all drugs are reported.
Pressure is already causing some changes within the pharmaceutical industry. And it has put the US Food and Drug Administration (FDA), which approves new drugs, in the hot seat. If reforms are carried out, they could bring an unprecedented level of transparency to drug research.
The solution now under consideration: a public database, or registry, of drug trials, where companies would post the results of those trials.
In congressional testimony Thursday, a spokesman for the American Medical Association endorsed the registry and said it should include information on each trial’ s purpose and objective, its design, and the dates it begins and ends. If the trial is not completed, the registry should include an explanation.
While drug companies have been eager to make public any positive results of their trials, recent revelations suggest they’ ye balked at divulging tests when the results are not what they’ d hoped to see. The furor has centered around the use of anti- depressants on children.
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 Intemet. 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.
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 non-approved purpose to know why it hasn’t been approved for that use.
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 (director of the Center for Bioethics at the University of Pennsylvania in Philadelphia) suggests, would be to require that a new drug not only be "safe and do what it’ s sup posed 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.
Who is willingly to introduce the registry of drug trials