Pull the Veil from Drug-Study Secrets


By Amy Barrett The pharmaceutical industry is racing to remedy a major headache: how to make data from drug studies more accessible to the public. After a lawsuit by New York State Attorney General Eliot Spitzer earlier this summer questioned whether drugmakers were suppressing negative results of clinical trials, industry critics called for a public registry of all such studies.

And on Sept. 8, the Journal of the American Medical Association, the New England Journal of Medicine, and other prestigious journals jumped into the fray. They called for a new policy that would force researchers to register in such a database as a condition for getting their work published. "We have only been getting part of the picture," says Dr. Catherine De Angelis, editor in chief of JAMA. "The issue is to make the field more honest."

The pressure can't hurt. Indeed, it's a positive development. Already, industry trade group Pharmaceutical Research & Manufacturers of America has come forward with a registry proposal, albeit a voluntary one. At the same time, some leading drugmakers including Merck (MRK) have said they'll register all late-stage trials in a government database.

MESSAGE SHAPING. Congress, which is holding hearings on the issue on Sept. 9, may also get into the act. On Sept. 8, Representatives Henry Waxman (D-Calif.) and Ed Markey (D-Mass.) said they plan to introduce legislation to require companies to register their clinical studies at the time they're initiated and to provide the results when the studies are complete. "We expect a number of colleagues in the Senate to take similar action," Waxman said. "I hope we can enact these bills this year."

A public registry of drug trials would make it harder for companies to hide negative study results. But it won't completely solve the problems surrounding lack of information on prescription drugs. That's because big drugmakers, with billions of dollars to spend on marketing and studies, still largely shape and control the messages that reach consumers and doctors about their products. More objective information needs to be made available to help physicians and patients make better informed decisions about their medicines.

Take the issue of how clinical trials are structured. Most are sponsored by a company hoping to generate positive data, thereby wowing the medical community. By sponsoring the studies, companies can shape the design of a trial, including how a drug is given or in what dose. This increases the chances that the test will produce more positive results. In addition, drugmakers are unlikely to do studies if they believe their drug will fare poorly.

HELP AT HOME. That's why it's so important to provide more funding, whether from foundations or from the government, that can sponsor independent trials. After all, it was a government study that two years ago revealed that hormone-replacement therapy taken by many women raised the risk of heart attacks, stroke, and breast cancer. Not surprisingly, that study wasn't done by the leading manufacturer of hormone-replacement therapy, Wyeth (WYE).

Consumer also need better ways to assess such information. After all, too much data can be almost as dangerous as too little. Sure, everyone gets those package inserts that lay out the approved uses and side effects of their medicines. But the leaflets are often in tiny print with endless medical jargon -- hardly an easy read for most patients.

In addition to an online database of clinical studies, drugmakers need to develop concise, easy-to-read brochures for their drugs that lay out in plain English what the Food & Drug Administration has determined about the drug's safety and effectiveness.

Until now, pharmaceutical companies's spin has driven the debate about the value of prescription drugs. A little more in the way of transparent, unvarnished information would be a healthy change. Barrett is BusinessWeek's Philadelphia bureau chief


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