SECRET Consumers don’t have access to all studies about the drugs they take.

Do you use drugs? No, not that kind. I mean prescription drugs OK’d by the Food and Drug Administration and prescribed by your doctor. As patients, we put trust in both to keep us healthy. But when it comes to drugs, they may not have all the information, because drugmakers may not have told them. Just consider the following:

Before a drug can go on the market, pharmaceutical companies must prove to the FDA that it’s safe and effective. But once doctors begin prescribing it, more and different side effects might emerge. Drugmakers may follow up with more clinical trials, especially in cases where the drug is prescribed for a different type of patient or for reasons different from those originally intended.

The problem is that patients, doctors, and even the FDA don’t have access to the results of all those trials. Further, when the news is good (a six-month study shows that COX-2 inhibitors, prescribed for inflammation, are relatively easy on your stomach) it’s trumpeted by the manufacturer, which paid for the trials. When the news is iffy (after 12 months, they may not be so easy on your stomach) it’s far less likely to be publicized.

Yes, pharmaceutical companies are required to report to the FDA all findings related to a drug’s safety before the drug is approved. But regulations protecting confidential commercial information essentially prohibit the agency from making the studies public before the drug is on the market. The result of that information gap can be tragic. (See "Antidepressents and teen suicide" in our October 2004 report on mental health, available to subscribers.)

Consumers Union believes that withholding information about how well or poorly a drug works is unacceptable. Several influential groups agree. The World Health Organization wants all randomized controlled trials that it approves to be registered in an international, publicly accessible database. The American Medical Association has urged Congress and federal health officials to call for a national clinical-trials registry. The International Committee of Medical Journal Editors also plans to propose a registry.

The Pharmaceutical Research and Manufacturers of America, which represents the industry, has voluntary principles including “timely communication of meaningful study results, regardless of the outcome of the study.” Recently, some drugmakers have agreed to post all their trial results on company Web sites. But there shouldn’t be anything voluntary about giving consumers and doctors information they need to make medical decisions. Almost any unbiased approach will be better than the one we have now, where drugmakers know the downside of a drug, but patients and doctors often don’t.

Jim Guest President