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Drug trials show but no one tells.(have you heard?)

Consumer Reports

| October 01, 2004 | Guest, Jim | COPYRIGHT 2004 Consumers Union of the United States, Inc. This material is published under license from the publisher through the Gale Group, Farmington Hills, Michigan.  All inquiries regarding rights should be directed to the Gale Group. (Hide copyright information)Copyright

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 ...

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