What You Don't Know About a Drug Can Hurt You

Untold Numbers of Clinical-Trial Results Go Unpublished; Those That Are Made Public Can't Always Be Believed.

There's a common assumption that when a drug makes it to market, it has run a rigorous gantlet of testing and proper disclosure. Testing, yes. Disclosure -- not necessarily. Findings from many clinical studies assessing prescription drugs never see light of day. That skews the basic scientific record that every patient, physician and researcher needs to judge whether treatments cause more harm than good. There is no easy way to discover how much knowledge we've been missing, raising the possibility that we may be taking medications that are less effective than we've been led to believe or may have undisclosed side effects.

After years of congressional debate, however, the FDA now has imposed more stringent reporting requirements to ensure the complete scientific record of clinical drug experiments is readily available. Under a new federal law, researchers for the first time will have to post their basic results publicly on the federal online registry maintained by the National Library of Medicine.

Since it was established nine years ago as a voluntary patient guide, the federal registry at www.ClinicalTrials.gov has logged 65,000 studies. Prodded by medical journal editors and settlements in five major lawsuits, researchers have gone from registering 25 new studies a week to about 350 every week. Until this past September, though, researchers only had to report the start of a clinical trial. They had no federal obligation to report the outcome in the registry or in a peer-reviewed journal.

Several recent surveys of the medical literature offer a glimpse of how much data about drugs already on the market never made it into the published record.

Last month, analysts led by health research expert Lisa Bero at the University of California in San Francisco checked 164 clinical trials testing 33 different drugs submitted for FDA approval from 2001 to 2002 and found that one in four had yet to be published. Almost all of the unpublished findings made the drug in question look bad.

http://online.wsj.com/article/SB122903390105599607.html

Steve - this WSJ piece is a must read. It lays out the reasons why we always say to wait on trying a new medication for one to two years, sometimes longer, after it comes to market.