Supporting trials for FDA approved drugs often stay unpublished making physicians less informed about new drugs.
A team of researchers from University of California, San Francisco examined 909 trials conducted for 90 prescription drugs, which were approved by U.S. Food and Drug Administration (FDA) during the period between 1998 and 2000.
Researchers found that 76% of pivotal trials is being published within 3 years after the drugs are approved by FDA and only 43% of supporting trials is being published at all. There have been even cases when the same trial was published two or three times. Pivotal trials are conducted to measure the safety and efficacy of certain drugs.
Researchers concluded that the published trials do not give detailed information on drugs, this is why they mislead doctors to clearly understand new drugs. Most of published trials favor new, expensive drugs and show that the new drugs are better than the old one. Physicians have no other choice rather than to believe the published results.
This research raises the issue of FDA Amendments Act 2007, which was aimed at making sure that every single supporting trial should be published in U.S. National Institutes of Health's clinical trial Web site within a year after a drug received FDA approval. Each drug should have at least two trial results published despite of positive or negative result. This should be done to ensure that doctors and patients are completely aware of new drugs and have enough information to decide what to prescribe and what to receive.
By Ruzanna Haroutiunyan
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