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Healthy Skepticism Library item: 14389

Warning: This library includes all items relevant to health product marketing that we are aware of regardless of quality. Often we do not agree with all or part of the contents.

 

Publication type: news

Many Trial Reports on FDA-Approved Drugs Go Unpublished
The Washington Post 2008 Sep 23
http://www.washingtonpost.com/wp-dyn/content/article/2008/09/23/AR2008092300627.html


Full text:

More than half of all supporting clinical trials for U.S. Food and Drug Administration-approved drugs remain unpublished five years after permission has been given to sell the drugs in the United States, say University of California, San Francisco researchers.

They combed the medical literature to determine the publication status of all 909 clinical trials that supported the 90 new drug applications approved by the FDA between 1998 and 2000.

They found that 76 percent of pivotal trials — such as large Phase II and Phase III trials designed to determine the overall risks and benefits of a drug — had been published in medical journals, usually within three years of FDA approval of the drug. However, only 43 percent of all supporting trials submitted to the FDA had been published.

The UCSF team also found evidence of selective reporting of the results from these trials. For example, a pivotal trial in which a new drug outperforms an old drug is more likely to be published than a trial showing a new drug is no better than an old one.

This type of publication bias may lead to an inaccurately favorable record in the medical literature of a drug’s performance compared to similar drugs. That can cause physicians to favor newer and more expensive drugs, the researchers explained.

They said their study findings, published in the journalPLoS Medicine, provide a baseline for monitoring the impact of the FDA Amendments Act 2007. It was introduced to improve the accuracy and completeness of drug trial reporting.

The act requires that all trials supporting FDA-approved drugs be registered when they start and that all outcomes must be posted within a year of drug approval on the U.S. National Institutes of Health’s clinical trials Web site.

 

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Far too large a section of the treatment of disease is to-day controlled by the big manufacturing pharmacists, who have enslaved us in a plausible pseudo-science...
The blind faith which some men have in medicines illustrates too often the greatest of all human capacities - the capacity for self deception...
Some one will say, Is this all your science has to tell us? Is this the outcome of decades of good clinical work, of patient study of the disease, of anxious trial in such good faith of so many drugs? Give us back the childlike trust of the fathers in antimony and in the lancet rather than this cold nihilism. Not at all! Let us accept the truth, however unpleasant it may be, and with the death rate staring us in the face, let us not be deceived with vain fancies...
we need a stern, iconoclastic spirit which leads, not to nihilism, but to an active skepticism - not the passive skepticism, born of despair, but the active skepticism born of a knowledge that recognizes its limitations and knows full well that only in this attitude of mind can true progress be made.
- William Osler 1909