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Healthy Skepticism Library item: 14796

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

Rubenstein S.
How Many Negative Drug Studies Still Go Unpublished?
The Wall Street Journal Blog 2008 Dec 12
http://blogs.wsj.com/health/2008/12/12/how-many-negative-drug-studies-still-go-unpublished


Full text:

Based on clinical trials, we know a fair amount about drugs on the market. But how much don’t we know?

It’s been a long-running controversy, and has come to a head in recent years after a string of drug-safety scandals. There are efforts to get drugmakers to disclose more trial results, such as a rule requiring them to register trials and provide results on clinicaltrials.gov. But today’s WSJ Science Journal column presents some recent stats that bring the issue into sharp relief. Some highlights:

Last month, analysts led by an expert at the University of California in San Francisco checked 164 clinical trials testing 33 different drugs submitted for FDA approval from 2001 to 2002. One in four had yet to be published. Almost all of the unpublished findings made the drug in question look bad.
In September, some UCSF folks reviewed 900 FDA filings involving 90 new drugs. More than half of the clinical trials were still unpublished 5 years after the drugs had been approved. (More on UCSF’s work here.)
Earlier this year, doctors at the University of Washington reported in the journal Oncology that only one in five cancer clinical trials ever is disclosed.
Earlier this fall, researchers at the State University of New York reviewed 1,835 clinical research articles from four leading otolaryngology journals and reported that a third of them failed to mention any side effects at all.
For a taste of the controversies that come up, take a look at some of our past posts about a negative study of Pfizer’s Neurontin, unpublished negative studies of depression, and of course, the brouhaha early this year after Merck and Schering-Plough delay in releasing findings about cholesterol-drug Vytorin that turned out to be unflattering. Those results were published ultimately in the New England Journal of Medicine in April.

 

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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