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Clinical Trials and Industry Influence: Major Report

By John S. James

June 2, 2000

A major health policy overview on what is happening in clinical trials -- and on pharmaceutical-industry manipulation of the design, conduct, and reporting of trials to get commercially favorable results(1) -- was published May 18 in the New England Journal of Medicine; it is available on the Web at http://www.nejm.org/content/2000/0342/0020/1539.asp.

A related editorial,(2) "Is Academic Medicine for Sale," appeared in the same issue, and is available at http://www.nejm.org/content/2000/0342/0020/1516.asp.

An example from the article:

"If a drug is tested in a healthier population (younger, with fewer coexisting conditions and with milder disease) than the population that will actually receive the drug, a trial may find that the drug relieves symptoms and creates fewer adverse effects than will actually be the case. Rochon et al. found that only 2.1 percent of subjects in trials of nonsteroidal anti-inflammatory drugs were 65 years of age or older, even though these drugs are more commonly used and have a higher incidence of side effects in the elderly... Rochon et al. concluded that trials of nonsteroidal anti-inflammatory drugs always found the sponsoring company's product superior or equal to the comparison product..."

Another section concerns the "guest-ghost syndrome," by which journal articles are increasingly ghostwritten by medical writers, based on information packets supplied to them by pharmaceutical companies -- and then signed by well-known "guest authors" who did not analyze the data or write the manuscript, and sometimes were not involved in the trial at all.

And from the accompanying editorial:

"It is difficult to believe that full-time faculty members can generate outside income greater than their salaries without shortchanging their institutions and their students."


References

  1. Bodenheimer T. Uneasy Alliance -- Clinical Investigators and the Pharmaceutical Industry. New England Journal of Medicine May 18, 2000; volume 342, number 20, pages 1539- 1544.

  2. Angell M. Is Academic Medicine for Sale? New England Journal of Medicine May 18, 2000; volume 342, number 20, pages 1516-1518.



ISSN # 1052-4207

Copyright 2000 by John S. James. Permission granted for noncommercial reproduction, provided that our address and phone number are included if more than short quotations are used.


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