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Pharmaceutical Companies Often Do Not Publish Negative Results From Clinical Trials

Armen Hareyan's picture

Pharmaceuticalcompanies often do not publish negative results from clinical trials that theyconduct to obtain approval for antidepressants, a practice that can misleadphysicians and consumers about the effectiveness of the medications, accordingto a study published on Thursday in the New England Journal of Medicine,the New York Times reports (Carey, New York Times, 1/17).

For the study -- led by Erick Turner, a psychiatrist at Oregon Health & Science University and a former reviewer of data on psychotropicmedications at FDA -- researchers used results from 74 trialsregistered with FDA between 1987 and 2004 that involved 12 antidepressants and12,564 patients (Armstrong/Winstein, Wall Street Journal, 1/17).The study found that pharmaceutical companies published 37 of 38 trials thatFDA considered to have positive results, compared with 14 of 36 trials that theagency considered to have negative results. In addition, 11 of those 14 trials"conveyed a positive outcome" not justified by reviews conducted byFDA, the study found.

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According to the Times, the study likely will "inflame acontinuing debate about how drug trial data is reported" (New YorkTimes, 1/17). Pharmaceutical companies do not have to publish theresults of trials that they submit to FDA, but many companies promise todisclose all results. An FDA spokesperson said that the agency does notwithhold documents related to reviews of medications (Wall Street Journal,1/17).

Critics also have said that medical journals publish only positive results fromtrials and that researchers revise their hypotheses after trials conclude tomake the results appear more positive (Desmon, Baltimore Sun, 1/17).

NEJM Editor-in-Chief Jeffrey Drazen said that the journal since2002 has "made a conscious effort" to publish more negative resultsfrom trials and that an analysis by the staff found one-third of trials publishedin the journal in 2003 had negative results (Bloomberg/Long Island Newsday, 1/17). In addition, 12 journals inrecent years have agreed to only accept trials registered before they begin toensure that researchers do not revise their hypotheses. FDA in December 2007mandated registration for all federally funded trials before they begin (Baltimore Sun,1/17).

Reprintedwith permission from kaisernetwork.org. You can view the entire Kaiser Daily Health Policy Report, search the archives, and sign upfor email delivery at kaisernetwork.org/email . The Kaiser Daily Health PolicyReport is published for kaisernetwork.org, a free service of The Henry J.Kaiser Family Foundation.