HealthLawProf Blog

Editor: Katharine Van Tassel
Case Western Reserve University School of Law

Thursday, May 26, 2005

Drug Companies Influencing Drug Studies

Science Daily has reported on a survey released Wednesday that says many university medical schools permit the pharmatceutical companies to influence what gets published from industry sponsored drug studies.   The article expressed concern about the possible negative consequences of withholding negative study results since pharmaceutical companies fund over 70 percent of clincial drug trials.  Harvard's Michelle Mello in her article in the May 26 issue of the New England Journal of Medicine (abstract) insists that the relationship between academia and the drug companies should be closely monitored.  Dr. Peter Lurie of Public Citizen in Washington is concerned that correcting the problem in the academia area will only shift it to the private sector where drug companies can contract out research to privatec contract research organizations (CROs).   These CROs may have even less of an incentive to publish negative results. 

After two notorious recent incidents (the removal of Vioxx and the use of anti-depressants in children) there have been allegations that drug manufacturers withheld data that indicated the possibility of safety problems from academic researchers. 

In her study, Mello sent 107 university medical centers questionnaires about their policies for conducting research sponsored by the drug industry.  She found that 85% of medical centers said they would not allow industry sponsors to revise manuscripts for publication in journals or give them th authority to decide whether results of a study should be published.   24 percent said they permit industry sponsors to insert their own statistical analysis in manuscripts.  50 percent said they permitted industry people to draft the manuscript.  41 percent said they allowed the drug industry to prohibti investigators from sharing research results with third parties. 

According to the N.Y. Times, the study reported that 69 percent of administrators surveyed said competition for research money "created pressure on adminstrators to compromise" with drug companies.   Scott Lassman, assistant general counsel for Pharmaceutical Research and Manufacturers of America stated that "it's a hypothetical study and doesn't measure what these institutions routinely do or don't do."  One medical center reported that a commercial sponsor refused to make the last payment for a drug trial "apparently because they did not like the results of the study." 

The AP also reported on this conflict of interest.  The article mentions several efforts to remedy the situation such as:

  • AMA working with the drug industry to eliminate gag clauses in research contracts;
  • American Assocation of Medical Colleges developing set of principles for researchers and sponsors of studies;
  • bill pending in Congress that would require public and private sponsors to register their studies in a government database;
  • 11 members of International Committee of Medical Journal Editors promised last year not to publich any studies not registered in the database.

Thanks to my reearch assistant, Lindley Bain, for her help in preparing this post. [tm]

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