September
04
  10:36:31 PM

Should clinical trials be used as marketing exercises?

from Mother JonesUniversity of Minnesota bioethicist Carl Elliott has written a stinging article in Mother Jones magazine about how pharmaceutical companies allegedly abuse clinical trials to market their products. He has based it on the 2004 suicide of Dan Markingson, a 26-year-old man struggling with paranoid schizophrenia, while enrolled in a trial for anti-psychotics at the University of Minnesota.  

“The Nuremberg Code stipulates that an ‘experiment should be such as to yield fruitful results for the good of society,’ and ‘the degree of risk to be taken should never exceed that determined by the humanitarian importance of the problem to be solved by the experiment.’ But what if a research study is not really aimed at producing genuine scientific knowledge at all? The documents emerging in litigation suggest that pharmaceutical companies are designing, analyzing, and publishing trials primarily as a way of positioning their drugs in the marketplace. This raises a question unconsidered in any current code of research ethics. How much risk to human subjects is justified in a study whose principal aim is to ‘generate commercially attractive messages’?...  

“If these experts are right, then the study in which Dan Markingson committed suicide was not simply a matter of inadequate informed consent, or financial conflicts of interest, or even failure to monitor a subject’s care. The ethical breach was built into the study from the start. It is one thing to ask people to take risks for science, or the common good, or to help other people. It is another thing entirely to ask them to risk their lives for the marketing goals of AstraZeneca.”

It is a fascinating and challenging article – although it is one-sided and passionate, and suffused with the author’s “sting of shame” that his own university had apparently treated this patient and his mother so badly. ~ Mother Jones, Sept-Oct




 

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