July 1, 2022

Should clinical trials be used as marketing exercises?

Death in anti-psychotic trial raises disturbing questions.

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

Michael Cook
Big Pharma
clinical trials
informed consent