Monday, August 23, 2010

New York Times Recommends

Carl Elliot's Article on Clinical

Trials at the University of Minnesota

and the Death of Dan Markingson

A university official, quoted in the article, said: “To date, there has been no finding of wrongdoing from any of the investigations or reviews done by the university on this issue.”

[How about: First, do no harm?]

From the New York Times:

Carl Elliott, a professor of bioethics at the University of Minnesota, dissects his own institution — and its conduct in a clinical trial of antipsychotic drugs — in an article in the September issue of Mother Jones.

The narrative centers on the case of Dan Weiss, 26, who was enrolled by university researchers in an antipsychotic drug study without his consent. Mr Weiss, who later changed his last name to Markingson, committed suicide during the study.

Dr. Elliott uses the case to examine the general state of the clinical trial industry, delivering a withering critique.

People, including patients who volunteer to be guinea pigs for medical research, generally assume that the purpose of clinical trials is to produce scientific knowledge, he writes. But some drug trials my be little more than marketing exercises for drug makers, he writes, raising ethical questions about whether it is appropriate to expose participants to the health risks involved in such research.

“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?’

And universities can be complicit, he writes, when their own panels of independent experts — called institutional review boards, or I.R.B.’s — whose mandate is to protect study participants, fail to do so. When lawyers in the Weiss case deposed board officials at the University of Minnesota, for example, the officials said that protecting research subjects was not their responsibility, according to the article.

Instead, Minnesota’s I.R.B. director said that the role of her oversight group was to ensure that a researcher overseeing the drug trial and the drug maker sponsoring the study had a plan to protect patients, Dr. Elliott writes:

“If this were true, it would render I.R.B.’s worthless: The sponsor and investigators are the ones that the I.R.B. is supposed to protect subjects from.”


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