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As we begin the new year …

… those of us with an interest in universities should keep this important development in mind:

It used to be that clinical trials [of new prescription drugs] were done mostly by academic researchers in universities and teaching hospitals, a system that, however imperfect, generally entailed certain minimum standards. The free market has changed all that. Today it is mainly independent contractors who recruit potential patients both in the U.S. and—increasingly—overseas. They devise the rules for the clinical trials, conduct the trials themselves, prepare reports on the results, ghostwrite technical articles for medical journals, and create promotional campaigns.

Two writers for Vanity Fair note the vanishing relevance of the university in the field of pharmaceutical trials, and the advent of the wild, wild west, east, north and south.

In theory, a federal institutional review board is supposed to assess every clinical trial, with special concern for the welfare of the human subjects, but this work … has now been outsourced to private companies and is often useless. In 2009 the Government Accountability Office conducted a sting operation, winning approval for a clinical trial involving human subjects; the institutional review board failed to discover (if it even tried) that it was dealing with “a bogus company with falsified credentials” and a fake medical device. This was in Los Angeles. If that is oversight in the U.S., imagine what it’s like in Kazakhstan or Uganda. Susan Reverby, the Wellesley historian who uncovered the U.S. government’s syphilis experiments in Guatemala during the 1940s, was asked in a recent interview to cite any ongoing experimental practices that gave her pause. “Frankly,” she said, “I am mostly worried about the drug trials that get done elsewhere now, which we have little control over.

Anecdotally, UD knows that prescription drug addiction – among family, friends, friends of friends, children of friends – has gone absolutely haywire. The statistics say the same thing. It’s hideous to anticipate an escalation of this trend.


And don’t forget.

Margaret Soltan, January 3, 2011 9:47AM
Posted in: ghost writing, high as a kite

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4 Responses to “As we begin the new year …”

  1. cloudminder Says:

    even if they are done well – there are real questions about quality control and :


    who at universities might benefit from it- Chancellors and boards allowed to have huge holdings in their stock etc.

  2. Joseph P. Arpaia, MD Says:

    Sorry, but the article you link to on prescription drug addiction is abysmal. I’m really surprised that you would use it as a reference since it is full of hyperbole, uses relative instead of absolute risk, and fails to mention that the data on opiate related deaths are exaggerated due to how they are counted. I would expected a much higher degree of scholarship from you.

    Perhaps you could check out Gary Schwitzer’s healthnewsreview.org for pointers on how to discriminate between responsible health journalism and emotionally inflammatory nonsense.

  3. Margaret Soltan Says:

    I can’t judge your scholarship, since you provide no links to research supporting your claims.

  4. Brad Says:

    Vanity Fair could have said “Let’s do clinical studies in the countries with the least corruption.” That would be a measure of ethics. If they used that, the US might not make the list, and, if it did, Estonia probably would too (Corruption Perception Index: http://bit.ly/gKDzTq).

    The authors used or targeted globalization, free markets, and lack of affiliation with a university as markers of poor ethics. They attacked countries on the basis, not of their ethics, but because the average person in the US couldn’t locate the countries on a map. I thought they had an agenda and played to their readers’ fears.

    Brad (currently unaffiliated-with-a-university and therefore ethically-challenged person)

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