on the dark side…

Posted on Saturday 21 August 2010

This post is about a tragic and outrageous story. It’s about a young man who had a Schizophrenic Break after college. He was involuntarily hospitalized after becoming homicidal. He ended up voluntarily enrolling in a drug study comparing three atypical antipsychotics [even though he had been declared legally incompetent]. His condition deteriorated, but the medicine remained unchanged. In spite of desperate warnings to his doctors by his mother, he finally committed suicide. There are few things more ominous than such a psychotic episode in the life of a young adult. In spite of the toxicity of the drugs used to treat this condition, it is something of a modern miracle that such an illness can be treated. But it requires careful monitoring, often changing drugs or dosage depending on the response. To simply place a person on an arbitrary dose of a randomly assigned drug would be unheard of in a rational clinical setting. And to enroll a person as flagrantly psychotic and dangerous as this young man in such a study is simply folly [any Psychiatry Resident could tell you that after a month working on the wards]. Dr. Bernard Carroll, who alerted me to this article, labels irresponsible studies like this one experimercials, to highlight the fact that they’re not driven by a scientific quest, but rather by a marketing strategy.
Continuing Our All-Carl-Elliott Issue: More on the Dan Markingson Case
Hooked: Ethics, Medicine, and Pharma

by Howard Brody
August 20, 2010

Back in April I blogged about the tragic case of Dan Markingson and the so-far-futile efforts of his mother, Mary Weiss, to get justice from the University of Minnesota. Carl Elliott’s book [White Coat, Black Hat: Adventures on the Dark Side of Medicine (Boston: Beacon Press, 2010, ISBN 978-0-8070-6142-8)] contains a brief synopsis of this case; but he goes into more detail in an article in the current Mother Jones, "Making a Killing." [To access, go to the Mother Jones current issue website, http://motherjones.com/toc/2010/09, and look for the title "Making a Killing." Click on that and you’ll get a screen that will allow you to register for free access.]

In "Making a Killing," Carl not only describes the sad case but also puts it in the context of the pressure placed on universities today to compete for grant dollars with commercial research entities, all funded by a drug industry that is looking for marketing, not science. As Carl summarizes:

    "If these experts [who have reviewed the study in which Dan Markingson was enrolled, and have declared it to be scientifically next to worthless] are right, then 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 goal of [the sponsoring drug company] AstraZeneca" …
Dan Markingson with his mother and girlfriend, 2001The medications known as the "atypical antipsychotics" were originally touted as being less toxic that the traditional drugs we used to treat psychosis. Fact is, it just isn’t true. But these drugs have all but replaced the older drugs, even though they are much more expensive. And worse, they have become widely used in illnesses other than Schizophrenia bringing in huge profits to their manufacturers even though their toxicity does not justify their widespread use. Even big paypouts from successful suits against the pharmaceutical companies for false advertising and harmful effects on patients have made little dent in the profitability of the drugs. Dan Markingson died needlessly in a study focused only on increasing market shares.
    August 29, 2010 | 3:01 PM

    Hi, I’ve also written about this story http://bipolarsoupkitchen-stephany.blogspot.com/2010/08/drcharles-schulz-university-of.html and am alarmed that Seroquel XR is currently being trialed at the UMN by Schulz, Principal investigator and sponsored by AZ. It’s a bad deja vu for this unethical trial for Borderline Disorder based on the history of the CAFE trial. Seroquel XR is being trialed against a placebo, for a patent extension as far as I am concerned.

    I agree, that Dan’s death was a preventable tragedy, and this practice of allowing AZ to trial and approve Seroquel for blushing, anxiety, depression, anorexia, etc is out of control–the ethics and data buried by Schulz, the fact that he was aware of info and promoted the drug is unacceptable.


    August 29, 2010 | 11:49 PM

    Thanks. I hadn’t seen that one.

    Carlat has more on the CAFE study. Dr. Carroll has a nice summary of all that’s wrong with the CAFE study summarized in the comments. What a tragedy, and they’re still at it…

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