living history…

Posted on Thursday 28 February 2013

The ABPI’s first response was to reject the claims contained in Bad Pharma saying they were historical – a response widely seen as inadequate – but the industry organisation is now making moves to ensure pharma companies comply with existing pledges to publish data.

There is little more infuriating to me than this particular argument – that PHARMA should be off the hook because the examples are "historical" – out of date. Is there a statute of limitations on corruption in medicine? I don’t think so. If a murderer stood before a judge and said, "I don’t do that anymore, so let me go," the courtroom would break out in laughter. So it’s insulting to suggest that Ben Goldacre is off base in using examples that are "historical." It takes a long time to get to the bottom of these cases. It was a decade before we could see the actual data from Paxil Study 329. It was eight years from Allen Jones’ discovery of the TMAP scam before he could get it in a courtroom. And Carl Elliot has been chasing the case of Dan Markinson’s suicide in the CAFE Study for nine years:
Drug study recruiting at U of M questioned
Star Tribune: Minneapolis, MN
February 28, 2013

A University of Minnesota ethics professor is asking for an investigation into drug study recruiting at the school and raising questions about whether mentally ill patients have been rubber-stamped into research. The professor, Carl Elliott, says he has obtained consent documents for two separate schizophrenic patients that appear to be exact copies — not just in the subjects’ apparent replies, but in the positions of the lettering on the pages.

Elliott said it is improbable that separate patients would provide identical responses to the questionnaire, which includes open-ended questions about the risks and requirements of clinical research. And that, he said, raises questions about whether the university was really examining patients to determine their ability to consent to research. In comments following the publication of this story, the university’s general counsel, Mark Rotenberg, challenged the authenticity of the documents and disagreed that study recruiters failed to obtain proper and independent consent from mentally ill patients.

“I am challenging these allegations directly,” he said. “We have no reason to believe the consent forms were prepared inappropriately.” Elliott’s allegation revives concerns about patient recruiting tactics that surfaced after the May 2004 suicide of Dan Markingson, who was participating in a drug trial known as CAFE, which compared the effectiveness of antipsychotic drugs.

The university was dismissed from a lawsuit by Markingson’s family and cleared of blame in the suicide by an arm of the U.S. Food and Drug Administration. But Elliott, a professor of bioethics, and others have maintained that the university’s recruitment of Markingson was coercive and a breach of research ethics. “Judging from this admittedly circumstantial evidence,” Elliott wrote on his blog, “it appears as if someone in the Department of Psychiatry may have been using a generic, photocopied form with predetermined answers as documentation that mentally ill research subjects were competent to consent to research studies.” One of the evaluation forms Elliott posted was from Markingson’s lawsuit case file. The other came from another family. Elliott said he has heard from more families since his blog post about identical letters in their medical files…

If you need visible proof, here’s Carl’s blog post, and here are the forms in question, one from Dan’s Chart and one from another patient’s Chart. It has taken Carl nine years with dogged persistence to get this far. These cases are only "historical" because the misconduct has been so deliberately defended and access has been so systematically obstructed that it’s a wonder that we know as much as we do. Don’t tell us that the Zebra has changed its stripes and expect anything but laughter. Goldacre’s campaign is for data transparency up front on every trial – period. The time to say "trust me" is long past…
Hat tip to Jack Friday: Pharmagossip:  
    March 1, 2013 | 1:12 AM


    I can appreciate your sentiments on this.
    The drug companies misled doctors.
    No question about that.

    But is it not the responsibility of *prescribers* to weed through what was obviously hype and propaganda?

    Why did so many doctors fall for the lines of recent college grads (many of whom have little or no medical training or knowledge) – with their drug samples, glossy marketing brochures and free lunches… often with pretty smiles, high heels and short skirts? (stereotyping, but true)

    And why did they fall hook-line-and-sinker for so *long*?
    Long enough to create a statute of limitations?

    Fool me once…

    The buck stops the only place it can stop.
    On the medical profession.
    On the prescribers.


    March 1, 2013 | 1:17 AM

    Re: Pretty smiles, high heels and short skirts

    Before I get accused of being “sexist”…
    Anyone who’s been in a waiting room more than once knows exactly what I’m talking about.
    Let’s not kid ourselves.


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