a contrarian frame of mind…

Posted on Monday 18 May 2015

"Over the past two decades, largely because of a few widely publicized episodes of unacceptable behavior by the pharmaceutical and biotechnology industry, many medical journal editors [including me] have made it harder and harder for people who have received industry payments or items of financial value to write editorials or review articles. The concern has been that such people have been bought by the drug companies. Having received industry money, the argument goes, even an acknowledged world expert can no longer provide untainted advice. But is this divide between academic researchers and industry in our best interest? I think not — and I am not alone. The National Center for Advancing Translational Sciences of the National Institutes of Health, the President’s Council of Advisors on Science and Technology, the World Economic Forum, the Gates Foundation, the Wellcome Trust, and the Food and Drug Administration are but a few of the institutions encouraging greater interaction between academics and industry, to provide tangible value for patients. Simply put, in no area of medicine are our diagnostics and therapeutics so good that we can call a halt to improvement, and true improvement can come only through collaboration. How can the divide be bridged? And why do medical journal editors remain concerned about authors with pharma and biotech associations? The reasons are complex. This week we begin a series of three articles by Lisa Rosenbaum examining the current state of affairs."
by Jeffrey M. Drazen, MD, Editor
NEJM 2015 372:1853-1854.

We are currently in the midst of a three part series of articles in the New England Journal of Medicine making the case that we’re overly concerned about medical experts having financial ties to industry – specifically, their being excluded from writing "editorials or review articles" in our medical journals. The series is introduced with an editorial [Revisiting the Commercial–Academic Interface] by editor Jeffrey M. Drazen, MD [excerpted above]. The thing is – I know from the outset that I’m guaranteed to disagree with what this editorial and the articles that follow are going to say before I read a word. We have taken such a massive hit in psychiatry along in this area that it’s hard for me to believe the NEJM is even publishing such a series. And when I read them, I find myself generating contrary-arguments, rather than following what the editor or author says with an open mind. I know I’m biased. But I come by that bias honestly. I already have a slant in my mind on this topic. For example, when Dr. Drazen writes…
    Over the past two decades, largely because of a few widely publicized episodes of unacceptable behavior by the pharmaceutical and biotechnology industry, many medical journal editors [including me] have made it harder and harder for people who have received industry payments or items of financial value to write editorials or review articles
I’m thinking…
    A few? You’ve got to be kidding me – they’re everywhere! And it’s not just editorials and review articles. How about all those RCTs that were really written by paid expert medical writers instead of the guest authors, the key opinion leaders, whose names appear on the by-line? Didn’t you read my last post? what Dr. Healy said "But perhaps an even greater shame will be seen to lie with the fact that, during this era, most publications on on-patent drugs in our best journals were ghost-written"?
Instead of thinking about my own bias, I’m wondering about Dr. Drazen’s bias. And earlier, when he gives this example…
    In the mid-1940s, Selman Waksman, a soil microbiologist, and his team discovered streptomycin, an antibiotic with action against the tubercle bacillus. Although he was able to show efficacy in the laboratory, Waksman realized that if his discovery was to be of value to the world, he needed a partner capable of manufacturing adequate amounts of the material under conditions that would make it suitable for use in humans. He therefore struck a deal with Merck to produce streptomycin for clinical use. Soon thereafter, the British Medical Association undertook a large randomized, controlled trial of streptomycin for the treatment of tuberculosis. The results, including a description of the utility of streptomycin and resistance to it, were published in the British Medical Journal. This partnership between an academic researcher and a drug company went on to alleviate substantial human suffering and should be a model for current behavior. Unfortunately, it is not.
I was thinking something like…
    But that’s not the rule. That’s an exception. Waxsman was one of those exceptions in science. He had ‘nailed’ the treatment of Tuberculosis. He didn’t have to sell us anything or refine any arguments.  We were eager to hear what he had to say. And we already knew about his industry connections. There weren’t any secrets or hidden motives to wonder about.
Editor Drazen mentions powerful groups that are encouraging greater interaction and cooperation between academic institutions and industry:
    The National Center for Advancing Translational Sciences of the National Institutes of Health, the President’s Council of Advisors on Science and Technology, the World Economic Forum, the Gates Foundation, the Wellcome Trust, and the Food and Drug Administration are but a few of the institutions encouraging greater interaction between academics and industry, to provide tangible value for patients. Simply put, in no area of medicine are our diagnostics and therapeutics so good that we can call a halt to improvement, and true improvement can come only through collaboration.
But once again, I’m thinking…
    That interaction and cooperation between academia and industry may well facilitate improvements in something. But what does that have to do with the question of bias when academics with a financial relationship to a company write a review or editorial about that company’s product in an academic journal? An academic can interact and cooperate without money changing hands…
Plato's Academy [Pompeii Mosaic]And so it goes as my bias generates contrarian counters to his arguments. Back in the days of the Academy in Ancient Greece, a time when they fell in love with the rules of argument and logic, they initially thought they could reach absolute truth with their debates. So they studied logic and cataloged wrong arguments as the fallacies. Then along came questions of bias, and motive, and later even unconscious motive. And the sacred olive groves of Plato’s Academe [and later Aristotle’s Lyceum] moved from the quest for dogmatic truth to becoming cloistered havens for skepticism and a questioning attitude. And Academia has been under siege ever since [with arguments not unlike the ones coming from this NEJM series].

In psychiatry, this kind of rationalizing away Conflicts of Interest has characterized the current era with disastrous results. We almost don’t have much we can call academia any more. When we look at RCTs, it’s hard to even locate an industry-funded Clinical Trial that isn’t ghost-written  with authors on the by-line with extensive financial connections to industry. The sacred olive grove full of scholars has been replaced with professional Key Opinion Leaders, professional Medical Writing companies, Clinical Research Organizations, and Pharmaceutical Marketing Departments.

I’m going to try to read the coming three part series with an open-ish mind, but this prequel feels a lot like the introduction to a polemic that will evoke a similar contrarian frame of mind…
  1.  
    Brett Deacon
    May 18, 2015 | 10:01 PM
     

    Wow, that NEJM editorial left me without words. “You’ve got to be kidding me” was my response as well. Drazen is using the “a few bad apples” argument when, to paraphrase Robert Whitaker, it seems like an obvious “bad barrel” problem. He even holds up the FDA as an example of an institution “encouraging greater interaction between academics and industry, to provide tangible value for patients,” despite clear evidence to the contrary (http://www.ncbi.nlm.nih.gov/pubmed/24329178). Such words would never have been uttered by former NEJM editor Marcia Angell. I know nothing about the forces surrounding the replacement of Angell with Drazen, but I wonder if the powers that be felt a more industry-friendly editor was desirable? The journal certainly seems to have one.

  2.  
    Winge D. Monke, Ph.D.
    May 19, 2015 | 4:25 AM
     

    Drazen, 2012, on the topic of industry-funded trials: “Believe the data.” I’m sorry I read it.

    “…clinical research […] is possible because of a union between a critically posed research question and the altruism of patient participants. One would therefore think that the translation of research findings into clinical actions would depend solely on the importance of the research question and the quality of the data used to answer it.”

    “Patients who put themselves at risk to provide these data earn our respect for their participation; we owe them the courtesy of believing the data produced from their efforts and acting on the findings so as to benefit other patients.”

    I have to log off now.

    http://www.nejm.org/doi/full/10.1056/NEJMe1207121 (free)

  3.  
    May 19, 2015 | 6:39 PM
     

    Few“” stands out like a sore thumb, signaling everything that follows is not reality-based.

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