a snail’s pace…

Posted on Monday 20 July 2015

First there was the editorial and a three  part series in the New England Journal of Medicine that advocated dropping their ban on authors with conflicts of interest writing editorials or review articles…
I  obviously didn’t care too much for that idea, and I was in good company. These posts of mine catalog many other dissenting voices…
Now we have other versions. This from the Canadian Medical Association Journal suggesting that only industry can afford to support innovation…
Part I of a series on conflicts of interest in medicine
Canadian Medical Association Journal
by Roger Collier
July 16, 2015

… In an ideal world, there would perhaps be no need for a conversation about conflicts of interest in medical research. Academic researchers with good ideas for new medications would have all the funding and resources they need to manufacture compounds and launch large-scale clinical trials without support from industry. That, however, is not reality. Today, like it or not, the expensive and risky process of getting new medications into the hands of patients requires resources unavailable in academic laboratories. "We are in the business of making patients better," said Drazen, a pulmonologist. "When you develop something and want to take it that last step, from a general idea to making a difference for patients, you really need a way to work with commercial entities"…

"The problem is that people are taking the marketing arm, where doctors are selling a drug, and they conflate it with the discovery arm, where we want to encourage interaction," said Drazen. "We need to figure out a way for researchers to work with commercial entities that won’t paint them as having sold their soul to the devil."

If negative attitudes about all financial ties between doctors and industry don’t change, they will continue to undermine innovation in medicine, according to Dr. Thomas Stossel, author of the book Pharmaphobia. Over the course of his lengthy career, the practice of medicine has improved tremendously, said Stossel. He attributes that improvement to better tools, most of which came from the medical-products industry. "We get that stuff at great difficulty and at great expense," said Stossel, director of translational medicine at Brigham and Women’s Hospital in Boston, Massachusetts. "With respect to innovation, intelligent, educated people — even doctors — have no idea. They think this stuff comes from Santa Claus"…

Next: Part II: The costs of vilifying pharma
Here’s a useful commentary that sees full disclosure of conflicts as key and also proposes that we find alternative ways of funding science…
Health Affairs Blog
by Christopher Robertson
July 16, 2015

In 1984, the New England Journal of Medicine [NEJM] began requiring authors of research papers to disclose financial relationships with the pharmaceutical or device industry. The policy was controversial then, and even a decade later still faced criticism, with noted scholars charging that it “thwarts the principle that a work should be judged solely on its merits.”

Though every respectable scientific journal has now adopted such a policy, this critical view has received new attention in a three-part series on conflicts of interest appearing in NEJM, again asking whether disclosures “foster an ad hominem approach to evaluating science.” Three former NEJM editors fired back in the pages of The BMJ, calling this a “seriously flawed and inflammatory attack” on a longstanding consensus about conflicts of interest. Who is right?

It is tempting to answer with heated rhetoric about “industry greed” and the “taint” of industry money, or with a romantic account of the “life-saving innovations” funded by industry. But both arguments miss the point. The question should be simply whether disclosures will support physician decision-making and ultimately enhance patient health outcomes. And more fundamentally, whether there are better models for funding science…
I particularly liked this framing of a dichotomy, because most commentaries fall in one or the other of these two categories: "It is tempting to answer with heated rhetoric about “industry greed” and the “taint” of industry money, or with a romantic account of the “life-saving innovations” funded by industry. But both arguments miss the point." I guess I’m usually in the heated rhetoric about “industry greed” camp. It would be hard to be a psychiatrist and end up anywhere else. To quote Richard Friedman [in the recent New York Times Op-Ed, Psychiatry’s Identity Crisis]:
"With few exceptions, every major class of current psychotropic drugs — antidepressants, antipsychotics, anti-anxiety medications — basically targets the same receptors and neurotransmitters in the brain as did their precursors, which were developed in the 1950s and 1960s."
I don’t think many [if any] of the post-50s-60s drugs were developed by academics. They came to us from the labs of the pharmaceutical industry. But it doesn’t seem reasonable to use the word "innovation" to describe them. In fact, we usually call them the "me too" drugs. And the academic professors who refer to themselves as "researchers" are in fact doctors who rarely [if ever] see a lab bench and mainly involve themselves with clinical trials [often signing on to articles about trials conducted by Contract Research Organizations, analyzed by the Pharmaceutical Company Statisticians, and written by the Pharmaceutical Company’s hired Medical Writing Firms AKA ghost-writers]. At least in psychiatry, the academics have occupied themselves talking about drugs developed by others, often up to their necks in Conflicts of Interest themselves.

So I, for one think that the New England Journal’s argument is not applicable to psychiatry, and probably equally flawed in other specialties. If there are no "untainted" academics to write editorials and review articles, then I’d just as soon we do without editorials and review articles. In fact, the point being made in the CMAJ article above that only Pharmaceutical Companies have the resources to do drug research is an even stronger argument to keep academics that write editorials and reviews free of industry connections. Who else is going to counter the barrage of hype that comes when each new drug becomes available?

Truth-be-told, the field of Medicine moves much more slowly than you might imagine – at a snail’s pace. Left to my own devices, there are only two medications that I would regularly prescribe that weren’t available to me on the day I finished my psychiatric residency in 1977 – one SSRI and one Atypical Antipsychotic. That was forty years ago. And my patients and I could get by if they weren’t around. They’re just a little gentler and better tolerated than the older drugs. But, if anything, they’re also just a little less effective. Both are now available as generics.
  1.  
    AA
    July 21, 2015 | 7:08 AM
     

    Mickey,

    As one who ended up in the ER due to an adverse reaction to a med that should have never have been prescribed for me (long story), I wonder how much influence pharma had on this prescription since I received a drug coupon that I am sure didn’t just end up in the office under benign circumstances. Because this visit turned out to be quite costly since insurance didn’t cover everything, I am quite pissed although I guess I should be grateful I didn’t suffer any damage.

    No, I don’t blame the doctor for my adverse reactions but with all the other available choices that had a much lower starting dose which is what I needed, I think it is understandable that I wonder about the role of conflicts even if it was only very subtle.

    On a similar note, another doctor prescribed a med at the end of a visit that I knew would be totally inappropriate and it was according to the insert I read that came with the med. Again, there is no doubt in my mind that she had received a visit from this drug rep and was trying to pawn it off on all patients who might be candidates. The doc isn’t a bad person by the way but in this case, I felt the conflict of interest even if it was very subtle caused her to not serve me well as a patient.

  2.  
    James O'Brien, M.D.
    July 21, 2015 | 1:00 PM
     
  3.  
    Bernard Carroll
    July 21, 2015 | 3:03 PM
     

    James, having looked at your link, I would say your comment sounds a bit like blaming all of Wall Street for the Bernie Madoffs. What I mean is that in the matter to which you linked, the journals were exploited rather than complicit. Best.

  4.  
    James O'Brien, M.D.
    July 21, 2015 | 4:22 PM
     

    Using your analogy, I’m blaming the SEC, not all of Wall St. for Madoff. In that case they were alerted and blew it off. My point was that peer review has become a form of academic logrolling. Also there are too many journals and too many ways to pad CVs. It’s as if the major leagues expanded to 200 teams and we sat there wondering why the teams weren’t as talented. I’ve commented before on the problems with Elsevier as well.

    http://svpow.com/2012/01/13/the-obscene-profits-of-commercial-scholarly-publishers/

    724m on 2 b? Nice work if you can get it.

  5.  
    Bernard Carroll
    July 21, 2015 | 5:41 PM
     

    LOL… no argument about the logrolling. I can recall over 30 years ago sitting in faculty A&P Committee meetings listening to surgeons defend collections of piddling little publications in bottom feeding journals, making out like these counted just as much as major studies in first tier journals.

  6.  
    James O'Brien, M.D.
    July 21, 2015 | 7:50 PM
     

    Earning 724m on 2b is a much better deal than the risky and late payoff business of pharma and FDA trials. Big Journo makes money no matter what…they’re really the picks and shovels companies (trolls) of this whole enterprise. I mean look at those returns.

  7.  
    Bernard Carroll
    July 21, 2015 | 8:58 PM
     

    Yes, and a large part of that profit derives from the pro bono work academics do in the review process. Meanwhile, the publishers ratchet back on basic support of the operations of editorial offices, to the eventual detriment of tradecraft.

  8.  
    July 21, 2015 | 10:22 PM
     

    Mickey, which antidepressant and which antipsychotic would you prescribe, and why those and not the others?

  9.  
    July 21, 2015 | 10:30 PM
     

    Alto,

    You guess first…

  10.  
    July 21, 2015 | 11:36 PM
     

    Re: “I don’t think many [if any] of the post-50s-60s drugs were developed by academics. They came to us from the labs of the pharmaceutical industry.” I don’t think this is necessarily true. Gotzsche addresses this in Chapter 20 of Deadly Medicines “Busting the Industry Myths” specifically myth 4 and 6. Only fluoxetine is mentioned – it came from outside industry, from public funded science. I expect many and likely most others as well.
    And thanks so much James re “The obscene profits of commercial scholarly publishers” – that is important and VERY relevant information, and I had absolutely NO idea!!! I doubt many others do, but it puts the purposes of the NEJM and CMA editorials into clear perspective for me. That gravy train needs to keep rolling along, and the experimercials are the coal feeding the furnace. (to mangle metaphors!)

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