but I should’ve…

Posted on Monday 25 November 2013

I sort of stepped out of my usual box talking about the Statins [and here I go again]. They are a bit like many of our psychiatric drugs in that they’re optional, but they differ in that they’re focused on a measurable biologic marker [serum lipids]. In an exempler…, I talked about objecting to massive treatment for such a small, if any, health outcome and discussed the risk/benefit equation. Dr. Poses has a much more detailed review of the issue and adds some sobering dimensions – primarily in the area of conflict of interest:
Healthcare Renewal
by Dr. Roy Poses
November 22, 2013

… One possible reason that the guideline developers got so enthused that they seemed unable to think straight appears to be their own conflicts of interest, as first publicly noted in a post on Pharmalot. Reviewing the disclosure forms provided with the guidelines revealed more detail.
  • Of the 13 people on the main treatment guideline panel who were not NHLBI staffers serving ex-officio, 7 had financial relationships with pharmaceutical companies that manufacture statins…
  • Of the 10 expert reviewers for this panel, 3 had financial relationships with pharmaceutical companies that manufacture statins…
  • Of the 11 people on the risk prediction panel who were not NHLBI staffers serving ex-officio, 5 had financial relationships with pharmaceutical companies that manufacture statins…
  • Also, in the Abramson and Redberg NY Times op-ed, the authors noted:
      …both the American Heart Association and the American College of Cardiology, while nonprofit entities, are heavily supported by drug companies
As noted on Pharmalot, the prevalence of conflicted panel members did not appear to conform to the standards for the development of trustworthy guidelines recently published by the Institute of Medicine:
    …whenever possible, guideline development group members should not have conflicts of interest… and the chair or co-chairs should not be a person(s) with conflicts of interest.
Also, noted by the Los Angeles Times was this comment from Dr John Abramson, lead author of the commentary on statins in primary prevention,
    ‘There is overtreatment that’s been built into the risk calculator, and this is a warning sign about the overtreatment that’s built into the guidelines themselves and the conflicts of interest in the organizations that are overseeing the production of these guidelines,’ said Dr. John Abramson, a Harvard University cardiologist who has argued that statins offer little value for people with a 10-year risk level of heart attack or stroke of less than 20%. ‘There aren’t brakes being put on the enthusiasm and overreaching of the experts.’
    There are statin believers, and when you hear these experts talk, they’re talking emotionally, not scientifically,‘ Abramson added. ‘The experts are using emotion, not science‘…
Summary
Guidelines for management of a very common problem promulgated by a major medical society and a major disease oriented non-profit organization suggested a strategy that would vastly increase drug treatment of currently healthy patients.  The strategy appears not to have been based on good evidence.  When some of the problems with this evidence were pointed out, the guideline developers responded with illogic.  Apparently many of the guideline developers have financial relationships with the drug companies that would most profit from increases in drug treatment as recommended by the guidelines  Implementation of the new guidelines might results in millions of people in the US receiving unneeded drugs, with resultant side effects and costs. .

Do we need more examples of how conflicts of interest are causing the poor outcomes and excess costs that are wrecking our health care system?  Do we need more excuses not to eliminate conflicts of interest from guideline development?  Do we need more delay implementing the standards provided by the Institute of Medicine report on trustworthy guidelines?  Do we need more excuses not to drastically reduce conflicts of interest affecting academic medicine, medical societies, and disease specific non-profits, specifically starting with the earlier [and so far generally disregarded] Institute of Medicine report on conflicts of interest in medicine?

While we in the US argue incessantly in the details of minor reforms of our supposed free health care market, we ignore the rot at its foundations.  True health care reform would attack the conflicts of interest that have put money, not patients, at the center of health care…
I didn’t know it was quite that bad [but I should’ve]. No matter how often it’s pointed out, I still fall prey to discussing the issue itself when some matter medical bothers me. But by now, I ought to start with conflict of interest, or as Peter C Gøtzsche labels it - Organized Crime [a major force…]. And speaking of Peter Gøtzsche, one of the justifications for the new recommendations is a Cochrane Collaboration Meta-analysis update [Statins for the primary prevention of cardiovascular disease]. So do our idols have feet of clay? While that question is open for another day, the level of COI in the guideline authors is enough to invalidate the recommendations pending a review by a non-compromised panel. We’ve had more than our share of this kind of thing, and rather than debating how much COI is allowed, we’d best say "None!" At least for now, perhaps forever…
  1.  
    wiley
    November 26, 2013 | 4:16 PM
     

    Aside from labeling one of the body’s requirements for healthy functioning as “bad”, it seems to me that demonstrating the benefits of a statin would require far more testing on with a large sample size for an extended period of time, before getting a green light to be passed out like candy as prevention for any conceivable measure of risk.

  2.  
    November 26, 2013 | 5:26 PM
     

    The sound of the other shoe, dropping.

  3.  
    Peggi
    November 27, 2013 | 9:01 AM
     

    When one is trying simply to be an informed patient and has become aware of all this corruption and COI in so many aspects of medicine, how on earth can a sound decision about medication be made? My internist wants me on statins; I have familial hypercholesterolimia (that’s probably not the correct spelling) and a family history of heart disease but I don’t smoke, I’m not overweight, I exercise, and I eat a fairly healthy diet. My blood pressure is okay. So how do I know whether or not I need to be taking a statin? This is all very confusing for those of us attempting to be good “consumers.” It’s tempting just to say I’ll take my chances and not take anything that’s advertised!

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