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The Medical Professionalism Blog

Thank You, Dr. Greenfield

Dear Dr. Shelly Greenfield and the Institute of Medicine’s Committee Members on Standards for Developing Trustworthy Clinical Practice Guidelines,

Thank you for bestowing this gift to the health care industry: For the first time, we have universal standards for developing clinical practice guidelines and systematic reviews.

The Committee was wise to have “establishing transparency” as the first standard for clinical practice guidelines. Your collective wisdom also drafted standards for group composition of guideline committees, rating the strength of the evidence and recommendations, external review and updating.

I wonder…

Should we be questioning the validity of some existing practice guidelines as there’s no way to tell if they adhere to your new standards?

Will the Secretary of HHS consequently develop an organization to certify that institutions are using an adherence process or can specialty societies self-regulate and abide by the standards? Maybe a separate public-private organization can be tasked with this role.

How will the public know if the studies used in the practice guidelines are using good scientific method and don’t have a bias caused by pharmaceutical support?  Shelly, I worry as a future patient how it can be OK to have 49% of a practice guideline committee have a conflict of interest due to their relationships with the pharmaceutical and device industries. (I do understand you would not be able to get expertise in the area being studied because so many have relationships with the industry, which is unfortunate.)

Shouldn’t we have researchers working in the field of medicine without conflict of interest?

Would we build the research enterprise differently if we had to do this all over again?

How much does it cost the taxpayers if we have distorted medical decisions because the guidelines are built on faulty science? Yes, I know researchers given monies currently available have to go to industry for support but we could change all of this.

Shelly, I know these standards aren’t perfect but I don’t know what we were doing without them all these years. Thank you and the Committee — your efforts are greatly appreciated.

Warm regards,

Daniel Wolfson

3 Comments to Thank You, Dr. Greenfield

  • Ronald B. Miller, M.D.'s Gravatar Ronald B. Miller, M.D.
    April 5, 2011 at 6:52 pm | Permalink

    Mister Wolfson: You worry that the IOM CPG standards are insufficiently stringent. I believe you seek utopia where only those without conflicts of interest are allowed to participate in the development of CPG. I applaud your perspective but also the pragmatism of the I OM task force since there are doubtless many who will find the guidelines excessively stringent.. If the proposed standards are followed, CPGs will be significantly better than in the past..
    Ronald B. Miller, M.D., FACP, Clinical Professor of Medicine Emeritus; founding Chief of the Renal Division and founding Director of the Program in Medical Ethics, Department of Medicine; past President UCI Emeriti Association; Chair Ad Hoc Committee on Academic Integrity, School of Medicine Academic Senate, School of Medicine and College of Health Sciences, University of California Irvine

    • Daniel Wolfson's Gravatar Daniel Wolfson
      April 11, 2011 at 10:05 am | Permalink

      Dear Dr. Miller,

      I think it’s important to set in motion the gradual change that will ultimately get us to a desired state — the “utopia” you speak of. I wish the Committee had set a suggested timetable to decrease the “acceptable” conflict of interest threshold for guideline committees; reducing it from 49% to 25% in five years and further down to 10% in 8 years. It would have provided a clear message from leadership that conflicts of interest surrounding clinical practice guidelines are not the desired state. We need clear vision.

      Thank you for your comment – we need to proceed gradually with our eyes wide open to our shared vision.

      – Daniel

    • April 13, 2011 at 11:16 am | Permalink

      There is a growing literature that supports Daniel’s “utopian vision.” Allow me to cite a JAMA commentary from 2009 (full disclosure: I am one of the authors) which articulates the hazards of conflicted committees and proposes an alternative approach. While the focus of this commentary is industry funding of professional medical associations (PMAs), the same principles would apply to all bodies who formulate clinical practice guidelines:

      “One of the most significant activities of many PMAs is to formulate practice guidelines and devise performance and outcome measures. These activities guide physician diagnostic and treatment decisions and set evidence-based standards for decision making. By so doing, PMAs also influence reimbursement policies by third-party payers and carry weight in malpractice litigation. Clearly, pharmaceutical and medical device companies have a stake in all of these activities.

      “For these reasons, the establishment of guidelines and registries must be independent of all industry influence, actual or perceived…PMAs must hold the individuals who write guidelines and outcome measures to the most stringent conflict-of-interest standards. Disclosure of industry relationships by committee members is not sufficient protection. Professional medical associations should be encouraged to appoint to these committees only individuals who have no ties to industry. At a minimum, PMAs must exclude from such committees persons with any conflict of interest ($0 threshold) involving direct salary support, research support, or additional income from a company whose product sales could be affected by the guidelines.

      “One concern might be that such restrictions will exclude the most qualified individuals from guideline committees. However, there is a tendency to confuse the most qualified with the most visible. Moreover, any difficulties can be easily circumvented by circulating drafts of guidelines widely for comment, but leaving the drafting of the final document to a group of knowledgeable professionals, who are free of conflict of interest insofar as a particular class of drugs or devices is concerned.”

      The full article can be viewed here: http://jama.ama-assn.org/content/301/13/1367.full.pdf+html

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