LYMEPOLICYWONK: IDSA Lyme Guidelines—A Poster Child for Guidelines Reform? Institute of Medicine Says IDSA Lyme Guidelines Highlight Need for Change
I was surprised. I had just settled into my long read of the 217 page new Institute of Medicine report on guideline reform (Clinical Practice Guidelines, We Can Trust, 2010), when the report took an amazing left turn. No, this is not the IOM report on Lyme disease (no telling when that comes out). This is the one on the need for medical guidelines reform in general—not just for Lyme disease. The IOM points to the Connecticut Attorney General investigation into the IDSA Lyme guidelines and says: “This case highlights the need for standardization and transparency in all aspects of systemic data collection and review, committee administration, and guideline development, so that questions about these issues do not detract from the science. [Guideline developers]. . . must be aware of the many, varied observers who will consider their development processes,
particularly when their recommendations are likely to be controversial.” That’s a public slap on the wrist to the IDSA and it matters.
I was surprised. I had just settled into my long read of the 217 page new Institute of Medicine report on guideline reform (Clinical Practice Guidelines, We Can Trust, 2010), when the report took an amazing left turn. No, this is not the IOM report on Lyme disease (no telling when that comes out). This is the one on the need for medical guidelines reform in general—not just for Lyme disease. The IOM points to the Connecticut Attorney General investigation into the IDSA Lyme guidelines and says: “This case highlights the need for standardization and transparency in all aspects of systemic data collection and review, committee administration, and guideline development, so that questions about these issues do not detract from the science. [Guideline developers]. . . must be aware of the many, varied observers who will consider their development processes, particularly when their recommendations are likely to be controversial.” That’s a public slap on the wrist to the IDSA and it matters.
Oh sure, the IOM notes that some commentators called the AG action “politicization of professional practice guidelines.” But, the fact of the matter is that the IDSA Lyme guidelines are a poster child for why we need guideline reform. Why? Because, as the Connecticut Attorney General found, the IDSA 1) excluded divergent viewpoints, 2) handpicked their evidence, 3) didn’t screen for conflicts, and 4) held up copycat guidelines (by the American Academy of Neurology) as independent when they were not. Don’t get me wrong. The IOM report presents both sides. The key thing is that slap on the wrist. In public. That means the IDSA is being held accountable and called out publicly for a shoddy guideline development process in its Lyme disease guidelines. As they should be! These guidelines make a mockery of the concept of evidence based medicine.
Those of you who follow this blog may know that Dr. Stricker and I have published peer reviewed articles about how the IDSA guidelines fail to follow the core principles of evidence based medicine. The IOM report cites one of our articles: Johnson L, Stricker RB. Attorney General forces Infectious Diseases Society of America to redo Lyme guidelines due to flawed development process. J Med Ethics. 2009; 35(5). Some of our other relevant articles include:
Johnson, L. and R. B. Stricker (2010). “The Infectious Diseases Society of America Lyme guidelines: a cautionary tale about the development of clinical practice guidelines.” Philos Ethics Humanit Med 5: 9. This article is available free of charge.
Johnson, L. and R. B. Stricker (2010). “Final report of the Lyme disease review panel of the Infectious Diseases Society of America: a pyrrhic victory?” (2010) Clin Infect Dis 51(9): 1108-1109.
Stricker RB, Johnson L. (2009) The Infectious Diseases Society of America Lyme Guidelines: Poster Child for Guidelines Reform. South Med J. 102(6):565-6.
The IDSA is in the process of revising its new guidelines—let’s see if they can manage to get it straight this time. They are a huge organization, they have over 50 treatment guidelines, their annual revenues approach $10 Million dollars. The IDSA can afford to do it right and they owe it to the patients who have been harmed by their guidelines. The Lyme disease discussion in the report is in Chapter 3, pages 41 and 42.
What would they need to do, this time around? Take a look at the standards the IOM presents.
You can contact Lorraine Johnson, JD, MBA at firstname.lastname@example.org.
- March 30, 2011 at 8:42 am
Very good news, but will it be headed?
They seem to be very good at ignoring what they don't like.
- March 30, 2011 at 6:15 pm
Thank you for posting this, Lorraine. This is very important, and I'm grateful that they referenced the IDSA Guidelines in their report. I sent them information on this subject last year prior to the IOM meeting in California and asked them to address it. I'm glad that they did. Thanks again.
- March 30, 2011 at 6:32 pm
I think that the public reprimand will be heeded, and it is helpful that the IDSA is cited specifically. Thank you, Lorraine–you took a "nothing day" and made it worthwhile!
- March 30, 2011 at 7:12 pm
As a lyme sufferer who deals with the challenges of advanced chronic lyme disease, including severe pain and suffering resulting in an altered lifestyle with diminished quality, I applaud Lorraine Stricker and Mr. Johnson. They are providing research data based on scientific evidence. Thank you on behalf of all those who suffer with these complex diseases. It is long overdue that professionals stop burying their head in the sand! We have an epidemic, and it's not going to suddenly disappear. There exists no excuse to ignore this rapidly growing,life altering,life threatening disease!!!! The time to act is NOW! There exists a Patient Bill of Rights, and we have a right to know the truth about lyme disease, and the two standards of care. The IDSA guidelines are outdated, unjust, and do not reflect the truth. They harm us- the patients. The patient is a partner in making important decisions about their treatment choices, once accurate knowledge has been provided and explained. Our rights are being violated, and this must end. This is our life, and if you walked in our shoes (and I wish this disease on no human being), you would see with great clarity the betrayal to all lyme sufferers and the medical community. I will fight for my rights and the rights of others until I draw my last breath, and that may be sooner than later because of my mis-diagnosis. Thank you.
- March 31, 2011 at 6:37 pm
Sorry for any confusion. This is not the IOM report on Lyme disease. It's their report on guideline development called "Clinical Practice Guidelines We Can Trust". So different report, but important message specifically addressing the IDSA Lyme guidelines. Whether this will have any impact on the other IOM report on Lyme disease is hard to say. They are completely different panels. I don't think this panel had any IDSA members on it.
- April 1, 2011 at 8:09 pm
Thanks Willy, but just to clarify, on April 19, 2010, I submitted a letter to the Institute of Medicine's Committee on Standards for Developing Trustworthy Clinical Practice Guidelines, the committee that issued the Report referenced in Lorraine's article. I sent this IOM Committee information about the AG's antitrust investigation, so I'm not referring to the IOM Report on Lyme Disease; I am referring to the IOM Guidelines Development Committee Report. I hope that clears up any confusion. Thanks.
- April 4, 2011 at 1:25 pm
POSTER CHILDREN! Exactly what is Needed! Poster Children who have suferred and recovering from Lyme diseae and co-infections, with national fundrasiers for class-action for unlawful evidence-based medicine Discrimination and Harassment. Some communities/families/patients denied their right to choice of healthcare, exposed to blatant (IDSA) Retaliation.
- February 11, 2018 at 12:25 pm
I have studied two chronic diseases: Lyme and continuing symptoms of hypothyroidism. Both have guideline proscriptions that produce populations of patients that are systematically, unethically, unscientifically denied care. Their suffering is maintained purposefully.
We invite you to comment on our Facebook page.
Visit LymeDisease.org Facebook Page