Most of you know the hearing on July 30th before the IDSA hearing panel was about "contested recommendations" in the IDSA 2006 guidelines. These are recommendations and language in the IDSA guidelines that we contest or take issue with. They are important because they provide the road map for what the IDSA hearing panel must review. Contested recommendations must be evaluated by the panel. In order to remain in the guidelines, a supermajority (7 of the 9 panel members) must find that the contested recommendation is supported by the medical/scientific evidence presented at the hearing or otherwise submitted.

In my presentation, I highlighted the key question—namely whether the clinical discretion of physicians should be limited by restrictive guidelines in the face of science that is limited, emerging, and uncertain.  The presentations from the hearing are archived and may be viewed at www.idsociety.org. 

The fact is that there is substantial and compelling evidence opposing the guideline recommendations which the 2006 guideline panel ignored or misinterpreted.  As a result, the IDSA guidelines as written mislead clinicians and result  in poor patient care.  A recent CALDA survey of 3,600 patients found that 54% of patients had tried and failed treatment under the IDSA guidelines.

ILADS alone submitted almost 300 pages of analysis contesting the IDSA recommendations and over 1,300 pages of peer reviewed research supporting that analysis.   This submission included papers by  Drs. Cameron, Maloney, Stricker, Phillips, Zackrison, Green and Liegner as well as a statistical analysis by Tao Liu, PhD, Allison DeLong MS and Barbara Blossom, BA.

At the hearing, the IDSA guideline recommendations were contested by the following presenters:  Lorraine Johnson, JD, MBA, Drs. Cameron, Donta, Fallon, Luft, Volkman, Liegner, Phillips, and Stricker, and Allison DeLong, MS.  The theme of these presentations—three of which were from independent researchers (Drs. Fallon, Luft, and Volkman) who do not treat Lyme disease—was consistent.

***Lab tests are too insensitive to be required for diagnosis of Lyme disease. 

***Evidence of persistent infection exists in animals and humans.

***Restrictive treatment duration recommendations are inappropriate given the high failure rates of the treatment protocols in the guidelines for early, late and arthritic Lyme disease.  On an intent-to-treat analysis—the treatment failures range from 5 to 40% for early Lyme and exceed 65% for late Lyme.

***The prophylactic recommendation in the guidelines is not only ineffective, but may actually harm patients by abrogating their immune response.

***There is no evidence to support the definition of Post-Lyme Disease Syndrome advanced in the guidelines or to limit treatment to patients whose health is not restored under the IDSA 21-day treatment protocols.

***Despite assertions to the contrary, treatment studies cited in the IDSA guidelines do not support its recommendation not to retreat patients who remain ill after the short term treatment.  The treatment studies cited are either too statistically flawed to be relied on (Klempner) or, when properly interpreted, actually support retreatment of patients (Fallon and Klempner).

***Specific language in the guidelines is inaccurate and misleading.  Examples of this include, the statements that there is no evidence of persistence, that the vast majority of patients are seropositive, or that persistent symptoms are no more than the aches and pains of daily living.

ILADS submitted a list of contested IDSA recommendations and proposed revisions to the guidelines to help panel members with their deliberations.  You can download a copy of this submission by clicking the link at the bottom of this posting.

Please check my blog for more to come!   www.lymepolicywonk.com .

If you are not a member of CALDA, please take a moment to join and support our good work!

 Lorraine Johnson, JD, MBA