IDSA’s 2006 Lyme Guidelines Ignite the Skirmish to a Battle

by J. David Kocurek, Ph.D.

The face of Lyme has changed again dramatically with the publication of the Infectious Disease Society of America’s (IDSA) 2006 Guidelines .for Treatment of Lyme Disease. Lyme’s face is now writhing in pain that is only surpassed by that caused by the disease itself. The new guidelines can be linked from the CDC’s website at http://www.cdc.gov/ncidod/dvbid/lyme/index.htm.

The Guidelines were electronically published on October 2, by Clinical Infectious Diseases [2006;43:1089-1134]. They were submitted and accepted on the same day, August 21, 2006. There is no indication of manuscript revision hinting that there was no review by a peer review committee of the publisher. The lead and corresponding author is Dr. Gary P. Wormser, Rm. 245, Munger Pavilion, New York Medical College, Valhalla, NY 10595 (Gary_Wormser@nymc.edu).

The following disclaimer precedes the Executive Summary: “These guidelines were developed and issued on behalf of the Infectious Diseases Society of America.

It is important to realize that guidelines cannot always account for individual variation among patients. They are not intended to supplant physician judgment with respect to particular patients or special clinical situations. The Infectious Diseases Society of America considers adherence to these guidelines to be voluntary, with the ultimate determination regarding their application to be made by the physician in the light of each patient's individual circumstances.”

Unfortunately, only a small number of physicians and medical professionals have taken the time to educate themselves and become Lyme Specialists so that they can make the responsible determination of a Lyme patient’s needs. The vast majority of physicians are simply not inclined to invest the time to learn, or worse yet, lack the intellectual curiosity to look beyond the several guidelines covering all treatment areas. I’m inclined to refer to them as technicians, except that demeans my mechanic for whom I have more respect.

The new Guidelines were at once identified as targeted and designed to undermine the now long established clinical practices shown to produce best patient outcome. The Guideline authors amassed a weighty 405 references carefully selected to support their opinions and conclusions while diminishing anything in the literature from an opposing position. Disclaimer aside (or ignored), the Guidelines have within weeks of their release caused insurance denials for prescribed medication, and even a pharmacist’s refusal to fill a prescription because the medication was listed by IDSA as ineffective for Lyme treatment.

Medical politics that toy with people’s lives – what can be more horrific? IDSA’s panel of expert authors are well known to those who have studied Lyme politics. We are left to wonder if there must be something more valuable than their reputations to protect.

I have come to describe the relationship between the Centers for Disease Control and Prevention (CDC) and IDSA as a consortium when it comes to Lyme disease. The CDC has reflected IDSA position and deferred to IDSA Guidelines on the CDC website. A current inquiry to CDC will return, in effect, a sales brochure statement of the 2006 Guidelines. CDC had long ago taken on sponsorship of the IDSA system of belief and promotes it even more with the new Guidelines. The CDC website information on Lyme disease is sadly misinformed in fact and dismissive of the seriousness of the disease and its prevalence. This isn’t new. It’s always been that way.

To bolster my assertion of a consortium, you have only to review the well-known names in the Guideline author’s list and check their continuing funding sources. CDC and IDSA are joined at the hip. Inbreeding leads to the death of any organization, but that’s too kind a description. The CDC/IDSA Consortium is incestuous and it’s causing harm. Complaining to IDSA is pointless in my view. They have always ignored criticism on the subject.

However, the CDC has Vision, Mission, Core Values, and a Pledge under which it operates, http://www.cdc.gov/about/organization/mission.htm. The reader is well advised to review these statements with scrutiny to determine if CDC has met its own standards in explicitely claiming ownership of the 2006 Lyme Guidelines. I believe it has failed substantially.

The CDC answers to the public directly and through legislative channels. CDC’s Director is Dr. Julie L. Gerberding, M.D., M.P.H. The Director’s office can be reached at (404) 639- 7000, and letters can be sent via FAX to (404) 639-7111. Electronic mail is discouraged and the address in fact not disclosed. You can read Dr. Gerberding’s welcome message at http://www.cdc.gov/about/director.htm.

CDC’s Chief Science Officer is Tanja Popovic, M.D., Ph.D., available at (404) 639-3311. The CSO is in charge of CDC’s Information Quality Peer Review, http://www.cdc.gov/od/science/PHResearch/peerreview.htm. Did the Guidelines undergo a formal CDC review before endorsement and release through CDC’s website, or were they blindly accepted from a “family member”?

As part of Public Law 107-116, signed by President Bush on January 10, 2002, the Congress expressed to CDC a number of significant concerns regarding Lyme and made a number of strong recommendations, the last of which is “The CDC is encouraged to include a broad range of scientific viewpoints in the process of planning and executing their efforts. This means including community-based clinicians with extensive experience in treating these patients, voluntary agencies who have advocacy in their mission, and patient advocates in planning committees, meetings, and outreach efforts.”

None of the Congress’ year 2002 recommendations have been implemented to date. Julie Gerberding took over CDC’s directorship in 2002. The responsibility is hers. There needs to be an accounting. An effort in the current Congress to reform the health care agencies is being made. HR 6164, National Institutes of Health Reform Act of 2006, passed the House on September 26, and is now in the hands of the Senate. Perhaps, the CDC needs another critical review.

The principal sponsor of HR 6164 is Rep. Joe Barton [TX-6] who chairs the Energy and Commerce Committee. His stated goal is to get the politics out of the health care agencies so that grants and contracts are awarded purely on merit. This is the same committee where H.R. 3427 (House Companion Lyme Bill) is waiting action. Constituents, especially, need to lobby their U.S. Legislators to push all of these issues.

The Lyme community is receiving a number of calls to arms on the new guideline challenge and old issues that dog this disease. At the time you will be reading these words, important discussions will have been held at conferences, and those thoughts will be making their way through the various channels that we depend on for information.

There is much to consider and weigh, plans to coordinate and then the important work of individual effort. Everyone has a high-risk stake in the outcome. Everyone is needed to make whatever contribution of effort that they can muster to achieve a breakthrough.