The Mayday Project Responds to Dr. Paul Auwaerter’s Defense of IDSA Guidelines for Lyme Disease

The Mayday Project welcomes the response by Dr. Paul Auwaerter to our concerns about the IDSA guidelines for diagnosis and treatment of Lyme disease, which were discussed in a recent Medscape article about Mayday’s outreach to IDSA members at the IDWeek medical conference in October 2014.

Dr. Auwaerter’s statement that there can be “productive collaboration among advocacy groups” was especially encouraging.

Mayday also appreciates the open-mindedness of the doctors and researchers who spoke with us at IDWeek, and those who read our open letter to IDSA members (http://tinyurl.com/IDSAletter). We gained valuable insight into the complications of battling emerging diseases, such as Lyme, and a better understanding about the dangers related to overuse of antibiotics.

However, we take issue with Auwaerter’s statement that “the recommendations in IDSA’s guidelines are safe, effective…”

If the guidelines are effective, why do so many people remain chronically ill despite receiving the treatment specified by the guidelines? If the guidelines are effective, why are so many patients who are later confirmed to have Lyme misdiagnosed by doctors who follow the guidelines?

Dr. Auwaerter’s statement that “IDSA considers all relevant scientific information when developing its guidelines” is also misleading.

If that statement is true, then why haven’t the guidelines been updated to reflect the abundance of evidence for chronic Lyme disease that has accumulated over the past twenty years? Of the more than 300 peer-reviewed articles that support the existence of chronic Lyme, certainly some must be contain relevant scientific information.

A fundamental problem is that the CDC definition of Lyme disease is so restrictive that the true scope and spread of the Lyme epidemic has been vastly underreported.

In 2013, the Centers for Disease Control (CDC) announced that rather than 30,000 new Lyme cases annually, there are likely 300,000.

But other Lyme disease experts such as New York Times best-selling author Dr. Richard Horowitz, M.D. estimate that there are likely 1 to 2 million new cases annually in the U.S. alone:
 
“The CDC based their 300,000 estimate on 3 surveys that were large enough to be extrapolated nationwide. The most recent 2012 survey indicates there are almost 1 million new Lyme disease cases per year. If you then add those misdiagnosed due to inaccurate Lyme testing or outdated diagnostic standards and Lyme endemic states not included (NYS), you have somewhere between 1-2 million cases.”

The result of this underreporting is less attention to the disease. The result of less attention is that Lyme disease has received a fraction of the federal research dollars it otherwise would receive with more accurate reporting. IDSA’s guidelines compound the problem by promoting an ineffective standard of care, based on outdated science and the same narrow definition of Lyme that CDC uses.

The consequences have been devastating for patients, especially for those suffering from chronic Lyme, where an active, disease-causing infection persists even after treatment that exceeds the two to four weeks of antibiotics specified by the IDSA guidelines.

A study by LymeDisease.org published in the March 2014 issue of PeerJ, an open-access medical journal, found that Lyme patients reported a poorer quality of life than patients with other chronic diseases, including congestive heart failure, diabetes, multiple sclerosis, and arthritis.

Many of these very sick patients are forced to learn about relevant science and newer, evidence-based treatment options not recommended by the IDSA guidelines. Something is wrong when large numbers of chronically ill patients have to do research because widely followed medical guidelines do not provide an acceptable standard of care.

The report Conflicts of Interest in Lyme Disease: Laboratory Testing, Vaccination and Treatment Guidelines by the Lyme Disease Association suggests that a handful of influential researchers, with serious conflicts of interest, have corrupted the process of guideline development.

Before the guidelines were published, several of the authors published studies that support the existence of chronic Lyme disease. These same researchers later put their names on guidelines and articles that emphatically maintain there is no evidence for chronic Lyme. Either they have redefined the word “no” or they are making a false assertion.

This is especially troubling because they are senior academic researchers who are subject to very high standards for the accuracy and veracity of publications they author.

Kenneth Liegner, M.D., who specializes in internal medicine, critical care, Lyme disease, and related illnesses, included several examples in his remarks at a 2013 World Wide Lyme Rally & Protest in New York City. Liegner, who practices in Pawling, New York, near the epicenter of the Lyme epidemic said:

“Raymond J. Dattwyler, signatory to the 2006 Lyme disease guidelines, which assert that chronic Lyme disease does not exist, states exactly the opposite in a United States patent that issued almost contemporaneously with the IDSA Guidelines.”

Dr. Liegner continues: “Allen C. Steere, signatory to the 2006 IDSA Lyme Disease Guidelines, which declare chronic Lyme disease does not exist, states exactly the opposite in his published scientific articles and private letters.”

In the same talk, Dr. Liegner asks the question: “When a physician signs on to a practice guideline that directly contradicts their position in their own published peer-reviewed journal articles, statements in the public record, private letters, and in their own United States Patents, does that signify medical and scientific misconduct?”

Senator Richard Blumenthal provides some insight into the most serious conflicts of interests. When he was the Attorney General of Connecticut, Blumenthal launched an investigation of IDSA, based on allegations of abuses of monopoly power and exclusionary conduct, in violation of antitrust law.

In a May 2008 press release Blumenthal said, “My office uncovered undisclosed financial interests held by several of the most powerful IDSA panelists. The IDSA’s guideline panel improperly ignored or minimized consideration of alternative medical opinion and evidence regarding chronic Lyme disease, potentially raising serious questions about whether the recommendations reflected all relevant science.”

IDSA reached a consent agreement with Blumenthal’s office calling for creation of a review panel to thoroughly scrutinize the 2006 guidelines. In 2009, the guidelines were reviewed, but no significant changes were made, despite the large amount of evidence for chronic Lyme that was presented to the panel. According to Blumenthal, the panel used an “improper voting procedure,” based on a process of its own design, which undermined the integrity of the voting process and violated the consent agreement.

Much of the evidence that IDSA rejected was presented in a July 2009 public forum hosted by the guidelines review panel.

According to the article Lyme Disease: the Next Decade by Raphael B. Stricker and Lorraine Johnson (Infection and Drug Resistance. 1.6.11): “The review panel held a public hearing that featured more than 300 peer-reviewed articles and 1600 pages of analysis supporting the concept of persistent infection despite short-course antibiotic therapy of 2 to 4 weeks in patients with persistent Lyme disease symptoms. Despite this extensive evidence, the IDSA review panel voted unanimously to uphold the flawed Lyme guidelines.”

In a February 2012 letter to Congressman Chris Gibson (R-NY), Dr. Liegner had the following comments about the 2009 guidelines review panel:

“Very substantial evidence from the worldwide published peer-reviewed scientific literature was presented to the panel, demonstrating the reality of seronegative and serovariable Lyme disease and chronic persistent infection in humans and animals despite application of antibiotic therapy.”

Furthermore, according to Dr. Liegner: “Notably, all panel members were selected by the IDSA, most panelists were IDSA members, and physicians who earned more than $10,000/year caring for persons with Lyme disease were excluded from the panel. As a result, physicians most experienced with treating persons with Lyme disease, including chronic Lyme disease, were not represented on the panel.”

Mayday believes in the principles of Evidence Based Medicine (EBM), which is commonly defined as the integration of best research evidence with clinical expertise and patient values (Sackett, et al. BMJ 1996, 312).

Unfortunately, IDSA’s guidelines for Lyme disease ignore a tremendous amount of relevant research, they ignore the clinical experience of our doctors, and they ignore our values. Something is terribly wrong when an organization that repeatedly cites EBM in defense of its guidelines violates most of the principles of EBM.

A key flaw of the guidelines is the requirement for a positive result on the FDA-approved two-tier test for a physician to diagnose a patient with Lyme disease. It is well-documented that the current test for Lyme disease is unreliable. Several studies show that it misses up to 50 percent of Lyme disease cases, regardless of how long patients have been sick.

The reason for this flaw is the panel that defined Lyme disease at the 1994 conference in Dearborn, Michigan, chose to exclude two Lyme-specific “bands” related to the LYMErix vaccine that was withdrawn from the market after a flood of lawsuits claiming the vaccine caused arthritis and other illnesses. The exclusion of these bands, combined with the CDC’s high threshold for a positive result, ensures that Lyme disease remains underreported and that the sickest patients remain sick.

An increasing number of physicians who treat patients with Lyme, including one of the founding members of IDSA, have published case studies that strongly suggest persistent infection after IDSA recommended treatment.

In 2011, Burton A. Waisbren, a co-founder of the IDSA (now deceased) published a book, Treatment of Chronic Lyme Disease: Fifty-One Case Reports and Essays in Their Regard, that provides solid evidence, from 51 case studies, that chronic Lyme disease is not rare.

Improving the guidelines is a win-win situation. Better guidelines benefit Lyme patients, who would otherwise go undiagnosed and/or untreated. Better guidelines benefit physicians, who face the risk of medical board investigations when they treat Lyme patients beyond the limits imposed by the IDSA guidelines. Better guidelines also benefit the IDSA by improving its reputation among the public and within the medical industry.

The Mayday Project believes the following are required to fix the current guidelines and prevent similar trouble in the future:

- Adherence to the principles of evidence-based medicine.
- Inclusion on the panel of physicians whose practice focuses on treating Lyme patients.
- Inclusion of panelists with divergent viewpoints.
- Removal of the requirement for a positive test for diagnosis.
- Expansion of the definition of Lyme disease to includes all species of Borrelia that cause disease, or define a new disease called “Borreliosis.”

In addition to updating the guidelines, we call on the IDSA to strengthen and enforce conflicts of interest policies for panel members. We also call on the IDSA to fast track the publication of updated guidelines and work with a sense of urgency to combat this rapidly growing epidemic.

As a medical society dedicated to “improving the health of individuals, communities and society by promoting excellence in patient care, education, research, public health and prevention,” IDSA has a special obligation to make it a top priority to correct the deficiencies in its guidelines for Lyme to prevent further harm to patients.

We truly hope that IDSA will respond productively and treat this matter with the sense of urgency deserved by the thousands whose lives have been devastated from the effects of the IDSA guidelines.

Respectfully,

The Mayday Project, Inc.

About the Mayday Project
The Mayday Project is an advocacy group for Lyme disease patients, formed by volunteers who have been touched by Lyme in many ways. They aim to raise awareness about Lyme disease and related tick-borne illnesses. Mayday supporters advocate for more accurate tests, better guidelines, improved access to treatment, increased education for physicians, and more funding for research.

For more information visit http://www.themaydayproject.org.


References

The Infectious Diseases Society of America Lyme Guidelines: a Cautionary Tale About the Development of Clinical Practice Guidelines
http://www.peh-med.com/content/5/1/9

Review of Evidence for Immune Evasion and Persistent Infection in Lyme Disease
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC3636972/

Proof That Chronic Lyme Disease Exists
http://www.hindawi.com/journals/ipid/2010/876450

Severity of Chronic Lyme Disease Compared to Other Chronic Conditions: A Quality of Life Survey
https://peerj.com/articles/322/iionti

Contact Information

Josh Cutler

Co-founder

The Mayday Project

Contact via E-mail