I am wholeheartedly in agreement with Dr. Stricker's and Ms. Johnson's response to Dr. Gershon's letter. Lyme Disease and its associated conditions are extremely complex illnesses, and patients who are suffering from them have their suffering exacerbated by misguided attempts to "treat ideologically".

Just last week, a new patient gave me the history that her clotted 'pic' line was ignored for hours by an ER physician who said he didn't "believe" in treating Lyme Disease IV, and who had his working diagnosis as psychiatric, until the infection became fulminant in the ER!

Such needless risk and suffering would be best avoided if we can at least "agree to diagree" and carry on with supporting the treatment plan of the specialist who began the treatment. I find the collaboration of my local colleagues invaluable, as we cope with the increase in severity and number of cases of tick-borne illnesses of all types in this area.

Many thanks to Dr. Stricker and his colleagues from around the world for sharing their experiences in treating these conditions, which appear to have some regional variations in the types of illnesses presenting, as well as their frequency and severity. I would encourage all who are interested in these conditions to attend the excellent LDA/IDSA conferences which will be held in Bethesda, MD in October this year.

Sincerely, Amelia Withington MD

It is ironic that Dr. Gershon, president of the IDSA, would decree the article by Johnson and Stricker to be full of “inaccuracies and misleading information” only to mislead readers using inaccurate information. A look at the science may be enlightening.

The IDSA holds that Lyme disease is easily cured, yet data from treatment trials cited in the 2006 IDSA guidelines suggests otherwise. The issue of persistent symptoms following treatment for Lyme disease is a particularly vexing one, and the etiology of these symptoms remains unproven. Animal studies and human case reports suggest that persistent infection with the Lyme spirochete does occur. To investigate this further, four separate trials studied the use of additional antibiotics in patients with persistent symptoms following standard IDSA-sanctioned therapy for Lyme disease. The patients in the retreatment trials had been ill for extended periods of time. For example, in one study, patients, on average, had been symptomatic for roughly 4.5 years despite previous antibiotic therapy. The response to treatment in these trials was mixed. While one investigator found no improvement with treatment, two others found a significant and sustained treatment-related reduction in fatigue. Debilitating fatigue is a prominent complaint in patients with persistent symptoms following standard antibiotic therapy for Lyme disease. Thus the statement by Dr. Gershon, “(b)linded, randomized controlled trials show that long-term antibiotic treatment is not effective for any condition described as ‘chronic Lyme’ ” is inaccurate and misleading.

The semantics involved in identifying patients who remain symptomatic after treatment is important. Dr. Gershon notes that there are no consistent markers for chronic Lyme disease, implying that there is no evidence for its existence. Yet the IDSA guidelines create a new diagnostic category, “post-Lyme syndrome”, with a similar problem: “Post- Lyme syndrome” implies the existence of definitive evidence that the initial bacterial infection has been cleared. However, available testing modalities cannot provide such evidence, nor is there a specific biologic marker for “post-Lyme syndrome”. Rather, the syndrome seems to be defined by failure of a restricted course of antibiotics to eliminate Lyme disease -related symptoms in a given individual. It is more likely that “post-Lyme syndrome” represents a failure of restricted antibiotic therapy to clear the infection, as outlined in the animal and human studies mentioned above, rather than a nebulous entity with no clear definition and no available treatment.

Dr. Gershon contends that Lyme disease is not a fatal illness. This statement is incorrect. Lyme disease has been associated with fatal myocarditis and encephalomyelitis (1,2), as well as intrauterine fetal death (3). Furthermore, tick-borne coinfections with the agents of Babesiosis, Anaplasmosis, Ehrlichiosis, Rickettsiosis and Tularemia are well-known direct causes of mortality, and these coinfections can be transmitted together with the Lyme spirochete (4-7). Because of clinical ignorance about these diseases and poor laboratory test sensitivity, it is likely that fatal cases of tick-borne diseases may go unrecognized and consequently are under-reported (7,8).

Politicians, including the Attorney General of Connecticut, are drawn into the Lyme disease arena because IDSA has allowed politics to enter into the discussion of this illness through its restrictive guidelines process. Generalizable studies that address the many variables affecting patients with Lyme disease are desperately needed to improve our understanding of the illness in order to better guide treatment. Until that work is completed, minds and options need to remain open. The 2006 IDSA guidelines take the opposite approach, which is why they need to be substantially revised.

1: Tavora F, Burke A, Li L, Franks TJ, Virmani R. Postmortem confirmation of Lyme carditis with polymerase chain reaction. Cardiovasc Pathol. 2008; Mar-Apr;17(2):103-7. 2: van Assen S, Bosma F, Staals LM, Kullberg BJ, Melchers WJ, Lammens M, Kornips FH, Vos PE, Fikkers BG. Acute disseminated encephalomyelitis associated with Borrelia burgdorferi. J Neurol. 2004 May;251(5):626-9. 3: Markowitz LE, Steere AC, Benach JL, Slade JD, Broome CV. Lyme disease during pregnancy. JAMA. 1986 Jun 27;255(24):3394-6. 4: Javed MZ, Srivastava M, Zhang S, Kandathil M. Concurrent babesiosis and ehrlichiosis in an elderly host. Mayo Clin Proc. 2001 May;76(5):563-5. 5: Bakken JS, Dumler JS. Clinical diagnosis and treatment of human granulocytotropic anaplasmosis. Ann N Y Acad Sci. 2006 Oct;1078:236-47. 6: Penn RL, Kinasewitz GT. Factors associated with a poor outcome in tularemia. Arch Intern Med. 1987 Feb;147(2):265-8. 7: Paddock CD, Holman RC, Krebs JW, Childs JE. Assessing the magnitude of fatal Rocky Mountain spotted fever in the United States: comparison of two national data sources. Am J Trop Med Hyg. 2002 Oct;67(4):349-54. 8: Millar BC, Xu J, Moore JE. Molecular diagnostics of medically important bacterial infections. Curr Issues Mol Biol. 2007 Jan;9(1):21-39.

IDSA Lyme Guidelines: Response to Dr. Gershon

It is not surprising that Anne Gershon, the current president of the Infectious Diseases Society of America (IDSA), would come to the defense of her society's beleaguered Lyme guidelines. What is disturbing is that Dr. Gershon relies on the same specious arguments that were debunked by the Connecticut Attorney General's investigation of the IDSA Lyme guidelines process (<http://www.ct.gov/AG/cwp/view.asp?a=2795&q=414284>) and refuted in our article. Here is a rebuttal to her views.

As stated in our article, the IDSA Lyme guidelines are not "simply guidelines", as Dr. Gershon meekly maintains. They are a highly restrictive set of directives published by the largest group of infectious disease specialists in the world, and they allow a monopolistic medical society to set a standard of care that forecloses treatment options for patients. The IDSA guidelines trivialize Lyme disease, ignoring the growing number of patients with persistent symptoms of tick-borne illness leading to significant disability. The guidelines also discount the importance of clinical judgment and fail to provide treatment options for Lyme patients. As Dr. Gershon knows, the IDSA Lyme guidelines are treated as the mandatory standard of care by insurers, government agencies and medical boards, and they are used to deny patients access to the only viable treatment option for chronic Lyme disease.

Readers can easily refer to the findings of the Attorney General to dispel Dr. Gershon's protestations regarding suppression of evidence and the use of a hand-picked panel with known biases and substantial conflicts of interest, as the findings on these points are clear. Basically, IDSA researchers selected their own papers based on their own research bias, found no faults with their own studies, discounted the studies of others, and excluded opposing viewpoints in reaching their conclusions. Even the strongest proponents of evidence-based medicine would cringe at the amount of bias the panel members brought to the table. As noted in our article, their conclusions support the interests of vaccine patent holders who favor a narrow disease definition that increases the efficacy and odds of approval of a vaccine. Their conclusions also favor diagnostic test patent holders by mandating a positive test for diagnosis. Their conclusions put money in the pocket of consultants who help to deny patient care and reduce costs for insurers. The Attorney General found that IDSA panel members had conflicts of interest in each of these areas. Did anyone on this panel represent the interests of patients to gain access to the only medical option that might improve their quality of life? The answer is no.

Nor can IDSA shore up its guidelines by asserting that other medical societies independently corroborate them. First, most of the groups listed by Dr. Gershon do not endorse IDSA's 2006 guidelines. Second, as pointed out by the Attorney General in his findings, corroboration of the IDSA guidelines was anything but independent. Hence, the Attorney General found that "The IDSA portrayed another medical association's [American Academy of Neurology] Lyme disease guidelines as corroborating its own when it knew that the two [guidelines] panels shared several authors, including the chairmen of both groups, and were working on guidelines at the same time". The New England Journal of Medicine article cited by Dr. Gershon also shared authors with the IDSA panel. Both publications appeared after the Attorney General's investigation was launched, and there was no disclosure of the rather glaring conflict of interest of panel members who authored these "independent" attempts to exonerate themselves in the face of an ongoing investigation.

Dr. Gershon implies that "Lyme-literate" physicians prey upon misinformed and misguided patients. Nothing could be further from the truth. In reality, patients by the thousands seek care from "Lyme- literate" physicians because the IDSA guidelines have failed them and the IDSA physicians who rely on those guidelines have abandoned them. Dr. Gershon also derides treating physicians for being paid fees for their services. However, there is a big difference between being paid to care for patients and profiting from third-party industry ties that should have no place in determining patient care. If patients are unhappy with their treatment, they have the power to leave a treating physician and seek another, and they also have the ability to express their concerns and ensure that those concerns are addressed. In short, their physicians are accountable for their care. Patients have no similar recourse with the guidelines panel of a dominant medical society that has the authority to set the rules for patient care but is not accountable to those patients when care fails.

It is all too easy to turn a blind eye on treatment failures and patient suffering when one never sees or treats the patient, is not responsible for the consequences of failure and neglect, and has no obligation to the individual. IDSA's assertion that this medical abandonment is necessary to honor its hypocratic oath to "first, do no harm" could be used to justify the denial of any medical treatment, as all treatments have the potential to do harm. While this may appeal to insurers, Lyme patients who are suffering a disability equivalent to congestive heart failure certainly deserve better.

Lorraine Johnson, JD, MBA, Chief Executive Officer, California Lyme Disease Association <http://www.lymedisease.org>

Raphael B. Stricker, MD, Past President, International Lyme & Associated Diseases Society <http://www.ilads.org>

The article entitled “Attorney General Forces Infectious Disease Society of America to redo Lyme guidelines due to flawed development process” that appeared in the Journal of Medical Ethics purporting to explain the agreement between the Connecticut Attorney General and the Infectious Diseases Society of America (IDSA) regarding its Lyme disease guideline was extremely disturbing. This article is riddled with inaccuracies and misleading information. The article is the latest salvo from a small but vocal group of physicians and patients who attribute a wide range of vague symptoms to what they call “chronic” Lyme disease. To treat “chronic” Lyme infection, this self-described “Lyme-literate” group promotes the use of long-term antibiotics – often delivered intravenously for months or even years. The cost of this treatment must be borne by patients themselves, leading a discerning person to question the authors’ interest in the real reason why they want the treatment guidelines changed.

Blinded, randomized controlled trials show that long-term antibiotic treatment is not effective for any condition described as “chronic Lyme” – a condition that currently has no consistent diagnostic markers. Far worse, this treatment has been shown to be extremely risky, potentially leading to fatal infections, serious drug reactions and fostering development of life-threatening drug-resistant superbugs. That this group continues to use its assaults on the IDSA and its Lyme disease guidelines as a platform to promote a not only unproven but expensive and potentially dangerous therapy is, we believe, clearly unethical.

Among the many inaccuracies in this article, the most egregious charge is that the IDSA’s Lyme disease guidelines “excluded most Lyme patients and denied them treatment for their illness.” It is difficult to find an accurate sentiment in that statement. To start with, the guidelines are simply that, guidelines, and by their very nature do not “exclude” patients, nor “deny” them treatment. Further, the authors seem intentionally to confuse Lyme disease – a proven and highly treatable illness – with “chronic” Lyme infection, an unproven condition that a small group of doctors may provide as a “diagnosis” for patients with vague but often serious symptoms. There is no solid evidence of the existence of “chronic” Lyme infection. Although we do not doubt that there are patients who initially were treated for Lyme disease infection and subsequently have ongoing, vague symptoms, we are concerned these patients likely are suffering from a different or new illness and are receiving potentially dangerous “treatment” rather than being evaluated, properly diagnosed, and treated appropriately.

Although a comprehensive response to the remaining charges would require an entire article, following are our comments regarding several of the most salient.

• Regarding the agreement (not “settlement”) between the IDSA and the Connecticut Attorney General, the IDSA was not forced to “redo” the Lyme guidelines and no “antitrust laws” were broken. The Lyme disease guidelines remain in effect. IDSA voluntarily agreed to a special one-time review of the Lyme disease guidelines. IDSA paid no fines or penalties and is not restricted from promulgating guidelines of Lyme disease or other conditions.

• The statement “at least 21 studies documenting death in patients with this potentially devastating tick-borne illness” is patently wrong. Lyme disease is not a life-threatening disease. This statement is reminiscent of a tabloid headline – the patients may have had Lyme disease, and may have died, but not of Lyme disease.

• The IDSA Lyme disease guideline panel spent months scouring all of the Lyme disease research. Specific studies were not “selectively ignored,” but in fact stringently reviewed along with all of the other research. Based on widely accepted principles of evidence-based medicine, some studies were determined to lack scientific rigor, and were therefore not used as a basis for treatment guidelines.

• The comment that the guidelines are “treated as mandatory” and end up “denying” treatment to patients is inaccurate. The purpose of the guidelines is to attempt to guide physicians in providing the highest- quality treatment that is not harmful to patients. However, they are guidelines, not mandates.

• IDSA does not have nor seek monopoly power. We do not work with insurers on any guidelines, nor do we develop our guidelines for the sake of insurers. We develop guidelines to provide guidance to our members, with the ultimate goal of ensuring the best quality in patient care and to protect the public’s health.

• Regarding the makeup of the guidelines panel, the IDSA chose the panel of experts that we believe is the most knowledgeable for the job. Further, the panel was not limited to “researchers known to have a bias against the diagnosis and treatment of Lyme disease.” In fact, the point of the panel was to guide physicians in treating Lyme disease, a known and highly treatable disease.

• The remark that some of the panel members were working on the development of vaccines is irrelevant. There are no Lyme disease vaccines approved for use in humans and the IDSA has made no recommendations in that regard. The vaccine mentioned in the article was previously in development, but the decision not to manufacture it was made before the guidelines were published.

• Regarding conflicts of interest among panel members, physicians with expertise in a specialty of medicine are often called upon to serve as expert witnesses, just as lawyers are often asked to do. This is a professional activity, and compensation is relatively modest. The same is true of consultation fees with commercial organizations, as long as specific guidelines are followed. The physicians on our panel followed those guidelines. The implication that physicians on the guidelines panel stand to monetarily gain from their recommendations seems particularly hypocritical coming from a group of practitioners who stand to gain financially from treating vulnerable patients with an unproven condition using an unproven, expensive, invasive and risky long-term therapy.

The IDSA is widely recognized as the pre-eminent authority on the treatment of infectious disease. We are in good company in our lack of support of the therapy advocated by the authors of this article, including the American Academy of Pediatrics, the American College of Physicians, the Medical Letter, the Centers for Disease Control and Prevention (CDC), the National Institutes of Health (NIH), and even review articles in major medical journals such as the New England Journal of Medicine. We take our responsibility as protectors of the public health seriously, and as physicians who stand by our Hippocratic Oath to “above all, do no harm,” we wish there were more evidence that these authors and the groups they represent did the same.

Sincerely, Anne Gershon President, IDSA