Ethics of Lyme Activism Article

Scientific evidence and best patient care practices should guide the ethics of Lyme disease activism

Paul G Auwaerter,1 Johan S Bakken,2 Raymond J Dattwyler,3 J Stephen Dumler,4

John J Halperin,5,6 Edward McSweegan,7 Robert B Nadelman,8 Susan O’Connell,9

Sunil K Sood,10 Arthur Weinstein,11 Gary P Wormser 8

ABSTRACT

Johnson and Stricker published an opinion piece in the Journal of Medical Ethics presenting their perspective on the 2008 agreement between the Infectious Diseases Society of America (IDSA) and the Connecticut Attorney General with regard to the 2006 IDSA treatment guideline for Lyme disease. Their writings indicate that these authors hold unconventional views of a relatively common tick-transmitted bacterial infection caused by the spirochete Borrelia burgdorferi.

Therefore, it should come as no surprise that their opinions would clash with the IDSA’s evidence-based guidelines for the diagnosis and treatment of Lyme disease. Their allegations of conflict of interest against the IDSA resemble those made against the National Institutes of Health, the Food and Drug Administration and the Centers for Disease Control and Prevention in 2000, which were found to be baseless. It is the responsibility of all physicians and medical scientists to stand up to antiscientific, baseless and unethical attacks on those who support an evidence-based approach to caring for patients.

Johnson and Stricker1 published an opinion piece in the Journal of Medical Ethics presenting their views on the 2008 agreement between the Infectious Diseases Society of America (IDSA) and the Connecticut Attorney General, Richard Blumenthal, with regard to the 2006 IDSA treatment guidelines for Lyme disease. They write as if they were disinterested arbiters in what they term ‘the Lyme disease controversy ’, purporting to reveal that the IDSA and its members have ulterior motives in designing guidelines for the diagnosis and treatment of Lyme disease. Their arguments, however, are based on numerous distortions and inaccuracies, as well as their own self-interests.

To begin, the title of their opinion piece is wrong. Blumenthal did not ‘force’ the IDSA to withdraw or redo its 2006 Lyme disease guidelines. As a result of the potential legal costs involved in defending against Blumenthal’s charges and threatened actions, the IDSA agreed to appoint an independent panel to review the 2006 guidelines to determine if there should be an update or revision.2 3 On 22 April 2010 the new panel concluded that the 2006 Lyme disease guidelines were accurate and appropriate.4 Besides the title, there are numerous other inaccuracies throughout the opinion piece

(see table 1).1 5e7

Johnson and Stricker1 in their paper focus on two broad themes in their critique of the development of the IDSA’s Lyme disease guidelines: (1) that the guidelines contribute to centralisation of medical decisions and thereby limit the doctor ’s ability to use clinical judgement and (2) that conflicts of interest affected the outcome of the process.1 In the material that follows we will demonstrate serious flaws in their analysis.

CENTRALISATION OF MEDICAL DECISIONS

Although Johnson and Stricker1 contend that evidence-based guidelines limit clinical discretion in a way that is detrimental to patient care, they provide no evidence to substantiate this claim. In addition, the authors fail to acknowledge that in order to make decisions that are in the best interests of individual patients, ethical physicians are in fact constrained by the availability of credible scientific evidence. The purpose of guidelines is to provide guidance to physicians; guidelines are not intended to supercede a physician’s judgement in the care of an individual patient. In fact, the IDSA Lyme disease guidelines explicitly stated: ‘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’.5 To understand the concerns of Johnson and Stricker1 about the application of science-based practice to the management of patients, it is helpful to appreciate the unorthodox perspectives that exist concerning Lyme disease.

Lyme disease, post-Lyme disease symptoms and ‘chronic Lyme disease’

Lyme disease is an Ixodes tick-transmitted bacterial infection caused by Borrelia burgdorferi sensu lato. It has been intensively studied for over 30 years and its natural history is well documented. The most common clinical manifestation is a characteristic skin lesion called erythema migrans that occurs at the site of the tick bite. Other clinical manifestations may involve the musculoskeletal system (eg, arthritis of the knee), nervous system (eg, facial nerve palsy) or the heart (eg, heart conduction disturbances). In addition to such objective clinical manifestations, patients with Lyme disease may concomitantly have subjective symptoms including fatigue, arthralgia, myalgia, headache, stiff neck and impaired concentration.

1

Division of Infectious Diseases, Department of Medicine, The Johns Hopkins Medical Institutions, Baltimore,

Maryland, USA

2

Section of Infectious Diseases, St Luke’’s Hospital, Duluth, Minnesota, USA

3

Division of Allergy, Immunology and Rheumatology, Department of Medicine, New York Medical College, Valhalla, New York, USA

4

Division of Medical Microbiology, Department of Pathology, The Johns Hopkins Medical Institutions, Baltimore, Maryland, USA

5

Atlantic Neuroscience Institute, Summit, New Jersey, USA

6

The Mount Sinai School of Medicine, New York, New York, USA

7

Crofton, Maryland, USA

8

Division of Infectious Diseases, Department of Medicine, New York Medical College, Valhalla, New York, USA

9

Lyme Borreliosis Unit, Health Protection Agency Microbiology Laboratory, Southampton General Hospital, Southampton, UK

10

Division of Pediatric Infectious Diseases, Schneider Children’s Hospital at North Shore, Manhasset, New York, USA

11

Section of Rheumatology, Department of Medicine, Washington Hospital Center and Georgetown University Medical Center, Washington, DC, USA

Correspondence to Dr Gary P Wormser, New York Medical College, Division of Infectious Diseases, Munger Pavilion Room 245, Valhalla, NY 10595, USA; gary_wormser@nymc.edu

Received 28 August 2009

Revised 6 September 2010

Accepted 17 September 2010

Auwaerter PG, Bakken JS, Dattwyler RJ, et al. J Med Ethics (2010). doi:10.1136/jme.2009.032896 1 of 6

C l i n i c a l e t h i c s

JME Online First, published on November 21, 2010 as 10.1136/jme.2009.032896

Copyright Article author (or their employer) 2010. Produced by BMJ Publishing Group Ltd under licence.

The vast majority of Lyme disease patients treated with a short course of antibiotic therapy resolve their infections and become asymptomatic following therapy. A small minority may experience subjective symptoms such as fatigue or musculoskeletal pain despite resolution of the objective clinical manifestations.5 8 9 Such patients are referred to as having post-Lyme disease symptoms or post-Lyme disease syndrome, depending on the symptom duration and severity.5 8 Post-infectious symptoms are not unique to Lyme disease and are not caused by active infection.10

The term ‘chronic Lyme disease’ has been adopted by certain Lyme disease activists and Lyme disease activist physicians (the latter group is often referred to as ‘ Lyme literate medical doctors’) as a designation for the presence of persistent B burgdorferi infection despite previous antibiotic treatment.8 11 Although the term ‘chronic Lyme disease’ is sometimes applied to patients with post-Lyme disease symptoms, evidence indicates that the majority of patients with this diagnosis in fact have no convincing clinical or laboratory evidence of ever having had B burgdorferi infection.8 12 This is not surprising because, to our knowledge, there are no consistent or objective diagnostic criteria for‘chronic Lyme disease’. Instead, the diagnosis relies on ‘clinical judgement’, which appears to mean that if a physician

Table 1 Selected erroneous statements made by Johnson and Stricker1 in their Journal of Medical Ethics article

Statement or claim Location in article Factually correct statement

Attorney General forces IDSA to redo Lyme guidelines due to flawed development process

Page 283

The IDSA agreed to convene a panel to evaluate whether its guidelines should be updated or revised. The IDSA did not admit that the process was flawed or that the guidelines are scientifically incorrect.

Most patients are aware that obtaining a diagnosis and treatment for Lyme disease can be difficult

Page 283

Diagnosis and treatment of active B burgdorferi infection is standard practice and readily available

The IDSA promoted a narrow definition of Lyme disease in 2000

Page 283

The IDSA did not define Lyme disease in 2000; however, in 2006 it stipulated that such a definition require that it be caused by B burgdorferi infection

The IDSA guidelines excluded most Lyme patients and denied them treatment

Page 283

The IDSA advocated not re-treating patients with post-Lyme syndrome and not treating patients for Lyme disease who do not have evidence of B burgdorferi infection

The level of disability of patients with Lyme disease is equal to that of congestive heart failure and Lyme disease may be fatal

Page 283

This level of disability was based on a study of post-Lyme disease syndrome in which functional disability was a prerequisite. Lyme disease is not fatal. It is usually treated very successfully with short courses of

antibiotics

The IDSA Lyme panel selectively ignored evidence of persistent infection or clinical improvement with antibiotic treatment in patients with persistent symptoms

Page 283

The IDSA panel carefully evaluated the clinical evidence for persistent infection, as well as the benefit of prolonged courses of antibiotic therapy; they found the evidence to be unconvincing, as did the newly appointed panel4

The IDSA intentionally ignored divergent evidence

Page 283

See above and see pages 1114e21 in the IDSA guidelines5

Lyme vaccine was withdrawn because of serious arthritis and neurological

side effects

Page 284

No such effects were found to be vaccine related, based on extensive studies conducted by the FDA.6 7 The vaccine was withdrawn for economic reasons

It is claimed that Abbott makes a Lyme diagnostic test

Page 284

There is no FDA-cleared diagnostic test for Lyme disease made by Abbott

In its previous guidelines, the IDSA summarily tossed out the one panel member who disagreed with the panel chair

Page 284

One panel member voluntarily withdrew. No one was dismissed

The IDSA guidelines restrict the definition of the disease and mandate laboratory testing

Page 285

The IDSA restrict the definition to B burgdorferi infection.

The IDSA recommends against laboratory testing for patients with erythema migrans, which comprise the majority of cases of Lyme disease5 Guidelines that restrict the disease definition are favourable to vaccine

manufacturers

Page 285

Even before the IDSA guidelines were developed, trials of vaccines required evidence that the subjects participating in the trials who are diagnosed with Lyme disease actually had B burgdorferi infection. A narrow definition may in fact reduce the potential market for a vaccine. Guidelines that mandate testing for disease diagnosis promote the interests of those who develop and manufacture diagnostic tests

Page 285

The IDSA recommended against testing for the majority of patients with Lyme disease, ie, those who have erythema migrans. The IDSA did not recommend any particular diagnostic kit or test5

Guidelines that deny treatment to patients are favourable to insurance companies and their consultants

Page 285

The IDSA only recommended against antibiotic treatment of patients who have no evidence of active infection, who do not require antibiotic treatment and for whom such treatment may be injurious5

With evidence-based guidelines, someone other than the treating doctor will be selecting, interpreting and making recommendations regarding treatment. There is an obligation to comply with guidelines as a ‘mandated standard of care’

Page 285

The guidelines state the following: ‘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 IDSA 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’5

Specialty societies embrace treatment guidelines to expand their sphere of influence in an insurance-driven environment

Page 285

The IDSA writes guidelines to assist physicians and to promote quality care for the patients whom they treat

The guidelines published by the IDSA in November 2006 were extremely restrictive and denied the use of clinical judgement

Page 286

See above

The IDSA restricts treatment to 30 days and offers no suggestions for alternative treatments

Page 286

Incorrect. See page 1106 and pages 1110e13 in the guidelines5

G Wormser, the panel chair, was selected inappropriately and picked a panel without approval of the IDSA oversight committee

Page 286

None of the panel members or the chair could have served without the approval of the IDSA; 16 other individuals served as consultants rather than panel members

The IDSA had significant financial conflicts of interest

Page 286

See text for extensive discussion

FDA, US Food and Drug Administration; IDSA, Infectious Diseases Society of America. 2 of 6 Auwaerter PG, Bakken JS, Dattwyler RJ, et al. J Med Ethics (2010). doi:10.1136/jme.2009.032896

thinks that a patient has ‘chronic Lyme disease’, then that is the diagnosis.11 There is certainly no requirement for a positive laboratory test result to substantiate the diagnosis.8 11 12 Patients who in reality have medically unexplained symptoms (MUS) or other yet undiagnosed medical conditions, including multiple sclerosis, Parkinson’s disease, depression or fibromyalgia, among many possibilities, may potentially be labelled as having ‘chronic Lyme disease’.8 12 13 Regrettably, the misdiagnosis of such patients precludes or delays the possibility that they will have the opportunity to receive appropriate medical treatment for their conditions. Furthermore, because of the presumption of persistent infection it has been argued that patients with ‘chronic Lyme disease’ may require treatment with antibiotics for months to years.1 8 11 12

In our experience, any response, whether good, bad or indeterminate to antibiotics may be used by practitioners who believe in ‘chronic Lyme disease’ to claim support for the diagnosis. If patients feel better on antibiotic therapy, this is believed to establish the diagnosis, notwithstanding a well-documented placebo response rate of up to 36% in treatment studies of post- Lyme disease syndrome,11 14 and the fact that certain antibiotic classes have well-recognised anti-inflammatory and neuroprotective effects independent of their anti-infective actions.15 16

If the patient worsens at any point while on antibiotic therapy, paradoxically, this may also be interpreted to support the diagnosis, as it is attributed to a JarischeHerxheimer reaction from the effect of massive spirochaetal killing.8 In reality, however, JarischeHerxheimer reactions begin only during the first 24 h of initial antibiotic therapy in spirochaetal infections, and not months to years into sequential antimicrobial therapy.17 An unchanged condition is also deemed to be consistent with ‘chronic Lyme disease’, as these patients may be regarded as having an ‘incurable’ illness.8 Indeed, we frequently hear patients with ‘chronic Lyme disease’ use terms similar to those often employed by oncologists for patients with cancer, for example, being ‘in remission’ or having a ‘relapse’.

In their article, Johnson and Stricker1 use the terms ‘ Lyme disease’ and ‘chronic Lyme disease’ interchangeably. This is misleading insofar as one term has a recognised definition and one does not. Johnson and Stricker1 also state that the IDSA guidelines panel ‘selectively ignored evidence of persistent infection.’. This statement is misleading if it is construed to mean that the subject was not considered by the panel. In fact, eight pages (w5000 words) of the 2006 IDSA Lyme disease guidelines were devoted to analysing the available scientific data on the persistence of infection by B burgdorferi after antibiotic therapy in both humans and animals, and whether prolonged or repeated courses of antibiotics might benefit patients with chronic post-Lyme disease symptoms.5

Geography of ‘chronic Lyme disease’

The geographical range of B burgdorferi and the tick vectors that spread it are limited. More than 90% of cases of Lyme disease that meet the Centers for Disease Control and Prevention’s (CDC) surveillance criteria occur in just 10 states located in the mid-Atlantic, northeast and north central regions of the USA.18 ‘Chronic Lyme disease’, however, is not confined to regions where tick transmission of B burgdorferi could possibly occur.19 Indeed, many Lyme disease support groups exist in non-endemic areas, even in areas where Ixodes scapularis or Ixodes pacificus ticks, the only vectors that transmit Lyme disease in the USA, are not found. Therefore, it is reasonable to surmise that these Lyme disease support groups may include patients with MUS or other medical conditions rather than patients with current or past Lyme disease. Patients with MUS are indeed an important group to consider; however, appropriate advocacy should focus on determining the cause(s) of these condition(s) and their most effective treatment(s), rather than incorrectly attributing them to B burgdorferi infection.

Evidence-based diagnosis of Lyme disease

The 2006 IDSA Lyme disease guidelines clearly argue for an evidence-based approach for the diagnosis and treatment of Lyme disease, and dispute the notion of ‘chronic Lyme disease’.5 For example, the IDSA guidelines recommend laboratory support for the diagnosis except for erythema migrans, which can be reliably identified based on the appearance of the skin lesion. The reason that a positive laboratory test result from a reputable laboratory is necessary to confirm a presumptive diagnosis of the extracutaneous clinical manifestations is that other causes are actually more common.5 20 For example, in one study only approximately 25% of patients in a high-risk area of Long Island, New York, with the onset of facial nerve palsy during warm weather months actually had B burgdorferi infection as the explanation for the palsy.21 Of course, a positive serological test result even in a patient with a high pretest likelihood of having the disease is not proof positive of a diagnosis of Lyme disease; it only means that the probability of Lyme disease is higher than it was before the test was done.22

Treatment of Lyme disease

The most troublesome question to both the general physician reader and those with expertise in infectious diseases is why anyone would rationally promote treatment for what they presume to be B burgdorferi infection (or any other antibiotic-susceptible bacterial infection) that is open-ended, sometimes involving multiple antibiotics given simultaneously or sequentially, and often in high doses over a period of many years.8 11 Such unconventional therapy can be associated with serious adverse events such as hospitalisations for Clostridium difficile colitis or central venous catheter infection, can promote the emergence of strains of the patients’ normal bacterial flora that are resistant to antimicrobial agents and is costly. Other ‘therapeutic’ modalities, such as deliberate inoculation with malaria parasites, or the administration of bismuth injections (which were lethal for one patient), have also been used.5 8 The IDSA Lyme disease guidelines clearly argue against such treatments.5 As stated in the IDSA guidelines, the conclusion of the investigators of the three National Institutes of Health-sponsored double-blind, randomised, placebo controlled treatment trials of patients with post-Lyme disease syndrome was that the risk/ benefit ratio of additional courses of antibiotic therapy strongly favours non-antibiotic management approaches.5 14 23 Consistent with these conclusions, there was also no microbiological evidence for the persistence of B burgdorferi in these studies despite rigorous examination of multiple body fluid samples using several different assays.5 14

Criteria for enrolment in the aforementioned, randomised treatment trials of patients with post-Lyme disease syndrome required the presence of functional disability.14 23Consequently, it is inappropriate to generalise the severity of illness in these subjects to all patients with subjective complaints after having had Lyme disease, as Johnson and Stricker have done.1 9 24 In fact, patients with at least 6 months of functionally disabling symptoms following a well-documented episode of Lyme disease are very uncommon, as demonstrated by the difficulty that the investigators experienced in finding the desired number of

Auwaerter PG, Bakken JS, Dattwyler RJ, et al. J Med Ethics (2010). doi:10.1136/jme.2009.032896 3 of 6

subjects for the trials.14 23 It is even more misleading to characterise Lyme disease as a fatal infection.1 For some practitioners such mischaracterisations might serve to justify the prescription of prolonged intravenous courses of potentially harmful antibiotic therapy, despite the weight of evidence against such an approach, as discussed above.14 23 25

CIRCUMSTANCES SURROUNDING THE INVOLVEMENT OF THE CONNECTICUT ATTORNEY GENERAL IN THE IDSA LYME DISEASE GUIDELINES

Supporters of the concept of ‘chronic Lyme disease’ raised objections to the 2006 Lyme disease guidelines even before they were published. However, it should be noted that the 2006 guidelines, as they pertain to post-Lyme disease symptoms and the treatment of the objective manifestations of Lyme disease in North America, are essentially identical to the 2000 IDSA Lyme disease treatment guidelines.26 By 2006, however, the level of evidence against prolonged and repeated courses of antibiotics had strengthened to level 1 (ie, evidence from randomised, double-blind, placebo controlled treatment trials).

The American Academy of Neurology reached a similar conclusion in its 2007 Lyme disease practice guideline.27 Although the IDSA and the American Academy of Neurology guidelines had three authors in common, between the two guidelines there were 20 different panelists involved, including the principal investigators of all three randomised, placebo controlled treatment trials for post-Lyme disease symptoms that had been published by that time. Both sets of guidelines were extensively peer-reviewed before they were published. In addition, these guidelines are similar to 14 other sets of guidelines for diagnosis and treatment published by European medical societies and expert panels.28

According to published reports, three chronic Lyme disease activist groups, the New Jersey-based Lyme Disease Association, the California Lyme Disease Association and the Connecticut-based Time for Lyme organisation, registered complaints with several State Attorneys General regarding the IDSA guidelines.29 Of note, Johnson is Chief Executive Officer of the California Lyme Disease Association. Only Richard Blumenthal, the Connecticut Attorney General, initiated legal action. Notably, he has served on the advisory board of Connecticut Time for Lyme, helped raise money for the ‘chronic Lyme disease’ movement,

helped draft a state law assuring patients in Connecticut access to prolonged antibiotic therapy for ‘chronic Lyme disease’ and supported a paediatrician found to have negligently diagnosed and treated children for ‘chronic Lyme disease’ from a non-endemic area without ever examining them.30 The reason for Blumenthal’s long-time support of the ‘chronic Lyme disease’ movement is unclear. For many advocates, it is based on a personal connection, such as having a family member diagnosed with ‘chronic Lyme disease’, although there is no evidence that Blumenthal falls into this category.

Blumenthal instituted his ‘anti-trust’ investigation in the autumn of 2006 within days after the publication of the 2006 IDSA guidelines. Initiating an anti-trust investigation may seem like an odd approach at first glance, because a 1996 policy statement from the Federal Trade Commission and the Department of Justice states that treatment guidelines issued by medical societies do not limit competition.31 However, an anti-trust investigation provided broad authority to conduct an investigation at the expense of Connecticut tax payers.

Blumenthal never provided any evidence of an anti-trust violation by the IDSA, which is in accord with the legal analysis of the matter by independent attorneys.32 We agree with those who have characterised this action as an attempt to politicise health policy against the weight of scientific evidence.30 32 33

CONFLICTS OF INTEREST

Blumenthal concluded that the IDSA guidelines panel was ‘rife with conflicts of interest’,29 apparently based on voluntary disclosures of associations with commercial entities by panel members in different contexts and at different times. The majority of the panelists had nothing to disclose, and those who had disclosures do not benefit financially from the recommendations made in the IDSA guidelines.

With regard to laboratory diagnosis, the 2006 IDSA Lyme disease guidelines reiterated the CDC recommendations for two-tier serological testing that has been the standard of care since 1995 and is also the strategy recommended in Europe and Canada.5 34e38 Although several panel members received research grants to study various new or novel diagnostic tests for Lyme disease, this was not a conflict because no specific serological tests or test kits were recommended by the panel. In the past, some panel members had been involved in Lyme disease vaccine development; however, the guidelines do not recommend any Lyme vaccine, and in fact the sole such commercial product was withdrawn by the manufacturer in 2002 as a result of poor sales.

It is difficult to discern how IDSA panel members would benefit financially by recommending against treating patients who either do not have Lyme disease or who have had Lyme disease but do not require additional treatment. For patients with active Lyme disease, the IDSA guidelines recommended 10e28-day antibiotic regimens using generic antibiotics that are no longer under patent protection.5 Although intended for use in North America, the recommendations are similar to those widely used in Europe.28 38 39 All guidelines should strive to recommend cost-effective therapies with treatment restricted to those who require it, and for a duration limited to that which is safe, effective and required based on scientific evidence. It is also unclear that insurance companies would necessarily benefit financially from these recommendations, as suggested by Johnson and Stricker.1

In fact, it could actually be less expensive for insurance companies routinely to approve treating patients with MUS with unnecessary and ineffectual antibiotic therapies, rather than incurring additional healthcare expenditures for diagnostic procedures to identify the patient’s actual problem and for appropriate treatment, including pain management and other symptomatic therapies if warranted. The concept of listing holdings in a health insurance company as a potential conflict of interest is not a standard practice. Nevertheless, to the best of our knowledge none of the 2006 IDSA panelists had a vested interest in any health insurance company.

By contrast, it is possible to imagine the repercussions of the IDSA Lyme disease guidelines on the economic wellbeing of some healthcare providers who specialise in ‘chronic Lyme disease’ and favour indefinite treatment. In addition to direct patient care services, these providers also have the opportunity to profit by providing intravenous treatment or from their associations with intravenous infusion companies.40 It has been reported that several ‘chronic Lyme disease’ healthcare providers were disciplined by their state medical boards for receiving payments or conspiring with intravenous infusion companies.40

One ‘chronic Lyme disease’ healthcare provider, who practises in a state in which Lyme disease is not endemic, is reported to have collected, in the year 2005 alone, US$6 million from a single health insurance company.40 The allegations of conflicts of interest against the IDSA panel resemble those made against the National Institutes of

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Health, the Food and Drug Administration and the CDC by the ‘chronic Lyme disease’ activist groups and their supporters in 2000. A complete and detailed investigation by the United States General Accounting Office found such allegations to be baseless.41e43

It is noteworthy that Blumenthal did not initiate an investigation of the International Lyme and Associated Diseases Society (ILADS), a Lyme disease activist organisation that published its own Lyme disease treatment guidelines.11 Johnson is currently Secretary of ILADS, and Stricker is a past president and co-author of the ILADS treatment guidelines. These guidelines, which were published in a supplement to a journal, did not undergo a peer review process by the journal.11 44 45 None of the ILADS guidlines authors disclosed any potential conflicts of interests whatsoever, including the individual who was chief executive of a laboratory that developed a non-standard diagnostic test for Lyme disease used by many in the ILADS physician community.34 Stricker is said to be treating approximately 1800 Lyme disease patients in his practice in San Francisco,46 a number all the more impressive when one considers that over the 10-year period between 1998 and 2007, only 951 cases of Lyme disease in total were reported to the CDC from the entire state of California.

Dr Stricker was previously found by the Office of Research Integrity at the National Institutes of Health to have falsified research data on the pathogenesis of thrombocytopaenia in HIV-infected patients.47 The paper describing the spurious results was published in the New England Journal of Medicine, but when the falsification was uncovered, it was retracted by an official from Stricker ’s university (now former university) and by all of its authorsdexcept for Stricker.48

CONCLUSIONS

Assaults on the IDSA and its Lyme disease guidelines panel appear to be the latest strategy to undermine an evidence-based approach for the diagnosis and treatment of Lyme disease. This is potentially risky for patients, ethically questionable, and contrary to the scientific evidence on which medical practice should be based.49 Importantly, treatment recommendations for Lyme disease offered by the IDSA in 2006 are consistent with those advocated by the American Academy of Pediatrics, the American College of Physicians, the Medical Letter and the American Academy of Neurology among other organisations, and are similar to those guidelines independently developed and widely used in Europe.27 28 38 39 In contradistinction, no

professional societies that we are aware of endorse the recommendations that supporters of ‘chronic Lyme disease’ espouse.11

It is the responsibility of all physicians and medical scientists to stand up to antiscientific, baseless and unethical attacks on those who support an evidence-based approach to caring for patients.

Acknowledgements The authors would like to thank Diana Olson, Lisa Giarratano and Lenise Banwarie for their assistance.

Competing interests PGA, JSB, RJD, JJH, JSD, RBN, SKS and GPW are members of the Infectious Diseases Society of America (IDSA) and JSB, RJD, JSD, JJH, RBN and GPW served on the 2006 IDSA Lyme disease guidelines panel. SOC and AW served as consultants to the 2006 IDSA panel. EM is a former Lyme disease programme officer at the National Institutes of Health.

Provenance and peer review Not commissioned; externally peer reviewed.

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