The Lyme Disease Controversy
Camp A & Camp B
By Lucy Barnes
People who have been stricken with Lyme disease are not only faced with a serious infectious disease, they may easily become distressed over the political predicament they are facing when attempting to find treatment.
Little did they know that once they were bitten by a tiny infected tick, they would be bitten a second time by a group of practitioners who once swore an oath to 'first do no harm'.
Since day one a controversy has been brewing in the world of Lyme, pitting doctors against doctors, labs against labs and insurance companies against anyone they may have to reimburse.
Lyme patients have literally been hung out to dry by this group of so-called professionals and left without proper testing, a definitive diagnosis or a successful treatment protocol.
A patient who falls prey to a doctor on the wrong side of the Lyme fence eventually learns these so-called healers do not have the patient’s best interest at heart. Everything is stacked against them.
Instead, they have learned some doctors are being lead around by the nose and are following whoever happens to be signing their paychecks at any given point in time.
A dwindling group of these callous medical professionals are causing growing number of patients to become chronically ill and disabled by ignoring obvious Lyme symptoms, disputing test results from experienced labs and suggesting or prescribing drugs to try to mask symptoms as opposed to addressing Lyme as what it is- an active infectious disease of the worst kind.
These doctors have been quick to talk the talk to any unsuspecting passer-by or colleague, but not walk the walk with their patients down the road to recovery. Concrete evidence and tons of it continue to surface, proving these dinosaurs' original theories are obsolete; however, they still stick by their guns in an attempt to save their declining reputations and almighty pocket books.
As the talkers (Camp A) cut corners and devise new schemes to prevent going down with their ship, the front-line physicians (Camp B) who are actually treating patients are saddled with increasing numbers of extremely ill people who shouldn’t have ended up in that leaky Camp A boat.
For the sake of the almighty dollar Camp A's floundering medical misfits have allowed the Lyme controversy to exist and drag on for over 30 years with support from the Centers for Diseases Control (CDC).
While patients needlessly suffer Camp A dismisses and actively attacks any scientific research that contradicts their original asinine conclusions. Aditionally, Czamp A proactively fights any legislation designed to improve the situation for patients for fear it would eventually sully their names and expose their wrong doings.
In spite of the growing numbers of reported Lyme cases, Camp A keeps singing the same old tune that Lyme disease is, "over diagnosed and over treated". They have concluded that if someone is bitten by a deer tick they should just "wait and see" if the organisms disseminate and cause a multitude of symptoms before addressing the spreading infection.
Camp A ignores or dismisses research that has proven the Lyme spirochetes can travel to the spinal fluid within hours, and as we all know time is of the essence if treatment is to have a chance. They oppose any studies indicating spirochetes can be viable after short term (inadequate) treatment because they think the spirochetes shouldn’t be.
Camp A still insists Lyme patients must prove they were bitten by a deer tick bite, have a typical "bulls-eye rash" and must have two positive blood tests before Lyme can be considered a possibility. Research has shown that less than 50 percent of patients with Lyme recall a tick bite and less than 50 percent of adults develop a rash (less than 10 percent of children have a rash).
The standard lab tests promoted by Camp A, often ones they have financial interests in, miss as many as 80 percent of those who are infected and are notorious for providing inaccurate results.
Members of Camp A blatantly ignore warnings issued by the CDC, FDA, International Lyme and Associated Diseases Society, Lyme Disease Association and many other prominent organizations that agree a negative test should never be used to rule out Lyme disease.
Camp A insists Lyme disease, a systemic infection that can attack multiple organs or systems at random, fit into a nice neat box and conform to antiquated lab standards that were made up over a decade ago. Then, they claim, and only then, should Lyme disease be considered a possible cause for investigation.
Camp A also falsely claims patients who remain ill or relapse after short-term treatment must not have had Lyme disease and were originally misdiagnosed. These patients, many who not only have acute or chronic Lyme, but one or more active tick borne co-infections are often told they are faking it or malingering and are ordered to go back to their normal routines, seek mental health counseling, and/or get more exercise.
Increasing numbers of physically sick patients are prescribed psychiatric drugs and are told to accept the fact that nothing is wrong with them. To compound patients problems, many have been ordered to endure a multitude of invasive tests intended to rule out an obvious case of Lyme, which leave the patients with a know-nothing, do-nothing diagnosis of ABLS (Anything But Lyme Syndrome).
As time progresses and the smoldering infections accelerate, ABLS patients are often misdiagnosed with chronic fatigue syndrome, ALS, MS, arthritis, depression, fibromyalgia, lupus or a combination of various conditions, instead of the true tick borne infections that remain active in their brains and throughout their bodies.
~Early days of “Lime arthritis” ~
Camp A first speculated that antibiotics would not work on patients with Lyme disease because it was a virus. Therefore, they recommend no treatment and as a result patients were expected to recover on their own. This plan obviously did not work and crippled many adults and children along the way.
In the meantime, concerned front line physicians caring for a growing number of Lyme patients discovered they could successfully treat Lyme patients with antibiotics. They quickly realized something was wrong with the original "virus" theory and that Lyme MUST be caused by a bacterial infection. They were right!
Camp A, now walking about with egg on their face for wrongly declaring Lyme was a virus that needed no treatment, dilly-dallied about until they were eventually forced to jump over the bodies they left in their wake and onto a new bandwagon to declare, "oh yes, a short course of antibiotics would cure Lyme disease".
However, as some of the sicker Lyme patients began returning to doctor’s waiting rooms when Camp A's short term treatment protocols failed, retreatment or longer courses of antibiotics were proven by front line doctors to help these patients recover.
After facing more and more criticism, and after a good deal of foot dragging was done to prevent change, Camp A was eventually forced to admit they too were successful when retreating patients who remained ill and it might be necessary in some cases.
During this time Camp A's wavering and ineffectual theories and protocols adversely affected thousands of patients and their families. In turn, many suffered from long-term chronic Lyme and additional tick borne infections that resulted in permanent damage and even death.
In desperation, patients searched world wide for skilled physicians who would help them properly address their ongoing infections.
To help people who were suffering and to distinguish a doctor who was knowledgeable about treating Lyme, patients began telling others to see what they referred to as a "LLMD". (Lyme Literate MD)
As the number of reported Lyme cases increased and patients began seeing positive results with extended treatment, Camp A came under fire from newly formed volunteer Lyme organizations and front-line physicians who had scientific proof Lyme organisms could survive after short-term treatment.
The mounting evidence concluded long-term treatment resulted in more successful outcomes for many patients. LLMD's said that it was not only necessary to treat the chronically ill, but it was the humane thing to do.
A handful of people at the CDC with vested interests in the outcomes (patents, etc.) strongly disagreed and fought as if their lives depended on it against sick patients having access to better tests and recieving additional treatment.
The Infectious Diseases Society of America (IDSA) and CDC, aka Camp A, actively fought sick patients, their doctors and the Lyme patients in a most vile way for decades, and still do.
Camp A doctors fussed like crazy and dug in their heels even more while physicians treating patients outside the IDSAs limited "box" had success and had proven them wrong again. Unfortunately, the good news- that patients could improve with longer courses of treatment- apparently fell on the deaf ears of Camp A members. Or, as many suspect, they had something to hide.
It wasn't until Camp A discovered more money could be funneled their way by developing a vaccine to prevent Lyme that they actually changed their tune and shockingly admitted Lyme was indeed a devastating and debilitating illness!
Camp A’s sudden flip-flop saw them abandoning their original claims of Lyme being "no big deal". The CDC hung close on their coat tails too, with dreams of financial gains dancing in their heads.
Their research into the chronic phases of Lyme lent credence to the actual truth, which they documented extensively and then widely promoted in order to stir fear in people so they would insist on getting a vaccine that Camp A promoted as something to save the world from this horrible disease.
In preparation for the vaccines release, television and newspaper advertisements began promoting Camp A's latest cash cow, and what was once an unknown rare disease suddenly became a household word.
Camp A, no doubt with an eye on their precious bank accounts, also found time to register Lyme-related patents and promote their newly developed lab tests with their CDC buddies egging them forward.
As Camp A raced to the patent offices to claim their prize money, they were also sucking down available research money to use to pad the medical journals with their detailed reports about the unremitting consequences and serious nature of Lyme disease.
Finally, feeling like they were back on top of the Lyme world, they convinced major university hospitals, and unsuspecting physicians to promote their vaccine too.
Little did they realize their apple cart was preparing to topple once again.
After reports of serious problems surfaced, the FDA issued warnings and cautioned physicians and the public not to rely solely on the Lyme tests as a diagnostic tool. To make matters worse, the new vaccine once thought to be Camp A's ticket to fame and fortune quickly blew up in their faces after 1,000 plus adverse event reports (complaints) were filed with the FDA in less than two years.
The failed lab tests and the failed vaccine, which many in Camp A considered to be their proverbial ship coming in, suddenly sank. Legal actions and multiple lawsuits threatened Camp A's reputation and livelihood.
As panic set in and the sparks began to fly over money, positions, job benefits and stocks there was a serious parting of the ways between some of Camp A's good old boys network. Things got so bad they were actually suing each other!
One after another, Camp A associates put their tails between their legs to scatter near and far while back in the kitchen the Lyme fires were burning out of control.
Sick and disabled Lyme patients, realizing they had been subjected to the worst of the worst in medical care, were filing complaints and initiating legal actions against Camp A doctors and their brown-nosing insurance companies.
Many patients had become permanently disabled or had lost family members as a result of Camp A's response to their illness and quest for the almighty dollar. Patients believed the very ones they had trusted and paid dearly to help them regain their health, had knowingly caused them irreversible harm.
Some Camp A members were accused of failing to diagnose or properly treat serious infectious diseases and the courts agreed.
Compensation in the millions of dollars was awarded to disabled victims. Attorneys, on behalf of patients who died or who had reported serious complications from the vaccine also filed lawsuits against Camp A members.
Floating up the creek without a paddle, Camp A was forced, once again, to flip-flop their position in an attempt to save their rear ends.
They initiated the "cover your rump” campaign complete with PR firms that shouted to anyone who would listen, true or not, that Lyme was, once again, over diagnosed and over treated and no big deal. Having backed themselves in a proverbial corner, they tried desperately to convince the public that patients suffered more from "Lyme anxiety" instead of a serious infectious disease that could disable or kill them.
Members of Camp A pulled all the stops and waged a full blown war on the very patients they were suppose to be helping. They became consumed and obsessed with accomplishing their mission.
Camp A tried to convince everyone that positive tests for Lyme were often false positives (rather than false-negatives) and labs, other than their own, that specialized in detecting tick borne diseases were faulty for one reason or another.
They continued bedding down with insurance companies who were delighted to discuss any dollar saving tactics that were hidden up the sleeves of Camp A members.
Camp A doctors went so far as to claim that people with Lyme disease were not actively infected and often not physically ill, but instead they suffered from a variety of undiagnosed mental disorders. One notable mental disorder- one Camp A invented for their own purposes and tried to make "official" (and failed) - was called "antibiotic seeking behavior".
While the war against patients raged on, insurance companies snuck in the back door and developed rules with Camp A’s literature as the basis for their policies. With the assistance from the CDC/IDSA, insurers could reduce the length of time (and money) needed to treat patients.
Insurers were thrilled, while patients suffered even more.
Camp A spent their spare time applying for more research money and spent time in court testifying against sick Lyme patients and the doctors brave enough to treat them. Camp A members were quick to brag when they “screwed over” a patient in court, and awarded themselves extra brownie points when they also burned the patient’s treating physician in the process.
Some, who obviously had high opinions of themselves and too much time on their hands, volunteered to testify in hearings against front line physicians who were successfully treating chronically ill Lyme patients. No extra-curricular activity it seemed was too bothersome to go out of their way for if it succeeded in discrediting Lyme-treating physicians who were gaining respect and were successful in the public's eye.
In order to try and regain credibility, Camp A doctors also granted press interviews and sparked a miniature media frenzy around themselves. To insure only their views concerning Lyme would be taken seriously, leaders on the Camp A bandwagon declared Camp A doctors actually needed bodyguards to protect themselves from crazed Lyme patients who didn't really have Lyme, but some sort of mental illness.
Literature coming from Camp A at this point once again promoted the false notion that the treatment time required to cure Lyme should be shortened dramatically and because of that unsubstantiated theory, their new best friends in the insurance industries placed them high on their pedestals.
In another attempt to try to boost their credibility, Camp A members published additional medical papers using themselves and their own literature to support their own faulty, biased theories.
As the self-promotion of Camp A doctors and their theories became totally unbearable, hundreds of chronically sick and disabled patients from across the county gathered together and peacefully protested Camp A meetings.
Adding insult to injury for Camp A, some of Camp B's leading tick borne disease specialists walked out of an international conference in NY city in protest, claiming a Camp A conference was spewing nothing more than “hog wash”. (Decades later they still haven't been invited back.)
Camp A's most recently published articles falsely claim that only ONE dose of Doxycycline is needed to cure Lyme disease. And oh what a magical pill it must be, indeed.
Perhaps if Camp A continues on their stroll backwards through time, lessening the supposed need for adequate treatment each year, those with a tick bite may soon be able to click their heels together and wish away a serious tick borne infectious disease.
Considering the fact Lyme disease currently costs society over a billion dollars a year and can ultimately destroy the lives of hundreds of thousands of people, Camp A's magic pill theory should be considered a true miracle or as it truely is, a total disaster.
In the meantime...
Camp B disagrees wholeheartedly with Camp A on many points. Camp B knows through personal experience, clinical experience and scientific research that Lyme disease can be a complicated and complex infectious disease that destroys lives and at the least requires prompt, intense and aggressive treatment in order to have a better chance at a successful outcome.
With so many people originally following the misguided lead of Camp A doctors and becoming chronically ill, Lyme disease advocates and their educational messages are being shared on websites.
Camp B's sites receive millions of hits each month from patients in need of assistance. Hundreds of new Lyme disease support groups have formed across the country out of desperation and the leaders report being overwhelmed by the growing numbers of terribly ill patients they see who have been booted out of Camp A offices while still actively infected with tick borne diseases.
Telephone hot lines dedicated to providing information for people with Lyme disease respond to over hundreds of thousands of calls a year and membership in Lyme organizations continues to increase.
As the public demands to know more, numerous articles and books have been published on how to deal with Lyme disease and co-infections. While Camp A sticks to their guns and sucks up available grant money to support their antiquated notions, private volunteer non-profit groups across the country are holding dinners, dances, walk-a-thon's and other fund raisers to try to educate and support the public.
While patients are donating money from their own pockets to advance Lyme disease research and education, Camp A health departments across the country are spending billions of dollars each year on unimportant projects like how many fruits and vegetables individuals consume in a year’s time.
Camp B physicians on the front lines are increasingly overwhelmed with the number of new cases of tick borne disease patients. Many people come to the LLMD's offices already severely and chronically ill after following the outdated protocols and recommendations from Camp A that the CDC continues to support.
As the infection within the patients take a stronger hold, they are suffering and dying from a disease still reported to be "easily cured and easily treated" by Camp A profiteers.
Unfortunately, most of us are or know people in Camp B who have suffered from tick borne illnesses.
Documented research over the past twenty five years, along with biopsy and autopsy reports, countless medical documents and bacteria cultured from patients tissues after treatment have proven beyond a doubt that Lyme is a complex infection that can remain active and very destructive even after treatment.
Additionally, we know the Lyme picture may be complicated by other known or unknown tick borne infections. Yet, Camp A continues to promote flawed reasoning and failed protocols with no allowance for those who are not cured using their insurance friendly methods.
Members of Camp B have learned the hard way that Lyme is not "over diagnosed, over treated, or easily cured" and patients who were ill for many months or even years actually do improve once they have a proper diagnosis and proper treatment.
For their efforts, Camp B’s front-line physicians are under continual pressure and direct attack for treating patients with chronic Lyme disease. They are ridiculed by Camp A, investigated by medical boards, denied the ability to accept insurance and are threatened with losing their license if they treat patients above and beyond Camp A’s wishes.
So why do Camp A doctors still refuse to diagnose or treat a serious debilitating infectious disease, or test for and treat co-infections that may be complicating the Lyme disease picture? It doesn’t make sense to countless sick people who find themselves stumbling out of Camp A offices looking and praying for help from someone.
The answer is simple, but shameful.
One reason is that some Camp A members haven’t kept abreast of or are ignoring years of medical research and documentation that overwhelmingly proves the original theories from Camp A wrong. Many doctors simply think they know better and refuse to actually listen to their own patients, continually dismissing complaints of ongoing symptoms.
Another reason is that Camp A doctors are in fear of losing their medical licenses and livelihoods if they don't stick to their guns and continue to support their original BIG mistakes. In fact, some of the most successful lawsuits against doctors have been for NOT properly diagnosing and treating Lyme disease.
Lastly, insurance companies lose money when treating chronically ill Lyme patients. We all know that situation can hurt a number of powerful pocket books.
Why should you be concerned about this situation?
There are increasing numbers of chronically ill and disabled children and adults still stumbling out of Camp A's offices and realizing the treatment they were provided didn’t work.
These sick patients also see many of their neighbors losing the battle with Lyme after years of pain and suffering. They have witnessed Camp B physicians who care for them being harassed, ridiculed and shut down, one after the other.
The madness must stop.
If Camp A were right, there wouldn't be a Camp B.
Why Can't I Get Diagnosed and Treated?
Patients continue to ask why they are unable to find doctors who can accurately diagnose and adequately treat them for Lyme and tick borne diseases. The authors listed below and Ad Hoc Group members have been promoting the theory that sick Lyme disease patients should not be treated with more than a minimal amount of antibiotics, stating basically there is no such thing as "chronic Lyme disease". They theorize that the symptoms patients experience after receiving the IDSA's recommended course of "cost-effective" antibiotics is simply the "aches and pains of daily living", nothing more.
The individuals listed below have promoted the idea that not providing access to antibiotic treatment and many other treatments for chronically ill Lyme patients is best for them (drug side effects) and for society in general (to prevent resistance). Some are members of the Infectious Diseases Society (IDSA) and/or the American Lyme Disease Foundation (ALDF). Others are staunch supporters of the IDSA and/or the ALDF and its theories.
If you were exposed to Lyme disease and are still sick, or you relapse after your initial treatment, some or all of these people's theories may be partially responsible for your inability to receive additional antibiotic treatment.
"Chronic Lyme disease, which is equated with chronic B. burgdorferi infection,
is a misnomer, and the use of prolonged, dangerous, and
expensive antibiotic treatments for it is not warranted."
Henry M. Feder, Jr., M.D., Barbara J.B. Johnson, Ph.D., Susan O'Connell, M.D., Eugene D. Shapiro, M.D., Allen C. Steere, M.D., Gary P. Wormser, M.D., and the Ad Hoc International Lyme Disease Group. The following members of the Ad Hoc International Lyme Disease Group were also authors: Gundersen Lutheran Medical Foundation, La Crosse, WI — W.A. Agger; National Microbiology Laboratory, Health Canada, Winnipeg, MB, Canada — H. Artsob; Johns Hopkins Medical Institutions, Baltimore — P. Auwaerter, J.S. Dumler; St. Luke's Hospital, Duluth, MN — J.S.Bakken; Yale University School of Medicine, New Haven, CT — L.K. Bockenstedt, J.Green; New York Medical College, Valhalla — R.J. Dattwyler, J. Munoz, R.B.Nadelman, I. Schwartz; Danbury Hospital, Danbury, CT — T. Draper; Johns Hopkins Medical Institutions, Crofton, MD — E. McSweegan; Atlantic Neuroscience Institute, Summit, NJ, and the New York University School of Medicine, New York — J.J.Halperin; Boston University School of Medicine and Boston Medical Center, Boston — M.S. Klempner; University of Connecticut School of Medicine and Connecticut Children's Medical Center, Farmington — P.J. Krause; Centers for Disease Control and Prevention, Fort Collins, CO — P. Mead; University of British Columbia, Vancouver, Canada —M. Morshed; University of Medicine and Dentistry of New Jersey–Robert Wood Johnson Medical School, Piscataway — R. Porwancher; University of ConnecticutHealth Center, Farmington — J.D. Radolf; Maine Medical Center, Portland, ME — R.P. Smith, Jr.; Schneider Children's Hospital at North Shore, Manhasset, NY — S. Sood; Washington Hospital Center and Georgetown University Medical Center, Washington, DC — A. Weinstein; Wadsworth Center, New York State Department of Health, Albany — S.J. Wong; and Connecticut Children's Medical Center, University of Connecticut, Hartford — L. Zemel.
A Critical Appraisal of "Chronic Lyme Disease"
Henry M. Feder, Jr., M.D., Barbara J.B. Johnson, Ph.D., Susan O'Connell, M.D., Eugene D. Shapiro, M.D., Allen C. Steere, M.D., Gary P. Wormser, M.D., and the Ad Hoc International Lyme Disease Group
Lyme disease, the most common tick-borne infection in the northern hemisphere, is a serious public health problem. In North America, it is caused exclusively by Borrelia burgdorferi sensu stricto (hereafter referred to as B. burgdorferi), whereas in Europe it is caused by B. afzelii, B. garinii, B. burgdorferi, and occasionally by other species of borrelia.1
This complex infection has a number of objective manifestations, including a characteristic skin lesion called erythema migrans (the most common presentation of early Lyme disease), certain neurologic and cardiac manifestations, and pauciarticular arthritis (the most common presentation of late Lyme disease), all of which usually respond well to conventional antibiotic therapy.2 Despite resolution of the objective manifestations of infection after antibiotic treatment, a minority of patients have fatigue,musculoskeletal pain, difficulties with concentration or short-term memory, or all of these symptoms. In this article, we refer to these usually mild and self-limiting subjective symptoms as "post–Lyme disease symptoms," and if they last longer than 6 months, we call them "post–Lyme disease syndrome."
The word "chronic" has been applied to Lyme disease in a wide variety of contexts and is sometimes used interchangeably withthe preferred term "late Lyme disease." For example, in Europe, certain late neurologic manifestations of previously untreated or inadequately treated infection, such as borrelial encephalomyelitis or long-standing meningitis, have been referred to as "chronicneuroborreliosis" (Table 1).1,2,3 In the United States, reports have described untreated patients with recurrent or persistent arthritis that lasts for up to several years, presumably because of active infection.4 The focus of this review, however, is not the objective manifestations of late Lyme disease but rather the imprecisely defined condition referred to as "chronic Lyme disease." This term is used by a small number of practitioners (often self-designated as "Lyme-literate physicians") to describe patients whom they believe have persistent B. burgdorferi infection,a condition they suggest requires long-term antibiotic treatment and may even be incurable.5 Although chronic Lyme disease clearly encompasses post–Lyme disease syndrome, it also includes a broad array of illnesses or symptom complexes for which there is no reproducible or convincing scientific evidence of any relationship to B. burgdorferi infection. Chronic Lyme disease is used in North America and increasingly in Europe as a diagnosis for patients with persistent pain, neurocognitive symptoms, fatigue, or all of these symptoms, with or without clinical or serologic evidence of previous early or late Lyme disease.
View this table:
Table 1. Selected Late or Long-Term Manifestations of Borrelia burgdorferi Infection.
Chronic Lyme Disease
The diagnosis of chronic Lyme disease and its treatment differ substantively from the diagnosis and treatment of recognized infectious diseases. The diagnosis is often based solely on clinical judgment rather than on well-defined clinical criteria and validated laboratory studies, and it is often made regardless of whether patients have been in areas where Lyme disease is endemic.6,7 Although proponents of the chronic Lyme disease diagnosis believe that patients are persistently infected with B. burgdorferi, they do not require objective clinical or laboratory evidence of infection as a diagnostic criterion.5,8,9,10
Several lines of reasoning are used to provide support for this diagnostic rationale. One is the unproven and very improbable assumption that chronic B. burgdorferi infection can occur in the absence of antibodies against B. burgdorferi in serum (Table 2). Negative results of serologic tests are often attributed toprevious antibiotic therapy or to the theory that chronic infection with B. burgdorferi suppresses humoral immune responses; neither theory is well supported by scientific data.12,13,14 When physicians who diagnose chronic Lyme disease obtain laboratory tests to provide support for their diagnoses, they often rely heavily on "Lyme specialty laboratories." Such laboratories may perform unvalidated in-house tests that are not regulated by the Food and Drug Administration, or they may perform standard serologic tests interpreted with the use of criteria that are not evidence-based.11,12,15,16,17
View this table:
Table 2. Laboratory Diagnosis of Lyme Disease and Chronic Lyme Disease in North America.
Once the diagnosis of chronic Lyme disease is made, patients are commonly treated for months to years with multiple antimicrobial agents, some of which are inactive in vitro against B. burgdorferi.2,5,18,19,20 Antibiotics may be prescribed either simultaneously or sequentially, and they are often administered parenterally. Occasionally, these patients are treated with unconventional and highly dangerous methods such as bismuth injections or deliberate inoculation of plasmodia to cause malaria.2,21,22 No other spirochetal infection, including the neurologic complications of tertiary syphilis, is managed in an analogous fashion.2,23 The duration of treatment commonly prescribed for chronic Lyme disease often far surpasses even the conventional 6-month course of therapy successfully used for most cases of tuberculosis.
Categories of Chronic Lyme Disease
Diagnoses of chronic Lyme disease appear to fall predominantly into one of four categories (Figure 1).8,9,10 Patients with category 1 disease do not have objective clinical manifestations or laboratory evidence of B. burgdorferi infection, and they receive a diagnosis on the basis of the presence of nonspecificsymptoms such as fatigue, night sweats, sore throat, swollen glands, stiff neck, arthralgia, myalgia, palpitations, abdominal pain, nausea, diarrhea, sleep disturbance, poor concentration, irritability, depression, back pain, headache, and dizziness.5 Nonspecific symptoms such as these are common, and some occur in more than 10% of the general population, regardless of whether Lyme disease is endemic in the area.24,25
View larger version (13K):
Figure 1. The Four Predominant Categories of Disease Associated with Chronic Lyme Disease.
Only patients with category 4 disease have post–Lyme disease symptoms.
Patients with category 2 disease have identifiable illnesses or syndromes other than Lyme disease. Such patients may or may not have a history of Lyme disease. They have received either a misdiagnosis or a diagnosis (e.g., multiple sclerosis) that they are reluctant to accept and have sought an alternativediagnosis from a physician willing to treat them for chronic Lyme disease.
Data from studies of patients who underwent reevaluation at academic medical centers suggest that the majority of patients presumed to have chronic Lyme disease have category 1 or 2 disease.8,9,10 Since patients in these two categories do not have evidence of active infection with B. burgdorferi, the potential benefit of treating them with antibiotics, beyond a placebo effect, would be attributable to the antiinflammatory or other nonantimicrobial effects of antibiotics.26 Antibiotic therapy in these patients is not warranted.
Patients with category 3 disease do not have a history of objective clinical findings that are consistent with Lyme disease, but their serum samples contain antibodies against B. burgdorferi, as determined by means of standardized assays that were ordered to investigate chronic, subjective symptoms of unknown cause.27 Patients with disease in this category have at most only equivocal evidence of B. burgdorferi infection, since the predictive value of positive serologic results in this setting is low.27,28 Although some clinicians would offer patients with category 3 disease an empirical trial of 2 to 4 weeks of an oral antibiotic, such patients should be told that the diagnosis is uncertain and that a benefit from treatment is unlikely.
Patients with category 4 disease have symptoms associated with post–Lyme disease syndrome.29,30,31 In prospective studies of patients with erythema migrans, subjective symptoms of unknown cause were present 1 year or more after treatment in 0.5 to 13.1% of patients.31 Whether this prevalence exceeds that of such symptoms in the general population is unknown, since none of these studies included a control group. A meta-analysis suggested that the prevalence of such symptoms exceeded that in control groups without Lyme disease, but this analysis relied on several retrospective studies in which the diagnosis and treatment of Lyme disease often did not meet current standards.30,31
Treatment of Post–Lyme Disease Symptoms
Controlled treatment trials have been conducted only for patients with category 4 disease. Data from three double-blind, randomized, placebo-controlled trials have shown that there is substantial risk, with little or no benefit, associated with additional antibiotic treatment for patients who have long-standing subjective symptoms after appropriate initial treatment for an episode of Lyme disease.32,33,34
One of these trials enrolled 78 patients who were seropositive for antibodies against B. burgdorferi at trial entry; a second trial enrolled 51 patients who were seronegative.32 All patients had antecedent objective signs of Lyme disease, most often physician-diagnosed erythema migrans. Patients were treated either with a 1-month course of ceftriaxone administered intravenously, followed by 2 months of doxycycline given orally, or with identical-appearingintravenous and then oral placebos. Patients were assessed at enrollment and 3 months after completion of treatment with the use of the Medical Outcomes Study 36-item Short-Form General Health Survey (SF-36). There were no significant differences in the scores between the patients in the antibiotic and placebo groups.
In a single-center trial conducted by Krupp et al., 55 patients with severe fatigue (as measured by an 11-item questionnaire) after treatment of well-documented Lyme disease underwent randomization to receive ceftriaxone or an identical-appearing placebo for 28 days.33 The investigators reported a reduction in scores for fatigue severity in the ceftriaxone group that exceeded the reduction in the placebo group by 13 percentage points (i.e., a reduction of 22% vs. 9%; P=0.01) but no significant improvement in cognitive function. There was no significant difference between the groups with regard to the degree of improvement in reported health status on the basis of the SF-36 score. Patients in the ceftriaxone group were significantly more likely than thosein the placebo group to identify their treatment assignment correctly at the end of therapy, raising a concern that masking was compromised and that a placebo effect may explain the greater improvement in scores for fatigue severity in the treated group.33
Antibiotic therapy can cause considerable harm to patients treated for chronic Lyme disease or post–Lyme disease symptoms.2 Life-threatening anaphylaxis33 and biliary complications requiring cholecystectomy35 have occurred after ceftriaxone administration. Candidemia from infection of an intravenous catheter has resulted in death.36 In an unpublished study in which 37 patients underwent randomization to receive 10 weeks of treatment with either ceftriaxone or placebo, about one fifth of the patients had serious adverse events, the majority of which were related to intravenous catheters.37 In light of the risk of serious adverse events in their study, Krupp et al. concluded that "repeated courses of antibiotic treatment are not indicated for persistent symptoms following Lyme disease, including those related to fatigue and cognitive dysfunction."33
Eligibility criteria for two controlled trials stipulated that symptoms must be severe enough to interfere with the patient's ability to function.32 Thus, the physical health status of the patients enrolled in these two studies was equivalent to that of patients with congestive heart failure or osteoarthritis.32 This finding was preordained by the study design, but it has been incorrectly interpreted by some to indicate that patients with post–Lyme disease symptoms typically are severely disabled.
The investigators who conducted the controlled treatment trials had great difficulty finding patients who met the criteria for entry, despite intensive efforts that included both the notification and involvement of Lyme disease support groups and associations.32,33 For two of the three studies, additional sites had to be engaged,32 and the enrollment period had to be extended for all three studies.32,33 To enroll 55 patients in one of the studies, investigators had to screen more than 500 people, most of whom were excluded because of the absence of a substantiated history of Lyme disease.33 This difficulty with enrollment appears to reflect the scarcity of persons with well-documented Lyme disease in whom clinically significant problems develop after conventional treatment.
Although anecdotal evidence and findings from uncontrolled studies have been used to provide support for long-term treatment of chronic Lyme disease,18,19,20 a response to treatment alone is neither a reliable indicator that the diagnosis is accurate nor proof of an antimicrobial effect of treatment. Many patients with intermittent or self-limited symptoms may feel better over time as a result of the natural course of their condition, and controlled trials indicate that nearly 40% of patients with post–Lyme disease symptoms have a positive response to placebo.32 In addition, the assessment of a change in symptoms may be confounded by antiinflammatory and other nonantimicrobial effects of antibiotics.26 Furthermore, the published reports of uncontrolled trials of antibiotic treatment for chronic Lyme disease used poorly standardized case definitions and either undefined criteria for interpreting immunoblots or criteria that have subsequently been found to have very low specificity (approximately 60%).38
Persistent B. burgdorferi Infection and Post–Lyme Disease Symptoms
A report by Phillips and colleagues39 is often cited to provide support for the hypothesis of persistent B. burgdorferi infection. They indicated that they detected B. burgdorferi in blood specimens from 43 of 47 patients who had received or were receiving prolonged antibiotic therapy for chronic Lyme disease (91%). Other investigators have been unable to reproduce these findings in patients with well-documented post–Lyme disease syndrome.32,40,41,42Moreover, Phillips and colleagues used a new culture medium that specifically included Detroit tap water; this medium was subsequently shown to be bactericidal for B. burgdorferi.41 In contrast to the findings from their report,39 B. burgdorferi could not be detected in any of 843 specimens of blood or cerebrospinal fluid, tested by means of either culture or polymerase chain reaction (PCR), from the 129 patients enrolled in two of the controlled treatment trials.32,40 Moreover, there was no serologic evidence of tick-borne coinfections in the vast majority of patients.32
In another report, DNA of B. burgdorferi was detected by means of PCR in urine specimens from nearly three quarters of 97 patients who had received the diagnosis of chronic Lyme disease.43 However, the authors did not sequence the amplicons to confirm that the DNA was from B. burgdorferi. Such a high rate of positive results among patients who had been treated extensively with antibiotics is unlikely when one considers that only 1 of 12 urine samples(8%) from untreated patients with erythema migrans was found to be positive in a careful evaluation of this technique's value as a diagnostic test.44Moreover, detection of bacterial DNA is not necessarily an indicator of either active infection or clinical disease.45 The central question is not whether a fewspirochetes might persist after antibiotic treatment, but whether clinical disease can be attributed to their presence.
It is highly unlikely that post–Lyme disease syndrome is a consequence of occult infection of the central nervous system. This conclusion is based on evidence such as the absence of inflammation in the cerebrospinal fluid,32,33 negative results of both cultures and PCR assays for B. burgdorferi in the cerebrospinal fluid,32,40 the absence of structural abnormalities of the brain parenchyma,46 and normal neurologic function, with no effect of antibiotic therapy (as compared with placebo) on cognitive function.33,34
Additional evidence against the hypothesis that chronic symptoms are due to persistent infection is the fact that antibodies against B. burgdorferi in many of these patients are undetectable, which is inconsistent with the well-established immunogenicity of the spirochete's lipoproteins.13,14,20,29,32,47 Patients in whom treatment for most infectious diseases, including syphilis, has failed typically have persistent or rising titers of antibodies because of ongoing B-cell stimulation by microbial antigens.23
The lack of convincing evidence for the persistence of B. burgdorferi in treated patients (Table 3) is not surprising.2,20,23,24,29,30,31,32,33,40,47,48,49 The failure of treatment for bacterial infections typically occurs as a result of pathogens that either have or acquire resistance to antibiotics, difficulties in achieving sufficient concentrations of antibiotic at sites of infection, or impaired host-defense mechanisms.2 None of these factors are generally applicable to infection with B. burgdorferi. Although B. burgdorferi can develop into cystlike forms in vitro under certain conditions that can be created in the laboratory,50 there is no evidence that this phenomenon has any clinical relevance. B. burgdorferi may penetrate cells in vitro, but there is no evidence that the organism may be sheltered from antibiotics during an intracellular phase and then disseminate and cause clinical relapse.51,52 Indeed, the strategies used by B. burgdorferi to adapt to the vertebrate host and evade host defenses indicate an extracellular existence.53
View this table:
Table 3. Evidence against Active Infection in Patients with Subjective Symptoms Persisting for More Than 6 Months after Antibiotic Treatment for Lyme Disease.
Advice to Clinicians
How should clinicians handle the referral of symptomatic patients who are purported to have chronic Lyme disease? The scientific evidence against the concept of chronic Lyme disease should be discussed and the patient should be advised about the risks of unnecessary antibiotic therapy. The patient should be thoroughly evaluated for medical conditions that could explain the symptoms. If a diagnosis for which there is a specific treatment cannot be made, the goal should be to provide emotional support and management of pain, fatigue, or other symptoms as required.54,55,56 Explaining that there is no medication, such as an antibiotic, to cure the condition is one of the most difficult aspects of caring for such patients. Nevertheless, failure to do so in clear and empathetic language leaves the patient susceptible to those who would offer unproven and potentially dangerous therapies. Additional advice to clinicians is included in the Supplementary Appendix, available with the full text of this article at www.nejm.org.
Chronic Lyme Disease in the Public Domain
Physicians and laypeople who believe in the existence of chronic Lyme disease have formed societies, created charitable foundations, started numerous support groups (even in locations in which B. burgdorferi infection is not endemic), and developed their own management guidelines.5 Scientists who challenge the notion of chronic Lyme disease have been criticized severely.
The attorney general of Connecticut has begun an unprecedented antitrust investigation of the Infectious Diseases Society of America, which issued treatment guidelines for Lyme disease that do not support open-ended antibiotic treatment regimens.2 In some states, legislation has been proposed to require insurance companies to pay for prolonged intravenous therapy to treat chronic Lyme disease. The media frequently disregard complex scientific data in favor of testimonials about patients suffering from purported chronic Lyme disease and may even question the competence of clinicians who are reluctant to diagnose chronic Lyme disease. All these factors have contributed to a great deal of public confusion with little appreciation of the serious harm caused to many patients who have received a misdiagnosis and have been inappropriately treated.
Chronic Lyme disease is the latest in a series of syndromes that have been postulated in an attempt to attribute medically unexplained symptoms to particular infections. Other examples that have now lost credibility are "chronic candida syndrome" and "chronic Epstein–Barr virus infection."57,58 The assumption that chronic, subjective symptoms are caused by persistent infection with B. burgdorferi is not supported by carefully conducted laboratory studies or by controlled treatment trials. Chronic Lyme disease, which is equated with chronic B. burgdorferi infection, is a misnomer, and the use of prolonged, dangerous, and expensive antibiotic treatments for it is not warranted.2
Dr. Feder reports receiving lecture fees from Merck and serving as an expert witness in medical-malpractice cases related to Lyme disease. Dr. Johnson reports holding patents on diagnostic antigens for Lyme disease. Dr. O'Connell reports serving as an expert witness related to Lyme disease issues in civil and criminal cases in England. Dr. Shapiro reports serving as an expert witness in medical-malpractice cases related to Lyme disease, reviewing claims of disability related to Lyme disease for Metropolitan Life Insurance Company, and receiving speaker's fees from Merck and Sanofi-Aventis. Dr. Steere reports receiving a research grant from Viramed and fees from Novartis. Dr. Wormser reports receiving research grants related to Lyme disease from Immunetics, Bio-Rad, and Biopeptides and education grants from Merck and AstraZeneca to New York Medical College for visiting lecturers for infectious-disease grand rounds, being part owner of Diaspex (a company that is now inactive with no products or services), owning equity in Abbott, serving as an expert witness in a medical-malpractice case, and being retained in other medical-malpractice cases involving Lyme disease. He maybecome a consultant to Biopeptides. No other potential conflict of interest relevant to this article was reported.
The findings and conclusions in this article are those of the authors and do not necessarily represent the views of the Centers for Disease Control and Prevention.
We thank Alex P. Butensky, Julie Chacko, Rachel Hart, and Lisa Giarratano for assistance.
* Other members of the Ad Hoc International Lyme Disease Group who were authors are listed in the Appendix
From the Departments of Family Medicine and Pediatrics, Connecticut Children's Medical Center, Hartford, and University of Connecticut Health Center, Farmington (H.M.F.); Microbiology Laboratory, Division of Vector-Borne Infectious Diseases, Centers for Diseases Control and Prevention, Fort Collins, CO (B.J.B.J.); Lyme Borreliosis Unit, Health Protection Agency Microbiology Laboratory, Southampton General Hospital, Southampton, United Kingdom (S.O.); Departments of Pediatrics and Epidemiology and Public Health, Yale University School of Medicine, New Haven, CT (E.D.S.); Division of Rheumatology, Allergy and Immunology, Massachusetts General Hospital, Harvard Medical School, Boston (A.C.S.); and the Division of Infectious Diseases, Department of Medicine, New York Medical College, Valhalla (G.P.W.)
Address reprint requests to Dr. Feder at the Departments of Family Medicine and Pediatrics, University of Connecticut Health Center, Farmington, CT 06030, or at firstname.lastname@example.org.
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- Rauter C, Mueller M, Diterich I, et al. Critical evaluation of urine-based PCR assay for diagnosis of Lyme borreliosis. Clin Diagn Lab Immunol 2005;12:910-917. [CrossRef][Medline]
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The following members of the Ad Hoc International Lyme Disease Group were also authors: Gundersen Lutheran Medical Foundation, La Crosse, WI — W.A. Agger; National Microbiology Laboratory, Health Canada, Winnipeg, MB, Canada — H. Artsob; Johns Hopkins Medical Institutions, Baltimore — P. Auwaerter, J.S. Dumler; St. Luke's Hospital, Duluth, MN — J.S. Bakken; Yale University School of Medicine, New Haven, CT — L.K. Bockenstedt, J. Green; New York Medical College, Valhalla — R.J. Dattwyler, J. Munoz, R.B. Nadelman, I. Schwartz; Danbury Hospital, Danbury, CT — T. Draper; Johns Hopkins Medical Institutions, Crofton, MD — E. McSweegan; Atlantic Neuroscience Institute, Summit, NJ, and the New York University School of Medicine, New York — J.J. Halperin; Boston University School of Medicine and Boston Medical Center, Boston — M.S. Klempner; University of Connecticut School of Medicine and Connecticut Children's Medical Center, Farmington — P.J. Krause; Centers for Disease Control and Prevention, Fort Collins, CO — P. Mead; University of British Columbia, Vancouver, Canada —M. Morshed; University of Medicine and Dentistry of New Jersey–Robert Wood Johnson Medical School, Piscataway — R. Porwancher; University of ConnecticutHealth Center, Farmington — J.D. Radolf; Maine Medical Center, Portland, ME — R.P. Smith, Jr.; Schneider Children's Hospital at North Shore, Manhasset, NY — S. Sood; Washington Hospital Center and Georgetown University Medical Center, Washington, DC — A. Weinstein; Wadsworth Center, New York State Department of Health, Albany — S.J. Wong; and Connecticut Children's Medical Center, University of Connecticut, Hartford — L. Zemel.
Mayer L., Merz S., Maloney E. L., Holmes K. D., Volkman D. J., Cameron D. J., Drapkin M. S., Feder H. M. Jr., the Ad Hoc International Lyme Disease Group
N Engl J Med 2008; 358:428-431, Jan 24, 2008. Correspondence
Are They Working Against Lyme Patients and
Those Helping Them?
U.S. DEPARTMENT OF HEALTH AND HUMAN SERVICES
PUBLIC HEALTH SERVICE
CENTERS FOR DISEASE CONTROL AND PREVENTION
National Center for Infectious Diseases
Board of Scientific Counselors
Minutes of Meeting
May 12 and 13, 2005
The second topic of discussion among members of the breakout group is Lyme disease --- particularly the challenges presented by this disease that extend beyond science.
Recently, highly organized groups of people have been expressing concern for CDC’s current case definition and laboratory criteria. Much of this effort has been triggered by unpaid insurance claims from patients with symptoms that are not included in CDC’s case definition for Lyme disease.
In addition to these vocal organized groups, laboratories across the country are conducting inappropriate, or questionable, testing for Lyme. The tests are being sent to physicians who have not been appropriately trained to interpret them.
The breakout group issued the following recommendations for DVBID regarding these Lyme-disease-associated issues.
• The IDSA guidelines should be updated; a consensus document should be made available to physicians who need guidance.
• The CDC guidelines for interpreting laboratory tests should be updated in collaboration with industry and government experts.
• As updated guidance becomes available, an effort should be made to notify physicians and other practitioners regarding availability of clinical and laboratory documents.
• CDC researchers should focus on science and not on the concerns of patient groups; other groups may need to step in and assist DVBID with public interface.
• Dr. Lemon reiterated that the building should be completed sooner rather than later. He asked Dr. Petersen to provide the Board with a business plan to be used to develop recommendations. Dr. Petersen informed him that a business plan is being developed but is not yet available.
• Dr. Neill expressed the need for more detailed information regarding build-out of the phase I “shell” facility before the Board can support the completion of the laboratory building. Dr. Schuchat noted that NCID believes the build out of the facility is important; however, funding is lacking. The agency is not pushing HHS for additional funding at this time.
• Dr. Eberhart stated that inappropriate laboratory testing and treatment are occurring in many states. Commonalities throughout the states should be identified. Dr. Quinlisk concurred; she receives e-mails from constituents asking why the state health department does not agree with their private doctors. Many of these constituents can not be convinced by science; therefore, accurate information should be distributed to clinicians.
• Dr. Stamm commented that rogue guidelines are legitimizing long-term treatment for chronic Lyme disease; as long as these guidelines can be accessed, this type of treatment can be legitimized.
• The breakout group also discussed the concept of “breaking down the walls” between different CDC organizations. The group members would like CCID and NCID leadership to review the proposed organization for viral and rickettsial diseases and consider aligning these subject areas with vectorborne infectious diseases. Doing so may reduce redundancy.
Dr. LeDuc commented that aligning programs can present logistical problems, as some activities are better placed at the Ft. Collins campus, whereas others function better in Atlanta.
• The issue of emerging vectorborne diseases was raised. These diseases should be recognized in the bioterrorism arena, along with other natural agents that could become a substantial public health threat within the United States. Resources should be appropriately allocated.
• Dr. LeDuc added that NCID recognizes the need for new policy guidelines regarding transplantation. Recently, rabies has been transmitted from organ donors to their recipients. A policy for tracking this type of transmission must be defined.
Dr. Granger expressed appreciation to the Board for including USDA in its discussions. USDA is interested in tickborne diseases, particularly because these diseases cause disease in cattle. The agency is examining tick collections and is trying to isolate agents at a Ft. Collins facility. This presents an excellent opportunity for synergy between USDA and CDC’s DVRD. USDA and CDC have a different focus on achieving the same mission; collaboration could be beneficial to both agencies. Dr. Lemon concurred that the agencies should work together --- such a collaboration could help link animal and human health.
Is the CDC Ignoring Their Mission? You decide...
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Health and Human Services Mission:
Baltimore Sun Editorial
Missing the mark
November 30, 2006
Lyme patients - many of them afflicted with debilitating ailments that began with the bite of a tiny tick - have traveled from Maryland and a dozen other states to a medical center in Valhalla, N.Y., where today they will demand that the Infectious Diseases Society of America retract medical treatment guidelines it released last month. Lyme disease sufferers experience headaches, fatigue, chills, fever and, in advanced cases, heart and nervous system problems. The last thing they needed was to have their pains burdened additionally by a segment of the medical community that by recommending against long-term antibiotic use essentially threatens to reduce the quality of care they receive.
Maryland averages about 17 reported cases of Lyme disease per 1,000 residents, ranking it seventh in the country. Most of the cases can be found on the Eastern Shore, where not only are infected ticks plentiful, but Lyme disease education is promoted aggressively by volunteer health-service activists who also happen to be Lyme patients.
The illness is easily misdiagnosed and frequently undertreated. Lyme patients have no shortage of horror stories about how their early symptoms were casually dismissed as arthritis, a lack of sleep and proper diet or, even worse, an emotional disorder, before they found a sympathetic physician who finally pinpointed the problem and prescribed antibiotics. In too many cases, the prognosis came late and the patient had to accept living with the disease.
The most contentious piece of the new IDSA guidelines is a claim that long-term use of antibiotics is not a remedy and that they should not be prescribed beyond initial preventive doses. Lyme patients and their doctors are understandably shocked by this assertion. Their own experiences tell them differently. And though adherence to the guidelines is voluntary, the implications are that insurance companies and HMOs will refuse to pay for further antibiotic treatment and that doctors, even against their better judgment, will stop prescribing for fear of being brought up before medical boards.
Maryland's Lyme-literate physicians and their patients would have had some protection against the IDSA guidelines had a prescient bill addressing this issue made it through the state legislature in 2005. By the time the bill came up for a final vote, it was so watered down in favor of the insurance industry that even its original backers sanctioned its demise.
On the matter of helping Lyme patients cope with the disease, the IDSA - like the 2005 legislature - missed the mark by a mile.