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Controversies surround treatment of Lyme disease

IDSA and ILADS disagree on the optimal therapy for patients with Lyme disease

by Jay Lewis
IDN Managing Editor

December 2006

TORONTO – The duration of treatment for Lyme disease has become a somewhat divisive issue among physicians. Fueling this
controversy, two major medical associations – the Infectious Disease Society of America and the International Lyme and
Associated Diseases Society – have released diverging recommendations regarding the diagnosis and treatment of Lyme disease.

At the Infectious Disease Society of America’s (IDSA) 44th annual meeting, Raphael Stricker, MD, president of the
International Lyme and Associated Diseases Society (ILADS) and medical director of Union Square Medical Associates in San
Francisco, and Paul Auwaerter, MD, clinical director of the division of infectious diseases at Johns Hopkins University School of
Medicine in Baltimore, discussed the controversy regarding treatment for Lyme disease.

Difficult to diagnose

Stricker said he believes one factor adding to the Lyme disease controversy is that the disease can be difficult to diagnose. The
classical symptoms of Lyme disease, transmitted by tick bite, include a bullseye–shaped rash and swelling or pain in the

“The problem is that these classic features of Lyme disease are somewhat unreliable,” Stricker said. “Only 50%
to 60% of patients typically recall a tick bite; the rash is reported in only 35% to 60% of patients; joint swelling typically
occurs in only 20% to 30% of patients.” Stricker added that in some patients, joint swelling may be masked by
anti-inflammatory medication.

Stricker said many patients with Lyme disease will continue to experience a variety of symptoms, even after treatment. “Some
of these patients may go on to develop a syndrome of multiple, nonspecific symptoms, making it very difficult to diagnose and
treat as Lyme disease,” he said. “The question becomes: is this post-Lyme syndrome or a persistent infection?”

One reason for the difficulties in diagnosing Lyme disease is that Borrelia burgdorferi, the spirochete that is the
disease’s causative agent, has an unusual genetic makeup. This spirochete contains more than 1,500 gene sequences and has at
least 132 functioning genes. Due to the organism’s complex pathophysiology, it can evade the body’s immune system,
thus making it more difficult to eradicate.

According to Stricker, Borrelia burgdorferi invades multiple tissues and is able to assume a dormant state much like tuberculosis,
which can add to the diagnostic difficulties.

In addition to these complicating factors, laboratory testing for Lyme disease is flawed. “Lab testing is not very good for
the diagnosis of Lyme disease,” Stricker said. “Commercial testing has about a 90% specificity but only a 50% to 60%
sensitivity. This is too insensitive for a reliable diagnostic test.”

Extended therapy

In accordance with the position of ILADS, Stricker said he believes extended therapy for Lyme disease is sometimes necessary,
particularly in later disease that is more difficult to eradicate.

Stricker also noted that failure to respond to current Lyme disease treatments may be more common than many doctors realize.
“Culture-confirmed failure of antibiotic treatment was first reported in 1989,” he said. “Studies have shown
that Borrelia burgdorferi can persist after antibiotic treatment.”

This remains a particularly contentious issue and many in the medical community believe there is insufficient evidence to prove
the persistence of Borrelia burgdorferi after antibiotic treatment. But Stricker noted that several studies conducted in animals
– including mice, dogs and monkeys – indicate that the bacteria can persist after treatment is completed. Persistence
in humans has been confirmed by culture or molecular testing in at least 12 studies.

Stricker added that there is extensive clinical evidence supporting a longer duration of antibiotic therapy in treating chronic
Lyme disease. Studies from several teams of researchers indicated that a longer duration of treatment may be beneficial for some
patents with Lyme disease. “Prolonged antibiotic therapy appears to be useful and appropriate in persistent Lyme
disease,” Stricker said.

Science in this area is still evolving, according to Stricker. “We don’t have all the answers and it is too early to
adopt treatment strategies that assume we do. Meanwhile, doctors need flexible treatment approaches,” he said.

Tickborne coinfections may also be a problem and may exacerbate the symptoms of Lyme disease. “If a patient comes back in
follow-up and has symptoms that have persisted or symptoms that have gotten worse, it may be because they are coinfected,”
Stricker said. “Although these patients have been treated for Borrelia burgdorferi, they may have coinfection with babesia,
anaplasma, ehrlichia or bartonella.” He added that extended antibiotic therapy may help to treat these coinfections as well.
IDSA’s view

Concurring with the IDSA, Auwaerter said he disagrees that extended therapy is the best option for patients with Lyme disease.
“Long-term antibiotics are not in your patients’ best interest,” he said. “Prospective data do not suggest
a significant benefit from longer term courses of antibiotics in patients with Lyme disease.”

Auwaerter urged health care professionals to consult the new IDSA guidelines for treatment of Lyme disease, which were released in

In addition to offering recommendations for treatment of Lyme disease, the new guidelines attempt to clarify the disease.
Auwaerter said the controversy regarding Lyme disease treatment may be related to the lack of definitive data and confusing
terminology. For example, he said chronic Lyme disease should be called “Post Lyme Disease Syndrome.” The definition
of this is one of the most important additions to the new guidelines. Patients should be considered to have this syndrome if they
still have symptoms of Lyme disease after six months, defined by the CDC criteria; patients who had these symptoms prior to the
diagnosis of Lyme disease should be excluded. Post Lyme Disease Syndrome may be present if patients are still experiencing
symptoms such as fatigue, widespread musculoskeletal pain, cognitive problems and a significant reduction in functional status
after an appropriate antibiotic course.

“The subjective problems may be difficult to quantify, but the patient does not feel well and it is a marked difference from
the past,” Auwaerter said. However, he stated that even if patients have Post Lyme Disease Syndrome, longer-term therapy
with antibiotics may not offer a significant benefit.

A lack of evidence

Auwaerter said there is a lack of evidence to indicate that long-term antibiotic therapy will help to cure Lyme disease.
“Longer term therapy with antibiotics does not influence outcomes,” he said.

He noted one study by Klempner et al that examined 78 patients with Lyme disease; the average duration of symptoms of Lyme disease
was four years. The patients were randomized to treatment with either an antibiotic regimen or placebo. All patients had
well-documented Lyme disease and had already been treated with an initial therapy of antibiotics at baseline. After antibiotic
therapy of up to 180 days, the results were similar in both treatment groups. In both the placebo group and the antibiotic group,
one-third of patients improved, one-third stayed the same and one-third worsened; there was no statistical difference in outcomes
between groups.

A companion study examining cognitive functioning in 129 patients with Lyme disease indicated that although 70% of patients said
they had impaired neurocognitive functioning, tests showed no reduction in neurocognitive functioning. “The interesting part
was that the neurocognitive testing was normal in all patients,” Auwaerter said. “Although patients reported
neurocognitive problems, they performed well on tests.”

Auwaerter noted another study by Krupp et al that showed there was some reduction in fatigue in patients with Lyme disease after
six months of antibiotic therapy. “But this is only one subjective parameter and there was no change in any other primary
endpoint,” he said.

Auwaerter said he agrees with the new IDSA guidelines and urges doctors to avoid extended antibiotic therapy for patients with
Lyme disease. “We should treat patients on the basis of what we know, not on the basis of theory,” he said.
“Furthermore, for many patients, long term antibiotic therapy can have complications.”

Editor’s Note: The new IDSA Lyme Disease Guidelines have indeed proven to be contentious. Those of you who have followed the
IDSA News Clips since their release have been treated to a series of newspaper articles, mostly from areas of Lyme disease
endemicity, and seemingly initiated by unhappy patients. Phraseology applied to the Guidelines include words such as “object
strenuously,” “with great alarm,” “reckless,” “a travesty,” “outrageous,”
and on and on. Obviously, many patients who are desperate to believe they have Lyme Disease are unhappy because their beliefs have
not been validated in the Guidelines. Insurance reimbursement issues are playing a major role as well. The Connecticut Attorney
General’s office is investigating the IDSA Guideline Development process, and a bill is likely to be introduced into the
Massachusetts Legislature in the next term to prohibit the state medical board from disciplining physicians who prescribe
long-term antibiotics to patients with alleged chronic Lyme disease. So stay tuned, there’s more to come.

— Theodore C. Eickhoff, MD
Chief Medical Editor

For more information:
Stricker R, Auwaerter P. Controversies in Lyme disease diagnosis and treatment. Presented at: The 44th annual meeting of the
Infectious Disease Society of America; Oct. 12-15, 2006; Toronto.

*footnote: Canadian IDSA controlled magazine
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Postprzez Krętka » Czw Wrz 10, 2009 11:03 am

Lyme Wars: Lyme Disease Expert Critical of New Treatment Guidelines
Published on: November 28th, 2006 12:06am by:

Mount Kisco, NY (OPENPRESS) November 28, 2006 -- A nationally-recognized expert in the study and treatment of patients with
Lyme Disease, Dr. Daniel Cameron, a New York internist, epidemiologist and medical author, is criticizing the
recently-released Lyme treatment guidelines published by the Infectious Diseases Society of America (IDSA). He is not alone.
Other professional medical organizations and the Lyme Disease Association are vehemently questioning the new guidelines, and,
the Connecticut Attorney General has taken unprecendented legal action.

Cameron says, “The guidelines are based on flawed assumptions. The guidelines recommend against treating Lyme disease
patients more than once, possibly leaving them chronically ill.”

"The clinical assessment, treatment, and prevention of Lyme disease, human granulocytic anaplasmosis, and babesiosis: Clinical
practice guidelines by the Infectious Diseases Society of America (IDSA)," is co-authored by Dr. Gary Wormser, chief of the
division of infectious diseases at Westchester Medical Center and the affiliated New York Medical College in Valhalla, NY. The
last IDSA guidelines were published in 2000.

During his two decades in the Northeast, Cameron has seen Lyme as a growing epidemic locally and throughout the US. He has
seen the number of patients needing long-term treatment steadily increasing.

“It’s amazing to me that Dr. Wormser and I can be seeing patients from the same pool of people and have a totally
different take on this disease. I am truly concerned for the people of Westchester if someone associated with the
region’s academic medical center is turning their backs on the realities and complications of Lyme disease and other
tick-borne illnesses,” says Cameron.

The International Lyme and Associated Diseases Society (ILADS), of which Cameron is a board member, has called for a
retraction of the guidelines. Cameron is the lead author of ILADS’ "Evidence-based guidelines for the management of Lyme
disease," published in 2004.

Seen as another accepted standard of care for tick-borne disease, the ILADS guidelines call for long-term treatment with
antibiotic therapies for persistent Lyme disease or co-infection complications. According to ILADS, Lyme disease testing is
more often than not inaccurate and it is up to the doctor to make a clinical diagnosis. A clinical diagnosis is one based on
the physician’s evaluation of the patient, his symptoms, and knowledge of the disease.

The IDSA, on the other hand, says Lyme must be diagnosed by a visible rash and/or common two-tiered blood tests, is easily
treated with standard 21 to 28 days of antibiotics, and even questions the existence of chronic Lyme disease. Earlier
guidelines and the CDC stated that Lyme disease is a “clinical diagnosis,” supported by lab testing. The new IDSA
guidelines do an about face.

Cameron reminds his colleagues, “There is no test to measure the disease infecting a patient, only a measure of antibody
response which can be compromised by the action of the bacteria itself.”

Cameron has just published a paper refuting assumptions by one of the quoted references in the IDSA guidelines, and has had
another Lyme-related study accepted and about to be published by another peer-reviewed journal.
In "Generalizability in two clinical trials of Lyme disease" in the current issue of Epidemiologic Perspectives &
Innnovations. Cameron’s “Analytic Perspective” takes aim at a commonly-cited study on long-course treatment
of patients with Lyme disease. Simply known as “Klempner, et al. trials,” published in the New England Journal of
Medicine in 2001, this small study has been generalized in medical literature and certainly by insurance companies to be the
be-all proof that 12 weeks of antibiotics for sick patients does not help. Cameron pulls apart the science of the study, and
makes it clear that the study is not useful when dealing with a broader population.

His concern, like that of many of his colleagues, is that Guidelines published by America’s large professional
organizations are often seen by the medical community at large, by insurers and the Centers for Disease Control (CDC) of the
National Institutes of Health (NIH), as the final word on treatment. And the wording in this one leaves very little room for
the clinical diagnosis of the disease.

“The IDSA guidelines do not offer an answer for the thousands of individuals with Lyme disease left with a poor quality
of life after their 21 to 30 days of treatment,” says Cameron. “How can we, as scientists and physicians, turn our
backs on all the things we do not yet know about this complex emerging disease and its long-term affects on individuals and
our communities?”

Even if the blood tests were 100 percent accurate they cannot be performed on a patient for four to six weeks after onset
– which may cause a treatment delay and its possible consequences. That is another issue tackled in Cameron’s
work. His next article to be published has been accepted by the Journal of Evaluation in Clinical Practice. "Consequences of
Treatment Delay in Lyme Disease," a research letter, discusses “the poor outcome after treatment delay (of 4 wks to 8
yrs in his study group) supports the hypothesis that treatment delay is a major risk factor for developing chronic Lyme

Again, this study flies in the face of the IDSA guidelines.

Lyme Disease is America’s most common and fastest growing vector-borne disease. The spiral-shaped bacteria, Borrelia
burgdorferi (Bb), which causes Lyme Disease, can be spread by the bite of ticks carried by birds, deer, house pets and
rodents. It can be transmitted through human blood and from mother to child in utero. According to the CDC, “Typical
symptoms include fever, headache, fatigue, and a characteristic skin rash called erythema migrans. If left untreated,
infection can spread to joints, the heart, and the nervous system. Lyme disease is diagnosed based on symptoms, physical
findings (e.g., rash), and the possibility of exposure to infected ticks; laboratory testing is helpful in the later stages of
disease.” (

(It should be noted that human granulocytic anaplasmosis (HGA) was formerly known as human granulocytic ehrlichiosis (HGE) or
its common name, ehrlichiosis.)

Dr. Cameron is a member of the IDSA and ILADS, and is an attending physician at Northern Westchester Hospital, Mount Kisco,

For more information on Daniel Cameron, MD, please go to
Media contact: 914-238-7197
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