Lyme
disease guidelines spark controversy
By Charlotte
LoBuono
Drug Topics
Jan. 22, 2007
Last fall,
the Infectious Diseases Society of America (IDSA) released updated
guidelines for the diagnosis and treatment of Lyme disease.
(See Drug Topics, Nov. 20, 2006, "Updated Lyme disease
guide clarifies confusion".) Approximately one month later,
Connecticut attorney general Richard Blumenthal issued a Civil
Investigative Demand (CID) to look into possible antitrust violations
by IDSA in connection with exclusionary conduct and monopolization
in the development of its Lyme disease guidelines.
Said Blumenthal,
"We are concerned about the potential anticompetitive implications
of guidelines that preclude certain forms of diagnosis and treatment,
particularly if they interfere with insurance coverage."
The national, nonprofit Lyme Disease Association (LDA) said
in a statement that it applauded Blumenthal for beginning an
investigation into IDSA's guidelines development process.
The LDA and the International
Lyme and Associated Diseases Society (ILADS) have also called
for a retraction of the IDSA guidelines. As Pat Smith, president
of the LDA, explained, "The IDSA guidelines are extremely
restrictive. They say that certain alternative treatments such
as intravenous immunoglobulin, certain antibiotics, and even
entire classes of antibiotics should not be used to treat Lyme
disease. The guidelines also do not recommend prolonged antibiotic
therapy. Well, these are the therapies that Lyme docs are using.
Patients often use alternative therapies in addition to their
regular antibiotic therapy."
Raphael Stricker,
M.D., president of ILADS and a practicing physician in San Francisco,
agreed, pointing out that the availability of a variety of treatment
options is necessary because "Lyme disease is a very complex
illness, and it is very difficult to treat, especially in the
chronic form.
"Pharmacists
need to consider that patients may need alternative treatments
that are very useful yet not recommended by IDSA," Stricker
said. "We have heard from patients who have taken their
prescriptions to the pharmacy, where they have been asked by
the pharmacist, 'Why did your doc prescribe this? The IDSA guidelines
do not recommend that drug,'" Stricker said.
The guidelines also
advocate the use of very narrow diagnostic criteria, Smith said.
She stated that "IDSA has said physicians must diagnose
Lyme disease based either on the presence of an Erythema migrans
lesion, which occurs in approximately 50% of patients, or positive
'2-step' serology—a positive ELISA followed by a positive
Western blot."
Smith estimated that
50% of patients with Lyme disease are not being diagnosed because
they do not meet these criteria. She mentioned that the criteria
are based on Centers for Disease Control & Prevention surveillance
criteria, which the CDC has said are to be used for surveillance
purposes only.
"So many patients
are not being expediently diagnosed and treated, which means
that they will likely go on to develop chronic disease, or those
who have been diagnosed with chronic disease may no longer be
able to get any kind of treatment," said Smith. She went
on to explain that, because clinical guidelines now drive the
standard of care in this country, they are being adopted by
insurance companies and state agencies, which cite them as the
reason for denying treatment. Even the CDC is promulgating them,
said Smith.
Contacted for comment,
an IDSA spokeswoman said that the organization is cooperating
fully with the Connecticut attorney general's investigation.
In addition, Gary Wormser, M.D., lead author of the IDSA guidelines,
said that "ILADS had plenty of opportunity for input. As
a matter of fact, Stricker was invited to address the IDSA annual
meeting to discuss why he disagreed with the guidelines."
As Wormser explained,
"We certainly considered Dr. Stricker's viewpoint. We even
mentioned in the guidelines that we considered long-term antibiotic
therapy as an option. When the IDSA first published Lyme disease
guidelines in 2000, we did not recommend prolonged antibiotic
therapy. Then between 2000 and 2006, several studies came out
to corroborate that long-term therapy was not beneficial in
treating Lyme disease, so we did not change our recommendation
at this time.
"By the way,"
said Wormser, who is also the chief of the division of infectious
disease and vice-chairman of the department of medicine at the
New York Medical College in Valhalla, "everything in this
document is subject to change when scientific data become available
that make it reasonable to amend the guidelines. If scientific
evidence comes out that XYZ is a good drug or is appropriate
for treating any aspect of Lyme disease, it will not be a problem
for us to recommend it. However, in the absence of scientific
data, or if the data are not credible upon review, we could
not possibly recommend it."
THE
AUTHOR is a clinical writer based in New Jersey.
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