Lyme
disease debate provokes treatment divide, legal action
In
what may be a first, the government has taken steps to investigate
the drafting of medical guidelines.
By Susan J. Landers
AMNews staff
Dec. 25, 2006
Washington
-- Dueling guidelines developed by two medical organizations
for treating patients with Lyme disease have sparked such an
uproar that Connecticut's attorney general has stepped in to
see if one side ran afoul of antitrust statutes.
The Infectious
Diseases Society of America and the International Lyme and Associated
Diseases Society each assembled expert panels that sat down
separately and examined the evidence on the nature of and best
treatment for this tick-borne illness. But they arrived at different
conclusions.
IDSA, a
scientific organization of physicians, scientists and other
health care professionals who specialize in infectious diseases,
characterizes Lyme disease as primarily acute and treated successfully
in the vast majority of cases with, at most, a few weeks of
antibiotics. ILADS, which is a multidisciplinary medical society
focused on the diagnosis and treatment of Lyme disease, holds
out the possibility that the disease is chronic and may need
months of antibiotics.
The differing
conclusions call into question how best to treat the more than
20,000 people who contract the infection each year. Although
Lyme disease has been reported in nearly all states, most cases
are found in the Northeast, mid-Atlantic and North Central regions
of the nation. Left untreated, the infection can spread to joints,
the heart and the nervous system, according to the Centers for
Disease Control and Prevention.
It is not
unusual for different medical and scientific groups to take
varying clinical positions on specific conditions. But this
particular situation quickly has become far from typical.
The battle
over how to treat the infection grew so heated that, in Connecticut,
the state in which the disease was first recognized and named,
Attorney General Richard Blumenthal began an investigation in
mid-November. "We issued a subpoena to the IDSA because
its guidelines may severely constrict choices and legitimate
diagnosis and treatment options for patients," he said.
20,000
people contract Lyme disease each year.
Advocacy groups in the state and elsewhere had expressed outrage
over the IDSA guidelines and applauded Blumenthal's action.
"Clinical guidelines now drive the standard of care, and
these IDSA guidelines have already been published on the CDC
Web site," said Pat Smith, president of the Lyme Disease
Assn. The advocacy community contends that the guidelines deny
the existence of chronic Lyme disease and could lead to limits
on physicians' treatment options.
IDSA, which
notes that it is responding fully to the subpoena, believes
its guidelines are based on the best that science currently
has to offer. It was the association's development and Nov.
1 publication in Clinical Infectious Diseases of an updated
version of its guidelines that resulted in the current furor.
For its
part, ILADS finds the rival guidelines to be very restrictive
to the point of limiting treatment options and even excluding
certain treatments that have been used by physicians for years,
said the group's president, Raphael Stricker, MD.
What's
more, insurance companies may deny coverage of treatments not
supported by the infectious diseases society guidelines, said
Daniel Cameron, MD, MPH, who led the panel that developed ILADS'
guidelines.
These perspectives
have contributed to the guidelines' scrutiny.
"At
this stage, to debate the guidelines is a bit like debating
religion or science," said Paul Auwaerter, MD, clinical
director of Baltimore's Johns Hopkins School of Medicine's Division
of Infectious Diseases and a fan of the IDSA guidelines.
"I
don't think there is anyone in the middle," he noted. "I'm
sure both of us are right in some regards and wrong in other
regards. But that's always the case with medicine."
Gary Wormser,
MD, who led the IDSA team in the development of its guidelines,
pointed out that they are, after all, recommendations and, according
to a statement included on the document's first page, are not
intended to replace physician judgment.
"We
don't dispute that there are patients who had Lyme disease and
who continue to have symptoms, whatever the reason," he
said. "We think this illness is a real problem and definitely
needs more research and attention. But I think where we differ
is the idea of treating these individuals indefinitely with
antibiotics."
Antibiotic
overuse has been seen as a major contributor to the rising number
of infections that are resistant to these once-powerful weapons,
and the IDSA has been among those campaigning for their judicious
use.
ILADS supporters
point out that diseases such as tuberculosis are treated with
long-term antibiotic use and no one questions that treatment's
validity and effectiveness.
Although
a spectrum of opinions is not unusual in medicine, the issuing
of a subpoena is rare when it comes to guidelines. "We
have done other investigations of the health care industry,
but none, as far as I can recall, having to do with guidelines,"
Blumenthal said. His inquiry triggered a variety of responses
from those closely involved.
"While
I don't support in principle the government interfering with
medical affairs, I think in this situation, IDSA has so overstepped
its bounds and abused its power in promulgating these guidelines
that I think there is no other option," said ILADS' Dr.
Stricker.
The response
from Dr. Auwaerter, an IDSA guideline proponent: "My sense
is that [Blumenthal] won't find anything improper."
Dr. Cameron's:
"The attorney general's response is in reaction to the
frustrations patients are having with getting more attention
to the problems of chronic Lyme disease." Dr. Cameron,
who was the ILADS panel leader, and lives in Westchester County,
N.Y., coincidentally just a few miles from Dr. Wormser, pointed
to one study showing that significant numbers of Lyme patients
in his area had persistent symptoms.
In general,
guidelines continue to have a key place in physicians' toolkits
-- a likely reason why this debate has been so intense.
"There
is so much data out there that we rely on expert panels to review
available evidence and come up with recommendations," said
Dr. Auwaerter.
More than
1,800 guidelines are posted under the "disease/condition"
heading on the federal National Guideline Clearinghouse Web
site. Both IDSA and ILADS guidelines are there. The site gets
more than 100,000 visits each month, said Jean Slutsky, MSPH,
director of outcomes and evidence at the Agency for Healthcare
Research and Quality, the overseeing agency.
--------------------------------------------------------------------------------
ADDITIONAL
INFORMATION:
Treating Lyme disease
The National Institutes of Health has posted the following treatment
information on its MedlinePlus Web site for Lyme disease:
Antibiotics
are prescribed based on disease stages and manifestations. Doxycycline,
tetracycline, cefuroxime, ceftriaxone and penicillin are some
of the choices.
Anti-inflammatory medications, such as ibuprofen, are sometimes
prescribed to relieve joint stiffness.
If diagnosed in the early stages, the disease can be cured with
antibiotics. If left untreated, complications involving joints,
the heart and the nervous system can occur.
--------------------------------------------------------------------------------
Weblink
Centers for Disease Control and Prevention on diagnosis, treatment
and prevalence of lyme disease (www.cdc.gov/ncidod/dvbid/lyme)
National
Guideline Clearinghouse's list of Lyme disease guidelines, including
those of the International Lyme and Associated Diseases Society
and the Infectious Diseases Society of America (www.guideline.gov/search/searchresults.aspx?type=3&txtsearch=lyme&num=20)
Infectious
Diseases Society of America (www.idsociety.org)
International
Lyme and Associated Diseases Society (www.ilads.org)
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