IDSA Advocates Science-based Approach to Lyme Disease
Chuck P Adams
IDSA recently opposed a Pennsylvania bill, H.B. 1534, which supports
long-term use of antibiotics for treatment of Lyme disease-an
approach that IDSA contends is "based on ill-informed assertions that
are not science-based." The Society has also weighed in on Lyme disease
bills that have been introduced in the U.S. Congress.
"Controlled clinical trials have shown no benefit from prolonged
antibiotic therapy for the treatment of Lyme disease," said IDSA
President Walter E. Stamm, MD, in a June 28 letter to Pennsylvania Gov.
Edward G. Rendell. "Not only does prolonged therapy cause unnecessary
patient discomfort, inconvenience, and expense, but most alarmingly, it
may be harmful."
IDSA's letter, which was shared with state lawmakers, explained that
prolonged therapy can cause problems not only for individual patients
but also for public health due to the consequences of antibiotic
resistance in the community. The Pennsylvania bill also would create a
state task force to investigate and make recommendations to the
Department of Health. Unfortunately, the bill proposes that the only
physician members of the task force come from the International Lyme
and Associated Diseases Society (ILADS), a group that advocates
long-term antibiotic therapy for Lyme disease.
IDSA's guidelines on Lyme disease call for treatment regimens ranging
from 14 to 28 days. ILADS contends that the duration of therapy should
be guided by "clinical response" and that it may be "reasonable to
continue treatment for several months after clinical and laboratory
abnormalities have begun to resolve and symptoms have disappeared."
According to IDSA, the evidence does not support the effectiveness of
such therapy. "Although patients sometimes report feeling better after
taking a drug long-term, that does not necessarily prove cause and
effect," said Gary Wormser, MD, lead author of IDSA's guidelines. "In
one clinical trial of long-term treatment for Lyme disease, almost 40
percent of the patients who received a placebo felt much better."
H.B. 1534 passed the Pennsylvania House, but it is not expected to be
taken up by the Senate. The Pennsylvania to be taken up by the Senate.
The Pennsylvania Department of Health wrote a letter to IDSA in
"complete agreement" with the Society's position.
Meanwhile, three Lyme disease bills have been introduced in Congress.
All three bills would authorize funding (between $10 million and $20
million) for research, education, and similar goals, and all three
would establish a federal advisory committee on tick-borne disorders.
One House bill mentions ILADS as an example of an organization that
would be represented on the advisory committee; however, it does not
preclude other groups. In addition, the bill calls for an Institute of
Medicine (IOM) study on "chronic" Lyme disease, including:
a systematic assessment of empirical evidence from treating physicians
and published peer-reviewed data
recommendations to address research gaps for diagnosis and treatment
an assessment and utilization of treatment guidelines including those
of IDSA and ILADS
In a recent letter to members of Congress, IDSA supported providing
additional funding for Lyme diseases research, as proposed in the House
and Senate bills. However, the Society stressed that such increases
must not come at the expense of other equally important areas of
infectious diseases research.
The Society also agreed to a scientific review of Lyme disease, as
proposed by the bills, but only if IOM conducts such review. The
Society said it does not support establishing an advisory committee
unless IOM deems it necessary. If Congress decides that an advisory
committee should be established through legislation, then IDSA would
like to see representation from established scientific groups that
support evidence-based medicine.
None of the federal bills is expected to move soon. However, IDSA staff
will continue to monitor the legislation and respond appropriately.
IDSA's Lyme disease treatment guidelines are available on our
website, www.idsociety.org, under "Practice Guidelines."
IDSA's letters to Congress and Gov. Rendell are available on the
"Policy & Advocacy" section of our website. Under "Policy Focus Areas,"
click on "Disease Prevention."
CDC, FDA Advise Caution on Lyme Disease Testing
Earlier this year, the Centers for Disease Control and Prevention (CDC)
and the Food and Drug Administration (FDA) issued a notice about
commercial laboratories that conduct testing for Lyme disease using
assays "whose accuracy and clinical usefulness have not been adequately
established." The tests cited by CDC and FDA include urine antigen
tests, immunofluorescent staining for cell wall-deficient forms of
Borrelia burgdorferi, the organism that causes Lyme disease, and
lymphocyte transformation tests. Some labs perform polymerase chain
reaction tests for B. burgdorferi DNA on specimens that CDC and FDA
consider inappropriate, such as blood and urine, or interpret Western
blots using criteria that have not been validated in the scientific
literature.
According to the notice, initial testing should use an enzyme
immunoassay (EIA) or immunofluorescent assay (IFA). Specimens that
yield positive or equivocal results should be tested further by using a
standardized Western immunoblot assay. Specimens that are negative by a
sensitive EIA or IFA do not need further testing. For more information,
see MMWR 2005;54:125
(http://www.cdc.gov/mmwr/preview/mmwrhtml/mm5405a6.htm).
pm...@direcway.com
Insurance companies work hand-in-hand with IDSA to ensure that cost
containment is achieved and that the costs associated with untreated,
chronic, persistent Lyme disease are borne by public agencies (i.e. the
taxpayer) rather than their own shareholders. People with chronic LD
often are denied coverage for expensive treatments. Their appeals are
successful only 13% of the time in state-mandated independent reviews,
compared to a 49% success rate related to other diseases. Second
opinions are often routed to ID specialists, who are less likely to
approve long-term treatments (29% vs. 55% for internal medicine
specialists approve treatments of more than 6 months). [This
information is from the Special Insurance issue of the LymeTimes,
#39/40, available from CALDA.]
IDSA guidelines authors benefit from this cozy arrangement since they
have patents on test kits and vaccines; they serve on peer review
panels for prestigious journals and so control the research that can be
published; and they serve as paid consultants for insurance companies,
denying treatment to people with chronic, persistent, Lyme disease.
The IDSA follows restrictive diagnostic guidelines that exclude many
people with Lyme disease. This practice leads to many more cases of
untreated, chronic, persistent Lyme disease that may be diagnosed as
some other disease like fibromyalgia, chronic fatigue syndrome, etc.
and result in longterm, expensive disability, pain and suffering.
Standard therapy for late-diagnosed Lyme results in a 15-20% treatment
failure rate, according to the mainstream peer reviewed literature. The
pain and disability of people with chronic Lyme disease is comparable
to that of people with congestive heart failure. Therfore it is
understandable that patients in the short-term treatment failure group
will seek out doctors who are willing to treat them more aggressively,
especially if short term treatment had some success but symptoms
returned when it was stopped.
When more than one standard of care exists, the critical question is
who decides the appropriate course of treatment for the patient. Under
the medical ethical principle of autonomy, the treatment decision
belongs to the patient. The American Medical Association requires that
the physician disclose and discuss with the patient not only the risks
and benefits of the proposed treatment, but also the risks and benefits
of available alternative treatments (regardless of their cost or the
extent to which the treatment options are covered by health insurance).
Antibiotics are the only effective form of treatment for chronic,
persistent Lyme disease. Although some physicians believe that symptoms
which persist in chronic Lyme after short-term treatment reflect an
autoimmune response without active infection, there are no studies
supporting this hypothesis. Only 20% of medicine practiced today is
supported by double-blind studies. This includes the medicine practiced
by the IDSA.
In summary, IDSA is compromised by its members' financial ties to the
insurance industry, test kits and patents. Following IDSA treatment
guidelines results in an unacceptably high treatment failure rate. IDSA
selects evidence that supports its position and ignores evidence that
supports alternative views. Patients are entitled to have information
about all available treatment options and to make their own choice.
Newsgroup Leader Kathleen ActionLyme
In the right navigation bar, you can see the crimes committed by Gary
Wormser.
Kathleen