"IDSA's primary concern is for the health and safety of patients," said IDSA President Richard Whitley, MD.

SPECIAL REVIEW PANEL UNANIMOUSLY UPHOLDS LYME DISEASE TREATMENT GUIDELINES
Short-term Antibiotics Proven to be Best Treatment for Patients

Infectious Disease Society of America
News Release

Contact:
Diana Olson, (703) 299-0201, dolson@idsociety. org
John Heys, (703) 299-0412, jheys@idsociety. org
Gina Czark (312) 558-1770 Ext. 139, gczark@pcipr. com

April 22, 2010

Arlington, Virginia – A special Review Panel has unanimously agreed that
no changes need be made to the 2006 Lyme disease treatment guidelines developed by the Infectious Diseases Society of America (IDSA), the nation’s pre-eminent authority on infectious diseases.

The guidelines, voluntarily used by physicians to help them decide what
treatments are best and safest for patients, were the subject of an
antitrust investigation begun in 2006 by Connecticut Attorney General
Richard Blumenthal. Blumenthal examined whether the guidelines’ authors had conflicts of interest and failed to consider divergent medical
opinions. IDSA maintains those assertions were unfounded and, as part
of an agreement to end the Attorney General’s investigation, voluntarily
agreed to a one-time special review of the guidelines by an independent
scientific Review Panel whose members were certified to be free from any conflicts of interest by an independent ombudsman.

Lyme disease is caused by an infection with a type of bacterium called
Borrelia burgdorferi, which typically is transmitted by the deer tick.
Lyme disease often causes a red, circular rash and muscle and joint
aches. A short-course of oral antibiotics remains the standard treatment
for patients with Lyme disease, the most common tick-borne illness,
which first was discovered in Lyme, Conn.

At issue is the existence of a “chronic” form of Lyme disease and its
treatment with long-term antibiotics for months or years. This
controversial and costly treatment, which is typically delivered
intravenously through a catheter, is advocated by self-described “Lyme
literate” physicians.

“IDSA’s primary concern is for the health and safety of patients,” said
IDSA President Richard Whitley, MD. “Our goal is to ensure that patients
are given treatment that is safe, effective and supported by scientific
evidence. Allegations that the 2006 guidelines panelists stood to gain
from the recommendations are unfounded. In fact, one could argue the
opposite was true, because the panelists recommended short courses of
generic drugs.”

To ensure a fair and unbiased review of the 2006 guidelines, IDSA and
the Attorney General jointly selected an ombudsman, Howard Brody, MD, PhD, an author and respected medical ethicist at the University of Texas Medical Branch. Dr. Brody screened all potential Review Panel members for conflicts of interest using criteria jointly approved by the
Attorney General and IDSA. The Review Panel was comprised of nine
scientists and physicians from relevant disciplines who had not served
on any previous Lyme disease guidelines panel.

The Review Panel’s work took more than a year to complete, with the
group convening 16 times, including at an all-day public hearing in
Washington, D.C. More than 150 individuals or organizations submitted
evidence and other information including letters, newspaper articles,
patient medical records and other materials on Lyme disease and its
treatment.

“This was truly an extraordinary review process,” said Carol J. Baker,
MD, who chaired the Review Panel and is a pediatric infectious diseases
specialist at Baylor College of Medicine, Houston. “The final report
includes more than 1000 citations, and after thoughtfully and carefully
reviewing myriad materials, the panelists feel confident that advice to
physicians treating Lyme disease should remain the same as set forth in
the 2006 Lyme disease guidelines.”

The Review Panel concurred that all of the recommendations from the 2006
guidelines are medically and scientifically justified in light of the
evidence and information provided, including the recommendations that
are most contentious: that there is no convincing evidence for the
existence of chronic Lyme infection; and that long-term antibiotic
treatment of “chronic Lyme disease” is unproven and unwarranted.
Inappropriate use of antibiotics (especially given intravenously) has
been shown to lead to deadly blood infections, serious drug reactions
and C. difficile diarrhea, as well as the creation of
antibiotic-resistan t bacteria or “superbugs.”

As noted in the Review Panel report, “In the case of Lyme disease, there
has yet to be a single high quality clinical study that demonstrates
comparable benefit to prolonging antibiotic therapy beyond one month.”
The report also noted that “the inherent risks of long-term antibiotic
therapy were not justified by clinical benefit.”

At the request of the Attorney General, the Panel also reviewed a
statement in the guidelines’ executive summary concerning diagnostic
testing. The Panel was evenly split on whether the statement would
benefit from modification or clarification. In its final report, the
Panel offered this guidance to clinicians: “Symptoms that are commonly
attributed to chronic or persistent Lyme, such as arthralgias, fatigue,
and cognitive dysfunction, are seen in many other clinical conditions
and are, in fact, common in the general population…. It would thus be
clinically imprudent to make the diagnosis of Lyme disease using these
nonspecific findings alone.” On the other hand, the Panel said, “in
clinical practice, the presence of certain classic complications of Lyme
disease such as aseptic meningitis, AV nodal block, inflammatory
arthritis, and cranial or peripheral neuropathies, in a patient with
epidemiologic risk of Lyme disease and in whom alternative diagnoses
have been excluded or are unlikely, may be sufficiently convincing as to
constitute an exception to the statement in the Executive Summary.”

Dr. Whitley notes that, as per the Review Panel’s recommendation and
IDSA’s practice, IDSA will review the Lyme disease guidelines on a
regular basis to determine the need for updating based on any newly
available evidence that would warrant a change to the current
recommendations. Guidelines involve synthesizing the highest-quality
research available to guide physicians seeking to provide the best and
safest care for their patients. In addition to Lyme disease, the
Society authors treatment guidelines for more than 50 infectious
diseases and conditions, including HIV/AIDS, influenza, pneumonia, and
C. difficile.

“This special review validates the recommendations, which are again
proven to be based on the best science available,” said Dr. Whi
tley.
“Our number one concern is the patients we treat, and we’re glad
patients and their physicians now have additional reassurance that the
guidelines are medically sound.”

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The Infectious Diseases Society of America (IDSA) is an organization of
physicians, scientists, and other health care professionals dedicated to
promoting health through excellence in infectious diseases research,
education, patient care, prevention, and public health. The Society,
which has more than 9,000 members, was founded in 1963 and is based in
Arlington, Va.