10
The Lyme Times
Guidelines Process Remains Flawed
Despite the antitrust investigation, IDSA priorities remain unchanged: revenues, reputation
and reduced liability
By Lorraine Johnson, JD, MBA
Restrictions contained within the Infectious Diseases Society
of America (IDSA) Lyme treatment guidelines continue to leave
patients sick and without treatment options. Treatment failure
rates under their guidelines are unacceptably high — as much as
40% for early Lyme and exceeding 65% for late Lyme.
Insurance companies rely on the IDSA guidelines to deny
reimbursement for patient care. Under its first set of guidelines
published in 2000, doctors who did not comply were subject to
unprofessional conduct actions. Insurance companies denied
patients reimbursement for essential treatment, and patients
could not find physicians willing to treat them.
In 2005, the IDSA seated
a panel to revise their Lyme
treatment guidelines. A number
of physicians with divergent
viewpoints, including some
members of the IDSA, applied
for a seat on the panel, but were
told that the panel was full,
even though other panelists
whose views aligned with IDSA
viewpoints were later seated on
the panel. Although the guidelines
purport to be “evidence-based,”
most of the recommendations
in the guidelines are based solely
on the “expert opinion” of panel
members. Many of those members
had extensive commercial conflicts of interest.
Connecticut AG antitrust investigation
When the 2006 IDSA guidelines were released,
LymeDisease.
org
(previously CALDA) spearheaded a national effort with other
advocacy groups, including the national Lyme Disease Association
(LDA) and the Connecticut-based Time for Lyme (now Global
Lyme Alliance). Focusing on antitrust law as a vehicle to address
the restrictive guidelines, the groups approached the Attorney
General of Connecticut, Richard Blumenthal, who responded by
launching an antitrust investigation.
Following an extensive investigation, the Attorney General
released his findings in May 2008. Among his conclusions
he found: the panel chair ‘‘handpick[ed] a like-minded panel
without scrutiny by or formal approval of the IDSA’s oversight
committee.” Panel members also had financial interests ‘‘in drug
companies, Lyme disease diagnostic tests, patents and consulting
arrangements with insurance companies’’
Settlement review process
As part of the mandated settlement, the IDSA agreed to review
its guidelines with a panel free from conflicts of interest. While the
IDSA called the review process “voluntary,” the AG noted that the
IDSA “effectively admitted the flaws by agreeing to a review and
reassessment of its 2006 guidelines by a conflicts-free panel.” The
panel was not independent, however, and the review process was
not impartial. The IDSA selected the panel and ran the process,
having an interest in preserving its reputation and shielding itself
from potential legal liability arising from flawed guidelines.
Manipulated process
Process irregularities were rampant. The settlement agreement
forbade individuals who had previously written Lyme guidelines
from sitting on the panel. Nevertheless, the IDSA selected two
panel members who had authored previous Lyme guidelines: Dr.
Weinstein and Dr. Baker. Dr.
Weinstein was removed from
the panel under patient protest,
but Dr. Baker remained as
the panel Chair despite the
violation and despite the fact
that she had previously served
as IDSA president. Physicians
who treat chronic Lyme disease,
including members of the
IDSA, applied for the review
panel and were summarily
rejected. As a result, the review
panel was essentially stacked in
favor of upholding the existing
guidelines. Potential panel
members were reviewed for
conflicts of interest by an ethicist who, although chosen jointly by
the Attorney General and the IDSA, was paid by the IDSA .
On July 30, 2009, the panel heard presentations from those
opposing and those supporting the guidelines. Evidence submitted
to the panel by the International Lyme and Associated Diseases
Society (ILADS) included more than 300 pages of analysis and
roughly 1,300 peer-reviewed research studies opposing the
recommendations in the guidelines.
In the end, the panel — stacked by the IDSA to achieve an
intended result — did not comply with the voting process required
in the settlement agreement. The violation was spotted by the AG’s
office, which was monitoring the minutes of the process.
IDSA Report
On April 22, 2010, the review panel released its report. Despite
the voluminous testimony presented by ILADS, the panel voted
almost unanimously to uphold all guidelines recommendations.
A particularly important vote — about whether lab tests were
required for diagnosis of Lyme disease — ended in a tie. The panel
side stepped the implications of the vote, however, by claiming
that the lab test requirement was not a “recommendation” subject
to the agreement. The AG's office announced that it would