LYMEPOLICYWONK: Congressmen Call For Removal of Outdated IDSA Guidelines from National Guideline Clearinghouse
On January 17, 2012, Congressmen Smith, Wolf, and Gibson called on the National Guidelines Clearinghouse (NGC) to remove the IDSA’s outdated Lyme guidelines. We applaud them! But, this, of course, is the middle of the story not the beginning, so let’s go back.
In early September, LymeDisease.org asked the IDSA whether it was in the process of reviewing its outdated guidelines. The IDSA merely referred us to their website, which said its guidelines were current and refused to provide any further information. We then contacted the NGC who told us they planned to continue listing the 2006 IDSA guidelines until 2015. We have been working behind the scenes with Lyme disease groups, including Time for Lyme, the International Lyme and Associated Diseases Society, the national Lyme Disease Association, and other patient groups and individuals, including David Roth to focus attention on this issue.
We have also been in communication with the IDSA and NGC since that time. Our last letter to the NGC on January 3rd, explained in detail how the continued posting of the IDSA guidelines violated the NGC’s own rules for listing outdated guidelines. After we sent our last letter, advocates began reaching out to legislators seeking their assistance in addressing this problem. Currently, we are awaiting a response from the NGC as to whether they will remove the IDSA guidelines from their site. We expect to hear from them shortly.
Why is this important?
Treatment guidelines are tremendously important in determining your medical treatment options. All important treatment guidelines are listed by the NGC. NGC requires that guidelines be updated every 5 years.
The IDSA has not revised its guidelines for more than 5 years. Nevertheless, the NGC recently permitted them to continue listing the guidelines without updating them because the IDSA guidelines had been reviewed in the antitrust hearing settlement hearing. This is wrong because:
1. The IDSA antitrust review panel was not empowered to revise the guidelines;
2. The IDSA antitrust review panel only had authority to review the guidelines for compliance with the legal standard set for them in the settlement agreement.
3. The IDSA antitrust review process recommended over 25 changes to the guidelines—none of which have been implemented. You might recall that there was a split vote on the settlement panel regarding whether lab testing should be mandatory for a diagnosis of Lyme disease.
4. The 2006 guidelines do not reflect new science including the Barthold mouse study and the Embers monkey study, both of which demonstrate persistent infection—a fact denied by the 2006 guidelines.
The IDSA guidelines result in patients being denied necessary care. They are used by insurers to deny patients reimbursement for care and by the IDSA as a club to drive out its competitors in unprofessional conduct actions.
We will keep you posted on this as more information becomes available and let you know what actions are needed. Meanwhile, a copy of the letter from Congressmen Smith, Wolf, and Gibson is set forth below.
January 18, 2012
Vivian H. Coates, MBA
Vice President, Information Services and Health Technology Assessment
5200 Butler Pike
Plymouth Meeting, PA 19462-1298
Dear Ms. Coates:
As your organization is currently contracted by the U.S. Department of Health and
Human Services’ Agency for Healthcare Research and Quality (AHRQ) to maintain the National
Guidelines Clearinghouse (NGC), we write to you as representatives of areas that have a large
and growing Lyme disease problem. Our constituents have again contacted us about an issue that
needs immediate attention to protect their welfare.
As you no doubt know, the Lyme disease guidelines of the Infectious Diseases Society of
America (IDS A) have been highly controversial and have been responsible for insurance
company denials of Lyme disease treatments. We have recently been informed that these
guidelines have been re-instated on the NGC Web site, notwithstanding the fact that they are
more than 5 years old and, hence, are no longer current. Our constituents are concerned that
these guidelines have not been subject to a complete review for currency and that the
methodology of any review has not been disclosed as required by the NGC’s guidelines.
Our understanding is that the recently re-submitted guidelines are based on the July 2010
Final Report of the Lyme Disease Review Panel of the Infectious Diseases Society of America,
which specifically was “not charged with updating or rewriting the 2006 Lyme disease
guidelines.” This aforementioned review panel was convened pursuant to an agreement between
the Connecticut Attorney General and the IDS A to end the Attorney General’s antitrust
investigation into the IDSA’s 2006 Lyme disease guidelines. The 2010 panel recommended
more than 25 revisions to the guidelines, which have not been addressed. We have been
presented with considerable evidence that the NGC process, which requires that guidelines be
reviewed for currency and disclosure of the methodology for the process, was not complied with
before reinstating the guidelines until 2015.
We urge you to follow NGC currency compliance procedure and remove the guidelines
until they have been fully reviewed and revised. The mission of the NGC is “to provide
physicians and other health professionals, health care providers, health plans, integrated delivery
systems, purchasers, and others an accessible mechanism for obtaining objective, detailed
information on clinical practice guidelines and to further their dissemination, implementation,
and use.” Only a careful and transparent procedure will remove the cloud that has hung over
Thank you for your serious consideration. We look forward to your reply.
CHRISTOPHER H. SMITH, Member of Congress
FRANK WOLF, Member of Congress
CHRIS GIBSON, Member of Congress