January 28, 2012
To: Virginia Department of Health Agencies and Governor Bob McDonnell
We would like to alert you to the fact the Infectious Diseases Society of America (IDSA) Lyme Disease Guidelines have not been properly reviewed or updated since they were originally published in 2006. Medical guidelines are considered expired by many health care organizations after five years on the market.
In order to remain on the market guidelines must undergo a rigorous review and be updated to reflect new science, a process that has not been accomplished by the IDSA in regards to their Lyme disease guidelines before re-submitting them to the National Guideline Clearinghouse (NGC).
Additionally, the guidelines do not include any of the twenty plus changes recommended by the IDSA's own review panel – a panel assembled as part of an anti-trust settlement with the CT Attorney General, Richard Blumenthal (2008). To note- the IDSA’s anti-trust review panel was specifically NOT empowered to revise or update the 2006 IDSA Lyme disease guidelines.
Any other reviews the IDSA may have performed since the original publication date have not been in compliance with their own internal guideline policies on Grading of Recommendations, Assessment, Development and Evaluation (GRADE), nor with policies set forth by the Agency for Healthcare Research and Quality (AHRQ), American Medical Association, American Association of Health Plans, National Guideline Clearinghouse (NGC), the Department of Health and Human Services (DHHS), nor those of the National Institutes of Medicine (IOM).
IDSA’s Lyme disease guidelines originally cited 405 references, all pre-dating 2006, with a large percentage of the articles/opinions created by the authors and their associates. Today, the 405 references reflect less than 1% of the available scientific and medical literature on ticks and the multiple diseases they carry. This reason alone is sufficient to not recommend them for use in any capacity.
If changes were made today by IDSA to reflect current science, include the anti-trust panel recommendations, or address recommendations made by the Virginia Lyme Disease Task Force, it would still not eliminate the fact the IDSA guidelines were originally prepared by a handful of people determined to be extremely biased and riddled with conflicts of interest (AG of CT investigation).
Considering the IDSA knowingly re-submitted its outdated, tainted guidelines without adhering to policies designed to protect the public, were deemed to be less than honorable during the original development process, purposely avoided including years of scientific literature that would benefit doctors and patients in their re-submission process (over 70 persistence articles), all cast serious doubts on the trustworthiness and the reliability of any future guidelines stemming from this organization.
To protect residents, we feel the IDSA Lyme disease guidelines should not be sanctioned or promoted by the Commonwealth of Virginia. The use of outdated, substandard guidelines for children and adults with cancer, diabetics, or HIV patients, would not knowingly be tolerated, therefore, this practice is not acceptable for Lyme patients.
Several members of Congress have recently called for the removal of the guidelines from the NGC, as have a number of various States’ officials. Lyme disease organizations and patients world-wide are also calling for their removal from the market.
In light of the above facts, and recent studies (Tulane University & University of CA Davis), which determined, once again, that spirochetes have been confirmed to be viable after 3 months of IV and oral treatment- completely debunking the IDSA’s theories on which they base all their guideline recommendations- we request all references to the IDSA Lyme disease guidelines, its Lyme courses, and links to the IDSA’s outdated information be removed from Virginia government websites, literature and future correspondence.
We are confident you will agree that knowingly promoting outdated, substandard diagnostic and treatment guidelines or related educational classes of any kind is a disservice to the public and leaves health care professionals at risk for legal actions. If someone were to follow the recommendations and fail to be properly diagnosed using the recommended tests, or cured following treatments promoted within, it could open the door to a host of liability and legal issues for health care professionals and the Commonwealth of Virginia, not to mention the loss of quality of life for those who become chronically ill and disabled as a result.
We would also appreciate it if the Virginia DOH would post a notice on their websites to inform physicians and insurers that the IDSA Lyme disease guidelines have expired and should not be used as a basis to diagnose patients, to determine treatment protocols, or deny payment for Lyme-related insurance claims.
Thank you for your anticipated action in this regard. If you have any questions, please do not hesitate to contact me. If you would kindly let me know when the above changes will be made, I will be pleased to let patients and residents across the state know of your cooperation and concern for their well-being.
Sincerely,
Lucy Barnes
www.VirginiaLyme.org