Recently the Infectious Disease Society of America (IDSA) released new guidelines for the diagnosis and treatment of Lyme disease and chronic Lyme disease. 

Lyme disease is a controversial diagnosis and there are conflicting views among practitioners, especially in regards to persistent manifestations of Lyme disease. In addition to the Infectious Disease Society of America (IDSA) guidelines, the International Lyme and Associated Diseases Society (ILADS) has published guidelines and we can also look to the National Institute for Health and Care Excellence (NICE), the insurer in England, for their guidelines. 

For full transparency, it would be best for IDSA to disclose that there are other conflicting guidelines. These other guidelines, unlike the IDSA guidelines, recognize that Lyme can present with non-specific symptoms, and provide recommendations for longer initial treatment to reduce treatment failures, and provide some guidance for retreatment if needed.

In fact, there has been a 57-page rebuttal to the IDSA guidelines, written by a coalition consisting of over 75 organizations, from 8 countries, who are concerned these guidelines will further restrict access to care and harm patients by leaving them undiagnosed and undertreated. Although the IDSA is not a government agency, its guidelines have become a widely accepted standard and are posted on the CDC website. 

These guidelines wield a lot of power in what insurance companies will pay for and also in reprimanding physicians. Patients are caught in the middle and left feeling scared and frustrated, not knowing where to turn and who to trust in the medical system. These guidelines pose a great risk to access to care in a disease in which a timely diagnosis and treatment make all the difference.  

The rebuttal goes into some ethical issues with the IDSA guidelines which I think are important to highlight briefly.

• The Institute of Medicine requires that guideline panels include “representatives from key affected groups,” yet the IDSA excluded two groups who are profoundly affected by the guidelines: chronic Lyme patients and the physicians who treat them (only 6% of chronic Lyme patients see IDSA physicians). 
• Guideline panels should include two patient representatives and the IDSA only included one, and this ‘patient representative’ has no experience with Lyme disease. 
• The panel also includes researchers who were under investigation by the Connecticut Attorney General for antitrust violations in connection with the 2006 Lyme guidelines. 
• Some panel members who are involved with developing diagnostic tests have financial conflicts of interest. 

Another theme the rebuttal brings up is how the IDSA guidelines violate basic GRADE guidance in determining the strength of recommendation, often citing strong recommendations when they meet criteria for a weak recommendation. These recommendations are not arbitrary and can affect policies and insurance coverage.

The IDSA strongly recommends a single 200 mg prophylactic dose of doxycycline only if the following criteria are met: tick attached for a minimum of 36 hours, tick infection rate greater than 20% in an area where the bite occurred, and treatment to begin within 72 hours of tick removal. This recommendation should be weak. The relative ineffectiveness of single dose doxycycline and its potential to evade the immune response warrant a weak recommendation against single dose doxycycline. The ILADS guidelines recommend 20 days of doxycycline 200 mg twice daily regardless of endemic information or how long the tick was attached.

Needing to meet criteria of being in an endemic area can be a limiting factor in early diagnosis.

It should be noted that no other country imposes a geographical restriction on Lyme disease. Using inaccurate geographic endemicity data based on CDC surveillance for diagnosis can leave patients with Lyme disease undiagnosed and untreated. The geographic reach of the disease is expanding and so-called “low incidence” states have much higher rates of Lyme disease when measured by other independent big data sources.  

The strong recommendation against testing patients with ALS, relapsing-remitting multiple sclerosis, Parkinson’s disease, or dementia for Lyme disease is based on weak evidence. While delaying appropriate evaluations and exposing patients to antibiotics unnecessarily is a risk, a true positive result would be life changing given the degenerative nature of these conditions and the lack of cures.

The IDSA ranked adverse outcomes from treatment as critically important while the ILADS guidelines put the emphasis on cure of infection or prevention of disease relapse. I would expect increased treatment failures with IDSA guidelines due to shorter treatment duration than other guidelines. These guidelines will make it difficult for patients with persistent Lyme disease or anyone who has a treatment failure to get access to additional treatment. 

The IDSA strongly recommends a single 200 mg prophylactic dose of doxycycline only if the following criteria are met: tick attached for a minimum of 36 hours, tick infection rate greater than 20% in an area where the bite occurred, and treatment to begin within 72 hours of tick removal. This recommendation should be weak. The relative ineffectiveness of single dose doxycycline and its potential to evade the immune response warrant a weak recommendation against single dose doxycycline. The ILADS guidelines recommend 20 days of doxycycline 200 mg twice daily regardless of endemic information or how long the tick was attached.

How do physicians and lyme literate practitioners balance antibiotic stewardship with treating suffering patients and not turning our back to those that need help most?

This is where individualized medicine and guidelines that support clinical decision making come in. We need to set our differences aside and put patients first. Division within the medical community is prolonging time for patients to get diagnosis and the greatest opportunity in Lyme disease is to achieve earlier diagnosis and treatment in order to prevent the development of persistent Lyme disease. 

References

https://www.lymedisease.org/idsa-comments-part-2/

https://www.lymedisease.org/idsa-excluded-chronic-lyme/

https://www.lymedisease.org/wp-content/uploads/2019/09/Ad-Hoc-Patient-Physician-Coalition-Comments-Sept-6.pdf

https://www.lymedisease.org/tbdwg-public-comments-idsa-vs-ilads/#:~:text=Because%20care%20is%20often%20either,improve%20under%20the%20IDSA%20guidelines.

https://academic.oup.com/cid/advance-article/doi/10.1093/cid/ciaa1215/6010652