Government Documents, Bills, Conferences, and Working Groups
AGS Excerpt from the TBDWG September 12, 2019 meeting summary
Together, the three Co-Chairs of the Alpha-Gal Subcommittee presented the subcommittee’s work. Leigh Ann first introduced herself, the other two Co-Chairs, and other members of the subcommittee and highlighted their expertise related to alpha-gal syndrome (AGS) and tick-borne diseases in general.
Leigh Ann noted that the overall objective of the subcommittee is its final report to the Working Group, and that the subcommittee has aligned its goals with the Working Group’s goals. The subcommittee, Leigh Ann noted, is taking an overarching approach to look at a number of important topics (for example, cause[s], treatment, and prevention of AGS). To achieve these goals, the subcommittee has sought input from subject matter experts, patients, and cross-functional stakeholders to enhance understanding of AGS; and they have identified areas of additional research need. Leigh Ann noted that the ultimate goal is to advance human protection and reduce human suffering.
Background and Identified Needs
Subcommittee Co-Chair Scott Palmer Commins, BS, MD, PhD, Associate Professor of Medicine & Pediatrics, University of North Carolina; Member, UNC Food Allergy Initiative, Thurston Research Center, then explained the characteristics of AGS, provided brief background information, and explained the special needs identified by the subcommittee thus far.
Distinct factors of AGS
- AGS is an allergic reaction to mammalian meat; some people may also be allergic to dairy, cheese, and gelatin.
- AGS is associated primarily with bites from the lone star tick.
- AGS is not currently recognized/reportable as a tick-borne disease by the National Institutes of Health (NIH) and the Centers for Disease Control and Prevention (CDC).
- Symptoms of AGS may vary in individual pediatric and adult patients.
- AGS may significantly change a patient’s lifestyle, and co-factors (for example physical activity, alcohol, and stress) may affect individual allergic reactions and exposure as mammalian products are ubiquitous.
- AGS does not appear to be caused by a pathogen.
- Factors of AGS similar to those of other tick-borne diseases
- AGS drastically affects the lives of the patients and their families and caregivers.
- Currently there are no FDA-approved therapeutic products for AGS; treatment plans are generally “off-label,” which may affect payer coverage, and/or part of clinical protocols.
- Brief background and special needs
- AGS is an allergy that develops in response to tick bite(s); however, currently there is no evidence proving that it is an infectious disease or caused by a pathogen.
- Accumulating data suggest there is an increase in AGS incidence and an expanding geographic risk.
- Establishing an AGS diagnosis code and diagnostic marker(s) would further help the understanding of AGS prevalence.
- Including human tick-bite data in epidemiological investigations and linking them to clinical data would help overcome the limitations of current alpha-gal surveillance and risk assessment.
- Major Challenges and Issues
- Scott further explained that the subcommittee has identified the following major challenges and issues.
More information is needed to develop educational materials and programs and to improve patient outcome, including the following.
- Accurate diagnostic data on the scope and incidence of AGS
- Knowledge of how to identify individuals pre-disposed to AGS
- Treatment guidelines/plans
- Validated resources related to foods and other products containing alpha-gal
Co-Chair Angel M. Davey, PhD, Program Manager, Tick-Borne Disease Research Program, Congressionally Directed Medical Research Programs, U.S. Department of Defense, noted that, moving forward, the subcommittee would continue seeking expert input, begin putting all information together, and start working on the Results section. The subcommittee, she added, was aiming to complete their report before the January 2020 deadline.