Dear Chairman Sanders and Ranking Member Cassidy:
We write to request that the Senate Committee on Health, Education, Labor and Pensions hold a public hearing to investigate the extent and impact of health inequities related to persistent/chronic Lyme disease.
We believe the exposure from a public hearing will open the door for policy changes and legislative remedies that will lead to reductions in cases and improved health outcomes, which will ultimately result in reduced healthcare and disability costs[1] and increased tax revenue as more chronically ill patients return to the workforce.
Persistent/chronic Lyme disease is a major public health crisis. Of the estimated 476,000 Americans who are diagnosed with Lyme disease each year[2] , between 10 and 20 percent continue to have symptoms[3] that seriously impact their health, finances and quality of life[4], despite receiving antibiotic treatment consistent with clinical practice guidelines endorsed by CDC[5].
CDC and many researchers refer to the chronic symptoms experienced by many Lyme disease patients as Post-Treatment Lyme Disease Syndrome (PTLDS).[6] Patients, advocates and many physicians who specialize in treating Lyme disease[7] prefer the term “chronic Lyme disease,” which has a more comprehensive case definition[8] that covers significantly more patients than the case definition for PTLDS[9].
A 2019 analysis published in BMC Public Health found that close to 2 million Americans suffer from PTLDS.[10] The number of cases is likely many times more when the case definition for chronic Lyme disease is used.[8]
With an average societal burden of $2,000 per patient, for all forms of Lyme disease, according to a 2022 study published in Emerging Infectious Diseases[11], the annual burden on the U.S. economy for chronic Lyme disease is at least $4 billion and likely much more,
The HHS Tick-Borne Disease Working Group’s 2022 report to Congress[12] identifies the prioritization of health equity for sufferers of tick-borne diseases as a major new theme. Its Access to Care and Education Subcommittee report[13] focuses on inequities faced by patients with “persistent Lyme disease/chronic Lyme disease (PLD/CLD).”
The Subcommittee found that “Patients with PLD/CLD encounter many barriers to accessing care, including structural barriers created by insurers and medical boards. Some cannot find local clinicians to treat them, and many report that their care is not covered by insurance.”
Health inequities faced by patients with PLD/CLD include:
Decreased quality of life (Johnson et al., 2014; Rebman et al., 2017),Increased rates of disease (Fallon et al., 2021),Increased disease severity (Dennison et al., 2019),Preventable death (Congressionally Directed Medical Research Programs,2022; Dahlgren et al., 2012; Marx et al., 2020), andLimited access to care (Johnson et al., 2011).
The Working Group’s report notes that “Various aspects of Lyme disease appear to affect males and females unequally.”
According to the article Does Biological Sex Matter in Lyme Disease? The Need for Sex-Disaggregated Data in Persistent Illness “Women reported more tick-borne coinfections, worse symptoms, longer diagnostic delays, more misdiagnoses, and worse functional impairment than men.”[14]
A study cited by the Access to Care and Education Subcommittee found that pregnant women were “less likely to have a classic ‘bull’s-eye’ rash or present with constitutional symptoms such as fatigue, headache, myalgia, arthralgia, dizziness, nausea, and fever” and that “diminished symptoms/findings could place pregnant women at a disadvantage for being diagnosed early in their infections, when treatment is most likely to be successful.”[15]
Pregnant women may also transmit Lyme disease to their children in utero.[16,17,18] This can result in adverse birth outcomes for both treated and untreated mothers, according to An In-Depth Review of the Benefits of Antibiotic Use in the Treatment of Borreliosis in Pregnancy.[19]
This retrospective analysis of 31 studies found when no antibiotics were used, 74% of pregnancies had adverse outcomes. When oral antibiotics were used, 29% had adverse outcomes. Adverse outcomes dropped to 12% when intravenous (IV) antibiotics were used. Adverse outcomes included miscarriage, newborn death, cardiac abnormalities, hyperbilirubinemia, respiratory distress and syndactyly.
Children who are infected in utero and do not exhibit obvious symptoms at birth often go undiagnosed and untreated for many years. When Lyme disease goes undiagnosed and untreated in a child, the physical health, mental health and capacity to learn can be severely compromised, adversely affecting their entire life trajectory.[20,21,22]
The Working Group’s report says racial and ethnic “inequities may be a function of differences in Lyme disease awareness, language barriers, and limited access to health care.”
A recent study by Johns Hopkins Medicine Lyme Disease Research Center, Time to Diagnosis and Treatment of Lyme Disease by Patient Race, revealed major disparities in the diagnosis and treatment of Lyme disease between Black and White patients. The researchers found that Black patients were 4.93 times more likely to have advanced stages of Lyme disease and that Black patients waited an average of five times longer before receiving appropriate antibiotic treatment.[23]
The Access to Care and Education Subcommittee’s report emphasizes that challenges posed by “structural governmental barriers” impede patients from obtaining access to quality health care and deter physicians from providing such care.”
A major structural barrier that restricts progress and contributes to misdiagnosis, denial of care and suffering for large numbers of patients is the endorsem*nt of unreliable diagnostic tests for Lyme disease by CDC and NIH, and use of the surveillance case definition for Lyme disease as the entrance criteria and/or end point for federally funded research.
According to the case definition, patients must have an erythema migrans (EM) rash or test positive on the two-tier blood test. Yet many patients never get a rash,[24] and a systematic meta-analysis of 20 years of published data shows the mean sensitivity of two-tier test to be only 35.4% in the acute stage and 64.5% in the convalescent stage, with an overall sensitivity of 59.5%.[25]
Patients with Lyme disease who test negative, frequently remain undiagnosed and untreated. Untreated or insufficiently treated Lyme disease can cause neurological, musculoskeletal and cardiac damage and, occasionally, death.[26,27]
Lyme disease also has been linked to an increased risk of mental disorders, including depression, obsessive-compulsive disorder, mania, psychosis, and cognitive impairment. A study published in the American Journal of Psychiatry found that “Individuals diagnosed with Lyme borreliosis in the hospital setting had an increased risk of mental disorders, affective disorders, suicide attempts, and suicide.”[28]
The risk of treatment failure and development of chronic illness is significantly higher in patients who were undiagnosed or misdiagnosed during the early stages of the infection, with estimates ranging from 30 – 40% for late diagnosed cases.[28] The limited sensitivity of standard laboratory tests means that misdiagnosis and delays in diagnosis and treatment occur frequently in the community practice of medicine.[29]
Use of the surveillance case definition as an entrance criterion for research discriminates against patients with PLD/CLD who are excluded from these studies because they fall outside the narrow definition, which includes a disclaimer from CDC that the case definition is “not intended to be used by healthcare providers for making a clinical diagnosis or determining how to meet an individual patient’s health needs.”[30]
The Subcommittee’s report says “Taken together, policies and processes that promote the use of Lyme disease surveillance case criteria as diagnostic and entrance criteria for research studies are structural determinants of health that perpetuate the health disparities experienced by many patients with Lyme disease.”
The Working Group notes that “Identifying and changing the educational, research, and administrative policies, processes, and practices that result in barriers to receiving and providing care is essential to achieving health equity for these patients.” Its 2022 report to Congress includes five detailed recommendations that, if implemented, will go a long way towards reducing health inequities for patients with PLD/CLD.
We believe a public hearing will be a good investment of the Committee’s time and will raise awareness among policy makers, agency officials and researchers who can address these inequities.
In addition to holding a hearing, we urge the Committee to support legislative remedies that address root causes and monitor agency effectiveness in reducing and eliminating inequities associated with Lyme disease. Agency performance in combating PLD/CLD should be measured with people-level indicators that are linked to improved health outcomes and reductions in cases.[31]
The cost of not addressing these inequities is substantial. Every year that passes, means increasing numbers of chronically ill patients will continue to suffer from misdiagnosis, delayed treatment and the financial burden from out of pocket costs, and the burden on the U.S. economy from inequities associated with PLD/CLD will continue to grow.
We appreciate your attention to this matter and look forward to your response.
References
1. Bhatt J, Gerhardt W, et al. US Health Care Can’t Afford Health Inequities. Deloitte's Life Sciences and Health Care Consulting Services, 2022 Jun.
2. Kugeler KJ, Schwartz AM, Delorey MJ, Mead PS, Hinckley AF. Estimating the Frequency of Lyme Disease Diagnoses, United States, 2010-2018. Emerg Infect Dis. 2021 Feb;27(2):616-619. doi: 10.3201/eid2702.202731. PMID: 33496229; PMCID: PMC7853543.
3. Aucott JN, Yang T, Yoon I, Powell D, Geller SA, Rebman AW. Risk of Post-Treatment Lyme Disease in Patients with Ideally-Treated Early Lyme disease: A Prospective Cohort Study. Int J Infect Dis. 2022 Mar;116:230-237. doi: 10.1016/j.ijid.2022.01.033. Epub 2022 Jan 21. PMID: 35066160.
4. Johnson L, Wilcox S, Mankoff J, Stricker RB. Severity of Chronic Lyme Disease Compared to Other Chronic Conditions: A Quality of Life Survey. PeerJ. 2014; 2.
5. Centers for Disease Control and Prevention website. Treatment of Lyme Disease.
6. Centers for Disease Control and Prevention website. Post-Treatment Lyme Disease Syndrome.
7. International Lyme and Associated Diseases Society (ILADS).
8. Shor S, Green C, Szantyr B, Phillips S, Liegner K, Burrascano JJ Jr, Bransfield R, Maloney EL. Chronic Lyme Disease: An Evidence-Based Definition by the ILADS Working Group. Antibiotics (Basel). 2019 Dec 16;8(4):269. doi: 10.3390/antibiotics8040269. PMID: 31888310; PMCID: PMC6963229.
9. Aucott JN, Crowder LA, Kortte KB. Development of a Foundation for a Case Definition of Post-Treatment Lyme Disease Syndrome. Int J Infect Dis. 2013 Jun;17(6):e443-9. doi: 10.1016/j.ijid.2013.01.008. Epub 2013 Feb 23. PMID: 23462300.
10. DeLong A, Hsu M, Kotsoris H. Estimation of Cumulative Number of Post-Treatment Lyme Disease Cases in the US, 2016 and 2020. BMC Public Health. 2019 Apr 24;19(1):352. doi: 10.1186/s12889-019-6681-9. PMID: 31014314; PMCID: PMC6480773.
11. Hook SA, Jeon S, Niesobecki SA, Hansen AP, Meek JI, Bjork JKH, et al. Economic Burden of Reported Lyme Disease in High-Incidence Areas, United States, 2014–2016. Emerg Infect Dis. 2022 Jun.
12. HHS Tick-Borne Disease Working Group 2022 report to Congress.
13. HHS Tick-Borne Disease Working Group 2022 Access to Care and Education Subcommittee report
14. Johnson L, Shapiro M, Janicki S, Mankoff J, Stricker RB. Does Biological Sex Matter in Lyme Disease? The Need for Sex-Disaggregated Data in Persistent Illness. Int J Gen Med. 2023 Jun 17;16:2557-2571. doi: 10.2147/IJGM.S406466. PMID: 37351009; PMCID: PMC10284166.
15. Maraspin V, Lusa L, Blejec T, Ružić-Sabljić E, Pohar Perme M, Strle F. Course and Outcome of Erythema Migrans in Pregnant Women. J Clin Med. 2020 Jul 24;9(8):2364. doi: 10.3390/jcm9082364. PMID: 32722090; PMCID: PMC7463612.
16. Schlesinger PA, Duray PH, Burke BA, Steere AC, Stillman MT. Maternal-Fetal Transmission of the Lyme Disease Spirochete, Borrelia Burgdorferi. (1985) Ann Intern Med, 103, 67-8.
17. Gardner T. Infectious Diseases of the Fetus and Newborn, 5th Edition, (1995) Chapter 11, page 447 – 528.
18. Lambert JS.An Overview of Tickborne Infections in Pregnancy and Outcomes in the Newborn: The Need for Prospective Studies. Front Med (Lausanne). 2020 Mar 6;7:72. doi: 10.3389/fmed.2020.00072. PMID: 32211414; PMCID: PMC7069275.
19. Cook MJ, Moynan D, Avramovic G, Lambert JS. An In-Depth Review of the Benefits of Antibiotic Use in the Treatment of Borreliosis in Pregnancy. Applied Microbiology. 2023; 3(2):312-321.
20. Greenberg, R. Infections and Childhood Psychiatric Disorders: Tick-Borne Illness and Bipolar Disorder in Youth. Bipolar Disorder. (2017) Volume 3, Issue 1.
21. Mothers Against Lyme website. Advocacy and Education About Congenital and Childhood Lyme https://mothersagainstlyme.org
22. Greenberg R. Aggressiveness, Violence, Homicidality, Homicide, and Lyme Disease. Neuropsychiatr Dis Treat. 2018 May 14;14:1253-1254. doi: 10.2147/NDT.S168751. PMID: 29799538; PMCID: PMC5957477
23. Starke SJ, Rebman AW, Miller J, Yang T, Aucott JN. Time to Diagnosis and Treatment of Lyme Disease by Patient Race. JAMA Netw Open. 2023;6(12):e2347184.
24. Stonehouse A, Studdiford JS, Henry CA. An Update on the Diagnosis and Treatment of Early Lyme Disease: "Focusing on the Bull's Eye, You May Miss the Mark". J Emerg Med. 2010 Nov;39(5):e147-51. doi: 10.1016/j.jemermed.2007.06.007. Epub 2007 Oct 18. PMID: 17945460.
25. Cook MJ, Puri BK. Commercial Test Kits for Detection of Lyme Borreliosis: A Meta-Analysis of Test Accuracy. Int J Gen Med. 2016 Nov 18;9:427-440. doi: 10.2147/IJGM.S122313. PMID: 27920571; PMCID: PMC5125990.
26. Scheffold N, Herkommer B, Kandolf R, May AE. Lyme Carditis--Diagnosis, Treatment and Prognosis. Dtsch Arztebl Int. 2015 Mar 20;112(12):202-8. doi: 10.3238/arztebl.2015.0202. PMID: 25838022; PMCID: PMC4395762.
27. Kiersten J. Kugeler, Kevin S. Griffith, L. Hannah Gould, Ken Kochanek, Mark J. Delorey, Brad J. Biggerstaff, Paul S. Mead. A Review of Death Certificates Listing Lyme Disease as a Cause of Death in the United States, Clinical Infectious Diseases, Volume 52, Issue 3, 1 February 2011, Pages 364–367.
28. Fallon BA, Madsen T, Erlangsen A, Benros ME. Lyme Borreliosis and Associations With Mental Disorders and Suicidal Behavior: A Nationwide Danish Cohort Study. Am J Psychiatry. 2021 Oct 1;178(10):921-931. doi: 10.1176/appi.ajp.2021.20091347. Epub 2021 Jul 28. PMID: 34315282.
29. Rebman AW and Aucott JN (2020)Post-Treatment Lyme Disease as a Model for Persistent Symptoms in Lyme Disease. Front. Med. 7:57. doi: 10.3389/fmed.2020.00057
30. Hirsch AG, Herman RJ, Rebman A, Moon KA, Aucott J, Heaney C, et al. Obstacles to Diagnosis and Treatment of Lyme Disease in the USA: A Qualitative Study. BMJ Open. (2018) 8:e021367. doi: 10.1136/bmjopen-2017-021367
31. Centers for Disease Control and Prevention website. Lyme Disease (Borrelia burgdorferi) 2022 Case Definition.https://ndc.services.cdc.gov/case-definitions/lyme-disease-2022/
32. Rozner, Steve. December 2013.Developing and Using Key Performance Indicators. A Toolkit for Health Sector Managers. Bethesda, MD: Health Finance & Governance Project, Abt Associates Inc.
