Unethical to withhold viable Lyme treatments, while awaiting more research
Julia Wagner delivered the following public comment by telephone to the federal Tick-Borne Disease Working Group on December 2.
Good morning. I am Julia Wagner, President of PA Lyme Resource Network. Our support groups see over 5,000 patients coming through our regional support groups every year, suffering from persistent Lyme and tick-borne diseases.
My comments focus primarily on the draft reports and proposed actions from the Babesiosis and Tick-Borne Pathogens; Clinical Aspects; Pathogenesis & Pathophysiology; the Training/Education/Access subcommittees and proposed actions.
The research agenda is missing a focus on several critical areas. Improved understanding in these areas will lead to better therapeutic targets. These areas include:
- Multi-pathogen disease, including biofilm and host-pathogen interactions. Studies have found more than half of TBD patients produce immune responses to various microbes. Technologies are now available to model and study multi-pathogen diseases which should be leveraged in TBDs.
- Immune dysfunction in tick-borne diseases. Pathogenesis studies indicate TBDs may cause immune dysfunction and impact the severity and course of infection. Patients may develop a weakened immune system, and many present evidence of opportunistic infections such as chlamydia, coxsackievirus, cytomegalovirus, Epstein-Barr virus, human parvovirus B19, and mycoplasma. In addition, many patients now present with mast cell disorders.
- Inflammation in tick-borne diseases and neurological manifestations – including CIDP, other neuropathies, dysautonomia/POTs, and neuropsychiatric/cognitive impacts (PANS) — severely compromising symptoms we see in children and youth affected by these diseases .
Immediate solutions – the overall recommendations focus heavily on longer term solutions, but it is imperative that these recommendations also address immediate improvements in patient care – specifically:
- Therapeutic options: Public health authorities must communicate the spectrum of options, the state of the evidence, and the critical role of clinicians in individualizing treatment plans, based on the knowledge we have available today. Patients need options now – it is unethical to withhold viable treatments waiting for more research. The range of guidelines and published protocols such as combination Dapsone therapy (Johns Hopkins, Horowitz, Stanford and others) should be readily communicated as options for persistent disease.
Access to care – structural barriers – the evidence in this section includes the RICO case against the IDSA and insurers, indicating that one insurer (Kaiser) had settled. This section must be updated to reflect that all eight insurers have now settled in this case which charged that they and the IDSA conspired and colluded to deny patients access to care. Our legislative efforts in PA produced significant evidence of such denials and the harm this has caused to patients. In fact, one of the complainants in the RICO suit lost all mobility due to significant delays in diagnosis and treatment, and continues to be in a wheelchair in his 20s, requiring full-time care.
- Immediate action must be taken to ensure the CDC and other federal agency websites, content, and materials, accurately reflect the broad spectrum of treatment options available, without bias, and stresses the need for individualized treatment approaches. Insurers should be made aware of this shift to address this structural barrier and improve patient access to care. These are, for the most part, well established medicines being repurposed for better treatment of tick-borne diseases.
Julia Wagner can be contacted through the website of the Pennsylvania Lyme Resource Network.