Our Role & Impact

Position Statements

NatCapLyme focuses our efforts on helping people with tick-borne diseases through awareness, education, support, advocacy, and research. After careful deliberation, we issue formal position or policy statements on issues that are of critical importance to our community and our association’s mission. We invite you to read through our past position statements:

Position-Statements

NatCapLyme Presents to the Tick-Borne Disease Working Group at the Department of Health and Human Services in Washington, DC

Gregg P. Skall, Esq.
Key Stakeholder Presentation
HHS’s Tick-Borne Diseases Working Group
Hubert H. Humphrey Building, Washington, DC
December 11, 2017at 2:40 p.m.

Condensed Version for 10-Minute Oral Presentation

Good afternoon. My name is Gregg Skall—I am legal counsel for the National Capital Lyme Disease Association, also known as NatCapLyme. I am here also because my wife, Monte, has been struggling with tick-borne disease for more than two decades and I have seen the devastation that these diseases have had on hundreds, if not thousands of people.

We have been asked by HHS to comment on three important questions. To answer these questions, we should first acknowledge that tick-borne diseases are a significant problem, because, frankly, it has been denied for so long by so many respected medical professionals. Hopefully, in convening this Working Group, we will finally gain recognition that tick-borne disease is not simply a medical anecdote, but, in fact, represents a national health epidemic that must be seriously addressed and conquered.

Seven years ago I was privileged to participate in the Institute of Medicine’s (IOM) workshop Critical Needs and Gaps in Understanding Tick-Borne Diseases. While that workshop provided important insights, unfortunately, it produced little progress, even with respect to awareness, let alone treatment of tick-borne diseases.

Disturbingly, tick-borne illnesses continue to be discounted by the vast majority of medical professionals, government policy makers and researchers who cling to the inaccurate belief that Lyme disease is hard to catch and easy to treat. [For an enlightened rebuke to this mantra, see Holy Ahern’s presentation at Focus on Lyme.

https://on-lyme.org/en/sufferers/lyme-stories/item/275-the-flawed-science-behind-the-current-global-lyme-policies-diagnostics-and-treatment]

Accordingly, patients are still being misdiagnosed and denied treatment, and the incidence of tick-borne diseases is surging. It is now old news that the CDC currently estimates more than 300,000 new cases of Lyme disease each year. This number does not include all other tick-borne diseases, only Lyme.

WHAT WOULD OFFER THE GREATEST IMPACT ON THE GREATEST NUMBER OF PEOPLE?

The first question posed was what would offer the greatest impact on the greatest number of people.

The key to any future advancement lies in the development of better diagnostic tools. We desperately need accurate tests for the detection of all tick-borne diseases, tests that are capable of identifying all their stages. Equally important, we must be able to confirm eradication of the pathogens. Such tests will enable us to better characterize both acute and persistent manifestations.

We need to abandon the two-tier testing approach. The problem with tests like the Elisa is its dependence on identifiable antibodies, which, as we learned from Dr. Aucott, may not develop until weeks or months after infection – well after the optimum time to treat a tick-borne disease. Public education and patient informed consent require accurate patient notification of testing reliability, including the potential for a false negative result, and this should be recognized in every state, as Maryland and Virginia have done legislatively.

Given the current state of research, creating these tests, as well as pioneering research in the field of tick-borne disease, may seem like a tall order. To accomplish this we have to reach out to new players who offer innovative and creative ideas and look for real solutions. We would like HHS to expand its funding criteria to reach emerging and promising research that comes from fresh and new perspectives instead of new studies only confirming old results.

Here are some examples that offer promise to which NatCapLyme has contributed:

Dr. Neil Spector of Duke University, researching immune therapy.
Dr. Ying Zhang of Johns Hopkins, focusing on antibiotic resistance and bacterial persistence.
Dr. Kim Lewis of Northeastern University, researching new antibiotics for persistent bateria.
Dr. John Aucott of Johns Hopkins, this Group’s chair, with his SLICE study, to understand what he calls “post-treatment Lyme disease syndrome.”

Most distressing is the fact that the medical community is still so strongly divided and “establishment medicine” so entrenched in the belief that Lyme is not a problem. You must find a way to bring together ALL the best minds and theories, examining empirical observation and clinical “anecdotal” experience as well as controlled studies. We must never forget that “[T]he medical elite thought they knew what caused ulcers and stomach cancer,” until Barry Marshall drank H. pylori, lighting a better path.

Look to the model created by the Alzheimer’s Disease Neuro-Imaging (ADNI) initiative. Their three-point program was extremely important in moving their research agenda forward. Specifically, their researchers agreed:

  1. To share all their data;
  2. Every finding would be made public immediately, and
  3. To renounce ownership and patent rights.

Dr. John Trojanowski, a member of the research team, said, “. . . we all realized that we would never get biomarkers unless all of us parked our egos and intellectual-property noses outside the door.”

NatCapLyme believes that true solutions to the dilemma of Lyme and tick-borne infections may only be found when all parties are willing to consider the views that each seeks to contribute.

We would like to see clinical trials broadened to include patients with persistent Lyme Borreliosis as well as the entrance criteria for clinical trials to include entire classes of Lyme patients whose disease expression and treatment response are poorly understood. We would also like to see medical trials conducted that better mirror the variety of treatment regimens actually used by treating physicians.

METHODS TO IMPROVE THE LIVES AND HEALTH OF PEOPLE LIVING WITH TICK-BORNE DISEASES

The second question posed was how to improve the lives and health of people living with tick-borne diseases.

First and foremost, discard the CDC case definition of Lyme disease for diagnosing patients. That definition designed specifically and only for surveillance, is consistently misused as the “definitive diagnostic criteria” in the clinical setting. The CDC needs to clarify to all health service providers and health departments that the surveillance case definition was never intended to be used in clinical diagnosis.

Patients, medical professionals and scientists need a better case definition, expanded to include the entire emerging spectrum of Lyme disease and tick-borne coinfections.

Stemming the epidemic requires medical providers to be competent to recognize, diagnose, and treat tick-borne diseases. Thus, a national education course for medical providers should be developed that reflects the diverse approaches to treatment and diagnosis of tick-borne diseases as well as CME courses.

It is critical to support medical providers who practice on the front-lines. State medical boards routinely penalize doctors who deviate from the IDSA guidelines by subjecting them to investigations and disciplinary procedures. Many patients lose their doctors, who stop treating out of fear of that costly gauntlet or even of losing their license.

When multiple protocols meet the new rigors for publication by the National Guideline Clearinghouse, government favoring one over another places an unnecessary burden on patients needing the disfavored protocol. Physicians must be allowed to treat the patient and the symptoms they present, to practice the “true art of medicine” and the patient should have the right to accept that treatment with informed consent. Medical guidelines are designed to provide recommendations, not mandates.

Paraphrasing Dr. Wolitski last year at USCA: treat the patient, not the health care system. NatCapLyme says: “Treat the patient, not the test.”

https://youtu.be/KGfXDaiYEyQ?t=373

METHODS TO PREVENT NEW TICK-BORNE INFECTIONS

Finally, we were asked to discuss methods to prevent new tick-borne infections.

Mass media campaigns effectively expose large populations to messages about changing health risk behaviors. A CDC mass media campaign on awareness, similar to that of the Zika response, would significantly reduce the rate of infection and could relieve society from the extreme economic burden of persistent incapacitating diseases. A 2015 Johns Hopkins study found that Lyme alone costs the U.S. health care system as much as $1.3B per year. With indirect costs, such as lost wages, that number jumps to many billions.

Children ages 5 through 14 face the highest risks of exposure to tick-borne infections. A tick awareness and prevention curriculum should be designed as a learning tool for public, private and home schools, as well as for educational settings including camps and youth organizations.

We know the importance of vaccines. While NatCapLyme would like to see the development of a “safe and effective” vaccine, a narrow-focus of a few strains of Borrelia, and a rush to certify a vaccine, offers only a limited public-health benefit and harbors a serious potential health risk. The perception of protection can be dangerous if the vaccine is not effective against the full range of Borrelia strains and co-infections. In NatCapLyme’s opinion it is premature to inoculate the general public with a tick-borne disease vaccine. We do hold out hope for a “safe and affective” vaccine in the future.

Lastly, we must make certain that tick-borne diseases, such as Babesia, are not transmitted through the national blood supply and that proper screening techniques are in place to ensure public health safety.

CONCLUDING COMMENTS

Tick-borne diseases erode every facet of an individual’s life, decimate marriages and livelihoods, and cause children to leave school and even lose their childhoods. For many, life never returns to normal.

The patient community is extremely angry about the lack of scientific and medical progress and the inadequate response from the agencies responsible for the health and welfare of the general public. This anger propels us to insist that our government, medical professionals, insurers and healthcare system address our needs as we hold these entities and individuals accountable for the delivery of the results upon which our lives depend and for which we have paid as taxpayers.