Who Knew? The Feds.

We're battling from state to state to gain recognition for the epidemic which is Lyme, to protect doctors who want to treat patients with Lyme, to force insurance companies to cover said treatment and to push for more research for better testing and treatment options. State by state, inch by inch, taking years to get even one of those goals met in one state. Why does it take so long? One reason is that everybody claims there is no understanding for the need. We must prove our case each and every time anew.

Yet, who did know that the "widespread misuse of the current Lyme disease surveillance case definition" was being "misused" to set a standard for care? Who did realize that for proper tracking, research and care we needed to "to include a broad range of scientific viewpoints"? Who has already understood that some patients "have encountered some difficulty when applying for assistance through SSA offices"?

Well, the federal government did. Look at the text of this bill signed by President Bush in 2001:

Public Law 107-116
Departments of Labor, Health, and Human Services, and Education, and Related Agencies Appropriations Act 2002

Signed by President Bush 1/10/02

(Passed by the Senate (11/06/01, 12/20/2001) and House (10/11/01, 12/19/01) and included as part of the final bill was signed into Public Law)

Centers for Disease Control and Prevention Lyme Disease

The Committee is deeply concerned about the safety of the Lyme disease vaccine (LymeRix). Over 1,000 adverse event reports were filed with the Food and Drug Administration from December 1998 to October 2000. The Committee encourages CDC to work closely with the FDA to ensure that all adverse event reports are thoroughly and expeditiously investigated to ensure public safety as the vaccine is being distributed. Investigators should pay particular attention to patients' reports of arthritis when evaluating these reports.

The Committee recognizes that the current state of laboratory testing for Lyme disease is very poor. The situation has led many people to be misdiagnosed and delayed proper treatment. The vaccine clinical trial has documented that more that one third (36 percent) of the people with Lyme disease did not test positive on the most sophisticated tests available. The ramifications of this deficit in terms of unnecessary pain, suffering and cost is staggering. The Committee directs CDC to work closely with the Food and Drug Administration to develop an unequivocal test for Lyme disease. 

The Committee is distressed in hearing of the widespread misuse of the current Lyme disease surveillance case definition. While the CDC does state that `this surveillance case definition was developed for national reporting of Lyme disease: it is NOT appropriate for clinical diagnosis,' the definition is reportedly misused as a standard of care for healthcare reimbursement, product (test) development, medical licensing hearings, and other legal cases. The CDC is encouraged to aggressively pursue and correct the misuse of this definition. This includes issuing an alert to the public and physicians, as well as actively issuing letters to places misusing this definition. 

The Committee recommends that the CDC strongly support the re-examination and broadening of the Lyme disease surveillance case definition by the Council of State and Territorial Epidemiologists. Voluntary and patient groups should have input into this process. Currently there is just one definition (`confirmed case') of seven possible categories. By developing other categories while leaving the current category intact, the true number of cases being diagnosed and treated will be more accurately counted, lending to improved public health planning for finding solutions to the infection.

The CDC is encouraged to include a broad range of scientific viewpoints in the process of planning and executing their efforts. This means including community-based clinicians with extensive experience in treating these patients, voluntary agencies who have advocacy in their mission, and patient advocates in planning committees, meetings, and outreach efforts

National Institutes of Health - Office of the Director Lyme Disease

The Committee recommends that the NIH improve its communication across Institutes in order to better coordinate Lyme disease research and outreach to public and private scientists with the goal of stimulating research interest in this field. The Committee encourages the Office of the Director to involve NIAID, NHLBI, NINDS, NEI, NIMH, and NCCAM in promising areas of research. The Committee urges NIH officials to identify appropriate NIH advisory committees for Lyme disease representation and ensure the appointment of qualified persons. The NIH is encouraged to include a broad range of scientific viewpoints in the process of planning and executing these efforts, including community-based clinicians with extensive experience in treating these patients, voluntary agencies who have advocacy in their mission, and patient advocates.

Social Security Administration
The Committee understands that some patients with Lyme disease and other tick-borne disorders have encountered some difficulty when applying for assistance through SSA offices, due to SSA employees' unfamiliarity with these illnesses. SSA is encouraged to work on developing educational materials for SSA employees to facilitate a better understanding of the potential debilitating effects of these disorders. The Committee suggests that SSA collaborate with clinicians who have expertise on the multi-system chronic effects of Lyme, as well as patient and voluntary communities, to accomplish this goal."

 Thing is: it's 2010 and none of these issues have been addressed. That's nine years later. What happened?

MA Protects Physicians Who Treat Lyme

Massachusetts Lyme disease advocates pose with Governor Deval Patrick in his office following his signing of the FY2011 budget, which included legislation which will protect physicians who treat Lyme disease longer than 30 days.  From left to right to right: Robin Lemieux of Groton; Susan Fairbank-Pitzer of Danvers; neurologist Luz Jacqueline Ruiz, M.D., of Harvard, MA; Donna Castle of Groton; Governor Duval Patrick; Representative Robert Hargraves (R-Groton); clinical psychologist Sheila Statlender, PhD, of Newton; and Jayme Kulesz of Groton.
 

Last Fall, I testified at the Massachusetts State House. I was there to support legislation which would protect physicians who treat patients with Lyme Disease. There has been a chill in doctor's offices across this state. It is a traumatic challenge when you are unlucky enough to end up with a case of Lyme which leads to persistent, debilitating health problems and discover that you can't find a doctor in your state who is willing to help you. They are unwilling to help either because they have been grossly misinformed or they are afraid of being punished by the state health board and shunned by their peers.

It was a long, uphill battle, but dedicated advocates trudged on year after year and we finally have a first step in the legal process which will potentially give patients a chance to find a treating physician. Here is the press release from the Lyme Disease Legislation Action Group:

For Immediate Release:

Jayme Kulesz , Lyme Disease Legislation Action Group

978 448-2696 (h)

978 273-0037 (c)

jkulesz@charter.net

Lyme Disease Legislation for Physician Protection signed by Governor Patrick

Massachusetts Governor Deval Patrick signed Lyme disease legislation into law as outside section 67 of the FY 2011 budget, effective July 1. "The intent of the law is to protect the freedom of Massachusetts doctors to treat Lyme disease comprehensively according to their best professional judgment, citing specifically the option for extended antibiotic treatment beyond 30 days," according to Brenda Boleyn, Chairperson of the Cape & Islands Lyme Disease Task Force, an advisory group appointed by the Barnstable County Commissioners.

The legislation provides the definition for Lyme disease which includes, “the presence in a patient of signs and symptoms compatible with acute infection with Borrelia burgdorferi; or with late stage or persistent or chronic infection with Borrelia burgdorferi, or with complications related to such an infection.”  In addition, the legislation provides for updating the Lyme disease definition if other strains are found to cause Lyme disease.

The legislation also legitimizes and defines the “clinical diagnosis“ of Lyme disease. This   may be based on knowledge obtained through medical history and physical examination only, or in conjunction with testing that provides supportive data for such clinical diagnosis, as determined by the treating physician.  

Governor Patrick’s signing of this important piece of legislation is the result of months of work by a core legislative action group, who worked with Representative Robert Hargraves (Groton-R) and Senate Majority Leader Fred Berry (Peabody-D) in drafting the bipartisan legislation and meeting with a number of state officials over the last year. “We are deeply grateful to Representative Hargraves and Senator Berry for taking time to meet with us and to understand the reasoning behind this law,” said clinical psychologist Sheila Statlender, Ph.D., a member of the legislative action group.

“Representative Hargraves and Senator Berry led a large team of legislators that supported this law and spent countless hours working to insure it was headed to the Governor’s desk for signature,” added Statlender. “This is an initial step towards helping the many Massachusetts residents suffering from chronic Lyme disease, and perhaps will lead to their being treated in their own communities, instead of having to travel hundreds of miles out of state for treatment.”

Representative Hargraves expressed gratitude for the outpouring of support from Lyme disease patients across the Commonwealth who sent letters to their legislators, the Governor and the Department of Public Health. “This groundswell of support from Lyme patients and their families was key to the signing of the legislation by Governor Patrick,” said Hargraves.

Following the signing of the legislation, Governor Patrick took the time to meet with members of the legislative action group and Representative Hargraves, and expressed his support.  

Massachusetts joins Connecticut, Rhode Island and California as the fourth state in the country to sign legislation that protects physicians who treat Lyme disease long term. Language of the legislation is posted on the Governor’s website.

I say "first step" because we all know that the real key to getting treatment is getting your health insurance to pay for it. Sick people, particularly when the illness is debilitating and you become unable to generate an income, can't afford to pay for the treatment on their own. We buy health insurance specifically for this reason. Even if we wanted to, the cost of some treatments is so exorbitant only the extremely wealthy could afford it. We need our insurance policy to actually insure that our health care needs are met.

Still, your doctors have to be legally protected from sanctioning first, so this is a critical, foundational first step. We must acknowledge the accomplishment here and the significance. Its has required very arduous work and our community is both small and living with illness. So, this has been no small feat. We hope the world can understand that we might need to rest and rejuvenate before setting our sights on the next huge goal: requiring that insurance companies cover treatment ordered by a licensed physician.

That work will require going head to head with the gargantuan power of the insurance industry. Not something we look forward to. For now, we will celebrate this victory and envision doctors coming out of their offices and into their reception areas to welcome all the Lyme patients who need their care.