Westerly, RI – Congressional Forum

Westerly, RI – Congressional Forum

Westerly, RI – Congressional Forum

Westerly Rhode Island Congressional Forum August 7, 2002
By: Pat Smith, President, Lyme Disease Association, Inc.

The LDA has acquired five nationwide affiliates and was honored by Columbia along with its affiliate, Connecticut-based Greenwich Lyme Disease Task Force, at a luncheon announcing Columbia’s partnership with us in the opening of an endowed chronic Lyme disease research center to be housed at Columbia. Academy award-nominated actress Mary McDonnell, a national spokesperson for the LDA, attended the luncheon to support our endeavor.

Lyme, the fastest-growing vector-borne disease in the U.S., is found in many countries throughout the world; yet, it is rarely given the weight it deserves. The situation facing patients in Rhode Island and Connecticut is a microcosm of the national scene. Patients frequently cannot obtain diagnosis, treatment, insurance reimbursement, disability, education or even understanding from their families and peers, partly because treating physicians nationwide have faced a variety of licensure sanctions including being supervised, fined, not allowed to treat Lyme patients, and even suspension and revocation. As you heard, Rhode Island took unprecedented steps recently to correct part of that situation with the enactment of its new doctor protection law and incorporation of patient friendly treatment language into RI Blue Cross agreements.

The pattern of patient and physician problems appears to be an anomaly when considered in light of activities at the federal level. The LDA was surprised while visiting US Army Centers for Health Promotion and Preventive Medicine, CHPPM, by its aggressive tick-borne disease program, which includes impregnating uniforms at the time of manufacture with permethrin for troops going into tick-infested areas, development of a pocket-sized PCR lab to test ticks in the field so that soldiers may receive immediate treatment if bitten by Lyme positive ticks, and research on ticks carrying babesiosis and Ehrlichiosis. Tick populations on military installations are mapped with resultant data stored in GPS satellites. This data will soon be beamed to soldiers in the field wearing special helmets being developed which contain heads-up displays that will show the soldiers where the heaviest tick concentrations and highest tick infectivity rates are, allowing armies to maneuver around them.

The National Aeronautics and Space Administration, NASA, and the National Institutes of Health, NIH, have a joint 3-dimensional culturing project for Lyme disease bacteria using microgravity chambers, which mimic conditions in space and in the human body. The cells are grown in a more natural manner in a spinning fluid medium. As the cells replicate, they form a complex matrix of chemicals, which tells them who is next to them, what shape they should become, how they should respond to stimuli. Researchers can then study the complex order of tissue in a culture system that can be manipulated by drugs, hormones, and genetic engineering. HIV, Ebola, and Lyme are all targeted infections for space age technology.

So why is Lyme being virtually ignored as a serious illness? Part of the problem stems from the CDC (Centers for Disease Control & Prevention) surveillance criteria for Lyme disease. To be a CDC reported case of Lyme disease, the case must meet the following criteria: a physician diagnosed EM (bullseye) rash, or positive blood work and other system involvement. Unfortunately, less than 50% of those infected develop a bullseye rash, and tonight you have heard how unreliable testing may be, so few meet those criteria. Thus the number of reported Lyme cases is misleadingly low. The actual number of Lyme cases is estimated to be 10 times higher than reported cases. Therefore in the year 2000, 17,730 cases were reported nationwide, which equals 177,300 probable new cases for that year. New York, Connecticut, New Jersey and Pennsylvania reported the highest case numbers, although CDC per capita data from 1990-1999 shows Rhode Island at 39 cases per 100,000, behind only Connecticut with 63/100,000.

Besides reporting, patient diagnoses are often affected by the CDC surveillance criteria when doctors inappropriately use the criteria for diagnosis. The CDC warns physicians not to use its criteria for diagnosis. Physicians often require a positive antibody response test for Lyme disease diagnosis, despite its unreliability, and insurance companies often require that same unreliable test for treatment reimbursement. According to a document from the NY DOH to the CDC, if they followed the CDC’s 2-tier testing requirement for 1995 cases, an ELISA, if positive, followed by a western blot, 81% of non-EM cases would not have been confirmed.

Insurance companies often do not accept doctor-prescribed testing such as PCR, which shows the presence of the DNA of the infecting organism, although PCR is accepted for other diseases such as HIV, hepatitis, and TB. They limit treatment to 28 days, substitute orals for IV and deny treatment reimbursement to anyone not meeting the CDC surveillance criteria, presenting doctors with a dilemma: treating sick patients who do not meet the criteria. Privately, doctors in several states have revealed that their insurance carriers strongly suggested they either leave the plan or stop treating Lyme patients long term. A few continue to treat, some refer their patients to other long-term treating physicians, while others, fearing reprisals or facing economic hardship, stop seeing Lyme patients.

Government officials spurred by patients and advocacy groups have taken measures to combat the growing problems associated with Lyme. Connecticut, Texas, Rhode Island, New York have all held hearings to become educated about the problems facing patients and physicians alike. Officials, advocates, and doctors have met with medical board representatives in New York and New Jersey, with health commissioners in Connecticut, New Jersey, and Rhode Island, and with the Pennsylvania House of Representatives majority policy committee. New Jersey, California, and Rhode Island all have state Lyme disease advisory bodies.

In Connecticut, Attorney General Blumenthal is holding patient meetings to assess the impact of the treatment law passed there which seems to have some unexpected problems for patients trying to obtain treatment. The New York State Assembly passed a resolution asking its professional medical licensing body and insurance companies to cease from attacking Lyme doctors on either side of the treating controversy, and it also passed a OPMC reform bill. New Jersey’s laws include identifying tick-control bodies in the state and requiring teachers with Lyme disease students to be inserviced annually on Lyme disease. New Jersey also adopted a statewide Lyme disease curriculum for schools.

The LDA has been an active part of many of the meetings and actions taken. Our message has been the same: become educated about Lyme and other tick-borne diseases (TBD’s), share data, strategies, and even personnel if necessary. Health departments need to take an active role in ensuring that cases are being reported and that accredited medical conferences for physicians on LD are promoted and publicized. Physicians need to be permitted to treat tick-borne diseases using their best clinical judgment, since cookbook approaches are not the answer. The depth of the Lyme problem needs to be understood by all, and preventive strategies, including tick control, need to be employed.

We must stop thinking that state boundaries govern our actions with respect to TBD’s. A study in the Archives of Neurology showing Bartonella henselae, the agent of cat-scratch fever, to be a potential tick-borne pathogenic co-infection in New Jersey, came as no surprise to California researchers who had already discovered it there in ticks, and as of my trip to California in March of this year, were already confirming human cases in their research labs.

We need to carefully assess the significance of the fact that the American Red Cross has recently amended its blood donor guidelines which originally stated, “Accept persons with Lyme disease if they were treated, the disease resolved and at least one year has passed” now adding “Those with chronic Lyme disease are not eligible to donate blood.” Individuals who have babesiosis are also prohibited from giving blood. The American Society of Clinical Pathologists (ASCP) released blood donor guidelines a few months agounder “serious illness,” it states, defer indefinitely babesiosis and Lyme disease.

V.I. Technologies, Inc. (Vitex), a biotechnology company dedicated to developing products that improve the safety of the transfusion blood supply by pathogen reduction or removal, just announced their INACTINE™ red blood cell process was successful in inactivating the Lyme bacteria as well as the West Nile virus. These studies have been accepted for presentation at the October American Association of Blood Banks Meeting in Florida. According to Mr. John R. Barr, President and CEO, Vitex, “further epidemiologic studies in human transfusion recipients are needed before the transfusion risk, if any, can be ascertained.”

The disease is here, there, everywhere, and we better begin to take responsibility for the implications of that fact. LDA has been contacted by Siberian, South American, Australian and Chinese doctors and researchers seeking pieces of the puzzle. Lyme disease is a vastly underrated threat to all who inhabit this ever-shrinking planet. By the time we decide whose backyard this disease is really in and freely allow doctors to treat it without political interference, we will have maimed, crippled, and killed tens of thousands more, many of them our children. Columbia University researchers have shown a drop of 22 points in IQ in children who suffer from chronic Lyme disease, a drop that is reversible with antibiotic treatment.

I hope that advances will come in time to protect your children. It may be too late for mine. Thank you.

Thank you. I am former chair of the NJ Governor’s Lyme Disease Advisory Council, former president of the Wall Township Board of Education and am a director for International Lyme and Associated Diseases Society (ILADS), a professional, medical society. The Lyme Disease Association, LDA, is an all-volunteer national organization providing Lyme disease education and funding for research projects nationally, including a past grant to URI for tick control and an $80,000 current grant to UMDNJ for a Lyme disease comparative genomic study.