Ukiah, CA – CALDA (Known as LDRC in 2003) Conference Speech

Ukiah, CA – CALDA (Known as LDRC in 2003) Conference Speech

Ukiah, CA – CALDA (Known as LDRC in 2003) Conference Speech

Pat Smith, President, Lyme Disease Association
Ukiah Conference May 17, 2003 Ukiah California

The Lyme Disease Association, LDA, is an all-volunteer national organization providing Lyme disease education and funding for research projects coast to coast, a number of which have been published in peer reviewed literature including JAMA. Several past projects LDA has funded include work on immune complexing, neurocognitive deficits in children, and borrelia in the gastrointestinal system. We funded some projects here in California including work on the effects of hormonal fluctuations on the disease. We are also funding two studies to determine if semen are present in sperm and/or in cervical tissue.

Some of the newest projects LDA is funding:
• Dr. Maria Pickens at Loyola University looking at the genomic sequence of Borrelia Lonestari, the bacterium which is found in Amblyomma americanum, the Lone Star Tick which produces STARI, Southern Tick Associated Rash Illness.
• Dr. Sam Donta, Boston University Medical Center investigating where the bacteria reside in the central nervous system.
• Dr. Joseph Burrascano is doing a patient retrospective study, plugging patient data into a computer program, which will categorize the data.
• LDA also has an exciting genetic research project underway Dr Steven Schutzer at University of Medicine & Dentistry. Dr Schutzer hopes to have some material ready to present at the LDAs medical conference co-sponsored with Columbia University to be held November 14, 2003 with CMEs awarded to physicians. The public is also invited to register. The International Lyme & Associated Diseases Society, ILADS, conference will follow November 15 & 16 and that conference is only open for ILADS members and non-member physicians.

I want to take a moment to speak about ILADS, International Lyme & Associated Diseases Society on whose board I also sit. It is a professional medical society composed of physicians, researchers and other health care providers. I sit on the Board of Directors as a representative to the Lyme disease community. ILADS is developing position statements and treatment guidelines to be disseminated to health care providers around the world. Its website,, contains useful information about physicians, and members can join the private discussion group through the site. ILADS has held several medical meetings already and the meetings include case discussions and treatment practices of the member physicians. Anyone interested in becoming a member can go to the site for details.

LDA has five national affiliates including Time For Lyme (TFL), formerly the Greenwich Lyme Disease Task Force. LDA and TFL are now in partnership with Columbia University to open an endowed chronic Lyme disease research center to be housed at Columbia. We are beginning a national fundraising effort for the center, with LDA and TFL already having raised one third of the monies required to open the center. Oscar-nominated actress Mary McDonnell, the LDA’s national spokesperson, is supporting our efforts and will be part of the national fundraising campaign. Interested donors can send contributions to the Center through the LDA. This will be the first center anywhere in the world devoted to chronic Lyme disease. It will use state-of-the-art brain imaging and bring an interdisciplinary approach to the study of the disease. Researchers from across the country will be able to apply for funds from the center. RFPs will come from Columbia to researchers soon. Dr. Brian Fallon will be its director.

Several projects currently underway at Columbia are being funded by LDA and TFL as part of the Center including one which will examine whether SPECT scans can be used to differentiate patients with LD with neurocognitive complaints from patients with anxiety/depressive disorders and from controls. Another study will determine whether CNS metabolic profile determined by MR Spectroscopy in patients with CNS Lyme is different than the CNS profile of controls and to determine whether neuronal degeneration is present in LD patients indicated by a decrease in levels of certain metabolites. A third project at Columbia has Dr. Steven Schutzer UMDNJ teaming with Dr. Fallon to identify Bb antigens in whole cell sonicates and recombinant Bb proteins by mass spectrometry and peptide mapping of individual peaks after enzymatic digestion, comparing these with known data base peaks, and determining if you can detect Bb antigens by peaks in patients

LDA is also affiliated with Lymenet, one of the best websites in the world for LD, and is a coalition partner with an organization in NY called STOP, Stop Ticks on People, which deals with tick control issues and LDA has a support program in Manhattan. Our affiliate in Lyme Association of Greater Kansas City just hosted me this past week and I was able to speak to educators in Kansas about the problems of children with Lyme. Our affiliate in Pennsylvania LDA of Southeastern Pennsylvania hosted a forum last weekend with Dr Burrascano and me speaking which drew over 500 people. LDA also has Chapters in Rhode Island, Pennsylvania, and a newly formed chapter in Massachusetts. We need to bring groups together from coast to coast to make inroads into understanding this disease.

Unlike other diseases, a discussion of Lyme is often not medical but political. The political climate dictates what the disease is, who can treat it, how it can be treated, and who gets treatment. Lyme is the most prevalent vector-borne disease in the U.S. and the most prevalent vector-borne bacterial disease in the world according to the World Health Organization coordinating committee, yet is rarely given the weight it deserves. Patients frequently cannot obtain diagnosis, treatment, insurance reimbursement, disability, education or even understanding from their families and peers because treating physicians throughout the country have faced a variety of licensure sanctions including being supervised, fined, not allowed to treat Lyme patients, and license suspension and revocation.

This pattern of patient and physician problems appears to be an anomaly when considered in light of activates at the federal level. Visiting the US Army Centers for Health Promotion and Preventive Medicine (CHPPM) at Aberdeen Proving Grounds, the LDA was surprised at its aggressive program, which includes impregnating army uniforms at the time of manufacture with permethrin for troops going into tick infested areas. CHPPM developed a pocket-sized lab to test ticks in the field so that soldiers may receive immediate treatment if bitten by ticks that test Lyme positive. Babesiosis and Ehrlichiosis are also being studied. Tick populations are mapped with resultant data stored in GPS satellites. This data will soon be beamed to soldiers in the field wearing special prototype helmets containing heads-up displays, which will show the soldiers where the heaviest tick concentrations and highest tick infectivity rates are, allowing armies to maneuver around them.

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. They are studying how bacteria communicate in a 3-dimensional situation. The NASA official in charge of the project spoke at the last LDA conference. The NIH granted Dr. Brian Fallon $4.7 million for a treatment study at Columbia University for patients who have failed prior treatments.

An issue with TBDs that has come to the forefront nationally is how they affect the blood supply. New Red Cross blood donor guidelines accept persons with Lyme disease if they were treated, the disease resolved and at least one year has passed. Those with chronic Lyme disease are not eligible to donate blood. Individuals who had babesiosis are also prohibited from giving blood. The American Society of Clinical Pathologists (ASCP) blood donor guidelines stateunder “serious illness,” defer indefinitely babesiosis and Lyme disease. In their April 1999 report to Congress entitled Activities Regarding Lyme Disease and Other Tick-borne Diseases, US Army CHPPM expressed its concern about the blood supply and tick-borne illness, mentioning Ehrlichiosis and possibly Rocky Mountain spotted fever as having been transferred through blood transfusions. Several studies in peer review discuss the actual transmission of babesiosis through the blood supply.

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 announced their INACTINE™ red blood cell process was successful in inactivating the Lyme bacteria as well as the West Nile virus. These studies were accepted for presentation at the October 2002 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.”

As early as 1993, in Washington, DC, US Senator Edward Kennedy held hearings focusing on the problems with the disease and the resultant political problems created for treating physicians. In 2002, the US Senate passed legislation (S 969) that would provide $50M over five years for research for a diagnostic test, and for prevention, and education. The LDA and TFL were heavily involved with this process and with Congressman Christopher Smith on the House side and Senator Christopher Dodd on the Senate side. At a Greenwich fundraiser a few weeks ago, LDA and Time for Lyme presented Connecticut Senator Christopher Dodd an award for his work with LD. The Senator graciously spoke some kind words about the work of the LDA and committed to Lyme disease efforts in DC this year. Since it is a new Congress this year, the bill will have to go through both House and Senate again.

In September 2002, Congressman Smith, Chair of the House Veterans Committee and the Commission on Security and Cooperation in Europe, hosted a meeting for the LDA in Washington, DC with the military. LDA took Drs. Burrascano, Liegner, and Fallon who presented data supporting the persistence of Lyme disease to about a dozen military officials and Congressman Chris Smith. The reason for the meeting was the LDA has received reports from the military and their families about not being able to receive appropriate treatment for the disease. The officials in DC did admit they had similar treating problems inside as we were having out outside. Subsequently, we have had communications with some of the officials, and I have provided a wealth of material on Lyme to the military.

I flew here from the Midwest where I spoke at the Emerging Infectious Diseases of the Central States Conference held at a veteran’s hospital in Columbia Missouri. Congressman Smith knew I was going and sent me a letter to read there. Here is an excerpt: “As you know, Lyme disease is not only the most common vector-borne infectious disease in the United States but it also is endemic in many other areas of the world , including places where thousands of US military personnel are deployed, like Bosnia and Kosovo. Moreover, many thousands of American soldiers, sailors, airmen, and marines–and their civilian counterparts and family members–live and work on military bases here in the US that are endemic for Lyme disease and other tick-borne infectious diseases.

As chairman of the house Veterans’ Affairs Committee, I believe these factors make Lyme and other tick-borne infectious diseases an issue of significant concern for the Department of Veterans’ Affairs. To the extent our military service members are being exposed to multiple vector-borne health threats, including Lyme disease, it is critical that the Veterans Health Administration is fully prepared to meet the needs of veterans who may need health care services to treat these tick-borne illnesses…. It is my job as Chairman, to make sure the VA has the resources and the managerial flexibility to meet these medical challenges.”

Federal case reporting requirements create problems for physicians and patients alike. As you know, cases of Lyme disease that are reported from each state to the Centers for Disease Control & Prevention, CDC, must meet the CDC surveillance criteria. The first problem concerns the numbers. The actual number of Lyme cases is estimated to be 10 times higher than reported cases. In the year 2000, nationally reported case numbers rose 8% with 17,730 cases reported, which equals 177,300 actual new cases for the year 2000.

Another problem with the LD reporting system occurs despite the warning the CDC places on its website which states “This surveillance case definition was developed for national reporting of Lyme disease; it is not appropriate for clinical diagnosis.” Many physicians still mistakenly diagnose based on the CDC case definition. The surveillance definition states that one must have either an EM rash or positive serology plus major system involvement. Studies have shown that the EM rash appears less than 50% of the time, and that other types of rashes may appear, or there may be no rash at all. Lyme disease tests are inaccurateantibody response tests such as ELISA and Western Blot can be negative when the victim has Lyme disease for many reasons including antibody-antigen complexing shown by Dr. Steven Schutzer of UMDNJ. Many insurance companies often do not accept doctor-prescribed testing such as PCR, which actually tests for the Lyme bacteria, although PCR is accepted for other diseases.

Insurance companies often use the CDC surveillance criteria for reimbursement determination. They may also limit treatment reimbursement to four weeks and substitute orals for IV. Therefore, treating physicians have a dilemma: treating sick patients who do not meet the criteria. Privately, several doctors 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 long-term treating physicians, while others, fearing reprisals or facing economic hardship, stop seeing Lyme patients.

At issue nationally to patients and doctors is the volume of complaints by medical boards against these treating physicians who already constitute a very small number overall. To address the Lyme disease situation in New Jersey, in 1993, Congressman Christopher Smith, now Veterans’ Committee Chair for the US House of Representatives, and Chair of the Helsinki Committee, held a public Congressional Lyme forum in New Jersey. At LDAs request two years ago, Congressman Smith’s office met with the NJ State Board of Medical Examiners, followed by an LDA meeting with the Examiners to discuss harassment by the medical licensing board.

State hearings on Lyme disease are increasing. Attorney General Richard Blumenthal held Connecticut hearings where he concluded that Lyme is a scientific controversy and doctors should be permitted to treat accordingly. The Texas state senate held hearings on Lyme and directed the Texas Board of Medical Examiners to develop review guidelines for doctors who provide medical care related to tick-borne illnesses. New York Assembly Health Care Committee held two hearings on Lyme disease due to concerns about OPMC harassment of treating physicians. I was asked to testify at both. A letter from Congressman Christopher Smith to the Health Committee, states: “that medical examiners are supposed to review complaints against physiciansstate boards of medical examiners to review complaints logged against doctors and to take action when needed, a concern that was expressed in my state was that some of the complaints were filed not by patients, by but insurance companies (and entities associated with them) who did not want to pay for the costs associated with treating Lyme patients under an aggressive antibiotic regimen. Using a state panel that is supposed to investigate malpractice to help achieve financial gain is simply wrong.” A letter from U.S. Congressman Joseph Pitts’ (PA) office to the same body states in part “We believe that Lyme disease is a scientific controversy and, consequently, medical boards should not prosecute physicians based on their treatment of this devastating illness.”

A resolution, which the LDA helped draft, resulted from those hearings and passed the NY State Assembly last year requesting that insurance companies and the Office of Professional Medical Conduct cease and desist from targeting physicians who fall on one side or the other of this controversy. A bill reforming the Office of Professional Medical Conduct, OPMC, also passed the Assembly last year and has been reintroduced this year. A new bill (A07365) just introduced in the Assembly protects physicians from being charged by the medical board for treating Lyme disease long-term.

The LDA was invited to testify before the Rhode Island Lyme Disease Commission last year. As a result of the hearing, Rhode Island successfully passed a law which protects physicians from harassment merely for treating Lyme disease patients. Additionally, the state was able to negotiate an agreement with Blue Cross that helps patients with the disease receive long-term treatment for Lyme disease. I am also excited to announce that the newly formed Lyme Disease Association, Rhode Island Chapter, LDARIC, was instrumental in the unanimous passage of a bill through the Rhode Island House of Representatives two weeks ago. The bill requires insurers in RI to pay for long-term treatment for Lyme disease. Next stop is the Senate.

California, Massachusetts, Minnesota, Connecticut, New Jersey, and New York, have enacted or introduced legislation addressing issues ranging from Lyme Advisory Councils to treatment and tick control to mandatory teacher in-service for educators in New Jersey who have students with Lyme disease. We have children around the country who are out of school for months and even for years. My own daughter was on home instruction for four years and then in school for a few hours each day the remainder of time.

The Connecticut treatment law enacted in 2000 appears to be causing problems for patients with Lyme disease. The original bill was crafted to enable patients to receive long-term treatment, unfortunately unacceptable language changes were inserted before passage. Obtaining treatment reimbursement from the insurance company after a mandatory second opinion from a specialist delineated in the bill (rheumatologist, infectious disease) has become difficult. States need to be wary when treatment issues are legislated, since changes can turn a patient friendly bill into an insurance friendly bill.

LDA has launched an educational campaign with state officials and to date has met with
• Connecticut State Attorney General Richard Blumenthal and Commissioner of Health Joxel Garcia
• New Jersey Senior Assistant Health Commissioner Blumenstock and the NJ State Board of Medical Examiners
• Rhode Island State Health Director Pat Nolan and the Governor’s office. I spoke at the bill signing in RI last year at the invitation of then Governor Almond.
• New York State Department of Health, Office of Professional Medical Conduct, and Governor Patakai’s office.
• Pennsylvania House of Representatives majority caucus and several forums including one last month in Sunbury sponsored by the Pennsylvania House of Representatives Majority Leader, Merle Phillips.
• LDA has helped organize and spoken at several congressional forums and forums hosted by state officials.

Last year I traveled throughout California speaking to officials, doctors, advocates and patients at your newly formed California Lyme Advisory Council. I told them that the problems I heard in California mimicked those of the east coast 5-6 years ago: a blindness to the fact that Lyme and other TBD’s exist and are mentally and physically crippling thousands of people. I suggested that they could learn from what had happened in the east. What I did not say was that many in the east still need to open their eyes and their minds to the devastation Lyme produces for patients and families alike.

Lyme disease is here, there, everywhere, and we had better begin to take responsibility for the implications of that fact. We have been in contact with Australian doctors looking at the disease, South American researchers looking for help, and a neurologist studying the neurological manifestations of the disease in China. The United Kingdom Lyme group is having its second conference, which LDA is sponsoring, in Britain. Germany is having another conference. We have heard from Siberian researchers seriously studying the disease there. I have heard of people getting the disease from infected ticks in the desert. A guidebook for Death Valley warns people to beware of the ticks there. This should send alarm bells to the thinking individual that 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 practice medicine without interference, we will have maimed, crippled, and killed tens of thousands more, many of them our children. Thank you.