NY– Assembly Health, Education & Codes Committee Lyme Hearing

PAT SMITH’S, PRESIDENT, LYME DISEASE ASSOCIATION, TESTIMONY TO NEW YORK ASSEMBLY HEALTH, EDUCATION & CODES COMMITTEE, JANUARY 31, 2002

 
(Note: after a brief history of the Lyme disease situation, I will be primarily discussing questions 7, 8, and 9)
 
(Testimony included in parenthesis was spoken testimony added at the hearing and thus just summarizes these comments)
 
The Honorable Chairmen Gottfried, Sullivan, & Lentol, and Members of the Committees,
 
Thank you for inviting me today. Besides president of the Lyme Disease Association, I serve on the Board of Director of ILADS, International Lyme and Associated Diseases Society, a professional medical society, am former chair of the (NJ) Governor’s Lyme Disease Advisory Council and former president of the Wall Township Board of Education.
 
The Lyme Disease Association is in all volunteer nonprofit 501 (c) 3 organization dedicated to prevention, education and raising funds for research for Lyme and other tick-borne diseases, TBD’s.[1] In March, with our affiliate, the Greenwich Lyme Disease Task Force, we will be presenting a check to Columbia for the establishment of an endowed research center for Lyme and other TBD’s to be opened at Columbia University.[2] (At this time, I invite Chairman Gottfried, Assemblyman Miller, and Assemblywoman Mayersohn to attend the opening celebration on March 21.)
 
Lyme is the fastest growing vector-borne disease in this country with New York State reporting the highest number of cases followed by Connecticut, New Jersey, and Pennsylvania. The Centers for Disease Control & Prevention, CDC, announced last week that cases increased by 8 percent in the year 2000.[3] Reported cases represent about 1/10th of actual reportable cases.   The Northeast region constitutes about 90 percent of the cases in the country. There are thousands of patients in these states that require doctors to treat them for chronic disease—symptoms that last longer then a typical 28-day treatment and may include ophthalmologic, cardiac, and central nervous system problems including seizures, depression, and psychiatric manifestations. [4] 
 
To prevent chronic disease, individuals must be diagnosed early and treated adequately. Lack of effective tests and physician education combined with the increase in other TBD’s is contributing to late diagnoses and often, undertreatment. The CDC has criteria for Lyme disease meant for surveillance purposes only, not for diagnostic purposes.[5] Many people do not meet the surveillance criteria set up by the CDC, but some doctors are only diagnosing using that criteria and insurance companies are often only paying for treatment based on those criteria. [6]
 
Lyme literate physicians, LLMD’s, often treat patients who do not fit that surveillance criteria, and therefore, they frequently find themselves in the difficult position of battling with their insurance providers and also with their state licensing boards. LLMD’s generally base their treatment regimen on clinical findings and sometimes use testing to support those findings.[7] In NY, a small number of physicians are willing to take the risks associated with treating chronic patients, and we estimate that 60% of our LLMD’s have been investigated for treatment practices by the OPMC.
 
New York, recognizing the significance of clinical practice issues states that in clinical practice cases, “Experts may be made available by the state medical society of the state of New York, by county medical societies and specialty societies, and by New York state medical associations dedicated to the advancement of non-conventional medical treatments.” [8]
 
The law does not, however, define “expert,” so individuals who have little or no clinical experience treating chronic Lyme disease can be called to testify as experts in cases involving physicians treating chronic Lyme disease. Plus, the OPMC process does not include a disclosure mechanism for the expert witness or discovery proceedings. Thus, witnesses who may have significant vested interests may provide information to an OPMC committee or testify against doctors without ever disclosing these interests unless or until the doctor’s attorney elicits them during the hearing. Since no discovery proceedings are available, it can’t be determined if, for example, an expert against the doctor may have used the exact same practice or procedure for a patient in the same circumstance in his own practice, yet he is now testifying against the doctor for that same practice—a circumstance, which we know, has already arisen.       
 
The initial interview the doctor has with the OPMC is an extremely important one in the process. This meeting is the basis for the determination of charging or not charging the doctor, yet no official transcript is kept of that meeting, thus, the doctor’s attorney has no way of subpoenaing the record of this interview, if said interview results in the doctor being charged. An official transcript should be made of this meeting.
 
In clinical practice cases, the role played by supportive evidence is crucial. Currently, in New York State, evidence is only admissible after two tiers are satisfied. First, the hearing officer rules whether evidence is/is not admissible. Second, if evidence is ruled admissible, upon cross-examination, the state expert is asked to recognize the authoritativeness of a particular journal. That same expert has usually been involved in making the initial recommendations that the doctor be charged, and now he/she is deciding on the evidence to be admitted. If he/she refuses to recognize the journal, it cannot be admitted as evidence. In one instance, evidence was allowed to be introduced in a case in defense of the doctor, yet in another case, the same evidence was not allowed to be entered. The first doctor was able to support his practices and was vindicated on most charges, while the second doctor was unable to admit the same evidence and his case was not so favorably disposed. There is existing federal case law, which New York does not recognize, that says the judge may take judicial notice and allow the literature to be presented. [9] A summary of the case is included.
 
Due Process is often an issue. The Federation of State Medical Boards states on its website “Whatever the complaint, physicians are afforded the rights of due process as the board investigates a complaint of misconduct. The tenants of due process state that an individual is innocent until proven guilty and apply to formal hearing/judicial procedures, which the medical board carries out by following established rules and principles, to ensure that a physician is not treated unfairly, arbitrarily or unreasonably.” [10] It seems that the literature standard results in unfair treatment of certain doctors since “hostile” experts solely determine which particular peer reviews qualify as evidence. 
Rules of evidence, such as bringing in outside evidence such as decisions from another case, need to be modified. Currently, precedence is not set, so that the hearing committee may conclude in one case, for example, that Lyme disease is indeed mired in scientific controversy and should not be the basis for OPMC investigation, yet the next doctor can be similarly charged and may not be able use that previous finding.                                                                                            
Secrecy surrounding the process should be examined. Currently, doctors are never told the original complainant or complaint. It puts the doctor in the position of not being able to confront his/her accuser. While some secrecy is understandable, the legislature might consider a more equitable practice, perhaps following New Jersey’s example with a form which clearly states on the application cover letter that “a copy of the complaint will be forwarded to the licensee with a cover letter from the Board requiring a detailed written response to the allegations in the complaint…. the complainant should understand that any information supplied on the complaint form may be subject to public disclosure.” [11] Another option is to have the OPMC use a form, which states that all complainants and complaints will be released to the doctor unless the complainant specifies why that disclosure could be harmful to him/her.
 
At the least, complainants could be separated by category, e.g., patients, insurance companies, peers, other entities. Patient complainant identities could always remain confidential if that is felt necessary, but other complainants would need to give a reason if they felt their identity should be kept secret. A peer’s reason to remain anonymous could be evaluated by the OPMC and a determination made based on the reason(s) provided. Insurance companies or other entities most likely to have vested interests could be identified immediately to the charged physician and hearing committee. As expressed in a letter addressed to Assembly Health Chair Dick Gottfried by Congressman Christopher H. Smith, Chairman of the US House of Representatives Veterans Affairs Committee, “While it is the job of state 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.”[12]
 
Secrecy has also perpetuated some questionable viewpoints. Officials have been publicly adamant in the cases of several of our treating physicians who were charged that the charges were unrelated to Lyme disease treatment. A few advocates, including me, and some NY assembly people attended a series of meetings with OPMC, health department, and other NY State officials. We were repeatedly told at these meetings that the Department of Health was not targeting Lyme doctors, nor were they soliciting complaints against them, and that charges against them were unrelated to Lyme disease treatment.
 
According to an NY assemblyman present at the last meeting we attended, the charges are indeed, directly related to Lyme disease treatment. We also subsequently discovered the word “Lyme” appears a total of 41 times in the factual allegations against two of the doctors. As for not soliciting complaints, a patient letter suggesting otherwise details her call to the NYDOH and two subsequent calls from them to her. Only seeking information on Lyme and other TBD’s from the DOH, she was subject to her diagnosis being questioned, told to see another physician other than her own, received an unsolicited complaint form in the mail from the DOH, and was pressured to file a complaint against her treating doctor. The DOH doctor told her that he and the DOH could obtain anyone’s record that they chose, including hers. She never filed a complaint; however, her medical records were pulled soon after the call, and she never heard from that DOH doctor again. [13] Her treating physician was eventually charged, despite the fact that the patient never filed a complaint against him. (What concerns me about this morning’s testimony relating to whether the OPMC solicits doctor complaints is that they appear not to be aware of what their employees are doing. I brought the above example to their attention at the first meeting in New York with health department and OPMC officials and Assemblypeople. Now at today’s testimony, the OPMC indicated in response to Chairman Gottfried that the individual(s) mentioned have not been disciplined, despite the fact they appear to have violated the confidentiality of that doctor. They not only told a patient on the phone that she should file complaints against her doctor, whose indentity she had not revealed according to her, but also told her that other complaints had been filed against her doctor, which appears to violate NY confidentiality laws.)
 
We in the Lyme community believe the targeting of NY Lyme physicians began in 1993, when U.S. Senator Edward Kennedy heard a prominent New York physician testify in his DC Senate hearing concerning the problems facing Lyme treating physicians: “…a few state health departments have now begun to investigate in a very threatening way, physicians who have more liberal views on Lyme disease diagnosis and treatment than they do… And indeed, I have to confess that today I feel I am taking a personal risk, a large one, because I am stating these views publicly.”[14] Two weeks after that hearing, that physician received a notice that an investigation was begun by New York State.
 
Even after he was cleared by the OPMC on initial complaints, his lawyer informed him his case was kept open, something the lawyer had never seen in his 30 years of experience. The investigation continued with more charts pulled. Although chart selection was supposedly random, only charts of chronic Lyme patients were kept for further review. He was eventually charged. In 2001, eight years after the initial investigation, he was exonerated on most of the charges against him. Incredibly, the OPMC then filed an appeal of that decision rendered by its own hearing committee. Ironically, one of the OPMC officials told us at a meeting that New York State provided the best example of due process for doctor disciplines in the nation. 
 
Targeting physicians and rendering discipline in a scientific controversy are not the role of the OPMC or any state licensing review board. Comments from numerous officials nationwide support this statement: Office of US Congressman Joseph Pitts, PA, to Health Committee Chair Dick Gottfried, “We believe Lyme disease is a scientific controversy and, consequently, medical boards should not prosecute physicians based on their long term treatment of this devastating illness.”[15]
 
Congressman Christopher Smith, NJ, to Chairman Gottfried: “Lyme disease is unique because debates among the medical and scientific community often revolve not only around treatment, as is the case for other diseases, but around diagnosis as well. Two well-trained and well educated physicians could review identical patient symptoms and make a different diagnoses….I do not want anyone…to suffer because the doctor they were depending on for treatment has decided to stop seeing Lyme patients out of fear that aggressive therapy will result in an investigation of their practice. The investigatory “chilling effect could have a real impact on the ability of patients to receive quality health care when seeking assistance with this disease.” [16]
 
From Connecticut Attorney General Blumenthal at his state hearings on Lyme disease: “Different people at various stages of the disease may need different treatments, and my own basic philosophy is that decisions about diagnosis and treatment ought to be made by the treating physician and the patient, and those decisions ought to be respected by insurance companies, by government officials and ought not to be governed by arbitrary artificial dictates or regulations.”[17]
 
From the interim report The prevalence of Tick-borne Illnesses in Texas from the Texas Senate Committee on Administration “The Committee has concluded from this study that insufficient information on how these diseases should be identified and managed over the long term exists for ANYONE [their emphasis] to make a definitive determination of appropriate diagnostic or treatment guidelines.” Furthermore, a report recommendation “Directs the Board of Medical Examiners to develop guidelines in reviewing and investigating medical care providers when treatment of tick-borne illnesses is involved.”[18]
 
A letter to U.S. Senator Rick Santorum, PA, from the PA Commissioner of the Bureau of Professional and Occupational Affairs: “Regarding your inquiry into whether the office is conducting any investigations into the medical practices of Pennsylvania licensed physicians who treat Lyme disease…anecdotal responses indicate that there may have been one or two such complaints in recent years, which were closed without any action by the Prosecution Division because of lack of consensus in the medical community as to the appropriate standard of care made it difficult or impossible for a prosecutor on behalf of the Commonwealth, with an expert’s opinion in support, that a particular method of treatment did not meet the standard of care.”[19]
 
The ultimate irony is embodied in my last quote, which also appears to hint at a double standard for Lyme disease treating physicians. In a letter to a Lyme patient who filed a complaint against a doctor opposed to long term treatment, Dr Ansel Marks, MD, JD, Executive Secretary for the NY Board of Professional Misconduct states: “As defined by law, a difference of medical opinion, in and of itself, is not medical misconduct.” [20]
 
The secrecy surrounding the OPMC process combined with the power of the agency is a concern for legitimate physicians and patients alike, since there appears to be little or no oversight of the OPMC. Through their actions, they have the power to bring New York physicians and consequently, patients, to bended knee, but where is the authority that can bring them to their knees? Even at the first hearing before the Health Committee in November, no one from that office appeared. I wondered what message that sent to the legislators. I know what message it sent to me—we are not accountable to you in the actions we have taken against Lyme disease treating physicians. 
 
After hearing today’s testimony, I ask that you find a way to rein in the power of the agency without losing site of its mission to protect the patients. Please remember Lyme disease patients
·         are not being protected when their treating physicians are afraid to treat in New York and patients have to travel elsewhere to get treatment,
·         are not being protected when their doctors must spend half their practice time defending their right to practice medicine according to their best clinical judgment, and
·         are not being protected when their already small number of doctors become smaller because their licenses are revoked for treatment of a debilitating illness, Lyme disease, about which the then Commissioner of the New York State Department of Health, David Axelrod, MD said in a 1988 communication to all New York Physicians, “Treatment of secondary and tertiary LD may require prolonged therapy with intravenous antibiotics.”[21]
 
 
(Before ending, I would ask that the committee to ascertain when the OPMC changed their policies regarding Lyme disease treatment guidelines. This morning they testified that they did not use treatment guidelines in cases of Lyme disease physicians. Yet we have many letters, I would hesitate to say dozens, but probably dozens, to patients and Lyme disease groups which state the guidelines the OPMC said they used.
 
Chairman Gottfried, in response to your question as to whether an increased use of lay people on the committees would help, I would like to say it could be a factor, but it is my personal opinion as an outside observer studying this process these past few years and speaking with doctors, lawyers, and patients on the issue, I believe the most important change which could be made would be to lift the veil of secrecy surrounding the process. I think almost all the speakers here today have agreed that that aspect is necessary. It has been my experience in government, 12 years on the board of education, that government agencies are only accountable when you hold them accountable. I see very little accountability here for the OPMC due to the vast secrecy involved. When you lift that veil, as was begun today, I do not think you will like what you see, I know I haven’t liked it.)
 
Thank you.
 


[1] LymeR Primer, The ABC’s of Lyme Disease

[2] Letter to LDA & GLDTF from Gerald Fischbach, MD, Dean of the Faculty of Medicine, Columbia University              

[3] AP online January 17, 2002

[4] http://columbia-lyme.org/dept/nyspi/flatp/lymeoverview.html

[5] http://www.cdc.gov/ncidod/dvbid/lyme/casedef2.htm

[6] Aetna guidelines http://www.aetnaushc.com/cpb/data/CPBA0215.html, Prudential Guidelines, March 1995

[7] http://www.cdc.gov/ncidod/dvbid/lyme/diagnosis.htm

[8] Section 230 10(a)(ii) State Board for Professional Medical Conduct Proceedings

[9] Daubert vs. Merrell Dow Pharmaceuticals (92-102), 509 U.S.579, 1993

[10] http://www.fsmb.org/

[11] NJ State Board of Medical Examiners complaint form

[12] Congressman Christopher H. Smith letter to Chairman Richard Gottfried, November 27, 2001

[13] K.M. letter To Whom It May Concern, about experiences calling NY Department of Health July 2, 1998

[14] Lyme disease: A Diagnostic and Treatment Dilemma Hearing of the Committee on Labor and Human Resources United State Senate, August 5, 1993

[15] Office of Congressman Joseph Pitts to Health Committee Chair Dick Gottfried, November 23, 2001

[16] Congressman Christopher H. Smith letter to Chairman Richard Gottfried, November 27, 2001

[17] http://www.cslib.org/attygenl/mainlinks/tabindex6.htm

[18] [Texas] Senate Committee on Administration, The Prevalence of Tick-Borne Illnesses in Texas, Interim report, 77th legislature, November 2000

[19]Pennsylvania Commissioner Bureau of Professional & Occupational Affairs Dorothy Childress letter to U.S. Senator Rick Santorum, April 26, 2000

[20] Executive Secretary, NY BPMC Ansel Marks, MD, JD letter to Joseph Burke, December 29, 1999

[21] Commissioner of Health David Axelrod, MD, to all NY doctors, October 6, 1988




Ukiah, CA – CALDA Lyme Disease Conference


Doctor Greg Bach, Professional Advisory Board Member for the Pennsylvania Chapter, Lyme Disease Association (PCLDA), and Jeri-Lynn Weir, Co-president PCLDA, Edina Gibb, LDA County Coordinator, and Pat Loughran had previously met with Mary to discuss the effects of Lyme disease. After my three days with Mary in California, she agreed to become a spokesperson for the Lyme Disease Association. A few days after I retuned home from California, I attended the Columbia University luncheon honoring the effort of our affiliate, Greenwich Lyme Disease Task Force (GLDTF), and LDA and our initial commitment to the endowed Lyme disease research center. Mary flew to New York to join us for the luncheon and met Dr. Brian Fallon and Dr. Carolyn Briton in person. Dr, Briton, Columbia neurologist, had given the LDA powerful video presentation for the Albany hearings.


On my last day on the southern leg of my trip, Barbara Barsochini arranged for me to be interviewed for a TV program on Lyme disease, which continues to air, for Malibu Public Television. Barbara proved to be a delightful host and knowledgeable interviewer. Before I traveled North, I also received word that the Lyme Association of Greater Kansas was interested in coming on board as an affiliate of the LDA. I had conferenced with them and we had emailed back and forth prior to my trip. This was affiliate number five.


Flying north, I was singled out for a wand and luggage search on my flight to Palo Alto, making me cognizant of the strict procedures put in place to screen for terrorists. There was something about that episode that made me confident the government was doing its job. It also made me continue to wonder why we had not yet developed strict screening procedures for Borellia burgdorferi, a terrorist of another sort, an unseen enemy slowly marching its way across the nation almost unopposed by those who are charged with stopping its carnage.


The Harrises were wonderful, although Dr, Harris may have some observations on the heft of my suitcase he was too polite to mention, and the tour of IGeneX Labs was elucidating, as I was able to actually see firsthand some of the tests being performed and meet those responsible for carrying them out. I was surprised at the amount of interest in the LDA and Lyme disease from IGeneX staff.

Karen Chew was my next host, and her friendliness, not to mention her penchant for fabulous cooking, was not dampened even when my suitcase knocked over her lemon tree. She introduced me to someone whose avocation, I believe, makes her a valuable ally to the Lyme community. Karen drove me to the lovely Sacramento Valley, home to the meeting of the California Lyme Advisory Committee where I was able to finally put faces to the names of many Lyme activists whom I had communicated with over the years and who are doing a great job in California, including Peg Leonard and Nancy Brown. The judge I mentioned earlier showed up to hear me speak, but unfortunately, had to catch a plane before that happened at the end of the day.


I believe what I said was well received, and some health department officials who attend asked for copies of the speech to be disseminated. Unfortunately, I spoke extemporaneously, but the entire event was videoed courtesy of Dr. Lynn Shepler, who agreed I could have a copy of the tape, which I am anxiously awaiting. Dr Shepler has been a continued critic of the Council and was instrumental in helping obtain open forums.

NY– Assembly Health Committee Lyme Hearing

Pat Smith’s, President of the Lyme Disease Association, testimony to the New York Assembly Health Committee, November 27, 2001, in Albany, New York
 
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 I sit on the board of directors of the International Lyme and Associated Diseases Society, a professional, medical society. The LDA is an all-volunteer national organization providing Lyme disease education and research dollars. Along with an affiliate, The Greenwich Lyme Disease Task Force, the LDA is opening an endowed Lyme disease research center at Columbia.
 
Lyme is the fastest-growing vector-borne disease in the U.S., yet it is rarely given the weight it deserves. The situation facing patients and physicians in New York is not unique; it mirrors the nation. Patients frequently cannot obtain diagnosis, treatment, insurance reimbursement, disability, education or even understanding from their families and peers. Treating physicians have faced a variety of licensure sanctions including being supervised, fined, not allowed to treat Lyme patients, and license suspension and revocation.
 
In one of the earliest responses to Lyme problems, New Jersey enacted the first Governor’s Lyme Disease Advisory Council in 1991. California and Rhode Island are following suit. Minnesota, Connecticut, New Jersey, New York (Tick-borne Disease Institute), and Pennsylvania have enacted or introduced legislation, addressing issues ranging from treatment and tick control to mandatory teacher in-service for educators.
 
At the federal level, several pieces of legislation are before congress. Additionally, in 1993, Senator Edward Kennedy heard a prominent New York physician testify in DC Senate hearing concerning the problems facing treating physicians: “…a few state health departments have now begun to investigate in a very threatening way, physicians who have more liberal views on Lyme disease diagnosis and treatment than they do… And indeed, I have to confess that today I feel I am taking a personal risk, a large one, because I am stating these views publicly.”[1] The doctor was later charged by the New York OPMC .
 
The US Army Centers for Health Promotion and Preventive Medicine has developed a pocket-sized lab to test ticks in the field. Soldiers may receive immediate treatment if bitten by ticks that test positive for Lyme. Babesiosis and Ehrlichiosis are also being studied. Tick populations are being mapped. Satellites are beaming the data to special prototype helmets worn by field soldiers, allowing armies to maneuver around heavy tick concentrations. NASA and the NIH have a joint culturing project for Lyme disease bacteria using microgravity chambers, which mimic conditions in space and in the human body. [2]
 
New York, with its highest reported Lyme disease cases, joins its contiguous states Connecticut, Pennsylvania, and New Jersey constituting a block of the top four states in the nation in reported cases. Reported cases must meet the CDC (Centers for Disease Control & Prevention) surveillance criteria: a physician diagnosed EM (bullseye) rash, or positive bloodwork and other system involvement.  The actual number of Lyme cases is estimated to be 10 times higher than reported cases.[3] The CDC reports 3,626 Lyme disease cases in New York for the year 2000, which equals 36,260 actual cases for that one year alone. Nationally in 2000, the reported number is 15,328, which equals 153,280 actual cases.[4]
 
According to the CDC, the surveillance criteria is NOT to be used for diagnosis, since patients often do not meet the strict surveillance definition. Despite CDC warnings, many physicians use the surveillance criteria to diagnose cases, and many insurance companies deny treatment to anyone not meeting those criteria. Excerpts from two Lyme protocols used by insurance companies seem to base coverage on the surveillance criteria, requiring symptoms supported by positive antibody response tests. [5]  
 
Insurance companies use graphs depicting antibiotic prescribing patterns and 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, TB, even anthrax. They limit treatment to 28 days, substitute orals for IV, and use the surveillance criteria for reimbursement determination. Therefore, doctors 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.
 
An insurance company letter to a New Jersey patient states: “Unfortunately, a number of unscrupulous practitioners in this and neighboring states have held themselves out as experts in the treatment of Lyme disease. These individuals have subjected patients to improper diagnoses, excessive treatments, inordinately long courses of intravenous therapy, and other activities not supported by science or generally accepted standards of medical practice. Because our organization has been appropriately vigilant and aggressive in dealing with certain practitioners, they have chosen to leave our network.” [6]
 
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 situation in New Jersey, in 1993, Congressman Christopher Smith held a public Congressional Lyme forum. Last year, the NJ State Board of Medical Examiners met with Smith’s office, followed by a meeting with the LDA and a Lyme literate physician. The LDA had other meetings on the controversy with state health commissioners in Connecticut, Rhode Island and New Jersey, and we addressed the Pennsylvania House of Representatives majority caucus.
 
Today’s hearings are not without precedent. Besides Attorney General Blumenthal’s Connecticut hearings, Texas recently held state senate hearings on harassment of physicians who treat Lyme. A recommendation from that hearing committee “Direct[ed] the Texas Board of Medical Examiners (BME) to develop review guidelines for doctors who provide medical care related to tick-borne illnesses.” [7]
 
In New York, we met with representatives of the OPMC, health department, and the Governor’s office, motivated by the fact that almost 60% of doctors who treat chronic Lyme disease in NY State have faced OPMC scrutiny the past year. At a meeting this year OPMC reps said that “some of our best tips come from insurance companies.” NY law prevents doctors from ever knowing the original complaint or complainant, thus treating doctors run the risk of spending tens of thousands of dollars defending their right to treat a patient even when the patient has improved, the patient is not complaining, and the patient objects to his/her records being used against the doctor. (See Sowell letter in packet).
 
In a letter from Congressman Christopher Smith, House of Representatives Veterans’ Affairs Committee Chairman, to the NY Assembly Health Committee he states: “While it is the job of state 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.”[8]
 
Additional concerns arose from the NY meetings when officials repeatedly assured us that none of the charges against the NY physicians was related to Lyme disease. We subsequently discovered the word “Lyme” appears a total of 41 times in the factual allegations against two of the doctors. A New York Assemblyman who viewed the charges, confirmed at the meeting with the Governor’s chief counsel that the charges were Lyme-related.
 
The Department of Health indicated that it was not actively soliciting complaints against treating doctors. A patient letter suggesting otherwise details her call to the NYDOH and two subsequent calls from them. Only seeking information on Lyme and other tick-borne diseases, she was subject to her diagnosis being questioned, told to see another physician other than her own, received an unsolicited complaint form in the mail from the DOH, and was pressured to file a complaint against her treating doctor. The DOH doctor told her that he and the DOH could obtain anyone’s record that they chose, including hers. She never filed a complaint; however, her medical records were pulled soon after the call, and she never heard from that doctor again. [9] Her treating physician eventually faced charges.
 
Lyme disease is so complicated that physicians whose publications are often quoted to deny persisting infection have been shown to make statements that appear to be conflicting. Witness a 1990 response letter from a prominent rheumatologist to the Connecticut Department of Health. He refers to a specific doctor “treating these people with prolonged courses of antibiotic therapy. …patients have usually not required the prolonged courses of antibiotics suggested in his handout….I think it is unfortunate that the Lyme Borreliosis Foundation and the doctors often associated with them have become major spokesmen for Lyme disease. I believe they are the principal force leading to the overdiagnosis and overtreatment of this illness. Do you have any ideas regarding what to do about this?” [10] Coincidentally, the two physicians named in the letter by the rheumatologist were subsequently charged in their respective states.
 
In 1994, that same rheumatologist wrote to patients: “I would like to invite you to participate in long-term follow-up studies of our patients who have had Lyme disease. It has become increasingly apparent that the Lyme disease spirochete,… may persist in some patients for years. Of particular concern, recent studies have shown that the spirochete may persist in the nervous system in a small percentage of patients and may cause chronic neurologic involvement.”[11]
 
(Present book with persistence of infection documentation). Add that the committee is free to review or not review these articles which give peer-review weight to persistence; contrast this with our doctors in New York, who have not been permitted to enter into evidence in their OPMC hearings, many peer-reviewed articles supporting their treatment regimens so that the validity of their treatments could be more adequately assessed.
 
Also at this time ask hypothetical question: How would the committee feel if I announced at this time that I am a CEO of a major pharmaceutical company? Would you be upset that I am testifying and you would have called another witness if you had known in advance, since I could benefit significantly from testimony? Would you look back on my testimony and assess it a different weight because of my position, give it less credibility perhaps? This is how our doctors feel, because as I found out in directly questioning OPMC officials, they have no disclosure policy or procedure for either selecting or during proceedings disclosure from witnesses testifying against our doctors, and although it may be exposed during lawyer cross-examination, this exposure may come later in process or not at all. For the record, please let it be known I am not now nor never have been a CEO for a major pharmaceutical.
 
 
 
Lyme is an enigma. While the debate rages over proper diagnostic and treatment procedures, patients get sicker and some even die. [12] The rational answer to this medical and moral dilemma lies in a quote from Ansel Marks, MD, JD, Executive Secretary for the Board of Professional Misconduct. In a letter to a Lyme patient who filed a complaint against a doctor opposed to long term treatment, Dr Marks states: “As defined by law, a difference of medical opinion, in and of itself, is not medical misconduct.” [13]
 
 
 
 
 
 
 
 


[1] Lyme disease: A Diagnostic and Treatment Dilemma Hearing of the Committee on Labor and Human Resources United State Senate, August 5, 1993

[2]Lyme & Other Tick-borne Diseases: A 21st Century View, LDA Princeton medical conference brochure, November 10, 2001

[3] Roberts, David M., et.al., “The bdr Gene Families of the Lyme Disease and Relapsing Fever Spirochetes,” Emerging infectious Diseases, 6(2), 2000. Centers for Disease Control

[4] Centers for Disease Control & Prevention,ed., Morbidity & Mortality Weekly Report, November 17, 2001
 

[5] Aetna guidelines http://www.aetnaushc.com/cpb/data/CPBA0215.html, Prudential Guidelines, March 1995

[6] Horizon Blue Cross Blue Shield letter to patient, August 24, 1999

[7] [Texas] Senate Committee on Administration, The Prevalence of Tick-Borne Illnesses in Texas, Interim report, 77th legislature, November 2000

[8] Congressman Christopher H. Smith letter to Chairman Richard Gottfried, November 27, 2001

[9] K.M. letter To Whom It May Concern, about experiences calling NY Department of Health July 2, 1998

[10] M.D. letter to George Kraus, Director of Health, DOH, Milford, Connecticut, July 30, 1990

[11] M.D. letter to physicians, August 11, 1994

[12] Death certificate

[13] Ansel Marks, MD, JD letter to Joseph Burke, December 29, 1999




MD – Vaccines & Related Biological Products Advisory Committee

REMARKS OF PAT SMITH, PRESIDENT, LYME DISEASE ASSOCIATION, INC. BEFORE THE VACCINES AND RELATED BIOLOGICAL PRODUCTS ADVISORY COMMITTEE, JANUARY 31, 2001, BETHESDA, MD

 

The Lyme Disease Association’s mission is Lyme disease education, prevention, and research funding, so one might automatically assume we’re favorable to a safe and effective vaccine for Lyme disease. That’s certainly a valid assumption. The Association’s board consists of patients and families of patients—all of whose lives have been personally touched by this disease, and all who are dedicated to preventing others from experiencing the physical, mental, and emotional devastation Lyme disease can produce. To that end, we fund research projects, sponsor medical conferences and continue to work with Members of Congress developing federal legislation providing $125 million for Lyme disease research, physician education, and prevention.

I am here today because we do favor a safe and effective vaccine, but we are unsure whether an OSP A based vaccine can meet those criteria. Since the inception of OSP A vaccine trials, we heard from individuals experiencing difficulties after immunization. The information was startling, not only because of the problems described, but also because of doctors’ apparent incomprehension of the problem. At a vaccine meeting sponsored by the LDF where pharmaceuticals reps were discussing how well the trials were going, I questioned, without satisfaction, the issue of these trial-patient complaints.

After vaccine approval, LDA received inquiries about the vaccine, many from individuals who had received all or some of the vaccination series. Most proceeded to talk about symptoms they developed subsequent to receiving the vaccine. When asked if they had reported this to the administering doctor, and if the doctor had reported the adverse event, the usual response was that the doctor did not take the complaint seriously or did not think the symptoms were related.
Sadly, none were aware of the HLADR4 situation, and several were in the midst of the immunization series and did not know whether to continue taking the shots. Some called to ask if they should get the shots if they had had Lyme in the past, a question which appears to have no clear answer—particularly in light of the unreliable antibody response tests used to determine who has or had Lyme disease. A few insisted they had gotten “full blown Lyme” from the shots, and after further discussion, indicated they had had Lyme disease in the past.

I want to share an email I received Monday. “I live in Wisconsin. I received your name from person X who told me you may be able to give me some direction. I received two vaccines in the spring of 2000. Couple days within the first shot my neck and higher back stiffened up severely. In a month I went back for the second shot and asked the nurse and doc to check for side effects before I took the second. They informed me there were none. I took the second dose and the problem with my neck and back worsened within a couple of days. My family doctor gave me anti-inflammatories but they did nothing. I’ve tried a chiropractor but the only relief was for a couple of hours. Never tried one before but am getting desperate. Then I went to a orthopedic and am now on anti inflammatories again but not helping. He told me that I have a disc that is somewhat smaller than the others in my neck and maybe the vaccine somehow aggravated it. Prior to the vaccine I have had 0 neck or back problems. I am looking for treatment somehow someway.” I called him. He is 39 years old. He asked me to help him. He wants treatment for what he has.

Today you are hearing about how this vaccine has physically impacted human lives. It appears that little can be done to stop whatever process triggers some of these reactions, or if something can be done, it remains as yet undiscovered. I listen to the despair and bewilderment of those adversely impacted: How can this happen from a medicine to keep me from getting sick? Who can help me get better? I can only comfort them as I do not have any answers, and I do not know who does.
 
This committee has the authority to formulate recommendations that may prevent others from potentially suffering the same fate. You can revisit the original data and research which appears to show a link between OSP A and adverse reactions and view it in light of the adverse events you have now heard about. You can recommend further studies. You can find out why many doctors who treat chronic Lyme disease are not giving the vaccine.

The Advisory Committee on Immunization Practices recommends under future considerations in their report on the Lyme disease vaccine, June 4, 1999 MMWR, “establish post licensure epidemiological studies of safety, efficacy, prevention effectiveness, cost effectiveness, and patterns of use.” We concur with that recommendation and would like to see a moratorium on vaccine administration until those studies are completed and the results critically analyzed.

Thank you for your time.
 



Sunbury, PA – Conference Hosted by PA Representative Merle Phillips

Sunbury, PA – Conference Hosted by PA Representative Merle Phillips


(For introduction: Pat Smith, President, Lyme Disease Association; Member, Board of

Directors, ILADS, International Lyme & Associated Diseases Society; Advisor, Greenwich Lyme

Disease Task Force; Former chair, Governor’s Lyme Disease Advisory Council (NJ); Former

President, Wall Township Board of Education)

Lyme Disease Association President Pat Smith’s Remarks in Sunbury, PA Forum

Sponsored by PA House of Representatives Majority Leader, Merle Phillips

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. Several past projects LDA has funded in Pennsylvania

were at Fox Chase Cancer Center and at University of Pennsylvania. Additionally, we are

funding a study here looking for the Lyme disease bacteria in semen to take the first step to

determine whether Lyme disease may be sexually transmitted.

The LDA has a Pennsylvania Chapter and has five national affiliates including the Lyme Disease

Association of Southeastern Pennsylvania. Along with its CT affiliate, the Greenwich Lyme

Disease Task Force, LDA has partnered 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 GLDTF already having already contributed $.7

million, leaving $2.3 million remaining to open the center.

Lyme is the most prevalent vector-borne disease in the U.S. and the most prevalent vector-borne

bacterial disease in the world, yet is rarely given the weight it deserves. The situation facing

patients in Pennsylvania 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 because treating physicians 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.

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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 NASA official in charge of the project spoke at the last LDA conference.

As early as 1993, US Senator Edward Kennedy held hearings in Washington, DC focusing on

the problems with the disease and the resultant political problems created for treating physicians.

More recently at the federal level, congressional members commissioned a General Accounting

Office (GAO) investigation of government agency funding of Lyme disease studies. 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. Pennsylvania Senator Rick Santorum worked

closely with Connecticut Senator Dodd in the passage of this bill, and the LDA was heavily

involved in that process. Unfortunately, the House did not review the bill before the session

ended, so the bill died. It will be reintroduced into congress again this session.

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 reporting system itself creates

several problems, the first being 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. New York,

Connecticut, Pennsylvania and New Jersey, respectively, are the top four states in the country for

Lyme disease. To date, Pennsylvania has reported 2,848 Lyme cases in the year 2002, which is

about 20,848 actual cases. Only four PA counties had no reported cases from 1999-2000, and

Chester and Cameron Counties had the highest incidences. Northumberland County where we

are tonight is endemic for Lyme (two cases acquired or infected vector present) and is in the top

16% of counties in PA for reported Lyme disease cases (11/67).

Another problem occurs despite a CDC warning 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!underActivities Regarding Lyme Disease and Other Tick-borne Diseases, US Army

 

the victim has Lyme disease. 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 such as HIV, hepatitis, and TB.

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.

An insurance company letter to a New Jersey patient states: “Unfortunately, a number of

unscrupulous practitioners in this and neighboring states have held themselves out as experts in

the treatment of Lyme disease. These individuals have subjected patients to improper diagnoses,

excessive treatments, inordinately long courses of intravenous therapy, and other activities not

supported by science or generally accepted standards of medical practice. Because our

3

organization has been appropriately vigilant and aggressive in dealing with certain practitioners,

they have chosen to leave our network.”

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, 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 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

“Direct[ed] the Texas Board of Medical Examiners (BME) 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 the Lyme disease due to concerns about OPMC

harassment of treating physicians. A letter from Congressman Christopher Smith to the Health

Committee, states: “While it is the job of state 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. It states in part “Resolve That this legislative body pause in its deliberations

to request 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, until such

time as medical research and the medical community have determined the appropriate

parameters for the diagnosis and treatment of tick-borne illnesses.” A bill which would reform

the Office of Professional Medical Conduct in NY, OPMC, also passed the Assembly last year.

Both measures will probably be reintroduced this year.

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. Some bugs remain to be worked out in the agreement, and a Lyme

group in RI is currently working on that issue.

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. The Connecticut law

(Managed Care Reform Bill #7032) enacted January 1, 2000, appears to be causing problems for

patients with Lyme disease. Getting treatment has become more difficult. The original bill was

4

crafted to enable patients to receive the appropriate treatment, unfortunately, unacceptable

language changes were inserted before passage.

LDA has advocated a regional approach to the Lyme problem and has met in Connecticut with

State Attorney General Richard Blumenthal and Commissioner of Health Joxel Garcia, in New

Jersey with Senior Assistant Health Commissioner Blumenstock, and in Rhode Island with State

Health Director Pat Nolan. In New York, LDA has met with representatives from the State

Department of Health, Office of Professional Medical Conduct, and Governor Patakai’s office.

Here in Pennsylvania, we spoke to the Pennsylvania House of Representatives majority caucus.

Last year, I traveled throughout California for two weeks speaking about Lyme disease to

doctors, patients, advocates, and officials. I had the opportunity to address the newly created

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 here in the east. What I did not say was that many in the east need to

open their eyes and their minds to the devastation Lyme produces for patients and families alike.

Last fall, Congressman Christopher Smith hosted a meeting for the LDA in Washington, DC

with the military. There, several doctors presented data to about a dozen military officials

supporting the persistence of the disease. The reason for the meeting is the LDA has received

reports from the military and their families about not being able to receive appropriate treatment

for the disease. The officials did admit they had similar treating problems inside as we were

having out outside. Subsequently, we have had communications with some of the officials.

An issue with TBDs that has come to the forefront is how they affect the blood supply. New Red

Cross blood donor guidelines state “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

“serious illness,” defer indefinitely babesiosis and Lyme disease. In their April 1999 report to

Congress entitled

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.

Lyme disease is here, there, everywhere, and we had better begin to take responsibility for the

implications of that fact. We have been contacted by Siberian researchers seriously studying the

disease there, South American researchers looking for help, and a neurologist studying the

neurological manifestations of the disease in China. I have heard of people getting the disease

from infected ticks in the desert. 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.




Gettysburg, PA – T.O.F.U. Lyme Awareness Day


PAT SMITH

This speech is dedicated with love to C.S., 7 weeks from graduation, who has inspired me with her tenacity, positive attitude, and commitment to succeed and live life to the fullest despite all the obstacles thrown in her path.

To: Senator Santorum, Mr. Mayor, other elected officials or their representatives, and especially, the Lyme community

One hundred thirty seven years ago, two conflicting armies met here for a decisive battle considered to be the turning point in the Civil War. Later that same year, Abraham Lincoln dedicated this battlefield to those who sacrificed themselves in that war. That war was about personal freedom.

Today, it is not a coincidence that we have come from across the country and assembled here in Gettysburg. We have fought our own kind of war, many for more than a decade. Like the Civil War, we as a people are divided, state against state, community against community, family member against family member, doctor against doctor. Each carries the banner of righteousness. While the sides battle, the victims drop.

We are the only ones who can uncover this truth, those of us who have lived in its shadow for so long. We must drag it out of the shadows and into the sunlight for all to see. What is this truth? This truth is that Lyme disease is a serious illness, an illness which can be carried by several types of ticks but is predominantly transmitted by an animal the size of a poppy seed. The infected tick is found in great abundance here in Pennsylvania, a fact that has made PA 3rd in the nation in Lyme cases. That little but mighty animal, the tick, has caused us great harm, but it is an animal with no ability to reason. The infected tick bites us to survive, the bacteria enters us to survive. There is no reasoning there, no malice intended.

Fortunately, our officials in NJ and PA have been responsive to our plea for help. Congressman Christopher Smith has written and introduced the Lyme Disease Initiative 1999 in the House, and Senator Santorum in the Senate. The bill will provide $125 million for Lyme disease research. The prioritized goals are a sensitive and specific test, examination of the Centers for Disease Control surveillance criteria for Lyme, physician education, the role of other tick borne diseases, and a reduction of disease in the ten highest states. Monies would go to the CDC, NIH, DoD, DoA, and DoI. You must understand that government money for Lyme has been spent in the past, and without this bill, will continue to be spent without input from the Lyme community. Under this bill, for the first time, the Lyme community will have some influence as to how Lyme money is spent. We can try to get more monies awarded to credible individuals such as Dr. Brian Fallon, Columbia University, who just received a $4.7 million grant from the NIH for a brain imaging treatment study.

With this measure, the United States will be leading the way in this worldwide epidemic. It will provide protection for our doctors who will be able to treat in a friendlier climate. It will give us leverage with insurance companies who have denied us coverage. It will encourage other doctors to come out of the shadows and treat. It will force school districts to recognize that the needs of our children are serious, and most importantly, it may save your life or the lives of your family and friends.

Thank you and may you, find health and peace.

 

 

 

 




LDA Vaccine Position Paper

VACCINE POSITION PAPER * (There are currently no human vacciens on the market in the US. This applied to the vaccine LymeRix which was withdrawn by the manufacturer citing poor sales).

The Association recognizes the need for a safe effective vaccine against Lyme Disease.  Several pharmaceutical companies have developed vaccines that are going through the FDA’s vaccine approval process. One has been FDA approved.*

The Association does not recommend for or against products, including the vaccine, used for the treatment or prevention of Lyme disease. An individual and his/her doctor need to make the decision whether or not to receive the vaccine.

Several questions about the vaccine:

·         Since there is no effective test for active Lyme, what happens to individuals who have active Lyme disease and receive the vaccine?

·         Since the vaccine is effective against certain strains of the Lyme bacteria, Borrelia burgdorferi, what happens if someone is infected with a different strain?

·         What happens to individuals who receive the vaccine and become vaccine failures and contract Lyme?  After receiving the vaccine, they will now have a positive test for Lyme. Will doctors know enough about the vaccine effects on LD testing to diagnose Lyme, and will insurance companies pay for treatment, or will the record of the vaccine and subsequent positive test prevent diagnosis and treatment?

·         Since having had Lyme disease itself does not confer immunity, can one conclude that a positive titer means immunity to the disease? Are positive titer and conference of immunity the same thing?

·         What tests have been done to determine the length of protection of the vaccine beyond 2 years?

·         In the vaccine trials, people were not challenged with the disease; they were just monitored to see if they came down with it.  What happens if someone actually is infected?

·         Bacteria inside a tick that is feeding on a vaccinated animal are mostly destroyed. Can the remainder enter the human body and produce disease?

·         Some researchers have found that OspA may trigger an autoimmune arthritis in certain susceptible people.  Since this vaccine is OspA based, will getting the vaccine produce arthritis in some otherwise healthy individuals?

Adopted: 4/21/98,

Revised: 5/19/98, 2/16/99

[*Note: This vaccine, LymeRix, was withdrawn from the market by manufacturer on Feb. 25, 2002. Currently, there are no vaccines on the market for humans]




Howell, NJ – Seminar for Parents, Educators and School Officials


Lyme Disease and the Schools 1998 Howell High School Pat Smith


Between Jan 1, 1996 and December 31, 1997, NJ had almost 4000 newly reported cases of LD. These cases are only the ones that fit the Centers for Disease Control, CDC, criteria for surveillance. Many more people were actually diagnosed by physicians with estimates from some medical professionals indicating that the 4,000 reported cases represent only 1/10 the actual cases in NJ. NJ has traditionally ranked either third or fourth in the nation for reported LD cases, many of which are children.


When children develop chronic Lyme, they are not only fighting disease, but also they and their parents must fight to get a proper education. Numerous school districts are unaware of the problems of LD and its potential psychiatric manifestations. Therefore, instead of getting proper treatment for the disease causing the symptoms, the children are being ignored, punished, or ostracized. Sometimes children are getting improperly classified or not classified at all because some individuals think Lyme is not a serious disease.


In 1992, I prepared and presented to Congressman Smith, the CDC, and the NIH, National Institutes of Health, a 9 district school study showing the impact of Lyme disease on children. As a result of my study, the CDC came to NJ and studied Lyme in 5 of those 9 Monmouth and Ocean districts. This Oct. 1992 CDC study of 64 students showed that the median duration of illness at the time of interview was 363 days, and the mean number of school days missed because the child was too ill to attend was 103 days (with a range of 2 to 548 days). The median duration of home instruction was 98 days, with a range of 5 to 792 days.


For several years, I have been working with districts statewide training teachers and acting as an advocate in IEP meetings for children with Lyme. This is the fifth statewide school conference the LDANJ has hosted in NJ.
Schools usually either classify children with Lyme as chronically ill or they develop 504 plans under federal legislation. Classification costs the district a lot more money, however, they do receive some state aid for that. 504 students do not usually generate additional aid for the district but the identification process is simpler. Districts need to understand that parents/students have similar rights under 504 as they do under the classification with an IEP, Individualized Education Program. Often, children exhibit behavior problems that are associated with Lyme disease and these go unrecognized by districts. At times, children are being improperly classified. For example, they have psychiatric or neurologic manifestations and they are labeled NI (neurologically impaired) or ED (emotionally disturbed) when perhaps a multiply handicapped classification which includes chronically ill might be necessary.


The new special education guidelines being developed could be a problem for children with Lyme whose designation is often neurologically impaired, since the definition of neurological impairment will be more strictly defined to agree with federal guidelines.
Children are identified with ADD, attention deficit disorder, medicated for those symptoms, and no cause is ever sought. Districts need to carefully evaluate any child who has a history of Lyme and is experiencing neurologic, psychiatric, and attention deficit problems to ensure that the problems are not organically produced by Lyme disease.
Fluctuations in symptoms present another problem. Lyme symptoms can vary from day to day and even hour to hour. Children with LD on long term home instruction may need to have a school program which enables them to come to school when feeling well and receive home instruction when they are not. They should not have to wait 10 days or any set number of days to receive the home instruction after each absence. Flexibility must be written into the IEP or 504 plan.
The number of hours of home instruction needs to be adequate to provide a thorough and efficient education. Often, districts only provide 5 hours a week to a child, telling parents this is all they need to provide by law. Classified children may receive 10 hours of home instruction per week. 5 hours is certainly not adequate to provide a thorough and efficient education for children on long term home instruction. Specify the hours in the IEP or 504 plan.

DC – US Senate Lyme Hearing, before Senator Edward Kennedy

August 6, 1993

Written Statement of Pat Smith, Wall Township, NJ

I have two daughters, Michelle and Colleen, who suffer from Lyme disease. Colleen is a fifteen year old honor student who has been out of school for 3 years. She receives home instruction and is currently working feverishly over the summer to try and complete her freshman year. She has been experiencing seizure activity for a year and has abnormal EEG’s consistent with Lyme. During the temporal lobe seizures, which can last for 2-3 days, she initially experiences speech impairment and a paralysis of her legs, and throughout the seizure, she is withdrawn from reality and experiences mental confusion, paranoia, and emotional turmoil. In addition to the seizures, she has had arthritic, opthalmologic, dermatologic, and other neurologic and musculo-skeletal symptoms of Lyme.

Colleen has had to give up most of her childhood because of Lyme Disease. She was a very athletic and musical child who has had to forego all her activities and has experienced weight gain and dramatic changes to her fife due to Lyme. In the past 3 years, she has had eye problems which have not allowed her to read for any extended period of time without violent headaches and/or distorted vision. Throughout these ordeals, she has maintained a positive attitude.

Over the past 4 years, Colleen has had approximately 5 months of IV antibiotic treatment with several different drugs. For the past 2 years, she has been on oral antibiotics. The antibiotics have helped; when she was removed from them for an
extended time period, she relapsed. Her doctors include an internist, rheumatologist, opthalmologist, neurologist, MD nutritionist, and chiropractor.

Michelle is twenty-four and has had Lyme disease since college. After oral antibiotic treatment, she suffered no symptoms for almost 3 years, then relapsed. She is chronically tired, has headaches and recurrent eye infections. Her current treatment regimen includes oral and opthalmic antibiotics. She continues to work, since
her symptoms are not as severe as Colleen’s.

Last year while serving on my local board of education, I prepared a preliminary report on how Lyme has affected nine New Jersey school districts. I presented this to the Centers for Disease Control and the National Institute of Health in Washington by invitation of my Congressman. As a result of the report, CDC sent Dr. David Dennis to New Jersey to complete a more in-depth report on the effects of the disease on school children. I worked with him and the New Jersey Department of Health to expedite the data gathering. Although I do not agree with some of the conclusions drawn by the CDC in its follow-up report, I believe the data collected speaks to the seriousness of the disease.

There are a number of problems with the State and Federal public health response to Lyme that deserve Congressional scrutiny. The doctors currently underreport the number of Lyme disease cases, primarily because the CDC definition of the disease is an epidemiological one which has been inappropriately applied to diagnosis in clinical situations. Additionally, when these agencies had obtained useful data and case studies on Lyme, they applied the information toward focusing on one treatment complication of a particular antibiotic rather than focusing on the *

The National Institute of Health (NIH) also possesses data, including tissue sam- *

Jiles exhibiting spirochete survival after long-term antibiotic therapy, which it has *
ailed to release to extramural researchers.

In conclusion, I urge serious consideration be given to the testimony of physicians such as Dr. Burrascano who treat hundreds of chronic Lyme patients and are knowledgeable about the variability of symptoms and the survival of the spirochete even after extensive antibiotic therapy.

Lyme has deprived children such as my daughter of their activities, friends, school and of their childhood; for others, it has taken their lives. You have the ability to stop this mmscriminate killer. Dont let our children down. Thank you.

http://www.archive.org/stream/lymediseasediagn00unit/lymediseasediagn00unit_djvu.txt

* This testimony may contain some missing segments which is beyone our control since it came from the Senate Hearing record with those omissions.