1

MD – Vaccines & Related Biological Products Advisory Committee 2002

REMARKS OF PAT SMITH, PRESIDENT, LYME DISEASE ASSOCIATION, INC. BEFORE THE VACCINES AND RELATED BIOLOGICAL PRODUCTS ADVISORY COMMITTEE, MAY 21, 2002

DISCLOSURE: No money from SKB.

The Lyme Disease Association, LDA, an all-volunteer organization with five nationwide affiliates, consists of patients and families of patients. The LDA has provded funding for research coast to coast, some published in peer review journals including JAMA. Along with our Greenwich affiliate, we were recently honored at a luncheon by Columbia University for partnering with them in the establishment of an endowed chronic Lyme disease research center at Columbia, and we also co-sponsored a fully accredited medical conference for physicians with Columbia. Working with legislators, we developed a bill in Congress, HR 1254, which will provide $125 million for Lyme disease research, prevention, and physician education.

The Lyme Disease Association provided testimony to this committee in January 2001, seeking a moratorium on the vaccine, but felt no action was taken by the FDA, and to that end, in January 2002, the LDA had a private meeting with the FDA’s Center for Biologics Evaluation and Research (CBER) and brought several experts to discuss the vaccine issue with FDA officials including Karen Midthun, Susan Ellenberg, Peter Beckerman, Norman Baylor, Miles Braun, and Robert Ball.

Donald H. Marks, MD, PhD, former lab director for Cannaught, fourteen years of clinical research and regulatory affairs experience in the pharmaceutical industry including Director of Clinical Research, in charge of the Lyme disease vaccine program at Aventis Pasteur, presented to the FDA. Dr. Marks was the leader of the compettitive effort to
manufacturer a virtually identical vaccine.

Currently, his focus is diagnosis of adverse events from medications, vaccines, biologicals, and medical devices. Lymerix associated cases he reviewed included athralgias and arthritis as well as complicated neurological problems and include adverse events that are long-lasting. A summary of Dr. Mark’s power point presentation follows.

WHY MORE ADVERSE EVENTS WERE SEEN AFTER THE VACCINE REACHED THE MARKET:

  • People receiving Lymerix after product launch lived in Lyme-endemic areas.
  • Many people may have had prior exposure and clinical or subclinical infection. In these cases, Lymerix could be triggering or reactivating the damage caused by old and presumably cured Lyme disease.
  • Pattern of symptoms experienced after Lymerix mimicked pattern of prior infections in many individuals. In these patients, Lymerix-related symptoms seemed to respond to antibiotics, as did the initial infection, bolstering the theory of disease reactivation.

ISSUES WHICH CONFUSED THE VACCINE PICTURE

  • As proof of safety, the company inoculated arthritis-prone mice with Osp-A. But since the mice did not possess the HLA marker known to interact with Osp-A in humans, rendering the experiment meaningless.
  • The company masked serious causally-related adverse events behind qualifiers, such as “…and which may have no causal relationship with the vaccine” and “…cannot be distinguished from the natural history of the underlying disease.”
  • The company says that “the possibility of a severe rheumatologic, neurologic, autoimmune adverse event is inherent in Lyme disease,” attempting to shift the blame onto the patient and their illness, and does not inform physicians that the same adverse events can be separately caused by the vaccine, in addition to the symptoms of an underlying disease
  • As a result of these actions, GPs in the US were kept in the dark about the life-threatening side effects of Lymerix, severe rheumatologic, neurologic, autoimmune adverse events.
 
SOME BASIC PROBLEMS.
  • Non-specific hyper-activation of the immune system, often evidenced through swollen hands or arthritis, is an adverse event associated with Lymerix. This may be due to the presence of adjuvant.
  • This hyper-activation creates “dirty” Western blots in which multiple Lyme disease bands appear, whether the individual has Lyme disease or not.
  • The dirty banding makes it impossible for physicians to differentiate between Lymerix vaccination, new infection with Borrelia burgdorferi, or reactivation of infection.
  • The net result is that cases of Lyme disease will go undiagnosed and untreated. Adverse reactions to Lymerix will be misdiagnosed as Lyme disease and people will   be unnecessarily treated with antibiotics.
  • The vaccine manufacture provides no warnings as to these possibilities.
  • Physicians unaware of the spectrum of problems cannot appropriately treat these patients.
  • The intention of FDA regulations is to provide a vaccine that is safe and effective. The intention of prescribing regulations is to provide sufficient information to prescribing physicians to enable safe and effective use of the vaccine. In both regards, SKB’s actions appear to be contrary to FDA regulations and intentions, and contrary to accepted standards within the vaccine industry.

Dr. Marks provided some case assessments based on stringent parameters and his extensive experience in the field. “The adverse events I have examine from Lymerix are similar to those I am familiar with from another vaccine.” In the cases Marks examined —in his opinion, the adverse events were not anecdotal but a medical certainty.

  • 4 of 4 neurological adverse events were related to Lymerix with presentations including transverse myelitis, inflammatory polyneuropathy, radiculopathy and cervical throacic myelopathy with multiple neurologic, including CNS, symptoms, memory loss and difficulty concentrating with immune-related complex of joint pain and fatigue.
  • 15 of 17 rheumatologic adverse events were related, including inflammatory seronegative spondyloarthropathy, polyarthropathy, arthralgias, and arthritis.
  • 2 of 2 miscellaneous reports were unrelated. These included chest pain and myofacial pain.

Based on his research, Marks said, “SKB should have devised and conducted clinical trials, epidemiological studies, or after-the-fact investigations to study the causal relationship between severe rheumatologic, neurologic, autoimmune and other adverse events and the use of Lymerix….there is sufficient evidence that Lymerix is causally related to severe rheumatologic, neurologic, autoimmune, and other adverse events in some individuals. This evidence is such as to warrant a significantly heightened degree of warnings and possible limitations or removal from marketing of Lymerix.”

Andrea Gaito, MD, a rheumatologist seeing 35 patients with vaccine problems described three categories (bold) of problems to FDA. The first case, no history of Lyme, presented with acute synovitis, tests showed negative rheumatoid factor, Western Blot suggestive of active Lyme disease, with eight IgM and three IgG bands. Patient had minimal response to doxycycline, was prescribed and continues on anti-inflammatory medication. Conclusion: autoimmune disease.

The second case, asymptomatic at time of innoculation, with a history of IV treated Lyme meningitis. After Lymerix, patient experienced the onset of Obsessive Compulsive Disorder, headache, and fatigue. Upon testing, he had a positive ELISA and a Western Blot with every band positive. Retreatment with IV was not effective. Patient remains sick.

The third case, three shots of Lymerix, then bitten by a tick. She went on to develop symptoms of Lyme disease, including night sweats and fatigue. Tests showed: a Western Blot with every band positive; positive for the HLA markers that have been associated with Lyme-related autoimmune disease. Two courses of antibiotics produced no response. This patient now has Lyme disease but does not respond to treatment.

Dr Gaito is concerned about the efficacy of this vaccine and boosters. Will vaccinated individuals with prior Lyme who ultimately present with symptoms respond to retreatment? Is the vaccine itself retriggering an autoimmune response? She felt it is possible that the difference between the pre- and post-marketing results of Lymerix relates to the fact that those using it post-marketing lived in endemic areas for Lyme disease.


The LDA is concerned that despite presentations to the contrary by individuals at both the Vaccine Advisory Committee hearing in January 2001, the private meeting above, VAERS data, and other communications from the public, the FDA has not seemed to find any problems with this vaccine. LDA’s concern stems from the fact that although the approved vaccine is not on the market currently, since it was a unilateral decision by the company to remove the product, this same or a similar product may be remarketed without the full implications of the safety and efficacy of the current vaccine having been fully assessed or integrated into the Lyme vaccine picture. The LDA asks this committee to advise the FDA that significant arguments have been raised about safety and efficacy of this vaccine and that objective studies should continue on safety and efficacy of this vaccine or any other future vaccine that may seek FDA approval. Thank you for your time.

 




RI – Lyme Disease Commission Hearings

2002-04-08 RI – Lyme Disease Commission Hearings


2002-04-08 RI – Lyme Disease Commission Hearings

 

Hearing of the Committee on Labor and Human Resources

4

H.R. 1254

5
infectious Diseases

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

6

Centers for Disease Control & Prevention November 17, 2002 www.cdc.gov/ncidod/dvbid/lyme

2

Rhode Island with an annual Lyme disease incidence of 39 per 100,000, behind only Connecticut with 63.

7

Maine recently reported an upsurge in both tick populations and the disease itself, with 100 new cases last
year and numerous others receiving preventative treatment.

8

Despite CDC warnings not to use their surveillance criteria for diagnosis, many physicians do, 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.
1996 to the CDC, if they followed the 2-tier testing requirement for 1995 cases, 81% of non-EM cases would
not have been confirmed.

9 According to a document enclosed from the NY DOH in10

Insurance companies often do not accept doctor-prescribed testing such as PCR, which shows the presence of
the DNA of the infecting organism, although PCR is accepted for other diseases such as HIV, hepatitis, and
TB. They limit treatment to 28 days, substitute orals for IV, and 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.”

11

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, now Veterans’ Committee Chair for the House of
Representatives, held a public Congressional Lyme forum in New Jersey. Last year, at our request,
Congressman Smith’s office met with the NJ State Board of Medical Examiners, followed by an LDA
meeting with the Examiners.
Attorney General Richard Blumenthal invited us to Connecticut to present New Jersey efforts against Lyme.
We then met with Commissioner Garcia and were invited back to discuss our strategy, advocating a regional
approach to the problem. The Commissioner agreed to help, and at a subsequent meeting with the senior
assistant commissioner in New Jersey, we advocated the same approach. In Rhode Island, we met with
Commissioner Nolan and also with Senator Chafee’s office and in New York, with State with the Health
Department, Office of Professional Medical Conduct, and Governor Patakai’s office. We addressed the
Pennsylvania House of Representatives majority caucus. Our message has been the same: become educated
about Lyme and other tick-borne diseases (TBD’s), share data, strategies, and even personnel if necessary.
Health departments need to publicize physician education conferences given by the LDA and other
organizations. Physicians need to be permitted to treat tick-borne diseases using their best clinical judgment,
since cookbook approaches are not getting to the root of the disease.
We must stop thinking that state boundaries govern our actions with TBD’s. A study in the
Neurology
pathogenic co-infection in New Jersey,
discovered it there in ticks, and who are now finding human cases in their research labs.

Archives ofshowing Bartonella henselae, the agent of cat-scratch fever, to be a potential tick-borne12 came as no surprise to California researchers who had already

7
www.cdc.gov/ncidod/dvbid/lyme/ldcases90-99.htm

CDC LD Chart: LD Cases reported by State Health Departments 1990-1999

8

Bangor Daily News 3/30/02 as reported by Maine’s Bureau of Health

9

Aetna guidelines http://www.aetnaushc.com/cpb/data/CPBA0215.html, Oxford Health, Medical Policy Manual

10

NYSDOH to CDC April 15, 1996

11

Horizon Blue Cross Blue Shield letter to patient, August 24, 1999

12

Arch Neurol. 2001;58:1357-1363 Concurrent Infection of the CNS by Borrelia burgdorferi & Bartonella henselae

3

We need to access the implications of 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.
months ago

13 The American Society of Clinical Pathologists (ASCP) released blood donor guidelines a few!under “serious illness,” defer indefinitely babesiosis and Lyme disease.14

Today’s hearings are not without precedent. Besides Blumenthal’s Connecticut hearings where he concluded
that Lyme is a scientific controversy and doctors should be permitted to treat accordingly,
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.”
Assembly Health Care Committee held two hearings on the Lyme disease recently due to concerns about
OPMC harrassment of treating physicians. A letter from my 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.”
“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.”

15 the Texas state16 New York17 A letter from U.S. Congressman Joseph Pitts’ (PA) office to the same body states in part18

A resolution, which the LDA helped draft, resulting from those hearings already has 101/105 Assembly
cosponsors: “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.”

19

California, Minnesota, Connecticut, New Jersey, and New York (Tick-borne Disease Institute), have enacted
or introduced legislation addressing issues ranging from treatment and tick control to mandatory teacher inservice
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. The original bill was
crafted to enable patients to receive the appropriate treatment, unfortunately, unacceptable language changes
were inserted before passage. The law states that insurance companies cannot deny payment to people with
Lyme disease who are treated with antibiotics for 60 days or IV for 30 days, then patients must get a
mandatory medical recommendation from a rheumatologist, infectious disease specialist, or neurologist.
Our affilaite, The Greenwich Lyme Disease Task Force, has surveyed physicians on the effects of the
Connecticut legislation. Dr. Liegner who has extensive Lyme experience says “In my opinion and
experience, Lyme disease is a chronic infection….the insurance legislation does not address this small subset
of patients [who require prolonged IV] and in fact does not even address those patients who require oral
antibiotics for longer than six weeks. Finding specialists is another dilemma in continuing treatment under
this law. There are not enough Lyme literate physicians in the areas of specialization that have been
identified by this legislation.”

20

Dr Charles Ray Jones, Connecticut pediatrician addresses the following to the Rhode Island Commission He
has treated over 6,000 children with Lyme, three-quarters are well after 3 months to seven years of treatment,
averaging nine months to two years. The remaining one-quarter are still receiving treatment. “Most of these

13

American Red Cross website www.redcross.org

14

Press release American Society of Clinical Pathologists

15

Public Hearing on Insurance Coverage of Lyme Disease

16

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

legislature, November 2000

17

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

18

Congressman Joseph Pitts’ office letter to New York Assembly Health Care Committee

19

Current, New York Assembly Resolution LBDC(P) 3-5-02

20

The Greenwich Lyme Disease Task Force Letter to NY Assemblywoman Nettie Mayersohn

4

children have been denied insurance coverage of necessary antibiotic therapy because of …Bill#7032.
It was easier to obtain insurance coverage for antibiotic therapy for Lyme disease patients prior to the
bill….Educate. Do not legislate.”

21

Both doctors’concerns seem justified. Enclosed is a letter of treatment denial for a seven year-old who has a
brain SPECT with sever hypoperfusion, Western Blot with specific Lyme bands, and neuropsych testing
supporting the Lyme diagnosis. The law is cited by the insurance company as a basis for denial of coverage
despite a letter of medical necessity from the treating pediatrician, as the parents are unable to find pediatric
specialists in the mandated areas. According to the mom, “I’ve been in contact with… assistant Attorney
General since the beginning of January. He agrees the law was never intended to be used this way [and] has
been in contact with Connecticare over this issue but is not hopeful that anything will change.”

22

Another case involves an adult denied further IV treatment despite the fact he had received approval from a
board certified neurologist. The Attorney General’s office was forced to intervene and even then, a portion
of the treatment time was not covered as required.
fight for themselves.
Targeting of second opinion doctors remains a concern. Greenwich co-presidents Blanchard and Siciliano
comment in their report to the New York legislators “Because of the divide in the medical community on the
existence of chronic Lyme disease (in spite of a large body of literature on its existence) there are very few
board certified physicians in these specialties who will continue treatment. We are personally aware of two
board certified physicians in these specialties (who are unwilling to identify themselves for fear of further
repercussions) who have felt the pressure from their group practices to limit Lyme patients. Because they
did not heed the warning, one was squeezed out of his practice and the other chose to leave rather than refuse
patients.”

23 Without the AG’s intervention, many would be left to24

The LDA’s initial fears about the Connecticut law were based on its own past NJ experience. In the mid
nineties, we developed NJ bills permitting patients to receive any physician recommended treatment for
Lyme disease. Unfortunately, after the successful passage in one house and movement in the other, some
legislators appeared to capitulate to insurance company influence. Second legislation was introduced which
would have enacted a 56-day treatment provision followed by a mandatory second opinion panel. We were
told it was their new bill, or none at all. Attorneys opined that if that new bill became law, it would in effect
establish a de facto 56 day treatment regimen for Lyme, one which insurance companies would use against
patients. We also had serious concerns about the doctors sitting on the mandated second opinion panel and
whether they would become targets of the medical board and/or insurance companies. We killed the bill. In
light of the CT law, our concerns seem to be validated.
Lyme disease is so complicated that even physicians whose publications are often quoted to deny persisting
infection have been shown to make statements that appear to be conflicting. A 1999 letetr from a prominent
rheumatologist to the Connecticut Department of Health 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…”Certain doctors associated with a Lyme organization “are the
principal force leading to the overdiagnosis and overtreatment of this illness. Do you have any ideas
regarding what to do about this?”
rheumatologist were subsequently charged by medical boards 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

25 Coincidentally, the two physicians named in the letter by the

21

Jones letter to RI Commission, April 5, 2002

22

Letter (3/29/02) from PC to LDA President Pat Smith regarding Connecticut insurance law

23

Brooks letter to GLDTF March 29, 2002

24

The Greenwich Lyme Disease Task Force Letter to NY Assemblywoman Nettie Mayersohn

25

M.D. letter to G. K., Director of Health, DOH, Milford, Connecticut, July 30, 1990

5

shown that the spirochete may persist in the nervous system in a small percentage of patients and may
cause chronic neurologic involvement.”

26

Dr. Reinhard Straubinger, a world renown Lyme researcher with famous dog studies at Cornell, wrote to the
NY State Department of Health that he was able to culture spirochetes from 3/23 30-day antibioticallytreated
dogs (human dosage comparable), detect spirochetal DNA in 20, and quantify spirochetal DNA in 12.
“In contrast to many human studies we could show persistent infection, because a lengthy time period
separated the phase of treatment and the phase of testing. …the spirochetes may need sufficient time after
antibitoic treatment in order to recover and multiply to sufficient numbers so we can detect them with the
techniques we have currently available.

27

Last month, I traveled throughout California for two weeks speaking about Lyme disease to doctors, patients,
advocates, and politicians. 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.
Sometimes even those who accept the seriousness of the disease suffer from the NIMBY syndrome, Not In
My Back Yard. Witness an April 4 quote from an Albany rheumatologist, who said he is “quicker to suspect
Lyme disease in Capital Region residents these days, even when they don’t remember a tick bite and haven’t
traveled to places… like the Jersey shore.” Take it from a resident of the Jersey shore, our Lyme disease is
acquired in upstate New York. While in California I met a microbiologist who contracted Lyme in a
California desert, yet she cannot convince her employer of that fact, despite taking an entomologist to the
desert to bring back the ticks.
The disease is here, there, everywhere, and we 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 (actually I was invited to visit there but world events prevented that from happening). 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
thousands more, many of them our children. Thank you.

28 tens of

26

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

27

Dr. Straubinger’s letter to NYSDOH, November 22, 2001

28

Death certificate

United State Senate, August 5, 1993

 



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




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.
 



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.