14 MR. GOTTFRIED: Okay. We're going to

15 reconvene. We have not been able to make the phone

16 connection with Connecticut yet. We're continuing to

17 work on that. So, we're going to proceed with the

18 next witness, who is Dr. Kenneth Liegner, who is

19 associate editor of the Journal_of_Spirochetal_and_

_______ __ ___________ ___

20 Tick-Borne_Diseases.

__________ ________

21 KENNETH LIEGNER, M.D.; Sworn

22 MR. GOTTFRIED: Good morning.

23 DR. KENNETH LIEGNER: I wish to take

24 the opportunity to thank you, Mr. Gottfried, and the

25 Assembly Committee on Health for convening this

28

1 hearing.

2 I'd like to tell you briefly about my

3 background. I am a born and bred New Yorker and I

4 love the beautiful state of New York. I received

5 most of my training in New York State. I am board

6 certified in internal medicine, and was trained and

7 certified in critical care medicine. During the

8 course of my training, I did a full year of anatomic

9 pathology and performed 20 to 30 complete autopsies.

10 I went into private practice in Armonk

11 in 1985, not realizing at the time that I had plunked

12 myself down in the midst of what was to be a

13 burgeoning epidemic of Lyme disease. Like many other

14 internists, I began seeing patients with Lyme

15 disease.

16 Lyme disease is a tick-transmissible

17 infectious disease caused by the spirochete,

18 Borrellia burgdorferi, a spirochete similar to the

19 spirochete that causes syphilis. Best known for the

20 bull's-eye rash, swollen knee, and Bell's palsy, it

21 is turning out to be a very complex infectious

22 disease with systemic effects, as well as varied

23 manifestations affecting individual organ systems

24 such as the skin, visual and auditory systems,

25 joints, nervous system and heart. To give you a

29

1 sense of the wide scope of manifestations associated

2 with the illness, please refer to Document 1, an

3 outline of a talk I gave in Chicago in 1998.

4 Also, because of time constraints, I am

5 abbreviating my written testimony, and I would

6 respectfully request and urge that the committee

7 members at their leisure, when they have a chance, to

8 review the full written testimony and all 19

9 documents that are appended thereto.

10 The range of manifestations associated

11 with Lyme disease has been continually expanding. It

12 can be difficult to distinguish Lyme disease from a

13 number of other disorders which it can greatly

14 resemble, including rheumatoid arthritis, multiple

15 sclerosis, lupus, the chronic fatigue syndrome,

16 fibromyalgia, Lou Gehrig's disease, Alzheimer's

17 disease and others.

18 Many persons who proved to have Lyme

19 disease have no recollection of a tick attachment or

20 rash. Testing for Lyme disease can sometimes be

21 quite clear-cut and exclusive, but false positive as

22 well as false negative test results may occur. Thus,

23 the treating physician's judgment in making a

24 clinical diagnosis is crucial. Over-reliance on

25 imperfect tests can result in failure to treat true

30

1 Lyme disease when it is present, which can have

2 disastrous consequences for patients.

3 Patients who test negative on standard

4 tests but who really have the disease, the so-called

5 seronegative negative subset, may be most ill. There

6 is ample precedent for variable expression of

7 severity in infectious diseases, depending upon a

8 patient's immune response. In leprosy, for example,

9 patients having a vigorous immune response are able

10 to contain the illness with resultant mild disease.

11 Those with an ineffective immune response have more

12 devastating leprosy, with deformity and loss of a

13 appendages.

14 For the most part, academic medical

15 centers have restricted their studies to the

16 seropositive subset only.

17 When I first started seeing patients

18 with Lyme disease in the mid 1980s, I very quickly

19 found that they didn't always behave the way the

20 books said that they should. Some would respond

21 favorably to antibiotic treatment but when treatment

22 was stopped they relapsed, only to respond again to

23 reinstitution of antibiotic therapy and relapse once

24 again when treatment was stopped. It began to dawn

25 on me that this might be a chronic infection that

31

1 could be treated but perhaps not cured with

2 antibiotics. Because of this, I gradually lengthened

3 the duration of treatment I offered patients.

4 Many reputable workers from around the

5 world have independently proven that the Lyme disease

6 organ is capable of surviving in both animal and

7 human hosts despite application of antibiotic

8 therapy, including intensive intravenous antibiotics.

9 It seems in some cases the infection can endure for

10 months or years, and even the natural life of the

11 host, despite application of antimicrobial treatment.

12 Due to my background and training, I

13 began to see the more complex and more seriously ill

14 persons with chronic and neurological illness. I

15 would like to share with you the case of one of the

16 most seriously ill cases I have cared for. This case

17 exemplifies some of the problems associated with

18 diagnosis and treatment of Lyme disease. I have been

19 given permission by the patient's wife to identify

20 him. I believe his wife will be a speaker later

21 today.

22 Martin Eisenhardt, a 61-year-old

23 outdoorsman, a resident of Cairo, New York - not very

24 far from where we sit today - developed a

25 grapefruit-sized red rash on one thigh, fall of 1985.

32

1 Its significance was not appreciated and no treatment

2 was given. The following winter and spring he

3 developed serious neurologic symptoms, and spinal

4 fluid examination showed a lymphocytic meningitis. A

5 Lyme screening test, an ELISA, was negative, for

6 which reason the possibility of Lyme disease was

7 discounted, despite the fact that his wife repeatedly

8 raised the question: Could it be Lyme disease?

9 Instead, he was diagnosed with vasculitis, or

10 inflammation of blood vessels, and treated with

11 prednisone and immunosuppressive chemotherapy, the

12 type of drugs that you would use to treat cancer.

13 And he developed a state of progressive deterioration

14 to just above a vegetative state.

15 In 1988, he finally had a positive Lyme

16 ELISA at SUNY Stony Brook and was treated with two

17 weeks of intramuscular Rocephin, the most commonly

18 used intravenous antibiotic for Lyme, with slight

19 benefit. In 1992, he was transferred to Northern

20 Westchester Hospital Center in Mount Kisco, New York

21 in order to be re-evaluated by me. He was found to

22 be in status epilepticus; that is to say, a state of

23 continuous seizures.

24 This is a CAT scan taken at the time he

25 was admitted to my hospital. That sort of figure

33

1 eight black area is the cerebral ventricles.

2 Normally, this would be a very, very small cleft.

3 And the massive space that is there is what is called

4 hydrocephalus, and it reflects the amount of injury

5 to his brain, so that he really has a very thin rim

6 of brain cortex left.

7 Based on the history, I felt it likely

8 that he had chronic neurologic Lyme disease. I want

9 to point out that I had to defend my decision to

10 admit him to my hospital and to treat him. And I

11 refer to -- refer you to Document 8, and I hope that

12 you will all read that when you have a chance.

13 Initial laboratory tests were

14 inclusive. One of my colleagues expressed to me his

15 opinion that the best thing that could happen to the

16 patient was to die and have him autopsied. His wife

17 certainly didn't feel that way. She felt he deserved

18 a chance to be treated, and I agreed. He was treated

19 for one month with daily intravenous Rocephin and

20 then for about one year with once weekly so-called

21 "pulse" Claforan. That's another commonly used

22 intravenous antibiotic for Lyme disease.

23 Although he was already very severely

24 brain damaged when he was placed under my care, he

25 still improved modestly, as vouched for by Jane

34

1 Lampman, who is a nurse with the Greene County Public

2 Health Service, which cared for him for many years.

3 And that document is also appended. Treatment with

4 intravenous antibiotics was discontinued in the late

5 spring of 1993, after which he was treated with oral

6 antibiotics. He eventually succumbed to his illness,

7 July of 1993. A complete autopsy was performed by

8 Jeff Hubbard, M.D. of Bender Laboratory right here in

9 Albany.

10 I'd like to show you some photographs

11 from the autopsy, including a picture of cut brain,

12 again, showing the hugely enlarged ventricles, or

13 hydrocephalus. This is the floor of the fourth

14 ventricle. Again, those whitish plaques on the floor

15 are inflammation, or what's called ependymitis. This

16 is a microscopic section through his cerebellum, and

17 I think you can see in between the tissue there is --

18 well, you probably -- at this power you can't say

19 that there is inflammation, but at a higher power you

20 can see that the tissues are very densely infiltrated

21 with inflammatory cells. Paul Duray, who is probably

22 the number one pathologist in the world on Lyme

23 disease, showed these slides around at the NIH in

24 Bethesda, and the neuropathologists there said they

25 had never seen anything like this.

35

1 Electron microscopy was done of these

2 tissues by Dagmar Hulinska of the Borrellia Reference

3 Laboratory in the Czech Republic, and she was able to

4 identify structures. I'm no expert in electron

5 microscopy, but that structure with the small arrow,

6 according to her, is consistent with a bacterial

7 structure. This is a greatly, greatly magnified;

8 about 26,000 times. She also identified structures

9 that she felt were consistent with cut sections of

10 Borrelia organism. Additionally, she performed PCR,

11 or polymerase chain reaction, which is a special

12 method to detect the DNA of the Lyme organism, or

13 whatever you're looking for, and she was able to

14 detect very convincingly evidence of the DNA of the

15 Lyme organism in the patient's brain. Additionally,

16 we had made arrangements to send his spinal fluid to

17 Patricia Coyle, a research neurologist at SUNY Stony

18 Brook, who has special research assays for detecting

19 evidence of the Lyme organism in spinal fluid, and

20 these were very, very strongly positive. So that we

21 have multiple modalities that all confirm persistence

22 of the infection in this patient's case.

23 This patient's illness was extremely

24 severe; however, it is not an isolated case. I have

25 dealt over the past 15 years with many, many other

36

1 very seriously ill patients whose nervous systems

2 have been damaged or destroyed by the infection. I

3 have had a number of fatalities due directly to Lyme

4 disease in my practice, including in a seven-year-old

5 child. And Document Ten is the abstract that was

6 presented on that case. This child was improving on

7 intravenous antibiotic treatment. A successful

8 appeal to Cigna's IntraCorp review physician, a

9 third-party administrator, resulted in extension of

10 treatment from three to six months. And that

11 document is appended. When the physician reviewer,

12 following Cigna's corporate policies, denied further

13 intravenous antibiotic treatment, uncontrollable

14 status epilepticus recurred despite maximal

15 anti-convulsant therapy. The patient died within one

16 month of cessation of intravenous antibiotic therapy.

17 I should hasten to add that, in

18 contrast to these devastating cases, when Lyme

19 disease is correctly diagnosed and treated

20 appropriately, intensively before irreversible

21 neurologic injury has occurred, recovery to a greater

22 or lesser extent is the rule. I have had innumerable

23 cases in my practice where intensive treatment has

24 restored very compromised individuals to normal or

25 near-normal status where they can enjoy a

37

1 satisfactory and satisfying quality of life as

2 opposed to one of utter misery and suffering.

3 The controversies about the nature of

4 Lyme diseases and what constitutes appropriate

5 treatment for it need to be put in perspective. At

6 the turn of the 20th century, bitter debate raged

7 within the medical profession about another

8 spirochetal disease, syphilis. It has taken medical

9 science more than 400 years to understand syphilis as

10 a chronic multi-system infectious disease which

11 evolves over time. We are but 25 years into

12 understanding the spirochetal infection known as Lyme

13 disease.

14 I also want to point out that in

15 syphilis there is very ample precedence and a great

16 deal of literature underscoring the reality of

17 seronegativity and the reality of chronic persistent

18 infection in syphilis despite prior application of

19 antibiotic therapy. And I've included a couple of

20 references that highlight that.

21 A major difference between the syphilis

22 controversy at the turn of the 20th century and the

23 Lyme controversy at the turn of the 21st century is

24 the existence and the influence of the insurance

25 industry.

38

1 Spring of 2000, the Infectious Diseases

2 Society of America, so-called IDSA, published

3 "Practice Guidelines for the Treatment of Lyme

4 Disease." It asserted that there was no significant

5 evidence that chronic Lyme disease exists as a

6 separate diagnostic entity, and that there is no role

7 for treatment with antibiotics beyond one or, at

8 most, two months for any case of Lyme disease. And

9 that documented is appended. Insurance companies

10 have glommed on to these guidelines and routinely

11 deny reimbursement to insureds for oral and

12 intravenous antibiotic therapy extending beyond 60

13 days.

14 At the very least, the IDSA guidelines

15 are highly scientifically biased; at worst, they may

16 be, frankly, fraudulent. The document omits scores

17 of articles from the worldwide peer-reviewed

18 literature demonstrating the reality of chronic

19 persistent infection despite prior antibiotic

20 treatments. No clinicians who actually care for the

21 majority of patients having chronic Lyme disease were

22 invited to participate in drafting the guidelines.

23 The sole academician in the IDSA, known to advocate

24 the existence of chronic Lyme disease, was purged

25 from the committee drafting the document. That some

39

1 committee members involved in the creation of the

2 guidelines had long-standing financial relationships

3 with the insurance industry was not disclosed in the

4 publication. Lack of disclosure of potential

5 conflicts of interest in peer-reviewed research and

6 publications has been the subject of a recent

7 editorial in the Journal_of_the_American_Medical_

_______ __ ___ ________ _______

8 Association, decrying such practices on grounds of

___________

9 medical ethics.

10 The single greatest obstacle to badly

11 needed progress in development of improved methods of

12 diagnosis and treatment for Lyme disease is the

13 chronic persistent denial of chronic persistent

14 infection in the illness. Such denial, in the face

15 of so much objective evidence to the contrary, must

16 be viewed as a type of social pathology.

17 What is being promoted at the standard

18 of care for chronic Lyme disease is medical neglect,

19 a vast de facto and unintended Tuskegee experiment

20 whose hapless subjects are your constituents.

21 Ladies and gentlemen of the committee,

22 you can do something about it. Thank you for your

23 attention.

24 MR. GOTTFRIED: Please. I certainly

25 appreciate your feelings, but the hearing will

40

1 proceed better if we don't have these pauses.

2 Doctor, thank you very much for your

3 testimony, and we will include all of the

4 documentation in the hearing record.

5 I have a couple of questions. One,

6 the -- you made the statement, and others have as

7 well, that there are patients who may test negative

8 for Lyme disease, which is to say on the standard

9 tests they show up as not having Lyme disease, but

10 upon further diagnosis turn out to have the disease.

11 Without seeking a medical education from you, if

12 people -- if a patient continues to test negative,

13 how do you diagnose that what the patient has is Lyme

14 disease?

15 DR. LIEGNER: That's an excellent

16 question. There are many levels of testing for Lyme

17 disease. Also, I should comment that when physicians

18 fail to diagnose Lyme disease, I don't always think

19 it's totally their fault, because they are following

20 what I would -- what I would call fatally flawed

21 guidelines. For example, the Centers for Disease

22 Control is advocating, and departments of health

23 follow - and rank-and-file physicians who are not

24 intimately involved in Lyme disease tend to follow -

25 the recommendation that you do a screening Lyme

41

1 ELISA, and only if that is positive or maybe

2 borderline then you do a Western blot.

3 In 1996, we did a study -- the last

4 quarter of 1996, we looked at all comers to my

5 practice, which is pretty much basically Lyme disease

6 and other tick-borne diseases, and we didn't follow

7 what's called a so-called two-tiered method of

8 testing. Now, the two-tiered method of testing was

9 extrapolated from HIV, where it appears to work very

10 well. You do an ELISA - the ELISA is very sensitive

11 in HIV - and if that's positive, then you do a

12 Western blot to confirm. Unfortunately, the ELISA is

13 not very sensitive in Lyme disease. And what we did

14 was shotgun and do both an ELISA and a Western blot

15 simultaneously on all presenting patients to our

16 practice. What we found was 16 percent of the

17 patients had a positive ELISA and a confirmatory

18 Western blot, but 21 percent of the patients had a

19 dead negative ELISA and still had fully diagnostic

20 Western blots. I can't really explain, I'm not a

21 laboratorian, but that's the facts. And also many,

22 many others had Western blots that had very highly

23 specific bands that, while not satisfying the CDC

24 criteria, should at least raise a very high index of

25 suspicion for the possible presence of the disease.

42

1 So, those are antibody methods, but in

2 addition to that there is PCR, which for some

3 reason -- although PCR has been around in Lyme

4 disease for at least ten years and it is widely used

5 for many infectious diseases without question, when

6 it comes to Lyme disease, the PCR is suspect. And

7 why is it suspect? Because the insurance

8 companies -- first of all, they will not even

9 reimburse a patient for getting a PCR, so that puts

10 another obstacle. And then once they get a PCR,

11 their physician consultants question the credibility

12 of the laboratory, even though the laboratories that

13 we use participate in and satisfy the College of

14 American Pathology's proficiency testing programs;

15 that is to say, they get blinded specimens, nobody

16 knows the answers, and they have to test the

17 specimens and get the right answers, and they do.

18 That should satisfy any reasonable person that PCR is

19 a valid method.

20 Another thing I would like to point

21 out, since you asked. I mentioned that Martin

22 Eisenhardt's spinal fluid was tested by Pat Coyle at

23 the research lab that she has at SUNY Stony Brook.

24 Pat Coyle is an excellent researcher. And that

25 method, which was for detection of what are called

43

1 Lyme-specific immune complexes -- that method has

2 been available for many years. There's also

3 something called OspA antigen capture assay, and that

4 has also been available for many years now in a

5 research assay. Those had enabled me to make the

6 diagnosis -- to help make the diagnosis in Martin

7 Eisenhardt's case.

8 It's extremely disturbing to me that

9 those research assays are available, have been

10 available on a very limited basis at the research

11 laboratory at SUNY Stony Brook. Some of the same

12 academicians that are stringing up physicians who

13 treat Lyme disease have available to them methods

14 that can demonstrate conclusively that people who

15 test negative on standard tests are positive on their

16 research assays, and also can demonstrate that

17 despite treatment they have persisting infection.

18 There's a big problem there. I see a big problem

19 there.

20 I would also just say that Lyme disease

21 is complex to diagnose. The CDC, from its earliest

22 involvement with Lyme, to their credit have always

23 insisted that Lyme disease should be a clinical

24 diagnosis first and foremost, supported, hopefully,

25 by laboratory data if possible. But absence of

44

1 supportive laboratory data in the face of compelling

2 clinical date should not vitiate a diagnosis of Lyme

3 disease. Martin Eisenhardt had the rash, but he

4 tested negative on ELISA. No one listened to his

5 wife, no one listened to the patient and their

6 family. They were more focused, obsessed with tests

7 that are imperfect.

8 MR. GOTTFRIED: Is there -- I don't

9 know whether it's in the material you gave us or not.

10 Is there published literature on this question of the

11 tests and their validity?

12 DR. LIEGNER: Yes, a great deal.

13 MR. GOTTFRIED: Okay. Is that in the

14 material that you gave us?

15 DR. LIEGNER: No, I did not include

16 that.

17 MR. GOTTFRIED: Okay. If you could

18 provide us with some of that, that would be -- either

19 copies of articles or citations.

20 DR. LIEGNER: I would be happy to do

21 so.

22 MR. GOTTFRIED: That would be very

23 helpful.

24 DR. LIEGNER: I would be happy to

25 provide you with the actual articles.

45

1 MR. GOTTFRIED: And, finally, can you

2 tell me what the Infectious Disease Society of

3 America that you referred to in your testimony is?

4 What does it represent? What does it do for a

5 living?

6 DR. LIEGNER: Well, I haven't really

7 looked into that much. As far as I know, it tends to

8 represent -- it's an official body that represents

9 board certified infectious diseases experts around

10 the country. They also publish a journal called

11 Clinical_Infectious_Diseases, which is very

________ __________ ________

12 influential within the medical community.

13 MR. GOTTFRIED: Do they -- are they a

14 board certifying entity or something else?

15 DR. LIEGNER: No, they're an

16 association of physicians who have a special

17 interest. And I don't know what their criteria for

18 entry into the membership is, but they tend to

19 represent many of the board certified infectious

20 diseases internists around the country.

21 MR. GOTTFRIED: Okay. But if you were

22 looking to be certified as a board certified

23 infectious disease specialist, you would get that

24 certification from -- the American Board of Internal

25 Medicine would certify an infectious disease

46

1 specialist.

2 MR. GOTTFRIED: Thank you.

3 MS. O'CONNELL: Doctor, thank you for

4 your testimony. I've heard you speak before us

5 before, and you were every bit as good this time as

6 you were the last time, particularly in explaining

7 some of the real pertinent data that you have

8 developed in your experience.

9 Going back to the research assays that

10 you were mentioning, in a Lyme disease patient --

11 will there be any patients who are negative, even who

12 receive the research assay testing? Will any of

13 those patients still remain negative in the research

14 assay --?

15 DR. LIEGNER: First of all, I want to

16 indicate that the case that I presented -- one of the

17 reasons it was published is that it was so thoroughly

18 documented, with so many different modalities. I

19 also want to point out to you that at that point in

20 time that I was working with that patient, I had a

21 close collaborating relationship with Patricia Coyle

22 and I had access to these assays. I no longer have

23 access to these assays.

24 MS. O'CONNELL: And why is that?

25 DR. LIEGNER: That's a good question.

47

1 I think the NIH has been supporting Dr. Coyle and

2 certain other people in trying to look at Lyme

3 disease in a very scientific way, using these assays,

4 and I think the resources that make these assays

5 available are being focused on very careful studies

6 of chronic and neurologic Lyme disease. And

7 hopefully, we look forward to seeing those kinds of

8 publications.

9 However, I would point out that some of

10 these assays -- they are not rocket science. Like,

11 the Lyme-specific immune complexes are very simple.

12 They're exceedingly simple. And I think it's very,

13 very unfortunate - and I'm not sure I understand all

14 the reasons why - that type of assay couldn't be

15 widely available at commercial laboratories. There

16 would be many, many diagnoses that could be uncovered

17 in people who are presently walking around without a

18 diagnosis. I would say, however, even with every

19 research assay that we have, I believe it is quite

20 possible that there are cases that clinically seem to

21 be Lyme disease, appear to respond to antibiotic

22 therapy, which we just don't have the means to prove

23 it with tests, even with all the tests that we have

24 available.

25 In the article that includes Martin

48

1 Eisenhardt's case is a case of another woman who went

2 on to develop spinal cord involvement, was very, very

3 seriously ill. She had a brother who lived in

4 Dutchess County, she visited him, she had a tick

5 bite, she had a rash, and it took me 13 years of

6 careful, intensive study to prove her diagnosis. I

7 can't fully explain it. You know, Lyme disease is,

8 as I've said before, complex and mysterious.

9 MS. O'CONNELL: How were you -- just

10 one last question. How were you able to prove it on

11 that case you just described?

12 DR. LIEGNER: In her case?

13 MS. O'CONNELL: Yes.

14 DR. LIEGNER: In the last case I

15 just --?

16 MS. O'CONNELL: Yes. After 13 years,

17 what was it that enabled you to --?

18 DR. LIEGNER: Well, first of all,

19 again, that was at a time that I was working with

20 Patricia Coyle. This particular woman had a

21 lymphocytic meningitis with 70 white cells when I

22 first tapped her. She got about five or six months

23 of intravenous antibiotics, which we had to fight

24 tooth and nail for. I did no less than five spinal

25 taps during the course of her treatment. And

49

1 clinically she improved. She did test positive on

2 Patricia Coyle's assays. And, also, late in the

3 course of her treatment she did evolve very highly

4 specific bands on Western blot, although she -- I

5 think she finally -- five bands out of the ten bands

6 is iron-clad to satisfying the surveillance case

7 definition. At best, she finally got up to four

8 bands, including some very highly specific bands.

9 MS. O'CONNELL: And this was after how

10 many years of what you would believe as, you know,

11 active Lyme or chronic Lyme?

12 DR. LIEGNER: Well, she had a tick

13 bite -- it was about 13 years that it took me to

14 prove the diagnosis.

15 MS. O'CONNELL: Thank you, Doctor.

16 DR. MILLER: First of all, let me thank

17 you for presenting the presentation that you did. I

18 certainly think it was excellent, but I'm getting a

19 little confused. Physicians, I thought they were

20 trained for medical diagnosis. And are you

21 suggesting that an insurance company would deny a

22 physician the right to make a diagnosis on a patient,

23 using some criteria that are vague, arbitrary and

24 capricious, that might, in fact, lead to a patient's

25 continuous decline in health? That the physician, in

50

1 spite of their training -- is that what we're saying?

2 You're obviously a highly-trained physician, but is

3 it some accountant at an insurance company that is

4 better trained at diagnosis than you, so that they're

5 denying patients' benefits on the basis of their

6 accounting experience?

7 DR. LIEGNER: That's my opinion, yes.

8 DR. MILLER: It seems that that would

9 be a major problem. I mean, clearly, you've seen

10 cases where after years and years of fighting with

11 people, having the patient die -- is there much

12 satisfaction in finding out at autopsy that you were

13 right and they were wrong? I mean, it seems that's

14 what we're dealing with, that that's the final

15 conclusive step, and then the insurance has to say,

16 "I guess we were wrong, but nothing can happen to

17 us." Have you had to deal with something like that?

18 DR. LIEGNER: I have many patients who

19 I've done my best to try to help, and it's -- to me,

20 it's very heart-rending to have patients who you know

21 have active infection. There are some patients --

22 there are many patients who can be very well-treated

23 with oral antimicrobial therapy, and certainly that's

24 preferable. I tend to see some of the most serious

25 cases, who have very serious brain and spinal cord

51

1 involvement, and in my experience they require the

2 most intensive kinds of treatment.

3 And, by the way, I also want to

4 emphasize that I don't think antibiotic therapy is so

5 wonderful, I really don't. I think that there could

6 be far, far better methods of treatment than what we

7 currently have. And I don't even think that

8 antibiotics, per se, may necessarily be the answer,

9 but it is what we have presently. It's the best

10 thing that we have presently. I think if the denial

11 of chronic Lyme was able to -- if we were able to put

12 an end to the denial of chronic Lyme, I think we all

13 could move forward and, hopefully, people could all

14 work together to try to solve the very serious

15 problems that confront us.

16 And I would just like to say that I

17 don't even think that the enemy is the insurance

18 industry, because I think they are in a very tough

19 spot. They really are in a tough spot. I think we

20 should have some sympathy for the insurance industry.

21 They are faced with a massive epidemic of very, very

22 serious, life-threatening -- an illness that can

23 either threaten life and can damage neurologically,

24 irreversibly. If they were -- if they were forced to

25 confront their responsibilities towards their

52

1 insureds, they actually could go bankrupt. They

2 really could. One of the early comments that I saw

3 in one of the newspapers in response to the overuse

4 of intravenous antibiotics was to say, "We're

5 hemorrhaging." This is an insurance company

6 spokesman, "We're hemorrhaging." Okay. This is the

7 corporation speaking, "We are hemorrhaging." They've

8 got to stanch the hemorrhage; okay?

9 DR. MILLER: Let me ask you this

10 question. You have patients that come to you that

11 are seriously ill. Have they been receiving any type

12 of successful treatment from any other type of

13 medical specialist that has been getting them well

14 before they see you?

15 DR. LIEGNER: Not generally.

16 DR. MILLER: So, it's not as if you're

17 luring these patients away from some other specialty

18 where they've been doing well. In fact, they come to

19 you because no one else is really providing any type

20 of treatment for them at all; is that basically what

21 happens?

22 DR. LIEGNER: The majority of the

23 medical profession at the present time does not

24 accept the possibility that Lyme disease can be a

25 chronic infection.

53

1 DR. MILLER: But for the symptoms they

2 have, are physicians providing treatment for them

3 that allows them to stay awake during the day, that

4 allows them to function in their community, that

5 allows them to remember who their family and

6 co-workers are, that allows them to function in their

7 life, or in fact has the rest of the medical

8 profession pretty much given up on them and then

9 complained when you treat them?

10 DR. LIEGNER: They tend to say --.

11 DR. MILLER: I don't want anyone to get

12 the feeling that these are loaded questions or

13 anything. I'm trying to get Dr. Liegner to smile.

14 You know, he hasn't smiled once; he's that serious a

15 guy. But I'm working on it, you know. He smiled.

16 Okay.

17 DR. LIEGNER: They tend to say things

18 like this: It's an ill-defined process, we really

19 don't know what it is, and just don't offer patients

20 anything. Anything.

21 MS. O'CONNELL: Is that because they

22 don't have the experience in treatment of this

23 disease, Doctor, as -- to the extent that you do? Is

24 that what you're finding?

25 DR. LIEGNER: I think they really don't

54

1 get it. They just don't understand it. They're

2 clueless.

3 DR. MILLER: Thank you.

4 MS. MAYERSOHN: I was just wondering if

5 they recommended psychiatry? That's usually --.

6 DR. LIEGNER: That often happens to

7 patients.

8 MS. MAYERSOHN: Yeah. Doctor, do you

9 feel that doctors who share your position have been

10 unduly targeted by OPMC for investigation? And you

11 don't have to answer if you're uncomfortable.

12 DR. LIEGNER: Oh, there's no doubt

13 about it.

14 MS. MAYERSOHN: Okay.

15 MR. COHEN: Good morning.

16 DR. LIEGNER: Good morning.

17 MR. COHEN: A patient comes to a

18 physician; Lyme disease is suspected. What is the

19 period of time between when a test is given for Lyme

20 disease confirmation and when that test result is

21 final? Let's say the -- according to testing that is

22 acceptable to OPMC and the insurance companies, what

23 would be the lapse of time?

24 DR. LIEGNER: Well, when I see a new

25 patient in my practice, we do extensive testing and

55

1 usually have the patient come back in about a month

2 to make sure that we have everything back. Some of

3 the tests we can get back within about two weeks,

4 some of them are a little bit longer. So, if we give

5 a month, usually we'll have everything back of the

6 methods that we -- of the usually

7 clinically-available methods.

8 MR. COHEN: And if Lyme disease is

9 suspected, is there the luxury of waiting for the

10 result, or would you recommend immediate treatment

11 based upon a suspicion of Lyme disease?

12 DR. LIEGNER: It depends on the

13 clinical circumstances. If a person has been ill for

14 five years and they come to you and they're still

15 seeking a diagnosis, from my point of view, in the

16 global scheme of things, to wait a month is -- you

17 know, is acceptable -- although I have had patients

18 who have come to my office actually having been

19 discharged from major medical centers, telling them

20 that they are psychiatrically ill, when they had a

21 lymphocytic meningitis and had significant cognitive

22 dysfunction.

23 I had a young man who couldn't even

24 recognize his own mother. And I put him on

25 intravenous antibiotics the very day he was seen in

56

1 my office, because I thought it was that compelling,

2 and he already been worked up and already had a

3 diagnosis of Lyme. We've had patients who've been at

4 some of the major medical centers, gotten recommended

5 treatment, and they're told that they don't have Lyme

6 disease anymore. And I had one young man -- he

7 was -- it was being recommended to his mother that he

8 be shipped off to a psychiatric hospital, when he had

9 organic infection and required -- we treated him for

10 six months with intravenous ceftriaxone and then oral

11 antibiotic therapy subsequently. And he made a very,

12 very good recovery. But had the advice been

13 followed, he would probably have been one of cases

14 like what I presented.

15 MR. COHEN: Just a follow-up. If you

16 suspected that a potential -- I'm sorry, that a

17 patient had recently contacted -- contracted Lyme

18 disease, would immediate treatment be reimbursable by

19 insurance companies under the current guidelines?

20 DR. LIEGNER: Are your talking about

21 oral antibiotic therapy, intravenous antibiotic

22 therapy?

23 MR. COHEN: Any therapy.

24 DR. LIEGNER: Well, the --.

25 MR. COHEN: The question is

57

1 essentially: Do you feel it's advantageous in some

2 circumstances to start treatment prior to the

3 finalization of the tests? And if you felt that that

4 was necessary would insurance companies consider

5 that's something that they would reimburse for?

6 DR. LIEGNER: Okay. There definitely

7 are situations in which it would be appropriate and

8 advantageous to embark on treatment at the earliest

9 possible occasion. There's very few things that

10 people in the Lyme disease field agree on, with all

11 of the polarization. One of the things that I think

12 there's universal agreement on is that the sooner you

13 embark on treatment, assuming that Lyme is the

14 correct diagnosis, the better the prognosis and the

15 better the outcome. So, that's why many of us, you

16 know, advocate -- obviously, if you see a Lyme rash,

17 the patient should be treated.

18 Unfortunately, you know, you wouldn't

19 believe what happens even now. People come into a

20 doctor's office, they have a rash consistent with

21 erythema migrans -- you know, if you have the rash,

22 you have the disease, and it should be treated

23 regardless of tests. Many patients I have seen in

24 the past, and continue to see -- they go into the

25 doctor's office with a bull's-eye rash, the doctor

58

1 does a test and says, well, come back in X weeks.

2 And then if the test is positive, they get treated.

3 And if test is negative, they don't get treated,

4 missing a golden opportunity to quell the infection

5 completely. And then, even though some physicians

6 will see a rash, if the test is it not positive, they

7 will tell the patient that it's not Lyme disease and

8 not treat. This is a very, very common and very,

9 very disturbing occurrence.

10 A few years ago, Barbara DeBuono, who

11 is the former Health Commissioner, sent a letter to

12 every physician in the state of New York advising

13 them that every county in New York state must be

14 regarded as endemic for Lyme disease. Nonetheless, I

15 continue to get -- I continue to see patients -- even

16 very recently, within the last two month, I've seen

17 two terrible cases from Central New York state, young

18 people who I believe have Lyme disease, have had

19 devastating neurologic illness, where they were told

20 that we don't have Lyme disease around here. And,

21 again, if they test negative on a screening test,

22 just like in Mr. Eisenhardt's case, Lyme is

23 completely discarded and not even pursued further.

24 That is what I call one of the terrible

25 false teachings in Lyme disease: That seronegative

59

1 Lyme disease is rare, people with late Lyme disease

2 almost invariably are seropositive. Nothing could be

3 further from the truth. And patients are suffering

4 and deteriorating as a result, and not getting

5 diagnosed.

6 MS. O'CONNELL: Why is that, Doctor?

7 Why is there such an institutional block to

8 understand the pathology and the course of this

9 illness? Why, in your opinion, do you think that

10 exists?

11 DR. LIEGNER: I use the term "social

12 pathology." There is a type of social pathology

13 going on here. I think the interjection of the

14 insurance industry has a great deal to do with the

15 distortion of what would otherwise be maybe a

16 passionate but not a destructive debate within the

17 medical community. Also, I think there's a desire

18 for things to be black and white. You know, people

19 want things to be black and white. Either you have

20 it or you don't. Either you test positive --

21 unfortunately, that's just not the way it is.

22 In other words, the people who

23 originally did the work on Lyme disease -- which, by

24 the way, a lot of that work is very, very valuable

25 work, and I have a great deal of respect for the

60

1 people who have done that work, but they had a

2 certain concept of what the disease ought to be. And

3 it was very nice, it fit very nicely, you had a

4 positive test, you had arthritis -- you know, it was

5 all very, very neat. Unfortunately, that's just not

6 the biologic reality of the illness.

7 And then this notion pretty much got

8 fixed in stone that -- you know, that you must test

9 positive or you don't have Lyme disease - on an

10 ELISA, mind you. And it's just gotten sort of built

11 into the literature. The physicians who published

12 that and advocated that practiced in that way. So,

13 for them to acknowledge that they might have been

14 wrong, A, it's professionally embarrassing; B, it

15 opens them to tremendous litigation. And the best

16 thing to do is to stonewall; put your troops

17 together, you know, circle the wagon trains, and try

18 to insist that this is the way it is. Unfortunately,

19 as I said in one of my letters to that insurance

20 company reviewer, that this is on a collision course

21 with reality, and the patients are the ones who are

22 suffering.

23 MR. COHEN: If I may, Doctor? If a

24 patient comes to you and, after examining the

25 patient, you feel that it's possible that the patient

61

1 has contracted Lyme disease - not probable, but

2 possible - would you recommend some type of immediate

3 treatment while awaiting laboratory results?

4 DR. LIEGNER: Again, it depends on the

5 clinical circumstances. Basically, the answer is

6 that there definitely is a role for empiric

7 treatment. If you suspect Lyme disease strongly

8 enough, depending on the severity of the situation,

9 yes, in my opinion it is definitely appropriate to

10 institute antibiotic therapy of some sort while

11 you're waiting for your data. However, in

12 approaching intravenous antibiotic therapy, it is

13 definitely to the advantage of the patient, as well

14 as to the clinician, to try to get your ducks in a

15 row, so that you have the evidence, the ammunition

16 that can support what you're doing for the patient to

17 have any chance of being reimbursed.

18 So, nonetheless, there are situations

19 in which you don't have that data, but -- you know,

20 in the patient's behalf, you must treat them. But

21 that's risky in terms of reimbursement. Because if

22 you don't have all the data, you may not be able to

23 satisfy an insurer that they ought reimburse for the

24 treatment. They will challenge the diagnosis and

25 withhold reimbursement to the insured.

62

1 MR. COHEN: Thank you.

2 MR. GOTTFRIED: Thank you very much.

3 DR. LIEGNER: Thank you.