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_
_______ __ ___________ ___
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
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
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
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
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
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
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
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.
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
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
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
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.
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
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
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
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
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
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
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
24 MR. GOTTFRIED: Please. I certainly
25 appreciate your feelings, but the hearing will
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
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
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.
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
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
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
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
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
22 MR. GOTTFRIED: That would be very
24 DR. LIEGNER: I would be happy to
25 provide you with the actual articles.
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
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
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.
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
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
25 In the article that includes Martin
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
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
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
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
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
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.
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.
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
1 get it. They just don't understand it. They're
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
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
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
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
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
23 MR. COHEN: Any therapy.
24 DR. LIEGNER: Well, the --.
25 MR. COHEN: The question is
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
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
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
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
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
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
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
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.
1 MR. COHEN: Thank you.
2 MR. GOTTFRIED: Thank you very much.
3 DR. LIEGNER: Thank you.