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24 MR. GOTTFRIED: Okay. Thank you.
25 We're going to modify the order of
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1 witnesses somewhat. Dr. Shapiro, who is going to be
2 testifying by telephone, will not be able to testify.
3 We will then go -- we will go now to Dr. Robert
4 Bransfield, who will be followed by Carl Brenner, and
5 then we'll return to the regular order. And I think
6 we need the lights back up.
7 ROBERT BRANSFIELD, M.D.; Sworn
8 DR. ROBERT BRANSFIELD, LYME ALLIANCE,
9 INC., PROFESSIONAL ADVISORY PANEL: Good afternoon.
10 And I thank Dr. Brenner for allowing me to change the
11 order to catch a train today.
12 To introduce myself first, I'm a
13 psychiatrist in New Jersey, and I specialize in
14 working with treatment-resistant patients. I'm also
15 involved in medical quality assurance, and I work
16 with a number of pharmaceutical companies. And in
17 that capacity, I'm involved with research, FDA
18 approval research, continuing medical education, and
19 I'm on advisory panels, including international
20 advisory panels for these pharmaceutical companies.
21 And I do some other activities, some legal work as
22 well.
23 And in the capacity as a psychiatrist,
24 we often referred patients who have Lyme disease, and
25 that's for basically two reasons: One reason is that
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1 many of these people have significant
2 neuropsychiatric symptoms caused by the Borrellia
3 infection; and the other reason is that often they
4 have a very complex, confusing case, and many doctors
5 don't know how to make sense out of it. It seems to
6 go against some of the prevailing dogma that they
7 adhere to, so there seems sometimes a psychosomatic
8 malingering, Munchausen's -- quite a variety of
9 things like that where it's considered all in the
10 head or something of that sort.
11 And psychiatry is quite different in
12 that the brain is much more complex, the most complex
13 organ in the body. And when we looking at Lyme
14 disease, we're looking at an illness that -- the
15 standards are set by many rheumatologists based on
16 what happens in the knee joint. And the brain is
17 more complex than the knee joint; there are 100
18 million cells in the brain with 100 trillion
19 synapses, 100 difference neurotransmitters, and the
20 complexity is very high. And what we know about the
21 brain and what we know about the body is very
22 minimal, so we have to be careful to retain our
23 humility in medicine as we approach diseases,
24 particularly complex disease.
25 Now, it's been asked today of -- why is
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1 there such controversy with Lyme? And I've asked
2 myself that question many times. And from what I can
3 tell, the problem is, it is such a complex disease.
4 If we look at a simple disease like -- maybe
5 something more limited, like appendicitis, it maybe
6 involves mostly one organ system. Whereas Lyme
7 disease, we have to look at it from a
8 neuropsychiatric standpoint; we need microbiologists,
9 pathologists, epidemiologists. The complexity of it
10 is overwhelming, and it's very hard for people to
11 work together as a unified team.
12 And it's unfortunate that there's such
13 controversy, because the people -- some of these
14 doctor who are really the leaders of tomorrow -- and
15 we often see that many of tomorrow's leaders are
16 persecuted by people who are very much invested in
17 the past, and that's been the case with some of these
18 proceedings; that the doctors who have been
19 persecuted truly are the leaders, the thought
20 leaders. And that's nothing new in history.
21 Now, I have a couple of petitions here
22 that I would like to present. One is a petition --
23 and this is from the Lyme Alliance, and I'm on the
24 Medical Advisory Panel of the Lyme Alliance. And
25 I'll read the petition. And there's close to 2,300
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1 people who have signed this petition.
2 "We, the undersigned, believe that Lyme
3 disease can and does exist as a chronic illness with
4 persisting infection, and that the disease is greatly
5 underdiagnosed and undertreated. To this end, we
6 insist that: One, physicians who are on the front
7 lines of Lyme disease patient care not be harassed,
8 persecuted, or made to fear for their medical
9 practices because they do not adhere to the
10 conservative short-term care for Lyme disease;
11 "Number two, insurance companies not be
12 permitted to deny payment for treatment of Lyme
13 disease, as no conclusive diagnostic tests exist and
14 the prevailing conservation short-term care is not
15 backed by definitive scientific research;
16 "Three, access to treatment methods of
17 our choice, which are both the patient and the
18 treating physician's choice, not be denied or blocked
19 based on guidelines that are not thoroughly
20 researched or controversial;
21 "Four, research in Lyme disease and
22 other tick-borne illnesses be adequately funded in
23 order to develop better diagnostic and treatment
24 methods."
25 Now, in addition to this petition, I
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1 have another petition, and that petition is signed by
2 the medical community. And that's in your packet;
3 it's towards the back. And that's about 90 --
4 they're about half physicians and other people in the
5 medical field. And what we're saying there is that
6 we stand behind these doctors who are being the
7 target of prejudicial actions. And you can read the
8 wording that -- for brevity, I'm trying to be concise
9 and cover a number of points now.
10 Now, the key thing today that we seem
11 to be covering is standard of care. What are the
12 standards of care? And that seems to be where the
13 rubber meets the road in this whole issue. What are
14 the standards of care and who has the power to decide
15 the standard of care? That's the basic thing here.
16 Now, the other day I was reading a
17 deposition that was done by a chief medical officer
18 of one of the New York insurance companies, and he
19 was describing how guidelines for Lyme disease were
20 established. And he quoted a company called Millman
21 and Robertson (phonetic spelling). And Millman and
22 Robertson he referred to as the guidelines that they
23 used in deciding what were these guidelines for
24 treatment.
25 Now, let's think of a couple of words
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1 here. There's guidelines, standards of care,
2 criteria. Now, when you look at -- what's Millman
3 and Robertson? Millman and Robertson is an actuarial
4 firm, so they manage money. No one there -- it's not
5 a medical entity, it's an actuarial firm. It says
6 that on their letterhead. Now, when they're
7 questioned about these so-called guidelines, what
8 they say is, well, they are goals. They are
9 financial goals. Now, that makes sense from their
10 standpoint, in terms of liability issues -- and there
11 apparently is a liability suit involved with this in
12 Texas. Now, however, somehow goals -- financial
13 goals somehow become criteria that somehow become
14 guideline that somehow become standards. And then
15 physicians who deviate from these standards, that
16 somehow started out as goals, then get flagged - and
17 that's also in a deposition - and their cases are
18 more stringently reviewed and -- for deviating from
19 these guidelines.
20 Now, what are valid guidelines? And
21 that's the big argument in managed care; how are
22 guidelines established? Now, on the front page of
23 that packet I address guidelines in JAMA -- my letter
24 in JAMA. And you if you think of it, it's an issue
25 not just in Lyme disease, but it particularly comes
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1 up in Lyme disease because it's just such a complex
2 issue, a complex disease. But it comes up in any
3 disease. And there's a lot of buzz words - and I
4 heard quite of a number of them - of evidence-based
5 management -- evidence-based medicine, disease
6 management. Let me talk about those words and let's
7 try to define them.
8 First of all, disease management,
9 that's one criteria. Now, if you think of it, what's
10 disease management? Disease management is like
11 cookbook. And I actually teach disease management,
12 but I teach it as a rough guideline, which is a
13 teaching tool, but it's not something that anyone can
14 rigidly adhere to. You can't really use it as a
15 guideline that you can impose on someone. So,
16 disease management basically says, well, this is how
17 you manage depression or diabetes or Lyme disease.
18 But in reality in medicine, we never treat diseases.
19 It is malpractice to treat a disease. As physicians,
20 we only treat patients, not diseases. So, therefore,
21 no one can ever sit in an office and set a guideline
22 that applies for a patient that they have never seen.
23 And if we look at what are guidelines,
24 what are true standards of care, number one standard
25 of care is to do a thorough exam of the patient.
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1 Another standard of care is use clinical judgment and
2 combine all the information. Now, with
3 evidence-based medicine -- in reality, what I heard
4 today sounded more like evidence-biased medicine.
5 And there's about 6,000 citations in the medical
6 literature on Lyme disease. Now, here's some that
7 says long-term treatment is appropriate. And it's
8 like a legal case, proving a case in court, that you
9 can always look at the evidence one way or the other.
10 And when you are advocating a particular cause, you
11 may bias the evidence that you use. So, when a
12 doctor examines a patient, what evidence does he
13 truly use?
14 Now, there's been a distortion of many
15 words in medicine. For instance, managed care is not
16 the only managed care. Health maintenance
17 organizations don't really maintain health. And
18 there's a lot of oxymorons that are buzz words, that
19 are catchy, that are deceptive - deceptive to the
20 point that they may be considered fraudulent - but we
21 hear them so much that we kind of accept them and
22 there's a little twist on the truth.
23 Now, in my article -- I have two
24 articles on the Klempner article in your packet: One
25 is my -- it was published in the New_England_Journal_
___ _______ _______
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1 of_Medicine two weeks ago; and behind that -- when
__ ________
2 you publish a letter in the New England Journal you
3 have 250 words, so you have to be very concise.
4 Behind that is my more detailed rebuttal to the
5 Klempner article, which I could never get into 250
6 words. But in that I talk about how evidence is
7 often twisted and biased and slanted, just like we
8 see in the courtroom, where evidence is presented in
9 its best light, depending on who you are advocating
10 for. Now, as physicians, it's our responsibility to
11 advocate for the patients first. And we realize that
12 we're dealing with entities who advocate for other
13 interests. And there are some people in the
14 insurance industry, for example, who have a certain
15 financial bias. There are some people in research
16 who look at research criteria or they look
17 epidemiological criteria, but that's not really
18 clinical practice criteria.
19 So, how do you set the guidelines in
20 practical medicine? You have to look at a thorough
21 exam of the patient, judgment; you have to look at
22 the standards of the community; you have to look at
23 an objective review of the medical literature. And
24 that's true evidence-based medicine. But what is
25 called evidence-based medicine by the insurance
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1 industry today is not truly evidence-based medicine.
2 Now, one argument I heard earlier was
3 you need double-blind studies to prove something.
4 The reality is, most of medicine is not proven by
5 double-blind studies. I'll give an example.
6 Millions of people are treated with antidepressants
7 to reduce their risk of suicide. There has never
8 been a single article, double-blind controlled study
9 that proves that antidepressants reduce the risk of
10 suicide. Now, if we went out and did a study like
11 that, it would be unethical. Once something is well
12 accepted, it's unethical to prove it by double-blind
13 studies. So, we're in a quandary here. Most of
14 medicine that's obvious, that's self-evident, does
15 not fall into this category of double-blind
16 research-proven. And when we're at the leading edge
17 of medicine, we don't have double-blind studies
18 supporting things. We didn't have a double-blind
19 study that supported using the mechanical heart in a
20 patient recently. Would have been a good idea. How
21 you can you ever do that?
22 So, whenever we deal with people that
23 are the difficult patients to treat, the challenging
24 patients, we never have the luxury of evidence-based
25 medicine. That comes long in the wake, when the
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1 masses of people get involved after it's been
2 well-established for many years. But we need to
3 treat people today with symptoms that are severe
4 today, and we can't wait for evidence-based medicine
5 to catch up with the realities of clinical practice.
6 Now, I also have in there a survey that
7 I did of physicians who treat Lyme disease in Lyme
8 endemic areas. And I asked them: What are your --
9 what's your experience? And looking at that, that
10 helps in many ways to establish a standard of care of
11 what people are truly doing in a community. Now, you
12 don't want to look at people -- every now and then, I
13 get into things on the telephone or in courtrooms,
14 with various legal issues surrounding managed care,
15 and I may talk to the expert who is questioning my
16 work. And I say to them, "Well, how many cases of
17 Lyme disease have you treated?" And often they may
18 say, "None." They're looking at -- in one these
19 guidelines. Now, maybe that's a Millman and
20 Robertson goals guideline. Who knows where it come
21 from? But often you're dealing with people who don't
22 have the -- who aren't at the front line, who aren't
23 dealing with this every day.
24 Now, when I see a patient who I suspect
25 to have Lyme disease, I review methodically a list of
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1 258 signs and symptoms in my initial interview. And
2 that's what I have to look at to get a comprehensive
3 view of their status. And you have to look at the
4 whole thing, not just one small piece of it, and
5 that's the basic fundamental of medicine. So, who
6 has that power to make a decision? Is it the patient
7 and the doctor of their choice, or is it some
8 third-party entity who looks at -- wants to get into
9 that equation?
10 Now, medicine is over a trillion-dollar
11 business per year. It's 14 percent of the Gross
12 National Product. And when you're looking at that
13 much money, there's many other people who want to get
14 involved in medical care for the wrong reasons. If
15 the cost of medicine were insignificant people would
16 stay out. We don't have these debates about giving a
17 year of tetracycline for acne. Everybody stays out
18 of that; there's no money in that. But there's big
19 money in this and -- there's money at stake and
20 there's reputations at stake. So, a lot of people
21 get into that equation that interfere with and
22 violate the confidentiality and the freedom of the
23 patient-physician relationship. It's very odd that
24 we have a country that is founded on rights and we
25 have many freedoms - religious freedom, freedom to
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1 bear arms - but what about freedom in health care?
2 Why don't we have that freedom just like other
3 freedoms? And that freedom is jeopardized. And as
4 more and more political, legal, financial issues
5 involve health care, we're going to see more and more
6 of an assault on the freedom for us to access health
7 care.
8 And maybe I'll ask a question. If
9 anyone in this room were to become sick, how would
10 you want to be treated? Would you want to be treated
11 as an individual, with an individualized assessment
12 by a physician of your choice, or would you want to
13 follow a cookbook protocol that was basically
14 designed by an actuarial firm? What would you prefer
15 if you become sick? What would you prefer for your
16 family? And can we in good conscience provide any of
17 our patients anything less?
18 Now, the physicians who have come under
19 assault from OPMC could not provide anything less.
20 They were ethical leaders and they were scientific
21 leaders, and this is scientifically founded in truly
22 good science. And we can look at the arguments of
23 science, and you can debate that all day long -- and
24 as Dr. Barkley pointed out, much is not known. So,
25 we always have to have that humility. And we always
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1 have to have an open mind and look at the feedback
2 that if a protocol doesn't work, we have to look at
3 it and say, well, maybe there's something else. And
4 having that open mind is what needs to be preserved.
5 And having that -- the rigidity has been the problem.
6 Now, insurance is based on
7 predictability, and for that reason, probably,
8 insurance companies don't particularly like
9 psychiatry because it's a more complex field; it
10 seems more amorphosis, it's harder to predict. And
11 actuaries want to be able to predict, so we have a
12 clash. We have a group of people that want to
13 predict, and we have scientific reality that can't be
14 predicted, that can't be quantitated and
15 well-defined. So what do you do? Do you try to --
16 it's like Cinderella. Do you try to put a foot in a
17 shoe that doesn't fit, or do you make the other
18 systems adapt to the clinical reality of what we're
19 dealing with in Lyme disease? That's what I feel we
20 need to do. And that's what I would appreciate any
21 support for you to do in that area.
22 Now, if legislation is passed, we know
23 what happens. That often on the back end of it, when
24 it goes into committee, there's a lot of lobbying,
25 and what starts out as one thing may end up as
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1 something else. What starts out as privacy
2 legislation may be privacy violation when there are
3 different clauses put in in committee. So, that
4 would be a critical thing to watch out for: That if
5 we do enact something, it truly is what it is, which
6 is contrary to what we've been seeing too much in
7 medicine today.
8 A couple other points. One point is
9 that one argument against the treatment of Lyme is
10 saying that, well, the antibiotic resistance -- you
11 can get antibiotic resistance. Now, let's look at
12 that. Antibiotic resistance is a problem, that is a
13 concern, but there are three major causes of
14 antibiotic resistance.
15 Number one is antibiotics are used all
16 over the place. They're used in agriculture; they're
17 used in hand soaps; they're used in many commercial
18 products, particularly agriculture. That's a major,
19 major cause of antibiotic resistance.
20 Number two, which is a very major
21 cause, is undertreatment. An example of that is,
22 we're seeing new strains of tuberculosis evolved in
23 Russian prison systems because of undertreatment.
24 When we have populations of people that are
25 adequately treated for serious diseases you don't see
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1 the evolution of resistant strains. So,
2 undertreatment of serious illness, such as Lyme,
3 helps prevent antibiotic resistance.
4 The third area, which is an area, is
5 overtreatment of trivial illnesses. So, that's, for
6 example, giving an antibiotic for the common cold,
7 when it's a viral infection and may not really help
8 anything. And that's valid, everybody agrees on
9 that.
10 Another thing that comes up is placebo.
11 Is this a placebo effect or is this a real effect?
12 And when you look at -- that's often an argument.
13 And when you look at studies, placebo is a real
14 effect. So, when you're treating -- when you're
15 doing a study, everybody gets treatment, but the
16 placebo group gets less treatment. But they still
17 get treatment. And when you have the study that's
18 getting the real thing, the drug, you see a higher
19 response, but you do see a response in the placebo
20 group, because there is partial treatment but of a
21 different sort. Now, placebo responses are more
22 dramatic in the initial phases of the study. As the
23 study goes on over months, over a more extended
24 period of time, then you see that dissipate. And
25 when we're looking at Lyme and we're looking at
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1 people that have this year after year, I think it's
2 hard to discount everything as the placebo effect. I
3 think that just doesn't hold water.
4 Those were the basic points that I
5 wanted to make. I don't know if there's any
6 additional questions or -- if not, that's all I have
7 to say.
8 MR. GOTTFRIED: I don't have any
9 questions.
10 Anyone else?
11 MS. O'CONNELL: Thank you very much,
12 Doctor.
13 MR. GOTTFRIED: Thank you for the
14 material you gave us.
15 Okay. Our next witness is Carl
16 Brenner, who is also at Columbia University, member
17 of the Chronic Lyme Disease Study Committee of the
18 National Institute of Allergy and Infectious
19 Diseases. So, I guess the first question is, how
20 come everybody else at Columbia is down there and
21 you're up here?
22 CARL BRENNER; Sworn
23 MR. CARL BRENNER, COLUMBIA UNIVERSITY,
24 MEMBER, CHRONIC LYME DISEASE STUDY COMMITTEE OF THE
25 NATIONAL INSTITUTE OF ALLERGY AND INFECTIOUS
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1 DISEASES: Well, I would like to begin by first
2 thanking Dr. Bransfield for bestowing an honorary
3 doctorate on me, because I'm here as a patient. I
4 work at Columbia, but I'm not a physician.
5 I'd like to talk a little about the
6 actions of the OPMC. I'm a member - as an informed
7 patient, not as a physician - of the National
8 Institute of Health's Advisory Committee for Chronic
9 Lyme Disease studies, and I want to discuss briefly
10 the present state of knowledge of Lyme disease,
11 particularly its chronic form, and how the medical
12 paradigm for this clinical entity has evolved over
13 time. I hope that in doing so I can frame the
14 actions of the OPMC in what I believe should be the
15 appropriate historical context.
16 I should confess at the outset that I
17 have had some difficulty in preparing my remarks,
18 because the workings of the OPMC are shrouded in some
19 degree of secrecy. I'm sure you've heard about the
20 way that the OPMC investigations are triggered: A
21 complaint about a physician is received, either from
22 a patient, another physician or an insurance company;
23 the complaint is kept confidential and the
24 complainant remains anonymous in order to prevent
25 retaliation; an investigation of the targeted
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1 physician is undertaken if the OPMC determines that
2 one is warranted; and a disciplinary hearing follows
3 if, according to the OPMC, one is merited.
4 Given that this process takes place
5 largely behind closed doors, one is forced to do some
6 reading of tea leaves in order to glean what is
7 really going on. So, I've made some observations and
8 assumptions in preparing my remarks today. For
9 starters, it seems that an awful a lot of doctors
10 with significant Lyme disease caseloads are being
11 investigated by the OPMC. I have heard that the OPMC
12 denies that these investigations are actually about
13 Lyme disease, but there is really no other feasible
14 common denominator here, so I'm going to say way out
15 on a limb and say that, yes, I suspect these
16 investigations are actually about Lyme disease. I
17 find it interesting, however, that the OPMC wishes to
18 avoid the appearance of singling out Lyme-disease
19 physicians, since such a denial seems to me to be an
20 admission of sorts that such a policy would be
21 inappropriate or, at the very least, somewhat
22 distasteful.
23 It's also common knowledge that the
24 physicians under investigation are known to be a
25 little more liberal in both diagnosing and treating
247
1 Lyme disease, so my second assumption is that it's
2 these practices that have caused them to run afoul at
3 the OPMC. And, third, since there is general
4 agreement among all parties that early Lyme disease
5 should and can be treated with antibiotics, I'm
6 assuming that it is the handling of patients
7 presenting later in the course of their illnesses
8 that has sparked the OPMC's actions. Specifically,
9 these would be those patients who were treated early
10 but did not experience complete resolution of their
11 symptoms, or patients showing up in their doctor's
12 office with a symptom complex that has never been
13 treated and which may or may not be an advanced form
14 of Lyme disease.
15 So, why is there a controversy about
16 Lyme disease and how did it evolve? You're probably
17 aware that Lyme disease is considered a relatively
18 new illness in the United States, having only been
19 recognized as a distinct clinical entity in the last
20 25 years. In truth, it has been around far longer,
21 but until the last quarter century it was always
22 misdiagnosed as some other malady - a tribute to its
23 protean nature and ability to defy easy
24 categorization. As you may have been told earlier
25 today, the earliest recognized Lyme disease cases
248
1 were rheumatic in nature. There was an unexplained
2 outbreak of arthritis in coastal Connecticut in the
3 mid-1970s, an epidemiological investigation was
4 initiated, and this emerging disease of the joints
5 was recognized as something new and worrisome. Not
6 long after, it became clear that the disease had many
7 other manifestations; it affected the heart, the
8 eyes, the brain, the nerves, and other parts and
9 systems of the body as well. A number of these other
10 manifestations had been described even before the
11 Lyme arthritis outbreak, but had not been recognized
12 as belonging to a larger whole.
13 I would liken these earlier
14 descriptions of Lyme disease to the well-known fable
15 of the blind man and the elephant, where each man
16 touches a different part of the elephant and reaches
17 an erroneous conclusion about the totality of the
18 animal based on the part he touches. The man
19 touching the trunk describes the elephant as
20 snake-like; the man encountering the tusk describes
21 the elephant as a spear; and the man touching the leg
22 intuits a tree-like creature, and so on. But please
23 don't take the metaphor of the blind man too far.
24 None of this is meant in any way to disparage that
25 early work, as virtually all emerging diseases are
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1 described in this sort of piecemeal fashion. I'm
2 simply trying to point out that Lyme disease has been
3 somewhat of a moving target over the years, and the
4 conventional wisdom has been subject to frequent
5 amendments and refinements.
6 The development of a treatment paradigm
7 evolved in the similarly lurching manner. Initially,
8 it was posited that antibiotic treatment was utterly
9 useless. A few years later it was considered
10 moderately helpful; a few years after that, two weeks
11 of treatment with antibiotics was suddenly presented
12 as almost a silver bullet cure. But not long after
13 that it was decided that maybe four weeks would
14 provide a better outcome, except for the cases where
15 perhaps six would be more appropriate, or maybe even
16 two courses of four weeks, for a total of eight.
17 Sometimes these treatment recommendations were tested
18 in controlled studies, but not always. In any case,
19 the point is that the standard of care was always a
20 work in progress and underwent several revisions, not
21 all of them logical, as researchers and physicians in
22 the field groped for consensus and a sense of
23 certainty in treating what was to be turning out to
24 be, in some patients, a stubbornly difficult disease
25 to cure. I am not at all sure we've seen the end of
250
1 this process, and further revisions may well be in
2 store.
3 The National Institutes of Health,
4 recognizing that deficiencies exist in the areas of
5 both testing and treatment for Lyme disease, have
6 funded a number of studies over the years to look at
7 these issues. But significant problems with testing
8 still remain, as you've no doubt heard in the talks
9 over today.
10 Here are some direct quotes from the
11 National Institutes of Health Web page on diagnosing
12 Lyme disease.
13 One: "Lyme disease may be difficult to
14 diagnose because many of its symptoms mimic those of
15 other disorders."
16 Two: "The only distinctive hallmark
17 unique to Lyme disease, the erythema migrans rash, is
18 absent in at least one-fourth of the people who
19 become infected."
20 Three: "Unfortunately, the Lyme
21 disease microbe itself is difficult to isolate or
22 culture from body tissues or fluids."
23 Four: "The inadequacies of the
24 currently available diagnostic tests may prevent
25 physicians from firmly establishing whether the Lyme
251
1 disease bacterium is causing a patient's symptoms."
2 Five: "In the first few weeks
3 following infection, antibody tests are not reliable
4 because the patient's immune system has not produced
5 enough antibodies to be detected."
6 Six, "Antibiotics given to a patient
7 early during infection may also prevent antibodies
8 from reaching detectable levels, though even the Lyme
9 disease bacterium is the cause of the patient's
10 symptom."
11 And so on and so on. As you can see,
12 there remains a great deal of uncertainty in
13 determining who has Lyme disease, and as a result,
14 considerable effort is currently being expended to
15 try to advance the medical community's knowledge in
16 the area of Lyme disease testing.
17 As if things aren't difficult enough,
18 another important development has complicated the
19 chronic Lyme disease picture - the possibility that
20 many patients with so-called chronic Lyme disease may
21 be infected with other tick-borne pathogens in
22 addition to, or perhaps even instead of, the Lyme
23 organism. You heard Dr. Schutzer allude to this
24 earlier today. Several new tick-transmitted
25 disease-causing microbes have been discovered in
252
1 recent years, and the current list is surely far from
2 complete. Even before the Lyme disease was described
3 in the U.S., medical scientists were aware of
4 babesiosis, a malaria-like disease also transmitted
5 by the deer tick. Since the emergence of Lyme
6 disease, other microbes carried by the deer tick have
7 also been discovered; the agent of human granulocytic
8 ehrlichiosis, for example, which infects human immune
9 cells and causes fever, aches, nausea and vomiting,
10 and which is occasionally fatal. It also known that
11 Bartonella organisms, which cause cat scratch fever,
12 are present in deer ticks, and a recent publication
13 in the medical journal Archives_of_Neurology
________ __ _________
14 describes several cases of likely tick-transmitted
15 human infection with this organism. Finally, a new
16 spirochete similar to the Lyme disease agent has just
17 been discovered in deer ticks. It too may have a
18 role in the so-called chronic Lyme disease. It's
19 also important to note that the treatments for some
20 of these other diseases are quite difference from
21 those for Lyme, so past treatment for Lyme disease
22 may be useless in resolving symptoms if they are
23 caused by these other organisms.
24 So, if I may return to the blind
25 man/elephant metaphor for a moment, it now seems that
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1 we may not even be looking at single elephant after
2 all, but rather two or three elephants, or perhaps
3 several elephants with a zebra thrown in.
4 Furthermore, the tests for some of these other
5 diseases are in some cases as limited as those for
6 Lyme, as new strains of these infections -- of these
7 infectious microbes pop up with distressing
8 regularity. Tests developed 20 years ago to detect
9 Babesia, for example, may not pick up newly
10 recognized strains of this organism.
11 So, as a clinician trying to cope with
12 this complex, multi-systemic, clinical entity known
13 as chronic Lyme disease, what are you supposed to do?
14 Most of the testing and treatment guidelines, or at
15 least those produced by responsible authors, are
16 riddled with qualifications and equivocations, and
17 rightfully so. There are still many questions to be
18 answered. Too many patients are not recovering after
19 a short course of antibiotic therapy. They may still
20 be infected with the Lyme organism, or they have
21 another infection, or they may have multiple
22 infections, or they may no longer be infected and
23 instead be suffering from some post-infectious
24 process. As a physician, though, are you going to
25 sit around and wait for new tests and treatment
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1 recommendations, or are you going to try to help your
2 patients now? I maintain that the proper,
3 responsible course of action under these
4 circumstances is for the clinician and the patient to
5 work together to pursue appropriate treatment
6 options, as long as this can be done without unduly
7 endangering either the patient or the community at
8 large.
9 As I mentioned earlier, the NIH is
10 currently funding several studies that deal with the
11 question of how to treat chronic Lyme disease - you
12 heard Dr. Fallon talk about that earlier today - and
13 I sit on an advisory committee for some of these
14 studies. The studies are in progress now, as we
15 speak. It seems to me that this is de facto evidence
16 that the proper treatment for chronic Lyme disease is
17 still an open question. You're not going to waste
18 precious monetary and scientific resources studying
19 something that's already resolved. Thus, by
20 inference, I believe it would be entirely fair to
21 conclude that there must be legitimate differences of
22 medical opinion concerning this topic.
23 Which bring us back to the actions of
24 the OPMC. It is not at all uncommon in contemporary
25 medicine for there to be a lack of consensus on the
255
1 diagnosis and treatment of an emerging disease, but I
2 do think it's unusual to see such a persistent and
3 systematic effort to rout one's opponents by using a
4 state medical board to investigate them. Because the
5 identities of the complainants to the OPMC are kept
6 confidential, it's impossible to know exactly why all
7 of this is happening, but one thing is clear: The
8 initiating complaints do not appear to be coming from
9 patients. That leaves only other physicians or
10 insurance companies as the source, and neither of
11 these scenarios is very pretty. I cannot honestly
12 say that I know that the diagnosis and treatment
13 practices of every physician who has been
14 investigated by the OPMC, or that I would personally
15 approve of them if I did. But I do know organized
16 harassment when I see, and I do not think that the
17 OPMC should be employed as a tool to harass
18 physicians over what can appropriately be described
19 as legitimate differences in medical opinion.
20 Thank you.
21 MR. GOTTFRIED: Well, thank you. As
22 you may know, we will be holding a hearing, I expect,
23 sometime in January or February on the operation of
24 OPMC, and several of the issues that you've raised
25 will be part of our study at that time, both in terms
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1 of what they've been doing and what some possible
2 procedural remedies might be.
3 Questions?
4 MS. MAYERSOHN: No. I just assume you
5 have no objections if we submit this to the OPMC?
6 MR. BRENNER: No, I guess not. Don't
7 give them my address.
8 MR. GOTTFRIED: We do know that they
9 can't take away your license.
10 MR. BRENNER: Right. I'm safe.
11 DR. MILLER: We were basically very
12 sorry that we hadn't subpoenaed the OPMC to sit here
13 and listen to this all day long. But we have offered
14 them the opportunity to be infected with the Lyme
15 spirochete, and see which line of treatment they
16 would like to pursue after they were no longer cured
17 after the first four weeks of -- thank you.
18 MR. GOTTFRIED: Let me note that Dr.
19 Miller's last comments were tongue-in-cheek.
20 DR. MILLER: I didn't know that.
21 MR. GOTTFRIED: We're used to that in
22 the Assembly. I just wanted to clarify it for the
23 record.
24 MS. O'CONNELL: Thank you very much for
25 your testimony.
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1 MR. GOTTFRIED: Thank you.
2 Okay. We can, indeed, see the light at
3 the end of the tunnel. We are going to take a short
4 break again of, hopefully, something close to five
5 minutes, and then well reconvene. At that time, we
6 expect to have Dr. Barbour from University of
7 California testifying on the phone, and we will then,
8 after Dr. Barbour, proceed with the remainder of
9 witnesses pretty much in order. So, we will now take
10 a brief recess.