24 MR. GOTTFRIED: Okay. Thank you.

25 We're going to modify the order of

228

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

229

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

230

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

231

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

232

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

233

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

234

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.

235

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_

___ _______ _______

236

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

237

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

238

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

239

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

240

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

241

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

242

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

243

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

244

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

245

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

246

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

249

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

253

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

254

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

256

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.

257

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.