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11 (A recess was taken.)

12 MR. GOTTFRIED: Okay. If everyone

13 could take their seats, we do need to reconvene. The

14 sooner we reconvene, the sooner everyone gets to

15 testify.

16 Okay. We're going to make another

17 change in the order of speakers to accommodate a

18 witness who isn't feeling well. Before we call Dr.

19 Barbour in California, where it is only quarter to

20 two, we will call on Sarah Rude.

21 MS. RUDE: I'm her mother; okay? She

22 wants me to sit next to her.

23 MR. GOTTFRIED: Absolutely.

24 SARAH RUDE; Sworn

25 MS. SARAH RUDE: Good afternoon. My

 

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1 name is Sarah Hale-Rude. I am 13 years old and have

2 been co-infected with Lyme, babesiosis and

3 ehrlichiosis since August of 2000. My symptoms began

4 with headaches and fatigue, which gradually became

5 severe. In November of 2000, I developed new

6 symptoms of back and neck pain, joint pain, and

7 mental confusion. My family doctor was hesitant to

8 start me on antibiotics for Lyme because I did not

9 have a rash or find a tick on me, but we eventually

10 convinced him to put me on doxycycline. I took this

11 medicine for three weeks and began to feel a little

12 bit better. However, after stopping the medicine, I

13 felt considerably worse. We pleaded with the doctor

14 to keep me on more antibiotics, but he refused,

15 saying that three weeks of doxycycline is enough to

16 treat even the worst case of Lyme disease.

17 After this, my parents took me many

18 specialists, and all of them found every possible

19 reason to deny that I had Lyme disease. The reason

20 they gave for my being so sick was chronic fatigue

21 syndrome, fibromyalgia, and severe depression.

22 By this time, I had already missed a

23 few weeks of school, not having any idea I wouldn't

24 be back for almost a year. Not only had I lost the

25 pleasure of going to school - though it was growing

 

259

1 considerably harder since I had been sick - I was

2 also forced to drop out of the drama club play in

3 which I had a lead part.

4 At this point, I didn't think things

5 could get much worse. People were accusing me of

6 being a psych case. I had lost my ability to read,

7 my favorite pastime, and every day I felt worse and

8 worse, and my part in the play was given to another

9 girl. But I certainly was not prepared for how

10 horrible my life would get.

11 I was in excruciating pain. Not only

12 were my headaches nearly blinding, I was sleeping 15

13 hours a day. My sister was going to visit family in

14 Chicago for Easter break, and all my friends were

15 going away also, so I was lonely over that holiday.

16 Words cannot describe how miserable I was.

17 By May, I was falling frequently and

18 hardly able to follow a tutoring session with my

19 tutor because of my severe mental confusion and

20 fatigue. A few weeks later, I was admitted to

21 Northern Dutchess Hospital for testing because of my

22 frequent falling and dizziness. My new family doctor

23 was also quick to suspect a psychological problem and

24 reluctant to even consider Lyme disease. I could

25 barely move at all, for I was in such pain. Almost

 

260

1 everyone at the hospital thought I was crazy. Once

2 when two of the nurses brought me to the bathroom,

3 they said to each other, "This one definitely belongs

4 in a psych ward." I was already howling in pain, but

5 when I heard this, I started to sob. I couldn't

6 sleep at all that night because those words hurt so

7 badly. To this day, I don't understand how anyone

8 could be so cruel. They spoke as if I couldn't hear

9 them. I was so unhappy and desperate. By now,

10 hardly a soul would believe me when I said I had Lyme

11 disease, except my family and friends.

12 While in the hospital, I was put on IV

13 for a sinus infection, which is ironically the same

14 medicine that is used to treat Lyme disease. After

15 the IV was put in, I was almost completely bedridden

16 for almost a month. My parents thought this was a

17 Herxheimer reaction, which is something that happens

18 to Lyme patients when the bugs are killed and release

19 their poisons into your body. I was almost

20 completely paralyzed. I couldn't even hold my head

21 up. When I went home, my family doctor kept me on IV

22 because I was starting to believe that -- he was

23 starting to believe that I had Lyme. The only way I

24 could get around from June through August was in a

25 wheelchair.

 

261

1 Of course, my mom had to cancel my

2 place at sleep-away camp. My sister and cousins were

3 able to go for two weeks to the camp I had been

4 looking forward to returning to since it ended.

5 Knowing they were at camp, having fun, and I was at

6 home, sick and miserable, made me feel even worse.

7 As summer grew closer I started to feel

8 a little bit better, but not enough to do anything

9 fun. I spend my days mindless looking at the TV, for

10 I could not follow what was going on. In June, I was

11 finally officially diagnosed with Lyme disease. As

12 July turned into August, I started on babesiosis

13 medicine and was slowly able to walk again. This

14 made me feel -- this made me feel wonderful. Soon

15 after, I was reading again. This made me happier

16 than anything. I was devouring books like I used to

17 do.

18 When my sister was heading off to

19 school, I was determined to go back to school also,

20 but my parents and my new favorite doctor, who was

21 treating me for Lyme disease, agreed that I wasn't

22 ready for school yet. This doctor has been treating

23 me for Lyme, babesiosis and ehrlichiosis since July,

24 and without him I wouldn't be doing as well as I am

25 today. I'm also glad my mom and dad never stopped

 

262

1 trying to find a doctor to treat me for my diseases.

2 They found an excellent doctor for me and have spent

3 about $15,000 on my medical care, since our HMO won't

4 pay for much of my treatments. I am walking much

5 better now and will soon be attending school, and

6 it's all thanks to my doctor. It would be a tragedy

7 for so many people if he lost his medical license. I

8 admire that he can make so many people better when

9 the OPMC is threatening him. If he can help me get

10 better and back to my life, he can do the same for

11 many other sick people. My future and his are in

12 your hands. Please help us.

13 MR. GOTTFRIED: When you say you were

14 diagnosed with Lyme eventually, how did that -- how

15 was that done, do you know?

16 MS. SARAH RUDE: I was -- my parents

17 took me to a specialist in Connecticut --

18 MS. RUDE: No, in Poughkeepsie.

19 MS. SARAH RUDE: -- in Poughkeepsie,

20 actually. It was Dr. Stokes. And she was --.

21 MS. RUDE: She did an IFA, a special

22 test for -- I'm not sure what it stands for. It's

23 something -- fluorescent assay was the type of test

24 that they used, and that's how they were able to

25 determine that she did have Lyme disease.

 

263

1 MR. GOTTFRIED: Thank you.

2 Questions?

3 MS. O'CONNELL: I'm sorry, I missed

4 your earlier testimony, but I just want to ask you:

5 How long a process from the onset of your feeling

6 sick until the diagnosis and the treatment?

7 MS. SARAH RUDE: It was about ten

8 months or so. Yeah, ten or eleven months.

9 MS. O'CONNELL: And you had been to

10 many physicians in search of a diagnosis or --

11 MS. SARAH RUDE: Yes.

12 MS. O'CONNELL: -- trying to figure out

13 what was wrong and what was going on,

14 MS. SARAH RUDE: Yeah, I went to -- I

15 think it was a total of 17 doctors in all, and none

16 of them found any -- they all, you know, were just

17 very reluctant to consider Lyme disease.

18 MS. O'CONNELL: And when you went to

19 them, did you articulate -- or did you tell them that

20 you thought you may have had Lyme disease? At some

21 point --

22 MS. SARAH RUDE: Yes.

23 MS. O'CONNELL: -- did you think that

24 you had it or --?

25 MS. SARAH RUDE: Yes.

 

264

1 MS. O'CONNELL: Was that earlier on, or

2 was that sometime later --?

3 MS. SARAH RUDE: That was around

4 December. We read an article and it had almost all

5 of my symptoms, so we started to believe that that

6 was what I had. So, we tried to convince my family

7 doctor to put me on doxycycline. And then after

8 three weeks was up, he took me off that, and that's

9 when I really started to get very bad.

10 MS. RUDE: But we did take her to many

11 specialists within our health plan, and they -- some

12 of them -- most of them did some type of blood tests,

13 including multiple Western blots, and it was that

14 they basically couldn't -- now we know that they were

15 not reading the blood tests properly.

16 MS. SARAH RUDE: They were going by the

17 CDC criteria. And on the test it said that you could

18 not go by that. It was -- if you had less than that,

19 it was inclusive, but it was not negative. And they

20 were all telling us that I was negative. So, they

21 were leaving me sick for months, without even --

22 without even properly reading the tests.

23 MS. O'CONNELL: What sort of

24 specialists did you see. If you would just give us a

25 range of the subspecialties of internal medicine? I

 

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1 presume --.

2 MS. RUDE: We saw --

3 MS. O'CONNELL: Infectious disease?

4 MS. RUDE: -- at least two infectious

5 disease people, rheumatoid arthritis, juvenile

6 rheumatoid arthritis specialist. When she was told

7 that she had chronic fatigue and fibromyalgia, one of

8 the things that she had was very, very low blood

9 pressure. And so we took her to a specialist who was

10 doing work on kids who had very low blood pressure;

11 he did this special test on her -- even though my

12 husband took her and insisted that they please check

13 around for Lyme disease. And specialist after

14 specialist, even the major medical centers, were

15 completely missing the picture.

16 MS. O'CONNELL: Thank you.

17 MR. GOTTFRIED: Miss Rude, are you

18 essentially now a year behind in your education as a

19 result of this?

20 MS. SARAH RUDE: No, I've been doing

21 tutoring with my very good friend - she's my tutor -

22 and I've been keeping up with the school work. But

23 last year when I was in sixth grade, about May, I

24 just stopped -- I couldn't do any more work, so I

25 just stopped doing it. I couldn't follow it all. I

 

266

1 couldn't even follow a coherent conversation. I

2 couldn't talk, barely.

3 MR. GOTTFRIED: And are you --?

4 MS. RUDE: But she's now in seventh

5 grade.

6 MS. SARAH RUDE: I'm now in seventh

7 grade. They passed me.

8 MR. GOTTFRIED: So, you're now back in

9 school?

10 MS. SARAH RUDE: I'm going to return to

11 school, hopefully, Thursday.

12 MS. O'CONNELL: The first time?

13 MS. SARAH RUDE: Yes.

14 MS. RUDE: But the school has been

15 providing tutoring service, and they've been really

16 very helpful in terms of meeting with us and creating

17 a part-time schedule for her when she goes back. So,

18 I've got to say that through all of this the medical

19 system may not have been particularly there for her,

20 but the school system hasn't been too bad.

21 MR. GOTTFRIED: Are there questions?

22 DR. MILLER: I just would like to make

23 a comment on how nice it is to see Sarah -- even with

24 canes, as opposed to the wheelchair, the first time I

25 met her in the office. And I know we had talked

 

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1 about what you mentioned here, but I think it was

2 swept over very quickly. And that's the fact that we

3 have an extremely bright and articulate young lady

4 who was constantly being told that she was crazy, at

5 the same time she couldn't function. The failure of

6 the medical profession was made to be her failure or

7 her problem, not her problem, and I think that was

8 very, very sad. And so I'm glad that you continue to

9 mend, and continued good luck.

10 MS. SARAH RUDE: Thank you.

11 MS. O'CONNELL: I just have one other

12 question. Did you ever have the bull's-eye rash at

13 any point, or a tick bite that you were able to

14 identify?

15 MS. SARAH RUDE: No, I never did.

16 Well, actually --.

17 MS. O'CONNELL: Tell me anything you

18 want to tell me.

19 MS. RUDE: We never found the tick and

20 we never found the rash. And that was one of the

21 things that the doctors kept saying, "Oh, it can't be

22 Lyme. You didn't have the tick, you didn't have the

23 rash."

24 MS. O'CONNELL: Thank you.

25 DR. MILLER: Well, that really is, you

 

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1 know, a failure of the patient population. You're

2 supposed to save those ticks and photograph the rash,

3 so if you can't get to the doctor immediately -- and

4 it's a 24-hour program. You have to keep constantly

5 photographing. You don't want to miss that

6 opportunity to get diagnosed quickly.

7 MS. MAYERSOHN: Just one question. Who

8 is the doctor who finally started treating for Lyme

9 disease?

10 MS. RUDE: Are we allowed to say his

11 name?

12 MS. MAYERSOHN: If you want to.

13 MS. SARAH RUDE: Dr. Richard Horowitz.

14 MS. O'CONNELL: That's okay.

15 MS. SARAH RUDE: Thank you very much.

16 MR. GOTTFRIED: Thank you very much,

17 and good luck.

18 We are now going to hear testimony by

19 Dr. Alan Barbour of the University of California at

20 Irvine, Department of Microbiology and Molecular

21 Genetics and the Department of Medicine.

22 Dr. Barbour?

23 DR. ALAN BARBOUR, UNIVERSITY OF

24 CALIFORNIA AT IRVINE, DEPARTMENTS OF MICROBIOLOGY AND

25 MOLECULAR GENETICS AND MEDICINE: Yes, I'm here.

 

269

1 ALAN BARBOUR, M.D.; Sworn

2 MR. GOTTFRIED: Okay. Thank you.

3 Please, begin.

4 DR. BARBOUR: All right. I have no

5 idea what has gone on previously during the day, but

6 I thought I would mainly leave most of my time to

7 answering questions; and I would read a couple things

8 that I've written in the past, that are in the public

9 record and available for the public to see.

10 One is a short couple of sentences from

11 an op. ed. piece I wrote for the New_York_Times on

___ ____ _____

12 July 5th, 1997. And there I wrote:

13 "Many scientists who study Lyme disease

14 find themselves uncomfortably in conflict with

15 advocacy groups that might otherwise be their

16 benefactors. The controversy is not only about

17 priorities for research, but also about how to define

18 the disease and how best to treat it."

19 I basically feel that this is the same

20 situation now, in 2001, as what occurred in 1997.

21 The other -- a little longer piece is

22 from a book I wrote called Lyme_Disease:__The_Cause,_

____ ________ ___ ______

23 The_Cure,_The_Controversy, by Johns Hopkins Press,

___ _____ ___ ___________

24 published in 1996, and this is from page 190. And

25 it's after I describe a hypothetical case of someone

 

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1 who might have had Lyme disease and might not have

2 been given the diagnosis of chronic Lyme disease.

3 And her name was Evelyn. This is, again, a

4 hypothetical situation. And the subtitle for this

5 paragraph is, quote, "Is Lyme disease equivalent to a

6 Borrellia burgdorferi infection?"

7 "Before reconsidering Evelyn's

8 diagnosis, let's back up to the point when her

9 physicians concluded that she did not have Lyme

10 disease. As should be clear by now, since your

11 conclusion is controversial, some of these

12 differences of opinion over the diagnosis and

13 management lie in the fact that some people

14 distinguish between 'Lyme disease' and Borrellia

15 burgdorferi infection. Separated in many people

16 minds are, on the one hand, a clinical syndrome Lyme

17 disease which might be defined on the basis of

18 symptoms in a way that is valid and useful to patient

19 care, and on the other hand, an infection by a

20 particular microorganism, Borrellia burgdorferi. The

21 acknowledged difficulty in detecting the

22 microorganism widens the gulf between the concept of

23 Lyme disease and a spirochete infection. In a

24 situation such as this, that is, where the diagnostic

25 line between infection and no infection is fuzzy, it

 

271

1 is tempting to make a diagnosis on the basis of a

2 constellation of symptoms alone, rather than a more

3 comprehensive view incorporating not only symptoms,

4 but also laboratory data and the likelihood of

5 becoming infected. Attributing a troubling,

6 disabling and chronic disease to a potentially

7 treatable infection is appealing for both physician

8 and patient.

9 "Nevertheless, diagnosis on these

10 grounds may be hasty. To invoke one type of

11 bacterium to account for all cases of what falls

12 under the broader diagnostic umbrella of Lyme disease

13 is akin to saying that all or most forms of arthritis

14 of the knee are due to Borrellia burgdorferi. There

15 are many kinds of arthritis, only one of which is

16 Lyme arthritis. A common form of arthritis,

17 rheumatoid arthritis, may be initiated by one or more

18 infectious agents, but this has not been proven.

19 Even the suspicion that an infection is the causative

20 agent has not yet led to a widely-accepted treatment

21 or means of prevention.

22 Those physicians who have a more

23 restricted definition of chronic Lyme disease appear

24 to be on the firmest scientific ground to judge from

25 the medical literature and textbooks, but that is not

 

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1 to say that the observations of those arguing for a

2 more broadly defined chronic Lyme disease are

3 invalid. It has been suggested by some that certain

4 patients do benefit from extended courses of therapy

5 and only approach normal health while being treated

6 with antibiotics, then these reports warrant serious

7 consideration. As has been discussed" - elsewhere in

8 the book - "this positive outcome with antibiotics

9 may be the consequence of a placebo effect either of

10 the medication itself or the physician's optimism and

11 encouragement. Alternatively, non-specific effects

12 of antibiotics may play a role in producing the

13 patient's sense of greater well-being. Perhaps,

14 through the poorly understood effects,

15 anti-inflammatory effects, or another bacterium.

16 Nevertheless, until a group of patients meeting the

17 broader definition of Lyme disease are treated

18 blindly and randomly in a controlled trial, it may be

19 shorted-sighted to reject on hand some of these

20 reports of inexplicable benefits from antibiotics."

21 Now, that's by -- where I stop.

22 I would just add that since I wrote the

23 book there has been the NIH study. And Dr. Klempner

24 is the principal investigator, and I'm sure you have

25 that information before you and it probably been

 

273

1 discussed.

2 I think the other information that may

3 be relevant here is the results of the study of the

4 Persian Gulf -- people with -- who have been said to

5 have Persian Gulf syndrome. And there's a large

6 Veterans Administration study - I think it's still

7 going on, I'm not sure if that's completed or not -

8 of treating these individuals with antibiotics,

9 mainly a form of tetracycline. And I think if --

10 this may be relevant in the sense that if a benefit

11 is shown of antibiotics in this situation, it might

12 indicate, you know, an effect of antibiotics that

13 hadn't been anticipated in terms of treating people

14 with these fairly non-specific symptoms.

15 I'm open to questions.

16 MR. GOTTFRIED: Thank you, Doctor. I

17 have a couple of questions.

18 You were making the distinction between

19 Lyme disease and infection with the specific

20 bacterium that we've all been talking about --

21 DR. BARBOUR: Yes.

22 MR. GOTTFRIED: -- which I won't try to

23 pronounce. Is your point that the collection of

24 symptoms that we call -- that are associated with

25 Lyme disease may be caused by bacteria other than

 

274

1 that or may be somehow non-bacterial or what?

2 DR. BARBOUR: Well, I think here we

3 come back to the question of how you define Lyme

4 disease just on the basis of symptoms. For

5 epidemiologic purposes, for county cases, it's -- I

6 think everybody would agree it's best to be very

7 precise so you don't mix apples and oranges. But for

8 an individual patient, then I think most physicians

9 and health care professionals would be, you know, a

10 little broader in their definition.

11 So, I think if -- but even if we accept

12 that limitation, I think Lyme disease can be -- has

13 been defined. I've seen it defined this way on Web

14 sites and literature that's so broad that, you know,

15 it could include other -- it certainly could include

16 other causes for that person's symptoms. And these

17 may be other bacteria; they may be a combination of

18 problems, as has been suggested for the Persian Gulf

19 syndrome, as a combination of various factors coming

20 together to produce symptoms of fatigue, muscle aches

21 and things like that. So, yes, to answer your

22 question, if it's defined broadly enough, then --

23 yeah, then I think there could be another

24 explanations. I think the idea that erythema

25 migrans, the skin rash which was once thought to be

 

275

1 characteristic of Lyme disease, I think there's -- in

2 my mind, I think there is evidence that it can be

3 caused by other bacterium. They're related to

4 Borrellia burgdorferi, but they're another species.

5 MR. GOTTFRIED: Okay. On the question

6 of appropriate treatment, we had at least one witness

7 earlier in the day, the medical director of one of

8 our major managed care companies, saying that they

9 reject long-term antibiotic treatment unless

10 essentially ordered to pay for it by our external

11 review system. Because they only believe in paying

12 for treatment or providing treatment that comes out

13 of evidence-based medicine, and that long-term

14 antibiotic treatment is not backed up by

15 evidence-based medicine, suggesting -- although I

16 guess we -- well, implying that there was an

17 evidence-based judgment against long-term antibiotic

18 treatment.

19 Do I understand your testimony to be

20 that there is not at this point an evidence-based

21 medicine judgment as to what the appropriate

22 treatment is?

23 DR. BARBOUR: My understanding of the

24 data is that if someone has had Borrellia burgdorferi

25 infection and this decision -- this conclusion has

 

276

1 been reached after considering the clinical history,

2 the epidemiology, the laboratory tests, such was done

3 in the study in Boston - an NI-sponsored the study -

4 my understanding of the data, of that data and other

5 data, is that there's no additional benefit of

6 prolonged treatment for those individuals.

7 But my point is, I think there isn't

8 enough evidence-based medicine with regard to

9 individuals who may never have had Lyme disease to

10 begin with, but have a constellation of symptoms

11 that, you know, in some cases have led to a diagnosis

12 of Lyme disease by a health care professional and

13 have ended up being treated. I don't think -- from

14 what I understand, there has not been an adequate

15 study of those individuals to see if, really, in

16 fact, they're being benefited by antibiotics. This

17 was done -- has been done in the case of the VA study

18 with the Persian Gulf -- the people with Persian Gulf

19 syndrome, and they're testing that. It's very

20 well-defined in terms of, you know, their symptoms in

21 individuals and what they were at risk for, but they

22 are doing that study.

23 As far as I know, there hasn't been

24 another study that would be at all comparable to

25 that, with individuals who really don't even -- might

 

277

1 not even be considered to have Lyme disease to begin

2 with by, you know, the strict definition of the NI

3 study.

4 MR. GOTTFRIED: Okay. Other questions?

5 DR. MILLER: Yes.

6 I'm Joel Miller. I'm on the Health

7 Committee. And I have a quote that you had made. It

8 said -- and this was on -- well, this is what you

9 have said:

10 "I think we need to go back to an

11 organism-based definition of the infection. And when

12 it comes to treating disease, we need a more

13 empirical approach to conditions that don't fit in

14 that diagnostic box. Also, as with most scientific

15 quests, there is still a lot to learn, but at least

16 there are these organisms identified. It remains for

17 research as to understand what happens when someone

18 is infected with more than one of them at a time."

19 Now, it's been the testimony today that

20 there is a great deal to learn: That, in fact, we

21 haven't been able to rule out the infection of these

22 organisms; that the one common theme is that the

23 diagnostic tests are more a failure than a help,

24 they're more a confusion than an assistance; and that

25 to base treatment on waiting for these laboratory

 

278

1 tests to come back, it may, in fact, put the patient

2 at great risk. There was also testimony today about

3 the study that you're citing, in Boston, which talked

4 about the long-term treatment of antibiotics. And

5 basically the testimony was, it was neither long-term

6 nor the appropriate treatment with the appropriate

7 antibiotic.

8 And so the question is: Wouldn't you

9 like to stand on your comment that there's a great

10 deal to learn, and we have to learn more about how

11 these organisms function, than to say that there is

12 no basis to treat the organisms unless you can have a

13 laboratory test show you that they're there and that

14 this is probably not an organism-based disease?

15 DR. BARBOUR: Well, that's a lot to

16 comment on. I think I know where that quote came

17 from. It was fairly recently. It was on a Web

18 publication, if I'm correct. And that had to do with

19 mixed infections, which I think is another issue.

20 DR. MILLER: But we have more than one

21 microorganism here. Sometimes --

22 DR. BARBOUR: Right. I'm an infectious

23 disease physician, and we're used to finding out

24 what's the cause of diseases; that's how we operate.

25 Other physicians are in the position of acting and

 

279

1 treating people for diseases in which they have no

2 idea what the cause is -- and maybe in the future we

3 will know. I think in most cases of Lyme disease

4 that I'm familiar with, either directly or hearing

5 about or reading about, going to meetings, the

6 individuals have, you know, through a combination of

7 talking to them, the patient history, physical, some

8 laboratory tests, including the ELISA and/or Western

9 blot, I think that you can come to a pretty good

10 conclusion about whether they have that infection or

11 not.

12 I think the -- what is, in my mind, the

13 problem and why, you know, we're all struggling with

14 this and -- you know, for a long, long time, for

15 several years now -- is coming to some agreement

16 about -- what about the individuals who really don't

17 fall into that more classical presentation? I think

18 no one would argue about how to manage the people if

19 they do have the positive blood test, they do have

20 the classic skin rash and live in an area that has a

21 lot of Lyme disease. It's the people who don't fall

22 in that category that everybody has difficulty with.

23 And my point is, why not study those individuals and

24 do a study of whether antibiotics help or not? I

25 agree that the study in Boston, it was well done in

 

280

1 term of how it was set up and defined. And they had

2 to -- obviously, by their criteria had to stop at

3 some point. I would hope that they or someone else

4 is planning to do a study that would, you know, look

5 at longer oral treatments and -- with people who may

6 not have had Lyme disease to begin with by the

7 classic definition.

8 DR. MILLER: Did I hear you to say that

9 that study was well done?

10 DR. BARBOUR: Well, I think it was well

11 done in the sense of how it was defined, yeah. I

12 mean, they were --.

13 DR. MILLER: Yeah, they defined --.

14 DR. BARBOUR: I'm not in a position --

15 I don't have it in front of me or reviewed it

16 intensely last night to know, but --.

17 DR. MILLER: But if you use six weeks

18 as a definition of long term, but use low doses of

19 potentially the inappropriate antibiotic to determine

20 whether long-term treatment by antibiotics was

21 adequate -- we had one study presented today that

22 took two years for resolution, checking on clear

23 symptoms of infection.

24 Empirically speaking, though, if

25 someone comes and has symptoms, and you treat them

 

281

1 with antibiotics and they continue to get better, in

2 spite of the fact that they haven't found your

3 particular bacteria yet, would you say that continued

4 treatment with antibiotic, as long as they were

5 getting better, made sense?

6 DR. BARBOUR: Well, I would think it

7 would make sense if there was a controlled trial to

8 show that it had a benefit, yeah.

9 DR. MILLER: In other words, if they're

10 really not getting better because of the antibiotics,

11 or even if they're getting better with the

12 antibiotics, we should immediately find someone with

13 the same symptoms and not give them the antibiotic to

14 see if they get equally better over the same long

15 period of time?

16 DR. BARBOUR: I'm sorry, I didn't hear

17 that.

18 DR. MILLER: Well, we have someone who

19 goes into a physician's office, the physician

20 diagnoses them based on their skill as a physician,

21 says, "I think you have Lyme." They begin a regimen

22 of antibiotic treatment, the patient continues to get

23 better. And you're saying, well, we really don't

24 know if the patient is getting because of the

25 antibiotic; we should immediately find someone with

 

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1 the same symptoms and not treat them, and see if they

2 get equally better? How else do you do a

3 double-blind study, or how else -- do you have some

4 other way of doing the study, unless you do that? I

5 mean, is that what you're suggesting, that it's not

6 enough that the person is getting better? I mean, we

7 can prove they're getting better. You're doubting

8 whether they're getting better because of the

9 antibiotic. So, the only way we can make a

10 determination here is to find someone with the same

11 symptoms and not give them the antibiotic and see if

12 they get well also; is that what you're saying?

13 DR. BARBOUR: Well, I think that's

14 maybe an overly simple way of saying it, and I

15 think --.

16 DR. MILLER: It's pretty direct, I

17 thought. It was about as simple as I could make it.

18 DR. BARBOUR: I don't think you just

19 one person versus another. It would have to be a

20 large study --

21 DR. MILLER: So, you can't treat --?

22 DR. BARBOUR: -- which there was a

23 question whether antibiotics help or not. Some

24 people walk into an office, who have an bacterial

25 infection, and we treat them for as long as

 

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1 necessary.

2 DR. MILLER: There you go. That's

3 exactly what we would like to see. I mean, frankly,

4 if someone walks into your office and they have what

5 you perceive to be infection, you can't tell them to

6 wait in the waiting room until you have ten other

7 people, so you can have a group. I mean, each

8 physician, don't you believe, has to treat the

9 patients as they come in, with the symptoms that they

10 have, with the treatment that they have on hand.

11 I mean, it's interesting that, you

12 know, we have to look for this bacteria. I wonder --

13 was his name Lister, who couldn't quite tell whether

14 the bacteria were causing illness, but he thought if

15 we eliminated bacteria in general maybe people would

16 survive in a hospitals instead of dying? I mean,

17 sometimes you have to make this leap.

18 But clearly we're in the middle of a

19 major controversy and disaster. We have 10,000

20 people in New York State that have - quote, unquote -

21 chronic Lyme disease, which in your opening remarks

22 you suggested was not the same as the spirochetal

23 disease, which is an infection but something else,

24 yet they get better with antibiotics, and you're

25 suggesting it's not valid because we don't have a

 

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1 double-blind study. And then you alluded to a study

2 in Boston, which the only -- I mean, the overwhelming

3 comments about it was that it was totally flawed. I

4 mean, if that study was totally flawed, we shouldn't

5 refer to it at all. I mean, I remember a time in the

6 paper where they talked about someone discovered cold

7 hydrogen fusion. That lasted a week, until someone

8 said no one else could produce it.

9 But, I mean, frankly, at this point we

10 have physicians treating sick patients, and what

11 you're suggesting is, in spite of the fact they're

12 getting better with antibiotics, this may not be an

13 infection and we should wait to do another study. I

14 mean, what would you like us to wait for?

15 DR. BARBOUR: Well, I don't know what

16 the testimony has been before, you know, I spoke.

17 But I am very convinced that if this is going to

18 be -- that sort of opinion was widespread, that all

19 it took is -- someone gets better with antibiotics,

20 we really don't know if there is an infection or not,

21 and we're just going to continue it for symptoms that

22 I consider to be non-specific and could have another

23 cause, not -- when I'm speaking about infection and

24 we continue antibiotics for something like a fever, a

25 documented fever, a documented elevated white

 

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1 count -- the documented recovery of the tuberculosis

2 bacteria from the sputum, from the bone -- you know,

3 we have evidence that the infections continued. We

4 have evidence from controlled studies that if someone

5 stops antibiotics after four weeks, that they have a

6 ten percent chance of relapsing, and so we use it for

7 six to eight week. There are studies that indicate

8 this.

9 And I am very sure that in the case

10 that -- you know, such that you're describing,

11 except, you know, for the occasional one which, you

12 know, no one else knows what to do, then I think the

13 physician has the justification for going ahead and

14 treating. But for most cases, we can't operate in

15 medicine that way. We have to have some sort of

16 evidence that this is doing some good. I mean, I

17 think we gave up bleeding people a long time,

18 leeches, even though that was the accepted treatment

19 for a number of diseases, because, you know, we found

20 out that that really wasn't doing any good for most

21 people. So, I think if the idea of treating - you

22 mentioned 10,000 people - for long period of times, I

23 think we need better evidence that this is going to

24 do them some good.

25 DR. MILLER: I appreciate what you're

 

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1 saying. We just have a number of problems, and that

2 is the relative total abandonment of these 10,000

3 people by other specialists in the health field. So,

4 it's not as if they're being asked to come to an

5 office where someone is treating them successfully

6 for anything else, and so that's a problem. The

7 other problem is that, yes, sometimes we can find the

8 bacterium. Unfortunately, it's at autopsy, which

9 doesn't have the patient or their family at this

10 particular time. And that's been the problem.

11 Sometimes it's three years, sometimes it's five

12 years. In one case, it was 13 years later that they

13 finally found the spirochetes or -- you know, the DNA

14 evidence that the spirochetes were there.

15 And so, you know, the problem that we

16 have right now is that there is enough peripheral

17 evidence to show that there is a good possibility

18 that the bacteria are present, just that our current

19 techniques are not fully capable of identifying them

20 at this particular point. And that's something we

21 have to consider. If it's our diagnostic skills that

22 are failing us, but not our ability to treat, don't

23 you think we should go ahead with the treatment if,

24 in fact, it shows improvement in 80 percent of the

25 patients that come in for treatment and the other 20

 

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1 percent are not really being hurt? Because, again,

2 no other physician is willing to treat them for

3 anything.

4 So, you know, under a circumstance like

5 that, wouldn't you agree that it might not be a bad

6 idea to continue the antibiotic treatment as long as

7 80 percent of the people are getting better, the

8 other 20 percent aren't being hurt, that no other

9 physicians are rushing forward to treat them? And

10 that many times, many years later, in fact, we

11 finally do get a positive test for these. You know,

12 you sort of try to do the best you can and treat the

13 patients best way you can. Doesn't it seem that that

14 would be an appropriate best way?

15 DR. BARBOUR: Well, I think my earlier

16 remarks tried to emphasize that I have -- I'm open to

17 the idea that, you know, antibiotics help here, I

18 really am.

19 But what bothers me is, why does it

20 have to be a Borrellia burgdorferi infection? You

21 know, California doesn't have very many cases of Lyme

22 disease - there's some - but there are a lot of

23 individuals here in California who have a very

24 similar illness as what folks in New York are

25 suffering from. I don't think that most of them have

 

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1 Lyme disease; they may have something else. They may

2 get better with antibiotics, but if Lyme disease --

3 my point is, if you're trying to define Lyme disease

4 just on the basis of these symptoms and not take into

5 account negative laboratory results, then why

6 couldn't it be some other bacterial infection? In

7 the '50s, brucellosis was considered to cause exactly

8 the same symptoms, and there was -- chronic

9 brucellosis was the cause of this. Chronic fatigue

10 syndrome was considered for a long time to be caused

11 by the Epstein-Barr virus. There are other

12 infections that might be doing this.

13 And what bothers me is, you know, the

14 failure of imagination to consider other things. And

15 if antibiotics are helping, then why not do a study,

16 you know, to determine if they're really working or

17 not? I've suggested this to individuals with the

18 Lyme Disease Foundation, I've suggestion it to

19 individuals at NIH, and at meetings, to people at

20 CDC. Why not find out if this works or not? You

21 know, the study in Boston was some information. I

22 agree it wasn't complete, but I disagree that it was

23 completely flawed. I don't agree with that at all,

24 that statement. So, I'm very -- I'm trying to

25 encourage people to do an adequate study of this.

 

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1 Does it help or not?

2 I urge you to contact the people at the

3 VA. Dr. Sam Donta, who I'm sure some of you are

4 familiar with, is the lead investigator of that

5 study. Perhaps he has some data on whether

6 tetracycline helps these folks who have very similar

7 symptoms as what some of the folks with chronic Lyme

8 have.

9 DR. MILLER: I'm not going to dwell on

10 this much longer.

11 MS. MAYERSOHN: I just want to ask --.

12 DR. MILLER: I just want to say that we

13 do have two different spirochetes that have been

14 identified as the possible cause of problems, along

15 with other bacterium as well, that have to be treated

16 in addition to spirochete. So, this is an infection

17 that we lumped together, and it could be caused by

18 more than one entity. But the key factor is that all

19 of them respond to antibiotics and that you need the

20 antibiotics.

21 I'm going to stop at this point. I

22 thank you for your testimony. But Nettie Mayersohn,

23 who is my boss, is going to say something.

24 MS. MAYERSOHN: No, I'm just wondering

25 why the study comes even into what we're trying to do

 

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1 today, which is to allow doctors and patients to

2 decide on the course of treatment without

3 interference by any outside group. So, you can do as

4 many studies as you like, no one cares. And we all

5 support the study, but let the treatment go on the

6 way it's suppose to go on, with a decision being made

7 by the doctor and the doctor's patient.

8 By the way, Doctor, I wanted to ask

9 you: Do you treat many cases of Lyme disease in the

10 course of a year?

11 DR. BARBOUR: No, I don't. No. Well,

12 let me say something about -- I don't have problem

13 if, you know, a physician and a patient, an informed

14 patient, you know, undergo -- the patient undergoes

15 prolonged treatment with antibiotics in the case

16 where somebody doesn't have a better explanation. I

17 stress that I hope that a thorough diagnostic workup

18 had been done to rule out other possibilities. But

19 if it's an adult and they're willing to pay for it,

20 or someone is willing to pay for it, then I -- you

21 know, that's up to them. But I do have a problem --

22 I've seen children being treated for long periods of

23 time with multiple antibiotics, and I'm not sure

24 that's in all cases justified. And so that -- and

25 I've seen people with complications --

 

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1 MS. MAYERSOHN: Those children --.

2 DR. BARBOUR: -- from antibiotics for

3 the longest period of time.

4 MS. MAYERSOHN: Those children have

5 parents, Doctor.

6 DR. BARBOUR: And I think that people

7 need to be informed about those possibilities.

8 MS. O'CONNELL: Doctor, this Maureen

9 O'Connell. I'm a member of the committee as well.

10 And I'm just going to tell you that, you know, we're

11 going to end our comments with you very shortly, and

12 I thank you for your testimony. But we just had a

13 youngster in here who -- when you talk about a

14 thorough diagnostic workup, she had seen 17

15 specialists before someone would even venture to make

16 a diagnosis of this young lady. And by that time she

17 was practically -- and ten months -- wherein she was

18 practically completely and totally incapacitated to

19 the point that she could not lift up her head. And

20 of those 17 consults that she had, no one initiated

21 any treatment or made any definitive diagnosis, and

22 other -- all tests were inconclusive.

23 So, we're facing a dilemma here. And

24 physicians who are treating, who are on the front

25 lines, are facing a dilemma, and patients are

 

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1 suffering. So, until such time as we have more

2 definitive tools, we need to do something for these

3 patients. And I don't think you would disagree with

4 that. This just is a process that may take more time

5 to do some very good studies, but in the interim we

6 do have a problem that needs to be addressed.

7 DR. BARBOUR: Well, maybe I don't

8 understand what the problem is. Why can't a

9 physician with an informed patient treat them with

10 antibiotics if -- I mean, who is preventing that?

11 MR. GOTTFRIED: Well, Doctor, this is

12 Assemblyman Gottfried. Part of the issue here is

13 that you -- well, what's preventing it is, A,

14 insurance companies that refuse to pay. And for many

15 people, if the insurance company can't pay for the

16 treatment, that effectively keeps it from them. And,

17 secondly, our State Health Department has been

18 bringing a significant number of physician discipline

19 cases at physicians who were providing this long-term

20 antibiotic treatment. And part of our inquiry is to

21 determine whether that form of treatment and the

22 chronic Lyme diagnosis is in the reasonable ballpark

23 of professional judgment, and if so, would that lead

24 you to believe that these physician discipline cases

25 are inappropriate? And so while the Legislature is

 

293

1 not in the business of making medical judgments,

2 there are public policy consequences or public policy

3 related reasons why this kind of issue would be of

4 interest to us.

5 DR. BARBOUR: Yeah, I understand. I

6 obviously can't make a comment on individual cases.

7 There may be other factors involved than just simply

8 the length of antibiotic treatment. It's a difficult

9 problem, I agree. I think the data that's out there

10 suggests that -- you know, the published data in

11 peer-reviewed papers suggests or indicates, strongly

12 indicates, that prolonged therapy is not going to do

13 much good. So, that's why I stress again, why not do

14 a controlled study to help settle this issue?

15 MR. GOTTFRIED: Well, let me just

16 ask --.

17 DR. BARBOUR: Until you have that

18 evidence-based medicine, then one can understand why

19 the insurance companies would be a little reluctant

20 to pay for something that may not work.

21 MR. GOTTFRIED: Doctor, when you say

22 studies document that the long-term treatment is not

23 effective, we've heard -- I mean, we're aware of the

24 Klempner study that was published in the New England

25 Journal this spring. Are there others that come to

 

294

1 that conclusion, that you could point us to?

2 DR. BARBOUR: Well, let me turn it

3 around. I think that, as far as I know, is the only

4 one that addresses that question. Let me turn around

5 with it, though. There are other studies -- and I

6 don't have them in front of me and I couldn't quote

7 them -- but my recollection is that there are other

8 studies indicating that relatively short periods of

9 treatment, for instance, up to a month, are effective

10 in the majority, if not large majority, if not all

11 patients. So, there is that data available.

12 MR. GOTTFRIED: Okay.

13 DR. BARBOUR: You know, again, we're

14 not -- that's individuals that have very well-defined

15 cases of Lyme disease. I don't think that's what

16 either one of us are talking about here. I think

17 we're talking about people, as you said - or someone

18 said - that may have, you know, a negative test,

19 laboratory test, standard test, or who don't get

20 better with antibiotics after a month or so.

21 MS. MAYERSOHN: They're not the issue.

22 DR. BARBOUR: That's what we're dealing

23 with, and that's what there is very little data on.

24 MR. GOTTFRIED: Okay. Okay. I

25 appreciate your being available to us and your

 

295

1 testimony, and I know we had to -- we had you lined

2 up for earlier in the day, and I appreciate your

3 willingness to be available at this point. And I

4 want to thank you for your testimony.

5 DR. BARBOUR: Okay. Well, good luck in

6 what you're trying to do. I think it's a tough job.

7 MR. GOTTFRIED: Well, thank you.

8 DR. BARBOUR: Bye.

9 MR. GOTTFRIED: Okay. Which reminds me

10 of a passage in Confucius which says that it is

11 difficult to be a ruler, but being a subject isn't

12 easy either. Okay. One of his disciples asked

13 whether there was one expression that could save the

14 empire, and that was his answer.

15 Okay. Our next witness is Pam

16 Weintraub, a reporter with HMS_Beagle and former

___ ______

17 editor of Omni magazine. And just, again, let me

____

18 know -- and this comment is not particularly aimed at

19 you, but if both the witnesses and the legislators

20 are efficient and expeditious, we can all get home.

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