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20 (A recess was taken.)

21 MR. GOTTFRIED: If everyone could take

22 their seats.

23 It may have occurred to many of you

24 that we have been running sort of behind schedule,

25 which we certainly have been. That tends to happen

 

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1 in hearings. We often -- those of us up here asking

2 questions tend to sort of get a lot of them out of

3 our system with the first few witnesses. We do,

4 however, need to pick up the pace, so I'm going to

5 remind the witnesses to keep their initial remarks to

6 with ten minutes. If you think your written

7 testimony is going to run longer than that, I would

8 urge you, as one of our previous witnesses did, to

9 sort of look ahead at your testimony and skip over

10 paragraphs and sections. And we will try to -- at

11 this side of the podium, try to speed things up as

12 well, because we do want to make sure that everyone

13 has an opportunity to testify, and I understand many

14 of you have, you know, transportation concerns.

15 Our next witness is Dr. Steven

16 Phillips, President-elect of the International Lyme

17 and Associated Disease Society. Is Dr. Phillips --?

18 DR. STEVEN PHILLIPS, PRESIDENT-ELECT,

19 INTERNATIONAL LYME AND ASSOCIATED DISEASES SOCIETY:

20 I'm right here.

21 MR. GOTTFRIED: Oh, okay. Okay. The

22 stenographer will swear you in. Is there a way to

23 dim the lights? Good question. It's happening.

24 STEVEN PHILLIPS, M.D.; Sworn

25 DR. PHILLIPS: Thank you very much.

 

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1 MR. GOTTFRIED: By the way, if the

2 people who had the power to dim the lights are also

3 in a position to raise the level of warmth in the

4 room, that would be good.

5 DR. PHILLIPS: You know, it is cold.

6 Okay. I found Dr. Muney's testimony

7 fascinating for several reasons, and one reason was:

8 I don't think I've ever heard the term

9 "evidence-based medicine" repeated so many times in

10 one presentation. And, ironically, there was so

11 little evidence presented in that presentation. I

12 will attempt to do the opposite here by presenting a

13 distillation, if you will, of the current

14 peer-reviewed medical data surrounding the

15 controversies of chronic Lyme disease.

16 Basically, every aspect of this illness

17 is highly controversial, from diagnosis - because the

18 symptoms can be so variable and because current

19 laboratory testing is widely accepted to be poor - to

20 definition of "cure." The debate continues over

21 patients with persistent symptoms despite

22 antibiotics. Is this post-Lyme syndrome or is this a

23 persistent infection with B. burgdorferi, the Lyme

24 disease bacteria? And what about antibiotic

25 treatment? How long and how well do the antibiotics

 

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1 work?

2 Well, in terms of diagnostic

3 controversies, the first one is clinical diagnostics

4 controversies. The symptoms of Lyme can be so

5 varied, it's really hard to make a clinical

6 diagnosis. In terms of laboratory diagnosis, the

7 bacteria are extremely difficult to grow from

8 patients with Lyme disease, and this is the real

9 critical issue. So, the most commonly used tests are

10 Lyme antibody tests, which looks for the body's

11 reaction to the bacteria rather than the presence of

12 the bacteria itself. And, unfortunately, Lyme

13 antibody testing has been unreliable.

14 So, what does the CDC say about this?

15 Well, you heard in some prior presentations about CDC

16 case definition criteria, and indeed they have

17 developed criteria for their interpretation of a

18 positive Lyme antibody test result. But this direct

19 quote from the CDC is from their Web site as of last

20 night, and it says, "Comment: This surveillance case

21 definition was developed for national reporting of

22 Lyme disease. It is not appropriate for clinical

23 diagnosis." That capital N-O-T in not was

24 capitalized by the CDC, not me. Evidently, because

25 of their enthusiasm of these tests and their

 

140

1 interpretation of these tests were not meant as

2 exclusionary criteria.

3 Well, what happens if you use them as

4 exclusionary criteria? It turns out, in a very

5 well-documented study of culture-confirmed bull's-eye

6 rashes, so patients with erythema migrans, bull's-eye

7 rashes that were confirmed as definite Lyme disease,

8 a full 78 percent of the patients remained

9 seronegative by CDC criteria. So, it should come as

10 no surprise that seronegative Lyme disease, which is

11 Lyme without a positive blood test, is not uncommon.

12 And this study by Dr. Sam Donta, noted infectious

13 disease professor and well-recognized expert in the

14 field, at least 71 percent of the patients were

15 seronegative by CDC criteria, despite the diagnosis

16 of late-stage Lyme disease.

17 So, it should further come as no

18 surprise that seronegative Lyme has been wildly

19 reported throughout the medical literature. Again,

20 these all peer-reviewed documented studies, no

21 anecdotes here.

22 And here there's some more -- two more

23 studies documenting seronegative Lyme. And in this

24 study on the evolution of Lyme serologies, they

25 evaluated 74 patients with Lyme disease and found

 

141

1 that both acute and chronic - Borreliosis means Lyme

2 in this case - can be either seropositive or

3 seronegative, but that high titers of specific

4 antibodies were rare. The problem is that not only

5 is seronegative Lyme disease common, these patients

6 may be potentially worse off. In this study, it very

7 clearly demonstrates that those with a positive

8 antibody were PCR negative, whereas those with a

9 negative antibody were PCR positive. As you may

10 remember, PCR is a DNA test which looks for the

11 active presence of the bacteria's DNA, implying those

12 who were seronegative had a higher bacterial burden,

13 thus allowing them to pick it up by PCR positivity.

14 Well, how do you diagnose central

15 nervous system Lyme disease? How does it compare

16 with blood testing? It turns out that culturing Lyme

17 bacteria from spinal fluid has been as hard as

18 culturing it from the blood. So, just as in blood,

19 most tests rely on the body's reaction to the

20 bacteria in the spiral fluid rather than the presence

21 of the bacteria itself. However, people with central

22 nervous system Lyme frequently don't have

23 abnormal-appearing spinal fluid. And even Dr. Allen

24 Steere, who is widely recognized as one of the most

25 conservative voices in the Lyme research community,

 

142

1 has been quoted as saying that local antibody

2 production in spinal fluid is an inconsistent finding

3 in American patients with late neurologic

4 manifestations of the disorder.

5 In this study of central nervous system

6 Lyme, this is a nice reference -- well, Dr. Liegner

7 had referred to antigen capture testing. And in this

8 study of patients with positive Lyme proteins and

9 spinal fluid, of the 35 who had such proteins, a full

10 43 percent were antibody negative in their spinal

11 fluid. And of those, 47 percent had otherwise

12 normal, routine spinal fluid analyses, such as

13 protein and white count. And of those, again, 60

14 percent were initially seronegative.

15 So, just to recap, we have patients

16 with known Lyme, by an advanced test in their spinal

17 fluid, and high percentages had antibody negative in

18 their spinal fluid, antibody negative in their blood,

19 and otherwise completely normal, routine spinal fluid

20 analyses. Unfortunately, this antibody capture test

21 is not widely available to most physicians.

22 Here's a nice case of a long-term case

23 of Lyme disease, both seronegative and spinal fluid

24 antibody negative - very well documented, in fact -

25 where the patient received a total of seven courses

 

143

1 of intravenous antibiotics and three years of

2 continuous oral antibiotics. Unfortunately, she

3 never got cured and she never had the ability to go

4 off antibiotics for any length of time, actually.

5 Although the patient never had free detectable

6 antibodies to B. burgdorferi in serum or spinal

7 fluid, the spinal fluid was positive on multiple

8 occasions for complex anti-B. burgdorferi antibodies,

9 B. burgdorferi nucleic acids and free antigen.

10 You'll notice, however, that this patient did not

11 have a positive culture for Lyme bacteria out of the

12 spinal fluid. And, again, I mention that culturing

13 Lyme bacteria has been extremely difficult. And with

14 other infectious diseases that are bacterial, usually

15 the bacteria can be cultured.

16 But as hard as it is to do, it has been

17 done. And, in fact, there have been multiple

18 articles in the peer-reviewed medical literature

19 documenting culture-proven central nervous system

20 Lyme, meaning Lyme disease bacteria grown right from

21 the spinal fluid, despite that the antibodies and the

22 protein and white counts and everything else was

23 negative on the spinal fluid. And here's two

24 articles documenting that, and then there's two more

25 articles documenting the same thing, basically.

 

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1 So, what about treatment? The

2 controversies are that many patients with Lyme

3 disease will relapse after therapy is withdrawn.

4 Some people call this post-Lyme syndrome or post-Lyme

5 fibromyalgia, which has up to now basically been

6 defined as, coincidentally, the same symptoms of Lyme

7 disease which just happen to come on after you're -

8 quote, unquote - cured of Lyme with the antibiotics.

9 And the problem is that there's no evidence that the

10 antibiotics are actually curative. So, it's kind of

11 like circulating reasoning. And because of this,

12 critics call this post-Lyme syndrome kind of a

13 nonsense, just fabricated to explain why there are

14 treatment failures, when it just seems like it's an

15 initial relapse of the disease.

16 A couple of conservative authors have

17 actually looked at post-Lyme fibromyalgia and they

18 had some interesting studies. In the first study,

19 the Steere study, that's a prospective study; and the

20 second one is retrospective. So, they basically

21 found the same thing in different ways. And,

22 basically, patients that were treated with

23 antibiotics improved and then, when they went off the

24 antibiotics, they got worse again.

25 So, just to backspace, these were

 

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1 patients who had been treated in the past for Lyme

2 disease and had persistent symptoms that were

3 consistent with what they term post-Lyme

4 fibromyalgia. In the first study, they re-treated

5 them with antibiotics and found that a whopping 71

6 percent of the patients improved with antibiotics.

7 So, these are basically antibiotic-responsive cases

8 of chronic symptoms, but the author unfortunately

9 concluded that this was placebo effect. I want to

10 point out that this was not a placebo-controlled

11 study and in my view this is an inappropriate

12 conclusion.

13 One more note is that every one of the

14 primary symptoms associated with fibromyalgia or

15 chronic fatigue syndrome - which are vague diagnoses

16 by anybody's estimation - such as persistent

17 headache, fatigue, muscle aches, joint pains, sleep

18 disturbances, et cetera, are really common in active

19 Lyme disease and really can't used for the

20 differential diagnosis.

21 So, it should come as no surprise,

22 then, that other researchers have found Lyme bacteria

23 DNA in the muscles, actually, of patients with this -

24 quote, unquote - post-Lyme syndrome, post-Lyme

25 fibromyalgia, really conclusively proving that this

 

146

1 is just an extension of the initial Lyme disease and

2 there's no such thing as post-Lyme syndrome.

3 Well, let's take a look specifically at

4 antibiotic treatments. Because if these patients

5 with post-Lyme syndrome didn't get cured with their

6 antibiotics, that implies that maybe these

7 antibiotics aren't the cure that everybody thinks

8 they are. So, they took dogs that didn't have Lyme,

9 and they infected them with Lyme and treated them

10 with high doses of amoxicillin and doxycycline just

11 to see what would happen. And it turns out that,

12 although it helped, it didn't get rid of the

13 infection.

14 So, what if we use stronger

15 antibiotics? People a lot of times talk about

16 intravenous antibiotics versus oral. Well, here they

17 tried a few different antibiotics: A very powerful

18 oral antibiotic called azithromycin; and ceftriaxone,

19 which is Rocephin. It's usually the drug of -- when

20 intravenous drugs are used, it's usually the one

21 that's the drug of choice. And they use if for 30

22 days. And although the antibiotics helped, it also

23 did not resolve the infection from these infected

24 dogs.

25 Well, what about people, because maybe

 

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1 we're a lot better than beagles. It turns out that

2 people don't fare much better than beagles. And in

3 this study, I wanted to point out that Dr. Steere is

4 one of authors and he's also been on many of the

5 boards. We've been talking about these criteria set

6 up by different societies on how to treat Lyme

7 disease, and I know that Dr. Steere has had

8 significant input into these boards. Here's a study

9 that he co-authored in 1994, where 30 percent of

10 patients remained PCR positive despite multiple

11 courses of - quote, unquote - adequate antibiotic

12 therapy. So, back in '94 they knew that this was

13 adequate antibiotic therapy was inadequate.

14 And just like a couple of other

15 presenters here today have talked about how DNA

16 evidence is admissible for virtually every other

17 field of infectious disease, such as HIV and

18 hepatitis C, that if you have a positive PCR with

19 those diseases, that equates to persistent infection.

20 Yet, somehow with Lyme disease they're held to a

21 higher standard, and it's not clear why that is.

22 In this study, the author found that 74

23 percent of the patients were still PCR positive

24 despite extensive antibiotic therapy. When I use the

25 word "extensive" in this presentation, I'm referring

 

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1 to more than four weeks antibiotic therapy. And here

2 the author used multiple PCR primers and that

3 resulted in a higher yield. Each PCR primer looks

4 for a specific snippet of DNA, and you can increase

5 the sensitivity if you look for more snippets.

6 So, okay, fine. These are DNA

7 evidence, these two studies, showing that persistent

8 infection is a reality despite antibiotics; and, yes,

9 it is the standard for other infectious diseases,

10 such as HIV and hepatitis C; and, yes, you can put

11 people in jail based on DNA and PCR evidence. But we

12 still -- let's say, for the sake of argument, we

13 don't want to accept this hard-core evidence for Lyme

14 disease. Well, the next best thing, if you wanted to

15 go a level higher, would be to actually look for the

16 presence of the bacteria in biopsy specimens and in

17 fluids.

18 The problem is that Lyme bacteria are

19 really hard to find in biopsies specimens and in

20 fluids. And if you take animals with Lyme and never

21 treat them with antibiotics, and let that animal live

22 for a couple of years, let them have a nice case of

23 late-stage Lyme disease, and then cut that animal up,

24 you really don't find many of the bacteria, no matter

25 where you look. So, it's very hard to find; however,

 

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1 it's been done.

2 And here we have human persistent

3 infection, despite antibiotics, proven by the

4 presence of B. burgdorferi. Here they found it in

5 the skin, despite extensive antibiotics - and I would

6 like to point out, in a seronegative patient -

7 extensive meaning more than four weeks.

8 Look, it's been done again. This time

9 they found it in the eye. And this is despite

10 intravenous antibiotics. I want to point out that

11 the eye anatomically is an extension of the brain,

12 which means basically that they grew the -- they

13 found the bacteria in this person's brain. And

14 intravenous antibiotics cross into the brain and in

15 the eye, but it still did not eradicate the

16 infection.

17 Here they found it in the blood and the

18 spinal fluid, despite antibiotics, in both

19 seronegative and spinal fluid antibody negative

20 patients.

21 And here it was found in the heart.

22 Unfortunately, this patient died, actually, from Lyme

23 carditis. Carditis means swelling of the heart. And

24 the result was that this was not a curative therapy,

25 obviously, despite - quote, unquote - antibiotic

 

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1 therapy -- adequate antibiotic therapy. Excuse me.

2 In the next case here, despite several

3 short courses of - quote, unquote - adequate oral and

4 intravenous antibiotic therapy, this patient also

5 died. And her lymph nodes demonstrated Lyme bacteria

6 on autopsy.

7 So, I have to ask a question again:

8 Who decides whether this antibiotic therapy is

9 adequate? I mean, certainly these patients that

10 died, it was not adequate. Certainly for the

11 patients' families it was not adequate. And just in

12 my opinion, as a human being with morals and ethics,

13 this is not adequate either.

14 And yet, again, here it's found in the

15 joints despite more rounds of - quote, unquote -

16 antibiotic therapy, both oral and intravenous. So,

17 I'm getting a trend here that these antibiotics are

18 not necessarily curative. Here they found it in the

19 spleen despite intravenous antibiotics.

20 And I kind of echo Dr. Liegner's

21 sentiments the he's not so crazy about antibiotics.

22 I'm not so crazy about them either. I mean, in some

23 patients they just don't seem to work that well. And

24 here we certainly have ample evidence that they're

25 not the cure.

 

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1 Here, again, they found it again, this

2 time in the joints, despite antibiotics. And in this

3 case the patient had Lyme arthritis for seven years,

4 despite multiple courses of antibiotic trials, and

5 the spirochetes were documented in the joint tissue

6 and the joint fluid.

7 So, these cases that I all presented,

8 they actually visualize the Lyme spirochetes. They

9 were identified by DNA testing, they were identified

10 under the electromicroscope, and they were identified

11 by monoclonal antibodies. So, you have very highly

12 sophisticated tests identifying that, yes, it

13 definitely was Lyme bacteria in these patients,

14 despite extensive antibiotics. Some of these

15 patients were seronegative, some were seropositive.

16 So, I ask: Is it still a gray issue that persistent

17 infection is a reality? Well, if you think that it

18 is, I'll present more slides.

19 And these are not just finding the

20 bacteria in specimens, these are actually when you

21 can actually grow the bacteria from the patients and

22 keep growing them alive. And it's very hard to do

23 that, but despite that it's been done.

24 And here's a case -- it was cultured

25 alive from the skin in early Lyme, despite

 

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1 antibiotics. And most people think that early Lyme

2 is easily curable, and that's why I'm presenting this

3 case.

4 And here, again, it was cultured live

5 from joint fluid, despite antibiotics.

6 And here, again, it was cultured alive

7 from spinal fluid, despite intravenous antibiotics.

8 And you know when you culture it from spinal fluid

9 that it has invaded the brain. Intravenous

10 antibiotics is supposed to be the - quote, unquote -

11 cure for that, but it didn't work.

12 Here's multiple cases presented, B.

13 burgdorferi cultured alive from the eye and the

14 spinal fluid, despite antibiotics, in seronegative

15 patients, negative Lyme antibody tests. Here, again,

16 multiple cases presented, Lyme bacterial cultured

17 live from the skin and spinal fluid, despite

18 antibiotics, again, seronegative patients.

19 Here it was cultured from the blood

20 alive, despite extensive antibiotics, in seronegative

21 patients, meaning more than four weeks, again,

22 antibody negative patients.

23 Here they cultured alive from spinal

24 fluid, despite extensive antibiotics, in seronegative

25 patients.

 

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1 And in this study, it was cultured

2 alive from the ligaments, despite oral and

3 intravenous antibiotic therapy, in a seronegative

4 patient. I included the quote because I thought it

5 was interesting. Although the IgG titer, which is

6 the antibody titer, was initially positive in this

7 patient, it rapidly decreased within a few weeks

8 after the first antibiotic therapy and remained

9 negative thereafter, despite progression of the

10 disease. So, it clearly points out how you can't

11 follow these antibody titers to tell you when someone

12 is cured. It just doesn't work that way.

13 And here, again, proven by live

14 culture, multiple cases presented. It was cultured

15 alive from the mitral valve of the heart, a very

16 interesting, unfortunate case where person got Lyme

17 and it basically ate up his heart valve and the heart

18 valve blew.

19 A culture from the skin, another

20 patient, and joints in another patient. And this was

21 despite both oral and intravenous antibiotics, again,

22 in seronegative patients.

23 And in this study, it was cultured out

24 of 91 percent of the patients, the vast majority of

25 whom - in fact, 94 percent - were seronegative by CDC

 

154

1 criteria, and this was despite the fact that entrance

2 criteria for the study were six weeks of antibiotic

3 therapy. It turns out that the median time of IV

4 antibiotic therapy for patients in this study was

5 just under three months. So, although you had to

6 have had six weeks, these people actually were

7 extensively treated. These were the - quote,

8 unquote - horror show cases of chronic Lyme disease

9 that nobody wants to treat, and were treated

10 extensively and did not get cured.

11 So, what do we have here? In terms of

12 treatment controversies, here's a study that

13 documents that with two months of antibiotic

14 treatment, 33 percent of patients improved

15 significantly; and after three months, it went up to

16 61 percent. And the results here were supporting the

17 use of longer courses of antibiotic treatment in the

18 management of patients with chronic Lyme disease.

19 Another study recommending longer

20 antibiotic treatment -- not only does it make that

21 recommendation, it also illustrates that in late

22 borreliosis - borreliosis here meaning Lyme again -

23 that false negative serology is present, meaning

24 false negative antibody testing, which we kind of

25 already knew already.

 

155

1 In this case that I'm showing you, I'm

2 presenting it for two reasons. The first reason is

3 that they're recommending at the end here prolonged

4 antibiotic therapy, but it's a case of fatal

5 neuropsychiatric Lyme disease that was expressed by

6 progressive frontal lobe dementia. And that

7 antibiotic treatment resulted in transient

8 improvement, but the patient stopped when the

9 antibiotics were -- the patient - excuse me -

10 relapsed when the antibiotics were stopped. And

11 their recommendation that Lyme disease must be

12 considered, even in cases with purely psychiatric

13 presentation.

14 I haven't really talk too much, because

15 of time limitations, on the spectrum of illness, but

16 Lyme can cause a lot of kooky symptoms and a lot of

17 times these patients are sent to psychiatrists,

18 perhaps inappropriately so.

19 So, what is the standard of care? I

20 mean, do these -- do doctors actually read the stuff

21 that comes out of a core group of very conservative

22 researchers, or do they read all the literature like

23 I'm presenting, a more heterogenous body of

24 literature, or do they focus on these minority of

25 articles that say treat with four weeks and the

 

156

1 patient is definitively cured?

2 Well, the standard of care is defined

3 by what the majority of physicians are practicing in

4 an area such as this. Here they took 78 doctors -

5 who are not Lyme doctors by any stretch of the

6 imagination, these are just ordinary doctors - and

7 they surveyed them. And 50 percent not only believe

8 that 25 percent or more of patients who have Lyme

9 were seronegative, they also found that 43 percent of

10 them for bull's-eye rash stage disease -- excuse me,

11 for post-bull's-eye rash stage disease, 43 percent of

12 responders treated for three months or more; and for

13 chronic Lyme disease, 57 percent of responders treat

14 for three months or more. Now, we don't know exactly

15 how long they do treat for, it's just three months or

16 more. They could have been treating six months or a

17 year. We just don't know. But the fact of the

18 matter is, they treat with - quote, unquote -

19 extensive antibiotics in the majority of times, and

20 that is the true standard of care among the medical

21 community.

22 So, before I close, I just wanted to

23 point out that there is several general review

24 articles on the overdiagnosis of Lyme disease. And

25 there are things published in the medical literature

 

157

1 which, in my opinion, just because they're published,

2 don't mean that they have a basis in scientific fact.

3 And I just wanted to very briefly review one of

4 these.

5 Here the author reviewed 788 patients

6 who had been diagnosed with Lyme and found that only

7 23 percent had active Lyme disease. Twenty percent

8 had previous Lyme but now have, coincidentally,

9 either chronic fatigue or fibromyalgia; and 57

10 percent did not have Lyme at all and, again,

11 coincidentally, had either chronic fatigue or

12 fibromyalgia. Of the patients who did not have Lyme

13 disease, he found that 45 percent had positive blood

14 tests in other laboratories. Well, remember what the

15 CDC says. And it's specifically not to rule out a

16 case of Lyme based on the inability to meet CDC case

17 surveillance criteria. Unfortunately, exclusionary

18 criteria for many of these patients who do not have

19 Lyme disease was precisely that in this case.

20 And the second point I want to make is

21 that it's also a case of "my test is better than your

22 test," whereas there's no evidence that that's the

23 case. They said that 45 percent of the patients had

24 positive blood tests in other laboratories, but all

25 were negative in Dr. Steere's laboratory. Well, who

 

158

1 says that Steere's Lyme testing is better than anyone

2 else's? Well, certainly not this patient. And this

3 is the documented and published case of a 24-year-old

4 woman who gave birth to a stillborn infant. And both

5 the CDC and the New York State Department of Health

6 found strongly positive Lyme antibody testing in her

7 blood, yet, Dr. Steere's lab at Yale found negative

8 results. Fetal autopsy showed B. burgdorferi in the

9 liver, adrenals, brain, heart and placenta.

10 So, in summary -- and I don't want to

11 make this sound like I'm Yale-bashing or anything

12 like that. I actually trained at Yale. I did my

13 microbiology training in Lyme there; I've been doing

14 research in Lyme for 11 years. I just will pick on

15 anything that's not -- that doesn't sound

16 scientifically based in my opinion.

17 Now, in summary, I believe that chronic

18 Lyme is caused by infection with B. burgdorferi.

19 That is not just my opinion; this is from a

20 distillation of the medical literature at large.

21 Current antibody testing is grossly inadequate, this

22 is common knowledge, and seronegative Lyme is a

23 frequent finding. CDC case definition criteria

24 should not be used for clinical diagnosis. And

25 although there is limited studies in this area, it

 

159

1 seems, at least on a preliminary basis, that longer

2 antibiotic treatments, from what has been published

3 on longer treatments in association with Lyme, are

4 more effective than shorter. Post-Lyme fibromyalgia,

5 which is quickly, I believe, and quietly retiring

6 into obsolescence, is really just a persistence of

7 the initial infection. And although curative

8 therapies are desperately needed for patients with

9 chronic Lyme disease, the fact of the matter is that

10 this type of research just isn't being done because

11 of the persistent denial of what is a self-evident

12 fact.

13 Thank you. I'm finished.

14 MR. GOTTFRIED: If the people in

15 control of the lights could bring them back up again?

16 Well, thank you. First of all, for the

17 benefit both of us and, I think, also for the

18 stenographer, if you could provide us with a copy of

19 your presentation?

20 DR. PHILLIPS: I have the written

21 statement. Ten copies were provided. But it's --

22 everything that's documented here is documented

23 there, but if differs, obviously. I just kind of

24 wing it when I talk.

25 MR. GOTTFRIED: Okay. But if you can

 

160

1 print out the slides, if that's --

2 DR. PHILLIPS: Oh, sure. That's no

3 problem at all.

4 MR. GOTTFRIED: I think that would be

5 useful.

6 DR. PHILLIPS: Yeah.

7 MR. GOTTFRIED: Could you comment --

8 with the previous witness, we were discussing at some

9 length -- this past spring, New_England_Journal_of_

___ _______ _______ __

10 Medicine article --.

________

11 DR. PHILLIPS: Sure, I can comment on

12 it.

13 MR. GOTTFRIED: Can you talk about that

14 study, and what it did or didn't show?

15 DR. PHILLIPS: I know that Dr. Marilynn

16 Barkley will be speaking on that study in great

17 length afterwards. But if you like, I can give some

18 preliminary comments.

19 In my opinion, that was -- that study

20 was terminally flawed by a series of interrelated

21 errors, which the end result is that you can get no

22 conclusive data which is scientifically valid. I can

23 go down the list, if you like. For starters --.

24 MR. GOTTFRIED: But if Dr. Barkley will

25 be going through that, you know, maybe we'll just --.

 

161

1 DR. PHILLIPS: Okay. That will be

2 fine.

3 MR. GOTTFRIED: If that's fine with

4 you.

5 DR. PHILLIPS: No, that would great.

6 MR. GOTTFRIED: Well, we don't need --

7 if one witness is planning on focusing on that point,

8 we don't need to have two.

9 DR. PHILLIPS: Right. That's perfectly

10 reasonable.

11 MR. GOTTFRIED: You had a lot of slides

12 that were -- slides about a lot of studies that found

13 persistence of infection after varying lengths of

14 antibiotic treatment. And it may be that I missed

15 them, but I -- were there studies in there that

16 document that longer periods of antibiotic treatment

17 are then effective in reducing or eliminating the

18 infection?

19 DR. PHILLIPS: In some of the studies

20 where they had isolated Lyme bacteria, either by

21 pathology specimen or culture, they then went on to

22 re-treat the patient again and again and again, and

23 then further cultural wasn't performed. In some of

24 the studies, the patients became asymptomatic and

25 were lost to follow-up. In other studies, they

 

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1 developed a chronic, horrible case of Lyme that was

2 never cured.

3 So, they haven't done -- as a rule,

4 they haven't said, okay, this is the rule: We're

5 going to do, for these culture studies, a comparison

6 of shorter in culture versus longer in culture. The

7 problem is that culturing with a high yield has been

8 a near impossibility. The bacteria -- when I say

9 it's hard to grow, I'm not making any type of

10 understatement.

11 The crucial, critical and singular

12 issue that is underlying the controversy with Lyme

13 disease is that if you can't grow the bacteria and

14 say, look, you still have it -- well, number one, how

15 do you know that you have it in the first place if

16 you can't isolate it? Well, if you have a positive

17 Lyme test, if you're lucky and have a bull's-eye

18 rash, then it's an easy diagnosis to make. But even

19 if you're treated and if you're unlucky enough to

20 have persistent symptoms, how do you ever know when

21 you're cured or when you're not? And if you respond

22 to antibiotics and then you relapse when you're off,

23 and the same pattern of response and then relapse

24 recurs -- I mean, logic kind of dictates that, yes,

25 this looks like a chronic infection. But if you

 

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1 can't ultimately grow the bacteria, you're left in

2 this kind of quandary.

3 And that is precisely why denial can

4 occur. Because you can say, well, look, grow it, and

5 then the response to that is to say, well, we

6 couldn't grow it before they took an antibiotic. So,

7 it's not like saying we could grow it before the

8 antibiotic and you can't grow it now. You can just

9 not grow it. It's just remember very, very rare.

10 And as hard as that is, it's been done innumerably

11 throughout the medical literature. So, you have

12 proven that, at least in these patients with the

13 culture positives, that these antibiotics did not get

14 rid of it.

15 MR. GOTTFRIED: But are there

16 double-blinded, controlled placebo studies that

17 document that long-term antibiotic treatment is more

18 effective in eliminating or reducing symptoms --

19 DR. PHILLIPS: Right.

20 MR. GOTTFRIED: -- than long-term

21 placebo treatment?

22 DR. PHILLIPS: To my knowledge, this

23 Klempner study is the first longer term placebo

24 controlled trial of its kind. However, before I say

25 the word "longer term" -- it's something that

 

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1 everyone says about the study. It's not really a

2 longer term study, it's a re-treatment study. The

3 patients in this study were re-treated with four

4 weeks of IV antibiotics, Rocephin, and then followed

5 up with two months of low-dose doxycycline. Without

6 getting into Dr. Barkley's area that she'll be

7 commenting on, even the choice of antibiotic therapy

8 is so flawed, how can you ever expect this to work?

9 A lot of the patients in the study were already

10 treated with four weeks of Rocephin, were already

11 treated with standard courses of antibiotics.

12 The problem with doxycycline, at a 100

13 milligrams twice a day, it doesn't even across into

14 the brain at sufficient dosage to even treat the

15 central nervous system Lyme. How could they even use

16 this? If you use a tetracycline class antibiotic,

17 you have to use the right one at the right dose.

18 It's a very easy thing to do. I question why that

19 wasn't taken care of. I mean, you can effectively

20 treat the brain with tetracycline. The dosage that

21 they used was just inadequate.

22 So, that is the only double-blind,

23 placebo controlled trial that I'm aware of that is

24 purported to be a long-term trial. However, from

25 start to finish, its design was inadequate. It is

 

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1 not a long-term trial, it is a four-week re-treatment

2 trial of Rocephin. And, unfortunately, Rocephin is

3 not this -- everything that's it's cracked up to be.

4 I mean, I wish that it was, but it's not. If it was

5 the cure, everyone would just take it and, whether

6 you knew they had Lyme or not -- oh, we're not really

7 sure, but you know what? We have this absolute cure,

8 here it is. It's gone. You don't worry it anymore.

9 It's not the case.

10 It is -- before going into the prospect

11 of intravenous antibiotics you have to make

12 double-damn sure that -- excuse my French -- that the

13 person has Lyme, if you're considering Rocephin.

14 Because it's not only expensive, but it is more risky

15 than oral antibiotics. I'm don't -- I'm not really

16 here to advocate one antibiotic over the other. I

17 don't actually see very many patients; I do mostly

18 microbiology research. But when I do treat patients,

19 I don't happen to use very much in the way of

20 intravenous antibiotics, because I believe that

21 everything in life is a risk-benefit ratio and many

22 of the orals work just as well. That's not to say

23 that it cannot be a life-saving and lifestyle-saving

24 action by using these intravenous versus the oral

25 antibiotics, and that's up to the individual patient

 

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1 and physician to decide.

2 So, in some cases it's absolutely

3 necessary, but it's not just Wonder Bread, you know.

4 MR. GOTTFRIED: From what I know about

5 evidence-based medicine, in order -- and feel free to

6 correct me. Because while you and I both have

7 doctorates, mine begins with a J, yours begins with

8 an M, and it's a lot easier to get mine than yours.

9 But as I understand the notion of

10 evidence-based medicine, it says that you can say

11 that a particular judgment is evidence-based if you

12 have preferably not one, but several, you know,

13 controlled, double-blinded - controlled meaning, you

14 know, with a control group - studies that reach a

15 conclusion. And for a given treatment you could

16 certainly have an evidence-based judgment that that

17 treatment is no good whatsoever or does harm. You

18 could have an evidence-based judgment that it's the

19 right treatment to use. You could also be in a

20 position where we don't yet have an evidenced-based

21 judgment. Where on that spectrum would you think

22 long-term antibiotic treatment for persistent Lyme

23 disease stands?

24 DR. PHILLIPS: I don't think any of the

25 research has been done. Like I said, the Klempner

 

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1 study is but one study of double-blind placebo

2 controlled. It wasn't a long-term study of

3 sufficiently effective treatment. There are a lot of

4 design changes I would have made to that study, had I

5 had input, so I can't comment on that at all. I

6 can't even draw any -- in my opinion, any useful

7 conclusions from that study. So, the answer is, I'm

8 not aware of any long-term double-blind placebo

9 controlled studies on the effectiveness of antibiotic

10 therapy long-term for chronic Lyme disease.

11 What I can point out to is, even the

12 conservative author's own observations -- there was a

13 study in there that I mentioned, of Dr. Steere, where

14 he re-treated people with post-Lyme fibromyalgia -

15 which is essentially chronic Lyme disease, let's face

16 it - and he found that a whopping 71 percent of these

17 patients responded to re-treatment with antibiotics.

18 And it wasn't a long-term study, it was an adequate

19 antibiotic therapy, meaning two to four weeks. Those

20 patients remained relatively well for several months

21 and then relapsed, and then drew the conclusion, oh,

22 placebo effect, because they didn't permanently get

23 cured of their symptoms. The initial assumption

24 being that the antibiotics are the cure. Therefore,

25 if you didn't cured from the cure, you can't have the

 

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1 infection. It's just a circular reasoning, no basis

2 in logic.

3 So, there is evidence. If you choose

4 to define evidence-based reasoning based on

5 double-blind placebo controlled studies, there just

6 aren't any. If you choose to base it on

7 peer-reviewed medical literature, there are countless

8 studies showing documented persistent infection

9 despite antibiotics.

10 The question is: Is longer better?

11 Well, there are a few studies. And Dr. Donta's study

12 on tetracycline is one of the noteworthy studies

13 where he found a continued improvement the longer the

14 patient was treated. That was not a double-blind

15 placebo controlled study, however, so there are, you

16 know, flaws in that study design. And we can go one

17 by one and analyze all the studies, but none of them

18 have been double-blind placebo controlled. The

19 Klempner study was the first one and -- you know, I

20 applaud them for their attempt; however, I couldn't

21 think of a more poorly-designed study. It's almost

22 as if -- and I doubt this was the case -- but it's

23 almost as if it was designed to the prove no benefit

24 from antibiotics, if you can imagine that.

25 MR. GOTTFRIED: Or, perhaps -- I mean,

 

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1 it would seem, from the way you describe the study,

2 it could be just as much evidence that the sort of

3 second round of relatively brief antibiotic doesn't

4 usually do the trick. And you could cite that almost

5 as much, perhaps more, as evidence that one ought to

6 either do more than that or, certainly, seriously

7 consider doing more than that, rather than evidence

8 that one should do less than that.

9 DR. PHILLIPS: I agree with your

10 sentiment, but -- actually, the International Lyme

11 and Associated Diseases Society, of which I'm

12 president-elect - it's a multi-specialty group of

13 doctors from around the world - is setting up a

14 rebuttal that will be submitted to you in the future,

15 in the near future -- it's just being passed by the

16 board now -- a rebuttal of the Klempner study. And

17 when you read it, I think you'll see that the study

18 is so flawed in so many respects that, although I

19 would like to draw the conclusions that you've just

20 have drawn, I can't draw any useful conclusions from

21 the study whatsoever and cannot be in good conscience

22 refer to it in any way.

23 MR. GOTTFRIED: Okay.

24 DR. PHILLIPS: So, I would like --

25 yeah. I mean, I'm on the side of persistent

 

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1 infections, so I would like to say the same thing,

2 but I just really can't draw anything from it.

3 MR. GOTTFRIED: Well, it's interesting.

4 This past summer, I was at a week-long seminar on

5 evidence-based medicine given by some people who I

6 came away extremely, highly impressed with. And I

7 don't remember at the moment the name of the leader

8 of the effort, from Canada. At one point, I asked

9 him, "Is there some place that a lay person like me

10 can turn to and believe that the articles that I read

11 there are going to be reliably, you know, in

12 conformity with, you know, your guidelines of what's

13 good, rigorous evidence-based medicine?" And he

14 said, "Well, unfortunately, actually, no." And I

15 said, "Not even the New_England_Journal_of_Medicine?"

___ _______ _______ __ ________

16 And he said, "No."

17 So, what you're saying tends to confirm

18 that. I think that's all that I want to ask. I

19 don't know if my colleagues have questions.

20 DR. MILLER: Just a quick comment,

21 because we just had someone presenting who liked the

22 idea of evidence-based medicine and used it to

23 totally justify an insurance company not paying for

24 all kinds of things. And I listen to you and it

25 turns out that that evidence-based medicine just

 

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1 didn't have any evidence. I mean, it's kind of fun

2 to have evidence-based medicine with no evidence, but

3 clearly you can't to any substantive conclusion --

4 which you carefully came to, that there is no

5 conclusion. This is a large part of the problem that

6 we have. People will seize anything that supports

7 their view, before they've actually studied it, so

8 that they've just reinforced their view, or they can

9 get the benefit from their view and prevent people

10 from getting treated or deny payment for these

11 treatments.

12 Any efforts that you're aware of right

13 now to try and get more money into the program from

14 any sources at all? Either come up with more real

15 studies, or at least to get the medical profession as

16 a whole to realize there is no evidence in the

17 evidence-based? I mean, to me, that's really the

18 scary thing. We have 95 percent of the medical

19 profession believing that the simple is the answer --

20 that it's just that simple. And what do they cling

21 to? Why is it this problem? We had a Lyme disease

22 conference -- a two-day conference in Dutchess

23 County. Not a single local physician was willing to

24 show up for that Lyme disease conference. Why is it

25 that the medical profession is so adamant in their

 

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1 observance of no evidence at all?

2 DR. PHILLIPS: Dr. Liegner mentioned

3 social pathology. I like to think that a lot of it

4 is kind of a group dynamic. You know, there is such

5 a thing as scientific arrogance. I'm sure someone,

6 at some point during this hearing, will be commenting

7 on financial conflicts of interest and things I'm not

8 well briefed in. I don't have all the answers, but I

9 know they've done studies of how long it takes for

10 relatively new ideas to be accepted in medical

11 science, and it is in the order of decades, not

12 years. But these are not new. I mean, this has

13 been -- these have been going on for decades already.

14 It is about time that the paradigm has changed. It

15 is an obvious denial of the self-evident, in my

16 opinion.

17 I think that double-blind,

18 well-designed placebo controlled studies have to be

19 done. I'm just concerned that this one, in my

20 opinion, highly flawed study is going to prevent that

21 from ever happening. I know that there is some data

22 coming down the pike, not published yet - from,

23 apparently, other sources - that contradict the

24 Klempner data, and that will be out very soon, so I'm

25 told.

 

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1 MS. MAYERSOHN: Just one question.

2 Are you finished? I'm sorry.

3 DR. PHILLIPS: Yes.

4 MS. MAYERSOHN: Do you know where it

5 will be published? Is it going to be the New_England

___ _______

6 Journal_of_Medicine?

_______ __ ________

7 DR. PHILLIPS: No, I wouldn't be able

8 to comment, even if I knew. I'm sorry.

9 MS. MAYERSOHN: Okay. What percentage

10 of error in the current testing?

11 DR. PHILLIPS: Percentage of error,

12 false positive or false negative?

13 MS. MAYERSOHN: Both.

14 DR. PHILLIPS: To get a true known

15 percentage of error in sensitivity and specificity,

16 you have to compare it to a gold standard. When you

17 compare it to bull's-eye rashes -- the problem is

18 that for an acutely-affected mammal, the Lyme test

19 may work fairly well. The question is, what happens

20 later on? Well, in some studies, like the study that

21 I presented about documented bull's-eye rashes, where

22 only 22 percent developed, you know, confirmed CDC

23 criteria -- obviously that wasn't a very sensitive

24 test if only 22 percent were getting a positive. I

25 know that in infected deer, only five to seven

 

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1 percent actually test positive for Lyme. They did a

2 study of deer, where each deer had on average -- they

3 counted up the engorged, infected ticks on the deer.

4 And it was on average more than 100, so you would

5 think that each deer should have Lyme. And the deer

6 were seropositive five to seven percent of the time.

7 So, in a chronically infected mammal

8 like you may see in a late-stage Lyme case, it may be

9 very, very different. And most of the studies on

10 seropositivity were looked at with, you know,

11 early-stage disease rather than late-stage disease.

12 They weren't really looking at chronic Lyme when they

13 kind of wrote the rule book. They were looking at

14 early-stage Lyme and trying to define it in a nice,

15 tidy, little package of bull's-eye rash, arthritis,

16 and Bell's palsy. And, yes, some people develop

17 those things, and a lot of people don't.

18 MR. GOTTFRIED: Thank you very much.

19 Your testimony has been really super, and I look

20 forward to getting a printout of those slides.

21 DR. PHILLIPS: Okay. Thanks.

22 MR. GOTTFRIED: Thank you very much.

23 Our next witness is Dr. Steven

24 Schutzer, Associate Professor of Medicine at the

25 University of Medicine and Dentistry of New Jersey.

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