 at the outset that I
17 have had some difficulty in preparing my remarks,
18 because the workings of the OPMC are shrouded in some
19 degree of secrecy. I'm sure you've heard about the
20 way that the OPMC investigations are triggered: A
21 complaint about a physician is received, either from
22 a patient, another physician or an insurance company;
23 the complaint is kept confidential and the
24 complainant remains anonymous in order to prevent
25 retaliation; an investigation of the targeted
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1 physician is undertaken if the OPMC determines that
2 one is warranted; and a disciplinary hearing follows
3 if, according to the OPMC, one is merited.
4 Given that this process takes place
5 largely behind closed doors, one is forced to do some
6 reading of tea leaves in order to glean what is
7 really going on. So, I've made some observations and
8 assumptions in preparing my remarks today. For
9 starters, it seems that an awful a lot of doctors
10 with significant Lyme disease caseloads are being
11 investigated by the OPMC. I have heard that the OPMC
12 denies that these investigations are actually about
13 Lyme disease, but there is really no other feasible
14 common denominator here, so I'm going to say way out
15 on a limb and say that, yes, I suspect these
16 investigations are actually about Lyme disease. I
17 find it interesting, however, that the OPMC wishes to
18 avoid the appearance of singling out Lyme-disease
19 physicians, since such a denial seems to me to be an
20 admission of sorts that such a policy would be
21 inappropriate or, at the very least, somewhat
22 distasteful.
23 It's also common knowledge that the
24 physicians under investigation are known to be a
25 little more liberal in both diagnosing and treating
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1 Lyme disease, so my second assumption is that it's
2 these practices that have caused them to run afoul at
3 the OPMC. And, third, since there is general
4 agreement among all parties that early Lyme disease
5 should and can be treated with antibiotics, I'm
6 assuming that it is the handling of patients
7 presenting later in the course of their illnesses
8 that has sparked the OPMC's actions. Specifically,
9 these would be those patients who were treated early
10 but did not experience complete resolution of their
11 symptoms, or patients showing up in their doctor's
12 office with a symptom complex that has never been
13 treated and which may or may not be an advanced form
14 of Lyme disease.
15 So, why is there a controversy about
16 Lyme disease and how did it evolve? You're probably
17 aware that Lyme disease is considered a relatively
18 new illness in the United States, having only been
19 recognized as a distinct clinical entity in the last
20 25 years. In truth, it has been around far longer,
21 but until the last quarter century it was always
22 misdiagnosed as some other malady - a tribute to its
23 protean nature and ability to defy easy
24 categorization. As you may have been told earlier
25 today, the earliest recognized Lyme disease cases
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1 were rheumatic in nature. There was an unexplained
2 outbreak of arthritis in coastal Connecticut in the
3 mid-1970s, an epidemiological investigation was
4 initiated, and this emerging disease of the joints
5 was recognized as something new and worrisome. Not
6 long after, it became clear that the disease had many
7 other manifestations; it affected the heart, the
8 eyes, the brain, the nerves, and other parts and
9 systems of the body as well. A number of these other
10 manifestations had been described even before the
11 Lyme arthritis outbreak, but had not been recognized
12 as belonging to a larger whole.
13 I would liken these earlier
14 descriptions of Lyme disease to the well-known fable
15 of the blind man and the elephant, where each man
16 touches a different part of the elephant and reaches
17 an erroneous conclusion about the totality of the
18 animal based on the part he touches. The man
19 touching the trunk describes the elephant as
20 snake-like; the man encountering the tusk describes
21 the elephant as a spear; and the man touching the leg
22 intuits a tree-like creature, and so on. But please
23 don't take the metaphor of the blind man too far.
24 None of this is meant in any way to disparage that
25 early work, as virtually all emerging diseases are
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1 described in this sort of piecemeal fashion. I'm
2 simply trying to point out that Lyme disease has been
3 somewhat of a moving target over the years, and the
4 conventional wisdom has been subject to frequent
5 amendments and refinements.
6 The development of a treatment paradigm
7 evolved in the similarly lurching manner. Initially,
8 it was posited that antibiotic treatment was utterly
9 useless. A few years later it was considered
10 moderately helpful; a few years after that, two weeks
11 of treatment with antibiotics was suddenly presented
12 as almost a silver bullet cure. But not long after
13 that it was decided that maybe four weeks would
14 provide a better outcome, except for the cases where
15 perhaps six would be more appropriate, or maybe even
16 two courses of four weeks, for a total of eight.
17 Sometimes these treatment recommendations were tested
18 in controlled studies, but not always. In any case,
19 the point is that the standard of care was always a
20 work in progress and underwent several revisions, not
21 all of them logical, as researchers and physicians in
22 the field groped for consensus and a sense of
23 certainty in treating what was to be turning out to
24 be, in some patients, a stubbornly difficult disease
25 to cure. I am not at all sure we've seen the end of
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1 this process, and further revisions may well be in
2 store.
3 The National Institutes of Health,
4 recognizing that deficiencies exist in the areas of
5 both testing and treatment for Lyme disease, have
6 funded a number of studies over the years to look at
7 these issues. But significant problems with testing
8 still remain, as you've no doubt heard in the talks
9 over today.
10 Here are some direct quotes from the
11 National Institutes of Health Web page on diagnosing
12 Lyme disease.
13 One: "Lyme disease may be difficult to
14 diagnose because many of its symptoms mimic those of
15 other disorders."
16 Two: "The only distinctive hallmark
17 unique to Lyme disease, the erythema migrans rash, is
18 absent in at least one-fourth of the people who
19 become infected."
20 Three: "Unfortunately, the Lyme
21 disease microbe itself is difficult to isolate or
22 culture from body tissues or fluids."
23 Four: "The inadequacies of the
24 currently available diagnostic tests may prevent
25 physicians from firmly establishing whether the Lyme
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1 disease bacterium is causing a patient's symptoms."
2 Five: "In the first few weeks
3 following infection, antibody tests are not reliable
4 because the patient's immune system has not produced
5 enough antibodies to be detected."
6 Six, "Antibiotics given to a patient
7 early during infection may also prevent antibodies
8 from reaching detectable levels, though even the Lyme
9 disease bacterium is the cause of the patient's
10 symptom."
11 And so on and so on. As you can see,
12 there remains a great deal of uncertainty in
13 determining who has Lyme disease, and as a result,
14 considerable effort is currently being expended to
15 try to advance the medical community's knowledge in
16 the area of Lyme disease testing.
17 As if things aren't difficult enough,
18 another important development has complicated the
19 chronic Lyme disease picture - the possibility that
20 many patients with so-called chronic Lyme disease may
21 be infected with other tick-borne pathogens in
22 addition to, or perhaps even instead of, the Lyme
23 organism. You heard Dr. Schutzer allude to this
24 earlier today. Several new tick-transmitted
25 disease-causing microbes have been discovered in
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1 recent years, and the current list is surely far from
2 complete. Even before the Lyme disease was described
3 in the U.S., medical scientists were aware of
4 babesiosis, a malaria-like disease also transmitted
5 by the deer tick. Since the emergence of Lyme
6 disease, other microbes carried by the deer tick have
7 also been discovered; the agent of human granulocytic
8 ehrlichiosis, for example, which infects human immune
9 cells and causes fever, aches, nausea and vomiting,
10 and which is occasionally fatal. It also known that
11 Bartonella organisms, which cause cat scratch fever,
12 are present in deer ticks, and a recent publication
13 in the medical journal Archives_of_Neurology
________ __ _________
14 describes several cases of likely tick-transmitted
15 human infection with this organism. Finally, a new
16 spirochete similar to the Lyme disease agent has just
17 been discovered in deer ticks. It too may have a
18 role in the so-called chronic Lyme