Persecution of doctors not new...Lymenet 1994

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II. LYME TIMES: Threat Of Disciplinary Action Creates Tense

Atmosphere For Lyme Docs

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Source: The Lyme Times

Byline: By Phyllis Mervine, Editor

Date: October 1994

In 1993, a physician at a New Jersey hospital is investigated because

a number of patients, treated with the IV drug ceftriaxone, have to

have their gall bladders removed. In Oregon, a physician is reported

to the State Medical Board by an HMO which disagrees with his

diagnosis. A disciplinary hearing is held, and the physician's

practice is subsequently restricted. In Pennsylvania, an

investigator from the State Medical Board shows up at a doctor's

office in response to a complaint that the doctor is overtreating

patients. Another physician opts for a court trial after the Michigan

State Medical Board, acting on complaints from other physicians,

accuses him of misdiagnosing and overtreating his patients.

What do these four physicians have in common? According to reports,

they all treat large numbers of patients with Lyme disease. In each

case, officials have questioned whether the patients treated actually

have Lyme disease, and whether the treatments used were appropriate.

The question of why these particular physicians are being singled out

for such intense scrutiny can be addressed by examining the diagnosis

and treatment picture in the United States. The first impression of

Lyme disease for many physicians comes from the Centers for Disease

Control case definition. This case definition is admittedly strict,

and necessarily so, because is intended for use as a surveillance

tool, to include only cases about which there is no doubt. The

problem comes when physicians unfamiliar with Lyme disease try to use

the case definition as a diagnostic tool. That many patients with

actual Lyme disease do not meet the CDC case definition has been

demonstrated by a 1993 active surveillance program in California

(Ley, West J Med 1994; 160:534-539).

To complicate matters, questions about diagnosis are frequently

referred to the researcher who first described the disease in 1977,

Dr. Alan Steere of the New England Medical Center. Dr. Steere, a

rheumatologist, takes a very conservative stance on the prevalence

of Lyme disease. In a recent controversial study his research team

concluded that up to 77% of patients who had previously been diagnosed

with Lyme disease by other physicians, actually did not have the

disease (JAMA 1993;269:1812-16). Some treating physicians, including

the four mentioned above, obviously do not agree with Dr. Steere's

assessment. Two cogent critiques of his methodology and conclusions

were published in the Lyme Times (No.11, Sept. 1993)

Another stumbling block is the question of endemnicity. Whether Lyme

disease is or is not thought to exist in a certain area depends upon

the willingness of physicians in that area to diagnose the disease.

That willingness is, in turn, dependent upon the physicians'

perception of the likelihood of the disease occurring in the area.

Geographical areas are considered non-endemic unless cases are

reported from the area, but patients from those areas are sometimes

told that they can't have Lyme disease because " we don't have it

here. " A case in point is British Columbia, Canada, which was

described in the medical literature as nonendemic until

epidemiological and entomological studies culminating in 1993 proved

the existence of Borrelia burgdorferi in native ticks, rodents, and

human beings (Banerjee, Can Dis Wkly Rpt 1993;19-24:204-5). This

research was published shortly after authors of another study

suggested that a Lyme disease clinic could be useful even in a

" nonnendemic " area, since the physician could tell most patients with

suspected Lyme disease that they did not, in fact, have it (Burdge,

Clin Infect Diseases 1993:16:558-60).

The CDC and other authorities frequently emphasize that Lyme disease

is a clinical diagnosis. Negative tests cannot conclusively prove

non-Lyme, nor can positive tests conclusively prove Lyme.

Unfortunately, both these facts are liable to misuse. According to

one expert, the seronegative patient is likely to be sickest.

(Liegner, J Clin Microbiol 31;8:1961-63) Borrelia burgdorferi (Bb)

has been reported to suppress the immune system (Barthold, Lyme Times

13:26), as well as to evade it. On the other side, serologic surveys

of endemic areas show many people who have antibodies to Bb, but who

are not sick (Huyke, J Infect Dis 1992;165:1133-37). Some of these

individuals may have subclinical symptoms (Vidaillet, Amer J Cardiol

1993;17:1249-51).

Disease descriptions can be used as a guideline, but the constellation

of symptoms may vary considerably from case to case. The diagnosing

physician must rely on her/his personal experience and intuition.

This is that gray area where the physician becomes an artist.

Optimal treatment for Lyme disease is another subject of intense

debate within the medical community. Early studies recommended two

weeks of antibiotics as curative. As experience with refractory cases

mounted up, some physicians tried longer treatments, as well as

different combinations of drugs. Although some of these experiments

were successful, other physicians cling to the original protocols,

apparently discounting several studies which prove persistence of

infection despite antibiotic treatments (Preac-Mursic, Infection

17:355, and others). Some of the drugs used have documented risks and

side effects. In the New Jersey case, patients testified that they

knowingly and willingly undertook the risks of using the drugs in

order to be free of their disease symptoms.

Diagnosis and treatment of Lyme disease are complex arts. The unnamed

physicians above now have to defend their art to the skeptics. They

were diagnosing and treating many patients with Lyme disease. When

their patients did not get well with two weeks of antibiotics, they

questioned the hypothesis of the easy two-week cure and struck out

over uncharted territory. Although some of their patients responded

well to their innovative treatments, the doctors are now being

censured by the medical community.

Dr. Dorothy Pietrucha, a pediatric neurologist who treats many Lyme

disease patients, is angry about the situation. " Why should doctors

extend themselves? " she asks. " Lyme disease is hard to diagnose and

hard to treat, but instead of getting support from the medical

community, doctors who treat Lyme disease patients are having their

licenses threatened. If a Lyme patient has a complication of

treatment, though he is better, the doctor is criticized. If an

AIDS patient dies, the doctor receives sympathy and support. "

Dr. Brown of Portland, Oregon learned how to treat Lyme

disease by catching it himself. A constellation of symptoms emerged

after a nine-year latency period. Brown was diagnosed with

myofasciitis, reactive arthritis, and atypical multiple sclerosis

before discovering he had seronegative Lyme disease. A two-week

treatment with ceftriaxone led to temporary improvement, but did not

cure him. He finally recovered fully after using long-term

combination oral antibiotics, and started to use what he had learned

in his own practice. Brown became the focus of unwanted attention

when an HMO reviewer reported him to the State Board.

" I went to the hearing with my charts and literature, including papers

by Preac-Mursic, Liegner, and others, " states Brown. " I acknowledged

that yes, I do treat seronegative patients and yes, I do treat with

long-term antibiotics. I cited and provided some of the papers

documenting the validity and need for both. I discussed the problems

with Lyme serologies, and reviewed the other tests I use in

differential diagnosis. They weren't interested in my discussion or

the papers I brought. I was grilled for several hours, and was

treated like a pariah.... It was a disciplinary hearing; they weren't

there to learn anything. The fact that 5 out of the 6 patients whose

charts they reviewed had dramatically improved, and returned to

productive lives, didn't matter. " On April 1, 1994, Dr. Brown signed

a consent letter, agreeing to no longer treat Lyme disease.

The Pennsylvania doctor was luckier. When another physician

complained to the State Medical Board that he was using two

antibiotics on one of his patients, an investigator came to visit.

The office nurse assembled and mailed to the complainant a three-inch

thick folder of articles with particular citations supporting the

treatment highlighted in yellow, with a summary of the conclusions of

each article stapled in front. She included a copy of Appendix F: FDA

Drug Bulletin, which states in part: " The FD & C Act does not, however,

limit the manner in which a physician may use an approved drug. Once

a product has been approved for marketing, a physician may prescribe

it for uses or in treatment regimens or patients populations that are

not included in approved labeling. Such 'unapproved' uses may be

appropriate and rational in certain circumstances.... Valid new uses

for drugs already on the market are often first discovered through

serendipitous observations and therapeutic innovations, subsequently

confirmed by well-planned and executed clinical investigation. "

The episode was concluded without further repercussions, but the

doctor feels vulnerable. " I have never claimed to be a 'Lyme

expert,' " he says. " We just have a lot of hands-on experience. "

Dr. ph Natole is in trouble after accepting patients who had been

told by other physicians that they did not have Lyme disease. He had

already made the Michigan Department of Health nervous by reporting

50 Lyme cases in 1989, before reporting was mandatory, from counties

which were not believed to be endemic, since no tick had been

discovered. The State has produced an " expert " witness, a physician

who admitted in court that she has not treated one case of Lyme

disease in the past five years. Several patients are scheduled to

testify for Dr. Natole, but defense attorney McGraw lamented

that of 111 physicians invited, all known to treat Lyme disease, only

two responded. The others do not want their names known. The

Attorney General's office, on the other hand, has obtained a

deposition from Dr. Steere. The situation today may be blamed partly

on the anonymity and specialization of our medical care system.

Many physicians no longer live in the communities where their patients

reside, instead, they treat from urban specialty clinics. Correct

diagnosis is more important than ongoing care. Patients who are

unsuccessfully treated at such centers are unlikely to return.

Country doctors have a different experience. Ed Masters, MD, of

Missouri, can't escape from his patients, who are also his friends and

neighbors. If he stops treatment before they are well, they return to

his office and insist he treat them again. In this way Dr. Masters

learned that two weeks of antibiotics often did not cure Lyme disease.

What is to be done? " Go to your Department of Health and to your

elected officials, and do something! " recommends Dr. Pietrucha.

" If the patients don't stop this, they are going to find they will

have no doctors willing to treat them. Doctors who are willing to

take on a difficult disease should be given some support, and should

not have to operate with this cloud hanging over them. "

" The bottom line is that the physician's responsibility is to help the

patient feel better, whether or not s/he can affect a cure, " says Dr.

Willy Burgdorfer, discoverer of the Lyme disease spirochete. He

reminds us that another spirochetal disease, syphilis, is not

considered curable in its later stages, but patients receive

antibiotic treatment nonetheless. The State Medical Boards now

sitting in judgment over these doctors are attempting to usurp the

power of deciding which patients should be treated. This power should

belong to the individual physician, as long as s/he is acting in good

faith and is not committing any crimes. Science has not yet provided

the answers to all our questions about Lyme disease, but the welfare

of the patients should be the primary focus. Persecuting the doctors

who treat them is not the solution.

O'Donnell contributed to this report.

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