Article New Haven Advocate July 23, 1999

July 23, 1999

While Lyme disease runs rampant, the medical community gets caught up in a

power struggle.

By Stefanie Ramp

Having Lyme disease is like being a demon-possessed 90-year-old with the flu

and a hangover. At least that's how Lyme sufferer and activist

Montes explains it. While his experience with Lyme has been more horrific

than most, his story is echoed by many tortured by the later-stage

complications of the disease.

Montes' troubles began with a bite from a deer tick, which infests the

Northeast and transmits the bacterium responsible for Lyme disease. The tiny

tick, barely larger than the period halting this sentence, has spawned an

elaborately twisted power struggle that challenges the scientific, ethical

and moral pillars of the medical community. This acrimonious rift among

doctors often perpetuates and prolongs patient suffering, as was the case

for Montes.

When diagnosed early, most Lyme cases are effectively treated with a

moderate dose of oral antibiotics. But diagnosing Lyme disease is the first

chasm severing the medical community; a conservative faction -- including

many Yale researchers and physicians -- believes the disease is

overdiagnosed and that Lyme detection tests should be relied upon for

diagnosis. The opposing faction believes diagnosis should be based primarily

on a patient's history and symptoms, with tests providing support.

As Montes discovered, when Lyme goes undiagnosed, the later stages can be

brutally tenacious and, in the opinion of some doctors, incurable. Protocol

for late-stage Lyme engenders the second major conflict surrounding this

disease: whether patients are experiencing a persisting infection or merely

persisting symptoms (caused by the body's lingering inflammatory response to

the disease). The medical community, therefore, disagrees on how to treat

it.

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Before Lyme irreversibly scarred his life, Montes was an avid rock-climber,

fisherman, runner and outdoorsman. Most days now, he's accomplished

something if he can make it through a full day's work as a psychologist

working for the community services office of New Britain.

A tick bite in 1987 seems to have caused what has now been more than a

decade of illness for Montes. He was treated with a short course of

antibiotics for the bite and had no immediate symptoms. But after a couple

of years, a seemingly random set of problems began plaguing him. Heart

palpitations, joint pain, sore ears and jaw, dizziness, panic attacks,

flu-like symptoms, severe headaches, light and sound sensitivity, depression

and staggering fatigue sent him befuddled to his doctor in 1993.

Eight different doctors made nine different diagnoses: everything from

allergies to post-concussive syndrome. Over the next several months, Montes

even had two unnecessary root canals. To date, he has seen more than 20

doctors for Lyme-related diagnosis and treatment.

In hindsight, he suspects he suffered another tick bite during a trip to

tick-infested Nantucket in July 1993 and became reinfected with Lyme, along

with a secondary tick-borne illness, babesiosis, for which he tested

positive last year. " I started to have thoughts that were not my own, " he

says, " intrusive thoughts that were violent, homicidal, suicidal. "

Finally, in November 1993, Dr. Virginia Bieluch, co-chief of infectious

disease at New Britain General Hospital, treated Montes for Lyme. When

therapy begins, the disease sometimes intensifies before subsiding. " It was

Thanksgiving Day 1993 and I just wanted to die, " Montes recalls, shuddering.

" If you had a gun that day, and you said, 'I'm going to put it to your head

and I'm going to pull the trigger,' I would have said, 'The sooner the

better -- please do it.' "

But on the 17th day of antibiotics, Montes had a brief reprieve and felt

good for the first time in months. Although fleeting, it fueled his faith in

a recovery, and he sought out Dr. Phil Watsky, an internist in Bristol known

for his work with Lyme patients. After Watsky treated Montes with several

more courses of oral antibiotics to no avail, he prescribed a six-week

course of IV antibiotics. " My life came back, " Montes exclaims. " It was

amazing, just amazing. "

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For patients like Montes who continue to suffer from Lyme symptoms even

after standard treatment, long-term antibiotic therapy offers the best hope.

But the conventional wisdom, among the more conservative medical faction, is

that Lyme rarely requires IV treatment, and never long-term. Because of the

traditional treatment guidelines, insurance companies have refused coverage.

(In Connecticut, at least, many of these patients got good news when the

legislature passed a law this year mandating coverage of extended antibiotic

treatment.)

Instead of what should be a cooperative and scholarly quest for the truth,

politics, power and greed have polarized medical professionals, creating

what one doctor calls " an all-out war. "

Biologically speaking, Borrelia burgdorferi (Bb), the spirochetal Lyme

bacterium, is an admirably crafty organism that can hide in its host's body,

escaping eradication and even detection. So most of the medical community,

including the Centers for Disease Control, agree that a diagnosis of Lyme

should not depend on positive tests. The most common tests are the ELISA and

Western Blot, both antibody tests measuring the body's reaction (or lack of

one) to Bb. Like many antibody tests, they may produce false negatives early

on. By the time a patient does test positive (and some patients never do) it

can be too late for simple and effective treatment.

Although the CDC guidelines for reported cases of Lyme require positive

tests, the CDC itself clearly states that its criteria should not be used

for clinical diagnosis. Rather, the CDC says, Lyme should be diagnosed based

on a doctor's evaluation of symptoms and history, with the tests providing

support. The federal Food and Drug Administration's just-released summer

medical bulletin reiterates this belief.

Without definitive diagnostic tools, a haze of confusion has settled over

doctors and patients alike, breeding misunderstanding and mistrust.

Diagnostic parameters for Lyme are merely the beginning of the rift caused

by this disease, which often obscures the more important issue of how to

treat it.

According to several Lyme physicians, disagreements over Lyme treatment have

evolved from academic squabbles to active animosity, with some doctors

accusing their colleagues of everything from overdiagnosis to malpractice to

profiteering.

" It's not an exaggeration to call it a war -- a war of ideas -- and there

have been casualties in the process, " says Dr. Liegner of Armonk,

N.Y. " People have been scapegoated. Careers have been, if not permanently

destroyed, seriously damaged. " Liegner notes that syphilis engendered a

similarly ferocious controversy around the turn of the century and that

spirochetal diseases seem to have had the innate power to spark chaos

throughout history.

Nationally, more than 100,000 cases have been reported following the strict

CDC guidelines, according to the Lyme Disease Foundation, a national

nonprofit organization based in Connecticut. Some studies estimate that

nearly 2 million people have been infected with Lyme, costing society

approximately $18 billion.

New York and Connecticut have the highest incidence of Lyme in the country.

More than 3,000 cases in Connecticut were reported and met the CDC criteria,

but the CDC admits that its numbers may account for only 7 percent to 10

percent of actual cases -- potentially 30,000 to 45,000 last year in

Connecticut.

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Despite a substantial faction of proactive doctors and patients who believe

in long-term antibiotic treatment for chronic Lyme -- based on clinical

experience and a widening body of published research -- old habits are still

dying hard, particularly for tradition-bound academics at research

institutions like Yale.

Yale set the protocol for Lyme treatment (generally, a relatively short-term

oral antibiotic therapy) in part because Dr. Steere, the physician

credited with first identifying the spirochetal disease now known as Lyme,

was on the Yale faculty. And Yale is still largely perceived as the beacon

of Lyme wisdom.

Yale doctors have done a great deal of valuable research on Lyme. But many

observers criticize the old-school Lyme vanguard, primarily Steere (who has

relocated to Tufts-New England Medical Center) and his key Lyme associates

from Yale -- Dr. Schoen and Dr. Eugene Shapiro -- for clinging to

their conservative opinions and jealously guarding their presumed founders'

rights to the disease.

With no definitive evidence proving or disproving the existence of chronic

infection, treatment must be based on an individual doctor's beliefs about

the nature of Lyme disease, anecdotal evidence and clinical experience. So

it's not so much the conflict of medical opinion that Yale critics take

exception to. Rather, it's what many perceive as the closed-minded arrogance

of Yale's most prominent Lyme doctors, who seem to exclude every possibility

save for those conceived by a Yale physician.

Montes, for example, lost an appeal for insurance coverage after his case

was reviewed by Yale's Dr. Schoen. " They [Yale Lyme doctors] have this

attitude like, 'If we didn't diagnose it, it isn't real, " says Montes. " I

don't understand how, in the face of published research, they can refuse

other doctors' findings. "

Carl Brenner, one of two patients on a National Institute of Allergy and

Infectious Diseases advisory committee on chronic Lyme, sees the medical

community on both sides as stuck.

" You have a situation where people selectively call on data that agrees with

their position and ignore the data that doesn't. You can create a pretty

good case for either side of this controversy, " he says. " My interest is

simply to make sure that enough data gets gathered so that we can get some

momentum towards figuring what the true nature of this illness is. "

Forschner, executive director and co-founder of the Lyme Disease

Foundation, suspects that potential legal liability may encourage some

doctors' resistance to the concept of chronic infection and underdiagnosis.

" If, in fact, these patients are chronically infected, and there's mounting

evidence that this is a possibility, some of these doctors who have been

going around obstructing patients' treatment -- literally going out of their

way to do that at times, and testifying for insurance companies, etc. -- are

potentially at risk for lawsuits. "

In fact, attorney Ira Maurer has devoted his Westchester County, N.Y.,

practice to Lyme lawsuits. Along with a multitude of malpractice suits, he's

also handling the cases of doctors whose peers have allegedly ostracized and

professionally injured them -- what Maurer terms a " witchhunt " -- because of

their aggressive diagnosis and treatment of Lyme.

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Dr. Eugene Shapiro, a professor of pediatrics and epidemiology at Yale, does

not buy the notion of chronic Lyme infection or the need for long-term

antibiotics.

" I don't believe, " he says, " there's any scientific evidence that more than

one or two courses of antibiotics is necessary to eradicate the bacteria. "

In Shapiro's opinion, chronic symptoms are the result of an auto-immune

problem rather than persisting infection in all but extremely rare cases,

when people weren't diagnosed and treated for many years.

Not all Yale-affiliated Lyme physicians agree. Dr. Amiram Katz, assistant

clinical professor of neurology, believes that denying the possibility of

persistent infection is counterproductive and ultimately harmful.

" In the textbook of pathology which every medical student reads, it is

written that there is chronic Lyme, " he says. " We know from syphilis that

this type of bacteria, the spirochete, can be alive and persistent though at

times dormant. " Katz says refusing to accept the evidence for chronic

infection is " an example of how people are going to an extreme and damaging

both themselves and the patients. "

" I don't know if it's an ego issue or if this is the only way to deal with

the problem according to their training and beliefs, " Katz continues. " There

are some sound reasons on both sides of the fence and people are not hearing

them -- that's a shame. "

Katz also suggests that more conservative doctors might fear " misuse of

treatment facilities and antibiotics, and they're afraid that people will

suffer from the side effects of those prolonged treatments. " Katz himself

believes that there isn't enough information about repeated courses of

long-term IV therapy. He limits such treatment in his own practice to three

months, extending it only if a careful reassessment of the patient seems to

warrant it.

In most cases, antibiotic-related risks are not severe, according to Dr.

Schoen, who nonetheless opposes long-term therapy. In rare cases, Schoen

explains, prolonged use of antibiotics can cause gallstones, temporary and

occasionally permanent liver damage and, more commonly, mild allergic

reactions, susceptibility to yeast and fungal infections, gastro-intestinal

dysfunction, inflammation or infection from the IV line and

antibiotic-resistant strains of the bacteria.

For patients who have successfully undergone long-term antibiotic treatment,

the benefits outweigh the risks. Bonnie Friedman, a Lyme patient and office

assistant for Dr. Bernard Raxlen, a Lyme physician in Greenwich, and her

daughter have been on long-term antibiotic therapy several times. Her

daughter was treated for 10 months and started having seizures when she

discontinued therapy.

" No parent wants to put that amount of antibiotics into their child, " says

Friedman. " It takes a lot of heartfelt thinking to make a decision like

that. "

While both have suffered some side effects from the antibiotics, " They were

nothing compared to what my daughter's life would've been like without

therapy, " Friedman remarks. In June 1998, " she was in bed and totally

incapacitated. " This May, " she graduated cum laude from Fairfield

University. "

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Both Schoen and Shapiro believe Lyme is overdiagnosed and overtreated.

" There's this myth that's been perpetrated that Lyme is difficult to treat

and causes horrible complications, and that rarely is true, " remarks

Shapiro. " I also think it's more socially acceptable to have Lyme disease

than to have, say, depression, and people like to put a name on things. "

Schoen suggests that long-term treatments carry a psychological risk as well

as a physical one. " There are many patients who're being treated and told

that they have a chronic, very difficult-to-cure problem, with long-term,

wide-spectrum antibiotics as the only treatment option. If I feel that the

patient doesn't have Lyme disease and doesn't need that treatment, then I

mean that to be reassuring to that patient -- that they don't have this

disease. "

Less reassuring to some patients are the facts that Schoen consults for

several insurance companies and Shapiro formulates insurance coverage

policies. Critics charge Schoen's apparent conflict of interest may prevent

chronic Lyme patients from getting coverage for the care they need, and that

Shapiro is making sweeping decisions about what treatments Lyme patients

deserve.

Even though many patients suffering from chronic Lyme symptoms have been

prescribed IV treatment, insurers won't approve coverage unless one of their

own consultants concludes that it's necessary. For consultants, then,

medical opinion and money -- several hundred dollars an hour in consulting

fees -- become irrevocably intertwined.

Lyme patient McFadden, a NASA engineer who now lives in Alabama, says

he was denied coverage for antibiotic treatment after Schoen reviewed his

case in 1994 for his insurance company and reported that McFadden did not

have Lyme. This despite a positive test and a well-documented,

diagnostically definitive " bulls-eye " rash, which his treating physician

noted as " being the size of a dinner plate. " Further frustrating McFadden,

Schoen wouldn't or couldn't explain what exactly McFadden was suffering from

if not Lyme.

McFadden's insurance company ultimately reassigned the case to a different

consultant who agreed with McFadden's physician; treatment was covered and

the insurance company has been relatively supportive ever since. When

McFadden requested a copy of his complete records, he found tucked in the

file a bill for Schoen's consulting job on his case, charging the insurance

company $700 for two hours of work.

McFadden has accumulated a good deal of research on Schoen's practices and

has been contacted by many other Lyme patients who feel the doctor has dealt

with them unfairly. One patient, an attorney in New Jersey, had two positive

tests, but Schoen said she did not have Lyme. According to McFadden, based

on statistical analysis the chance that both would be false positives would

be one in 50,000.

" No university or group of individuals is responsible for more patients with

Lyme disease going without treatment than Yale, " he says.

Schoen responds: " I deal with questions about Lyme disease all day long in

all kinds of different settings. I don't feel anyone has any leverage over

me at all. Wherever the questions are coming from, I give the answers I

consider to be in the patient's best medical interest. "

While most insurers pay for the standard oral antibiotic treatments for

acute early-stage Lyme, they often deny coverage for long-term IV therapy,

which can cost up to $6,000 a month. Albert May, a Blue Cross/Blue Shield

spokesman, says there isn't enough evidence in reputable journals that

long-term antibiotic treatment works, and that one can't base policy on what

a doctor thinks might work.

He declines to comment on how Blue Cross accounts for the number of patients

and doctors reporting positive results from long-term IV therapy, except to

say that a significant enough portion of the medical community, including

well-paid consultants like Schoen, doesn't believe it works. Blue Cross/Blue

Shield, he says, is willing to change its policy if the medical community

reaches a consensus.

Insurers " probably feel besieged by Lyme cases, " says Bruce Fletcher, a

patient advocate instrumental in getting the new Connecticut legislation

passed. " But there frankly is an epidemic in Connecticut. "

The new law, effective next Jan. 1, mandates insurance coverage for a

minimum of 30 days of IV antibiotic therapy and 60 days of oral antibiotics.

Further treatment requires diagnosis by a rheumatologist, neurologist or

infectious disease specialist, but this doctor is selected by the patient,

not assigned as a consultant by the insurance companies, to help ensure an

unbiased opinion.

Some Lyme patients remain concerned about the bill's failure to delineate

diagnostic requirements for extended treatment coverage. If positive tests

are required, it could be a potential loophole for the insurance companies.

State Rep. Eberle, co-chairwoman of the Public Health Committee,

doesn't think that will be a problem. Patients, she says, " have to have some

indication as to why the doctor thought it was Lyme. My guess is that if a

patient comes in with a tick bite and they're exhibiting the rash, the

[insurance] companies aren't going to fight the first 21 days of

treatment -- they're probably not going to fight the first 60 days. If

during that time, four tests have come back negative, I think they have the

ability to question whether this is really Lyme. "

Complicating matters is the fact that Lymerix, the new Lyme vaccine, negates

the accuracy of the Lyme antibody tests. (See related story.) For people who

have taken Lymerix, a positive test requirement could dash any hope of the

protection the legislation has promised.

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Definitive research on Lyme in humans is lacking, in part because you can't

euthanize people and study their brain tissue -- one of the places the

spirochete is thought to hide. Nevertheless, a study by Reinhard

Straubinger, published in the Journal of Clinical Microbiology in January

1997, provided solid evidence of persisting infection in dogs.

The National Institutes of Health has been working on a comprehensive study,

the first major Lyme research endeavor of its kind, to help elucidate this

possibility. Mark Klempner, principal investigator for the Chronic Lyme

Disease Study, and Louisa C. Endicott, professor of medicine at Tufts

University School of Medicine, explain that the chronic Lyme component of

the study hopes to discover whether chronic infection persists, whether

long-term antibiotic treatment works and whether better diagnostic tests can

be developed. Dr. Janine of the Yale Lyme Clinic is overseeing a new

satellite study center in New Haven.

A related nonhuman primate study, being conducted at Tulane Regional Primate

Center, may prove even more helpful. Researchers infect rhesus monkeys,

allow the spirochete to disseminate, then administer the same treatment

regimen as is used in the human study. They will study the monkeys' tissue

in an attempt to discover whether the spirochete has survived treatment.

The study has been in progress since 1996, and will continue for another two

to three years. " It's an extremely complex disease and it's painful to admit

that, " cautions Brenner, a patient member of the Advisory Committee. " I

don't care how much money and effort you throw at this and how much good

faith people on both sides can show -- I don't think the answers are right

around the corner. "

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How to Stay Healthy

So how can you protect yourself against Lyme? The vaccine Lymerix,

manufactured by Kline Beecham, hit the market in January with shaky FDA

approval. Developed from a recombinant protein, OspA, that was pioneered at

Yale, the vaccine was tested over four years involving 11,000 patients, 10

states and 31 researchers. But like everything else about this disease,

Lymerix is not without controversy.

The FDA is apprehensive about the vaccine's safety for children under 15

(trials in children 4 to 15 are currently underway), those with chronic Lyme

and those with family histories of rheumatoid arthritis.

Even after three doses, the vaccine is only 78 percent effective and may

require subsequent boosters. Lymerix works by generating antibodies that

kill the Bb spirochete inside the gut of the tick itself as it ingests its

host's blood. One concern is that bacteria could evade the antibodies and

slip into the host's blood system, at which point the vaccine is

ineffective.

Once a person has had the vaccine, antibody tests are no longer effective,

creating an even larger diagnostic nightmare. It also doesn't protect

against all strains of the disease or other tick-borne illnesses such as

babesiosis, ehrlichiosis or Rocky Mountain spotted fever. On the other hand,

if you work outside in an endemic area, some protection is better than none.

Aside from apprehensions about the vaccine's safety and efficacy, patients

and doctors are worried that research for a cure, or at least better

treatment, will fall by the wayside in light of the vaccine. " They're not

even thinking cure; there's no money for cure, " says Barbara Goldklang, a

Lyme patient and founder of the Lyme Coalition of New York and Connecticut.

" Nobody is looking for better treatment right now except maybe some of the

clinicians struggling with the patients who have chronic illness, " adds Dr.

Liegner of Armonk, N.Y. " There should be a major, major effort on

the part of everybody -- the government, pharmaceutical companies, basic

researchers -- on designing better treatment. "

Regardless of the vaccine, people should consider seeking medical evaluation

for an embedded deer tick. Whether to treat all bites prophylactically with

antibiotics is another scorching debate, although much of the medical

community agrees that by the time definitive tests and symptoms occur (and

in 17 percent of cases, symptoms never occur), the spirochete has had a

chance to disseminate throughout the body, increasing the risk for chronic

problems. On the other hand, some highly active families would never make it

out of the doctor's office if every tick bite warranted a visit. While

sweeping statements in support of or opposition to prophylactic treatment

may prove too rash, a talk with a trusted physician who is well-versed and

open-minded about this enigmatic disease will, at the very least, ease the

emotional strain Lyme engenders.

-- S.R.

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Where to Turn

Lyme Disease Foundation:(860) 525-2000; National Hotline, (800) 886-LYME;

<http://www.lyme.org/>

Lyme Coalition of New York and Connecticut: Hotline for Volunteers, (914)

769-6243.

American Lyme Disease Foundation: <http://www.aldf.com/>

Lyme Disease Information Resource: <http://www.x-1.net/lyme/

Lyme Disease Network: www.lymenet.com>

Kline Beecham Information About The Lymerix Vaccine: 1-888-LYMERIX

(596-3749) (ext. 700), <http://www.lymerix.com/>

National Institutes of Health: <http://www.nih.gov/>

For Information and Participation in the NIH Chronic Lyme Study: (888)

LYME-CTR

Centers for Disease Control: <http://www.cdc.gov/>

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New Haven Advocate home page

July 23, 1999

I am very interested in this article. I tried downloading the rest of it but

just can't seem to get it. If it is not too long to copy and if someone can

cut & paste it for me & the rest of us that can't get it . I'd be so grateful.

: )

Thanx,

July 23, 1999

From: " J & M McCoy " <mlmccoy@...>