Lyme Disease Care Under Fire (News-Times 5-12)

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_http://www.newstimes.com/ci_9231161_ (http://www.newstimes.com/ci_9231161)

Asked last week if the IDSA guidelines could remained unchanged after the

review, Shapiro said flatly, " Yes. "

Lyme disease care under fire

Medical groups differ on courses of treatment

_By Staff Writer_

(mailto:bmiller@...?subject=NewsTimes.com: Lyme disease care under

fire)

05/12/2008

In the battle over how best to treat Lyme disease, a new settlement between

Attorney General Blumenthal and a major medical group might seem to

offer at least a little hope of expanded treatment for those with the

tick-borne disease.

That, however, would involve a change in the lines of debate over the

disease, and it's not clear there will be any yielding.

The settlement, reached this month between Blumenthal and the Infectious

Diseases Society of America, provides for a review of the IDSA's guidelines for

treating Lyme disease -- guidelines that a second group of doctors, the

International Lyme and Associated Diseases Society, say are strict and

inflexible

to the point of harming some patients.

But the IDSA's guidelines will remain unchanged until that review ends. And

while the review process will include the participation of an ombudsman, the

guarantee that opposing voices will get their say, and hearings that will be

broadcast on the Internet, they may not yield a single change, said Dr.

Eugene Shapiro, a pediatrician, epidemiologist and professor of investigative

medicine with the Yale School of Medicine in New Haven.

Asked last week if the IDSA guidelines could remained unchanged after the

review, Shapiro said flatly, " Yes. "

" If the scientific data recommends a change, we'll be happy to change, "

Shapiro said. " But we have 25 years of research on Lyme disease. We feel very

comfortable the guidelines will stand up to any scientific scrutiny. "

Doctors who are opposed to the IDSA guidelines said they believe there's at

least a chance their position -- that infection from the Lyme disease

bacteria Borrellia burgdorferi can create a chronic illness that needs

long-term

treatment with antibiotics -- will gain some credence with the review panel.

" I hope it will lead to an improvement to patient care, " said Dr.

of Wilton, who has been one of the doctors opposing the strict

guidelines in favor of those in which doctors can tailor treatment to

individual

patients.

is a past president of the International Lyme and Associated

Diseases Society, which believes there is ample scientific evidence to treat

people

for chronic Lyme disease.

" We've looked at the same evidence as IDSA and come up with significantly

different conclusions, " said Dr. Cameron of Mount Kisco, N.Y., the

current president of the group.

This isn't a merely a spat between two opposing medical groups.

In a press release, Blumenthal's office pointed out that insurance companies

now use the IDSA guidelines to restrict care for patients and refuse to pay

for long-term antibiotic care.

" It's a good way to have people denied insurance, " said Maggie Shaw of

Newtown, a member of that town's Lyme Disease Task Force. " It also puts the

fear

factor in doctors.

" Here are two standards of care, but only one gets recognized, " Shaw said.

" It's because of the stranglehold the IDSA has on this. "

The settlement between Blumenthal and the IDSA came after Blumenthal sued

the group -- which represents about 8,000 infectious disease specialists in the

United States -- in 2006 for antitrust violations.

Blumenthal said his investigation discovered many examples of conflicts of

interest among the doctors who wrote the IDSA guidelines. He also said they

refused to " accept or meaningfully consider " any evidence concerning chronic

Lyme disease in writing the 2006 guidelines and blocked the appointments of

scientists and physicians who differed with the IDSA view that all Lyme disease

can be treated with two to four weeks of antibiotics and that chronic Lyme

disease does not exist.

" Our focus has not been on medicine but the process, " Blumenthal said.

" There may have been violation of the law and it's my job to enforce the law. "

Dr. Sam Donta, a Massachusetts-based infectious disease specialist, was on

the panel that drew up the IDSA guidelines. Donta said he refused to sign off

on the guidelines when the group refused to acknowledge that chronic Lyme

disease is a problem.

--The issue should not be whether there's chronic Lyme disease, but why

we're seeing these patients, " he said

The review process established in the settlement, Blumenthal said, will be

" fair, open and free of conflict. " Donta said Friday he hopes to serve on the

panel.

But in its own press release on the settlement, the IDSA emphatically denies

there was any " significant " conflict of interest on the part of any of the

doctors who wrote the 2006 guidelines, or that they excluded conflicting

points of view while writing them.

In fact, Shapiro said, having stricter guidelines means doctors who follow

the IDSA protocols see patients fewer times and prescribe only short-term

regimens of generic antibiotics.

Shapiro said the IDSA agreed to the settlement simply to end any attempt by

Blumenthal to take the case to court.

" The alternative was spending a lot of money in an expensive lawsuit, " he

said.

Shapiro said all the scientific evidence on long-term treatment of Lyme

disease, including five double-blind studies in which some patients got

antibiotics and others a placebo, show that long-term antibiotics did not cure

the

symptoms that people include in the diagnoses of Lyme disease.

" It's not that data isn't there. It is, " he said, pointing out that 95

percent of all Lyme cases are successfully treated with only two or three weeks

of

standard antibiotics.

But Cameron said the double-blind studies, all with a small number of

patients, only show that Lyme disease is complicated.

" The evidence is quite mixed, " he said.

And the trials often look at the effect of just one type of antibiotic on

patients, Donta said.

" If one doesn't work, do you say all antibiotics don't work?, " he asked. " If

one cancer drug stops working, do you not try and find another? There's

insufficient information in the guidelines for physicians to make a decision. "

of Wilton said many peer-reviewed articles published in medical and

scientific journals make the case that chronic Lyme disease does exist.

What they hope the new review of the IDSA guidelines do, they said, is take

all this into account and give doctors a chance to treat each case

individually, rather than with a one-size-fits-all approach.

" Let the doctors have some flexibility, " Cameron said.

Contact

at _bmiller@..._ (mailto:bmiller@...)

or at (203) 731-3345.

Coughlan, President

MA Lyme Disease Awareness Assoc.

Mashpee, MA

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