Lyme disease debate provokes treatment divide, legal action

In what may be a first, the government has taken steps to investigate the drafting of medical guidelines.

By Susan J. Landers — Posted Dec. 25, 2006

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Dueling guidelines developed by two medical organizations for treating patients with Lyme disease have sparked such an uproar that Connecticut's attorney general has stepped in to see if one side ran afoul of antitrust statutes.

The Infectious Diseases Society of America and the International Lyme and Associated Diseases Society each assembled expert panels that sat down separately and examined the evidence on the nature of and best treatment for this tick-borne illness. But they arrived at different conclusions.

IDSA, a scientific organization of physicians, scientists and other health care professionals who specialize in infectious diseases, characterizes Lyme disease as primarily acute and treated successfully in the vast majority of cases with, at most, a few weeks of antibiotics. ILADS, which is a multidisciplinary medical society focused on the diagnosis and treatment of Lyme disease, holds out the possibility that the disease is chronic and may need months of antibiotics.

The differing conclusions call into question how best to treat the more than 20,000 people who contract the infection each year. Although Lyme disease has been reported in nearly all states, most cases are found in the Northeast, mid-Atlantic and North Central regions of the nation. Left untreated, the infection can spread to joints, the heart and the nervous system, according to the Centers for Disease Control and Prevention.

It is not unusual for different medical and scientific groups to take varying clinical positions on specific conditions. But this particular situation quickly has become far from typical.

The battle over how to treat the infection grew so heated that, in Connecticut, the state in which the disease was first recognized and named, Attorney General Richard Blumenthal began an investigation in mid-November. "We issued a subpoena to the IDSA because its guidelines may severely constrict choices and legitimate diagnosis and treatment options for patients," he said.

Advocacy groups in the state and elsewhere had expressed outrage over the IDSA guidelines and applauded Blumenthal's action. "Clinical guidelines now drive the standard of care, and these IDSA guidelines have already been published on the CDC Web site," said Pat Smith, president of the Lyme Disease Assn. The advocacy community contends that the guidelines deny the existence of chronic Lyme disease and could lead to limits on physicians' treatment options.

IDSA, which notes that it is responding fully to the subpoena, believes its guidelines are based on the best that science currently has to offer. It was the association's development and Nov. 1 publication in Clinical Infectious Diseases of an updated version of its guidelines that resulted in the current furor.

For its part, ILADS finds the rival guidelines to be very restrictive to the point of limiting treatment options and even excluding certain treatments that have been used by physicians for years, said the group's president, Raphael Stricker, MD.

What's more, insurance companies may deny coverage of treatments not supported by the infectious diseases society guidelines, said Daniel Cameron, MD, MPH, who led the panel that developed ILADS' guidelines.

These perspectives have contributed to the guidelines' scrutiny.

"At this stage, to debate the guidelines is a bit like debating religion or science," said Paul Auwaerter, MD, clinical director of Baltimore's Johns Hopkins School of Medicine's Division of Infectious Diseases and a fan of the IDSA guidelines.

"I don't think there is anyone in the middle," he noted. "I'm sure both of us are right in some regards and wrong in other regards. But that's always the case with medicine."

Gary Wormser, MD, who led the IDSA team in the development of its guidelines, pointed out that they are, after all, recommendations and, according to a statement included on the document's first page, are not intended to replace physician judgment.

"We don't dispute that there are patients who had Lyme disease and who continue to have symptoms, whatever the reason," he said. "We think this illness is a real problem and definitely needs more research and attention. But I think where we differ is the idea of treating these individuals indefinitely with antibiotics."

Antibiotic overuse has been seen as a major contributor to the rising number of infections that are resistant to these once-powerful weapons, and the IDSA has been among those campaigning for their judicious use.

ILADS supporters point out that diseases such as tuberculosis are treated with long-term antibiotic use and no one questions that treatment's validity and effectiveness.

Although a spectrum of opinions is not unusual in medicine, the issuing of a subpoena is rare when it comes to guidelines. "We have done other investigations of the health care industry, but none, as far as I can recall, having to do with guidelines," Blumenthal said. His inquiry triggered a variety of responses from those closely involved.

"While I don't support in principle the government interfering with medical affairs, I think in this situation, IDSA has so overstepped its bounds and abused its power in promulgating these guidelines that I think there is no other option," said ILADS' Dr. Stricker.

The response from Dr. Auwaerter, an IDSA guideline proponent: "My sense is that [Blumenthal] won't find anything improper."

Dr. Cameron's: "The attorney general's response is in reaction to the frustrations patients are having with getting more attention to the problems of chronic Lyme disease." Dr. Cameron, who was the ILADS panel leader, and lives in Westchester County, N.Y., coincidentally just a few miles from Dr. Wormser, pointed to one study showing that significant numbers of Lyme patients in his area had persistent symptoms.

In general, guidelines continue to have a key place in physicians' toolkits -- a likely reason why this debate has been so intense.

"There is so much data out there that we rely on expert panels to review available evidence and come up with recommendations," said Dr. Auwaerter.

More than 1,800 guidelines are posted under the "disease/condition" heading on the federal National Guideline Clearinghouse Web site. Both IDSA and ILADS guidelines are there. The site gets more than 100,000 visits each month, said Jean Slutsky, MSPH, director of outcomes and evidence at the Agency for Healthcare Research and Quality, the overseeing agency.

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Treating Lyme disease

The National Institutes of Health has posted the following treatment information on its MedlinePlus Web site for Lyme disease:

  • Antibiotics are prescribed based on disease stages and manifestations. Doxycycline, tetracycline, cefuroxime, ceftriaxone and penicillin are some of the choices.
  • Anti-inflammatory medications, such as ibuprofen, are sometimes prescribed to relieve joint stiffness.
  • If diagnosed in the early stages, the disease can be cured with antibiotics. If left untreated, complications involving joints, the heart and the nervous system can occur.

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External links

Centers for Disease Control and Prevention on diagnosis, treatment and prevalence of lyme disease (link)

National Guideline Clearinghouse's list of Lyme disease guidelines, including those of the International Lyme and Associated Diseases Society and the Infectious Diseases Society of America (link)

Infectious Diseases Society of America (link)

International Lyme and Associated Diseases Society (link)

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