Magazine article Drug Topics

Lyme Disease Guidelines Spark Controversy

Magazine article Drug Topics

Lyme Disease Guidelines Spark Controversy

Article excerpt

Last fall, the Infectious Diseases Society of America (IDSA) released updated guidelines for the diagnosis and treatment of Lyme disease. (See Drug Topics, Nov. 20, 2006, "Updated Lyme disease guide clarifies confusion," p. 25.) Approximately one month later, Connecticut attorney general Richard Blumenthal issued a Civil Investigative Demand (CID) to look into possible antitrust violations by IDSA in connection with exclusionary conduct and monopolization in the development of its Lyme disease guidelines.

Said Blumenthal, "We are concerned about the potential anticompetitive implications of guidelines that preclude certain forms of diagnosis and treatment, particularly if they interfere with insurance coverage." The national, nonprofit Lyme Disease Association (LDA) said in a statement that it applauded Blumenthal for beginning an investigation into IDSA's guidelines development process.

The LDA and the International Lyme and Associated Diseases Society (ILADS) have also called for a retraction of the IDSA guidelines. As Pat Smith, president of the LDA, explained, "The IDSA guidelines are extremely restrictive. They say that certain alternative treatments such as intravenous immunoglobulin, certain antibiotics, and even entire classes of antibiotics should not be used to treat Lyme disease. The guidelines also do not recommend prolonged antibiotic therapy. Well, these are the therapies that Lyme docs are using. Patients often use alternative therapies in addition to their regular antibiotic therapy."

Raphael Stricker, M.D., president of ILADS and a practicing physician in San Francisco, agreed, pointing out that the availability of a variety of treatment options is necessary because "Lyme disease is a very complex illness, and it is very difficult to treat, especially in the chronic form.

"Pharmacists need to consider that patients may need alternative treatments that are very useful yet not recommended by IDSA," Stricker said. "We have heard from patients who have taken their prescriptions to the pharmacy, where they have been asked by the pharmacist, 'Why did your doc prescribe this? The IDSA guidelines do not recommend that drug,'" Stricker said.

The guidelines also advocate the use of very narrow diagnostic criteria, Smith said. She stated that "IDSA has said physicians must diagnose Lyme disease based either on the presence of an Erythema migrans lesion, which occurs in approximately 50% of patients, or positive '2-step' serology-a positive ELISA followed by a positive Western blot. …

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