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".) 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."
"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."
Smith estimated that 50% of patients with Lyme disease are not being diagnosed because they do not meet these criteria. She mentioned that the criteria are based on Centers for Disease Control & Prevention surveillance criteria, which the CDC has said are to be used for surveillance purposes only.
"So many patients are not being expediently diagnosed and treated, which means that they will likely go on to develop chronic disease, or those who have been diagnosed with chronic disease may no longer be able to get any kind of treatment," said Smith. She went on to explain that, because clinical guidelines now drive the standard of care in this country, they are being adopted by insurance companies and state agencies, which cite them as the reason for denying treatment. Even the CDC is promulgating them, said Smith.
Contacted for comment, an IDSA spokeswoman said that the organization is cooperating fully with the Connecticut attorney general's investigation. In addition, Gary Wormser, M.D., lead author of the IDSA guidelines, said that "ILADS had plenty of opportunity for input. As a matter of fact, Stricker was invited to address the IDSA annual meeting to discuss why he disagreed with the guidelines."
As Wormser explained, "We certainly considered Dr. Stricker's viewpoint. We even mentioned in the guidelines that we considered long-term antibiotic therapy as an option. When the IDSA first published Lyme disease guidelines in 2000, we did not recommend prolonged antibiotic therapy. Then between 2000 and 2006, several studies came out to corroborate that long-term therapy was not beneficial in treating Lyme disease, so we did not change our recommendation at this time.