Lyme treatment accord ends antitrust probe

Contentious issues remain over long-term versus short-term antibiotic use and whether this condition can be chronic.

By — Posted June 9, 2008

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An April 30 agreement with the Connecticut Attorney General's Office has ended an antitrust investigation into the Infectious Diseases Society of America's development of its 2006 Lyme disease guidelines.

The arrangement calls for IDSA, which has 8,000 members, to convene a new, independent panel to review the evidence and determine whether its guidelines should be revised. An ombudsman has been appointed to oversee the process. The society's treatment guidelines, meanwhile, will remain in effect.

This understanding was reached without the filing of a complaint, any court findings against IDSA or any admission of wrongdoing.

The areas of medical contention that gave rise to the investigation center on whether the disease, which is transmitted by ticks, is chronic or acute, and how long antibiotics should be used in its treatment. IDSA's guidelines characterize the disease as primarily acute and recommend treatment with, at most, a few weeks of antibiotics. The recommendation is similar to that of the Centers for Disease Control and Prevention.

Others, including several patient groups and the International Lyme and Associated Diseases Society, or ILADS, which has between 200 and 300 members, believe that long-term treatment with antibiotics for more than 30 days may be necessary for some patients with persistent and severe joint pain and fever, which has been called chronic Lyme disease or post-Lyme syndrome.

Connecticut Attorney General Richard Blumenthal said his investigation had uncovered "serious flaws in the IDSA process" for writing guidelines, adding that the panel that drafted the guidelines had ignored or minimized consideration of alternative medical opinion and evidence.

"The IDSA guidelines have sweeping and significant impacts on Lyme disease medical care," Blumenthal said. Insurers, relying on the IDSA guidelines for justification, have denied coverage for long-term antibiotic treatment, he said.

IDSA President Donald M. Poretz, MD, said he was confident that his society's guidelines represent the best medical advice and that he looked forward to the "opportunity to put to rest any questions about them."

IDSA agreed to the review because it will be conducted solely by physicians and scientists, Dr. Poretz said in a letter to his members.

Dr. Poretz noted that IDSA already had incurred considerable expense and likely would have incurred hundreds of thousands of dollars more had the investigation continued. "While we were prepared to defend in court any claim that the Connecticut Attorney General might bring and were confident that we ultimately would have prevailed, we concluded that ending the investigation at this stage is in the best interests of IDSA, our members and our patients," he wrote.

Blumenthal said his investigation had uncovered "undisclosed financial interests held by several of the most powerful IDSA panelists." But he declined to name the panelists or their financial interests, saying the "failure was institutional" rather than individual.

Some panelists had acknowledged in the 2006 guidelines that they had received grants and consulting fees from a firm working on a new Lyme vaccine and another that markets a test for the disease. But last month the panelists denied that they had benefited financially from the guidelines, noting in a May 19 statement, "Apparently the panel was accused of profiting financially by recommending to not treat with unnecessary and prolonged courses of antibiotics."

Dr. Poretz also dismissed the notion that any 2006 panelists had relevant conflicts of interest. "Furthermore, the guidelines (like all IDSA guidelines) were subjected to a rigorous, multilevel review and approval process. We stand by our 2006 guidelines panel, and we believe they reached the right conclusion," he wrote.

ILADS President Daniel J. Cameron, MD, MPH, who led the development of his group's guidelines, would like physicians to have the choice of a longer term of antibiotics when treating Lyme patients. Many patients referred for intravenous antibiotic treatment lasting longer than four weeks are denied coverage by their insurers, Dr. Cameron said.

"IDSA has been seen as a powerful organization based on their leadership in AIDS and other diseases," he said. "The hope is that with this increased publicity and attention, the public and physicians will see that IDSA has a narrow and limited view of Lyme disease that is open to question."

The agreement requires that members of the new review panel should not have helped to develop previous recommendations and guidelines, said Thomas M. File Jr., MD, chair of IDSA's Standards and Practice Guidelines Committee. A public hearing also will be required. No dates have been set for the review, Dr. File said, but they will be posted on the IDSA Web site.

Paul G. Auwaerter, MD, clinical director of the Johns Hopkins School of Medicine's Division of Infectious Diseases, IDSA member and a reviewer of its 2006 guidelines, said the investigation already had cast a shadow over treatment of Lyme disease. "I have observed among infectious diseases fellows that they don't want to see these [Lyme] patients." Emotions run high over the illness's treatment, he said. "It has become a poisonous atmosphere."

Dr. Auwaerter added that many researchers who began work on Lyme disease in the 1970s are now retiring and that younger physicians aren't stepping up to replace them, saying AIDS and tuberculosis are now the more "sexy" infectious diseases.

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How the review of IDSA guidelines will be handled

In concluding an antitrust investigation against the Infectious Diseases Society of America, Connecticut's attorney general crafted an "action plan" that the society has agreed to follow in reviewing its 2006 Lyme disease guidelines. Among its provisions:

  • IDSA shall convene an eight- to 12-member review panel, none of whose members will have served on any previous Lyme disease guideline panel.
  • Howard Brody, MD, PhD, medical ethicist and director of the Institute for the Medical Humanities at the University of TexasMedical Branch at Galveston, shall serve as ombudsman and oversee the review process.
  • All applicants for the review panel shall disclose their financial relationships and competing interests.
  • An open public hearing shall be held to provide a forum for presentation of relevant written or oral evidence on Lyme disease. The hearing also will be broadcast live on IDSA's Web site.
  • The review panel's main function shall be to determine whether each recommendation in the 2006 guidelines is both medically and scientifically valid in light of the evidence provided.

Source: "Infectious Diseases Society of America Action Plan Requirements," Connecticut Attorney General's Office, April 30

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