On May 1, Connecticut Attorney General (AG) Richard Blumenthal announced that an antitrust investigation conducted by his office had “uncovered serious flaws” in the development of Lyme disease guidelines issued by the Infectious Diseases Society of America (IDSA) in 2006. Under an agreement between the AG and the IDSA, the guidelines remain in effect but the IDSA will convene a panel to reassess them with the help of an outside arbiter.
“My office uncovered undisclosed financial interests held by several of the most powerful IDSA panelists,” Blumenthal said in a press release. “The IDSA’s guidelines panel improperly ignored or minimized consideration of alternative medical opinion and evidence regarding Lyme disease, potentially raising serious questions about whether the recommendations reflected all relevant science.”
However, in a press release issued by the IDSA, President Donald Poretz, MD, said the organization “has agreed to this unique, singular review of our guidelines because the panel will consist solely of physicians and scientists. We are confident that our guidelines for the diagnosis and treatment of Lyme disease represent the best advice that medicine currently has to offer … and we look forward to the opportunity to put to rest any questions about them.”
Point …
According to the AG’s office, the investigation of the IDSA Lyme disease guideline development process revealed conflicts of interest among panel members. Though unspecified, these included financial interests in “drug companies, Lyme disease diagnostic tests, patents, and consulting arrangements with insurance companies.”
The AG’s office contends that the IDSA “failed to conduct a conflicts of interest review for any of the panelists prior to their appointment to the 2006 Lyme disease guideline panel.” Furthermore, the organization “failed to follow its own procedures for appointing the 2006 panel chairman and members, enabling the chairman, who held a bias regarding the existence of chronic Lyme, to handpick a like-minded panel without scrutiny by or formal approval of the IDSA’s oversight committee.”
Blumenthal’s investigative team also concluded that the IDSA’s panels for both the 2000 and 2006 Lyme disease guidelines “refused to accept or meaningfully consider information regarding the existence of chronic Lyme disease.” The AG’s office alleges that the IDSA panel in 2000 went so far as to remove a panelist with a dissenting viewpoint, in order to “achieve consensus,” and that they “blocked appointment of scientists and physicians with divergent views on chronic Lyme who sought to serve on the 2006 guidelines panel by informing them that the panel was fully staffed, even though it was later expanded.”
Noting the “tremendous influence” that clinical practice guidelines may have on treatment decisions and reimbursement, Blumenthal said, “Medical societies that publish such guidelines have a legal and moral duty to use exacting safeguards and scientific standards.
“Our investigation was always about the IDSA’s guidelines process—not the science,” he added. “IDSA should be recognized for its cooperation and agreement to address the serious concerns raised by my office.”
… Counterpoint
The IDSA, however, said it has voluntarily entered into the agreement with the AG “in an effort to clear the air.” The organization counters the AG’s “unfounded” allegations about its guideline development process and points out that no charges or formal complaints have been filed, nor any fines imposed.
The IDSA “strongly disagrees” with the AG’s conclusion that members of the Lyme disease guideline panel had significant conflicts of interest that would have affected, or been affected by, the recommendations made. “Panel members do not stand to profit from any recommendation in the guidelines,” according to the IDSA’s press release. “In fact, the panel members denied themselves and their colleagues an opportunity to generate a significant amount of revenue when they recommended against expensive, repeated, long-term antibiotic therapy.
In the case of the 2000 panel member with the dissenting opinion, the IDSA says that individual “voluntarily stopped participating. He was not removed from the panel, as the Attorney General has alleged.” The IDSA also stands behind its “rigorous, multilevel review and approval process” for guideline development.
Terms of the Agreement
Under the agreement between the AG and the IDSA, the organization will create a review board of eight to 12 members, none of whom served on the 2006 Lyme disease guideline panel. Panel members will be screened by an ombudsman specially selected for the purpose by the IDSA and the AG: Howard A. Brody, MD, PhD, a recognized expert on medical ethics and conflicts of interest.
To ensure that the panel obtains and considers divergent viewpoints, an open hearing will be conducted, at which interested parties can present relevant medical and scientific information. The hearing will be broadcast live to the public on the IDSA’s Web site (www.idsociety.org).