Connecticut attorney general, IDSA settle Lyme disease case

As part of the settlement, the IDSA will conduct a new review of the Lyme disease guidelines.

The Infectious Diseases Society of America and the Connecticut attorney general’s office have reached a settlement in the landmark case regarding treatment guidelines for Lyme disease. As part of the settlement, the Infectious Diseases Society of America has agreed to conduct a new review of its Lyme disease treatment guidelines, which were published in 2006.

The agreement ends the investigation of the IDSA by Connecticut Attorney General Richard Blumenthal. The agreement does not impose any penalties or fines on the IDSA and does not affect its right to establish guidelines for the treatment of Lyme disease or any other conditions.

“IDSA has agreed to this unique, singular review of our guidelines because the panel will consist solely of physicians and scientists,” Donald Poretz, MD, IDSA president, said in a press release. “We are confident that our guidelines for the diagnosis and treatment of Lyme disease represent the best advice that medicine currently has to offer, as is the case with all of the medical guidelines issued by [IDSA], and we look forward to the opportunity to put to rest any questions about them.”

Shortly after the IDSA Lyme disease guidelines were released in 2006, the Connecticut attorney general’s office announced it would begin an investigation of the IDSA. The investigation was deemed necessary to determine if dissenting views were disregarded when the guidelines were developed and if there were any financial interests among the writers of the guidelines. This marked the first time antitrust allegations have been levied against the development process of a medical society’s guidelines.

There is no relationship between the IDSA and any insurance company, according to an IDSA press release.

The IDSA has indicated that the guidelines were reviewed by nonparticipating clinicians before publication and that the panel carefully considered a wide range of Lyme disease-related evidence submitted by organizations and individuals.

The settlement called for a new panel of physicians to fully review the Lyme disease guidelines. Previous panel members will be excluded from the review. The new panel will hold a live internet broadcast, which will address a range of data related to the disease.

Howard Brody, MD, PhD, director, Institute for the Medical Humanities, and John P. McGovern, professor of family medicine at the University of Texas Medical Branch, will preside over the forum. Brody is a specialist in financial conflicts of interest in medicine who was jointly selected by the office of the attorney general and the IDSA.

The IDSA has agreed to the review under the terms that the present guidelines remain in effect at least until the new panel completes the process. The IDSA hopes that cooperation will resolve the legal issues surrounding the case and put to rest claims that the original panel ignored certain evidence in developing the guidelines.

Currently, the guidelines recommend a short course of antibiotics for nearly all patients with Lyme disease. The guidelines recommend against repeated, long-term antibiotic therapy with brand-name drugs in favor of generic drugs and diagnostic tests, eliminating the possibility of profit for panel members.

Despite the fact that the guidelines are voluntarily followed by physicians, they are sometimes viewed as mandatory. Physicians who have used treatment methods which fall outside of the recommendations, including the use of long-term antibiotic therapy, have faced investigation or sanction by state medical boards, according to a press release. Also, insurance companies have failed to recognize treatment methods that are not stated in the guidelines and have accordingly refused to cover longer-term antibiotic treatment.

Patient groups respond

Members of several Lyme disease patient advocacy groups applauded the outcome of this case.

“The IDSA guidelines are dangerous for patients who suffer long-term Lyme symptoms that do not fall within the IDSA’s narrow disease definition,” Diane Blanchard, co-president of Time for Lyme, an advocacy group for patients with Lyme disease, said in a press release. – by Rob Volansky

PERSPECTIVE

This entire issue (not the settlement but rather the entire investigation) leaves a sour taste in my mouth, and I suspect in all IDSA member’s mouths as well. The temptation is to make the Connecticut Attorney General, Richard Blumenthal, the villain, but that is an oversimplification. He was, unlike Elliot Spitzer, simply doing his job for his constituency, the citizens of Connecticut. Rather, the real villains are the insurance carriers, who happily seized on the guidelines and treated them as rules to deny reimbursement, even to the occasional outlier for whom more extended treatment may have been justified. A guideline is a guideline is a guideline!

Theodore C. Eickhoff, MD

Chief Medical Editor

For more information:

The Infectious Diseases Society of America and the Connecticut attorney general’s office have reached a settlement in the landmark case regarding treatment guidelines for Lyme disease. As part of the settlement, the Infectious Diseases Society of America has agreed to conduct a new review of its Lyme disease treatment guidelines, which were published in 2006.

The agreement ends the investigation of the IDSA by Connecticut Attorney General Richard Blumenthal. The agreement does not impose any penalties or fines on the IDSA and does not affect its right to establish guidelines for the treatment of Lyme disease or any other conditions.

“IDSA has agreed to this unique, singular review of our guidelines because the panel will consist solely of physicians and scientists,” Donald Poretz, MD, IDSA president, said in a press release. “We are confident that our guidelines for the diagnosis and treatment of Lyme disease represent the best advice that medicine currently has to offer, as is the case with all of the medical guidelines issued by [IDSA], and we look forward to the opportunity to put to rest any questions about them.”

Shortly after the IDSA Lyme disease guidelines were released in 2006, the Connecticut attorney general’s office announced it would begin an investigation of the IDSA. The investigation was deemed necessary to determine if dissenting views were disregarded when the guidelines were developed and if there were any financial interests among the writers of the guidelines. This marked the first time antitrust allegations have been levied against the development process of a medical society’s guidelines.

There is no relationship between the IDSA and any insurance company, according to an IDSA press release.

The IDSA has indicated that the guidelines were reviewed by nonparticipating clinicians before publication and that the panel carefully considered a wide range of Lyme disease-related evidence submitted by organizations and individuals.

The settlement called for a new panel of physicians to fully review the Lyme disease guidelines. Previous panel members will be excluded from the review. The new panel will hold a live internet broadcast, which will address a range of data related to the disease.

Howard Brody, MD, PhD, director, Institute for the Medical Humanities, and John P. McGovern, professor of family medicine at the University of Texas Medical Branch, will preside over the forum. Brody is a specialist in financial conflicts of interest in medicine who was jointly selected by the office of the attorney general and the IDSA.

The IDSA has agreed to the review under the terms that the present guidelines remain in effect at least until the new panel completes the process. The IDSA hopes that cooperation will resolve the legal issues surrounding the case and put to rest claims that the original panel ignored certain evidence in developing the guidelines.

Currently, the guidelines recommend a short course of antibiotics for nearly all patients with Lyme disease. The guidelines recommend against repeated, long-term antibiotic therapy with brand-name drugs in favor of generic drugs and diagnostic tests, eliminating the possibility of profit for panel members.

Despite the fact that the guidelines are voluntarily followed by physicians, they are sometimes viewed as mandatory. Physicians who have used treatment methods which fall outside of the recommendations, including the use of long-term antibiotic therapy, have faced investigation or sanction by state medical boards, according to a press release. Also, insurance companies have failed to recognize treatment methods that are not stated in the guidelines and have accordingly refused to cover longer-term antibiotic treatment.

Patient groups respond

Members of several Lyme disease patient advocacy groups applauded the outcome of this case.

“The IDSA guidelines are dangerous for patients who suffer long-term Lyme symptoms that do not fall within the IDSA’s narrow disease definition,” Diane Blanchard, co-president of Time for Lyme, an advocacy group for patients with Lyme disease, said in a press release. – by Rob Volansky

PERSPECTIVE

This entire issue (not the settlement but rather the entire investigation) leaves a sour taste in my mouth, and I suspect in all IDSA member’s mouths as well. The temptation is to make the Connecticut Attorney General, Richard Blumenthal, the villain, but that is an oversimplification. He was, unlike Elliot Spitzer, simply doing his job for his constituency, the citizens of Connecticut. Rather, the real villains are the insurance carriers, who happily seized on the guidelines and treated them as rules to deny reimbursement, even to the occasional outlier for whom more extended treatment may have been justified. A guideline is a guideline is a guideline!

Theodore C. Eickhoff, MD

Chief Medical Editor

For more information: