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Should Medical Guidelines Be on Trial?: Neurology Responds to an Unsettling Settlement


doi: 10.1097/01.NT.0000326353.90935.b9

Just what role should government play in setting medical policy? For neurologists and legal staff at the AAN, that is the question — still unresolved — by a legal case that pitted an Attorney General's office in Connecticut against a major medical society, the Infectious Disease Society of America (IDSA).

The issue: Did the IDSA guidelines — suggesting that the medical evidence did not support prolonged antibiotic treatment for Lyme disease — amount to restraint of trade because third-party payers were relying on the guideline to deny reimbursement for the therapy?

On May 1, the Attorney General, Richard Blumenthal, announced a settlement between his office and the IDSA, in which the medical association agreed to create a review panel “to thoroughly scrutinize the 2006 Lyme disease guidelines and update or revise them if necessary.” This ended an investigation began in November 2006.



As part of the investigation into the IDSA, the Attorney General subpoenaed documents from the AAN to learn how its guidelines for Lyme disease were developed and to look at the AAN's relationship to the IDSA. The AAN was never a target of the investigation, which was reported in Neurology Today. (Visit for “Guidelines on Trial: AAN Subpoenaed as Part of Investigation into Treatment Parameters for Lyme Disease,” Oct. 16, 2007.)

Patients and physicians who believe that administration of long-term intravenous antibiotics provide beneficial therapy for post-Lyme syndrome requested and lobbied for the investigation. Their position is supported by guidelines of the International Lyme and Associated Disease Society (ILSDA). They claimed that their insurance companies were denying them coverage for antibiotic treatment beyond 30 days based on the IDSA guidelines, which cited evidence of no benefit to prolonged antibiotic treatment. They further held that by limiting options of medical practitioners' use of long courses of antibiotics to treat Lyme disease, the guidelines constituted an antitrust violation.

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A settlement in a case related to Lyme disease guidelines by the Infectious Disease Society of America raises questions about the role that the government should play in establishing medical policy.

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No reference to the antitrust charge appeared in the settlement, AAN General Counsel Murray Sagsveen pointed out in a telephone interview with Neurology Today. However, the agreement states that the Attorney General's office found some procedural irregularities and outlined a plan to correct them. “I question the Attorney General's jurisdiction to get involved in the internal processes of an association developing its own guidelines,” Sagsveen said. “State officials have only the authority that is authorized by statute, and I am unaware of any statute authorizing an Attorney General to investigate an association for alleged non-compliance with its own processes.”

A May 1 news statement from Blumenthal's office stated the investigation revealed flaws in the IDSA Lyme disease guideline process, including conflicts of interests among the panelists who created the guidelines. Although Blumenthal disclosed neither specific panelists nor their alleged conflicts of interest, he told Neurology Today in a telephone interview that “they generally consisted of consulting fees, ownership of stocks in affected companies, patent interests, general overall financial interests that were undisclosed, and at the very least, created an appearance of conflicts of interests.” He also claimed that some of the panel members had consulting arrangements with one or more insurance companies.



In response to the settlement, the IDSA strongly denied the Attorney General's charges of conflict of interest and exclusion of competing viewpoints. In its own news release, the IDSA said it agreed to the guidelines settlement “to put to rest any questions about them.”

“I would like to see what conflicts the Attorney General is talking about, and whether they were an issue,” commented Jacqueline French, MD, professor of neurology at the New York University School of Medicine, who co-chairs the AAN Quality Standards Committee with Gary Gronseth, MD. She is concerned the conflict of interest issue may have been used inappropriately.

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The original charge represented a misinterpretation of the nature of guidelines, according to John J. Halperin, MD, lead author of the AAN treatment guidelines for Lyme disease, and a member of the IDSA treatment guidelines panel. “All guidelines are summaries of the available evidence, to provide guidance to clinicians — but they never mandate a specific course of action,” he explained. “The IDSA Lyme disease guideline similarly did not mandate anything, but rather reviewed all available data and offered recommendations based on this analysis.”

Dr. French agrees that guidelines are sometimes inappropriately taken as absolute truth, even though they most often result from a combination of evidence-based data and consensus. “The AAN tries to avoid consensus-based guidelines wherever possible,” she said. “Nevertheless, at the end of the day, no matter how evidence-based they may be, the clinician has to assess whether the clinical trials do in fact address a specific patient or population and that always involves a little bit of a value judgment.”

She also believes it is completely appropriate for people to review and question results of guidelines. “Obviously patients are going to have concerns about guidelines because they are not always going to like what they say,” she explained. In general guidelines are patient-friendly, she said, although occasionally a medical society may determine there is no evidence that a certain treatment or device is effective, and some desperate patients will want to be able to access that therapy or device. “Clearly, we don't want to see the day when disappointed patients go to a government agency to fight it every time that occurs,” she said.

Sagsveen, of the AAN, challenged the Attorney General's claim of an improper connection between IDSA and the AAN in the development of Lyme disease guidelines. “Both societies develop their own guidelines and there are members of the AAN who are also members of the IDSA. These people are experts in their fields. The Attorney General seems to allege that this is inappropriate, whereas we believe, as do several federal agencies, that having fewer guidelines on the same issue is better because it tends not to confuse the practitioner. If the practitioner is working with Lyme disease and one organization says one thing and another says another, that's confusing. But if you have several organizations collaborating and saying the same thing, that provides a good public service,” he explained.



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So, is the recent case a cause for concern? Dr. French contends that government involvement in guidelines is not advisable, particularly if people from the government agency don't understand the guidelines development process or are not content or guideline experts. “Hopefully this case is an isolated situation,” she commented.

Dr. Halperin added: “This case had the potential to be an earthquake but so far has been more a thunderstorm.” He fears the case will have some chilling effect, however — that some very busy people will think twice about dedicating many hours of their time to guideline development.

“I think people will be a little more cautious about getting involved in the guideline process,” he said. “The threat of becoming involved in political and legal proceedings, and of being personally maligned by individuals who disagree with the conclusions, will certainly inhibit the sense of volunteerism essential for this process.”

Dr. Halperin is also concerned that the settlement will be viewed as a precedent. From the IDSA perspective, a review of the 2006 guidelines was due about this time anyway. But the review will be perceived somewhat differently this time because of the appearance that it is occurring in response to political forces, not by any new medical evidence. He believes and hopes that this case was a fairly unique political situation, “but the precedent is now out there and that's more than a little bit worrisome to anyone who works on guidelines.”

As for the AAN, Dr. French emphasized that the Academy has very strict policies in place related to conflict of interest. Any potential conflicts are open to the public to review and the AAN tries to balance its panels so particular conflicts of interest will not be a concern for the majority of the panel. “You can't eliminate conflicts of interest,” she said. “For example, if you eliminate everybody who performs a certain procedure, you won't have anybody on your panel who fully understands that procedure, even though you want them to be part of your panel.”

Dr. French said the full implications of the settlement will not become clear until the IDSA has concluded its second reassessment. “Some people feel that the IDSA guideline process was done in a very reasonable and forthright manner, and predict that the society will come up with the same conclusions it did in 2006. This will be a victory for the IDSA. Others feel the Blumenthal was able to change the process from what it would have been and this is a victory for the Attorney General and the patients who went to him to initiate the suit. If the practice parameters and recommendations are changed I think it would be a bad thing for evidence-based practice parameters and guidelines developed by medical societies because I don't believe there was any reason for interference in this case,” she concluded.

©2008 American Academy of Neurology