About Practice Guidelines

Practice guidelines and statements developed and/or endorsed by the IDSA are prepared to assist practitioners in making decisions about appropriate diagnosis and management of specific clinical conditions. Recent clinical guidelines have included topics such as appropriate antimicrobial agent use, infections of organ systems, and infections due to specific organisms, as well as general topics of importance (e.g., prevention and management of catheter-related infections, opportunistic infections in stem cell transplant recipients, and travel medicine). As new information becomes available, guidelines are updated to provide the most useful and current recommendations. The 2006 practice guidelines for management of Lyme disease [1] replaced a 2000 guideline [3]. The authors are chosen by a guideline committee on the basis of expertise in the subject. The content is evidence based, and recommendations are graded with use of criteria for strength of recommendation and quality of evidence.

Why Did the AG Challenge the Lyme Disease Guideline?

The AG acts as the chief law enforcement officer of the state and has the authority to enforce the Connecticut Antitrust Act. The motivation of the AG in bringing this action against the IDSA appears to be a response to the concerns of Lyme disease advocacy groups in Connecticut that the IDSA guideline raised doubts about the diagnosis of “chronic Lyme disease”; and discouraged long-term antibiotic therapy. A press release from the office of the AG noted that the IDSA guidelines “have sweeping and significant impacts on Lyme disease medical care. They are commonly applied by insurance companies in restricting coverage for long-term (>90 days) antibiotic treatment or other medical care and also strongly influence physician treatment decisions–….–The guidelines are also widely quoted for conclusions that chronic Lyme disease is nonexistent”; [4]. The statement from the office of the AG was correct; the guideline concluded that “There is no convincing biologic evidence for the existence of symptomatic chronic Borrelia burgdorferi infection among patients after receipt of recommended treatment regimens for Lyme disease. Antibiotic therapy has not proven to be useful and is not recommended for patients with chronic (>6 months) subjective symptoms after recommended treatment regimens for Lyme disease”; [1, p. 1094].

Response of the Officers of the IDSA to the Requirements of the AG

The officers of the society responded to the subpoena and provided the appropriate documents. Legal counsel was provided to the officers and to the authors of the guideline. By the spring of 2008, the society had incurred more than $250,000 in legal fees, and there was no certainty that continued defense of the guideline would be upheld in a state court (D. Poretz, personal communication). Rather than continue to spend time and money to defend the guideline, the officers of the society entered into an agreement that ended the Lyme disease investigation by the Connecticut AG.

An Agreement Between the IDSA and the AG

The agreement on 30 April 2008 between the AG and the IDSA noted that the AG had conducted an antitrust investigation of the IDSA relating to its development and promulgation of clinical practice guidelines for the treatment of Lyme disease. The AG contended that his investigation had uncovered certain significant procedural deficiencies related to the IDSA's development of its 2006 guideline. In response, the IDSA contended that it developed the 2006 Lyme disease guidelines on the basis of a proper review of the medical and scientific evidence by a panel of experts in the prevention, diagnosis, and treatment of Lyme disease.

The IDSA agreed to an action plan, including recruiting a review panel whose task will be to determine whether the 2006 Lyme disease guideline should be revised or updated. The IDSA will select a chairperson of the review panel who “must not have previously published a particular viewpoint regarding Lyme disease diagnosis or treatment”; and “must be knowledgeable about the subject of Lyme disease but not necessarily an expert”; [5, p. 2]. The review panel of 8–12 panelists who were uninvolved with prior Lyme disease guidelines will conduct a comprehensive search and retrieval of the medical and scientific literature. The review panel will conduct an open public hearing to offer a forum for the presentation of relevant written or oral data on the topic of Lyme disease. All public stakeholders may apply to make an oral presentation. The office of the AG and the IDSA will jointly select an ombudsman whose duties will include reviewing the chairperson selection, determining that applicants for the review committee have no conflicts of interest, working with the review panel to determine presenters at the open public hearing, and having a role in the vote of the committee. The last responsibility of the ombudsman is vague: “the review panel chairperson is to manage any vote on any key finding or recommendation and report such vote to the ombudsman”; [5, p. 4].

In accordance with the agreement, the review panel “shall be to make an individual determination whether each of the recommendations in the 2006 guideline is medically/scientifically justified in light of all of the evidence and information provided”; [5, p. 4]. The review panel may choose 1 of the 3 following options: (1) no changes in the 2006 guidelines are necessary; (2) there is need for sectional revision, in which case, the panel will propose revisions; or (3) a complete rewriting of the 2006 guideline is required. The recommendations of the review panel are binding on the IDSA.

Danger Ahead

The intrusion of an officer of the state into the business of a professional society is cause for concern. The AG is not only protector of the rights and needs of citizens of Connecticut but is also a politician and elected official who responds to the interests of constituents and advocacy groups. In the press release related to the agreement, Blumenthal stated, “This agreement vindicates my investigation–finding undisclosed financial interests and forcing a reassessment of IDSA guidelines”; [4]. No specific information was provided about the financial interests or the nature of the purported bias. The public has become wary of associations of medical consultants and the pharmaceutical or vaccine industries, and the use of vague terms such as “undisclosed financial interests”; may be accepted as valid without evidence of bias. In recent months, pharmaceutical companies and scientists have been criticized for increasing the frequency of use and extending the duration of drug therapy; in contrast, the Lyme disease guideline recommended restricting duration of treatment. The AG's press release stated, “The IDSA's Lyme guideline process lacked important procedural safeguards. The panel improperly ignored or minimized consideration of alternative medical opinion and evidence regarding chronic Lyme disease”; [4]. This statement is incorrect. The guideline carefully reviewed evidence for the diagnosis of “chronic Lyme disease”; and concluded that the diagnosis was frequently made for patients with vague symptoms. We know that there are and will always be “alternative medical opinions,”; and the purpose of a guideline is to weigh the evidence for validity, reliability, and reproducibility and to provide the best opinion.

The action of the AG against the IDSA should raise concern for all medical and scientific groups that issue practice recommendations or guidelines. The door is open to any constituency that feels it was not adequately represented in the process of developing the recommendations. If an AG can undermine evidence-based guidelines on the basis of dissenting views of medical and nonmedical advocacy groups, then every guideline for management of a disease or condition presented by any medical organization is at risk of challenge. For example, an antivaccine group could request action by federal or state officials to bring an action against organizations that provide guidelines for pediatricians or family physicians or even against the Advisory Committee on Immunization Practices. The threat of suit may have a chilling effect on the recruitment of experts to participate in guidelines that are likely to be controversial.

The agreement included additional areas of concern, including the perception that the 2006 guidelines were deficient in the selection of authors and that review of the recommendations is warranted, that a public forum is necessary to provide alternative views of management, and that an ombudsman should have a role in the review process. First, the agreement requires a panel of general infectious diseases physicians or other specialists to review the guideline prepared by experts who have devoted all or much of their clinical and investigative careers to the study of Lyme disease. Second, a public forum to provide opportunity for presentation of alternative viewpoints may be a reasonable step to take at the time of the initial development of selected guidelines but not after the guideline has been published and concern has been raised among advocacy groups. The Institute of Medicine holds public hearings at the initiation of reviews [6], and such a hearing should be considered by the IDSA for possible use in development of future guidelines. Third, the requirement that an individual–the ombudsman–who is not a member of the IDSA and who is without infectious diseases expertise should review the process established by the society appears to be an intrusion into the business and responsibility of the IDSA. An ombudsman has been chosen by the AG and agreed to by the IDSA: Dr. Howard Brody, Professor of Family Medicine and Director of the Institute for the Medical Humanities at the University of Texas Medical Branch. Dr. Brody is a member of the Institute of Medicine and is the author of articles on medical ethics and the philosophy of medicine; he recently published a text on the ethical and political implications of the relationship between the medical profession and the pharmaceutical industry [7].

Did the Officers of the IDSA Act Appropriately in Agreeing to the Action Plan?

The IDSA does not have deep pockets. Prolonged litigation would be costly without certainty of the outcome. Although the features of the agreement may be questioned and concern may be raised about accommodating the intrusion of a public official into the responsibilities of a professional society, the agreement has been solidified, and there is little value in carping about the decision of the officers of the IDSA to end the litigation. None of the features imposed by the action plan detract from the responsibility of the IDSA to develop practice guidelines prepared by the most knowledgeable experts weighing the most complete evidence available and providing recommendations for health care workers that guide optimal diagnosis and management for the benefit of patients. It is possible that the agreement sets a precedent for politicians representing the views of aggrieved constituents to challenge the recommendations and guidelines of professional societies. The action plan must be considered as a work in progress, and the proceedings must be monitored to assure that the process and the science are not subverted by advocacy groups or their political representatives.