Ethics and Lyme Disease is something I have been discussing at length today and so I decided that it was a good day to link into this recent article written by Lorraine Johnson and Raphael Stricker.
IDSA guidelines: A cautionary tale about development of clinical practice guidelines
The Infectious Diseases Society of America Lyme guidelines: a cautionary tale about development of clinical practice guidelines
Lorraine Johnson and Raphael B. Stricker
Philosophy, Ethics, and Humanities in Medicine 2010, 5:9doi:10.1186/1747-5341-5-9
9 June 2010
Flawed clinical practice guidelines may compromise patient care. Commercial conflicts of interest on panels that write treatment guidelines are particularly problematic because panelists may have conflicting agendas that influence guideline recommendations. Historically, there has been no legal remedy for conflicts of interest on guidelines panels. However, in May 2008, the Attorney General of Connecticut concluded a ground-breaking antitrust investigation into the development of Lyme disease treatment guidelines by one of the largest medical societies in the United States, the Infectious Diseases Society of America (IDSA). Although the investigation found significant flaws in the IDSA guidelines development process, the subsequent review of the guidelines mandated by the settlement was compromised by a lack of impartiality at various stages of the IDSA review process. This article will examine the interplay between the recent calls for guidelines reform, the ethical canons of medicine, and due process considerations under antitrust laws as they apply to the formulation of the IDSA Lyme disease treatment guidelines. The article will also discuss pitfalls in the implementation of the IDSA antitrust settlement that should be avoided in the future.
Attorney General Blumenthal’s investigation ‘exposed a deeply flawed process rife with conflicts of interest that improperly excluded alternative views and information’ . The application of antitrust law was based on IDSA’s dominant position in the marketplace and the foreclosure of treatment options for healthcare consumers. IDSA’s response to the guidelines investigation reaffirmed the need for Attorney General Blumenthal to apply antitrust law to insure procedural fairness.
The recent calls for guidelines reform dovetailed with the issues giving rise to the IDSA antitrust investigation. Medical societies have an obligation to acknowledge legitimate controversy in treatment approaches, particularly when the controversy is fueled by a paucity of high-quality evidence. At a minimum, the guidelines issued by a dominant medical society should conform to fundamental rules of due process, fairness, and accuracy. It is critical that the interests of all stakeholders be given a voice, that legitimate controversies be acknowledged, and that treatment options be preserved. The application of antitrust law may provide a much-needed vehicle of
reform to prevent future abuses.
As we have argued elsewhere, the exclusion of competing evidence in treatment guidelines is clinically and ethically unacceptable [74,75]. Failure to disclose treatment options violates the principles of patient autonomy and informed consent, which require that treatment options
should be disclosed to patients and that treatment decisions should be made with the patient’s informed consent . Treatment guidelines should not inhibit patient access to treatment options; rather, guidelines should describe treatment options and default to the clinical judgment
of treating physicians in order to maximize the ability of patients to get well.
I would particularly like to draw attention to page 29 and 30
On February 1, 2010, the Connecticut Attorney General, who was monitoring the panel review process, sent a letter to IDSA that expressed concern over an improper voting procedure adopted
by the panel . The procedure used by the panelists essentially flipped a supermajority voting requirement to make revision of the guidelines less likely. For example, according to the letter by the Attorney General, the panel’s vote on whether laboratory tests, which ILADS contends
are flawed, should be required for a diagnosis of Lyme disease was deadlocked at 4 to 4, indicating that there was no consensus even on a panel that excluded divergent viewpoints .
However, the IDSA panel employed different voting requirements and initially concluded that this vote meant that the guidelines did not require revision. According to the Attorney General, the IDSA panel not only violated the voting procedure stipulated in the settlement agreement, it
also failed to comply with an internal IDSA memo directing the panel on the proper procedure for voting . A copy of the letter from the Attorney General to IDSA and a copy of the internal memo from IDSA to the panel are included as Additional Files 3 and 4 to this article.
On April 22, 2010, the IDSA review panel released its report . Despite the voluminous testimony presented by ILADS, the panel voted almost unanimously to uphold the guidelines without exception. Carol Baker, the panel chair and former president of IDSA, stated that for 69
guideline recommendations the panel found that each was “medically and scientifically justified in light of all the evidence and information and required no revision.” The panel report expressed concern that prolonged use of antibiotics puts patients in danger of serious infection while not
improving their condition. The report stated: "In the case of Lyme disease, there has yet to be a single high-quality clinical study that demonstrates benefit to prolonging antibiotic therapy beyond one month." As to the existence of a chronic persistent form of Lyme disease, the panel
concluded that "symptoms that are commonly attributed to chronic or persistent Lyme, such as arthralgias, fatigue and cognitive dysfunction, are seen in many other clinical conditions and are, in fact, common in the general population. It would thus be clinically imprudent to make the
diagnosis of Lyme disease using these nonspecific findings alone. "
To deal with the testing issue where the panel vote was split, the final report concluded that testing was not a true recommendation and therefore did not fall within the parameters of the settlement agreement . The guideline language at issue states: “Diagnostic testing performed in laboratories with excellent quality-control procedures is required for confirmation of extracutaneous Lyme disease.” Hence, although the panel originally voted on the testing recommendation with a split vote, when pressed to redo the vote in conformity with the agreement, the panel recharacterized the testing requirement as a “statement” that did not
constitute a recommendation. This seemingly transparent attempt to manipulate the vote to ensure a desired outcome, coupled with the exclusion of divergent viewpoints and other process irregularities, show how easy it is for political considerations, such as avoiding legal liability or
protecting organizational reputation, to trump impartial scientific review. The Attorney General's office has announced that it will "carefully and comprehensively assess the final report and the review process leading to that report to determine whether the IDSA fulfilled the requirements of our settlement. "