In the Lymelight: Law and Clinical Practice Guidelines

Susan J.D. Ronn

Disclosures

South Med J. 2009;102(6):626-630. 

In This Article

Law in the Lymelight

Enter Connecticut Attorney General (AG) Richard Blumenthal. His office filed a Civil Investigative Demand (CID) on IDSA, under antitrust laws, and conducted an investigation. The AG represents the people in civil legal matters to protect the public interest, and therefore has the authority to enforce the state's antitrust statute and portions of federal antitrust laws as well. Blumenthal invoked antitrust laws because the guidelines have the potential to place a restraint on physician and patient treatment decisions and restrict insurance company payments. If the guidelines supplant competing forms of diagnosis and treatment, antitrust principles prohibiting restriction of competition and monopoly apply. Under the law, the process of setting guidelines must therefore be open, fair, and unbiased.

The AG's investigation found serious flaws with IDSA's process in developing the 2006 guidelines. Blumenthal stated, The IDSA's 2006 Lyme disease guideline panel undercut its credibility by allowing individuals with financial interests - in drug companies, Lyme disease diagnostic tests, patents and consulting arrangements with insurance companies - to exclude divergent medical evidence and opinion.[1] His findings include: IDSA did not conduct a conflict of interest review for its panel, and several panelists had conflicts of interest; IDSA did not follow its own procedures for appointing the panel chairman and its members, which allowed a like-minded panel (holding a bias regarding the nonexistence of chronic Lyme) to be assembled; the panel did not consider information regarding the existence of chronic Lyme disease and blocked inclusion of scientists and physicians with divergent views; and IDSA portrayed the AAN's Lyme disease guidelines as corroborating its own, when it knew the two panels shared several guideline authors, thus violating IDSA's own conflicts of interest policy.

The AG and IDSA entered into a legal agreement. The agreement requires a new panel of experts to re-evaluate the guidelines, and aims to ensure a fair process. Key points include:[17]

  • By entering into the agreement, the AG resolves the investigation and any claims against IDSA arising prior to the agreement. It does not, however, release IDSA from claims arising after the date of the agreement. The AG has the power to enforce the agreement, and, if its authority is inadequate, IDSA consents to the jurisdiction of the Connecticut Superior Court.

  • An ombudsman will work to ensure a conflict-of-interest-free panel of 8-12 members and a chairperson, who must be trained in infectious diseases. The AG and IDSA appointed as ombudsman Dr. Howard Brody, an expert and author on medical ethics and conflicts of interest.

  • A review panel, consisting of all new members, will decide whether the 2006 guidelines should be revised or updated. The panel must reflect a balanced variety of perspectives and experience across a broad range of relevant disciplines, and must include at least one physician with clinical experience treating Lyme disease.

  • Data collection will include a comprehensive search and retrieval of all medical and scientific literature, and IDSA must post a link on its website in order to collect input from individuals and organizations.

  • There will be an open public hearing to collect data, which must be broadcast live on IDSA's website.

  • The review panel will make a determination regarding whether each recommendation of IDSA's 2006 guidelines is medically/scientifically justified in light of all evidence and information provided.

  • Overall voting will be made public, although the individual's votes will remain private. Recommendations require a 75% supermajority and may include:

    • No changes necessary to 2006 guidelines.

    • Sectional revisions required; in this case, the panel will make proposals, which will be considered and implemented by IDSA.

    • A complete rewriting is required; in this case, IDSA must convene a guideline panel consistent with the terms of the agreement and their own guidelines.

  • The recommendations of the review panel are binding, and a link to the final report must be posted on IDSA's website for one year.

IDSA agreed to the review because the panel will be made up of physicians and scientists.[18] The AG stated his investigation was always concerned with process, not science. And ILADS applauded the effort to ensure a conflict-free review.[19]

On January 26, 2009, IDSA announced the new guidelines panel.[20] Since this announcement, a flurry of activity has taken place. One of the panelists on the original list was removed, leaving a nine-member panel.

Three patient-advocate groups and a Congressman issued a press release, voicing concern and disappointment, and calling the new panel unbalanced and biased. In particular, the concern centers on the exclusion of any physician making over $10,000 treating Lyme disease, which was considered a conflict of interest by the ombudsman. The parties argue that excluding the viewpoint of all physicians who treat chronic Lyme creates a bias in the new panel.[21]

IDSA opened the 60-day public input period required by the agreement. IDSA also announced April 27 as the date for the open public hearing, held in the Washington, DC area.[22]

And, in the same week, a Lyme bill introduced in the Connecticut House of Representatives was scheduled for public hearing. The bill states that no physician who prescribes long-term antibiotics for Lyme disease patients may be subjected to disciplinary action solely on that basis.[23]

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