In May 2008, the IDSA agreed to re-evaluate its guidelines as part of the settlement agreement for an antitrust investigation by the Attorney General of Connecticut, which found significant conflicts of interest on the original panel, suppression of scientific evidence, and exclusion of panel members with opposing viewpoints. This is the first time a guidelines panel has been forced to re-examine its guidelines under antitrust law.

In May 2008, the IDSA agreed to re-evaluate its guidelines as part of the settlement agreement for an antitrust investigation by the Attorney General of Connecticut, which found significant conflicts of interest on the original panel, suppression of scientific evidence, and exclusion of panel members with opposing viewpoints. This is the first time a guidelines panel has been forced to re-examine its guidelines under antitrust law.

Settlement process timeframe and phases.

The entire re-evaluation process is expected to between 8-12 months and has three phases:

1. the selection of the chair and the panel (see above)
2. the internal collection of scientific evidence and call for submissions of scientific evidence from the public
3. the public hearing of the evidence, which will be aired live on the Internet.

Panel selection.

The IDSA must convene a new panel to determine whether contested recommendations need to be revised. The new panel will have between 8 and 12 members (including the chair) and must “as a group, reflect a balanced variety of perspectives and experience across a broad range of relevant disciplines, ranging from clinical experience in treating patients with Lyme disease to experience in investigating the best methods to diagnose and treat Lyme disease or other infectious diseases”.

Prospective panel members are chosen by the IDSA Standards and Practice Guidelines Committee and the Chairman of the new panel. Panelists cannot have previously served on a Lyme guidelines panel, must be free of conflicts of interest, must be a clinician or a researcher, and need not be a member of IDSA. All panelists will be screened for potential conflicts of interest by Dr. Brody, the independent medical ethicist. ILADS physicians are encouraged to apply for panel seats.

The chair of the panel is critically important because this person and the IDSA Standards and Practice Guidelines Committee will select the panel members from the pool of applicants. The chair will be selected by the IDSA Standards and Practice Guidelines Committee in an open process—meaning any qualified individual can apply. In addition to the requirements imposed on panel members, the chair must be trained in infectious disease, must not have a published viewpoint on Lyme disease, and must have experience managing tasks, building consensus, and considering varying viewpoints.

FOR MORE INFORMATION ON QUALIFICATIONS FOR PANEL MEMBERS CLICK HERE.

Evidence selection.

IDSA staff will compile evidence internally for the panel to consider. However, in addition, the IDSA must post an announcement on its website and permit others to submit scientific studies for review by the panel over a 60 day period.

Public presentations and hearing.

After the scientific evidence has been reviewed, the IDSA must permit people who would like to present publicly to apply. Although preference will be given to researchers and physicians, any stakeholder may apply. The final list of presenters must reserve time divergent opinions. The panel will work with the medical ethicist and the Connecticut Attorney General’s office to finalize this list. Conflicts of interest of presenters must be disclosed, but will not preclude the presenter from participating. A public hearing of the presentations that will be aired live over the Internet. The presenters should identify specific recommendations of the IDSA guidelines that they contest (these are considered contested recommendations) and present evidence opposing the recommendation. Only contested recommendations will be reconsidered by the panel—so focus is critical.

Panel determinations.

Each contested recommendation will require a supermajority vote (75% or greater) to affirm that it is “medically/scientifically justified in light of all the evidence presented”. After the vote on each contested recommendation, the Review Panel will recommend whether the IDSA guidelines need to be revised in whole, in part, or not at all. If the guidelines need to be revised, then the new treatment recommendations will also be subject to the 75% voting requirement. The notion here is that a “consensus” of the panel is 75%, and all determinations require a consensus.