The IDSA Guidelines Re-Evaluation Process

Byldoadmin


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.

Similar Posts

  • LYMEPOLICYWONK: Study Finds Coinfections in Lyme Disease Common

    The largest survey of chronic Lyme disease patients was recently published in PeerJ. LymeDisease.org conducts these large-scale surveys to collect information directly from Lyme patients. Although the incidence of coinfections in chronic Lyme disease is unknown, many people assume that co-infections are rare in Lyme patients. The fact is no one has asked the question. So we asked over 3,000 chronic Lyme patients whether they had coinfections that were confirmed by laboratory tests.

  • LYMEPOLICYWONK: Lyme Patient Groups Withdraw from IOM Lyme Workshop

    TFL, LDA, and CALDA, announced today that they are withdrawing from the IOM Lyme Workshop due to bias and the lack of balance in scientific viewpoints scheduled to be presented at the conference. The three groups had been commissioned to write a paper for the proceedings and Diane Blanchard of Time for Lyme had been slated to speak. Four of the six IOM panel members responsible for selecting speakers, topics and timeslots are members of IDSA, which is known to have a strong bias against the diagnosis and treatment of Lyme disease. The resulting agenda reflects this bias with key speaking positions granted to Dr. Wormser, who chaired the IDSA Lyme guidelines panel, and Dr. Aguero-Rosenfeld, who until recently worked with Dr. Wormser at NYMC. No comparable time slots were awarded to provide the opposing viewpoint, and no ILADS physicians are scheduled to speak at the conference. Details and Press Release follow. . .

  • Publication Alert: IDSA Review Hearing Report–Lipstick on a Pig

    On April 22nd, the IDSA guidelines review hearing panel rubber-stamped its Lyme disease guidelines in its final report of the hearing. Those of us who presented and attended the hearing were appalled. Sure we had our reservations about the ability of a panel stacked with IDSA members to impartially review the guidelines, but there were 1,600 pages of peer reviewed evidence that had been presented to the panel and independent scientists had attested to the persistence of the Lyme bacteria and the low quality of the tests. How could they ignore the weight of such evidence? How could they decide to leave the guidelines completely unchanged even though a panel of their own choosing was divided on the testing? To make matters worse, the IDSA then trumpeted the results of a stacked panel as "independent" in their report. Dr. Stricker and I were given the opportunity to respond to the IDSA "spin" and our letter to the editor was just published. An excerpt follows:

  • LYMEPOLICYWONK: Meeting with Dr. Ben Beard of the CDC–The Importance of Dialogue and Lingering Concerns

    Dr. Ben Beard of the CDC met with directors of CALDA on March 10 as part of an effort to reach out to Lyme patient groups across the nation. After meeting with CALDA, he attended the regularly scheduled meeting of the California State Lyme Disease Advisory Committee, which was created under legislation sponsored by CALDA to encourage dialogue with the California Department of Public Health. If you have not met Ben Beard before, he is both engaging and likable and has a measured tone. CALDA believes that respectful dialogue is essential to moving forward for the Lyme community, and we are pleased with this first step. We also believe that patients need to be meaningful participants in any solution for Lyme disease. We raised a number of concerns about the CDC's Lyme disease policies, including the need to treat to cure disease, the education of physicians and government funding of research. Here are the issues that loom large.

  • Let’s give a hand to Volkman–a little thank you can go a long way

    Sometimes someone does something so wonderful. Really! Something so wonderful that you have to stop, take a breath, exhale, and look again. In this world, the world of patients with Lyme disease, it happens rarely. And, when it does, we need to acknowledge it, and, more importantly, we need to acknowledge those who do the right thing no matter what. When someone outside this community steps up to bat for us, well, we should just stop what we are doing and give thanks. Here is my thank-you to Dr. David Volkman. (p.s. you can write one too)