Today, the United States Department of Health and Human Services will convene the first of two planned public deliberations of the federal Tick-Borne Disease Working Group. According to the HHS website:
The Tick-Borne Disease Working Group was established by Congress in 2016 as part of the 21st Century Cures Act to provide subject matter expertise and to review federal efforts related to all tick-borne diseases, to help ensure interagency coordination and minimize overlap, and to examine research priorities. The focus of this effort is the development of a report to the Secretary of Health and Human Services and Congress on the findings and any recommendations of the Working Group for the federal response to tick-borne disease prevention, treatment and research, as well as how to address gaps in these areas. The Working Group is required to submit a report every two years, starting in December 2018.
Early Controversy
As is common with Lyme and other tickborne diseases, controversy already has cropped up surrounding this working group, as Gary Wormser—a defendant in a recently filed federal antitrust lawsuit alleging his and other medical doctors’ financial motivations have compromised and in some cases condemned the health of 28 Lyme disease patients—was initially included among announced members of the HHS Tick Borne Disease Working Group.
LymeDisease.org launched a petition to remove Wormser from the working group, which within a couple of days had over 10,000 signatures. Wormser’s name subsequently disappeared from the publicized list of members and staff.
An HHS spokesperson told LymeDisease.org that “Dr. Gary Wormser has declined the invitation to serve on the Tick-Borne Disease Working Group. A nominee will be selected to replace him from the list of highly qualified persons whose names had been previously submitted in response to the public call for nominations. It is unlikely that this selection will be made and finalized before the December 11 meeting.”
LymeDisease.org Vice President for Outreach and Education Dorothy Kupcha Leland told me via email that “Dr. Wormser and his conflicts of interest have been a lightning rod for indignation in the Lyme community for many years, stretching back to the 2006 IDSA Lyme guidelines. I think the Working Group is better positioned to accomplish its job without him.”
HHS and CDC Inquiries
To date, as far as I have been able to discern, there’s been no explanation of who nominated Wormser against his interest or what the motivation for doing so was, or for why HHS listed his name among members who had accepted their nominations. I asked the HHS Working Group via email why Wormser had been listed as a member of the Working Group rather than a nominee. An HHS spokesperson responded with the same language as was given to LymeDisease.org, that “Dr. Gary Wormser has declined the invitation to serve on the Tick-Borne Disease Working Group. A nominee will be selected to replace him from the list of highly qualified persons whose names had been previously submitted in response to the public call for nominations. It is unlikely that this selection will be made and finalized before the December 11 meeting.”
Lyme disease patient advocates for many years have questioned the rationale for the CDC’s continual endorsement of the Infectious Diseases Society of America’s (IDSA) tickborne diseases diagnostic and treatment guidelines, which ceased on December 1, 2017, then the CDC updated its website to remove links and all direct references to the IDSA guidelines.
I asked the CDC on December 4 why it removed the IDSA’s guidelines from its website on December 1. A spokesperson wrote that “It has been over a decade since the IDSA guidelines, developed in 2006, were published. Additional published research further informs Lyme disease treatment. As a result, we’ve updated our website with treatment information that is more immediately helpful to health care providers and people with Lyme disease.”
I asked for clarification about why the CDC chose to remove the guidelines now, nearly two years since the HHS’s National Guidelines Clearinghouse (NGC) removed the IDSA guidelines from its federal repository for being outdated, and why the CDC makes no reference to the guidelines published by the International Lyme and Associated Diseases Society (ILADS), which were accepted into the NGC.
The CDC’s response last Friday, December 8:
AHRQ/NGC does not endorse any of the guidelines included on the Web site, https://www.guideline.gov. This includes the guidelines published by the International Lyme and Associated Diseases Society.
With regard to currency of the guideline content, NGC’s inclusion criteria require that the guideline is the most recent version published, that it was developed, reviewed, or revised within the past five years, and that it be underpinned by a systematic evidence review. Please note NGC makes no guarantee that the content provided in the guideline is the most up-to-date information on a given topic.
I replied with the following questions:
Why does the CDC does not acknowledge that the ILADS guidelines exist given that they've undergone an evidence review and are available to practitioners via the NGC, whereas the CDC did until last week both acknowledge and recommend the IDSA guidelines. Has the CDC determined the ILADS guidelines to be valid? If so, for what reason? If not, why does it not acknowledge them given that they are available to practitioners via the NGC?
The CDC has not responded to the above questions. If it does, I will update this page accordingly. (Update: On 12/11/17, a CDC spokesperson replied that: “We believe that the information on our website accurately represents the scope of the scientific literature.” This is the entire response to the above questions.)
In the same serious of communications, I asked the CDC whether the federal antitrust lawsuit that names Gary Wormser and several other individuals who co-authored the 2006 IDSA tickborne diseases guidelines raises any questions for the CDC about the integrity of the 2006 guidelines, noting that while the CDC has eliminated explicit links and references to the 2006 IDSA guidelines on its website, the agency instead refers practitioners to four published academic articles—one of which is a literature review co-authored by Gary Wormser. The CDC’s spokesperson replied that “CDC is not involved in these legal actions. We’ve made these changes in an effort to make our treatment information more immediately helpful to health care providers and people with Lyme disease. Questions about the The Tick-Borne Disease Working Group should be directed to HHS.”
I asked the HHS Working Group spokesperson about the nature of the Working Group’s relationship with other federal agencies and with outside, nongovernmental organizations.
Regarding relationships with other federal agencies, “The Tick-Borne Disease Working Group has members from seven federal agencies/programs: CDC, NIH, FDA, OASH, and the Centers for Medicare and Medicaid Services (CMS), the Office of Management and Budget (OMB), and the Department of Defense’s Naval Medical Research Center. The first four agencies were specified by Congress in the 21st Century Cures Act. The remaining agencies were identified by the Secretary.”
Regarding relationships with third-party organizations such as the IDSA, “The Tick-Borne Disease Working Group has no official relationship with any outside organization or group. Public members of the Working Group represent a range of organizations. You can find their organizational affiliations on the Member webpage.”
Those organizations include Johns Hopkins University Lyme Disease Clinical Research Center, Bay Area Lyme Foundation, U.S. Centers for Disease Control and Prevention, Centers for Medicare and Medicaid Services, National Institute for Allergy and Infectious Diseases, World Health Organization’s Ad Hoc Committee for Health Equity, Food and Drug Administration’s Office of Counterterrorism and Emerging Threats, American Academy of Pediatrics, Department of Defense’s Naval Medical Research Center, HHS’s Office of the Assistant Secretary for Health, Lyme Disease Association, and Lyme Disease Foundation.
For the Record
The HHS Tick Born Disease Working Group spokesperson noted several times that “All meetings of the Working Group are open to the public and will be webcast. All interested groups and individuals are welcome to attend meetings and provide comments.”
According to the Working Group website, public comments will be limited to three minutes each.
Today’s meeting will take place from 12:30 - 4:30 p.m. at the Hubert H. Humphrey Building in Washington, D.C. Public comment will be invited from 3:10 p.m. until 4:00 p.m., according to the agenda published online.