https://www.lymedisease.org/wormser-wrong-choice-lyme-panel/#comment-24002

Conflicts of interest make Wormser wrong choice for Lyme panel

Gary_Wormser
The federal Tick-Borne Disease Working Group was established by 2016’s 21st Century Cures Act. The idea was to bring together a diverse set of stakeholders, including treating physicians, researchers, patients, advocates and government officials to help inform federal policy regarding Lyme and other tick-borne diseases. The US Department of Health and Human services named members of the Working Group last week.

LymeDisease.org supports the concept of the federal working group. However, we feel HHS made a big mistake by appointing Dr. Gary Wormser, due primarily to his financial conflicts of interest with companies who stand to make money from the panel’s decisions.

LymeDisease.org President and Founder Phyllis Mervine sent the following letter to Dr. Richard Wolitski, Designated Federal Officer of the Tick-Borne Disease Working Group.

Dear Dr. Wolitski:

I am writing on behalf of LymeDisease.org to protest the appointment of Gary Wormser, MD, to the Tick-Borne Disease Working Group and to request that he be replaced.

LymeDisease.org is the largest communications network representing Lyme disease patients in the United States, with over 4 million unique visitors to our website each year. We are the most trusted source of information on Lyme disease for millions of patients.

Conflicts of interest

Dr. Wormser has substantial conflicts of interests with lab companies and other commercial interests. In a recent article he disclosed conflicts of interest with Immunetics, Inc. (the developer of the C6 Lyme test, which he promotes). The C6 Lyme test is known to be highly insensitive, yet the IDSA guidelines require positive lab tests in order for patients to be diagnosed and treated for Lyme disease. This means that patients must obtain repeated blood tests to obtain positive results, which helps drive up the profits of testing companies such as Immunetics.

Dr. Wormser also discloses Lyme-related conflicts of interests with Abbott, Institute for Systems Biology, Rarecyte, Inc, and Quidel Corporation. He also has financial ties to insurance companies, having served as an expert witness in court cases against doctors for treating Lyme disease outside of the IDSA guidelines

Dr. Wormser cannot sit on this panel without these conflicts of interest influencing his messages. He does not represent the interests of an independent, truth-seeking researcher, but rather the commercial interests of profit-making companies. As such, he has no place in this Working Group.

Lyme testing

The fact that Dr. Wormser is the only panel member with a background in Lyme testing is also problematic. Several other professionals who were recommended for the Working Group—including Dr. Raphael Stricker, Dr. Sam Donta, and Dr. Elizabeth Maloney—could fill the lab expertise role without conflicts of interest with laboratory companies. The selection of Dr. Wormser for the Working Group sends a strong signal of commercially motivated bias.

NIH grants

Another major concern is that Dr. Wormser has received a large share of NIH grants for Lyme-related research and is influential in the selection of grant recipients. This will make it difficult for other researchers on the panel to be candid, fearing repercussions on their ability to obtain future grants. Deciding the direction of research and the needs for funding is likely to be an important function of the Working Group. Now-retired UC Davis researcher Stephen Barthold testified before a Congressional committee that Lyme research that doesn’t conform to the IDSA paradigm does not receive funding, for political reasons. We believe that having Dr. Wormser on the Working Group will perpetuate that injustice.

Biased guidelines

As chairman of the Infectious Diseases Society of America (IDSA) Lyme guidelines revision panel, Dr. Wormser was a defendant in the 2006 antitrust investigation of the IDSA by then-Attorney General Richard Blumenthal of Connecticut. The IDSA is a medical specialty society that represents the interests of its members, and the members who deal with Lyme disease are primarily researchers.

AG Blumenthal concluded that the “IDSA’s 2006 Lyme disease guideline panel undercut its credibility by allowing individuals with financial interest—in drug companies, Lyme disease diagnostic tests, patents, and consulting arrangements with insurance companies—to exclude divergent medical evidence and opinion.”

Those guidelines leave many patients chronically ill. Patients do not trust the IDSA and do not want to be treated according to the IDSA guidelines. Yet the IDSA guidelines are influential and are used by state medical boards in disciplinary proceedings against nonconforming physicians and by insurers to deny essential care to patients. This has a chilling effect on the willingness of doctors to stray from the IDSA guidelines or even to accept people with chronic Lyme disease as patients.

Lack of trust

Dr. Wormser is featured in Under Our Skin, a compelling documentary about the ravages of chronic Lyme disease. In the film, he insists that there is no objective evidence that chronic Lyme disease exists and trivializes the effect of the illness on patients. He is likely to be a lightning rod for controversy and his continued presence on the Working Group will undermine all efforts to gain the public trust.

To sum up, LymeDisease.org speaks for a large community of patients in requesting that you remove Dr. Wormser from the Working Group. We urge you to replace him with someone less biased and with fewer financial conflicts of interest. We advance three nominees to replace his position: Dr. Raphael Stricker, Dr. Elizabeth Maloney, and Dr. Sam Donta. We believe materials on these individuals has already been forwarded to you as part of the nomination process.

Thank you for your consideration.

Sincerely yours,

Phyllis Mervine
President and Founder, LymeDisease.org

The first meeting of the Tick-Borne Disease Working Group will be in Washington DC on December 11. LymeDisease.org urges readers to send an email to Dr. Richard Wolitski at the following address: tickbornedisease@hhs.gov . Tell him why you feel Dr. Wormser is a poor choice for this panel.

Sources:

Asher T. Unprecedented Antitrust Investigation into the Lyme Disease Treatment Guidelines Development Process. Gonzaga Law Rev. 2011 Jan;46(1):117-145. Available from: https://www.law.gonzaga.edu/law-review/files/2011/01/Asher.pdf

Institute of Medicine, Committee on Lyme Disease and Other Tick-Borne Diseases: The State of the Science Board on Population Health and Public Health Practice. Critical Needs and Gaps in Understanding Prevention, Amelioration, and Resolution of Lyme and Other Tick-Borne Diseases: The Short-Term and Long-Term Outcomes: Workshop Report. 2011. Available from: https://www.nap.edu/read/13134/chapter/1#ii

Johnson L, Stricker RB. Attorney General forces Infectious Diseases Society of America to redo Lyme guidelines due to flawed development process. J Med Ethics. 2009 May;35(5):283-8. Available from: http://www.ncbi.nlm.nih.gov/pubmed/19407031 http://jme.bmj.com/content/35/5/283.

Pfeiffer MB. Chronic Lyme disease: Is it real? Poughkeepsie Journal, 05/19/2013. Available from: http://www.poughkeepsiejournal.com/story/news/health/lyme-disease/2016/06/24/archive-chronic-lyme-disease-real/86349798/

Wormser GP, Shapiro ED, Strle F. Studies that report unexpected positive blood cultures for Lyme borrelia—are they valid? Diagn Microbiol Infect Dis. 2017 Nov;89(3):178-81. Available from: http://www.ncbi.nlm.nih.gov/pubmed/28918069

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For a list of the panel members:  https://madisonarealymesupportgroup.com/2017/11/22/tbi-working-group-members-named/

For commentary and interview on the panel:  https://madisonarealymesupportgroup.com/2017/11/14/thayer-interview-commentary-on-tick-borne-disease-working-group/