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Advocates and CDC Clash on Frequency of Lyme Rash

Washington, DC – WEBWIRE

Because absence of rash does not equal absence of Lyme disease, these studies come to invalid conclusions, which hampers the development of improved diagnostics and treatments.

Despite evidence that its published information on the frequency of the bull’s-eye/erythema migrans (EM) rash in Lyme disease patients is inaccurate, the Centers for Disease Control and Prevention (CDC) continues to insist that the rash appears in most cases of the disease.

In March 2019, the Patient Centered Care Advocacy Group filed an Information Quality Request for Correction complaint that calls on CDC to update its published materials to acknowledge that the classic bull’s-eye rash appears in fewer than 10% of cases and close to 50% of patients do not present with a rash of any kind.

“The reason this is important,” says Bruce Fries, President of the Patient Centered Care Advocacy Group, “is the presence of an EM rash is considered prima facie evidence of Lyme disease. In addition, most research on Lyme disease in humans uses development of an EM rash as either the primary end point or as enrollment criteria for clinical trials designed to research potential treatment or diagnostic approaches. Because absence of rash does not equal absence of Lyme disease, these studies come to invalid conclusions, which hampers the development of improved diagnostics and treatments.”

In a July 2019 response to the complaint, Lyle Peterson, MD, Director of CDC’s Division of Vector-Borne Diseases, wrote “the best available evidence supports an estimate of 70-80% as the frequency of EM among patients with Lyme disease.”

Not true, says Holly Ahern, associate professor of microbiology at SUNY Adirondack and co-author of the complaint. “There is considerable scientific evidence that contradicts the CDC, including data from 1992-2006 surveillance showing that 31% of CDC surveillance cases lacked an EM rash. Studies with non-human primates (NHPs) infected with the bacteria that cause Lyme disease and followed to observe disease progression found that only 10% of the infected NHPs developed a classic “bulls-eye” EM rash, and nearly half did not develop any type of rash.”

Ahern noted that because the EM rash was a unique characteristic of the disease, early research became overly focused on investigating the rash, not the full disease. The prevailing opinion that an EM rash occurs in 70-80% of Lyme disease cases can be traced directly to a 1984 study titled “Epidemiologic features of Lyme disease in New York.

According to Ahern, “Obvious ascertainment bias occurred in the design of the 1984 study. Ascertainment bias occurs when study participants do not fully represent the disease that occurs in the broader population. In this study, physicians were advised to be on the lookout for patients with a new disease and emphasized the EM rash as a primary indicator of the disease.”

Ahern concludes “The lack of research that has been done to objectively investigate the frequency of EM rash in human Lyme disease patients, along with contradictory evidence from existing studies, simply does not support CDC’s continued use of the 70-80%, statistic.”

Fries and Ahern have filed an appeal that requests that CDC conduct a systematic and unbiased review of the scientific evidence about the frequency of EM rashes in patients with Lyme disease and publish the results in CDC’s Morbidity and Mortality Weekly Report.

Below are links to the complaint, CDC’s response and the appeal.

Information Quality Request for Correction

CDC Response - EM Rash.pdf

Information Quality Appeal

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 Lyme Disease
 Erythema Migrans

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