For years, patients and advocates have blasted the Centers for Disease Control and Prevention (CDC) and the Infectious Disease Society of America (IDSA) for pushing and promoting outdated guidelines and antiquated protocols while turning a blind eye to newer scientific and evidence-based studies that produced newer information. They have fought for new evidence-based scientific studies to be accepted by mainstream medicine and providers and most recently, are calling on the CDC to withdraw its endorsement of single-dose antibiotic prophylaxis for prevention of Lyme disease following a tick bite.

The contested information on tick-bite prophylaxis—which is included on CDC’s website and in the CDC publication, Tick-Borne Diseases of the United States, Fifth Edition, 2018—states:

“The Infectious Disease Society of America (IDSA) does not generally recommend antimicrobial prophylaxis for prevention of Lyme disease after a recognized tick bite. However, in areas that are highly endemic for Lyme disease, a single dose of doxycycline may be offered to adult patients (200 mg) who are not pregnant and to children older than 8 years of age…”

This week, I want to share how a group of advocates has publicly challenged the CDCs endorsement of a single dose antibiotic for Lyme disease prevention, claiming this outdated policy not only harms patients but violates HHS standards for information quality. The Patient Centered Care Advocacy Group, led by Bruce Fries, filed an “information quality request for correction” on Feb. 14 with the CDC’s Office of the Associate Director for Science. The complaint argues that the IDSA recommendation endorsed by CDC “lacks utility, objectivity, and integrity and misleads patients and healthcare providers. This not only can result in human harm but can increase the number of long-term Lyme disease cases, worsening the current Lyme epidemic and increasing the financial impact on our country in terms of lost productivity, disability, and increased medical expenses.”

According to Fries. “CDC’s endorsement of the IDSA recommendation for a single dose of doxycycline to prevent Lyme disease has potential to cause serious harm to patients for whom the prophylaxis fails to prevent infection.  CDC’s dissemination of this information also violates HHS Guidelines for Ensuring and Maximizing the Quality, Objectivity, Utility, and Integrity of Information Disseminated to the Public.” (https://aspe.hhs.gov/report/hhs-guidelines-ensuring-and-maximizing-quality-objectivity-utility-and-integrity-information-disseminated-public)

Holly Ahern, associate professor of microbiology at SUNY Adirondack and Lyme Action Network board member, states that this recommendation, based on a single 2001 study that has never been reproduced, has the following scientific limitations:

“The ‘primary endpoint’ used to determine whether the prophylactic treatment “prevented” Lyme disease was the appearance of an erythema migrans rash at the site of the tick bite. More recent studies consistently show that the rate of any type of skin rash is less than 50%, and the rate of EM is less than 10%. Therefore, this study excludes more than half of true cases of Lyme disease from the data analysis.”

Subjects who developed subjective symptoms of Lyme disease such as headaches, profound fatigue, brain fog, joint pain without swelling, weakness, numbness, or difficulty controlling specific muscles were excluded from the data analysis.

Participants were only observed for six weeks before being considered “negative” for Lyme disease, and therefore persons who developed symptoms after six weeks were excluded from the data analysis.

The complaint maintains that, “Patients and healthcare providers alike gain a false sense that a tick-borne disease was prevented with this prophylaxis and, therefore, full treatment may be delayed or denied. Research shows that delayed treatment increases the rate of treatment failure. In addition, this partial treatment has been shown to result in false negative blood test results for Lyme disease in the future.”

In 2016, as part of the 21st Century Cures Act, the Tick-Borne Disease Working Group was established 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.

However, having Congress’s attention on the deficiencies associated with tick-borne diseases, many advocacy groups are taking this “foot in the door” approach, working steadfast, identifying gaps and issues in the current policies and taking public measures to rectify the situation. With new scientific, evidence-based studies, there is absolutely no reason to continue using outdated guidelines and recommendation that have proven to cause harm. It’s time for an overhaul of all the policies associated with Lyme and tick-borne disease, reviewing new and outdated information and doing what is best in the interest of the patient and holding those accountable to change.

“There’s been literature suggesting that patients with PTLDS have some chronic inflammation somewhere, but until now we weren’t able to safely probe the brain itself to verify it,” says Jennifer Coughlin, M.D., associate professor of psychiatry and behavioral sciences at the Johns Hopkins University School of Medicine, and one of the first authors of the study report.

Paula is the president of the MLDSE, the co-chair of the Access to Care Services and Patient Support subcommittee of the federal HHS Tick-borne Disease Working Group, the Maine-partner of the national Lyme Disease Association, member of Maine’s CDC Vector-borne Workgroup and active in Maine’s Lyme legislation. You can reach her at paula@mldse.org and visit her website www.mldse.org