Congress Commends NIH Collaboration with Advocacy Groups to Advance Research on Maternal-Fetal Transmission of Lyme Disease

Congress is pleased that NIH has taken action to advance research on maternal-fetal transmission of Lyme disease. In response they have issued a directive that commends NIH officials and encourages them to intensify research on adverse outcomes from Lyme disease during pregnancy and continue collaboration with advocacy organizations to advance research.

The House report for the fiscal year 2022 appropriations bill for NIH that was signed into law on March 15 includes the following directive:

“The Committee is gratified that NIH officials have recognized the need for further exploration of maternal-fetal or vertical transmission of Lyme disease and the occurrence of adverse outcomes among women with untreated and disseminated Lyme disease during pregnancy. The Committee encourages NIH to intensify research on adverse outcomes related to Lyme disease during pregnancy and to continue to participate with Lyme advocacy organizations on these issues.”

The Senate report for the bill includes even stronger language that explicitly directs NIH to conduct this type of research:

“The Committee directs NIH to conduct research to better understand modes of transmission for Lyme and other tick-borne diseases, including vertical transmission.”

An example of NIH collaboration with advocacy organizations was participation in the April 29, 2021 webinar: Lyme Disease and Pregnancy: State of the Science and Opportunities for Research Support.

Presenters included research program managers from the National Institute of Allergy and Infectious Diseases (NIAID) and the Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD).

The webinar was hosted by Mothers Against Lyme and co-sponsored by Project Lyme. The event was attended by a wide variety of researchers, research administrators, healthcare professionals, caregivers and advocates.

According to Mothers Against Lyme Chair, Isabel Rose, “We had a good response to the webinar and have been following up with researchers to encourage them to contact NIH program managers for guidance on how to submit applications for research grants.”

The webinar was a follow-up to a December 7, 2020 meeting between Mothers Against Lyme and a group of officials and research program managers from NIAID and NICHD.

The goal of the meeting was to establish a working relationship and discuss a formal request for NIH to designate Lyme disease as a high priority perinatal infection of interest.

While NIH has yet to make that designation, they issued a notice of special interest that encourages research on “gestational Lyme disease” and the impact of pregnancy on immune response. During the meeting they emphasized this type of research was “investigator initiated” and that the “community” could help get the word out to researchers about opportunities for funding and research support.

Rose says, “The webinar and notices of special interest are examples of how NIH can advance this much needed research. We need NIH to issue similar notices for research to better understand links between Lyme disease and adverse birth outcomes and for research to improve diagnosis and treatment for pregnant women with Lyme and children who are congenitally infected. As a mother who has experienced firsthand the devastating impact of misdiagnosed and untreated Lyme disease on my children and family, I urge NIH to fund and support research that will prevent other families from suffering.”

Rose cites the November 2018 article A Systematic Review on the Impact of Gestational Lyme Disease in Humans on the Fetus and Newborn as an example of why this research is urgently needed. In its meta-analysis, adverse outcomes were noted for 11% of pregnant women treated with antibiotics and 50% of untreated women. Adverse outcomes included spontaneous miscarriage, fetal death and a range of congenital abnormalities and health issues.

“Anyway you look at it, treated or untreated, the incidence of adverse outcomes is a concern,” says Rose. “In addition to NIH making this research a priority, collaboration with advocacy organizations and other federal agencies is essential to make sure the research is focused on studies that will improve health outcomes for pregnant women and children with Lyme.”

According to Bruce Fries, President of the Patient Centered Care Advocacy Group and co-founder of Mothers Against Lyme, “NIH participation in the webinar on Lyme disease and pregnancy was a good start. The true test of NIH’s response to this urgent issue is the amount of research they fund on gestational and congenital Lyme that has measurable benefits for patients.”

In a July 2020 letter to NIH Director Francis Collins, Mothers Against Lyme outlined the following objectives for this research:

1. Improve prevention, diagnosis, testing, and treatment of Lyme disease and other tick-borne diseases in pregnant women, infants, and children.
2. Determine the extent of maternal-fetal transmission and investigate the impact of congenital Lyme disease.
3. Establish best practices for prevention and treatment of maternal-fetal transmission and congenital Lyme disease.
4. Understand the social, educational, cognitive, psychological, behavioral, and life outcomes for children infected with Lyme disease.
5. Increase awareness of common symptom presentations among obstetricians and pediatricians.

To achieve these goals, the letter asks NIH to incorporate input from parents of children with Lyme disease when setting research priorities and requested that patients, advocates, researchers, and physicians with experience treating tick-borne diseases be included as representatives on the Advisory Board/Councils that review grant applications.

The letter said research is needed to:

1. Assess birth outcomes and monitor growth and development in babies born to mothers with acute, previously treated or late disseminated Lyme disease.
2. Determine the appropriate antibiotic regimen to prevent transmission of Lyme disease from mother to fetus.
3. Examine the effects of pregnancy on immune response and symptoms.
4. Assess the immunological response in children who are congenitally infected with Lyme disease.
5. Evaluate the role co-infections play in the diagnosis and treatment of Lyme disease in pregnant women and in children who may have acquired Lyme disease in utero or through tick bites.

The letter also urged NIH to authorize longitudinal studies on the risks of developmental disorders and other long-term impacts of untreated or insufficiently treated Lyme disease in children that address the following areas:

1. Social, educational, cognitive, psychological, behavioral, and life outcomes for children infected with Lyme disease in utero or in childhood.
2. Common neuro-psychiatric presentations of congenital and primary Lyme disease in children.
3. Educational needs of children affected with Lyme disease, with recommendations for school accommodations that allow for treatment of neuropsychiatric and physical disease.

Fries adds, “We look forward to ongoing collaboration with NIH, the research community and other advocacy organizations to advance this much needed research. Mothers, children, and families whose lives have been disrupted by the devastating effects of Lyme and associated tick-borne diseases are counting on NIH to provide solutions by making this a high priority and by supporting scientific research and evidence-based policy.”

About Mothers Against Lyme
We’re a group of mothers, and mother-advocates, who are concerned about the impact of Lyme disease and its co-infections on pregnant women, children and families. Our focus includes awareness, education, advocacy and community building, as we promote research that advances diagnosis, treatment and prevention.

For more information visit www.MothersAgainstLyme.org

Contact Information

Bruce Fries

Research and Public Policy

Mothers Against Lyme

Contact via E-mail