For the first time ever, NIH Released a Notice of Special Interest for Celiac Disease on November 23, 2021. With the support of the celiac patient community and a committed group of celiac disease researchers, the Celiac Disease Foundation began its concerted push for NIH funding of celiac disease research with testimony from CEO Marilyn Geller to the House Appropriations Subcommittee on Labor, Health and Human Services, Education, and Related Agencies on April 9, 2019. Those efforts continued without pause right up to this announcement. We are delighted because this NOSI has been acknowledged by every party participating in this campaign as a key step toward our common goal of curing celiac disease. We are grateful to everyone who has supported our efforts. What follows are more details about this monumental announcement. We encourage you to take a few minutes to read it.
The announcement from NIH’s website:
“The purpose of this Notice of Special Interest (NOSI) is to inform potential applicants to the National Institutes of Health (NIH) of special interest in research on the etiology and pathogenesis of celiac disease, identification of therapeutic targets, and development of preventative or disease ameliorating therapies/strategies.”
The NOSI was issued by the following Institutes within NIH: National Institute of Allergy and Infectious Diseases (NIAID), National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS), National Center for Complementary and Integrative Health (NCCIH), National Cancer Institute (NCI). Each of these units has a specific interest in celiac disease that is detailed here.
The NIH explains the reasoning behind the NOSI for celiac disease in a “Background” statement this way:
“Celiac disease is an autoimmune disease that occurs in genetically susceptible individuals who develop an immune response to ingested gluten. This disease affects greater than 1% of the US population, and incidence appears to have been increasing over the last several decades. The only known treatment is life-long strict avoidance of all forms of wheat, rye, and barley. Although a gluten-free diet is an effective treatment in many individuals, recent research has revealed that up to 50% of individuals following a gluten-free diet are inadvertently exposed to gluten, and a substantial minority develop persistent or recurrent symptoms.”
It concludes its “Background” stating:
“While much is understood about the mechanism of disease, unmet needs in understanding celiac disease pathogenesis remain, including limited understanding of pathways of disease and tissue destruction, and what causes the loss of tolerance to a component of food. On March 18-19, 2021, NIAID and NIDDK co-sponsored a virtual workshop that brought together a diverse group of experts in celiac disease and related scientific areas to discuss research focused on celiac disease. The goal of the workshop was to identify research gaps, promote this research area to investigators outside of the field, seek avenues for training new/young investigators on approaches and methods common to the field, and understand the future needs for the most promising research.”
As noted before, the path of securing this NIH announcement of a NOSI for celiac disease has been a focused effort involving thousands of patients and caregivers, biomedical researchers, key Members of Congress and Congressional Staff, our Washington, D.C.-based lobbying firm, and CDF staff. Here are some key dates for reference:
April 2019 – CDF CEO Marilyn Geller testifies before the House Appropriations Subcommittee responsible for NIH funding.
October 2019 – CDF retains Baker Donelson, D.C.-lobbying firm with respected healthcare practice.
December 2019 – FY 2020 NIH Appropriations Bill includes for the first time “report language” about celiac disease written by a CDF volunteer that asks both for research funding for celiac disease and that primary responsibility within NIH for celiac disease research be shifted from National Institute of Diabetes and Digestive and Kidney Diseases to National Institute of Allergy and Infectious Diseases because this unit studies autoimmune diseases.
January 2020 – CDF leadership meets in Bethesda, MD with NIDDK and NIAID leadership to discuss opportunities and problems regarding NIH funding of celiac disease research.
February 2020 – CDF hosts the first National Patient Advocacy Summit in Washington, D.C. to train patient advocates to lobby their elected representatives. Groups of patients, caregivers, and researchers go to Capitol Hill and meet with key legislators about NIH funding, including Congressman Tom Cole, Congresswoman Betty McCollum, Congressman Tim Ryan, and Senator Richard Blumenthal.
March 2020 – CDF, the Society for the Study of Celiac Disease, and Columbia University host Consensus Conference with leading celiac disease researchers and clinicians from around the world to debate and establish priorities for celiac disease research. NIH sends a representative.
May 2020 – CDF CEO Marilyn Geller joins Bana Jabri, MD, PhD, Joseph Murray, MD, and Ciaran Kelly, MD in presenting Consensus Conference findings to the NIH Autoimmune Diseases Coordinating Committee (ADCC). CDF is subsequently invited to become a member of the ADCC.
December 2020 – FY 2021 NIH Appropriations Bill includes for the second time “report language” about celiac disease written by a CDF volunteer that urges NIAID to support new research and to report on the progress made toward “promoting, recruiting, and supporting additional celiac-focused research.”
March 2021 – CDF hosts its second Patient Education & Advocacy Summit, this time virtual, that is attended by more than 1,700 patients and caregivers. Representative Steve Stivers and Congresswoman Betty McCollum announce the creation of the first-ever Congressional Celiac Disease Caucus.
March 2021 – CDF CEO, Marilyn Geller, testifies at the NIH Accelerating Progress in Celiac Disease Workshop on patient unmet needs in celiac disease in collaboration with the world’s leading researchers to support the need for a Notice of Special Interest in Celiac Disease.
October 2021 – NIH appropriations report language for FY 2022 includes sufficient funding for NIH to devote focused research to the study of celiac disease, to establish a Research, Condition, and Disease Categorization (RCDC), and issue a Notice of Special Interest.
December 2021 – NIH issues a Notice of Special Interest in Celiac Disease to provide dedicated research funding for the study of celiac disease.
If you have any questions about any of the above, please contact me at [email protected] or 818.716.1513, x102.
Again, we are deeply grateful to everyone who has supported our work, and to our research community for all that we have and will continue to accomplish together.
Our work is far from over, however. That is why your support of our Annual Gift of Hope Challenge is so appreciated.
Marilyn G. Geller