Overview
On November 23, 2021, the National Institutes of Health (NIH) announced new funding to support Celiac Disease with the "Notice of Special Interest (NOSI): Accelerating Progress in Celiac Disease Research."
America Strong with David Muir Amplified Clarion Call from the Celiac Community
On May 19, 2021, World News Tonight with David Muir reported on Celiac Disease Awareness Month and Jax Bari's two primary goals: 1) increasing Federal funding for Celiac Disease research, and 2) requiring that Gluten be labeled on all packaged foods in the US, just like it is in 85 countries around the world including in Canada and across Europe.
As America’s #1 most watched newscast across all of television, The World News Tonight story amplified the clarion call from the Celiac community that action on Federal funding for Celiac research was very much needed and very much past due!
Getting NIH Funding For Celiac Disease Research Has Been Notoriously Difficult
At the 20th Annual Virtual Gala Benefit for the Celiac Disease Center at Columbia University on November 11, 2021 (just 12 days before the NIH Notice of Special Interest was announced), Dr. Benjamin Lebwohl, the Director of Clinical Research shared that while the NIH is the Gold Standard and major funder of biomedical research in the United States, it has historically been very difficult to get NIH funding for Celiac Disease research. Dr. Lebwohl's lived experience is quite instructive...
Dr. Lebwohl remarked,
"The NIH is really the Gold Standard and major funder of the top medical, biomedical research, in the United States! Getting NIH funding is notoriously difficult. The competition is very fierce, and Celiac Disease has historically been underrepresented in the diseases that the NIH funds. It's particularly underrepresented given how common Celiac Disease is, and this is for a number of reasons, including the notion, misguided, that Celiac Disease is a solved problem, that the Gluten Free diet is all we need for Celiac Disease.
This is something that we've been working on for a very long time. I personally first started applying for NIH funding, I think it was in 2012, a nearly decade long process. Many drafts later, many rejections later, and not a few gray hairs later, I'm proud to say that we are in an NIH funded Center.
The primary clinical trial that my group is working on is the NIH funded clinical trial of Gluten detection technology. In addition, there are a number of clinical trials that involve the testing of non-dietary therapies for Celiac Disease. This ranges from enzyme therapy that digests Gluten, to therapy that blocks Gluten from getting into the section of the intestine where the immune system misperceives it as a threat, to retraining the immune system to tolerate Gluten so that it no longer causes damage in the intestine and throughout the body. There's so many therapies now being tested in various phases, and I'm proud to say that we've been there on the ground floor, giving advice to those scientists and companies who are developing these therapies so as to set up trials in a way that really tests them fairly, and gives them the best shot possible to be proven safe and effective for our patients."
It’s Time to “Reverse These Troubling Trends” - 62 United States Senators
Dr. Lebwohl's findings on how difficult it is to get NIH funding concurs with the findings from a bipartisan majority of the U.S. Senate. On April 15, 2019, Senators Robert Casey, Richard Burr and 60 (sixty) other U.S. Senators sent a letter on Fiscal Year 2020 funding for the NIH to the Senate Appropriations Committee leadership including Senators Richard Shelby, Roy Blunt, Patrick Leahy, and Patty Murray.
"As NIH grants become more competitive, researchers can easily spend half their careers working before receiving a grant. Secure NIH funding allows scientists to do what they do best - discover tomorrow's therapies and cures; preventing promising, talented young researchers from leaving the field of biomedical research; and ensuring seasoned investigators do not abandon scientific research altogether or conduct their research outside the United States. We hope that the renewed commitment to NIH funding will help reverse these troubling trends."
Historical Significance - Looking Back 8,202 Days
According to Beyond Celiac, "the NIH has the power to encourage research in desired areas, but their last request for funding applications for Celiac Disease was made 22 years ago." On June 10, 1999, the NIH issued a Request for Applications entitled "NIH - Prevalence and Diagnosis of Celiac Disease".
In other words, from June 10, 1999 (when the NIH's last request for funding applications for Celiac research was made) until November 23, 2021 (when the NIH issued its Notice of Special Interest in Celiac Disease research), 8,202 days had elapsed! That's 22 years, 5 months, and 13 days, but who's counting? I'll tell you who has been counting. The Celiac community has been counting.
"Five hundred, twenty five thousand, six hundred minutes, Five hundred, twenty five thousand moments so dear, Five hundred, twenty five thousand, six hundred minutes, How do you measure, measure a year? In daylights, in sunsets, In midnights, in cups of coffee, In inches, in miles, In laughter, in strife!" -"Seasons of Love", Rent
NIH's Notice of Special Interest in Celiac Disease - The Details
According to the 2021 NIH Notice of Special Interest, "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."
In their 2021 Notice of Special Interest (NOSI), the NIH is seeking applicants for NIH grants supporting research on the origin or cause of Celiac Disease; the development of Celiac Disease; the identification of therapeutic targets; and the development of therapies or strategies to prevent, manage or treat the disease.
Throwing Symbolic Research Crumbs to Marginalized People in the Name of Equality
"While I am pleased with the NIH's Notice of Special Interest, it is important to remember that a measure of interest and inclusion by the NIH is not the same as equal interest and inclusion. It’s a good step by the NIH to be sure, but we need to hold the NIH accountable to ensure that this is not just an example of reactionary research, but evidence of systemic change." Jon Bari, Founder of Celiac Journey
To understand and correct the historically inadequate NIH funding of Celiac Disease, it is also instructive to read the peer reviewed academic analysis published in 2017 by the American Gastroenterological Association entitled, “Disparities Among Gastrointestinal Disorders in Research Funding From the National Institutes of Health.” This analysis was written by some of the world’s leading GI researchers, which found that, out of various Gastrointestinal Disorders, from 2011-2015:
“Celiac disease consistently received the lowest amount of NIH funding over the 5-year period, at approximately $3 million per year.” NIH has spent about $1.00 per American with Celiac per year, and that is far too little to move the needle.
“Celiac disease consistently received the lowest amount of NIH grants, at approximately eight grants per year.”
“In conclusion, NIH funding of GI diseases is not proportional to disease prevalence or mortality.” (emphasis added)
Unfortunately, not much has changed since that seminal analysis was published in 2017 by the American Gastroenterological Association entitled, “Disparities Among Gastrointestinal Disorders in Research Funding From the National Institutes of Health.”
In spite of a lower number of disease specific mortalities as well as many available and emerging treatment options, Crohn’s disease received about 40 NIH grants per year averaging a total of about $16 million annually from 2011-2015, in comparison to Celiac Disease which received about 8 NIH grants per year averaging a total of about $3.0 million annually from 2011-2015.
In 2018, the NIH RePORT suggests that Celiac Disease research received a modest increase to 13 grants totaling approximately $4.7 million. In contrast, in 2018, NIH research funding for Crohn’s disease encompassed 210 grants totaling $69 million.
NIH Funding Scarcity Has Been Causing a Negative Feedback Cycle for Celiac Research
On January 14, 2020 (right before the Covid-19 pandemic), Jon and Leslie Bari testified at a Congressional Hearing on Securing Significant Federal Funding for Celiac Disease Research. The Baris presented their findings about the historic Federal underfunding of Celiac Disease research.
Public funding is perceived as validation of the seriousness of a disease and its research needs. Absent public funding validation, a vacuum has been created, which has caused private and philanthropic funding to also be scarce. Research in Celiac Disease has lagged behind in the biomedical imagination of other GI and Autoimmune diseases that have received more NIH funding.
For example, in contrast to Celiac Disease, the NIH funded Crohn’s disease research model is an example of “success breeds success” that has created a Positive Feedback Loop (network effects) with ongoing and meaningful government validation, more established research programs recruiting more young investigators, increased NIH grant submissions, increased private sector funding, and increased philanthropic funding.
Summary of Negative Feedback Cycle Caused by Scarcity of NIH Funding for Celiac Research
As the Baris also presented at the Congressional Briefing, the biomedical research vacuum in Celiac research has been created by:
Lack of meaningful Federal funding
Lack of validation for Celiac Disease as a serious disease
Perception that the Gluten Free diet is all that is needed for treatment, as opposed to all that has ever been available
Small number of established research, advocacy and education programs
Under-resourced research, advocacy and education programs
Recruitment of young investigators has been inhibited
Brain drain of scientific and medical talent away from Celiac Disease
Fewer NIH grant submissions for Celiac research
Narrow expertise of NIH review committees over time continuing through today
No representation from the Celiac community on the NIH's Autoimmune Disease Coordinating Committee (this was changed in 2020 after this was highlighted to the NIH)
NIH did not put out any requests for Celiac Disease funding from June 1999 to November 2022 (the focus of this article)
Scarcity of corporate funding, especially without NIH funding validation
Scarcity of philanthropic funding, especially without NIH funding validation
NIH Web site language in 2020 suggests that: 1) Celiac Disease is just a digestive disorder and not an auto-immune disease with many debilitating symptoms, 2) a Gluten Free diet is all that is needed, 3) no recognition of food insecurity and treatment burden and 4) no recognition of food labeling laws with the Food Allergen Labeling and Consumer Protection Act and the implications of voluntary Gluten Free labeling
Celiac research funding has principally come from just National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), and not also National Institute of Allergy and Infectious Diseases – suggests an either/or approach by NIH, rather than a holistic strategy.
Ample Federal funding for other diseases have made those diseases more desirable among research institutions and investigators, so focus has been directed elsewhere.
We are hopeful that the NIH's Notice of Special Interest (NOSI): Accelerating Progress in Celiac Disease Research really does accelerate research in Celiac Disease, and begin to turn the tide for 3 million Americans with Celiac.
Celiac Disease can be cured! It is just a matter of money and time. In the interim, a treatment other than a strict Gluten Free diet for life can be found. It is just a matter of money and time.
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