The National Foundation for Celiac Awareness (NFCA) breaks down the most commonly asked questions about the landmark GREAT3 Workshop.
Big things are happening in the field of celiac disease. On March 31, 2015, the U.S. Food and Drug Administration (FDA) will be hosting a landmark event that will examine the unmet needs of the celiac disease community and look for treatments beyond the gluten-free diet. This event, called the Gastroenterology Regulatory Endpoints and the Advancement of Therapeutics (GREAT) 3 Workshop, is the first of its kind in the field of celiac disease.
The celiac disease community has voiced both their concerns and excitement surrounding potential pharmaceutical treatments for the serious genetic autoimmune condition. Lots of questions about the Workshop and the need for pharmaceutical options have come up, so we are addressing your concerns in this GREAT3 FAQ.
Q. Why is the FDA hosting the GREAT3 Workshop?
A. Research is showing that the gluten-free diet is not enough to manage celiac disease for most people affected by the condition. Even those who are incredibly strict about maintaining their gluten-free diet may still be having persistent intestinal damage and ongoing symptoms. These effects can lead to patients experiencing a reduced quality of life and may also put patients at risk for developing other serious health problems. Left untreated or mismanaged, celiac disease has been linked to certain cancers, other autoimmune diseases, infertility, osteoporosis and more. Because of this, an alternative to or supplement for the gluten-free diet is essential for the health of those living with celiac disease.
The FDA is seeking to understand the needs of the community and outline what success in the field of celiac disease therapeutics looks like.
Q. What does the Workshop mean for me?
A. The GREAT3 Workshop is a major milestone for the celiac disease community. For the first time, the FDA is coming together to talk about the remaining unmet medical needs of the community. This means that celiac disease is being recognized as the serious genetic autoimmune disease that it is, not the passing fad diet or food allergy that it is commonly made out to be.
The Workshop is a stepping stone on the path to better understanding how important stakeholders including physicians, scientists, the biopharmaceutical and diagnostics industries, patients, and the FDA can work together to improve the lives of those living with celiac disease using new treatment options. Understandably, some in the community would prefer to maintain a gluten-free diet instead of using pharmaceuticals. The unfortunate truth, however, is that most people with celiac disease still have ongoing intestinal damage and symptoms, despite their best efforts to remain strictly gluten-free. Having a pharmaceutical treatment could help people with celiac disease live longer and live better without persistent symptoms or a reduced quality of life.
Q. Why is my participation in research important?
A. In every field, research cannot move forward without the participation of those affected by the disease. We are in the midst of an exciting time where doctors and patients are working hand-in-hand to accelerate research. Only through patient participation can drugs be made available. This is the case for every medication available on the market – from over-the-counter pain relievers to prescription drugs, like those used to treat thyroid disease, for example, have gone through a clinical trial process that included patient participation.
By staying educated on research milestones, like the GREAT3 Workshop, you will gain a better understanding of your disease and know the latest issues, advice and research results so you can live better with celiac disease.
Q. How is the National Foundation for Celiac Awareness (NFCA) involved?
A. NFCA President and CEO Alice Bast will be presenting during the Workshop. She will focus on the burden of living with celiac disease (financially, socially, emotionally, etc.), explain what daily life is like for those living with the condition and share the community’s opinions on what they desire when it comes to treating celiac disease.
Kristin Voorhees, MA, NFCA Director of Healthcare Initiatives, will be moderating an NFCA free webinar following the Workshop entitled, “The Future of Drug Therapy for Celiac Disease: Get the Honest Facts.” Learn more about the webinar, its expert panel and register here.
Q. Will other experts be attending the Workshop?
A. Yes, many experts in the celiac disease field will be at the Workshop. The Workshop is being driven by an expert Steering Committee:
You can also see the Workshop’s meeting agenda here.
Q. How can I get involved in the GREAT3 Workshop?
Webcast access:
Telephone access:
Q. How can I keep up-to-date on the latest in celiac disease drug therapies?
A. In the near future, the FDA plans to make the presentation slides available at www.great3.org.
In addition to tuning in to GREAT3 through remote access, you can stay in the loop by:
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