St. John’s Awarded FDA Grant to Conduct Groundbreaking Celiac Disease Study

January 05, 2012


The College of Pharmacy and Allied Health Professions and the National Foundation for Celiac Awareness (NFCA) have received a highly competitive $50,000 grant to conduct the first major research study on gluten in medications.     

The need for this research is underscored by the fact that an estimated 3 million people nationwide have celiac disease — a condition in which an intolerance to gluten results in damage to the small intestine as well as other complications. Gluten is found in all products containing wheat, barley or rye. The grant was conferred by the Food and Drug Administration (FDA).
 
Robert A. Mangione, Ed.D., R.Ph., Dean of St. John’s College of Pharmacy and Allied Health Professions and a member of the NFCA Scientific/Medical Advisory Board is the study’s Co-Primary Investigator. Along with NFCA Consultant Loretta Jay, the study’s other Co-Primary Investigator, he created the survey that will make it possible to gather information on adverse reactions to specific medications. The survey, which has been posted on the NFCA website, will reach a significant portion of the nation’s celiac disease population.   

Praising the FDA for supporting the study, Dean Mangione hailed the agency for what it has done so far to safeguard celiac patients. “While the agency has made significant progress in the labeling of foods that contain wheat,” he noted, “it still needs to do the same for foods containing rye or barley.”  

“Focusing on the need to also identify pharmaceutical products containing gluten,” Dean Mangione added, “will greatly enhance the ability of patients to manage their disease.”  

A celiac patient himself, Dean Mangione is personally as well as professionally committed to educating fellow patients and pharmacists about how to manage the disease. As part of this commitment, he is also involved in raising public awareness about the seriousness of the disorder. “According to current estimates, “ he said, “95 % of those who have the disease have not yet been diagnosed.”  

He is gratified that St. John’s has been asked to collaborate on this project and has enlisted the services of two of his colleagues — S. William Zito, Ph.D., Professor of Pharmaceutical Sciences and Somnath Pal, Ph.D., Professor of Pharmacy and Administrative Sciences. Dr. Zito will analyze the percentage of gluten content in cited medications, while Dr. Pal will provide a statistical analysis of the study’s findings. 

Plans call for the research to be completed by March 2012 to make it possible to deliver the results as soon as possible. “Our goal,” said Dean Mangione, “is to lay the foundation for further FDA studies about this critical issue as soon as possible.”

With the invaluable help of one of his students, Priyanka Gaitonde, ’11GP, he also participated in a recent study evaluating the quality of care pharmacists provide to people who have celiac disease or other forms of gluten sensitivity. The results of the study, which was conducted in partnership with Dr. Peter H.R.Green, Director of the Celiac Disease Center at Columbia University, will be submitted for publication in the near future.

Describing celiac disease in the U.S. as a “hidden epidemic,” Dean Mangione said, “I am convinced that pharmacists can and should play a major role in raising public awareness about this often overlooked condition. They also are ideally positioned to help patients live with and manage this serious disorder.”