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.”