St. John’s College of Pharmacy and Health Sciences was
recently awarded a $50,000 grant by the Food and Drug
Administration (FDA) to conduct research into the presence of
gluten in medications. The study is being conducted in conjunction
with the National Foundation for Celiac Awareness (NFCA), a
national not-for-profit organization created to raise awareness of
celiac disease and gluten intolerance among the general public and
healthcare community.
“We designed a survey instrument that’s posted on the NFCA Web
site,” said Robert Mangione, R.Ph.’77P, ’79GP, ’93PD, ’99Ed.D.,
Dean of St. John’s College of Pharmacy and Health Sciences who, along with NFCA Consultant Loretta Jay, is
Co-Primary Investigator of the study. “What we’re looking for in
the survey is to determine whether the respondent has ever taken a
medication that he or she feels has caused an adverse effect
because it contained gluten. Once we get that information we’ll
actually acquire the medication and Dr. S. William Zito ’66P, who
is a medicinal chemist on our faculty, will do a special
examination to see if it has gluten in it. Then Dr. Somnath Pal,
another faculty member who happens to be a bio-statistician, will
help us with crunching the data to determine what’s really
significant and what’s not. This is one of the first comprehensive
studies of gluten in medication from a patient’s perspective, and
that’s what makes it so significant.”
Since being diagnosed with celiac disease in 2004, Mangione has
been personally active within the NFCA and currently serves as a
member of their Scientific and Medical Advisory Board. He began to
investigate this issue on his own, and soon realized that there
were numerous anecdotal references but very limited concrete data
to support the belief that the presence of gluten in medications is
a legitimate concern. He and his NFCA colleagues saw this as an
opportunity to generate a unique grant proposal that subjected the
suppositions of consumers to rigorous scientific examination. They
were informed in late 2011 that their proposal had been
approved.
Most drugs contain fillers and binders that are derived from
starches, and many of these ingredients contain gluten. These
fillers are used to give the tablets bulk and shape, and impact the
way in which the active ingredient is absorbed into the body. There
are, however, many substitutes that can be used in gluten-free
fillers and binders for medications.
“Corn is certainly an acceptable alternative that’s commonly used,”
noted Mangione. “In the food industry, gluten-free foods are much
more expensive, but with pharmaceuticals, replacing gluten with
something else should not impact the cost of the product, because
the manufacturing process will remain the same. Of course, we’d
have to do additional research on the new gluten-free medications’
bioavailability, which is the ability of the tablet to dissolve
within the body. Happily, we have some very smart people here at
St. John’s who can study that factor.”
Research confirms that as little as 50 milligrams or less of a
daily exposure to gluten is enough to cause both short- and
long-term adverse effects in sensitive individuals. It is estimated
that approximately 3 million Americans currently suffer from celiac
disease, and nearly 95% of those patients remain undiagnosed and
regularly ingest medications that contribute to or worsen their
condition.
Mangione believes that once consumers and prescribers become more
aware of the prevalence of gluten in some medications and not in
others, the social implications of consumer and prescriber behavior
will have an impact on society, similar to the way that an
awareness of gluten in foods has produced many gluten free
alternatives.
“I believe that a knowledge of the gluten content in
pharmaceuticals will impact prescribing behavior,” he said. “When
healthcare professionals are caring for celiac patients, they
should really be thinking about whether a product is gluten-free,
because that will impact the way in which their patient needs to be
medicated. If prescribers are aware that a particular medication is
gluten-free, that’s what they will hopefully use if they know or
even suspect that a patient has celiac disease. Studies such as
ours will definitely help to provide this awareness.”
He also sees an expanded role for pharmacists in the overall
treatment of celiac disease patients once the results of the study
are made public.
“Pharmacists have not been consistently involved in celiac care,”
he said “They’re becoming more involved now, and hopefully this
study will demonstrate the contributions that pharmacists can make
in this important area of healthcare. At the College of Pharmacy and Health Sciences, the approach that we’re taking in
conducting this research is very much in line with our Vincentian
and Catholic mission, because as pharmacists we’re definitely doing
something to make a difference for others, particularly when you
realize that this is an area that’s been overlooked for some
time.”