Category Archives: GF Items of Interest

Gluten in Medicines?

We all know that given the world we live in, gluten is nearly as prevalent as the air we breathe. It’s everywhere, including maybe some of the prescription-issued and OTC medicines we use. And when the GF-free question is asked of the doctor or pharmacist, not always is an accurate answer immediate, although the need for the medicine is. This question of gluten free excipients, which are the inert substances used in drugs, can also apply to eye contacts and contact solutions.

Presently, there are no regulations – state or federal – that require medicine manufactures to list gluten ingredients in their drugs or products, but the The Food and Drug Administration recognizes the need for such labeling and has issued a $50,000 grant to the National Foundation for Celiac Awareness to conduct scientific research into gluten in medication; the study is titled Gluten in Medication.

NFCA will be joined in the study by experts in the field who will be examining both prescription and OTC drugs, and will consult with people who are on a gluten free diet who have expressed adverse affects when taking specific medications.

Scientific research began in November, 2011, and questionnaires are due to be sent out in early 2012 to the gluten free community seeking their input which will all be factored into the mix before recommendations are suggested to the FDA.

For more information you may contact NFCA at www.celiaccentral.org.

Progress On Developing Drug To Combat Gluten for Celiacs

We all know, only too well, how very difficult it is to live a gluten free life. Not so much at home where we are in control of the foods, recipes, and products bought, prepared and consumed, but what happens when we go out? Shopping, dinner, to attend events from funerals to weddings, to tailgate parties before a ballgame, to reunions, to business meetings, and ad infinitum. There’s a hundred, if not a thousand times we are uncomfortably confronted with the burden of politely refusing to eat what’s being served – although we’re starving! Not to mention snuggling up to a bar and ordering a gluten free beer? “A what free?” is too often the reply. And food is only the beginning. Shampoos, medicines, makeup, incorrect or no labeling on products – all enter into the life of we who must avoid products that contain wheat, barley or rye.

On the horizon are a number of promising drugs that do not, at this time, portend to be able to reverse a person’s autoimmune system to accept gluten but rather, to neutralize the affects of gluten ingestion. Think of it. You’re invited out with friends to their favorite Italian restaurant where homemade pasta and fresh bread are their specialties. If you could take a pill that would neutralize the gluten you would be consuming, would it not be worth it? And then, next day, back to your gluten free diet.

Alvine Pharmaceuticals in San Carlos, California completed their 2nd Phase of testing a drug that has the potential to “Diminish gluten-induced injury for Celiacs.” The following is a direct quote from the company’s October 24, 2011 News Release attributed to Markku Maeki, M.D. chair and professor of pediatrics at the University of Tampere, Finland and coordinating investigator of the ALV003 Phase 2 trial.

“The results are groundbreaking as they demonstrate for the first time, in a controlled clinical trial, that a drug has the potential to diminish gluten-induced injury in celiac patients.

Phase 2a Trial Design in the double-bind, placebo-controlled Phase 2a clinical trail, 41 well-controlled, well-characterized adult celiac patients who were maintained on a GFD for one or more years, were randomized to receive ALV003 or placebo daily for six weeks at the time of ingestion of 2g of gluten in the form of bread crumbs. Study participants underwent small bowel biopsy at the beginning of the trail and after being given the daily gluten challenge for six weeks.

The results:

– Biopsy date demonstrated significantly less small intestinal mucosal injury as measured by Vh:Cd in patients treated with ALV003 then in placebo-treated patients

– IELs, including CD3+ and CD3+ alpha/beta and gamma/delta sublets, which measures inflammatory response, were significantly unchanged in the ALV003-treated patients but significantly increased in the placebo-treated patients.”

More on this encouraging R&D as it becomes available.

Is Bullying a problem towards children with Celiac?

Children often experience teasing when growing up and it can occur at any time, any place and can have serious affects both physically and emotionally. We often associate teasing with the way one dresses, the way one talks, nationality or who their friends are, but being labeled as having a “disease” can also be cause for taunting and to be shunned.

Think of it. Johnny walks into a pizza parlor and his friends, trying to be funny and smart, move away exclaiming “ Johnny has Celiac Disease” but chances are no one in the group knows that Celiac Disease is an autoimmune condition, is not contagious and therefore of no danger to anyone. Johnny is devastated, smiles the best he can, turns and walks home, depressed with his self-esteem at rock bottom. This form of bullying can have negative consequences on his school work, his behavior and unless it is recognized and addressed, could carry over into his adult life with equally serious consequences.

But the very word ‘disease’ frightens most children (and some adults too) and it’s a problem the Celiac community needs to address. Why, when new gluten free products come out or Celiac is being reviewed by the media, why do they list the disastrous ‘could-happen’ physical problems if Celiac is left untreated, and why do they always say “Celiac Disease” instead of just “Celiac.”

We know that Cancer is a disease but no one says “Cancer Disease.” Diabetes is a disease but no one says “Diabetes Disease.” And when cancer or diabetes is mentioned, there is rarely if ever a list of dire consequences if left untreated as there are when Celiac Disease is mentioned.

More on this later. What do you think?