Lawrence Anderew Welkowitz - Comment
|Document ID: FDA-2011-N-0842-0037||Document Type: Public Submission|
This is comment on Notice: Gluten in Drug ProductsDocket ID:
I am Professor of Psychology at Keene State College in NH, USA and a parent of a child with diagnosed Celiac Disease. I am writing both as a parent and as a professional who has been working with a gastroenterologist, Dr. Daniel Rath, Director of GI at Dartmouth Clinic/Keene in discussion of issues related to Celiac Disease. I have had several recent experiences in which I have purchased medicines (e.g., aspirin or tylenol subsititute) where it has taken several days to learn about gluten content of the medicines. The information is extremely difficult to obtain, involving first calling the number on the label, contacting a distributor (e.g., for generic distiributors who are only available during work hours), who in turn contact pill makers, who in turn take days (if ever) to return calls with correct information. The contact people are often not knowledgeable about basics (e.g., what might be in gelatinous starch). In one case, it took 4 days to obtain information, in the second case I have not received information after 5 days of waiting). Please understand that if my child has a fever, and I am unable to find out the gluten content of something as basic as aspirin or tylenol, then I have to decide between delaying treatment of her fever or possibly making her sick. What is even more frustrating is that this information is not available to pharmacists at where these drugs are sold (e.g., Shaw's Supermarkets, Supervalu, Ostco, local pharmacies) nor available on the label or on the web. Also, most individuals with Celiac are not aware that medicines often contain gluten. Customer Service at pill distributors know little about gluten and tend not even to know who the pill manufacturers are...at least not without considerable research. Most people with Celiac are not aware of these problems, do not have the research skills to find answers, and distributors and pill makers are well aware that they are poisoning tens of thousands of patients.