Asperger's Conversations

Testimony/Comments on Gluten in Medications for FDA (Continued)

It's not easy to find your way through the gov documents to locate public submissions to the FDA regarding public commentary on gluten in medications.  After a bit of whining (message to "person in charge" of this particular "docket") I was directed through the maze of links to get there.  To view all comments click HERE.

Here is one of 46 comments submitted (I posted mine earlier).  This one by Ian Taylor, MD on behalf of the American Gastroenterological Association.  The AGA strongly supports clear labeling of gluten and that information be available to pharmacists and others about gluten in medications:

March 20, 2012

Margaret Hamburg, M.D. FDA Commissioner Food and Drug Administration Division of Dockets Management (HFA‐305) 5630 Fishers Lane, Rm.1061

Rockville, MD 20852

Re: FDA–2011–N–0842 Gluten in Drug Products; Request for Information and Comments

Dear Commissioner Hamburg:

The American Gastroenterological Association (AGA) is the trusted voice of the GI community. Founded in 1897, the AGA has grown to include 17,000 members from around the globe who are involved in all aspects of the science, practice and advancement of gastroenterology. The AGA Institute administers the practice, research and educational programs of the organization. The AGA appreciates the opportunity to provide comments on the request for information regarding gluten in drug products.

Celiac disease is an increasingly‐common, lifelong condition affecting as many as two million Americans. The only effective treatment for this is a gluten‐free diet, wherein the affected individual must avoid ingesting any gluten, i.e. the protein from wheat, barley and rye. The patient must remain highly vigilant in terms of hidden glutens in food or other ingested materials. The diet is not only difficult to follow, but patients must be aware of the non‐obvious gluten; even non‐food sometimes may be a problem. Very low doses or concentrations of gluten may be sufficient to cause inflammatory changes and/orsymptoms in patients with celiac disease. Doses as low as 50 mg have been shown to induce change.

The median age at diagnosis of celiac disease in the United States is 45 years. Many patients are diagnosed in advanced adulthood by which time they often need prescription medications for common conditions like hypertension. A frequent concern among patients and their doctors is whether their medications could contain gluten. This fear or concern leads to often‐difficult interrogations of patient’s medications by their pharmacists and physicians.

Recommendation

It is the view of the AGA that no ingredient derived from wheat, barley or rye should be included as part of any incipient ingredient in medications, over‐the‐counter or prescription. The only exceptions to this would be derivatives that have been proven to have a concentration of less than 20 parts/million verified by an assay sensitive for these proteins. Any medication wherein these ingredients exceed or could exceed >20 parts/million threshold need to be clearly labeled as “gluten‐containing.” This labeling must be clearly evident to the pharmacist and patient, as well as declared on the insert.

Rationale

There are many reasons why we believe that this should be so. Firstly, the difficulty of getting accurate information on gluten content makes life very difficult for manufacturing, physicians, pharmacists, and patients with celiac disease. This is further exacerbated by the wide use of generic medications, which are often interchangeable in patients from one prescription refill to another. This often occurs due to contracting or changes in insurance coverage by patients. Secondly, the essential nature of many medications for patients’ wellbeing and the hazard that patients avoid medications because of fear of gluten contamination is another reason why medications should generally be free of gluten. Thirdly, there should be consistency within the FDA

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between the food branch and the regulatory branch for medications. Currently, foods cannot contain wheat unless they are so labeled. At a minimum, this should apply to medications. Wheat is one of the listed common allergens that require specific labeling on foods under the FANA 2004.

The impact of avoiding gluten medications could be many fold. 1. This would have a substantial, reassuring effect on patients,

pharmacists, and physicians caring for patients with celiac

disease. 2. It would have significant time saving for any of these

individuals. 3. It may improve compliance of patients with their therapies. 4. There should be a cost saving to these patients as generic

medications would be interchangeable with no need to order

“dispense as written.” 5. Pharmacists would be clearly able to reassure clients of the

gluten‐free nature of the medications. 6. Doctors who care for celiac disease patients can prescribe freely

without the time wasting or without the concern regarding potential contamination or patient compliance with either prescribed medication or the gluten‐free diet.

It is possible that there could be some impact on the pharmaceutical industry for this change; however, as most of the incipient ingredients are likely sourced from relatively few manufacturers, it should not take a major change. It may be easier for the pharmaceutical company’s consumer/medical information line to accurately inform patients, pharmacists and physicians on gluten content of their products. In addition, the major source of starch in the U.S. is corn. Wheat is a major source of starch in other jurisdictions, such as Europe. It would seem to be economically beneficial to the U.S. to base much of the starch used as a filler on the dominate grain source available in the U.S. We believe that whatever temporary or minor impact there might be on the U.S. pharmaceutical industry will be minor compared to the

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savings and improvement of quality of life and efficiencies in caring for patients with celiac disease.

Thank you for your consideration of AGA’s comments on the presence of gluten in drug products. If we may provide additional information, please contact Elizabeth Wolf, AGA director of regulatory affairs, at 240‐482‐3223 or ewolf@gastro.org.

Sincerely,

Ian L. Taylor, MD, PhD, AGAF Chair American Gastroenterological Association

 

Tagging Celiac in Digital Pharmacy Files: Attorneys Get Your Parachutes Ready

I recently wrote a piece about my frustrations in determining whether certain medications were gluten-free or not (summary note: It's not always easy to determine).  I also posted testimony I submitted to the FDA on gluten-free labeling of medications.  Most recently I had an experience at a local CVS where I discovered that my kid's CVS digital "profile" did note that she had Celiac Disease but that the pharmacist on night duty claimed that he "never heard of Celiac."  After I informed him about it, I asked if you would find out but he replied that it was not possible to find out "after hours" but that he would leave a message for the pharmacist on duty in the morning.

As it ended up, the pill manufacturer did have a 24 hour service (I called them myself).  The CVS pharmacist also told me to "go online and find out." When I explained that some of the websites seemed difficult to decipher and were of unknown reliability, he responded by saying, "We don't have internet at the pharmacy." (Note: I did then asked him if he carried a smart phone but he ignored the question).

My big point: Pharmacies must 1. Take note if patients have Celiac Disease (Sprue) in their digital profile 2. Make note of the pill manufacturer AND LOT NUMBER on the pill bottle (use of wheat or corn in gelatinized starch or modified food starch varies from lot to lot) and 3. Contact the pill manufacturer (with lot number in hand) to determine gluten-free status of the pills.  

With prevalence rates conservatively estimated to be 1/130  companies like CVS and Ostco need to be on high alert that they may well be poisoning thousands of patients daily.  Aside from the moral question, the legal ramifications are huge.  I keep telling them this, but if the FDA fails to step in soon, the lawyers will begin parachuting in just as they did in the McDonald's class action gluten suit.

It takes a village (or two condos and a non-profit) to compost

I bumped in to my neighbor, Peter, who lives across the street in the old Cracker Factory (condo in Keene, NH).  Mary Ann (from the non-profit business incubator nearby) had asked him to bring over his composting bin that's been sitting idle in my condo building (The Carriage House) on the same street.  I helped Peter carry it over and so began a little experiment in city composting.  I think it's working because there's quite a bit of stuff already in the bin.  As Arlo Guthrie might say, people might just think it's a movement!

College Profs' nightmare: Custom Paper Writers on Net

It's one thing for people to cook up awful ways to make money ("let's write papers for students so they don't have to do it themselves!"), but another thing when they go one step further: Post nonsense comments on my (and other profs') blogs to create links to their websites.  So I won't post a link to the latest web criminal ("Rapid Writers") but let's at least be aware that these folks are not only promoting academic dishonesty but also violating the unwritten ethical rules of the web (they're not nice people).

Tags and strange bedfellows: Space Travel and College Kids Gone Wild

Jon Udell recently talked about tags and how they can serve as a connector in communities.  As a humorous (I think) note to that, I have observed that the college students here at Keene State College use the hashtag #KSC on twitter.  Not surprisingly, the folks at the Kennedy Space Center use the same #KSC identifier.  This means that our college kids' tweets pile up in the same space as those of the people working at the Kennedy Space Center (think intoxicated ramblings mixing with ideas about space travel!).  The "Global Brain" creates strange connections and I'm sure that employees at the Space Center are marveling at what our students here in Keene are bragging about (oy vey).

My Comments Submitted to FDA on Gluten labeling of Medicines

Document Details

Lawrence Anderew Welkowitz - Comment

Document ID: FDA-2011-N-0842-0037	Document Type: Public Submission
This is comment on Notice: Gluten in Drug Products Docket ID:  FDA-2011-N-0842

View Document:

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Comment:

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.

 

Thoughts About Keene State College President and Provost Leaving

Last week both the President and the Provost of our College announced that they were leaving, one to be President of a university in Philadelphia, the other to be Chancellor at another in Washington State.  Quite a lot for a small state college to hear in one week and quite a lot of chatter about “what’s gonna happen?”  There have even been more than a fair share of “Al Haig…who’s in charge?” jokes and general confusion about who’s making decisions around here.

Lots of folks have been asking me “what’s going on? Why did the President and Provost take off? Who’s taking over those positions?  Will things fall apart?”

The funny part is that of course things are not falling apart.  And if you walked our campus today, you would see students walking to class, Professors teaching and meeting with students in their offices, lacrosse players heading to the sports fields for a scheduled match.  In truth, everyone knows how to do their jobs despite a kind of power vacuum at the top.  Admissions staff work on admissions, Campus safety officers patrol the campus, lab assistants prepare labs, and college life continues.

When asked by local press about my thoughts about our President and Provost I had positive things to say.  One working hard to support changes in college curriculum and help bring positive attention to our campus from across the country, the other taking an active role to integrate new technologies and teaching and research.  All good!

There is something else, though, that should be said.  And here is where “personal” becomes “political.”  And that is that our departing President and Provost were struggling to maintain high standards in a state that has shown little interest in supporting higher education.  The NH legislature has made draconian cutbacks to its colleges and universities…nearly 45% which is by far the largest slashing of higher education than any other state in the country.  Put simply, NH ranks last in the United States in supporting public college education.  We are the worst.

In truth, I love this College and our staff and faculty and students.  We do a lot with what we’ve got, and I admire my colleagues who work hard to provide excellent service to our students.  But let’s be honest, the continued assault by the state must have exhausted these fine folks.  Their jobs must have become a bit depressing.

And in the end, the people who are hurt the most are our students.  The kids we care about who are forced to pay higher and higher tuition and take on the largest debt of any students in any state because of the lack of support of our citizenry.  I know my friends and colleagues here at the College will keep our noses to the grind stone, continue to teach and bring in research funds to pay our students to collaborate in our studies so that they can publish and move on to do great things themselves.  But this is wearing thin and it’s time for those of us in the trenches to speak up so that the college kids we care so much about have a running chance in a tough world.

 

Gluten-Free labeling of Medicine: What Exactly are the FDA rules?

I recently talked about a frustrating experience in trying to find out whether chewable aspirin I purchased contained gluten.  The label said it contained "starch" but did not specifiy whether it was "wheat" or "corn" starch, a critical difference for those with diagnosed Celiac Disease (about 1 percent prevalence according to the FDA).  I bounced from customer service to company pharmacists to pill distributors to pill maker across several days...provided lot numbers, waited for call backs, and finally got the answer from a guy named Matthew at Perrigo (named by Fortune Magazine as one of the top 100 growing companies).  Sadly, Matthew and I played phone tag since their offices close at 5pm EST in the U.S. but eventually he was able to look it up based on the lot numbers on the bottle.

My question for Matthew (and his supervisor): Why not make the information on Matthew's screen available to everyone (or at least to pharmacists at the supermarkets and pharmacies where the pills are sold)?  The supervisor (who was very cordial) talked about various problems in labeling, for example, finding space on already crowded labels, revenue systems for access to information, gradual movement toward changes in labeling coming from the FDA.

But the answer seems simple to me.  If the pill maker "knows" the answer (it either has gluten in the pills or doesn't) why not make that information freely available...either on the web or on the label?

I've sent a message to the FDA asking for clarification on their rules and I'll be sure to post any relevant information on my blog.

Twitter in the Classroom: Chatting with Colleagues about my Experiment

Y-Combinator, Connectors, Success

Emma Haak and David Lidsky interviewed scores of techies in the Valley to figure out their paths to success.  An infographic of their interviews can be found on Cliff Kuang's blog which I found on Ben Robertson's Twitter page (always cite sources, right?).  In sum, social connections matter and they happen in lots of ways, from being on each others' frisbee teams to being video game buddies...and to having planned dinners designed to connect innovators.  The paths are often circuitous, e.g., from meeting at a wedding, to joining each others' broom ball team, to meeting others at those games, and so on (see the infographic and pick a random path).  The big point is that Y-Combinator can be "manipulated" by arranging regular "connector meetings" in the form of weekly dinners and so on.  In this way, individuals get to meet potential mentors in a more direct and guaranteed manner.

I am reminded of social media breakfasts which became popular, at least on the seacoast out this way (I'm actually tucked in the southwest corner of NH near VT...away from most happenings).  But social media gatherings did not deliberately pair innovators with mentors, but instead were simply gathering places for social media types.

I'm thinking we should consider the "Y-Combinator" concept as we try to help out lots of folks, including graduating college students seeking jobs, internships, graduate opportunities; individuals with special skills but poor connecting skills, and so on.