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Found 15 results

  1. Celiac.com 07/09/2009 - Rates of celiac disease are four times higher today than they were just fifty years ago, according to the results of a new study by scientists at the Mayo clinic. In addition, the study showed that people with undiagnosed celiac disease died at rates four times higher than non-celiacs over the 45 year follow-up period. Celiac disease is an immune system reaction to gluten in the diet which, left untreated, celiac disease causes damage to the lining of the digestive tract and leaves sufferers at risk for various cancers and other associated conditions. When people with celiac disease eat wheat, barley or rye, a protein called gluten triggers an immune system attack, which damages the villi in the small intestine.Villi are finger-like folds in the intestine that increase surface area for nutrient absorption. Celiac disease symptoms may include diarrhea, abdominal discomfort, weight loss, anemia, unexplained infertility, loss of teeth or even premature or severe osteoporosis, among others. Joseph Murray, M.D., the Mayo Clinic gastroenterologist who led the study says celiac disease "now affects about one in a hundred people. We also have shown that undiagnosed or 'silent' celiac disease may have a significant impact on survival. The increasing prevalence, combined with the mortality impact, suggests celiac disease could be a significant public health issue." So, celiac disease is striking a higher than ever portion of the population, yet doctors don't yet fully understand the reasons for this reality. A team of Mayo Clinic scientists team performed celiac disease antibody tests on blood samples gathered at Wyoming's Warren Air Force Base (AFB) between 1948 and 1954. They then compared those blood test results with results from two recently collected groups from Olmsted County, Minn. Tests for the first group were matched by age to those from the Warren AFB group at the time of the blood draw, while the second group was matched by birth years. Researchers found that young people today are 4.5 times more likely to have celiac disease than young people were in the 1950s, while those whose birth years matched the Warren AFB participants were four times more likely to have celiac disease. Celiac disease was once thought to be rare, and many physicians still regard it as so, but, according to Dr. Murray, that is no longer the case. "Celiac disease is unusual, but it's no longer rare," he says. Dr. Murray adds: "Something has changed in our environment to make it much more common. Until recently, the standard approach to finding celiac disease has been to wait for people to complain of symptoms and to come to the doctor for investigation. This study suggests that we may need to consider looking for celiac disease in the general population, more like we do in testing for cholesterol or blood pressure." For Dr. Murray, the findings underscore the importance of raising awareness of celiac disease, both among physicians and patients. He adds that some studies "have suggested that for every person who has been diagnosed with celiac disease, there are likely 30 who have it, but are not diagnosed. And given the nearly quadrupled mortality risk for silent celiac disease we have shown in our study, getting more patients and health professionals to consider the possibility of celiac disease is important." One interesting point not touched on in the study is the increase in the gluten content of commercial varieties of wheat now being grown compared to gluten levels of 50 years ago. Additionally, people are eating more wheat and gluten than ever before. (http://www.mayoclinic.org/bio/13032852.html) Gastroenterology, July 2009;137(1)pp 373-374
  2. Celiac.com 04/12/2011 - Paul Seelig was found guilty today of 23 counts of obtaining property by false pretense after a two-week trial in Durham, NC. The jury found that he illegally represented baked goods as gluten-free, but they actually contained gluten. Mr. Seelig received an 11 year prison sentence for his crimes, which included the sickening of more than two dozen customers, one of whom had a premature delivery that was possibly caused by her involuntary gluten consumption. Seelig's company, Great Specialty Products, purchased regular gluten-containing items from companies in New Jersey such as Costco, and then repackaged them in his home kitchen and sold them as "gluten-free" at the NC State Fair, various street fairs and via home delivery. Seelig claimed that his baked items were homemade in his company's 150,000-square-foot commercial kitchen, and that his company raised its own grains on its 400-acre farm. High gluten levels were detected by both customers and investigators in Seelig's supposedly gluten-free bread, even though he claimed that he tested his bread weekly for gluten and found none. Mr. Seelig could not produce any of his test results at trial. Source: http://www.newsobserver.com/2011/04/12/1123724/bread-seller-lied-jurors-find.html
  3. Celiac.com 08/12/2017 - The latest research report from HTF Market Intelligence Consulting is titled "Global Celiac Disease Drugs Market 2017-2021." The report offers detailed information and analysis of the competitive market landscape, forecast and strategies. The report covers geographic analysis that includes regions like Americas, APAC, EMEA, along with important players, including F. Hoffmann-La Roche, Johnson & Johnson, Merck, and Pfizer. It provides information, market insights, future trends and growth prospects for forecast period of 2017-2021. The report presents a detailed picture of the market by way of study, synthesis, and summation of data from multiple sources, and research analysts project the global market for celiac disease drugs to grow at a CAGR of 24.22% during the period through 2021. The primary treatment for celiac disease is still a completely gluten-free diet. There are a small number of anti-inflammatory and immunosuppressant drugs and nutritional supplements that are used as off-label, secondary treatments in celiac disease, but as yet, no drugs approved for primary treatment of celiac disease. Development of such treatments for celiac disease offers huge potential for profit to any company who can get a drug approved for the commercial market. The growth projections attempt to reflect the data behind a fast growing global market. Request a sample report at: htfmarketreport.com
  4. This article originally appeared in the Winter 2004 edition of Celiac.com's Journal of Gluten-Sensitivity. Celiac.com 10/04/2010 - When Tyler was diagnosed with celiac disease at the age of 18 months, I wanted desperately to talk to a kid––one who could talk––about what it’s like to have celiac disease. Do you feel jipped? Does it make you sad? Do you feel “different” from the other kids?!? I was heartbroken––grief-stricken––I had a long way to go before I would evolve into the cheerleader I hope I’ve become in helping people live––and love––the gluten-free lifestyle. Oh, sure, friends and family told me “it would be okay,” the way friends and family do in tough situations. But I felt they were just placating me––after all, what did they know? They hadn’t even heard of celiac disease before I had explained the diagnosis. And to be honest, I didn’t care much at that time about what adults thought of the situation––I wanted desperately to hear from a kid: “Look at me––I turned out just fine!” That was nearly 13 years ago, and there weren’t any kids who had celiac disease––none that I knew of, anyway. So we blazed our own trail, working hard to approach our unique challenges with optimism each and every step of the way. Recently, I was reminded of the way I felt when Tyler was first diagnosed, when a woman with tears in her eyes approached me after one of my talks. “I know you talk about how we can all learn to live and love this lifestyle, and I appreciate your suggestions for raising happy, healthy, gluten-free kids––but,” she seemed shy and embarrassed to continue, looking at the floor as she asked, “would you mind if I talked directly to Tyler?” But of course! How could I have forgotten? That need to talk to a child who had been through it was so compelling at first––and now Tyler could talk! Sure you can, was my automatic reply, knowing that my 14 (and-a-half) year-old-I-at-least-like-to-pretend-that-everything-you-do-annoys-me son would be less than thrilled to take the call. I would love for Tyler to write an article telling you how celiac disease is no big deal in his life. He did so a few years ago for my first book, “Kids with Celiac Disease,” when he wrote Chapter One: “What it’s like to be a kid with celiac disease,” but that was when he was only ten. That was before he turned into a teenager and had to start pretending not to want to do the things we ask him to do. The truth is that this has never been a big deal for Tyler. We gave him control of his diet from day one, which I believe is crucial. We have always maintained an optimistic, yet realistic approach, with Tyler and his non-celiac but oh-so-supportive sister Kelsie, her being our guiding light in terms of inspiration and positive attitude. One day, a few months after he had been interviewed on a local TV station, Tyler was approached by a woman who attended one of our R.O.C.K. (Raising Our Celiac Kids) parties. I watched with curiosity and felt somewhat protective and guarded as this woman I didn’t know quickly approached him and took one of his hands in both of hers in what seemed to be an affectionate gesture. “Tyler, you have changed my life,” she said boldly. Then 13 years old, he did what most 13-year-old boys might do, and said nothing––shooting an anxious glance my way, looking for guidance, but I was as bewildered as him. She began to get tears in her eyes as she continued. “I’m 65 years old. Three months ago, I was as sick as I could be. I had been to dozens of doctors, and had a list of symptoms a mile long. Everyone thought I was crazy––I even had to quit my job, because I was so sick. I truly wanted to die. Then I saw you on TV talking about celiac disease. I insisted on being tested, and was positive for celiac disease. I’ve been gluten-free ever since, and feel absolutely wonderful.” With that, she gave him a bear hug, and he shot me a glance that I couldn’t read. I’ve learned not to embarrass my kids (well, sometimes I do it intentionally, but that’s another story), so I said nothing, and Tyler went about his business. Several minutes later, Tyler approached me with a beaming smile. “Mom, now I know why you do this! It feels really good to help other people!” He has since decided that he’s blessed to have celiac disease, because it has provided him with an opportunity to reach out and help others––an act that even at his young age he realizes is as satisfying for him as it is for those he helps. Quite a perspective for a teenage boy, if I may brag about him a little! So while I would love for Tyler to write an article about this, those of you who have teenagers understand that it would be easier to teach my dog quantum physics than to have him sit down and write an article––so you’ll have to take my word for it. Thankfully, at this point, Tyler is a happy, healthy, gluten-free young man who thinks a lot more about baseball and his friends than he does about the restrictions of his diet. Other kids, teens, and young men and women I’ve met over the years have been equally optimistic and inspiring. So rest easy, parents––your kids will, in fact, be just fine…and I really do know this!
  5. Celiac.com 06/20/2016 - One evening in October 1999, while in my academic office at Baylor University Medical Center, Dallas, my professional and personal life changed in an instant. I had recently had the idea of testing stool for gluten sensitivity to possibly prove that patients with microscopic colitis, whom displayed an epidemiologic, pathologic, and genetic overlap with celiac disease but who rarely had positive blood tests against gluten (because they rarely had the small bowel villous atrophy of celiac disease; they had colitis which is inflammation in the colon). I had remembered that previous researchers in Scotland invasively placing tubes into certain patients without villous atrophy had been able to find antibodies to gluten deep inside the small intestine when they were absent from the blood. They called these patients latent celiacs. However, they never reported results of testing stool, which would have been a lot easier to collect because it did not require the multiple hours and patient invasion of placing tubes deep inside the intestine. That October afternoon I received the first set of results from my laboratory of a newly improved method we had developed for testing stool for the presence of antigliadin IgA, the main antibody against wheat gluten. It was about 7:00PM, it was dark outside, and late enough in the office for everyone to have gone home, allowing me a quiet setting to review these results. What I saw that night seemed like a window into the future and a medical-scientific Pandora's box, all at the same time. Not only did I see that about 75% of the microscopic colitis patients had a positive fecal antigliadin test but 25% of asymptomatic volunteers did also. I quickly did the math, and realized that celiac disease at a prevalence of even 1% would pale in comparison to these statistics, revealing that hundreds of thousands of people in the US and the world may be gluten sensitive without having celiac disease. I knew that I had just been given information that no one else in the world knew, and that it would likely have major public health implications resulting from a new dietary-induced disease paradigm. That the main staple food of Western civilization may be causing large percentages of the population to have symptoms and syndromes, not only colitis, but perhaps also irritable bowel syndrome, autoimmune syndromes, short stature in children, multiple allergies and chemical sensitivities, and even idiopathic psycho-neurologic syndromes like depression, Parkinson's Disease or Lou Gehrig's disease. Not to mention what it might mean for me as the holder of this information. Then it happened—the most significant moment of my life up to that point—it felt like someone had tapped me on my left shoulder. Though I knew I was alone in the office, I turned to the left and looked upward for some reason for what or whom might have tapped me on my shoulder. And though, while I saw no one there, I immediately knew there was a presence with me at that moment, a spiritual or angelic presence. And then I heard these words in my head "You have to leave this place". And within minutes, the decision came to me that I indeed did have to leave my academic post of 15 years to bring the results of this new fecal testing method to the public: to the 25% of otherwise asymptomatic people reacting to dietary gluten with the same immunologic reaction measured in celiac disease, antigliadin antibody, as well as to the 75% of patients with microscopic colitis and perhaps other GI ailments and syndromes who, with a gluten-free diet, might heal their chronic refractory inflammatory bowel conditions. This was a bold line of thinking for me, as I had been on a professional trajectory toward the normal milestones of a successful young academic medicine career, becoming head of a sub-specialty medical department (for me, Gastroenterology), the prospects for which had just begun to surface in my life. Yet, I had just been called it seemed, by an encounter with a supernatural force, to an assignment of sorts with a mission to fulfill. And so, the idea of creating a specialty intestinal laboratory to make this new line of testing available to those in need of its benefits was born, EnteroLab.com (entero means intestine in Greek and in medical terminology). A "dot com" I thought? Yes, this form of testing should originate "in the comfort of your own home". Why make people with GI problems fly on an airplane half way across the country merely to give stool specimens for lab analysis (the practice of my Dallas hospital for decades up until that time). If I could create a mechanism whereby only the specimens but not the person could do the flying, then we could deliver results and follow-up dietary recommendations electronically, and the healing would begin shortly thereafter with dietary elimination of the causative antigenic foods. And if the client desired, they could have a paid phone consult with me or my nurse and still not have to spend the time, money, and difficulty flying to Dallas. And I have to admit, in 2000 it was kind of exciting to be the first doctor in the world to turn his entire medical career over to the internet, as well as to have created the first clinical laboratory serving people directly without the need of a prescription or previous doctor's visit, both incredibly bold and revolutionary ideas at the time (and perhaps still). I had learned from similar major paradigm shifts in my field of gastroenterology (specifically, in 1983 when doctors in Australia found in their research that ulcers might be caused by bacteria, but whom were laughed at and ignored for about 15 years, yet later in 2005 received a Nobel prize) that it would likely take 15-20 years before anyone in the medical field would believe my new research findings relating to non-celiac gluten sensitivity and its simple diagnosis with fecal testing. This, even though I was regarded even at my young age as an expert in the field, with a significant track record for developing unique and successful ideas for diagnosis and treatment of GI diseases (see my CV at www.intestinalhealth.org/CV), and having been trained by one of the most successful and respected gastroenterologists of all time, Dr. John Fordtran. While my medical peers might not believe my results for some time, people suffering the symptoms would not care whether or not it was too soon for a scientific paradigm to shift, because they would want to try a gluten-free diet to get better. And try, they did. Following positive stool test results from EnteroLab, they got better in droves going gluten-free, and in most cases with complete healing of long-standing symptoms and syndromes. And eventually I predicted, with such remarkable improvements that had never been possible before, their health practitioners (at least the honest, inquisitive, and non-egotistical ones) would ask them what had brought on such improvement. Eventually these practitioners would begin sending other patients for the same testing that had opened the door to the dietary miracle the gluten-free diet posed for those previously tested. Beyond the consequences of having to leave my academic positions and stature behind, I had to withstand some public and more often professional criticism for undertaking a bold and somewhat maverick professional move without the permission of my peers in doing so. This does not always go over smoothly in scientific and medical professional circles. Despite having been a highly respected young published researcher at that time (40 publications by the time I was in my mid-30's), my submissions both to professional GI society meetings and GI journals (journals that I had served as a reviewer for years) were rejecting my research submissions relating to this new paradigm of non-celiac gluten sensitivity. And it seemed, the rejections were not for objective reasons, but more subjective and for principle. Other researchers in this specific field and other fields have had to endure similar treatment. Sadly, submissions to these journals addressing paradigm-shifting topics are not always reviewed in unbiased, objective ways if they deal with a subject or contain conclusions that go against what the reviewers inherently believe to be true at that time (the "I'll see it when I believe it" scenario rather than "I'll believe it when I see it"). And yet, despite submissions of excellently performed and written studies that were rejected for these reasons by a system that seemed unready for this new paradigm, the most common public and professional criticisms of my methods primarily centered around my "lack of publication". This seemed circular and nonsensical to me. After all, had Michael Dell ever published his methods of making computers delivered in a revolutionary way (mail order) to its customers? These computers worked and served its customers well without a published method? Why is lack of publication of a medical technologic method equated with lack of Truth or efficacy? My response was and still is to remain true to my own data and experience, and my desire to serve and help people, and to not proceed according to the needs and critical dictates of others having no experience with my techniques. And so, 15 years later, as EnteroLab approaches our millionth patient tested, and with the current number of referring health practitioners in excess of 1,500, EnteroLab.com stands as a successful purveyor of medical Truth and public service. I ask people "How could hundreds of thousands of people be satisfactorily served over 15 years if what we are doing was not worthy and True?"; at some point, a person's or business' track record has got to stand for something positive and meaningful. And it seems my estimate of the time it would take for other researchers or mainstream practitioners to begin getting on board with the new paradigm was correct. Non-celiac gluten sensitivity has recently been further researched and substantiated to exist, just as I reported in public and professional lectures as early as 1999 (but published by others as early as 1980). And it has only been in the last 2 years or so that I have seen the question being raised at national and international GI meetings by "celiac researchers", but at least they are now doing so. Yet, the public has been the patron of the paradigm all along. In the last 4-5 years gluten-free food companies have carried the ball farther down the field than ever before. Yet interestingly, this focus on the food has mistakenly led people to regard this serious clinical syndrome as "a diet" not a disorder. And as we all know, "diets" come and go for people, even week to week. This is not healthful for any diet, but especially not for a gluten-free diet where the immune system can be hyperstimulated by repeatedly withdrawing and reintroducing such an immunogenic food. And yet, whether or not people choose to test for the syndrome with our stool test (the only test available to sensitively detect non-celiac gluten sensitivity), if they decide to go gluten-free, that must be a lifelong dietary decision. Otherwise, the test should be employed to help determine how serious the circumstances might be, and to further reinforce the clinical need of its permanency. Because after all, 25% of people, even when asymptomatic, have detectable immune reactions to gluten, and in many of these, damage to the intestine can be detected as well (measurable by EnteroLab from a fecal fat test from the same stool specimen). We have stood firm on the Truth of our research and clinical results, patiently waiting these 15 years for the public and professional paradigm-thinking to catch up. And catch up it has. Everyone today has at least heard about gluten, and people are not called crazy because going gluten-free makes them better physically, mentally and/or emotionally. But our work is not done. There are many millions more children and adults suffering not only from gluten sensitivity, but from other food sensitivities as well, and other diet-related maladies (obesity, endocrine problems including diabetes, eating disorders, food addictions, etc.). I am appreciative of the support and respect given to me and EnteroLab by Celiac.com and its founder, Scott Adams, who also knew early on there was something real about gluten sensitivity. His 14 year old "Journal of Gluten Sensitivity" is evidence of that. And so now, we are proud to partner with Celiac.com by allowing them to be the first company outside our own to offer our proprietary EnteroLab tests for sale, having created some special gluten-oriented testing panels for them. And as we go into the next decades of service, I leave you with a hint of the next, new paradigm… which is really the old paradigm. Gluten sensitivity is not limited to wheat, barley, and rye, but often includes oats as well (not just because of wheat contamination of the oats). This was the clinical standard from its beginning by the founder of the gluten-free diet, Dr. Willem Dicke, but that got changed in the last 10-15 years by substandard research methods based only on celiac disease as the end point and bias toward wanting to find such a result (all studies contain bias by the researchers, it's the nature of the mind influencing reality). So for the first time anywhere, we are using a diagnostic test for non-celiac oat sensitivity, and showing that about 50% of people reacting to wheat, barley, and rye, also react to oats with a similar immunologic reaction detectable in stool. But more on this as the information and paradigm-acceptance develops. Hopefully, this one won't take another 15 years to be accepted. We at EnteroLab and my non-profit public educational institute, The Intestinal Health Institute (www.IntestinalHealth.org), have been greatly honored to serve all our patrons to date, and we look forward to meeting and serving more of you in the future. For more information on testing at EnteroLab.com, please call 972-686-6869 or go to www.EnteroLab.com. Thank you for reading this historic account.
  6. Celiac.com 01/22/2016 - The number of children with gluten intolerance in one part of Scotland has more than doubled in just five years, according to a new survey. The results of the survey, which were presented at a major meeting of children's health experts, indicate that the number of children diagnosed with celiac disease in the Lothian health region rose sharply between 2010 and 2015. Between 2010 and 2014, data from the Royal Hospital for Sick Children revealed a total of 168 patients under the age of 16 with celiac disease, with 30 per cent of these diagnosed in 2014, compared to just 12.5 per cent in 2010. Statistics show 21 cases in 2010, a number which rises to 34 in 2012 and 49 by 2014. Doctors have not yet determined if the rise in celiac cases in Lothian is due to better disease awareness, and more stringent diagnostic techniques. They will undoubtedly be following up to determine the likely cause of the rise in celiac cases. Meanwhile, they are urging doctors and clinicians to do more to spot celiac cases early, so as to help patients avoid possibly serious celiac-related complications as they age. Source: heraldscotland.com
  7. Celiac.com 07/16/2014 - Information about the number of cases and and overall rates of celiac disease and dermatitis herpetiformis in the UK have not been well studied over time, either by region or by age. Yet, this type of information is essential for determining potential causes and quantifying the impact of these diseases. To provide this information, a team of researchers recently conducted a population-based study to assess incidence and prevalence of celiac disease and dermatitis herpetiformis in the UK over two decades. The researchers included J. West, K.M. Fleming, L.J. Tata, T.R. Card, and C.J. Crooks. They are variously affiliated with the Division of Epidemiology and Public Health, City Hospital Campus, The University of Nottingham, the NIHR Biomedical Research Unit in Gastrointestinal and Liver Disease at Nottingham University Hospitals NHS Trust, and the Division of Epidemiology and Public Health at the City Hospital Campus of The University of Nottingham in Nottingham, UK. They used the Clinical Practice Research Datalink to identify patients with celiac disease or dermatitis herpetiformis between 1990 and 2011, and calculated incidence rates and prevalence by age, sex, year, and region of residence. They found a total of 9,087 incident cases of celiac disease and 809 incident cases of dermititis herpetiformis. From 1990 to 2011, the incidence rate of celiac disease rose from 5.2 per 100,000 (95% confidence interval (CI), 3.8-6.8) to 19.1 per 100,000 person-years (95% CI, 17.8-20.5; IRR, 3.6; 95% CI, 2.7-4.8). During that same period, incidence of dermatitis herpetiformis decreased from 1.8 per 100,000 to 0.8 per 100,000 person-years (average annual IRR, 0.96; 95% CI, 0.94-0.97). The absolute incidence of celiac disease per 100,000 person-years ranged from 22.3 in Northern Ireland to 10 in London. Celiac disease showed large regional variations in prevalence, while dermatitis herpetiformis did not. The team found a fourfold increase in the incidence of celiac disease in the United Kingdom over 22 years, with large regional variations in prevalence. This contrasted with a 4% annual decrease in the incidence of dermatitis herpetiformis, with minimal regional variations in prevalence. These contrasts could reflect differences in diagnosis between celiac disease (serological diagnosis and case finding) and dermatitis herpetiformis (symptomatic presentation) or the possibility that diagnosing and treating celiac disease prevents the development of dermatitis herpetiformis. Source: Am J Gastroenterol. 2014 May;109(5):757-68. doi: 10.1038/ajg.2014.55. Epub 2014 Mar 25.
  8. Celiac.com 01/22/2014 - With many major grocery brands struggling to generate sales growth, and with top gluten-free brands Udi's and Glutino racking up combined net sales growth of 53% last quarter, the writing is on the wall: More and more wheat based brands will be looking to break into the gluten-free market in the next three to five years. Boulder Brands CEO Steve Hughes told analysts on the firm's Q3 earnings call that Boulder is seeing "strong, consistent velocity in distribution builds across all channels" for gluten-free products. According to Hughes, 5-10% of all wheat-based product categories will be gluten-free in the next three to five years, or else they will disappear from the market. Again, as many wheat-based brands struggle for market share, Udi’s remains the fastest-growing brand in the conventional grocery store channel, and retailers are responding. Hughes said that Udi's 3rd quarter net sales were up 74% year-over-year, adding that "Glutino net sales grew 29%. Combined, our gluten-free brands increased net sales 53%." Udi's and Glutino now average nearly twenty items on retail shelves, up from about fifteen and a half just a year ago. Meanwhile, Hughes notes, the gluten-free pizza business has been performing“extraordinarily well.” He points out that many retailers now have three dedicated gluten-free sections, including a 4-12ft section in the ambient grocery aisles, half the full door in the frozen food aisles, and a frozen or shelf-stable rack in bakery. Hughes wrapped up his presentation by adding that gluten-free items are also gaining a share of the club store channel. He said that they were "...starting to get some testing of bread into the club channel, which could be very meaningful next year.” Hughes' presentation does imply that growth also means the pressures of competition for market share, both among gluten-free manufacturers and retailers, and between gluten-free and wheat-based manufacturers and retailers. All of this is basically good news for consumers of gluten-free products, as it means more and, hopefully, better quality products. Source: Food Navigator USA
  9. Celiac.com 02/15/2013 - If you think the FDA has dropped the ball on gluten-free food labeling, you are not alone. In 2004, the Food Allergen Labeling and Consumer Protection Act (FALCP) gave the FDA four years to create and implement final rules for gluten-free food labeling. The FALCP requires manufacturers to identify these allergens by their common names (i.e. wheat, milk, or soy) on labels so that consumers can easily identify them. In 2007, the FDA followed FALCP's mandate by issuing a proposed rule "Food Labeling: Gluten-Free Labeling of Foods." The proposed rule states that a food is gluten-free if the food does not contain any of the following: an ingredient that is any type of wheat, rye, barley, or crossbreeds of these grains; an ingredient derived from these grains and that has not been processed to remove gluten; an ingredient derived from these grains and that has been processed to remove gluten, if it results in the food containing 20 or more parts per million (ppm) gluten; or 20 ppm or more gluten. -- "Food Labeling; Gluten-Free Labeling of Foods," 72 Fed. Reg. 2795 (proposed January 23, 2007) (to be codified at 21 CFR Part 101). The FDA's proposed rule was based on the fact that currently-adopted analytical methods can reliably detect gluten at or above 20 parts per million in most foods. Also, under that rule, food manufacturers looking to market products as 'gluten-free' would voluntarily test those products prior to labeling. However, the FDA allowed the comment period for the proposed rule to pass with no action, and issued no final rule for gluten-free labeling. In 2011, the FDA announced a second comment period for their proposed rule, but that comment period also closed with the FDA taking no action. A full year and a half later, on Dec. 14, 2012, the FDA issued a new proposed rule titled "Request for Comments and Information on Initiating a Risk Assessment for Establishing Food Allergen Thresholds; Establishment of a Docket." They opened comment period on this proposed rule until Feb. 12, 2013, and scheduled an advisory committee meeting of the FDA for March 7, 2013 from 8 a.m. to 5 p.m. It has been eight years, since FALCP mandated the FDA to devise standards for gluten-free labeling, and five years since the legal deadline for final gluten-free rule, and the FDA has yet to accurately define the term "major food allergen," establish safe gluten thresholds for food products, and meet its statutory mandate to create and implement final rules for gluten-free food labeling. Until the FDA formally adopts a final rule for gluten-free labeling, there is no legal definition for what makes food "gluten-free" in the United States, and people with celiac disease will no clear assurance that when a product claims to be gluten-free, it is safe to consume. Please go to the Federal Register and comment on the FDA's latest ofrmulation of their rule (Docket No. FDA-2012-N-0711) regarding gluten-food.
  10. Celiac.com 08/16/2012 - Tests for blood antibodies against native gliadin (anti-nGli) are still often assumed to perform better in the diagnosis of celiac disease in young children than tests for antibodies to deamidated gliadin (anti-dGli), tissue transglutaminase (anti-tTG), and endomysium (EmA). A team of researchers recently set out to determine whether testing IgG and IgA antibodies Against native gliadin was best for diagnosing celiac disease in children under 2-years old. Specifically they wanted to compare the performance of assays for anti-nGli, anti-dGli, anti-tTG, and EmA in this age group. The research team included T. Richter, X. Bossuyt, P. Vermeersch, H.H. Uhlig, M. Stern, A. Hauer, K.P. Zimmer, L. Mearin, J.H. Roo, C. Dähnrich, and T. Mothes. They are affiliated with the University Children's Hospital, the Children's Hospital of the Clinical Centre, "Sankt Georg," and the Institute of Laboratory Medicine, Clinical Chemistry and Molecular Diagnostics at University Hospital in Leipzig, Germany; with the Department Laboratory Medicine of University Hospital in Leuven, Belgium, the University Children's Hospital in Tübingen, Germany, the University Children's Hospital in Graz, Austria, the University Children's Hospital in Giessen, Germany, the Department of Paediatrics at Leiden University Medical Centre in Leiden, The Netherlands, and with EUROIMMUN Medizinische Labordiagnostika GmbH in Lübeck, Germany. For their study, they conducted a retrospective analysis of 184 children. The study group included 42 children with celiac disease under normal diet, and a control group of 142 children up to 2 years of age. The team measured immunoglobulin (Ig) A- and IgG-anti-dGli, IgA- and IgG-anti-nGli, IgA- and IgG-anti-tTG, and IgA-EmA in blood samples. They calculated areas under receiver operating characteristics curves, sensitivities, specificities, positive and negative predictive values, positive and negative likelihood ratios, as well as diagnostic odds ratios. When all the data was complete, they found that only tests for IgG-anti-dGli, IgA-anti-tTG, and IgA-EmA had high specificity (≥0.96) connected with high sensitivity (≥0.86), with high positive predictive values (≥0.52 and ≥0.69 at pretest probabilities of 0.05 and 0.1, respectively) and negative predictive values (≥0.99 and ≥0.98 at pretest probabilities of 0.05 and 0.1, respectively). These tests also showed high positive likelihood ratio (≥24) at low negative likelihood ratio (≤0.15) and high diagnostic odds ratios (≥136). From their data, the team concluded that using anti-nGli tests to diagnose celiac disease in young children was not helpful. They maintain that IgA-anti-tTG, IgA-EmA, and IgG-anti-dGli provided much more reliable results than anti-nGli in diagnosing celiac disease in young children. Source: J Pediatr Gastroenterol Nutr. 2012 Jul;55(1):21-25.
  11. Celiac.com 08/10/2011 - For growing numbers of Americans, and millions overall, it is important to eat food that is gluten-free. For these people, maintaining good health, and avoiding serious and unpleasant side effects means avoiding gluten, a protein found in wheat, rye and barley. However, the question of what, exactly is meant by a food label that claims the food to be "gluten-free" has continued to elude the FDA for the last seven years. Because the FDA has no current standard for the term, "gluten-free" means essentially whatever any given manufacturer wants it to mean. Thus, a "gluten-free" label does not mean that a food is free of any and all gluten, or even that it's free of all but trace amounts. There should be a gluten-free standard by now, but there is not. In 2004, Congress passed a law requiring the Food and Drug Administration to define the phrase 'gluten-free' by 2008. That deadline passed with the FDA providing no such definition, and we still have no official ruling today, in 2011. For people who must avoid gluten, doing so is essential to maintaining good health. However, avoiding gluten in processed products, even those that are gluten-free in theory, can be a challenge. Also, to be fair, there can be unforeseen challenges to establishing these standards. Sometimes products that seem to contain gluten-free ingredients - corn tortillas, say, or roasted peanuts - can pick up traces of gluten during processing. Often, gluten can hide deep inside an ingredient list, as such ingredients as "caramel coloring," "emulsifiers," "natural juices" and dozens of other common additives may or may not contain gluten, depending on where and how those ingredients were made. A "gluten-free" label ought to offer peace of mind, but so far, the phrase has been better for corporate bottom lines than for consumers. While the FDA has dithered about the meaning of "gluten-free," the market for those products has exploded. In 2003, it was $100 million; next year, it's estimated to be $2.6 billion. Some manufacturers go to great lengths to ensure that their gluten-free products are, in fact, free of gluten. Many test ingredients and scrupulously avoid contamination in their factories. Many also test final products to make sure they are safely gluten-free. Other manufacturers do none of that. And without a uniform standard for labels, people at risk can't reliably know the difference. The Center for Celiac Research has faulted the FDA for spending far too much time on studies. The group calls for the agency to act quickly to establish a uniform definition. Celiac.com concurs one-hundred percent. Millions of Americans with celiac disease and gluten intolerance deserve to be able to shop for and eat foods that are reliably gluten-free. This article echoes an editorial in the Houston Chronicle, titled: Sickening - After seven years, why can't the FDA define 'gluten-free'?
  12. Celiac.com 10/07/2011 - A number of studies suggest that women with celiac disease have reproductive difficulties, but data have been inconclusive and contradictory. A research team recently set out to assess fertility in women with biopsy-verified celiac disease. The study team included Daniela Zugna, Lorenzo Richiardi, Olof Akre, Olof Stephansson, and Jonas F Ludvigsson. They are affiliated variously with the Cancer Epidemiology Unit at the Centre for Experimental Research and Medical Studies and Centre for Oncologic Prevention at the University of Turin in Turin, Italy, the Department of Paediatrics at Örebro University Hospital in Örebro, Sweden, and with Clinical Epidemiology Unit of the Department of Medicine, the Department of Molecular Medicine and Surgery, the Division of Obstetrics and Gynaecology, and the Department of Women's and Children's Health at the Karolinska Institutet in Karolinska, Sweden. For their Swedish population-based cohort study, the team gathered data all 28 pathology departments in Sweden on 18,005 biopsy-proven duodenal/jejunal biopsy, using Marsh III, villous atrophy as their baseline. They also established a control group of 51,109 age-matched women without celiac disease. They then found 11,495 women with celiac disease who were aged 18–45 years. The team used multinomial logistic regression and Cox regression to estimate fertility in these women compared with the age-matched reference women. The team defined 'fertility' as the number of children according to the Swedish Multi-Generation Register. Their results showed that women with celiac disease had 16,309 births compared with 69,245 for the reference group. Overall, the total number of children in the group of women with celiac disease was slightly higher compared with the reference group. Adjusting for age, calendar period and parity and stratifying by education, the overall fertility hazard ratio (HR) for women with celiac disease was 1.03 (95% CI 1.01 to 1.05). Specifically, the fertility HR was 1.05 (95% CI 0.96 to 1.14) for celiac disease diagnosed in women under 18-years of age, 1.04 (95% CI 1.01 to 1.07) for celiac disease diagnosed in women between 18 and 45 years, and 1.02 (95% CI 0.99 to 1.04) for celiac disease diagnosed in women >45 years of age. Factoring in the dates of celiac disease diagnosis, fertility was decreased 0–2 years before time of diagnosis (HR=0.63; 95% CI 0.57 to 0.70), but was identical to that of controls 0–5 years subsequent to diagnosis and increased to 1.12 (95% CI 1.03 to 1.21) thereafter. The data for this study show that women with celiac disease had a normal fertility, but their fertility was decreased in the last two years before diagnosis. Interestingly, fertility in women with celiac disease was also slightly higher after five years, comported to the control group. Stay tuned... Source: Gut 2010;59:1471-1475. doi:10.1136/gut.2010.219030
  13. Celiac.com 10/30/2007 - Many studies over the years have supported the idea that celiac disease is a permanent condition, and that those who strayed from the strict gluten-free diet that forms the core of celiac treatment risked relapsing and suffering the telltale intestinal damage associated with celiac disease. However, it was generally assumed that symptoms of celiac disease and associated intestinal degradation occurred within two years of reintroducing gluten back into the diet. The medical journal GUT recently published a paper by Matysiak-Budnik et al. concerning the natural history of celiac disease, which indicates that classic celiac damage to the intestinal lining may take years or decades to develop in some cases. A team of researchers looked at 61 adults who had been diagnosed with celiac disease as children, and who felt themselves to be asymptomatic for anywhere from 3 to 21 years, with a group average of 11 years. An exam revealed that 48 of the 61 test subjects indeed showed villous atrophy with crypt hypoplasia. The 13 other patients showed no celiac-associated intestinal damage. Strangely, 2 of the 13 patients with no signs of damage had showed such damage a short time after gluten was reintroduced into their diets, only to return to normal as they continued to consume gluten. From this, the researchers concluded that some people might actually become truly latent and tolerate gluten with no adverse effects. It’s also possible that such people actually still have celiac disease and that the intestinal damage has yet to recur, as villous atrophy occurs only at the tail end of celiac disease. In fact, delayed relapse of celiac disease after gluten reintroduction supports the notion that people with normal mucosa may in fact have celiac disease. Still, it is highly uncommon for patients with celiac disease to show no clinical symptoms on a long-term gluten-inclusive diet. The level of celiac disease+ intraepithelial lymphocytes has proven to be more useful than mucosal Marsh Type 1 lymphocytes in revealing early developing celiac disease in such cases and in general. Reliable diagnosis of celiac disease is important, as untreated celiac disease carries a broad range of associated risks including markedly higher rates of certain cancers. A recent study also suggests celiac disease may also adversely impact both the peripheral the central nervous systems. However, regarding the 13 asymptomatic patients, the original diagnosis of celiac would seem to be accurate in each case, as each had celiac-type HLA, either HLA DQ2 or DQ8, and their follow-up exam results showed that 5 of those patients had positive serum antibody results and higher densities of small bowel mucosa celiac disease+ and CD3+ intraepithelial lymphocytes than did the non-celiac control groups. Two of the 13 patients developed symptoms of a relapse during the follow-up. The study team concluded that the “2 year rule” for reintroducing gluten is invalid and supports the view that celiac disease exists beyond villous atrophy. As villous atrophy of the small intestine is only one manifestation of genetic gluten intolerance, and that the present diagnostic guidelines based on mucosal damage and ignoring early developing celiac disease and dermatitis herpetiformis is only one incarnation of celiac disease. GUT 2007; 56:1339-1340 Katri Kaukinen, Pekka Collin, Medical School, University of Tampere and Department of Gastroenterology and Alimentary Tract Surgery, Tampere University Hospital, Tampere, Finland Markku Ma¨ki, Medical School, University of Tampere and Department of Paediatrics, Tampere University Hospital, Tampere, Finland
  14. J Pediatr Gastroenterol Nutr. 2004 Jul;39(1):80-84 Celiac.com 04/10/2005 - A study by Spanish researchers has found that celiac disease is highly prevalent among Spanish children—at least 1 in 118 of them are born with it. The study looked at 830 healthy children born between October 1998 and December 1999 whose parents had enrolled them in an early diagnosis program. Of the 830 children who initially enrolled, 613 were screened for anti-tissue transglutaminase antibodies at 1.5 years of age, and 484 were screened at 2.5 years of age. At 1.5 years none of the children screened positive for the antibodies, but by 2.5 years 9 tested positive, and 7 of those 9 also had positive follow-up intestinal biopsies. The researchers conclude that at least 1 in 118 Spanish children are born with celiac disease, which is comparable to that found in other European populations—but the incidence determined in this study might actually have been higher had all of the children who participated in the initial 1.5 year old screening returned a year later for the second screening. The authors stop short of making a recommendation for a general screening of all Spanish children for celiac disease, and instead define the best timing for such a screening: 2-3 years of age. This study indirectly highlights just how many celiac disease diagnoses are missed--most people with celiac disease are still never diagnosed and must live with the disease and its associated problems for life. Those who finally get a diagnosis often spend years suffering before it is figured out. Many get lymphoma and die--which is why we must continue to advocate for celiac disease screenings for the general population--perhaps starting as early as 2-3 years of age.
  15. An article on celiac disease by the National Institute of Diabetes and Digestive and Kidney Diseases of the National Institutes of Health, Bethesda, Maryland, at http://www.niddk.nih.gov/health/digest/pubs/celiac/index.htm states the following: In Italy, where celiac disease is common, all children are screened by age 6 so that even asymptomatic disease is caught early. In addition, Italians of any age are tested for the disease as soon as they show symptoms. As a result of this vigilance, the time between when symptoms begin and the disease is diagnosed is usually only 2 to 3 weeks. In the United States, the time between the first symptoms and diagnosis averages about 10 years.
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