The Only Available Treatment for Celiac – Gluten Free Food – Must Be Viewed as a Human Right

First Lady Eleanor Roosevelt, Chair of the United Nations Human Rights Commission

"Where, after all, do universal human rights begin? In small places, close to home — so close and so small that they cannot be seen on any maps of the world. […] Unless these rights have meaning there, they have little meaning anywhere. Without concerted citizen action to uphold them close to home, we shall look in vain for progress in the larger world." -- Eleanor Roosevelt, Chair of the United Nations Human Rights Commission

Executive Summary

• Celiac is a disease, not a diet!

• Strict adherence to a complex and very restrictive Gluten Free diet is the only available treatment option for Celiac Disease patients since there is no medicine available to treat Celiac (even in the event of accidental ingestion of Gluten), there is no surgical treatment, and there is no known cure.

• For Celiac patients and their caretakers who medically require a lifelong special dietary need, the issue of food being cross contaminated with Gluten contributes to a constant situation of food and nutritional insecurity. The Celiac condition exposes individuals with this auto-immune disease to permanent food and nutritional insecurity, which can cause loss of quality of life, socialization, and health of the individual, both in the short and long term.

• In addition to the constant threat of cross contact with Gluten, food insecurity for Celiacs is caused because 80% of foods have Gluten in them and the high price of Gluten Free foods. In the U.S., food insecurity for Celiacs is exacerbated because Gluten is not required to be labeled as a major food allergen on all food products like it is in 85 countries around the world including across Europe and in Canada.

• The Universal Declaration of Human Rights expressly and directly links "health and well-being" with adequate food.

• According to the United Nations Office of the Commissioner for Human Rights, "The right to [adequate] food is recognized in the 1948 Universal Declaration of Human Rights as part of the right to an adequate standard of living, and is enshrined in the 1966 International Covenant on Economic, Social and Cultural Rights."

• According to the United Nations Office of the Commissioner for Human Rights, "Human rights are interdependent, indivisible and interrelated. This means that violating the right to [adequate] food may impair the enjoyment of other human rights, such as the right to health, education or life, and vice versa."

• Food and nutritional insecurity is the everyday life of any Celiac patient, no matter his/her age or socio-economic status, albeit the underserved population of patients with Celiac Disease who simply cannot afford the Gluten Free diet those are subject to a heightened state of food insecurity.

• "Because Celiac Disease can be considered the most common food intolerance in the world, it is one that both individuals and social structures need to address as a mainstream issue. From how laws and consumer protections are designed at the macro level, to how food is made available and prepared at the micro level, rights of people with Celiac Disease hang in limbo."

Overview

Human Rights Day is observed every year on December 10th – the day on which in 1948 the United Nations General Assembly adopted the Universal Declaration of Human Rights. December 10th is a day when the Celiac community should join forces to stand up for their Human Right to Adequate Food, nutrition, health and well-being!

The intention of this article is to further contextualize the constant state of food and nutritional insecurity that afflict Celiac Disease patients and their families with regard to the universal Human Right to Adequate Food. In other words, the only available treatment option for Celiac Disease -- a strict Gluten Free diet for life - must be viewed in the context of a human rights issue, the Human Right to Adequate Food.

On September 17, 1796, President George Washington counseled America in his Farewell Address that the Constitution of the United States is "sacredly obligatory upon all." Until such time as there are treatment options (other than a Gluten Free diet) and/or a cure for Celiac Disease, the Universal Declaration of Human Rights and the Human Right to Adequate Food for people with Celiac Disease should also be sacredly obligatory upon all.

In the seminal work by Juliana Nadal at the Department of Nutrition, Food Quality and Nutrition at the Federal University of Parana in Brazil reviews in her journal article, "The principle of human right to adequate food and Celiac Disease" (Demetra; 2013; 8(3); 411-423), Nadal linked the Human Right to Adequate Food with Celiac Disease,

"By understanding food as a basic human right, it is less complex to understand the fact that the absence of foods that address this particular need, such as that of Celiac individuals, represents a concrete case that this group of people are having, constantly, their rights – to adequate nutrition – violated and, in turn, they are in a state of food and nutrition insecurity."

Yvonne Vissing Ph.D. and Christopher Moore-Vissing advanced Nadal’s discussion and provided thought leadership in their article, "Going Gluten Free as a Human Rights Issue" (Journal of Gluten Sensitivity, Summer 2016 Issue, July 11, 2016),

"Because Celiac Disease can be considered the most common food intolerance in the world, it is one that both individuals and social structures need to address as a mainstream issue. From how laws and consumer protections are designed at the macro level, to how food is made available and prepared at the micro level, rights of people with Celiac Disease hang in limbo. Some places and people are very attentive to their rights protections while others are not. Nadal contextualizes food and nutrition insecurity that afflicts individuals with Celiac Disease with specific regard to the principle of the Human Right to Adequate Food (HRAF)." (emphasis added)

The Only Available Treatment for Celiac Disease – Gluten Free Food – Should Be Viewed in the Context of a Human Rights Issue

Celiac Disease is a potentially life-threatening food allergy and auto-immune disease that afflicts greater than 1% of the population. In the United States, there are 3.3 million Americans who have Celiac Disease, including my 6-year-old son. In Celiac Disease patients, Gluten, a protein found in Wheat, Barley, Rye and most Oats, triggers an immune response leading the body to attack the small intestine. This intestinal damage causes more than 200 debilitating symptoms. Moreover, Gluten ingestion for people with Celiac Disease causes permanent immunological scarring, doubles the risk of heart disease, and acts as a carcinogen, quadrupling the risk of small intestinal cancers. Strict adherence to a Gluten-Free diet is the only available treatment. But, as respected Celiac Disease researchers including at University of Chicago Celiac Disease Center agree, "'There is no such thing as a truly Gluten-FREE diet' because of the constant risk of cross-contact with Gluten, and Gluten is in 80% of our foodstuffs."

The Gluten Free Diet

The Gluten Free diet is complex and very restrictive in nature. Further, the Gluten Free diet is not a complete treatment in light of the fact that recent studies have shown some patients continue to have symptoms and intestinal damage even when they strictly follow the Gluten Free diet. The idea that the Gluten Free diet is all that is needed by the Celiac community, versus all that has ever been available, has stifled funding for medical research to find any treatment options (other than a Gluten Free diet), much less to find a cure.

The Status Quo from 1952 Remains

Since it was first theorized in 1887 that treating Celiac Disease patients “must be by means of diet” (1887 was ironically the same year that the NIH was founded), and it was discovered in 1952 that Gluten was the trigger of Celiac Disease, the one and only treatment is still the same. For all intents and purposes, the status quo from 1952 remains — strict adherence to a Gluten Free diet has been the only available treatment!

According to the article by Vissing and Moore-Vissing,

"When you've got Celiac Disease and people aren’t attentive to making sure you can eat gluten-free foods that are safely prepared and not contaminated, you can end up very sick in the short-run. The short-term effects may include symptoms such as gastrointestinal upset, migraines, fuzzy brain, sweats, and general malaise. As a fundamental right, what one eats should ensure people’s access to a healthy, dignified and full life. People who have been “glutened” do not feel dignified as they writhe in pain, wrestle with fears of embarrassment, or modify their lifestyle and social schedules to accommodate the illness."

What is a Human Right?

According to the United Nations, “Human rights are rights inherent to all human beings, regardless of race, sex, nationality, ethnicity, language, religion, or any other status. Human rights include the right to life and liberty, freedom from slavery and torture, freedom of opinion and expression, the right to work and education, and many more. Everyone is entitled to these rights, without discrimination.”

For a frame of reference, it is helpful to distinguish human rights from civil rights, even though there is overlap between the two rights. Human rights are existential, or in other words arise simply by the state of being a human being. Civil rights, on the other hand, are those rights that a person is entitled to by virtue of citizenship in a particular nation or state. For example, in the United States, Civil rights are enshrined for American citizens by the Constitution of the United States. While there is overlap with between the Right to Adequate Food with the Americans with Disabilities Act (ADA), including with regard to accommodating Celiac Disease, the focus of this article is on the Right to Adequate Food with regard to Celiac Disease.

The Right to Feed Oneself in Dignity

The Preamble to the Universal Declaration of Human Rights is predicated in part on “the dignity and worth of the human person” and “the inherent dignity and of the equal and inalienable rights of all members of the human family”. To those ends, the intent of the United Nations Charter is to “promote social progress and better standards of life…” As a preface, for Celiac Disease patients and their caretakers, the “right to feed oneself in dignity” underpins the human right to adequate (safe) food, and these rights can be greatly impacted by perpetual circumstances including:

• being poisoned by the consumption of Gluten (i.e., being “glutened”) and suffering from a myriad of symptoms including vomiting, diarrhea, cramping, joint pain, fatigue, brain fog, etc. (and not having any medicine that can treat the auto-immune response triggered from the ingestion of Gluten)

• worrying about cross contact with every meal and snack with short term sickness and long-term damage to one’s small intestine

• being hungry and not being able to find safe Gluten Free food options (i.e., eating out away from home including at school and while travelling)

• affording the high cost of the Gluten Free diet and being able to maintain adherence to the Gluten Free diet due to high cost and availability challenges, which can then lead to further serious health complications

• scrutinizing food labels for accurate and comprehensive ingredient lists, while navigating various disclaimers (i.e., there are no Gluten containing ingredients, but the product has not been tested for Gluten and/or may be at risk for Gluten cross-contamination due to the way it was manufactured or processed)

• having the medical requirements of a strict Gluten Free diet not be taken as seriously as nut allergies by government and society

• being required to share your personal and private medical history with strangers who are food service providers (many are untrained or have limited training in food allergies and intolerances such as Celiac) and entrusting your health unto them

• being excluded from having a seat at the table with friends, family and/or colleagues when restaurants and venues refuse to allow you to bring in your safe Gluten Free food, even when the establishments may not offer any foods that are Celiac safe

• treating one’s other health issues with medicine that is not adequately and fully labeled for Gluten containing ingredients and/or possible cross contact with Gluten in the manufacturing process

The Universal Declaration of Human Rights (UDHR)

For the estimated 75 million people worldwide with Celiac Disease, the Universal Declaration of Human Rights expressly and directly links “health and well-being” with adequate food.

In 1948, the United Nations Universal Declaration of Human Rights (UDHR) was established as a foundational document in the history of human rights. “Drafted by representatives with different legal and cultural backgrounds from all regions of the world, the Declaration was proclaimed by the United Nations General Assembly in Paris on 10 December 1948 by General Assembly resolution 217 A (III) as a common standard of achievements for all peoples and all nations. It sets out, for the first time, fundamental human rights to be universally protected.”

Article 25 of the Universal Declaration of Human Rights states,

"1. Everyone has the right to a standard of living adequate for the health and well-being of himself and of his family, including food, clothing, housing and medical care and necessary social services, and the right to security in the event of unemployment, sickness, disability, widowhood, old age or other lack of livelihood in circumstances beyond his control.

2. Motherhood and childhood are entitled to special care and assistance…" (emphasis added)

According to the UN’s “Plain Language Version” of the UDHR, Article 25.1 means,

"You have the right to have whatever you need so that you and your family: do not fall ill; do not go hungry…"

Even though the Universal Declaration of Human Rights holds the Guinness World Record as the most translated document in the world (into more than 500 languages as of 2019), there are many people who are still unaware of their basic rights as human beings, including those in the Celiac community with the right to adequate food.

The United Nations Convention on the Rights of the Child

The United Nations Convention on the Rights of the Child expressly and directly links the importance of “combating (pediatric) disease and malnutrition, including within the framework of primary health care… through the provision of adequate nutritious foods”. Additionally, the Convention on the Rights of the Child addresses “the right of the child to the enjoyment of the highest attainable standard of health and to facilities for the treatment of illness and rehabilitation of health. States Parties shall strive to ensure that no child is deprived of his or her right of access to such health care services.” Additionally, the concept that “childhood is entitled to special care and assistance” as enshrined in the United Nations Universal Declaration of Human Rights is expressly included in the Preamble to the “Convention on the Rights of the Child” that went into effect on September 2, 1990.

According to Article 3.1.,

"In all actions concerning children, whether undertaken by public or private social welfare institutions, courts of law, administrative authorities or legislative bodies, the best interests of the child shall be a primary consideration." (emphasis added)

According to Article 24.1,

"States Parties recognize the right of the child to the enjoyment of the highest attainable standard of health and to facilities for the treatment of illness and rehabilitation of health. States Parties shall strive to ensure that no child is deprived of his or her right of access to such health care services."

According to Article 24.2,

"(b) To ensure the provision of necessary medical assistance and health care to all children with emphasis on the development of primary health care;

(c) To combat disease and malnutrition, including within the framework of primary health care, through, inter alia, the application of readily available technology and through the provision of adequate nutritious foods and clean drinking-water, taking into consideration the dangers and risks of environmental pollution;

(e) To ensure that all segments of society, in particular parents and children, are informed, have access to education and are supported in the use of basic knowledge of child health and nutrition, the advantages of breastfeeding, hygiene and environmental sanitation and the prevention of accidents;" (emphasis added)

The bottom line is that to address the historical underfunding of Celiac Disease, including with Federal research funding for finding a treatment and a cure, the “legislative bodies” such as the U.S. Congress and the “administrative authorities” such as NIH, CDC, and DoD should use the Convention on the Rights of the Child as a guiding principle in the allocation of funding resources: “the best interests of the child shall be a primary consideration.”

To those ends, the legislative and administrative bodies should “recognize the right of the child to the enjoyment of the highest attainable standard of health” whereby “[t]o combat disease and malnutrition, including within the framework of primary health care,… through the provision of adequate nutritious foods” is foundational. In addition to research for a treatment and a cure, appropriations from the USDA and DoE should be allocated “[t]o ensure that all segments of society, in particular parents and children, are informed, have access to education and are supported in the use of basic knowledge of child health and nutrition” with respect to Celiac Disease.

The Right to Adequate Food, United Nations Office of the Commissioner for Human Rights

According to the United Nations Office of the Commissioner for Human Rights “The Right to Adequate Food, Fact Sheet No. 34,”

“Combating hunger and malnutrition is more than a moral duty or a policy choice; in many countries, it is a legally binding human rights obligation. The right to food is recognized in the 1948 Universal Declaration of Human Rights as part of the right to an adequate standard of living, and is enshrined in the 1966 International Covenant on Economic, Social and Cultural Rights.” (emphasis added)

As a preliminary matter, it is important to note that one of the common misconceptions about the Right to Food. According to the United Nations,

“The right to food is NOT the same as a right to be fed. Many assume that the right to food means that Governments have to hand out free food to anyone who needs it. They conclude that this would not be feasible or might cause dependency. This is a misunderstanding. The right to food is not a right to be fed, but primarily the right to feed oneself in dignity. Individuals are expected to meet their own needs, through their own efforts and using their own resources.” (emphasis added)

What is the Right to Food?

According to the United Nations, food must be available, accessible and adequate:

"Availability requires on the one hand that food should be available from natural resources either through the production of food, by cultivating land or animal husbandry, or through other ways of obtaining food, such as fishing, hunting or gathering. On the other hand, it means that food should be available for sale in markets and shops." "Accessibility requires economic and physical access to food to be guaranteed. Economic accessibility means that food must be affordable. Individuals should be able to afford food for an adequate diet without compromising on any other basic needs, such as school fees, medicines or rent." "Adequacy means that the food must satisfy dietary needs, taking into account the individual’s age, living conditions, health, occupation, sex, etc. For example, if children’s food does not contain the nutrients necessary for their physical and mental development, it is not adequate. Food that is energy-dense and low-nutrient, which can contribute to obesity and other illnesses, could be another example of inadequate food. Food should be safe for human consumption and free from adverse substances, such as contaminants from industrial or agricultural processes, including residues from pesticides, hormones or veterinary drugs. Adequate food should also be culturally acceptable. For example, aid containing food that is religious or cultural taboo for the recipients or inconsistent with their eating habits would not be culturally acceptable." (emphasis added)

According to Vissing and Moore-Vissing in their article entitled, “Going Gluten Free as a Human Rights Issue,”

"The issue of gluten contamination contributes to a constant situation of food and nutritional insecurity to holders of this special dietary need. The celiac diet must be completely gluten-free, which allows people to have a life relatively free of major pathological complications. Maintaining a totally gluten-free diet is not an easy task because the violation of the diet may occur voluntarily or involuntarily, and range from incorrect information on food labels to the gluten contamination of processed products. Difficulties in the availability and access to food without gluten violates the principle of the [United Nations] human right to adequate food. The condition of being a Celiac individual exposes one to permanent food and nutrition insecurity, which could cause loss of quality of life, socialization, and health of the individual, both in the short and long term." (emphasis added)

The Link between the Right to Adequate Food and Other Human Rights According to the United Nations Office of the Commissioner for Human Rights “The Right to Adequate Food, Fact Sheet No. 34,”

"Human rights are interdependent, indivisible and interrelated. This means that violating the right to [adequate] food may impair the enjoyment of other human rights, such as the right to health, education or life, and vice versa."

For example, according to the United Nations, the Right to Adequate Food is interdependent and interrelated with these rights:

• "The right to health. Nutrition is a component of both the right to health and the right to food… When a child is suffering from diarrhoeal disease but denied access to medical treatment, it cannot enjoy an adequate nutritional status even if he or she has access to food."

• "The right to life. When people are not able to feed themselves and face the risk of death by starvation, malnutrition or resulting illnesses, their right to life would also be at stake."

• "The right to information. Information is crucial for the right to food. It enables individuals to know about food and nutrition, markets and the allocation of resources. It strengthens people’s participation and free consumer choice. Protecting and promoting the right to seek, receive and impart information thus facilitates the enjoyment of the right to food." (emphasis added)

Conclusion: The Rights of People with Celiac Hang in Limbo

In summary, it is worth repeating one of the salient points that Vissing and Moore-Vissing made -- "From how laws and consumer protections are designed at the macro level, to how food is made available and prepared at the micro level, rights of people with Celiac Disease hang in limbo." By way of example and not limitation, the following are examples of how the rights of people with Celiac Disease currently "hang in limbo" and could change in 2020 if treating Celiac Disease was taken seriously by our Federal government:

Treatment Burden

My wife and I can attest to the treatment burden including the continuous concern over intestinal healing, proper nutrition, cross contact, and inclusion of our son in life’s numerous daily activities that involve food at home, at school and away from home in daily life. Research from the NIH has shown that the treatment burden of Celiac Disease is comparable to end-stage renal disease, and the parent (caretaker) burden is comparable to caring for a patient with cancer. According to Columbia University’s “Persistent Economic Burden of the Gluten Free Diet” that was published on February 14, 2019, “Diabetes, hypertension and congestive heart failure patients ranked their overall treatment burden below the participants with Celiac Disease.”

Notwithstanding the Herculean efforts by some brilliant, small and under resourced research teams and advocacy groups, the paucity of NIH funding has created a vacuum and stifled innovation in the efforts to treat and cure Celiac Disease. This can change in FY 2020 with meaningful NIH funding that validates research ready initiatives at multi-institute translational research centers including at the University of Chicago Celiac Disease Center, Celiac Disease Center at Columbia University Medical Center, Harvard Medical School Celiac Research Program, Celiac Disease Program at Children’s National Health System and Children’s Hospital of Philadelphia’s Celiac Disease Center.

The Economics of Celiac Disease – The Financial Burden of the Gluten Free Diet

The treatment burden for Celiac Disease is compounded by the increased cost of a "market basket" of Gluten Free products against a comparable market basket of Gluten containing products whereby research indicates that Gluten Free products were 183% more expensive nationwide. For the average family with Celiac Disease, that additional cost represents an incredible expense, and one that can contribute to poor adherence to maintaining a strict Gluten Free diet, which in turn can cause more serious health issues. According to the 2019 Columbia University study, "The study market basket was based on the food and beverage portion of the USDA market basket which includes breakfast cereal, bread, milk, coffee, wine, chicken, service meals, and snacks based on national consumption data from the United States Department of Labor statistics."

There should be some financial offset to compensate families with Celiac Disease. While in theory there are some tax deductions available for medical expenses associated with Gluten Free food, not many people are able to take advantage of these deductions based on the IRS filing requirements. In addition to changing the tax code to allow for all Celiac patients and their families the right to deduct the incremental cost for Gluten Free food, another way to accommodate the high cost of Gluten Free food would be for all of the associated expenses therefore to qualify as medical expenses towards meeting certain health insurance plan deductibles.

Gluten in Medicine Disclosure Act

In 2004, the Food Allergen Labeling Consumer Protection Act required packaged food labels to identify all ingredients containing wheat and other allergens. Unfortunately, this requirement does not extend to prescription drugs making it nearly impossible to determine the presence of Gluten in prescription medicine. After repeated efforts to shed light on this issue, the FDA initiated draft guidance in 2017 (which is still being finalized), encouraging drug manufacturers to disclose the presence of Gluten in medicine. While some pharma manufacturers have proactively taken this step, many manufacturers have not. This leads to anxiety of not knowing whether or not medication is doing more harm than its intended good. On April 3, 2019, Congressmen Tim Ryan along with his colleague Congressman Tom Cole introduced the Gluten in Medicine Disclosure Act of 2019, which will require drug manufacturers to label medications intended for human use with a list of ingredients, their source, and whether Gluten is present. If passed, the bill would amend the Federal Food, Drug, and Cosmetic Act to require gluten be labeled in all medications. A Gluten-containing drug that does not meet these requirements would be considered misbranded under Section 502 of the Federal Food, Drug, and Cosmetic Act. This labeling will allow concerned Celiac impacted consumers to know, for example, if the starch in their prescription medicine comes from wheat or corn, an important distinction.

On December 11, 2019, Senator Richard Blumenthal (Democrat-Connecticut) introduced S.3021, to the Senate floor. This bill is meant to amend the Federal Food, Drug, and Cosmetic Act to require the label of a drug that is intended for human use and contains an ingredient that is derived directly or indirectly from a Gluten containing grain to identify each such ingredient, and for other purposes. It will also be known as the Gluten in Medicine Disclosure Act of 2019 and uses the same language as H.R. 2074, the bill Representative Tim Ryan [D-OH] introduced to the House on April 3, 2019.

Hopefully, in 2020 the Gluten in Medicine Disclosure Act becomes law.

Articles

1. “The Principle of Human Right to Adequate Food and Celiac Disease: Advancements and Challenges”, by Juliana Nadal (Department of Nutrition. Food Quality and Nutrition Area. Federal University of Parana, Curitiba, PR, Brazil), Sila Mary Rodrigues Ferreira, Islandia Bezerra Da Costa, Suely Teresinha Schmidt (Post-graduation Program in Food and Nutrition Security. Federal University of Parana, Curitiba, PR, Brazil), 2013.

2. “Going Gluten Free as a Human Rights Issue”, By Yvonne Vissing Ph.D. and Christopher Moore-Vissing, Journal of Gluten Sensitivity, Summer 2016 Issue, July 11, 2016.

Human Rights Documents

1. Universal Declaration of Human Rights

2. United Nations Office of the Commissioner for Human Rights “The Right to Adequate Food, Fact Sheet No. 34“

3. United Nations Convention on the Rights of the Child