Open Letter To M. Mishustin

Open letter to M. Mishustin

The autonomous non-profit organization "Center for Problems of Autism" (CAP) represents the interests of parents who are raising children with disabilities caused by autism spectrum disorders (ASD) and other neurodevelopmental disorders. Now such families are in despair, because they are trying to deprive them of one of the basic rights - access to nutritious food for special children.

Photo: autismchallenge.ru 22971

Autism spectrum disorder is a group of diseases that manifest themselves at an early age and are characterized by impaired social behavior, communication, verbal abilities, and narrowing of interests. According to the World Health Organization, one in 160 children suffers from ASD, which is a fairly common disease in the world. In Russia, according to the Ministry of Health, more than 31 thousand children with ASD are officially registered alone, and experts consider this figure to be underestimated.

There is currently no specific drug treatment for autism. But both numerous studies and clinical practice confirm that diet and nutritional deficiencies can slow the progression of the disease and significantly improve the prognosis in the correction of autism. It is important to note that it is much more difficult to provide a child with autism with adequate nutrition than an ordinary, neurotypical child: among children with ASD, allergies are much more common than the average in the population; in addition, such children are extremely selective in their food, and it is often not possible to feed them with normal food.

Children with ASD vitally need nutritional supplements - vitamins, minerals and amino acids, moreover, developed taking into account their characteristics, of the highest hypoallergenic quality. In Russia, they are practically not produced and even imported in insufficient quantities. Until recently, families with children with ASD found their way out by buying these nutraceuticals on the iHerb marketplace.

However, since May 15, 2020, iHerb suspended the operation of its mobile application for Russian users due to the decision of the Ulyanovsk Regional Court, which satisfied the claim of the prosecutor of the Zasviyazhsky district of the city of Ulyanovsk. The reason for filing a claim was the complaint of the executive director of the Union of Nutritional Supplements Manufacturers Alexander Zhestkov, who in 2018 discovered 10 products in the iHerb store that allegedly did not comply with the technical regulations of the Customs Union. As a result, based on the materials transferred by Alexander Zhestkov, the prosecutor's office filed two lawsuits in court. Based on the results of considering the first of them, the court ruled to restrict the access of Russian users to the 10 goods indicated in the complaint of Mr. Zhestkov on the iHerb.com website. As a result of the second, after a series of lengthy proceedings,iHerb was ordered to remove the entire mobile application.

The expert on this claim was Svetlana Orlova, Doctor of Medical Sciences, Professor, Head of the Department of Dietetics and Clinical Nutrition, RUDN MI FPKMR. We knew her as an excellent specialist who perfectly understands the specifics of working with children with ASD. In particular, Professor Orlova was a speaker at the IV International Scientific and Practical Conference “Autism. Challenges and Solutions”, where she presented a report on nutritional correction of metabolic disorders in ASD.

However, the conclusion on products from the iHerb website prepared by her at the request of Alexander Zhestkov caused us extreme bewilderment. Unfortunately, due to the lack of special knowledge and competence, the prosecutor and the judges seem to have failed or did not want to understand this, as a result of which thousands of Russian families raising children with ASD suffered.

In an open letter, which, perhaps, will be read not only by specialists, we will omit the issues of the incorrect use of regulatory legal acts, although, in our opinion, there are also such issues. In order not to be unfounded, we will give just one example. Speaking about dosages, Professor Orlova refers to Methodological Recommendations MP 2.3.1.2432-08. This document regulates the production of food products, the organization of meals in organized groups or the development of official recommendations on nutrition for the population - that is, it cannot even theoretically regulate the individual consumption of food additives in medical and preventive purposes.

But in this address we would like to dwell on something else. So, for example, in the list of drugs that allegedly do not comply with the technical regulations there is an additive “NowFoods. Sports nutrition. L-carnitine liquid ". The expert opinion states that it contains excessively high dosages of the amino acid levocarnitine (L-carnitine), vitamin B12 and pantothenic acid (vitamin B5).

These three substances are very often used in the preparation of the so-called mitochondrial cocktail, which many children with ASD need due to mitochondrial dysfunction associated with autism. Therefore, we at the CPA are well aware of all the latest research related to the action of the above substances, the permissible dosages and the possibilities of their use in the correction of autism.

But the fact is that there is no vitamin B12 in the composition of the drug, in fact it contains another substance - pyridoxine hydrochloride, that is, vitamin B6. It is a little strange to talk about exceeding the permissible dosage of an ingredient by two to three times, which is not at all in the composition of the drug.

As for L-carnitine, numerous studies show that it is perfectly safe at doses up to 3000 mg per day, and a meta-analysis of randomized trials indicates that more than 3 g (3000 mg) may be quite safe. Therefore, the dosage of L-carnitine in NowFoods poses no threat. (We are ready to provide, upon request, links to all studies mentioned in this letter.)

The same applies to pantothenic acid (vitamin B5). According to the US Federal Food and Drug Administration (FDA), the acceptable upper intake for pantothenic acid has not been established because there are no reported side effects. The oral average lethal dose for mice is 10 grams per kilogram of body weight, while the "dangerous" product of vitamin B5 claimed in the lawsuit is several orders of magnitude less - while, obviously, people, even children, are much heavier than mice.

We would like to focus on another substance mentioned in the lawsuit because of its vital importance for children with ASD. This substance is melatonin.

Children with autism have dysregulation of the melatonergic pathways, and if melatonin is not taken in the form of drugs, a child with autism (and as a result, all other members of his family) has a fatal sleep disorder. Lack of sleep leads to a decrease in learning and adaptability, becomes the cause of mental breakdowns and even deeper disability.

Melatonin in Russia is absolutely freely sold in pharmacies under many brands, and there is no problem to buy it. However, the prices for it in Russian pharmacies and on the iHerb website differ significantly. So, one capsule of melatonin with a dosage of 3 mg from the iHerb store costs an average of 3.5 rubles, and a capsule with exactly the same dosage produced by the Evalar company costs 10.5 rubles. It may seem that in absolute terms, the difference in the price of melatonin capsules is not that significant. But children with ASD have to take this drug all the time, and the families in which they grow up, as a rule, are economically very vulnerable. Due to the dire condition of their children, parents are often unable to work, and members of such families often live on pension and disability benefits, saving on literally everything. Having to overpay three times for the drug they need will put them on the brink - or even beyond - survival.

We understand that Russian law only permits the production of melatonin preparations in the form of registered medicines. However, this substance itself is not prohibited, and in fact, its circulation is almost unlimited. We believe that prohibiting families of children with disabilities from ordering melatonin from abroad is discrimination against people with disabilities, a restriction of their rights guaranteed by the Convention on the Rights of Persons with Disabilities, which Russia ratified in 2012.

People with disabilities, as a rule, do not have the opportunity to travel abroad, purchase the drugs they need there and import them into Russia in their own suitcase, as more mobile and wealthy citizens do quite legally. Not a single Russian law prohibits the import of permitted substances into the country for personal consumption. However, it turns out that some of our citizens can exercise this right guaranteed by law, while the most vulnerable, disabled children and their parents, cannot.

The delivery of the iHerb store works in such a way that the volume of the package is limited. This completely excludes the possibility of importing not only "industrial", but even small wholesale consignments of food additives: everything that the parents of our wards order, they order exclusively for themselves. Therefore, another argument of the Zasviyazhsky District Prosecutor, namely that some products from iHerb fall under the so-called food embargo, in our opinion, is untenable: Russian “counter-sanctions” have never extended to the import of goods for personal consumption. In addition, dietary and specialized food, including dietary supplements, was excluded from the sanctions lists back in 2014.

The website of the iHerb.com store is still available in Russia, and theoretically, parents of children with disabilities can make an order through it. However, not all Russian families have a computer. Very often, especially in the provinces, the possibility of accessing the Internet is only available from a smartphone, namely the option of orders through the iHerb mobile application is now blocked. And we again have to admit that our families are faced with artificial barriers, the elimination of which should be guaranteed by the Convention on the Rights of Persons with Disabilities.

Summing up our appeal, we want to remind you that the Convention on the Rights of Persons with Disabilities provides for such a measure as "reasonable accommodation", that is, the introduction, when necessary, of the necessary modifications and adjustments, allowing people with disabilities to exercise their rights on an equal basis with other citizens. In the case of children with ASD, this “reasonable accommodation” is the ability to receive special hypoallergenic food at an affordable price.

Therefore, in the decision of the Ulyanovsk Regional Court, we see signs of discrimination against our category of children on the basis of disability. This decision interferes with the privacy of families of children with disabilities, disrupts well-established livelihoods, and forces them to spend more time and money looking for alternative nutrients.

We are good citizens, we respect the law, the principles of independence and independence of the judiciary. However, we believe that injustice cannot be recognized as legal.

Judicial acts based on errors in the interpretation and application of the rules of law, resulting in the violation of the fundamental rights of the most vulnerable categories of citizens, need to be revised. And the authorities, which initiated such court decisions in favor of certain departmental interests, must show courage and responsibility - to admit the violations committed and refuse to support, in our opinion, an unfounded position.

According to Art. 7, part 2 of Art. 19 of the Constitution of the Russian Federation, providing state support for disabled people, creating for them equal (non-discriminatory) conditions of life and work is one of the most important tasks of Russia as a social state. Therefore, we call on the government of the Russian Federation to intervene in this situation and provide unconditional protection of the constitutional rights of children with ASD.

We also call on the relevant ministries (Ministry of Labor and Social Protection, Ministry of Health, Ministry of Industry and Trade, Ministry of Economic Development):

within the framework of their competence and interdepartmental interaction, ensure the holding of an event to analyze and evaluate the regulatory and legislative practice related to the implementation of measures to recognize information that is prohibited for dissemination on the territory of Russia, posted on international electronic trading platforms in order to sell goods, including dietary supplements, in for individuals for personal use;

• to promote the elimination of the legal possibility of excessive, arbitrary application of such measures;
• ensure the improvement (clarification) of legal regulation in order to exclude the corresponding vicious practices that violate the rights and legitimate interests of children with disabilities.

ANO "Center for Autism Problems" is a leading scientific, educational and human rights organization in the field of autism. It has been working since 2011, providing advisory, educational and social assistance to hundreds of families with children with autism and dozens of patient NGOs throughout Russia. He is a multiple winner of the presidential grants competition.