24 April 2009

Dietary supplements: fraud in law

On April 21, a press conference "Bioactive additives: who legalized fraud and how?" was held at the Independent Press Center (Moscow, Prechistenka, 17/9).

The following issues were covered at the press conference:

  • Dietary supplements as a national disaster
  • Legal aspects of dietary supplements turnover
  • How the business of distributing dietary supplements works – the results of the investigation.

The following speakers addressed journalists and just curious citizens: Chairman of the Public Council for the Protection of Patients' Rights at Roszdravnadzor, President of the League for Patient Protection Alexander Vladimirovich Saversky; President of the Society of Evidence-Based Medicine Specialists Kirill Dmitrievich Danishevsky; Executive Director of the Interregional Public Organization "Society for Pharmacoeconomical Research" Oleg Vasilyevich Borisenko.

Below is a transcript of their reports.

A.V. Saversky:The public council for the protection of patients' rights under Roszdravnadzor and the League of Patients are often contacted by people who have actually been subjected to some form of fraud: they were promised the declared therapeutic effect, they do not receive it.

Dietary supplements, as you know, are quite expensive, and often we encounter situations when an elderly person living on one pension takes a leaflet from the mailbox, believes in what is written there and, hoping to be cured, buys a drug for 12-20 thousand rubles. He drinks this dietary supplement for a month, then suddenly a call rings: "You are worried about the doctor from the center where you purchased our drug, we looked at your medical history, we recommend you to buy a second drug, if you do not do this, you may have a heart attack." A person buys, spends another 12-20 thousand rubles. The most amazing thing is that it doesn't end there – the third bell rings, the chief doctor of the clinic calls: "You know, we looked, if you don't get a third dietary supplement in two days, then you may have a stroke." These are the methods people use. And the doctor says there or not, no one knows.

A lot of appeals of deceived people to the Public Council became an occasion for the Council to pay attention to this problem and make a decision, which I will introduce to you today. At the heart of everything is the positioning of dietary supplements in the market of medicines. The problem is related to the fact that they really appear to be such. A typical example is the drugs of the Tianshi Corporation (do not consider it advertising). They claim their drugs in general as the main ones in the treatment of the disease. "Wellness. To maintain the health of the body (in cases when a person is practically healthy). Preventive. For the prevention of a number of diseases and adaptation of the body to environmental conditions. Preparatory. Preparation of the body for treatment with synthetic drugs. Protective. To mitigate the effect of synthetic drugs when they are used. Restorative. To restore the body after treatment with synthetic drugs. After operations. Therapeutic (therapeutic). In acute diseases as the main drugs. Therapeutic (therapeutic). In chronic conditions."

What is a dietary supplement? "Biologically active additives are natural (identical to natural) biologically active substances intended for use simultaneously with food or introduction into the composition of food products" (Article 1 of the Federal Law of the Russian Federation dated 02.01.2000 No. 29-FZ "On the quality and safety of food products"). That is, it's food! In addition, there is nothing about treatment, prevention, etc. in this definition. Definition of medicines "Medicines are substances used for the prevention, diagnosis, treatment of disease, prevention of pregnancy, obtained from blood, blood plasma, as well as organs, tissues of a person or animal, plants, minerals, by synthesis methods or using biological technologies.

Medicinal products also include substances of plant, animal or synthetic origin that have pharmacological activity and are intended for the production and manufacture of medicines (pharmaceutical substances)" (Article 4 of the Federal Law of the Russian Federation "On Medicines"). This law establishes that for the admission of medicines to the market, they undergo state registration, which is based on the results of preclinical and clinical studies. According to Part 1 of Article 37 of the Federal Law of the Russian Federation "On Medicines", "The purpose of clinical trials of medicines is to obtain by scientific methods assessments and evidence of the effectiveness and safety of medicines, data on the expected side effects from the use of medicines and the effects of interaction with other medicines."

Medicines, before they get into pharmacies, go a very long way, starting with toxicological studies, preclinical studies, clinical studies with the most complex design. Dietary supplements do not undergo any clinical trials, their effectiveness and safety, as preventive, therapeutic and other medicines, has not been confirmed by anything. Dietary supplements shorten the path to the consumer at times, saving time and a lot of money, because clinical trials are expensive. The entourage of dietary supplements marketing – the effect of medicines is claimed, and even more; it is sold in pharmacies, and Russian citizens believe that only proven, safe and effective drugs can be sold in a pharmacy; it is prescribed by doctors or people who pose as doctors.

When a doctor prescribes dietary supplements, it is almost a crime, because he, just like the patient, does not know without clinical trials how this drug works, he does not know about the dosage, nor about the methods of administration, nor about the interaction with other drugs – all that clinical trials allow to learn. When dietary supplements are prescribed by people posing as doctors, using the rhetoric of doctors, etc., then this is pure fraud.

Fraud (Article 159 of the Criminal Code of the Russian Federation) is the acquisition of the right to someone else's property (money) by deception or abuse of trust. The position of the Ministry of Internal Affairs is not very clear here, because you know that criminal cases arise periodically, but the selection criteria are unclear. Why do criminal cases arise periodically, and everything else exists on the Internet, in our mailboxes, in pharmacies, as legal drugs? Not to mention the fact that there is also a "Violation of safety requirements for the life and health of consumers" (Article 238 of the Criminal Code of the Russian Federation).

Summarizing what has been said: dietary supplements are not a medicinal product! Dietary supplements cannot be sold in pharmacies, since pharmacies serve for the sale of medicines and other medical products, to which dietary supplements do not apply. Dietary supplements are used simultaneously with food – thus, all dietary supplements that are not used simultaneously with food are subject to withdrawal from circulation. Doctors do not have the right to prescribe dietary supplements, since this is not a drug. From the instructions for dietary supplements, their advertising, any mention of their preventive, diagnostic, therapeutic and similar properties should be removed, which would at least somehow allow one to think that dietary supplements are a medicinal product. The instructions for dietary supplements must necessarily indicate that this is a biologically active additive used simultaneously with food or introduced into its composition.

The Public Council for the Protection of Patients' Rights sent the following recommendations to the state: to prohibit the sale of dietary supplements through pharmacies; to prohibit the appointment of dietary supplements by doctors; to withdraw from circulation dietary supplements that are not used simultaneously with food; to remove from the instructions for use and advertising of dietary supplements any mention of the actions of dietary supplements that medicines possess according to the law; mandatory use in the instructions for the use of dietary supplements of words indicating that this dietary supplement must be used simultaneously with food; to sell dietary supplements through grocery stores.

Dietary supplements are not sold in pharmacies anywhere in the world. The food supplement must be sold together with the food. There is a very important question that a patient, a consumer should have in mind when thinking whether to buy him a dietary supplement: "Would you eat it if you were told that it was food"? The question that solves the whole problem.

With regard to dietary supplements, we have a problem not only with making money through network marketing, but also with massive clinical trials in Russia without permission. Why submit documents to Roszdravnadzor for obtaining some permits for approval of a clinical trial plan, when I can simply register a dietary supplement, launch it on the market and look at the consequences. Dietary supplements show very well the conflict of private capital, whose task is to earn in any way, and the principles of medicine, where the main task is "Do no harm!" This is a direct clash, and the state needs to solve this problem, taking into account this systemic conflict. Today, private capital acts very aggressively on an unprepared society. The patient is not ready to distinguish a harmful substance from a helping one, he does not have special knowledge, and we have no right to count on this. There should be bodies that protect the population from such aggression.

K. D. Danishevsky:At the end of last year, a press conference was held, which was attended by 10 Russian academicians, some from the medical Academy, and some from the large Academy of Sciences, who unanimously claimed that some Russian dietary supplements help almost all diseases and old age.

In the last six months, in my free time, I began to explore how dietary supplements are marketed. It was unclear to me how it was possible to sell products made from food production waste for a lot of money, to actually "breed" people.

It all started with an investigation of the site's activities "antiparazit.ru ". A very hyped site, its advertising is placed on many mail servers. They sell a device that supposedly removes parasites from the body and strengthens the immune system. They want 12 thousand rubles for this miracle. The site has a huge number of positive reviews of alleged patients. A refund is guaranteed if the treatment is ineffective. The website claims that all diseases are caused by parasites, and it is recommended to use the device for many "chronic" diseases. The first thing you see when you visit the site is a link to the WHO, the Russian version, which says that parasites pose a huge problem for the population. Undoubtedly, this is a big problem for Africa, that is, it was a translation of an article addressed to the people of Africa. In Russia, the share of deaths from infectious diseases from the total number of deaths is about 3%. Of these, from the parasites themselves – less than 1%. The website proves that all chronic and allergic diseases can be treated with their device, because, in their opinion, they are all parasitic in nature.

The first thing I did was to look at the reviews of several thousand patients on the site. I wrote a letter doubting the effectiveness of the device on behalf of the doctor, the letter should have been placed automatically in this "reviews" forum. Nothing like this happened, after a while I just received a letter explaining to me that I am an idiot, I don't understand anything about medicine and in general I need to read a physics textbook to understand how their wonderful device works. Then I sent a letter on behalf of the patient, which said that against the background of the use of the device, I began to have an exacerbation of the disease, I got worse. I was told that this is how it should be, it means that the device is working, you have a chronic disease that you didn't even know about, you are being treated with the device further, time will pass, and it will heal you. The attempt to "return" the money for the allegedly bought greetings by me was also unsuccessful. The company's turnover is huge…

I became interested in the marketing system, and I switched to dietary supplements. Relatively speaking, there are two types of dietary supplements, they do not always exist in their pure form.

Pharmacy. Marketing is similar to unethical models of pharmaceutical promotion, more often – with pharmacological "garbage", just as ineffective drugs are promoted – through opinion leaders (they hire a famous person with a lot of regalia, pay him a fee, give him ready-made slides, and he voices them at various events. Influential people are actively involved. There is a very interesting move in the promotion of dietary supplements – it may be written on the website that dietary supplements help from all forms and stages of cancer – an egregious case. I come to the pharmacy to check the information, I read in the annotation – the drug is made from what they are usually made from, from food industry waste: spoiled milk, blood of killed cows, pigs, etc. or algae – from what costs nothing. And there is nothing about cancer in the annotation, it says "apply as prescribed by a doctor."

And the second group is network. They work according to a different scheme. The scheme is classic, as it was in MMM. Relatives and acquaintances are involved. Sometimes the work is done through "kickbacks" to doctors.

I will tell you about one company whose activities I studied – I went to their seminars, collected all the information. 4life company, American capital, turnover of about $ 1 billion. Products – "trans-factors" from cow's milk colostrum, 5 types are sold in Russia. The developed model of psychological processing, a detailed business strategy, is actively used in more than 40 countries around the world. A clear mathematical model of bonuses. The rollback to the doctor is up to 70%. The company has prepared a very detailed, high-quality package for the distributor, where it is clearly spelled out what and how to do, to whom and what to say. It explains in detail how to make a list of people who need to be involved, it is recommended to include at least 120 people in it. At the same time, any person who gets involved can automatically also become a distributor. At the "medical" lecture, the beautiful doctor, who did not introduce herself from which clinic she was from, told that she feeds all her patients with this product and helps everyone. At the same time, she speaks a special language. If you have read Tolkien, then here is the same parallel world, with its own language, life, terminology. In the issued instructions, there are actually instructions on how to hypnotize a person so that he buys dietary supplements. If a person becomes a distributor, then he begins to receive a percentage of sales from all up to 35 knee, who will be involved next. On their website, you can trace the so–called "branch" - which of your involved bought how many goods and how much you are owed for it. But that would be half the trouble – some healthy people go, some banks sell to each other, naturally without any cash receipts and taxes. After all, responsibility is largely removed and lawsuits are excluded, people sell it primarily to their friends, relatives, and they will not sue you ... The most egregious thing is a contract signed with doctors. There are already ready-made prescriptions, from each prescription that gets to the pharmacy, the doctor automatically receives 500 rubles plus 25% from all sales, because he also acts as a distributor. It turns out that the average doctor earns from 17 to 20 thousand rubles a month on this. I was horrified after studying all this. Stunningly well-developed marketing, there is content, the meaning of words does not matter much, in this way you can sell anything.

Another example is the Russian company LLC "HBO at the RAS "Vita Firm", the same one that was advertised by 10 academicians, claiming the presence of a medical effect in the products. A huge set of "peptides" to regulate the activity of all organs and systems. They promise rejuvenation for 20 years, but it was not noticeable by the appearance of the professors and academicians present. The most scandalous statement of Professor Havinson is that taking "Bronchogen" eliminates the negative effects of smoking. For the information of the professor: the main negative effects of smoking are not associated with the bronchopulmonary system – more than half of smokers die from diseases of the cardiovascular system: heart attacks, strokes.

When I asked another company why they wouldn't register their drug as a medicinal product if it was so miraculous, they told me that while the company hadn't decided to register it even as a dietary supplement, and then we'll see how it goes, if it sells well, then we'll register… This, of course, is an extreme degree of lawlessness, usually firms simply say that it is expensive to conduct clinical trials. It is very important to understand here that clinical trials of truly miraculous drugs do not require a lot of money. For "miraculous" you need a very small number of people and a short time.

The situation is egregious. I tried to call a representative of Roszdravnadzor to the press conference. They said very rightly: "Dietary supplements are food, what do we have to do with it?" That is, we have to get through to Rospotrebnadzor. I understand perfectly well that Rospotrebnadzor has enough problems, they have both the alcohol and tobacco market, the food market, infectious diseases. But this colossal fraud is a problem that can be solved very simply. Russian citizens are accustomed to believe that if something is sold, it is not harmful, otherwise they would not sell it, if dietary supplements are sold in a pharmacy, then it means it is a medicine. This gullible population, apparently, needs to be better protected by the relevant services, because until they themselves recover from trust, there may no longer be any population left.

O. V. Borisenko:

Today, the dietary supplements market in Russia is comparable to the turnover of medicines. Only official statistics show that a billion dollars worth of dietary supplements are sold in Russia per year. This is only official, that is, what is sold through pharmacies and official ways that can be traced. But there are also illegal sales and network marketing. In the whole country, medicines are sold for $17 billion a year. That is, 1 to 17, the numbers are of the same order, the size of the problem is huge. Dietary supplements, of course, are not just a useless dummy. Today, many dietary supplements distributed in Russia have the properties of medicines, but these are bad, these are untested medicines that have not passed the path laid down by any substance that is then used in the drug, but go the short way without checking the effectiveness and safety. Dietary supplements are a food supplement all over the world and they cannot be positioned in any other way, in Russia dietary supplements are positioned as medicines, patients use them as a substitute for drug therapy, delay going to the doctor and, accordingly, delay adequate treatment. There have already been several recipes for fighting dietary supplements announced. Of course, control is very important here, but there is also another aspect. To date, there is no universal fair system of drug provision in Russia. This has been mentioned many times in the documents of the Formulary Committee of the Russian Academy of Medical Sciences. When there is no universal provision of medicines for citizens, they often turn to fraudsters in the hope of finding help. If a universal drug supply system is created – and it takes very little for this – then this dietary supplement market will go away in a matter of months.

Portal "Eternal youth" www.vechnayamolodost.ru24.04.2009

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