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- Painful injection: the gray analogue of Ozempika is sold under the guise of cosmetics
Painful injection: the gray analogue of Ozempika is sold under the guise of cosmetics
The peptide drug Tirzepatide for the treatment of obesity, as well as other potent drugs of this kind, are illegally sold in Russia, the Anti-Counterfeit association said. On one of the websites, these drugs are passed off as cosmetics, Izvestia found out. "Tirzepatide" is intended for subcutaneous injections into the abdominal area and is an alternative to the popular medicines "Ozempik" and Mounjaro. At the same time, the drug sold online is not registered in Russia as a medicine, its manufacturer is also unknown, which means that such injections can be dangerous to health, doctors warned. Who promotes "miracle peptides" and how they can harm - in the Izvestia article.
Peptides are sold under the guise of cosmetics
An active trade in the peptide drug "Tirzepatide" of unknown production under the guise of a cosmetic product has developed in Russia, the international Anti-Counterfeit association told Izvestia. This is an analogue of such drugs as Mounjaro from the American company Eli Lilly and Ozempik from the Danish company Novo Nordisk. But on some sites, in particular in the Peptides Shop online store (the name has been changed. — Ed.), to people who want to lose weight, it is sold according to certificates of conformity issued to cosmetics, explained in the "Anti-counterfeit". In addition to Tirzepatide, other medicines are sold there, for example, Gonadorelin and Rapamycin, and also under the guise of cosmetics and nutraceuticals.
The price of "Tirzepatide" is indicated on the website — from 3.5 to 45 thousand rubles, depending on the volume. Its description states that it is "a synthetic analogue of a gastroinhibitory polypeptide (GIP) developed to stimulate the release of insulin, which makes it possible to treat both type 2 diabetes mellitus and non-alcoholic fatty liver disease."
Such a description corresponds to a medicinal product and should be subject to the law "On the Circulation of Medicines," Alexander Nosenko, head of the Center for the Protection of Copyright Holders at the Anti-Counterfeit Association, told Izvestia.
—Tirzepatide is a prescription drug for the treatment of obesity, and a drug with such an active ingredient is already available on the Russian market — this is Tirzetta," the expert noted. — Its international nonproprietary name is "Tirzepatide". The dosage should be selected individually. Uncontrolled intake can lead to excessive weight loss with the risk of nutritional deficiencies, the development of drug resistance, and a relapse of weight gain after withdrawal.
Another peptide, Rapamycin, is presented on the website as a drug for longevity and costs 12 thousand rubles per bottle. This substance is not a dietary supplement, but a potent immune suppressant used to prevent transplant rejection. It has attracted the attention of scientists as a potential remedy for aging, but its effect has not been unequivocally proven, a transplant specialist at one of the largest multidisciplinary medical centers told Izvestia.
According to the expert, uncontrolled intake of the drug can cause a decrease in immunity, lead to changes in the reproductive system and disrupt metabolism, which, in turn, can increase the risk of diseases of the cardiovascular system.
The third equally serious peptide presented on the website is Gonadorelin, priced at 3.5 thousand rubles per 2 mg. This is a potent hormonal drug that is not registered for human use in Russia, so its official use is impossible, said Artem Zhukov, a therapist and endocrinologist at Dr. Alexandrovsky Medical Center.
"Clinical trials have not been conducted, so it is difficult to identify unambiguous side effects," he stressed. — At the same time, based on the experience of using similar drugs from this group, it can be assumed that the side effects from the reproductive system can be very different.
Who promotes the "magic" peptides
All of these drugs are prescription drugs, but they are sold on the website without a prescription, since they are not registered as a medicine, explained Alexander Nosenko. The certificates of conformity on them indicate that the drugs are certified as cosmetics (serums). And the number of the commodity nomenclature of foreign economic activity (HS) corresponds to the position "other cosmetics — for make-up and skin care, tanning products, manicure and pedicure".
— On the Peptides Shop website, drugs are recommended to be used by injection, — the expert noted. — However, injection of drugs that are not registered as medicines is fundamentally excluded.
Peptidpharminternational LLC sells peptides. Its co-founders are individual entrepreneur Marat Ravilevich Morozov and Gleb Gennadievich Kuzminov. The website about Kuzminov says that he is a candidate of medical sciences, a general practitioner, a doctor of regenerative medicine and a leading expert at the international institute of Prevent Age.
Drugs are actively advertised on social networks, including by doctors. In their video presentations, they assure listeners that they are conducting an experiment involving 31 women and six men.
On the first visit, the website issues a warning stating that all the presented peptide preparations "are not medicinal products and are intended solely for research purposes."
"The drugs are designed for in vitro testing and exclusively for laboratory experiments. All information provided on the site is purely educational in nature, and any introduction of this product into the human or animal body is prohibited," reads the text that appears on the site.
According to Alexander Nosenko, any clinical trials of medicines for medical use are conducted in medical organizations.
— And in vitro is an experiment in vitro, which is not carried out on a living organism or even on mice, — he said.
Izvestia called the phone number listed on the website under the guise of buyers. The manager who took the call immediately warned that "these are not medicines, but materials for research purposes," and suggested that before using them, consult a doctor during a free consultation on Telegram.
"Our doctors are qualified and have been trained," the manager assured. When asked where peptides are produced, the seller's representative replied that "some are in Russia and some are in the USA."
At the same time, on some other sites in the Russian segment of the Internet, "Tirzepatide" is also presented, the manufacturer of which is Apex Biopharma, and the manufacturing country is China.
What harm can peptides do?
The use of any drugs that are not officially registered as a medicinal product is potentially dangerous to health, endocrinologist and nutritionist Alexei Kalinchev told Izvestia.
— The effect of using such drugs has not been studied. Their use is at your own risk," he explained.
The expert stressed that there are quite a lot of such products on the market now. According to him, this is due to the fact that their turnover is not controlled by anyone, as the drugs are not registered and are sold through illegal channels.
"Doctors who prescribe such drugs do not realize that they can harm the health of patients," he added. — Experts may not know that they do not have an official registration.
Peptides are drugs that, in principle, have not passed high—quality clinical trials, said Maria Milutina, MD Group reproductologist. According to her, they are most often registered as a dietary supplement or a serum with amino acids.
— Peptides are not included in the clinical guidelines. Therefore, the big question is whether they can be taken even under the supervision of a doctor," the expert emphasized.
Alexey Starchenko, a medical lawyer and member of the public council for the protection of patients' rights at Roszdravnadzor, noted that the educational activities stated on the company's website do not imply sales.
— This information may partially protect the company. But if a person purchases a product and takes it to a laboratory, where it is checked for safety and it is not confirmed, a criminal case may be opened for the provision of services that do not meet safety requirements (art. 238 of the Criminal Code of the Russian Federation)," he said.
Alexey Starchenko stressed that this is certainly not the only company that develops peptide drugs.
— For example, in St. Petersburg they create peptide preparations from animal proteins. But they register them as medicines there," he added.
Without trials
The lack of state registration of the drug as a medicinal product indicates that it has not passed the necessary preclinical and clinical studies, including toxicological assessment, studies on mutagenicity, effects on the fetus and the likelihood of cancer, as well as clinical trials for safety, effective dosage and side effects, medical lawyer Irina Gritsenko told Izvestia..
"Such drugs cannot be considered safe, as they can potentially cause allergic reactions, up to anaphylactic shock, infectious complications with impaired sterility, systemic metabolic disorders, hormonal disruptions and unpredictable consequences when combined with other drugs," the expert emphasized.
Irina Hrytsenko also noted that injectable drugs cannot be registered as cosmetics. According to her, according to the current technical regulations, cosmetics are not intended to be injected into the bloodstream, tissues or organs, especially if they have a systemic pharmacological effect.
— The use of injectable drugs involves the provision of medical services, which can only be carried out by medical organizations or specialists who have the appropriate license for this. The use of such drugs, for example, by cosmetologists without a license is unacceptable," the expert explained.
The reservation about the research purpose of the product does not exempt from liability, Irina Gritsenko emphasized. This formulation, according to her, indicates that drugs cannot be used in the framework of routine medical or cosmetology practice, and conducting clinical trials requires compliance with the procedure established by law. Consequently, the sale and use of such drugs, contrary to the stated reservation, is a violation of the law and cannot be considered legitimate activity, she concluded.
We found a loophole
"Tirzepatide", "Gonadorelin" and other peptide hormones for injection cannot be considered cosmetics, since the latter is intended exclusively for external application to the body, Oleg Pavlov, chairman of the Public Consumer Initiative (OPI), told Izvestia.
— Nevertheless, the practice of selling these drugs under the guise of cosmetics exists, — said the expert. — This is mainly due to the shortcomings of the procedure for assessing and confirming the compliance of cosmetic products with mandatory requirements.
According to Oleg Pavlov, unscrupulous manufacturers or importers accept declarations of conformity based on commercial laboratory protocols. It is only enough to confirm the compliance of the presented liquid with the safety requirements established for cosmetic products. At the same time, the method of application of the product is not specified and is not reflected in the protocol and declaration.
After receiving such a protocol, the declarant releases liquid for injection into circulation formally as a cosmetic product.
— This method of application often does not cause any doubts among buyers due to the presence of a syringe in the kit, — the expert noted. — And the supplier, with reference to the test report, will be able to indicate that when applied externally, the products meet the requirements for cosmetics.
The solution to the problem may be to tighten control in this area and use the capabilities of the digital labeling system to identify illegal participants in the turnover and block the sale of products that do not meet mandatory requirements, the chairman of the OPI summed up.
Izvestia asked sellers of peptides about why medicines that are sold for injection are registered as cosmetics. Izvestia also asked Roszdravnadzor about whether these peptide preparations are registered as medicines.
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