Deadly falsifications

Irina Reznik, Mednovosti 

Rospotrebnadzor began revoking certificates of registration of dietary supplements for improving potency, in which the chemicals tadalafil and sildenafil, which are part of prescription drugs for erectile dysfunction, were found. In case of overdose, these drugs can lead to the death of a person.

As it became known to Mednovosti, the Ministry of Health of Belarus was the first to react to the facts of falsification of "plant" food additives. According to the decree of the Deputy Minister and Chief Sanitary Doctor of 16.07.2015, the import and circulation of dietary supplements "Tongkat Ali Platinum" produced by Polens (M) SDN.BDN, Malaysia, has been suspended. And importers are ordered to withdraw it from circulation.

After Belarus, with reference to the technical regulations, the dietary supplement "Tongkat ali platinum" and Rospotrebnadzor withdrew. The corresponding order No. 631 dated 07/29/15 was signed by the chief sanitary doctor Anna Popova. According to the electronic register of the EEC, all certificates of state registration of Tongkat Ali Platinum have been canceled. This means that the additive cannot be traded on the market and is actually outside the law. Nevertheless, it continues to be sold and actively advertised. 

The test was initiated by the developer of Tadalafil, the British pharmaceutical corporation Eli Lilly. The company sent to Rospotrebnazdzor research protocols on the availability of its pharmaceutical substation in Sealex Fort. But then there was no reaction from the regulatory authorities. In February 2013, Eli Lilly made another attempt to deal with the illegal use of its pharmaceutical substance and purchased 15 images of Sealex Forte, Alikaps and Tongkat Ali Platinum in several Russian regions for analysis. As a result, tadalafil was found in all samples in an amount from 13.4 mg/caps. to 23 mg/caps. ("Tongkat Ali Platinum"). But even after that, the case did not get a move.

In April 2015, the self-regulating organization "Association of Dietary Supplements Manufacturers", the Union of Professional Pharmaceutical Organizations and the Pharmacy Guild conducted a joint control purchase of 29 samples of various dietary supplements in six federal networks (Sealex, Alikaps, Laveron, Tongkat Ali Planinum, Saimy, Fuzhunbao Super) to improve potency.

The studies, which were conducted in three laboratories accredited by the Ministry of Health, shocked specialists – substances not declared during state registration and prohibited for use in dietary supplements were found in 80% of samples. They contained phosphodiesterase-5 (iFDE-5) inhibitors tadalafil and sildenafil in amounts up to 31.1 mg/caps.. In some samples, the dosage was even higher than in medicines. And in order to make it difficult to detect the active substance, manufacturers placed it not inside the capsule, but in its outer gelatin shell. According to experts, this also indicates the "high-tech" production of counterfeits. International pharmaceutical companies have been using similar technologies since 2009, and just in dietary supplements to improve potency.

In early June, the research protocols were presented at a press conference dedicated to the problem of the turnover of counterfeit drugs in the Russian pharmaceutical market. Counterfeit medicines are sold under the guise of dietary supplements, which can cost the health and even the lives of consumers of surrogates, and huge profits push manufacturers to falsify, they said at a press conference. All materials were then sent to the heads of relevant departments and law enforcement agencies, the issue was taken under parliamentary control.

(The additions to Article 238.1 (from 3 to 12 years of imprisonment), which established responsibility for the falsification of medicines and dietary supplements, entered into force on January 23, 2015). The decree of July 16, 2015 states that "in pharmacies of the largest chains, dietary supplements Laveron, Orgasex, Sealex Forte, Alikaps, Tongkat ali platinum were sold, containing pharmaceutical substances of prescription drugs that were not declared during state registration."

After seeing what was happening, small manufacturers began to recall their products themselves. So, the company Nilen Alliance Group (USA), the manufacturer of Orgasex and Laveron products, together with LLC Nylen and LLC Vitamin Paradise, sent official letters to distributors about the recall of their products. Major manufacturers remain calm. And the order of Rospotrebnadzor No. 631 on the recall of Tongat Ali Platinum remains the only one of its kind so far. Although, logically, the departments that occupied more than 70% of sales of Sealex and Alikaps should have been next on the "black list" – tadalafil was found in all their samples purchased for research.

According to Sergey Maksimov, Professor, Head of the Criminal Law Sector of the Institute of State and Law of the Russian Academy of Sciences, the initiation of a criminal case is "a real breakthrough in the fight against the falsification of products entering the pharmacy chain." Until now, unscrupulous manufacturers got off with symbolic fines. Now, according to the professor, the investigation is obliged to take measures to protect potential consumers of dangerous products in Russia and the EAEU states that have a common customs border with it.

"The legislation of the Russian Federation allows in such cases (in case of a threat to the safety of public health) to promptly suspend not only the circulation of specific series of products, but also the functioning of specific economic entities until court decisions are made," the expert believes. He also recalls that responsibility under Article 238.1 of the Criminal Code of the Russian Federation is borne not only by manufacturers, but also by distributors of falsified dietary supplements. The problem directly concerns about 10 million Russian men, and the state should "immediately stop this large-scale crime," Maximov believes.

The instructions for the drugs say that they increase libido, improve the functional state of the genitourinary system, stabilize the psychoemotional background, eliminate complexes and tension and also contribute to the overall improvement of the body. The advantages of dietary supplements manufacturers include their one hundred percent "naturalness". The claimed composition of such additives includes plants that are really known as effective stimulants of potency – ginseng, licorice root, etc. However, as it turned out, this is far from the case.

According to Academician of the Russian Academy of Sciences, Doctor of Medical Sciences Sergey Kolesnikov, tadalafil and its derivatives have a serious impact on the cardiovascular system. And overdose, especially coupled with alcohol and other medications, can lead to sudden cardiogenic death. "Mortality from CVD in Russia averages about 56%. In men, this indicator is even higher, – the academician reminds. – Every year 100 thousand men aged 25 to 60 years (the main target audience of drugs for potency) die from CVD. One can only guess how many of them have suffered from receiving such falsifications. Therefore, the entire medical community is waiting for decisive measures to combat this demographic threat."

To date, Rospotrebnadzor simply registers dietary supplements entering the market without checking their composition. However, as the head of the State Duma Committee on Healthcare Sergey Kalashnikov said, the committee is preparing a bill that will transfer the authority to regulate the dietary supplements market from Rospotrebnadzor to Roszdravnadzor. It is assumed that this agency will not just register new drugs, but check the composition of each of the drugs available on the market and new ones coming in for the presence of drugs there. 

So far, however, none of these initiatives have received a move – the "food supplement" lobby is very much. According to the executive director of the NP "Union of Professional Pharmaceutical Organizations" Lilia Titova, in 2014 the dietary supplement market reached 29 billion rubles, and continues to grow in 2015, despite the crisis (by 15% in six months). And the turnover of chemical surrogates under the guise of food additives in Russian pharmacy chains, according to preliminary estimates of the Union of Professional Pharmaceutical Organizations, can reach 4-5 billion rubles a year.

According to the head of the Department of Dietetics and Clinical Nutritionology of the RUDN, Professor Svetlana Orlova, the high demand for dietary supplements to increase potency and the relative ease of obtaining synthetic PDE-5 inhibitors led to the appearance of a large number of counterfeit medicines sold under the guise of dietary supplements. For example, in Singapore, the content of synthetic PDE-5 inhibitors was detected in 77% of 175 "natural products" for men's health, in the USA, 81% of 91 samples contained medicinal PDE-5 inhibitors or their analogues.

In response to the tightening of regulatory control by the US, EU and Southeast Asian countries, manufacturers have begun to use more sophisticated and sophisticated technologies to introduce synthetic iFDE-5 into products. The first message about the inclusion of synthetic iFDE-5 in the capsule shell appeared on May 8, 2009, when the Singapore Health Sciences Authority issued a warning to consumers that tadalafil was detected in the shell of the XP Tongkat Ali Supreme dietary supplement. In 2010, "vegetable" dietary supplements, which also contained sildenafil and tadalafil in their gelatin shells, were withdrawn from the New Zealand market.

In the Netherlands, they even developed a comprehensive method for detecting synthetic iFDE-5 in capsules of falsified dietary supplements. The presence of tadalafil in the form of particles and in dissolved form in the gelatin matrix of capsules was determined by microscopy and Raman spectroscopy. Methods of HPLC mass spectrometry and HPLC with a diode-matrix detector were proposed to quantify the content of tadalafil in capsules.

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23.09.2015