madman
Super Moderator
Abstract
Substandard/counterfeit drugs are a growing global problem. According to the World Health Organisation, counterfeit medicines are medicines that are mislabelled deliberately and fraudulently regarding their identity and/or source. In high-income countries, drugs seized are mainly represented by performance and image enhancing drugs (PIEDs). The aim of this study was to present the qualitative and quantitative results of toxicological analyses of pharmaceutical and dietary supplements seized from the black market among bodybuilders in France. All dietary supplements and pharmaceuticals seized from the black market and addressed to the laboratory for a qualitative and quantitative analysis between January 2016 and December 2019 was included in the study. The screening was carried out by gas chromatography-mass spectrometry and liquid chromatography-high resolution mass spectrometry. Identified compounds were quantified by liquid chromatography-tandem mass spectrometry. One hundred and ten products were seized and submitted to the laboratory for identification of active compounds and quantification: 75 pharmaceuticals and 35 dietary supplements. This included 39 oily and 3 aqueous solutions for intramuscular injection, 34 tablets, 13 capsules, 14 powders, 4 liquids, and 3 lyophilizates. Among the pharmaceuticals, 25/75 (33%) were substandard (dosage not on the acceptable range defined for original products), 24/75 (32%) were counterfeit (qualitative formulation does not match the label) and 14/75 (19%) were original (qualitative formulation and levels of active ingredients fully match the declared formulation. The analysis of the 12 remaining products revealed a correct qualitative content for 11/75 (15%), but quantitation could not be carried out because of the lack of reference standards at the time of the analysis. Fifty-four pharmaceuticals contained anabolic-androgenic steroids (AAS). Four out of 54 (7.4%) AAS were found as original, 8/54 (15%) could not be quantified (one with wrong active ingredient), corresponding to 43/54 (80%) AAS being non-original. In contrast, only 1/35 dietary supplement (3%) was adulterated, with a doping substance (1,3-dimethylbutylamine, DMBA). This work allows to show that France is not spared by the trafficking of PIEDs. The use of counterfeit drugs in the mainstream population is an underestimated public health issue.
1. Introduction
Counterfeit drugs are considered by the World Health Organization (WHO) as those which are substandard and falsified, and either fail to meet quality standards or are deliberately manufactured to imitate a legitimate product [1]. They may contain no active ingredient, a wrong active ingredient, the true active ingredient associated with other active substances, or an incorrect amount of the correct active ingredient. These products can lead to a panel of life-threatening adverse events up to deaths due to therapeutic inefficacy or toxicity [2–4]. Counterfeit drugs affect mainly low-income countries with a 10% risk of experiencing this problem, whereas this risk falls to 1% in high-income countries [1,5].
As part of the fight against drug trafficking, Interpol organized in 2018 an operation (Pangea) mobilizing police, customs, and health regulatory authorities from 116 countries targeting the illicit online sale of medicines and medical products [6]. This operation resulted in 859 arrests worldwide and the seizure of potentially dangerous pharmaceuticals worth more than USD 14 million. Focusing on delivery services manipulated by organized criminal networks, the operation saw 3671 web links closed down, including websites, social media pages, and online marketplaces. Almost one million packages were inspected during the week of action (9–16 October), with 500 tons of illicit pharmaceuticals seized worldwide. These figures allow us to appreciate the extent of the black market for drugs in the world.
In high-income countries, drugs seized are mainly represented by performance and image enhancing drugs (PIEDs). These molecules are taken with the aim of improving athletic performance, body image and as a complement or even substitute for physical exercise. Focus and preoccupation with body image are increasingly common for both genders in recent decades [7]. The use of enhancement drug supplements is reportedly widespread among athletes of all ages and competitive levels [8]. Several analytical studies have been conducted on drugs and nutritional supplements seized on the black market [9–14]. The most common substances found are anabolic-androgenic steroids (AAS). In France, only one testosterone ester (enanthate) is still marketed under medical prescription to treat hypogonadism. The multitude of websites selling PIEDs and the low cost offered has led to an explosion in their consumption among mainstream fitness groups or even among people who do not practice sport and has contributed to an emergent public health issue. The use of such a product poses a health risk to consumers, who have reported harms such as infections at injecting sites when counterfeit or contaminated products are used [15]. Furthermore, chronic exposure to AAS is responsible for many complications: cardiovascular, endocrine, hepatic, and behavioral [16].
To our knowledge, no study carried out on the analysis of pharmaceuticals products from the black market has been conducted in France. The aim of this study was to present the qualitative and whenever possible quantitative results of toxicological analyses of pharmaceutical and dietary supplements seized from the black market among bodybuilders in France.
4. Conclusion
This study shed light on the issue related to the trafficking of anabolic products in France. The majority of the products analyzed were counterfeit or substandard. Two products were devoid of active substances. The low quality of these products associated with invasive modes of administration (injection) exposes users to risks of acute and chronic toxicity. Regarding food supplements, only one sample was adulterated with DMBA, this proportion is clearly lower than those reported in previous studies. This may reflect an improvement in the quality of the marketed products. Few studies have been carried out on anabolic steroids in France, this work allows to show that France is not spared by the trafficking of PIEDs. The use of DCs in the mainstream population is an underestimated public health.
Substandard/counterfeit drugs are a growing global problem. According to the World Health Organisation, counterfeit medicines are medicines that are mislabelled deliberately and fraudulently regarding their identity and/or source. In high-income countries, drugs seized are mainly represented by performance and image enhancing drugs (PIEDs). The aim of this study was to present the qualitative and quantitative results of toxicological analyses of pharmaceutical and dietary supplements seized from the black market among bodybuilders in France. All dietary supplements and pharmaceuticals seized from the black market and addressed to the laboratory for a qualitative and quantitative analysis between January 2016 and December 2019 was included in the study. The screening was carried out by gas chromatography-mass spectrometry and liquid chromatography-high resolution mass spectrometry. Identified compounds were quantified by liquid chromatography-tandem mass spectrometry. One hundred and ten products were seized and submitted to the laboratory for identification of active compounds and quantification: 75 pharmaceuticals and 35 dietary supplements. This included 39 oily and 3 aqueous solutions for intramuscular injection, 34 tablets, 13 capsules, 14 powders, 4 liquids, and 3 lyophilizates. Among the pharmaceuticals, 25/75 (33%) were substandard (dosage not on the acceptable range defined for original products), 24/75 (32%) were counterfeit (qualitative formulation does not match the label) and 14/75 (19%) were original (qualitative formulation and levels of active ingredients fully match the declared formulation. The analysis of the 12 remaining products revealed a correct qualitative content for 11/75 (15%), but quantitation could not be carried out because of the lack of reference standards at the time of the analysis. Fifty-four pharmaceuticals contained anabolic-androgenic steroids (AAS). Four out of 54 (7.4%) AAS were found as original, 8/54 (15%) could not be quantified (one with wrong active ingredient), corresponding to 43/54 (80%) AAS being non-original. In contrast, only 1/35 dietary supplement (3%) was adulterated, with a doping substance (1,3-dimethylbutylamine, DMBA). This work allows to show that France is not spared by the trafficking of PIEDs. The use of counterfeit drugs in the mainstream population is an underestimated public health issue.
1. Introduction
Counterfeit drugs are considered by the World Health Organization (WHO) as those which are substandard and falsified, and either fail to meet quality standards or are deliberately manufactured to imitate a legitimate product [1]. They may contain no active ingredient, a wrong active ingredient, the true active ingredient associated with other active substances, or an incorrect amount of the correct active ingredient. These products can lead to a panel of life-threatening adverse events up to deaths due to therapeutic inefficacy or toxicity [2–4]. Counterfeit drugs affect mainly low-income countries with a 10% risk of experiencing this problem, whereas this risk falls to 1% in high-income countries [1,5].
As part of the fight against drug trafficking, Interpol organized in 2018 an operation (Pangea) mobilizing police, customs, and health regulatory authorities from 116 countries targeting the illicit online sale of medicines and medical products [6]. This operation resulted in 859 arrests worldwide and the seizure of potentially dangerous pharmaceuticals worth more than USD 14 million. Focusing on delivery services manipulated by organized criminal networks, the operation saw 3671 web links closed down, including websites, social media pages, and online marketplaces. Almost one million packages were inspected during the week of action (9–16 October), with 500 tons of illicit pharmaceuticals seized worldwide. These figures allow us to appreciate the extent of the black market for drugs in the world.
In high-income countries, drugs seized are mainly represented by performance and image enhancing drugs (PIEDs). These molecules are taken with the aim of improving athletic performance, body image and as a complement or even substitute for physical exercise. Focus and preoccupation with body image are increasingly common for both genders in recent decades [7]. The use of enhancement drug supplements is reportedly widespread among athletes of all ages and competitive levels [8]. Several analytical studies have been conducted on drugs and nutritional supplements seized on the black market [9–14]. The most common substances found are anabolic-androgenic steroids (AAS). In France, only one testosterone ester (enanthate) is still marketed under medical prescription to treat hypogonadism. The multitude of websites selling PIEDs and the low cost offered has led to an explosion in their consumption among mainstream fitness groups or even among people who do not practice sport and has contributed to an emergent public health issue. The use of such a product poses a health risk to consumers, who have reported harms such as infections at injecting sites when counterfeit or contaminated products are used [15]. Furthermore, chronic exposure to AAS is responsible for many complications: cardiovascular, endocrine, hepatic, and behavioral [16].
To our knowledge, no study carried out on the analysis of pharmaceuticals products from the black market has been conducted in France. The aim of this study was to present the qualitative and whenever possible quantitative results of toxicological analyses of pharmaceutical and dietary supplements seized from the black market among bodybuilders in France.
4. Conclusion
This study shed light on the issue related to the trafficking of anabolic products in France. The majority of the products analyzed were counterfeit or substandard. Two products were devoid of active substances. The low quality of these products associated with invasive modes of administration (injection) exposes users to risks of acute and chronic toxicity. Regarding food supplements, only one sample was adulterated with DMBA, this proportion is clearly lower than those reported in previous studies. This may reflect an improvement in the quality of the marketed products. Few studies have been carried out on anabolic steroids in France, this work allows to show that France is not spared by the trafficking of PIEDs. The use of DCs in the mainstream population is an underestimated public health.
