Laboratoire de Pharmacologie - Toxicologie, Centre Hospitalier Universitaire Raymond Poincaré, FHU Sepsis, AP-HP, 104 boulevard Raymond Poincaré, 92380 Garches, France; Plateforme de Spectrométrie de Masse MassSpecLab, INSERM UMR 1173, UFR des Sciences de la Santé Simone Veil, Université Paris-Saclay (Versailles Saint-Quentin-en-Yvelines), 2 avenue de la source de la Bièvre, 78180 Montigny-le-Bretonneux, France.
Institut de médecine légale, Strasbourg, France.
Forensic Sci Int. 2021 May;322:110771. doi: 10.1016/j.forsciint.2021.110771. Epub 2021 Mar 30.
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 were included in the study. A 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 matches 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 mainstream population is an underestimated public health issue.
假冒伪劣药品是一个日益严重的全球性问题。根据世界卫生组织的定义，假冒药品是指在身份和/或来源方面被故意伪造和欺诈性标记的药品。在高收入国家，缉获的药物主要是性能和形象增强药物（PIEDs）。本研究的目的是介绍法国黑市上从健美运动员那里缉获的药品和膳食补充剂的毒理学分析的定性和定量结果。本研究包括 2016 年 1 月至 2019 年 12 月期间，实验室对从黑市上缉获并进行定性和定量分析的所有药品和膳食补充剂。通过气相色谱-质谱联用和液相色谱-高分辨质谱进行筛选。通过液相色谱-串联质谱法对鉴定出的化合物进行定量。共缉获并提交实验室鉴定活性化合物和定量 110 种产品：75 种药品和 35 种膳食补充剂。其中包括 39 种油性和 3 种水性肌内注射溶液、34 片、13 粒胶囊、14 种粉末、4 种液体和 3 种冻干粉。在药品中，25/75（33%）为劣药（剂量不在可接受范围内），24/75（32%）为假药（定性配方与标签不符），14/75（19%）为原药（定性配方和活性成分水平与申报配方完全匹配。对其余 12 种产品的分析显示，11/75（15%）的定性内容正确，但由于分析时缺乏参考标准，无法进行定量。54 种药品含有合成代谢雄激素类固醇（AAS）。4/54（7.4%）AAS 为原药，8/54（15%）无法定量（一种含有错误的活性成分），对应 43/54（80%）AAS 为非原药。相比之下，只有 1/35（3%）的膳食补充剂受到掺杂，含有一种兴奋剂（1,3-二甲基丁基胺，DMBA）。这项工作表明，法国也无法避免 PIEDs 的贩运。假冒药品在主流人群中的使用是一个被低估的公共卫生问题。
