What is actually in gray-market vials
4 primary sources
The largest published investigation comes from Swiss customs seizures. Weber, Krug, Kamber and Thevis analysed 1,190 seized doping products and published the results in Substance Use & Misuse (2017). Of those, 146 samples — about 12 per cent — were labelled as containing peptide hormones or growth factors. Fewer than 20 per cent of the products contained the promised substance in the promised amount. The authors describe the pharmaceutical quality as unsatisfactory and note that an alarming number of the products tested fell below acceptable pharmaceutical standards.
A Belgian study went further into what was inside. Janvier and colleagues examined, in Talanta (2018), the ten most commonly counterfeited polypeptide drugs on the Belgian market, bought from three suspected illegal online pharmacies. They tested for the active substance, substance-related impurities, small-molecule impurities, elemental impurities and residual solvents. Purity ranged from 5 to 75 per cent for the cysteine-containing peptides. Samples contained arsenic and lead. In several cases lead reached ten times the international toxicity limit for injected medicines, and the arsenic was present in its more toxic inorganic form. The authors highlight the risk of slow-building toxicity from repeated use.
Sterility is a separate question from purity. Janvier, Wattijn, Botteldoorn, De Spiegeleer, Deconinck and Vanhee reported in Drug Testing and Analysis (2018) that they found haemolytic Bacillus cereus in two illegal peptide drugs. That finding means something very different for a product meant to be injected than for one that is swallowed. The fact that testing methods for this had to be developed at all is clear from Vanhee and colleagues in the Journal of Pharmaceutical and Biomedical Analysis (2015), who built a screening method covering 25 different peptides, because peptides were already turning up in illegal and counterfeit products seized across several European countries.
The conclusion here is about method, not morals. Purity, identity, sterility and endotoxin level are four different properties measured four different ways. A certificate of analysis showing a purity figure says nothing about the other three, and a certificate supplied by the seller is not independent verification. The analyses above were done by regulators and university laboratories on products that were seized or bought anonymously, which is a materially different thing.
Sources
- [01]Qualitative and Semiquantitative Analysis of Doping Products Seized at the Swiss Border (Weber et al., Subst Use Misuse, PMID 28156209) (2017)
- [02]Impurity profiling of the most frequently encountered falsified polypeptide drugs on the Belgian market (Janvier et al., Talanta, PMID 30029448) (2018)
- [03]Are injectable illegal polypeptide drugs safe? Case report demonstrating the presence of haemolytic Bacillus cereus in 2 illegal peptide drugs (Janvier et al., Drug Test Anal, PMID 28941153) (2018)
- [04]Analysis of illegal peptide biopharmaceuticals frequently encountered by controlling agencies (Vanhee et al., PMID 26003685) (2015)