Pharmaceuticals

Faking it

BMJ 2012; 345 doi: http://dx.doi.org/10.1136/bmj.e7836 (Published 20 November 2012)
Cite this as: BMJ 2012;345:e7836

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  1. Andrew Jack, pharmaceuticals correspondent
  1. 1Financial Times, London, UK
  1. andrew.jack{at}ft.com

Globalisation has helped increase the risks of counterfeit drugs endangering human life. Andrew Jack looks at the scale of the problem and the latest attempts to crack down on crime

When US investigators earlier this year identified vials of the cancer medicine bevacizumab (Avastin) without the active ingredient, they began a probe that led them on a complex trail via intermediaries in Barbados, the United Kingdom, Denmark, and Switzerland into Turkey and the Middle East.

The falsified product, which was sold through dozens of medical practices within the US, highlighted how even citizens of one of the world’s richest countries with extremely tight regulation are vulnerable to the health threats from counterfeit drugs.

Substandard medicines, whether the result of deliberate action or neglect, have long been a health hazard in developing countries. The absence or wrong dose of the active pharmaceutical ingredient, and contamination with harmful substances, may harm unsuspecting patients and has resulted in many deaths, although it is often difficult to identify the medicine as the cause.

But most examples in the industrialised world have been limited to medicines purchased by consumers through the internet, which circumvent doctors and pharmacists. The more recent spread of counterfeits into the mainstream pharmacy supply chain has triggered fresh concern and action by policymakers. None was more striking than the adulterated heparin that was linked to more than 80 deaths in the US in 2008. The heparin had been made in China in a way that was deliberately hard for quality assurance tests to identify.1

Securing drug distribution is difficult, with those seeking reforms not only struggling against organised criminal groups but also torn between public health concerns and divergent commercial perspectives of competing equipment and software providers, as well as rival drug companies holding varied views.

Defining the problem

The first difficulty is …

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