We don’t know the prevalence of counterfeit or substandard drugs (more on the distinction in a later post). The recent deaths caused by the Baxter brand of heparin illustrate the potential risks of adulterated product. But is that case the tip of the iceberg or an exception to the rule… the rule of a safe, well-controlled supply chain?

The high rates of counterfeit pharmaceuticals in developing countries have been well documented. Phony anti-malarials alone undoubtedly cause untold deaths. But a widely cited estimate that the counterfeit industry will be worth $75 billion by 2010 comes from a report by the Center for Medicines in the Public Interest. The report (which CMPI was kind enough to send) provides little information on how this extrapolation was derived, other than to say it was based on the “author’s calculations.” Nor does break down the number between wealthy countries with well-controlled drug supplies and countries with endemic counterfeiting and poor health infrastructure. So what is the situation in the US and similar nations? The authors of a PLoS Medicine article suggest that pharmaceutical manufacturers in the US and the UK deliberately fail to report incidences of counterfeiting. As a first step toward understanding the extent of this problem, an international and publicly accessible registry should be established to track counterfeit products. Governments should mandate that industry report all known or suspected cases.