Nature Medicine | Spoonful of Medicine

HHS reports on pharma’s world tour

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You might be leaving for vacation soon, but your medication’s probably already well-traveled.

A report on the prevalence of new drugs being tested outside the US by the Inspector General of the US Department of Health and Human Services is scheduled to be released today. The New York Times obtained an advance copy, and the results underscore the sheer scope of pharmaceutical globalization.

80% of all drugs that were approved for sale in 2008 were tested outside the US, and 78% of all clinical trial patients were enrolled in studies that took place abroad. Ten medicines approved by the US Food and Drug Administration (FDA) that year didn’t have a single trial subject in the US. The FDA inspects less than 1% of all foreign clinical trial sites, and is often unaware of foreign studies until after they are completed.


Last year, an article in the New England Journal of Medicine voiced concerns that the globalization of clinical drug trials could have ethical and scientific consequences. The foremost concern was the lack of oversight, resulting in an ethical vacuum that could lead to the exploitation of trial participants. The NEJM article points out that 90% of published clinical trials conducted in China in 2004 did not mention any ethical review of their protocols. Health care infrastructure and quality of care varies widely among foreign clinical sites, resulting in research conditions that may not reflect those faced by patients that will end up buying the drug.

Genetic differences between ethnic populations can also affect drug trials. For example, there is a mitochondrial polymorphism found in 40% of East Asians that impairs the individual’s ability to respond to nitroglycerin and nitric oxide, which are found in many investigational drugs for heart conditions and degenerative neurological disorders like Alzheimer’s. “Genetic diversity,” the NEJM authors warn, “is often not considered in study design and interpretation and in the reporting of trial results.”

Image by mollypop via Flickr Creative Commons.

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