Phake: shining a light on substandard and falsified medicines

Many of our regular readers will be aware of the work of Roger Bate of the American Enterprise Institute, who has been at the forefront of an effort to provide empirical data on falsified and substandard medicines through fieldwork, sampling and testing of medicinal products around the world.

Some of you may also have read Bate's excellent book Making a Killing, which was published in 2008 and was one of the first volumes to provide a comprehensive look at the international counterfeit drug trade.

Bate has now written a new book - entitled Phake: The Deadly World of Falsified and Substandard Medicines - which draws together his experience and study data generated over the last few years and presents what is probably the most reliable and informed assessment yet of drug quality worldwide.

The findings make for thrilling but grim reading. After sampling thousands of drugs from 17 countries, Bate concludes that around 12 per cent of medicines will not work as expected because they failed quality tests and were substandard, degraded or counterfeit.

The data "paint a picture of a world beset by inconsistent drug quality", with the scale of the problem generally inversely proportional to the affluence of the country.

Almost half (46 per cent) of the drugs that failed quality tests were likely to be counterfeit as they had no detectable active pharmaceutical ingredient (API), but a proportion of those deemed to be fake contained API that was probably added to fool basic identity testing.

All told, Bate estimates that the death toll that can be attributed to counterfeit medicines is more than 100,000 people a year.

Phake delivers a fascinating first-hand account of the counterfeit drug trade whilst also providing policy analysis and recommendations that could make the supply of medicines more reliable and safe.

Among the measures proposed is the introduction of an international treaty penalising counterfeits, tracing drug components' geographical origin, improving intellectual property protection, and deploying innovative technology, such as the use of codes on medicine packs to allow consumers to authenticate their medicines using mobile phones.

The book concludes with a plea for stronger and more cooperative action against dangerous drugs, in light of "extreme positions from both industry and health activists and similarly extreme positions of antagonistic countries".

Along with Mark Davison's recently published Pharmaceutical Anti-counterfeiting, Phake is a must-have addition to the bookshelf of anyone working in the area of medicine counterfeiting and supply chain security. Highly recommended.