In my book Phake: The Deadly World of Falsified and Substandard Medicines, I stress the difference between substandard medical products and deliberately falsified ones. The latter are made by criminal enterprises that have no interest in the contents of their medicine while the former are made by legal firms, which either made mistakes or willfully cut corners in production.
Combating falsified products has been a slow process and is often delayed because criminals bribe and intimidate regulators and police. However, since criminal groups endanger lives, pay no taxes, and don’t employ many people (except in China), most countries take action against them once sunlight is shone on their lethal activities. As a result, laws and actions against these deadly counterfeiters are slowly improving.
But as I stressed in Phake, combating the legal manufacturers of substandard products will be much harder for the obvious reasons that they often do produce decent products, they do pay taxes, and they do employ a lot of people.
Investigating essential medicine quality (used to treat malaria, tuberculosis, and bacterial infections) in emerging markets led my research team to publish several peer reviewed papers in the medical science literature. We found that producers approved by the World Health Organization performed roughly four or five times better than non-approved producers, yet were not universally of good quality. We sent details of these products to WHO in June, and we sent remaining samples of the products in July so WHO could investigate further.
In late December, they published a report essentially claiming the medicines met international quality standards even though WHO largely relied on the companies themselves to verify quality. Furthermore, after five months they still have not tested the samples we sent them – a competent PhD scientist could have tested the products in just a few hours.
As we explain in our detailed criticism of the report, WHO rushed their findings because Congressional leaders have begun paying attention to the subject of substandard medicines. Since WHO complacency is unacceptable, Congress must continue to shine a light on this important topic to prevent tax-funded medicines from killing the very people they’re intended to save.