China and Unsafe Drugs--Any Progress Made?

I have in the past blogged about drug safety issues with U.S. companies buying critical drug ingredients from unregulated and uninspected Chinese factories, such as: http://brodyhooked.blogspot.com/2010/08/policing-unsafe-drugs-toothless-system.html and http://brodyhooked.blogspot.com/2009/01/outsourcing-of-drug-supply-market.html. Our friends over at the Health Care Renewal blog have kindly alerted me to a recent article from Reuters updating us on this issue: http://www.reuters.com/article/2012/08/28/us-china-pharmaceuticals-idUSBRE87R0OD20120828.

Time out for a bit of history. In HOOKED I recounted a story well known to all historians of American pharmaceuticals--how Massengill and Company, in Tennessee, killed more than 100 people in 1937 with a new formulation of the miracle antibiotic, sulfanilamide. Massengill decided people might like the drug in the form of a syrup, and set their chemist to find a nice vehicle that would dissolve the drug and create a smooth texture on the palate. The chemist came up with diethylene glycol--the stuff they make antifreeze with. Which happens not to be good for you or your kidneys. The result of this disaster was new Federal legislation giving the FDA for the first time the authority to demand proof that a drug was safe before it could be marketed. (It took thalidomide in the 1960s to force the next step, that drugs had to be proven to be both safe and effective.)

That, as I said, was in 1937. So what are we to think of the fact (according to the Reuters article) that in 2006, about 100 people died in Panama from a cough syrup made with a Chinese-manufactured sweetener that contained diethylene glycol? Besides the fact that dead people in Panama are not worthy of being covered in the US news media?

There are a number of important points made in the article, but perhaps the bottom-line message is that US drug firms are getting a bit cagier about buying impure chemicals from shady Chinese factories. Some Chinese firms are certified by Good Manufacturing Practice, an internationally recognized standard, and US companies can if they wish do business selectively with those firms (as several drug companies told Reuters). So the unsafe drugs are now being shunted selectively to poorer countries, with Africa taking up the brunt of the traffic.

One thing that has not changed is our dependence on China to manufacture the chemicals that go into drugs (called APIs).  Reuters quotes Guy Villax, a Portuguese drug executive: "If China for some reason decided to stop exporting APIs, within three months all our pharmacies would be empty."