Chantal, Medicine that makes you sick?

In his article “Trusting Medicine from China,” Jean-Francois Tremblay discusses whether or not active pharmaceutical ingredients (APIs) from China are safe. He begins with an example of how counterfeit Chinese glycerin used in a cough syrup killed dozens in Panama in November of 2006. Glycerin is often used in medicinal liquids and is sometimes substituted with diethylene glycol to reduce production costs. The FDA has recommended that if pharmaceutical manufacturers are using glycerin in a medicine, they should first test it to ensure it is pure glycerin(3).

Chinese companies have defended their actions by saying that they have always advertised exactly what they are selling and have not lied about selling diethylene glycol in place of glycerin. According to Tremblay, some companies also claim that they are merely filling the orders of drug manufacturers; it is not their responsibility to make sure the ingredients they are selling are in line with that country’s drug regulations. The general secretary of the Chinese Pharmaceutical Producer’s Association, Yan Zhou, admits that there is drug counterfeiting throughout China, but insists that the major drug exporters supply legitimate, safe products. After all, if APIs exported from China were frequently inferior, there would be far less demand for such products(3).

According to the Synthetic Organic Chemical Manufacturers Association (SOCMA), just like product or food shipments from China, most of the API imports enter the Country without ever being inspected by American officials such as the FDA. While inspections do occur, plants that supply over-the-counter (OTCs) or nutraceuticals are often exempt. When time allows, the FDA visits all pharmaceutical supply plants for inspection. However, in the case with OTCs and nutraceuticals, only the actual manufacturing plants are inspected. Fortunately, according to the senior vice president of sales at Chemwerth (the biggest US importer of Chinese APIs), Dave McCleary, counterfeit ingredients are rarely used in prescription drugs (3).

What is diethylene glycol and what makes it so bad?
Diethylene glycol is a chemical used in making resins, plasticizers, and acrylic (2). According to the FDA, this is a poisonous chemical that has also been found in imported Chinese toothpaste (4).

What are nutraceuticals?
Nutraceuticals are foods that have medicinal benefits including vitamins and dietary supplements (1).

This is pretty scary stuff, but I think the FDA usually takes control before too much damage is done. It’s good to know that prescriptions are usually safe!

Unfortunately, it doesn’t look like there is too much the average citizen can do about this other than stay away from drugs as much as possible. The FDA is already on overload so I am not sure how much more can be done to inspect imported drugs. The FDA’s suggestion for manufacturers to inspect glycerin seems like a great start on the manufacturer’s part to ensure safe products. An easier solution (but not very realistic) would be to stop buying APIs from China or at least only buy from the top exporters.

References

1. DeFelice, Stephen. What are Nutraceuticals?. National Nutraceutical Center. 10 January 2008. < http://www.clemson.edu/NNC/what_are_nutra.html>.

2. The Dow Chemical Company. Ethylene Glycols. DOW. 10 January, 2008. 2008. .

3. Tremblay, Jean- Francois. Trusting Medicine from China. C&EN Hong Kong.18 June, 2007. .

4. US Department of Human Services. Imported Toothpaste. US FDA. 10 January 2008. 9 October, 2007. .