Heparin Contaminant Identified; Tougher Inspections in the Works for Chinese Products?

One of the most disconcerting defective drug cases of recent months has involved drugs containing the substance heparin, a blood-thinning agent used in coronary bypass surgeries and for treatment of heart attacks. A number of individuals have become ill recently in associated with heparin use, and heparin has been suspected as a contributing factor in several deaths.

However, new findings reported in the Los Angeles Times suggest that heparin is not the culprit, but rather a compound similar to heparin that was used a substitute in certain batches of blood thinners shipped from China. The substitute was a substance called hypersulfated chondroitin sulfate, which is related to heparin on the molecular level and used in nutritional supplements for arthritis.

The only question that officials want to know is, was this compound used by mistake, or was it deliberately inserted as a cheaper alternative to boost profits? Unfortunately, as the LA Times makes clear, because of the vagaries of the Chinese manufacturing industry, the FDA may never be able to be sure.

Over the last year, China has become the focus of public outcry over many of its exports to the United States, including tires, children's toys and dog food. Due to discrepancies between U.S. and China factories on inspection and manufacturing procedures, many products made in China do not comply with U.S. standards of production. U.S. consumers are becoming evermore wary of purchasing items manufactured in China, and this latest fiasco involving drugs might be the last straw.

Lawmakers who had discussed implementing tougher standards on Chinese imports and inspection practices may find this incident the last straw as well. Senator Ted Kennedy from Massachusetts released a statement saying, "It is unacceptable that Americans have died and been seriously injured by what appears to be deliberate tampering." Congress may well decide to crack down this time, and none too soon for American consumers.

Experts on international trade suggest that the practice of substitution isn't unheard of, based on the need for countries to boost production to keep up with required growth and demand. In China's case, the heparin substitute was not that difficult to slip through inspectors in the United States. Inspection on drugs from China in general is very low, with only 6% of Chinese drugs facing FDA inspection despite the fact that drugs from China account for 22% of the total market.