Heparin, China, Reagents, and Your Lab

MANY OF YOU HAVE HEARD THE NEWS about the contaminant that was found in the heparin manufactured and sold by Baxter International, Inc. Authorities, responding last fall to reports of hundreds of bad reactions and 19 deaths to the drug, quickly focused on the Chinese companies that supplied the ingredients used by Baxter to manufacture heparin.

In recent days, the FDA announced that the contaminant was over-sulfated chondroitin sulfate. Chondroitin sulfate is “abundant and cheap,” according to an FDA official quoted in The Wall Street Journal. Chondroitin is frequently sourced from animal cartilage and, when sulfate is added, the compound clumps together with heparin in a fashion that makes the contaminant challenging to identify in regular quality control testing.

Further, authorities now say that the contaminate was added early in the supply chain in China. Thus, it was already in the raw heparin that Scientific Protein Laboratories (SPL) purchased in China which it then processed into the active pharmaceutical ingredient that SPL sold to Baxter.

This latest episode of flawed or dangerous Chinese products making their way to the United States reminds us that manufacturing in many countries across the globe lacks the rigorous oversight and quality control standards that we take for granted in the United States and Europe. It also leads to this question: How many in vitro diagnostics (IVD) manufacturers and vendors are sourcing reagents, chemicals, and similar compounds from companies in China? Is there a risk that poor quality reagents or other flawed products that American IVD suppliers could be purchasing in China might move undetected through distribution channels, eventually reaching clinical laboratories in this country?

This is a reasonable question for labs to ask their IVD suppliers. After all, just in the past year, we have seen pets die from contaminated pet food and the discovery of tainted toothpaste, seafood, vitamins, and food additives. The contamination of heparin, a prescription drug, is just the latest example. To my knowledge, no major IVD manufacturer has issued a press release declaring its status relative to its purchase in China of reagents, chemicals, and other compounds used in its products. That disclosure might be a smart, proactive business strategy by leading IVD manufacturers. Their laboratory customers deserve the right to know if, what, and how much of the products they buy and use contain components made in China.


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