It looks like heparin and acts something like heparin, but it isn't heparin. It's a mysterious contaminant the FDA has found in batches of Baxter's heparin linked to nearly 800 serious drug reactions and as many as 19 deaths. Only detected by sophisticated testing not typically done by drug makers or their suppliers, the look-alike substance made up between 5 percent and 20 percent of the product's active ingredient in those samples. Might it be a heparin copycat blended in with the real thing, perhaps to cut the cost of production? "At this point, we do not know whether the introduction was accidental or whether it was deliberate," said FDA deputy commissioner Dr. Janet Woodcock.
Nor has it been proved that this contaminant is the actual culprit that caused the hundreds of adverse reactions, though it was found only in batches associated with deaths or illnesses. It was found in samples that originated both at a Chinese plant and a Wisconsin plant operated by Baxter's active-ingredient supplier. In both cases, though, the plants used materials made in China. Said Peter Arduini, president of Baxter's medication delivery business, "either both plants have problems with processing or there's something wrote further up the stream."
The heparin investigation comes at a time when more and more drug makers are outsourcing their manufacturing to China and sourcing active ingredients there. In fact, China now supplies more pharma ingredients than any other country in the world. At the same time, the FDA's oversight of foreign facilities has been seriously lagging as the agency saw its funding cut repeatedly while the number of drug-related imports skyrocketed.
Should the contaminant prove to have been deliberately mixed with the real heparin--just as melamine was mixed into pet food to make it appear higher in protein, but less expensive to produce--can drug makers in good conscience continue to trust their Chinese suppliers? What might the FDA and pharma do to prevent future tragedies? Woodcock suggested yesterday that the agency would ask other countries to conduct the same high-tech tests on future batches of heparin. Yet, until another round of injury or death, we may not know which sorts of contaminants to test for. It's a conundrum, and one both government and industry will have to solve to retain public trust in the drug supply.