The active ingredients in that Vitamin C pill you popped this morning probably came from China. The same goes for the penicillin a pediatrician prescribed for your child’s ear infection, and the B6 supplements an orthopedist recommended for your sore wrist.
China is the world’s largest producer of raw pharmaceutical ingredients. Its entry into the drug-supply business has been key to keeping ingredient prices for both over-the-counter and prescription medications from going even higher than they have. But as the recent deaths linked to adulterated Chinese ingredients in the blood thinner heparin remind us, the quest for lower prices can have lethal side effects.
At least four people have been killed since late December, when Deerfield-based Baxter International Inc., one of the major U.S. suppliers of heparin, noticed a rise in adverse reactions to the drug. Baxter has since suspended production of the drug.
The toll could grow. As many as 19 deaths and 785 serious illnesses since Jan. 1, 2007, might be linked to contaminated heparin, the U.S. Food and Drug Administration says.
The tampering may have been intentional. Heparin is made from pig intestines, supplies of which were tight last year in China because nearly 250,000 pigs were afflicted by “blue ear,” an often fatal disease. Suppliers may have used the intestines of sick pigs, or introduced other unknown substances into the supply chain. “We don’t know whether the introduction of the contaminant was accidental, as part of the biological process, or if it was deliberate,” says Dr. Janet Woodcock, acting director of the FDA’s center for drug evaluation and research.
This is a variation on a theme: Chinese suppliers also have compromised safety by using cut-rate substitutes in several export products. From lead-laced toys to poisonous toothpaste, from killer pet food to shoddy tires, “Made in China” has, in the last year, become synonymous with “Buyer Beware.”
But consumer vigilance is difficult with drugs such as heparin that are often administered during surgery. The patient isn’t exactly in a position to check the label.
The FDA has done little to help. According to a 2007 U.S. Government Accountability Office report, the FDA doesn’t even know how many foreign facilities manufacture U.S.-bound drugs. One FDA database pegs the number at 3,000, another at 6,800.
The FDA used information from both databases to create a list of 3,249 overseas drug manufacturers, although it admits that that number isn’t entirely accurate. And of those 3,249, the FDA inspects only 7 percent in any given year — and 2,133 have never been inspected at all. China is home to nearly 22 percent of those 3,249 factories, more than any other country. But China ranked only seventh in total inspections by FDA officials between 2002 and 2007.
What’s more, the FDA does not have the advantage of surprise in investigating foreign factories. And the agency does not provide its inspectors with independent translators. So the inspectors have to rely on what English-speaking factory officials tell them.
In a 1998 report the GAO noted that up to 80 percent of substances used by U.S. companies to make prescription drugs were imported. That number has risen since then.More frequent and reliable FDA inspections would help. But the real solution lies with U.S. drug companies, which must demand unimpeachable quality from their foreign suppliers. APP Pharmaceuticals Inc., currently the sole manufacturer of heparin in the U.S., buys its ingredients from a Chinese supplier that maintains more than 300 pages of data for each batch. That data ensures that ingredients can be traced back to specific groups of pigs, according to The Wall Street Journal. APP’s supplier also places its own inspectors in the facilities of each supplier from which it buys pig intestines.
All American companies must demand similarly thorough documentation. And foreign companies need to embrace similar stringency. Until then, it’ll be difficult to ensure the quality of America’s drug supply.
