"Chinese Counterfeits and American Failures," the title of a congressional hearing on April 29, laid bare a shocking problem: A counterfeit ingredient in a blood-thinner widely used in surgery, combined with the Food and Drug Administration's failure to inspect Chinese imports, appears to be responsible for at least 81 deaths in the United States.
The blood-thinner, heparin, which is made from pig intestines, had been safely used for about 70 years. What's different today is that most heparin is imported from China, a country that has no compunction about putting poisons in its products to make them cheaper for the world market.
The CEO of Baxter International, which supplies half the heparin used in the U.S., accused the Chinese of having engaged in a "deliberate scheme to adulterate" the medication by using a poisonous product (an altered form of chondroitin sulfate) that mimics the effects of heparin. U.S. patients suffered severe side effects such as abdominal pain, decreased blood pressure, burning sensations, chest pain, diarrhea, dizziness, loss of consciousness, vomiting and death.
The FDA didn't discover this deception because the FDA inspects China's drug makers every 13 years. Government auditors admit that the FDA conducted only 30 inspections of the more than 3,200 foreign drug companies during the last fiscal year, and plans to conduct only 50 this year.
The FDA did only 21 inspections annually of Chinese drug-making facilities in fiscal 2002 through 2007. The FDA is now trying to establish offices in three Chinese locations as a base for just eight U.S. inspectors, but China has yet to give its OK.
At the congressional hearing, the FDA officials refused to name the Chinese companies that sold the poisoned heparin. The officials argued that such information is somehow "commercial confidential."
Some congressmen at the hearing urged the FDA to inspect foreign companies every two or three years, but FDA Commissioner Andrew C. von Eschenbach said, "I don't believe that's the solution to the problem. It's much more complex."
Indeed it is. The FDA would need 500 more inspectors to inspect foreign companies with the same regularity as domestic companies. That would cost seven times the current budget. Heparin is made in thousands of small unregulated, unlicensed, unsupervised family home workshops where three to five people stir pig intestines in a concrete vat to transform them into a dry substance. It's impossible to trace the ingredients back to the slaughterhouses.
There is no paper trail to document the supply chain, there are no records, and documents, if any, are easy to fake. There is no tagging of the pigs, monitoring of the feed, or files on each animal's vaccinations.
Since mid-2006, China's pig herds have suffered serious outbreaks of a viral illness commonly known as blue-ear disease. Sick animals are supposed to be rejected by slaughterhouses, but enforcement is lax.
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