"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.
These home heparin workshops are not regulated by Chinese because they are designated as chemical makers, not drug producers or pharmaceuticals. Neither China nor the United States has any current procedure or future plan to make the ingredients consistent, clean or traceable.
The FDA calls the contamination "a worldwide problem" that has appeared in 11 countries. Recalls of heparin have also taken place in Germany, Denmark, France, Italy and Japan.
What’s the surprise? It is already known that the Chinese intentionally poisoned other products they exported to the United States.
U.S. cats and dogs were sickened and killed by Chinese pet food that had been adulterated by melamine, a chemical used in plastic, which was added to wheat gluten to fake higher protein levels. The Chinese poisoned toothpaste and children’s anti-fever medicines by using diethylene glycol instead of glycerin. These poisons are not only dangerous in themselves, but they can compromise the overall usefulness of certain critical drugs by giving rise to drug-resistant mutant bacteria.
Millions of Chinese-made toys had to be recalled because of lead paint used at unacceptable levels. Some 6,000 baby T-shirts were just recalled in Japan following detection of high levels of formaldehyde.
The World Health Organization estimates that 10 percent to 15 percent of the world’s drug supply is counterfeit. Some products are completely fake; others have been tampered with, contaminated, diluted, repackaged or mislabeled in a way that misrepresents the contents, dosage, origin or expiration date.
At least 80 percent of active and non-active ingredients in U.S. drugs now come from overseas, the majority from China. Your next medicine might contain cement, gypsum, antifreeze, talcum powder, sawdust, industrial solvents or paint. As a devotee of free trade at all costs, the Bush administration apparently has no plan to ensure that imports of Chinese ingredients into the United States for prescription drugs, food, medical devices, and animal feed meet U.S. safety standards. When will Americans wake up to the high cost of "free" trade?