U.S. Identifies Tainted Heparin in 11 Countries

Contamination in the blood thinner Heparin that was produced in China has been discovered in eleven countries, accounting for 81 deaths in the United States, so far.

Dr. Janet Woodcock, director of the Food and Drug Administration’s drug center, said that German regulators uncovered a cluster of illnesses among dialysis patients who took contaminated heparin. She said Chinese officials had conceded that heparin produced in their country contained a contaminant, though they say it was not connected to the illnesses.

“Heparin should not be contaminated, regardless of whether or not that contamination caused acute adverse events,” Dr. Woodcock said. “We are fairly confident based on the biological information that we have had that this contaminant is capable of triggering these adverse reactions.”

Heparin is one of the oldest drugs currently still in widespread clinical use. It was discovered in 1916 at Johns Hopkins and entered clinical trials in 1935. It was originally isolated from dog's liver cells (hepar is Greek for liver"), then moved to beef membranes as a source and can be attributed to the research of Jay McLean and William Henry Howell.

FDA officials said the man-made chemical compound known as over-sulfated chondroitin sulfate is cheap and abundant. It mimics heparin when tested, but is not naturally occurring and not something that would be part of the normal production chain for heparin.

Heparin in China is made from slaughtered pigs. The Chinese, while acknowledging the contaminate, an additive that mimics Heparin but is non-functional as a drug (much like Melamine mimicked ingredients in pet food with disastrous results), have denied it has caused the illnesses and deaths. This new report contradicts that claim.

The F.D.A. warned the Chinese plant contracted to provide the drug to Baxter International that they have been using unclean tanks to make the heparin, obtained their raw materials (mucus membranes of pig intestines) from an unacceptable source and that it had no way to remove impurities.
Heparin is made from the mucous membranes of the intestines of slaughtered pigs that, in China, are often cooked in unregulated family workshops. The contaminant, identified as oversulfated chondroitin sulfate, a cheaper substance, slipped through the usual testing and was recognized only after more sophisticated tests were used.
The eleven impacted countries are: Australia, Canada, China, Denmark, France, Germany, Italy, Japan, the Netherlands, New Zealand and the United States.

The problem of cheaper additives has been identified in past Chinese products, resulting in the deadly melamine in pet food and anti-freeze in toothpaste. This latest problem was discovered in Germany. The FDA does not have adequate inspectors, following budget cuts by the Bush Administration, to track more than a minor percentage (one percent in some cases) of imports into the United States from China.