Federal officials have announced that a fairly common ingredient in nutritional supplements has been identified as the contaminant in heparin, a blood thinner used in surgery and kidney dialysis. Heparin helps to prevent blood clots that may cause heart attacks and strokes. The contaminant known as hypersulfated chondroitin sulfate, or chondroitin sulfate, is made from animal cartilage and is an ingredient in several nutritional supplements used to promote healthy joints. However, the hypersulfated chondroitin sulfate is not approved for use in the U.S. Levels of the contaminant ranged from 2% to 50% in lots of heparin tested.
Unknown Origin
It is believed that this substance is the culprit that sickened and killed hundreds of patients across the U.S. How it got into heparin is a question authorities are still investigating. The contaminant originated in China, and there are several theories about how it made its way into the drug. There may have been some kind of “mishap.” Or perhaps it was an experiment gone awry. However, it may have also been deliberately added to the heparin to boost profits of middlemen. FDA officials may never find out due to difficulties in back-checking.
Sen. Edward Kennedy, chairman of a panel overseeing the FDA, stated, “it is unacceptable that Americans have died and been seriously injured by what appears to be deliberate tampering.” He went on to say that those responsible must be brought to justice. Independent experts tend to agree that this is deliberate tampering, and akin to the pet food case in which thousands of cats and dogs were sickened by food ingredients from China last year.
Heparin manufacturer, Illinois-based Baxter Healthcare Corp., believes the contaminant was introduced before raw heparin ingredients reached its supplier, Scientific Protein Laboratories. Scientific Protein Laboratories is a joint venture partner with the Chinese facility that supplied the heparin in question.
Chinese Cooperation
It is hoped that this case will lead to better cooperation between the U.S. and China regarding imports. The last year has seen several high profile examples of the poor monitoring of products from China, including tainted pet food and lead in children’s toys, as well as this case. But Chinese officials expedited the visas of FDA investigators. Their Chinese counterparts seem to have been more helpful with this case than others.
Rep. John Dingell wants a more stringent system that will oversee imports from other countries. It is unknown if the Bush Administration will go for it because the system would need to be financed by new industry fees.
If you, or a loved one, have been sickened by tainted heparin, please contact an experienced injury lawyer in your area.
