By JONATHAN D. ROCKOFF AND RICARDO ALONSO- ZALDIVAR , SUN REPORTER|April 22, 2008
WASHINGTON --A contaminated blood thinner from China suspected in dozens of U.S. deaths has now become a worldwide public health problem, with 10 other countries detecting the often-toxic ingredient, federal investigators said yesterday.
The compound, which in tests mimics the real blood thinner heparin but costs less to make, may have been added deliberately somewhere along a production chain that began on farms in China, beyond the reach of U.S. regulators.
Food and Drug Administration officials also announced a major scientific breakthrough in their attempt to understand how patients got sick from the contaminated heparin. In addition, the agency stepped up its enforcement actions against a facility in China that supplied the medication for the U.S. market. And officials raised the possible death toll from 62 to 81.
The rapid developments came on the eve of a congressional hearing expected to show that the FDA lacks the resources to carry out adequate inspection of thousands of foreign facilities now producing a significant share of the medications consumed here.
"Contamination of the heparin supply is a worldwide problem," said Dr. Janet Woodcock, director of the FDA's Center for Drug Evaluation and Research. Thus far in the investigation, about a dozen Chinese facilities of varying sizes have been identified as being part of the supply chain that handled contaminated heparin, although it is still unclear where and how the problem began.
Heparin is a widely used blood thinner, given to patients undergoing kidney dialysis or heart surgery to prevent dangerous clots. The ingredient that contaminated the drug, a chemically modified from of a common nutritional supplement, has now been shown in laboratory and animal tests to cause the dangerous reactions that some patients experienced, Woodcock said. These included a sudden drop in blood pressure, leading to shock.
"We have data in the test tube, and animal data, that shows this contamination can trigger events that would lead to these types of reactions," Woodcock told reporters. "That doesn't tell us ... the whole story, but it does establish the link."
Woodcock explained that the contaminant - a compound called an oversulfated chondroitin sulfate - can trigger chemicals in blood cells that produce serious allergic-type reactions.
