Texas Personal Injury Lawyers – Jim Adler & Associates – Blog

Wonder Blood Thinner Turned Killer Drug

A team of scientists led by MIT professor Sam Sasisekharan on April 24, 2008 formally announced that they had identified the contaminant in the blood-thinning drug Heparin, imported from China. Contaminated batches of the Baxter International-produced blood thinner slipped through a series of safety screens leading to death and injuries to scores of patients in the U.S.

The contaminant is a synthetic compound known as “oversulfated chondroitin sulfate” (OSCS). Based on the findings of two studies conducted by the scientists, the U.S. Food and Drug Administration (FDA) has now put screening methods in place to detect contaminated heparin.

Studies Published in Respected Medical Journals

The results of the two studies conducted by Professor Sasisekharan’s team were published in the British journal Nature and the New England Journal on Medicine. The study published in Nature, reported that heparin is only tested for contaminants such as protein, lipids or DNA. OSCS consists of long, complex chains of repeating sugar molecules that are almost impossible to detect. The MIT scientific team used the latest technology developed for analyzing complex sugars to find a method for detecting OSCS. The study in the New England medical journal revealed that OSCS activates two “inflammatory pathways” in the body: one that triggers blood clotting and dilation of blood vessels, resulting in dangerous blood pressure decreases while the other generates toxins that produce severe, and often deadly, allergic reactions.

U.S. Trade Officials Cite Need for China Reforms

China’s pig industry has a sordid history. Heparin, produced from Chinese pig intestines, is critical to the U.S. health care delivery system because the blood thinner is used by millions of patients during kidney dialysis and heart surgery to prevent blood clotting. U.S. commerce officials are now seriously concerned about health products from China. Reuters reported on April 25, 2008 that Christopher Padilla, U.S. Undersecretary of Commerce for International Trade, told a group of businessmen that Chinese regulators lack both the ability and will to monitor the nation’s pharmaceuticals and chemical industries. Padilla said that China’s State Food and Drug Administration (SFDA) has no authority to regulate the production of pharmaceutical ingredients not considered to be of medicinal use. He added that the Chinese manufacturer of the ingredients imported by Baxter to produce heparin was not registered with SFDA as a maker of active pharmaceuticals.

U.S. Officials to visit China

Padilla is leading a group of healthcare executives to China with hopes of introducing the concept of healthcare reform to the Chinese. Healthcare services and products have become one of the America’s fastest growing exports to China. Foreign investors, especially from America, have now become more cautious about Chinese products as the country continues to produce and export dangerous products. This acknowledgement provided little comfort to American drug consumers, especially since China did not inspect SPL because it was listed as a chemical producing plant, not a pharmaceutical plant.