Baxter Heparin Reactions Now Exceed 400, and Investigation ContinuesFeb 28, 2008 | Parker Waichman LLP
Tainted Baxter Heparin has now sickened more than 400 people in the US, and investigators are trying to determine if the raw material for the Baxter Heparin became contaminated in a supply chain that originates from Chinese slaughterhouses. The owner of the factory, known as Changzhou SPL—which supplies much of the active ingredient in Baxter’s Heparin—claims its supply chain is safe, it buys raw material from only two reputable wholesalers, and audits their 10 to 12 suppliers.
Heparin is a blood thinner administered in surgery and other critical care areas to prevent blood clots, is crucial in dialysis and heart surgery, and is used for the bedridden. Heparin is administered to millions of patients yearly; Baxter manufactures about half of all multiple-dose heparin vials sold in the U.S. Heparin is made from pig intestines from which mucous membrane is collected and cooked, producing dry crude heparin which is then sold to companies—like Baxter—that produce the final product. Some feel as much as 70 percent of China’s crude heparin comes from small factories in poor villages, which act as heparin production centers, some for years. Experts say the small, unregulated factories could pose dangers because they do not have the same controls and rules as large slaughterhouses, which also produce crude heparin.
“We have a collection chain in place and we stick with that,” said David Strunce, president of Scientific Protein Laboratories, an American company that owns a majority of Changzhou SPL. But, interviews with producers and traders in several Chinese provinces indicate a convoluted and unregulated supply chain comprised mostly of small family. After an outbreak of blue ear pig disease plagued much of China, prices soared and many suppliers used small workshops. A sales manager for a large Shandong slaughterhouse said he was approached by an SPL buyer offering cheap prices for crude heparin. Ruihua Biochemical said it provided a mix of crude heparin it manufactured and some it bought “from small factories nearby in several villages,” according to owner, Hua Ruihua, who said he never inspected the small factories. “We are not the government. We have no right to inspect their pigs or intestines or facilities,” he added. The owner of one workshop, Fan Yinan, said, “I sold to Ruihua several times before.” American officials certified SPL’s Changzhou plant, although neither government inspected it; the plant has exported to Baxter since 2004. The Chinese FDA believed the SPL factory produced the chemical ingredients and was not a drug factory, therefore, was not inspected.
Strunce says his company only buys through its wholesalers, but sales manager, Chen Jianjun, for major supplier, Nantong Koulong, said he sells directly to SPL, “We provided crude heparin to Changzhou SPL.” “Some of Koulong’s stock comes from the unregulated workshops,” he said. The owner of one such workshop, Ms. Zhu in Xinwangzhuang, said she sold to SPL and sells to Koulong. “We are really a traditional family-style plant,” she said. “We have no certificate.” Two officials of Zhejiang Willing Animal Byproducts Processing said they sold to SPL, “We supply Heparin to Changzhou SPL,” said Fang Weicai, general manager.