Bayer found to have sold dangerous blood products overseas
BY Advocate.com Editors
May 23 2003 12:00 AM ET
Pharmaceutical company Bayer sold millions of dollars in blood-clotting products for hemophiliacs in Asia and Latin America in the mid 1980s that carried a high risk for HIV transmission, despite safer products being available and sold by the company at the same time in the West, The New York Times reports. Cutter Biological, a division of Bayer, introduced the safer-blood products in the United States and other Western nations in February 1984 but continued selling the more hazardous product, called Factor VIII Concentrate, in Malaysia, Singapore, Indonesia, Japan, Hong Kong, and Argentina through at least mid 1985 and possibly longer.
Internal Cutter documents obtained by the Times show that company officials continued to manufacture and sell the possibly tainted products in part because it was cheaper to sell the older, cheaper version of Factor VIII Concentrate through fixed-price contracts negotiated with overseas governments and treatment programs. It is not clear how many people in Asia and Latin America were exposed to HIV through the Cutter product, but health records in Hong Kong show that at least 100 hemophiliacs there contracted HIV through Factor VIII Concentrate after 1984.
Bayer officials, responding on behalf of Cutter, said in a statement that the Cutter division "behaved responsibly, ethically, and humanely." The company continued to sell the older products for several reasons. According to the Bayer statement, some countries were slow to approve the safer blood-clotting medication, and some overseas customers questioned the efficacy of the new product, while a shortage of blood plasma needed to make the safer version of Factor VIII Concentrate kept initial production low. However, other industry leaders were shocked by the information contained in the documents, which included marketing plans to minimize the danger of the company's products, despite the fact that company executives were aware that blood products carried a high risk for HIV infection. "These are the most incriminating internal pharmaceutical industry documents I have ever seen," said Sidney M. Wolfe, director of the Public Citizen Health Research Group.
Factor VIII Concentrate, which provides hemophiliacs with missing blood proteins needed to make blood clot, was made by pooling plasma from 10,000 or more donors and extracting the needed proteins. Because HIV antibody tests were not available at the time, the pooled blood products carried a high risk of being tainted with HIV. The newer, safer version of the product made available in early 1984 was heat-treated to kill HIV and other pathogens in the compound.