High-risk drug sold alongside safer version

A unit of German drug and chemical maker Bayer AG sold medicine in Asia and Latin America in the 1980s that carried a high risk of transmitting AIDS. During the same period it sold a safer medicine in the United States and Europe.

AIDS virus could contaminatethe earlier medicine 
AIDS virus could contaminatethe earlier medicine 

AIDS virus could contaminate

the earlier medicine 

The company, Cutter Biological, kept selling an old version of a blood clotting medicine for haemophiliacs abroad as the product became more difficult to market in the US and Europe, according to a report in the New York Times.

   

Bayer is already facing a series of legal cases over the cholesterol drug Baycol, which was recalled by Bayer in August 2001. Cutter is the biological products business unit of Bayer’s pharmaceuticals business, and is based in Research Triangle Park, North Carolina.

   

A spokeswoman for Bayer Healthcare in Connecticut, Meredith Fischer, said she could not immediately comment on the report, but said the company has been “heavily involved” in working with the newspaper on the story.

   

The report quoted Bayer officials as saying  Cutter “behaved responsibly, ethically and humanely” when it sold the older product.

 

“Decisions made nearly two decades ago were based on the best scientific information of the time and were consistent with the regulations in place,” Bayer said.

 

Increased risk

 

The company said it kept selling the older clotting medicine because of doubts by some customers about how effective the new medicine was. Some countries were also slow in approving the marketing of the newer version, it said.

 

The medicine in question, called Factor VIII concentrate, was made with pools of blood plasma. This increased the risk of contamination with AIDS virus since scientists at the time lacked a test that could screen the disease.

 

The newer product was heat-treated in order to kill HIV, the virus that causes AIDS.

 

In one example cited by the Times, Cutter asked a Hong Kong distributor to “use up stocks” of the medicine that was not heat-treated.

 

In all, the company appears to have exported more than 100,000 vials of the older product after it began selling the safer product.

 

Bayer had paid about $600 million to settle more than a decade of lawsuits related to the product.

 

Details about the sales of the product in Asia and Latin America were found in documents related to litigation that were not previously investigated, the Times said.