Bayer backs decision to sell product for hemophiliacs

Drug maker says it acted responsibly during 1980s in selling blood-clotting medicine linked to HIV

? Chemical and drug maker Bayer said Thursday that it acted responsibly and in line with the best medical knowledge at the time when it sold a blood-clotting product that saved hemophiliacs from potentially fatal bleeding — but was linked to the risk of HIV infection.

The company’s statement was in response to a New York Times report that during the 1980s Bayer sold an older version of the medication in Latin America and Asia while marketing a newer, safer product in the United States and Europe.

The New York Times, citing documents from earlier litigation, said the Bayer’s Cutter Biological division continued selling old stocks after it introduced a version in February 1984 that had been heat-treated to kill HIV.

The medicine, called Factor VIII concentrate, can stop or prevent potentially fatal bleeding in people with hemophilia.

Early in the AIDS epidemic, the medicine was made using mingled plasma from 10,000 or more donors. Because at the time there was not yet a screening test for HIV, the virus that causes AIDS, thousands of hemophiliacs were infected.

Bayer and three other companies that made the concentrate have settled 15 years of lawsuits from people who took the drug, paying about $600 million the newspaper said.

The documents from that litigation, examined by the Times, include internal memos, minutes of marketing meetings and telexes to foreign distributors.

“Bayer has always behaved responsibly, ethically, and humanely to provide lifesaving products for the global hemophilia community,” the Bayer statement said.

Bayer said there were concerns at first that heat-treating might make the factor less safe or less effective.

“Doctors, scientists, manufacturers, caregivers and individuals with hemophilia were faced with a terrible dilemma — weighing the risk of potentially contracting a never before seen retrovirus, against trying an unproven technology (heat treatment) that could adversely affect the safety and efficacy of their lifesaving medicine.”

Bayer, based in the western German city of Leverkusen, also said some countries were slow to approve the sale of the new 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. “They cannot be judged on the information available today.”

The Times said at least 100 hemophiliacs in Hong Kong and Taiwan alone contracted AIDS after using the older product, and that many have since died. Li Wei-chun said her son, who died in 1996 at the age of 23, was among the victims.

“They did not care about the lives in Asia,” she said. “It was racial discrimination.”

Cutter also sold the older medicine in Argentina, Indonesia, Japan, Malaysia, and Singapore after February 1984, according to the documents. The newspaper said Cutter shipped more than 100,000 vials of unheated concentrate, worth more than $4 million, after it began selling the safer product.

The sales continued partly because of Cutter’s desire to deplete stocks of the older medicine, and partly because of fixed-price contracts, for which the company believed the older product would be cheaper to make, the newspaper said.