Healthy Skepticism Library item: 1146

Warning: This library includes all items relevant to health product marketing that we are aware of regardless of quality. Often we do not agree with all or part of the contents.

Publication type: news

Bayer sold risky drug abroad: Drugmaker’s medication spread HIV to consumers overseas
Associated Press 2003 May 22

Full text:

NEW YORK – A division of Bayer sold millions of dollars worth of a medicine that carried a high risk of spreading HIV to customers in Asia and Latin America in the mid-1980s, while selling a new, safer product in the United States and Europe, The New York Times reported Thursday.

CUTTER BIOLOGICAL sold the blood-clotting medicine for hemophiliacs to Asia and Latin America for more than a year after it introduced a new version in February 1984 that was heat-treated to kill HIV, according to documents obtained by the newspaper. The medicine, called Factor VIII concentrate, can stop or prevent hemophiliacs’ bleeding, which can be fatal. Early in the AIDS epidemic, the medicine was made using plasma from 10,000 or more donors. Because there was not yet a screening test for HIV, the virus that causes AIDS, even a small number of HIV-positive donors could taint a large pool of plasma recipients.

As a result, AIDS was passed along to thousands of hemophiliacs. Bayer and three other companies that made the concentrate have paid about $600 million to settle more than 15 years of lawsuits accusing them of making a dangerous product, 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 DEFENDS ACTIONS The newspaper said Bayer officials declined to be interviewed, but answered written questions for Cutter and its then-president, Jack Ryan. Cutter “behaved responsibly, ethically and humanely” in selling the medicine overseas, said Bayer, which is based in Germany.

Cutter continued selling the older, untreated version because some customers doubted the new one’s effectiveness, and because some countries were slow to approve its sale, Bayer said. “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’s statement said. 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 says Cutter shipped more than 100,000 vials of unheated concentrate, worth more than $4 million, after it began selling the safer product.

SALES OF RISKY DRUG CONTINUED 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.

In March 1983 the federal Centers for Disease Control warned that blood products appeared responsible for AIDS among hemophiliacs. Three months later, Cutter sent a letter to distributors in nearly two dozen nations saying that AIDS was “the center of irrational response in many countries. In late 1984, as Hong Kong hemophiliacs began testing positive for HIV, some doctors wondered whether Cutter was sending “AIDS-tainted” medicine into less-developed nations. But the company assured its distributor that the unheated product posed “no severe hazard” and was the “same fine product we have supplied for years.” In May 1985, Dr. Harry M. Meyer Jr., the Food and Drug Administration’s blood-products official, called the companies to a meeting, believing they had broken an agreement to stop selling the older medicine, the Times said. But Meyer decided to handle the matter quietly instead of notifying the public, the newspaper said.