WASHINGTON, May 22 (AFP) - A division of the pharmaceutical giant Bayer in the 1980s sold a medicine to Asia and Latin America that carried a high risk of transmitting AIDS while it was selling a new, safer product in the west, The New York Times alleged Thursday.
Cutter Biological wanted to avoid being stuck with large stores of a product that was becoming increasingly unmarketable in the United States and Europe, according to internal company documents obtained by the daily.
The company also sought to save money by honoring several fixed-price contracts with the old product, which was cheaper to produce than the new, safer blood-clotting medicine, the daily said other company records suggest.
"These are the most incriminating internal pharmaceutical industry documents I have ever seen," said Dr. Sidney Wolfe, who as director of the Public Citizen Health Research Group has been investigating the industry's practices for three decades.
In a statement to the daily, Bayer said Cutter had "behaved responsibly, ethically and humanely" in selling the old product overseas, adding that it did so because some customers doubted the new drug's effectiveness, because some countries were slow to approve its sale and because a shortage of plasma hindered mass production of the new medicine.
"Decisions made nearly two decades ago were based on the best scientific information of the time and were consistent with the regulations in place," the Bayer statement said."
The New York Times said it was practically impossible to determine how many hemophiliacs in Latin America and Asia were affected by the company's sale of Factor VIII concentrate after February 1984 when the new product came out.
However, in Hong Kong and Taiwan alone, more than 100 hemophiliacs were infected with the HIV virus after using Factor VIII, and many since have died, according to records and interviews obtained by the paper.
Cutter also continued to sell the older product after February 1984 in Malaysia, Singapore, Indonesia, Japan and Argentina, the daily alleged.
In the early 1980s, when the Acquired Immune Deficiency Syndrome was first detected, there was no screening test for the HIV virus to prevent it from contaminating blood products. Companies later developed a heat treatment for plasma products to kill off the HIV virus.
Bayer in its statement said it acted quickly to halt the manufacture and shipment of products that had not been heat-treated.
"Once data became clear that the heat-treated product offered a new level of patient safety without compromising therapeutic protein integrity, Bayer had acted swiftly to stop the manufacture and shipments of the non-heat treated product, and to register the heat-treated product subject to regulatory approval even before consensus had been reached among regulators, scientists and treaters," the company said.
The Cutter documents were produced in connection with lawsuits filed by American hemophiliacs, which had gone largely unnoticed until the daily said it began asking about them.
In the United States, according to the Times, thousands of hemophiliacs were infected with AIDS from contaminated blood-clotting medicine.
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