This subject has been off the collective radar screen for awhile, but a recently unearthed court document reminded us of a passionate controversy that's played out for the past two decades ago over the use of a blood-clotting medicine that was blamed for infecting hemophiliacs with HIV in Asia and Latin America, while a newer, safer version was sold in the US and other Western nations.
The backdrop: A former Bayer division known as Cutter Biological introduced a new version of its med in 1984, but continued to sell the old one overseas, according to documents filed in federal court in Illinois. By doing so, Cutter avoided a build-up of inventory of its old Factor VIII concentrate, which provided a missing ingredient that allows a hemophiliac's blood to clot. Look here.
Why would a build-up have occurred? A new version, which was more expensive to produce, was heat-treated to make HIV undetectable and, in 1984, this was introduced in the US, as the memo indicates. By then, studies had shown HIV could survive the use of the older product look here and here. But the older med was still actively marketed in Asia in 1985. Look here.
A growing ruckus was under way, however, and the FDA called a meeting of Cutter and others companies selling older Factor VIII overseas and told them to comply with an earlier agreement the agency believed had been broken. Here's the memo. For the curious, The New York Times wrote a detailed account of this episode five years ago.
Why do recount all this now? A previously unknown Cutter budget estimate for 1985, which became available two weeks ago, offered a cold calculation. The assumption was that AIDS wouldn't become a "major issue" among Asian hemophiliacs that year, but if there was "hysteria over AIDS," the fallout could reduce sales of its older med by $400,000 and gross profits by $110,000. There are patients, and there are profits.
A Bayer spokesman referred us to a statement issued after the Times story - at the time, the drugmaker denied allegations that patients were deliberately exposed to HIV and blamed differing registration requirements in other countries for the delay in switching over to the new med. "Bayer acted responsibly, ethically and humanely at all times," the statement reads. The drugmaker also contributed to compensation funds and has settled some lawsuits.