HIV-Tainted Drugs

This story (1, 2) came out a decade ago, but I thought that I should share with the class to see your thoughts on the subject since HIV/AIDS is, with fighting other infectious diseases, one of the Millenium Development Goals.  Bayer sold Factor VIII concentrate, a crucial component in the blood-clotting cascade that is missing in individuals with hemophilia A (3, 4).  The protein was isolated from plasma donors and the drug developed prior the development of an HIV screening test.  The typically self-injected drug was a breakthrough in medicine as that meant that hemophiliacs could finally lead a normal life, some using it as much as three times a week (2).  However, amid the HIV pandemic, Bayer heat-treated, which, according to a government study, led to the virus being ''undetectable'' (1, 2).  Although the un-heated product was pulled from the shelves in America, thousands of American hemophiliacs were infected with HIV, and was exported to Asia when a distributor took interest (2).  Cutter Biological, the Bayer branch in charge of Factor VIII, “asked the distributor to 'use up stocks' of the old medicine before switching to its 'safer, better' product. Several months later, as hemophiliacs in Hong Kong began testing positive for H.I.V., some local doctors questioned whether Cutter was dumping 'AIDS tainted' medicine into less-developed countries. Still, Cutter assured the distributor that the unheated product posed 'no severe hazard' and was the 'same fine product [they had] supplied for years” (2).  Over 15 years of lawsuits led to a settlement of $600 billion paid to American families.  The NY Times article goes on to describe that when Cutter was asked by an Asian distributor for the “new” (heated” Factor VII concentrate, “Cutter replied that most of the new medicine was going to the United States and Europe, and that there was not enough left for Hong Kong, though a small amount was available for the 'most vocal patients'” (2).  But my question is, what about those families abroad who have lost their loved one and isn’t there more government regulation?

What shocks me most is that the FDA did not seem to have done much to have stopped or regulated Cutter’s actions.  By May 1985, which is when the FDA realized that the unheated product was being exported and an FDA official asked that the issue be “‘quietly solved without alerting the Congress, the medical community and the public, ‘according to Cutter documents” (2), the CDC had already established that HIV was transmitted through blood products (2).  Additionally, other countries likely had ministries of health/health departments so wouldn’t they also have an equivalent of our FDA to ensure the safety of their own people?  Last but not least, with the added heating process, wouldn’t the FDA have inquired about the safety of the old product and asked that the latter be discarded (despite the large loss of capital and material)?

(1) http://www.cbsnews.com/news/bayer-sold-hiv-risky-meds/

(2) http://www.nytimes.com/2003/05/22/business/2-paths-of-bayer-drug-in-80-s-riskier-one-steered-overseas.html?pagewanted=all&src=pm

(3) http://www.hemophilia.org/NHFWeb/MainPgs/MainNHF.aspx?menuid=180&contentid=45&rptname=bleeding

(4) http://www.qiagen.com/products/genes%20and%20pathways/pathway%20details?pwid=64