Hemophilia is a rare genetic blood clotting disorder, most often passed from mother to son, resulting in severe crippling and often death. But in the 1960s, Factor concentrates, a revolutionary new treatment derived from human blood, was processed, bottled, and offered for sale by drug companies, to be injected by the patients themselves at home. The medicine transformed hemophilia from a fatal disease to a chronic condition and the patients were now able to lead nearly normal lives. This “miracle” product was considered so beneficial that it was approved by the FDA despite known risks of viral contamination, including the near-certainty of infection with hepatitis — and despite the fact that the process by which it was made, the pooling of blood from thousands of donors, was otherwise outlawed. Because of its manufacturing process, each dose of Factor concentrate was made by pooling 60,000 individual blood donations, opening these vulnerable patients to an enormous contamination risk. At the time, pharmaceutical companies, government regulators, and even doctors considered hepatitis an “acceptable risk” for these patients. The patients themselves were rarely warned.
In the early 1980s, a deadly, unknown virus began to affect gay, urban men – and quickly spread to the hemophilia community, raising concern that the virus was in the nation’s blood supply. Yet even as HIV was identified, hemophiliacs dependent on multiple doses of Factor concentrate were advised by their doctors and advocacy group to keep using them. By the time the medication was pulled from the market in 1985, 10,000 hemophiliacs had been infected with HIV, and 15,000 with hepatitis C; causing the worst medical disaster in U.S. history.
In the aftermath, dire questions remained. How could this have happened? What would prevent something like this from happening again – both for hemophilia medications or for any FDA-approved medication?
As the hemophilia community realized the extent to which the government had been lax in overseeing pharmaceutical companies, and the extent to which the safety of patients figured last in the equation of costs, benefits, and profits, they began to fight back. Patients and families demanded more stringent regulation of industry by the government and spurred government reform over the safety of the U.S. blood supply. Today this small community stands as the guardians of the nation’s blood supply.
BAD BLOOD, a feature-length documentary film, recounts this cautionary tale from the perspective of six families affected by this tragedy and the doctors, nurses, and scientists who cared for them. Challenging viewers to their own vigilance, BAD BLOOD humanizes this under-reported medical disaster, stimulating further and much-needed public debate about the government’s role and effectiveness in regulating the pharmaceutical industry today.