UK Government Warned of Infected Blood Risks from US Prison Donors in the 1970s: Documents Reveal
In the 1970s and 1980s, the UK government approved the use of a blood product for haemophiliacs despite being informed that it was harvested from US convicts and potentially contaminated with viruses.
Thousands of patients, including children, were infected with HIV and hepatitis C as a result.
The product, which was used to help clot their blood, contained plasma from up to 20,000 donors, many of whom were from impoverished areas in the US with high rates of drug use and sexual infections.
Government officials were aware of the risks and were told that virus contamination "should be assumed." A contaminated batch of blood products from Bayer's subsidiary, Cutter Laboratories, is believed to have caused the deaths of approximately 3,000 people.
An investigation led by Sir Brian Langstaff is ongoing and has already determined that wrongdoing occurred at individual, collective, and systemic levels.
In the 1970s, Cutter Laboratories warned in licensing application documents that their commercial blood product, Koate, may contain viruses, specifically hepatitis, and that the presence of such viruses could not be proven with absolute certainty.
In August 1976, a factor VIII concentrate, a blood product used to treat hemophilia, was approved along with similar treatments.
However, it was later discovered that these treatments were contaminated with deadly viruses for several years.
The source of the contaminated blood was revealed to include American state prisons.
Studies had shown a greater risk of hepatitis infection from prison-harvested blood.
The Committee on Safety of Medicines warned that the product was prepared from multi-centre donations which could not be properly inspected, contributing to the contamination.