U.S. official defends export to Canada of high-risk prison blood
By DENNIS BUECKERT -- The Canadian Press
OTTAWA (CP) -- U.S. prisoners were permitted to donate high-risk blood plasma for export partly because it was felt this would help in their rehabilitation, says a spokeswoman for the U.S. Food and Drug Administration.
Business factors may also have played a role in the decision to permit the shipment of prison blood to Canada after its use within the United States was halted in 1982, the official said in an interview Thursday from Washington.
"During that time ... it was seen as a way for prisoners to rehabilitate themselves, they were giving something back to the community by donating their blood," said the official who asked not to be named.
The official expressed regret that Canadians may have been infected after receiving blood products made from plasma collected in prisons in Arkansas and Louisiana.
"It's always so difficult when you're talking to consumers who have been directly affected by something so life-altering. It's too flimsy an excuse, but we didn't have a lot of information back in the '80s.
"There was some sort of consensus building that they (prisoners) were high-risk donors, but we had no way to prove that they were."
Canadian tainted-blood victims are demanding an inquiry into why the FDA continued to license prison blood centres despite evidence that prisons were hotbeds of HIV and hepatitis C infection.
There have been numerous reports about irregularities in the blood collection program at the Arkansas Department of Corrections Cummins Unit, in Grady, Ark.
A delegation of Canadian hemophiliacs plans a news conference in Washington later this month to press for answers.
"The FDA found these guys (at the Grady prison) were destroying records and committing serious violations and somehow they got relicensed every time," says Mike McCarthy, an Ontario hemophiliac infected with hepatitis C.
"Everybody knew -- the FDA knew these were not good areas for production of fractionated products. They turned a blind eye to repeated violations."
Michael Galster, a doctor who worked in the Arkansas prison system in the mid-1980s has said prisoners were permitted to donate blood even when they were visibly ill with the symptoms of AIDS and hepatitis C.
The Krever Report on the tainted blood scandal says that on Dec. 13, 1982, Dennis Donohue, director of the FDA Office of Biologics, asked major U.S. fractionaters to stop using blood from high-risk areas, including prisons.
But the FDA official interviewed Thursday insisted the agency never asked the fractionaters to stop using prison blood.
She said fractionaters made that decision voluntarily and the FDA continued to license a few small prison centres which were exporting product "overseas."
The convenience of prison collection may have appealed to manufacturers of blood products, she added.
"It might have been a very businesslike decision too. This is a group of people who are willing to donate and donate regularly, and you have to go to one site to pick it up. So it might have been an economic issue as well."
Arkansas officials have said the prison centres produced 300 to 500 units of blood every weekend. Since blood plasma is pooled for fractionation, a single contaminated dose can infect thousands of units of final product. |