Why Did U.S. FDA Approve Sale of Prison Blood?
April 12, 1999
. . . And Why Did Canada Buy It?
On February 24, a group of Canadians held a press conference
at the National Press Club in Washington, D.C., to ask
the United States government to investigate the U.S.
Food and Drug Administration's (FDA) approval of the
sale of prison blood to Canada in the 1980s.
Canadian Victims Speak from the Heart
"Many Canadian hemophiliacs, infected with the horrible
viruses that cause AIDS and hepatitis C, were exposed
to high-risk prison plasma from the United States,"
said Michael McCarthy, a Canadian hemophiliac who was
infected by the prison blood products.
He explained that between 1980 and 1985, over 1,000
hemophiliacs in Canada were exposed to U.S. prison plasma,
which was collected from convicts who were known to
be at high risk for hepatitis and, by implication, AIDS.
"By 1982, your FDA decided that this prison plasma
wasn't suitable for American domestic production of
[a] hemophilia product. Unbelievably, the FDA allowed
this high-risk plasma to be exported to Canada to be
put in the veins of innocent Canadians.
"Why, if this dangerous plasma wasn't safe enough
for American use, was it suitable for your neighbors?"
asked McCarthy. "The result of your country's [FDA]
failure to protect us from this lethal plasma is that
half of the thousand Canadian hemophiliacs who were
exposed to this plasma are now dead.
"Scientific and medical knowledge in the early eighties
were advanced enough to understand the threat of hepatitis
and AIDS in the blood system. Officials at the FDA knew
that prisons were considered dangerous areas to collect
plasma from," continued McCarthy.
"They knew that one infected prison donation would
contaminate huge lots of plasma that would be made into
hemophilia product. They knew that testing for AIDS
and hepatitis was crude and subject to error. Why on
earth then did they allow this unsavory practice to
continue?" asked McCarthy.
FDA Could Have Prevented Tragedy
"In 1984 the FDA investigated the Arkansas prison
system plasma program and revoked the operating license
for the Cummins prison programs," he said. According
to McCarthy, the FDA cited a litany of problems:
- Disqualified donors were allowed to continue to
- Plasma was inadequately stored, allowing it to be
- Records were altered.
- There were instances of intentional and willful
disregard of standards.
- Plasma center staff were inadequately supervised.
- People in management positions at the center attempted
to hide the fact that they were either initiating
or condoning the destruction or alteration of records
concerning these activities.
"The tragedy is that they could have done something
to stop it. But the FDA turned a blind eye and allowed
money to be made on the backs of the dying. The FDA
should not have reinstated the prison's plasma license.
This prison was the last place on earth that should
have been allowed to collect plasma," said McCarthy.
Call for U.S. Investigation
He continued by calling for the U.S. Justice Department
and FBI to investigate why Canadians were given high-risk
tainted plasma collected from U.S. prisons. "Do we have
to dig up our dead and rebury them on American soil
to get a criminal investigation into this cloaked and
deadly practice?" asked McCarthy.
Canadian Government Owned Forty Percent of Blood Product
Grant Hill, M.D., a member of the Canadian Parliament,
explained that a special commission was established
in Canada to investigate the tainted-blood issue.
According to Dr. Hill, the Krever Commission (named
after Justice Horace Krever) was thorough, but some
important documents were withheld from it. "I couldn't
understand, as a politician, why the government was
so restrictive of some of the documents that they turned
over to Krever," said Hill. "It wasn't until fairly
late on in the game that I found out the Connaught Laboratories,
the laboratories that actually spread this blood through
the [Canadian] system, was 40 percent owned by the Canadian
Canada Compensates Some Tainted-Blood Victims
"Last year, thousands of victims of tainted Canadian
Red Cross blood staged angry protests in Ottawa, Canada's
capital, forcing the government to agree to a compensation
plan totaling $1.1 billion Canadian," reports Reuters
However, compensation covers only those infected with
hepatitis C between 1986 and 1990, since blood wasn't
screened for that disease and HIV before 1986. Yet those
who were exposed before 1986 feel that the cutoff date
is unfair and are suing for compensation.
Dave Harvey, the Canadian group's attorney, announced
that "On the 28th of January, we filed a $1.1 billion
dollar Canadian lawsuit against the federal government,
blood brokers who purchased plasma from American prisons
and brought it into Canada, and the pharmaceutical company
in Canada who processed it into the products that these
"At the moment, we are working with a team of lawyers
in the United States, all of them veterans of the tainted
blood litigation. And we are putting together a lawsuit
to parallel what we're doing in Canada in the United
States. We're focusing on the federal Food and Drug
Administration, on the states of Arkansas and Louisiana,
and on the companies who were operating plasma collection
sites within prisons in those states," said Harvey.
He continued, "When you ask, and I hope you do, these
defendants what they were doing and what their justification
was, I can tell you what their defense is going to be.
They are going to say, 'This was the early 80's, we
didn't know, we couldn't test for AIDS, we couldn't
test for hepatitis C.' Don't let them get away with
"Let's focus on what they did know. Hepatitis and
AIDS were running in the same circles. What were those
circles? People with tattoos, people engaged in homosexual
sex, people using IV drugs. Where could you find a better
collection of those three groups than in a prison?
"The second point, which is essential here, is that
blood donor screening relies on the honesty of the donor
in answering screening questions. Again, how can you
place a life and death system, based on honesty, inside
"These are people who have already showed a willingness
to break the law. When inside a prison, and their only
source of income is donating plasma, how can you be
sure that they're going to be honest about their eligibility
to donate plasma? Don't let those simple defenses stand
up. Ask the tough questions!" stressed Harvey.
FDA's Regulatory Role
In the United States, the FDA is the government agency
in charge of overseeing the safety of the blood supply
through licensure and registration of blood collection
facilities, development of policies and regulations
for the manufacture of blood products, and surveillance
and enforcement of regulations.
Manufacturers wishing to ship blood or blood products
in interstate commerce and abroad must obtain a U.S.
license. To obtain a license, the centers collecting
the blood and blood components must submit applications
and demonstrate that they operate according to product
standards. They must also show that they follow current
good manufacturing practices defined in the regulations.
U.S. Blood-Shield Laws
Was the FDA negligent for licensing the sale of high-risk
prison blood? That question, hopefully, will be answered
by the forthcoming class-action lawsuit. However, "The
Canadian hemophiliacs face an uphill battle. Half of
those infected have already died and too much time may
have elapsed since the alleged offences occurred to
make a claim stick," reports Barrie McKenna, the Washington
bureau reporter for the Globe and Mail, a major Canadian
According to McKenna, "The hemophiliacs also face
a hostile legal environment. The U.S. government has
never compensated U.S. tainted-blood victims and has
steadfastly refused to investigate the tragedy.
"Nearly all states, including Arkansas, have so-called
blood-shield laws, which provide extensive legal protection
to the people running the blood system. An official
with the Department of Health and Human Services, which
oversees the FDA, said the government would not comment
on pending litigation," reports McKenna.
For a complete version of the Canadian government's
Krever Commission Report, see the following website:
The lead plaintiff in the lawsuits, Michael McCarthy,
can be reached at (519) 274-4178; and Canadian attorney
David Harvey at (416) 595-2482.
This article was originally published in the March/April
1999 issue of Health