Why Did U.S. FDA Approve Sale of Prison Blood?
. . . And Why Did Canada Buy It?

April 12, 1999

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:

1. Disqualified donors were allowed to continue to donate.
2. Plasma was inadequately stored, allowing it to be contaminated.
3. Records were altered.
4. There were instances of intentional and willful disregard of standards.
5. Plasma center staff were inadequately supervised.
6. 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 Company

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 government."

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 News Service.

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.

Class-Action Lawsuits

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 gentlemen took.

"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 it!

"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 a prison?

"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 newspaper.

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: http://www.hc-sc.gc.ca/english/krever/#Table 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 Freedom Watch, the bimonthly watchdog report published by the Institute for Health Freedom.