Canadian Health Commissioner Releases Report on Tainted Blood

During the 1980’s, blood tainted with the human immunodeficiency virus, or HIV, and hepatitis C entered the Canadian blood supply. Justice Horace Krever led a commission in 1993 that began an inquiry into the tainted blood and the Canadian government’s response to the emergency. The resulting document, the Krever Report, was released in 1997.


Summary of Event

During the late 1970’s and throughout the 1980’s, Canada faced a massive outbreak of human immunodeficiency virus, or HIV, and hepatitis C cases among hemophiliacs and blood-transfusion recipients. In response, a Canadian House of Commons committee authorized an inquiry into the possible contamination of the blood supply and requested recommendations for policies to maintain a safe and efficient supply of blood. [kw]Tainted Blood, Canadian Health Commissioner Releases Report on (Nov. 26, 1997)
Krever, Horace
Royal Commission of Inquiry on the Blood System
Krever Commission
Health Management Associates scandal
Blood, tainted
Krever, Horace
Royal Commission of Inquiry on the Blood System
Krever Commission
Health Management Associates scandal
Blood, tainted
[g]Canada;Nov. 26, 1997: Canadian Health Commissioner Releases Report on Tainted Blood[02850]
[c]Drugs;Nov. 26, 1997: Canadian Health Commissioner Releases Report on Tainted Blood[02850]
[c]Medicine and health care;Nov. 26, 1997: Canadian Health Commissioner Releases Report on Tainted Blood[02850]
[c]Government;Nov. 26, 1997: Canadian Health Commissioner Releases Report on Tainted Blood[02850]
[c]Law and the courts;Nov. 26, 1997: Canadian Health Commissioner Releases Report on Tainted Blood[02850]
[c]Business;Nov. 26, 1997: Canadian Health Commissioner Releases Report on Tainted Blood[02850]
Perrault, Roger
Furesz, John

Ontario Court of Appeals justice Horace Krever, one of the country’s foremost experts on the confidentiality of health records, was appointed to lead the Royal Commission of Inquiry on the Blood System in Canada, or the Krever Commission. Public hearings began on November 22, 1993. The commission heard testimony from those infected and from doctors, officials of the Red Cross, Canadian Canadian Red Cross Society (CRCS), and organizations responsible for blood collection and distribution. The hearings ended in December, 1995, after testimony from close to five hundred persons and a cost of millions of dollars.

The CRCS, founded in 1896, was responsible for the majority of blood and blood-components coordination, collection, and distribution. The Canadian government did not regulate the CRCS because of the organization’s excellent reputation. The Canadian Blood Committee (CBC) was established in 1981 to financially manage the blood supply system throughout Canada. The blood system as a whole was uncoordinated and inefficient, with no clear line of authority, so that the agencies involved could not respond quickly to a widespread emergency. Until 1989, the federal Canadian government had no legal control over whole blood and its components.

During the 1970’s, more than 200,000 Canadians received blood or blood products annually, including approximately twenty-three hundred hemophiliacs, those who have a blood-clotting disorder. By 1971, testing was available to detect hepatitis B, and the CRCS no longer collected blood from prisons, where the hepatitis rate was higher than in the general population. By 1974, the first cases of hepatitis C (originally called non-A and non-B hepatitis) were identified and found to be transmitted through blood transfusions. Hepatitis C can lie dormant for up to twenty-five years and cause liver cancer and cirrhosis. Effective tests were available by 1986, but the CRCS did not begin testing until 1990, and unscreened plasma was given to patients through 1992.

By March, 1983, the United States was screening all persons considered part of a higher-risk group for acquired immunodeficiency syndrome (AIDS), an autoimmune disease that develops from HIV. Persons no longer allowed to donate blood included gay men, Haitians, intravenous-drug users, and their sexual partners. The U.S. Food and Drug Administration (FDA), however, allowed the export of tainted plasma from prisons in Arkansas and Louisiana to Canada during the 1980’s. By this time, the FDA already had ruled that prisoners’ plasma was too unsafe for the manufacture of blood products in the United States. Health Management Associates (HMA), the company that ran the Arkansas prisoners’ plasma program from 1978 to 1994 and bought prisoners’ plasma from Louisiana, purchased most of the tainted plasma from the Cummins Unit, a correctional facility in Arkansas. The Arkansas Department of Corrections sold the inmates’ blood to HMA, which then sold it to North American Biologics, a subsidiary of Continental Pharma Cryosan, a blood broker in Montreal. Cummins was known to have used dirty needles and for failing to test donors for AIDS and hepatitis C. The FDA accused the prison of numerous violations during the early 1980’s and ordered its closure, but HMA continued to sell inmates’ blood to Connaught Laboratories, a Canadian company.

Even though potential donors were being screened in the United States in early 1983, Roger Perrault, national director of the CRCS, implemented a policy of asking members of higher-risk groups to not donate, but to refrain voluntarily. Especially in the face of a severe shortage of blood, it would be poor policy to question potential donors, who were being generous by donating. To question them showed distrust. In August, 1982, John Furesz, director of Canada’s Bureau of Biologics, which was responsible for regulating blood products, asked the CRCS to report new cases of HIV and AIDS. The request was rejected because the CRCS believed that hemophiliacs were not at risk of HIV infection and that such risk was exaggerated and inconclusive.

The CRCS began screening Canadian blood donations for the HIV antibody in November, 1985. Potential donors were given health-related information and asked if they were in good health, but they were not asked about sexual activities or drug use until 1986. The Bureau of Biologics did not insist that blood donors be informed about AIDS symptoms or asked if they had symptoms of AIDS, nor were they asked if they were in a higher-risk group. The bureau also did not require that higher-risk groups be excluded from donating blood.

The Krever Commission released an interim report on February 15, 1995, containing forty-three recommendations. The report called for a comprehensive, effective program to provide transfusion recipients with information about the risks of HIV. Other major recommendations included that hospitals notify all patients who had transfusions between 1978 and 1985 about the risk of developing AIDS, and to notify all patients who received blood or blood products between 1978 and 1990 about the risk of hepatitis C.

By the time the final report was released on November 26, 1997, many of the recommendations from the interim report had been enacted. The Krever Report found misconduct at every level. Among the findings were that the CBC failed to create a national blood policy and regulate donations; it also failed to provide quality blood products to hemophiliacs. The report found that the CRCS failed to oversee and provide resources for the blood system, to recognize HIV transmission by blood, and to implement donor screening, and that the CRCS underestimated the risk of HIV transmission.



Impact

The tainted blood scandal was the worst preventable public health disaster in Canadian history. The Krever Report of 1997 highlighted numerous problems with Canada’s blood system, and Canadian governmental bodies began working to establish a new blood system to improve safety.

In September, 1998, the blood-related tasks of the CRCS were taken over by the newly formed Canadian Blood Services (CBS). CBS had the authority to oversee and integrate services and provide accountability. In addition, the federal government tightened regulations for improving manufacturing standards, reporting adverse drug reactions, and sharing information on transfusion risks. CBS also would provide national control over the blood system. Also in 1998, provincial and federal governments began authorizing compensation for those infected by tainted blood and blood products.

In April, 2001, the Supreme Court of Canada Supreme Court of Canada ruled that the CRCS was negligent in managing the blood system. In November, 2002, the CRCS and four physicians, including Perrault and Furesz, were charged with criminal negligence. In May, 2005, the CRCS was fined five thousand dollars for its role in the tainted blood scandal, a small amount, but the maximum amount allowed for the charge of distributing a contaminated product. Six other criminal charges were dropped. In October, 2007, after an eighteen-month trial, all the physicians were acquitted of criminal negligence charges.

The cost in terms of human suffering and death was substantial. By 1985, about eight hundred hemophiliacs were infected with HIV. Approximately 1,148 cases of AIDS were attributed to transfusions received between 1978 and 1985, and 627 of these persons were dead by 1993. Since infected recipients and donors were not identified, located, and treated, the number of people actually infected was higher because it included family members infected through sexual and maternal transmission. Between 1986 and 1990, 28,600 people were infected with hepatitis C by blood transfusion, even though heat-treated products and AIDS screening tests were available. Eighty-six percent of the infections could have been prevented had adequate screening techniques been introduced in 1986, the year they first became available. Approximately 95 percent of the hemophiliacs who received blood products before 1990 contracted hepatitis C. The Krever Report estimated that as many as twenty thousand Canadians contracted AIDS and more than sixty thousand had been infected with hepatitis C.

With multiple layers of testing and screening, the blood supply by 2007 was considered safe. More funding boosted safeguards at laboratories and other health facilities and helped to increase the monitoring of international trends and other related health concerns. Krever, Horace
Royal Commission of Inquiry on the Blood System
Krever Commission
Health Management Associates scandal
Blood, tainted



Further Reading

  • DeMont, John. “A Harsh Rebuke: The Krever Report Dissects the Tainted Blood Scandal.” Maclean’s, December 8, 1997. Magazine article that lists examples of negligence and error, describes the current state of blood donation, and discusses changes made with new blood system.
  • Gilmore, Norbert, and Margaret A. Somerville. “From Trust to Tragedy: HIV/AIDS and the Canadian Blood System.” In Blood Feuds: AIDS, Blood, and the Politics of Medical Disaster, edited by Eric A. Feldman and Ronald Bayer. New York: Oxford University Press, 1999. Overview and discussion of Canada’s blood system and the tainted blood scandal. Points out numerous failures to act that resulted in tragedy.
  • Sillars, Les. “Bureaucratic Serial Killers: (Horace) Krever’s Tainted-Blood Inquiry Lays Bare in Meticulous Detail the Death Toll from Political Correctness.” Alberta Report, December 15, 1997. Highlights results of the Krever Report and examines the inaction of the Canadian health system to protect the blood supply. Provides statistics and some personal accounts.
  • Starr, Douglas. Blood: An Epic History of Medicine and Commerce. New York: Alfred A. Knopf, 1998. An exposé of the global business of human blood, namely the “blood-services complex.” Discussion includes the distribution of blood in the context of the rise of HIV and AIDS during the early 1980’s.
  • “Tainted Blood: Poison from the Prisons.” The Economist, March 13, 1999. Brief magazine article discussing the sale to Canada of contaminated prisoners’ plasma from the United States during the 1980’s.


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