Krever Report Released
They still serve up doughnuts and juice afterward. Otherwise, much has changed for anyone giving blood at a Red Cross clinic in Canada. The questions are chastening. Have you ever paid for sex, a nurse asks. Has anyone ever paid you for sex? Do you have AIDS? Have you had sex with anyone who has AIDS? Have you ever taken illegal drugs? Have you used cocaine within the past 12 months? The nurse takes the potential donor's temperature and blood pressure to check for signs of infection, then examines the inside of the arms for needle tracks. The donor is asked to sign a waiver, attesting to his honesty. Only then is the blood drawn from his veins - and carried off to a laboratory to be tested for the AIDS virus.
All told, the process usually takes over an hour - a far cry from a few years ago when a donor could walk into a clinic, roll up his sleeve, have that glass of juice and doughnut and be out in 30 minutes. That was before thousands of Canadians became infected with HIV and hepatitis C through tainted blood products in the late 1970s and 1980s. What has made tainted blood the Canadian medical scandal of the century is the undeniable fact - obvious even before Justice Horace Krever started his probe into the tragedy in 1994 - that the blood system had failed the very people it was entrusted with protecting. All of which makes Krever's final report, which became public last week and sheds new light on the institutions and individuals who are ultimately responsible for the tragedy, so devastating.
Krever's long-anticipated report is no high-octane potboiler. After nearly four years, 427 witnesses, 50,000 transcript pages of testimony and more than $17 million in taxpayers' money, it frustrated some critics because it assigned no blame - even though Krever had fought for, and won, the right to name names in the face of numerous legal challenges spearheaded by the Canadian Red Cross Society. Moreover, the legal manoeuvring delayed the report. As a result, many of its 50 recommendations for revamping the blood system - including the exclusion of the Red Cross - have already been embraced by the politicians, who have decided that a new blood supply system must be in place by September, 1998. Instead, the enduring value of the report is the methodical way it dissects a tragedy that, according to Krever, is much more widespread than originally estimated.
What emerges from the cold, bureaucratic prose is a horrific, haunting tale of bungling and negligence. Some examples:
» Lax monitoring by the Bureau of Biologics, the blood regulatory arm of Health Canada, failed to ensure that a system of checks was in place in the early 1980s when Canada faced a serious plasma shortage. Under pressure from Canadian authorities, Toronto-based Connaught Laboratories Ltd., Canada's largest manufacturer of blood products, began buying blood products in the United States. The higher overall incidence of HIV infection there, and the American practice of collecting plasma in prisons, Krever writes, increased the risk of disease for Canadian hemophiliacs. And, in fact, some of Connaught's purchases - made unknowingly through a broker - turned out to be infected plasma from U.S. prisons and San Francisco, which the AIDS epidemic had struck very hard.
» Government officials were reluctant to trace recipients of possibly tainted blood and blood products who were at risk because, Krever notes, the bureaucrats "appear to have been more concerned about preventing public questioning about the safety of the blood system and deflecting controversy," than with providing timely health information.
» The Red Cross decided to deliberately exhaust its inventory of non-heated blood concentrates before making heat-treated concentrates available. Heat-treating destroys the AIDS virus, and the new concentrate "almost completely ended the spread of AIDS among Canadian hemophiliacs," according to the Krever report. But delays in acquiring sufficient supply, and the continuing use of the non-heated concentrates, unnecessarily prolonged the risk for Canadians.
» The Red Cross's "slow and bureaucratic" development of a pamphlet about AIDS was only one of the ways in which regulators and public-health officials missed a vital opportunity to reduce the risk of infection.
Under pressure from tainted blood victims groups, the RCMP last week announced it was reviewing Krever's report to see if criminal charges were warranted. Meantime, the institutions that all along did their best to block the inquiry from criticizing individuals seemed contrite. "To the victims and their families, while we cannot feel your pain, we hurt with you; while we cannot know your suffering, we weep with you; while we cannot feel your loss, we grieve with you," declared Red Cross president Gene Durnin, the successor to Douglas Lindores - who refused to offer an apology to victims when he testified before the inquiry.
Federal Health Minister Allan Rock issued his own apology for the federal government's role in the scandal. "We can't undo the damage - I wish we could - but we can express our profound sadness and our deep regret for the harm done to so many Canadians and their families," he said. "The federal government accepts its share of responsibility." Rock also vowed the report would do more than gather dust. But when it came to one of Krever's key recommendations - a call for no-fault compensation to all tainted blood victims, including those who contracted hepatitis C - Rock was non-committal, saying he would have to discuss the matter with the provinces. After a four-year federal program expired in 1993, only the tenacity of the victims and their representatives forced the provinces to offer those who had contracted AIDS through tainted blood - although not family members who were infected by the original victim - $30,000 a year for life. "Compensating some needy sufferers but not others cannot, in my opinion, be justified," Krever wrote.
For the provinces - who will have to fund any no-fault system - the price tag is a big worry. Estimates on the number of Canadians who contracted hepatitis C from the blood system vary wildly - with some running higher than 60,000. Provincial health ministers are also concerned that once a no-fault compensation system is introduced for blood, there would be immense pressure to adopt the same scheme for other medical procedures. "It is a can of worms people are reluctant to open," conceded one Nova Scotia health department official.
Many victims of the blood scandal, meanwhile, took what solace they could from the inquiry report. Some, like Dartmouth, N.S., activist Janet Conners - she contracted AIDS from her husband, Randy, a hemophiliac who died in 1994 - seemed to find the report's conclusions cathartic. "I feel at long last I can tell my son why his father died," she said after listening to Rock's apology. Many, though, still burned with anger over the fact that Krever did not assign blame - the Supreme Court had ruled in September that the inquiry could only state facts and not impute culpability by any individuals. "We've been forgotten again," lamented Bill Decarie, who, along with his eight-year-old daughter, Billie Jo, and wife Johanne, suffers from AIDS - she as a result of receiving a transfusion of tainted blood in 1985. "The Krever inquiry will not have done its job, and will not be seen to have any value, if those who could have - and didn't - do something are not identified."
In fact, Krever is deeply critical of some individuals. But in the end, he blamed the tragedy on a "systemic failure" of Canada's blood system. And with a few exceptions, his final report - and the 50 recommendations for a new Canadian blood system - follow the same direction he laid out in his interim report issued in February, 1995. Since then, the new blood system, which the federal and provincial governments have ordained will be up and running by next September, has already become a work-in-progress. Entrusted with the task of crafting the details is a small transition team of consultants and experts working out of cramped Ottawa offices, just a few kilometres from Parliament Hill. Concedes transition director Bernard Doyle: "It is a daunting job."
The make-over might be further along now if not for the lingering uncertainty over the role of the Red Cross, which has been at the centre of Canada's blood system since 1939 and wanted to remain the key player. One of the major proponents of a continued, central role for the society was David Dingwall, Rock's predecessor as health minister. Like many of his health department bureaucrats, Dingwall feared that downgrading the charity's role would cause a crisis of confidence among blood donors who had already been staying away in droves since Krever began hearing more and more shocking testimony. Moreover, medical insiders suggest that Dingwall may have wanted to ensure that the Red Cross's plans, now abandoned, for a $300-million blood fractionation plant - which would have taken plasma from blood and broken it down into its component parts - in his home province of Nova Scotia stayed on track.
But Dingwall lost his seat in the June 2 federal election. Weeks after the election, Rock and his provincial counterparts - with the exception of Quebec's health minister - announced the creation of a new blood agency. The Red Cross was offered a much reduced role in donor recruitment - and opted instead to get out of the blood supply system altogether once the new agency is in place. The charity's Canadian arm will now focus largely on such things as relief efforts - for example, during disasters like last spring's Manitoba floods.
Even before Krever made his final recommendations, the new system's outlines had already taken shape. The centrepiece: the Canadian Blood System, the new agency created with $81 million in federal government money, whose operations will be funded by the provinces and the territories. Like the Red Cross before, the CBS will have absolute power over Canada's blood supply, doing everything from bringing in donors and collecting blood to educating the public on safety questions. Its architects, though, envision an organization that will also meet even Krever's high standards. "Our goal is to have a system that is safe, accountable and fully transparent to consumers and the public," stresses Doyle.
At a glance, the changes seem subtle. A plan to grant the CBS a three-year operating budget - and an annual contingency fund - gives it the fiscal flexibility and speed to face any future blood system emergencies, like tainted blood, head on. To prevent complacency within the system, external advisory bodies will be appointed to provide outside scrutiny. And unlike the old system, in which a diffuse chain of command made it impossible to determine who was ultimately responsible for decision-making, the CBS will be run by a chief executive officer, who reports to a 12-person board of directors but is solely responsible for day-to-day operations. "Now if there's a problem everybody knows whose head is on the line," points out Derhane Wong-Rieger, president of the Canadian Hemophilia Society, who is also a member of the group managing the transition to the new blood system.
The hundreds of thousands of Canadians who annually give blood have already felt the winds of change. Not surprisingly, given the stringent screening many would-be donors simply do not make the grade: from July through November fully 14 per cent of the 425,000 donors who entered Red Cross clinics across the country were turned away. If that alone is not enough to make anyone needing a transfusion feel better, there are other reasons for renewed confidence. Since Krever's interim report, provincial, territorial and federal governments have poured millions of dollars into boosting existing safeguards within the system. The Laboratory Centre for Disease Control now has an improved ability to monitor international trends to keep abreast of new screening techniques - and an eye on blood viruses that could make their way into Canada. The Bureau of Biological Reproduction has upped the level of surveillance to ensure that laboratories and other facilities meet stringent safety standards.
Meanwhile, the provinces, territories and federal government remain embroiled with the Red Cross in negotiations over how the charity's 17 blood centres, medical equipment and other assets will be transferred to the CBS. The big question: who will assume the legal responsibilities of the charity, which is already the defendant in a rash of class-action suits brought by thousands of Canadians who contracted HIV or hepatitis C from tainted blood?
With the RCMP now considering a criminal investigation, tainted blood cases could crowd the courts for years to come. None of the evidence heard by Krever can be tabled during any court trial. The findings of a commission of inquiry, said one legal expert last week, "cannot be used in a civil or criminal proceeding to prove the truth of anything." But for those in search of the truth, Horace Krever's report is a good place to begin.
Highlights of the Krever Commission Report:
» Statutory, no-fault schemes should be established to provide prompt compensation for "all blood-injured persons." But Krever's language makes it unclear whether the aid should be retroactive.
» Krever does not give specific figures, but on the basis of the report it is clear that the number of Canadians infected with blood-borne diseases is far greater than previously estimated. The total of 1,200 commonly given for HIV-infected persons counts only those who received the virus directly through blood products, not family members who subsequently became infected through sexual or maternal transmission. In the case of hepatitis C, where 12,000 has been the accepted figure for victims, the true number could be more than 60,000. Of the 28,000 cases that occurred after 1986 - when a reliable test was adopted in the United States but rejected in Canada on the grounds of cost and efficiency - 85 per cent could have been avoided.
» The blood system should be governed by five principles: treating blood as a public resource; declining to pay donors who give blood; Canada should be self-sufficient in blood; free, universal access to blood; making safety paramount.
» Although Krever does not accuse individuals of any wrongdoing, he provides exhaustive details of where the decision-making process broke down. (And in the wake of his report, the RCMP announced it was closely examining it to decide if a criminal investigation is warranted.)
» A single independent blood authority should be created and the Canadian Red Cross Society - which received some of the most stinging criticism in Krever's report - should be removed altogether from the blood system. (In May, Ottawa and the provinces decided on this course of action; in August, after being offered a reduced role in the new system, the Red Cross decided to withdraw from blood services.)
» The number of people infected with HIV and hepatitis C could have been minimized had the Red Cross and federal and provincial health departments not dragged their feet, ignored warnings, acted irresponsibly and without concern for consumers.
Looking Forward to Going Home
Some time between now and the end of the year, Horace Krever will walk away from a suite of sterile highrise offices in downtown Toronto for the last time. No more junk-food lunches. No more meddlesome politicians. No more of the bitterness and rancor that dogged his marathon inquiry into the nation's tainted-blood scandal. Early in January, for the first time in nearly four years, Krever will return to the company of his 17 fellow Ontario appellate court judges and the muted corridors of Osgoode Hall. The decor is judiciously upscale, the hours are better and the dining room has never served a burger and fries. "Justice Krever will be pleased to be back," remarked a member of the court staff with understated assurance.
But whether he stays remains to be seen. The often-emotional, nearly four-year-long blood inquiry marked the fourth time in his 40-year career that Krever, 68, had been persuaded by governments to investigate a health-care issue. Associates say the Montreal-born former lawyer and law professor is drawn by the need for social reform. "Krever is a guy who is almost passionate in his desire to rectify and correct things," Toronto trial lawyer Ian Outerbridge once said in an interview.
There is ample evidence to support that assessment. Thirty years ago, Ottawa lured Krever from his teaching job in the University of Toronto's law faculty to be co-chairman of a panel asked to recommend better ways to educate and regulate dozens of health-care occupations. That job took four years. Only a few months after it ended, when he had begun teaching law at the University of Western Ontario, the Ontario government put Krever in charge of a committee to design a tougher law against bootlegging human donor organs.
But prior to the blood inquiry, Krever's biggest challenge was probably his investigation in the late 1970s into the improper disclosure of patients' health records in Ontario. His sharply worded report was especially critical of the roles played by the police and hospital employees. The Ontario government put some of his recommendations into law, but disagreed with Krever that patients ought to have easier access to their own medical files.
Last week, Krever refused requests for interviews. "He says he doesn't want to be the story," commented a friend. "He wants the report to be the story and he has nothing to add to it." But, said another, "you can be sure that he's glad to see the end of this." He will probably savor that feeling - at least until Ottawa, or someone else, tries to recruit him to right yet another wrong.
Maclean's December 8, 1997