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How did this happen? Who is responsible? Can it happen again?

Marek Ciezkiewicz

This was the first article of the two-part series “Bad Blood: A life sentence,” originally published on Nov. 18, 1992. Part two is available here.

The front page of The Globe and Mail on Nov. 18, 1992.

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Francois, Roger and Gerald Blanchard all died of AIDS within six months of each other. Now their brother Claude is dying too, and so is his wife Raymonde.

The four brothers, from Allardville, N.B., were all hemophiliac. They, like almost 700 others with the clotting disorder, contracted the AIDS virus from blood products approved by the Canadian government and distributed by the Canadian Red Cross.

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Their story and that of their fellow hemophiliacs has been one of silent suffering, a story lost in the larger tragedy of AIDS and the public’s ignorance about hemophilia.

Francois, 35, Roger, 37, and Gerald, 43, were too busy trying to live out their lives in dignity to make much of a fuss. Physical suffering, economic hardship and social stigma limited their battle to daily survival, with no time to search for explanations.

Yet people like Claude and Raymonde are beginning to ask the tough questions about Canada’s tainted-blood scandal: How did this happen? Who is responsible? Can it happen again?

Contaminated blood products already have left 43 per cent of the country’s hemophiliacs with the human immunodeficiency virus, which causes AIDS. Half of those have developed AIDS symptoms, and that proportion is expected to reach 90 per cent in the next couple of years “Canadians shouldn’t accept that this was just some accident. Me and my wife and my brothers were poisoned, and the guilty parties should be brought to justice,” Claude Blanchard said in an interview. He and his wife are 34.

In France, the former head of the national blood bank and two other senior civil servants have been convicted of criminal negligence for allowing AIDS-tainted blood to be distributed to hemophiliacs. A special court will convene to hear charges against a former prime minister, a health minister and a social affairs minister.

In Canada, where the basic facts of the tainted-blood scandal are hauntingly similar to those in France, no one has been called on the carpet. Federal Health Minister Benoit Bouchard has said a public inquiry is out of the question.

George Weber, head of the Canadian Red Cross Society, has said that the role of governments in the affair merits closer scrutiny by an independent body, but that the complex issue of legal responsibility should be left to the courts to decide.

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Hemophiliacs with the virus have launched at least 80 lawsuits against the Red Cross, federal and provincial governments and private laboratories in Canada and the United States, seeking damages of almost $350-million.

The consensus seems to be that Canada’s public-health system failed to react quickly enough to a potential problem, the magnitude of which few could imagine. But the fact remains that the tangled web of bureaucracy is now costing a lot of people their lives.

The distribution of contaminated blood to hemophiliacs was a “horrendous medical catastrophe, a colossal failure of the country’s blood system,” the Canadian Hemophilia Society said in a confidential 1988 brief to the federal government. In retrospect, it seems the system failed in at least seven important ways: Canada was not and is not self-sufficient in plasma collection or the manufacture of blood products, importing large amounts of U.S. products that turned out to be contaminated. A desire to promote regional economic development meant blood was sent to a Canadian treatment plant, despite the fact that the plant was inefficient; as a result, plasma had to be imported from the United States, which was more expensive and far more contaminated. Lack of a national blood policy, of centralized decision making and of political leadership prevented health authorities from acting swiftly when the danger of contamination became known. Implementation of measures to ensure that blood products were treated to kill the virus was delayed by months. Withdrawal procedures were so shoddy that tainted blood products were distributed as late as November, 1987, almost six years after the first hemophiliac died of AIDS. Hemophiliacs, the people most likely to be affected by contaminated blood products, were not warned early enough of the risk of using them. Although the federal government has provided $120,000 each to AIDS-infected hemophiliacs, provinces have refused to provide survivor benefits to affected families – an economic blow to families of hemophiliacs because many hemophiliacs are uninsurable.

Hemophilia is a hereditary disorder that interferes with blood clotting in about one male in 5,000. Internal bleeding can occur without warning. Women can transmit the deficiency to their sons, but almost never show symptoms.

The two most common forms of hemophilia are Factor 8 deficiency and Factor 9 deficiency, also known as Christmas disease. Patients, both male and female, with another clotting disorder called von Willebrand’s disease undergo treatment with the same blood factors and run much the same risks.

Until the early seventies, the accepted treatment for hemophiliacs was regular blood transfusions to replace the clotting factor they lacked. The development of blood-factor concentrates allowed patients to receive treatment quickly at home by simple injection and to lead more normal lives.

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In 1972, the average age of hemophiliacs was 11, a figure that doubled within a decade. Concentrates, however, had some drawbacks. Cryoprecipitates (produced by freezing blood, then thawing it) contained impurities, were difficult to reconstitute and had to be administered in hospitals.

That problem was eliminated by the development of easy-to-use lyophilized (freeze-dried) blood products. Yet because these were made in batches that mixed plasma from as many as 25,000 different donations, one unit of contaminated blood could contaminate large amounts of clotting factor. Soon, virtually every hemophiliac was infected with hepatitis B, a disease that would claim many lives and would alert medical experts to the danger of blood-borne viruses.

We can’t hide the fact that we almost all went along with the experts who downplayed the urgency. There were a small number of alarmists – as they were described at the time – who turned out to be right.

— David Page, vice-president of the Canadian Hemophilia Society

In January, 1982, a 69-year-old Florida hemophiliac died of what was then being called “gay pneumonia,” the same disease that had killed his 70- year-old wife a few months earlier and that soon would become known as one of the principal signs of acquired immune deficiency syndrome.

The man’s doctor, Bruce Evatt, immediately recognized the implications: Not only was this deadly new illness caused by a blood-borne virus, it could prove as devastating to every hemophiliac as to his own patient.

The U.S. Centers for Disease Control investigated and found that by July three more hemophiliacs had died of AIDS.

On Aug. 6, 1982, the Bureau of Biologics of Health and Welfare Canada warned the Canadian Red Cross of the “theoretical risk that an unknown transmissible agent present in (blood products) may be responsible for AIDS” and asked the agency to alert all physicians in blood-transfusion centres “to increase surveillance of hemophilia patients for AIDS and co-ordinate laboratory studies if cases are reported.”

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At the time, only eight Canadians had developed AIDS, and six of those were dead. The tracking began, but measures to test blood products and heat blood had not been developed and would not be implemented until 1985. Nor would hemophiliacs be advised against the use of the freeze-dried clotting concentrates.

On March 31, 1983, a 28-year-old hemophiliac from New Westminster, B.C., died of AIDS. The coroner’s inquest into the death of Artibano Milito was told that one month before he died he was refused surgery because the concentrate required to keep him alive was too risky to use.

“Surgery on [Mr. Milito] would require large doses of Factor 8, and the Red Cross is not releasing quantities unless it’s an emergency because of the dangers of transmitting AIDS,” wrote Dr. Michael Noble, a blood specialist at Royal Columbian Hospital.

Nevertheless, many hemophiliacs across the country were using the same Factor 8 concentrate regularly. They injected between one and five vials per treatment, either weekly or monthly depending on the severity of their condition, and any one injection could cause infection.

On Nov. 16, 1984, the Bureau of Biologics ordered that all blood products used in Canada be heat-treated. Tests in the United States had showed that the AIDS virus could be killed at high temperatures.

The implementation of such a policy, however, was left to the Canadian Blood Committee, a group made up of one civil servant from each of the provinces and one from the federal government.

At a meeting Dec. 10, 1984, the committee, in consultation with interest groups such as doctors, users and manufacturers, decided distribution of heat-treated clotting products would begin in May, 1985, and would be complete by July 1.

In France, it was decided to require heat treatment of blood as of on May 1, 1985, but that decision was not fully implemented until five months later to allow for inventory to be used up. That decision was the heart of the prosecution’s proof of criminal negligence.

In Canada, the Red Cross considered existing stocks of blood products “therapeutically effective” – that is, they still worked against bleeding – and although their withdrawal was ordered, the procedure was not always effective. In effect, the Red Cross was asked warn hospitals to advise doctors to inform their patients about the dangers of using untreated products. Such products continued to be used during and after the implementation of the heat-treating directive.

In its brief, the Canadian Hemophilia Society calls the nearly eight-month delay between the order for heat treatment in November and the July deadline for full implementation the “most egregious example of bureaucratic abdication of responsibility.”

Yet the approach had the tacit approval of every government and medical group in the country, including the Canadian Medical Association, the Red Cross and the hemophilia society.

“I was at that meeting. and I can tell you there was a certain level of concern,” said Dr. Georges-Etienne Rivard, director of the hemophilia clinic at Montreal’s Ste-Justine Hospital. “But there wasn’t a sense of urgency.”

During the last two months of the phase-in, the hemophilia society was even called upon to decide which hemophiliacs would be given priority for heat-treated blood. (The safer products were assigned to children.) “We can’t hide the fact that we almost all went along with the experts who downplayed the urgency,” David Page, vice-president of the CHS, said in an interview. “There were a small number of alarmists – as they were described at the time – who turned out to be right.”

One of those so-called alarmists, who spoke to The Globe and Mail on condition that he not be identified, said: "The question today is the same as it was then: Did we do enough, and did we do what we did quickly enough?

“The answer is no. Hemophiliacs are now dying of AIDS because measures were not taken to adequately protect the blood supply.”

Dr. Francine Decary, medical director of the Montreal Transfusion Centre, said it is unfair to make those judgments in hindsight. “Nobody had a crystal ball. Sound decisions were made based on all available information at the time,” she said.

A second crucial protective measure that was slow in coming was screening blood for the AIDS virus. Testing measures were not implemented until November of 1985, eight months after the Centers for Disease Control recommended it in the United States, and a full year after New Zealand made screening mandatory. Many medical experts were not convinced of the need for such testing, and the provincial officials were concerned about the cost – about $5.2-million in the first year.

In France, by comparison, the national blood agency, with the approval of the cabinet, delayed testing blood for the virus for five months to allow a French laboratory time to develop a test, a move that would eventually earn the company tens of millions of dollars.

It will probably never be known exactly how many Canadian hemophiliacs were infected in the time between the orders for heat treatment and testing and the implementation of those policies – perhaps scores. Most of those infected undoubtedly contracted the virus earlier.

One study suggests that about 50 per cent of hemophiliacs with HIV were infected by 1983, cases that, in retrospect, were probably unavoidable. The federal government has compensated more than 900 hemophiliacs infected by tainted blood products.

Regardless of the final numbers, there are pointed questions being asked about why there should be such a high level of infection at a time when there was very little AIDS in Canada. The answers are found in the Pandora’s box that is another chapter in Canada’s blood scandal.

“The single most important bad decision among many bad decisions is ancient history,” said Mr. Page. “It was the day in 1979 when a decision was made to fractionate blood in Canada. That resulted in Canadian plasma being sent to Connaught during a very crucial period.”

Presumably to help Canada on the road to self-sufficiency in blood products, provincial health ministers (who ultimately pay the bills) ordered the Red Cross to tear up a contract with Cutter Laboratories in California to transform most of Canada’s plasma into the blood products needed by hemophiliacs. The output would have supplied about half Canada’s needs.

Instead, the Red Cross had to sign a contract with Connaught Laboratories Ltd. of Willowdale, Ont., to produce half the Factor 8 and Factor 9 that Canada would need from 1981 through 1984. The Red Cross and the hemophilia society objected vigorously, contending that the suburban Toronto laboratory would produce a second-rate and expensive drug because its technology was outdated.

The rest of production was to have been divided evenly between the Rh Institute in Winnipeg and the Armand Frappier Institute in Laval, Que., neither of which had ever produced the blood products in commercial quantities.

The original processing contract would have paid Cutter $9.1-million a year; Connaught alone received $13.5-million. Although the main role of the Canadian Blood Committee was to keep costs in check, there were economic and political reasons to opt for the more-expensive, less- efficient producer.

At the time, Connaught was owned by a federal Crown corporation. Dennis Timbrell, then Ontario’s health minister, made it clear that the Ontario government wanted plasma collected in the province processed there.

The Red Cross, whose proposal to build a state-of-the-art fractionation plant was turned down by the health ministers, was left particularly angry about the political manoeuvring, a bitterness that exists to this day.

Earlier this week, George Weber, the agency’s secretary-general, said that if Canada had built a fractionation plant and collected its own plasma most of the AIDS infections of hemophiliacs would have been avoided.

The three-year term of the Connaught contract was a troubled time, marked by low yields, poor quality and shortages that caused Factor 8 concentrates to be imported from U.S. processors. (Demand for Factor 9 is far lower, and quotas were easily filled.) By one estimate cited by the hemophilia society, the laboratory wasted plasma equivalent to more than 200,000 blood donations, worth more than $2-million. To make up the shortage, Connaught proposed paying donors for plasma, a suggestion the Red Cross said threatened to destroy the entire Canadian system of volunteerism.

Instead, the company imported large quantities of plasma from the United States.

Connaught officials refused to comment on the allegation that the company produced concentrates contaminated with the AIDS virus.

Don McKibbin, director of corporate communications, provided a brief written statement which read, in part: “All plasma products processed by the company fully conformed to the licencing standards set by regulatory authorities at that time. While Connaught has great sympathy for anyone suffering from AIDS, the company is unable to comment further at this time as the issue is now before the courts.”

Unquestionably, at the beginning of the AIDS epidemic in the early 80s, the U.S. blood supply was far more contaminated with HIV than was the Canadian supply. There were proportionally more people in high-risk categories such as intravenous drug users and homosexual men with multiple partners. Further, the common U.S. practice of paying for blood and plasma tended to attract the very donors who were most likely to be infected, IV drug users and male prostitutes among them.

There are other indications that AIDS infections were the result of U.S. imports. Countries with limited domestic capacity to produce blood concentrates during the same period have infections rates proportional to their imports. In Spain, where about 90 per cent of concentrates were purchased from the United States, 82 per cent of hemophiliacs are infected with the AIDS virus. In Belgium, which used only its own blood, the infection rate is under 4 per cent.

Canada produced all its own Factor 9 concentrate from Canadian blood, and fewer than 10 per cent of hemophiliacs with Factor 9 deficiency have tested positive for the AIDS virus. Users of Factor 8 concentrates during the same period – made in part from U.S. blood – have an infection rate of 43 per cent.

Another key statistical anomaly that points to the U.S. blood supply as the culprit is the province of Nova Scotia, where fewer than 10 per cent of hemophiliacs treated with blood products during the crucial 1979-85 period have tested positive. The rate is 50 per cent in neighbouring New Brunswick.

Apparently, a local policy of the province’s hemophilia treatment centre was that only products from Canadian-source plasma be used. A number of hemophiliacs in the province may have also used cryoprecipitates rather than freeze-dried concentrates, in which case the Factor 8 would have been drawn from a much smaller sample of donors.

“We’re trying to get a handle on that issue, to explain exactly how many hemophiliacs in Nova Scotia avoided getting AIDS,” said Daniel Doran, president of the provincial chapter of the Canadian Hemophilia Society. “This is the kind of question that can probably only be answered with a wide-ranging public inquiry, where all the facts are on the table.”

Other hemophiliacs are more militant, demanding a full-scale criminal investigation into the actions of medical officials and political figures, saying foot dragging and buck passing continued long after the full scope of the AIDS epidemic was clear.

In October 1986, the Red Cross said all Factor 8 concentrates in the country were safe because they had been heat-treated and tested for HIV. In its report, the hemophilia society says unscreened products were still in circulation in February, 1987, and concentrates made of mixtures of screened and unscreened blood were delivered to Ontario centres in late 1987.

Also in 1987, despite the double safety net of heat treatment and HIV testing, the Bureau of Biologics approved a shipment of blood products that turned out to be lethal. Britain and the Netherlands had banned imports from a U.S. company, Armour Pharmaceuticals, because of questions about the effectiveness of its heat treatment, but Canada had not. The result was that seven people in Western Canada were infected with the virus. Even today, Dr. Decary said, there is one chance in 225,000 that a unit of HIV-contaminated blood could get through the Canadian system.

The Red Cross says that, since 1987, more than 300 million units of blood products and blood have been distributed without a single case of infection.

Today, more than 70 per cent of Canada’s 2,300 hemophiliacs are leading healthy, normal lives. They are acutely aware, however, that there are always dangers in using blood products, that any blood-borne virus – such as hepatitis A or non-HIV AIDS – could strike them suddenly and dramatically.

There may be a solution on the horizon, in the form of recombinant DNA that would allow the production of Factor 8 concentrates without using blood. The fear of hemophiliacs is that economic considerations will delay the widespread use of such new technology.

For Claude and Raymonde Blanchard, it is too late for a miracle. Three of Mr. Blanchard’s brothers are dead; he and his wife are ill, and the stress has split apart their close-knit family – a situation he knows has repeated itself many times over across the country.

“I don’t think anyone can imagine the sadness and suffering this family has experienced, that all hemophiliacs have experienced, and all because we trusted the system,” he said.

“Me and my wife are going to die, and our 14-year-old boy is going to be left an orphan. We don’t want to leave him with just heartache; we want him to know that in Canada there is still justice, still people who care.”

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