Saturday, September 4, 1993
BY ANDRE PICARD
The Globe and Mail
Rockland, Ont. -- BILLIE Jo Decarie, the youngest victim of Canada's tainted-blood scandal, sits quietly, red crayon in hand, scribbling furiously on a blank white page.
The tale of the four-year-old girl born with the AIDS virus is as striking as the blood red on pure white and her plight is as unfathomable as the dreams hidden in the blur of lines.
Billie Jo's mother, Johanne Decarie, 34, was infected with the human immunodeficiency virus during a blood transfusion in August of 1985. Later, unaware of her condition, she infected her husband, William, 40. And, despite using condoms, the Rockland couple conceived a child who inherited the cruel legacy of a blood system that failed.
"We trusted the system and we were betrayed," Mr. Decarie says, clutching his wife's hand for support. "We live our lives in constant fear; the cliff is right there, but we don't know when we're going to plunge over."
The story of Bill, Johanne and Billie Jo Decarie is one of the most poignant to emerge from Canada's tainted-blood scandal. Yet they are but three faces among 1,000 in a tragedy that is killing three people a week. Like the country's 300,000 transfusion patients and 1.3 million blood donors a year, the victims had long taken the safety of the blood system for granted.
There is no question that Canada's blood is among the safest in the world.
But the sad truth is that no fundamental structural changes have been made to the system since the safety net broke in the mid-1980s.
During that period, more than 1,000 people, mostly hemophiliacs, were infected with HIV because of delays in the availability of heat-treated blood concentrates and in the testing of blood donations for AIDS. The delays were attributed to the bureaucratic structure of the blood system and the financial concerns of the funding provinces.
When Mrs. Decarie received contaminated red cells during surgery in August, 1985, all blood in the United States was already being tested and a test kit had been approved in Canada several months earlier, but was not in use yet. She was also not told that she was probably infected until eight months after the transfusion, after the donor had died of AIDS, and by that time her husband was also infected.
Today, the system that failed to deal swiftly with the threat of acquired immune deficiency syndrome remains vulnerable to a new infectious agent. It is leaderless, its regulation timid, its decision-making process ponderous, and the accountability of its main players unclear.
Public faith has been shaken.
The first step in restoring that faith will be taken this month when health ministers from the provinces and territories meet to establish the terms of reference for a public inquiry into the Canadian blood system.
The inquiry will try to determine what went wrong in the past and the best way to proceed to avoid a tragedy in the future.
It will examine practical issues such as the cost and the process for collecting blood and distributing its products, political issues such the division of power between the federal and provincial governments and the philosophical underpinnings of the system such as public versus private enterprise.
Blood products and services accounts for only one-third of 1 per cent of the $66-billion a year Canada spends on health care, but blood is the symbolic cornerstone of the medicare system.
The woes of the blood program are also indicative of a larger ill - a overburdened health-care system - and the reforms that emerge are bound to have a ripple effect through the medical establishment.
So, while the heart-rending stories of HIV-infected hemophiliacs and transfusion patients have dominated the news media and the courts, the main players in the blood system have turned their energies to revamping the program. They have been huddled away in the back rooms scribbling, like Billie Joe, their visions of the future.
All the main players - health ministers, the Canadian Red Cross Society, the Canadian Blood Agency, the Canadian Hematology Society, the Canadian Hemophilia Society and the HIV-Transfused Support Network - agree on some fundamentals: the blood system needs an emergency-response procedure, decision-making needs to be more swift, the roles of the main players must be defined, there must be accountability for decisions and communication has to be improved.
But there is little agreement on how these goals can best be achieved and much lingering acrimony that makes the process more difficult.
Jerald Freise, head of the HIV-Transfused Support Network, says all the talk of reform is moot until the actions of those who made and did not make decisions that led to the infection of 1,000 people are examined and they are held accountable.
"What possible right do these people have to continue to administer the blood system, to suggest that it be 'reformed?' They have proven themselves to be unworthy of our trust," he says.
But once one wades into the reform debate, three fundamental political, legal and social-policy questions spring up:
What are the limits of government control and funding of the blood system?
Who owns the blood that Canadians donate?
What role should blood recipients play in a system that demands increasingly
difficult treatment choices?
The Canadian Red Cross Society, which collects, manufactures and distributes
all of the country's blood and blood products, has been the most aggressive
in its proposals for reform.
In a letter sent to deputy health ministers, a copy of which was provided exclusively to The Globe and Mail, Red Cross secretary-general Douglas Lindores calls for a radical shift in approach to bring the blood system into the 21st century.
Until the 1970s, the Red Cross was little more than an unregulated bottler of whole blood, while today it is a sophisticated and regulated manufacturer of more than 20 biological products derived from blood.
Yet the method of providing services and paying for them has not changed dramatically: in substance, the Red Cross provides all products requested by hospitals free and the provinces pick up the tab.
Mr. Lindores says what the Red Cross wants, in effect, is to stop being treated like an arm of provincial health-care systems, such as hospitals, and to start being treated as a manufacturer of biological products (albeit a non-profit one), selling a service to government.
Instead of provinces paying a lump sum for blood at the beginning of each year, hospitals should be billed directly for the cost of the products they use, he says.
Mr. Lindores argues that by ending the practice of providing unlimited free blood products, the system would be streamlined and modernized overnight. The shift also would place legal and financial responsibility squarely on the shoulders of the Red Cross, eliminating provincial government involvement with the exception of negotiating contracts and facilitating the regulatory role of the federal government, he says.
"This is not a power grab, it's an accountability grab," Mr. Lindores says.
"It's a model that depends on market forces and that will provide reasonably priced products without ever compromising safety."
(Blood was classified as a drug in 1989 under the federal Food and Drugs Act, forcing the Red Cross to be licenced as a manufacturer. Regulations on collection, testing and storage of blood were enacted last year.) Implicit in the Red Cross proposal is the virtual elimination of the Canadian Blood Agency, which was established by the provinces and the territories in 1991 to "direct, co-ordinate and finance" the blood system.
The problem with the agency is that it has no legal authority to run the system on a daily basis. It cannot, for example, tell the Red Cross to close a blood-transfusion centre, but it can cut the charitable agency's funding in the way a health ministry can cut a hospital's budget.
(The cost of Canada's blood system does not reflect its importance; the budget of about $220-million is equivalent to that of the Vancouver General Hospital.)
William Dobson, executive director of the Canadian Blood Agency, agrees with Mr. Lindores that the blood system's future revolves around the fundamental question of government control, on whether the Red Cross is treated as a de facto private enterprise or as a public-sector partner.
But his view, bluntly stated, is that he who pays the piper calls the tune.
"My perspective, and I think that of most Canadians who give the issue some serious thought, is that the Red Cross is a charitable organization providing a valuable public service," he says. "But the bottom line is that the person who pays for a system must have the ultimate say in how it is run."
At a time when governments are obsessed with cutting costs, health ministers are acutely aware that more than $1-billion has been spent on blood over the past five years and that the system's failings have caused them a lot of grief and unforeseen costs.
Mr. Dobson says cost controls, efficiency, accountability and leadership improvements can all be achieved, while allowing governments to exercise ultimate control, by creating a legal structure either through a contract between the Canadian Blood Agency and the Red Cross or though legislation.
"Right now, you can't say who's in charge," he says candidly. "But at the end of this exercise somebody has to be wearing the captain's hat."
Russell King, New Brunswick's Health Minister, agrees that there has to be a "nice tight and quick means of making decisions" and national standards for blood services and products, but beyond that he is willing to entertain all proposals.
"It doesn't matter who provides the service, as long as it is done as efficiently as possible," he says. "But the thing that has to be avoided is a major turf battle."
Both the Red Cross and Canadian Blood Agency have been jockeying for position and control since it became clear in May that a sweeping inquiry would be held. Relations between the two have been strained largely because their powers and responsibilities are not well-defined.
Incredible as it may seem, the current blood system operates as informally as when the Canadian Red Cross Society got into the blood business 45 years ago, collecting plasma from volunteers and sending it to soldiers abroad during the Second World War.
The Canadian Blood Agency and the Red Cross have no contract for the $160-million in blood services the charitable organization provided last year. Similarly, no contracts exist between the Red Cross and the 900 hospitals and 30 hemophilia treatment centres that were supplied with $57- million in blood fractionation products. In addition, no legislation defines and sets legal limits on the roles and responsibilities of the main players in the blood system, as the Hospitals Act does for health- care facilities.
The legal vacuum allows for some bizarre occurrences.
For example, the Red Cross announced plans this year to build a $400- million plant to fractionate blood into its components in conjunction with Miles Inc., the world's leading fraction manufacturer. The Canadian Blood Agency's board, after an independent review, rejected the proposal, but the Red Cross is proceeding with the plan, saying that because the venture is being financed privately, the provinces have no say.
"We are fundamentally convinced that a fractionation plan is a good thing for Canadians," Mr. Lindores says. "It would be irresponsible for us to not proceed."
But what one group defines as a responsible and humanitarian gesture, another views as arrogant and self-serving.
"We don't have any firm ideas on what the role of the Red Cross should be, but what is obvious is that a strong monitoring system is required to keep them in check," says David Page, president of the Canadian Hemophilia Society.
"Look at them, going around willy-nilly, twisting arms to get a fractionation plant in defiance of the health ministers who provide all the funding (for the blood system). We don't see that as accountability." Right now, there is little review of Red Cross policies and costs and their proposal for reform would exacerbate that problem, Mr. Page says.
The touted "free-market" protections do not apply because the Red Cross has a monopoly and no one can effectively compete against it because the society collects its plasma free.
In fact, any model in which the Red Cross would be treated as a private entrepreneur selling blood products and services rather than an arm of the public sector opens a Pandora's box, releasing the question of who owns the donated blood.
There is no doubt that the Red Cross can attract volunteer donors like no one else; it is synonymous with blood. (Canada is exceptional in that regard, one of a handful of countries where the Red Cross dominates the domestic blood system.)
But will the more than a million Canadians who perform the selfless act of charity of donating blood want to engage in a crass debate about ownership and corporate rights to the gift of life?
And will the tens of thousands of citizens who generously give money or time to the Red Cross see it in a different light when they realize that behind the sweet retirees who dole out cookies and juice at blood-donor clinics is an organization that sells about $220-million in products and services to the provinces, wheels and deals with pharmaceutical giants, employs 3,000 full-time people, sits on a $40-million stock portfolio and aspires to be a premier manufacturer of biological products?
The daily clients of the blood system argue that it has changed so radically since Canadians started giving, and the tragedy of tainted blood has so shaken the foundations, that the tough questions have become unavoidable.
The victims of tainted blood want to start the process of reform with a blank slate, but feel that the established players are reluctant to do so.
"There cannot be any sacred cows," says Mr. Page of the Canadian Hemophilia Society, adding that the health and safety of individuals are far more important than the continued existence of any organization.
Mr. Freise of the HIV-Transfused Support Network argues that Canadians must not only wade into the debate about reform, but also be guaranteed a greater say in decision-making to help avoid future disasters.
"One of the biggest deficiencies of the blood system, and the health- care system in general, is the lack of a consumer voice," he says. "One of the lessons to come out of this is that we can't blindly trust the so- called experts. If life and death decisions are going to be made, we have to have input."
Bill and Johanne Decarie agree. They say Canadians and their political leaders should be thankful that they have to tackle only the tough philosophical questions about blood, rather than the daily struggle of being a family living with HIV and AIDS.
Mrs. Decarie has already lived with the deadly virus for eight years and her husband a little less. Virtually nothing is known about AIDS in children, but babies born with HIV rarely make it to the age of seven.
"We can't get our hopes up. We can't allow ourselves to dream of our little girl going to high school, getting married, having children - all the stuff parents take for granted," Mr. Decarie says, the tears welling up in his eyes.
Mrs. Decarie says, "Other people can do something. They can make sure this doesn't happen to them and their kids."
The couple have ended their isolation, decided to tell their story publicly, in the hope that it will help prevent a repetition of the tragedy.
Billie Jo Decarie starts school this week. She is colouring to practice, so that she will fit in with the other preschoolers, though she has already packed a lifetime of learning into her four years.
For the millions of Canadians who give and get blood, the learning is just beginning. When the inquiry starts, they and the people they trust to administer the gift of life on their behalf will have to digest the difficult lessons of tainted blood, untangle the lines of authority in the blood program, then reshape one of the pillars of their cherished health- care system in a manner that will do their children proud.
THE PRICE OF BLOOD
| Province | Red Cross Operations | Fractionation Products |
|---|
The provinces, through the CBA, pay 100 per cent of blood products and services an 80 per cent of donor recruitment costs. The result is that the Red Cross kicks in an additional $2.9-million. Source: Canadian Blood Agency
***************
Monday, September 6, 1993
BY ANDRE PICARD
The Globe and Mail
Provincial and territorial health ministers will soon announce the terms of reference for a public inquiry into Canada's blood system. In a four- part series, The Globe and Mail examines fallout from the tainted-blood tragedy.
Moncton, N.B.
HOW do you tell your children that they're going to die?
That question came rushing at Normand and Anne-Marie Landry in January of 1987, when they first heard that half of Canada's hemophiliacs were infected with the AIDS virus.
After receiving confirmation that their twins, Serge and Stephane, were carrying the human immunodeficiency virus, the Landrys needed a year to summon the courage to sit the hemophiliac boys down at the kitchen table and tell them that the blood concentrates that had helped them lead normal lives had infected them with a deadly disease.
Today, Serge is dead. Stephane, 17, fights a losing battle against the virus. He is a shadow of his former self, in many ways a living symbol of a community ripped apart, of innocence lost.
As the parents sit down at that same kitchen table to talk to a reporter, it is obvious that their initial disbelief and fear have turned to anger and activism. They have immersed themselves in the fight to reform Canada's blood system, convinced that the best medicine is knowledge about health care and the best way of getting justice for their boys is refusing to be silenced by the pain.
Eight years after the blood system was declared, once again, to be as safe as scientifically possible, Mr. Landry believes that it is still an accident waiting to happen. "Nothing has changed. If there is another disease like AIDS, more people will die. How many bodies is it going to take to get them off their behinds?"
Despite the infection of more than 1,000 hemophiliacs and transfusion patients with HIV in the early 1980s and almost unanimous agreement that Canada's blood system is not efficiently meeting the needs of Canadians, structural changes have been minimal.
And despite proposals for radical reform, users of the blood system say there are daily problems with its functioning that underline the need for swift action.
Its problems with acquired immune deficiency syndrome problem have pretty well been whipped. No one has been reported infected from blood concentrates since 1987.
But a few Canadians a year still contract HIV from transfusions because an infected donor can slip through the testing process during the so- called window period, which lasts about six weeks from the time of infection until tests will reveal the presence of the virus.
Researchers have pegged that risk at about one in 250,000 in Canada, in contrast to one in 60,000 in the United States. In practical terms, that means that a patient who gets 50 units of blood during heart surgery in a Canadian hospital has about one chance in 5,000 of contracting HIV. AIDS is not the last disease to infect the blood system. Thousands of Canadians have contracted hepatitis C, a potentially debilitating liver disease, from the blood supply. Critics cite that as an example of continuing problems, but regulators point to the system's response to the hepatitis threat as proof that lessons have been learned from the experience with AIDS: Canada was one of the first countries in the world to screen blood for hepatitis C shortly after a test was developed in 1990.
"The Canadian blood supply is as safe now as it can reasonably be expected to be and as safe as any blood supply in the world," says Peter Pinkerton, an officer with the Canadian Hematology Society. "Absolute safety in the blood supply is an unobtainable objective."
The most glaring failure in Canada's blood system is a lack of preparedness for an emergency.
The early-warning system is informal and so is the response mechanism. When hepatitis A infected the blood supply in four European countries this year, the bureau of biologics of the federal Health and Welfare Department convened a meeting with the main players in the blood system, just as it had done in the early stages of the AIDS epidemic. Organizations at the meeting - the bureau of biologics, Canada Red Cross Society, Canadian Blood Agency and Canadian Hemophilia Society - agreed to monitor the situation, each in its own way. Soon afterward, the source of the European contamination was identified, so the issue did not come up again.
"Hepatitis A never came here, so we just forgot about it," says William Dobson, executive director of the Canadian Blood Agency, which was created in 1991 by the provinces and territories to co-ordinate and finance a national blood program. "As a response, that's not good enough." On Friday, more than a decade after Serge and Stephane Landry were infected with HIV, the main players in Canada's blood system met to take the first steps to draft a formal emergency response plan, but the steps were tentative.
In fact, even though the collection of blood and fractionation of it into components have become endeavours as complex as production of pharmaceuticals, formality and regulation are relatively new in the process.
Some blood concentrates have been regulated since their introduction into Canada in 1968. But before 1989, blood collection and much component manufacturing was unregulated. Four years ago, blood was classified as a drug under the Food and Drugs Act, but that made no practical difference until last year, when regulations were published.
"I wouldn't say there were no rules before; it's just that the procedures were not regulated by the federal government," says Wark Boucher, chief of the blood products division of the bureau of biologics.
Today, the Red Cross is licenced as a manufacturer of biological products, and its 17 blood-collection centres and the U.S. fractionation plants to which it ships plasma are inspected annually. (Health and Welfare Canada refuses to make the inspection reports public.)
Given that the law was written to conform with standard operating procedures in place at the Red Cross, it is likely that the inspections were passed with flying colours.
On the other hand, David Kessler, commissioner of the U.S. Food and Drug Administration, warned last month that it may soon begin inspections in Canada.
Red Cross officials acknowledge that Canadian procedures do not meet standards set out in U.S. blood regulations, and they are scrambling to do so. "I guess it's a possibility that they could stop our plasma from going to the U.S. for fractionation, but hopefully it's a remote one," says Stephen Vick, assistant national director of manufacturing and development at the Red Cross.
He stresses that Canada's failings are not safety-related but technical. For example, FDA regulations require everyone to have their blood pressure taken before donating, impose stricter storage requirements and treat information about donors as a byproduct of biologics, meaning that there are strict rules about records and computerization.
The FDA demands the latest manufacturing processes and has proved to be a strong-armed regulator that brooks no delay. The agency recently got an injunction against the American Red Cross for violations of regulations and closed a transfusion centre in Portland, Ore.
Canada's bureau of biologics has never ordered a product recalled. Even after it knew that blood products such as Factor VIII, a clotting agent, were contaminated in 1985 and ordered a switch to heat-treated products, the bureau allowed the Red Cross and the provinces to phase in safer products over eight months. The United States moved to mandatory heat treatment of blood in a month.
Mr. Boucher of the bureau of biologics remains one of the few main players in the blood system unconvinced that it has to be reformed. "The system today would react quickly to a problem like an infectious agent. You have to be cautious, to not just change for the sake of change."
One of the main reasons that infection rates in Canada's blood supply are comparatively low is the country's volunteer donor program. Countries such as the United States and Germany, where commercial blood banks operate, tend to attract donors with a higher risk of having AIDS.
While Canada collects enough red cells for the needs of hospitals, it is still not self-sufficient in collecting plasma or breaking it down into its components - and that can have a dramatic effect in a time of crisis.
There is scientific and anecdotal evidence that blood concentrates made with U.S. plasma were responsible for higher contamination rates during the tainted-blood tragedy and users fear a new infectious agent would bring the same results.
Before heat treatment became mandatory in November of 1985, up to half the Factor VIII concentrates were made with U.S. plasma, but concentrates of Factor IX, another clotting agent, were made exclusively with Canadian plasma. About 90 per cent of hemophiliacs severely deficient of Factor VIII contracted HIV, but only 10 per cent of those with a severe Factor IX deficiency were infected with the deadly disease.
In Nova Scotia, where Health Department officials insisted on products made exclusively with Canadian plasma, the overall infection rate of hemophiliacs is less than 10 per cent. In neighbouring New Brunswick, which had no such restriction, the rate is more than 50 per cent.
"The Canadian blood system has paid lip service to the principle of plasma self-sufficiency for 15 years," says David Page, president of the Canadian Hemophilia Society. "Getting more volunteer donor plasma into the system is where our energies and money should go."
The easiest way is to expand the Red Cross plasmapheresis program - a method of donating plasma instead of whole blood. The Red Cross is proposing to build a network of plasma-collection centres, but such plans have had trouble getting government funds in the past.
Plasmapheresis is also being overshadowed by the Red Cross plan to build a $400-million plant for fractionation, the process by which plasma is broken down into components such as Factor VIII and albumin.
Red Cross officials feel that a domestic fractionation plant is essential to guarantee the stability of supply and prices, but users of blood products, such as the Hemophilia Society, argue that such guarantees can be achieved through contract negotiations with existing fractionators and that building a plant will tie Canada to technology soon to be outdated.
More important, however, they argue that such policies should be decided by a central agency overseeing the blood supply, not by the Red Cross on its own and in defiance of users and funders.
Mr. Dobson, who heads the Canadian Blood Agency, agrees that the governments that finance the system should ultimately make the decisions.
Spurred on by the complaints of users, he has begun to question things such as Red Cross purchasing policies for blood products and the lengthy delays in implementing computerization.
"Any comment I make is not a knock on the Red Cross," Mr. Dobson says. "But there is more than one way to do things and we want to ensure that the best decisions are made at all times."
Computerization of blood records is a major issue because, among other things, it would speed up the process of finding potentially infected blood recipients in the case of an emergency.
Jerald Freise, head of the HIV-Transfused Support Network, says the society's record of tracking down victims of tainted blood was dismal. Only 12 per cent of the group's members learned that they had received contaminated blood from follow-up procedures. Others found out when they got sick, after many had infected sexual partners and children.
The Red Cross began the computerization process in 1979. The Computerized Information System for Centre Operations, costing $16-million and counting, is not quite ready yet.
Maung Aye, national director of blood services for the Red Cross, rejects the criticisms as unfair because the undertaking was massive and unprecedented - to keep computer records from the time a donor walks in the door to when someone receives a blood product and beyond.
"It's on track and it's on schedule," he says. "It's the first time any blood system in the world has produced such an all-encompassing system."
Of all the questions about the functioning of the Canadian blood system, however, the most controversial is probably the continuing dispute about Factor VIII concentrates.
Hemophiliacs need the concentrate to control bleeding. But the life- saving product can also carry impurities and disease - the reason so many hemophiliacs have hepatitis and HIV.
Two new generations of Factor VIII, high purity (monoclonal) and genetically engineered (recombinant), have recently been approved for sale. Users want those products, and HIV-infected hemophiliacs desperately want them, because they contain no impurities.
But the decision-makers in the blood system are hesitating, just as they hesitated to introduce heat treatment for blood concentrates until they were 100 per cent convinced of the benefits.
Another key element, now and then, is money.
The Canadian Hemophilia Society, the directors of the 30 hemophilia clinics in Canada, and the Red Cross have all recommended that the high- purity products be provided. The provincially funded Canadian Blood Agency, concerned about the additional cost of up to $47-million, has decided to phase them in over time, largely because the current block- funding method does not allow for much new spending in the middle of a budget year.
Hemophiliacs say the issue is not strictly one of dollars, arguing that it is unethical to provide a patient with heat-treated products when safer ones are available.
And they do not relish having to decide who will get the better treatment. While the debate takes place in the back rooms, the safer products are simply not available to anyone. Later, lists will be drawn up of who is eligible for the higher-purity products.
The last time around, Serge and Stephane were not on the list when a limited number of heat-treated products became available for Canadian hemophiliacs. "A normal family just assumes that the government is going to provide you with the best treatment available," Anne-Marie Landry says bitterly. "Well, think again."
************
Tuesday, September 7, 1993
BY ANDRE PICARD
The Globe and Mail
Provincial and territorial health ministers will soon announce the terms of reference for a public inquiry into Canada's blood system. In a four- part series, The Globe and Mail examines fallout from the tainted-blood tragedy.
Paris THE day the verdict was delivered, a driving rain fell on the protesters, sprawled on the Paris courthouse steps like corpses. But the rain, like the tears, only partly washed away their scrawled message, "Tainted Blood: In France, you can murder with impunity."
The message would have surprised senior administrators of France's blood system. Four had just been found guilty of criminal charges for the actions and inactions that allowed thousands to become infected with the AIDS virus.
France now has recorded 1,200 hemophiliacs and 3,500 transfusion patients infected, and most of these cases are considered to have been avoidable.
Michel Garretta, former director of the National Blood Transfusion Centre, was given four years on a fraud charge, the maximum sentence for "deception over basic product quality." Dr. Jean-Pierre Allain, director of research at the centre, received four years on the same charge, but half the sentence was suspended.
Jacques Roux, former director-general of the ministry of health, received a three-year suspended sentence for "failure to assist a person in danger." Dr. Robert Netter, former director of the National Health Laboratory, got a one-year suspended sentence on the same charge.
"Another chapter has been written, but it is not yet time to close the book on this sad tale," Francis Graeve, honorary president of the Association of Hemophiliacs, said after the verdict. He, like other victims, knows that many misdeeds will go unpunished.
The principal line of defence was that the men on trial did not act alone. "Why four?" defence lawyer Francois-Xavier Charvet said repeatedly. "Why not 30? Or 300 on trial?
"These are the sacrificial lambs of tainted blood." In Canada, a small but growing number of the 1,000 victims of a tainted-blood incident point to France as an example and urge that those responsible be brought to justice.
One Crown attorney, speaking on the condition that he not be identified, says charges such as fraud or failure to assist are unlikely under Canadian law. But, he says, a recent Supreme Court of Canada judgment opens the door for prosecution of anyone who knows that blood or blood products are contaminated with the virus that causes acquired immune deficiency syndrome and does not inform recipients.
James Charles Thornton of Ottawa was convicted in 1989 of committing a common nuisance after donating blood infected with the human immunodeficiency virus. In upholding the conviction, the Supreme Court ruled in June that the Criminal Code imposes a "duty of care" on citizens, which Mr. Thornton "breached by not disclosing his blood contained HIV antibodies.
This common nuisance obviously endangered the life, safety and health of the public."
The French prosecutions not only satisfied the desire for revenge, but led to financial compensation unmatched in the world and dramatic reform to the blood system. The intense media coverage of the scandal also contributed to the defeat of the Socialist government.
Aline Boyer, a Paris lawyer who represented the interests of transfusion patients at the trials, likened the process to surgery. "There is only one way to remove a tumour. Without this process, the tumours would still be spreading, we would still have a diseased system. Now the healing can begin."
Mr. Graeve said that he was initially skeptical of the criminal charges, but now he is a believer. "The prospect of jail tends to cure bureaucratic amnesia. You may be able to rationalize the death of others, but the fear of your own career and life being ruined - it focuses the mind."
In Canada, the suggestion that anyone could have been criminally negligent in failing to prevent distribution of HIV-contaminated blood and blood products is dismissed - just as it was in France until 1991.
Making comparisons between the French and Canadian situations, particularly years after the most controversial decisions were made, is not easy.
Canadians do not like confrontation and ugly legal fights. While about 120 lawsuits are under way, many victims say they would settle for an apology and fair compensation. But in Canada as in France, the quest for truth is unrelenting.
That has led victims' groups to insist that a promised inquiry into Canada's tainted-blood tragedy be judicial in nature and sweeping in scope.
"We need to know all the facts, to clear the air," says Jerald Freise, head of the HIV-Transfused Support Network. "After that, the proper authorities can determine if crimes were committed."
In France, an internal inquiry had been plodding along since 1988, mostly in back rooms, but a magazine article set off a chain reaction that speeded up the process and ended in the conviction last month of the four senior officials.
On April 25, 1991, Anne-Marie Casteret, one of the few journalists tracking the inquiry, published excerpts from the minutes of a meeting in May of 1985 at the National Blood Transfusion Centre that turned out to be a bombshell.
The document revealed that Mr. Garretta told senior officials of the national transfusion agency, which does work equivalent to the Red Cross in Canada, that distribution of blood products not heat-treated would continue until stocks were used up or until explicitly forbidden by law.
He knew from scientists at the National Blood Transfusion Centre that six blood donations per 1,000 were infected with HIV and that almost 100 per cent of blood concentrates were contaminated. (Anti-clotting factors needed by hemophiliacs are manufactured by mixing blood components from up to 30,000 donors.) The information had not been revealed to France's health ministry or the hemophilia association.
Between the meeting in May and Oct. 1, 1985, when products not heat- treated were outlawed, the National Blood Transfusion Centre distributed at least 16 million units of clotting factors to hemophiliacs.
Officials even reissued products returned by people who feared contamination after what Mr. Garretta called the "unfortunate publicity" revealing that other countries were switching quickly to heat treatment of blood. At the same time, Dr. Allain made sure that a young hemophiliac boarding at his home used only heat-treated products.
A retrospective study by Dr. Jacques Leibowitch suggested that in Paris alone, seven people a day were infected with the AIDS virus through tainted blood during that period.
In Canada, the main players in the national blood system held a meeting on Dec. 10, 1984, at which it was decided to phase in heat-treated products between May 1 and July 1, 1985. The Department of Health and Welfare never ordered a recall of products not heat-treated.
Although inventory and purchase records from December of 1984 to July of 1985 have not been made public, it is known that about one million units of coagulation products were distributed each week - about 28 million for the seven months - and only 2.5 million were destroyed. One study suggested that four blood donations per 1,000 carried HIV at the time, meaning that almost all the blood concentrates used during the transition period would have been contaminated. The reason for the high rate of contamination is that parts of thousands of plasma donations go into the making of a single blood concentrate.
In France, the revelation that officials of the blood system knowingly risked lives to use up inventory and stay within budget was the tip of the iceberg.
The second aspect of the French scandal was the refusal of senior government officials to introduce mandatory testing for AIDS. At another meeting in May of 1985, health ministry representatives refused to approve the sale of a U.S.-manufactured AIDS test kit because it would reflect badly on a French pharmaceutical company also developing a kit. That refusal would subsequently result in the convictions of Mr. Roux and Dr. Netter on the charges of "failure to assist a person in danger."
In an act that came to be seen as symbolic of the political cynicism at the heart of the scandal, social affairs minister Georgina Dufoix donated blood and declared the system the safest in the world, thanks to the French AIDS test. More recently, in a television interview, she declared, "I feel responsible, but not guilty."
In Canada, some of the most troubling questions revolve around the introduction of testing for HIV in blood and the duty of provincial health officials to protect the public.
The U.S. test kit was approved for sale in Canada on April 1, 1985, but a testing program was not implemented fully until seven months later. The Red Cross said it needed three months to prepare laboratories and train staff, pending funding. But the Canadian Blood Committee, made up of representatives of provincial health ministries, refused to authorize the $5-million in additional expense. It took the provincial health ministers four months to agree to pay for the process that would eliminate the AIDS threat from the blood supply.
The principal difference between the Canadian and French situations, however, has been the seriousness with which the concerns of victims have been investigated.
Even before Ms. Casteret's revelation in the media, the inspector- general of the social affairs ministry had launched an investigation. He eventually worked more than three years, along with four other inspectors, to gather evidence.
Also, a senior investigator with the Gendarmerie, France's equivalent of the RCMP, spent three years uncovering facts. The information gathered by Colonel Jean-Louis Recordon served as the basis for the prosecution.
But the impetus came from victims. In France, criminal prosecutions can be initiated by individuals. The case that made headlines around the world was brought by Edmond-Luc Henry, a Parisian accountant and hemophiliac who contracted HIV and later infected his spouse.
"I don't care who or how much it hurts," he said at the outset of the trial. "I want the world to know the wrong we have suffered."
His lawyer had tried initially to have Mr. Garretta and Dr. Allain, along with three ministers and a host of other bureaucrats and administrators of the blood system, charged with manslaughter and poisoning.
Sabine Paugam charged that despite the convictions, there was a massive government cover-up to protect politicians.
Ms. Paugam said that despite his flagrant disregard for the lives of hemophiliacs, Mr. Garretta was charged with a form of consumer fraud, "as if he had sold some rotten mustard," and that others who participated in the decision making were getting off free.
The process that Mr. Henry launched hurt a lot. Blood donations plummeted, causing severe shortages.
But the criminal charges brought dramatic results. Before the scandal erupted, the French government had offered HIV-infected hemophiliacs and transfusion patients a compensation package worth the French equivalent of about $75,000. Infected spouses were offered the equivalent of about $25,000. After the charges were laid, an independent compensation tribunal was established. Its awards average the equivalent of about $450,000 a person.
In the civil part of the trial of Mr. Garretta, the former director of the National Blood Transfusion Centre was ordered to pay the equivalent of about $3-million to 70 victims who brought suit.
The European Court of Human Rights also condemned the French government for the slow claims process, ruling that because the victims had a fatal disease, they were entitled to swift compensation. It ordered payments of the equivalent of about $30,000 each to a group of victims.
A French administrative tribunal also awarded the equivalent of about $450,000 each to about 400 complainants, ruling that the state had failed in its duty to patients. France, like Canada, has a universal medicare system.
The health ministry "has committed grave errors in the exercise of its functions as the health police," the tribunal concluded. "The breadth of this health catastrophe demanded that the distribution of contaminated blood and blood products be halted without delay and in an authoritarian manner."
On appeal, the French equivalent of the Federal Court of Canada upheld the principle that bureaucrats cannot hide behind the argument that they cannot act without the approval of their political bosses. "Some errors are so grave that they become the responsibility of the state at all levels," the court said.
In Canada, it has been four years since the federal government gave transfusion and hemophiliac victims $120,000 each as compensation. All but two provinces are still discussing what kind of financial assistance programs to offer to victims.
Often overlooked in the sensational criminal proceedings in France is the dramatic reform of the blood system.
The National Blood Transfusion Centre was replaced with the Agence francaise du sang, a government agency equivalent to an amalgam of the Red Cross and the Canadian Blood Agency, a provincially created and funded group that co-ordinates a national blood program.
The French agency is responsible for blood from collection through distribution of products and follow-up testing. It employs 30 doctors, who oversee the country's 163 blood-collection centres and hospitals and clinics that collect and distribute blood. The executive director reports directly to the minister of health. The biggest change, however, is that the agency has 15 inspectors, who constantly monitor the blood supply.
Users of blood products demanded and got a change in purchasing policies, similar to what Canadian hemophiliacs are demanding. While the French agency maintains a monopoly on production and imports of blood products, like the Red Cross in Canada, hospitals can also demand products from a list approved by the health ministry - a mechanism designed to force the agency to keep up with product developments.
"Secure, secure and more secure" is how health minister Bernard Kouchner described the revamped system. "Given our history, the French people would tolerate nothing less."
Tainted Blood Around The World: How Canada Stacks Up
CANADA
800 hemophiliacs infected (43 per cent)
Testing: November, 1985
Heat treatment: July, 1985
State compensation: $120,000 from federal government; $30,000 a year for
life from Nova Scotia; $10-million fund offered by Quebec, with distribution
according to need Five-month delay in replacing non-heat-treated products;
eight-month delay in instituting testing
FRANCE
1,200 hemophiliacs infected (45 per cent)
Testing: August, 1985
Heat treatment: October, 1985
State compensation: up to two million francs ($450,000) Non-heat-treated
products ordered used up; testing delayed until French product developed.
UNITED KINGDOM
1,227 hemophiliacs infected (45 per cent)
Testing: October, 1985
Heat treatment: September, 1985, by law, but December, 1984, by private
companies State compensation: private foundation No state control, so
infection rates vary from hospital to hospital
UNITED STATES
10,000 hemophiliacs infected (75 per cent)
Testing: March, 1985, by law, but
November, 1984, by private companies Heat treatment: October, 1984;
available in late 1983
State compensation: none Blood infected early and heavily because of system
of paid donors
BELGIUM
35 hemophiliacs infected (7 per cent)
Testing: August, 1985
Heat treatment: May, 1986
State compensation: none Rigorous screening of donors; switched from blood
concentrates to cryoprecipitates
SWEDEN
100 hemophiliacs infected (16 per cent)
Testing: May, 1985
Heat treatment: January, 1986
State compensation: none, but generous support for AIDS patients Strict
screening of blood donors; early AIDS education program
SPAIN
1,200 hemophiliacs infected (47 per cent)
Testing: February, 1987
Heat treatment: September, 1985
State compensation: the federal government contributed 80 million pesetas
($800,000) to a private fund to assist victims; the Catalonia government has
set up its own fund of 40 million pesetas Virtually all blood products were
imported from the United States
SWITZERLAND
68 hemophiliacs infected (30 per cent)
Testing: May, 1986
Heat treatment: September, 1986
State compensation: the pharmaceutical company Immuno provided 40,000 Swiss
francs ($35,000) to each victim, an amount matched by the government One of
the last countries to impose regulatory measures
DENMARK
89 hemophiliacs infected (47 per cent)
Testing: January, 1986
Heat treatment: January, 1986
State compensation: 740,000 kroner ($145,000) to each victim The internal
affairs minister and two senior officials of the board of health ordered
continued distribution of HIV-tainted product after risks were known
GERMANY
1,200 hemophiliacs infected (55 per cent)
Testing: October, 1985
Heat treatment: January, 1985
State compensation: none, but pharmaceutical companies have settled lawsuits
by giving the equivalent of two years salary of the victim Dependence on
U.S. blood products
Sources: World Federation of Hemophilia, International Society of Blood
Transfusion
**************
Wednesday, September 8, 1993
BY ANDRE PICARD
The Globe and Mail
Montreal -- DESPITE the blunders, despite the tragedy, Canada's blood system still delivers the gift of life every 20 seconds.
Each year, more than 300,000 Canadians receive a blood transfusion during surgery or the treatment of trauma, burns, cancer, leukemia, anemia, measles or a blood disorder.
When a public inquiry into the blood system begins later this year, the spotlight will be on the tainted-blood crisis of the 1980s, which left more than 1,000 hemophiliacs and transfusion patients infected with the AIDS virus.
But equally challenging will be redesigning the blood system to reflect the dramatic scientific advances of the past generation and to help it adapt to medical breakthroughs and prepare for new diseases.
There is a common misconception that blood is taken from a healthy person, shipped to a hospital and transfused into a patient in need.
In reality, when a donor sits down for a pin-prick test of blood type, he or she is being primed to provide the source for up to 20 life-saving products.
The volunteer donor at the heart of Canada's blood system saves not only lives, but also tens of millions of dollars for provincial health- care plans. A unit of blood in the United States costs $50 to $80, at least half of which is payment to the donor and profit. In Canada, there is neither.
Getting blood free also makes specialized blood derivatives cheaper. For example, albumin - a protein substance in blood used to treat burns - costs $67 a unit in the United States and $41 in Canada, and Canadian hospitals used almost 300,000 units to treat burn victims last year. (The Canadian Red Cross Society, which wants to build a plant to fractionate blood into its components, says the cost would be $26 a unit if albumin were produced here.)
While advances in genetic engineering raise the possibility of the bloodless blood system in the next century, for the foreseeable future the need for blood will grow.
Luckily, there are people like Jean-Guy Duclos around. More than 87 per cent of the 5,000 people a day who go to clinics and transfusion centres are repeat donors, but the retired fireman from L'Assomption, Que., is in a class of his own: He has given almost 400 times since 1961.
At first, Mr. Duclos stayed away because he was terrified by needles. But, as a fireman, he saw the daily traffic accidents, burns and workplace injuries that make the blood supply so vital. (Demand for blood in Canada peaks every Labour Day weekend, and the clinics that will spring up everywhere this week are needed to replenish stocks.)
Mr. Duclos overcame his phobia, and now describes giving as second nature and the needle prick as less noticeable than a mosquito bite. "You always feel good when you see them take away the bag. You know that you just gave somebody hope, maybe a second chance," he says.
During the Second World War, the Canadian Red Cross Society began collecting blood from volunteers to supply the country's armed forces with plasma, the yellowy liquid part of blood. More than 2.5 million bottles were delivered to troops in Europe and North Africa.
After the war, hospitals and provincial health departments asked the Red Cross to continue the program to help veterans, along with the growing number of surgery patients and women in childbirth.
At the time, most hospitals had institutional blood banks and obliged every patient's family to donate twice as much blood as was administered to the sick person. Most hospitals would also pay $25 a pint for blood, a practice that was later outlawed.
Free blood laid the foundations for Canada's universal medicare system. Until 1972, less than 10 per cent of blood was used to manufacture specialized blood products and the rest was transfused whole. Today, more than 99 per cent goes into manufactured products.
The revolution was partly due to the advent of the sturdy plastic blood bag, which replaced the glass bottle and allowed the shipment of the huge quantities of blood components needed to make specialty products.
While the manufacturing aspect changed dramatically 20 years ago, the donor recruitment is only now beginning to reflect the new reality.
Mr. Duclos typifies the new breed of donors: While he gives whole blood every 70 days (the minimum interval), he also donates a whole range of specialty components weekly, sometimes even daily.
A process called pheresis allows the extraction of specific blood components. A specialized machine draws whole blood, extracts plasma, platelets or white cells, and returns the rest. It is not as taxing on the body, but the catch is that a person gets two needles - for outgoing and incoming blood. The bag that holds the donor's blood contains a bit of anti-coagulant to prevent it from clotting.
Each unit of whole blood - 450 millilitres - is immediately divided into plasma and red cells, while a tiny portion of the whole blood goes off to testing labs. The average person's body contains about five litres of blood. Red cells have a short shelf life so they serve as the basis for collection targets. About 1.1 million units were collected last year and just under one million used. Red cells are broken down into three components:
Concentrated red cells are used for surgery and the treatment of anemia.
They must be matched for blood type (O, A, B, AB) and Rh factor.
White cells (leukocytes) are used to prevent and fight infections, particularly in people with leukemia and cancer.
Platelets are used to treat blood disorders and to help clotting in cancer and leukemia patients.
White cells and platelets must be matched for human leukocity antigens. The chance of finding a match for a sample in the general population is only 1 in 10,000, so donors are sometimes asked to give daily in emergencies.
Plasma is easy to store (frozen, it can be kept for 10 years) and is very valuable. Because of a growing demand for blood products, Canada is perpetually short of plasma, but the Red Cross plans to expand the plasmapheresis program.
Plasma contains important proteins, minerals and enzymes and it is broken down into the following major components:
Pure plasma serves to maintain blood pressure, so it is used to treat people with serious burns or trauma.
Immunoglobulins (IGiV or antibodies) are used for the manufacture of serums to treat immune deficiencies and diseases such as measles, chicken pox and hepatitis.
Albumin serves to treat serious burn victims, to control hemorrhages and during heart-bypass surgery.
Coagulation factors are used to treat hemophiliacs, people whose blood does not clot normally. The most common forms of hemophilia are Factor VIII deficiency (1,388 patients in Canada) and Factor IX (311 patients). The Red Cross also purchases specialized products for a number of patients with rare blood disorders including Factor V (two patients), Factor VII (20 patients), Factor XI (five patients) and Factor XIII (four patients).
Blood concentrates allow hemophiliacs to lead normal lives. Until the 1970s, a minor injury would require blood transfusions in hospital, and non-treatment led to disability or death.
Since 1985, all factor concentrates have been heat-treated to kill viruses. Before that, half of Canada's hemophiliacs contracted the AIDS virus and two-thirds got hepatitis.
For while blood is a life-saver it can also transmit disease, as witnessed by the tainted-blood tragedy in the 1980s. So before any blood component is transfused or sent for fractionation into components, it also goes through a series of tests.
Testing accounts for more than 25 per cent of the cost of blood and blood products. In total, however, fewer than 9 per cent of blood donations - 155,000 of 1.1 million - are discarded in a year.
The Red Cross currently tests for the following viruses:
Human immunodeficiency virus: Testing for HIV 1 began in 1985 and for HIV 2 in 1992. The incidence of the AIDS virus in Canadian blood is 2.8 per 100,000. There are still a couple of infections with HIV by blood transfusion each year in Canada because of the six-week "window period" during which the virus does not show up in tests.
Human T-cell lymphotropic virus type 1 (HITVL1): Testing began in 1990 and the incidence is 3.8 per 100,000.
Hepatitis B, an extremely contagious liver disease: Testing began in 1970. Its recorded incidence rate is 27 per 100,000 and it poses a serious risk to health-care workers who are in contact with blood. Even the most sensitive test cannot detect all cases.
Hepatitis C: Canada became the first country in the world to routinely test for the virus in 1990. With an incidence of 82 per 100,000 and one- third of those infected developing serious liver disease, infection with hepatitis C is a growing public health-care issue.
Syphillis: Testing began for the granddaddy of blood-borne viruses in 1940.
Today, the incidence is negligible.
Cytomegalovirus (CMV): It is not routinely tested for, but blood products designated for transplant patients are screened because the common virus can be harmful to them.
Other sexually transmitted diseases, Epstein-Barre disease and malaria are not routinely tested for, but potential donors who have been exposed to them are excluded from donating blood. People are also temporarily excluded if, within specified time periods, they have had tattoos, have had ears or other body parts pierced, have been pregnant, have breast-fed or have received any kind of immunization.
As long as human blood is used, the possibility of disease transmission will exist.
To date, the only genetically engineered product on the market is recombinant Factor VIII. While the product is more expensive than Factor VIII made from human plasma, it is being hailed as a revolution on a par with the switch from the glass vacuum tube to the microchip.
But, currently, the science of blood is halfway between. The recipients of blood products can only hope that donors will continue to hear their plea for the gift of life, but that the message will come across even a little more clearly.
Last in a series
The gift of life
1 unit of blood (450ml)
Minerals - 1%
White blood cells - 2%
Protein: Immune Globulins, Albumin. - 4%
Red blood cells - 43%
Water - 50%
Traces of enzymes used in manufacture of coagulative products.
*****************
Saturday, September 4, 1993
BY ANDRE PICARD
Quebec Bureau
MONTREAL -- From the eight-year-old boy who contracted HIV because a well-meaning doctor ordered a two-teaspoon "top-up" of blood at birth, to the four hemophiliac brothers who died of AIDS, to the grandparents whose doctor did not tell them they were infected to spare them the embarrassment, the stories of the 1,000 victims of Canada's tainted-blood tragedy are legion.
What has yet to emerge, however, is a definitive explanation of why so many Canadian hemophiliacs and transfusion patients were infected through the safest blood system in the world.
Administrators of the system and victims agree that some of the infections were unavoidable because the scientific knowledge and defence mechanisms did not exist to respond adequately to the strange new disease called acquired immune deficiency syndrome.
But it is increasingly clear that bureaucratic foot-dragging, a lack of leadership and some questionable decisions (and non-decisions) may have caused more than half of the infections.
To date, two crucial series of actions have been red-flagged, one pertaining to hemophiliacs and the other to transfusion patients.
On Dec. 10, 1984, all the main players in the blood system gathered for a "consensus conference" on heat-treating blood products. At the time, scientists knew that 55 per cent of the country's hemophiliacs were infected with the human immunodeficiency virus. It was also known that heat-treating blood concentrates killed the virus.
The policy of heat treatment was adopted, but the meeting decided that the safer products could be phased in only by July, 1985, a full eight months later.
Today, victims charge that the delay allowed stocks of tainted products to be used up and that no efforts were made to buy safer products from the six companies selling them at the time - a crass economic decision.
The Canadian Red Cross Society says it takes a minimum of six months for plasma to be treated in the United States and returned as blood concentrates, and that world shortages made it impossible to purchase heat-treated products any earlier.
The government never ordered a recall of non-heat-treated products and, in the end, about 2.5 million units of concentrates, about a two-week supply, were destroyed.
For transfusion patients, an important issue is the implementation of testing for HIV in donated blood. The U.S. Food and Drug Administration approved an anxiously awaited test kit on March 2, 1985, and it was available for sale to Canada within weeks. All U.S. blood was being tested by April, but it took until November for testing to begin in Canada.
Some of the delay was unavoidable because of the implementation time for mass testing, but the reluctance of provincial representatives to fund the tests contributed at least three months to the delay.
Aside from those two key issues, the victims of the tragedy argue that many other measures could have been taken to lessen the scope of infections with the AIDS virus.
AIDS was first reported in Canada in February, 1982, and within the year it was clear that hemophiliacs and transfusion patients ran a particularly high risk. A number of lawsuits argue that legal responsibility to act, and hence negligence, on the part of the administrators of the blood system started at this point.
Some countries vigorously screened out high-risk donors with questionnaires and information pamphlets, but there was little of this effort in Canada during the early stages of the epidemic.
There were also indicators of the risk of AIDS contamination in blood, such as the presence of hepatitis B, that could have been used as a crude method of screening out potentially infected donations.
Victims also argue that the Canadian blood system was unduly bureaucratic. As a result, decision-making was painfully slow and so dangerously secretive that they can argue that they did not give informed consent for their treatment.
Hemophiliacs, for example, could have used alternative therapies or cut back the use of blood products to reduce the AIDS risk. Transfusion patients could have put off elective surgery or turned to self-donations.
Further, there are serious questions about efforts made to get in touch with people who may have been infected. People who received blood and blood products, even in the later part of 1985, the highest risk period, were never systematically contacted.
The magnitude of the tainted-blood tragedy and the continued inefficiencies of the blood system have come to the fore only in the past year, largely because of the large number of victims who are dying and the media coverage their plight has received.
There has not been a single case of HIV infection from a blood concentrate since 1987, but one or two of Canada's 300,000 transfusion patients are still infected each year because testing is not foolproof.
There are currently more than 120 lawsuits against the Red Cross, provincial governments, pharmaceutical manufacturers and hospitals.
While the federal government paid compensation of $120,000 each to the victims, only Nova Scotia and Quebec have offered some form of financial assistance. The other eight provinces are expected to table a common offer to infected hemophiliacs and transfusion patients within the next two weeks.