BAD BLOOD?

Revelations about safety are shaking public faith in Canada’s blood supply

COVER,D’ARCY JENISH September 19 1994

BAD BLOOD?

Revelations about safety are shaking public faith in Canada’s blood supply

COVER,D’ARCY JENISH September 19 1994

BAD BLOOD?

COVER

Revelations about safety are shaking public faith in Canada’s blood supply

D’ARCY JENISH

For millions of Canadians it is a familiar scene: men and women stretched out on cots or reclining chairs with a nurse at their side and a tube flowing from one arm to a plastic bag that collects their contribution to the nation’s blood supply. All across Canada every week, donors at scores of Red Cross blood clinics held in school gyms, church basements and shopping malls give “the gift of life.” At noon hour one day last week, a clinic on the shopping concourse of a downtown Toronto office tower was full of donors like 51-year-old Brent Bisson, who had passed on lunch to give blood. Bisson, a data processing manager who donates up to six times a year, said he supports the system and has complete confidence in the safety of blood products. “I wouldn’t hesitate to have a transfusion if I needed one,” Bisson said before racing back to work.

But many Canadians no longer have that kind of rock-solid confidence in the blood system. Their faith was shaken by revelations throughout the late 1980s that an estimated 1,050 Canadians, most of them hemophiliacs, had received blood products contaminated by the human immunodeficiency virus (HIV) prior to 1985. About half of those people have since died of acquired immune deficiency syndrome (AIDS), a tragedy that is being investigated by a federal-provincial judicial inquiry headed by Ontario Court of Appeal Judge Horace Krever (page 28). And last week, public confidence in the system was jolted again when the results of a U.S. Food and Drug Administration (FDA) inspection of the Red Cross Toronto blood centre in July were reported.

The American inspectors found 19 deficiencies in the collection and handling of blood products at the centre, including mislabelling of as many as 30 units of donated blood per month, inadequate screening of donors and substandard methods of tracking people who may have contributed blood containing HIV. As a result of the inspection, the FDA halted shipments of some Canadian plasma, the fluid part of blood, to a fractionation facility in Clayton, N.C., where it is broken down into about a dozen different products before being shipped back to this country. For many critical observers of Canada’s blood supply network, the FDA report confirmed their suspicions that safety remains a serious problem despite the publicity that led to the Krever inquiry. “We knew the problems of the past had not been corrected,” said Durhane Wong-Rieger, president of the Montreal-based Canadian Hemophilia Society. “The Red Cross is doing nothing to change.”

In response to the FDA report, medical professionals and officials at the Canadian Red Cross Society vigorously defended the safety of blood supplies. They also insisted that the 17 Red Cross blood centres across the country are operating in full compliance with domestic regulations established by Health and Welfare Canada. But officials with the federal Health Protection Branch undermined those assertions by saying that they had, in fact, briefly closed four centres—in Montreal, London, Ont., Regina and Saskatoon—earlier this year for failing to meet all the regulations. The Red Cross later insisted that only some operations at those centres had been suspended.

At that point, federal Health Minister Diane Marleau intervened directly. On Thursday, she sent a group of officials from the Health Protection Branch to the Toronto blood centre to discuss the implications of the FDA inspection. Marleau later said she planned to study a report on the meeting, prepared by her officials, before commenting. Nevertheless, she, too, adamantly defended the integrity of the country’s blood supply. “At no time since I’ve been the minister of health has the safety of the blood system in

Canada been in question,” Marleau insisted. “It’s very important that we reassure Canadians that when there are irregularities we address them very quickly.”

As the controversy intensified, Red Cross officials argued that the FDA inspectors had found deficiencies largely because they applied American regulations, which in many cases were inappropriate for assessing Canadian procedures (page 26). Doug Lindores, secretary general of the Red Cross national office, cited, as an example, the incidents of assigning incorrect blood types to individual donations. He said any errors would have been detected under Canadian double-testing techniques, but the American inspectors did not allow for differences in the systems used by the two countries.

The adverse publicity may already be hitting the Red Cross where it hurts most—at the blood donor clinics. Donations during the first six months of the society’s fiscal year, which began on April 1, are down from five to nine per cent in various parts of the country, due to several factors. Budget cuts have led to reductions in operating hours for many clinics. And lower demand for blood products, largely because doctors now administer fewer transfusions than they once did, has also led to a decline in contributions. But Lindores conceded that controversy is keeping potential donors away. “The publicity of this past week is potentially devastating,” he said. “We have already had very important clinics cancelled by sponsoring companies, which have said they don’t want to be associated with the Red Cross any more.”

Lindores conceded that the FDA report will have an impact on the operation of Red Cross blood centres. They must adapt their operating procedures to American standards because there are no facilities in Canada capable of breaking down blood plasma into medically useful products, such as albumin, which is used to treat bum victims, and Factor VIII, a clotting agent needed by hemophiliacs. The society has formed a partnership with an American company to build a $150-million fractionation plant in New Bedford, N.S., and construction is to begin next spring at the earliest. Until the project is complete, the society will continue to rely on the U.S. facility in North Carolina to process Canadian plasma.

The FDA inspectors halted shipments of only about 25 per cent of the plasma o collected in Canada. Lindores said the Red Cross hopes to negotiate with the American agency to resume those shipments while the blood centres amend their operating practices. In the meantime, some critics say, Canadian hospitals could face shortages of plasma products unless the Red Cross buys them from pharmaceutical manufacturers— and that would be very expensive. “It could cost us millions of dollars more than it would to produce them from our own plasma,” said WongRieger, “because they are in short supply all over the world, and spot purchases are not cheap.”

Despite those concerns, the key issue remains public safety according to Wong-Rieger and others associated with groups representing Canadian hemophiliacs. They insist that the American procedures for screening and tracking donors, as well as testing blood for the presence of disease, are the most stringent in the world and should be adopted by the Canadian Red Cross. Donors at Canadian clinics are required to show proof of identity and complete a questionnaire dealing with health issues and sexual practices (including whether they have accepted money or drugs in exchange for sex, or had a male homosexual contact since 1977).

The donor then has a brief interview with a nurse to review the answers to the questionnaire.

In the United States, clinic nurses conduct face-to-face interviews with would-be donors rather than allowing them to fill out a questionnaire. They also conduct a brief physical examination of every donor that involves checking for swollen lymph glands, taking their temperatures and examining their forearms for signs of intravenous drug use. “The United States believes these standards are critical, and we feel Canada deserves the same level of safety as the United States,” said Wong-Rieger.

“In essence, we’re being told Canada will accept lower standards and a higher degree of risk.”

But Canadian healthcare professionals insist that the standards in the two countries are simply different—and for valid reasons. Dr. Judith Hannon, director of hematology at the University of Alberta Hospitals, noted that some American clinics are privately operated and pay for donations. “You tend to attract people who need money, sometimes for drugs, which makes them higher-risk donors,” said Hannon. ‘We never use paid donors in Canada, so we have a much safer donor base.”

Besides screening and tracking donors, the Red Cross tests every unit of blood donated in Canada for the presence of HIV, syphilis, hepatitis B and C and a leukemia virus. Hannon and other hematologists across the country contend that the tests are very effective. But they also note that infected blood, in rare cases, can slip through the testing process. That occurs, they say, because the human immune system does not

WE'RE BEING TOLD CANADA WILL ACCEPT A HIGHER DEGREE OF RISK'

produce antibodies to protect itself against a virus immediately after being infected. Because of the time lag between infection and the production of antibodies, tainted blood can still get into the system undetected.

Lindores said that Gilles Delage, a Montreal-based specialist in infectious diseases, conducted a study for the Red Cross in 1989 that showed that the odds of infected blood slipping through the tests are about one in 250,000. The Red Cross collects more than 1.1 million units of blood annually, meaning that, theoretically, up to five contaminated units could get into the system each year. But Lindores said the actual number is much lower because since 1985 there have been only 10 known cases of HIV transmission through tainted blood.

Doctors say they now treat blood transfusions like any medical procedure. They regard them as very safe, but they also know that nothing in medicine is ever 100 per cent effective. For that reason, most doctors will I not order a transfusion “ unless they believe it is I clearly necessary. “If I § have to transfuse a pail tient, I don’t have a great I deal of hesitation,” said I Dr. Jeffrey Weitz, a hematologist at the Hamilton Civic Hospital Research Centre. “On the other hand, no matter how good you are, some things are going to sneak through. So my trigger for transfusing someone is much higher than it was, say, before 1980. I transfuse much less often than I used to, and I think that has been the trend for all of us.”

But, given the potentially fatal consequences of receiving tainted blood, some observers insist that the government must make the system safer. Several members of organizations representing hemophiliacs have suggested that Ottawa should force the Red Cross out of blood collection and distribution altogether, and set up an alternative service. Others argue that, as a bare minimum, Health and Welfare Canada should insist that the Red Cross make improvements at almost every stage of the system. “It costs no more to do it the right way,” said Wong-Rieger. “The question is: how much value do you place on safety?” That is a question that the Red Cross—and all Canadians—will have to wrestle with.

SCOTT STEELE