Both Canadian Blood Services (CBS) and the US Food And Drug Administration are reconsidering their bans on blood donations from all men who have had sex with men (MSM) even once since 1977 because more sensitive screening techniques further mitigate the risk that pathogens, like HIV and hepatitis C, will enter the blood supply.
“We’re watching what is going on south of the border with interest, but that’s not going to be determinant of what we do here,” declares Ron Vezina, director, media relations and external communications for CBS. “We’re looking for our own made-in-Canada solution.
“We actually began a risk assessment of our own on the MSM issue last fall, and it’s still ongoing,” he continues. “As you can imagine, on a complex issue like this, there’s consultations; the whole epidemiology of the science, the ethical side, [and] the societal issues. We’re hopeful that by the end of this calendar year we’ll be closer to a position.”
The MSM ban has been in place in the US since 1983. The same ban exists in Canada, but Vezina does not know when it came into effect. “It has certainly been in place since our organization was created in 1998, but I wouldn’t be able to tell you what exact year that policy came into effect because it was another operator of the blood system at that time.”
That other operator was The Canadian Red Cross Society that managed the country’s blood supply for more than 50 years until CBS was formed. A spokesperson for the Red Cross confirms that the MSM deferral policy was introduced in Canada in March 1983.
CBS is a national, independent, not-for-profit, charitable organization whose sole mission is to manage the blood and blood products supply in all provinces and territories, except Quebec, which is governed by Hema-Quebec. CBS sets its own guidelines about policy and procurement, but they are ultimately reviewed and approved by Health Canada.
Thousands of Canadians were infected in the late 1970s and early 1980s with HIV and hepatitis C from donated blood that was not properly screened. The federal government convened a public inquiry led by justice Horace Krever that lasted more than four years. The Commission of Inquiry on the Blood System in Canada, tabled in the House of Commons in 1997, made many recommendations to improve the management of the blood supply in areas including safety, accountability, financing, research and development, public confidence, and blood utilization.
The reevaluation of the MSM ban in the US is the result of a workshop in March entitled, Behavior-Based Donor Deferrals in the Era of NAT, conducted by the FDA’s Center for Biologics Evaluation and Research. According to Paul Richards, public affairs specialist at the Center: “If and when we get to the point that we are ready to propose a change, or options for change, we would bring that proposal to the advisory committee for discussion. We are not able to predict when that might be.”
Nucleic Acid Amplification Testing (NAT) is the highly sensitive method of testing blood that is used to detect different viruses from donations before they enter the blood supply. It can detect low levels of genetic material present when an infection occurs but before the body begins producing antibodies in response. The test reduces the window period-time between initial infection and when a virus is first detectable.
CBS has been using NAT to screen for hepatitis C since 1999, and HIV since 2001. This technology can detect HIV in blood three to five days earlier than existing tests that have a window period of about 16 days. CBS also screens for West Nile Virus.
NAT is used in addition to other tests because infected individuals may be NAT-negative if their viral load falls below detectable levels, and yet still test positive using other, more common, antibody tests.
Such exceptions led the Canadian Hemophilia Society to post a paper on its website supporting the current donor deferral restrictions, including the MSM ban.
“We understand that people could perceive this as discriminatory, but that’s what donor deferral criteria by their very nature [are]. It’s not any discrimination, but it has to be justified in terms of protecting someone’s health,” offers David Page, director of programs and communications for the Society. “The question’s in the science: Can it be justified? And we think it can.
“Studies show that a change to a 12-month deferral would increase risk, albeit marginally,” he says. “The best data that I’ve seen says there’d be one new case every 16 years. That would translate into three new infections because the donations are split into components. That’s quite minimal admittedly,” he acknowledges, “but we don’t think it makes a lot of sense to increase risk at the same time [blood regulators] are looking at other measures which could further decrease risk.
“By removing a group of men who have had sex with men you are removing a population, which has a much higher percentage of HIV and hepatitis C than a population of males who have not had sex with a man. That difference is about 260 times less risk,” he clarifies.
“HIV infection among gay men is somewhere around 15 to 17 percent,” Phillip Banks, director of HIV prevention and awareness programs at AIDS Vancouver, points out. “That means that 83 to 85 percent of gay men don’t have HIV. Why is 83 to 85 percent of the population being barred from contributing to what is seen as a social cause?” he wonders. “[Blood is] something that everybody has and everybody can give. What they don’t say is, ‘except for homos.’ Any homo, it doesn’t matter if you’re HIV negative or not, you just can’t give your blood. That’s rooted in homophobia that is unchecked because of the silence in the gay community.”
Gay men are not the only group of potential blood donors who are prohibited. “People who lived in the United Kingdom or France between 1980 and 1996 are indefinitely deferred because of the risk of mad cow [disease]. People that are born in certain countries in Africa can’t give; people that have received money for sex, or even people that have certain medical conditions,” Vezina outlines. He reinforces his agency’s desire to ensure the safety of the blood supply. “Our policy [is] to minimize the risks for the blood recipients. We can never make blood 100 percent risk-free, it is a biological agent.”
Gilles Marchildon, executive director of Egale Canada has a different perspective. “In Portugal the blood collection agency [has] gone ahead and lifted the ban because modern day tests are precise enough to detect HIV and hepatitis in donated blood. It would seem now that science supports the lifting of the ban.”
Additionally, he suggests that the CBS’s donor “questionnaire is discriminatory and should be changed. It prevents people from giving blood based on the fact that they happen to belong to particular groups, not based on whether or not their sexual practices are risky.
“Where it is patently discriminatory,” he continues, “is that the straight man who has had unsafe sex can give blood, but a gay man who has had safe sex, cannot give blood simply because of his affiliation with a definable group. That doesn’t make sense.”
Banks agrees. “Gay men test for HIV at a much higher rate than most other populations, so we tend to know our HIV status. We are much more vigilant with regards to monitoring HIV, both in our own lives and in the community as a whole. Yet they don’t trust gay men to screen themselves out. They trust heterosexual men to screen themselves out; they trust heterosexual women.”
“It’s not that we’re targeting one group,” Vezina asserts. “We’re targeting specific risk factors. We’re not targeting lifestyles, or deferring lifestyles, we’re deferring risk behaviours.”