For months, Canadian Blood Services (CBS) spokespeople have claimed that a lack of research is hampering the organization’s ability to change a policy that bans gay men from donating blood.
CBS points to a $500,000 research grant, funded by CBS and the Canadian Institute for Health Research, that invites further research on gay men and blood donation. Although the grant was released in 2008, no scientist has come forward to take it on.
In an interview with Xtra in January, CBS spokesperson Lorna Tessier said the grant was the blood bank’s way of putting “our money where our mouth is.” In other words, CBS previously said it would look at research pushing for change. Now it is going after it.
That’s the claim. But activists, researchers and even a former CBS executive say science already makes the case for ending the lifetime deferral.
Dr Eleftherios Vamvakas, CBS’s vice-president of research affairs from 2002 to 2006, says that blood donor policies “can no longer claim the moral high ground.”
He makes that and other startling claims in an article released last month, “Relative Risk of Reducing the Lifetime Blood Donation Deferral for Men Who Have Had Sex with Men Versus Currently Tolerated Transfusion Risks.”
“A single donor platelet concentrate from an MSM donor who has abstained for five years would be considerably safer than a component pooled from five currently eligible donors,” he writes.
Vamvakas says he left CBS because he strongly disagreed with its MSM deferral policies, saying pooling blood from several donors was riskier than using blood from one gay man who had abstained from sex for a year.
“I left because I felt in my portfolio, I should tell them deferral made no sense whatsoever,” he says.
Adrian Lomaga has followed CBS for years. He’s at the centre of a legal challenge against Héma-Québec over its lifetime deferral of gay blood donors.
He says he’ll “wait and see” if the blood bank is genuine about changing the rules. In particular, he is skeptical of claims that the current research is insufficient.
“They’ve already funded studies in the past where they did nothing with the McLaughlin study, so is this a ploy to delay things?” he wonders.
The McLaughlin Report, commissioned by CBS, looks at other industrialized countries that accept gay male blood donors. Dr William Leiss, author of the report, was an expert witness in the Freeman v Canadian Blood Services case. He says CBS can easily hide behind statements saying it wants change. While CBS professes to be waiting for new research, Health Canada calls the shots and not them.
“The problem really is more with Health Canada than Canadian Blood Services,” says Leiss.
When Vamvakis left, CBS appointed Dr Dana Devine to replace him as vice-president of medical, scientific and research affairs. In an interview with Xtra, Devine discusses donor honesty, epidemiological research on HIV statistics comparing gays to the general public, and the complexity of gay men’s behaviour. She agrees that a lifetime deferral no longer makes sense. What should a new policy look like? That’s where Devine claims research is scarce.
Xtra: What happened with the McLaughlin Report?
Dana Devine: The McLaughlin Centre Report was actually commissioned by Canadian Blood Services in the first place. It was executed and completed and delivered to us. And then we reviewed it as an organization. It was also reviewed by our board of directors.
We then took the report and shared it with the stakeholder groups that we have interaction with. These are members of the general public, of patient communities, of folks who are interested in Canadian Blood Services and the blood system. We asked them to just feed that information back, what had been found in the McLaughlin Report. Then we helped Dr Leiss facilitate the publication of that report so it’s widely available to anyone who would be interested in its findings, either within Canada or for other blood systems that would be interested in what the situation is here.
Xtra: Right. I was easily able to get it off Google.
DD: That’s the idea — to make it widely available.
Xtra: We have Dr Leiss saying the men who have sex with men (MSM) donation deferral needs to be changed. Also, your former VP of research, Dr Vamvakas, says CBS’s current blood donation process is riskier than taking blood from MSM who have abstained for a year. There are many sophisticated countries around the world that allow their MSM population to donate blood. Why is more research necessary to approach Health Canada?
DD: In the publication Dr Vamvakas put out, he was assessing different kinds of risks that a patient would be exposed to based on different things that a blood system does in terms of the way it collects blood or the testing or the people it collects blood from. So the real issue there is about cumulative risk.
So to the patient, there are different little dollops of risk that a person can be the recipient of if [they] take a blood product. What the blood system needs to do is to keep that cumulative risk to the lowest level. So what Vamvakas was doing was comparing the different kinds of risk in his study.
To go back to the initial question about the statement of Dr Leiss that the donation deferral needs to be changed: we would not disagree with that. We do believe it is time for us to be looking at a definite deferral period rather than an indefinite deferral, which is currently in place now.
With respect to why more research is necessary to approach Health Canada, the issue is Health Canada has come out publicly and made a statement that we (or any organization preparing blood) need to be able to prove there is no reduction in safety associated with changing the deferral. So there needs to be data that are believed by enough people that we can achieve a medical consensus. So that the medical community and Health Canada regulatory staff all say there is no reduction in safety associated with changing the current deferral period.
We know right now there is no medical consensus. So we are going to have to approach Health Canada with new data.
Xtra: What about people who may be lying?
DD: We very much hope people aren’t lying. Like many things in our society, we rely on truthfulness as a fundamental principle of operation. Aside from the survey discussed earlier and one-off types of mechanisms, we do have people who come forward and tell us about members of their family who donated and shouldn’t have. Or people who have made an inappropriate donation come forward and let us know about it so we can remove those from our inventory.
Xtra: Is CBS interested in assessing risky sexual behaviour (ie sex without a condom) in the deferral process for MSM?
DD: Yes, absolutely. In fact, what we’re really appreciating through the dialogue we’ve been having, particularly with the gay men’s community and the activists groups on student campuses, is the issues here are very complicated. It’s not simple information about MSM behaviour, per se, but what that means in a broader context. So we are working to encourage groups who are actively involved in gay men’s health areas to work with us so we can collect this data and move this issue forward.
Xtra: Could you please describe the necessary steps required to approach Health Canada to change its policies?
DD: There are two different paths. One is a direct approach where Canadian Blood Services would take these data to Health Canada in a very formal, written submission process and ask to change the rule. Then Health Canada would decide yes or no.
The other way is a bit more indirect. The way we screen donors is part of a process that is under the authority of the Canadian Standards Association. Much the way there are standards for operating all kinds of businesses, we have standards as well in the blood business. The deferral we have for MSM is part of the Canadian Standards. We could go to Canadian Standards Association and seek to change the standard.
Then we would say to Health Canada we have the Canadian Standards Association standard changed and now we’re asking you to change it. Health Canada always has the right to overrule the Canadian Standards Association, but it does give you more of a backing — of another authoritative organization that would suggest an appropriate change in the deferrals. Those are the two different kinds of paths to approach Health Canada to change policy, which is not just for the MSM deferral.
Xtra: Does CBS have a planned timeline to approach Health Canada with suggestions for a change in policy for the MSM deferral?
DD: Not yet. We’re just in the process of formulating what information is missing and how long it is going to take to collect it and then to go forward. However, I will say Health Canada knows we are interested in opening this issue. So they’re well aware we’re trying to get a package together that would allow us to understand how we could change this deferral to a definite deferral rather than the indefinite deferral we have now.
Xtra: What studies do you have that say the MSM population should not give blood? What current scientific and epidemiological research supports the current MSM lifetime deferral policy? Could I take a look at them?
DD: We could certainly send you the data [that’s] out there… I don’t have them in front of me, don’t have them now, but we’re happy to forward those afterwards.
The studies that we have [that are] focused on not donating blood are related to incidents of transmissible agents in the general population. We tend to use HIV as the typical example. If you look at HIV risk, it’s much higher in MSM than the general population. If that fact weren’t on the table, we probably wouldn’t be having this interview. That is the kind of studies of epidemiology to say MSM population should not give blood.
Xtra followed up with CBS and asked for copies of the studies that justify the indefinite deferral. CBS pointed us to research on HIV infection rates among gay men but was unable to immediately produce studies that link that information to blood donation.
Find out more about the research grant here.