Backgrounder
In 2009 I wrote a scathing opinion piece about the MSM policy and sent it to all of the local and provincial papers I could find. The Province printed it, and Dr. Dana Divine read it and subsequently found me and invited me into the MSM Stakeholder group. A decade later I am still engaged. I trust that I carry a different-from-most, well-informed perspective on this policy. How does one make change? Get into bed with the enemy.
Since engaging with this policy on a national level I have learned one thing: this is complex AF. I have sat at the tables when it was a lifetime, a 5-year, and one-year and now a three-month deferral. I have sat at the table, with other international blood operators, brainstorming what we need to learn and what data needs to be gathered. I have sat at the table with blood recipients, learning about and empathizing with blood recipients who rely on blood products. This is 10 years of work, and, in turn, 10 years of progress. It moves at a glacial pace, but if I zoom out and take a look, there has been a lot of change.
This past weekend I was invited back to Toronto to participate in a knowledge-sharing forum with researchers engaged in projects that will inform the next generation of blood policy. For the first time, we talked about a “finish line”. In this context, a finish line is where elements of MSM discrimination are dissolved and more people are able to donate blood for transfusion, but this finish line certainly doesn’t mean perfection or that work to improve stops. I do feel hopeful that this is around the corner, and I feel proud of the progress that has been made in Canada.
I wanted to share my experience and thoughts with those who are interested. As I attend these meetings as an independent citizen and activist, not connected to any organization, I do not have a formal process to disseminate what has been learned. The following is from my notes over the two-day forum. I do not speak as a representative for CBS, or as a researcher, but as a cis, white, gay MSM who merely wants to donate blood.
(Inter)National Considerations
Canada is leading the pack internationally regarding MSM policies (sometimes referred to as gbMSM, or “gay, bisexual and other men who have sex with men”). While it feels like we are in the old days with this policy, and that nothing is changing, it is important to remember that this is currently the best in the world from a global perspective. Only the UK is where we are in terms of a time-based deferral, being 3 months for MSM, but only Canada is doing the necessary research and legwork to determine the impacts of moving to a gender-neutral, behaviour-based screening process with the hopes of advancing this policy even further. All other international deferrals are 4 months or to a year and beyond. Furthermore, there are still far too may countries that have maintained their lifetime deferrals and have made no headway in changing policy. The blood regulator, Health Canada, requires evidence-based data in any policy-change proposal, rightfully so, hence the ongoing research. It would be irresponsible and dangerous to change heath policy without adequate review. Many of the projects underway are completed and are in the process of publishing. Other projects are set to complete into 2020, and one into 2021.
There are some other countries, Spain and Italy for example, that have a different model, akin to behaviour-based screening. But, when looking into the residual risk (the chances of a transfusion-related infection), they are worse than in Canada. The systems there also operate quite differently in that there is no national blood operator, like what we see in Canada with Canadian Blood Services and Hema Quebec. So when it comes to safety for blood recipients, it cannot really compare. Also, when thinking about other countries, it is important to consider the differences in epidemiology that makes direct comparisons invalid. Take a look here for a deeper global perspective, recognizing that it was published 3 years ago and things have since changed.
In 2015 Canadians certainly heard a lot of promise from Trudeau that he would “end the ban”. In 2019 we heard it from Trudeau and Singh, maybe others. Given the politicized nature of the MSM policy, I wanted to explore what power the Prime Minister really has to effect changes in this field. It turns out, not much. I spoke with Dr. Dana Divine, the Chief Medical Officer for CBS, who reported that the PM’s office really has “no authority” over Health Canada or CBS. Beyond throwing money at CBS, there isn’t much clout. It is worth acknowledging, though, that the 3 million that came from the Liberal government has funded this research in question. So, the power to affect change comes by cheque. To be frank, we need more, particularly for a more robust approach to the trans-donor policy.
New Challenges and Ongoing Considerations
How does PrEP change the landscape?
People are beginning to enter blood clinics who are using PrEP. There is a new question on the screening questionnaire that asks if the donor has been taking this medication, and 15 people to date have answered yes. These implications are under review. There was far more talk about PrEP as both treatment and prevention, and how this impacts the blood system. One of the concerns is the potential for test interference, how PrEP can impact test results when testing pooled blood post-donation. Of course, I will leave it to the scientists to explain that piece further! What is clear, though, is that times are ever-changing, and CBS is trying to play catch up.
There have been recorded “breakthrough seroconversions” (folks who have been on PrEP but contracted HIV”), and in these instances it is difficult to identify seroconversion times, as it is hypothesized that PrEP may delay the process. There have been 7 of these breakthrough cases globally, one in Canada. Again, this is an area with an identified data shortage. Understanding serconversion in the context of PrEP, though, is important in setting an appropriate minimum deferral period for PrEP use… if continuing down a time-based deferral path.
What is the current window period?
CBS mentioned during this forum that 3 months is as far as they would go when thinking about time-based deferrals. They stated that this was due to the infamous “window period,” which is between 5-15 days, depending on the test used. Simple logic leads us to then think, “well, then shouldn’t the deferral period be 15 days?” What is always taken into consideration in their risk modelling are the outliers. Some folks seroconvert later than 15 days, so there is a cautious added buffer.
Interestingly, there has only been one incidence of HIV in a blood donor since the 3-month deferral policy came into effect in July 2019, and this donor was a woman, not falling within the MSM category at all.
Risk Compensation
There is consideration for risk compensation, where it is presumed that the element of safety and security provided by PrEP would increase risk-taking behaviour. It was recognized that this is an unfounded perspective and is a common argument when there are advances in sexual health science, for example with HPV vaccine and birth control.
But, U=U so I can donate, right?
U=U, the campaign that says undetectable is untransmissible, becomes invalid when considering transfusions. There are people who promote U=U in the context of blood donations, but it is invalid and CBS wants to clarify this. U=U is invalidated because of the nature of a blood transfusion, where blood has a direct, intravenous route with 5x the amount of inoculant, as opposed to an ejaculate that needs to make its indirect way into a blood stream, for example.
Isn’t there new tech?
Pathogen Reduction (PR) (or Pathogen Inactivation) is the new tech in the world of the blood system. In 2017 we were discussing how new tech may impact the MSM policy, and now as we enter 2020 it is becoming more of a reality. There is one licensee in Canada called INTERCEPT that can be used to “zap” the pathogens with UV-A, damaging nucleic acid to prevent replications. How and where this is used is not clear to me, however it is now an ongoing consideration, a consideration that may make the MSM moot overall. With screening questions, blood testing, AND PR, it is next to impossible for any Transfusion Transmitted Infections (TTI).
The Transgender Policy needs work, big time.
Transgender blood donation is a large gap that is recognized by CBS. This topic was often brought up by a trans stakeholder, and largely unaddressed beyond acknowledging the paucity of data. I understand that there is work being done to dig deeper into this piece and inform policy with evidence. What is clear to me though is that the move toward gender-neutral and trans-inclusive policy requires specific considerations. While a subset of Canadians want to eliminate sex/gender questions all together, it is not yet feasible from a blood system perspective given the potential for grave impacts on the blood recipient, as well as the donor.
If we take a look at a potential scenario it may help exemplify. Let’s say that a FtM donor presents to donate blood. This person has previously been pregnant prior to their transition. Now, they present to the clinic, identify as Male, and continue with the donation. All seems well, however there may have been antibodies in this person’s blood, developed during the pregnancy, which increases the risk to the blood recipient. These antibodies have the potential to case TRALI, transfusion-related acute lung injury, occurring shortly after transfusion. It has been argued that merely asking “have you ever been pregnant?” to every donor regardless of sex, is not enough to adequately capture this risk, given that a “heavy flow” menstrual cycle may have in fact been an unknown miscarriage. I am unaware of data and evidence around this argument.
In terms of the donors themselves, there are limits to how much blood can be drawn from a donor, and these limits are dictated by sex. Naturally, the blood operator wants to make sure the donors are not keeling over in the clinics, and so want to mitigate that risk as much as possible. Knowing sex assigned at birth, they report, is one such way to inform that risk assessment. I understand that some differences here are related to iron, and that it typically takes women longer to replenish it, which impacts their donation frequency. If blood operators disregarded this fact, there would be an increased risk to the trans donors. Personally, I think there is a way around this, with more individualized care and iron measurement. Again, knowledge gap.
I was thrilled to see Catherine Jenkins at this knowledge symposium; her voice was exactly what was needed. She was pushing back on trans-related issues the whole event, making people reflect on how much data is missing. I believe that CBS truly wants to and is committed to better addressing this component of their policy, however they, in my opinion, a) are knee-deep in MSM policy research, b) lack the funding to adequately explore this piece, and c) do not have the same pressure from society to address it (which speaks to the wider oppression of our trans siblings).
African, Caribbean, and Black MSM (ACB-MSM) was a discussion topic throughout the forum. There is need for reparation to ACB donors given the historically racist blood policies that have left these communities in a similar pool of resentment towards CBS and Health Canada. This illustrates the intersection of sexuality and race, and how CBS would be remiss not to look at “MSM” more holistically, not merely from a cis, white perspective. One of the projects underway looks more deeply into this.
They who bear the risk…
Patient Groups and blood recipients, while often unacknowledged by MSM social justice warriors, continue to sit at the table. Given that they bear 100% of any risk, their voices are integral to policy creation and stakeholder relations. Two patient groups, Canadian Immunodeficiencies Patient Organization (CIPO) and Sickle Cell Disease Association of Canada/Association d’Anémie Falciforme du Canada(SCDAC/AAFC), wrote statements for distribution at this symposium. In their statements they both agreed that a 3-month deferral was safe for their patient groups, however both made it clear that they wanted to maintain a time-based deferral and did not support changing to behaviour-based screening “in order to maintain the safety of the blood”. I argue that much of the resistance in the patient groups is fear-based and intangible, however it plays an integral role. These Canadians come from families who were directly impacted by TTIs during and after the blood scandal. CBS is balancing stakeholders, one group who adamantly demands justice and reparation due to ongoing perceptions of discriminations, and another who demands as much restriction and safety as is possible so as to protect their own wellness and lives. Meeting in the middle, with science, evidence and policy is an ongoing development.
Good intentions can have Bad impacts
When considering any change to the blood system, CBS needs to evaluate the potential loss of existing donors, or the impacts on new donor recruitment. Some of the research indicates a potential loss of 3-4% of annual blood donations if behaviour-based questions are implemented, which equates to about 30-40,000 units of blood. The concern of a substantial loss of existing donors is very important, and, again something not often considered by MSM advocates. As is understood, 3-4% is the maximum acceptable loss.
For example, when assessing the impacts of asking more specific sex-related questions, such as “have you had anal sex in the last 3 months”, many of the participants had an adverse reaction, feeling it was too personal <insert eye roll>. Now, given that LGBT+ communities have felt scrutinized by sex-actions their whole lives, this seems almost laughable, especially when MSMs are deferred for anal sex, and that CBS wants to ask Trans donors whether they have a penis or vagina.
When considering the loss of existing donors, what needs exploration is the potential gain. As we know, feelings of justice lead many to boycott blood donations. If there was a movement towards a policy that is perceived as less discriminatory, there may be a surge of new donors, moving beyond mere MSM donors and into their allies.
At the end of the day, I personally do not want a blood system where fewer patients get their blood products. If maintaining a time-based deferral is required in order to keep the blood system out of crisis, I can accept that. Peoples’ lives come before my drive for perceived justice.
I am married and monogamous, what about me?
Monogamous donors are always part of the discussion, but not as much as I was expecting this time. Whenever I bring up the MSM policy socially, this point is always the first starting-off point of the angry MSMers, rightfully so… I am one of them. Some of the research is attempting to address this point, looking at the impacts of a gender-neutral “have you had sex with more than one partner” question. There are ongoing worries that such a question could defer too many people. There are research projects that quantify the number of partnered, monogamous MSM who would be willing to donate if they could. For example, one study demonstrated that 52% of research participants were in a relationship, and 50% of those were closed. In 2017, we identified that we did not have any data to quantify the “monogamous argument”, and research results like this directly address it.
The Research
There have certainly been some fascinating research projects underway, many of which draw upon existing research projects such as the Momentum Health study and #iCruise. Since many findings are ongoing and largely confidential until completion and publication, we have been requested not to share. What I can say is that the research questions are provocative and much of the preliminary results are filling in gaps, likely informing the next phase of blood policy in Canada. Much of the data that is needed to propose new, globally-leading blood policy is difficult to collect, and I am hopeful that we are getting there.
The goal is to publish these papers in a special issue journal, so it will all be in one place. Given that some of these projects are ongoing into 2021, I cannot claim to know when such a publication will hit the public. More information of these projects are available in CBS website. You can also register for their email newsletter which provide updates.
What next?
I trust we are going to move ahead with less restrictive, more inclusive, increasingly safe blood policy. I do not know how it will look, but I believe Canada will continue to lead the way. Given that the research that is needed is still underway, and more gaps were identified, a policy change proposal wouldn’t be submitted to Health Canada for review for a couple years at least. But, Health Canada was at this meeting, and Catherine so eloquently pushed them to share their thoughts at the mic. They seemed open to a new model of screening, provided it maintained the safety of the blood supply. And, quite truthfully, isn’t that what we all want?
It sounds like one of the next steps in the MSM policy, coinciding with this ongoing research, will be something similar to what is happening in France, where MSM are eligible to donate plasma. In the French Model, these men donate plasma, but that plasma is held in quarantine until the same donor returns in 2-4 months to get tested and make another donation. If that test comes back negative, the plasma is released for processing (or “fractionation” in blood system terminology). If they test positive, or they do not return, the donation is destroyed.
I am in support of this, just as I am in support of donating blood for science in the interim. I understand, though, that many people will avoid and boycott the blood system indefinitely, or until there is a more acceptable policy. What is important to realize here is that any step forward that includes MSM donors will provide the needed data and evidence to inform even more inclusive, less restrictive blood policy. When CBS moved from a lifetime to a 5-year deferral, they used the post-implementation data to advocate to change from 5 to 1 year. The same is true for where we are today. After changing to 1 year deferrals, the subsequent data made Health Canada feel confident enough to move to 3 months. Any change made, will inform future changes.
I would like to see CBS make a statement about this all. Dare I go so far as saying an apology? Yes. I know that they write papers about MSM donors, and provide information in their website, but what I want to see is an honest, reflective, and thoughtful acknowledgement about the historical and current harm that lands upon gbMSM. A valid apology acknowledges harm, recognizes what needs to change, and takes action to do so. While I have seen a lot of policy progress and action over the years there has been one element that has remained quite static, and that is the hurt, resentment, and perception of discrimination within the LGBTQ2I community. We could change this policy all we want, making it more and more inclusive and safe, but our communities will be less likely to come forward as new donors without such an acknowledgement.
I truly hope they heard me when I stood at that mic and told them to do so. It is past due.
LifeAsChad 