Saturday, August 09, 2014

The way we were (Musings on TM history and its lessons for today)

Updated: 11 Aug. 2014
This month's blog discusses 3 recent news items (and associated scientific papers) related to men who have sex with men (MSM), HIV risks, and blood donation, plus a paper written by Canadian transfusion medicine experts on Canada's perspective on donor criteria for MSM.

The blog's title is from a 1975 Barbra Streisand classic (one of my favorites) and theme from an eponymous movie starring her and Robert Redford.

Please read the news items and papers as they provide fascinating, useful details beyond the brief reports presented in the blog. Although the specifics involve North America, the content and learning points apply everywhere.

1. USA: HIV positive man arrested and charged after donating plasma for $30
A man admitted to police that he donated plasma at BioLife in Elkhart, Indiana even though he knew he was HIV positive. He'd lost his job and needed money. 
Biolife pays $30 for plasma via a debit card and is a division of Baxter Healthcare
The plasma donor was charged with three counts of attempting to transfer contaminated body fluids and one count of transferring contaminated body fluids.
2. USA: Activists fight MSM policy (lifetime deferral if even once since 1977) with National Gay Blood Drive on 11 July, 2014.
The blood drive involves gay and bisexual men who want to donate bringing proxy donors who are eligible to donate and publicizes what activists believe is an outdated discriminatory and unscientific policy. 
The news item outlines the key issues on both sides of the argument with quotes from Paul Strengers, medical director at the Dutch Sanquin Blood Supply Foundation (anti-changing the policy) and the American Medical Association (pro-change). 
Related: AABB, ABC, ARC Joint statement on National Gay Blood Drive
Among other things, the US organizations were concerned that the event might disrupt blood center operations but support "rational, scientifically based deferral periods that are applied fairly and consistently among blood donors who engage in similar risk activities."
3. USA: 5 reasons HIV is on the rise among young gay and bisexual men
In brief, according to HIV researchers at CDC, the reasons include young gay and bisexual men's partners are more likely to
  • Have and transmit HIV
  • Engage in risky sexual practices
  • Use drugs
  • HIV's stigma could make people less likely to get tested
  • Younger men weren't around for worst of the HIV/AIDS epidemic and are less likely to know the dangers
Related: Johnson AS, Hall HI, Hu X, Lansky A, Holtgrave DR, Mermin J. Trends in diagnoses of HIV infection in the United States, 2002-2011. JAMA 2014;312(4):432-4.

4. Goldman M, Lapierre D, Lemay L, Devine D, Sher G. Donor criteria for men who have sex with men: a Canadian perspective. (Commentary) Transfusion 2014 Jul;54(7):1887-92.
With other jurisdictions considering a change in MSM policies, this paper was written by Canadian blood experts who thought it might be of value to share Canada's experience. It outlines CBS and Héma-Québec's extensive processes to consult interest groups / stake holders to achieve a consensus to support Canada changing its long-standing permanent deferral for MSM to a 5-year deferral from last MSM contact
The 'Commentary' begins by outlining the history of the HIV/AIDS/HCV 'tainted blood' disaster in Canada, which led to the Krever Royal Commission of Inquiry into Canada's blood system and its 'damning' (my word) 1997 report.  
As a result, in 1998 CBS and Héma-Québec were created; blood was regulated as a drug with blood centres considered biologics manufacturers, with more stringent regulatory oversight by Health Canada. 
I'll present only a few key highlights of the paper, those selected through my biased eyes. Also note [my Comments].
HISTORY: [One of the most explicit mea culpas I've seen from Canadian TM experts]:
* There was a lag between implementing measures to reduce transmission of AIDS/HIV in Canada compared to the US and others, including donor deferral criteria, HIV antibody testing, and sole use of adequately virus-inactivated factor concentrates.

* Delays contributed to infection of many transfused patients, with the hemophilia population particularly devastated by HIV. Delays also occurred in adopting measures to reduce HCV transmission. 
* Anger and bitterness over the (mis)management of HIV and HCV risk by the blood system cast a long shadow over the new organizations, CBS and H-Q. 
[Why did the delays occur? What's the root cause? A focus on cost over safety? A belief in evidence-based science that failed to consider what experts did NOT know? Or?]
STATISTICS: As of 2011 PHAC reports there were ~71,000 prevalent and 2250-4100 annual incident cases of HIV in Canada. MSM risk was high for prevalent and incident infections, accounting for about half of new infections.
* Large MSM studies demonstrate seroprevalence rates from 10% to 20% but generally recruit participants in gay venues and focus on currently sexually active MSM, often with frequent partner change (not those in longstanding monogamous relationships or those sexually inactive for a long time).

[Incidence of HIV seroprevalence in gays in long monogamous relationships is unknown.]

* With sensitive antibody detection assays and minipool nucleic acid testing (NAT), the window period for HIV is estimated at 9 to 11 days
* Residual risk for HIV is estimated at less than 1 in 8 million units at CBS and in the USA is 1 in 1.5 million units, due to higher rates of HIV+ donors. 
[FYI, residual risk is the risk of an infectious donation being present in the blood supply after all donor and donation screening activities occur and unsuitable donations are removed and discarded.  See Current information on the infectious risks of allogeneic blood transfusion - Residual risk. Put another way, it's the OOPS! factor.]
* Risk modeling in Canada found the incremental risk of a 5-year deferral for MSM was less than 1 infected HIV unit entering the blood supply in 1000 years. 
* A 5-year deferral for MSM would not substantially increase transfusion-associated HIV in Canada. Similar modeling studies were done in France, UK, and USA. 
[Sounds great, eh? Almost as if we can crow, 'Don't worry, be happy'. But the fly in the ointment...] 
* 'Although modeling studies are useful to estimate small risk increments, they involve assumptions about many variables, where data are often sparse. Additionally, they do not provide information on novel or emerging threats.' 
[Modeling involves many assumptions based on minimal data – so much for evidence-based. Plus, obviously new and emerging threats (unknown) are absent from modeling studies.]
I'm not going to report the guts of the Canadian paper, which outlines the processes used in Canada in 2001, 2006, 2008, 2009, 2011, and 2012 except to mention the Kyle Freeman court case.

But please read the paper if you have access because it explains the science and politics of MSM and blood donation as few resources have and the emotions and tension that marked the debate historically and still do.

In brief, the Freeman case involved a gay man who informed CBS via an anonymous e-mail that he donated and lied about his MSM status. To trace the anonymous e-mail and apply the appropriate deferral code, CBS sued for negligent misrepresentation as a way to obtain his identity from his e-mail service provider. He counter-sued, claiming CBS violated his rights under the Canadian Charter of Rights and Freedoms.

Freeman lost. Key elements of the judgment in favor of CBS were that blood donation is a gift and not a right and that MSM policy is not discriminatory based on sexual orientation.
Relevant reading:
MSM, HIV, and blood donation continue to be controversial and political. To me, key points from the Transfusion paper and related news items include 

#1. Goldman paper: 'Although modeling studies are useful to estimate small risk increments, they involve assumptions about many variables, where evidence is lacking. As well, they do not provide information on new or emerging threats.

In other words, models of HIV and other infectious disease risks to the blood supply are based on assumptions backed up with more or less zero data and do NOT consider new threats. So much for evidence-based decisions touted by TM experts.

#2. The role that student and gay rights activists play in changing blood safety policy is pure politics.

They claim discrimination (and a case can be made based on MSM vs engaging in risky behaviors regardless of gender) but ignore that HIV-prevalence of MSM presents a real risk to the blood supply. Moreover, HIV is on the rise among young gay and bisexual men, current HIV tests have a window period of 9 to 11 days, and donors may lie on blood donor screening questionnaires.

#3. Goldman paper: 'For patient groups, many of whom are chronic users of the blood supply, the change meant putting aside their fears of the past, assessing the available scientific information, and trusting in the system.'

To me, this is 'Don't worry, be happy' time (see earlier blog). Trust us. We've got your back covered based on science. Oh yah!

#4. All this aside, blood suppliers worldwide will cave to the political pressure of activist interest groups, claim it's evidence-based, and it won't affect blood safety until it does.

For interest, the UK's NHSBT donor policy on MSM:
The change means that only men who have had anal or oral sex with another man in the past 12 months, with or without a condom, are asked not to donate blood. 
Men whose last sexual contact with another man was more than 12 months ago are eligible to donate, subject to meeting the other donor selection criteria.
Other nations have permanent (indefinite) deferral or a 5 year deferral.              
The blog's topic is not funny. The 'for fun' bit is just for enjoying the song. Looking back on the HIV tragedy and its impact on blood transfusion, I'm reminded of the innocent way we were before HIV appeared.
Light the corners of my mind
Misty water-colored memories
Of the way we were. 
Scattered pictures,
Of the smiles we left behind
Smiles we gave to one another
For the way we were.
Can it be that it was all so simple then?
Or has time re-written every line?
If we had the chance to do it all again
Tell me, would we? Could we? 
Mem'ries, may be beautiful and yet
What's too painful to remember
We simply choose to forget.
So it's the laughter
We will remember
Whenever we remember...
The way we were...
As always the views are mine and mine alone and feedback is most welcome.