Saturday, October 10, 2009

Don't ask, don't tell... Time to fold 'em or bad moon rising?

It's not every day that a national blood supplier and blood donor are involved in a lawsuit involving blood, sex, duplicity, and a constitutional challenge. That's happening now in Ottawa and generating plenty of press coverage.

In brief, CBS sued a gay blood donor, Kyle Freeman, who lied repeatedly on his blood donor screening questionnaire, and the donor subsequently sued CBS and Health Canada. This blog examines the issues involved in the dueling lawsuits.

The blog offers musings on the MSM deferral policy for blood donors. Its title is a takeoff on

The Controversy
The key issue involves the MSM (men who have sex with men) deferral policy for blood donors. As described on the CBS website:

  • "...the policy excluding MSM is the subject of debate between the LGBTTQ (lesbian, gay, bisexual, transsexual, two-spirited, and queer) communities, who view it as a discriminatory policy and patient groups that depend on blood products, and who feel it is a critical safety measure."
In other words, is lifetime deferral for MSM scientifically justified to protect the blood supply because the incidence of HIV is much higher in men who have had sex with men than it is in individuals having exclusively heterosexual sex or is the policy discriminatory?
The controversy surrounding MSM policies has been widely reported, particularly protests on university campuses, which have tended to be full of passionate, hyperbolic political rhetoric, e.g.,
Note: The above SAQD pamphlet refers to the 2007 McLaughlin Report. Readers are well advised to read the original report below.
CBS, like many blood services worldwide, following the dictums of its government regulator Health Canada, bans donations from men who have sex with men, the so-called MSM policy. The CBS predonation screening question on the "Record of Donation" reads,
  • "Have you had sex with a man, even one time since 1977?"
Other Countries
MSM policies vary globally. From the CBS website:

  • Countries requiring indefinite deferrals: USA, UK, France, Germany, Switzerland, Holland, Norway, Denmark, Sweden, Finland, Iceland and Hong Kong
  • Countries with shorter deferral periods:
  • 1 year - Argentina, Australia, Japan, Hungary
  • 5 years - South Africa*
  • 10 years - New Zealand
  • Italy has a deferral based on specific activities

* According to the SA National Blood Service, the SA deferral was changed from 5 yrs to 6 mths in 2006.
The UK blood service also provides a Summary of International Policies relating to the Exclusion of Men who have Sex with Men from Blood Donation

In 2007 CBS reviewed its policy and decided to retain an indefinite deferral, effectively a permanent ban, as explained here
The UK has also recently issued a position statement on its policy:
CBS's position on the lawsuit is provided on its website.
The main facts of the case as reported in the media:

  • CBS accused Kyle Freeman, a gay man, of 'negligent misrepresentation' for lying on the screening form.
  • Freeman then sued CBS and Health Canada for $250,000 claiming CBS violates his charter rights* and those of other gay men by asking male donors about having sex with a man.*Canada's Charter of Rights and Freedoms
  • Freeman donated blood 18 times between 1990 and June 2002 but the case focuses on the 4 times he donated following the creation of CBS in 1998, i.e., between June 1998 and June 2002. (Canada's blood supplier prior to 1998 was the Canadian Red Cross.)
  • In June 2002 Freeman sent CBS anonymous e-mails admitting he lied on the questionnaire.
  • CBS attempted to get his Internet service provider to reveal his identity.
  • Freeman's blood donor screening HIV tests were negative but he has had gonorrhea and late latent syphilis.
For more details, see TraQ's news reports.
Interested Parties
Two other organizations have weighed in on the case:
The Canadian Hemophilia Society has 'intervenor status' in the case. CHS supports the position of CBS and Health Canada in maintaining the current MSM donor deferral criteria. Individuals with hemophilia were devastated by the tainted blood scandal of the 1980s, as documented in the Krever Report and elsewhere.

The Canadian AIDS Society will appear as a 'Friend of the Court.' It contests the constitutionality of the lifetime deferral on
men who have sex with men and proposes an amendment.

Below are the arguments on both sides of the MSM policy.

This document outlines the AABB, ABC and ARC position: They believe that the deferral period for MSM should be consistent with deferrals for those judged to be at risk of infection via heterosexual routes. i.e., 12 months.

Debate in the British Medical Journal:
If current blood donor screening tests for HIV and other agents leave no residual risk for transmitting infections then there would be no need for intrusive screening questions about high risk behaviors, i.e., a policy of Don't ask, don't tell.
Obviously there is some residual risk, albeit small, that make predonation questions essential.

The McLaughlin Report concludes this about MSM deferral periods:
  • Available evidence strongly suggests that a 1-yr deferral would "almost certainly give rise to an incremental risk of transfusion-transmitted infection"
  • Evidence is less clear for a 5- yr or 10-yr deferral partly because "current level of residual risk is so low that there are, inevitably, substantial ranges of uncertainties associated with the risk estimation."
  • "...there is no firm evidence that such a change in the deferral period ...would result in an incremental level of risk, although the possibility of a small increase in risk cannot be entirely ruled out."
  • "Under these circumstances, other social policy issues, relevant to the idea of changing the deferral period for MSM, become worthy of additional consideration."
This excerpt from the Report is instructive:
  • Therefore, would ...changing the MSM deferral period to 5 years pass the risk hurdle successfully? In the end, this is a matter of judgment, that is, a matter on which reasonable people may disagree.
  • What we can say with some assurance is that, at the very least, it may provisionally pass the risk hurdle. In other words, it is “within the ballpark” for discussion.
  • As a result, it is fair to ask if there may be other types of benefits that are likely to flow from making this policy change...
  • (1) ...possible impact on the size of the future donor pool, and
  • (2) ...potential social benefit attendant upon reducing the perceived stigma associated with homosexuality.
So....let's shorten the deferral for MSM to potentially get more blood donors and lessen a social stigma. And this based on a judgement on which reasonable people may disagree and is within the "ball park" of acceptable risks. Hmmmm......
The McLaughlin Report says that health risk data are equivocal and constitute very small risks so let's consider other worthwhile goals.

I'm always uneasy when someone suggests blood safety changes based on cost effectiveness or on politically expedient issues such as lessening social stigmas. Despite the clear desirability of such goals, patient safety should be the overarching, if not sole, determining factor.

The Gambler's wise advice is that you got to know when to fold 'em, know when to hold 'em.

Will the FDA, Health Canada and blood suppliers like CBS decide to fold 'em and change the lifetime MSM deferral policy to a shorter period?

Ladies and gentlemen, place your bets.

I see a Bad Moon Rising if changes to blood safety policies are based on pressure from activists as opposed to evidence of no incremental risk, accepting that zero risk is impossible.

Comments are most welcome BUT, due to excessive spam,  please e-mail me personally or use the address in the newsletter notice.