I later located the FDA's 2015 report on keeping at least a one-year ban. They carefully discussed all the studies done, and all the issues, laying out all the reasons for why the ban can't be completely lifted. These are some excerpts from it. They speak simply and succinctly to every claim being made by those wanting to lift the ban:
Some key quotes from the FDA's 2015 report on keeping the ban (very, very useful reference):
Although MSM represent a small percentage of the U.S. male population (
approximately 7% of men report that they have ever participated in MSM activity and approximately 4% of men report that they engaged in MSM activity in the last 5 years 1 ) (Ref. 26), they comprise a large proportion of adults in the United States with existing and newly diagnosed HIV infections. Among persons living with HIV in 2012,
CDC estimates that 56% were MSM (including MSM who were also IDU) (Ref. 27).
MSM remain at increased risk of HIV infection. In 2010, the majority of new HIV infections were attributed to male-to-male sexual contact:
63% among all adults and
78% among men, indicating that male-to-male sexual contact remains associated with high risk of HIV exposure (Ref. 28).
* * *
Sex with an HIV-positive partner was associated with a 132-fold increase in risk (multivariable adjusted odds ratio) for being HIV-positive, and a
history of male-to-male sexual contact was associated with a
62-fold increase in risk.
By comparison, the increase in risk for a history of multiple sexual partners of the opposite sex in the last year was
2.3-fold.
* * *
In addition, the compliance rate with the one-year MSM deferral among male donors in Australia following the policy change was >99.7% (Ref. 37).
Of note,
donors in Australia must sign a
declaration in the presence of blood center staff that they understand that there are penalties,
including fines and imprisonment, for providing false or misleading information.
No such declaration is required in the United States, nor are donors advised of penalties for providing false or misleading information.
* * *
However, some have argued that a five-year deferral would, in theory, add a safeguard by allowing time for intervention against
an emerging infectious disease that might spread rapidly among MSM and be transmitted through blood transfusion.
* * *
Specifically, the rate of partner infidelity in
ostensibly monogamous heterosexual couples and same-sex male couples is estimated to be
about 25%, and condom use is associated with a 1 to 2% failure rate per episode of anal intercourse (Refs. 38, 39, 40, 41).
In addition, the prevalence of HIV infection is significantly higher in MSM with multiple male partners compared with individuals who have only multiple opposite sex partners (Ref. 28).
* * *
HIV testing on blood donated in the United States is currently implemented by assays including nucleic acid testing. Nucleic acid testing is generally performed on pools of 6 to 16 donor samples. Pooling of samples both markedly reduces the cost of testing and is associated with a reduced number of false positive samples.
The window period when recent HIV infection might be missed using this testing strategy is approximately 9 days. Given this, it has been suggested that no donor deferral is necessary, given the relatively low likelihood that a recently infected individual would give blood.
However, in the setting of the
approximately 50,000 new HIV infections per year in the United States, conservative calculations performed by FDA estimate that this approach could potentially be associated with an
approximately four-fold increase in HIV transmissions resulting from blood transfusions each year.
Such a policy, increasing the potential for the transmission of HIV infection, is
not aligned with maintaining or improving the safety of the blood supply in the U.S.
* * *
In addition,
self-report of monogamy cannot be relied upon because of the relatively high rate of infidelity between partners in any type of sexual relationship (Ref. 38). Even if a potential donor is truthful in providing responses regarding his or her own behavior, the response may not be meaningful if a partner has not been monogamous.
* * *
As a group, in the United States,
MSM have the highest HIV risk: according to CDC, two-thirds of new HIV infections occur in the approximately 2% of the population who are MSM (Ref. 27). The risk of HIV among MSM is more than twenty-fold higher than that of men who have sex with multiple female partners and women who have sex with multiple male partners (Ref. 32).
Thus, absent another scientifically-validated way of identifying individuals at highest risk of transmitting HIV,
a time-based deferral for MSM since last sexual encounter is
the one deferral policy that has been
demonstrated to be effective in a setting with similar HIV epidemiology to the United States.
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