Anti-gay Policy at the FDA and What You Can Do About It

Ireland recently became the first country to legalize gay marriage through public referendum, a major victory for the LGBT rights movement. The US Supreme Court is expected to follow in Irish voters’ footsteps soon; the court will probably rule in favor of legalized gay marriage when it issues an opinion on Obergefell v. Hodges, most likely by the end of June.

But the fight for LGBT rights is far from over – barriers to LGBT equality remain a persistent part of our culture and policies. Advocates have done an amazing job inciting change on the marriage front, and we must keep the momentum rolling by addressing outstanding forms of institutionalized discrimination.

Blood donation guidelines represent one such form of state-sanctioned prejudice. For over thirty years, the Food and Drug Administration has disqualified “men who have sex with men (MSM)” – gay and bisexual men – from giving blood. In response to calls from the public and scientific community to end the ban, the FDA recently proposed to modify its donor eligibility criteria. Yet its proposal amounts to mere window-dressing; by only allowing gay men who have been celibate for a year to donate, the FDA would preserve its policy’s core error and injustice.

The FDA’s “Draft Guidance for Industry” still recommends an effective ban on blood donation by gay and bisexual men.

While the FDA claims its proposed policy is intended to protect the blood supply from HIV, the science does not support the FDA’s claim. Being a man who has sex with other men is an identity characteristic, not a risk behavior for contracting HIV. Actual risk behaviors include “needle-sharing during injection drug use,” which the FDA does identify as high-risk, and certain sexual practices – like unprotected anal sex and unprotected sexual intercourse with multiple partners – that the FDA ignores when heterosexual people engage in them.

Fortunately, there’s still a way to help the FDA fix this policy error – for the next month-and-a-half, the FDA will consider comments on its proposal. My comment is at the end of this post, and you’re welcome to copy and use it if you don’t have time to write your own. Your comment in whatever form you choose can be submitted here.

Note that the FDA offers the following explanation for its decision to eschew the identification of high-risk sexual behavior and instead profile gay and bisexual men:

The individual risk-based options were not determined to be viable options for a policy change at this time for a number of reasons: pretesting would be logistically challenging, and would likely also be viewed as discriminatory by some individuals, and individual risk assessment by trained medical professionals would be very difficult to validate and implement in our current blood donor system due to resource constraints. Additionally, the available epidemiologic data in the published literature do not support the concept that MSM who report mutual monogamy with a partner or who report routine use of safe sex practices are at low risk for HIV. 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).

This explanation stands in stark contrast, however, to the FDA’s proposed use of its guidelines as “donor education material…so that donors can self-defer.” The recommendations appear as part of a “Donor History Questionnaire;” striking one question and adding a few in its place would not require any resources whatsoever beyond what the blood donor system can currently handle. And doing so would make the guidelines far more educational about the actual risks associated with sexual behavior – statistics about HIV prevalence, reported monogamy, and condom failure present a limited picture of an individual’s risk of HIV contraction. In fact, the FDA currently propagates misinformation about HIV risk by lumping “anal, oral, or vaginal sex, regardless of whether or not a condom or other protection is used,” into the same category, and then inaccurately suggesting that such broadly defined “sex” is high-risk when gay and bisexual men have it and low-risk when engaged in by anyone else.

The FDA’s insistence on a one-year ban for gay and bisexual men is even more absurd when considering the results of a study, called BloodDROPS, that the agency itself commissioned and that is cited in the FDA’s draft recommendations. The study found that some gay and bisexual men, correctly viewing the FDA’s policy “as discriminatory and stigmatizing,” chose to donate blood anyway. Far from wreaking havoc on the blood supply, however, these individuals actually had lower rates of HIV (0.25%) than are seen in the general population (over .35%). In other words, it appears that gay and bisexual men understand their HIV risk at least as well as the FDA does; they donate responsibly in spite of discriminatory practices and will continue to donate responsibly if and when the FDA issues accurate donor education materials.

Other countries, from Spain to Mexico to Italy, have already implemented more scientific policies that defer donors on the basis of sexual behavior instead of sexual orientation. A recent study on the Italian policy, which has been in place since 2001, concluded that the change away from profiling gay and bisexual men “did not significantly affect either the incidence or prevalence of HIV infection among blood donors.”

So without further ado, here’s the comment I have submitted to the FDA (again, please feel free to copy it, modify it, and/or to write your own comment and submit it here):

Dear FDA,

I am writing to express concern about the proposed revision to your blood donor deferral criteria for gay and bisexual men (MSM). Our knowledge of HIV transmission and the experience of other countries in adopting safe, reliable, and nondiscriminatory donor eligibility criteria indicate that a one-year deferral, while marginally better than the lifetime deferral currently in place, would continue to stigmatize gay men without improving the safety of the blood supply.

While the prevalence of HIV is higher among MSM than among the general population, an individual’s risk of contracting HIV from sexual contact depends both on the probability that a sexual partner has HIV and the probability that HIV will be transmitted through a given type of sexual contact. As a result, many individuals who engage in unprotected heterosexual intercourse with multiple partners have a greater risk of contracting HIV than gay or bisexual men who use protection, especially if those gay or bisexual men are in committed relationships.

In fact, the BloodDROPS study you commissioned found rates of HIV prevalence among MSM blood donors lower than rates of HIV prevalence seen in the general population. These results suggest that MSM who engage in riskier sexual behaviors already abstain from donation, and that they would continue to do so if provided with a more appropriately-constructed questionnaire.

I strongly urge you to strike items ix and x from your recommendations for an updated donor history questionnaire. I also urge you to strike the footnote that puts “anal, oral, or vaginal sex, regardless of whether or not a condom or other protection is used,” into the same category. Those items could be replaced with the following recommendations for deferral in the DHQ:

1. A history in the past twelve months of anal sex with multiple partners or of unprotected anal sex,

2. A history in the past twelve months of unprotected vaginal sex with multiple partners.

Making this change would not require new resources. It would preserve blood safety, end the FDA’s discrimination against gay and bisexual men, and improve the educational value of donor education material. And it would also bring the US policy in line with policies in place in Mexico, Spain, and Italy. A recent study of Italy’s policy, instituted in 2001, found that the country maintained the integrity of its blood supply after it discarded its ban on MSM in favor of unprejudiced deferral criteria.

I believe ending deferral based on sexual orientation entirely is the only way to simultaneously avoid discrimination, preserve the safety of the blood supply, and maintain the FDA’s credibility. Thank you very much in advance for considering my proposed revision.

Sincerely,
Ben Spielberg

Update (6/12/16): The FDA still has the one-year ban, an issue which has resurfaced after Orlando blood banks, in desperate need of blood following a mass shooting at a gay nightclub in Orlando, have had to turn away donors.