Tag Archives: LGBT

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.

FDA Blood Ban Proposal

The FDA’s “Draft Guidance for Industry” still recommends an effective ban on blood donation by gay and bisexual men.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

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Lessons About Gay Rights and Business from Arizona Bill’s Veto

On Wednesday, February 26, Republican Governor Jan Brewer vetoed S.B. 1062, a bill that would have helped Arizona businesses deny service to gay customers on religious grounds.  Brewer’s veto and the political controversy surrounding the bill illustrated several important developments in the gay rights movement.

First, US society is finally beginning to condemn religious opposition to gay rights; most of us now recognize that people who oppose gay equality, for any reason, are bigoted.  Though S.B. 1062 lacked explicit references to sexual orientation, most of the bill’s opponents correctly recognized it as an attempt to sanction discrimination against the LGBT population.  And while proponents of such discrimination continue to lie about their anti-gay animus and S.B. 1062’s impact, their influence on public perception is dwindling.  A recent poll conducted jointly by ABC News and The Washington Post found both that only 28% of Americans support the discrimination allowed by S.B. 1062 and that only 34% of Americans still oppose same-sex marriage.  Gay rights have “transformed from being a fringe, politically toxic position just a few years ago to a virtual piety that must be affirmed in decent company. This demonstrates why [defeatism is misguided]: even the most ossified biases and entrenched institutional injustices can be subverted.”

Second, the Republican Party platform is no longer uniformly anti-gay.  Not only did Brewer veto the bill, but John McCain and Mitt Romney also spoke out against S.B. 1062.  Mainstream Republican politicians at this year’s Conservative Political Action Conference (CPAC) “skirted around gay issues during the three-day gathering outside Washington, D.C” and focused on other issues instead.  Republican Party operatives seem to understand that opposition to gay rights is becoming more and more politically disadvantageous.

Third, Brewer’s veto indicates the potential impact of voting with our dollars.  The Hispanic National Bar Association, the Arizona Chamber of Commerce, the Arizona Lodging and Tourism Association, the NFL, and a plethora of large businesses including Apple, American Airlines, and Intel began to voice opposition to S.B. 1062 as pressure mounted from customers, clients, fans, and nonprofits.  Brewer’s anti-gay history suggests she only vetoed the bill because of the intense economic pressure to do so.

These developments are cause for optimism about the future for LGBT rights.  I bet a friend seven years ago that gay marriage will be legal in all fifty states by the end of 2023, and I am currently feeling pretty good about my chances.  However, proponents of gay rights must avoid calling business interests our “greatest ally in [the] LGBT equality pursuit.”

As Jon Stewart noted recently on The Daily Show, S.B. 1062 was “morally repugnant” and should have been vetoed based on ethical criteria alone.  Yet few opponents of the bill made ethics their central argument against it; critics of S.B. 1062 instead focused more on its economic impact.  That business interest has begun to align with the interests of the LGBT community is positive, but as Jeffrey Toobin mentioned in a recent piece for The New Yorker, that alignment only achieves the desired outcome “[w]hen, as with expressing opposition to S.B. 1062, it costs business nothing.”

In other words, it’s easy for businesses and politicians to support gay equality and non-discrimination because doing so furthers their economic and political self-interest.  Gay rights have become an issue that, like big philanthropy, “allows [politicians and business leaders] to preen as…great liberal champion[s] to…left-leaning voters, all while…simultaneously press[ing] an anti-union, economically conservative agenda that moneyed interests support.”  We should certainly celebrate the success of the gay rights movement, but we must simultaneously be careful not to enable what David Sirota calls “a bait and switch whereby social issues are increasingly used to perpetuate the economic status quo.”

So before we extol the virtues of the NFL for its opposition to S.B. 1062, let’s remember that the league and its owners routinely rob taxpayers.  Let’s remember, before we get too excited about Jan Brewer, that she supports racial profiling.  And let’s remember, before we pat the Arizona Chamber of Commerce on the back for defending the rights of the underprivileged, that the organization frequently lies about the impact of minimum wage laws.  Instead, let’s honor the success of the gay rights movement by calling its support what it is – the only ethical choice a business can make.  Let’s simultaneously demand that politicians and business leaders elevate ethics over greed in every other policy arena.

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