Category Archives: LGBTQ Issues

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The FDA’s “Draft Guidance for Industry” still recommends an effective ban on blood donation by gay and bisexual men.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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The FDA Modifies Gay Blood Ban But Continues to Disregard Facts

Just before Christmas, the FDA accepted the recommendation of a Department of Health and Human Services panel and announced its plan to modify its ban on gay blood donation. Instead of barring gay (and bisexual) men from donation for life, as the policy has up to this point, the FDA plans to accept blood from gay men who have been celibate for at least one year.

While this shift would represent nominally better policy, however, it would preserve the ban’s core problem: that the FDA is targeting a high-risk group (men who have sex with men) instead of high-risk behavior (unprotected sex, especially receptive anal sex, with multiple partners – regardless of the gender of those involved). Not only is the ban unjust, but statistics from the Centers for Disease Control and Prevention (CDC) also indicate that the policy is scientifically baseless.

The FDA’s blood donation guidelines apply to questionnaires used by the Red Cross and other blood collection agencies. Prospective donors respond to survey questions that ask about their travel history, drug usage, and other risk factors associated with disease transmission. People with certain responses are asked to disqualify themselves from donation.

Because it highlights activities that increase the risk of disease, this practice should function as an important educational tool. But by suggesting that gay and bisexual men are at risk and straight people aren’t, the FDA’s guidelines misinform the public. To the extent that it contributes to ignorance of the risks associated with certain types of heterosexual sex, the FDA’s policy, even in its revised form, actually presents a public health concern.

The FDA’s insistence on outdated, unscientific guidelines for blood donor deferral also undermines its credibility more generally. Diminished credibility could have significant ramifications; for example, it may be harder to debunk the myth that vaccinations cause autism without high levels of public confidence in the FDA. Most of the FDA’s recommendations about food and drug safety are surely legitimate, but critics of these recommendations can now point to a clear instance – blood donor eligibility criteria – in which the organization has disregarded the facts.

Some people might contend that the one-year ban is an improvement, albeit a very small one, to the lifetime ban. As minimal progress can be considered better than no progress at all, this argument isn’t necessarily wrong. But organizations also sometimes adopt nominally better policy to pacify opposition and avert or postpone more sweeping changes.

Regardless of the FDA’s motives in this case, their proposal remains backwards. In addition to inappropriately stigmatizing gay men, the blood ban spreads misinformation about public health and harms the FDA’s credibility. It is therefore imperative that activists apply pressure until the FDA embraces science and adopts the focus on actual high-risk behavior that has worked in Italy for the past thirteen years.

Note: A version of this article originally appeared in The Huffington Post.

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Dear FDA: Let Gay Men Donate Blood

Gay men cannot donate blood in America.

I was reminded of this discriminatory and illogical policy after a recent conversation about student advocacy on Twitter.  In 2005, at the end of my junior year of high school, several friends and I mounted a campaign to change this rule.  I wrote letters to and corresponded with members of the Red Cross and independent blood centers.  Many of the people I spoke with expressed agreement that the policy was misguided.  The Medical Director at the Red Cross’s Penn-Jersey Region branch, for example, wrote to me on October 3, 2005 that “the American Red Cross believes it is time for the FDA to reevaluate the issue.”  I reached out to the FDA, which sets the policy, and spoke with the Consumer Safety Officer in their Center for Biologics Evaluation and Research.  After he told me the decision lay with the FDA’s Blood Products Advisory Committee (BPAC), I followed up by drafting a letter to each of the committee’s members.

By that time, I had begun working for Equality Forum, a Philadelphia-based LGBT nonprofit.  I turned the blood drive policy campaign over to my new employer and, for the next two summers, worked primarily on the Fortune 500 Non-Discrimination Project and LGBT History Month.  The BPAC never responded to our letter, and the FDA continues to bar gay men from blood donation despite opposition from the American Osteopathic Association and the American Medical Association.

The FDA insists it is “open to changing the lifetime ban and is awaiting the results of new research that will provide additional evidence.”  However, despite the FDA’s claims to the contrary, additional evidence is not needed.  Evidence clearly supported changing the policy nine years ago, and the evidence is even stronger today.

A U.S. Department of Health and Human Services panel recently recommended replacing the lifetime ban with a one-year ban, but this change would only be a marginal improvement; the ban should be lifted altogether.  Since the FDA is meeting to discuss the issue on December 2, I am posting an updated, condensed version of my original letter below.

Open Letter

Dear FDA Staff,

I wrote to each member of the Blood Products Advisory Committee nine years ago on behalf of dozens of students from Moorestown Friends School and the New Jersey Governor’s School of International Studies.  We hoped you would reconsider the FDA’s policy barring “men who have had sex with other men (MSM), at any time since 1977” from donating blood.  I remain concerned about this issue and am following up with this “open letter” to continue the conversation.  The FDA’s policy still unnecessarily stigmatizes gay men and fails to most effectively “assure the safety” of individuals who receive donated blood.

The FDA claims this policy is warranted because gay men “are the population most severely affected by HIV. In 2010, MSM accounted for at least 61% of all new HIV infections in the U.S. and an estimated 77% of diagnosed HIV infections among males were attributed to male-to-male sexual contact.”  While these numbers might sound impressive after a cursory review, they do not justify the policy.

First, homosexual males – men who have had sex with other men – are the only people the FDA bans from donation on the basis of an identity characteristic.  While the FDA’s website implies otherwise, profiling on such a basis is discriminatory by definition.  Listing statistics about the incidence of HIV in the gay population is eerily similar to overtly racist arguments in favor of racial profiling.  The policy is (arguably) wrong regardless of its impact on the blood supply.

Second, the policy does not accurately identify risk behaviors for HIV.  As shown below, the Center for Disease Control and Prevention (CDC) periodically publishes the “Estimated Per-Act Probability of Acquiring HIV from an Infected Source” (these estimates do not factor in the effects of condom usage):

The CDC's "Estimated Per-Act Probability of Acquiring HIV from an Infected Source, by Exposure Act"

The CDC’s “Estimated Per-Act Probability of Acquiring HIV from an Infected Source, by Exposure Act”

Consider Tom, Heather, and John, three potential blood donors who don’t know whether or not their sexual partners have HIV.  Tom, a gay man, is in a monogamous relationship and only has oral sex.  Heather, a straight woman, is in a monogamous relationship and occasionally has anal sex.  John, a straight man, has unprotected penile-vaginal intercourse with multiple partners.

According to the CDC’s probabilities, Tom is least likely to contract HIV and taint the blood supply.  Yet Tom is the only person the FDA bars from blood donation.

The following revisions to the FDA’s policy would be more likely to “assure the safety” of donated blood:

1. Remove the clause identifying “men who have had sex with other men (MSM), at any time since 1977” as high-risk.

2. Add a clause identifying “receptive anal sex” as a high-risk behavior.

3. Add a clause identifying “unprotected anal and/or vaginal sex with multiple partners” as a high-risk behavior.

A policy that incorrectly identifies high-risk groups instead of high-risk behaviors is neither effective nor just.  I hope you will end the FDA’s institutionalized discrimination at your December 2 meeting and look forward to hearing your response.

Sincerely,
Ben Spielberg

Note: A version of this post appeared in The Huffington Post on November 19.  Another modified version appeared in The Washington Post on December 2.

Update (12/13/14) – The FDA did not respond and refused to even vote on this issue; the bigoted and irrational lifetime ban remains in place for now.

Update (12/23/14) – The FDA has now recommended replacing the lifetime ban with a one year ban, but this change would be minor and would still fail to address the policy’s core problems.

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Free Speech: More a Means than an End

Mozilla’s selection of Brendan Eich for CEO on March 24 prompted widespread outrage because of a $1,000 donation he made to the Prop 8 campaign in 2008. Though the tech world had long condemned Eich’s donation to the since-overturned anti-gay marriage ballot initiative, his promotion reinvigorated the criticism that eventually pressured him to resign.

Conor Friedersdorf, Andrew Sullivan, and a whole host of other journalists and bloggers typically supportive of gay rights have recently denounced Eich’s “forced resignation.” Other members of the business community protest the anti-Eich movement because the idea that “one’s politics is one’s own business [has] been the rule in American business for a very long time.” Friedersdorf worries that calls for Eich’s resignation will have “a chilling effect on political speech and civic participation.” Sullivan goes even farther and writes, “When people’s lives and careers are subject to litmus tests, and fired if they do not publicly renounce what may well be their sincere conviction, we have crossed a line. This is McCarthyism applied by civil actors. This is the definition of intolerance.”

Some of these commentators’ concerns are understandable, but their arguments paint an inaccurate picture of the effects of Prop 8, confuse the distinction between private and public views, and mistakenly equate two very different types of political speech and behavior.

Friedersdorf asserts that “no one had any reason to worry that Eich…would do anything that would negatively affect gay Mozilla employees,” while Sullivan contends, “There is not a scintilla of evidence that [Eich] has ever discriminated against a single gay person at Mozilla.” Both writers cite Eich’s vaguely-worded inclusivity commitments as evidence for their claims without recognizing that the entire complaint against Eich is based on his direct contribution to legalized discrimination against gay people in California. By way of his donation in support of Prop 8, he has already “negatively affect[ed]” every “single gay person at Mozilla.” Given Eich’s refusal to denounce the apartheid system of marriage he helped enact into law, it would be illogical to expect him to behave differently in the future.

Relatedly, commentators have bought Eich’s argument that his beliefs are personal and private. While the gay community would be significantly better off were that argument valid, it’s unfortunately completely false. Beliefs become public when they take the form of activism, votes, and donations that lead to laws that have consequences for other people. There’s nothing at all private about a $1,000 donation to a campaign that helped deny gay people equal application of the law for over four years.

Most alarming to Friedersdorf and Sullivan is their perception of the free speech implications of Mozilla’s behavior. Friedersdorf writes that Eich’s resignation sends the message “that if you want to get ahead at Mozilla, you best say nothing about any controversial political issue.” Sullivan similarly opines that “[w]hat we have here is a social pressure to keep your beliefs deeply private for fear of retribution. We are enforcing another sort of closet on others.” In addition to Sullivan’s erroneous (and offensive) suggestion that there’s an equivalence “between the oppression faced by the queer community and [the] intolerance [Prop 8 supporters] feel as ‘out’ bigots,” both writers also use a problematic analogy. Sullivan compares Mozilla’s behavior to “a socially conservative private entity fir[ing] someone because they discovered he had donated against Prop 8” and Friedersdorf similarly writes:

There is very likely hypocrisy at work too. Does anyone doubt that had a business fired a CEO six years ago for making a political donation against Prop 8, liberals silent during this controversy (or supportive of the resignation) would’ve argued that contributions have nothing to do with a CEO’s ability to do his job? They’d have called that firing an illiberal outrage, but today they’re averse to vocally disagreeing with allies.

For free speech purists, Friedersdorf and Sullivan make a good point. If all speech is considered equal and free speech is the most important end for us to consider, the type of reasoning used to oust Eich would be analogous to the reasoning used to fire a CEO who campaigned against Prop 8. However, the Supreme Court has long held that other considerations matter more than free speech in certain circumstances. While Sullivan is right that we should be able to “live and work alongside people with whom we deeply disagree,” there is a major difference between legitimate, intellectually honest disagreements and speech, activism, votes, and/or donations that oppress people. The right to speak freely applies differently to the different sides of the gay marriage debate for the same reason that it’s inaccurate to call Aamer Rahman a reverse racist: the power dynamic matters a great deal. Free speech is more important as a means to protect the powerless from being silenced and oppressed than it is as an end in and of itself. Arguments like Friedersdorf’s and Sullivan’s have been used in the past to justify a neo-Nazi intimidation march through a town inhabited by Holocaust survivors; completely free speech is the wrong cause to defend when it undermines a more important purpose.

Protecting the powerless is probably harder to legislate and enforce than free speech purity. Regardless, our priorities are severely warped when we consider Brendan Eich’s right to a discriminatory political donation ahead of gay individuals’ right to equal benefit of the law.

Update: A version of this article ran on The Left Hook on Wednesday, April 9.

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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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