Tag Archives: FDA

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The FDA’s “Draft Guidance for Industry” still recommends an effective ban on blood donation by gay and bisexual men.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