June July 2016
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To The FDA, Everyone Transgender Is a Gay Man

To The FDA, Everyone Transgender Is a Gay Man

The U.S. Food and Drug Administration announced in December that it would soon reevaluate policies to allow more gay and bisexual men to donate blood, but health and civil rights advocates say the administration still enforces a “heterosexist bias” against transgender donors.

The policy in place since 1983 indefinitely banned men who have had sex with men from donating blood, but after years of lobbying from medical organizations, activists, and politicians, the FDA said the policy would be reevaluated. Later this year, the FDA is expected to officially lift the lifetime ban, and instead enforce a one-year ban following the last time a man had sex with another man, and remained HIV-negative. 

Over the decades, the agency has been under increasing pressure to alter its strict stance. The American Medical Association (AMA), for one, declared it “supports the use of rational, scientifically-based blood and tissue donation deferral periods that are fairly and consistently applied to donors according to their level of risk,” but “opposes the current lifetime deferral on blood and tissue donations from men who have sex with men.”

As the Los Angeles Times reported, “The FDA was caught between the civil rights of prospective gay donors and its mandate to protect public health.”

But what has not been reported is that in addition to turning away all MSM, the FDA has a policy on the books that disregards the authentic gender expressions of transgender men and women which also prevents them from giving blood.

This policy has nothing to do with the fact that many trans people undergo hormone replacement therapy (HRT) to aid in their gender transition. Although the FDA mentions only hormones taken for menopausal symptoms and prevention of osteoporosis, the American Red Cross certifies this policy on its website: “women on hormone replacement therapy… are eligible to donate.”

So if it’s not the meds, what is it? It’s that, to the Food and Drug Administration, all trans people are gay men. But that information is not on the agency’s website or in a pamphlet.

The Advocate has confirmed with the FDA that a trans woman, even one who has undergone gender confirmation surgery and engages in heterosexual relations with a cisgender male, is still considered male in terms of her eligibility to donate blood, and that both she and her partner are banned — because their intercourse is considered by the FDA to be two men having sex.

In a written statement, spokeswoman Tara Goodin told The Advocate, “The FDA’s current donor deferral policy recommends that men who have had sex with other men (MSM) at any time since 1977 are indefinitely deferred from donation of blood based on well-documented observations of much higher rates of transmissible diseases among MSM than in the non-MSM population.”

When it comes to transgender people, Goodin says the FDA will continue the policy that the sex of the donor is determined at birth, at least as far as establishing the donor's eligibility. 

“For example, FDA recommends that genetic males be considered as males for donation purposes, even after gender-altering surgery,” Goodin wrote in an email December 31.

When asked for clarification of this apparent contradiction in LGBT acceptance throughout the Obama administration, Goodin told The Advocate on January 20, “the FDA currently recommends that male to female transgender individuals should be regarded as males for the purposes of determining donor eligibility.”

Goodin’s second email made clear the buck doesn’t stop with the FDA: “Additionally, please understand that with regard to blood donor deferral policies in general, the ultimate determination of donor suitability is made by the medical director of the blood or plasma establishment. Establishments may voluntarily elect more stringent donor deferral criteria than those required or recommended by the FDA.”

The policy gets more complex when it comes to trans men. A person who was assigned female at birth, and perhaps even conceived and delivered a baby, is not eligible according to the FDA — whether he transitions or undergoes bottom surgery — so long as he identifies as transgender and is presumed to engage in sex with men.

For transgender donors who were assigned female at birth, this stance raises important health considerations that could mean potential red flags are missed, including post-pregnancy complications like anemia, iron deficiency, breast problems and an increased risk of cervical cancer than is typically found in other people the FDA now calls “gay men.”

“Our bodies are complicated,” says Jamison Green, president of the World Professional Association for Transgender Health (WPATH). He says the assumption that all transgender people are engaged in sex with men is more proof that a large part of the medical community hasn’t kept up with the times.

“[Blood donation facilities] don’t screen females who have sex with men," Green told The Advocate. "For me, this policy shows a heterosexist bias [by the FDA] and it reveals a bigger problem of the lack of transgender inclusion in the practice of medicine.”

Is there a difference? Is female blood the same as male blood? Scientists rank human blood by type, not by gender, just as they would never classify blood as “black” or “white.” Archie Bunker helped Americans understand this in 1976, when the lead character of TV’s All in the Family learned he had received a blood transfusion from a West Indian woman.

Leading endocrinologist Vin Tangpricha, M.D., Ph.D., associate professor of medicine at Emory University in Atlanta, makes it clear: “Red Blood Cells don't have a gender, so why does it matter whether the blood is from a female, male or transgender person?”

According to Dana Beyer, M.D., a retired eye surgeon, transgender advocate, and political activist in Maryland, the FDA policy is “indirectly discriminatory, as well as harmful to the proper collection of data.”

Beyer says it may be understandble that some agencies have yet to settle on a definition for trans persons, but “there is a pressing need for trans women to be counted for HIV reporting purposes. In 2015, however, the Obama administration can do better and should finally agree, with community input, on an acceptable definition for trans women, so we can be counted to improve our access to health care as well as be counted in the 2020 census."

Rebecca Allison, M.D., a member of the board of both WPATH and the Gay and Lesbian Medical Association, told The Advocate that the FDA policy for trans people "conflates gender identity with sexual activity," and is too simplistic. 

“A trans woman, for example, may have sex with cisgender men, cisgender women, transgender men, or other transgender women,” Allison said. “A significant number don’t have sex at all.  Treating all these groups the same is too simplistic and will prevent some very low risk persons from donating."

Allison notes that transgender women share similar risks with all women: some women who engage in survival sex work or unprotected sex, for example, are at a high risk for contracting STDs and should not donate.

On the other hand, Allison says, "monogamous transgender persons are very low risk, as are celibate persons. A thorough individual sexual history is better for identifying an individual’s risk as a blood donor.”

Even with the rigid policy, the FDA says change is possible. The next step in the process of removing the lifetime blood ban for MSM will be when the FDA issues revised measures to reduce the risk of transmission of HIV, including the proposed change in the MSM policy.

“The FDA’s issuance of the draft guidance will include an opportunity for all stakeholders and interested parties to provide public input and any information they believe the FDA should consider related to the proposed change in policy,” Goodin wrote. “The FDA encourages all stakeholders, including those concerned about transgender issues, to take the opportunity to provide comments on the draft guidance.

The draft guidance will be announced in the Federal Register and posted to the FDA’s website, Goodin mentioned, adding that regulations.gov is the site where the public can add comments once the draft is posted.

The process is slow. Although it was back in November that the Department of Health and Human Services’ Advisory Committee on Blood Safety and Availability first suggested easing the ban, the FDA didn’t make its decision for a few weeks. It heard from a panel of independent experts who concluded that imposing this deferral, or waiting period, of one year would not endanger the safety of the nation’s blood supply.

However, there are critics who feel any restriction based on sexual orientation, in an age where blood is routinely screened for HIV and other infections, is discriminatory.

Australia adopted a one-year deferral policy for men who have had sex with men back in 2000. Sweden, the United Kingdom and Japan followed suit.

There is no known timetable for publication of the policy revision by the FDA, nor any information on when the public will be allowed to make comments.

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