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FDA-funded blood donation study recruiting gay, bi men

D.C.’s Whitman-Walker, L.A. LGBT Center working on study to ease restrictions

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gay blood ban, gay news, Washington Blade
A new study could make it easier for gay and bi men to donate blood.

D.C.’s Whitman-Walker Institute and the Los Angeles LGBT Center are among LGBTQ supportive organizations in eight U.S. cities working with the nation’s three largest blood donation centers on a study to find a way to significantly ease blood donation eligibility for men who have sex with men or MSM.

The study, which is funded by the U.S. Food and Drug Administration, calls for recruiting a total of 2,000 gay and bisexual men in eight U.S. cities selected for the study to test the reliability of a detailed donor history questionnaire aimed at assessing the individual risk of a gay or bisexual man transmitting HIV if they donate blood.

A statement released by the study organizers says the questionnaire, which could be given to a gay or bisexual person showing up at a blood donation site, could be a replacement for the FDA’s current policy of banning men who have had sex with another man within the previous three months from donating blood.

In the early years of the AIDS epidemic in the 1980s, the FDA put in place a permanent ban on blood donations by men who have sex with men. In 2015, with advanced HIV testing and screening techniques readily available, the FDA lifted its permanent ban on MSM blood donations and replaced it with a 12-month restriction for sexual activity between MSM.

The FDA further reduced the time of sexual abstinence for MSM to three months in 2020.

LGBTQ rights organizations and others advocating for a change in the current FDA restriction point out that at a time when the nation is facing a severe shortage of blood donations due to the COVID pandemic, the three-month donation deferral requirement for MSM is preventing a large number of blood donations from men whose risk of HIV infection is low to nonexistent.

Under the FDA-funded and initiated study, the American Red Cross, Vitalant, and OneBlood — the nation’s three largest blood donation centers — have been conducting the questionnaire testing since the study was launched in March 2021.

“To gather the necessary data, the blood centers will partner with LGBTQ+ Centers in Washington, D.C., San Francisco, Orlando, New Orleans/Baton Rouge, Miami, Memphis, Los Angeles, and Atlanta,” the study organizers say in a statement on a website launched to help recruit volunteers for the study.

“The study will enroll a total of 2,000 gay and bisexual men (250 – 300 from each area) who meet the study eligibility criteria,” the statement says.

Among the criteria for being eligible, the statement says, is the person must be between 18 and 39 years old, have expressed an interest in donating blood, must have had sex with at least one other man in the three months before joining the study, and must agree to an HIV test. A negative test result is also required for acceptance into the study.

The study is officially named ADVANCE, which stands for Assessing Donor Variability And New Concepts in Eligibility.

“The ADVANCE study is a first step in providing data that will help the FDA determine if a donor history questionnaire based on individual risk would be as effective as time-based deferral, in reducing the risk of HIV in the blood supply,” the study organizers statement says.

“If the scientific evidence supports the use of the different questions, it could mean men who have sex with men who present to donate would be assessed based upon their own individual risk for HIV infection and not according to when their last sexual contact with another man occurred,” the statement continues. “The ADVANCE study is groundbreaking because it’s the first time a study is being conducted that could result in individual risk assessment for men who have sex with men to donate blood,” the statement says.

The Whitman-Walker Institute, which is among the community-based organizations involved in helping organize and conduct the study, is an arm of Whitman-Walker Health, the LGBTQ supportive D.C. health center.

Christopher Cannon, director of Research Operations for Whitman-Walker Institute, said that since the D.C.-based part of the study was launched early last year prior to the official announcement of the study on March 20, D.C. has surpassed the original city goal of recruiting 250 participants for the study.

“We are currently at 276 as of last Friday’s report,” Cannon told the Blade in a Jan. 13 interview. “And the current goal is now 300,” he said. “So, we’re hoping to push this over that goal line in the coming days and weeks.

Cannon said that like the community organizations involved in the study in other cities, Whitman-Walker Institute’s role has been focused on recruiting gay and bisexual men to participate in the study and to send them to the American Red Cross headquarters building at 430 17th St., N.W. near the White House. That site, which serves as a blood donation center, is also serving as the site where study participants are screened, interviewed, and presented with a detailed questionnaire.

“We promote the study within Whitman-Walker,” Cannon said. “We promote it to our networks. We did social media promotions across the city.’

Although Whitman-Walker doesn’t have the final draft of the questionnaire being presented to study participants, Cannon said he has seen “bits and pieces” of it.  

“They ask very direct questions about the person’s sex life, sexual partners, sex acts, numbers of partners,” Cannon said. “There are questions about condom use, PrEP use, drug use. How recently have you had sex? Lots of related questions,” he said.

“It’s really about trying to figure out effectively which are the best questions,” according to Cannon. “The hope is by analyzing the questions and identifying maybe the best 10 to 12 questions that can be universally used…to get the best answers that identify the individuals that may have the highest risk,” he said. Doing that, he points, out can help determine which men who have sex with men should be eligible to safely donate blood.

A statement released by Whitman-Walker last March calls the study a “monumental research effort” that has the potential to lift the stigma imposed on gay and bisexual men whose ability to donate blood is currently based on their sexual orientation.

“The ADVANCE study is designed to understand if, by asking carefully crafted and research-informed research questions, blood collectors can screen potential blood donors for their individual HIV risk factors rather than applying a ban against sexually active gay and bisexual men,” the statement says.

“The goal is to move away from overly broad questions that exclude potential donors and spread stigmatizing messages about MSM and their HIV risks,” it says.

Cannon said that as of last week, study organizers had recruited a total of 879 study participants nationwide out of the goal of 2,000 participants needed to complete the study. He said issues related to the COVID pandemic created delays in the recruitment efforts, but study organizers were hopeful the study could be completed by this summer.

Information about participating in the study or learning more about it can be obtained at advancestudy.org.

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Federal Government

RFK Jr.’s HHS report pushes therapy, not medical interventions, for trans youth

‘Discredited junk science’ — GLAAD

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HHS Secretary Robert F. Kennedy Jr. (Washington Blade photo by Michael Key)

A 409-page report released Thursday by the U.S. Department of Health and Human Services challenges the ethics of medical interventions for youth experiencing gender dysphoria, the treatments that are often collectively called gender-affirming care, instead advocating for psychotherapy alone.

The document comes in response to President Donald Trump’s executive order barring the federal government from supporting gender transitions for anyone younger than 19.

“Our duty is to protect our nation’s children — not expose them to unproven and irreversible medical interventions,” National Institutes of Health Director Dr. Jay Bhattacharya said in a statement. “We must follow the gold standard of science, not activist agendas.”

While the report does not constitute clinical guidance, its findings nevertheless conflict with not just the recommendations of LGBTQ advocacy groups but also those issued by organizations with relevant expertise in science and medicine.

The American Medical Association, for instance, notes that “empirical evidence has demonstrated that trans and non-binary gender identities are normal variations of human identity and expression.”

Gender-affirming care for transgender youth under standards widely used in the U.S. includes supportive talk therapy along with — in some but not all cases — puberty blockers or hormone treatment.

“The suggestion that someone’s authentic self and who they are can be ‘changed’ is discredited junk science,” GLAAD President and CEO Sarah Kate Ellis said in a statement. “This so-called guidance is grossly misleading and in direct contrast to the recommendation of every leading health authority in the world. This report amounts to nothing more than forcing the same discredited idea of conversion therapy that ripped families apart and harmed gay, lesbian, and bisexual young people for decades.”

GLAAD further notes that the “government has not released the names of those involved in consulting or authoring this report.”

Janelle Perez, executive director of LPAC, said, “For decades, every major medical association–including the American Medical Association and the American Academy of Pediatrics–have affirmed that medical care is the only safe and effective treatment for transgender youth experiencing gender dysphoria.

“This report is simply promoting conversion therapy by a different name – and the American people know better. We know that conversion therapy isn’t actually therapy – it isolates and harms kids, scapegoats parents, and divides families through blame and rejection. These tactics have been used against gay kids for decades, and now the same people want to use them against transgender youth and their families.

“The end result here will be a devastating denial of essential health care for transgender youth, replaced by a dangerous practice that every major U.S. medical and mental health association agree promotes anxiety, depression, and increased risk of suicidal thoughts and attempts.

“Like being gay or lesbian, being transgender is not a choice, and no amount of pressure can force someone to change who they are. We also know that 98% of people who receive transition-related health care continue to receive that health care throughout their lifetime. Trans health care is health care.”

“Today’s report seeks to erase decades of research and learning, replacing it with propaganda. The claims in today’s report would rip health care away from kids and take decision-making out of the hands of parents,” said Shannon Minter, legal director of NCLR. “It promotes the same kind of conversion therapy long used to shame LGBTQ+ people into hating themselves for being unable to change something they can’t change.”

“Like being gay or lesbian, being transgender is not a choice—it’s rooted in biology and genetics,” Minter said. “No amount or talk or pressure will change that.” 

Human Rights Campaign Chief of Staff Jay Brown released a statement: “Trans people are who we are. We’re born this way. And we deserve to live our best lives and have a fair shot and equal opportunity at living a good life.

“This report misrepresents the science that has led all mainstream American medical and mental health professionals to declare healthcare for transgender youth to be best practice and instead follows a script predetermined not by experts but by Sec. Kennedy and anti-equality politicians.”




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The White House

Trump nominates Mike Waltz to become next UN ambassador

Former Fla. congressman had been national security advisor

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U.N. headquarters in New York (Washington Blade photo by Michael K. Lavers)

President Donald Trump on Thursday announced he will nominate Mike Waltz to become the next U.S. ambassador to the U.N.

Waltz, a former Florida congressman, had been the national security advisor.

Trump announced the nomination amid reports that Waltz and his deputy, Alex Wong, were going to leave the administration after Waltz in March added a journalist to a Signal chat in which he, Defense Secretary Pete Hegseth, and other officials discussed plans to attack Houthi rebels in Yemen.

“I am pleased to announce that I will be nominating Mike Waltz to be the next United States ambassador to the United Nations,” said Trump in a Truth Social post that announced Waltz’s nomination. “From his time in uniform on the battlefield, in Congress and, as my National Security Advisor, Mike Waltz has worked hard to put our nation’s Interests first. I know he will do the same in his new role.”

Trump said Secretary of State Marco Rubio will serve as interim national security advisor, “while continuing his strong leadership at the State Department.”

“Together, we will continue to fight tirelessly to make America, and the world, safe again,” said Trump.

Trump shortly after his election nominated U.S. Rep. Elise Stefanik (R-N.Y.) to become the next U.S. ambassador to the U.N. Trump in March withdrew her nomination in order to ensure Republicans maintained their narrow majority in the U.S. House of Representatives.

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U.S. Federal Courts

Second federal lawsuit filed against White House passport policy

Two of seven plaintiffs live in Md.

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Lambda Legal on April 25 filed a federal lawsuit on behalf of seven transgender and nonbinary people who are challenging the Trump-Vance administration’s passport policy.

The lawsuit, which Lambda Legal filed in U.S. District Court for the District of Maryland in Baltimore, alleges the policy that bans the State Department from issuing passports with “X” gender markers “has caused and is causing grave and immediate harm to transgender people like plaintiffs, in violation of their constitutional rights to equal protection.”

Two of the seven plaintiffs — Jill Tran and Peter Poe — live in Maryland. The State Department, Secretary of State Marco Rubio, and the federal government are defendants.

“The discriminatory passport policy exposes transgender U.S. citizens to harassment, abuse, and discrimination, in some cases endangering them abroad or preventing them from traveling, by forcing them to use identification documents that share private information against their wishes,” said Lambda Legal in a press release.

Zander Schlacter, a New York-based textile artist and designer, is the lead plaintiff.

The lawsuit notes he legally changed his name and gender in New York.

Schlacter less than a week before President Donald Trump’s inauguration “sent an expedited application to update his legal name on his passport, using form DS-5504.”

Trump once he took office signed an executive order that banned the State Department from issuing passports with “X” gender markers. The lawsuit notes Schlacter received his new passport in February.

“The passport has his correct legal name, but now has an incorrect sex marker of ‘F’ or ‘female,'” notes the lawsuit. “Mr. Schlacter also received a letter from the State Department notifying him that ‘the date of birth, place of birth, name, or sex was corrected on your passport application,’ with ‘sex’ circled in red. The stated reason was ‘to correct your information to show your biological sex at birth.'”

“I, like many transgender people, experience fear of harassment or violence when moving through public spaces, especially where a photo ID is required,” said Schlacter in the press release that announced the lawsuit. “My safety is further at risk because of my inaccurate passport. I am unwilling to subject myself and my family to the threat of harassment and discrimination at the hands of border officials or anyone who views my passport.”

Former Secretary of State Antony Blinken in June 2021 announced the State Department would begin to issue gender-neutral passports and documents for American citizens who were born overseas.

Dana Zzyym, an intersex U.S. Navy veteran who identifies as nonbinary, in 2015 filed a federal lawsuit against the State Department after it denied their application for a passport with an “X” gender marker. Zzyym in October 2021 received the first gender-neutral American passport.

Lambda Legal represented Zzyym.

The State Department policy took effect on April 11, 2022.

Trump signed his executive order shortly after he took office in January. Germany, Denmark, Finland, and the Netherlands are among the countries that have issued travel advisories for trans and nonbinary people who plan to visit the U.S.

A federal judge in Boston earlier this month issued a preliminary injunction against the executive order.  The American Civil Liberties Union filed the lawsuit on behalf of seven trans and nonbinary people.

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