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FDA approves injectable PrEP to reduce the risk of sexual HIV infection

Manufactured as Apretude, it will be available to at-risk adults & adolescents who weigh at least 77 pounds & have tested negative for HIV

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FDA headquarters, Silver Spring, MD (Photo Credit: U.S. government/FDA)

SILVER SPRING, Md. – The U.S. Food and Drug Administration announced Monday that the agency had approved the first injectable treatment for pre-exposure prophylaxis (PrEP) to reduce the risk of sexually acquired HIV.

Manufactured under the name Apretude, it will be available to at-risk adults and adolescents who weigh at least 77 pounds and have tested negative for HIV immediately beforehand the agency said in a press release.

By granting its approval, the FDA opens up the option for patients to receive the injectable drug instead of a daily HIV prevention oral medication, such as Truvada.

“Today’s approval adds an important tool in the effort to end the HIV epidemic by providing the first option to prevent HIV that does not involve taking a daily pill,” said Debra Birnkrant, M.D., director of the Division of Antivirals in the FDA’s Center for Drug Evaluation and Research. “This injection, given every two months, will be critical to addressing the HIV epidemic in the U.S., including helping high-risk individuals and certain groups where adherence to daily medication has been a major challenge or not a realistic option.”

According to the U.S. Centers for Disease Control and Prevention, notable gains have been made in increasing PrEP use for HIV prevention in the U.S. and preliminary data show that in 2020, about 25% of the 1.2 million people for whom PrEP is recommended were prescribed it, compared to only about 3% in 2015.

However, there remains significant room for improvement. PrEP requires high levels of adherence to be effective and certain high-risk individuals and groups, such as young men who have sex with men, are less likely to adhere to daily medication.

Other interpersonal factors, such as substance use disorders, depression, poverty and efforts to conceal medication also can impact adherence. It is hoped that the availability of a long-acting injectable PrEP option will increase PrEP uptake and adherence in these groups.

The safety and efficacy of Apretude to reduce the risk of acquiring HIV were evaluated in two randomized, double-blind trials that compared Apretude to Truvada, a once daily oral medication for HIV PrEP.

Trial 1 included HIV-uninfected men and transgender women who have sex with men and have high-risk behavior for HIV infection. Trial 2 included uninfected cisgender women at risk of acquiring HIV.

Participants who took Apretude started the trial with cabotegravir (oral, 30 mg tablet) and a placebo daily for up to five weeks, followed by Apretude 600mg injection at months one and two, then every two months thereafter and a daily placebo tablet.

Participants who took Truvada started the trial taking oral Truvada and placebo daily for up to five weeks, followed by oral Truvada daily and placebo intramuscular injection at months one and two and every two months thereafter.

In Trial 2, 3,224 cisgender women received either Apretude or Truvada. The trial measured the rate of HIV infections in participants who took oral cabotegravir and injections of Apretude compared to those who took Truvada orally.

The trial showed participants who took Apretude had 90% less risk of getting infected with HIV when compared to participants who took Truvada.

Apretude includes a boxed warning to not use the drug unless a negative HIV test is confirmed. It must only be prescribed to individuals confirmed to be HIV-negative immediately prior to starting the drug and before each injection to reduce the risk of developing drug resistance.

Drug-resistant HIV variants have been identified in people with undiagnosed HIV when they use Apretude for HIV PrEeP. Individuals who become infected with HIV while receiving Apretude for PrEP must transition to a complete HIV treatment regimen.

The drug labeling also includes warnings and precautions regarding hypersensitivity reactions, hepatotoxicity (liver damage) and depressive disorders

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Federal Government

National Park Service clarifies uniform policies for all events

National Park Service issued a memo clarifying uniform policies for employees from attending any event.

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Stonewall National Monument NPS park rangers marching in 2021 NYC Pride parade. (Photo Credit: NPS/Facebook)

By Erin Reed | WASHINGTON – The National Park Service on May 17 clarified its policy on employees wearing official uniforms to non-sanctioned events, which has implications for Pride events.

It’s unclear what triggered the clarification. A source at the National Park Service told the Blade in a statement that the uniform policy “has not changed,” but some LGBTQ employees report feeling betrayed and note that official Pride participation in major cities is uncertain as applications to participate in parades remain unprocessed.

The clarification comes amid increasing crackdowns on Pride flags and LGBTQ people nationwide.

The announcement was first disclosed in a memo to park service employees that did not directly address Pride but stated that “requests from employees asking to participate in uniform in a variety of events and activities, including events not organized by the NPS” conflict with park service policy.

The specific provision cited states that park service employees cannot wear the uniform to events that would construe support for “a particular issue, position, or political party.” Applying this provision to bar Pride participation drew ire from some LGBTQ employees who assert that LGBTQ Pride is not about an “issue, position, or political party,” but about identity and diversity. The employees, who spoke on condition of anonymity, also pointed out that the internal ERG guide allowed for participation in Pride events and that park employees had participated in Pride events with approval for years under the current set of rules.

NPS Email outlining the change May 9, 2024

In a follow-up, the park service stated that the ERG resource known as the “OUTsiders Guide to Pride” conflicts with its policy and that it is in discussion with ERG leaders to review it and similar documents.

Meanwhile, it stated that park service participation in Pride “could imply agency support … on a particular issue of public concern,” essentially stating that celebrations of LGBTQ employees would be considered an “issue of public concern” rather than a non-political celebration of diversity. As such, they determined that park service official participation in parades “should be extremely limited.”

Concern spread among some park service employees . They noted that the park service has participated in Pride parades across the United States for years under the same set of rules, including during the Trump administration, which notably cracked down on LGBTQ Pride in government agencies, such as at embassies abroad.

They also noted that Stonewall National Monument is run by the park service. Importantly, Stonewall National Monument’s founding documents state, “The purpose of Stonewall National Monument is to preserve and protect Christopher Park and the historic resources associated with it and to interpret the Stonewall National Historic Landmark’s resources and values related to the lesbian, gay, bisexual, and transgender civil rights movement.”

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Pride Parade Celebration from the Department of the Interior at Stonewall

One park service employee, speaking on condition of anonymity, stated that multiple Pride parade requests are currently sitting on desks “collecting dust” for participation and representation in major city Pride festivities. When asked about the determination that Pride festivals are an “issue of public concern,” they said, “Pride is not political, it’s not a cause, you just are LGBTQ+. It’s a celebration of who we are.” They added, “Morale is just so low right now. There’s not a lot of fight left in us.”

The Blade reached out to a park service spokesperson to ask about Pride parades in major cities and whether the park service would continue participating this year as they have in previous years. The spokesperson stated that the policy “had not changed” and that “Previous interpretations of the uniform policy were inconsistent and, as you can imagine, approving participation in some events and not others could be seen as discrimination based on viewpoint.” They added that in-park Pride events have not been canceled and that community events outside of the parks that “directly relate to a park’s mission” could be approved. However, they did not indicate whether these events would include continued contingents in major U.S. city Pride parades and celebrations and could not be reached for a follow-up on this question.

Park service resources currently live on the site call for people to “Celebrate Pride,” citing Stonewall National Monument to state that “The LGBTQ experience is a vital facet of America’s rich and diverse past.” This resource emphasizes the importance of not rendering LGBTQ people invisible, stating, “By recovering the voices that have been erased and marginalized, the NPS embarks on an important project to capture and celebrate our multi-vocal past.”

Park Service employees have marched in uniform for years. According to the Bay Area Reporter, in 2014, Christine Lenhertz of the park service requested that a group of LGBTQ park service employees be allowed to wear their uniforms in the Pride parade. They were initially barred from doing so, prompting the group to file a complaint. She then sought a ruling from the Office of the Solicitor for the Department of the Interior, who ruled that there was no reason to bar her and other LGBTQ people from participating in uniform. Since then, many park service contingents have participated in Pride events.

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San Francisco Pride NPS contingent.

The future of Pride parade participation with in-uniform park service employees is uncertain. While it appears that there will be some Pride events in certain national parks, such as Stonewall, external participation in major city Pride events seems to be on hold in at least some major American cities.

You can see the full response to the request for comment from a park service spokesperson here:

The NPS uniform policy has not changed. There are no restrictions on wearing of uniforms in NPS-organized in-park events. There has been no directive to cancel NPS-organized in-park events. Superintendents have discretion to approve park-organized events, which support park purpose and mission, and departmental mission, initiatives, and priorities (e.g., diversity, inclusion, climate change, and tribal engagement.) This would include many of the events planned to celebrate Pride month. 

Official NPS participation in community events that directly relate to a park’s mission can be approved by the park superintendent, provided it is consistent with applicable laws, rules, regulations, and NPS policies.

Last week, the service sent out a reminder about the uniform policy — specifically because there has been an in-flux of requests from folks asking to wear their uniforms for non-park service events. These requests run the gamut of topics, but could include weekend, off duty events that folks are of course able to do in their personal capacity, but not while wearing a uniform representing the federal government. Previous interpretations of the uniform policy were inconsistent and as you can imagine, approving participation in some events and not others could be seen as discrimination based on viewpoint. 

NPS employees represent a diversity of identities, cultures, and experiences, and we are committed to supporting all of our workforce. Like any large organization, we have a diverse workforce supporting myriad causes, and we welcome employees to express their personal support for various issues, positions, and political parties, provided they do not imply their presence or endorsement constitutes official NPS support for the same.  And, also like other large organizations, there are limits to what employees can do while on-duty and in uniform and seen as communicating on behalf of the NPS.

 

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Erin Reed is a transgender woman (she/her pronouns) and researcher who tracks anti-LGBTQ+ legislation around the world and helps people become better advocates for their queer family, friends, colleagues, and community. Reed also is a social media consultant and public speaker.

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The preceding article was first published at Erin In The Morning and is republished with permission.

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CDC issues warning on new “deadlier strain” of Mpox

As LGBTQ+ Pride month and events happen globally, there is more need for greater caution and people to take steps at prevention

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JYNNEOS Mpox vaccine. (Photo Credit: The Centers for Disease Control and Prevention-CDC)

ATLANTA, Ga. – The Centers for Disease Control and Prevention (CDC) have issued a health advisory regarding a deadlier strain of the Mpox virus outbreak which is currently impacting the Democratic Republic of Congo (DRC).

According to the CDC, since January of 2023, DRC has reported more than 19,000 suspect mpox cases and more than 900 deaths. The CDC stated that the overall risk to the United States posed by the clade I mpox outbreak is low.

The risk to gay, bisexual, and other men who have sex with men (MSM) who have more than one sexual partner and people who have sex with MSM, regardless of gender, is assessed as low to moderate the agency stated.

While no cases of that subtype have been identified outside sub-Saharan Africa so far, the World Health Organization said earlier this week that the escalating epidemic in Congo nevertheless poses a global threat, just as infections in Nigeria set off the 2022 outbreak according to a WHO spokesperson.

The spokesperson also noted that as LGBTQ+ Pride month and events happen globally, there is more need for greater caution and people to take steps at prevention including being vaccinated.

The CDC advises that while there are no changes to the overall risk assessment, people in the United States who have already had Mpox or are fully vaccinated should be protected against the type of Mpox spreading in DRC. Casual contact, such as might occur during travel, is not likely to cause the disease to spread. The best protection against Mpox is two doses of the JYNNEOS vaccine.

The CDC also noted the risk might change as more information becomes available, or if cases appear outside DRC or other African countries where clade I exists naturally.

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U.S. Justice Dept. takes major step toward reclassifying marijuana

“Far too many lives have been upended because of a failed approach to marijuana and I’m committed to righting those wrongs”

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President Joe Biden discusses his administration's move toward reforming drug policy on cannabis (Screen capture: X)

WASHINGTON — The U.S. Department of Justice on Thursday took a major step toward loosening the federal government’s regulation of marijuana by issuing a Notice of Proposed Rulemaking to the Drug Enforcement Administration, which outlines a proposal to reclassify it under the federal Controlled Substances Act.

The move comes pursuant to the Biden-Harris administration’s April 30 announcement of plans to recategorize cannabis as a Schedule III substance, which could substantially lessen the criminal penalties for those convicted of using, possessing, selling, distributing, or cultivating the drug.

A 60-day public comment period will begin after the NPRM is published on the Federal Register, along with a concurrent review of the proposed regulatory reforms by an administrative law judge assigned by the DEA.

Since the CSA was passed in 1971, cannabis has been listed under Schedule I, the category reserved for drugs that are considered to be the most dangerous and lacking any currently accepted medical use in the U.S.

In a press release, a senior administration official noted that “marijuana is currently classified higher than fentanyl and meth – the drugs driving our Nation’s overdose epidemic.”

President Joe Biden posted a video on X in which he said the proposal to house cannabis under the Schedule III regulatory regime constitutes “an important move towards reversing longstanding inequities.”

“Today’s announcement builds on the work we’ve already done to pardon a record number of federal offenses for simple possession of marijuana,” the president said. “It adds to the action we’ve taken to lift barriers to housing, employment, small business loans, and more for tens of thousands of Americans.”

“Look folks no one should be in jail for merely using or possessing marijuana,” Biden said. “Period.”

The president added, “Far too many lives have been upended because of a failed approach to marijuana and I’m committed to righting those wrongs. You have my word on it.”

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FBI warns of potential threats to LGBTQ+ Pride month events

Increased threat levels domestically included recently documented instances of homophobic and transphobic threats

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During an appearance before a congressional committee in early April, FBI Director Christopher Wray warned of "elevated threats" to U.S. public safety and security coming from both overseas terroirs groups as well as domestic threats. (Screenshot/NBC News)

WASHINGTON – Citing the rising numbers of violent threats primarily across the digital landscape online including emailed bomb and death threats, officials from the Federal Bureau of Investigation and Homeland Security Investigations have issued warnings that foreign terrorist organizations (FTOS) or their supporters are targeting the LGBTQ+ community during Pride Month.

In a notice released on May 10, the FBI and HSI warn that efforts to commit or inspire violence against LGBTQ+ celebrations, including Pride celebrations or other LGBTQ+-related venues, are compounded by the current heightened threat environment in the United States and other western countries. 

The FBI and HSI noted that June 12, 2024 marks the eighth anniversary of the Pulse Nightclub Orlando shooting, during which the attacker killed 49 and wounded 53 people. After the Pulse shooting, pro-ISIS messaging praised this attack as one of the high-profile attacks in Western countries, and FTO supporters celebrated it. There are concerns that instances like the Pulse anniversary could spark a violent attack.

In addition to the threats posed by off-shore groups, increased threat levels domestically including recently documented instances of homophobic and transphobic threats exemplified recently from reporting by multiple media outlets regarding Libs of TikTok’s creator Chaya Raichik, who had initiated an ongoing campaign against Planet Fitness, demanding a boycott in retaliation for the gym’s trans-inclusive locker room policy.

At least 53 locations of Planet Fitness have reported hoax bomb threats in recent weeks, the threats were primarily reported through emails, and in some cases, phone calls. continuing what has become a trend of violent threats against institutions targeted by Raichik. 

Raichik has a long documented history of fostering anti-LGBTQ+ animus through her posts which in turn has led to what NBC News, Media Matters, the SPLC, the Blade, and others documenting Raichik’s anti-LGBTQ+ acts of arguably stochastic terrorism.

In February, NBC News technology reporter David Ingram, detailed bomb threats and violent threats inspired by Raichik’s social media posts. NBC News identified 33 instances, starting in November 2020, when people or institutions singled out by Libs of TikTok later reported bomb threats or other violent intimidation. 

During his April 11 testimony on Capitol Hill, FBI Director Christopher Wray issued a warning to lawmakers telling a House subcommittee that there is a growing fear among law enforcement officials of possible “coordinated attack” inside the U.S. telling committee members that a “lone-wolf” attack promulgated by events in Middle East are the agency’s overarching worry.

Speaking with the Blade on background, a senior FBI official noted that Pride events in locales other than major urban settings, particularly the largest Pride gatherings in New York, San Francisco, Los Angeles, and Washington D.C. which have a traditionally large police presence, smaller cities and towns are at elevated risk.

In an emailed statement, the FBI said it has, in general, observed an increase in threats of violence targeting institutions like hospitals and schools.

“As a country and organization, we have seen an increase in threats of violence targeting government officials and institutions, houses of worship, schools, and medical facilities, just to name a few. The FBI and our partners take all threats of violence seriously and responding to these threats ties up law enforcement resources.

“When the threats are made as a hoax, it puts innocent people at risk, is a waste of law enforcement’s limited resources, and costs taxpayers. The FBI and our state and local partners will continue to aggressively pursue perpetrators of these threats — real or false — and hold them accountable,” the FBI statement said.”

Reacting to the elevated threat levels in a statement, GLAAD President Sarah Kate Ellis said:

“A fringe few extremists, domestically and overseas, are irrationally threatened by the rising tide of acceptance for LGBTQ people. It is important to keep Prides safe for all attendees, and for people to keep showing up during Pride and throughout the year to speak up for the equality and safety of their communities and all marginalized people.”

The FBI is asking that Pride event planners, organizers, and others be aware of possible indicators of potential threat activity:

  • Violent threats made online, in person, or via mail.
  • Unusual or prolonged testing or probing of security measures at events or venues.
  • Photography of security related equipment, personnel, or access points consistent with pre-operational surveillance without a reasonable alternative explanation.
  • Unusual surveillance or interest in buildings, gatherings, or events.
  • Attempts to gain access to restricted areas, bypass security, or impersonate law enforcement officials.
  • Observation of or questions about facility security measures, including barriers, restricted areas, cameras, and intrusion detection systems without a reasonable alternative explanation.
  • Eliciting information from facility personnel regarding the nature of upcoming events, crowd sizes, busiest times of day, etc. without a reasonable alternative explanation.
  • Attempts to enter a restricted area, bypass security, or impersonate law enforcement officials.

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U.S. Census Bureau testing survey on LGBTQ households

The Census Bureau proposes testing questions about sexual orientation and gender identity to meet the needs of other federal agencies

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The U.S. Census Bureau headquarters in Suitland, Maryland in suburban Washington D.C. (Photo Credit: U.S. Census Bureau)

SUITLAND, Md. – The U.S. Census Bureau is seeking public comment on a proposed test of sexual orientation and gender identity questions on the American Community Survey (ACS). The test would begin this summer and continue into next year.

The Census Bureau published the request as a Federal Register notice. In its press release the agency noted that the ACS is an ongoing survey that collects detailed housing and socioeconomic data. It allows the Census Bureau to provide timely and relevant housing and socioeconomic statistics, even for low levels of geography.

As part of the process for adding new questions to the ACS, the Census Bureau tests potential questions to evaluate the quality of the data collected.

The Census Bureau proposes testing questions about sexual orientation and gender identity to meet the needs of other federal agencies that have expressed interest in or have identified legal uses for the information, such as enforcing civil rights and equal employment measures.

The test would follow the protocols of the actual ACS – with one person asked to respond to the survey on behalf of the entire household. These particular questions are asked about people 15 years of age or older. Households are invited to respond to the survey online, by paper questionnaire or by phone.

The current Federal Register notice gives the public a final opportunity to provide feedback before the Census Bureau submits its recommendations to the Office of Management and Budget for approval. The public may provide feedback through May 30, 2024, online.

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New World Bank US executive director: LGBTQ+ rights are human rights

Felice Gorordo assumed role last year

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Acting U.S. World Bank Executive Director L. Felice Gorordo. (Photo courtesy of the World Bank)

WASHINGTON — Acting U.S. World Bank Executive Director L. Felice Gorordo recently told the Washington Blade that he is committed to the advancement of LGBTQ+ and intersex rights within the multilateral organization.

“LGBTQI+ rights are human rights and human rights are LGBTQI+ rights. Period. Hard stop,” he said during an exclusive interview at his D.C. office on March 27. “I see it, personally, from a human rights promotion lens.”

Gorordo, a Cuban American who was born in Miami, graduated from Georgetown University in 2005.

He co-founded Roots of Hope, an organization that seeks to empower young Cubans on the island through entrepreneurship and increased access to technology. 

Gorordo served in various roles in both the Obama and George W. Bush administrations, and served as advisor to then-Vice President Joe Biden’s cancer initiative after his mother died from pancreatic cancer.

He has also been the CEO of three-venture backed technology companies, an investor and advisor at two venture capital funds with focuses on global healthcare and infrastructure, and has sat on the boards of several for- and non-profit organizations. Gorordo was most recently the CEO of eMerge Americas and executive director of the Technology Foundation of the Americas before the U.S. Senate confirmed him in May 2023.

He has been the World Bank’s acting U.S. executive director since Adriana Kugler joined the Federal Reserve Board last September.

Gorordo, 41, throughout the interview referenced the Biden-Harris administration’s 2021 memo that committed the U.S. to promoting LGBTQ+ and intersex rights abroad as part of U.S. foreign policy.

“It starts off with us at the bank trying to build demand for the issues related to LGBTQI+ rights and people,” he said. “It’s about protecting LGBTQI+ rights in and outside of World Bank operations and projects and supporting LGBTQI+ people and rights inside and outside of our projects through inclusion. It’s using our voice and vote at every chance that we get to advance LGBTQI+ people.”

Gorordo pointed out his office reviews roughly 700 projects a year for the World Bank, and they have an average of $90-$100 billion in financial commitments. He said there is a “pretty extensive review process for due diligence” with criteria that include environmental and social frameworks and bank safeguards (that currently do not explicitly include sexual orientation or gender identity.)

“We take a critical lens at each one that it lives up to the values that we want to promote, and that includes looking at it through the lens of LGBTQI+ rights,” said Gorordo.

One LGBTQ-inclusive project is the World Bank International Finance Corporation’s $275 million loan to Banco Davivienda in Colombia, which provides funding for advisory services to LGBTQ+ and intersex people and for the design of LGBTQ+ and intersex banking products. The board in 2023 greenlighted $200 million for the Program for Universal Primary Healthcare Coverage and Resilience which, among other things, seeks to improve the quality of healthcare that LGBTQ+ and intersex people receive in Chile.

The World Bank’s EQOSOGI Project has already collected LGBTQ+- and intersex-specific data on legal gaps as well as practices that impact LGBTQ+ and intersex people in 16 countries, and it plans to expand its work to other nations in 2024. The World Bank is also expanding its research on the economic costs of discrimination based on sexual orientation and gender identity. 

The first studies focused on Serbia and North Macedonia, and found both countries’ annual gross domestic product would increase by .6 percent if LGBTQ+ and intersex people faced less discrimination in the workplace. A study that will focus on Brazil will be released later this year.

“There’s always more we can do,” Gorordo told the Blade. “What we believe we need to do, again, using our convening power and our voice and our vote is to help build because in the end we are still a demand-driven organization.” 

“We need to use our research and the data, in my opinion, our opinion, to help generate the demand for LGBTQI rights to be enshrined in our safeguards, in our strategies and in every single one of our products and the data speaks for itself,” he added.

Gorordo also noted the bank in the coming months will release a new gender strategy that recognizes gender as nonbinary.

“That’s a big step,” he said.

Gorordo described World Bank President Ajay Banga as “a champion of the rights of all, including LGBTQI+ people.” Gorordo, however, acknowledged there has been “some pushback from certain constituencies that have different views and opinions than ours” on the new gender strategy and support for LGBTQ+ and intersex rights.

“I see it as my responsibility to not just advocate for it in the board room or with management, but also using my office and chair to meet with other chairs bilaterally, to make the case for it, to try and bring folks along with us,” he added.

Uganda’s Anti-Homosexuality Act ‘needs to be struck down and repealed’

The World Bank last August suspended new loans to Uganda in response to the country’s Anti-Homosexuality Act that President Yoweri Museveni signed.

Uganda’s Constitutional Court earlier this month refused to nullify the law. A group of Ugandan LGBTQ+ activists have appealed the ruling.

“The law needs to be struck down and repealed. Hard stop,” said Gorordo. “We continue to advocate for that.”

Then-World Bank President Jim Yong Kim in 2014 postponed a $90 million loan to the Ugandan government in response to Museveni’s decision to sign a nearly identical version of the Anti-Homosexuality Act, known as the “Kill the Gays” law that imposed a life sentence upon anyone found guilty of repeated same-sex sexual acts. 

Uganda’s Constitutional Court later struck down the law on a technicality, but Kim’s decision to postpone the loan without first consulting the World Bank’s board sparked widespread criticism among board members. Advocacy groups had asked the World Bank not to fund future projects in Uganda, but they did not ask for the cancellation of existing loans.

The World Bank earlier this year organized a seminar with the Human Rights Promotion Forum of Uganda that upwards of 50 people attended virtually and in person.

“One of the things that I think is incredibly critical is hearing directly from those we seek to serve and who are being impacted by these discriminatory laws,” said Gorordo.

Gorordo said the World Bank in lieu of the law’s repeal has “been doing a review of mitigation efforts” that includes “a three-month trial period once there is an agreement of what those mitigation efforts would be, to see if they are fit for purpose.” 

“At the crux of it includes the protection as well as the equal access of benefits for LGBTQ communities in Uganda. If it is not fit for purpose, then we have to go back to the drawing board., So we will continue to push for the strictest mitigation measures that can be put into place, a very critical review through that process … and ensuring that we are able to guarantee equal access and protection for the LGBTQ community.”

Ghanaian President Nana Akufo-Addo has delayed a decision on whether he will sign a bill that would further criminalize LGBTQ+ people in his country. Lawmakers in Kenya and Tanzania have proposed similar measures.

“One of the reasons why we’ve taken such a critical view of the Uganda case is this is potentially one of many of these types of cases that we’ll have to deal with,” said Gorordo. “What we do in Uganda could have a ripple effect in other countries and we need to ensure that we are setting the right precedents for how we react in these cases.”

Gorordo further noted consensual same-sex sexual relations remain criminalized in upwards of 60 countries around the world.

“The discrimination that’s against LGBTQI+ people is unacceptable across the board,” he said. “We will use all the tools in the U.S. government’s toolbox to be able to make it known our objection and to try and stop discrimination and protect the rights of LGBTQ+ people every chance we get.”

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Health & Human Services reverses Trump era anti-LGBTQ+ rule

Public support for nondiscrimination protections for LGBTQ Americans continues at high levels among the American public

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Xavier Becerra is the 25th Secretary of the Department of Health and Human Services and the first Latino to hold the office in the history of the U.S. (Photo Credit: HHS Public Affairs/Facebook)

WASHINGTON – The U.S. Department of Health and Human Services Office for Civil Rights  has issued a final rule on Friday under Section 1557 of the Affordable Care Act (ACA) advancing protections against discrimination in health care prohibiting discrimination on the basis of race, color, national origin, age, disability, or sex (including pregnancy, sexual orientation, gender identity, and sex characteristics), in covered health programs or activities. 

The updated rule does not force medical professionals to provide certain types of health care, but rather ensures nondiscrimination protections so that providers cannot turn away patients based on individual characteristics such as being lesbian, gay, bisexual, transgender, queer, intersex, or pregnant.

“This rule ensures that people nationwide can access health care free from discrimination,” said HHS Secretary Xavier Becerra. “Standing with communities in need is critical, particularly given increased attacks on women, trans youth, and health care providers. Health care should be a right not dependent on looks, location, love, language, or the type of care someone needs.”

The new rule restores and clarifies important regulatory protections for LGBTQ+ people and other vulnerable populations under Section 1557, also known as the health care nondiscrimination law, that were previously rescinded by the Trump administration.

“Healthcare is a fundamental human right. The rule released today restores critical regulatory nondiscrimination protections for those who need them most and ensures a legally proper reading of the Affordable Care Act’s healthcare nondiscrimination law,” said Omar Gonzalez-Pagan, Counsel and Health Care Strategist for Lambda Legal.

“The Biden administration today reversed the harmful, discriminatory, and unlawful effort by the previous administration to eliminate critical regulatory protections for LGBTQ+ people and other vulnerable populations, such as people with limited English proficiency, by carving them out from the rule and limiting the scope of entities to which the rule applied,” Gonzalez-Pagan added. “The rule released today has reinstated many of these important protections, as well as clarifying the broad, intended scope of the rule to cover all health programs and activities and health insurers receiving federal funds. While we evaluate the new rule in detail, it is important to highlight that this rule will help members of the LGBTQ+ community — especially transgender people, non-English speakers, immigrants, people of color, and people living with disabilities — to access the care they need and deserve, saving lives and making sure healthcare professionals serve patients with essential care no matter who they are.”

In addition to rescinding critical regulatory protections for LGBTQ+ people, the Trump administration’s rule also limited the remedies available to people who face health disparities, limited access to health care for people with Limited English Proficiency (LEP), and dramatically reduced the number of healthcare entities and health plans subject to the rule.

Lambda Legal, along with a broad coalition of LGBTQ+ advocacy groups, filed a lawsuit challenging the Trump administration rule, Whitman-Walker Clinic v. HHS,  and secured a preliminary injunction preventing key aspects of the Trump rule from taking effect.

These included the elimination of regulatory protections for LGBTQ+ people and the unlawful expansion of religious exemptions, which the new rule corrects.  The preliminary injunction in Whitman-Walker Clinic v. HHS remains in place.  Any next steps in the case will be determined at a later time, after a fulsome review of the new rule.

Sarah Kate Ellis, CEO and President of GLAAD, released the following statement in response to the news:

“The Biden administration’s updates to rules regarding Section 1557 of the ACA will ensure that no one who is LGBTQI or pregnant can face discrimination in accessing essential health care. This reversal of Trump-era discriminatory rules that sought to single out Americans based on who they are and make it difficult or impossible for them to access necessary medical care will have a direct, positive impact on the day to day lives of millions of people. Today’s move marks the 334th action from the Biden-Harris White House in support of LGBTQ people. Health care is a human right that should be accessible to all Americans equally without unfair and discriminatory restrictions. LGBTQ Americans are grateful for this step forward to combat discrimination in health care so no one is barred from lifesaving treatment.”

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Federal Government

Lambda Legal praises Biden admin’s finalized Title IX regulations

The new policy also reverses some Trump-era Title IX rules governing how schools must respond to sexual harassment & sexual assault

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U.S. Secretary of Education Miguel Cardona (Photo Credit: Office of the U.S. Secretary of Education)

WASHINGTON – The Biden-Harris administration’s revised Title IX policy “protects LGBTQ+ students from discrimination and other abuse,” Lambda Legal said in a statement praising the U.S. Department of Education’s issuance of the final rule on Friday.

Slated to take effect on Aug. 1, the new regulations constitute an expansion of the 1972 Title IX civil rights law, which prohibits sex-based discrimination in education programs that receive federal funding.

Pursuant to the U.S. Supreme Court’s ruling in the landmark 2020 Bostock v. Clayton County case, the department’s revised policy clarifies that discrimination on the basis of sexual orientation and gender identity constitutes sex-based discrimination as defined under the law.

“These regulations make it crystal clear that everyone can access schools that are safe, welcoming and that respect their rights,” Education Secretary Miguel Cardona said during a call with reporters on Thursday.

While the new rule does not provide guidance on whether schools must allow transgender students to play on sports teams corresponding with their gender identity to comply with Title IX, the question is addressed in a separate rule proposed by the agency in April.

The administration’s new policy also reverses some Trump-era Title IX rules governing how schools must respond to reports of sexual harassment and sexual assault, which were widely seen as imbalanced in favor of the accused.

Jennifer Klein, the director of the White House Gender Policy Council, said during Thursday’s call that the department sought to strike a balance with respect to these issues, “reaffirming our longstanding commitment to fundamental fairness.”

“We applaud the Biden administration’s action to rescind the legally unsound, cruel, and dangerous sexual harassment and assault rule of the previous administration,” Lambda Legal Nonbinary and Transgender Rights Project Director Sasha Buchert said in the group’s statement on Friday.

“Today’s rule instead appropriately underscores that Title IX’s civil rights protections clearly cover LGBTQ+ students, as well as survivors and pregnant and parenting students across race and gender identity,” she said. “Schools must be places where students can learn and thrive free of harassment, discrimination, and other abuse.”

Rep. Mark Takano (D-Calif.), a Congressional leader on LGBTQ and education issues, also hailed the finalized rule on Title IX from the Biden Administration:  

The Education Department and Biden Administration showed real courage today, delivering on a long-held promise to ensure that the federal government does more to protect all Americans—especially LGBTQ Americans—from discrimination.  

This groundbreaking rule is a major victory, but we still have much to do. We need to enshrine and expand its protections by passing the Equality Act because for too many Americans, their rights and protections depend on the zip code they live in.   

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Federal Government

Guatemalan LGBTQ+ activist granted asylum in US

Estuardo Cifuentes fled country in 2019

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Estuardo Cifuentes outside a port of entry in Brownsville, Texas, on March 3, 2021, shortly after he entered the U.S. (Photo courtesy of Estuardo Cifuentes)

WASHINGTON — The U.S. has granted asylum to a Guatemalan LGBTQ+ activist who fled his country in 2019.

Estuardo Cifuentes and his partner ran a digital marketing and advertising business in Guatemala City. 

He previously told the Washington Blade that gang members extorted from them. Cifuentes said they closed their business after they attacked them.

Cifuentes told the Blade that Guatemalan police officers attacked him in front of their home when he tried to kiss his partner. Cifuentes said the officers tried to kidnap him and one of them shot at him. He told the Blade that authorities placed him under surveillance after the incident and private cars drove past his home.

Cifuentes arrived in Matamoros, a Mexican border city that is across the Rio Grande from Brownsville, Texas, in June 2019. He asked for asylum in the U.S. based on the persecution he suffered in Guatemala because of his sexual orientation.

The Trump administration forced Cifuentes to pursue his asylum case from Mexico under its Migrant Protection Protocols program that became known as the “remain in Mexico” policy.

Cifuentes while in Matamoros ran Rainbow Bridge Asylum Seekers, a program for LGBTQ+ asylum seekers and migrants that the Resource Center Matamoros, a group that provides assistance to asylum seekers and migrants in the Mexican border city, helped create.

The Biden-Harris administration in January 2021 suspended enrollment in MPP. Cifuentes entered the U.S. on March 3, 2021.

“We are profoundly relieved and grateful that my husband and I have been officially recognized as asylees in the United States,” Cifuentes told the Blade on Monday in an email. “This result marks the end of a long and painful fight against the persecution that we faced in Guatemala because of our sexual orientation.”

Vice President Kamala Harris is among those who have said discrimination and violence based on sexual orientation are among the root causes of migration from Guatemala and other countries in Central America.

Cifuentes is now the client services manager for Lawyers for Good Government’s Project Corazón, a campaign that works “hard to reunite and defend the rights of families impacted by inhumane immigration policies.” He told the Blade he will continue to help LGBTQ+ asylum seekers and migrants.

“In this new chapter of our lives, we pledge to work hard to support others in similar situations and to contribute to the broader fight for the rights and acceptance of the LGBTQ+ migrant community,” said Cifuentes. “We are hopeful that our story will serve as a call to action to confront and end persecution based on gender identity and sexual orientation.”

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FDA planning to lift ban on gay & bi sperm donors

When the FDA releases its draft policy around sperm donation, there will be a public comment period before the regulation is made final

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Los Angeles Blade graphic

By Rob Salerno | WASHINGTON – The Food and Drug Administration is planning to lift its ban on sperm donations from men who have sex with men, according to a report in the Wall Street Journal. The report also says the FDA would simultaneously lift the ban on donations of other tissues and organs from gay and bi men.

The Journal report suggests that the FDA could put out a draft of the new policy for public comment by the summer, with a final rule in place by the end of 2024 or early 2025.

Reached for comment, a spokesperson for the FDA would not confirm the Wall Street Journal story, but acknowledged that, “the FDA routinely reviews approaches regarding donor screening and testing for donors of human cells, tissues, and cellular and tissue-based products (HCT/Ps) to determine what changes, if any, are appropriate based on technological and evolving scientific knowledge.” 

Men who have sex with men have been barred from donating sperm since 2005

The FDA imposed the sperm donation ban on men who have sex with men in 2005, as part of an expansion on existing prohibitions on blood donations from gay and bisexual men which were meant to mitigate the risk that HIV could be spread through donations.

The policies stemmed from an erroneous belief that gay men were more likely to carry HIV, regardless of their individual behaviors and risk factors.

Last year, the FDA finally ended the ban on blood donations from men who have sex with men, which had been in place since the early days of the AIDS crisis. The FDA now requires that blood donors are screened based on individual behaviors in a gender-neutral manner, in addition to the donations themselves being tested for HIV and other blood-borne illnesses.

Alice Ruby, executive director of the Sperm Bank of California in Berkeley, says the lifting of the blood ban should provide a template for ending the sperm ban.

“I’m hoping it’s similar to the blood donation screening, where it’s based on behaviour, rather than being part of a population,” she says. “We test donors repeatedly for HIV as required by the FDA.”

The Sperm Bank of California has served many lesbian, bi, and trans people, and Ruby says that she’s often told her clients would like a queer donor, to ensure that the biological father won’t be someone who disapproves of queer families. The ban removes that choice from would-be mothers.

The Sperm Bank of California has been opposed to the gay sperm donation ban since the policy was first proposed twenty years ago and has advocated in tandem with the National Center for Lesbian Rights for the policy to be scrapped.

“People are pretty unaware that the ban exists. I think there’s a lot of gay men who would be happy to contribute in this way, especially since a large number of people using sperm donation are LGBT couples and single people,” Ruby says.

Sperm banks across the country have been experiencing shortages of donor sperm, especially from donors of color. Opening the donor pool to gay and bi men could help ease the shortage. Ruby has told the Blade that the Sperm Bank of California has had to turn away gay and bi donors every week, up to 400 men in a single year.

When the FDA releases its draft policy around sperm donation, there will be a public comment period before the regulation is made final. Ruby says anyone interested opening up sperm donation to gay and bisexual men should submit a comment to support the change.

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Rob Salerno is a writer and journalist based in Los Angeles, California, and Toronto, Canada.

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