Since 1996, Carl W. Dieffenbach, who holds a Ph.D. in biophysics from John Hopkins University, has served as director of the Division of AIDS at the National Institute of Allergies and Infectious Diseases, which is an arm of the U.S. National Institutes of Health or NIH.
In a June 10 interview with the Washington Blade, Dieffenbach gave an update on the extensive, ongoing research into the development of an HIV/AIDS vaccine that he has helped to coordinate for many years, including current human trials for a prospective AIDS vaccine taking place in the U.S., South America, and Africa.
One thing he feels passionate about is a development not widely reported in the media reports about the successful development of the COVID-19 vaccine. According to Dieffenbach, the extensive research into an AIDS vaccine in recent and past years, while not yet successful in yielding an effective AIDS vaccine, helped lay the groundwork for the rapid development of the different versions of a COVID vaccine.
“Because my division runs the largest clinical trials program in the word, we jumped in with both feet to help with coronavirus disease for both vaccines and drugs and things like that,” he said. “And the platforms that were used – the way they are making the coronavirus vaccines – the RNA vaccines with Moderna – were first piloted by NIH and Moderna to try to make an HIV vaccine,” Dieffenbach says.
“So, in many ways, the work for the past 25 years that we’ve done in HIV vaccines sped the development of coronavirus vaccines,” he told the Blade. “And now it’s time to take what we’ve learned from coronavirus and take it back to HIV and start afresh or continue with what we have and build upon from what we have learned.”
Dieffenbach says one reason the development of a COVID vaccine came about before an AIDS vaccine, despite more than 20 years of AIDS vaccine research, is that the HIV virus is far more complex than the coronavirus, especially its ability to infect and remain embedded in the infected person for life.
“Back in 2007 we had the first hint that an AIDS vaccine might be possible with a study called RV144,” Dieffenbach says. “We spent 10 years trying to replicate that, and we just completed that study – a study called HVTN702. And it showed no efficacy,” he said, meaning it did not work.
“So that was a big disappointment to us,” he says “But in the meantime, we had pushed forward with the J&J [Johnson and Johnson pharmaceutical company] vaccine and are pretty far along. We’ll see what happens. We should know in the next several months whether the N26 version of an AIDS vaccine, and HIV vaccine works or not,” he says. “We’re very close to an answer.”
Washington Blade: Where do things stand in the development of an HIV/AIDS vaccine in light of Dr. Fauci’s statement a few weeks ago that the development of a COVID-19 vaccine could provide a boost to developing an AIDS vaccine?
Carl Dieffenbach: Sure. So, maybe I can start by introducing myself to you as a way of putting this into a context.
So, I’m the director of the Division of AIDS, which is the largest funder of HIV research in the world. And I report directly to Dr. Fauci. So, I’m responsible for all AIDS, all the time. And that is my passion and purpose in life. Part of that is working toward a safe, effective, and durable HIV vaccine, which has been one of the two most challenging questions left in science today. The other is a cure. They are connected in some ways.
So, with that as background, when coronavirus disease came along – because my division runs the largest clinical trials program in the world – we jumped in with both feet to help with coronavirus disease for both vaccines and drugs and things like that. And the platforms that were used – the way they are making the coronavirus vaccines – the RNA vaccines with Moderna were first piloted by NIH and Moderna to try to make an HIV vaccine. So, we’ve being working on that platform with Moderna for several years.
The leadership at Pfizer used to be part of a group at Penn, where we were also working with them. The J&J vaccine – we currently have in two Phase III clinical trials for HIV, one in sub-Saharan Africa, specifically in young women and the other one in the Americas in men who have sex with men and transgender individuals. Both of those Phase IIIs are moving along. The women’s study is fully enrolled. The men’s study was hit hard by COVID, but we worked through and will be fully enrolled by September.
One other vaccine just to talk about is the Oxford vaccine, the AstraZeneca vaccine. That is also using a platform at Oxford University, which has been used for HIV. So, in many ways, the work for the past 25 years that we’ve done in HIV vaccines sped the development of coronavirus vaccines. And now it’s time to take what we’ve learned from coronavirus and take it back to HIV and start afresh or continue with what we have and build upon from where we have learned.
Blade: That’s very interesting. But can we assume, then, from the clinical trials that have taken place for an HIV vaccine that they did not succeed in providing the immunity needed for an effective vaccine?
Dieffenbach: So, that’s exactly the problem we have. Back in 2007 we had the first hint that an AIDS vaccine might be possible with a study called RV144. We spent 10 years trying to replicate that, and we just completed that study – a study called HVTN702. And it showed no efficacy. So, that was a big disappointment to us. But in the meantime, we had pushed forward with the J&J vaccine and are pretty far along. We’ll see what happens. We should know in the next several months whether the N26 version of an AIDS vaccine, and HIV vaccine works or not. We’re very close to an answer.
Blade: So, the human trials are ongoing.
Dieffenbach: Oh, again – the study in young women in sub-Sahara Africa is fully enrolled. The men’s study will be fully enrolled in September. So, we have fought through the coronavirus epidemic to maintain, to nurse these trials along to make sure with the $100 million or so we’ve invested, that we didn’t want them to go down the drain literally because we lost too many people for follow-up. So, this was a herculean effort that has gone on all the time trying to do the vaccine studies for coronavirus disease, which we were also incredibly successful in.
Blade: Can we assume all of the people participating in the studies were HIV negative?
Dieffenbach: Yes, they’re HIV negative. They are people who are at risk. And also, in South America, for example, the major countries we’re in are Peru and Brazil. And they’ve had a strong research culture with us, going back more than a decade. For example, both of those countries played big roles in our studies of pre-exposure prophylaxis. A study called I-PREX that demonstrated that in men who have sex with men that [a PrEP drug] works well to prevent HIV acquisition in seronegative men who have sex with men.
So, we’ve been there. This is a really good setup for the countries, for the citizens that are in those countries that want to avail themselves to the research that has benefited everybody.
Blade: Among those who are participating in these ongoing AIDS vaccine trials, can we assume they cannot be taking the PrEP anti-retroviral drugs that have been shown to be highly effective in preventing HIV infection?
Dieffenbach: So, what we’ve done is we – everything is by conversation. So, when somebody who is interested in the study comes in, we talk to them. What is your chief interest in being in this study? And a lot of people want to be in the study because then they can access PrEP. They want to make it easier to get a hold of pre-exposure prophylaxis. They feel that is the best way that they can protect themselves.
So, in that situation, what we do is we take those people and link them to PrEP services where they can easily get PrEP in their community. So, first it’s taking care of those people. Then there are people who really have no interest in PrEP. And we actually counsel them every time they come in for a study. Are you sure you don’t want to access PrEP? And those are the people we then say, if you’re not interested in PrEP, what do you think about participating in a vaccine trial?
Because they’re the ones who have the most freedom of thought. They don’t have an opinion about the vaccine or about PrEP. So, those are the people we’ve been focusing on and enrolling. So, we’ve been very careful to make sure that if people wanted PrEP they not only have access, but they didn’t feel like somehow having to trade something in order to get it. The freedom to join a study should be a free choice. And it shouldn’t be a coercive thing to get PrEP. So, we just took that off the table and said if you’re truly interested in PrEP we can get you PrEP and make sure that was available.
Blade: So, in that case, if they choose PrEP they would not be in the vaccine trial?
Dieffenbach: You know, it’s interesting that you ask it in that way. Because you have relationships with your community, many of the investigators have reported that people will say, you know I tried PrEP and it wasn’t for me. It made me gaseous. It upset my stomach. I wasn’t myself. I tried it. I couldn’t make it work for me. I want to stop PrEP. Am I still eligible for the [vaccine] study? And the answer is of course. Many people are very happy on PrEP and they come in for visits occasionally and say this is working for me and just have the relationship with the doctors there, so it works. So, again, it’s about maintaining contact with your communities.
Blade: Can you tell a little about what happens next after people become part of an HIV vaccine trial. Do you have to keep in touch with these people, and do they have to get an HIV test periodically?
Dieffenbach: Exactly. So, the vaccine consists of a series of injections. It’s a mixture of vector systems that delivers a series of encoded HIV genes that are specifically designed to induce very broad immunity. There’s a whole computer-based process to design those components of the vaccine to make sure that it has sequence similarities with all the different versions of HIV circulating in the globe. And then at the end there is a protein boost. And we carry this out.
So, about every three to four months people come in. They get a shot. They fill out questionnaires. They give a blood sample. And they’re tested for HIV and are given a boost or a placebo. And they stay in touch with the clinic. They come in and out of the clinic. And the retention is quite high in these situations because people really like having the attention of the clinic available to them. It’s part of the community.
Blade: So, they go to a clinic for all of this?
Dieffenbach: It’s a research clinic. It’s not like a state-run health clinic. It’s a research clinic. Clinic is just a term for where people are seen.
Blade: Are any of these AIDS vaccine trials that are going on taking place in the United States?
Dieffenbach: Yes. So, the study is called Mosaico. And it’s HVTN706. And we have sites throughout the United States as well as South America. But that study is limited to men who have sex with men – the one in the United States.
Blade: Is it broader than just men who have sex with men in other countries?
Dieffenbach: No, so we decided to really focus on specific at-risk populations. So, in the Americas we chose to focus on men who have sex with men and transgender individuals. And sub-Saharan Africa we focused on young women because that is the target of the study population. So, 705 is all women in sub-Saharan Africa. And in the Americas in North and South America it is all men who have sex with men and transgender individuals.
Blade: Can we assume that the researchers that are doing these studies have a sensitivity of LGBTQ people? Is there still an issue where people worry about being outed as being gay or transgender?
Dieffenbach: So, many of the sites that we work with have been part of our system for over 20 years. And so, they are trusted members of the LGBTQ community within their cities and states. And ‘states’ is a literal term where it’s a state in Colombia or Peru or Brazil. And so, it is part of the fabric of the gay community in these places. Just like in San Francisco the San Francisco health clinic and the DCF clinics are part and parcel of everything the community does there.
And so, the lead physician in San Francisco is Susan Buchbinder. She has been a leader in health in this population for over 25 years or actually closer to 30 years at this point. We’re all getting old. Do you know that? So, we have been at this a very long time. And really have tried to build structures that are durable and therefore are reliable to the community. And that’s where we go back to the same groups time after time.
Blade: Have the locations of the vaccine testing sites been released publicly?
Dieffenbach: Yes, all of that is publicly available on clinicaltrials.gov. If you go into clinicaltrials.gov and search HVTN705 or HVTN706 you will get a version of the protocol, all the times it’s been modified, where we are – the protocol. All of that is public knowledge and available to you. HVTN705 is the women’s study. HVTN706 is the men’s study.
Blade: Is there a timeframe for when these latest vaccine studies might be completed?
Dieffenbach: I think within the next several months. We will get an answer out of the women’s study and then the men’s study is probably a year away. We were slowed a little bit because of COVID. We actually had to pause enrollment for several months. But we’re back on track.
Blade: Isn’t there a parallel research effort for an HIV/AIDS cure?
Dieffenbach: Yes, we have a very large program in cure research. It is a lot earlier in the discovery process and so it’s still very ‘researchy.’ And we have a very large program called the Martin Delany Collaboratories for Cure Research. Martin Delany was an activist who really pushed NIH in so many wonderful ways to really take the need for a cure seriously. His argument was a cure is the next logical step after effective anti-retroviral therapy. You cannot stop with one pill once a day. You’ve got to keep going. And he was pretty persistent. And unfortunately, he died several years go and we just thought the best way to honor him, and his memory was to name a program after him.
Editor’s note: Next week, in the second and final installment of his interview with the Blade, Dr. Dieffenbach discusses the progress in research and studies into an HIV/AIDS cure and explains from a scientific standpoint why an HIV vaccine is taking longer to develop than a COVID vaccine.
Does a potential overturn of Roe imperil LGBTQ rights?
Some fear that Obergefell marriage decision could fall
The oral arguments before the justices of the United States Supreme Court had barely ended in the case brought by the state of Mississippi defending its law banning abortion after 15 weeks, Dobbs v. Jackson Women’s Health Organization, when alarms were set off in legal circles as some argued that Obergefell v. Hodges — the same-sex marriage decision — would be in danger should the high court rule to overturn Roe v. Wade.
Florida State University law professor Mary Ziegler, appearing on NPR’s ‘Heard on All Things Considered,’ told host Mary Louise Kelly that there was a basis for concern over whether the court would actually overrule its precedents in other cases based on the questions and statements raised during the hearing by the conservative members of the court.
Asked by Kelly if she saw a legal door opening Ziegler affirmed that she did. Kelly then asked her, “Them taking up cases to do with that. What about same-sex marriage?”
Ziegler answered, “Yeah, same-sex marriage is definitely a candidate. Justices Alito and Thomas have in passing mentioned in dicta that they think it might be worth revisiting Obergefell v. Hodges – the same-sex marriage decision.
“And I think it’s fair to say that in the sort of panoply of culture war issues, that rights for same-sex couples and sexual orientation are still among the most contested, even though certainly same-sex marriage is more subtle than it was and than abortion was.
“I think that certainly the sort of balance between LGBTIQ rights and religious liberty writ large is a very much alive issue, and I think some states may try to test the boundaries with Obergefell, particularly knowing that they have a few justices potentially willing to go there with them.”
As almost if to underscore the point raised by Ziegler during the hearing, Associate U.S. Supreme Court Justice Sonia M. Sotomayor pointed out that the high court has taken and “discerned” certain rights in cases from the Constitution.
Along with abortion, the court has “recognized them in terms of the religion parents will teach their children. We’ve recognized it in their ability to educate at home if they choose,” Sotomayor said. “We have recognized that sense of privacy in people’s choices about whether to use contraception or not. We’ve recognized it in their right to choose who they’re going to marry.”
In following up the cases cited by Justice Sotomayor, Associate U.S. Supreme Court Justice Amy Coney Barrett asked Mississippi Solicitor General Scott Stewart, who was defending the state’s abortion law, whether a decision in his favor would affect the legal precedents in those cases cited by Justice Sotomayor.
In his answer to Justice Barrett, the state’s Solicitor General said cases involving contraception, same-sex marriage and sodomy wouldn’t be called into question because they involve “clear rules that have engendered strong reliance interests and that have not produced negative consequences or all the many other negative stare decisis considerations we pointed out.”
However, Lambda Legal Chief Strategy Officer and Legal Director, Sharon McGowan had a different take and interpreted remarks by Associate U.S. Supreme Court Justice Brett Kavanaugh to mean that the decisions in Lawrence v. Texas, which decriminalized private sexual intimacy between same-sex couples, and Obergefell v. Hodges, which struck down remaining bans on the freedom of same-sex couples to marry, would actually justify overturning Roe v. Wade.
In a publicly released media statement McGowan noted: “During today’s argument, Justice Kavanaugh suggested that two key Supreme Court decisions protecting LGBTQ civil rights—Lawrence v. Texas and Obergefell v. Hodges—support overruling Roe v. Wade and Planned Parenthood v. Casey.
‘To that we say, NOT IN OUR NAME. LGBTQ people need abortions. Just as important, those landmark LGBTQ decisions EXPANDED individual liberty, not the opposite. They reflected the growing societal understanding of our common humanity and equality under law.
“Just as the Supreme Court in Brown v. Board of Education rejected the lie of ‘separate but equal,’ the Supreme Court’s decisions in Lawrence and Obergefell appropriately overruled precedent where it was clear that, as was true with regard to race, our ancestors failed properly to acknowledge that gender and sexual orientation must not be barriers to our ability to live, love, and thrive free of governmental oppression. …
“These landmark LGBTQ cases, which Lambda Legal litigated and won, and on which we rely today to protect our community’s civil rights, were built directly on the foundation of Casey and Roe. Our interests in equal dignity, autonomy, and liberty are shared, intertwined, and fundamental.”
On Sunday, the Blade spoke with Shannon Minter, legal director for the National Center for Lesbian Rights, a national LGBTQ+ legal organization that represented three same-sex couples from Tennessee, whose case was heard by the U.S. Supreme Court along with Obergefell and two other cases.
Minter is urging caution in how people interpret the court arguments and remarks made by the justices.
“We should be cautious about taking the bait from anti-LGBTQ groups who falsely argue that if the Supreme Court reverses or undermines Roe v. Wade, they are likely to reverse or undermine Obergefell or Lawrence. In fact, that is highly unlikely, as the argument in Dobbs itself showed,” he said.
“The only reason Justice Kavanaugh mentioned Obergefell and Lawrence, along with Brown v. Board of Education, was to cite them as examples of cases in which the Supreme Court clearly did the right thing. All of those decisions rely at least as strongly on equal protection as on fundamental rights, and even this extremely conservative Supreme Court has not questioned the foundational role of equal protection in our nation’s constitutional law,” Minter stressed.
During an interview with Bloomberg magazine, David Cortman, of the Scottsdale, Ariz.-based anti-LGBTQ legal group Alliance Defending Freedom, which has been listed by the Southern Poverty Law Center as an extremist hate group, said “two things in particular distinguish abortion from those other privacy rights: the right to life and the states’ interest in protecting a child.”
Cortman, whose group urged the justices to allow states to ban same-sex marriages, said those other rights may be just as wrong as the right to an abortion. “But the fundamental interest in life that’s at issue in abortion means those other rights are probably not in any real danger of being overturned.”
But Cortman is of the opinion that there is little impetus among the court’s conservatives to take up challenges to those cases.
However, the fact that the six to three makeup of the high court with a conservative majority has progressives clamoring for the public to pay closer attention and be more proactively engaged.
Kierra Johnson, executive director of the National LGBTQ Task Force, in an emailed statement to the Blade underscored those concerns:
“Reports and analysis coming out of Wednesday’s Supreme Court hearing on Dobbs v. Jackson Women’s Health Organization are extremely disturbing and represent a threat to our individual constitutional rights to privacy and autonomy. There is no ‘middle ground’ on what the Constitution guarantees and what was decided decades ago with the Roe v Wade decision.
“This is about liberty, equality, and the rule of law, not the political or partisan views of those sitting on the bench. The unprecedented decision to remove a constitutional right recognized by the Supreme Court 50 years ago would set back civil rights by decades. ….
“Abortion access is essential, and a fundamental right under the U.S. Constitution. Bans on abortion are deeply racist and profoundly sexist – the harshest impacts fall on Black and Brown women and pregnant people and on our families and communities.
“If you think this decision will not affect you, think again: a wrong decision by the Supreme Court means you, too, will lose your bodily autonomy, your ability to own your own personal and community power. This is not just about abortion; it is about controlling bodies based on someone else determining your worthiness. This is a racial justice issue. This is a women’s issue. It is an LGBTQ issue. It is a civil rights issue. These are our fundamental rights that are at stake.”
Minnesota middle school principal ousted for displaying Pride flag
Critics ramped up attacks on the career educator- some compared her to the Devil after publicly associating with LGBTQ+ people and students
MARSHALL, Mn. — A former middle school principal in Minnesota who lost her job after displaying a Pride flag alleges in a federal lawsuit that the school system retaliated against her for supporting LGBTQ+ students.
Mary Kay Thomas filed the complaint against Marshall Public Schools in the U.S. District Court of Minnesota Tuesday after anti-LGBTQ+ middle school staff, parents, students and local clergy began efforts to remove the Pride flag that she put up in her middle school’s cafeteria in 2020 as a part of an inclusiveness effort.
According to the lawsuit, Thomas has been a teacher and principal for more than three decades with a long track record of success. She held the principal position at Marshall Middle School for 15 years, receiving contract renewals, pay raises and praise for her performance.
“But when Thomas decided to display an LGBTQ Pride Flag in the school cafeteria in early 2020, everything changed,” reads the complaint.
Thomas refused to take down the Pride flag as critics ramped up attacks on the career educator. The lawsuit alleges that some even compared her to the Devil after publicly associating with LGBTQ+ people and students.
“Sadly, the Marshall School District has sided with these critics,” her lawyers wrote.
What followed was an “escalating series of adverse actions” taken by the Marshall School District, said the lawsuit. She claims that the school targeted her by threatening her employment, conducting a “bad-faith” investigation, putting her on indefinite involuntary leave, suspending her without pay and putting a notice of deficiency in her personnel file.
The complaint says that the deficiencies were “false, distorted, and/or related to Thomas’s association with members of the LGBTQ community.”
Thomas also claims that the District attempted to get her to quit by removing her as principal and assigning her to a “demeaning ‘special projects’ position.”
At one point, Marshall Public Schools Superintendent Jeremy Williams, who is named as a defendant in the case, told Thomas he could “make this all go away” if she stepped down, according to the complaint.
The school removed the Pride flag in August 2021 after settling a lawsuit brought by residents who opposed it.
The Blade reached out to Williams for comment but did not receive a response. However, according to the Marshall Independent, Williams did release a statement on the matter.
“Marshall Public Schools is committed to the education of every child and has strong policies and practices in place against discrimination, against both students and staff members. The school district is committed to creating a respectful, inclusive, and safe learning and working environment for students, staff and our families,” Williams said. “While the school cannot comment about the specific allegations made in the complaint, the school district strongly denies any allegation of discriminatory conduct. The school will vigorously defend itself against these allegations.”
In addition, Thomas alleges that she resisted unwanted sexual advancements from school board member Bill Swope. She claims she told Williams about the sexual harassment.
As of Thursday, the school has not filed a response, and no hearing has been scheduled yet.
Thomas is seeking a jury trial, damages and reinstatement as principal of Marshall Middle School.
Matthew Shepard honored at National Cathedral
Daylong services held to mark his 45th birthday
The parents of gay University of Wyoming student Matthew Shepard, who was murdered in a 1998 hate crime that drew international attention to anti-LGBTQ violence, were among those attending a day of religious services commemorating Shepard’s 45th birthday on Wednesday at the Washington National Cathedral.
The services, which the Cathedral organized in partnership with the Matthew Shepard Foundation, included tributes to Shepard at the Cathedral’s St. Joseph’s Chapel, where his remains were interred in a ceremony in 2018.
“Matthew Shepard’s death is an enduring tragedy affecting all people and should serve as an ongoing call to the nation to reject anti-LGBTQ bigotry and instead embrace each of our neighbors for who they are,” the Very Rev. Randolph Marshall Hollerith, Dean of Washington National Cathedral, said at the time of Shepard’s interment.
“In the years since Matthew’s death, the Shepard family has shown extraordinary courage and grace in keeping his spirit and memory alive, and the Cathedral is honored and humbled to serve as his final resting place,” Hollerith said.
The first of the Cathedral’s Dec. 1 services for Shepard began at 7 a.m. with prayers, scripture readings, and music led by the Cathedral’s Rev. Canon Rosemarie Logan Duncan. The service was live streamed on YouTube.
An online, all-day service was also held from 8 a.m. to 5 p.m. that Cathedral officials said was intended to “connect people around the world to honor Shepard and the LGBTQ community and pray for a more just world.”
The Shepard services concluded with a 5:30 p.m. in-person remembrance of Shepard in the Cathedral’s Nave, its main worship space. Among those attending were Shepard’s parents, Dennis and Judy Shepard, who have said they created the Matthew Shepard Foundation to continue their son’s support for equality for all.
A statement released by the Cathedral says a bronze plaque honoring Matthew Shepard was installed in St. Joseph’s Chapel to mark his final resting place at the time Shepard was interred there in 2018.
Following the Cathedral’s Dec. 1 services for Shepard, the Adams Morgan gay bar Pitchers hosted a reception for Dennis and Judy Shepard, according to Pitchers’ owner David Perruzza.
One of the two men charged with Shepard’s murder, Russell Henderson, pleaded guilty to the charge after prosecutors agreed not to seek the death penalty for him. The second of the two men charged, Aaron McKinney, was convicted of the murder following a lengthy jury trial.
Prosecutors said McKinney repeatedly and fatally struck Shepard in the head with the barrel of a handgun after he and Henderson tied Shepard to a wooden fence in a remote field outside Laramie, Wy., on Oct. 6, 1998. Police and prosecutors presented evidence at McKinney’s trial that McKinney and Henderson met Shepard at a bar in Laramie on that day and lured him into their car, where they drove him to the field where authorities said McKinney fatally assaulted him.
Shepard died six days later at a hospital in Ft. Collins, Colo., where he was taken after being found unconscious while still tied to the fence.
In a dramatic courtroom scene following the jury’s guilty verdict for McKinney, Dennis Shepard urged the judge to spare McKinney’s life by not handing down a death sentence. He said that out of compassion and in honor of his son’s life, McKinney should be allowed to live. The judge sentenced McKinney to two consecutive terms of life in prison without the possibility of parole, the same sentence given to Henderson.
Canadian Senate approves bill to ban conversion therapy
Chile marriage equality bill receives final approval
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