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PrEP not ready for prime time

Data supporting drug for HIV prevention weak, inconclusive

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By JAMES DRISCOLL, Ph.D.

Government picking favorites among technologies on the basis of politics is always risky.

Political favoritism that clears a regulatory path for marketing a new, incompletely tested, drug can cost lives.

Under pressure from Gilead Sciences and its AIDS advocate allies, the FDA antivirals advisory panel will soon consider accelerated approval for Gilead’s AIDS treatment drug Truvada for prevention of HIV infection. Opposition is widespread in the HIV advocacy and medical communities. AIDS advocates warn that such approval would be, at best, years premature. At worst, it would be an unwarranted, dangerous experiment with public health.

Clinical trial data supporting Truvada as prevention, or PrEP (pre-exposure prophylaxis), is weak and inconclusive.  PrEP is a far less effective preventative than are condoms (44% versus 98+% in U.S. conditions). Doctors fear that PrEP will be used instead of condoms or that its use will discourage condom usage. Cynthia Davis, an HIV doctor at Drew University of Medicine in Los Angeles, counsels that the drug must show 90 percent efficacy to be used safely in the U.S.

Davis worries that too many people will think that because they are taking the pill they will be safe. Dr. Kevin Fenton, CDC Chief of HIV-AIDS Prevention, has warned: “Some studies suggest that even a small increase in risk behavior due to a false sense of security about the pills’ effectiveness could actually increase HIV infections.”

Drug adherence among those already infected is difficult; it will be even more so among the uninfected. If the uninfected lack therapeutic levels of Truvada in their bloodstream before sex, they will remain unprotected. Patients will need careful monitoring and counseling to insure adherence; such handholding will be costly, inconvenient and in today’s economy unlikely.

Truvada is the most widely used anti-retroviral (ARV). Poor adherence, by the uninfected, will generate drug resistant viral strains. Curbing Truvada resistant strains is important to the well being of the HIV infected population and critical for those who become infected in the future.

ARVs are toxic, healthy people shouldn’t just pop them like vitamin C. The long-term toxicities of Truvada are unknown. Kidney damage, diabetes and hypertension have all been reported. Why risk these toxicities when safer, more effective prevention methods are readily available?

The NIH 052 study has proven that ARV treatment is 96+ percent effective in preventing infection of HIV-negative partners. Indeed, Science named 052’s results the No. 1 scientific advance of 2011.

Resources for ARV treatment in the U.S. are stretched to the limit. PrEP approval will result in scarce resources being diverted from proven preventatives that are 96+ percent effective into an experimental preventive which, even with ideal adherence, promises only 44 percent efficacy.

At $13,000/patient/ year retail, Truvada is a very expensive drug. In an era of severe fiscal constraints, Truvada used as PrEP would not only risk human lives, it would misallocate public and private resources needed for the healthcare of all Americans.

FDA Commissioner Margaret Hamburg has rebuffed appeals to meet with AIDS doctors and advocates who oppose accelerated approval for PrEP.  She is ‘too busy’ to listen to them about either the health risks of PrEP or the political influence on its behalf.  During the Clinton administration, Commissioner David Kessler met with AIDS advocates more than 20 times to discuss drug approvals.

Kessler’s door was open, he listened. Dr. Hamburg and her staff could learn from Dr. Kessler. One hopes the Obama White House can accelerate her learning curve — she appears to be stalled at go.

The FDA plays a crucial role in the fight against AIDS. When FDA listens to all AIDS advocates, it advances the solutions. If FDA closes the door to all but its friends, it becomes part of the problem.

President Obama has given America its first National AIDS Strategy, increased resources for HIV testing and ADAP, and sustained funding for international AIDS treatment in a difficult fiscal environment.

President Obama has listened and responded. The FDA needs to follow his example.

James Driscoll, Ph.D. is a longtime AIDS activist and an adviser to AIDS Healthcare Foundation.

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What LGBTQ veterans are building after ‘Don’t Ask, Don’t Tell’

DADT repeal took effect on Sept. 20, 2011. Trans servicemember ban reinstated

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The Pentagon (Photo by icholakov/Bigstock)

Fifteen years ago this month, the repeal of “Don’t Ask, Don’t Tell” took effect. At the time, the importance of the change was obvious: gay, lesbian, and bisexual Americans would no longer have to hide who they were to wear the uniform. What was harder to see was what would follow: a generation of LGBTQ veterans able to carry their service openly into American civic life.

Earlier this month, Alaska state Rep. Andrew Gray, an Army veteran, stood before the Anchorage Assembly and asked the city to recognize Sept. 20 as LGBTQ Veterans Day.

His former commander, Mike Grunst, followed him to the microphone. A 35-year veteran who had served in combat, Grunst called troops who had served while hiding who they were “the bravest I have ever served with.”

Then Denise Sudbeck stepped forward. A Vietnam-era Navy veteran who later served with both men in the Alaska National Guard, she thanked the country for the privilege of serving and asked that the next generation have the same chance.

The Assembly approved the recognition.

Nothing about the scene required a new vocabulary. A veteran made a request of his community. A commander vouched for those who served beside him. Another veteran asked that younger Americans inherit the opportunity she valued. They entered the civic record simply as veterans.

That identity can do more than win recognition.

When federal policy abruptly ended the careers of transgender servicemembers this year, veterans and servicemembers in California began asking a practical question: What happens when those Americans come home?

Republican Assemblyman Jeff Gonzalez, a Marine combat veteran, began one hearing with questions about transgender military service. He listened as veterans explained how the military handles medical care and deployment case by case.

Then the discussion turned to separation.

“I don’t wanna see any veteran homeless,” Gonzalez said. Before the hearing ended, he was asking: “How can I help? How can I understand? How can I be a good advocate?”

The legislation that followed would provide housing, employment and transition assistance to discharged servicemembers. Republican state Sen. Shannon Grove spoke for it. The Senate passed it 32 to 0.

Americans have plainly not settled their disagreements over transgender people. Nor should military service be a prerequisite for rights that belong to every citizen.

But military service creates relationships that are difficult to reduce to the abstractions of the culture war. Before a legislature, “the transgender issue” can become a veteran who deployed, an officer who led troops, or the person who once stood beside you.

The political question changes because the human relationship has already changed.

The pattern is beginning to appear across the country. Kansas is among the states recognizing LGBTQ Veterans Day for the first time this year. New York and Virginia are pursuing broader state-level programs for LGBTQ veterans.

Sept. 20 is deliberate. On that day in 2011, “Don’t Ask, Don’t Tell” ended.

We usually remember repeal for what LGBTQ Americans gained: the ability to serve openly. Fifteen years later, we can also see what the country gained.

A gay veteran can stand before his local government beside the commander who once led him. A transgender servicemember can sit before a legislator who begins with doubts and ends by asking how he can help. A veteran from an older generation can ask her neighbors to give those who follow her the same chance to serve.

This is citizenship in practice.

The enduring legacy of “Don’t Ask, Don’t Tell” repeal is not only that Americans were finally allowed to serve openly. It is also what they can now build after coming home.

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Gun reform is an LGBTQ rights issue

‘I am sick of Congress refusing to lift a finger to protect our communities’

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(Image by Andrii Koval/Bigstock)

Earlier this month, 44-year-old Ousman Ceesay allegedly shot two people in the parking lot of Venture-N, a well-known gay bar in Tucson, Ariz. Both victims — Vincent Anthony Siquerioes and Cameron Davis Capara — died at the scene. Police discovered a list of several LGBTQ businesses on Ceesay’s person, and evidence points to how Ceesay confronted Siquerios and Capara in the bar’s parking lot before killing them. According to a news release, police are investigating the incident as a hate crime. 

The event was reminiscent of the 2022 Club Q shooting and the Pulse nightclub shooting, where Omar Mateen shot and killed 49 people and wounded more than 50 more at the gay nightclub in Orlando. Survivors and the wider queer community recognized the 10th anniversary of the shooting this past June 12. As the queer community grieved another shooting targeting LGBTQ safe spaces this month, some members of the LGBTQ community are raising the call for gun reform as a key step to protect LGBTQ rights. 

Gun violence is a major issue for the LGBTQ community. LGBTQ people are more than twice as likely to be the victims of violent crime than straight and cisgender people, with one in five hate crimes in the United States motivated by queer phobia. This means that LGBTQ folks are more likely to be violently attacked by a stranger compared to their cisgender, straight counterparts. In school settings, 29% of transgender youth and 16% of gay and lesbian youth have been threatened or injured with a weapon, compared to 7% of cisgender youth. 

There is an ongoing epidemic of gun violence injuring and killing trans women of color in the United States today. One study by the nonprofit Everytown for Gun Safety identified that the number of trans people who were murdered in the U.S. doubled between 2017 and 2021, increasing 93% in that time period. Everytown for Gun Safety recognizes that these aren’t even the actual numbers as many trans people are misgendered or deadnamed by the police, media, or their families so their deaths are not incorporated into these numbers and tied to systemic gun violence against the wider LGBTQ community.

As a community with higher rates of self harm and suicide, easy access to firearms increases the risk that a suicide attempt will end in death. This does not mean that LGBTQ people are mentally ill, a popular far right talking point. LGBTQ people are not more likely to experience suicidal ideations and die by suicide not because they are LGBTQ but because of the stigma surrounding their identities. LGBTQ young people are more than four times likely than their non-LGBTQ peers to attempt suicide, and the Trevor Project estimates that 1.8 million LGBTQ people between the ages of 13 and 24 consider suicide in the United States.  

As the Williams Institute shows, this makes gun violence a serious public health concern for the queer community. As Dr. David Hemenway, co-author of a 2016 study published in the American Journal of Medicine said, “differences in overall suicide rates across cities, states, and regions in the United States are best explained not by differences in mental health, suicide ideation, or even suicide attempts, but by availability of firearms.”

Gun violence is also a major queer issue given that trans and gender expansive individuals are at greater risk of experiencing intimate partner violence. Compared to the 35% of straight women who experience intimate partner violence, 44% of lesbian and 61% of bisexual women report experiencing rape, physical violence, or stalking by an intimate partner. This number is also higher for bisexual men (37% of whom experience intimate partner violence compared to 29% of straight men). This number is much higher for trans folks; more than half of people surveyed reported some form of intimate partner violence, according to a 2015 survey

During the second Trump administration, ongoing legal attacks on LGBTQ rights, executive orders that deny the existence and protections of trans, nonbinary, and gender expansive individuals, and virulent opposition to and disbanding and defunding of DEI initiatives, LGBTQ employee resource groups, queer history collections, exhibitions, and education, LGBTQ representation in libraries and school settings, and the firing of federal workers allegedly because they are queer — realizing a new Lavender Scare — have emboldened violent homophobes.

After the Club Q shooting, Rodrigo Heng-Lehtinen, executive director of the National Center for Transgender Equality, explained that “the rhetoric and the legislative attempts to erase transgender people sends a signal that violence toward us is tolerated.” This has become even more dire after a 2025 White House memo prioritized identifying “radically pro-transgender” groups as national security threats, in line with the Heritage Foundation’s plan to designate trans people terrorists. In response, Congresswoman Suzanne Bonamici shared, “the Trump administration’s endorsement and proliferation of hateful and violent rhetoric against the trans community is putting lives at risk,” particularly the push to label trans people and their allies as terrorists. 

As Congresswoman Adelita Grijalva said on the House Floor following this latest tragedy, “when that [anti-LGBTQ+] hate is combined with easy access to firearms, the consequences can be deadly. I am sick and tired of Congress refusing to lift a finger to protect our communities while, every day, dozens of people are shot and killed across the country.”

A 2018 survey shows that the wider LGBTQ community supports gun reform — with 93% of lesbian, gay, and bisexual adults supporting background checks and 72% opposing legislation and procedural changes that make it easier to obtain concealed weapon permits. This is not to say that the wider LGBTQ community opposes gun ownership. In fact, a growing cohort of LGBTQ individuals and other members of minority and marginalized groups are investigating gun training and ownership to protect themselves. Part of their motivation is not just protecting themselves against perpetrators of hate-motivated gun violence but also against state and federal agents that are increasingly attacking the LGBTQ community.

After the shooting, Tucson police increased their presence at other LGBTQ businesses in the city, but locals expressed concern that this would alienate some LGBTQ patrons, especially queer and trans patrons of color, and might also lead to further violence knowing that police continue to be instigators in and perpetrators of queer phobic violence. A Williams Institute study published this past year highlighted how LGBTQ people, especially queer people of color, LGBTQ youth, and trans and gender expansive individuals experience higher rates of profiling, discrimination, harassment, and entrapment from law enforcement. 

This is one of the reasons that police presence at Pride events continue to be controversial, as community members remember how the police were the major antagonists at the Stonewall and Compton’s Cafeteria riots. The LGBTQ rights movement came to be largely because queer and trans people of color fought back against violent police harassment and abuse. 

As someone who was traumatized by active shooter drills in elementary, middle, and high school, I am exhausted and heartbroken by continued gun violence and politicians’ refusal to consider and take action through gun reform legislation. Whether intentional or not, their hesitation to discuss and address this issue publicly and to use their political power to prevent future shootings communicates to LGBTQ+ people that they do not care about us. With gun violence disproportionately affecting our community, their silence and inaction is a form of queer phobic violence itself allowing tragedies like Tucson to continue happening. 

(If you or someone you know is in crisis, call or text 988 to reach the Suicide and Crisis Lifeline. You can also text HOME to 741741 or visit SpeakingOfSuicide.com/resources for additional resources. You are not alone.) 


Emma Cieslik is a D.C.-based museum worker and public historian.

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Trump’s Cabinet: Dumb, dumber, dumbest, and evil

Corrupt officials working to undo 250 years of progress

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Secretary of State Marco Rubio (Washington Blade file photo by Michael Key)

Dumb, dumber, dumbest, and evil. Any of the felon’s Cabinet and close aides could fit these terms depending on the discussion. 

You have Commerce Secretary Lutnick saying “no American military were killed in Iran war.” Then it was reported our venal Vice President JD Vance said, “The current hostilities shouldn’t even be called a war, since ‘active combat operations’ ended months ago. Right now, there is no active shooting, Vance insisted. This despite the U.S. and Iran still currently exchanging fire, including around the Strait of Hormuz. 

Then the fool-in-chief, the felon in the White House, said about Vance’s comments, “U.S. strikes on Iran are now “intermittent” and a lot of people don’t call it a war. I can understand what he’s saying. I call it a military conflict because it’s small potatoes for us. It’s not a big thing.” All this even though this so called “conflict” has cost U.S. taxpayers more than $37.5 billion and left 18 U.S. service members dead, hundreds injured. 

All this after Secretary of State Marco Rubio said, “the Trump administration’s objective in the conflict surrounding the Strait of Hormuz is to restore shipping conditions to what they were before the war with Iran began.” Then self-hating, gay, Secretary of the Treasury, Scott Bessent, chimed in, after two days of meetings with finance ministers from around the world, blaming Ukraine for high oil prices citing “Ukraine’s attacks on Russia’s oil infrastructure as part of the reason for the global energy shock.” These people all belong in an asylum, or jail.  

When not talking about the war, as he is losing it badly, the felon-in-chief talks BS at a rally in Texas. Then he talks about redesigning Washington. Lutnick, speaking at a judicial hearing on whether Trump can put his name on the National Monument honoring JFK, said, “Donald Trump is the most credible person in the world” while arguing that the Kennedy Center should bear his name because he’s vowed to raise the funds to renovate it. That, even though the funds were approved by Congress and not raised by Trump. Then Trump’s tariff war on the world, now focused on Canada, which is screwing the American people, and his believing an Executive Order can get the world to call bodies of water like the Gulf of Mexico, and Lake Ontario, by different names. Or that he can change the name of the Department of Defense, to the Department of War, which only Congress can do. With the help of the fascist sycophants around him, he creates chaos in the world. 

He has torn down part of the White House, and tries to build an arch. Spent millions and caused the destruction of the reflecting pool. Some of these things will be undone, others will remain, but his name will go down in history, not on buildings, as the worst president ever. People will laugh at him as they move to remove his name from everything they can, just as New Yorkers did when he was first elected, embarrassed to be associated with him. 

Now for any sane person looking at, and listening to, this chaos, it is abundantly clear how embarrassing all this is for the country. It is clear he is moving the nation backwards when it comes to the equality and equity we have fought so hard to accomplish. Our country began with us killing, and taking land, from Native Americans. The founders of our nation 250 years ago only recognized white men. They left out women and Black men. We have spent the past 250 years trying to move forward from that beginning. Trying to live up to the statement in the Declaration of Independence that said, “We hold these truths to be self-evident, that all men are created equal, that they are endowed by their Creator with certain unalienable Rights, that among these are Life, Liberty and the pursuit of Happiness.” 

We have come a long way, but still have not been able to add women’s equality to our Constitution. But Trump, along with his fascist aides and sycophants in Congress, is trying his best to undo all we have accomplished in those 250 years. Trying either to take away the right to vote, or make it harder to do. They took away the right of women to control their own healthcare, and are making it harder for Black people and the LGBTQ community, to live their lives fully, with dignity and safety. They will accomplish all this, and more, if not enough people come out on Nov. 3 and say, NO MORE. However, if enough decent people vote, we can take back our country, and our future. 


Peter Rosenstein is a longtime LGBTQ rights and Democratic Party activist.

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