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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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The global cost of Trump’s foreign aid ideology

Expanded global gag rule polices people’s identity

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The White House (Official White House Photo by Adam Schultz)

U.S. Vice President JD Vance on Jan. 23 announced the new Promoting Human Flourishing in Foreign Assistance Policy. This policy, which has nothing to do with flourishing, is part of the Trump administration’s effort to weaponize U.S. foreign assistance to enforce ideological conformity, to police people’s identity, and to suppress dissent — both at home and abroad. 

One of the policy’s three pillars advances a discriminatory framework that denies transgender people’s existence and seeks to censor organizations that affirm transgender people and their rights. 

The new policy expands the Mexico City Policy, also known as the global gag rule, which has restricted U.S. foreign aid to non-U.S. civil society organizations providing abortion care under every Republican  administration since 1984. What is new — and unprecedented — is the expansion of this rights-restricting logic to efforts addressing gender identity and, more broadly, nondiscrimination efforts. 

The new policy also applies to more categories of aid recipients, including multilateral organizations such as UN agencies. 

With the expanded global gag rule, the Trump administration seeks to make transgender people invisible globally, as it has within the U.S. Whether it is threatening steep tariffs for countries that resist Trump’s appetite for Greenland, or withholding  funds for organizations that refuse to toe the ideological line, the chilling message is clear: standing in the way of the administration’s political or ideological goals will come at a high cost.

Under this rule, organizations risk losing U.S. funding if their activities are seen to fall under the spurious concept of “gender ideology.” Organizations are not allowed to provide, refer for, or support access to gender-affirming care. Neither can they offer accurate information, counseling, or public-facing support for transgender people. The restrictions even apply to cultural activities such as “drag queen workshops, performances, or documentaries.” 

Organizations that receive any foreign aid from the U.S. will need to censor themselves, even if their own national or regional laws enable — or oblige — them to speak up for human rights.

This new policy comes after the Trump administration dismantled the U.S. Agency for International Development, which has for decades provided the bulk of U.S. international development and humanitarian assistance.

To be clear, LGBT people, regardless of where they are, do not depend on the United States to organize, advocate, and stand up for their rights. And foreign aid is not the answer to undoing global inequity. But the sharp reversal of U.S. foreign policy will have wide-ranging consequences. 

For years, protecting the rights of LGBT people had been a core tenet of the U.S. commitment to human rights. U.S. embassies often functioned as safe havens for human rights defenders in places where governments stoked homo- and transphobia for political gain. For LGBT people in the 65 countries that still criminalize same-sex intimacy, civil society-run clinics, supported with U.S. funds, became life-saving spaces — people could get HIV and other care there without fear of being turned away, ridiculed, or reported to the police.

Much of this is progress is now at risk. As a result of the U.S. funding cuts, organizations that directly provided health care and other services for LGBT people were forced to stop services abruptly, cutting off people’s access to chronic medication often without alternative care in place. 

The impact extends beyond individual harm. Public health programs by definition are more likely to fail when stigma and fear are institutionalized. Transgender people are among the groups most at risk for ill health precisely because of discrimination and violence.

By prohibiting organizations, from local civil society groups to multilateral organizations like UNAIDS, from affirming transgender identities or addressing these underlying conditions, the expanded global gag rule actively undermines the foundations of effective public health programs. 

Under the new and expanded gag rule, organizations face a terrible choice for accepting any U.S. funding. They can either self-censor and stop all work related to transgender people’s rights and needs. Or they forego U.S. funds and risk jeopardizing their organizational survival in an increasingly tough economic and funding climate. 

This matters because civil society is one of the few effective counterweights to the global rise of populist and authoritarian governance. Alongside a coordinated global backlash against women’s and LGBT people’s rights are efforts to concentrate power, erode accountability, and close civic space.

Civil society organizations are crucial in exposing and resisting the authoritarian creep and in supporting marginalized groups. Gagging organizations into silence, or hollowing them out through funding cuts, accelerates civic space closure, and strengthens authoritarian governance.

Where the U.S. retreats and bullies, other countries and communities need to step up to offset the funding shortfalls and reduce organizations’ dependency on ideologically restricted U.S. foreign aid. 

They need to support marginalized groups, increase funding for civil society groups, and commit funds to bolster multilateral mechanisms such as the Global Fund, which supports funding to combat HIV/AIDS, TB, and Malaria. They should clearly and consistently affirm everyone’s human rights, without exception.

Alex Muller is the director of Human Rights Watch’s LGBT Rights Program.

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How do we honor Renee Good, Alex Pretti?

Lives more than last 10 seconds captured on video

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Protesters in Haymarket, Va. on Jan. 11 protest against U.S. Immigration and Customs Enforcement after an ICE agent shot Renee Good to death in Minneapolis. (Washington Blade photo by Michael Key)

Renee Good. Alex Pretti.

During this last year, I wondered who would be the first U.S. citizen to be shot by our government. It was not a matter of if, but when. Always.

And now we know.

I thought it would be soldiers. But the masked men got there first. Because when you mix guns and protests, guns inevitably go off. The powers that be always knew it, hoped for it, and wanted it to happen. 

Why? Because masked men and guns instill fear. And that’s the point. Ask yourself when’s the last time you saw masked men and guns in our cities, or anywhere for that matter. I always thought that men masked men with guns robbed banks. I was wrong.  

Masked men want to rob us of our dignity as human beings. Of our assurance in the calmness and contentment of our communities. They want to rob us of our trust in our institutions, and our faith in each other. And truly they want to rob us of the happiness and joy that we all constantly yearn to find in our lives.  

But our only collective ability as a nation to push back is our protests. Peaceful protests. As Renee and Alex did.

But peaceful protests? Because they are the perfect power to shame the cowardice of those that believe guns and force are the only true authority. Fortunately, our last hope and fiercest ally is our Constitution, which gives us the power — and the right — to protest. 

How much more peaceful can you get when you hear Renee Good’s last words, “I’m not mad at you, Dude.” I may be mad at the system, the government, the powers of unknown people pulling the strings but not you personally. “Dude.” Peaceful to the last word.

Yet, what becomes lost in the frantic pace of hair-trigger news cycles, of officials declaring impetuous damnations alongside johnny-on-the spot podcasters spouting their split-second opinions are the two human beings who have lost their lives.

How habituated we’ve become as we instantly devour their instant obituaries. The sum of their lives declared in less than 10 seconds of cellphone video. They haven’t just lost their lives.  They’ve lost all of their lives. And now we watch over and over again as their death is re-revealed, re-churned, re-evaluated, and re-consumed. In that endless repetition, we forget the meaning of life itself.

We must remember that Renee and Alex believed in their communities, in the purpose of their work, in the happiness of their loves and lives, and in the dignity and curiosity of life itself. They were singular individuals who did not deserve to die at the end of a gun barrel for any reason, ever.

How fitting that Renee was a poet. Sometimes in confronting the massiveness of loss in our lives, we look to our poetry and our psalms, our hymns and our lullabies, to find a moment of solace in our communal grief, and to remember Renee and Alex, for what they gave us in life.

Yet, at this moment, I cannot escape the reality of what was taken from them so soon, so violently and so forever. They were exceptionally courageous and normal people, and for that reason, I must remember them through a poem to explain to me, and others, the unexplainable. 

I dream of this not happening. 

I dream this day and night.

For none of this is real.

And none of this is right.

I dream of these sons and daughters

who now will not go home,

and dream of their mothers and fathers,

who now must stand alone.

I dream of all the flowers that they will never hold —

the kisses never shared again, the secrets to not be told.

I dream of all the sunsets that for them will never set,

I dream of all the love they gave and now they must forget.

I dream of all their dinners

with wine to never spill,

or books to read, or bread to break

or babies to be held.

I dream of each one still reaching 

in the middle of the night,

for a hand that needs another 

to stop a nightmare’s flight.

I dream of them not dreaming, 

which I could never do,

for how can you not dream a dream

that never will come true.

I dream of this not happening.

I dream this day and night.

For none of this is real

And none of this is right. 

Carew Papritz is the award-winning author of “The Legacy Letters,” who inspires kids to read through his “I Love to Read” and the “First-Ever Book Signing” YouTube series.

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Gay Treasury Secretary’s silence on LGBTQ issues shows he is scum

Scott Bessent is a betrayal to the community

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Treasury Secretary Scott Bessent (Washington Blade photo by Michael Key)

We all know the felon in the White House is basically a POS. He is an evil, deranged, excuse for a man, out only for himself. But what is just as sad for me is the members of the LGBTQ community serving in his administration who are willing to stand by silently, while he screws the community in so many ways. The leader, with his silence on these issues, is the highest ranking “out” gay ever appointed to the Cabinet; the current secretary of the treasury, the scum who goes by the name, Scott Bessent. 

Bessent has an interesting background based on his Wikipedia page. He is from South Carolina and is what I would call obscenely wealthy. According to his financial assets disclosure to the U.S. Office of Government Ethics, Bessent’s net worth was at least $521 million as of Dec. 28, 2024; his actual net worth is speculated to be around $600 million. He married John Freeman, a former New York City prosecutor, in 2011. They have two children, born through surrogacy. I often wonder why guys like Bessent conveniently forget how much they owe to the activists in the LGBTQ community who fought for the right for them to marry and have those children. Two additional interesting points in the Wikipedia post are Bessent reportedly has a close friendship with Donald Trump’s brother Robert, whose ex-wife, Blaine Trump, is the godmother of his daughter. The other is disgraced member of the U.S. House of Representatives, John Jenrette, is his uncle.  

Bessent has stood silent during all the administrations attacks on the LGBTQ community. What does he fear? This administration has kicked members of the trans community out of the military. Those who bravely risked their lives for our country. The administration’s policies attacking them has literally put their lives in danger. This administration supports removing books about the LGBTQ community from libraries, and at one point even removed information from the Pentagon website on the Enola Gay, the plane that dropped the first atomic bomb, thinking it might refer to a gay person. It was actually named after Enola Gay Tibbets, the mother of the pilot, Col. Paul Tibbets. That is how dumb they are. Bessent stood silent during WorldPride while countries around the world told their LGBTQ citizens to avoid coming to the United States, as it wouldn’t be safe for them, because of the felon’s policies. 

Now the administration has desecrated the one national monument saluting the LGBTQ community, Stonewall, in New York City, by ordering the removal of the rainbow flag. The monument honors the people who get credit for beginning the fight for equality that now allows Bessent, and his husband and children, to live their lives to the fullest. That was before this administration he serves came into office. I hope his children will grow up understanding how disgusting their father’s lack of action was. That they learn the history of the LGBTQ community and understand the guts it took for a college student Zach Wahls, now running for the U.S. Senate from Iowa, to speak out for his “two moms” in the Iowa State Legislature in 2011, defending their right to marry.  

Bessent is sadly representative of the slew of gays in the administration, all remaining silent on the attacks on the community. They are mostly members of the Log Cabin Republicans who have given up on their principles, if they ever had any, to be subservient to the felon, and the fascists around him, all for a job. 

There are so many like them who supported the felon in the last election. Some who believed in Project 2025, others who didn’t bother to read it. Many continue to stand with him, with the sycophants in the Congress, and the incompetents and fascists in the administration, as they work to destroy our country and end the democracy that has served us so well for 250 years. To keep out all immigrants from a nation of immigrants. They all seem to forget it was immigrants who built our country, who fought against a king, and won. These sycophants now support the man who wants to be king. Who openly says, “I am president I can do anything only based on my own morality,” which history clearly shows us he has none. 

I believe we will survive these horrendous times in American history. We have fought a king before and won. We have kept our country alive and thriving through a civil war. We the people will defeat the felon and his minions, along with the likes of those who stood by silently like Scott Bessent. They seem to forget “Silence = Death.” 

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

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