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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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Happy Thanksgiving to all

Dreaming of a brighter future for America

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(Photo by lilkar/Bigstock)

I hope you have a great Thanksgiving and can enjoy it with family and friends and that you have things you can be thankful for this past year. That you have your health. Now here is the column I would have liked to share with you this Thanksgiving: 

To all my friends and family. This year I am thankful the felon has left the White House. It feels we can all finally breath again. I am so happy his idea of a ballroom at the White House was a joke, and we can once again walk in Jackie Kennedy’s rose garden, and visit the beautiful East Wing. I am thankful the felon’s personal Goebbels, Stephen Miller, lost his job when the reality that he was a fascist was too much to take. It was wonderful to see the Supreme Court wake up and do their job once again. They stopped drinking the MAGA Kool-Aid and voided all the executive orders calling on museums to hide the history of Black Americans, women, and the LGBTQ community. They told the president he didn’t have the right to place tariffs, and that he couldn’t fire legally appointed members of commissions under the rubric of Congress’s control.

Then I am thankful the Congress began to do its job. That so many Republicans grew a set of balls and decided to challenge Speaker Mike ‘sycophant’ Johnson, reminding him they were an independent part of government, and didn’t need to rubber stamp everything the felon wanted. I was thankful to see them extend the SNAP program indefinitely, and the same with the tax credits for the ACA, agreeing to include these important programs in next year’s budget. Then they went further, and paid for the programs, by rescinding all the tax benefits they had given to the wealthy, and corporations, in the felon’s big ugly bill. Finally realizing it is the poor and middle class who they had to help if the country was to move forward. Then I can’t thank them enough for finally passing the Equality Act, and doing it with a veto proof majority, so the felon had to sign it, before he left office. They did the same for the Choice Act, and the Voting Rights Act. It was a glorious year with so much to be thankful for. 

Then I am so thankful Congress finally stood up to the felon and said he couldn’t start wars without their approval, and the Supreme Court ruled they were right. That attacking Venezuela was not something he had the right to do. Then the final thing the court did this year I am thankful for, is they actually modified their ruling on presidential immunity, and said the felon’s grifting was not covered, as under their decision that was private, and not done in his role as president. Again, can’t thank them enough for waking up and doing that. 

Then there is even more I am thankful for this year. It was so nice to see Tesla collapse, and Musk lose his trillion-dollar salary. The people finally woke up to him and insisted Congress mandate the satellite system he built, basically with money from the government, was actually owned by the government, and he could no longer control who can use it. It was determined he alone would not be able to tell Ukraine whether or not they can use it in their war defending against the Russian invasion. Then I am so thankful Congress went even further, and approved the funds needed by the Ukrainians for long-range missiles, and a missile defense system, accepting Ukraine was actually fighting a proxy war for the West, and Ukraine winning that war would help keep our own men and women off the battlefield. 

And speaking of our military, I thank Congress for lifting the ban on transgender persons in the military, and honoring their service, along with the service of women, Black service members, all members of the LGBTQ community, and all minorities. It was fun to see Pete Hegseth being led out of the Pentagon, and being reminded he wasn’t the Secretary of War. There is no Department of War, it is still the Department of Defense, with congressional oversight. Again, so many things to be thankful for this past year. It seemed like my heart runneth over. 

Then my alarm went off and I woke up from my big beautiful dream, only to realize I was still living in the Trumpian nightmare. 


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

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Elusive safety: what new global data reveals about gender, violence, and erasure

Movements against gender equality, lack of human rights data contributing factors.

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Activists who participated in a 2024 Pride march in San Salvador, El Salvador, carry a banner that calls for a country where “being a woman is not a danger.” (Photo courtesy of Colectivo Alejandría)

“My identity could be revealed, people can say whatever they want [online] without consequences. [Hormone replacement therapy] is illegal here so I’m just waiting to find a way to get out of here.”

-Anonymous respondent to the 2024 F&M Global Barometers LGBTQI+ Perception Index from Iraq, self-identified as a transgender woman and lesbian

As the campaign for 16 Days Against Gender-Based Violence begins, it is a reminder that gender-based violence (GBV) — both on– and offline — not only impacts women and girls but everyone who has been harmed or abused because of their gender or perceived gender. New research from the Franklin & Marshall (F&M) Global Barometers and its report A Growing Backlash: Quantifying the Experiences of LGBTQI+ People, 2022-2024 starkly show trends of declining safety among LGBTQI+ persons around the world.

This erosion of safety is accelerated by movements against gender equality and the disappearance of credible human rights data and reporting. The fight against GBV means understanding all people’s lived realities, including those of LGBTQI+ people, alongside the rights we continue to fight for.

We partnered together while at USAID and Franklin & Marshall College to expand the research and evidence base to better understand GBV against LGBTQI+ persons through the F&M Global Barometers. The collection of barometers tracks the legal rights and lived experiences of LGBTQI+ persons from 204 countries and territories from 2011 to the present. With more than a decade of data, it allows us to see how rights have progressed and receded as well as the gaps between legal protections and lived experiences of discrimination and violence. 

This year’s data reveals alarming trends that highlight how fear and violence are, at its root, gendered phenomena that affect anyone who transgresses traditional gender norms.

LGBTQI+ people feel less safe

Nearly two-thirds of countries experienced a decline in their score on the F&M Global Barometers LGBTQI+ Perception Index (GBPI) from 2022-2024. This represents a five percent drop in global safety scores in just two years. With almost 70 percent of countries receiving an “F” grade on the GBPI, this suggests a global crisis in actual human rights protections for LGBTQI+ people. 

Backsliding on LGBTQI+ human rights is happening everywhere, even in politically stable, established democracies with human rights protections for LGBTQI+ people. Countries in Western Europe and the Americas experienced the greatest negative GBPI score changes globally, 74 and 67 percent, respectively. Transgender people globally reported the highest likelihood of violence, while trans women and intersex people reported the highest levels of feeling very unsafe or unsafe simply because of who they are. 

Taboo of gender equality

Before this current administration dismantled USAID, I helped create an LGBTQI+ inclusive whole-of-government strategy to prevent and respond to GBV that highlighted the unique forms of GBV against LGBTQI+ persons. This included so-called ‘corrective’ rape related to actual or perceived sexual orientation, gender identity, or expression” and so-called ‘conversion’ therapy practices that seek to change or suppress a person’s gender identity or expression, sexual orientation, or sex characteristics. These efforts helped connect the dots in understanding that LGBTQI+ violence is rooted in the same systems of inequality and power imbalances as the broader spectrum of GBV against women and girls. 

Losing data and accountability

Data that helps better understand GBV against LGBTQI+ persons is also disappearing. Again, the dismantling of USAID meant a treasure trove of research and reports on LGBTQI+ rights have been lost. Earlier this year, the US Department of State removed LGBTQI+ reporting from its annual Human Rights Reports. These played a critical role in providing credible sources for civil society, researchers, and policymakers to track abuses and advocate for change. 

If violence isn’t documented, it’s easier for governments to deny it even exists and harder for us to hold governments accountable. Yet when systems of accountability work, governments and civil society can utilize data in international forums like the UN Universal Periodic Review, the Convention on the Elimination of All Forms of Discrimination Against Women, and the Sustainable Development Goals to assess progress and compliance and call for governments to improve protections. 

All may not be lost if other countries and donors fill the void by supporting independent data collection and reporting efforts like the F&M Global Barometers and other academic and civil society monitoring. Such efforts are essential to the fight against GBV: The data helps show that the path toward safety, equality, and justice is within our reach if we’re unafraid of truth and visibility of those most marginalized and impacted.

Jay Gilliam (he/him/his) was the Senior LGBTQI+ Coordinator at USAID and is a member of the Global Outreach Advisory Council of the F&M Global Barometers.

Susan Dicklitch-Nelson (she/her/hers) is the founder of the F&M Global Barometers and Professor of Government at Franklin & Marshall College.

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Second ‘lavender scare’ is harming our veterans. We know how to fix it

Out in National Security has built Trans Veterans State and Local Policy Toolkit

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(Photo by Cheryl Casey via Bigstock)

Seventy years after the first “lavender scare” drove LGBTQ Americans from public service, a second version is taking shape. Executive directives and administrative reviews have targeted transgender servicemembers and veterans, producing a new wave of quiet separations and lost benefits.

The policy language is technical, but the result is personal. Veterans who served honorably now face disrupted healthcare, delayed credentials, or housing barriers that no act of Congress ever required. Once again, Americans who met every standard of service are being told that their identity disqualifies them from stability.

Out in National Security built the Trans Veterans State and Local Policy Toolkit to change that. The toolkit gives state and local governments a practical path to repair harm through three measurable actions.

First, continuity of care. States can keep veterans covered by adopting presumptive Medicaid eligibility, aligning timelines with VA enrollment, and training providers in evidence-based gender-affirming care following the World Professional Association for Transgender Health Standards of Care Version 8.

Second, employment, and licensing. Governors and boards can recognize Department of Defense credentials, expedite licensing under existing reciprocity compacts, and ensure nondiscrimination in state veterans’ employment statutes.

Third, housing stability. States can designate transgender-veteran housing liaisons, expand voucher access, and enforce fair-housing protections that already exist in law.

Each step can be taken administratively within 90 days and requires no new federal legislation. The goal is straightforward: small, state-level reforms that yield rapid, measurable improvement in veterans’ daily lives.

The toolkit was introduced during a Veterans Week event hosted by the Center for American Progress, where federal and state leaders joined Out in National Security to highlight the first wave of state agencies adopting its recommendations. The discussion underscored how targeted, administrative reforms can strengthen veterans’ healthcare, employment, and housing outcomes without new legislation. Full materials and implementation resources are now available at outinnationalsecurity.org/public-policy/toolkit, developed in partnership with Minority Veterans of America, the Modern Military Association of America, SPARTA Pride, and the Human Rights Campaign.

These are technical fixes, but they carry moral weight. They reaffirm a basic democratic promise: service earns respect, not suspicion.

As a policy professional who has worked with veterans across the country, I see this moment as a test of civic integrity. The measure of a democracy is not only who it allows to serve but how it treats them afterward.

The second “lavender scare” will end when institutions at every level decide that inclusion is an obligation, not an exception. The toolkit offers a way to begin.

For more information or to access the toolkit once it is public, visit outinnationalsecurity.org/toolkit.

Lucas F. Schleusener is the CEO of Out in National Security.

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