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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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Commentary

He is 16 and sitting in a Cuban prison

Jonathan David Muir Burgos arrested after participating in anti-government protests

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Jonathan David Muir Burgos remains in a Cuban jail. (Graphic by Ignacio Estrada Cepero)

Jonathan David Muir Burgos is 16-years-old, and that fact alone should force the world to stop and pay attention. He is not an armed criminal, nor a violent extremist, nor someone accused of harming others. He is a Cuban teenager who ended up behind bars after joining recent protests in the city of Morón, in the province of Ciego de Ávila, demonstrations born out of exhaustion, desperation, and the growing collapse of daily life across the island.

Those protests did not emerge from privilege or political theater. They erupted after prolonged blackouts, food shortages, lack of drinking water, unbearable heat, and a level of public frustration that continues to deepen inside Cuba. People took to the streets because ordinary life itself has become increasingly unbearable. Families are surviving for hours and sometimes days without electricity. Parents struggle to find food. Entire communities live trapped between scarcity and silence.

Jonathan became part of that reality.

And today, he is sitting inside a Cuban prison.

The World Health Organization defines adolescence as the stage between approximately 10 and 19 years of age, a period marked by emotional, psychological, and physical development. That matters deeply here because Jonathan is not simply a “young protester.” He is a minor. A teenager still navigating the fragile years in which identity, emotional stability, and personal growth are being formed.

Yet the Cuban government chose to place him inside a high-security prison alongside adults.

There is something profoundly disturbing about a political system willing to expose a 16-year-old boy to the psychological brutality of prison life simply because he exercised the right to protest. A prison is never only walls and bars. It is fear, humiliation, emotional pressure, intimidation, and uncertainty. For a teenager surrounded by adult inmates, those dangers become even more alarming.

The situation becomes even more serious because Jonathan reportedly suffers from severe dyshidrosis and has previously experienced dangerous bacterial infections affecting his health. His condition requires proper medical care, hygiene, and adequate treatment, precisely the kind of stability that is difficult to guarantee inside the Cuban prison system.

Behind this story there is also a family living through a kind of pain impossible to fully describe.

Jonathan is the son of a Cuban evangelical pastor. Behind the headlines there is a mother wondering how her child is sleeping at night inside a prison cell. There is a father trying to hold onto faith while imagining the emotional and physical risks his teenage son may be facing behind bars. Faith does not erase fear. Faith does not prevent parents from trembling when their child is imprisoned.

And this is where another painful contradiction emerges.

While a Cuban pastor watches his son remain incarcerated, there are still political and religious voices outside Cuba romanticizing the Cuban regime from a safe distance. There are people who speak passionately about justice while remaining silent about political prisoners, repression, censorship, and now even the imprisonment of adolescents.

That silence matters.

Because silence protects systems that normalize abuse.

For too long, parts of the international community have spoken about Cuba through ideological nostalgia while refusing to confront the human cost paid by ordinary Cubans. The reality is not romantic. The reality is families surviving in darkness, young people fleeing the country in massive numbers, parents struggling to feed their children, and now a 16-year-old boy sitting inside a prison after joining a protest born from desperation.

No government has the moral right to destroy the emotional and psychological well-being of a teenager for exercising freedom of expression. No ideology should stand above human dignity. And no institution that claims to defend justice should remain indifferent while a child becomes a political prisoner.

Jonathan David Muir Burgos should not be in prison.

A 16-year-old boy should not have to pay for protest with his freedom. 

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Commentary

Celebrate Pride in Lost River, a slice of rural heaven

West Virginia LGBTQ getaway hosts events June 12-14

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(Washington Blade photo by Michael Key)

“Country roads, take me home, to the place I belong, West Virginia …” Those immortal lyrics describe one of the best-kept secrets for LGBTQ Washingtonians: Lost River, W.Va.

Less than 2.5 hours from the D.C. metro area, Lost River, in Hardy County, W.Va., is a haven for LGBTQ Mountaineers and our nearby city neighbors. From queer-owned businesses and artwork to a vibrant community of LGBTQ residents, Lost River has been a destination for LGBTQ visitors seeking a mountain getaway for nearly 50 years. For some, our rural community has become home for those who want to trade city life for country living.

Because Lost River welcomes all, we celebrate Pride each year in our slice of heaven.

Lost River Pride Weekend will be held June 12–14, the weekend prior to Capital Pride. If you haven’t been, our Pride is a little different from the urban Pride events most people are used to. In Lost River, forget the multinational corporate sponsors. Instead, think about local talent, grassroots community organizations, and our version of patriotism on full display. Most of all, we welcome people from all walks of life to live authentically as themselves, regardless of where they come from, how they think, or how they love. We truly welcome everyone.

Coincidentally, Lost River Pride Weekend is being held on President Trump’s birthday weekend, including a variety of traffic-jamming events in the D.C. area and the upcoming fight on the White House lawn. Why not come visit Lost River for the day or the weekend (we have some wonderful places to stay) and get a taste of West Virginia living?

While our town has only about 500 people at any given time, we swell to over twice that during Pride weekend. Friday evening includes an intimate cabaret at the Inn at Lost River (whose general store is on the National Register of Historic Places). Our centerpiece, the Lost River Pride Festival, is hosted on Saturday at the local farmers market, followed by an afternoon drag pool performance and an evening performance by the world-renowned Tom Goss at the Guesthouse Lost River. Finally, we finish the weekend with a closing brunch at the Inn to reaffirm our Pride. In between events and throughout the weekend, visitors and locals indulge in local art, restaurants, and more.

We recognize that West Virginia isn’t always seen as welcoming to LGBTQ people. State law does not protect against discrimination based on sexual orientation or gender identity, and cultural stereotypes remain persistent. Additionally, trans girls are prohibited from participating in sports of their affirmed gender in schools. In a state considered one of the most conservative, it can be difficult to see progress.

However, our community exists to prove that progress is possible. In fact, due to the work of statewide groups such as Fairness WV, 21 municipalities have passed local ordinances prohibiting discrimination based on sexual orientation and gender identity, covering more than 13 percent of the West Virginian population. Last year, Lost River Pride sponsored the first-ever equal cash prize for the nonbinary category of the Lost River Classic, a local bike race held annually. There is hope in every corner of our community.

Recently, Lost River Pride was the only West Virginia contingent in the 2025 World Pride Parade, which was held during Capital Pride Weekend. I will always remember our rugged truck coming down 14th Street to a sea of diverse, friendly faces, while waving our state flag and hearing many voices singing “Country Roads” in every remix available (trust me, there are many).

Lost River Pride is one of only a handful of Pride organizations in West Virginia and one of the few structured as a nonprofit. We sponsor the only LGBTQ scholarship in Eastern West Virginia for a graduating senior from a local high school. Moreover, we provide monthly community programming and make frequent donations to local allied nonprofits, including the fire department, food pantry, and schools.

I encourage you to attend Lost River Pride Weekend, especially this year’s Lost River Pride Festival on Saturday, June 13, from 12-4 p.m., at the Lost River Farmers Market (1089 Mill Gap Road, Lost City, W.Va. 26810). Feel free to reach us at [email protected] or visit our website at lostriverpride.org for more information.


Tim Savoy is president of the board of directors of Lost River Pride.

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Protection should mean protection

Disbelief as court modifies protective order against Pasha

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(Photo by Sergei Gnatuk/Bigstock)

There is a particular kind of disbelief that Black queer women know intimately. It is not always explicit. It shows up in hesitation, in “both sides” framing, and in systems that require us to prove, again and again, that we are worthy of safety. 

We see that disbelief happening now with the temporary protection order (TPO) involving an individual, D. Pasha. He is accused of repeatedly harassing staff, board members, and volunteers at the Capital Pride Alliance, which led the organization to ask the court for protection. 

The Capital Pride Alliance did not seek this order lightly. They spent over a year documenting his harassment, and several witnesses gave almost two hours of testimony about a pattern of behavior that caused real fear. The organization also spent months working out how to legally protect its staff, volunteers, board, and contractors from this individual. 

At first, the Court agreed and issued a stay-away order that included CPA’s office and other locations, setting a clear boundary to protect staff, volunteers, and community members. 

But that protection did not last. 

After the order was issued, Pasha spoke with a reporter from the Washington Blade and learned that CPA shares office space with the DC LGBTQ Center. It is important to note that he didn’t know this detail before. He then sought an emergency hearing, claiming he needed access to “vital services” from the CPA and DC LGBTQ Center shared offices.  

The Court granted it, allowing access with a 24-hour notice to CPA. According to the Court, the modification was based on Mr. Pasha’s claim that denying him entry to the DC Center would prevent him from accessing essential support services provided there. Although CPA objected and highlighted the lack of recent service usage and the availability of alternatives, the Court determined that his stated need for services warranted an exception to the stay-away order. 

Let’s be clear about what this means. 

There is no record of him accessing services or being at the DC LGBTQ Center in over a year. Numerous organizations across DC provide the same services he cited: food, clothing, computers, Wi-Fi, without placing him in proximity to the people who testified against him. 

And yet, the Court modified the order to allow exactly that. 

Then it escalated. Following the modification, he sent more than 20 emails and text messages in attempts to gain access to our office space, triggering another emergency hearing. At that second emergency hearing, the court maintained its previous decision, allowing Mr. Pasha continued access to the location. 

This is not a technicality. This is a failure of real protection. 

The outcome was shaped not just in the courtroom, but in how it was presented afterward. 

Recent coverage centered the acceptance of a less restrictive order, while giving the person at the center of this case a platform to define the narrative in his own words. He was described as an LGBTQ activist, quoted at length, and presented with his name, voice, and image, including statements like “I am happy with what we have accomplished so far,” “even if I lose this case, I am glad that I spoke up,” and that “the truth will come out.” 

That framing does not exist in a vacuum. It omits important context about the pattern of conduct that led to this case, including the history and the events that followed the Court’s initial order. It also gives weight to claims about access to services that are not reflected in actual usage. 

At the same time, the hours of testimony describing a pattern of conduct that caused fear, serious alarm, and emotional distress are reduced to a small part of the story. The individuals who came forward are largely unnamed, unseen, and unheard. The record that was built in court is condensed, while his narrative is expanded. 

When one side is given visibility, voice, and narrative, and the other is reduced to summary, that is not balance. It is distortion. 

We also need to be honest about who is being asked to bear the consequences of that failure. 

Two Black queer women testified. They followed the process. They showed up, told the truth, and trusted the system to do what it is designed to do: protect them. 

Instead, the system created a pathway back to proximity, back to fear. 

That is not a neutral outcome. It is a choice about whose safety matters most and whose safety can be compromised. 

This is not an isolated incident. It reflects a broader pattern in how systems fail Black women, survivors, and LGBTQ+ people, especially at the intersections of those identities. 

According to the Human Rights Campaign, data shows that over 60% of bisexual women and more than 40% of lesbian women experience physical violence or stalking.  

Violence does not start with homicide. It starts with being dismissed, with being minimized, and with systems that do not act fairly or quickly when harm is reported. 

It starts when people question the credibility of Black queer women. 

When access is granted to those who cause fear, instead of protection being fully extended to those who experience it. 

And it continues when we treat these outcomes as unfortunate, rather than unacceptable. 

Capital Pride Alliance believes in access. We invest in it. We help sustain the very services being cited in this case. But access cannot come at the expense of safety, especially when alternatives exist, and risk is known. 

The question here is not complicated: what does protection actually mean, and who deserves it? 

If a court acknowledges harm but still allows proximity, is that protection? 

If Black queer women testify and are still placed within reach of the person they testified against, what message does that send? 

We cannot keep calling these systems fair if they keep putting the same people at risk. 

Courts need to think about safety in a broader sense, one that reflects real life rather than just following procedures. This means looking at not only direct threats, but also ongoing harassment, intimidation, and the real fear survivors feel when they must share space with someone who has harmed them. 

Real changes could include ensuring stay-away orders are enforced even in shared spaces, working with community groups to offer alternative ways to access services, and asking survivors about their safety needs before changing protection orders. Courts should also get training on the experiences of Black queer women and LGBTQ+ survivors, so their voices and realities are at the center of decisions. 

Our community needs to work toward real safety and protection. Because visibility without safety is not liberation. Protection that can be so easily undone is not protection at all. 

May 28 is LGBTQ+ Domestic Violence Awareness Day.  

#SeenAndBelieved is a call to action: recognize the harm, trust survivors, and create systems that truly protect them. 


June Crenshaw is COO of the Capital Pride Alliance.

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