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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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‘Are you on PrEP?’

Md. lawmakers considering bill to expand access to medication

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From left, FreeState Justice Executive Director Phillip Westry and Maryland state Del. Ashanti Martinez (D-Prince George's County) (Courtesy photos)

When we’re out with friends, we ask a question that sometimes surprises people: Are you on PrEP?

PrEP is a medication that reduces the risk of getting HIV by about 99 percent when taken as prescribed. We’re both on it. And we both talk about it openly because too many people in our communities still haven’t heard of it, can’t access it, or have been made to feel like asking for it says something about who they are.

It doesn’t. Taking PrEP is about taking control of your health. It’s that simple.

But getting there wasn’t simple for either of us. Our paths to PrEP looked different.

Del. Martinez learned this firsthand. When he asked his primary care doctor about PrEP, the response wasn’t medical — it was judgment. Instead of a prescription, he got a lecture. He had to leave Maryland entirely and go to Whitman-Walker in D.C. just to get basic preventive care. He serves on the Health Committee and sits on the public health subcommittee. Even he couldn’t access HIV prevention in his own state. That reality was soul-crushing, not just for him, but because he immediately thought about every person in his community who doesn’t have the resources to find another way.

Phillip came to PrEP through his work at FreeState Justice, where he was learning about HIV transmission rates and the gap in PrEP access for queer people of color. Black Marylanders account for 65 percent of new HIV diagnoses but only about 35 percent of PrEP users. Latino Marylanders account for nearly 19 percent of new diagnoses but fewer than 8 percent of PrEP users.

Seeing those numbers, he had to ask himself why he wasn’t on it. When he walked into Chase Brexton’s HIV Prevention clinic in Baltimore, the experience was easy and affirming, exactly what it should be for everyone. No judgment, just care. That’s the kind of experience every Marylander deserves.

A proposed bill would make it the standard in Maryland. HB 1114 would let people walk into their neighborhood pharmacy and access PrEP without waiting months for a doctor’s appointment, remove insurance barriers that slow things down, and connect them to ongoing care. 

Our stories are not unusual. When we talk to friends about PrEP — and we do, regularly — we hear the same things. People who didn’t know about it. People who tried and gave up. People who assumed it wasn’t for them. People who couldn’t afford it or couldn’t find a provider. There’s still misinformation out there, and there’s still stigma. Among women in Maryland, most new HIV diagnoses come from heterosexual contact, but PrEP is still rarely part of the conversation from their doctors.

When we talk to our friends about PrEP, we lead with honesty. Here’s what it does, here’s what it costs, here’s where to go. We talk about the different options: daily pills or long-acting shots. Generic options are available, and in many cases, free. If you’re sexually active, it might be right for you. It’s not a morality question. It’s a health question.

We try to make it feel approachable, because it should be. We answer every question, because sometimes we’re the first person someone has had this conversation with. It’s a conversation between people who trust each other. And it works, but it can only go so far when the system itself is still in the way.

We have the medical tools to virtually end new HIV transmissions. What we need now are the policies to make sure everyone can reach them. At a time when the future of federal HIV prevention programs is under attack, Maryland has both the opportunity and the responsibility to lead.

We’re asking our friends to take charge of their health. We’re asking Maryland to make it possible.

If PrEP sounds right for you, talk to your provider. If you know someone who could benefit, share what you know. And if you want to see Maryland get this right, tell your legislators to support HB 1114.

State Del. Ashanti Martinez represents District 22 in Prince George’s County in the Maryland House of Delegates, where he serves as Majority Whip and sits on the Health Committee. Phillip Westry is the executive director of FreeState Justice, Maryland’s statewide LGBTQ+ advocacy organization.

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A dream: Democrats focus on candidates who can win

Defeating every Republican has to be the goal in 2026, 2028

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(Washington Blade photo by Michael Key)

I know this is just a dream, but I am a dreamer and continue to hope Democrats can get beyond Black or white, gay or straight, man or woman; to look at who can win in 2026, and then in 2028. It’s often said each election is the most consequential in our lifetime. The next two actually are. 

The reality is without change; we face losing our democracy. We have a racist, sexist, homophobic, lying felon, in the White House. He has a Cabinet of vile incompetents, and a cadre of fascist advisers, controlling our government. They threaten our freedoms, and even our health. They think the military is theirs to use at will, without restrictions. Again, my dream for elections in 2026 and 2028, is we put our personal desires aside, for the good of the nation.

Everyone is being hurt by Trump. Black women being fired in huge numbers. Transgender people literally having their lives threatened. The LGBTQ community facing new threats. Civil rights are being undermined, and the Latino community across the country is targeted. Women are losing the right to control their bodies. Our voting rights are being threatened, and all this is happening with the consent of the Republican sycophants in Congress who are either in complete agreement with the felon, or threatened into submission by him, and his fascist cohorts. This is what we are facing in the next two election cycles as we try to take back our country. As the opposition party, we must first take back Congress in 2026. If we succeed, we must replicate that success as we work to reclaim the White House in 2028. 

I believe we must all be represented in our elected officials. For years I felt comfortable looking at the equality issue in choosing a candidate, as even in the worst-case scenarios, when losing meant the election of the likes of a Richard Nixon or Ronald Reagan, I never believed my country’s existence was threatened. They, and others like them, may have been vile, but none professed wanting to be king. They didn’t go to court seeking full immunity for anything they did and getting it from judges they appointed. 

I am a proud gay man but will not automatically vote for an LGBTQ candidate in the next elections. In 2024, I worked hard, and proudly, to see two strong Black women elected to the United States Senate. In the 2008 primary I was proud to stand with Hillary Clinton, then support Barack Obama when he won the nomination. In 2016, I again stood with Hillary. In 2020, I proudly supported Kamala Harris as vice president and then supported her for president in 2024. 

Today, I am looking at the next two election cycles differently. I have written the only way to win back my country is to look at which Democrat can win in a particular race. I will support a Democrat committed to voting for the Democratic leadership in the House and the Senate, and in their state legislature, even if they don’t support fully everything I want. Because when Democrats win the leadership, they set the agenda. The Democratic platform has been about the same for many years. It stands for equality in every area. Have we accomplished all we stand for, clearly NO. Have we made progress, clearly YES. 

In these upcoming elections each Democrat may win their race with a different set of issues at the forefront. I have suggested in the morning they go to the diners in their district, and in the evening to the bars, to find out what people are talking about, and concerned about. Then respond to that by running on those issues. If there is a primary, demand each candidate pledge to fully support the winner. Think about what is said about Democrats and Republicans, “Democrats fall in love; Republicans fall in line.” Well in the next two election cycles, Democrats need to fall in line with every Democrat on the ballot in the general election willing to say, “if elected I will vote for, and support, the Democratic leadership.” 

If we don’t commit to doing that in the next two election cycles, we may actually not have future elections. It is the only way we can stop the felon, and his fascist government, from winning. Defeating every Republican in 2026 and 2028, has to be the goal for all who care about our country, and moving on to the next 250 years. Not winning is not an option.  


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

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Capital Pride must be transparent about sexual misconduct investigation

More questions than answers after two board members resign

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A scene from last year's WorldPride Parade organized by Capital Pride. (Washington Blade file photo by Michael Key)

We are living through some very difficult times in our country. We have a felon in the White House who has surrounded himself with incompetent sycophants and fascists. A Congress that bows down to him, often based on his threats. Things have gotten so bad that his supporters are beginning to wake up to the fact that he cares not a whit for them. They are demanding he stop hiding his involvement with the convicted sex trafficker, Jeffrey Epstein, and come clean. So, to distract them from this, he began a war in the Middle East in which members of the American military have already lost their lives. He says more lives will be lost. He hopes this war of distraction will have Americans forget his failed domestic policies and the Epstein scandal. 

But at the same time that all of this is happening, I am forced to look around at organizations I support and ask if they are being open and honest in the way we are demanding of the felon in the White House.

Recently, I have received calls about an organization I have the utmost pride in: Capital Pride. The calls are about Capital Pride’s internal investigation of “a claim” made against a former board chair, who resigned and no longer has any role with the organization. There has been no public proof of any wrongdoing. At the time, Capital Pride announced it had retained an “independent firm” to investigate the complaint. Now, more than four months later, a second board member has resigned sharing her letter of resignation with the Blade. 

Taylor Lianne Chandler, a member of the Capital Pride board of directors since 2019 who served as the board’s secretary, submitted a letter of resignation on Feb. 24 that alleges the board has failed to address instances of “sexual misconduct” at Capital Pride. 

“This board has made its priorities clear through its actions: protecting a sexual predator matters more than protecting the people who had the courage to come forward. … I have been targeted, bullied, and made to feel like an outsider for doing what any person of integrity would do – telling the truth,” Chandler wrote in her resignation letter. 

The Blade reported the organization announced, “As we continue to grow our organization, we’re proactively strengthening the policies and procedures that shape our systems, our infrastructure, and the support we provide to our team and partners.” 

Again, it is four months later, and there has been no information from Capital Pride regarding that investigation.

Chandler said a Capital Pride investigation identified one individual implicated in a “pattern” of sexual harassment related behavior over a period of time. She added she was bound by a Non-Disclosure Agreement that applies to all board members and she cannot disclose the name of the person implicated in alleged sexual misconduct or those who came forward to complain about it. She added, “It was one individual, but there was a pattern and a history.” 

Again, reading that letter from Chandler and because of the news being full of the Epstein scandal, it makes me want assurances that no organization representing my community will ever think it can cover up issues like this. Capital Pride leadership must be totally transparent. 

Capital Pride is a wonderful organization with so many incredible people working and volunteering there. They make our community proud. I never want to see a blemish on the organization. So, I am calling on them to be open and transparent about the investigation they themselves announced, and let the community know what they found, in detail. More important even than the entire community knowing, is for their staff and volunteers to know what they found. No one should be bound by an NDA, which leads to people thinking something really bad is going on.

I thought twice, even three times, before writing this column. I don’t want it to be seen as casting aspersions on all of Capital Pride, or anyone who may have worked there, or volunteered there. But again, because of the focus on the Epstein scandal, and my writing about the felon and his Cabinet officials involved in it, my calling for them to come clean and tell us all they know, I feel compelled to say the same to the organization I have supported over the years, which even honored me as a Capital Pride Hero in 2016. I want them to move forward and be a beacon of light for our community for many years to come. The work they do makes a difference for so many. 

I wrote in my memoir that coming to a Pride event helped me to come out, and I am sure it has done the same for so many others in our community. What Capital Pride does is important and it must be as transparent as we demand of any other organization.


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

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