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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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Pride is wherever you are

All of us are part of the struggle

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(Washington Blade photo by Michael Key)

I thought of titling this “A long way from WorldPride” to contrast the struggles of displaced LGBTQ+ people in Kenya with the recent celebrations in Washington. But that would miss the real story.

The United States is facing a concerted right-wing effort to erase and disenfranchise minorities in the name of fighting “wokeness,” a term used to disrespect the diversity of America’s population. The phrase “DEI hires” [referring to diversity, equity and inclusion initiatives] is used mockingly to pretend that no person of color or other minority is ever qualified for any job.

Meanwhile, my friend Rosamel, a trans woman who runs a safe house in Nairobi, is the very embodiment of pride under pressure. The two-dozen residents of the house include several orphaned children of queer folk. After Rosamel was hospitalized for days due to an injury and tetanus, the children have taken to sleeping next to her and following her around because they are afraid of losing her.

If that is not family, there is none. Those who use the claim that God created two and only two sexes as justification for denying legal protections to gender-non-conforming people need to take off their blinders and see the greater complexity of God’s creation.

Whether right-wing culture warriors recognize it or not, God created intersex people and people whose brain chemistry tells them their gender is different from what was assigned at birth.

The phrase “biological males” is routinely used by people on the right in a way that reduces biology to genitalia. Perhaps even more egregiously, many in the news media uncritically accept the right-wing vocabulary.

Thus our struggle continues. We still have work to do to build and honor what many good people of faith call the Beloved Community.

I attended the WorldPride Human Rights Conference in Washington featuring delegates from across the globe. Being surrounded by so many smart, dedicated activists was invigorating despite my suffering from stress and lack of sleep.

The final session at the conference was a conversation with the Congressional Equality Caucus. One of the panelists, Rep. Becca Balint (D) of Vermont, said, regarding right-wing threats to roll back LGBTQ+ progress, that she is a glass-half-full kind of person.

She is right. We could easily sink into despair, given the aggressive attacks on our community. But we must not let the haters rob us of our joy nor deflect us from our purpose.

Before the panel began, I spoke with moderator Eugene Daniels of MSNBC, an openly gay journalist who is president of the White House Correspondents Association. I thanked him for his fearlessness and excellence.

A friend told me that he didn’t care to emulate Eugene’s fashion-forward style nor his use nail polish. But my point in praising Eugene is not that all of us should try to be him. We are a diverse people. It is rather his poise and self-confidence that deserve emulation.

Eugene’s mother told him when he was younger, “You belong in whatever room you find yourself.” Yes.

The threats to LGBTQ+ people around the globe are real and daunting. But we have one another, and the examples set by those who came before us. We also have the wisdom of those children in Nairobi, who needed no one to tell them who loves and cares for them.

I raised money to pay for repairs to the safe house, and for the walking sticks Rosamel required after her injury. The need among these displaced people is always greater than the capacity of the handful of donors. More non-governmental organizations are needed to help those forced to flee their homes and countries because of unscrupulous politicians and clergy who scapegoat them for problems they had no part in causing.

Eugene Daniels was motivated to come out after the Pulse Nightclub murders in 2016. He didn’t want to die with no one knowing his true self.

By contrast, Utah state legislator Trevor Lee (R) backs HB 77, a measure to ban Pride flags in schools and local government buildings, with an amendment allowing Nazi and Confederate flags for “educational purposes.”

We must join forces to beat back the evil nonsense currently proliferating.

To find role models, we have only to look around us and around the world. Rosamel and Eugene did not wait for permission to step up and lead.

To quote a wise ancient man whose teaching is routinely ignored by the hatemongers on the so-called Christian right: “Go thou and do likewise.”


Richard J. Rosendall is a D.C.-based writer and former president of the Gay & Lesbian Activists Alliance.

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If you are sick, or old, maybe don’t run for Congress

We need to let younger candidates run for office

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(Washington Blade photo by Michael Key)

I am sure I will be called heartless after people read this column. But I have come to believe that if you are sick, or old, maybe you should not run for Congress. We now have three open Democratic seats in the House of Representatives. They are open because two members over 70, who had been diagnosed with cancer before the election, decided they had to run anyway. They won, but have since passed away early in their term. The other death was a congressperson who decided it was appropriate to run for his first term at the age of 70. 

I understand what being older means, and also what a cancer diagnosis is. I am fortunate and have survived three different cancers. It is also true, anyone, at any age, can die. Just listen to Joni Ernst (R-Iowa) who told her constituents they will die anyway so why worry about her voting to cut their Medicaid. But seriously, these three men should definitely have considered not running. They should have allowed a younger man, or woman, to run for what are considered safe Democratic seats. Just recently, Speaker Johnson got his ‘beautiful bill,’ actually a really disgusting bill, the one the felon in the White House is asking Congress to pass, through the House by only one vote. Just think if we had three more votes against it. 

Again, each of those seats is considered pretty safe for Democrats. In recent years we have seen Sen. Diane Feinstein (D-Calif.) hold onto her seat for much too long, and then there is the Republican congresswoman who was still in the House but missing votes, who they found was living in an assisted senior living center. Her son admitted she had issues with dementia. I have to mention here, it’s not only members of Congress, but those in statehouses, and even presidents, who need to know when it is time to move on. 

Running while ill is not a new phenomenon. I first saw this back in 1972, when Congressman William Fitz Ryan (D-N.Y.) had his district combined with that of Congresswoman Bella S. Abzug (D-N.Y.), based on the 1970 census. Bella decided to challenge him in the primary, and he decided to run even though he had cancer, hiding how serious it was. He won the primary against her, and then died before the general election. Bella became the Democratic candidate and won the election. There were those at the time who accused her of killing him by running against him. An outrageous accusation, the facts being he should never have run. So again, this is not something new. But I believe if Democrats want to attract more young people into politics, we need to think about this. In 2018, I wrote about term limits and retirement at 80 for the Congress and the Supreme Court. I still believe that. I am not mentioning names here, as I believe it is really a very personal thing for those who run for office. How they see their life after serving, if they are running for reelection, or what they think they can accomplish at an older age if they get elected for the first time.

Some may have read the column I wrote recently chastising David Hogg for how he is handling his PAC. I don’t disagree with his vision of supporting young people to run for state legislatures, and the Congress. I am all for that. My problem with David is how he is doing it. 

We live in a difficult world, and the felon in the White House, his MAGA cult, and his sycophants in Congress, are only making things more difficult for everyone. My generation of Democrats has done many good things, and we have moved the country forward in many ways. Until Trump, we were moving forward on equality, and climate change, among so many other issues. We recognize we have a global economy, and that is good. But it is clear we have left many things undone, and faced a backlash, which brought us Trump and his MAGA cult. 

So, today we need the younger generation, who are inheriting this world, to step up and take a role in running it. We need to be willing to step aside when it’s time. We can act as advisers and supporters for the younger generation. We can help them raise funds, and work to get them elected. We should always be available if they ask for help, but it is time we got out of their way when it comes to running for elective office. 


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

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Pride and protests: a weekend full of division

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(Canva image)

While many Angelenos celebrated the 55th annual L.A. Pride and mainstream news outlets like ABC7 and FOX11 news covered the celebrations, the reality for many other Angelenos involved tear gas, rubber bullets, and breaking news coverage from community outlets like CALÓ News.

If we were to take a step back into the history of Pride, we would be angered by the amount of violence and pain that led to the protests on the dawn of June 28, 1969. The Stonewall uprising took place as a result of police raids at the now-infamous Stonewall Inn on Christopher Street in New York City. That night that has gone down in history as a canon event for queer and trans life, started when police raided the Stonewall Inn and arrested multiple people. The arrests and the police brutality involved, led to an uprising that lasted a total of six days.

Marsha P. Johnson and Sylvia Rivera were credited as being the first people in that historical moment, to start the movement we now know and celebrate as Pride. They were brown, beautiful, people who transformed our notions of fear and action. Wherein, we must act in order to not live in fear. The people at the Stonewall Inn on that night in June all those years ago, and all of the queer and trans people now, have something deeply unsettling in common.

We both live in a constant state of fear and anxiety.

We live in such a major state of fear, that anxiety, depression and other mental health issues —  including substance abuse disorders — tend to be particularly prevalent in the LGBTQ community. According to Mass Gen, the U.S. is facing a mental health crisis. Nearly 40 percent of the LGBTQ population in the U.S. reported experiencing mental illness last year. That figure is around 5.8 million people. 

Pride began as the very type of protest that went on this past weekend over the U.S. Immigration and Customs Enforcement raids where people have now been taken into custody, reporters have been shot with rubber bullets and tear-gassed, and where union president David Huerta was taken into custody and allegedly charged with federal conspiracy charges.

Over the weekend, I celebrated Pride. I admittedly celebrated being queer, while my other communities experienced fear in the face of arrests, tear gas to the eyes and baton blows to the head.

I am a proud child of immigrants. My mother is Colombian and migrated here in the early 80’s, settled down in West L.A and built a life with children, houses and her religious community.

My father migrated here in the mid-to-late 80’s from Mexico, where he and his family were hardworking farmers. He has worked at his job without rest, for over 35 years. He raised the ranks from line worker, to general manager. He does not miss work. He follows every rule and he is never late. Both are documented, but only because of luck and the ease of getting papers back when there weren’t so many bureaucratic steps to gaining citizenship or a green card legally.

My parents and their extended family are proof of a now-distant American dream. One in which we gain status, we become homeowners, business owners, have children and send them off to college to learn things that those parents can’t even imagine.

Though they did the best they could, my parents had other challenges and barriers to their success. So I did it for them. I did it for all of us.

My road to where I am now was paved with uncertainty, food insecurity, homelessness, and many other factors that pushed and pulled me back. The analogy I can think of to accurately compare myself to, is a powerful catapult. I was pulled down with weights that added on more and more, until one day I catapulted forward into the life I now have the privilege to live. Though I still struggle in many ways, it is the first time in my life that I am not on survival mode. It’s the first time in my life that I get to exist as a queer person who can enjoy life, build a friend group, establish deep connections with people. It’s also the first time I get to enjoy Pride as someone who is single and who has spent the past 18 months healing from my Adverse Childhood Experiences (ACE’s) and from my last relationship.

It was the first time in my life as a lesbian whose been out for over a decade, that I truly planned to enjoy Pride with my groups of friends.

While I was there this weekend, my internal battle started and I felt torn between celebrating my life and my queerness, and covering the ICE raid protests happening not too far from Sunset Blvd.

What I didn’t expect, was to see so many other people at Pride, completely oblivious and completely disconnected from the history of Pride, instead glorifying corporate brands and companies that have remained silent over LGBTQ issues, while others have gone as far as rolling back their Diversity, Equity and Inclusion motions.

If Marsha P. Johnson or Sylvia Rivera were there in that moment, they would have convinced us to merge our Pride celebration with the protests. They would have rallied us all to join forces and in the spirit of Pride, we would have marched for our immigrant community members, fighting for their right to due process.

I’m not sure if I made the right decision or not, but the next 60 days will say a lot about every single one of us. We will have to learn when to act, how to react and when to find pockets of joy to celebrate in, because those moments are also acts of resistance.

The Trump administration vowed to strip away rights and has made it their mission to incite violence, fear and anxiety among all working class, BIPOC and LGBTQ people, so it is important now more than ever to unite and show up for each other, whether you’re at a Pride celebration or a protest.

Juneteenth is coming up soon and I hope to see more of us rally around our BIPOC brothers, sisters and siblings to not only fight for our rights, but to continue celebrating ourselves and each other.

In the words of Marsha P. Johnson: “There is no pride for some of us, without liberation for all of us.”

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