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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 latest Supreme Court case erasing LGBTQ identity

Chiles v. Salazar a major setback for movement

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(Washington Blade photo by Michael Key)

In its recent decision in Chiles v. Salazar, the U.S. Supreme Court invalidated Colorado’s law prohibiting licensed counselors from engaging in efforts to change the sexual orientation or gender identity of minors. The decision, which puts into question similar laws in 22 other states, relied on the First Amendment to hold that the law violates counselors’ free speech rights. But the decision also strikes a blow against LGBTQ dignity, a point the court’s opinion does not even address.  

The eight-member majority, which included Justices Elena Kagan and Sonia Sotomayor, who usually side with LGBTQ groups, justified its reasoning by suggesting that the law was one-sided: it permitted treatment that affirms LGBTQ identity but forbade treatment that seeks to change it. But the law is one-sided, as Justice Ketanji Brown Jackson’s lone dissent pointed out, because the medical evidence only supports one side: reams of research show that “survivors of conversion therapy continue to suffer from PTSD, anxiety, and suicidal ideation.” And major medical associations all agree, no evidence demonstrates the efficacy of conversion efforts. This isn’t surprising. Medicine often take sides — some treatments work, and some don’t.

But particularly concerning is the vision of LGBTQ identity that undergirds the majority opinion when compared to the dissent. Justice Jackson’s dissent explains that LGBTQ identity is simply “a part of the normal spectrum of human diversity” — not something to be “cured.” By contrast, for the majority, how best to help LGBTQ minors is “a subject of fierce public debate.” That can hardly be the case if LGBTQ identity stands on equal ground with straight, cisgender identity, or if LGBTQ people are as deserving of safety, rights, and dignity.

Indeed, the LGBTQ rights movement only began in earnest when advocates in the 1960s decided to end the “debate” over gay identity. Until then, community leaders would routinely cooperate with psychiatrists who were interested in researching homosexuality as a medical condition. A new generation of activists, led by Frank Kameny, a key movement founder, began arguing that this got the issue upside down: Rather than wondering if they could be “cured,” LGBTQ people had to assert a right to their identity. As Kameny put it—“we have been defined into sickness.” Only once the case was made that it was society that had to change, and not LGBTQ people, could LGBTQ consciousness, LGBTQ pride and LGBTQ rights develop. Their activism led to the first Pride parade in New York, and the official declassification of homosexuality as a disease in 1973. 

The Supreme Court’s conservatives don’t just want to reignite this half-century old medical “debate”; they also treat medical claims that undermine LGBTQ identity very differently from those who support it. Last year, in an opinion backingTennessee’s law that banned gender affirming care for minors, the court sympathetically marched through the reasons Tennessee offered for “why States may rightly be skeptical” of such care, and cited three times, in some detail, to “health authorities in a number of European countries” (that is, some Nordic countries and the UK) that had curbed pediatric care. It failed to mention that most of Western Europe and every major American medical association provides access to this care.

In Chiles, by contrast, the court cites none of the evidence that Colorado amassed that conversion therapy harms LGBTQ children. None of the countries that the court had invoked to justify anti-trans policies allow conversion therapy in their health care systems (indeed, one of them criminalizes such practices). So rather than cite medical evidence, the court simply asked — why trust medical evidence at all? “What if,” asks the court, “reflexive deference to currently prevailing professional views [does] not always end well?” and cites an infamous 1927 Supreme Court case, Buck v. Bell.

In Buck, the Supreme Court embraced eugenic reasoning, backing a eugenic state law that allowed the sterilization of individuals with mental disabilities, on the grounds that such disabilities were hereditary. As Justice Oliver Wendell Holmes opined, “three generations of imbeciles are enough.” Look at what happens when we listen to medical expertise, today’s court seems to say, as an excuse to disregard the LGBTQ-affirming medical evidence they don’t like.

But the court has missed the key lesson of Buck. The law at issue in Buckdiscriminated against a certain group, seeking, through sterilization measures, to erase it from existence. Indeed, LGBTQ people (whom doctors of the day would have referred to as sexual “inverts”) were exactly the kind of people that the eugenic program of Bucksought to eliminate. Conversion therapy seeks similar erasure.

The lesson of the 1960s LGBTQ rights movement remains as relevant today as it was then. Without an unapologetic LGBTQ identity, LGBTQ Pride, LGBTQ rights and the LGBTQ movement itself can all founder. By supporting only the anti-LGBTQ side in this medical saga — and by suggesting that LGBTQ existence is subject to medical debate at all — the court is reaffirming, rather than repudiating, minority erasure.


Craig Konnoth is a professor of law at University of Virginia School of Law.

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Response to a personal attack against me

Writers should stick to facts and reason

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I was disappointed when the Blade didn’t publish my response to a personal attack on me in a column by Hayden Gise, in last week’s print edition. They did publish it online. To be clear, I have no problem with people disagreeing with my columns and opinions. That is absolutely fair. But when they get into personal attacks, it often means they don’t have enough to say about the ideas they are trying to criticize. 

In a recent column ‘Why the Democratic Socialists of America are right for D.C.,’ the author decided to attack me personally. Here is the response I wrote to her column: 

“I am responding to a column by Hayden Gise who says in her column she is a transgender, lesbian, Jewish, Democratic Socialist, and supports having the Democratic Socialists of America (DSA) in Washington, DC. She is definitely as entitled to her view on this, as I am to mine. However, I was surprised she clearly felt it important to use the column to attack me personally, without even knowing me. What she didn’t do is respond to the issues in the DSA platform I wrote having a problem with, and which I asked candidates endorsed by the DSA to respond to. 1. Are they for the abolishment of the State of Israel? 2. What is their definition of a Zionist? 3. What is their definition of antisemitism? 4. Will they meet with Zionist organizations? 5. Do they support BDS? One needs to know when a candidate claims they are only a member of the local DSA, according to the DSA bylaws no person can be a member of a local DSA without being a member of the national organization. So Hayden Gise has a little better idea of who I am she should know: I was a teacher and a union member. I worked for the most progressive member of Congress at the time, Bella S. Abzug (D-N.Y.), and supported her when she introduced the Equality Act in 1974, to protect the rights of the LGBTQ community, and have fought for its passage ever since. I have spent a lifetime fighting for civil rights, women’s rights, disability rights, and LGBTQ rights. I have no idea what Hayden Gise’s background is, or what her history of working for the causes she espouses is. But I would be happy to meet with her to find out. But she should know, I take a back seat to no one in the work I have done over my life fighting for equality, including economic equality, for all. So, I will not attack her, as I don’t know her, and contrary to her, don’t personally attack people I don’t know much about. 

“I have, and will continue to attack, what the government of Israel is doing to the Palestinian people, and now to those in Lebanon and Iran. I will also attack the government of my own country, and the felon in the White House, and his sycophants in Congress, for what they are doing to our own people, and people around the world, and will continue to work hard to change things. However, I will also continue to stand for a two-state solution with the continued existence of the State of Israel, calling for a different government in Israel. I also strongly support the Palestinian people and believe they must have the right to their own free state.”

I have not heard from Gise, but I hope she knows that since she wrote her column indicating her support for Janeese Lewis George for mayor, her preferred candidate has attended a birthday party to celebrate a person who still refers to gay people as ‘fags.’   

We should not personally attack people we don’t know as a way to criticize their views on an issue. Once again, I have no problem with people disagreeing with what I write, and having the Blade publish those contrary columns. But a plea to all who disagree with any columnist, or story: disagree with the issues and refrain from making personal attacks on the writer. That actually takes away from whatever point you are trying to make. 


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

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Science said stop; the Supreme Court said no

What Chiles v. Salazar means for LGBTQ health

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(Washington Blade file photo by Michael Key)

Imagine if researchers found that coffee drinking increased your risk of death by more than 50%. The public health response would be immediate – regulations, warnings, a swift mobilization of policy to match the evidence. We would act, because protecting people from documented harm is what evidence-based policy exists to do.

The same logic is why Colorado banned conversion therapy. The science was clear: research from The Trevor Project and others shows that exposure to conversion therapy increases suicidal ideation among LGBTQ+ youth, and more than doubles suicide attempts for transgender youth. Every major medical organization in the country – the American Medical Association, the American Psychological Association, and the American Academy of Pediatrics – has condemned the practice. 

Colorado looked at the evidence and did what public health is supposed to do. It intervened. 

On March 31, 2026, the Supreme Court struck down that intervention 8-1 in the Chiles v. Salazar case, ruling that conversion therapy is protected speech.

This decision should alarm anyone who believes that science has a role in protecting human lives. The court did not dispute evidence. It did not produce contradicting research or question the methodology of the studies Colorado relied on. Instead, it decided that the ideological underpinnings of conversion therapy deserve more constitutional protection than the children being harmed by it. In doing so, it severed the fundamental link between what science tells us is dangerous and what the law is willing to prohibit. 

That severance has consequences far beyond Colorado, as Supreme Court Justice Ketanji Brown Jackson noted in her dissent. More than 20 states and Washington, D.C. have enacted conversion therapy bans. The court majority’s reasoning – that regulating talk-based practices constitutes censorship – hands challengers a blueprint. The scientific consensus that built those protections did not change on March 31, but its power to hold them in place did.

For LGBTQ+ public health researchers like us, this ruling is a reckoning. And a personal one. Both of us came to public health because it offered a way to ask questions that matter: How can we help people live safe, healthy, and happy lives?

As a Ph.D. student and an assistant professor focused on LGBTQ+ health, we have been energized by the possibility that rigorous research could inform policies that protect LGBTQ+ people. The Chiles v. Salazar ruling forces us to recognize something uncomfortable: the possibility of research driving policy is real, but it is not automatic. Evidence reaches policy only when researchers advocate to put it there. As it turns out, scientific evidence itself is not enough. 

This means the work of LGBTQ+ health researchers cannot stop at the journal article. It has to extend into the spaces where policy is actually made and public opinion is actually influenced. Researchers must work alongside educators, communicators, and community organizers to make evidence impossible to ignore or misrepresent. 

As Sylvia Rivera observed in 1971, “our family and friends have also condemned us because of their lack of true knowledge.” More than 50 years later, misinformation about conversion therapy, gender-affirming care, and LGBTQ+ health still fills the gap that researchers leave when they stay silent.

We also want to say this directly to LGBTQ+ young people: Science has not abandoned you. The evidence of your worth, your health, and your right to be protected is overwhelming and it is not going anywhere. The researchers, clinicians, and advocates who built that evidence are still here and still working to ensure it translates into the protection you deserve. 

The Chiles v. Salazar ruling is a serious setback. But it is not the end of the argument.

Science has shown us how conversion therapy causes harm. It has shown us clearly, repeatedly, and with the backing of every credible medical institution in the country. The Supreme Court chose to look away. The only response to that is to make looking away harder. To build a public, cross-sector, science-informed movement that refuses to let evidence be sidelined when lives are on the line.

The evidence is on our side. Now, we have to make sure it counts.


Vincenzo Malo is a Health Services Ph.D. student at the University of Washington’s School of Public Health who studies affirming health systems. Dr. Harry Barbee is an assistant professor in the Johns Hopkins Bloomberg School of Public Health whose research focuses on LGBTQ+ health, aging, and public policy.

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