STEP BY STEP
The HIV Drug Half a Million Women Need
Truvada activists were shocked when vocal critic Larry Kramer changed his tune. With a lack of campaigns for people other than gay men, there is a long way to go.
James Krellenstein and boyfriend Matt Ebert were stuck in traffic on Highway 17 on the way in to New York City, with boeuf bourguignon and butternut squash soup cooling in the back seat, when Krellenstein, a 24-year-old HIV activist, texted friend Peter Staley: “I am freaking out.”
After all, Krellenstein and Ebert weren’t just heading in for dinner. Krellenstein had planned a showdown with ACT UP and Gay Men’s Health Crisis cofounder Larry Kramer. And Kramer has been clear about how he feels about Truvada, an HIV drug that can prevent HIV-negative people from acquiring the virus. Famously, he has declared that those who take Truvada when condoms are readily available are “cowardly,” and said they “must have rocks in their heads.” Krellenstein, who is one of those people, as well as a staunch Truvada advocate, was determined to convince Kramer to sign a prepared statement in support of the prevention approach, known as pre-exposure prophylaxis (PrEP). He said he spent the week before the dinner tracking down every study, every fact that supported PrEP’s use.
It turned out, he needn’t have worried.
“It wasn’t even an argument,” said Krellenstein. “I was shocked.”
Indeed, on Monday night, Dec. 7, writer and activist Larry Kramer set down the saber, picked up the pen, and signed what’s being called the PrEP Dinner statement. It immediately went viral Tuesday morning when Staley posted it to Facebook. Headlines blared, “Larry Kramer has changed his mind about PrEP.” Now, the only high-profile PrEP opponent left is Michael Weinstein, president of the AIDS service organization the AIDS Healthcare Foundation, whom some have begun to call a PrEP denialist. (Full disclosure: Including me.)
It’s been a banner year for Truvada. An ex of Charlie Sheen’s recently revealed she used the pill to prevent HIV when she was dating Sheen. Dr. Anthony Fauci, director of the National Institute for Allergy and Infectious Disease at the National Institutes of Health, declared at the recent National HIV Prevention Conference that “the argument is over for PrEP. If you use it, it works.” Truvada use for prevention has skyrocketed, from 1,274 people in 2012 to as many as 30,000 people today, and it seems to be especially popular among those who could benefit from it most.
And now, this. Signers of the statement hope Kramer’s endorsement will spur wider adoption, especially among gay men and trans women, groups whose HIV rates far outstrip their demographic significance.
“We think it was a bit of history,” said Staley, founder of the Treatment Action Group, a longtime member of ACT UP, and member of New York Gov. Andrew Cuomo’s Ending the Epidemic Task Force. He and Ebert were the ones who arranged the dinner, to bring Krellenstein and Kramer together in one room. According to Krellenstein, Staley told him, “You need to talk about the issues face to face. As fun as insulting people on Facebook is, it doesn’t do anything.”
The PrEP Dinner Accord
The conversation did, indeed, start on Facebook—or, rather, the fight did. Starting in March and continuing on Facebook through last month, Krellenstein has posted Kramer’s comments to his timeline and on an ACT UP Facebook group with palpable vitriol. Of Kramer’s interview in The Advocate in March, Krellenstein referred to Kramer as “a man who managed to pervert his own internalized homophobia into a narrative that would stifle HIV prevention for decades.”
For his part, Kramer called Krellenstein’s comments “just rude.”
But Krellenstein said he wasn’t just venting. He was worried that Kramer’s negativity toward PrEP could influence his peers, who are acquiring HIV at alarming rates.
“When you live in a country where three gay men an hour get infected with HIV, this epidemic is not stopping, not slowing down—and he called us all cowards,” Krellenstein said. “I was fucking furious. I was… I was beyond angry. I’m still kind of amazed I sat down and had dinner with him.”
But he did, and Kramer did. And the fighting words dissolved. Kramer was on board.
What came of it was a public accord—three short paragraphs, heavy on the historical importance (“We—AIDS activists, new and old, aged 24 to 80—have just broken bread in the same apartment where GMHC was formed.”). It made three main points: One, that the activists agree that Truvada is effective in warding off HIV infection in gay men and trans women. Two, that Gilead Sciences, the California-based company that makes the drug, must end its “PrEP profiteering” and make the drug available at a reasonable price. And three, that it’s going to take more than just PrEP to end HIV.
“PrEP, along with condoms, TasP (Treatment as Prevention), and better access to healthcare, are now essential public health tools in lowering HIV infections among gay men and trans women,” the statement said, in part. “We must use every tool necessary to help them—and to help all those at risk—stop this virus, once and for all.”
A Power Bottom Move
For Maria Mejia-Laing of Miami reading the statement was like déjà vu—but not in a good way. It reminded her of earlier this year, when she attended the Conference on Retroviruses and Opportunistic Infections. She’s been HIV positive for 27 years.
“Every seminar, every symposium, it was all about men who have sex with men,” said Mejia-Laing, who runs two Facebook groups for people with HIV, one in Spanish and one in English, with a combined membership of 60,000 people worldwide. “I always came to the front and ask the same thing: What about women—trans women as well? Women are getting infected, as well. I believe in that dinner—and a lot of people mentioned it online as well, it was the same faces, the faces of white gay men.”
As women, “we are invisible,” she said. To Mejia-Laing, the omission matters, she said, because Kramer matters. She called him “our role model.”
Indeed, new estimates from the CDC say 1.2 million Americans could benefit from Truvada as PrEP. Nearly 500,000 of those are gay men. Another 115,000 are injection drug users as well as an additional 157,000 straight men who would be good candidates, according to the CDC. As for straight women (not counting trans women)? Four hundred and sixty-eight thousand straight women are said to be good candidates for the drug—just 24,000 less than gay men.
“They can change [the statement],” she said. “And they should.”
Mejia-Laing was glad the statement included trans women, even though some activists have bristled at trans women being lumped in with gay men again. Trans activists fought hard to stop researchers from classifying trans women as “men who have sex with men” in their PrEP studies. According to a meta-analysis of 29 published studies, nearly one in three trans women have been diagnosed with HIV, and their HIV infection risk is nearly 50 times as high as for other adults, regardless of gender.
That’s why Staley fought hard to include them in the statement. But Krellenstein said, in retrospect, he would rewrite the statement to include everyone. After all, straight women (whether trans or not) and gay men who are the receptive partners are in the same position—they have an increased risk of HIV, and rarely have the power to control whether the top (or man) wears a condom. As Staley said, Truvada is a “power bottom move.”
That’s not the only criticism the statement generated. As soon as the statement came out, people started calling on Kramer to publicly apologize and rescind his past statements against PrEP—something Kramer said he won’t do.
“I have nothing to apologize for,” he told The Daily Beast. “With what was known, or rather, unknown at the time, my opinions, concerns and fears were perfectly valid. Some of them still are.”
Indeed, Kramer repeated a statement he made to the New York Times that Truvada is “chemotherapy.” “It’s not aspirin,” he added. “There are side effects.”
Those side effects can include kidney damage and bone loss though so far kidney trouble has rarely been reported among HIV negative patients (it’s more common among people who take Truvada for HIV treatment). That’s why people taking the drug must have quarterly doctors’ visits, and lab work for kidney function, bone mineral density, HIV and other sexually transmitted diseases.
But Kramer added that he has been swayed by recent real-world studies that have found it effective, safe and not associated with any new cases of HIV among those taking it.
“Two years ago, we just didn’t have the facts and figures that we have now, which are impressive,” he said. “There’s more real-world experience. We also have a statement out of NIAD that everyone should be taking it. That’s where we are now, and it’s not a bad place to be, but it’s still a complicated place.”
That’s where Kramer comes in. He’s the one that added the “PrEP profiteering” piece to the statement.
“With PrEP, we have delivered to Gilead a huge patient population, a huge customer population, and all they’re doing is milking us dry,” Kramer said. “If Congress isn’t going to do anything about controlling the unruly pharmaceutical companies from charging whatever they want, we need to act up and make our voices heard again.”
In this, Kramer and his group are not alone. Since the FDA approved Truvada for prevention in 2012, PrEP activists around the country have been pressuring Gilead to increase its patient assistance program and copay assistance programs to make them more accessible, as well as working with state and government agencies to get around the drug’s high price. So far, they’ve been effective in increasing the amount Gilead will pay for copays to $300 a month, and now the drug company allows patients to use the full amount of the annual copay rebate—$3,600—up front, to cover high deductible health plans.
The next step, said Staley, is to collect enough stories of PrEP users maxxing out their $3,600 assistance and still struggling to afford Truvada, to push Gilead to increase the overall benefit.
Kramer wants the price dropped, period.
It will be an uphill climb. This is the drug company, after all, that Congress investigated for 18 months over the pricing of its new hepatitis C drugs, Havroni and Sovaldi. Sovaldi, famously, was initially priced at $84,000 for a course of treatment, or $1,000 a pill. The report, released Dec. 1, found “a pricing and marketing strategy designed to maximize revenue with little concern for access or affordability.” Havroni had a sticker price even higher.
And that’s complicated by the fact that, by law, neither Medicare, which covers seniors, or Medicaid, which covers the poor, pregnant, and disabled, are allowed to negotiate with drug makers on price.
“Gilead knew these prices would put treatment out of the reach of millions and cause extraordinary problems for Medicare and Medicaid, but still the company went ahead,” Sen. Ron Wyden (D-Oregon), said in a prepared statement. “If Gilead’s approach to pricing is the future of how blockbuster drugs are launched, it will cost billions and billions of dollars to treat just a fraction of patients.”
Lynda Dee, co-chair of watchdog group The Fair Pricing Coalition, isn’t surprised. She’s worked with Gilead almost since its formation, and compared the company’s change in approach to something out of Treasure of the Sierra Madre.
“Did you ever see that movie? They go up into the mountains for gold and they all go crazy with greed,” she said. “I’ve worked with people from Gilead since it started. They were nice people, sane people. But the more they’re criticized, the more they come out swinging.”
They were a little more conciliatory when The Daily Beast contacted them, pointing out the accommodations they’ve made with their assistance programs since Truvada was approved for PrEP.
Still, they said, “We stand behind the pricing of our therapies because of the benefit they bring to patients and the significant value they represent to payers, providers, and our entire healthcare system.”
For her part, Dee said she’d be surprised if Gilead significantly changed the price of Truvada before its patent expires in 2021. But, she added, Kramer can only help.
“Love him or hate him, he is effective at obtaining attention to whatever he endorses,” she said. “I welcome his fighting spirit to this effort. People’s lives are literally at stake.”