Why Is No One On the First Treatment To Prevent H.I.V.?

Source: The New Yorker.com
In November, 2010, the New England Journal of Medicine published the results of a three-year clinical trial, funded by the National Institutes of Health, announcing the arrival of a treatment that could reduce the risk of contracting H.I.V. by more than ninety per cent. The treatment involved a blue, oval pill containing emtricitabine and tenofovir. Marketed under the brand name Truvada, the pill was synthesized in 2004 by Gilead Sciences, the world’s largest producer of branded H.I.V. drugs, and has been used in combination with other antiretrovirals as a primary treatment for people living with AIDS.
The N.I.H. team discovered that a daily dose of Truvada not only suppressed the virus in people who were already infected but also prevented healthy people from contracting H.I.V. in the first place. Following the N.I.H. study, which tracked gay men in Peru, Ecuador, Brazil, South Africa, Thailand, and the United States, additional trials showed the drug to be effective for heterosexual men and women, as well as for injection-drug users. Researchers called the treatment “pre-exposure prophylaxis,” or PrEP for short. Others have called it “the new condom.”
But, in fact, adoption of the drug has been slow. According to Dawn Smith, a biomedical interventions implementation officer in the C.D.C.’s epidemiology branch, at least half a million Americans are good candidates for PrEP—meaning that they are at high risk for contracting H.I.V. through sexual activity—yet only a few thousand Americans are receiving the treatment. “As in most fields, many clinicians don’t want to be the first one out of the gate,” Smith said. Salim Karim, the chair of United Nations’ AIDS Scientific Expert Panel and the director of the Centre for the AIDS Programme of Research in South Africa, thinks that doctors’ hesitance may not have anything to do with sexual health. “Clinicians fundamentally have difficulty giving healthy people drugs,” he said. “This is not unique to H.I.V.” Meanwhile, despite repeated demonstrations that Truvada provides protection from H.I.V., an estimated hundred and fifty thousand Americans, more than a third of whom are in their teens and twenties, have become infected with the virus since the results of the study were released.
The medical community’s reluctance to prescribe Truvada—and patients’ reluctance to request it—also stems from a bitter fight over the treatment. Critics have questioned PrEP’s safety, efficacy, and cost, and have accused the government of colluding with the drug manufacturer at the expense of public health. Regan Hofmann, the former editor-in-chief of Poz, a magazine for people living with AIDS, called PrEP a “profit-driven sex toy for rich Westerners.” Michael Weinstein, the head of the AIDS Healthcare Foundation (A.H.F.), the world’s largest AIDS organization and the primary-care provider for more than two hundred thousand patients around the world, predicted a public-health catastrophe. “The applause for this approach shows just how disposable we consider the lives of gay men,” he wrote. When I interviewed Weinstein, he claimed the studies were “rigged” and that PrEP was essentially a plot by Gilead to force young people into buying unnecessary medication, and that it was going badly because A.H.F. wasn’t letting the company get away with it.
These kinds of claims helped to shape perceptions of the drug among patients, doctors, and journalists. At an open F.D.A. hearing in May, 2012, busloads of A.H.F. employees showed up to make statements against PrEP, raising questions about the drug’s side effects, its price tag, its potential to incite risky behavior, its failure to prevent other S.T.D.s, and the possibility that imperfect adherence to the pill’s daily regimen would lead to the spread of a Truvada-resistant strain of H.I.V. Though data from the studies largely contradicts these criticisms, they were widely circulated. “I think the advocacy that A.H.F. did was very effective,” Weinstein told me. “We were quoted in virtually every article that was written.”
Gilead’s efforts to promote Truvada for PrEP treatments have been somewhat meagre. “In any other kind of F.D.A. approval, there would have been beautiful ads, lots of TV, and lots of press touting the fact that this was the new thing to keep people protected from H.I.V.,” said Ernest Hopkins, the director of legislative affairs for the San Francisco AIDS Foundation. “Gilead chose not to do that.” According to Jim Rooney, Gilead’s vice-president of medical affairs, the company “spends several million dollars” on educational initiatives related to PrEP, delivered through third-party groups, but it “does not view PrEP as a commercial opportunity.”
Truvada is already a blockbuster drug for Gilead; it earned the company more than three billion dollars in global sales in 2012. As Rooney notes, “The role of antiretrovirals in H.I.V. prevention is not yet defined and not yet broadly accepted.” Although Gilead has donated drugs to researchers working on PrEP, it has not undertaken its own study. According to Jim Pickett, the director of prevention advocacy at the AIDS Foundation of Chicago, “Pharmaceutical companies had to be dragged into new prevention research. They weren’t excited about it. They didn’t want to do it.”
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