A great POZ.com article worth sharing.

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By David Evans on May 23, 2012 3:49 PM

 

 

Time to bring in the referees: a U.S. Food and Drug Administration (FDA) panel has voted to approve the first HIV prevention medication for adults in the history of the epidemic–and some people are not at all happy about it.

On May 10, 2012, an FDA advisory panel recommended with near unanimity that the antiretroviral (ARV) drug Truvada (tenofovir plus emtricitabine) may be used not only by HIV-positive people to treat their HIV, but also by some HIV-negative people to prevent them from acquiring the virus. The panel’s recommendation, which the FDA will likely follow, should have been an occasion for great joy–the triumph of the first new prevention tool in the 30-year history of the epidemic–but the hearing, just like the public discussions that led up it, was marred by apprehension, misinformation and controversy.
In my capacity as Director of Research Advocacy for Project Inform I attended the marathon twelve-and-a-half hour FDA advisory meeting, one that highlighted a schism among the audience members and some of the panelists, and suggests contentious public discussions about resource allocation and on PrEP’s efficacy and safety are still to come.
Since the vote, several prominent activists and researchers have expressed their displeasure, citing concerns about side effects and drug resistance and worries that people will throw out their condoms. While it’s understandable that tempers are running hot as we dissect the science, pragmatism, from all sides, is what’s truly needed.
AIDSmeds’ very own Tim Horn gives an excellent overview of the full hearing and its outcome here (so I won’t go into a blow-by-blow account), but I do want to draw attention to a presentation given at the beginning of the hearing by Susan Buchbinder of the San Francisco Department of Public Health, who made one of the most compelling cases for PrEP that I’ve heard yet.
Buchbinder described how condoms and behavior change alone have failed to put even a small dent in the epidemic for some time. There are myriad reasons for this, but at the heart of it is that lots of people struggle to use condoms consistently for vaginal or anal sex and our efforts to fix that have been only modestly successful. We are going on 16 years of flat HIV numbers overall–more than 50,000 new cases per year in the United States–and HIV rates are rising in young men who have sex with men (MSM), particularly young MSM of color. In fact, in some cities nearly 80 percent of young black men could become infected by the age of 60 if something doesn’t change–not because of greater risk-taking behavior, but simply because HIV is so prevalent among their sex partners that even one or two slip-ups can have devastating consequences.
On top of that, Buchbinder explained, our best interventions to help reduce HIV risk through behavior change have rarely demonstrated long-lasting effects in most people, nor have those studies ever documented an actual reduction in new HIV infections. Lastly, for many people condom use means risking the loss of a relationship or safe housing, or in some cases physical violence. Such people desperately need prevention tools that take such risks into account and that don’t require the consent and cooperation of their sex partners. PrEP fully meets those conditions.
Given the stigma and emotional hardship of an HIV diagnosis, the risk of discrimination and prosecution, the reduced life expectancy and astronomical cost of health care, allowing 50,000 more people to become infected each year is an unfolding moral and financial catastrophe.
Like condoms, PrEP can be a highly effective technology–more than 90 percent effective when used correctly. And just like condoms, PrEP only works if it is used. Unlike condoms, however, which are cheap, abundant and safe, Truvada for PrEP is expensive, and carries the risk of side effects and of causing those who become infected while taking Truvada to develop drug resistance. This is a substantial point of controversy. But as Buchbinder and others have pointed out so eloquently, for tens of thousands of people each year the choice won’t be one of PrEP versus condoms, but PrEP versus nothing at all.
It’s fair to assume that most people share the same goal at heart: to end the AIDS epidemic in a way that respects the rights and wellbeing of those living with HIV and those at risk for becoming infected. PrEP, I believe, is a critical step toward that aim, if we apply it properly. Here’s how……
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