LOS ANGELES—It would appear to be the case that if AIDS Healthcare Foundation ruled the world, there would be no research into methods of preventing the HIV virus from infecting the uninfected, and condoms would be the only method of prevention allowed—other than abstinence, of course. In this way, AHF is taking a similarly aggressive stance with an AIDS prevention drug currently seeking FDA approval as it does with mandatory condom use for adult performers, in that it refuses to see any value in any prevention mechanism other than condoms. However, the group also (and similarly) seems to be skewering the results of research in order to bolster its argument against approving the drug, Truvada, the FDA application for which was supported in January by 25 health organizations.
According to Reuters, AHF "has petitioned the Food and Drug Administration on the grounds that studies have shown that the pill, Truvada, made by Gilead Sciences, is only partially effective in preventing transmission. The drug is already approved to treat people infected with the human immunodeficiency virus that causes AIDS."
In addition to arguing against Truvada on the basis of its supposed partial effectiveness, AHF also argues that it "is associated with kidney problems and that use of the drug by healthy people could cause them to become resistant to it, complicating treatment if they contract HIV."
AHF president Michael Weinstein, commenting on the fact that Truvada must be taken every day, said yesterday, "Any approach that relies on adherence for people who don't have a disease is going to fail."
That's nice of Weinstein to make that determination for others, especially when condoms have their own failure rate. It would seem, however, that AHF wants to decide which forms of protection people are allowed to incorporate into their own health regimens.
But beyond that, a closer look at the research AHF seems to be referencing suggests a problematic misrepresentation of results in order to skew perception of the effectiveness of Truvada for non-HIV-infected people.
For instance, in a press release issued yesterday, AHF stated, "AHF has long voiced concerns that such a use [by non-infected individuals] would actually increase HIV infections, and the announcement comes just days after researchers reported that a component of Truvada (which is a combination containing two Gilead drugs—tenofovir DF and emtricitabine—in one tablet) is linked to a significant risk of kidney disease and damage. Most alarmingly, the risk remains even after people stop taking the drug."
However, a February article in the San Francisco Chronicle contradicts that assessment, stating, "Researchers who have been looking at tenofovir to prevent HIV infection note that studies so far have shown very little increased risk of kidney damage in people who are otherwise healthy. The most recent prevention study, involving 2,500 men who did not have HIV, was led by scientists at UCSF and the Gladstone Institutes. Only a handful of participants showed signs of kidney damage, and in all of their cases those signs went away once the drug was stopped."
Indeed, the study to which AHF refers, which was conducted by the the San Francisco VA Medical Center (SFVAMC) and the University of California-San Francisco (UCSF), "examined the medical records of 10,841 HIV-positive veterans in the national VA health care system who were new users of antiretroviral therapy from 1997 to 2007. It was published electronically in the journal AIDS on February 9," and did not include any non-HIV-infected people.
Yesterday's press release also stated, "AHF has long been critical that PrEP (pre-exposure prophylaxis) will not work on a large-scale basis because, consistent with poor medication adherence rates for most diseases, people will not be able to take Truvada as directed. Because of this, there will be little or no preventative effect, and drug resistance and drug resistant strains of HIV will develop. In addition, people who falsely believe they are fully protected against HIV very likely may engage in riskier behavior, thereby increasing their risk of HIV infection."
While the concern about resistance to drugs is well-founded, not everyone agrees that the risk for non-infected individuals poses anywhere near the same risk as it does for infected individuals, or that stopping research in this area is prudent.
According to the Microbicide Trials Network, "Only a person infected with HIV can get drug resistance. But because both tenofovir and Truvada are drugs routinely used as part of combination therapy for treating HIV, there is concern that individuals who become infected while in an ARV-based prevention trial could acquire or develop virus that is resistant to the drug or drugs being studied and, consequently, might not respond optimally to ART with that ARV or other ARVs in the same class. Trials of ARV-based prevention include several measures to prevent or reduce the risk of acquiring HIV, and by extension, the risk that resistance would occur in participants who, despite the study’s efforts, become infected. Some experts believe HIV drug resistance in the context of prevention will be much less prevalent than it is in the treatment setting. But until more information is available from current trials and long-term studies, the potential risks are not known."
As usual, however, and despite more balanced views by medical professionals on a disease that is global in scope and which manifests itself differently in different countries and cultures for a variety of factors, AHF continues to view HIV/AIDS through a one-size-fits-all prism: a condom.
"The idea of giving healthy people a toxic drug that will damage their kidneys in order to possibly prevent HIV—when simple condom use is 95% effective—is the height of irresponsibility and corporate greed," Weinstein is quoted in Thursday's press release as saying. "Widespread use of PrEP has all the makings of a public health disaster—increased HIV infections, drug resistant strains of HIV, and tens of thousands of damaged kidneys. And the FDA, in expediting its review and limiting further research, appears hell-bent on bringing this about as quickly as possible."
This is precisely the same sort of alarmist and hyperbolic language that Weinstein has consistently used in his campaign to control the sexual practices on porn sets. Where he gets the "tens of thousands of damaged kidneys" mentioned above figure is anyone's guess, but it is not from research. Weinstein has, of course, made similarly extravagant claims about infection rates for the adult entertainment industry.
But what is most disturbing about the manner in which AHF in general—and Michael Weinstein in particular—prosecutes his campaigns is the nonchalance with which he deigns to decide for others what the parameters of the options available to them should be.
With porn, Weinstein has consistently said that it is a workplace issue, and that no one is trying to control the private behavior of porn performers, but as one can plainly see from the Truvada situation, he has no trouble at all anticipating a lack of "adherence rates" for the general population, and thus coming to the conclusion that no one should have access to the drug.
It is this sort of intrusive behavior combined with a willful disregard for the facts that has the adult entertainment industry seething in rage over this individual who believes he knows better than anyone else how they should practice safe sex.
