Open letter ad challenges the Centers for Disease Control on its recommendation for community-wide use of the HIV/AIDS medication Truvada as pre-exposure prophylaxis (PrEP) for possible HIV prevention.
In May, the CDC recommended that 500,000 men-who-have-sex-with-men and other high-risk individuals go on PrEP, despite the fact that data from nearly all PrEP studies do not support such large-scale public deployment of PrEP due to adherence issues: Even in carefully monitored clinical trials demonstrating the drug’s efficacy, many study participants simply did NOT take the medication every day as prescribed.
AHF’s campaign starts Monday, November 17th in newspapers and magazines in seven markets or cities nationwide: New York, Los Angeles, San Francisco, Oakland, Dallas, Washington, DC and South Florida.
LOS ANGELES (November 19, 2014) On Monday, AIDS Healthcare Foundation (AHF) launched a new national ad campaign challenging the Centers for Disease Control (CDC), over its recent recommendation of the widespread scale up of the use of Gilead’s HIV/AIDS medication Truvada as pre-exposure prophylaxis (PrEP) as a possible HIV prevention tool.
AHF’s ad, written as an “Open Letter to the CDC: What if You’re Wrong About PrEP?”, first appeared Monday, November 17th in The Hill, a daily newspaper serving and reporting on elected officials and government staffers in Washington DC. AHF’s CDC/PrEP ad will then run over the next ten days in newspapers and magazines in seven markets or cities nationwide: New York, Los Angeles, San Francisco, Oakland, Dallas, Washington, DC and South Florida.
In May, the CDC recommended that 500,000 men-who-have-sex-with-men and other high-risk individuals go on PrEP, despite the fact that data from nearly all major PrEP studies do not support such large-scale public deployment of PrEP due to medication adherence issues: Even in carefully monitored clinical trials demonstrating the drug’s clinical efficacy, many study participants simply did NOT take the medication every day as prescribed.
Under the headline “An Open Letter to the CDC: What if you’re Wrong About PrEP?”, AHF’s ad test reads:
“The Centers for Disease Control and Prevention (CDC) recently recommended that half a million gay men in the United States receive Truvada for the prevention of HIV. Further, they changed their wording from “unprotected sex” to “condomless sex” to describe intercourse without a condom, thus saying that sex without a condom could still be safe if accompanied by medication while ignoring the transmission of all other STDs besides HIV. AIDS Healthcare Foundation (AHF) regards these decisions as dangerous to the public health of the country. Both of these decisions are based on the premise that PrEP (pre-exposure prophylaxis) with Truvada is a sound public health strategy.
AHF believes that while Truvada may work to protect a small segment of the population of HIV-negative individuals, all of the scientific studies have shown that it will not work on a community-wide basis because of consistently bad adherence by study subjects – even under ideal circumstances.
However, if the data that will be reported in the next two years show that we are wrong about PrEP, we will be the first to admit it. We challenge the CDC to make the same pledge.
Currently, the gay male community is facing soaring rates of syphilis and other STDs. 1,2 The CDC knows that Truvada offers no protection against syphilis. If those numbers continue to go higher, will the CDC go back to calling unsafe behavior “unprotected”? If people on Truvada become infected with HIV, will the CDC reconsider its rash decision on PrEP? If men who become infected develop drug resistance, will the CDC apologize?
Medical ethics are based on the concept of “do no harm.” 3 Beyond the potential damage to the health of the individuals, the CDC’s ill-advised strategy of mass treatment with Truvada poses a significant risk to the condom culture, which while it has eroded, has still prevailed among gay men for three decades.
Studies show that the majority of gay men use condoms always or sometimes. 4 This is borne out by the fact that the current rates of infection would be far higher if they didn’t. Therefore, spreading misinformation that Truvada is an effective community-wide prevention strategy has the potential to do grave harm.
Both the community and the government must be accountable for the guidance they give to vulnerable populations. The debate about safer sex goes back to the beginning of the epidemic. Every time we didn’t heed advice to protect ourselves, we paid a terrible price. AHF will do everything that we can to make sure that doesn’t happen again. However, if we are wrong, we will take responsibility for our decisions. We hope that everyone else will do the same.”
AIDS Healthcare Foundation
AHF Challenges CDC on Change of Prevention Wording from ‘Unprotected’ to ‘Condomless’
As noted in AHF’s “What if Your Wrong About PrEP?” ad, the CDC—with little fanfare and almost no public discussion—also recently changed its prevention wording from “unprotected sex” to “condomless sex” to describe intercourse without a condom. (NOTE: a request came via a community group letter to the CDC in December 2013; the CDC the changed the wording in January 2014—a mere four or five weeks later).
With this seemingly innocuous word change, the CDC has now in essence—and AHF believes improperly—declared that sex without a condom (condomless) could still be considered safe if accompanied by medication. While AHF acknowledges that PrEP can be clinically effective in HIV prevention (our concern is patient adherence), the Foundation is challenging the CDC to fully explain and defend the scientific rationale for this sudden word switch.
“Condomless” sex still leaves an individual completely “unprotected” from the possible transmission of nearly all other STDs. Besides HIV, PrEP offers virtually NO protection against diseases including syphilis, gonorrhea, chlamydia, HPV and others—some diseases of which are now being seen in far greater proportion among gay men and men-who-have-sex-with-men (MSM)—the very populations the CDC is targeting with its recommendation to scale up PrEP to 500,000 individuals.
In addition, and perhaps of greater alarm, the CDC’s sudden change of verbiage from “unprotected” to “condomless” appears to completely override the FDA and its guidelines and Black Box label indication for use of Truvada for a PrEP indication, as PrEP is NOT just a prescription that is provided in isolation.
PrEP, according to current FDA guidelines is a four-part HIV prevention strategy, consisting of: 1) a baseline HIV test to ensure the individual is HIV-negative; 2) taking Truvada every day, once a day;
3) periodic (recommended every three months) follow up HIV testing to ensure the individual remains HIV-negative while on PrEP, and 4) suggested continued use of “comprehensive management strategies” …to reduce uninfected individual’s exposure to HIV-1 infection,” including “…safer sex practices such as consistent and correct use of condoms.”
So, despite the CDC’s change of its prevention vernacular, according to the FDA, PrEP is NOT “condomless” sex. For the above reasons, AHF believes that the CDC should overturn its scientifically unsupported switch to “condomless” and return to the more accurate descriptor “unprotected,” and the Foundation will be seeking support on Capitol Hill to press the CDC to restore its wording to the more scientifically accurate wording.
AHF’s “CDC-What if you’re Wrong on PrEP?’’ ad campaign is running in the following publications: Washington, DC: The Hill (11/17/14), Metro Weekly (11/21/14), Washington Blade (11/21/14); California: Frontiers (11/27/14), Bay Area Reporter (11/27/14), Oakland Post (Date/Run TBD), Texas:Dallas Voice (TBD) and in South Florida: SFGN (South Florida Gay News—(11/19/14), Florida Agenda (11/18/14).
The ‘PrEP Facts’ campaign will likely expand to other markets as AHF continues to ramp up its public awareness and advocacy campaign cautioning against the widespread scale up of PrEP for possible HIV prevention. The ads also serve to educate the public as to the critical, but complicated role adherence to the controversial HIV prevention protocol plays the overall success of PrEP when deployed more widely among the general public.