LOS ANGELES--(BUSINESS WIRE)--Starting Monday, AIDS Healthcare Foundation (AHF) will launch 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?”, will first appear Monday, November 17th, in The Hill, a daily newspaper serving and reporting on elected officials and government staffers in Washington, D.C. 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, D.C., 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 text 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 You’re Wrong About PrEP?” ad, the CDC—with almost no public discussion—also recently changed its prevention wording from “unprotected sex” to “condomless sex” to describe intercourse without a condom. (NOTE: the request for the change came via a community group letter to the CDC in December 2013; the CDC then changed the wording in January 2014—four or five weeks later).
With this seemingly innocuous word change, the CDC has in essence—and AHF believes improperly—declared that sex without a condom (condomless) could still be considered safe or protected 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 “unprotected” from possible transmission of nearly all other STDs. Besides protection from HIV, PrEP offers virtually NO protection against diseases including syphilis, gonorrhea, chlamydia, HPV and others—some 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 has targeted 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 override FDA guidelines and its Boxed Warning label 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, as well as periodic hepatic function testing, 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. As such, AHF believes that the CDC should reverse its word switch to “condomless” and return to the more scientifically accurate descriptor, “unprotected.”
AHF’s “CDC-What if you’re Wrong on PrEP?” ad campaign will run in the following publications: Washington, D.C.: 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 “CDC-What if you’re Wrong on PrEP?” campaign may expand to other markets as AHF continues to raise public awareness in 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 in the overall success of PrEP when deployed more widely among the general public.
AIDS Healthcare Foundation (AHF), the largest global AIDS organization, currently provides medical care and/or services to nearly 356,000 individuals in 36 countries worldwide in the US, Africa, Latin America/Caribbean, the Asia/Pacific Region and Eastern Europe. To learn more about AHF, please visit our website: www.aidshealth.org, find us on Facebook: www.facebook.com/aidshealth and follow us on Twitter: @aidshealthcare.
1 Centers for Disease Control and Prevention (CDC). (May 9, 2014). Primary and Secondary Syphilis — United States, 2005–2013. Morbidity and Mortality Weekly Report (MMWR). Retrieved online: http://www.cdc.gov/mmwr/preview/mmwrhtml/mm6318a4.htm
2 Centers for Disease Control and Prevention (CDC). (2014). 2012 Sexually Transmitted Diseases Surveillance. Retrieved online: http://www.cdc.gov/std/stats12/Surv2012.pdf
3 Gillon R (1994). Medical ethics: four principles plus attention to scope. British Medical Journal, 309(6948): 184.
4 Rosenberger JG et al. (2012). Condom use during most recent anal intercourse event among a US sample of men who have sex with men. Journal of Sexual Medicine, 9(4): 1037-1047.