Patricia Nell Warren

PrEP: Some Red Flags

Filed By Patricia Nell Warren | February 05, 2011 2:00 PM | comments

Filed in: Media, Politics
Tags: CDC, drug resistance, HIV negative, HIV/AIDS, iPrEx study, PrEP, Sean Strub, self-medication, unsafe sex

We can always count on many of the media to give us a rosy once-over-lightly about the latest in HIV products. Why do they do this, when they're supposed to give us the pro-and-con analysis that has traditionally been expected of journalism? Especially with medical stories involving life and death?

One reason why: some media have been co-opted by the enormous power of pharmaceutical advertising, so they don't dare to be critical. They just obediently regurgitate the corporate press releases sent to them. Another reason why: in magazine and newspaper publishing, recession downsizing has led to hiring young low-salaried writers and editors who have little or no background in the screaming need to investigate medical stories.

Re AIDS, the latest media burbling has been about PrEP. Pre-exposure prophylaxis is defined as the daily use of ARVs by HIV-negative persons who worry that their relationships or sex activities might expose them to HIV. They could be partnered with someone who is HIV+, or they could be sex workers, or they could be party animals who rack up hundreds of sex adventures a year.

Right now, two ARVs are being scrutinized in clinical trials as candidates for oral PrEP against HIV-1: Viread (tenofovir disoproxil fumarate) and Truvada (a combination drug that contains emtricitabine and tenofovir). Some clinicians are already prescribing them for PrEP off-label.

How Things Get Garbled

Recently the New England Journal of Medicine published a report on the so-called iPrEx study, a clinical trial conducted in several countries. The authors claim that Truvada reduced the risk of HIV infection by 44 percent in a large cohort of 2499 HIV-negative men and transgender women, all of whom have sex with men. The study, which was funded by the NIH and the Bill and Melinda Gates Foundation, followed the cohort for a median 1.2 years. Participants were provided with a package of preventive services, including condoms, testing and counseling.

Right away, the babbling brooks of uncritical news stories were flowing. As I read through them, I noted that many garbled what the NEJM story said. Some omitted mention of the transgender women; others misquoted the final stats. Most didn't mention the package of preventive services, which could well have boosted the study's final prevention statistic. Also unmentioned was the article's comment that "The protective effect... was significant but not as high as originally hypothesized during the design of the study." A few publications even copycatted chunks of prose from one another. But few mentioned any downside to PrEP.

Even the government NIH News announcement was slanted to the overwhelmingly positive - it quoted NIAID director Anthony Fauci as saying that PrEP "has the potential to make a significant impact in the fight against HIV/AIDS."

Few media mentioned that PrEP can impact a person's wallet too. Given the implosion of our healthcare system, few U.S. service orgs and healthcare plans will likely cover PrEP. According to a 2008 study published in Journal of Acquired Immune Deficiency Syndrome, two-thirds of the gay and bisexual men surveyed said they would go for PrEP if they thought it was safe and effective. So daily Truvada treatment may cost each of these men as much as $14,000 per year. Even in developing countries, Viread can cost over $5000 per person per year.

No wonder the whole concept of using HIV drugs on HIV-negative persons is being viewed as a source of major new profit for pharma companies.

Fortunately, some seasoned media experts did take a more skeptical look.

One skeptic was Sean Strub, founder of POZ Magazine. In an 11/23 email to commentator Rex Wockner that circulated widely online, Strub said, "What is noted in the New England Journal of Medicine article, but not in many of the glowing press releases from various AIDS, public health and government agencies, is that the finding of a 44% reduction in PrEP vs placebo has a pretty wide Confidence Interval (15% to 63%). If you don't use a condom, allowing for the best statistical interpretation, a 44% reduction in infection (over only 1.2 years) is just nowhere near good enough.... It is tragic that the tone and shallowness of the press coverage will almost certainly lead some to start using PrEP without understanding how risky it is as a stand-alone HIV prevention strategy."

Red flags for PrEP can be seen waving right in the medical literature. For instance, some PrEP users will probably feel "safe" enough to push the envelope on personal risk. In a recent issue of AIDS Reviews, researchers at Rotterdam's University Medical Centre pointed out: "Any efficacious HIV prevention strategy can lead to behavioral disinhibition, in which a reduced fear of HIV leads to increasing risk behaviour." Some experts pooh-pooh this concern. Others are not so sure.

Perils of the "Party Pack"

The risk route can also include self-medication. Technically, tenofovir and Truvada can be purchased only with a doctor's prescription. But anybody who Googles can find both drugs being sold from online pharmacies without a prescription. According to Rod 2.0, tenofovir is available on the street as part of a "party pack" with Viagra and crystal meth. A single dose of tenofovir is popped by those who aim to have a good time but know that risk might happen before the night is out. They assume that one dose will protect them against HIV. Rod 2.0 calls these party packs "a trail mix that encourages unprotected sex."

Burbling media stories often omit mention of possible side effects. But the medical literature links Truvada with kidney problems, bone problems, and lipodystrophy. Some side effects can be fatal, including lactic acidosis, which happens when lactic acid builds up in the bloodstream faster than it can be removed. According to RXList (owned by WebMD), "Lactic acidosis can start slowly and get worse over time. Get emergency medical help if you have even mild symptoms of lactic acidosis, such as: muscle pain or weakness; numb or cold feeling in your arms." True-- other drugs can cause lactic acidosis as well. However, it's important to get fully informed on the possible effects of each and every specific drug we put into our bodies.

The maker of both drugs, Gilead, adds this caution: "Severe acute exacerbations of hepatitis B have been reported in patients who are co-infected with HIV-1 and HBV who have discontinued Truvada." Gilead also notes similar exacerbations with Viread, even though Viread has actually been FDA-approved for treating HBV. Translation: an HIV-negative MSM who leaps into self-PrEPing with Truvada without a doctor's oversight, and happens to have undiagnosed hepatitis B, might be at risk for a monstrous HBV flare-up when he stops his self-treatment with Truvada.

The same MSM might be at risk if he self-medicates with PrEP while also taking other drugs with the same or similar ingredients, thus doubling his risk of side effects.

Rise of Resistance

Last but not least, the media burblers seldom mention drug resistance. Conventional wisdom would insist that, if you aren't HIV+, using HIV drugs won't cause resistant strains to develop in your system. But according to the National Alliance for State and Territorial AIDS Directors (NASTAD): "Much is unknown (and will remain so until PrEP has been used for some time) about the possible development of drug resistance from its use." The NIH News report mentioned some instances of Truvada resistance that surfaced during the iPrEX study.

So those who launch themselves into long-term PrEP may be doing the same kind of borrowing, medically, as Americans who borrow financially against the equity in their home. It's nice to have the extra money today, but tomorrow, when you may suddenly need your home equity, it may be reduced... or even gone.

The point is -- how many people who self-medicate actually do their homework or read any medical literature before they leap? Given the 30-second attention span of most Americans today, many are likely to zoom into PrEP right after skimming the once-over-lightly in the news media.

Given the unknowns, people should be asking themselves these questions - and others as well - if they're considering PrEP. And the media should be urging people, and helping them, to find that life-or-death information.

The CDC Spin

Just before the 2010 holidays, even the CDC finally issued some caveats of their own on PrEP. They say they want only high-risk HIV-negative MSM to be using Truvada. (Why is CDC not mentioning the transgender women who also participated in the iPrEx study?)

In a press release from the CDC Newsroom, the agency added: "It is not time for anyone to stop using condoms or stop following proven prevention methods. Today's trial results show that PrEP is partially effective and does not protect against other sexually transmitted infections such as syphilis, gonorrhea, and chlamydia. It cannot be seen as the first line of defense against HIV. PrEP requires careful adherence, and is an intensive approach that won't be right for everyone."

CDC's caveat raises another question. If PrEP is only "partially effective" and "cannot be seen as the first line of defense against HIV," even with condom use and other prevention practices, why in the world would a person go to so much expense and effort to medicate this way? Especially when that person is taking the personal risk of what could be serious side effects?

Yes, many PrEP questions remain to be answered. Wouldn't it be nice if the major media help us get some answers?

________________________

A shorter version of this article was originally published in my "Left Field" column in A & U Magazine, January 2011


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Thanks for this post, Patricia ... even though I find it absolutely chilling.

My fear is that PrEP is the pharma industry's excuse for sliding HIV vaccine efforts off a back burner and onto a forgotten countertop that isn't even heated.

Worse than credit cards with hidden fees, this misinformation can get people to take risks they shouldn't even consider. Then, once they are infected, the newly sero-converted have no choice about taking these expensive drugs -- unless one is willing to get sick and maybe die.

To me, this is like going into a narcotics recovery house and sticking syringes full of heroin into a number of arms, then sitting back and waiting to see if anyone pushes a plunger down.

Do the science if one must, since it might have reasonable application in Africa and elsewhere where women (and men) sometimes have no choice about choosing abstinence or otherwise protecting themselves ... but promoting this to an affluent public such as America is pure insanity, a new fast-lane version of Russian Roulette.

Herein; one of the most insightful, poignant things I've ever read on Bilerico. It deserves an even wider audience than Bilerico can provide.
I will probably be cursed and assailed for saying this, but in my 20+ years of HIV prevention writing, I've become convinced that gay men will always hang their lantern on the caboose of that HIV train of information - and mis-information.
We may be sissies at a glance, but our hard-ons are things that we will always seek to preserve and remain un-assailable - no matter what illness or dire consequence it takes us to. Unlike rubbers; this latest notion of a prophylactic needs to be scrutinized, chewed up, spit up and spit out and analyed objectively for it's promise as well as it's curse. ...Thank you for writing this, Ma'm :)

I'm surprised people are having such favorable reactions to a single study, as if that were the end-all-be-all, even if the results were that this wasn't the end-all-be-all.

The problem isn't going to be solved with new tech. That's a neoliberal dream - that some smart person or small group of people will come up with a solution and we can keep on living as we're living without experiencing the slightest discomfort or even acknowledging that perhaps there are things we're doing right not to worsen the problem.

Especially since so much of global HIV/AIDS is tied closely to poverty. Could it be that the powers-that-be understand that and that's why they're looking for a way to address the problem without addressing poverty?