July #72 : Splitting Image - by Henry Scott

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Table of Contents

Splitting Image

Is That All There Is to Approval?

Combination Strategies

Gimme Shelter

Bells, Books and Candles

Quickies

Calling All Angels

It's Raining Meds

Demand Results

S.O.S.

Parody Killed The Prevention Ad

Genes In The Bunch

Deaths

Shop Till You Drop

Gyn and Bitters

The Untouchables

Mailbox

All Lit Up



Most Popular Lessons

The HIV Life Cycle

Shingles

Herpes Simplex Virus

Syphilis & Neurosyphilis

Treatments for Opportunistic Infections (OIs)

What is AIDS & HIV?

Hepatitis & HIV


email print

July 2001

Splitting Image

by Henry Scott

The attack on "too healthy" AIDS drug ads has exposed raw nerves and a new rift between the sick and the well. Who's reality is it anyway?

They're climbing mountains, sailing yachts, throwing javelins -- a positively Olympian assortment of activities. If you weren't a regular reader of this magazine, you might imagine that the vigorous and attractive people in these ads are demonstrating the benefits of some new allergy drug, such is the implied promise of happy health. But the ads are actually selling Crixivan, Viramune and Fortovase, powerful HIV meds with equally powerful side effects. They are, more subtly, marketing hope for a future as bright as the sky over Crixivan's mountains. These ads make Jeff Getty mad.

The veteran San Francisco activist says that this crop of direct-to-consumer (DTC) drug ads are, at best, misleading by not emphasizing the side effects of the medication. Getty also argues that ads featuring handsome, healthy, even sexy models project a false confidence that HIV is an easily managed managed disease, and thus promote unprotected sex. He offers as evidence a new San Francisco public health department study that shows most people exposed to such ads believe they encourage unsafe sex. "We don't think it's a sexy disease," says Getty, whose Survive AIDS group, formerly known as ACT UP/Golden Gate, has lost three-quarters of its membership to the disease in the past 10 years. "It's not about climbing mountains. It's about IV poles, wheelchairs and pain."

Not content with critiquing the ads' content, Getty and fellow activists launched a campaign to ban the ads from bus shelters, subway platforms and other San Francisco city property. Their effort has quickly spread beyond the borders of that notoriously quirky town, unwittingly illuminating deep divisions in an HIV community that was once united against the disease and the twin enemies of governmental and pharmaceutical-industry neglect. Today, Getty's campaign against Big Pharma draws sharp criticism from well-known HIVers as diverse as Dennis DeLeon, executive director of New York City's Latino Commission on AIDS, and author Andrew Sullivan, who sees pharmaceutical profits and innovation as key to surviving HIV. More important, the campaign also reveals an emerging AIDS apartheid, in which the relatively healthy are happy to distinguish themselves from those whom treatments have failed.

Getty and many others infected in the 1980s fall on one side of a viral divide, in part because they eagerly embraced AZT and other monotherapy as it arrived. Now it's painfully clear that such aggressive treatment produced resistant viral strains that make newer combination therapies of three or more drugs less effective. Across the divide are those of us infected in the 1990s who have been lucky enough to avoid more-complicated regimens in favor of protease-sparing triple therapy, fewer side effects and, in theory, a longer life -- if we faithfully take our medicine. For us, the folks on Crixivan Mountain do offer realistic hope and inspiration.

The campaign has had a quick and dramatic impact on pharmaceuticals. Starting in early March, the San Francisco activists fast-tracked their cause, supported by city supervisor Tom Ammiano, the department of public health and other local officials, straight to the U.S. Food and Drug Administration (FDA). By late April, the agency had sent a letter to all nine makers of anti-HIV meds, warning against ads "not generally representative" of people with HIV and noting, in particular, depictions of "robust individuals engaged in strenuous physical activity." The FDA, accustomed to reviewing ads individually, has never before targeted an entire category of advertising. Its action is likely to find favor among members of Congress concerned about a 1997 relaxation of FDA advertising rules that sparked a flurry of prescription drug ads and consumer spending. A Senate consumer-affairs subcommittee is holding hearings. Drug companies now spend $4.5 billion a year on DTC ads, which barely existed a decade ago.

The activists' goal is not a wholesale ban on consumer-oriented HIV drug advertising. "We're not telling drug companies they can't advertise -- the ads do have some educational role to play," says Alexis Schuler, the government-affairs director for AIDS Action, a Washington, DC, lobbying group. Schuler acknowledges that the ads include a gruesome list of possible side effects such as nausea, anemia, lipodystrophy and heart and liver damage. But she says those warnings, typically in small type, are overwhelmed by the glamorous action shots. "How many people actually read that fine print? The images minimize the side effects, and create the perception that HIV won't impact your life."

HIV has impacted both Jeff Getty's life and my own. Getty, 43, tested positive in 1987. He became a virtual Olympian of PWA self-empowerment, making international headlines in 1995 when he successfully battled researchers, government officials and even People for the Ethical Treatment of Animals to win a first-ever infusion of baboon bone marrow in an effort to boost his immune response. But the transplant failed, as have most HIV drugs, and Getty's health is not good. I, on the other hand, was infected on November 20, 1993. A wise doctor kept me from starting antiviral treatment until two and a half years ago, when it was impossible to ignore my ominous lab results. Now I pop seven pills each day. Luckily, I've never had a single side effect save for 72 hours of initial dizziness. After fearing that my infection meant I'd have to give up vigorous exercise, I resumed my gym workouts and completed two 130-mile, Boston-to-Provincetown bike rides in less than 10 hours. And last summer, at 49, I climbed not one, but two, mountains in the Bay of Naples.

So whose experience of HIV should one believe, mine or Jeff Getty's? The reality is, we're both the face of AIDS. HIV is about IV poles, wheelchairs and pain, and about mountain climbing, planning a future and enjoying the present. But it's clear which one of us Big Pharma would pick to illustrate the power of its products.

DTC ads are crucial to drug companies, which have developed more than 60 often-competitive meds to combat HIV and related infections alone in the past decade. The FDA's relaxation of restrictions on such ads gave drug makers a new weapon to fight for market share with ads on billboards and buses and in the pages of some 50 consumer health magazines. (Full disclosure: These publications, of course, include POZ, which Getty has asked readers to boycott, arguing that it is "a drug-company mouthpiece disguised as a magazine" and hasn't taken a forceful stand against the drug ads. For more information, check www.poz.com/boycott.)

In many ways, marketing prescription drugs is no different from selling anything else. The ads attempt to convey a benefit, often using pictures of shiny, happy people who presumably got that way from using the product at hand. But drug ads in general, and HIV drug ads in particular, differ in some very significant ways. For one, there's that list of possible side effects that seem to belie the imagery's promise. For another, the models in AIDS drug ads -- unlike, say, Claritin's carefree allergy sufferers -- actually have the disease. Such casting is the result of a campaign by activists, such as POZ founder Sean Strub, who helped recruit HIVers years ago in the belief that their presence in ads would empower people with the virus. But there is a flipside, one of those contradictions increasingly common in the third decade of AIDS: PWA authenticity also provides the drug companies with a "truth in advertising" credibility that counters activists' "misleading" claims.

One such model is Glenn Rivera, 39, an information-tech student who freelances at the all-HIVer Proof Positive modeling agency. Rivera, the face of Bristol-Myers Squibb's current Zerit ad and this month's POZ cover boy, is angered by the Survive AIDS crusade. "The idea that I look too healthy to be in an AIDS drug ad is absolutely absurd!" he says. "HIV has been a part of my life for more than 10 years. I wanted to come out publicly and let other people with HIV know that it is possible to live and plan for a future. For the FDA to step in now and say I have to look gaunt and sickly in order to be a public PWA is crazy."

Media hype aside, the FDA isn't actually saying that. In fact, the agency is treading carefully in its public comments. "We look at each ad closely. It should be representative and balanced," says Thomas Abrams, director of the FDA's Division of Drug Marketing, Advertising and Communications. "Some people look healthy. What we don't want to put out is the message that people with HIV have to look horrible." One must-see change, according to Abrams: "The ads need to be clear that these drugs do not cure HIV or reduce transmission."

Getty regards that "transmission" requirement as one of his biggest wins. "Every time I see a prevention message in an ad, it makes me feel like I've accomplished something," he says. But emphasizing the importance of preventing infection to the HIV negative, who aren't the target of the drug marketers, adds another burden to ads already charged with striking a delicate balance in portraying the benefits and risks of the drugs. It's also questionable whether the "transmission" requirement is even true, given recent studies that show much-reduced HIV transmission by people whose regimens have rendered the virus undetectable. While this information is enthusiastically discussed among HIVers, the topic is studiously avoided by prevention experts who prefer the message "use a condom every time."

WHILE THE BAN on the healthy, happy image has clearly struck a nerve in many HIVers, there remains little public opposition to the Survive AIDS campaign. The drug makers have argued mildly that the ads under attack have prompted consumers to seek testing and treatment. At the same time, they all met the FDA's mid-May deadline to outline how they intend to comply with its ruling. Pharma insiders say responses consisted mostly of additional reasons that current ads -- and healthy-looking models -- are already adequate. One advertising source, who works on a major AIDS drug account, says he thinks the FDA's request was "inappropriate" and could be considered censorship. But if the agency decides the justifications are not sufficient, it could require individual drug makers to make specific changes (see "Is That All There Is to Approval?,").

So who -- other than a handful of attractive, athletic HIV positive models such as Glenn Rivera -- will be hurt if the drug companies use "more realistic" faces in their ads to emphasize that the drugs aren't a cure?

People with HIV, says the Latino Commission on AIDS' Dennis DeLeon. "I feel so insulted that activists want to put people who look sick in the ads. It makes me very angry," says DeLeon, a long-term AIDS survivor on intimate terms with drug side effects and failure. "I find Getty's campaign to be anti-PWA and discriminatory. Representing people with HIV as ill will reinforce the public stigma and personal self-esteem issues that make it harder to get a job and re-enter life." And DeLeon highlights a common concern -- especially in communities of color where barriers to care are high -- that negative ads may scare off HIVers who need testing and treatment.

Andrew Sullivan, himself HIV positive and hardly an ideological bedfellow of DeLeon, agrees, labeling the activists "AIDS nannies." He argues that the campaign robs relatively healthy HIVers of hope. "It's true that some longtime PWAs are not doing well," he says. "They naturally feel more isolated when they see these pictures of health, because they're not representative of everyone. That's unfortunate. But it shouldn't be a reason to stop giving others with HIV role models and aspirations to live full and healthy lives."

Putting it another way, Martin Delaney, the founding director of Project Inform, the San Francisco-based AIDS information and advocacy organization, observes that the campaign is an ironic measure of the progress made in the fight against HIV. "Now we have the luxury to be able to complain about side effects," he says. While a supporter of the campaign, Delaney adds that it can be perceived as a historic reversal of an earlier fight by activists to change the public representation of PWAs. "In the '80s, the same activists, including myself, were screaming anytime anyone painted a picture of a PWA as weak and debilitated," he says. "We struggled to portray them as vigorous and active." What's different now? This time the enemy isn't the FDA or the Catholic Church. "This time," Delaney says, "it's a company with a financial motive."

DeLeon also suspects that opponents of the ads may be motivated by "the widespread sentiment that the drug companies are making too much money off of the drugs." Sullivan, ever the free-market champion, agrees. "This prohibition is related to a more general hostility to capitalism," he says. "The truth is, without capitalism, we'd all be dead by now. Only capitalism's profit motive gave us the variety of HIV meds we now have. This may not be politically correct, but it's demonstrably true."

Getty responds to such charges with a quick, characteristic expletive. He and other critics of the drug ads would rather stress the San Francisco Department of Public Health survey. The findings, however, are inconclusive. Jeff Klausner, MD, reported in April that 61 percent of the men in his sample answered yes when asked if the drug ads that depict "healthy, handsome and strong" men "affect a person's decision to have unsafe sex." However, respondents weren't asked whether the ads persuaded them to have unprotected sex, only whether they think such ads might lead someone, anyone, to do so. And the survey's correlation between "high exposure" to the ads and increased participation in unsafe sex is statistically insignificant. In short, the results don't prove either that the current ads promote unsafe sex or that ads with less desirable models and more dire warnings could promote safe sex. Nor does the study delve into the difficulty of determining precisely what compels people, even the well informed, to put themselves at risk in the first place. As River Huston, an HIV positive poet, performance artist and longtime prevention advocate, points out, "People looking for reasons to have unsafe sex are going to find them -- in these seductive-looking ads that suggest HIV is easily treated. In a bar drinking, thinking, 'Hmm, my penis itches and I bet your butt would make it feel better.' Wherever."

Take me, for example. I'm an introspective and analytical guy, and I've spent quite a few hours in psychotherapy trying to understand the behavior that led to my infection. Certainly I wasn't motivated by the false confidence that HIV is an easily managed disease. I knew too many people who had died horrible deaths. I think the main contributors to my infection were depression and alcohol. The depression is what led me to go home with someone I barely knew whose amorous attentions I hoped would make me feel good about myself. The alcohol made it possible for me to have unprotected anal sex for the first time in my life. Two weeks later, I had the usual flu-like symptoms, and soon my semi-annual HIV test turned up positive.

It would be difficult, if not impossible, to create an ad that dissuades a depressed person from seeking solace in a one-night stand and too many beers. Huston jokes, "We could put out ads that counter the 'manageable disease' message. Instead of hunks, use 'weakest survivors' models, who have lipo humps, sunken faces, protease pouches. But banning the ads is a waste of time."

For his part, DeLeon sees nothing funny in giving AIDS drug ads a radical makeover. "Do the activists want to see sick and dying PWAs in order to put out the message that HIV is bad?" he asks. "If they really care about stopping infections, they should be attacking prevention messages, which have failed miserably, rather than the ads." Walt Odets, a leading gay psychotherapist and author of In the Shadow of the Epidemic: Being HIV Negative in the Age of AIDS, agrees. While allowing that "the ads have always made me uneasy," he says, "Neither the drug companies nor the FDA is in any position to address the real issues underlying why half of the next generation of gay men is likely to get HIV. But it's certainly easier to direct our hostility at targets other than our own community."

Odets clearly sides with DeLeon, who says, "The prevention movement is running on empty." The two may part ways, however, over the deeper question that this ad-banning controversy raises: If healthy faces of AIDS have become a double-edged sword, what are we to do about it? "There's always been a community effort to make a culture that demonstrates respect for people with HIV and tries to help them feel good about being infected," he says. "The second effect is that it has normalized having HIV. And when you normalize, you cause new infections -- guaranteed."

So can we support our own empowerment and fight to survive by presenting images of positive HIVers and at the same time support the HIV negatives' fight to remain so by portraying AIDS as a bad thing? Or are we doomed to legitimate the longstanding apartheid that divides the infected from the uninfected, while promoting a new divide between the "undetectables" and the "treatment failures"?

Ads that try to address positive and negative people simultaneously, with both a treatment and a prevention message, are unlikely to work for either. I agree with Odets that it may be impossible to "normalize" having HIV and still mount the necessary "stay negative" warnings. Unfortunately, the division in the ranks of people fighting HIV, positive and negative, seem inevitable, and likely to deepen. So I struggle to accept the Internet profiles bearing the legend "HIV neg, UB2," no matter how much they sting. And when I see a profile of an openly positive guy who emphasizes "undetectable, 900 T cells," I imagine how Jeff Getty must feel. Yet if there is to be a viral divide, I confess that I am happy to be on my side of it, for however long that might be. I need to imagine myself climbing Crixivan's mountains -- and making this disease a part of my life, and not the whole of it.


IS THAT ALL THERE IS TO APPROVAL?

Folks at the FDA say they know what's wrong with the fine print when they see it. This ad for DuP

Folks at the FDA say they know what's wrong with the fine print when they see it. This ad for DuPont's Sustiva (efavirenz) was yanked last year after officials declared that it violated the Federal Food, Drug and Cosmetics Act -- enforceable by law -- with numerous "misleading claims." A revamped version was approved after the following corrections were made.

"So Life Goes on"
The FDA editors asked DuPont for a rewrite because the ad's main tagline was misleading: It implied that Sustiva "improves survival in patients with HIV infection," which "has not been demonstrated by substantial evidence." That is, the cutie-pie might be celebrating the big 4-0 because of luck, not drug. The new ad traded in so ("in order that" -- Webster's) for because ("for the reason that"), softening the so alliterative Sustiva-sustenance association.

"Lower Virus Levels-- Longer"
Claims that Sustiva is "superior to protease inhibitor-containing regimens" were rejected because the drug had been compared to "only two of six in head-to-head trials," the FDA wrote. Version No. 2 names indinavir and nelfinavir specifically. Plus, the new copy spells out that Sustiva must be taken with two NRTIs to be effective.

"Take it Once a Day"
DuPont added info specifying initial bedtime dosing and avoiding high-fat meals. "Failing to provide this context with your 'convenience' claims misleadingly implies that Sustiva can be taken without restrictions," the FDA wrote.

"Generally Tolerable Side Effects"
Sustiva's boast of "fewer gastrointestinal side effects" than Viracept was "an unsubstantiated superiority claim" -- diarrhea was more common among Viracept-takers, but rates of nausea and vomiting were about equal. New text: "Sustiva is generally well tolerated, with no long-term toxicities observed."

"Safety Information"
The ad "lacks fair balance because the risk information is inadequate," the FDA wrote. There was no mention of common side effects -- other than the famed Sustiva nightmares, dizziness and "a few reports of suicide, but Sustiva has not been established as the cause" -- or other meds with the potential for dangerous interactions. The revised version acknowledged "mild or moderate rash" and a number of drugs to avoid while on Sustiva.

-Shana Naomi Krochmal



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