We credit this story for tackling an interesting issue related to drug costs — something few stories we look at cover in any depth. But we have concerns about this story’s overall treatment of the issue and its exploration of the evidence. In its attempt to explain why so few healthy gay men in the U.S. are taking the drug Truvada to prevent HIV infections — a use that is recommended by the CDC — this story suggests that: 1) manufacturer Gilead is not marketing the drug sufficiently to primary care physicians, and 2) high costs are an obstacle to treatment for many people.
But the business angle is just one aspect of this multifaceted story. There are also legitimate concerns about whether the drug is as effective as is claimed, and the issue of preexposure prophylaxis or “PrEP” is controversial among HIV/AIDS healthcare experts. This story doesn’t provide any critical assessment of the evidence supporting PrEP, and so the reader is left with a skewed sense of what this controversy is all about. It’s not just the costs and copays that are at issue; there is real skepticism about whether PrEP delivers the benefits that this story assumes.
About 1.1 million Americans are currently living with human immunodeficiency virus (HIV), the virus that causes AIDS, according to the National Institute of Allergy and Infectious Diseases. With an estimated 50,000 new people being infected each year, it’s urgent that we identify and promote effective prevention efforts. Whether PrEP is one of those efforts deserved a deeper exploration than this story provided.
The article provides a very in-depth discussion of costs, including interviews with patients and a description of how a discount offered by Gilead Sciences, Truvada’s manufacturer, often removes most of the co-payment cost burden for insured patients, which can run up to hundreds of dollars a month. Still, the problem with discount programs is that they are subject to revision at any time. Also, the article doesn’t describe any assistance programs for uninsured patients, or discuss costs for developing world countries where the need for HIV prevention is great.
The story claims that the PrEP intervention has a 92 percent success rate for preventing HIV infection when taken daily. Unfortunately, we readers have no idea if this is a relative or absolute number, demanding we ask, “92% of what?” Also troubling is that the description of quantified benefits gives no information about what the drug was tested against. The 92% statistic comes from a trial that tested the active drug against placebo PLUS both groups carried out the normal preventive actions such as safe sex practices and condom use (prompting us to ask: How replicable are these results in the real world?).
The 92% success rate quoted in the story was for a subgroup of men with detectable levels of medicine in their blood — indicating that they faithfully took the medication every day. But apparently participants had trouble maintaining that high level of adherence. Overall, the trial reports that the differences between the drug and the placebo, in terms of those infected with HIV, was 44%, not 92%. These are the absolute numbers of men newly infected with HIV during the study: Drug: 36/1251 Placebo: 64/1248. This gives us an absolute rate of new infections of 2.9% in the drug group and 5.1% in the placebo group. The 44% is the relative difference between the two. So instead of saying the drug can prevent HIV 92% of the time, it may be more accurate to say that 5 in 100 taking placebo developed HIV in the follow-up period (median 1.2 years) and 3 in 100 on the drug developed HIV. The drug helps about 2 people in 100 — who are already counselled on and promising to practice safe sex practices — stay HIV free.
The story completely ignores harms associated with the drug. Use of the drug exposes some patients to liver problems, an excess of lactic acid in the blood, and can cause severe complications in previously infected patients and those with hepatitis C, according to the drug manufacturer’s website.
When antivirals fail it is often attributed to non-adherence on the part of the patient. Not sticking to the prescribed dosing schedule is a major problem with many therapies. The story would have been stronger if it had mentioned how lack of adherence to the prescribed daily dosing affects infection prevention.
There’s also potential harm for the patient in thinking the drug provides 100% effective protection that is only 92% or maybe only 44% effective. Recall this statement by one of the story sources: “The advantage to Truvada as PrEP is that it allows us to be unconcerned about HIV.” That’s a worrisome overstatement that the story should have pushed back against.
The story notes that in 2012, Truvada was approved by the FDA for use by people without HIV as a way of preventing transmission. While FDA approval provides some assurance of the quality of evidence supporting an intervention, we’d prefer to see a more thorough evaluation than what this story provided. As noted above under “Benefits,” it’s questionable whether this drug was studied under conditions that are applicable to the real world situations where it will be used. And readers receive no sense from the story that there are respected, knowledgeable experts who doubt the drug’s use for prevention. It took us just a few seconds to find an editorial from an FDA panel member who voted “no” on approval for Truvada. She noted that in two of the supporting studies, it’s difficult to separate the effects of the drug from the effects of traditional safe sex education provided to participants. “Of importance, data were presented that documented a statistically significant increase in condom use, a decreased number of sexual partners or acts of unprotected receptive anal intercourse, and reduced rates of syphilis for both studies,” she noted. “In this context, I found it difficult to get a sense of the additional benefit contributed by Truvada PrEP in reducing HIV transmission…”
What is inserted here as a rationale for using this drug is that the typical user (young, carefree gay men who might also be taking other mind altering substances) is careless. One user is quoted as saying: “Compliance with condom use requires one think logically and rationally when one is right about to have sex — when one’s mind is least likely to think logically and rationally.” We don’t think we’re being completely glib when we say there is a mild bit of disease mongering happening here, by implying that sexually aroused gay men make bad judgments and that this drug will prevent those judgments from having deadly consequences.
Having aired that concern, we don’t think the story over- or understates the seriousness of HIV in our communities. While overall rates of HIV have remained stable, a closer look at the incidence data shows that the rates of infections is declining in some populations and rising in others. The story gives the impression that it is an on-going problem. On that basis, we’ll award a satisfactory rating.
While the story at first glance appears to cover the bases very well with its sourcing — which includes a company spokesperson, an advocacy group official, and an independent public health expert — we question the story’s strong reliance on individual patient perspectives. Interviewing people who are obvious candidates for a drug, and asking them about their struggles with affordability and coverage, elicits information that is not completely bias free. We cite as an exhibit the closing quotation from a user who describes his daily ritual for taking the pill. He says, “I would hold up the pill and think of a dead friend, and say, ‘I’m taking this for you. God, I wish it was around to have helped you.’” That’s a bit too emotional a conclusion for a story about a drug that has serious questions about its effectiveness.
But the reason we’re ruling the story unsatisfactory is for failing to fully explore Gilead’s support for HIV/AIDS advocacy groups. While the story does note that Gilead supports these groups, it wasn’t clear that one of the story sources is employed by a group that receives this funding. This creates a potential conflict of interest when the source advocates for increased promotion of a Gilead drug.
The story does not talk about the alternatives to PrEP in HIV prevention. According to the NIH and the CDC, the other common prevention strategies are use of condoms, annual tests for STDs, and other “safer sex” strategies. In regard to medications, Truvada is the only FDA-approved medication for HIV prevention. This is also not mentioned in the story.
The article points out that the drug has been approved as a preventative therapy for HIV since 2012 and is covered by insurance companies. It discusses copayments and other cost barriers that can reduce access to the drug in the U.S. We’ll call that good enough for a satisfactory rating. The study ignores, however, the utter unavailability of the drug in the developing world where HIV transmission is a serious problem. The study discussed in the story enrolled gay men in Thailand, Peru, Equador, Brazil, and South Africa. It is doubtful that any participant from these countries could ever afford to ever take the drug at its $1300 per month price tag.
The story establishes that the drug in question was approved as a treatment in 2004 and approved for prevention in 2012. The story is clear that the angle being explored is the drug’s lack of use for prevention, which it ties to minimal promotion and affordability issues.
Given the wide range of sources, we can be sure that the story went beyond any press release.
Systematic, Criteria-Driven
NO! NO! NO! @TheHeartOrg - This study was on rabbits, and is at least 2 yrs away from human trials. THAT should be the headline, not "breakthrough". Journalists, pls check this @HealthNewsRevu toolkit when writing about animal studies. https://t.co/QFznfsn4ag https://t.co/L1WIStfV8G
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Comments (1)
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Mike
June 9, 2015 at 8:51 amVery helpful. But as the disease-mongering item, there’s evidence to show that judgment in the “heat-of-the-moment” leads to shocking lapses in judgment and hypothetical decision making, even to the extent of violating some of the most basic normative behavior (see http://www.contrib.andrew.cmu.edu/~gl20/GeorgeLoewenstein/Papers_files/pdf/HeatMoment.pdf).
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