This news release from Florida Atlantic University amplifies a bold claim made in a medical journal commentary that the FDA’s “black box” warnings on varenicline (Chantix) medication labels encouraged many people to avoid the drug — and that failure to use the drug caused thousands of people to die prematurely from heart attacks and cardiovascular disease.
That’s a speculative claim, and one that the release does not back up with evidence.
The release also urges wider use of Chantix, a prescription medication. The FDA required Chantix to carry the warning of side effects from 2009 until December 2016. The release does not address the lingering debate over the safety of Chantix — or note that the senior author of the commentary has served as an advisor to Pfizer, the company that sells Chantix.
Smoking tobacco is a serious health problem — that is, at this point, beyond argument. The questions of whether Chantix is safe and effective, and of how common and severe are its side effects, are much trickier questions. There is an ongoing, and heated, debate regarding the safety of Chantix (which we’ll touch on below) that this release glosses over. It’s important for readers to have a clear picture of the debate if they are going to make informed decisions about their own health. It does not help people make informed decisions if a release offers mortality numbers without explicitly explaining where the numbers come from. And it’s important for readers to be aware of any potential conflicts of interest among those who are offering advice.
While the release explicitly urges the widespread use of Chantix, it does not discuss cost — and cost can be a considerable obstacle. Online estimates of cost related to Chantix vary widely, but all of them indicate that a prescription would cost well over $100 per month.
The benefits here would presumably be the reduction in premature deaths among people who successfully quit smoking. The release provides one number, saying: “The authors speculate that if use of varenicline had not plummeted by 76 percent following the black box warning in 2009, perhaps 17,000 premature deaths from cardiovascular disease may have been avoided each year during the last few years.” However, that’s a somewhat vague estimate, and it’s not clear exactly where this number comes from. To be clear: the number may be completely accurate, but the release needs to explain where the number comes from. And it doesn’t.
It also states that those using Chantix have a 25 percent success rate at stopping smoking, but they don’t say how this compares to overall success rates for those attempting to quit.
The release includes results of the EAGLES study, which aimed to address concerns about the potential for Chantix users to experience related neuropsychiatric problems. However, there are significant concerns with both the EAGLES study and with the FDA’s subsequent decision to remove the “black box” warning from Chantix. Rather than trying to recap all of those concerns in this space, we refer you to a detailed piece by Alan Cassels that was published on HealthNewsReview.org’s blog in January. Suffice it to say, the EAGLES study did not settle the debate over the safety of Chantix — and that debate warrants some discussion in a release like this one.
This release describes harms from smoking and specifically the harms of under-treating smoking. But it doesn’t discuss side effects of Chantix. While those side effects may be much less severe than combusted tobacco smoke that does not excuse their elimination from the news release. Ideally, people are provided enough information necessary for realistic, rational shared decision-making with their doctor about pharmaceutical medications, not false reassurance that there are no risks to this type of treatment.
The release is focused on a commentary, and it makes that clear. Commentaries are, effectively, opinion pieces — and we bore that in mind when reviewing this release. The commentary does rely, in large part, on the EAGLES study, and the release does a fair job of providing an overview of the study design. While the release does not address the shortcomings charged by the study’s critics, we would not necessarily expect to see that in a piece designed to promote a commentary. What’s more, that’s an issue we raised above under the “harms” criterion, and we don’t want to ding the piece for the same thing twice.
No disease mongering here, unless you count the unexplained nature of the “17,000 premature deaths” claim — which we already addressed under the section on benefits.
The release includes an entire paragraph about the commentary’s senior author, but it fails to note that the author serves “in an advisory role…to Pfizer and their legal counsel” — as noted in the commentary itself. Pfizer is the company that markets Chantix. Note: this does not mean that the author is doing anything untoward, but it does raise the potential for a conflict of interest, and a release needs to make that clear.
The release states that patients assigned to Chantix in the EAGLES trial “achieved significantly higher abstinence rates at 12 weeks than those assigned to placebo, nicotine patch or bupropion.” We give the release credit for naming some common alternatives for smoking cessation that were evaluated alongside Chantix in the trial but wish it had defined the comparison more concretely.
It is clear that Chantix is commercially available.
It is not clear what makes this commentary novel — it is effectively restating longstanding public health concerns regarding smoking and reiterating claims about the safety of Chantix that have been made (and debated) since the EAGLES study was published last year.
It could be argued that the release (and the commentary it’s amplifying) took a novel approach in presenting a position on the issue of whether the 75% decrease in Chantix prescriptions was an overreaction to the black box warning — resulting in higher smoking rates and higher rates of mortality from smoking-related illnesses. However, since that’s speculative, there is no real novelty here.
The release states that “failure to use [Chantix] has caused preventable heart attacks and deaths from cardiovascular disease.” But, and this is a key point, what is more accurate is that a failure to quit smoking is likely to have contributed to preventable heart attacks and deaths from cardiovascular disease. Could Chantix have helped people quit? That may well be. But this release makes a cause and effect connection that simply doesn’t hold up. In short: a failure to take Chantix does not kill people.
Systematic, Criteria-Driven
The tale of two “negative” studies. Or, how spin is applied to make research findings look more impressive. A must read. https://johnmandrola.substack.com/p/the-tale-of-two-negative-studies
The @nytimes chose to interview one of the editors of the @AnnalsofIM (publisher of this paper) who "gushed with extraordinary glee: It’s huge! There are very few things that reduce your mortality by 30%."
Turns out coffee is not one of those few things despite all that glee. https://twitter.com/garyschwitzer/status/1533202075928215558
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