This op-ed-style piece 
about the safety of the Gardasil vaccine is to be commended for paying attention to a study with negative findings. Negative studies aren’t as sexy as research that reports amazing or frightening new effects from medical interventions, but the mundane finding of “no difference” is often the reality of medical research and a result that readers need to hear about more often.
The message here is sound, but we wish the story had followed some practices that would have buttressed the author’s viewpoint and thereby made the piece more useful for readers. These include: quantifying the benefits of the vaccine and its cost; describing the results of the study that’s the basis for the piece and the quality of evidence it reports; and seeking out an independent voice to comment on the findings.
The safety of Gardasil matters because it protects against cervical, vaginal, vulvar and anal cancer, and more than 178 million doses of it have been dispensed worldwide since it entered the marketplace eight years ago.
No mention was made of the cost of the vaccine.
The story focuses on safety to the exclusion of efficacy. It does not say which strains of HPV Gardasil protects against or how effective it is.at preventing the cancers those strains cause. It does not tell the reader that the more recently formulated vaccine, Gardasil 9, has expanded the protection conferred by the earlier version.
The story notes the vaccine is not associated with serious adverse effects sometimes attributed to it (e.g. multiple sclerosis). It mentions that syncope and possibly skin rash are thought to be side effects of the vaccine. Ideally, the story would have provided more information about how frequently these effects are seen (the main objective of the study being reported on).
The story says nothing about the quality of the evidence — i.e., that the researchers reached their conclusions by reviewing data accumulated in a number of studies carried out since the vaccine’s approval. There are no details provided regarding the methodology of these studies or their strengths and limitations.
The story’s assertion that cervical cancer causes 4,000 deaths each year in the United States is backed up by the Centers for Disease Control and Prevention. But that number doesn’t really give much sense of one’s overall lifetime risk of developing the disease and whether the disease is common or relatively rare. It would have been useful to know, comparatively, how common cervical cancer is and how it ranks in relation to other cancers.
There is no independent voice included, nor does the story alert readers to the fact that Merck funded the study. Drug company funding is obligatory for post-marketing surveillance data of this type. So while it’s worth mentioning, such funding is arguably not as important as when a company funds a study with glowing findings on a new unapproved device or drug.
The story notes that abstinence, if it worked, could obviate the need for the vaccine.
The story notes that more than 178 million doses of the vaccine have been dispensed, meaning that it is readily available.
The story notes that the study driving the coverage is “new,” but beyond that doesn’t establish what is different or interesting about this research compared with previous studies.
There’s enough context here that we can be sure the story does not rely on a news release.
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
Comments (1)
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Laurence Alter
August 5, 2015 at 4:53 amDear Reviewers:
Enlighten me. Explain the basis for the truism that, to quote your appraisal, “Negative reviews aren’t as sexy as research that reports amazing or frightening new effects.” First, “frightening” sounds pretty damn negative to me: it means something to fear, and that sounds positively negative.
Next, is my major objection to this truism: it appears that the other piece of conventional wisdom does not apply: ‘if it bleeds, it leads’ [in reference to dramatic news of a bloody character]. How do you reconcile these two truisms? Furthermore, it appears that people would be genuinely interested in learning of poor-performing drugs: both for interests of self-interest and in general. Sadly, sad news sells.
Yours,
Laurence
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