This article about reports of pain and fainting linked to Gardasil, the vaccine used to decrease risk of cervical cancer, fails to make the case for its publication.
By emphasizing fleeting pain and an uNPRoven link of fainting, and failing to emphasize the vaccine’s established benefits, the article does not serve the public interest well.
Curiously, the article acknowledges these shortcomings by including expert commentary that calls the story’s premises into question. The reporter and editor clearly knew the article’s thesis is not sustained by data and expert observations.
Why was it published?
The article states that the shots cost $120. The cost is around $120 per injection; three injections are required.
Using only the $120 figure is misleading. Most media reports more accurately cite the total cost of $300 to $400 for the series.
The article does not report the efficacy of the vaccine in preventing cervical cancer, thereby providing no corresponding balance.
The article focuses on harms related to the Gardasil vaccine.
Yet by focusing on one of the more trivial side effects, pain at the injection site, it fails to mention more severe side effects, such as Guillian Barre syndrome. Five percent of reported adverse effects were considered serious. Since 7 million vaccinations have been given, this 5 percent figure of serious events is certainly worth mentioning. Highlighting pain on injection seems a bit trivial in this context.
The articles uses informal observations and lower-quality data to make the case that the injections are unsually painful and linked to fainting.
The article fails to make clear the context and source of the data on fainting. The description in the article suggests the data is from the CDC/FDA Vaccine Adverse Event Reporting System, which accepts voluntary reports from across the healthcare system. The data is considered raw and at best suggestive of patterns worthy of investigation. The article should have made clear the source and limitations of the data.
It is not clear whether the number of reports linked to Gardasil are higher or lower than would be expected with any vaccination given to the same group of people.
The article exaggerates the amount and importance of injection-site pain, and it implies without justification that it is more likely to lead to fainting than other vaccines given to girls and teens.
The article quotes one patient, two clinicians, and one CDC expert in immunization safety. It also draws on raw federal data (without identifying its source) and information from the drug’s maker. Because of the multiple sources used, we’ll rate this satisfactory.
However, a key shortcoming is the failure to provide any detail about the "recent meeting of vaccine experts," where the public health authority comments about pain.
The article fails to make clear that this is the only vaccine shown to reduce the incidence of the types of human papilloma virus which are responsible for a majority of cervical cancers.
Tha story does indicate the vaccine has been available for a year. However, the main point of the story is the level of discomfort associated with the injection and the development of syncope in some recipients. But without discussing how widely the vaccine has been used, case reports provide no useful information. The fact that over 7 million doses of the vaccine has been distributed would have been a valuable piece of information for the readers.
The story does note that Gardasil is an "important new protection" but points out that another version in in clinical trials.
There is no evidence the article is based on a press 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
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