Our Review Summary
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.
- The suggestion that the vaccine stings and burns more than most may be accurate. But the article itself reports that the pain is often fleeting and in more serious cases may cause lingering discomfort for a day. Nothing in the article supports the implication in the first paragraph that Gardasil is the most painful vaccine given in childhood.
- The implication that the drug causes fainting is not justified by evidence. The article cites raw data that appears to suggest an increase. But the data are self-reported and do not have a denominator. There is no way to know whether the 180 reports of fainting cited are more or less than would be expected with the same number of girls getting any kind of vaccination.
- The report fails to indicate that the vaccine has been shown effective in preventing HPV and therefore likely to reduce risk of cervical cancer. It fails to mention that HPV is often passed between sexual partners unknowingly and that by the time cervical cancer is discovered it is often deadly.
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?
Criteria
Not Satisfactory
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.
Not Satisfactory
The article does not report the efficacy of the vaccine in preventing cervical cancer, thereby providing no corresponding balance.
Not Satisfactory
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.
Not Satisfactory
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.
Not Satisfactory
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.
Satisfactory
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.
Not Satisfactory
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.
Not Satisfactory
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.
Satisfactory
The story does note that Gardasil is an "important new protection" but points out that another version in in clinical trials.
Satisfactory
There is no evidence the article is based on a press release.
Total Score: 3 of 10 Satisfactory
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