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Cervical cancer vaccine up for FDA review


2 Star

Cervical cancer vaccine up for FDA review

Our Review Summary

This story clearly distinguishes between infection with the human papillomavirus (HPV) – which Merck’s new Gardasil vaccine aims to prevent – and the development of cervical cancer, prevention of which is the ultimate goal of the vaccine.

However, it fails to explain a few things about the vaccine and its target, such as how many women are infected with the cancer-causing HPV strains, how many women develop cervical cancer, and perhaps most importantly, what researchers know about how well this new vaccine works to prevent cancer or precancerous changes in the cervix. Hearing more about this from an independent expert, rather than from two Merck representatives, would have provided some balance.

While it states that cervical cancer is a leading cancer killer in developing countries, the article doesn’t address the potential cost of the vaccine in those areas (or in the US).


Does the story adequately discuss the costs of the intervention?

Not Satisfactory

There is no mention of the projected cost of the new vaccine. This information may not be available at this time, but an expert could have given an educated estimate.

Does the story adequately quantify the benefits of the treatment/test/product/procedure?

Not Satisfactory

As noted above, the article does not provide numbers of women who were protected from HPV infection in trials of the vaccine.

Does the story adequately explain/quantify the harms of the intervention?

Not Satisfactory

The story notes some questions raised by the FDA about the vaccine’s safety–but gives the last word on the concerns to the Merck spokesman, who downplayed their significance. In addition, the number of birth abnormalities was lower in the vaccine group, but it is reported as if it were higher (“less favorable showing”) and due to chance.

Does the story seem to grasp the quality of the evidence?

Not Satisfactory

The article states that the vaccine was “extremely effective” against the targeted HPV strains, but doesn’t note how many infections it prevented. It also does not mention what, if anything, is known about whether the vaccine does lower the risk of cervical cancer.

Does the story commit disease-mongering?


The article appropriately focuses on the target of the vaccine, the HPV virus, rather than on cervical cancer (many cases of which are linked to infection with the virus).

Does the story use independent sources and identify conflicts of interest?

Not Satisfactory

Individuals representing Merck are identified in the story, and an FDA briefing document is described as the source of some information. However, there is no comment from independent medical experts.

Does the story compare the new approach with existing alternatives?

Not Satisfactory

There is no mention of other methods for reducing the risk of HPV infection or cervical cancer.

Does the story establish the availability of the treatment/test/product/procedure?


The story makes it clear that the vaccine is not yet available and explains that FDA advisory panel recommendations are usually, but not always, followed.

Does the story establish the true novelty of the approach?


The article notes that the vaccine under review would be the first of its kind.

Does the story appear to rely solely or largely on a news release?


Does not appear to have relied solely on a press release; however, the article quotes two Merck staffers.

Total Score: 4 of 10 Satisfactory


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