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Gardasil Safety Questions

Rating

5 Star

Gardasil Safety Questions

Our Review Summary

The story reports on recent data published on the safety of the HPV vaccine Gardasil.  The vaccine has been available since 2006 and over 23 million doses have been distributed and recommended for use in girls and women aged 11 to 26. This story did an adequate job of summarizing the safety profile of the vaccine. However, it omitted an important limitation of the data that was stated in the JAMA article. The adverse events were reported after vaccination but this does not necessarily mean that they were caused by the vaccine. For example, by saying that there were "32 deaths, one in over 700,000 doses" it is implied that these deaths were caused by the vaccine when it cannot be known with certainty whether the vaccine caused these deaths. The story also highlights aggressive marketing techniques by the manufacturer Merck such as paying medical societies to promote the drug and understating the importance of evaluating the drug’s risk and benefits. This important information has not previously been made available to the public. In summary, this story devoted adequate attention and provided detailed information to inform the public about the safety profile of the HPV vaccination and the potential influence of aggressive marketing strategies on vaccination rates.

Criteria

Does the story adequately discuss the costs of the intervention?

Not Satisfactory

This story does not provide the cost of the vaccination or indicate whether it is covered by major health insurers.

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

Not Applicable

The goal of this story was to talk about risk, not benefits. The story accurately reported that the vaccine has a safety profile that is similar to other vaccines for people 11 to 26 years of age.  It also noted that the CDC, FDA and manufacturer Merck continue to recommend its use. 

 

However, more research is needed to understand the potential benefits of the vaccine in reducing the risk for cervical cancer.  Research to date has shown that the vaccine is 90 to 100% effective in preventing precancerous cells from developing in the cervix and vagina of young women.  But it is unclear that this actually decreases the incidence of cervical cancer.

 

A benefit that was not mentioned is that the vaccine has be shown to be effective in preventing vaginal warts which are generally caused by HPV.

 

 

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

Satisfactory

The story accurately reported the stastistics in the study about serious harms but failed to qualify this information by indicating that it is not possible to known whether the vaccine actually caused these harms.   For example, it should have said that over 12,000 side effects were reported after 23 million doses were distributed.  Six percent of the events that were reported were serious and included women who were hospitalized, permanently disabled or died.  This caveat also applies to the statement that more cases of fainting and blood clots [were reported] than were expected.

Nonetheless, with this note of hesitation, we’ll give the story the benefit of the doubt on this criterion. 

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

Satisfactory

The story adequately describes the current study. But it could have described some of the limitations of relying on an adverse event reporting system. For example, the story may have overstated the certainty that the adverse events were caused by the vaccine.  This story reproduced several statistics and information from the recent articles published in the Journal of the American Medical Association.  However, it omitted an important limitation of this data that was stated in the JAMA article. The adverse events were reported after vaccination but this does not necessarily mean that they were caused by the vaccine. For example, by saying that there were "32 deaths, one in over 700,000 doses" it is implied that these deaths were caused by the vaccine when it cannot be known with certainty whether the vaccine caused these deaths.

Nonetheless, we’ll give the story the benefit of the doubt on this criterion. 

Does the story commit disease-mongering?

Satisfactory

No overt disease mongering.

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

Satisfactory

This story presented information from several sources that presented somewhat differing view points on the safety data being reported for the vaccine. Information was presented via statements from the CDC’s chief medical officer who conducted the research, 2 independent medical experts, a statement from the manufacturer Merck and a brief, albeit out of context, endorsement from a young woman who chose to be vaccinated.

Does the story compare the new approach with existing alternatives?

Satisfactory

The story correctly indicates that PAP smears are an important way to help prevent cerical cancer.

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

Satisfactory

This story indicates that the HPV vaccine, Gardasil, is widely available by reporting that more than 23 million doses have been distributed since the drug’s approval in 2006.

Does the story establish the true novelty of the approach?

Satisfactory

While the HPV vaccine has been in use since 2006, this story presents the most recent data available on its safety profile. The story also presents new information on the manufacturer’s questionable marketing strategies which had not previously been available to the public.

 

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

Satisfactory

This story does not rely on a press release.

Total Score: 8 of 9 Satisfactory

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