The news release describes a recent study published in the journal Lancet Infectious Diseases demonstrating the potential benefits of human papillomavirus (HPV) vaccination in women 26 years and older. While the release makes an admirable attempt at summarizing the study in a concise and easy-to-understand manner, the resulting brevity leaves many questions unanswered regarding a public health issue as important as HPV. In particular, the release does not account for the specific study design — no sample sizes were reported and demographics of the patient volunteers were not described. Furthermore the specific benefits of HPV vaccination in women 26 years and older are not explicitly stated.
The news release devotes much of its focus on the lead author’s research biography. Journalists and other readers would have been better served if the “Who” section instead described the women who were recruited for the study and how many had a history of HPV infections, for example.
If HPV vaccination is indeed effective in preventing disease in women 26 years and older, this could have implications for HPV-related cancer screening and prevention procedures. The research may also be of interest to younger women (or their caregivers) who are making decisions about whether or not to get the vaccine.
The vaccine is expensive and requires three, possibly in the future two, doses. Insurance may not cover it since it is not currently recommenced for the age group studied.
“The drug company price for either vaccine is around $130 or $140 per dose,” according to the American Cancer Society, “This cost does not include the cost of giving the shots or the doctor’s charge. So, it’s possible that the cost for the series (3 shots over 6 months) could be $500 or more.”
The benefits of HPV vaccination for women 26 years and older are qualitatively described in the news release in statements such as:
“The study showed that women in this age group were still protected from HPV infections” and “The scientists followed each woman for four to seven years. They found that the vaccine protected the women against HPV infections during the follow-up period and that the women were protected from many types of HPV across a broad age range.”
Both statements lack quantification. In the first statement, the reader is left wondering exactly how many women were still protected. The second statement seems to suggest that the vaccination protects against any types of HPV infections while a close reading of the study suggests that only certain strains of HPV were considered, and for those strains only persistent infections were counted.
In general, statements such as the ones above should be tempered with further details on the study design. In this case, there is a lack of crucial information such as how many women were enrolled in the study and what proportion already had a history of HPV. Finally, what was the measured outcome? What does it mean exactly to be “still protected from HPV infections?” Did none of the women enrolled in the study have HPV going into the study? The release isn’t clear.
The news release does not mention harms, and that’s a troubling omission in a summary of a study devoted to a drug’s safety and efficacy. The published study states the following:
“Serious adverse events related to vaccination occurred in five (0·2%) of 2877 women in the vaccine group and eight (0·3%) of 2870 women in the control group.”
It is unclear from the news release what kind of study protocol was followed. Only the headline of the study listed at the bottom under the “When” subhead gives us a clue:
“The paper, “Efficacy, safety, and immunogenicity of the human papillomavirus 16/18 AS04-adjuvanted vaccine in women older than 25 years: 7-year follow-up of the phase 3, double-blind, randomised controlled VIVIANE study,” was published in the June 28, 2016 online edition of The Lancet (www.thelancet.com/infection).”
While the title informs us that this was a double-blind, randomised controlled trial, it is still unclear how efficacy, safety, and immunogenicity were measured. In particular, what were the primary and secondary, if any, endpoints of the study? What percentage of women enrolled in the study already had a history of HPV?
The news release gives a fair portrayal of the health implications of HPV without engaging in any disease mongering.
The study was funded by GlaxoSmithKline, the vaccine manufacturer, but that’s not mentioned in the news release.
It is difficult to gather from the news release what alternatives were considered in the study. Clearly one group of women received HPV vaccinations. We can only assume the other group did not.
Alternatives to this vaccine strategy include achieving higher rates of vaccination in younger women and expanding cervical cancer screening services.
Most readers are probably aware of HPV vaccinations and that the vaccine is widely available. However, the vaccine isn’t affordable to all.
The news release doesn’t make a claim of novelty, and rightly so. There wasn’t a basis for it.
The study and its results aren’t novel. The vaccine has been tested in older women before and not found to be very effective because of prevalence of HPV infection prior to vaccination. This study shows some benefit but needs to be compared and contrasted to previous studies on this topic.
The news release exhibits balanced language throughout.