Correction: Since posting this review, we’ve learned that this story wasn’t an original piece of journalism but rather a verbatim reprint of a news release from the Johns Hopkins Kimmel Cancer Center. There was no warning or disclaimer as to the origin of the text. Accordingly, we’ve downgraded the score from 4 stars to 0, to reflect the fact that this wasn’t a piece of original journalism. Read this related blog post for further explanation.
This very thorough analysis of a newly published study of an experimental vaccine had much to admire, including clear quantification of benefits and an acknowledgment of study dropouts and potential harms. It could have been improved by two things: an independent source or two providing their take on the publication and some information about what the vaccine might ultimately cost patients and insurers.
The development of a vaccine to prevent human papilloma virus (HPV) infection was a big advance in efforts to prevent cervical cancer. This study shows that a similar experimental vaccine can be of benefit to women who’ve already been infected with HPV and whose cervixes show evidence of precancerous changes. According to the study, the new vaccine can boost the body’s natural immune response and cause high-grade precancerous changes in the cervix to regress. It can also help clear the virus from the cervix, reducing the risk of future cancers. The current treatments for precancerous changes all involve some form of invasive procedure with tissue destruction in the cervix, which can compromise future childbearing ability. Thus the vaccine may offer a significant advantage over currently available treatments.
The story did not discuss the potential costs of the experimental vaccine. Since similar vaccines are commercially available, it should have been possible to provide at least a ballpark estimate of what the new vaccine might cost. The potential savings in terms of treatment costs for prevented cancers could also have been mentioned and discussed.
The story makes a clear comparison of the benefits of the vaccine, both in raw numbers and in percentages. It says, “Of 114 women who received at least one vaccine dose, 55 (48.2 percent) had a regression of their precancerous lesion, meaning their lesions disappeared or converted to low-grade lesions, compared with 12 of 40 (30 percent) who received saline injections.” It also says that, “Among women who completed all three injections, scientists could find no trace of HPV in the cervices of 56 of the 107 women who received the vaccine, compared with only nine of 35 saline recipients.”
The story does take the rare step of calling out the fact that some patients dropped out of the study and of spelling out the side effects, even though they were minimal. It says, “Two patients discontinued the study because of pain at the injection site. Skin redness was more common in the vaccine group compared with saline.”
The story does a nice job of explaining the quality of the evidence, including the sample size, the way the study was conducted, and the different phases of the study. It also notes where the study was published. Some comment on the limitations of the trial, which were discussed in some detail in the study itself, would have been welcome and likely would have been provided by an independent expert. But since none of these limitations seem to seriously compromise the interpretation of the study, we’ll let this omission pass.
We wished that the story had interviewed an independent source. It did, however, note that the study was funded by the company that makes the vaccine. It said, “The vaccine, given by injection into the arm, is made by Inovio Pharmaceuticals Inc., which funded the clinical trial, and whose employees co-authored the report with Trimble.” Although we can’t award a Satisfactory here, the story earns our appreciation for this clear statement on potential conflict of interest.
The story discussed the fact that typically precancerous lesions are either removed through surgery or watched to see how they progress. The vaccine would be a less invasive option than the surgery.
The story called the study a “first step,” and we think it’s reasonably clear that this was an early human clinical trial and that the vaccine is still not available for widespread use.
The story explains what may be novel about the study and the vaccine: “A vaccine able to cure precancerous lesions could eventually be one way women can avoid surgery that is invasive and can also harm their fertility.” But it doesn’t acknowledge that this type of immunotherapy approach is being investigated by a number of other research teams who’ve already published findings.The study itself tell us that “Previous attempts to develop a non-surgical treatment for CIN2/3 have had mixed success,” and it goes on to describe the results of a number of open label studies and randomized controlled trials of other similar therapies — some of which are reported to be at least moderately successful. Even a line about that context, and what makes the current approach different or better, would have been helpful.
The story did not rely on a news release.
Systematic, Criteria-Driven
Monday at #ADA2021, an infectious disease epidemiologist, a journalist, and a researcher shared perspectives on communication of risk in the era of COVID-19: http://ow.ly/ROfR30rMeE7 @AstleyCM @garyschwitzer @berthahidalgo @ADA_DiabetesPro
Shoutouts to @susan_bewley @drkevinknopf @MichaelBaum11 in this call for more than fawning coverage from press releases for these kinds of stories.
Also, linked history inside goes back 5 years just on Grail apparently trying to become Holy Grail. https://twitter.com/garyschwitzer/status/1408849696416841731
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