The authors of a 2018 paper purporting to find that the HPV vaccine guards against preterm birth have retracted the article after discovering they made a statistical error which could have masked the opposite effect.
The researchers, from New Zealand, also failed to appropriately disclose their financial ties to a company, CSL Limited, which owns the rights to the HPV vaccine in Australia and New Zealand.
The paper, “Association of prior HPV vaccination with reduced preterm birth: A population based study,” was published in Vaccine, an Elsevier journal. According to the abstract:
Emerging evidence suggests that HPV infection is associated with negative pregnancy outcomes such as preterm birth (PTB), and pre-eclampsia. We aimed to determine if prior HPV vaccination reduced adverse pregnancy outcomes. … PTB (OR: 0.87; CI 0.78, 0.96)) was significantly lower for women who previously received the HPV vaccine. A dose response effect was found with each successive dose received decreasing the likelihood of PTB. No associations between the vaccinated and unvaccinated groups were shown for pre-eclampsia or stillbirth. Conclusions: Prior receipt of the quadrivalent HPV vaccine was associated with a significant reduction in PTB (13%); suggesting that HPV vaccination may be effective in reducing PTB. The potential global public health impact is considerable and there is urgency to undertake further research to replicate and explore these findings.
The paper has been cited seven times, according to Clarivate Analytics’ Web of Science. But as the retraction notice indicates, those conclusions don’t appear to be correct:
This paper is being retracted at the request of the authors. The authors report that there was an incorrect interpretation of the odds ratio meaning that instead of HPV vaccination potentially being protective, there may be an associated increased risk of preterm delivery. The authors believe that an increased risk of preterm delivery is unlikely and not consistent with the evidence to date. Further, the authors have not been able to access the original source data as per protocol to check the data validity. The authors wish to repeat the study to reassure themselves that there were no data processing or other errors in the databases in order to reach definitive conclusions.
Lastly, it is of serious concern to the Editor-in-Chief that the Conflict of Interest statement was only added to the paper by the authors after acceptance and was not made visible to the editor or reviewers prior to acceptance. The authors state that there was no input to the methodology, implementation and results of this study by any commercial entity. The pharma distribution company CSL mentioned in the conflict of interest statement only knew about the study after publication.
The COI statement reads:
BL has received educational and conference grants from CSL Biotherapies who markets the HPV vaccine in NZ. CSL has had no input to this research. This research was commenced by corresponding author BL at University of Otago. Wellington and completed at Victoria University of Wellington New Zealand.
BL is Beverley Lawton, of the Victoria University of Wellington.
Noelyn Hung, of University of Otago Dunedin School of Medicine and the senior author of the paper, told us that a reader pointed out the erroneous stats, triggering the review:
essentially we had a rather inexperienced person (A stats phd candidate) who did the analysis (and probably inverted a data set), and then we couldn’t verify and start again with the raw data because our source declined to give it to us again. We complained. And complained to ethics. But to no avail. We decided to retract when we couldn’t start again with the raw data and guarantee the results.
It has been a wholly frustrating and embarrassing process that I never ever want to go through again!
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Who is this mysterious “stats phd candidate” that allegedly did the analysis and messed up? None of the authors match that description and there are no acknowledgments. The contribution statement offloads the analyses to someone who appears to be a human nutrition phd. Or did the authors go ahead with the work in spite of an earlier corruption of the data by a since-abandoned student? I don’t get it.
Also (perhaps related, perhaps not), what kind of nonsense is “then we couldn’t verify and start again with the raw data because our source declined to give it to us again”? I’m a mathematician, and don’t work with “data” in that sense, but it sounds peculiar to me that there might be fields of science in which it would be acceptable not to keep one’s “raw data” for at least a reasonable length of time after publication, or in which a “source” for one’s data (supposing that “source” to be subject to ethical rules) could “decline to give it” to one “again” (provided it had been ethical to give it in the first place). It’s all mysterious to me.
It is very much violating authorship rule. the stat phd candidate who analyzed the data for the paper is supposed to be included as a co-author of the paper. the senior authors’ excuse sounds terrible.
“The potential global public health impact is considerable and there is urgency to undertake further research to replicate and explore these findings.”
If this was true when the results were favourable to the HPV vaccine (it still seems like an exaggeration to me given there is plenty of room for confounding differences between those with the vaccine and those without) it would still be true if the results could be inverted.
Who is the mysterious “source”, and why is the data now inaccessible?
If someone in authority is committed enough to this program to bury an unfavourable finding, one that might well be blown out of all proportion by critics of the project, well that’s quite understandable – but how is it possible?
The raw data would be held, most likely, by the NZ Ministry of Health (vaccination data) and/or the several District Health Boards (vaccination data and outcomes). I could well imagine that a DHB might refuse to re-allow access to HPV data if aware of the authors’ predicament.
I predict this paper will be republished eventually, but will use a Bonferoni analysis or other method that differs from the original, so that the association is no longer anything to write home about.
It’s very interesting to read the comments and even Medscape’s article on it, and see that no one seems to be concerned that the data actually pointed towards the opposite finding:
“The authors report that there was an incorrect interpretation of the odds ratio meaning that instead of HPV vaccination potentially being protective, there may be an associated increased risk of preterm delivery.”
Does the pro-vaccine purview void you of the moral and ethical fibers that might prompt you to care that a vaccine may be harming unborn babies?
Why are you not asking for an investigation?
Where is the scientific curiosity as to the mechanisms for harm?
The clinical trials showed an effect on unborn babies, VRBPAC even flagged it.
Where is your sense of integrity to acknowledge that a company like Merck, maker of Vioxx, could possibly hide side effects in a clinical trial where 50% reported “new medical conditions” in the first 7 months of the trial – 12% of the healthy trial participants reported new “reproductive disorders,” all hidden from regulators and the public by this bizarre classification, requiring no follow up.
The “HPV vaccine must succeed at all costs” gene runs deep with mainstream scientists who will never give up on this golden goose, their professional raison d’être depends on it.
The cost of preventing a few cases of cancer in 50+ year olds cannot be justified by sacrificing healthy young lives and now, babies.
Cervical cancer is increasing in young women in highly vaccinated countries like the UK and Australia. There will never be enough carnage for Merck. It’s all justifiable. FDA approved it.
It’s disgusting how they talk about the person who caught their error without naming and giving proper credit to them and calling them with qualifiers such as “inexperienced”. When in reality that person deserves recognition and commendation for calling out a mistake that the supposedly experienced authors and reviewers and everyone down the pipeline missed.
Oh wait. This is not Science. It’s just academia. Salt, completely different things.
Salt=sadly