A few years ago, Dr. Diane Harper was the darling of the anti-vaccine world, for two reasons. First, she was one of the researchers who performed clinical trials for Gardasil. And second, she appeared to be against HPV vaccines, specifically Gardasil.
But the story was much more nuanced. I argued that her publication record presented a much different picture – she actually supported the vaccine. But typical of the zombie memes and tropes of the anti-vaccine world, every few months it’s breathless reported that Dr. Harper is opposed to Gardasil.
Recently, she published another article about HPV vaccines, and if there’s any doubt that she is in favor of HPV vaccines, that is gone. But that probably won’t stop the anti-vaccine crowd.
HPV and HPV vaccines
I know, I’ve written about this vaccine 100 times – however, this might be your first bit of research into the HPV vaccine, so here’s a brief overview. If you’ve read it before, just skip to the next section if you want.
Genital and oral human papillomavirus (HPV) are the most common sexually transmitted infections (STI) in the USA. There are more than 150 strains or subtypes of HPV that can infect humans, although only 40 of these strains are linked to a variety of cancers. HPV is generally transmitted from personal contact during vaginal, anal or oral sex.
Although the early symptoms of HPV infections aren’t serious, those infections are closely linked to many types of cancers in men and women. According to current medical research, here are some of the cancers that are linked to HPV:
These are all dangerous and disfiguring cancers that can be mostly prevented by the HPV cancer vaccine. If you’re a male, and you think that these are mostly female cancers, penile cancer can lead to amputation of your penis. Just think about that guys.
HPV is believed to cause nearly 5% of all new cancers across the world, making it almost as dangerous as tobacco with respect to cancer. According to the CDC, roughly 79 million Americans are infected with HPV–approximately 14 million Americans contract HPV every year. Most individuals don’t even know they have the infection until the onset of cancer. About 27,000 HPV-related cancers are diagnosed in the USA every year.
There were two HPV vaccines on the market. GSK, also known as Glaxo SmithKline manufactured Cervarix, a bivalent vaccine which has been withdrawn from the US market. Merck manufactures Gardasil9, a 9-valent vaccine, along with Gardasil, a quadrivalent HPV vaccine.
Who is Dr. Diane Harper?
Dr. Diane Harper has been described as “the lead researcher in the development of the human papilloma virus vaccines, Gardasil and Cervarix.” Dr. Harper herself describes her involvement with the vaccines as “a consultant for both GSK and Merck, for which I was paid.”
In addition, she stated that she was the “principal investigator (which) means that I was responsible for assembling a research team to recruit participants, deliver the health care during the study, collect biological specimens at the correct time, and retain subjects over the entire time frame of the study.”
But that role wasn’t the “lead researcher” for the whole clinical trial, as was promoted by the anti-vaccine tropes. In fact, the Medical Director (or Vice President of Medical Affairs) at Merck or GSK would have been responsible for all of the data, all of the research and all of the protocols across the world involved with the HPV vaccine trial.
Dr. Harper would have been one cog, amongst many, that didn’t have any strategic role in the research, just data collection.
There have been several randomized clinical trials involving Gardasil, and not once is she the lead author on published data for Gardasil or Cervarix clinical trials, which would probably indicate that she was the “lead researcher.” She was one of at least a dozen researchers.
Dr. Diane Harper continues to publish research and engage in research about the effectiveness of HPV vaccines, including a 2015 article that reported we may have underestimated the vaccine’s effectiveness against some HPV types. She was one of over 20 researchers involved, and she wasn’t the “lead researcher.”
Despite her publication record, she also has a record of pandering to the anti-vaccine world (and the especially obnoxious anti-Gardasil subset of them) with comments about Gardasil that don’t seem to be based on real scientific evidence. We can speculate all day long as to why she has this dual personality about HPV vaccine – her publication record seems to indicate her true beliefs.
A new paper from Diane Harper
Just recently, she published another article, which reviewed 10 years of HPV vaccine data, and it was generally positive and supportive of Gardasil and Cervarix.
- Gardasil9 and Cervarix are equivalent in efficacy against CIN 2 + regardless of HPV type. CIN (cervical intraepithelial neoplasia, also known as cervical dysplasia) 2+ (a grading of CIN) is a pre-malignant abnormal growth of squamous cells of the cervix which is closely related to HPV infections. According to Harper’s research, Gardasil9 is up to 100% effective in preventing HPV infections and CIN 2+. Cervarix also has fairly high efficacy against HPV infections and subsequent CIN 2+ cervical dysplasia.
- Cervarix has 91% efficacy in women older than 25 years lasting for at least 7 years. First of all, you will note a regular theme from Diane Harper – she’s much more enthusiastic about Cervarix for unknown reasons. Gardasil immunizes against the same two HPV types as Cervarix plus seven more. And Gardasil showed statistically similar efficacy against the same two HPV types as Cervarix, so I’m not sure why she’s focused on Cervarix only.
- Only two doses of HPV vaccine for 9–15 year olds at 6 month or 1 year intervals. Harper based her conclusion here on a small study that examined immunogenicity after 2 and 3 doses of both vaccines. The results say that the immune response was higher after a third dose, so I’m not sure I agree with this conclusion from Harper. According to Dr. Harper, “Both Cervarix and Gardasil induce the same antibody titers in two doses as in three doses, for their respective vaccine, if the two doses are six months apart.” The evidence seems to support her claims, although I think we need more studies to support this hypothesis. If she is correct, this will lower the cost of HPV vaccines, since only two will be required.
- HPV vaccines reduce abnormal screening tests, colposcopies and excisions. Importantly, Harper presents evidence that HPV vaccines actually reduce, by significant amounts, the number of diagnostic tests after cervical examination. This is an almost certain indicator of the overall effectiveness of the vaccines.
- Do not use Gardasil9 as a booster vaccine for those already vaccinated. Dr. Harper hypothesizes that re-vaccinating with Gardasil9 if the child has already received the three doses of quadrivalent Gardasil or bivalent Cervarix provides no benefit. In fact, there seems to be evidence that it may actually reduce the immune response to some HPV types. However, I would like to see more clinical research that supports her hypothesis.
Despite all the anti-vaccine hype about Diane Harper and Gardasil, when she publishes papers about HPV vaccines, she is pro vaccine. She does make some valid points about the vaccines – they are expensive, so reducing doses is important, and screening still is necessary. It’s hard to complain about those conclusions.
On the other hand, Harper seems to have a distinct anti-Gardasil bias. When comparing effectiveness of Cervarix (as a reminder, it’s no longer available in the USA) to Gardasil, she continues to favor Cervarix, even though she presents data that shows them to be roughly equivalent, with Gardasil9 being more effective against a broader range of HPV types.
Nevertheless, this paper once again negates some of her more outlandish statements about Gardasil, which were based on VAERS data, which simply cannot be trusted. Her publication record is real evidence of where she stands on the HPV vaccine, although her public comments are troublesome.
- Gilca V, Sauvageau C, Boulianne N, De Serres G, Crajden M, Ouakki M, Trevisan A, Dionne M. The effect of a booster dose of quadrivalent or bivalent HPV vaccine when administered to girls previously vaccinated with two doses of quadrivalent HPV vaccine.Hum Vaccin Immunother. 2015;11(3):732-8. doi: 10.1080/21645515.2015.1011570. PubMed PMID: 25714044; PubMed Central PMCID: PMC4514370.
- Harper DM, DeMars LR. HPV vaccines – A review of the first decade. Gynecol Oncol. 2017 Jul;146(1):196-204. doi: 10.1016/j.ygyno.2017.04.004. Epub 2017 Apr 22. Review. PubMed PMID: 28442134.
- Struyf F, Colau B, Wheeler CM, Naud P, Garland S, Quint W, Chow SN, Salmerón J, Lehtinen M, Del Rosario-Raymundo MR, Paavonen J, Teixeira JC, Germar MJ, Peters K, Skinner SR, Limson G, Castellsagué X, Poppe WA, Ramjattan B, Klein TD, Schwarz TF, Chatterjee A, Tjalma WA, Diaz-Mitoma F, Lewis DJ, Harper DM, Molijn A, van Doorn LJ, David MP, Dubin G; HPV PATRICIA Study Group. Post hoc analysis of the PATRICIA randomized trial of the efficacy of human papillomavirus type 16 (HPV-16)/HPV-18 AS04-adjuvanted vaccine against incident and persistent infection with nonvaccine oncogenic HPV types using an alternative multiplex type-specific PCR assay for HPV DNA. Clin Vaccine Immunol. 2015 Feb;22(2):235-44. doi: 10.1128/CVI.00457-14. Epub 2014 Dec 24. PubMed PMID: 25540273; PubMed Central PMCID: PMC4308870.