If you have any interest in HPV vaccines, you’ve probably heard about Diane Harper, who the anti-vaccine religion claims was a “lead Gardasil researcher” who came out against the vaccine. Many of us were never convinced that she was really anti-vaccine, although she seemed to have vacillating views on the HPV vaccine depending on a variety of random factors, including who was feting her at any particular point in time.
Dr. Harper was a frustrating character in the conversations about the HPV vaccine. Although some (but certainly not all) of her comments about the vaccine could be construed as an anti-HPV vaccine, her publications, and many other public comments, seemed to clearly show that she was a supporter of the vaccine.
A few writers in the scientific skeptic blogosphere have contacted her, either in person or through interviews, and most have come away with the impression that she was solidly in support of the vaccine. However, and I have no evidence of this whatsoever, she always seemed to be biased against Gardasil, manufactured by Merck, so maybe she had some personal vendetta. We will probably never know, I suppose.
But a recent announcement should put an end to the Diane Harper anti-Gardasil meme – well I’m more cynical than that, I know the vaccine denier mob will keep bringing it back like a zombie. So, let’s take a look at Dr. Harper and her announcement. No one should be surprised.
A quick primer about HPV vaccines
Genital and oral human papillomavirus (HPV) infections are the most common sexually transmitted infections (STI) in the USA. HPV is generally transmitted from personal contact during vaginal, anal or oral sex.
It’s important to note that there are more than 150 strains or subtypes of HPV that can infect humans – however, only 40 of these strains are linked to one or more different cancers. Although the early symptoms of HPV infections aren’t serious and many HPV infections resolve themselves without long-term harm, HPV infections are causally linked to many types of cancers in men and women.
HPV is believed to cause nearly 5% of all new cancers across the world, making it almost as dangerous as tobacco in that respect. According to the CDC, roughly 79 million Americans are infected with one or more strains of HPV – approximately 14 million Americans contract a new HPV infection every year. Most individuals don’t even know they have the infection until the onset of cancer.
The CDC also states that over 41,000 HPV-related cancers are diagnosed in the USA every year.
There were two HPV vaccines on the world market before 2014. GSK, also known as GlaxoSmithKline manufactured Cervarix, a bivalent (protects against two HPV strains) vaccine. It has been withdrawn from the US market (although available in many other markets), because of the competition from the quadrivalent (immunizes against four different HPV strains) and 9-valent (against nine HPV strains) Gardasil vaccines.
Merck manufactures Gardasil, probably the most popular HPV vaccine in the world. The first version of the vaccine, quadrivalent Gardasil, targets the two HPV genotypes known to cause about 70% of cervical cancer and two other HPV genotypes that cause genital warts. In Europe and other markets, Gardasil is known as Silgard.
Gardasil is one of the easiest and best ways to prevent a few deadly cancers that are related to HPV. It is definitely a cancer-preventing vaccine.
Currently, in the United States, the Advisory Committee on Immunization Practices (ACIP) recommends that preteen girls and boys aged 11 or 12 are vaccinated against HPV. The immunization is also recommended for teenage girls and young women up to the age of 26 who did not receive it when they were younger, and teenage boys and young men up to the age of 21.
Let me sum this all up so that if you come away from this section with nothing else, you get this summary. HPV is a sexually transmitted disease. HPV causes 41,000 cancers a year in the USA alone. The HPV vaccine prevents becoming infected by HPV, so you are protected from these cancers.
Who is Diane Harper?
Dr. Harper is an MD who also has a masters of public health, with focus on epidemiology and biostatistics. She would, by any standards, be considered an authority in vaccines. Based on her publication record, she has published extensively in vaccines, we can only state that she is an expert in vaccines, especially the HPV vaccine. Currently, Dr. Harper is a professor in the department of Family Medicine at Michigan Medicine, University of Michigan’s medical center. She is also the physician director for community outreach and engagement at the University of Michigan Rogel Cancer Center.
Dr. Diane Harper has been described as “the lead researcher in the development of the human papillomavirus 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.”
Although the relevance of her involvement was never an important point except to the anti-vaccine zealots, it was an overstatement to claim she was the “lead researcher.” She was one of many involved in data gathering from clinical trials.
Dr. Harper’s role in the Gardasil clinical trials, as is typical with most pharmaceutical companies, was to manage various aspects of the clinical trial at her institution. That would be everything from making certain that protocols are accurate, that her medical Institutional Review Board approved the trial, that appropriate numbers of patients are enrolled, that placebos and drugs are delivered in a blinded manner to the researchers, and about a few hundred other items.
There would have been an intentional wall between her, other clinical trial investigators and the companies, GSK and Merck. Moreover, she did not “develop” the drug in any meaningful manner, because her role wasn’t in basic R&D, but mostly in clinical trials.
Becoming an anti-vaccine poster child
Dr. Harper, as is claimed by a number of vaccine refuseniks (there are numerous websites that repeat the same story, almost verbatim), decided to “come clean” about Gardasil so that she could “sleep at night.” The anti-vaccine religion have attached themselves to this story, because they think it uncovers a conspiracy of lies by the vaccine manufacturers. Obviously, their conspiracy theories, Dr. Harper escaped from the evil clutches of Big Pharma.
During a presentation at the 4th International Public Conference on Vaccination (actually, an anti-vaccine propaganda meeting), which took place in Reston, Virginia on Oct. 2nd through 4th, 2009, Dr. Harper is alleged to have stated that the cervical cancer risk in the USA is already low, and that vaccinations will have no significant effect upon the rate of that cancer in the USA. It is correct to state that the number of HPV-related cancers is relatively low – but the second half of her statement is unsupported by real evidence.
Apparently, Dr. Harper went off the rails on this point. Even though the risk of these cancers is low, it is not 0. This misuse of statistics is one of the most problematic issues I have with anti-science, woo-pushing individuals. Over 31,000 cancers, most of them very deadly or damaging, can be prevented quickly and easily with a vaccine that has shown, in massive (millions of patients) clinical trials, with few serious side effects. Actually almost no serious side effects.
According to transcripts from the meeting mentioned above, Dr. Harper actually stated:
About eight in every ten women who have been sexually active will have HPV at some stage of their life. Normally there are no symptoms, and in 98 per cent of cases it clears itself. But in those cases where it doesn’t, and isn’t treated, it can lead to pre-cancerous cells which may develop into cervical cancer. (Emphasis mine.)
Clearly, she did not say that the vaccine was worthless – that’s not what I’m reading with that quote, she’s claiming that the cancer is rare. Everything in science is nuanced, so what Dr. Harper said was accurate.
But here’s how one conspiracist interprets her comments:
One must understand how the establishment’s word games are played to truly understand the meaning of the above quote, and one needs to understand its unique version of “science”. When they report that untreated cases “can” lead to something that “may” lead to cervical cancer, it really means that the relationship is merely a hypothetical conjecture that is profitable if people actually believe it.
In other words, there is no demonstrated relationship between the condition being vaccinated for and the rare cancers that the vaccine might prevent, but it is marketed to do that nonetheless. In fact, there is no actual evidence that the vaccine can prevent any cancer.
That’s not what she said. What she is saying is that the event is statistically rare, but it is not 0. When science says “it may develop into cancer” it means that for each individual the risk that the cancer “may develop” is small, but when looking at a large group, it’s no longer “may”– it is definite that some number of that group will contract the cancer as a result of an HPV-infection.
More importantly, HPV isn’t just related to cervical cancer. It’s related to several cancers, including oropharyngeal (mouth and throat), penile, anal, vulvar, and possibly prostate and skin cancer. And there might be many more. And not to abuse my right to be repetitive, but there are over 41,000 HPV-related cancers diagnosed in the USA every year. Not all of them are cervical cancers.
We don’t know why some people contract HPV-related cancers and some won’t. Cancer has a significant random component, that is outside of our ability to control. On the other hand, science deniers, including the anti-vaccine gang, lack understanding of how statistics work. A low risk is not a zero risk. In my eyes, preventing even one cancer is a win.
Diane Harper’s research
Setting aside her flirting with the anti-vaccine movement, Dr. Harper’s comments and actual scientific research betrays one fact about her – she is a consistent supporter of the HPV vaccine.
Dr. Ben Goldacre, who writes about making drug companies accountable for their actions and exaggerated claims, actually interviewed Dr. Harper after the anti-vaccine world exploded with this information. She told Goldacre that “I fully support the HPV vaccines. I believe that, in general, they are safe in most women.” That’s a pretty strong endorsement considering she uses typical scientific language.
Dr. Diane Harper’s view on the HPV vaccine is not a secret. She has published several articles about HPV, cancer and HPV vaccines. In one article, she distinctly states her point of view. She says we do not know how the protection from the vaccines will last, and this might affect a cost-benefit decision about the vaccine.
She is not saying that it’s a safety vs. benefit question, merely that the cost of an HPV immunization program, if the effect of the vaccine is not long enough, could mean that it is too expensive for the expected results. I would argue with her that there is a value of saving even a handful of lives. I wouldn’t be troubled by the cost of the HPV vaccine (well, unless it were $1 million per dose or something), given that it has a measurable effect on reducing the risk of cancer, and would purchase it for my daughters. Moreover, there is considerable and robust evidence of a direct link between the HPV vaccine and reduction of risk for HPV-related cancers.
Dr. Harper continues to publish research about the effectiveness of HPV vaccines, including a recent one that reported studies have underestimated the vaccine’s effectiveness against some HPV types. She was one of over 20 researchers involved, so none of that “lead researcher” claims have much credence.
More recently, Diane Harper has participated in new clinical trials for HPV vaccines, publishing in a new article as recently as August 2016. And she just co-authored a paper examining new ways to increase HPV vaccine uptake in college-aged students.
As someone once said, don’t listen to what they say, but what they do. And she continues to publish articles highly supportive of the HPV vaccine.
What Diane Harper is saying now
Well, this should end the Diane Harper memes regarding the HPV vaccine. At least, it should be the tool to debunk those memes.
In an press release from Michigan Medicine, Dr. Harper is quoted extensively. And I couldn’t help but laughing for about 20 minutes after reading it (though, to be honest, I’m easily amused by these things).
Dr. Harper seems to focus on cervical cancer, which is the original motivation for developing the vaccine, in her comments, ignoring the numerous other cancers that are HPV-related. Nevertheless, she states:
I strongly believe in cervical cancer prevention and the effects of the HPV vaccine. The vaccines will give you a higher chance of a normal screening.
Annoyingly, Dr. Harper still focuses on “screening” as the best way to prevent cervical cancer. This is true, but Gardasil prevents abnormal screenings, which are scary to women. Even the potential of a cancer diagnosis is a frightening thought to many people.
A recent systematic review, reviewed here, shows that the HPV vaccine actually reduces the number of cancerous and pre-cancerous lesions observed in cervical cancer screening. Screening is important, but the HPV vaccine prevents cancers that could show up in the screening.
And one more thing. Nearly 4,200 American women die each year from cervical cancer. Maybe some didn’t get a screening in time. Maybe some had an aggressive form of cancer. But a substantial percentage of those deaths can be prevented with the HPV vaccine. Cervical cancer screening is still necessary even if a woman has had the HPV vaccine – it’s just that the chances of a normal screening increases dramatically with vaccination.
But, let’s get back to Diane Harper. At the end of the statement, she states:
The #MeToo movement highlights that sexual activity occurs between males and females of all ages, willingly and unwillingly. The HPV vaccines can potentially protect these women as well, even though it will be an off-label use for this age.
I’ve been pushing this point for years. It doesn’t matter that your child isn’t sexually active. And that he or she marries someone who also isn’t. That’s not the real world – sexual violence, where the partner’s HPV status is unknown, is so common that it’s a risk, especially to women.
Moreover, Dr. Diane Harper seems to making one incredible point – she’s advocating an off-label use of the HPV vaccine for older women (and I would include men), because it can protect them against HPV. How many of you heard that thud when anti-vaxxers across the world fainted?
I’ve never thought that Diane Harper was as anti-HPV vaccine as the vaccine deniers thought. Her words and publications betrayed what the memes and tropes said about her.
Still, her prevarication about the vaccine can be frustrating, and I am not personally willing to overlook some of her statements. As the loquacious Orac (who I have heard supports the Wolverines) once wrote:
On the other hand, I fear that we skeptics are a bit too quick to dismiss Harper’s prior statements as having been misquotes when it is clear that she did, at least for a while, either wittingly or unwittingly give aid and comfort to the antivaccine movement through inflammatory statements about “experimentation” giving Gardasil to 12-year-olds and her speculation that Gardasil might be linked to ALS even though there was no good evidence to support that link. That she’s straightened up and flown right since late 2009 is a good thing, but her irresponsible, borderline antivaccine statements in multiple media outlets before that were too numerous to ignore.
Nevertheless, Diane Harper has now expressed her support for the National Cancer Institute initiative, joining cancer research institutes across America, to eliminate HPV-related cancers with the HPV vaccine. After years of the zombie memes about how Diane Harper is the Gardasil researcher who lost sleep over how horrible the vaccine was, we can now shut them down.
Well, I’m not delusional, I know the anti-vaccine religion doesn’t care about the facts. They’ll just claim that the University of Michigan used Big Pharma money to brainwash Dr. Harper. And make her support Michigan football.
- Arbyn M, Xu L, Simoens C, Martin-Hirsch PP. Prophylactic vaccination against human papillomaviruses to prevent cervical cancer and its precursors. Cochrane Database Syst Rev. 2018 May 9;5:CD009069. doi: 10.1002/14651858.CD009069.pub3. [Epub ahead of print] Review. PubMed PMID: 29740819.
- Harper DM. Preliminary HPV vaccine results for women older than 25 years. Lancet. 2009 Jun 6;373(9679):1921-2. doi: 10.1016/S0140-6736(09)61045-X. PubMed PMID: 19501728. Impact factor: 39.060.
- Harper DM, Vierthaler SL. Next Generation Cancer Protection: The Bivalent HPV Vaccine for Females. ISRN Obstet Gynecol. 2011;2011:457204. doi: 10.5402/2011/457204. Epub 2011 Nov 2. PubMed PMID: 22111017; PubMed Central PMCID: PMC3216348.
- LaJoie AS, Kerr JC, Clover RD, Harper DM. Influencers and preference predictors of HPV vaccine uptake among US male and female young adult college students. Papillomavirus Res. 2018 Jun;5:114-121. doi: 10.1016/j.pvr.2018.03.007. Epub 2018 Mar 23. PubMed PMID: 29578098; PubMed Central PMCID: PMC5886909.
- Ramanakumar AV, Naud P, Roteli-Martins CM, de Carvalho NS, de Borba PC, Teixeira JC, Blatter M, Moscicki AB, Harper DM, Romanowski B, Tyring SK, Ramjattan B, Schuind A, Dubin G, Franco EL; HPV-007 Study Group. Incidence and duration of type-specific human papillomavirus infection in high-risk HPV-naïve women: results from the control arm of a phase II HPV-16/18 vaccine trial. BMJ Open. 2016 Aug 26;6(8):e011371. doi: 10.1136/bmjopen-2016-011371. PubMed PMID: 27566633; PubMed Central PMCID: PMC5013348. Impact factor=17.215.
- 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.
- Szarewski A, Skinner SR, Garland SM, Romanowski B, Schwarz TF, Apter D, Chow SN, Paavonen J, Del Rosario-Raymundo MR, Teixeira JC, De Carvalho NS, Castro-Sanchez M, Castellsagué X, Poppe WA, De Sutter P, Huh W, Chatterjee A, Tjalma WA, Ackerman RT, Martens M, Papp KA, Bajo-Arenas J, Harper DM, Torné A, David MP, Struyf F, Lehtinen M, Dubin G. Efficacy of the HPV-16/18 AS04-adjuvanted vaccine against low-risk HPV types (PATRICIA randomized trial): an unexpected observation. J Infect Dis. 2013 Nov 1;208(9):1391-6. doi: 10.1093/infdis/jit360. PubMed PMID: 24092907; PubMed Central PMCID: PMC3789574.
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