Anti-vaxxers love their false authorities, so they invoke Gardasil researcher Diane Harper, MD as the authority of choice with regard to HPV vaccines. Obukhanych is truly a false authority, but Dr. Harper is much more complicated. She actually is an authority for HPV vaccines, but not in the way that the anti-vaccine world would like you to believe.
Because vaccine deniers lack any scientific evidence supporting their unfounded beliefs about vaccines, they tend to rely upon unscientific information like anecdotes, logical fallacies, misinterpretation of data, or false authorities to support their case about the lack of safety of vaccines.
The so-called “lead Gardasil researcher,” Diane Harper, a former “consultant” to Merck and GSK, had some responsibilities in the clinical trials for their HPV vaccines. But the claims about whether Dr. Harper supports or dislikes those vaccines are substantially more complicated than what the anti-vaccine zealots would like to claim about her.
Amusingly, every few months the social media haunts of the anti-vaccine crowd explode with claims that Dr. Diane Harper, lead Gardasil researcher, hates HPV vaccines.
Let’s take a look at the story and see what we find.
All about HPV and HPV vaccines
I know I cut and paste this section to every article I write about HPV vaccines, but it’s the first step to HPV vaccine myth debunking. Some readers may be coming here for the first time, and they ought to know just how the HPV vaccine prevents cancer.
However, I try to update this section when necessary with new information about either the disease or the vaccine. If you’ve read this section 47 times, just skip down to the next section where I discuss the key point of this article.
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. Of those 40 strains, most are fairly rare.
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. According to current medical research, here are some of the cancers that are linked to HPV:
In addition, there is some evidence that HPV infections are causally linked to skin and prostate cancers. The link to skin cancer is still preliminary, but there is much stronger evidence that HPV is linked to many prostate cancers.
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 HPV – approximately 14 million Americans contract a new HPV every year. Most individuals don’t even know they have the infection until the onset of cancer. The CDC also states that over 43,000 HPV-related cancers are diagnosed in the USA every year. It may be several times that amount worldwide.
There were two HPV vaccines on the world market before 2014. GSK, also known as GlaxoSmithKline, produced 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.
The newer Gardasil 9, approved by the FDA in 2014, is a 9-valent vaccine, protecting against HPV types 6, 11, 16, 18, 31, 33, 45, 52, and 58. It targets the four HPV strains found in the quadrivalent version, along with five additional ones that are linked to cervical and other HPV-related cancers. Both versions of Gardasil are prophylactic, meant to be given to females or males before they become exposed to possible HPV infection through intimate contact.
Gardasil is one of the easiest and best ways to prevent a few dangerous and, to abuse the definition slightly, common cancers that afflict men and women. Without a doubt, the HPV vaccine prevents cancer.
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 43,000 cancers a year in the USA alone. The HPV vaccine prevents becoming infected by HPV, which means you are protected from these cancers.
Who is Gardasil researcher Diane Harper?
Gardasil researcher Diane Harper, who 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.”
As I wrote above, GSK, also known as Glaxo SmithKline manufactures Cervarix, and Merck, of course, manufactures Gardasil, both of which are HPV vaccines.
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 isn’t the “lead researcher” for the whole clinical trial, and it was for one location. In fact, the Medical Director (or Vice President of Medical Affairs) at Merck or GSK would be 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 which would probably indicate that she was the “lead researcher.” She was one of at least a dozen researchers. She is truly overstating her role in this clinical trial.
I wouldn’t be as critical if she simply called herself “one” of the lead researchers, instead of making it seem that she had some overarching role in that research.
With that piece of misinformation out of the way, Dr. Harper’s capacity, 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.
What are the anti-vax claims about Dr. Diane Harper
Gardasil researcher Diane 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.” Anti-vaccine activists have attached themselves to this story because they think it uncovers a conspiracy of lies by the vaccine manufacturers.
Obviously, their conspiracy theories include “Gardasil researcher” Diane Harper escaping from the clutches of evil 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. Diane 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 40,000 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.
I don’t get the math of the antivaccine crowd. They round down the risks of not vaccinating to 0% and round up the incidence of adverse events to 100% – if this weren’t so serious, it would be one of the best statistics jokes ever.
But what did Gardasil researcher Diane Harper actually say?
According to transcripts, during the meeting, 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.)
Wait, when did she say that the HPV vaccine wouldn’t help? That’s not what I’m reading with that quote. Everything in science is nuanced, so what Dr. Harper said was accurate.
But here’s how one conspiracy theory, antivaccine pusher 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 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 cancer as a result of an HPV-infection.
We don’t know why some women will get cervical cancer and some won’t. Some women have better screening (but even finding it early can have bad consequences for reproductive health). Typically, science deniers, including the antivaccination gang, lack an understanding of how statistics work.
Low risk is not a zero risk. But on the other hand, low risk also does not mean a 100% risk (the antivaccine crowd works both angles).
Dr. Harper’s comments and research
But let’s set all of these “he said, she said” discussions aside – let’s go back to Dr. Harper’s comments. Guess what? The truth is a lot different.
- Dr. Ben Goldacre, who frequently writes about making drug companies accountable for their actions and exaggerated claims, actually interviewed Dr. Harper after the antivaccine 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.“
- Dr. Diane Harper’s view of 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).
- She also stated that she is concerned about the aggressive advertising campaign of Merck, which may lead individuals to believe they are now completely invisible to HPV, so they may avoid other STD-preventing precautions, which might lead to higher rates of other types of STD’s, even HIV infections. This is valid since this invincibility is suggested by Merck’s advertising. Moreover, many of us in the biomedical field, even ones who have worked for Big Pharma, are disgusted by the advertising claims for prescription pharmaceuticals.
- Dr. Diane Harper also suspects that women who get the HPV vaccine are probably the ones who will be more punctilious about scheduling and visiting their doctor for every one of their cancer screening appoints, so the vaccination would have little impact on their risk of death from cancer. But even there, she states that this select group will benefit in the reduction in certain conditions caused by treating for precancerous changes in cervical cells.
- Gardasil researcher Diane 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.
- Dr. Diane Harper continues to participate in clinical trials for HPV vaccines, publishing a new article in August 2016.
- Dr. Harper is so focused on the benefits of the HPV vaccine, she is the chief investigator (this time, a real title) for a new type of HPV vaccine, called the tipapkinogen sovacivec (TS) vaccine which is being developed by Transgene in partnership with Merck and Pfizer. This TS vaccine is different than Gardasil and other HPV vaccines in that it causes the immune system to destroy circulating HPV along with HPV-related pre-cancerous lesions.
- And in 2021, Gardasil researcher Diane Harper wrote an article entitled, “Elimination of cervical cancer depends on HPV vaccination and primary HPV screening.” She is highly supportive of the HPV vaccines.
But do you know what is the most telling point about Gardasil researcher Diane Harper? If she’s so negative about vaccines in general, and Gardasil specifically, where are her rants on antivaccination websites? Because other than the articles which misrepresent Dr. Harper’s actual viewpoint about Gardasil, it’s impossible to find any writing from Dr. Harper stating, either implicitly or explicitly, that she thinks that Gardasil is bad. Then she is quoted, it’s either from her nearly eight-year-old statements, or some very conflicted and nuanced statements since.
As someone once said, don’t listen to what they say, but what they do. And she continues to research HPV vaccines.
Again, she speculates that cervical cancer screening may be just as useful, but nowhere does she recommend that the vaccine not be used, that its safety profile is unacceptable, or that the vaccine cannot prevent cancer. In fact, she recommends expanding the guidelines for HPV vaccines for older women because as they age, they are more susceptible to other serotypes of HPV, against which Cervarix confers protection.
She also states that Cervarix may also have a protective effect against some autoimmune disorders. This does not sound like a researcher who is losing sleep about the HPV vaccine, but who fully supports its use, with some exceptions.
And here’s a problem with screening – it may include a diagnosis of cancer. Every physician who practices real medicine will state that cancer prevention matters more than a diagnosis. Women who get a diagnosis of “precancerous cells” from a pap smear are horrified and frightened. Of course, we have good screening methods for these cancers, but what if we have a vaccine that reduces the risk of those cancers? That’s infinitely better than the diagnosis. I don’t understand her logic.
Diane Harper doubles down (sometimes)
To be fair, she has made some odd comments about Gardasil (but never about Cervarix, a suspicious choice):
Gardasil is associated with serious adverse events, including death. If Gardasil is given to 11 year olds, and the vaccine does not last at least fifteen years, then there is no benefit – and only risk – for the young girl.
But where are the studies that support such a claim? There are none, there is simply nothing published that indicates that Gardasil is associated with serious adverse events, even when the studies included one million patients!
Maybe she uses passive data from the Vaccine Adverse Event Reporting System (VAERS), a system where individuals can report supposed adverse events post-vaccination, to “prove” certain adverse events. VAERS is one of the favorite “research tools” of the antivaccine crowd.
VAERS reports can be made online, by fax, or by mail. However, there are no investigations to show any type of causality between the vaccination event and the claimed morbidity or mortality that are reported to the VAERS database, and, frankly, it can be gamed by those with corrupt intentions.
VAERS is a feel-good system for those who think that there’s a link between vaccines and something terrible, but without an active investigation, the data is just above the level of totally meaningless and is absolutely not scientific. Most epidemiologists know it is valueless.
Even the VAERS system itself says that the data cannot be used to ascertain the difference between coincidence and true causality. There is a background rate for mortality, across all causes, irrespective of whether an individual is vaccinated or not, and unless you understand the background rate, the vaccine “mortality” rate has no scientific meaning.
In fact, we could provide a Starbucks coffee drinking in the car “mortality rate”, which may or may not have any causality whatsoever.
It seems like Dr. Harper, for whatever reason, repeats the anti-vaccine myth that can be found in the dumpsters of VAERS:
So far, 15,037 girls have reported adverse side effects from Gardasil alone to the Vaccine Adverse Event Reporting System (V.A.E.R.S.), and this number only reflects parents who underwent the hurdles required for reporting adverse reactions.
At the time of writing, 44 girls are officially known to have died from these vaccines. The reported side effects include Guillian Barré Syndrome (paralysis lasting for years, or permanently — sometimes eventually causing suffocation), lupus, seizures, blood clots, and brain inflammation. Parents are usually not made aware of these risks.
There is simply no evidence that 44 girls “are officially known to have died from these vaccines.” This is one of those myths that keep getting transmitted by one antivaccine group to another, much like an HPV infection. Using VAERS to make any kind of conclusion is merely an intellectually lazy and ignorant method of trying to make a point. Actual research done by actual researchers published in actual journals shows no evidence of any kind that Gardasil does anything but prevent HPV infections in young girls.
Real evidence found in real case-controlled epidemiological studies has established the fact that Gardasil is extraordinarily safe, maybe one of the safest vaccines EVER. And if Dr. Diane Harper wants to claim that she’s a “lead researcher” then at least try to understand how epidemiology works. VAERS provides neither correlation nor causation between any adverse event and Gardasil.
On the other hand, in a 2012 peer-reviewed article about Cervarix, Dr. Harper states that:
Cervarix is an excellent choice for both screened and unscreened populations due to its long-lasting protection, its broad protection for at least five oncogenic HPV types, the potential to use only one-dose for the same level of protection, and its safety.
Other than the number of antigens (with more being better), there is little practical difference between Merck’s Gardasil and GSK’s Cervarix. You’d almost think that Dr. Harper has something against Merck, and it’s not anything to do with safety.
The current state of Dr. Diane Harper
Dr. Harper’s interest in the HPV vaccine has become clearer recently. Not only is she working with Big Pharma to bring better HPV vaccines to the market, but she also took a position with the University of Michigan Medical School. She is a professor of family medicine, obstetrics, and gynecology, women’s studies, and a bunch of other positions. This is impressive.
In a 2018 press release from Michigan Medicine, Gardasil researcher Diane Harper is quoted extensively, but the key point is this:
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.
She’s doing community outreach for a medical school, so she is pushing the HPV vaccine! It’s hard to convince me that Gardasil researcher Diane Harper is anything more than an HPV vaccine supporter.
Summary, the TL;DR version
Gardasil researcher Dr. Diane Harper appears to be a fine scientist, an individual who has spent a lot of time studying HPV and vaccines. She has the academic training and research credibility at a level that if she said “Gardasil is dangerous”, many of us would stand up and begin to wonder.
But the facts are she has not said anything of the sort about Gardasil and Cervarix, except in one interview. In peer-reviewed articles published in important, high impact journals, she has given strong, but scientifically qualified, endorsements to HPV vaccines.
These are the facts. Any other allegations about her lack of support for vaccinations are based on misinformation, disinformation, and lies.
Gardasil does not increase the sexual activity of young girls. HPV vaccinations were found to be extremely safe, with no serious adverse events observed in large clinical trials. And it has been shown to reduce the prevalence of HPV in young women. These are the scientific facts, and from them, we can conclude, as did Dr. Harper, that HPV vaccines prevent cancer and save lives.
But let’s review:
- Dr. Diane Harper had a “consultant” role during clinical trials for Gardasil and Cervarix.
- Dr. Harper was compensated by Merck and GSK for those clinical trials.
- Dr. Harper may or may not have said that the vaccine’s economic benefits are sufficient to recommend it.
- Dr. Harper has made infrequent and unsupported claims about Gardasil’s safety, though interestingly, never about Cervarix.
- Dr. Harper continues to publish positive research about HPV vaccines, including Gardasil.
- Dr. Harper continues to participate in clinical trials sponsored by pharmaceutical companies on HPV vaccines, including a current clinical trial for a novel HPV vaccine.
- Dr. Harper was obviously used by the anti-vaccine movement and is frequently misquoted. This is sad.
Remember, the vast preponderance of the evidence, published in real journals, supports the fact that HPV vaccines are safe and are effective in preventing cancer.
- Arnheim-Dahlström L, Pasternak B, Svanström H, Sparén P, Hviid A. Autoimmune, neurological, and venous thromboembolic adverse events after immunisation of adolescent girls with quadrivalent human papillomavirus vaccine in Denmark and Sweden: cohort study. BMJ 2013 Oct;347:f5906 doi: 10.1136/bmj.f5906. Impact factor=17.215.
- Bednarczyk RA, Davis R, Ault K, Orenstein W, Omer SB. Sexual activity-related outcomes after human papillomavirus vaccination of 11- to 12-year-olds. Pediatrics. 2012 Nov;130(5):798-805. doi: 10.1542/peds.2012-1516. Epub 2012 Oct 15. PubMed PMID: 23071201. Impact factor: 5.119.
- Centers for Disease Control and Prevention (CDC). Human papillomavirus vaccination coverage among adolescent girls, 2007-2012, and post-licensure vaccine safety monitoring, 2006-2013 – United States. MMWR Morb Mortal Wkly Rep. 2013 Jul 26;62(29):591-5. PubMed PMID: 23884346.
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- 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.
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- Harper DM, Nieminen P, Donders G, Einstein MH, Garcia F, Huh WK, Stoler MH, Glavini K, Attley G, Limacher JM, Bastien B, Calleja E. The efficacy and safety of Tipapkinogen Sovacivec therapeutic HPV vaccine in cervical intraepithelial neoplasia grades 2 and 3: Randomized controlled phase II trial with 2.5 years of follow-up. Gynecol Oncol. 2019 Jun;153(3):521-529. doi: 10.1016/j.ygyno.2019.03.250. Epub 2019 Apr 4. PubMed PMID: 30955915.
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- 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.
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- 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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