Skeptical Raptor's Blog hunting pseudoscience in the internet jungle

Gardasil researcher is against the vaccine–another myth debunked


bullshit-meme-that-lies-about-harper

For New Year’s Day, I’m republishing the top 10 articles I wrote in 2013. Well, actually top 9, plus 1 from 2012 that just keeps going.

#9. This article was published on 8 August 2013, and has had over 22,000 views. Although Diane Harper seems to have been bought out by the antivaccine gang, she still publishes peer-reviewed articles providing strong evidence of Gardasil’s safety and effectiveness. The facts and evidence support Diane Harper the real medical researcher not Diane Harper the antivaccine shill.

Because vaccine deniers lack any scientific evidence supporting their unfounded belief system about immunizations, they tend to rely upon unscientific information like anecdotes, misinterpretation of data, or ignorant Italian provincial courts to make their case. It’s rather easy to debunk these claims, but because of the nature of the internet, old news is recycled as “brand new,” requiring a whole new round of blog posts to discredit the misinformation. It’s impossible to recall one single instance where a vaccine refuser made a statement about vaccines that was not, in fact, rather quickly debunked. Not one.

The pro-children’s health side, those of us who think that vaccines save lives, have been winning the hearts and minds for awhile, given that still around 95% of children in the USA get all of their immunizations prior to entering kindergarten. But that doesn’t stop the refusers from trying, because it’s apparent that the we have gone 360º, so a batch of old anti-vaccination memes are making the rounds again.

One of the latest ones involves a researcher, Dr. Diane Harper, a former Merck & Co. researcher who apparently had some management role in the clinical trials of the HPV quadrivalent vaccine, also known as Gardasil (or Silgard in Europe). The HPV vaccine prevents the transmission of certain types (pdf) of human papillomavirus (HPV), specifically types 6, 11, 16 and 18. Importantly, HPV types 16 and 18 cause approximately 70% of cervical cancers, and cause most HPV-induced anal (95% linked to HPV), vulvar (50% linked), vaginal (65% linked), oropharyngeal (60% linked) and penile (35% linked) cancers. These HPV-related cancers can be prevented as long as you can prevent the HPV infection itself, which are generally passed through genital contact, most often during vaginal, oral and anal sex.

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 antivaccination world have attached themselves to this story, because they think it uncovers a conspiracy or lies by the vaccine manufacturers, since obviously Dr. Harper escaped from the evil clutches of Big Pharma.

During a presentation at the 4th International Public Conference on Vaccination, 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.

According to the CDC, the annual numbers of HPV-related diseases in the USA are:

  • About 360,000 persons in the U.S. get genital warts each year
  • About 10,300 women in the U.S. get cervical cancer each year
  • 2,100 vulvar cancers
  • 500 vaginal cancers
  • 600 penile cancers
  • 2,800 anal cancers in women
  • 1,500 anal cancers in men
  • 8,400 oropharyngeal cancers in men and women (Note: oropharyngeal cancers are also related to smoking, chewing tobacco, and other factors, so it’s difficult to determine which are HPV-related and which are only partially related.)

So, though this 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 20,000 cancers, most of them very deadly or damaging, can be prevented quickly and easily with a vaccine that has shown, in massive (100′s of thousands of patients) clinical trials, to not have any serious side effects. None.

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.

Wait, did she say that the HPV vaccine wouldn’t help? That’s not what I’m reading with that quote. But here’s how one antivaccine lunatic 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. 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 understanding of how statistics work. A low risk is not a zero risk. But on the other hand a low risk is not a 100% risk (the antivaccine crowd works both angles).

Then the vaccine refuser writes:

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.

Let’s look at VAERS first. Vaccine deniers, especially in the USA, use 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. The 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 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.

Furthermore, 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. Real research done by real researchers published in real journals show no evidence of any kind that Gardasil does anything but prevent HPV infections in young girls.

But let’s set this aside, and go back to Dr. Harper. Guess what? The truth is a lot different.

  • First, Dr. Diane Harper is described as “the lead researcher in the development of the human papilloma virus vaccines, Gardasil and Cervarix.” Firstly, Cervarix is an HPV vaccine, but Dr. Harper had little to do with the development of that product. It is a bivalent vaccine (Gardasil is a quadrivalent vaccine) manufactured by GlaxoSmithKline.
  • With that piece of misinformation out of the way, Dr. Harper’s role, as is typical with most pharmaceutical companies, was to manage various aspects of the clinical trial for the company. That would be everything from making certain that protocols are accurate, that Institutional Review Boards have 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. In general, Dr. Harper, as an employee of Merck, would not have “lead the research”, and she could not vaccinate patients included in the Phase 3 clinical trial–that would be unethical and proscribed by ANY pharmaceutical companies’ protocols. There would have been an intentional wall between her and the clinicians. Moreover, she did not “develop” the drug in any meaningful manner, because she apparently was not a bench researcher–her role wasn’t in basic R&D, but mostly in clinical trials (though she may have provided a lot of guidance to the R&D staff, if Merck is structured like most Pharmaceutical companies).
  • Dr. Ben Goldacre, who consistently 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. 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. Though I am not a researcher of Dr. Harper’s level, 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.
  • 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. 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.

But do you know what is the most telling point about Dr. 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.

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.” Again, she speculates that cervical cancer screening may be just as useful, but nowhere does she recommend that the vaccine not be used, that it’s 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.

Dr. Diane Harper is one of the leading researchers in biomedical science, an individual who has spent her life studying 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. 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 is based on misinformation, disinformation and lies.

Gardasil does not increase 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 save lives.

 

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