The HPV Vaccine on Trial: Guilty as Charged

October 20, 2018

When Merck’s human papillomavirus (HPV) vaccine, Gardasil (since replaced by Gardasil 9), was first licensed in 2006, it was hailed as a tremendous achievement of modern medicine: a vaccine to prevent cancer! What could possibly be better?

Of course, this is a dramatically oversimplified picture painted by the manufacturer’s marketing team. Despite its billing as a “cancer vaccine,” implying to many of its recipients that Gardasil could potentially prevent all cancers, the vaccine was only intended to prevent some HPV-related cancers, and more specifically cervical cancer, which is of course a notable killer of women worldwide  and a worthy target for prevention. In addition, the vaccine had not even been shown to prevent cervical cancer in its clinical trials, because cervical cancer usually develops slowly, often over 20-30 years. As a result, cancer prevention could only be inferred by a reduction in the sorts of cervical lesions that may, eventually, lead to cervical cancer. As the majority of these lesions don’t lead to cervical cancer, we have no way of knowing yet if a reduction in the absolute number of lesions will translate to a reduction in cervical cancer or deaths from cervical cancer. It seems likely that it would, but that is just an assumption, an assumption that could be wildly wrong. For one thing, it’s quite possible that the vaccine selectively prevents less virulent lesions which would have resolved of their own accord.

When we consent to medical treatments, the most important consideration is how the risks stack up against the benefits for ourselves. With a preventative treatment, administered to healthy people— typically 12 to 13-year-old girls in the case of Gardsasil—the risks should be minimal. For teenaged girls—with virtually no immediate risk of cervical cancer—those risks should be vanishingly small.

Christina Tarsell, a young woman who died from an autoimmune reaction caused by Gardasil

Despite its proposed benefits, however, Gardasil was beset by controversy from the very beginning. Dr. Diane Harper, who conducted clinical trials of the drug, painted a very different, far less rosy, picture of the vaccine than its enthusiastic marketeers. According to Dr. Harper, the data indicated that for most girls (let alone boys) in industrialized countries (which had low cervical cancer and cervical cancer mortality rates due to regular Pap screening) the potential benefits of the vaccine would not outweigh the significant risk of injury—particularly serious injury. Merck’s marketing machine, which gave evidence of its strength and power when it promoted and protected the fatally flawed arthritis painkiller Vioxx, probably the most well-known recent pharmaceutical disaster that resulted in fines and cash awards totaling nearly a billion dollars, immediately went to work suppressing any nuanced discussion of the product’s risks and benefits just as it had with Vioxx.

The Merck PR machine has done its job well. If you live in the United States, you may hear nothing but glowing reports of the vaccine, which has since been recommended for all boys and most recently was approved for adults from age 27 to 45. Yet the controversy continues. Young girls all over the world developed mysterious and debilitating symptoms, often autoimmune in nature, soon after a dose of Gardasil, and now that the vaccine has been recommended for boys as well, they too are reporting devastating injuries. According to the manufacturer, these injuries are both “psychogenic” (mental rather than physical in origin) and “coincidental” (the rate of autoimmune disease in the clinical trial “control” groups was similar to that of the vaccinated groups), despite the fact that similar symptom clusters are showing up all over the world in populations that simply did not exhibit them prior to HPV vaccination drives. If—as Vioxx did heart attacks—Gardasil is really causing debilitating autoimmune disease in previously athletic young girls and boys, that’s something we really ought to know.


Given the lack of nuanced information in the mainstream media, how do parents, or adults seeking accurate information for themselves, determine whether the vaccine’s benefits are worth the inherent risks? The title of The HPV Vaccine on Trial: Seeking Justice for a Generation Betrayed, a new book by Mary Holland, Kim Mack Rosenberg, and Eileen Iorio, may sound sensational, but in reality the book is a thorough, rigorous, and scholarly consideration of the facts surrounding the development and distribution of HPV vaccines, from the problems with the clinical trials* (notably, the use of “fauxcebos” such as aluminum adjuvant in the place of a true saline control, poor tracking of “new medical conditions,” and no consideration whatsoever of possible effects on fertility) to an in-depth look at the science implicating aluminum adjuvants in the current explosion of autoimmune conditions.

I know all three of The HPV Vaccine on Trial’s authors personally, and I have been eagerly anticipating the book’s arrival for several years now, knowing how much such a book is needed as a corrective to the dangerously unbalanced information being propagated in the mainstream media. Two of the book’s authors are lawyers, and it shows. Unlike scientists, who usually consider very narrow subjects in exquisite detail but often miss the bigger picture, effective lawyers need to consider a topic from all angles, looking for any holes that may signal the potential for impending disaster, and are particularly good at weaving many disparate elements into a cohesive narrative. The authors make their case, and it is a damning case indeed. From time to time, they overstate things in a way that scientists (with significant exceptions; Paul Offit, I’m looking at you here) know better than to do, but overall the authors do a terrific—and very depressing—job covering the facts about HPV vaccines. Some that you will never find covered fairly in the mainstream media in the United States include the following:

  • Gardasil and Gardasil 9 contain amorphous aluminum hydroxyphosphate sulphate (AAHS), a “novel” adjuvant with zero safety testing.
  • Contrary to the manufacturer’s original assertions, the vaccine contains HPV DNA, which may be acting as a toll-like receptor agonist, triggering powerful cytokine production many times that of a natural HPV infection. Some of this DNA is not in a natural conformation and cannot be degraded and eliminated, which makes it a potential source of chronic inflammation.
  • Parts of HPV 16 proteins contained in the vaccine match human proteins that are capable of binding the vaccine-induced antibodies, which could also cause long-term inflammation and autoimmune damage.
  • There are more than 200 different types of HPV, 12–18 of which are potentially oncogenic. Even Gardasil 9 only covers 7 of those, and many HPV infections contain multiple types, which means that HPV vaccination presents a real potential for type replacement. In other words, in the absence of the common cancer-related types due to the vaccine, other, potentially even more virulent, strains may become more prevalent and could conceivably end up increasing cervical cancer rates in the long run.
  • In addition, a phenomenon known as Original Antigenic Sin may lead to increased cervical cancer death rates. (When someone has been exposed to one type of virus and develops antibodies to fight it, a second type that is closely related but not identical to the first may elicit the same antibodies, which may not be effective at all against the second type. This is a well-known phenomenon with dengue fever and is the reason why the vaccine can cause an intensification of the disease in people who have never had dengue before.)
  • Cervical cancer rates and cervical cancer death rates have been traditionally low in industrialized countries due to regular Pap testing. Testing patterns and recommendations for testing are changing as a result of HPV vaccination, and not necessarily for the better. If people consider themselves immune, they may avoid routine testing that could have caught cancerous lesions in time to treat them.
  • In some countries, HPV testing is replacing Pap testing. Yet a significant percentage of cervical cancer lesions test negative for HPV, which means that those cancers could be missed with routine HPV testing.
  • This also raises the question of whether HPV infection is directly causing cancer, or is its presence is simply an artifact of an old infection? If HPV infection is not the direct cause, HPV vaccination could have some unintended consequences.
  • The prevalence and virulence of HPV types varies in different genetic groups. The types most prevalent in African-American women are not contained in the original Gardasil or Cervarix vaccines, and African-American women die of cervical cancer in disproportionately high numbers. AA women may consider themselves “protected” by the vaccine yet be just as vulnerable to cervical cancer after vaccination than they were before.
  • The recommendation for full protection changed recently from three doses to two doses while Merck and governmental medical agencies continued to claim that the vaccines are “safe.” Yet it’s well known that adverse reactions increase in number and severity with each dose, and the majority of severe reactions resulting in long-term debilitation occur after the second or third dose.
  • Clinical trials demonstrated “negative efficacy” in people infected with HPV prior to vaccination, meaning that cervical cancer risk for a particular individual can actually go up with vaccination. (I personally know a woman who was vaccinated during the clinical trials and developed cervical cancer shortly afterward as a very young woman. She is lucky she is alive today.)
  • HPV transmission can occur from mother to child at birth, making assumptions about lack of prior exposure through sexual activity in young children dangerous.
  • Terrifying as “negative efficacy” is, even more terrifying is the fact that, not only is HPV testing not recommended prior to vaccination, it is actively discouraged. This cavalier disregard for a clear danger signal could have very serious consequences for children who have congenital HPV infections or are victims of sexual abuse, and the newest cohort of vaccine recipients, adults aged 27-45, who are very likely to have been previously infected with HPV.
  • Other governments have taken the reports of debilitating illnesses (and deaths) caused by HPV vaccines view rather more seriously than the United States. They are far more cautious and less cavalier when it comes to the health of their own young citizens. As a result, vaccine uptake in Japan, Denmark, and Columbia has plummeted. It remains to be seen whether this drop will reduce the incidence of complex regional pain syndrome and postural orthostatic tachycardia syndrome, the two conditions most often associated with HPV vaccination.

Professor Mary Holland, one of the book’s authors, addressing the United Nations

To my mind, the most important sentence in the whole book appears on page 230: “Aluminum has the ability to disrupt many biological systems. It acts on both the immune system and the central nervous system separately and synergistically.” As aluminum researcher Christopher Exley of Keele University in the U.K. says, we are living in the Age of Aluminum. It’s no wonder so many children and young adults are suffering from extensive neurological and immunological dysfunction. In the last ten years we have learned a great deal about the toxic effects of constant cumulative exposure to bioavailable aluminum, but the exposure with the most potential to cause future harm is the repeated injection of aluminum adjuvants. The adjuvant contained in Gardasil appears to be capable of causing widespread autoimmune disease when injected in what seems like tiny amounts (Gardasil 9 contains twice the amount that the original Gardasil contained). And other, less tightly bound, aluminum adjuvants are able to combine with food proteins in the vaccine itself or even in the blood due to a “leaky gut,” which is the likeliest mechanism behind the recent spike in anaphylactic food allergies.

It’s impossible to read The HPV Vaccine on Trial without feeling fear for America’s future: the future of our most active adolescents and young adults, our future ability to procreate, and the future of medicine itself. If a treatment designed to prevent serious illness in the distant future can cause so much devastation in the here and now in many of our best and brightest young people, and our media and medical community are not allowed to talk about it because doing so would threaten billion-dollar profits, that does not bode well for the country’s future. In fact, “health care” has become such big business that we are now living a paradox: We need a constant supply of chronically sick people pumping money into our insurance companies, our hospitals, and pharmaceutical companies, who in turn pump money through our media, universities, and medical journals, to keep our economy “healthy.” This is an obviously unsustainable scenario. Depressing as it is to read this book, it is also important: HPV vaccines may just be the cannibalistic tipping point that gooses the economy in the short run (to Merck execs’ glee) but kills it off altogether in the end, when few of our citizens are healthy enough to work to pay the bills for those who are sick.

As a society we must change course now, put our collective foot down, and declare that people are more important than profits.

We must acknowledge that it is in our society’s—as well as each individual’s—best interests to make our citizens’ good health a priority and a right.

We will have to make huge adjustments to our economy to make it happen, but if we don’t, our epitaph will read:

Here Lies the United States, Where Profit Won.

~ Professor

For more by Professor, click here.

For more on HPV vaccines, click here

 

*I was slightly disappointed that the authors did not mention one of the biggest problems I have with clinical trial 018, the only one that claimed (inaccurately, as is demonstrated in the book) to use an actual saline placebo. As we know autoimmune conditions can take years to develop, so the usual short-term period for tracking adverse events in a clinical trial is unlikely to detect an autoimmune signal even if it is there. As aluminum adjuvants are connected with increased autoimmune risk, the clinical trials using those as controls are useless in determining actual risk of vaccine-induced autoimmunity. The only trial where an autoimmune signal had a prayer of being revealed was trial 018 because of the “saline” placebo, but the researchers completely destroyed that possibility by vaccinating the control group a year after the original trial.
I was also disappointed that the authors didn’t cover the work of Italian scientists Antonietta M. Gatti and Stefano Montanari who found nanoparticle contaminants in the vaccine that have the potential to cause widespread long-term damage.
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8 Responses to The HPV Vaccine on Trial: Guilty as Charged

  1. Anon says:

    sorry, off topic, but just read this, and felt sad for the lack of free press…..

    (Canadian) Paper pulls vaccine column after backlash

    TORONTO – A major newspaper has removed an opinion piece that urged readers to consider “both sides of the vaccine debate” from its website after the column was the subject of widespread online backlash. ( a paper urging folks to consider BOTH sides? obviously scandalous)

    Adrienne Batra, editor in chief of the Toronto Sun, says in a post on Twitter that a number of medical professionals pointed out “inaccuracies” in the column, which remains up on the websites of several other publications.

    He says that while vaccines save lives, “history also shows that on rare occasions they have a potential hidden risk.”

    He said he wasn’t advocating that people forego vaccinations for themselves or their children — just that they have a discussion about the issue with their family doctor.

    “And I think the same thing occurs when you’re dealing with vaccines — you can never look someone in the eye and say, ‘You can take this vaccine and nothing’s going to happen to you.'”

    etc

    very sad that the paper felt they should pull this…

    http://www.msn.com/en-ca/health/medical/paper-pulls-vaccine-column-after-backlash/ar-BBP2Ngf?li=AAggFp5&OCID=AVRES000

    • ProfessorTMR says:

      I read the “opinion” column they ran soon after about how “facts” shouldn’t be overthrown in favor of opinion. The “article” was full of opinion. The writer had clearly never read any of the science that countered his extremely one-sided opinion.

  2. John Collins says:

    The only way to “prove” efficacy of a treatment is to have two populations, equal as much as possible, randomly chosen, get either the treatment or a control, and see if the incidence of a disease or other outcome is statistically different.

    • ProfessorTMR says:

      Yep, and as cervical cancer generally takes 20-30 years to develop, true efficacy of an HPV vaccine against cervical cancer would take that long to determine, and a thousand other factors could have changed in that timeframe including Pap screening behavior.

      In addition, the “control” in the Gardasil trials was usually the aluminum adjuvant, which is hardly an inert substance. It may be adequate for determining efficacy; it is by no means adequate for determining safety.

  3. Annie says:

    This is BRILLIANT!!!! Thank you so much!

    Just an fyi, the attachment doesn’t take you the Q&A where Ms Holland references the HPV vaccine. Not really a big deal as I realize she is one of the aurthors, just thought considering the subject of the book you wld want to know.

    Again thank you so very much for all you do!!!!!!

    • ProfessorTMR says:

      Oh, I know. I was present at the U.N. address. What Q & A are you talking about?

      (Thank you, and you’re welcome. ;-))

      • annie says:

        Sorry perhaps Q&A wasn’t the right expression, it was at the end and there’s a bit of a back and forth with the panel and I seem to recall Dr Durbak having questions people wrote in maybe? Anyway, at one point cervical cancer comes up and Dr Goldstein references his wife’s experiences. Along with other salient comments Ms Holland says something along the lines of “……has not been prove to prevent ONE case of cervical cancer”. There was ample applause. Again, no biggie, I just thought considering the subject matter is was prescient, however, I’ve searched and searched myself so I could try to attach it but I can’t find the end of the conference anywhere. And again, as always, a mountain of gratitude for all you do!

  4. John Collins says:

    Well done.

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