Gardasil cancer-preventing vaccine is the greatest medical scandal – nope

I am absolutely convinced that of all the vaccines on the market, the anti-vaccine radicals hate the Gardasil cancer-preventing vaccine more than any other. Nearly every day, I see article after article in pseudoscientific websites that make unfounded claims and outright misinformation about Gardasil, including one that crossed my path today.

The article, in a junk medicine website called RealFarmacy, blares this click-bait headline – “Merck’s Former Doctor Predicts Gardasil to Become the Greatest Medical Scandal of All Time.” Oh no, I’m frightened, are you? The article relies upon the Four Horsemen of the Gardasil Apocalypse™ for their fake facts.

In fact, there is robust scientific evidence, gathered from huge case control studies, that the Gardasil cancer-preventing vaccine is incredibly safe, and may be one of the safest vaccines on the market. But we all know what the anti-vaccine folks think of scientific facts – they ignore them unless it supports their preordained conclusions.

This article will tackle the key points of the RealFarmacy (what’s with the spelling error?) article. 

The Gardasil cancer-preventing vaccine

I know, I’ve written about this vaccine 100 times, so you’ve read these paragraphs enough to quote them without looking. Actually, I change it up with new information frequently.

However, for some of you, this might be your first bit of research into the human papillomavirus (HPV) vaccine, so it’s important to get a brief overview of HPV and the vaccines. If you’ve read this before, just skip to the next section if you want.

Genital and oral  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 a new 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 before 2014. GSK, also known as GlaxoSmithKline manufactured Cervarix, a bivalent vaccine, but it has been withdrawn from the US market, because of the competition from the other HPV vaccines. In Europe and other markets, Gardasil is known as Silgard.

Merck manufactures the other HPV vaccines. Its first vaccine, the quadrivalent Gardasil, targets the two HPV genotypes known to cause about 70% of cervical cancer and two other HPV genotypes that cause genital warts. The newer Gardasil 9, approved by the FDA in 2014, is a 9-valent vaccine. It targets the four HPV genotypes in the quadrivalent version, along with five additional ones that are linked to cervical and other types of cancer. Both versions of Gardasil are prophylactic, meant to be given before females or males become exposed to possible HPV infection through intimate contact.

RealFarmacy brings us Shaw and Tomljenovic…again

The first two of the Four Horsemen of the Gardasil Apocalypse™ are well known haters of the Gardasil anti-cancer vaccine – Christopher Shaw and Lucija Tomljenovic. I’ve written about them several times, but here’s a quick refresh.

Shaw and Tomljenovic are not immunologists. They are not epidemiologists. They are not microbiologists. They are not public health experts. In fact, they have no training in any area related to vaccines – Shaw is located in the Department of Ophthalmology in the University of British Columbia (UBC). Ophthalmology is not on ground zero of vaccine research.

There’s supposedly some back story as to why Shaw became a hater of vaccines, especially the Gardasil anti-cancer vaccine – that’s not relevant here. Only evidence is.

Shaw and Tomljenovic have had two (here and here) of their published articles retracted over the past 12 months. Is that bad? Well, it’s not good.

The World Health Organization has described their research as “seriously flawed.“ Is that bad? Well, it’s not good.

Their research has been paid by the Dwoskin Family Foundation. The Dwoskin Family Foundation is one of the most profoundly anti-vaccine sponsors of research in the world. Is that bad? Well, it’s not good

The pro-vaccine community is not sure why UBC has not done anything about these two “vaccine researchers.” I could write 4000 words about each one of their published articles on vaccines (most in low impact factor, predatory journals), tearing apart their amateurish attempts at epidemiology, toxicology, and other subjects. And I am an amateur myself!

Shaw and Tomljenovic are perfect examples of the appeal to false authority – they both appear to have reasonable credentials, but when you look at the evidence that supports their opinions, you find nothing. Like the other favorite false authority of the anti-vaccine radicals, Tetyana Obukhanych, the credentials don’t matter, just published evidence. And none of these individuals have any robust (or otherwise) scientific evidence to support their claims.

So, right off the bat, RealFarmacy tries to make a point by relying on the comments and claims of thoroughly discredited “scientists,” a term I use with great reluctance, since neither Shaw nor Tomljenovic have shown any skills with the scientific method.

Next up, Diane Harper

And if you’re going to try to “prove” that the Gardasil cancer-preventing vaccine is dangerous or ineffective, RealFarmacy jumps to third member of the Four Horsemen of the Gardasil Apocalypse™, Dr. Diane Harper. Who is she?

Well, she 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.” GSK, also known as Glaxo SmithKline manufactures Cervarix, and Merck, of course, manufactures Gardasil.

She has also 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.”

As I wrote before, it’s difficult to consider her as a “lead researcher,” since she was one of at least a dozen researchers involved in the clinical trials of HPV vaccines. In a clinical trial, study locations are spread over several locations to reduce bias. In fact, if there was a lead researcher, it would be the Medical Director of Merck who would be legally and scientifically responsible for clinical trials. Dr. Harper has never claimed to be, nor is there evidence supporting, her ever being a Medical Director at the company.

Although it’s not absolutely clear what Dr. Harper’s actual role was, typically someone in her position would 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.

Her job would be more managing lots of data and protocols rather than being a strategic decision maker in developing and studying the vaccine. And remember, her name is on the papers for the clinical trials for GSK’s Cervarix and Merck’s Gardasil. It’s damning to her claims when she is a part of the clinical trials for both vaccines, and has never once demanded a retraction of these articles or demanded that her name be removed from the article.

Furthermore, Dr. Harper has also penned additional articles about the safety and effectiveness of HPV vaccines as recently as 2017. And yes, they were positive about the HPV vaccines.

Dr. Harper has made unfortunate comments about the Gardasil cancer-preventing vaccine. We are not sure why she made these comments, but like the irrefutable Orac once said, “no, Diane Harper doesn’t hate Gardasil.”

Dr. Ben Goldacre, who frequently writes about making drug companies accountable for their actions and exaggerated claims, interviewed Dr. Harper after the antivaccine world exploded with the “Diane Harper hates Gardasil” memes. Harper told Goldacre that “I fully support the HPV vaccines. I believe that in general they are safe in most women.”

So, one of the Four Horsemen of the Gardasil Apocalypse™, Dr. Diane Harper, was never really a true member of the team. She occasionally makes public comments about Gardasil that aren’t favorable, but this is contradicted by the huge body of evidence that Dr. Diane Harper isn’t really part of the anti-Gardasil crowd. But I guess if you’re a desperate author at RealFarmacy who has no clue as to how to read scientific articles on PubMed, you resurrect the zombie trope about Dr. Harper.

Presenting Dr. Deirdre Little

The fourth member of the Four Horsemen of the Gardasil Apocalypse™ is the Australian Dr. Little. Just for a little back ground on Australia and the Gardasil cancer-preventing vaccine, it was one of the first countries to provide free Gardasil vaccine to their children. And because of that, there has been an greater than 60% drop in cancer causing HPV infections. Those are amazing results.

The anti-Gardasil forces totally misrepresent a case study (considered one of the lesser scientific sources in the hierarchy of scientific research) in which a young girl had premature ovarian failure a few months after a Gardasil vaccination. The actual paper, written by Dr. Little, a Catholic activist physician, concluded that “The diagnostic tasks were to determine the reason for her secondary amenorrhoea and then to investigate for possible causes of the premature ovarian failure identified. Although the cause is unknown in 90% of cases, the remaining chief identifiable causes of this condition were excluded.” In other words, this young girl fits in the unknown cause group, and there was no evidence whatsoever that Gardasil was a causal factor.

The sarcastic Orac looked at Little’s article, and offered this review:

Because Little and Ward can’t find any evidence that any of these causes were the root cause of this girl’s premature menopause, they gleefully leap to the conclusion that—you guessed it!—it must have been the Gardasil! I kid you not. And when did this girl receive her anti-HPV vaccine? According to the case report, she received doses in May and August of 2008. Now let’s go back to the case report. this girl started to have irregular menses in early 2009, more than five months after her last dose of Gardasil, and then she didn’t stop menstruating until a year later, in early 2010.

Yes, obviously, it must have been the Gardasil. (That’s sarcasm, in case you didn’t notice it.) In fact, the authors think it’s the Gardasil so much that not only did they report this girl’s premature ovarian failure as a possible adverse event to the Therapeutic Goods Administration of Australia, but they undertook a search for reports examining whether the HPV vaccine had any effects on rat ovaries, after having found a report that showed no effect due to Gardasil on rat testes. They even went so far as to submit a Freedom of Information request for such data, which, they darkly point out, hasn’t panned out yet.

Obviously, it must have been the Gardasil, and obviously the pharmaceutical companies are hiding something. (That’s more sarcasm, in case you didn’t realize it.)

In other words, it was not Gardasil. So once again, one of the Four Horsemen of the Apocalypse™, Dr. Deirdre Little, brings no evidence that would make any rational person believe that there are any safety issues with the Gardasil cancer-preventing vaccine.

Gardasil cancer-preventing vaccine overall safety

The RealFarmacy article then moved on to whining about the safety issues that appeared in the clinical trials (pdf). They listed 16 “new medical disorders” that occurred after the vaccination. I do love some outstanding cherry-picking,  but this one hit some serious new levels.

RealFarmacy failed to read the full document, where clinical researchers explained, in detail, the medical conditions for each of the participants that had these “new medical disorders.” And none of them appeared to be related to the vaccine.

Moreover, it’s important to note that RealFarmacy failed to examine the data compared to the control group – there were no statistical differences between the vaccinated group and the control group for all of these “new medical disorders” (see Table 44 of the FDA document linked above).

But what really matters are the significant post-marketing studies of Gardasil, of which there are many. Here’s a study of over 3 million women that showed no significant difference between Gardasil vaccinated and unvaccinated groups with respect to adverse events.

Here’s another study of over 2 million patients that showed no difference between vaccinated and unvaccinated groups with respect to autoimmune diseases.

Here’s a study of 2 million doses of Gardasil that showed no difference between vaccinated and unvaccinated groups with respect to neurological disorders.

Here’s a study of nearly 1 million young females that showed no difference between vaccinated and unvaccinated groups with respect to autoimmune, neurological, and venous thromboembolic events.

There are many more, but you get the point.

Summary

The largest, highest quality, peer-reviewed, published studies continues to provide us with robust, consistent evidence of the safety of the Gardasil cancer-preventing vaccine. RealFarmacy can babble on for 2000 words, telling us that Gardasil is dangerous, that a doctor claims that Gardasil will bring the downfall of Merck, and that it cannot actually prevent cancer. But they’d be wrong.

There are so few ways to actually prevent cancer. Stop smoking. Stay out of the sun. Keep a healthy weight. And get vaccinated against HPV, which is linked to several dangerous and disfiguring cancers.

RealFarmacy is trying to present implausible, if not impossible, scenarios that the Gardasil cancer-preventing vaccine can harm young teens. They’re trying to present claims from discredited researchers, Shaw and Tomljenovic. They’re trying to rehash Dr. Harper’s comments which are in conflict with what she publishes in peer-reviewed journals. They’re trying to give us a thoroughly discredited case report which provided precisely zero evidence of link to Gardasil.

Get the vaccine if you’re a young adult. Get the vaccine for your teenage boys and girls (actually you can vaccinate them at age 11). Protect yourself and your loved ones against deadly cancers. And don’t believe a pseudoscientific website like RealFarmacy.

Citations

 
 
The Original Skeptical Raptor
Chief Executive Officer at SkepticalRaptor

Lifetime lover of science, especially biomedical research. Spent years in academics, business development, research, and traveling the world shilling for Big Pharma. I love sports, mostly college basketball and football, hockey, and baseball. I enjoy great food and intelligent conversation. And a delicious morning coffee!