Gardasil vaccine safety – under attack again by a false authority

Here we go again – another lightweight “science paper” attacking Gardasil vaccine safety. Now, I have to spend time debunking it because we all know that this new article will be used as “proof” that Gardasil is dangerous.

As I have written dozens of times, there are precious few ways for us to effectively prevent cancer. Exercise regularly. Eat a balanced diet. Stay out of the sun. Quit smoking. Don’t drink alcohol. And get vaccinated against hepatitis B and the human papillomavirus (HPV). That’s it. No kale blueberry almond milk shake is going to suddenly make your risk of cancer drop to zero. Avoiding gluten, cleansing your colon, or smoking a joint will have no effect on your risk of cancer.

But the HPV cancer preventing vaccine, known as Gardasil, is a well-researched, scientifically-based medication to prevent a long list of cancers. So we’re going to take a critical look at this new article.

In every article about Gardasil, I include a few paragraphs about the disease and the vaccine. Why? So it’s clear to the new reader how this works. A lot of casual readers think that cancer is one disease that comes from bad living. Well, it’s not. So if you’ve read every article I’ve written about Gardasil, skip this section. Or maybe it will be a good refresher.

What is HPV?

Genital human papillomavirus (HPV) is a group of several hundred papillomaviruses that afflict almost every mammal. In humans, it is the most common sexually transmitted infection (STI) in the USA.

Additionally, there are more than 40 HPV types that can infect the genital areas of males and females. Some HPV types can also infect the mouth and throat of both men and women. HPV is generally transmitted from personal contact during vaginal, anal or oral sex.

HPV is linked to cancers in men and women, and because there are so many types, research has established which HPV types are linked to certain cancers.

  • Cervicalvulvarvaginal, and anal cancers can be caused by HPV types 16, 18, 31, 33, 45, 52, and 58.
  • Genital warts are caused by HPV types 6 and 11. Although genital warts are generally benign (though unsightly), there is a small chance they develop into cancers.
  • Various precancerous lesions of the cervix, vulva, vagina, and anus can be caused by HPV types 6, 11, 16, 18, 31, 33, 45, 52, and 58
  • Oropharyngeal and penile cancers are caused by types 16 and 18.

HPV is believed to cause nearly 5% of all new cancers across the world, making it almost as dangerous with regards to cancer as tobacco. According to the CDC, roughly 79 million Americans are infected with HPV–approximately 14 million Americans contract 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 among both men and women.

What is Gardasil?

The original HPV quadrivalent vaccine, known as Gardasil (or Silgard in Europe), can prevent infection by human papillomavirus, substantially reducing the risk of these types of cancers. An HPV bivalent vaccine, known as Cervarix, is used in some countries, but only provides protection again two of the subtypes most associated with cervical cancer.

The new version of Gardasil, recently cleared by the US Food and Drug Administration, protects teens and young adults from 9 subtypes of HPV, helping prevent more cancers.

According to the package insert, Gardasil 9 is indicated in females aged 9-26 years for the prevention of cervical, vulvar, vaginal, and anal cancer caused by HPV types 16, 18, 31, 33, 45, 52, and 58; genital warts caused by types 6 and 11; and various precancerous or dysplastic lesions of the cervix, vulva, vagina, and anus caused by types 6, 11, 16, 18, 31, 33, 45, 52, and 58. The vaccine is also indicated in males aged nine through 15 years for the prevention of anal cancer caused by types 16, 18, 31, 33, 45, 52, and 58; genital warts caused by types 6 and 11; and anal intraepithelial neoplasia grades 1, 2, and 3 caused by types 6, 11, 16, 18, 31, 33, 45, 52, and 58.

I know, that’s a lot of different numbers in that paragraph. The point is Gardasil-9 prevents infections of 9 different types of HPV, all of which are linked to one or more serious and dangerous cancers in adults. Let that sink in – HPV vaccine prevents cancer. Gardasil prevents at least 6 types of cancer, and that’s better than all the “natural” supplements that you could consume.

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.

It seems I should wrap the article right at this point, and state “the Gardasil vaccine is safe and effective, and saves lives.” But I can’t, because Gardasil is probably the most attacked vaccine on the market. Let’s take a look at this most recent article attacking it.

Dr. Mahin Khatami attacks everything

In a paper by Dr. Khatami, “Safety concerns and hidden agenda behind HPV vaccines: another generation of drug-dependent society?” published in Clinical and Translational Medicine, Dr. Khatami lays out a withering attack on Gardasil, concluding that,

For over a century all directors of NIH and other governmental health agencies, cancer centers and organizations, medical schools, Big Pharma and food industry (producers of genetically modified organisms/GMOs) have been physicians (with MD degrees). The only formal duty of these leaders was to improve and promote public health, prevent diseases and save American lives. However, despite excessive investment of American resources for healthcare the opposite has occurred. American health ranks last of 11 or last of 17, compared with other developed nations. Majority of vaccines that were designed to prevent diseases caused more death and diseases than public exposures to infective agents.

Policy makers and public should take a closer look at the long-lasting ‘medical/scientific ponzi schemes’ that cancer establishment created to control a drug-dependent sick society. Millions of cancer patients who enter clinical trials are treated with drugs (poisons) and procedures that postpone their death-sentence for short duration, while their resources (insurance and personal assets) are drained! In this medical ponzi scheme, not only trillions of dollars wasted on ‘molecular false flags’, but millions of precious lives were lost to such illegal, unethical and horrendous crimes against humanity.

Instead of using common sense to promote health and prevent or delay the onset of age-associated diseases, medical establishment has managed to gradually alter and destroy the natural immunity of Americans public and shift onset of diseases to younger age for increasing the population of sick people and pushing drug sale.

This is a wake-up call to make sure that the evil part of human being does not prevent the health services that the public deserves.

Answer to cancer and increased public health is possible only if policy makers and cancer-stricken public seriously realize that the might of establishment over the right of science must be drastically reversed.

Decision makers in Congress who appropriate funds and those who direct medical sciences, should return to the forgotten values of common sense and logics that our Forefathers used for serving the public. After all ‘we may be intelligent, but if not able to think and love well being of others, we use the intelligence against humanity’.

There are all kinds of nonsense and claims in this conclusion which will become the basis of everything written by Dr. Khatami. She oversimplifies this conclusions that makes it seem that the “NIH, other governmental agencies, cancer centers, etc. etc.” are the reasons that the American health care system ranks so poorly. In fact, it’s so complicated including racial divides (rich privileged whites get better access to better medicine), along with a government that is more obsessed by the access of birth control for women than in real women’s health. Dr. Khatami is showing her naiveté and lack of expertise in sociopolitical issues in the USA by trying to blame Big Pharma and GMO foods. And any regular reader of this blog knows that GMO foods are safe as determined by a consensus of international and independent scientists.

Indicative of bad writing, Dr. Khatami wanders from Gardasil vaccine safety to some maniacal condemnation of everything that has been done to save people who contract one of the 250 different cancers. She makes an unfounded claim that the “medical establishment” has somehow destroyed the natural immunity of the American public.

Of course, some of this is based on her withering attacks on vaccines, which have somehow demolished the immune system of all children. She starts with the old canard that “the public was intentionally inoculated with millions of doses of virus-contaminated polio vaccines, which increased the deadly cancer incidence in the current… generation, particularly in America.”

Let’s spend a moment with this oft-repeated polio vaccine myth. I’ve debunked it before, but it bears repeating. According to the antivaccination cult, the central story is that the CDC admitted that 98 million Americans received the polio vaccine during an 8-year span when it was contaminated with a cancer virusOther websites essentially repeat the same nonsenseAnd it’s in the lyrics of a rap song (seriously, the stuff people send me continues to amaze).

The real story is much more complex, so I’ll bullet point it:

  • The groundbreaking and lifesaving polio vaccines, developed separately by Jonas Salk (injected, inactivated virus, vaccine) and Albert Sabin (oral, live virus, vaccine). Immunization against polio went back and forth between the two versions, though since the early 1980’s, the USA use the Salk version of the vaccine almost exclusively.
  • The vaccines were developed in the early 1950’s, and were produced using VERO green monkey kidney cell lines. Typically, viruses used in vaccines need to be “grown” in a cell line, because viruses cannot replicate themselves without hijacking a normal cell, and reproduce using that cell’s machinery. I know that some of the antivaccine crowd think that viruses are grown magically, and you can just grab a handful of them, throw them in a blender and make a vaccine–sorry, not that easy.
  • In 1959, microbiologist Maurice Hilleman found a monkey virus in both vaccines—it was the 40th simian virus (SV) to be discovered by scientists, so it was given the moniker of SV40 (creativity in naming viruses isn’t important even today). Back in the 1950’s, we didn’t have the technology that we do now to screen for contaminants in the growth medium, so the SV40 virus had contaminated the VERO line well before the beginning of production of vaccines. Not all of the VERO cells in culture were contaminated, just some of them.
  • Salk’s inactivated virus vaccine, which was treated with formaldehyde (only a tiny amount remains in the vaccine, so let’s not spend time arguing about “danger” of formaldehyde in vaccines), had very small amounts of the SV40 virus. On the other hand, Sabin’s live oral vaccine was heavily contaminated with SV40, because there was no treatment made to the vaccine to inactivate the polio virus.
  • Worried about the potential effects the virus could have on humans, researchers injected it into hamsters, finding that nearly all of them developed massive cancerous tumors. But, as I’ve said on numerous occasions, primary research should be examined carefully before accepting that it has any type of applicability to human health. And causing cancer in rodents rarely transfers to human clinical knowledge.
  • Upon further review of the initial studies, it was observed hamsters that ingested SV40 instead of being injected with it didn’t develop any cancers. In other words, Sabin’s live oral vaccine (which actually had a higher burden of SV40 than the injected, inactivated virus Salk vaccine) did not cause any cancer. Additional studies showed that children who were given Sabin’s vaccine did not develop antibodies to SV40; apparently, the virus quickly and safely passed through the child’s digestive system, never causing an SV40 infection.
  • On the other hand, Salk’s vaccine, which contained very little SV40, but was given by injection, there was evidence that some of these children might have been infected with SV40.

So there was no secret that the SV40 virus contaminated polio cultures. There was no desire to “intentionally inoculate” American children, but we have to look at American society at the time. The fear of polio was palpable during the 1950s, and since the evidence seem to show that there was a very low risk of contracting the SV40 virus, which was compared to the risk of polio.

Moreover, recent studies have shown no credible evidence (hereherehere and here) that those children who received SV40 contaminated vaccines had an increased incidence of cancer as unvaccinated children. No plausible evidence suggests that SV40 has ever caused cancer in humans. A meta review of published research from the 1960’s to 2004 showed no evidence that supported any causal link between SV40 and any cancer. A review of cancers thought to be most associated with SV40 found no evidence to support causality.

And polio vaccines have been SV40 free since 1963 in most advanced countries, although Soviet bloc vaccines were contaminated until the 1980’s.

To support her “beliefs” about the polio vaccine, she cherry-picks some articles rather than doing the right thing, and examining everything published, which from a historical and scientific perspective does not support her conspiracy theory about polio vaccine

So far, nothing about the HPV vaccine. Let’s get there.

 

Attacking Gardasil vaccine safety

I don’t get the headline for this article, since about 80% of this article is not about HPV and Gardasil vaccine safety. It’s mostly about a wide-ranging attack on cancer treatments while claiming there’s no ethical or safety considerations for their use. I’m not going to discuss those parts of the article, because her claims are simply bad on most cases. Dr. Khatami really seems to have a beef with the medical establishment. But let’s stick with Gardasil.

Dr. Khatami prefaces her attacks on Gardasil with a statement that

…a wide range of vaccine-related health problems including autism (measles vaccines), multiple sclerosis (hepatitis B), menangioencephalitis (Japanese encephalitis), Guillian-Barre syndrome and giant cell arthritis (influenza), encephalomyelitis (semple rabies), neurological problems (e.g., H1N1, swine flu) have been reported in literature. The total number of death and diseases that were caused by polio, swine flu and other specific vaccines, even BCG vaccines are greater than diseases these vaccines were intended to prevent.

How can we trust this author, if she starts with the polio vaccine myth, then moves onto the measles vaccine causing myth, which is so thoroughly debunked by real science, we can only conclude that anyone pushing that dangerous myth must be a science denier of the highest order. Vaccines are unrelated to autism. Period, end of story. I have zero respect for a “scientist” who believes in the memes and ignorant misinformation of “vaccines cause autism” crowd, but ignore the vast body of science, published in high quality journals that show no link.

As for the other issues with vaccines, they are far events substantially rarer than what is seen in the general population. Even one of the articles she cited for this section actually claims that there’s no causal link between vaccines and a claimed adverse event. Yes, there appears to be a relationship between H1N1 vaccines and narcolepsy, in Europe – but it wasn’t the vaccine, it was the adjuvant.

Finally, she makes bold faced misinformed statement that “the total number of death and diseases that were caused by polio, swine flu and other specific vaccines, even BCG vaccines are greater than diseases these vaccines were intended to prevent.” There is no evidence to support that and none of her citations support it either. It’s like she decided to read a few package inserts, and make a broad conclusion from it. Oh yeah, she cites known anti-vaccine shill, Barbara Loe Fisher, as part of her support. Oh give me a break.

Then Dr. Khatami goes on the attack on Gardasil vaccine safety:

Professionals and policy makers in other countries started raising serious questions (pdf) about the “scientific uncertainties related to the safety of HPV vaccines…Sloppy science, combined with unprofessional and unfair criticism of independent research, such as the one the EMA raised against the diligent Danish researchers, is a serious threat to scientific progress and public health…”.

Dr. Khatami then relies upon an article by a SaneVax (read, anti-vaccination shill) author regarding this:

Recent clinical data already suggest adverse effects of HPV vaccines, composed of genotype-specific capsid proteins variations (e.g., HPV-16, HPV-6 or HPV-11) or expression of detectable HPVL1 protein and DNA fragments in aluminum-containing adjuvant, of virus-like-particles-VLPs by DNA recombinant methodologies.

More cherry picking, in each case.

In the former, I critiqued the claims pushed forward by  the Danish group attacking HPV vaccines. The European Medicines Agency (EMA), the European version of the FDA, stated the following:

The European Medicines Agency’s Pharmacovigilance Risk Assessment Committee (PRAC) has completed a detailed scientific review of the evidence surrounding reports of two syndromes, complex regional pain syndrome (CRPS) and postural orthostatic tachycardia syndrome (POTS) in young women given human papillomavirus (HPV) vaccines. These vaccines are given to protect them from cervical cancer and other HPV-related cancers and pre-cancerous conditions.

This review concluded that the evidence does not support a causal link between the vaccines (Cervarix, Gardasil/Silgard and Gardasil-9) and development of CRPS or POTS. Therefore, there is no reason to change the way the vaccines are used or amend the current product information.

PRAC thoroughly reviewed the published research, data from clinical trials and reports of suspected side effects from patients and healthcare professionals, as well as data supplied by Member States. It also consulted a group of leading experts in the field, and took into account detailed information received from a number of patient groups that also highlighted the impact these syndromes can have on patients and families.

Their reasoning was based on solid scientific evidence that overwhelming supports the lack of a causal relationship:

Symptoms of CRPS and POTS may overlap with other conditions, making diagnosis difficult in both the general population and vaccinated individuals. However, available estimates suggest that in the general population around 150 girls and young women per million aged 10 to 19 years may develop CRPS each year, and at least 150 girls and young women per million may develop POTS each year.

The review found no evidence that the overall rates of these syndromes in vaccinated girls were different from expected rates in these age groups, even taking into account possible underreporting. The PRAC noted that some symptoms of CRPS and POTS may overlap with chronic fatigue syndrome (CFS, also known as myalgic encephalomyelitis or ME). Many of the reports considered in the review have features of CFS and some patients had diagnoses of both POTS and CFS. Results of a large published study that showed no link between HPV vaccine and CFS were therefore particularly relevant.

If you don’t have the time to read all of PRAC’s reasoning for dismissing these claims, let’s get to their final conclusion:

The PRAC concluded that the available evidence does not support that CRPS and POTS are caused by HPV vaccines. Therefore there is no reason to change the way the vaccines are used or amend the current product information.

The Danish researchers were simply wrong.

And in the latter safety claim, regarding DNA fragments, was also debunked in an article I wrote. The claim made, and completely accepted by Dr. Khatami, was that somehow aluminum adjuvants (a compound that increases the immune response to the antigens injected) bound to HPV DNA fragments and caused the death of a child.

You can read the whole article to get the gist of the issue, but here’s the quick conclusion:

  • Dr. Lee’s hypothesis that some HPV DNA particle links to aluminum lacks two things: repetition by another, independent, researcher, and clinical importance. Who cares if the DNA is linked to aluminum, it’s just using big words to scare us. Unless someone says “hey this is why we are concerned, and here’s 2000 data points from a double blind, randomized clinical trial,” this barely rises to the level of observation.
  • Dr. Lee is supported by SANEVax, a notorious anti-vaccine gang. This, itself, doesn’t negate Dr. Lee’s work, but when added to his biases and lack of clinical research, it does point me in a direction of “this doesn’t smell right.”

SANEVax and Dr. Lee have been in bed together for a long time. David Gorski took on this nonsense 5 years ago (please read the article, it goes into more detail about Dr. Lee’s claims about HPV DNA). And here’s what Dr. Gorski had to say about HPV DNA and aluminum:

Wow. Sounds pretty scary, doesn’t it? Actual HPV DNA! But not just any HPV DNA. Oh, no. We’re talking recombinant HPV-11 and HPV-18 residues, which–horror of horrors!–were attached to the dreaded aluminum adjuvant! Stop the factories! Stop injecting our little girls with that evil vaccine whose only purpose is to encourage them to go out and have unprotected sex, knowing that they won’t get HPV!Now hold on just a minute. I got a little carried away.

Yeah, the same “SaneVax” that Dr. Khatami uses as a citation in an ostensibly quality article on HPV vaccine. Yet, we find nothing.

Gardasil vaccine safety has been established

Several large (really huge) epidemiological retrospective studies have carefully examined any potential risks of adverse events related to HPV vaccinations. Here are just a sample:

Khatami completely ignored these high quality epidemiological studies because they didn’t fit in her preconceived conclusions, which is the opposite of the scientific method. She wanted to crush HPV (for what appears to be a well developed conspiracy theory). Whatever her reason, ignoring large scale studies that refute the hypothesis that the HPV causes anything is ridiculous. Who peer reviewed this article?

One last thing – appeal to authority

No matter what I write here, the anti-vaccination crowd will say “look Gardasil is dangerous, because a top researcher wrote about it in a peer-reviewed article.” But this works only if you ignore the major faults with this article (and I didn’t even go into her specious claims about cancer treatments), and cherry pick bad articles (and anti-vaccine shills). If one uses the scientific method, and see where the really well done evidence leads, the conclusion is simply that the HPV vaccine is safe and very effective.

I’ve written about the appeal to authority logical fallacy before. It was an article about Tetyana Obukhanych, who seems to have all the credentials of a leading immunologist, yet isn’t highly published, nor seems to have any foundation in real immunology. Even though she’s an unemployed immunologist (I mean if she was so great, she could work anywhere) who has never studied vaccines, the anti-vaccine cult loves to quote her nonsense about vaccines.

The same here. Dr. Mahin Khatami seems to have some good credentials (though, as I always say, Ignore All Credentials) – she has a Ph.D. in molecular biology. But that certain does not make her an expert in immunology, epidemiology and vaccines. Almost all of Khatami’s research is in cancer research, where she is not very popular. Dr. Khatami was forced to retire from the NIH (yeah, here comes the conspiracy theories that she’s being silenced). After which, she started harassing one of the NIH directors, and a Peace Order had to be filed against Khatami. I’m not sure that’s indicative of a stable person.

Like many other scientists who wander outside of their field, they decide to chime in on something about which they have little or no experience, such as the HPV vaccine. Neil deGrasse Tyson can tell me anything about astrophysics, and I’m going to assume, as long as he doesn’t violate the basic science of the universe as I understand them, I’ll accept what he says. But if Tyson starts saying “vaccines done’t work because…,” I would simply ignore him.

Now, in my world of Tyson, if he stepped up to say “vaccines don’t work” because these 300 peer-reviewed articles seem to indicate that his hypothesis is accurate. In other words an authority becomes a false authority once they ignore the scientific consensus without contravening  evidence, they are just a science denier. And authority can be an expert in another field by examining the scientific consensus and rejecting low quality criticisms of that consensus. That’s why Neil deGrasse Tyson is a supporter of vaccines.

Remember one more thing. Khatami’s article is not a scientific one with original research and data. It is not a meta-review with lots of data. It’s a commentary. An opinion piece. An editorial by someone with an axe to grind.

But we can all guess how this article will spread through the anti-vaccine cult as “proof” of the failure of Gardasil.

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!