This is the 2nd out of 13 most popular articles on Skeptical Raptor for the 2016 Year in Review. It’s all about debunking the Gardasil safety and efficacy myths.
Recently, I read an article published in Pediatrics that described how educating either teenagers or their parents about HPV vaccinations had little effect on the overall vaccination rate for the vaccine. Essentially, the researchers found that it was a 50:50 probability that any teen would get the vaccine, regardless of their knowledge of HPV and the vaccine itself. Some of the reasons why the HPV vaccine uptake is so low is a result of several myths about Gardasil safety and efficacy.
So I thought about why that Pediatrics study found that education about HPV and Gardasil didn’t move the needle on vaccination uptake. It’s possible that the benefits of the vaccine is overwhelmed by two factors–first, that there’s a disconnect between personal activities today vs. a disease that may or may not show up 20-30 years from now; and second, that the invented concerns about the HPV quadrivalent vaccine, promulgated by the usual suspects in the antivaccination world, makes people think that there is a clear risk from the vaccine which is not balanced by preventing cancer decades from now. It’s frustrating.
What is HPV?
Genital human papillomavirus (HPV) is the most common sexually transmitted infection (STI) in the USA. There are more than 40 HPV sub-types that can infect the genital areas of males and females. Additionally, some HPV types can also infect the mouth and throat. 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 subtypes, research has established which HPV types are linked to certain cancers.
- Cervical, vulvar, vaginal, 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 subtypes 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.
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.
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.
A few weeks ago, I posted an article about how to actually prevent cancers. There are no magical panaceas that prevent any of the 250 or so cancers. There’s no magical supplement or pill. There are just a few ways to prevent cancers–stop smoking, stay out of the sun, lose weight, avoid radiation, and get the HPV vaccine.
Gardasil prevents at least 6 types of cancer, and that’s better than all the “natural” supplements that you could consume.
I’ve written nearly 50 articles about the HPV vaccine, mostly debunking myths, but also reviewing some of the best literature published today. I thought I’d bring them together in one place, so that it can work as a link of links for HPV vaccine information and myth debunking. I’ll just link to my articles that deal with the subject, and within those articles will be links and citations for the peer-reviewed articles, which hopefully will help the reader, if you are concerned about Gardasil safety and efficacy, or maybe you’ll pass it to someone else, if they are on the fence.
Gardasil is safe
- In a large study, that included nearly 200,000 young females who had received the vaccine, the researchers found that the vaccine was only associated with same-day syncope (fainting) and skin infections in the two weeks after vaccination. The authors stated that, “this study did not detect evidence of new safety concerns among females 9 to 26 years of age secondary to vaccination with HPV4.”
- In another huge study, that included nearly 1 million young females, a HPV vaccinated cohort was compared to an unvaccinated cohort. The authors concluded that “this study identified no safety signals with respect to autoimmune, neurological, and venous thromboembolic events after the qHPV vaccine had been administered.”
- Digging for data in VAERS, the Vaccine Adverse Event Reporting System, in an attempt to show some relationship between report adverse events and Gardasil is a form of “dumpster diving” for data. VAERS, a passive reporting system, is barely more than an anecdotal reporting system, not scientific. There is no review of medical records, a inquest into a causal relationship, or anything else that real clinicians would use to ascertain causality.
- Gardasil does not cause blood clots.
- Eight years of post licensure studies have shown no significant relationship between the vaccine and serious adverse events.
- An eight year clinical trial comparing the HPV vaccine vs. a saline control group (the saline control group eventually received the vaccine, after the study endpoints were reached) show no difference in adverse events.
- Even though there was no plausibility, researchers found that the HPV vaccine was unrelated to an increase the risk of multiple sclerosis (MS) or some other acquired central nervous system demyelinating syndrome (CNS ADS).
- Another huge study, including nearly 2 million doses of HPV quadrivalent vaccine, showed no increase risk of multiple sclerosis or other demyelinating neurological disorders in vaccinated vs. unvaccinated groups.
- A review of all of the post-licensure studies of quadrivalent HPV vaccines provide strong evidence that Gardasil is extremely safe.
- The European Medicines Agency is reviewing some potential adverse events that may or may not be related to HPV vaccines. It’s based on some very badly done, very biased studies.
- HPV vaccine anecdotes are not the basis of real science.
- No, the HPV vaccine does not cause primary ovarian insufficiency.
- Christopher A. Shaw and Lucija Tomljenovic are back with bad research (that may have been retracted). No the HPV vaccine does not cause behavioral problems.
- The American College of Pediatricians claims that Gardasil harms girls. Then they prevaricate. Then they don’t. Who knows? But we do know that they’re trying to co-opt the name of the American Academy of Pediatrics, which is a real science based organization that loves HPV vaccines.
- HPV vaccine and lupus – bad expert testimony in a lawsuit – no, Gardasil does not cause autoimmune diseases.
- A false authority attacks Gardasil – no, Gardasil does not harm people.
Gardasil is effective
- Gardasil has been shown to retain effectiveness at least 8 years post-vaccination.
- The vaccine has shown to reduce the risk of cervical neoplasms by nearly 40% in large population of Danish women.
- Since the vaccine was introduced in the USA in 2006, the prevalence of the HPV types prevented by the vaccine decreased by 56% among female teenagers, 14-19 years old.
- HPV infection rate in the UK dropped significantly after release of the HPV vaccine.
- Free HPV vaccine in Australia cause a greater than 60% drop in HPV infection rates.
- Even one dose of the HPV vaccine is sufficient to prevent cancer.
- More powerful Gardasil cancer prevention vaccine is recommended for teens and young adults.
- The Gardasil cancer prevention vaccine saves money by reducing the rate of oropharyngeal cancer in men.
- Gardasil cancer prevention vaccines prevents pre-cancerous lesions (cervical dysplasia) in girls 3-4 years after vaccination.
- The HPV vaccine prevents cancer in men and saves lives. Time to get that HPV vaccine uptake higher.
- The new, more powerful, version of the HPV vaccine , recently cleared by the US Food and Drug Administration, protects teens and young adults from 9 subtypes of HPV, helping prevent more cancers. The new vaccine, called Gardasil-9, prevents even more types of cancer.
- The CDC has recommended Gardasil for children who have been subjected to sexual abuse.
- Evidence has shown that the HPV infection rate is dropping in US teens as a result of the HPV vaccine. Good news!
- Increased uptake of Gardasil 9 will lead to a large reduction in HPV-related cancers and lower healthcare costs.
- HPV vaccine effectiveness – cervical cancer rate halved in 10 years.
- HPV vaccine effectiveness – even better than we thought – we’re getting better and better information that HPV vaccines are reducing the incidence of some cancers!
- We have a cancer prevention vaccine, and it’s called Gardasil – how many times do we have to say this?
The Japanese Health Ministry seems to love myths, so there has been a big kerfuffle in that country regarding HPV cancer preventing vaccine. Here are my articles that focus on that country’s activities with the HPV vaccine.
- Japan’s Ministry of Health did withdraw its recommendation for the vaccine, but only because they used bad mathematics. They accepted supposed “adverse events” after Gardasil vaccine as causal, even though the rate after vaccination was LOWER than the general non-vaccinated population.
- Japanese HPV vaccine lawsuit – no science, no evidence. A bunch of lawyers in Japan are trying to get money for their clients who were “injured” by the HPV vaccine. Of course, all evidence contradicts their claims.
- No no no. Japan did not ban Gardasil. Of course, they didn’t.
More about Gardasil safety and efficacy
- The HPV vaccine does not make young women more promiscuous or engage in more risky sexual behavior. In fact, it appears that those women who do so actually choose to get the vaccine to protect themselves.
- A French Court hands down a ludicrous decision stating that Gardasil caused damage to a young girl. Courts are not capable of deciding about scientific facts, unless you’re trying to create a vaccine manufactroversy.
- Gardasil does not make teens more promiscuous, despite a certain church’s adamant refusal to allow their teens to get the vaccine.
- And once again, Gardasil does not make teens more promiscuous and does not lead to risky sexual behavior.
- A French researcher claimed that he had “inside knowledge” of the Merck’s activities in manipulating data about the dangers of Gardasil. Interesting that he never worked for Merck, actually worked for a drug distributor (they don’t develop or research vaccines), and was made redundant when Merck acquired the distributor. In other words, he had no inside knowledge.
- The vaccine package insert doesn’t say what many think it says.
- Parents are refusing to immunize their kids against HPV for a wide range of reasons.
- A case report study, of no scientific or statistical value, claims that the HPV vaccine causes Postural orthostatic tachycardia syndrome (POTS), except they didn’t even diagnose it. Bad study.
- American boys aren’t getting cancer preventing HPV vaccine. We need to change this uptake.
- Gardasil DNA and aluminum – another manufactroversy debunked with nary a sweat bead forming on my forehead.
- Diane Harper, lead Gardasil researcher – what are the facts? Updated article about Diane Harper and her opposition or support of HPV vaccines.
As I’ve said a thousands times, there are no debates about vaccines, and certainly none about Gardasil safety and efficacy. The real science, published in real medical journals, and reviewed by experts in epidemiology, virology, infectious diseases, cancer, and other biomedical researchers, is all that matters. If the other “side” wants to be taken seriously, they need to get a Ph.D., get into real research, and publish real papers. I’m going to guess that if they did that, they would realize that vaccines are safe and effective, and they’d become as loud an advocate as I am.
Let’s be clear. Gardasil prevents cancer. And it’s about as safe a vaccine that’s ever been made. Every teenager in the USA, where the vaccine is essentially free (drop a comment if you can’t get it for free, and I’ll point you in the right direction), should get the vaccine.
Editor’s note: This article was originally published in December 2014. It will be constantly updated to include more comprehensive information, to improve readability and to add current research.
- Fishman J, Taylor L, Kooker P, Frank I. Parent and Adolescent Knowledge of HPV and Subsequent Vaccination. Pediatrics. 2014 Sep 15. pii: peds.2013-3454. [Epub ahead of print] PubMed PMID: 25225141.