Vaccines saves lives–HPV scientific evidence part 2
© Copyright CSL, 2013. All Rights Reserved.
Human papillomavirus (HPV) is a virus from the papillomavirus family that is capable of infecting humans. Like all papillomaviruses, HPVs establish productive infections only in keratinocytes of the skin or mucous membranes, making it easily transmitted sexually or through other intimate contact. While the majority of the known types of HPV cause no symptoms in most people, some types can cause warts (verrucae). HPV types 16 and 18 cause approximately 70% of cervical cancers, and cause most HPV-induced anal, vulvar, vaginal, and penile cancers. The HPV quadrivalent vaccine, also known as Gardasil (or Silgard in Europe), is marketed by Merck. The vaccine prevents the transmission of certain types of HPV, specifically types 6, 11, 16 and 18.
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Updates: LeRoy mystery neurological illnesses
This article is an update of one I wrote several months ago. I had presumed the story had ended. It hadn’t.
Background
In spring 2012, I had written a few articles about a mystery neurological ailment that had struck about 20 teenagers at a high school and surrounding area in LeRoy, NY, a small town about 30 minutes from the city of Rochester. They suffered tics that mimicked Tourette syndrome, but was never diagnosed as such. Most of them have recovered, although two new cases have appeared.
Medical and scientific findings
First, Erin Brockovich, yes THAT Erin Brockovich, decided to get involved. In an announcement in August, they stated that they found nothing:
There is no link specifically that I can draw to environmental exposure because there are so many environmental exposures that occurred at the high school.
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Religion vs Gardasil
Although I rarely state it on these pages, I am an atheist. As a scientist, I’ve examined the evidence for a god (any god), and found it lacking. I think religion, especially in the USA, can be dangerous. Religious fundamentalism is behind the attack on teaching of real science, such as evolution and global warming. Although some may argue that trying to block the teaching of evolution, in favor of creationism, is innocuous (though absolutely unconstitutional), most would argue that since evolution is the basis of all biology (and therefore, medicine), it is harmful.
It’s when fundamentalist religion gets involved in medicine, whether it’s therapeutic abortions, vaccines, or stem-cell research, that it’s clear that religion becomes dangerous to human lives. I just want to focus on one tiny corner of the medical world, where religious beliefs block good medicine–HPV vaccinations.
For those of you may be unfamiliar with the HPV vaccine, it prevents infection by the human papillomavirus (HPV), a sexually transmitted disease. The vaccine, known as Gardasil or Cervarix in the USA, specifically blocks HPV types 6, 11, 16 and 18; HPV types 16 and 18 cause approximately 70% of cervical cancers, and cause most HPV-induced anal, vulvar, vaginal, and penile cancers. Cervical cancer, which afflicts 12,000 additional women and causes over 4,000 deaths annually in the USA, is considered the “preventable gynecologic cancer” because of the HPV vaccines.
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Survey identifies reasons for not vaccinating teens
Vaccines are one of the most important and crucial aspects for the long-term health of babies and young children. Except for a tiny, and irresponsible, minority of individuals who are opposed to vaccinations, greater than 95% of children are fully vaccinated for most vaccine preventable diseases by kindergarten. Unfortunately, a recently published article in Pediatrics provided evidence that teens are not keeping up with vaccinations that are critical to avoid infections from serious, and deadly, diseases. The study examines how vaccination rates have changed over the three year study period, and some of the reasons why they are not getting vaccinated.
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I get an email about Gardasil
I get lots of email about my articles that are published here. Sometimes, it’s about grammar or spelling (and the grammar KGB can be uncivil at times). Sometimes, it’s compliments or questions about what I’ve written. Rarely, they’re rude and usually include quite immature comments about the location of my head. However, I recently received an email that is more or less polite, but is filled with so many errors and logical fallacies, that I thought it should be critiqued publicly.
Here are my point-by-point comments about the email:
I stumbled across your blog and could not believe what I was reading about the safety of Gardasil. As a mother of a Gardasil injured daughter, your profuse endorsement made me skeptical. I want to begin by saying I am not anti-vaccine; I am anti-Gardasil.
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HPV–early vaccination maximizes effectiveness
HPV protesters in Texas.
Human papillomavirus (HPV) is a virus from the papillomavirus family that is capable of infecting humans. Like all papillomaviruses, HPVs establish productive infections only in keratinocytes of the skin or mucous membranes, making it easily transmitted sexually or through other intimate contact. While the majority of the known types of HPV cause no symptoms in most people, some types can cause warts (verrucae). HPV types 16 and 18 cause approximately 70% of cervical cancers, and cause most HPV-induced anal, vulvar, vaginal, and penile cancers. The HPV quadrivalent vaccine, also known as Gardasil (or Silgard in Europe), is marketed by Merck. The vaccine prevents the transmission of certain types of HPV, specifically types 6, 11, 16 and 18.
Although the safety of HPV vaccine has been thoroughly vetted for safety in studies with large cohorts, the long time period (up to decades) from infection to a diagnosis of an HPV-related cancer has left questions about how to maximize effectiveness of the vaccine which required further research.
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Whatever happened to the LeRoy mystery neurological illnesses?
In spring 2012, I had written a few articles about a mystery neurological ailment that had struck about 20 teenagers at a high school and surrounding area in LeRoy, NY, a small town about 30 minutes from the city of Rochester. They suffered tics that mimicked Tourette syndrome, but was never diagnosed as such. Most of them have recovered, although two new cases have appeared.
Entering the Way-back Machine, let’s see what has happened.
First, Erin Brockovich, yes THAT Erin Brockovich, decided to get involved. In an announcement in August, they announced that they found nothing:
There is no link specifically that I can draw to environmental exposure because there are so many environmental exposures that occurred at the high school.
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Large study supports safety of Gardasil HPV vaccine
A study published in the current online issue of Archives of Pediatrics & Adolescent Medicine affirms the safety of the HPV quadrivalent vaccine, also known as Gardasil (or Silgard in Europe), is marketed by Merck. The vaccine prevents the transmission of certain types (pdf) of human papillomavirus (HPV), specifically types 6, 11, 16 and 18. HPV types 16 and 18 cause approximately 70% of cervical cancers, and cause most HPV-induced anal, vulvar, vaginal, and penile cancers.
The large study, which included nearly 200,000 young females who had received the vaccine, found that the vaccine was only associated with same-day syncope (fainting) and skin infections in the two weeks after vaccination. These findings support other large studies that also found the vaccine safe and an appropriate strategy to prevent cervical cancers. 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 an article in Science News, lead author Nicola Klein, MD, PhD, co-director and research scientist at the Kaiser Permanente Vaccine Study Center in Oakland, Calif, stated that,”taking into account all the analyses, subanalyses and relevant medical record reviews, an independent safety committee noted that there may be an association between HPV4 vaccination and same-day syncope, as well as skin infections during the two weeks after immunization.” Fainting is not an unexpected result with vaccinations reported the authors, because injections of all types are correlated with fainting.
The study’s strengths, a large, ethnically diverse population who received a total of nearly 350,000 HPV4 doses; an integrated health care delivery system (Kaiser-Permanente) that assured complete or near-complete medical information and follow-up; and a “pre-specified, validated, clinically meaningful system to categorize all outcomes.”
This study is powered in a way to find causal links to vaccinations as opposed to anecdotes, since patients are closely monitored after the vaccinations. The results strongly confirm the safety of this important vaccine and set aside the rumors and gossip that have floated across the internet about Gardasil.
Let’s repeat what was found in this study. 350,000 doses given. The only adverse reactions were fainting, an expected outcome from any needle injection, and skin infection, another expected (and preventable) outcome. So, in a well controlled study, where the patients could be observed carefully in a modern healthcare environment, no dangerous adverse events were observed. A vaccine that can prevent cancers–dangerous, life-threatening cancers–is safe.
So, who are you going to believe, a website that publishes anecdotes, or worse yet, lies? Or a huge, scientific study published in the Journal of the American Medical Association, one of the premier medical journals in the world? Unless you prefer pseudoscience, the answer should be easy.
Gardasil Saves Lives.
Anti-vaccine lunacy–more lies about Gardasil
One of the hallmarks of pseudoscience is an over-reliance on confirmation rather than refutation of a hypothesis. The anti-vaccine crowd are well-known for this particular violation of the scientific method. As discussed previously, science works on refutation–creating experiments that might actually disprove a hypothesis as a method to develop evidence in support of it. The anti-vaccination crowd actually hypothesizes (but not in a scientific sense) that a vaccine or set of vaccines was the causal factor in some side effect (autism, death, or whatever else), then they should establish an experiment (double-blinded of course) that would refute that hypothesis. If at some point, the data cannot refute it, then the anti-vaccinationists would have supporting data for their particular supposition.
But instead of actually performing experiments (which cost money, which may show that they are wrong, or which might not be ethical), they resort to mining data to prove their point. Data mining is dangerous, because confirmation bias, that is, finding information or data that supports a belief while ignoring all other data that does not, makes the data suspect or even useless. So, in that vein, the anti-vaccinationists often mine data from any database they can find, such as the Vaccine Adverse Event Reporting System (VAERS), which is a program for vaccine safety, managed by the Centers for Disease Control and Prevention (CDC) and the Food and Drug Administration (FDA). VAERS functions as a post-marketing safety surveillance program (similar to other programs for almost every regulated medical device and pharmaceutical) which collects information about adverse events (whether related or unrelated to the vaccine) that occur after administration of vaccines. VAERS has numerous limitations, including lack of scientifically designed questions, unverified reports, underreporting, inconsistent data quality, and absence of an unvaccinated control group. VAERS is basically a collector of information, but has limited value in making conclusions since it does not provide information that is obtained in a controlled manner. However, it does have some usefulness, in that certain trends may be spotted given enough time and data points.
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Why do Americans hate Gardasil?
In next week’s issue of Forbes, Matthew Herper, the magazine’s medical editor, penned the article, The Gardasil Problem: How The U.S. Lost Faith In A Promising Vaccine, an insightful analysis of why Gardasil, the vaccine for human papillomavirus (HPV), has not become as important to vaccination strategies as measles or whooping cough. All vaccines keep you alive, even if the disease does not appear to be scary. There’s a belief, especially amongst the anti-vaccination crowd, that measles is just a few spots, and there are few risks to being infected. The risk of severe complications is small, but significant.
On the other hand, the HPV vaccine does one thing and does it well–it prevents an HPV infection. Human papillomavirus, a sexually transmitted disease, causes 70% of cervical cancers, 80% of anal cancers, 60% of vaginal cancers, and 40% of vulvar cancers. It also prevents the majority of HPV caused oral cancers. In other words, these diseases are in a different league of danger. And they can be prevented.
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CDC makes recommendations on the use of HPV vaccine in males
The CDC’s Advisory Committee on Immunization Practices (ACIP) recommends routine vaccination of males aged 11 or 12 years with HPV4 administered as a 3-dose series (recommendation category: A, evidence type: 2§). The vaccination series can be started beginning at age 9 years. Vaccination with HPV4 is recommended for males aged 13 through 21 years who have not been vaccinated previously or who have not completed the 3-dose series. Males aged 22 through 26 years may be vaccinated.
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Another bogus anti-vaccination paper
I use Twitter not only to tweet about my favorite sports teams, but to see what’s being said in science, medicine, politics, and anything interesting. I actually have a list (you can read by list if you want) that I call “Pseudoscience” that are tweets from the biggest anti-science medical people around. Today, I received the following tweet:
So that lead me to a post at “Natural News” (OK, I’ll admit that my skeptical radar fired up) entitled, “Medical journal openly questions science, ethics of HPV vaccinations.” As an aside, Natural News’ url for the article is “vaccinations_quack_science_medical_journals.html”; not very subtle are they?
First a little background is necessary before starting this story. Gardasil (Merck’s brand name) is a vaccine against human papillomavirus (HPV), a sexually transmitted virus. In early stages, HPV only results in mild symptoms like warts in the genital and anal areas, but in some cases can lead to cervical cancers. The vaccine not only prevents the transmission of the disease but seems to reduce the long-term risks of cancer.
But, I digress. Imagine my reaction to the article. ”Oh no, HPV vaccinations are unethical!!!!!” Call the police. I’ve been all wrong about vaccines. Oh wait, let me look up the original article, because even very unbiased news sources like the Wall Street Journal and New York Times sometimes get medicine wrong. Let me run over to the article before I post my mea culpa about vaccines.
The article, Human papillomavirus (HPV) vaccine policy and evidence-based medicine: Are they at odds?, published in the Annals of Medicine in December 2011. The authors, Tomljenovic and Shaw are associated with the University of British Columbia, Department of Ophthalmology. I don’t want to degenerate into some sort strawman fallacy, but I question why two individuals in a medical specialty, ostensibly involved with the eyes, are so obsessed with vaccines. Furthermore, they have a long history of anti-vaccination papers, most published in low impact journals. For example, they recently published an article correlating aluminum with autism, though the correlation is specious and providing no causality. One of the worst mistakes of research is conflating causality and correlation.
Moving on to the article, their abstract states:
All drugs are associated with some risks of adverse reactions. Because vaccines represent a special category of drugs, generally given to healthy individuals, uncertain benefits mean that only a small level of risk for adverse reactions is acceptable. Furthermore, medical ethics demand that vaccination should be carried out with the participant’s full and informed consent. This necessitates an objective disclosure of the known or foreseeable vaccination benefits and risks. The way in which HPV vaccines are often promoted to women indicates that such disclosure is not always given from the basis of the best available knowledge. For example, while the world’s leading medical authorities state that HPV vaccines are an important cervical cancer prevention tool, clinical trials show no evidence that HPV vaccination can protect against cervical cancer. Similarly, contrary to claims that cervical cancer is the second most common cancer in women worldwide, existing data show that this only applies to developing countries. In the Western world cervical cancer is a rare disease with mortality rates that are several times lower than the rate of reported serious adverse reactions (including deaths) from HPV vaccination. Future vaccination policies should adhere more rigorously to evidence-based medicine and ethical guidelines for informed consent.
I won’t go through each point, but a couple are important to refute:
- Uncertain benefits. The Centers for Disease Control disagrees.
- Clinical trials show no evidence that HPV vaccination can protect against cervical cancer. This is partially true, since HPV-related cancers can take from 15-25 years to arise. Epidemiological data takes time. However, we know that HPV is the cause for several types of cervical and other cancers, so preventing HPV is a logical choice to make, given the prevalence of the virus.
- Vaccination polices should adhere more rigorously to evidence-based medicine. It does already. Pretty strongly. Anti-vaccination, as best as I can tell, is based on fraudulent journal articles (see anything by Andrew Wakefield).
HPV vaccine is safe and efficacious. If you need more information on the HPV vaccine safety, the good researchers at Science Based Medicine did a great article called, The HPV Vaccine (Gardasil) Safety Revisited.
Let me make this clear. Every single medical procedure, pharmaceutical, and device has some risk associated with it. Can you get an infection at the injection site? Yes! Can you be allergic to the injection? Yes! Can it cause paralysis? No. Can it cause a broken leg? No, though if you did a random study, you’d find a large percentage of young girls who broke their legs within six months of being vaccinated, so obviously correlation is equivalent to causation. Or it doesn’t.
If Tomljenovic and Shaw could prove either no benefit with some measurable risk, or little benefit with large risk, then there is an ethical issue with the HPV vaccine. But actually, there is a high level of benefit with almost no risk, or risk that actually is imaginary rather than shown in evidence based medicine. You see, just because you use “evidence-based” in your article title, it doesn’t mean you actually follow it.
HPV vaccine should be recommended for all young men and women (yes, I said men too), reducing the future risk of cancer and it’s burden to the family, individual and health-care system.
