A few weeks ago I wrote an article about Emma Mhic Mhathúna was a 37-year-old Irish mother of five who died in October 2018 from cervical cancer – an easily diagnosed and treated cancer if discovered early. She died because of a pap smear scandal in Ireland that led her to receive a false negative on her two pap smear tests in 2016. As a result of this scandal, HPV vaccine uptake has increased for preventing cervical cancer. Continue reading “Preventing cervical cancer – HPV vaccine uptake increases in Ireland”
On 5 October 2018, the FDA expanded the licensing Gardasil 9 – currently the only HPV vaccine marketed in the United States – to men and women up to the age of 45. If up till now getting the adult HPV vaccine was not a realistic option for me, now it was. But at this point, the vaccine is not yet recommended for my age group – the Advisory Committee on Immunization Practices has not made any additional recommendations after licensing. Which raised the question: should I get it?
On one hand, I am in a committed monogamous relationship. I am a married mother of two young children, I have no plans of changing partners, and I’ve already probably been exposed to anything my husband had. I have never had an abnormal pap smear. That means that I am likely pretty low risk for getting a new HPV infection and that I have cleared any I ever had (almost all sexually active people in the United States have had HPV). If you are in a relationship, including marriage, and if you had children, you likely had sex at some point.
So the benefits of the adult HPV vaccine for me are low – but not non-existent. You never know what will happen, and while I hope to stay with my partner forever, bad things can happen – like death or sexual assault. One hopes for the best, but it’s reasonable to also plan for the worst (for example, while we do not plan to die, we have a will written out with provisions for caring for our kids if we do) – and the vaccine is age-limited. There are nine cancer-causing HPV strains in the vaccine, and I am fairly certain that I have not been exposed to all of them.
The risks of the adult HPV vaccine are extremely minor. I’m likely to get a sore arm, may get other mild reaction like fever, and have a theoretical reaction of an allergic reaction (or fainting, though not being a teen, I think that’s unlikely). Studies pretty much rule out other risks.
In spite of anti-vaccine claims, getting the vaccine after being exposed to HPV does not increase your risk of cancer (but the vaccine won’t protect you against strains you were already exposed to).
So the adult HPV vaccine has low benefits but minuscule risks, at least for me. Still, it seemed to me to make sense to go for it, if possible. Especially because I speak up about HPV vaccines and encourage others to go for them, I thought it’s fair to get them myself, too. Show I mean it when I say that they are safe.
To be sure, I emailed Dr. Paul Offit, who I trust completely on vaccines. He recommended going for it.
I did not know, however, if my provider will give me the vaccine or if my healthcare insurance will cover it at my age (most health insurance in the USA does cover all vaccines, including the HPV vaccine, for children). In spite of what anti-vaccine people believe, I do not have secret ties to pharma or special access to vaccines.
So I emailed my doctor:
Dear Dr. X,
Since the FDA approved HPV vaccines for people up to 45, I would like to get the vaccine, if possible.
I emailed Dr. Paul Offit, a vaccine expert, for his opinion, and he recommended getting it.
Can you help me do that?
My doctor said: “Sure, let me see what our protocol is here and get back to you.”
After I did not hear back for over a week, I emailed again. My doctor answered:
Sorry that I could not repond in a timely manner.
I had forwarded your request to Dr. Y [details omitted to preserve my providers’ – and my own – privacy] but did not hear from them. I have ordered the shots. You can call your … health plan to see if it will be covered just to be sure.
You can go to ### injection clinic Mon-Fri 9am-12pm, 1:30-4:30 pm for the shot (ordered already).
Okay. All that was left was to actually get the vaccine. I wanted a picture – so I asked my eight-year-old son if he will act as photographer and come with me. He agreed. We went together, waited, and went in. I told him to take a lot of pictures all through, and he did.
The nurse asked if I was feeling okay, if I ever had a reaction to a vaccine, if I was allergic to latex or anything else I knew of (yes, no, no). She explained what the shot was, and gave me the Vaccine Information Statement. We also wrote out the schedule for the next two doses. Then she cleaned the area, told me to take a deep breath and let it out, and done. I barely felt the needle.
She told me my arm will hurt for a day or two. It didn’t, actually. Not complaining. I’m okay with less pain. But I would have been okay (not happy, but okay) with a sore arm for a few days, too.
My son did a great job taking a lot of pictures. I posted several of those pictures on Facebook and Twitter, because, again, I think it’s important to make it clear I stand behind what I say on HPV vaccines specifically, and vaccines generally.
So that’s my adult HPV vaccine story. One dose down, two to go. Maybe my arm will hurt next time.
The HPV cancer-preventing vaccine, especially Gardasil (or Silgard, depending on market), has been targeted by the anti-vaccine religion more than just about any other vaccine being used these days. So many people tell me that they give their children all the vaccines, but refuse to give them the HPV vaccine based on rumor and innuendo on the internet. This article provides all the posts I’ve written about Gardasil safety and efficacy.
As many regular readers know, I focus on just a few topics in medicine, with my two favorites being vaccines and cancer – of course, the Gardasil cancer-preventing vaccine combines my two favorite topics. Here’s one thing that has become clear to me – there are no magical cancer prevention schemes. You are not going to prevent any of the 200 different cancers by drinking a banana-kale-quinoa smoothie every day. The best ways to prevent cancer are to quit smoking, stay out of the sun, keep active and thin, get your cancer-preventing vaccines, and following just a few more recommendations.
The benefits of the vaccine are often overlooked as a result of two possible factors – first, there’s a disconnect between personal activities today and cancer that could be diagnosed 20-30 years from now; and second, people think that there are significant dangers from the vaccine which are promulgated by the anti-vaccine religion.
It’s frustrating and difficult to explain Gardasil safety and efficacy as a result of the myths about safety and long-term efficacy of the vaccine. That’s why I have written nearly 200 articles about Gardasil safety and efficacy, along with debunking some ridiculous myths about the cancer-preventing vaccine. This article serves to be a quick source with links to most of those 200 articles.
And if you read nothing else in this review of Gardasil, read the section entitled “Gardasil safety and effectiveness – a quick primer” – that will link you to two quick to read articles that summarize the best evidence in support of the vaccine’s safety and effectiveness.
Emma Mhic Mhathúna was a 37-year-old Irish mother of five who died on 7 October 2018 from cervical cancer – an easily diagnosed and treated cancer if discovered early. She died because of a cervical smear scandal in Ireland that led her to receive a false negative on her two pap smear tests in 2016 as a part of the CervicalCheck program run by Ireland’s Health Service Executive (HSE), which manages Ireland’s healthcare.
As a result of this cervical smear scandal, Ms. Mhathúna sued the HSE and the US clinical laboratory, Quest Diagnostics, which performed the tests. She settled in court for €7.5 million from HSE and Quest. Another US-based clinical laboratory, Clinical Pathology Laboratories (CPL) of Austin, TX, was involved in a similar lawsuit from another Irish woman, Vicky Phelan, who also received a false negative – they settled for €2.5 million.
Ms. Mhathúna’s death was both tragic and a cautionary tale about relying upon the results of this test. Continue reading “Cervical smear scandal – why the HPV vaccine is the best choice”
Sometimes we get good news about vaccines, and this week, we definitely got good news. The FDA approved Gardasil for 27 through 45-year-olds, greatly expanding the age indications for the vaccine. Consequently, more people are protected against dangerous and deadly cancers.
I always thought that the age cutoff, 26 years, was rather arbitrary and that the vaccine would be safe and effective for a 27-year-old as much as it is for a 26-year-old. The FDA can be very conservative with indications for all medications, including vaccines, so they probably awaited more data before moving the approved age for the vaccine up to 45 years. But it’s better late than never that the FDA approved Gardasil for “older” individuals.
The importance of the vaccine is because genital, anal, and oral human papillomavirus (HPV) infections are the most common sexually transmitted infections (STI) in the USA. HPV is generally transmitted from personal contact during vaginal, anal or oral sex.
HPV is believed to cause nearly 5% of all new cancers across the world, making it almost as dangerous as tobacco in that respect. 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. The CDC also states that over 43,000 HPV-related cancers are diagnosed in the USA every year. It may be several times that amount worldwide.
Although the early symptoms of HPV infections aren’t serious and many HPV infections resolve themselves without long-term harm, HPV infections are causally 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:
In addition, there is some evidence that HPV infections are causally linked to skin and prostate cancers. The link to skin cancer is still preliminary, but there is much stronger evidence that HPV is linked to many prostate cancers.
Merck manufactures Gardasil, along with Gardasil 9, approved by the FDA in 2014, which a 9-valent vaccine, protecting against HPV Types 6, 11, 16, 18, 31, 33, 45, 52, and 58. It targets the four HPV strains found in the quadrivalent version, along with five additional ones that are linked to cervical and other HPV-related cancers. Both versions of Gardasil are prophylactic, meant to be given to females or males before they become exposed to possible HPV infection through intimate contact.
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.
In the press release, Peter Marks, MD, PhD, director of the FDA’s Center for Biologics Evaluation and Research, said:
Today’s approval represents an important opportunity to help prevent HPV-related diseases and cancers in a broader age range.
The Centers for Disease Control and Prevention [CDC] has stated that HPV vaccination prior to becoming infected with the HPV types covered by the vaccine has the potential to prevent more than 90% of these cancers from ever developing.
Also, the FDA stated:
Effectiveness of Gardasil 9 in men 27 through 45 years of age is inferred from the data described above in women 27 through 45 years of age, as well as efficacy data from Gardasil in younger men (16 through 26 years of age) and immunogenicity data from a clinical trial in which 150 men, 27 through 45 years of age, received a 3-dose regimen of Gardasil over 6 months.
I know that some may claim that anyone who is 45 years old may have already contracted an infection from one or two HPV types. However, since the current Gardasil9 protects against 9 different HPV types, it’s very possible that the vaccine can provide protection against other HPV types.
As I have written over 100 times, Gardasil is demonstrably effective and incredibly safe. And now that the FDA approved Gardasil for up to 45-year-old men and women means more people can be protected against deadly cancers.
Why shouldn’t anyone up to the age of 45 get this vaccine? Of course, I think that 45 is still arbitrary, and if you can convince your healthcare plan (most will agree) or can afford the vaccine, I don’t think it matters if you’re 50, 55 or 60, especially if you’re sexually active, to get the HPV vaccine.
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As I’ve mentioned dozens of times, the anti-vaccine religion probably hates the HPV vaccine more than all others put together. They’ve invented numerous myths and tropes about the HPV vaccine, all without any foundation in science. One of these claims is that we don’t know anything about long-term HPV vaccine efficacy.
Of course, the HPV vaccine is a relatively new one, so long-term data requires us to wait for time to pass. Fortunately, we are accumulating a boatload of data that shows us that the long-term HPV vaccine efficacy is pretty strong.
And now, we have a powerful new study from Finland that shows that after 12 years post-vaccination, anti-HPV immunogenicity remains quite high. Let’s take a look. Continue reading “HPV vaccine efficacy – another study shows long-term immunogenicity”
There is a myth pushed by the anti-vaccine religion that the HPV vaccine leads to sexual promiscuity. I’ve debunked this fable previously, using peer-reviewed research, but you know the anti-vaccine zombie tropes – they never really die, and they always come back to life.
Let’s look at a couple of new studies that, once again, debunk the myth that sexual promiscuity is linked to the HPV vaccine. There is no link. Period. Full stop. Continue reading “Sexual promiscuity and the HPV vaccine – debunking an ignorant myth”
If you’ve been following the old dinosaur’s articles over the past few weeks, you’d know the ongoing kerfuffle between the anti-vaccine group located within Cochrane Nordic and the parent Cochrane Collaboration. Cochrane Nordic attacked a well done systematic review, published by Cochrane, of safety and effectiveness of the HPV vaccine without merit.
In case you are unfamiliar with the organization, Cochrane Collaboration is a critically important source of evidence-based medicine and a useful tool in providing analytical evidence that can debunk pseudoscientific beliefs. Cochrane’s goal is to organize research data and publications in a logical way that helps physicians and researchers make appropriate decisions about a proposed new therapy, medication or clinical idea.
According to Cochrane, their mission is:
…to provide accessible, credible information to support informed decision-making has never been more important or useful for improving global health. In the Internet age, people have much greater access to health information, but little way of knowing whether that information is accurate and unbiased. We do not accept commercial or conflicted funding. This is vital for us to generate authoritative and reliable information, working freely, unconstrained by commercial and financial interests.
Mostly, Cochrane produces systematic reviews, which utilizes systematic methods to collect published data, critically analyze research studies, and then synthesize data from numerous published studies in an attempt to eliminate bias and increase the power of the data that includes a larger number of patients than one study alone.
In the hierarchy of biomedical research, systematic reviews rank at the very top. They are, without a doubt, the most powerful pieces of scientific research available in medicine. To be fair, Cochrane is not perfect. They have made egregious errors in systematic reviews of acupuncture quackery in the past. Like all scientific literature, one must examine a systematic review (whether published in Cochrane or any other journal) with a critical eye.
So this whole Cochrane Nordic kerfuffle may seem like an internecine feud of no importance to the world of science. And it would have been, except it has evolved into one of those tropes that the anti-vaccine religion uses to attack the cancer-preventing HPV vaccine.
Let’s take a look at this whole Cochrane Nordic nonsense. Continue reading “Cochrane Nordic kerfuffle – HPV vaccine is still safe and effective”
Despite the robust body of evidence supporting HPV vaccine safety and effectiveness, the European Medicines Agency (the European Union’s version of the US FDA) began a review of human papillomavirus (HPV) vaccines “to further clarify aspects of their safety profile,” although the agency also points out that this review did not “question that the benefits of HPV vaccines outweigh their risks.” In other words, the EMA examined the HPV vaccine adverse effects, real or imagined.
After a few months of investigation, the EMA came to a conclusion about HPV vaccine adverse effects – there were no major ones. Let’s take a look at this story.
Continue reading “HPV vaccine adverse effects and the European Medicines Agency”
In May 2018, I wrote an article about a Cochrane HPV vaccine systematic review that provided solid evidence that the human papillomavirus (HPV) vaccine was safe and effective. I considered the review to be one of the seminal pieces that support the use of the cancer-preventing vaccine. Moreover, most scientists in the biomedical field consider Cochrane systematic reviews (see Note 1) as near the pinnacle of the hierarchy of biomedical research.
Then, in early August 2018, several anti-vaccine, and more particularly vehement anti-HPV vaccine, “researchers” at Cochrane Nordic, a branch of the Cochrane Collaboration, went on the attack against the HPV vaccine. They published a paper in BMJ Evidence Based Medicine that blasted the Cochrane HPV vaccine systematic review.
I thought that this critique was without merit. Moreover, nothing they wrote diminishes the quality of the original Cochrane HPV vaccine systematic review. Once again, that systematic review provided us with solid, high-quality support of the fact that the vaccine is, indeed, safe and effective.
Even though the anti-HPV vaccine group provided some apparently cogent criticisms, it was clear that they had an agenda. Well, there has been more backlash against the anti-vaccine “researchers” in a long post by a scientist who studies and analyzes systematic reviews. And Cochrane itself responded to the criticism. Let’s take a look. Continue reading “Cochrane HPV vaccine systematic review – responses to anti-vax criticism”