Gardasil facts – debunking myths about HPV vaccine safety and efficacy

Gardasil safety and efficacy

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.

Continue reading “Gardasil facts – debunking myths about HPV vaccine safety and efficacy”

Dorit Rubinstein Reiss – an index of her vaccine articles on this website

Dorit Rubinstein Reiss

Dorit Rubinstein Reiss – Professor of Law at the University of California Hastings College of the Law (San Francisco, CA) – is a frequent contributor to this and many other blogs, providing in-depth, and intellectually stimulating, articles about vaccines (generally, but sometimes moving to other areas of medicine), social policy and the law. Her articles usually unwind the complexities of legal issues with vaccinations and legal policies, such as mandatory vaccination and exemptions, with facts and citations.

Professor Reiss writes extensively in law journals about the social and legal policies of vaccination–she really is a well-published expert in this area of vaccine policy, and doesn’t stand on the pulpit with a veneer of Argument from Authority, but is actually an authority. Additionally, Reiss is also a member of the Parent Advisory Board of Voices for Vaccines, a parent-led organization that supports and advocates for on-time vaccination and the reduction of vaccine-preventable disease.

She was also one of the many contributors to the book, “Pseudoscience – The Conspiracy Against Science.”

Many bloggers and commenters on vaccine issues will link to one or more of her articles here as a primary source to counter an anti-vaccine claim. The purpose of this post is to give you a quick reference to find the right article to answer a question you might have.

Below is a list of articles that Dorit Rubinstein Reiss has written for this blog, organized into some arbitrary and somewhat broad categories for easy reference. This article will be updated as new articles from Professor Reiss are published here. We also may update and add categories as necessary.


Continue reading “Dorit Rubinstein Reiss – an index of her vaccine articles on this website”

Cervical smear scandal – why the HPV vaccine is the best choice

cervical smear scandal

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”

Marijuana cures cancer? Scientific research says probably not

marijuana cures cancer

Subjectively, one the wilder claims one can find on social media is that marijuana cures cancer. Or cannabis prevents cancer. It doesn’t matter what form – smoked, eaten, hemp oil (which is manufactured from the seeds of cannabis plants that don’t contain much THC, or tetrahydrocannabinol, the active hallucinogenic agent of cannabis) – some advocates for cannabis will try to make the argument that it is some miracle drug for cancer.

But is it? Yes, there are systematic reviews that indicate that cannabis may be effective in reducing nausea and vomiting in chemotherapy. But research has generated negative results in some well done clinical trials and some positive results in others. But that has nothing to do with actually curing or preventing cancer itself, just dealing with the effects of the treatment.

So what has real research said about “marijuana cures cancer?” Well, not to give away the conclusion, but not very much. Let’s take a look.
Continue reading “Marijuana cures cancer? Scientific research says probably not”

Vaccines for Children Program – saving thousands of children’s lives

Vaccines for Children Program

The United States of America is a great country, despite the ignoramus President currently in charge, but one of its contemptible failures is the lack of a comprehensive health care insurance for all citizens. Despite this, there is a ray of shining light that has saved hundreds of thousands of children’s lives – the Vaccines for Children Program, which provides free vaccines to children who otherwise have no access to them.

I was prompted to write this article because when I was reviewing some statistics from the Centers for Disease Control and Prevention that showed a lot of unvaccinated children lacked healthcare insurance. This study showed that 17.2% of unvaccinated children were uninsured compared to 2.8% of all children. Looking at the data from another direction, over 7% of uninsured children were unvaccinated compared to only 1.0% of children on Medicaid and 0.8% of children on private health insurance.

The purpose of this article is to describe the Vaccines for Children Program and to give parents an important resource and information on how to make sure that their children are fully vaccinated against dangerous and deadly diseases. Continue reading “Vaccines for Children Program – saving thousands of children’s lives”

Vaccine coverage in USA remains high, but refusal has increased

vaccine coverage

Annually, the US Centers for Disease Control and Prevention publishes reports on vaccine coverage in the country. This year, they produced two reports – one describing vaccine coverage for children 19-35 months old, and a second one discussing vaccination coverage for children entering kindergarten.

Although vaccine coverage remains quite high across most vaccines and hasn’t changed much over the past few years, there is a bit of troubling news. A tiny, but increasing number of children in the country are not getting some or all of their recommended vaccines as a result of parental refusal to vaccinate their children. In fact, the percentage of children under 2 years old who have received none of the recommended vaccines has quadrupled since 2001.

Vaccine coverage – 19-35 months old

The first study by Holly A Hill, MD Ph.D. et al., published in the Morbidity and Mortality Weekly Report, examine vaccine coverage for Advisory Committee on Immunization Practices (ACIP) recommended vaccines in children born in 2015.

For some of the vaccines, the vaccination coverage exceeded 90%:

Unfortunately, for some ACIP-recommended vaccines, the coverage lagged:

There are a few key observations about this data. First, despite the false claims about the MMR vaccine being linked to autism, the vaccine coverage for MMR remains at historically high levels. On the other hand, hepatitis B vaccine coverage, especially at birth, is too low, despite that the fact that these vaccines are important for cancer prevention.

Vaccine coverage by state also showed some interesting information – Massachusetts has the highest vaccination rates for children born in 2015 of all states. The City of New York, considered a “state” for the purposes of this study, had the lowest rate.

However, it is troubling that, even though the proportion of children who received no vaccines by age 24 months, it has increased from 0.3% for children born in 2001 to 0.9% for children born in 2011 to 1.3% for children born in 2015. This works out to be over 100,000 children born in 2015 who aren’t vaccinated against 14 dangerous and deadly diseases. This is worrisome.

Although I do not want to give credit to the anti-vaccine religion for causing this troubling increase in vaccine refusal. The internet is filled with ignorant and scientifically inaccurate information about vaccines. Quora, where individuals can ask questions about almost anything, is filled with individuals asking questions about vaccines in good faith. Although 95% of the answers are scientifically and medically accurate, there are many individuals who use misinformation, ignorance, and outright lies to scare people about vaccines.

Eventually, this can lead to the point, where the overall vaccine coverage will drop below the level to maintain the herd effect. At that point, there are insufficient numbers of immunized people to block the spread of an outbreak or epidemic of these vaccine-preventable diseases.

On the other hand, the study points out that part of the lack of vaccination may be a result of an ongoing issue with the USA – the lack of universal health insurance, especially for the poor. This study showed that 17.2% of unvaccinated children were uninsured compared to 2.8% of all children. Looking at the data from another direction, over 7% of uninsured children were unvaccinated compared to only 1.0% of children on Medicaid and 0.8% of children on private health insurance.

This is one of the great moral failings of the country. However, there really are no reasons why any child in the USA is denied vaccines. The Vaccines for Children Program provides free vaccines for all children in the USA who otherwise have no insurance coverage. The program has saved hundreds of thousands of lives over the past 20 years.

Vaccine coverage – kindergartners

A second report, by Jenelle L Mellerson et al. and published in the Morbidity and Mortality Weekly Report, examined vaccine coverage for children entering kindergarten in 2017. The good news is that, despite somewhat lower vaccination rates in states like DC, Idaho, and Colorado, the overall vaccine coverage for the major vaccines is well over 90% for kindergartners.

The researchers found that the exemption rate was low, about 2.2%. Unfortunately, it was the third consecutive school year that a slight increase noted. The 2.2% exemption rate during the 2017-18 school year was up from 2.0% in 2016-17, and 1.9% in 2015-16.

The study does not provide a breakdown between medical (where there is a valid medical reason to not vaccinate a child with one or more vaccines) and non-medical exemptions. The non-medical exemptions, often called “personal belief” exemptions are simply refusing to vaccinate a child because of a variety of reasons – religious (no religion is opposed to vaccines) or because “we don’t like vaccines.” Most exemptions are of the non-medical variety.

Only a few states disallow these personal belief exemptions – California, Mississippi, and West Virginia. Unsurprisingly, California and Mississippi have the lowest non-medical exemption rates in the USA, at less than 0.1%. Unfortunately, California has an issue where unethical physicians are giving out (or even selling) non-medical exemptions for parents who want to put their children in danger of vaccine-preventable diseases.

Summary

These two studies show us two dangerous trends – first, too many very young children are going unvaccinated because of parental ignorance or lack of health insurance. And second, too many parents are putting their children at risk of vaccine-preventable diseases by requesting non-medical exemptions.

However, despite the pseudoscientific lies of the hysterical anti-vaccine religion, nearly 95% of children are vaccinated before they enter school. Unlike the anti-vaccine zealots, who seem to dismiss a few thousand cases of cancer or deaths from measles as unimportant or trivial, most of us on the pro-science side of vaccines want all children protected from dangerous and deadly diseases. That’s why we fight to make sure every single child is vaccinated.

Why aren’t you making sure that your children are protected from vaccine-preventable diseases?

Citations



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Plus ça change – anti-vaccine activists revive the Hannah Poling case

Hannah Poling

Following a pattern we have seen repeatedly, anti-vaccine activists have tried to claim a conspiracy to hide a link between vaccines and autism. The latest effort, reviving the Hannah Poling case, follows the pattern we have seen in previous cases – anti-vaccine activists claim that the government knew of evidence that vaccines cause autism (in this case, through mitochondrial disorders), that the government committed fraud to hide that information, and that the combination of fraud and evidence should be a game changer.

As with those past events, the claims cannot withstand scrutiny. In this case, another claim was added – a denial of due process for claimants in the Omnibus Autism Proceedings generally and in one family’s case specifically. This claim, too, does not hold. 

In contrast to the claims in the latest set of anti-vaccine articles, there was no fraud by the government, the behavior they complain about did not decide the fate of the Omnibus Autism Proceedings, they provide no new evidence that vaccines cause autism, the mitochondrial claim is neither new nor strong, and there was no denial of due process to the claimants in the Omnibus Autism Proceeding or in the specific case in question. Continue reading “Plus ça change – anti-vaccine activists revive the Hannah Poling case”

FDA approved Gardasil vaccine for 45 year olds – preventing more cancers

FDA approved Gardasil

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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HPV vaccine efficacy – another study shows long-term immunogenicity

HPV vaccine efficacy

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”

Gluten-free foods for children – are they actually healthy?

gluten free

There are many food and nutritional fads floating around the internet that have limited scientific or medical evidence supporting their nutritional usefulness. One of them is the gluten-free diet that has become one of the most prevalent, and annoying, food crazes.

Of course, parents who buy into these fads often include their children. And it’s been the same for the gluten-free obsession. But are gluten-free foods “healthy” for children? Lucky for us, a new study has looked into it. And I am going to look into that study. Continue reading “Gluten-free foods for children – are they actually healthy?”