Hopefully you know that it can prevent cervical cancer and that lots of folks spread misinformation that is intended to confuse and scare you away from getting vaccinated and protected with it and other vaccines.
Did the FDA Approve a New HPV Vaccine for Adults?
News that the approved ages for Gardasil have been expanded will likely add to that confusion for a little while.
The FDA simply approved the expanded use of the existing Gardasil 9 vaccine – not a new vaccine.
The first thing to understand is that the FDA did not approve a new Gardasil vaccine for older adults.
They very simply expanded the age recommendations for who should get the existing Gardasil 9 vaccine, which was approved back in 2014, replacing the original Gardasil vaccine, which was approved in 2006.
“The U.S. Food and Drug Administration today approved a supplemental application for Gardasil 9 (Human Papillomavirus (HPV) 9-valent Vaccine, Recombinant) expanding the approved use of the vaccine to include women and men aged 27 through 45 years.”
Why the new age indication?
“In a study in approximately 3,200 women 27 through 45 years of age, followed for an average of 3.5 years, Gardasil was 88 percent effective in the prevention of a combined endpoint of persistent infection, genital warts, vulvar and vaginal precancerous lesions, cervical precancerous lesions, and cervical cancer related to HPV types covered by the vaccine.”
But isn’t the whole point of giving the HPV vaccine to preteens that you want to get them vaccinated and protected before they are sexually active and exposed to and infected by HPV?
Sure, but if you didn’t, and unless you are sure that you have been exposed to and have been infected by all 9 types of HPV strains that Gardasil 9 protects you against, then the vaccine is still a good idea when you are older.
Except FDA approval doesn’t automatically mean that your insurance company will pay for it.
That usually comes once a vaccine is formally added to the immunization schedule by the ACIP.
“In a 2005 study, 92% of insurance plans reported following Advisory Committee on Immunization Practices recommendations to determine covered vaccines; of those, 60% could extend coverage within 3 months after issuance of recommendations and 13% in 1 month.”
Lindley et al on Financing the Delivery of Vaccines to Children and Adolescents: Challenges to the Current System
And Obamacare still requires insurance plans to provide ACIP-recommended vaccines at no charge.
Not surprisingly, Peter Gøtzsche has had some defenders.
“A scandal has erupted within the Cochrane Collaboration, the world’s most prestigious scientific organisation devoted to independent reviews of health care interventions. One of its highest profile board members has been sacked, resulting in four other board members staging a mass exodus.”
Maryanne Demasi, PhD on Cochrane – A sinking ship?
Who is Maryanne Demasi?
“DISCLOSURE: Maryanne Demasi is a science reporter and a researcher working with Prof Peter C. Gøtzsche, the Nordic Cochrane Centre, and was present in Edinburgh at the time of the meeting, but not present in the discussion room.”
Oh…
Someone who works with Peter Gøtzsche is defending him. That doesn’t sound too surprising.
It is also not surprising the way that some folks are describing Peter Gøtzsche’s expulsion, saying that it was only about his behavior and not his work.
Did Peter Gøtzsche get expelled because of his work or behavior?
But the problem wasn’t that he wrote a critique of a Cochrane HPV meta-analsysis, but that his critique was so poorly done!
“I think it’s a hatchet job by people with several axes to grind, that needed better editorial peer review. I would be surprised if Cochrane’s investigation and update resulted in changed conclusions.”
Hilda Bastian on The HPV Vaccine: A Critique of a Critique of a Meta-Analysis
A hatchet job by people with several axes to grind…
Not the kind of work you would expect from a member of the Governing Board of the Cochrane Collaboration, especially after most of the same charges were refuted when they were made against the European Medicines Agency.
Did Peter Gøtzsche allow a bias against screening for cancer harm the Cochrane Collaboration?
And it wasn’t even the first time that he was accused of harming the Cochrane Collaboration .
“Cochrane wishes to state unequivocally that the views Professor Gøtzsche has expressed on the benefits and harms of psychiatric drugs are not those of the organization. As primarily a research organization Cochrane does not make clinical recommendations and we have not done so on this issue.”
Statement from Cochrane
How many times has the Cochrane Collaboration had to distance itself from the views of its Board Members?
How many times has the Cochrane Collaboration had to distance itself from the views and work of Peter Gøtzsche and the Nordic Cochrane Collaboration?
“I regret to inform you that I have been expelled from membership in the Cochrane Collaboration by the favourable vote of 6 of the 13 members of the Governing Board. No clear reasoned justification has been given for my expulsion aside from accusing me of causing “disrepute” for the organization.”
Peter Gøtzsche on A moral governance crisis: the growing lack of democratic collaboration and scientific pluralism in Cochrane
Or at least for Peter Gøtzsche and his association with the Cochrane Collaboration, which he co-founded in 1993.
I’m not sure how he thinks that there was no clear justification for his being expelled though.
Crisis at the Nordic Cochrane Centre
Most folks understand why Peter Gøtzsche was expelled from the Cochrane Collaboration…
They remember that he recently published a poorly done analysis in BMJ Evidence-Based Medicine, The Cochrane HPV vaccine review was incomplete and ignored important evidence of bias that was critical of a Cochrane Review on the HPV vaccine, Prophylactic vaccination against human papillomaviruses to prevent cervical cancer and its precursors, which concluded that the HPV vaccines work and that they are safe.
While Gøtzsche’s analysis prompted the Cochrane Collaboration to initiate an investigation, they concluded that his analysis “substantially overstated its criticisms” and that the allegations were “not warranted and provided an inaccurate and sensationalized report of their analysis.”
Is that it?
Nope.
Many people are also familiar with the Nordic Cochrane Centre because of their involvement in continued complaints about the HPV vaccine. Complaints that were not approved by the Cochrane Collaboration and that were not an official Cochrane viewpoint!
“…we highlight here how academic colleagues, under the purported banner of a respected authority, raise concerns about the HPV vaccine but they cite an evidence base of small and poor quality studies and ignore the extensive wealth of global literature that vividly demonstrate the excellent efficacy and safety record of the vaccine.”
Head et al on Inadvisable anti-vaccination sentiment: Human Papilloma Virus immunisation falsely under the microscope
Complaints that had already been investigated and dismissed by the European Medicines Agency and refuted by many other studies.
“This week at its meeting in Edinburgh, Cochrane’s Governing Board considered, as planned, the findings of an independent review and additional complaints related to the conduct of a Member. The Board’s conclusion was communicated to the individual concerned and is part of an ongoing process. The Co-Chairs of the Board will provide further details once this process is complete.
Following this, four Board members (Gerald Gartlehner, David Hammerstein Mintz, Joerg Meerpohl and Nancy Santesso) decided to resign as Cochrane trustees with immediate effect.”
Message from the Governing Board
Unfortunately, Gøtzsche’s being expelled led to others leaving the Cochrane Governing Board, including two appointed trustees who volunteered to step down to to comply with Cochrane’s Articles of Association.
Although they may not have been defending Gøtzsche’s opinions or behaviors, four other board members resigned in solidarity.
We can hope that this is the end of the matter, as Cochrane will soon have an election for new board members.
Peter Gøtzsche is out at the Cochrane Collaboration.
Will he be kept on at the Nordic Cochrane Centre, which he founded? Will the Nordic Cochrane Centre be allowed to keep ‘Cochrane’ in their name?
The Nordic Cochrane Centre is primarily funded by the Danish Government, and what do they get besides all of the anti-HPV vaccine stuff?
“Antidepressant drugs are another major killer that people could do well without.”
Peter C Gøtzsche: Prescription drugs are the third leading cause of death
Peter Gøtzsche seems to be against cancer screening, psychiatric drugs, and thinks that Big Pharma has corrupted health care. Is that the “plurality of opinions, views, and perspectives” that folks want at Cochrane or anywhere else in medicine?
Unfortunately, I bet this isn’t the last that we have heard from him.
Have you heard about the Cochrane HPV controversy?
What controversy?
Well, yeah, but anti-vaccine folks are crowing about what is essentially a letter that was published in BMJ Evidence-Based Medicine journal.
About the Cochrane HPV Controversy
What’s the controversy?
Seems that the folks at Cochrane Reviews recently published a review, Prophylactic vaccination against human papillomaviruses to prevent cervical cancer and its precursors, which concluded that the HPV vaccines work and that they are safe.
That doesn’t sound controversial…
Well, it seems that some other folks, associated with the Nordic Cochrane Center, disagreed. They published an “analysis” in BMJ Evidence-Based Medicine, The Cochrane HPV vaccine review was incomplete and ignored important evidence of bias.
So who do we believe when we have Cochrane vs Cohrane?
Who is the Nordic Cochrane Centre?
Some people will be familiar with the Nordic Cochrane Centre because of their involvement in complaints about the HPV vaccine that were investigated by the European Medicines Agency.
Cochrane Nordic has been filing multiple complaints with the EMA about HPV vaccine safety for years.
Complaints that were initially triggered by a case series that was published by Dr. Louise Brinth, when she was head of the Danish Syncope Group, but who is now part of the Nordic Cochrane Centre.
While the Cochrane Collaboration has a very good reputation, you can’t really say the same about the Nordic Cochrane Centre.
Complaints that were not approved by the Cochrane Collaboration and that were not an official Cochrane viewpoint!
“…we highlight here how academic colleagues, under the purported banner of a respected authority, raise concerns about the HPV vaccine but they cite an evidence base of small and poor quality studies and ignore the extensive wealth of global literature that vividly demonstrate the excellent efficacy and safety record of the vaccine.”
Head et al on Inadvisable anti-vaccination sentiment: Human Papilloma Virus immunisation falsely under the microscope
Complaints that had already been investigated and dismissed by the European Medicines Agency.
“In conclusion, in clinical trials conducted in the 9 to 26-year- old age range, vaccination was generally well tolerated with no apparent adverse health impact following completion of the vaccination regimen.”
Block et al Clinical trial and post-licensure safety profile of a prophylactic human papillomavirus (types 6, 11, 16, and 18) l1 virus-like particle vaccine.
Complaints that are also refuted by many other studies.
So we don’t actually have Cochrane vs Cochrane…
The Cochrane HPV Review
Once you read the complaint against the Cochrane HPV review, you realize that this isn’t even just about the Cochrane HPV review.
The main faults that the Nordic Cochrane Centre folks found is that the Cochrane review left out a bunch of what they consider to be eligible HPV vaccine trials, even though “twenty-six randomised trials were identified that contained data on vaccine efficacy and/or safety, which all together enrolled 73,428 women.”
But if this was just about a systemic review which didn’t stick to protocol about which studies to include, then why do the Nordic Cochrane Centre folks go on and on about placebos and active comparators?
“The Cochrane authors mistakenly used the term placebo to describe the active comparators.”
Lars Jørgensen et al. on The Cochrane HPV vaccine review was incomplete and ignored important evidence of bias
Would you be surprised to know that one of Nordic Cochrane Centre’s arguments to the EMA was about placebos?
“In all the vaccine trials apart from a small one, the “placebo” contained aluminium adjuvant, which is suspected of being neurotoxic.”
Cochrane Nordic Complaint to the European Medicines Agency (EMA) over maladministration at the EMA
Why do they talk about placebos?
Most of these folks want pure saline placebos to be used in clinical trials, even though doing so would make it hard to keep the trials blinded.
Placebos don’t have to be inert though. The BMJ and the Nordic Cochrane Centre authors mistakenly corrected the Cochrane authors on their use of the term placebo.
They make plenty of other mistakes too.
“The Cochrane authors did not mention a study from 2017 by the WHO UMC that found serious harms following HPV vaccination overlapping with two syndromes: postural orthostatic tachycardia syndrome (POTS) and complex regional pain syndrome (CRPS).”
Lars Jørgensen et al. on The Cochrane HPV vaccine review was incomplete and ignored important evidence of bias
What study?
Jørgensen cites a commentary that describes “a signal based on both spontaneous reports and published case series that is best characterized as a potential association between HPV vaccination and dysfunction of the autonomic nervous system.”
“There is currently no conclusive evidence to support a causal relationship between the HPV vaccine and POTS. It is of utmost importance to recognize that although temporal associations may be observed, conclusions of causality cannot be drawn from case reports and case series due to the small sample size and lack of control population inherent to this type of scientific literature. If POTS does develop after receiving the HPV vaccine, it would appear to do so in a small subset of individuals and would be difficult to distinguish from the normal prevalence and incidence of the disorder.”
Butts et al on Human Papillomavirus Vaccine and Postural Orthostatic Tachycardia Syndrome: A Review of Current Literature
So who do you believe?
Researchers who published a systemic review as part of the Cochrane Review Groups that confirms that the HPV works and that it is safe, or a group who seems to have an axe to grind against the HPV vaccines?
Update on the Cochrane HPV Controversy
Apparently, Cochrane has taken the Nordic Cochrane Centre complaints seriously enough to launch an investigation.
“Our current investigations appear to show that there may be a handful of missed but potentially eligible studies, but that this falls substantially below ‘nearly half of the eligible trials’.”
David Tovey, editor-in-chief of the Cochrane Library
And not surprisingly, Tovey stated that “To date, we also have no reason to believe that the main conclusions of the review relating to benefit and serious adverse effects are unsafe.”
And yet, as with their complaints to the EMA, resources get wasted as the attacks are put down.
Have you seen or heard about any of these movies about vaccines?
Vaccine Videos
Just as bad as so-called vaccine documentaries, many of the vaccine videos that you find on You-Tube are also filled with misinformation and propaganda, including many vaccine scare videos.
Where are you Jon Stewart? Measles is still around…
It wouldn’t be surprising if you hadn’t, as the number of folks with their own anti-vaccine organizations has increased over the years. Where we once just had the NVIC, now it seems like everyone has their own anti-vaccine Facebook group. That doesn’t mean that the anti-vaccine movement is growing though, as they are all fighting for the same members.
And it is over this membership fight where some folks got an introduction to Brandy Vaughan. She recently got in a tussle with the organizer for a more popular group.
When Anti-Vax Folks Don’t Get Along
Did you know that the anti-vaccine movement is corrupt?
“A video I wish I didn’t have to make. When I started in this movement, I had no idea it would be as corrupt as pharma.
But I have had my eyes opened many times over…this video describes just one of many disappointments along the way: Larry Cook, who runs a popular page and group.
In the beginning, I believed what he told me and tried to look past the many odd comments and strange behaviors. But it ultimately became clear that he puts his own profit far ahead of our children.
That in and of itself wasn’t enough to motivate me to speak out and open myself up to the hundreds of attacks I would get, I kept hoping the truth would be exposed by someone else. And while some have tried, the past couple of weeks I have seen too much to stay silent any longer.”
Brandy Vaughn
What was her problem with Larry Cook? It’s hard to know, but it seemed to have something to do with the way he was raising money.
“Brandy and I have not communicated in over 18 months (or so). There was a time when I supported her immensely, and then we parted ways (hey, look at the screenshot and see what I wrote and how I wrote it). This is an absolute unjustified attack on my character and absolutely is defamation of character. It’s character assassination. And, already, a LOT of people have been posting hostile comments on my posts, and of course, elsewhere, and I recently learned even VINE is now in on this. So yes, I do need to make a statement about this considering how many people are now involved in this narcissist drama. This is the time to have discernment. If some of it is blatantly untrue, then perhaps the rest is as well. Please use your discernment before proceeding.”
Larry Cook
Folks who understand that what they call a movement is really an anti-vaccine industry, likely aren’t surprised by all of this. Through movies, videos, books, seminars, online stores selling supplements and detox kits, and simply asking for donations, there is a lot of motivation for folks to make you fear vaccines.
Who Is Brandy Vaughan?
Is Brandy Vaughan really one of the world’s leading experts on the HPV vaccine?
So who is Brandy Vaughan and what is her connection to the anti-vaccine movement?
Brandy Vaughan used to work for Merck, but she isn’t an immunologist or vaccine researcher. She is a former pharmaceutical representative.
Was she a pharmaceutical representative for Merck vaccines?
Nope. She sold Vioxx, a painkiller that was taken off the market in 2004 because of safety problems and led to $5 billion in lawsuits.
And many years later, as lawmakers in California worked to increase vaccination rates, she created an organization to educate “the public on vaccine risk and dangers.”
This type of anti-vaccine propaganda never mentions the risks of leaving your kids unvaccinated.
Seems like she didn’t like the idea of having to vaccinate her “vaccine-free” son.
How does she educate people?
She raises money and puts up billboards that warn about what she thinks are the risks of vaccines.
She never seems to mention the risks of leaving kids unvaccinated though.
And she seems to encourage other parents to leave anti-vaccine propaganda wherever they can.
Depending on where you live, you might find their ‘risk’ cards in books at the library, stuck to cans of baby formula, or at the grocery store.
Why do they do it?
Because they think that vaccines aren’t safe and that they are injuring and damaging children.
“I’m tired of all the LIES LIES LIES. The chemical additives in vaccines have absolutely no place injected into the human body and are causing irreparable damage. And we are being lied to for profit— vaccines are NOT safe, just as most pharmaceutical drugs are not safe. They all have side effects. With vaccines, there are too many, too soon and this entire generation of children is suffering because of it. People have the RIGHT to know the risks before they do something that may change their lives forever — or the life of their innocent, healthy child.”
Brandy Vaughan
Of course, the overwhelming evidence shows that vaccines are safe and that most side effects are mild. Kids today do get more vaccines, but they protect them from many more diseases, life-threatening diseases, that children used to get very routinely.
Learn the Risks from Brandy Vaughan
Brandy Vaughn wants to teach you about the risks of vaccines.
“Everything I have gone through in my life has been in preparation for this moment. This is why I am who I am. All the pieces of puzzle are coming together. This is why I am here in this world. This is my calling, my purpose. In fact, I often feel like this work is being done through me, not actually by me. I feel like I am floating in a river just going with the current — I don’t even have to swim and I’m fully in the flow.”
Brandy Vaughan
But not the normal risks, like that your kids might get a fever, be fussy, or have some pain after their vaccines. Her organization’s idea of the risk of vaccine comes from the viewpoint that vaccines “have no place in the human body.”
She also believes that:
everyone needs to detox because “we are all exposed to a massive amount of toxins from our environment, and particularly from vaccines.” And of course, she sells essential oils and supplements to help you detox.
it’s good to get sick because “there are many benefits to common illnesses”
vaccines “cannot create real immunity”
if you have cancer, you should “say NO to chemotherapy and radiation (get off all medications and no vaccines!)” because “traditional medical approaches (drugs, chemo, radiation) only FURTHER damage the body and immune system”
This is likely why experts in Perth, Australia are trying to keep her latest billboard from staying up in their city.
They likely see all three components of anti-vaccine propaganda that the rest of us see:
Making parents think that it’s no big deal to get measles or polio, by underestimating the risks of vaccine-preventable diseases and overstating the benefits of natural immunity over the protection you can get from vaccines.
Whether these billboards stay up or not, parents only need to know one thing. The organization behind them isn’t helping them make an educated choice for their family. Don’t be scared into making a poor decision of skipping or delaying your child’s vaccines and leaving them unprotected. Be skeptical and learn the risks of getting the answers to your questions about vaccines from these folks.
HPV vaccines, including Gardasil and Cervarix, can reduce your risk of developing cervical cancer.
That doesn’t mean that you can stop getting Pap tests to screen for cervical cancer though.
Why not?
Vaccines are not 100% effective and while the HPV vaccines protect against the strains of HPV that are most likely to cause cervical cancer, they don’t include every single strain.
Does HPV Vaccination Decrease the Chances You Will Get a Pap Test?
Again, HPV vaccines don’t replace pap tests.
Whether or not a woman is vaccinated, if they have no extra risk factors (can mean extra screening), they should have:
their first Pap test at age 21 years, to look for cell changes on the cervix that can be a sign of precancers (was previously at age 18 years if sexually active)
a Pap test every 3 years from age 21 through 29 years (was previously done every year)
a Pap test with HPV cotesting (actually tests for the presence of HPV in cervical cells) every 5 years or a Pap test alone every 3 years from age 30 through 65 years
This routine testing can help find precancers before they turn into cervical cancer.
Why would anyone stop getting a pap test after getting vaccinated?
They shouldn’t.
Some folks worry that they might though, because those who are vaccinated might think they are at lower risk to get HPV and cervical cancer.
#SaidNoDoctor, except Dr. Jay Gordon, who made this statement about the HPV vaccine on the Ricki Lake Show.
Fortunately, most studies show that this doesn’t happen. Not surprisingly, studies have also confirmed that HPV vaccines are safe and they don’t encourage kids to have unprotected sex.
And data from the National Center of Health Statistics show that a steady number of women over age 18 years have been getting Pap tests since 1987. Numbers did drop a bit recently for young women between the ages of 18 to 24 years, but that coincides with the 2003 and 2012 changes for when to get Pap testing.
What makes this all a bit confusing is that there are actually some suggestions that women who have been vaccinated at an early age (before they are sexually active), with the newest HPV vaccines (cover more HPV types) might actually be able to get HPV testing instead of a Pap test, can start getting tested at a later age, and can get fewer tests.
None of those are formal recommendations though, so women should keep getting their Pap tests on schedule, whether or not they have been vaccinated.
What about reports of increased rates of cervical cancer in Sweden that are linked to an increase in HPV vaccination rates?
Lars Andersson became a pseudonym when he was outed as not being associated with Karolinska Institute.
In addition to fake credentials, the author came to bogus conclusions, as although there has been an increase in rates of cervical cancer in some of the smaller counties in Sweden, it is thought to be due to differences in regional cancer prevention. To put it more simply, if it was due to getting vaccinated, then since immunization rates aren’t that different in those counties (just like immunization rates vs autism rates in the United States), then why didn’t rates of cervical cancer go up everywhere?
“Joakim Dillner, professor of infectious epidemiology at Karolinska Institute and register holder for the National Quality Register for Cervical Cancer Prevention and Analysis, says, however, to the Medical Journal that there is nothing in the allegations that the increase would be due to HPV vaccination.”
Of note, Sweden, recently had the highest participation in their cervical cancer screening program ever, at 82.4% of the population.
“HPV-vaccination is so far associated with equal or higher attendance to cervical screening in Sweden in a cohort of opportunistically vaccinated young women.”
Herweijer et al on The Participation of HPV-Vaccinated Women in a National Cervical Screening Program: Population-Based Cohort Study
So much for the idea that getting an HPV vaccine decreases your likelihood of getting a Pap test…
What to Know About HPV Vaccines and Pap Testing
Although HPV vaccines can decrease your risk of cervical cancer, that shouldn’t influence your decision to get a Pap test.
