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infectious diseases, Lasso of truth, vaccines

Explaining Gardasil girls and HPV vaccine safety to the Toronto Star and Heather Mallick

imagesThe Gardasil girls are a group of young women who claim injury as a direct result of receiving the HPV vaccine, Gardasil. They have received press on Katie Couric’s now defunct show and most recently in The Toronto Star (read my rebuttal to the Star piece here). No one is doubting that these girls have had terrible medical problems, however, the claims that all of these issues are vaccine injury just doesn’t line up with the medical evidence.

I wasn’t the only one who had concerns with the Star’s article. However, instead of taking some time to reflect or to clarify or to point out where the Star disagreed with my post Heather Mallick, an op-ed writer, doubled-down and explained the “dark side” of Gardasil for those of us too obtuse to understand:

The Gardasil vaccine story reported Thursday by David Bruser and Jesse McLean of the Toronto Star was about information, and access to it. It was not about the drug itself — it is safe and effective — but about parents and girls not always being told what they need to know in order to make informed decisions, and being dismissed by doctors when they became terribly ill.

And then she added this charmer aimed at me:

Here’s a tip: don’t read a website run by a rural doctor whose slogan is “wielding the lasso of truth.”

So let me address Ms. Mallick’s concerns about information and access to it. I’m going to start with VAERS, which was used incorrectly in the Star’s article.

What is VAERS and what does it mean?

It is simply a reporting repository. Any event that seems possibly related in someway to the vaccine is reported. These events are then analyzed every few years or so. There is a lot of misinformation about VAERS (heck, even we rural docs know that) and of course the numbers sound frightening. After all, a hundred or so deaths must mean something is wrong!

This is what the Toronto Star had to say about VAERS:

In the U.S., where there is a public database of vaccine-related side-effect reports collected from around the world, the Star found thousands of suspected cases, including more than 100 deaths.

This data isn’t secret and only found by Star statisticians. It has actually been published and it’s open access (link is below). And again, these are not even suspected cases…reporters (and their editors) should know better.

What about the VAERS data and Gardasil.

The VAERS data was reviewed in 2009 in JAMA. This was data for 2 1/2 years after the vaccine was licensed and over 23 million doses had been given. The deaths (32) and all serious adverse events were reviewed. To give you an idea of the quality of the VAERS data, only 20 of the deaths had enough information for review. So VAERS isn’t great data. Four of the deaths were unexplained, the others all appeared to be due to pre-existing conditions or conditions not possibly vaccine-related. The rate of serious adverse events seemed in line with the studies, although there was a concern about fainting and blood clots. This study was paid for by the CDC and performed by professional statisticians. There was no drug company money involved. The Star made no mention of this article, yet touted its own investigation of VAERS. I have a hard time believing that the Toronto Star had the statistical support and medical expertise needed to evaluate VAERS in a way that was superior to the CDC.

OK, but what about the illnesses? Young women with bizarre, unexplained phenomena. That has to mean something bad is afoot.

Women are more likely than men to develop autoimmune conditions and this vulnerability begins around puberty, i.e. around the time the HPV vaccine series is started (just like the MMR is given around the time the first signs of autism become apparent). Sometimes these conditions present typically (such as sore joints, fevers, rashes), but other times they present in less typical ways (such as bowel perforations or bizarre ulcerations on the genitals or in the mouth). I know this because I am a vulvovaginal diseases expert and I see these kinds of cases when they present with genital ulcerations. This is one of my fields of expertise. They are very atypical and often it can take a while to get a diagnosis because many of these conditions have no firm diagnostic test. It’s more like getting enough puzzle pieces and trying to fit them together and often you need several puzzle pieces before you know what the picture will be.

The real explanation is of course a glitch in the genetic code, but that’s hard for a lot of people to accept and so it’s easier to look for external factors especially when you Google Gardasil and injury or fever or rash or any symptom.

But couldn’t the vaccine trigger these weird things?

It is a reasonable hypothesis that the vaccine could trigger autoimmune phenomenon, so that is why it has been studied. It was part of the original clinical trial (funded by Merck), but two recent studies also looked at the incidence of autoimmune disorders after Gardasil vaccination and found no increased risk over what is expected for the age group. One study looked at over 200 girls with autoimmune conditions and compared them with over 800 controls and found no link with Gardasil (partially drug company funded). The other study looked at a database of almost 1 million young women who had received the vaccine in Denmark and Sweden. The data came from national databases, not the drug companies. The funding came from the Swedish Foundation for Strategic Research and the Danish Medical Research Council, not drug companies. The study found no increased risk of autoimmune or neurological conditions or blood clots (to answer the JAMA/VAERS question).

But what about the product insert?

The Toronto Star says it is 61 pages, although the one I found online was 27 pages. I won’t quibble about length, but product monographs are all very long legal documents and very expensive to change, so even when new safety data emerges it often doesn’t make its way into the monograph. As an aside, they are all scary. They include every single thing that happened during the pivotal studies whether vaccine-related or not. I challenge you to read the one for acetaminophen (Tylenol) just so you get the idea.

The incidence of deaths in the product monograph with Gardasil (0.1%) was the same as placebo (0.1%). There were about 10,000 young women who got the vaccine and about 9,000 who got the placebo.

Here is the data from the monograph on autoimmune conditions:

vaccinesafety

Notice how the numbers are the same in the vaccine and the placebo columns?

And here is some more data from the monograph on non autoimmune events:

Headache [0.02% GARDASIL (3 cases) vs. 0.02% control (2 cases)]

Gastroenteritis [0.02% GARDASIL (3 cases) vs. 0.02% control (2 cases)]

Urinary tract infection [0.01% GARDASIL (2 cases) vs. 0.02% control (2 cases)]

Pneumonia [0.01% GARDASIL (2 cases) vs. 0.02% control (2 cases)]

Pyelonephritis [0.01% GARDASIL (2 cases) vs. 0.02% control (3 cases)]

Pulmonary embolism [0.01% GARDASIL (2 cases) vs. 0.02% control (2 cases)].

And some more data on adverse events:

gardasil

Statistically there are more minor reactions at the injection site with Gardasil versus the control (about 10% more will have pain and swelling), but that isn’t safety data.

So what the product monograph tells us is that deaths and serious adverse events are the same with placebo and Gardasil, which is exactly the conclusion of the three studies that I referenced. .

There are more studies on the HPV vaccine,all reaching the same conclusion. The Australian data is great because they have had a much higher uptake than North America. There are many more studies looking at the safety of the HPV vaccine that I have not quoted. Vaccines are among our best tested drugs.

Being dismissed by doctors when you are ill is wrong and it breaks my heart when I hear of young women who have seen multiple providers before I finally give them a diagnosis and treatment. No one should have to search like that for help. However, being dismissed or not being taken seriously when you are ill is an altogether different issue than counseling about vaccine safety.

I’ve read through the Gardasil product monograph several times and multiple studies and I’m not clear what patient safety data the Toronto Star and Ms Mallick feel doctors and nurses in  Canada are withholding that might better help with informed decisions?

In deciding for my own kids I know that high quality data, a lot of it not funded by drug companies, tells me the vaccine is very safe with no increased risk of death, autoimmune conditions, blood clots, or neurological illness. It can be a slightly more painful for 10% of female recipients. I also know it dramatically reduces the risk of acquiring HPV.

In other words it is safe and effective and without a dark side.

 

 

And as for my qualifications to write about this? 

I am board certified in OB/GYN in both Canada and the United States and have completed a fellowship in infectious diseases. I am also board certified in Pain Medicine by the American Board of Pain Medicine and by the American Board of Physical Medicine and Rehabilitation. I am a recognized expert in vulvovaginal disorders and pelvic pain. One of my specialties is treating women with autoimmune conditions of the vulva and another is treating vulvar pain and pain with intercourse for women who have had surgery and/or radiation for cervical, vaginal, and anal cancer due to the human papilloma virus (HPV). Dr. Jennifer Gunter MD, FRCS(C), FACOG, DABPM is who this “Jen Gunter” person is.

mallick

Discussion

39 thoughts on “Explaining Gardasil girls and HPV vaccine safety to the Toronto Star and Heather Mallick

  1. ( not sure if this is a repeat ) – Heather Mallick : Another person that does not put MD after their name .

    Posted by bojimbo26 | February 9, 2015, 4:31 am
  2. Homo sapiens is, apparently, the only species capable of abstract thought. To try to understand ‘beliefs’, ‘myths’ and so on, have a read of Yuval Noah Harari’s ‘Sapiens’. We are all capable of belief in entirely imaginary abstract ideas; it’s no surprise that so many of us accept uncritically the views of others. To which you can add ideas of ‘conspiracy theories’ to produce an very toxic brew.

    Posted by korhomme | February 9, 2015, 6:09 am
  3. I’ve accepted that as much as we would like it to, the vaccine debate is going to fizzle away anytime soon. We need more constructive dialogue like this to help people understand the scientific evidence supporting (or not supporting) safety claims so thank you for this post! It’s sad to see what could have been an opportunity to educate others degrade into trolling and name calling on Twitter.

    Posted by Betty | February 9, 2015, 6:55 am
  4. I wish Gardasil had been available when I was a pre-teen.

    Posted by Elizabeth Monkus | February 9, 2015, 6:57 am
  5. Great piece, Jen. And I’m glad you let Heather know just how accomplished you are. And how VAERS works.

    Posted by bethhavey | February 9, 2015, 7:31 am
  6. When someone like this Canadian ‘journalist’ attacks, I often wonder if they’re using the old ‘the best defense is a good offense’ kind of thing.
    After all, what are we talking about here? Not the lack of accurate Canadian research!

    Posted by erin bliss | February 9, 2015, 7:51 am
  7. Keep wielding your lasso, please. And to quote U2, “don’t let the [crabby/dullwitted/mean/erroneous] people grind you down.”

    Posted by annelippin | February 9, 2015, 8:00 am
  8. – and I’m super excited to hear that San Francisco has been reclassified as “rural.” Does this mean horses are allowed in the city now?

    Posted by annelippin | February 9, 2015, 8:16 am
  9. The phrase “the butthurt is real” comes to mind with Mallick.

    Posted by Anxious Mom | February 9, 2015, 9:05 am
  10. I didn’t know you’re a rural doc.

    Posted by Steve Hirsch | February 9, 2015, 10:09 am
  11. Dr Jennifer Gunter, you are my newest hero. Thank you for your efforts, many of us do appreciate and acknowledge the information you present. Hats off

    Posted by Alyssa Mohino | February 10, 2015, 6:19 am
  12. The thing is, I suspect the Star thinks it’s doing good here and exposing, er, something that’s not a secret. And I’m certain papers thought they were doing good when they wrote about that Wakefield paper based solely on the press release.

    VAERS data is also being used right now by folks against the MMR vaccine — “In the past ten years, nobody has died of measles but 100 people have died from the MMR vaccine.”

    http://www.snopes.com/politics/medical/mmrdeaths.asp

    Posted by Jack Sanders | February 10, 2015, 9:28 am
  13. Your pressure, and those of many others in the health care field, seems to have paid off. The publisher of The Star has admitted that they “failed” in running this story, and they have published an op-ed piece signed by 60 MD’s denouncing it:

    http://globalnews.ca/news/1825017/toronto-star-did-not-give-proper-weight-to-science-in-hpv-vaccine-article-public-editor/

    http://www.thestar.com/opinion/commentary/2015/02/11/science-shows-hpv-vaccine-has-no-dark-side.html

    On the radio this AM an editor mentioned they are discussing whether to formally retract the story.

    So well done!

    Posted by Faizal Ali | February 12, 2015, 6:01 am
    • But of course, now anti-vaxxers are claiming a conspiracy to silence the truth (just like they silenced Katie Couric!).

      So, I believe them when they say there’s no evidence of a link between these events and the vaccine — but can someone explain to us dummies how and why they know that? Do they look at every VAERS/Health Canada event and do tests?

      The thing is, most journalists have no training in any of this. We don’t really know how research works or what peer-reviewed means and we have to rely on experts.

      Posted by Jack Sanders | February 12, 2015, 10:45 am
  14. Okay, I googled “rural juror”. It appears to be a fictional show on 30 Rock. I still don’t know what Mallick is talking about. Does anyone?

    Posted by TBruce | February 12, 2015, 7:10 pm
  15. Fantastic take down! I don’t know what was more shocking- the complete lack of scientific rigor in the article or the fact that the media has apparently learned nothing after its shoddy reporting of the “MMR vaccine controversy”, which has directly led to the current outbreaks of measles.

    Here is the link to the Canadian product monograph (60 pages) as an FYI- http://www.merck.ca/assets/en/pdf/products/GARDASIL-PM_E.pdf

    Posted by brit lane | February 16, 2015, 8:40 am
  16. Heather Mallick often resorts to insults when she doesn’t have a well-reasoned argument to support her point of view or when she doesn’t like someone (just look at the Wikipedia history on her). Many years ago I got a telephone call from The Star asking why I cancelled my subscription, answered with two words: “Heather Mallick.” As expected, Mallick got mad and hurled insults towards Dr. Gunter for getting all “scientiffy with her.”

    Posted by Alex Davyduke | February 16, 2015, 7:11 pm
  17. Thank you again for your excellent posts about HPV vaccines safety and efficacy, Dr. Gunter.

    Posted by lilady | March 19, 2015, 1:58 pm
  18. “I also know it dramatically reduces the risk of acquiring HPV.” Serial monogamy with testing for HPV before starting sex with a new partner reduces it a lot more. I’m not an anti-vaxxer – I’m all for vaccines. The difference between Gardasil and all the childhood vaccinations currently available in Australia where I live, is that HPV is a sexually transmitted disease – you can’t catch it unless you have some form of sex. I’ve researched the data and I think there still needs to some monitoring of the long term effects of Gardasil, but even if it proves 100% safe – you still can’t catch HPV unless you have sex. You can’t accidentally infect someone like you can with measles or whooping cough or the like. I have informed my daughter what Gardasil is for and she is completely open about her relationships with boy and when she knows when she reaches the point where she decides to have sex, she can decide for herself if she wants the gardasil vaccination or not. She is well educated about sex, STIs and options to prevent STIs. When she chooses to have sex, she has all the knowledge necessary to protect herself from STIs. The only way she can catch HPV before she reaches the point of choosing to have sex is if she has sex not by choice, and if that happens, the risk of catching HPV will probably be the least of her worries.

    Posted by itaketoflight | March 22, 2015, 6:52 am
    • Serial monogamy with HPV testing DOES NOT reduce HPV. Where on earth did you come up with that piece of completely false information? And how, pray tell, do you propose testing men for HPV and then there’s that little issue of how often do you test? After every episode of sex?

      Posted by Dr. Jen Gunter | March 22, 2015, 7:49 pm
      • Wow. Your reply astounds me coming from a doctor. Why would you test after every sexual encounter if both partners are monogamous? You do realise it requires sex with an infected person to catch HPV??? If both partners have no infection and remain monogamous, they cannot catch an STI. A doctor would know that. It’s why testing for HPV is unneeded before a woman becomes sexually active.

        You may also want to do your research. Research has repeatedly shown that serial monogamy with testing for STIs before starting a new relationship is actually the best way by far to reduce ALL STIs including HPV.
        The reality is just not many people are serial monogamists these days and I’m guessing you’re one of those cynics who believes it’s not even possible.

        Posted by itaketoflight | March 22, 2015, 9:52 pm
      • Your statement makes absolutely no sense. HPV testing is not done for women under the age of 30 as the incidence of being positive is so high and men are never tested. What is your point?

        Posted by Dr. Jen Gunter | March 22, 2015, 10:07 pm
    • There is no form of HPV test for males, it simply doesn’t exist. Also it can be transmitted via “open mouth” or “french” kissing, so it’s also theoretically possible (though I know of no research done), to spread via saliva I.e. sharing a soda (which, incidentally, is how I got the “kissing disease”, mono without ever having kissed anyone). Also HPV can go “dormant” and not appear on a test for years, and then return with a vengeance during a time of stress.
      my friend contracted it via Sexual assault, has had several cryosurgeries, several “clear” pap smears(more than 4 years), and just had ANOTHER positive. I’m currently in the waiting game to see if it clears on it’s own or requires surgery, my spouse of 10 years and I were monogamous and he was a virgin. According to you I shouldn’t have it, but I do. I had a clear pap every year since age 13, I’m 39 now(positive test was last year ), and scared to death of what the future holds.

      Posted by Bobbi | June 20, 2015, 10:06 pm

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