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

The 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:

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:

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.