Here we go again. We recently wrote about Diane Harper, another “lead developer” of the HPV vaccines, who has a rather complicated view on HPV vaccines. She makes disparaging remarks about the vaccine, yet her peer reviewed publications are generally favorable to the HPV vaccine. Genevieve Rail, a kinesiology researcher at Concordia University in Montreal, Quebec, Canada is the next one being pushed by anti-vaccine activists.
Outrageous claims are made about Genevieve Rail’s expertise with HPV vaccines, like Gardasil. And she helps with the claims by making outlandish comments about the vaccine:
“I’m sort of raising a red flag, out of respect for what I’ve found in my own study, and for the despair of parents who had totally perfect 12-year-olds who are now in their beds, too tired to go to school. Yes, we’re going against the grain, and we are going against those who are believed, i.e. doctors and nurses and people in public health.”
So here we go again, another darling of the anti-vaccine world. Time to look into who Genevieve Rail is. And does she have any standing in the scientific knowledge about the HPV vaccine.
HPV and HPV vaccines
I know, I’ve written about this vaccine 100 times – however, this might be your first bit of research into the HPV vaccine, so it’s important to get a brief overview of HPV and the vaccines. If you’ve read this before, just skip to the next section if you want.
Genital and oral human papillomavirus (HPV) are the most common sexually transmitted infections (STI) in the USA. There are more than 150 strains or subtypes of HPV that can infect humans, although only 40 of these strains are linked to a variety of cancers. HPV is generally transmitted from personal contact during vaginal, anal or oral sex.
Although the early symptoms of HPV infections aren’t serious, those infections are closely 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:
These are all dangerous and disfiguring cancers that can be mostly prevented by the HPV cancer vaccine. If you’re a male, and you think that these are mostly female cancers, penile cancer can lead to amputation of your penis. Just think about that guys.
HPV is believed to cause nearly 5% of all new cancers across the world, making it almost as dangerous as tobacco with respect to cancer. According to the CDC, roughly 79 million Americans are infected with HPV–approximately 14 million Americans contract HPV every year. Most individuals don’t even know they have the infection until the onset of cancer. About 27,000 HPV-related cancers are diagnosed in the USA every year.
There were two HPV vaccines on the market. GSK, also known as Glaxo SmithKline manufactured Cervarix, a bivalent vaccine which has been withdrawn from the US market. Merck manufactures Gardasil9, a 9-valent vaccine, along with Gardasil, a quadrivalent HPV vaccine.
All about Genevieve Rail
Let’s start with the claim that she is or was a lead developer for HPV vaccines. In our previous discussion of a “lead developer” for Gardasil, it was Diane Harper. The thing about Dr. Harper is that she is:
- Actually a research physician.
- Actually has a substantial peer reviewed publication record on HPV vaccines.
- Actually participated in the clinical trials for Gardasil.
In other words, if Diane Harper was actually against HPV vaccines (she’s not) and were advertised by the anti-vaccine crowd as a “lead developer” (they do), there is substantial evidence supporting those bits of information.
On the other hand, here’s what we know about Genevieve Rail:
- Genevieve Rail is not actually a physician. She has a Ph.D. in Kinesiology, the study of human body movement. She has no background in any field germane to vaccines – immunology, microbiology, epidemiology, public health, or virology.
- Genevieve Rail has no research published in peer reviewed journals in any area related to vaccines, HPV, or Gardasil.
- Genevieve Rail has never participated in any clinical trial as a “lead developer” for Gardasil or other HPV vaccines. If she had a clinical role in any of the key studies for Gardasil or Cervarix, I cannot find her name associated it with. A “lead developer” would have their name on many papers related to the vaccine.
For some strange reason, Rail received a CAD$270,000 grant in 2015 from the Canadian Institutes for Health Research (CIHR), Canada’s version of America’s National institutes of Health. I don’t know who on the CIHR evaluation committee wasn’t paying attention, but giving a study out like this is similar to funding a study that tobacco doesn’t cause cancer.
Genevieve Rail’s claims
Remember, Rail has published nothing about the HPV vaccines (at least not in indexed medical journals). That doesn’t stop her from pontificating loudly about the HPV vaccine:
Rail, and her fellow researcher Abby Lippman, are involved a four-year observational study which involved 170 parents of teenage girls who were given the HPV vaccine.
According to the anti-vaccine article, “Rail has been the main recipient of pro-vaccine hysteria criticism, and she’s not budging from what she knows to be true.” So, what Genevieve Rail is saying here is that she has a conclusion already in her mind, and she’s unwilling to follow where the evidence leads her. That’s not science, that’s pseudoscience.
Of course, this kind of study would have little validity scientifically:
- Since it’s not randomized in any way, it is subject to both confirmation and observer bias. In other words, the pre-conceived bias of Rail will search for results that confirm this bias.
- There is no indication that the study will have a non-vaccinated population against which we can compare the results. As we find over and over, adverse events sometimes occur in the general population, irrespective of vaccination status.
- Rail is conflating correlation with causality.
- Finally, the numbers of participants are so small as to probably not provide us with much meaningful statistics.
What she did next
Based on their early results Rail and Lippman went to a local newspaper in Quebec to demand that the HPV vaccinations be halted in the province of Quebec, until their research was done. She wants to stop kids from being protected against cancer based on her lousy research?
She then makes these demands in the newspaper article based on ridiculous claims that have become the standards of the anti-vaccine diatribe.
- Parent’s aren’t giving informed consent to these vaccines. She claims that all of horrible adverse events listed in the package insert should be clearly shown to the parents. Of course, we know the real value of that vaccine package insert.
- The VAERS (Vaccine Adverse Event Reporting System) system of vaccine surveillance in the USA give us scary information about Gardasil. But here’s the thing about VAERS, it’s useless (see Note 1). It does not show causality. It does not show correlation.
- She claims there’s no proof of efficacy. There is plenty of evidence.
- She claims that not all HPV infections lead to cancer. That is true, but the point of vaccines is to make sure we don’t contract an HPV infection which could lead to HPV-related cancers. I do not get why these anti-vaccine activists dismiss the saving of even a few lives as unimportant. If there was a way to save every life possible, that’s what we should do.
- She claims Merck is fraudulently marketing Gardasil as an anti-cancer vaccine. All of the evidence supports the fact that Gardasil is anti-cancer.
As far as we can tell, Genevieve Rail has not a single credential that would make anyone think she knows anything about vaccines. She’s not an epidemiologist. She’s not a virologist. She’s not a public health exert.
In other words, she’s no Paul Offit, who invented a vaccine that saves 250,000 children’s lives every year.
Genevieve Rail is biased against the HPV vaccine, unwilling to accept the huge amount of evidence that supports the vaccine’s safety and effectiveness. As I keep saying, until I’m out of breath, the only thing that matters in science is evidence. And she’s published nothing that tells us there are any issues with the HPV vaccine.
- Matthew Herper at Forbes Magazine examined the VAERS claims for Gardasil, and concluded the following:
[L]et’s take a look at those 20,000 adverse events and 100 deaths and figure out what they mean. It’s absolutely clear that these are for the most part not side effects from Gardasil. Nor is the vaccine, which has been given to more than 10 million people, likely responsible for those deaths.
The Vaccine Adverse Event Reporting System was put in place in 1990 as a result of a 1986 law that requires health providers to report harm that comes to patients within a specific time period after vaccination. A great many of these reports can come from sales reps for drug manufacturers who hear about the incidents.
Unfortunately, VAERS data is notoriously spotty — better than nothing, but there’s no way to insure that potential side effects are reported. When a product gets bad press, the number of reported “adverse events” goes up. And there is no way to tell if a particular side effect is linked to the vaccine. Some people will die after any vaccination, not because vaccines cause death but because people, even babies and adolescents, die with terrible regularity.
It’s true that there have been 24,000 reports of adverse events with Gardasil. There have also been 60,000 reports of death with the mumps, measles, and rubella vaccine, and 26,000 following vaccination with Pfizer’s Prevnar, for pneumococcus bacteria. And yes, it’s true that there have been 106 deaths reported after Gardasil vaccination. There have also been 101 deaths reported after vaccination with Prevnar 13, a new version of Prevnar introduced in 2010. It’s normal for these reports to pour in for safe vaccines.
You can’t directly link any of those adverse events or deaths directly to the vaccines, any more than you could blame it on my morning coffee if I got hit by a truck later today. So to try to make use of this data, researchers compare the rates at which negative side effects are reported for different vaccines. The CDC and FDA did this for HPV vaccines in 2009, looking at the first 12,424 reports to VAERS and publishing the result in the Journal of the American Medical Association. They did note 2 cases of unusual neurological symptoms similar to Lou Gehrig’s disease, and there was an increase in patients who had potentially dangerous blood clots, although 90% of those patients had a risk factor for those clots, such as taking birth control pills, that might explain the increase. The researchers specifically looked at Guillain-Barré Syndrome, a neurological disorder that had been linked to a bad batch of flu shots; there wasn’t a signal that this was a problem with Gardasil. The study did result in the FDA advising doctors to watch adolescents after they get their shots, because some faint.
Based on that analysis, it seems that of those dozens of deaths, only a handful could possibly be linked to Gardasil. And based on the data available, it is unlikely (though not impossible) that even those deaths were caused by the vaccine. The risks from the vaccine are very small and may be limited to headaches and fainting caused by the needle, not the vaccine itself. Gardasil has been studied in clinical trials of more than 30,000 people; Cervarix, the competitor vaccine, has run a similar gantlet.
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