Chapter 6: Article 4
Slate wrote a concerning article titled, "What the Gardasil Trials May Have Missed." The article followed an eight month investigation, and stated.
...Experts I talked to were baffled by the way Merck handled safety data in its trials. According to Dr. Yoon Loke, a professor at the University of East Anglia who studies side effects, letting investigators judge whether adverse events should be reported is “not a very safe method of doing things, because it allows bias to creep in"... Of the short follow-up, Loke told me, "It's not going to pick up serious long-term issues, which is a pity. Presumably, the regulators believe that the vaccine is so safe that they don’t need to worry beyond 14 days.”
Dr. Little lectured about the possibility that HPV vaccination may be causing premature menopause in young women. In her lecture she explained the following (emphasis mine):
The reason why I’m actually here, and have been asked to speak was because of a case I wrote up and had published in the British Medical Journal. And I’ll just tell you the story of this [16 year old] girl...she had noticed that over some period of time, almost 2 years, her periods had become irregular and scant, and then they’d stopped. And then she’d developed hot flashes and no more periods at all after that. And she went in to see her GP in a nearby town and been prescribed the pill, but she was a fairly intelligent girl, and she thought, “Well that’s all very well, but I want to know why my periods have stopped.”
So, she came to see me in an adjacent town, and I think possibly because I’m sort of known for not prescribing the pill, so I think she thought she might get a fair hearing. She presented her symptoms to me and I organized some blood tests, saw her again in a couple of weeks time. But she asked the question at that initial presentation, she said, “Could it be Gardasil because that’s when things seemed to unravel in this department for me.” And I said, “I don’t think so, I’ve not heard of such things. But lets find out what’s going on and we’ll discuss it next time I see you.”
And by the time she came back in a couple of weeks, we had confirmation of premature ovarian failure...so she asked this question again, obviously after this diagnosis had to be put to her. We got a second opinion from a specialist in the city nearby. She asked the question again, “Could it be Gardasil?” I didn’t feel quite so confident to say no I don’t think so because I really didn’t know and so that’s when I started the research on this which is the beginning of 2011, so I could answer her question.
…So the first thing that I had done after this girl was confirmed menopausal at 16, was to notify the Therapeutic Goods Administration and to ask them if they had any other cases. And also, because I used to have rats when I was a kid, I kind of said, “Well what do the rat studies show?” And no, they couldn’t tell me, I had to file a Freedom of Information report, and so I did... what came back was that there was no histology report on the rat ovary ever presented, before licensing, or after the licensing of this drug. No histology report, which means they hadn’t actually looked at the rat ovary after vaccination, under a microscope and said, “Yes the eggs look normal, yes the tissue in between looks normal, yes it’s healthy looking. They’d never done that…the rats were killed after one [pregnancy] - this is the whole reproductive study on the animals before it was introduced to our girls. The rats were killed after one litter, so we don’t know how many more [litters] they might have been capable of having, how many pups in each littler, or what age they might have gone through menopause themselves. So, there was not much mammalian research out there.
...Now, lets look at some of the major studies that have been done, the very first one…it was a phase II trial…phase II studies look at the clinical effectiveness, as well as the safety of a vaccine. Now this phase II trial had written in it...“Participants in this trial were required to use effective contraception throughout the trial.” It was a three year trial, small number of women…In medical parlance, “effective contraception” is not barrier methods,…it’s not IUDs… So we’re left with hormonal contraception. So they were basically required to use hormonal contraception throughout the trial...That invalidated this study for reproductive health assessment. If you’re on the pill, you will have a pill cycle, dictated by the packet of pills. It’s got nothing to do with your ovary. It overrides the ovary. So that study was invalidated for reproductive health assessment. It had no capacity to detect ovarian effects. Later studies however, will quote this study, as establishing the safety of the vaccine.
...In [one] trial, the investigators themselves assigned what adverse events were likely to be due to the vaccine. And it was based on the "established safety profile" of the vaccine. This vaccine was new, it didn’t have an established safety profile, it didn’t even have rat studies on fertility. So how could they possibly be assigning causality on the basis, without evidence based medicine. I do not know.
Some countries like Japan, have stopped recommending the HPV vaccine because of the controversies surrounding it, whereas other countries have instead tried to reassure their citizens, by pointing to post marketing studies, studies that were conducted long after the vaccine was licensed. These post market studies looked at 100,000s of women who had been vaccinated against HPV. But these studies are also misleading. In one Canadian example, electronic health records for 195,270 vaccinated females were reviewed, looking at emergency room visits and hospitalizations following receipt of at least one dose of HPV vaccine.
The researchers explain that 99.2% of those Canadian's received Gardasil (meaning only 0.8% received Cervarix, which Dr. Harper explains is the more effective vaccine). The study explains that 19,351 of the participants (9.9%) experienced an emergency department visit (within 42 days of receiving a dose of vaccine), and 958 of them (0.5%) required hospitalization (within 42 days of receiving a vaccine dose). Unfortunately, the study did not examine a control group that hadn't received the HPV vaccine. The conclusion of the study was that despite 10% of vaccine recipients requiring emergency care within the 42 days following vaccination, the HPV vaccine adverse events were "minimal" and the vaccine is safe. To draw such a conclusion means the researchers assumed the unvaccinated experience Emergency Room visits at an equal rate.
In Dr. Little's lecture, she spoke about a different massive post marketing study, the Kaiser study, which was carried out in a very similar way as described in the Canadian study. Dr. Little described the Kaiser study as being deficient in its methodology for evaluating safety. Her same criticisms of the Kaiser study also apply to the Canadian study. She had the following to say (emphasis mine):
Now the study that’s always thrown at us, and thrown at me, I have to say, is the massive one that was published right after mine came out, which was 189,000 girls who were looked at for reactions after they had been given the Gardasil, long after it was licensed. And only 23% in the whole study by the way received all three doses. But how did they assess it? They said...the primary aim was to evaluate the safety of Gardasil during the course of routine clinical care. So to analyze the safety during the course of routine clinical care, they decided to see how many girls had turned up in accident and emergency after they had their vaccinations. How many had been hospitalized? And that was it... Now I’ve also worked in accident and emergency since 1992, except for my maternity leaves, and as well as doing obstetrics as a GP. I’ve NEVER gone into a cubicle and said, “What can I do for you today?” and had a girl say, “My periods have gotten scant and irregular.” Those girls don’t go to accident and emergency. You certainly don’t put them in hospital. So they are going to fly under the radar of this 189,000 Kaiser study… which tried to say… that Gardasil was safe …but this study had no capacity to assess reproductive safety signals.
So the Kaiser study looked at events on day 0, day 1-14, and day 1-60, that might have landed you in hospital. But it did more than that, it then compared girls and boys who ended up in hospital after this school vaccination... with how they were six months down the track. And if they were …still sick or still had a health problem, the conclusion was, “Well then it wasn’t Gardasil, because you’re still sick, so it couldn’t have been the Gardasil.”
The fact that the Kaiser researchers decided that the vaccine could NOT have been responsible for the kids enduring illness six months after vaccination, confirms my point from Ch5: Article 1 that vaccine makers and the Heath Authority assume that vaccine side effects are minor and short lasting. They make this assumption with no scientific data to back up their belief.
Another study that I found, conducted by Kaiser again, using the same 189,000 girls vaccinated against HPV, intrigued me because it compared the occurrence of autoimmune diseases in the vaccinated group against an unvaccinated control group. The conclusion of that study was that rates of specific autoimmune diseases were comparable across both groups. Now this was very interesting to me. As I've repeatedly stated, as far as I'm aware there has not yet been a large scale study comparing a vaccinated population to a never vaccinated population. So this study could be what I've been waiting and looking for. In reading deeper, I learned that such a comparison has actually still NOT occurred.
The study explains that a Case Review Committee looked carefully at the HPV vaccinated subjects' medical records, for evidence of new onset autoimmune disease. For the unvaccinated group, a careful review by the Case Review Committee did not occur. Also, the study provided very few details explaining the control group's "unvaccinated" status. Looking at a quote fragment from the paper, it states, "For the unvaccinated population (which includes members who will later become part of the vaccinated population)"...that statement subtly infers that these "unvaccinated" kids had likely received numerous vaccines in their pasts, they simply had not received the HPV vaccine, yet. The paper also states, "The 'background' incidence rates of autoimmune conditions in the unvaccinated female population 9-26 years old were estimated to compare with the observed incidence in the vaccinated women"...
Let's look at that statement in a slightly different way. Can you imagine what a tobacco study would show, if in the past, a tobacco company had compared rates of disease in heavy smokers and non-smoker groups, by estimating rates of disease in the group of "non-smokers." And not just that, the "non-smokers" had actually been heavy smokers but had quit smoking one month prior. If rates of disease were estimated in those "non-smokers" and compared against the observed rate of disease in the smoker group, WHAT do you think the conclusion of a such a tobacco study might be?
Unfortunately today, in the realm of vaccines, the universities, hospitals, manufacturers and government health agencies contribute to this incredibly poor quality of research. These institutions actually believe that real comparisons of real long term health outcomes, between vaccinated and never vaccinated populations, are completely unnecessary. NOTHING could be further from the truth.
CONTINUE to the next article: Ch6: Article 5
Article Sources Here
Slate - What the Gardasil Testing May Have Missed Here
Lecture on HPV by Dr. Deirdre Little Here
Dr. Little's medical paper about a case of premature menopause in a 16 year old girl following her HPV vaccination, published in the British Medical Journal Here
Canadian Study finds 10% of HPV vaccine recipients visit the ER Here
Kaiser Study evaluates emergency visits and hospitalization following HPV vaccination Here
Kaiser Study evaluates autoimmune conditions in HPV recipients Here
Gardasil Package Insert Here
Gardasil 9 Package Insert Here
Cervarix Package Insert Here