In essence, society’s attention has become focused on vaccination, focused solely on this health treatment. But TREATMENT is not what creates health, treatment is what changes or manages a persons’ symptoms of poor health. Instead of focusing solely on the treatment, there needs to be a shift. We need to evaluate the treatment in the context of the whole - what is working about the treatment? What needs improving? What is failing completely? How does the treatment affect evolution of the species? And how can health be supported moving forward so that the treatment is no longer needed?
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May 18, 2018

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Vaccine Approval Is Fast Tracked - Part 2

If we are going to have a discussion about the short-comings about vaccines in general, it becomes useful to start by critically evaluating the facts and testing process for the newest licensed vaccines, which right now are the HPV vaccines (there are 3 HPV vaccines). It's important to dissect the facts for these vaccines, because the newest vaccine is assumed to have been created and tested using the most modern and most technologically advanced medical science. If through a critical evaluation we discover any flaws or inadequacies in the newest vaccine's testing or function, then it also becomes reasonable to assume that the older vaccines likely share, at minimum, those same deficencies.

 

HPV Infection and Cancer Risk

To discuss the HPV vaccine, it's important to first provide some background as to what the human papillomavirus [HPV] is, how cervical cancer develops from it, and what the HPV vaccine was shown to do in its testing.

 

To begin, the FDA provides the following information:

There are over 100 different kinds of HPV and not all of them cause health problems. Some kinds of HPV may cause problems like genital warts. Some kinds of HPV can also cause cancer of the cervix, vagina, vulva, or anus. Most of these problems are caused by types 6, 11, 16 or 18.

 

To quote the manufacturer from the vaccine package insert for the Cervarix vaccine, it says:

Based on a large consensus among experts, the most common HPV types identified in cervical cancer worldwide were, in decreasing order of frequency, HPV-16, -18, -45, -31, -33, -52, -58, -35, -59, -56, -39, -51, -73, -68 and -66. 

 

According to the CDC (emphasis mine):

HPV infections are so common that nearly all men and women will get at least one type of HPV at some point in their lives. Most people never know that they have been infected and may give HPV to a sex partner without knowing it. Nearly 80 million Americans are currently infected with some type of HPV. About 14 million people in the United States become newly infected each year.

 

Dr. Diane Harper is a medical doctor who specializes in women's health and HPV infection. She was one of the principle investigators who worked with the HPV vaccine manufacturers, to help them design and manage their vaccine clinical trials, before the HPV vaccines were licensed for public use. In a radio interview available on youtube, she had the following to say:

My professional research career has been centered around women and abnormal pap smears and preventing cervical cancer. It was in the mid 1990s, when the two pharmaceutical companies, Merck and GSK, decided to pursue the commercialization and manufacturing of an HPV vaccine, but they needed to have the appropriate clinical trials designed and studied and presented to the FDA, for their business plan to be able to move forward. So there are not very many HPV experts in the world. There were about 50 of us who were gathered, independently first by Merck, and then most of us were gathered again by GSK, to work with them to design the clinical trials, design the endpoint, design the way in which we thought the science could best determine whether or not these vaccines would show any efficacy, safety and immunogenicity. So I was one of those very few American researchers that was involved on the clinical trial design side.

 

Interviewer asks: You were involved in the very formatting of the trials themselves, correct?

 

Dr. Harper's response: “Correct.”

 

Later in that interview she had the following to say:

We know that HPV infections occur at every single age of life. So, we know that kids from birth through the age of 11 - that 10% of those kids are going to have these high risk HPV types already, before anybody even talks about sexual activity….And then you look at this big peak between 16-24 years of age, where [HPV infection] goes up - to like 1 in 3 people have HPV infections. And then it drops back down again, but it never goes to zero. And what we see is that somewhere between 5 and 15 percent of women over the age of 30 continue to have HPV infections. We know that women in their 40s and 50s, sometimes their marriages fall apart, sometimes they see somebody new, sometimes their partner is seeing somebody new and brings something home to them, we see that there is an increase in HPV at that point in time…What we know, is that it takes HPV, if it’s going to stay around, it takes it a little while. As we said earlier, it might take decades before it actually goes into cancer. 

 

Before an HPV infection progresses into cancer, there are warning signs of prolonged infection that are usually detectable on a woman's cervix. The more serious degrees of infection, resulting from the higher risk HPV types, cause what are called CIN lesions on the cervix. To quote the UK Macmillan Cancer website (emphasis mine):

Cervical intra-epithelial neoplasia (CIN) is a term that describes changes in the squamous cells of the cervix.

 

CIN is not cancer, but you may need treatment to stop cervical cancer developing. You may hear doctors call CIN a pre-cancerous condition

 

You might not need treatment for CIN. If you do need treatment, it’s usually simple and very successful.

 

On another page within that same Macmillan website, they provide the following information:

 

Grading of CIN

CIN is graded depending on how deep the cell changes go into the surface of the cervix:

  • CIN 1 – one-third of the thickness of the surface layer is affected.

  • CIN 2 – two-thirds of the thickness of the surface layer is affected.

  • CIN 3 – the full thickness of the surface layer is affected.
     

Knowing the grade of your CIN helps your colposcopist plan the best treatment for you.

 

With all three grades of CIN, often only a small part of the cervix is affected by abnormal changes.

 

CIN 3 is also known as carcinoma-in-situ. Although this may sound like cancer, CIN 3 is not cervical cancer. Cancer develops when the deeper layers of the cervix are affected by abnormal cells. If CIN 3 is found during screening tests, it’s important to make a treatment plan.

 

It also becomes important to state what the rate and risk are for a CIN lesion progressing into cervical cancer. To quote Dr. Diane Harper again, this time from an interview she gave for the "One More Girl" Documentary, she said: 

What we know is that if you look at all of the women who get an HPV infection, approximately 70% of those are going to clear that infection all by themselves, within the first year, with no help from anybody. You don’t have to detect it and you don’t have to make it go away. The body is going to take over and do it. Within two years, about 90% of all of those HPV infections are going to clear all by themselves. Now by three years you’ve got 10% of that original group of women that had HPV infections that are left. By three years, half of those infections have progressed into what we call a CIN2/3 lesion, or a pre-cancerous lesion...What we know then is that amongst women with CIN 3 lesions, so that’s a little bit more severe than the other group, it takes five years for about 20% of them to become invasive carcinomas. That’s a pretty slow process. It takes about 30 years for 40% of them to become invasive cervical carcinomas.

 

In a Huffington Post article, Dr. Harper explains that without pap screening, the rate of cervical cancer is 90 cases for every 100,000 people. Of course, it needs to be repeated and emphasized that with regular pap screenings, almost NONE of those CIN 2 or 3 lesions are able progress into cancer. With pap screening, that cancer rate of 90 diagnoses per 100,000 people, dropped down to 7 cases per 100,000.

 

The Canadian Cervarix vaccine package insert states this clearly, and goes on to explain that the annual mortality rate is 2 deaths per 100,000 people. To quote the vaccine package insert, it states (emphasis mine):

Despite the significant reduction in the burden of disease from cervical cancer since the introduction of cervical cancer screening [pap smears], new cases and deaths from cervical cancer continue, with approximately 1350 new cases and 390 deaths from cervical cancer estimated in 2012. 

 

To provide a comparison of cervical cancer rates to other cancers, The Canadian Cancer website estimated that in 2017, 26,300 women will be diagnosed with breast cancer and 5000 will die, an incidence rate of 131.5 cancer diagnoses per 100,000 population. As well, that website also estimated that in 2017, approximately 28,600 Canadians will be diagnosed with lung cancer, and that 21,100 Canadians will die, meaning there are approximately 141.8 cases of lung cancer in every 100,000 people. 

 

Of course any death from any illness is equally devastating. I provide this comparison of statistics, not to minimize the loss of life from cervical cancer, but rather, to enlighten the reader as to the various degrees of risk they face.

 

So as stated, nearly 100% of people will experience an HPV infection at some point in their life, with the very rare few infections (7/100,000) resulting in a cervical cancer diagnosis. In contrast, the Statistics Canada website states that only 18.1% (a 2014 figure) of Canadians are smokers, yet 141.8 /100,000 Canadians will be diagnosed with lung cancer. 

 

It can therefore be said that if an HPV infection were a sole trigger, causing cervical cancer without any help from other factors, in the same way that smoking, by itself, can cause lung cancer, then cervical cancer rates would be significantly higher than they are.

Dr. Deirdre Little has researched HPV infection thoroughly, and in her lecture she gave, she explains:

HPV is found in most of the cancer of the cerivx. It’s found in 99.7%. However, it’s not the only cause. It’s a necessary, though not sufficient cause for development of cancer of the cervix. We do know that smoking plays a role, the pill plays a role, and we think heredity plays a role.

 

The HPV Vaccine - Its Efficacy and Safety

With that background, let's now move into a discussion about the vaccine and the clinical testing that was conducted. 

 

Efficacy

The effectiveness testing completed for the HPV vaccines was different, compared to how other childhood vaccines were scientifically tested and measured before licensing. For the non-HPV vaccines, the effect that was measured during clinical trials was "anti-body production." Did the participants generate an anti-body response?

 

The HPV vaccine testing was different though, because the tested effect in the 16-24 year age group was BOTH whether or not the vaccine produced an anti-body response in the recipients, AND whether or not that vaccine induced anti-body level subsequently reduced the incidence of HPV infections and CIN 2 or 3 lesions to specific HPV strains. The testing proved that, in the 16-24 year age group, having vaccine anti-bodies did reduce incidence of specific HPV infections and CIN lesions for a period of time. In your doctors office, and through vaccine marketing, young women hear that HPV vaccination prevents cervical cancer. To infer that a reduction in HPV infection and CIN lesions will subsequently result in a reduction of cervical cancer, is assumption based upon correlative evidence. 

 

Dr. Harper explains during her radio interview that it is unknown whether or not the HPV vaccine prevents cancer. That discussion begins with her explaining how the HPV vaccine testing process worked (emphasis mine):

It’s important to first understand what are you going to ask the patients to do. From the company’s perspective, [the participants] are going to get three shots, and the company has to know whether something bad happens to them immediately, after getting the shots or not. And then the company has to have some measure to say whether the vaccine is worthwhile or not. And the question then becomes what are you going to measure. And in this particular case, we can’t let women, it’s not ethical to enrol women in a trial, and let them proceed on to develop cancer, and another group, intervene, and ...by giving them a vaccine, potentially not letting them get cancer. So obviously cancer was not an ethical endpoint to use, to determine whether or not the vaccines would be effective or not. …So the first obvious end point that we would think about would be, “Well let’s show whether or not people got infected with the virus. If the vaccine’s supposed to prevent you from getting infected with it, then we should be able to see that you don’t get infected.” So that was the first end point.

 

Interviewer Question - Besides the fact that [a cancer] end point is unethical indeed, wouldn’t that be an unrealistic endpoint because…the cancers take years and years, maybe even decades to actually display?

 

Dr. Harper - Exactly. Exactly. They could take 10, 20 years to display. There’s no pharmaceutical company that’s going to make an investment in a trial that’s going to take that long, for them to even know whether they have an effective drug or not. And they have to have signs of efficacy before the FDA will allow them to sell it.

 

Question - So in essence, what you’re saying is they never really have proven [that HPV vaccine prevents cancer] - it’s only been what, about eight years or so since [the HPV vaccines] were released?

 

Dr. Harper - That’s right.

 

Question - So really, there’s been nowhere near enough time to accurately assess whether indeed they prevent cervical cancer?

 

Dr. Harper - That’s correct. 

 

And on this topic, in the Huffington Post article, Dr. Harper also states:

Gardasil is not really a cervical cancer vaccine. The vaccine prevents HPV infection, not the development of cervical cancer.”

 

In the radio interview with Dr. Harper, she alluded to the difference in performance between the Cervarix and Gardasil vaccines. She said (emphasis mine): 

..."one of the major concerns, is that the two vaccines that are currently released are similar, but yet very different. And there’s the major concern that the formulation within Gardasil will not give women protection that will last their lifetime, and therefore, even though it prevents them from getting an HPV infection early on, it’s not going to prevent them from getting an HPV infection later, and in effect, all we’re doing is delaying when they would get cancer...when you look at the data from Merck [for Gardasil] at the end of four years, and you look at the spread of antibody titers across all the people in the population, there’s a thousandfold difference in the way individual people respond to the exact same shot. So, I think that’s really powerful to say that, “You know we really just don’t know how long and what level of protection people are going to have."

 

In the Huffington Post article, Dr. Harper made the following statements (emphasis mine):

Cervarix is the superior cervical cancer vaccine, in that it prevents five types of cancer causing HPV infections. Gardasil is the superior vaccine in preventing HPV types causing genital warts." She also stated, "Regarding wart protection promotion, there is no mention [to the public] that the data showed protection against genital warts in men for only a 2.4-year period of time."

 

Gardarsil received licensing approval first, becoming the first HPV vaccine on the market. The first drug brand that is licensed, usually becomes the favoured brand that doctors rely upon, even if newer more effective drugs enter the market later. Such was the case with Gardasil. Dr. Harper has repeatedly expressed that the most effective HPV vaccine on the market is the Cervarix vaccine, however it is very rarely used. She says the following:

• Cervarix protects against five cancer-causing types of HPV, which lead to CIN 2+ (precancers and cancers).
• Gardasil protects against three cancer-causing types of HPV, which lead to CIN 2+ (precancers and cancers).
• Cervarix induces antibody titers for HPV 16 and 18 that are at least ten fold higher than natural infection titers; the antibody titers for the other three cancer causing types (HPV 31, 45, 33) are also significantly higher than natural infection titers, and the titers stay high for at least 7.4 years - lasting the longer of either vaccines.
• Gardasil only maintains antibody titers for HPV 16 (not 18, not 11, not 6) at five years, making the true long lasting (five years) coverage of Gardasil only for one type of cancer causing HPV.

• If duration of efficacy is less than fifteen years, then no cancers are prevented, only postponed.

 

To explain Gardasil's length of protection further, I would like to bring your attention to an interview that Dr. Suzanne Humphries gave. In it, she explains how long the Gardasil antibody levels last. She stated the following (emphasis mine):

Here’s [a study] where they checked the titers… they show you the antibody titers, and what you can see here is that…in the nine to fifteen year old girls... when it comes to the HPV 6 titer, there’s nothing left at month 48, that’s four years. There’s nothing left, and look how quickly [titers] drop, 929 in month seven, 156 in month 24. [For HPV 11] 1304 goes down to nothing, so it goes 1300 to 218 in two years. These titers are dropping like gravity. 

 

Below is the table she is referring to, taken directly from the Gardasil package insert. 

 

 

If you look at the different age groups shown in the table, you can see that the 9-15 year old population has the strongest anti-body response initially, seen at month seven, one month after all the groups received the third and final dose of vaccine. However, in all groups their titers drop rapidly and drastically in the subsequent months. The insert states, "studies in 9- to 15-year-old girls were planned to end prior to 48 months and therefore no serology samples were collected." The 9-15 year old girls had their titers tested between month 7 and month 36, a 2.5 year window, and during that time the girls anti-body levels dropped 87-92%. In the Huffington Post article, Dr. Harper stated that anti-body titers measured at year five showed memory against HPV 16 only, not 6, not 11, not 18. Because the package insert states that 9-15 year olds were not tested after 36 months, I infer that Dr. Harper's statement was specific to the older women only. And based on how the manufacturer's table above shows that testing occurred for the older women at 24 months, 36 months, and 48 months, I will assume that the older women were tested again at 60 months (year 5). So, recognizing Dr. Harper's statement, one could then speculate that maybe 9-15 year olds also retained some HPV 16 anti-body levels at year five, which was four and a half years after receiving the final dose of vaccine. But considering how significantly and consistently titers were shown to drop, in all HPV strain types and across all age groups, it's reasonable to assume that in the 9-15 year age bracket, the HPV 16 antibody titer would also return back to zero shortly after year five, if their titers even lasted into year five in the first place.

 

In Canada and the US, Gardasil is the vaccine of choice. What's important to point out is that according to the Government approved vaccination schedules, in some Canadian provinces the HPV vaccine is administered as early as grade five, to children aged nine and ten year. In the US, Gardasil is given at age 11. Does it make any sense to administer the HPV vaccine to children aged 9-11 years old, when the data shows that anti-body levels wear off in four to five years, which would make these kids 13-16 years old. The most critical age bracket, meaning the possibility of acquiring an HPV infection becomes most likely, is the group aged 16-24 years. Based on the data, it appears the Gardasil vaccine will not protect these kids even as they enter this critical age bracket, nevermind protecting them throughout the entire age bracket when the protection would be most worthwhile.

 

Also in the radio interview with Dr. Harper, she goes on to talk about a third, newest HPV vaccine. She gave this interview in 2013, which was the year before this newest vaccine was approved for use in the US and Canada. She had the following
to say (emphasis mine):

I should mention that there’s rumour that Merck is going to come out with another vaccine, where they are going to put more types in it, to say, “We’re even better now because we cover more types.” And I think people should just be really really cautious about that, because we don’t have any idea that it’s going to really prevent HPV infections. We don’t have any idea that it’s going to prevent them for a long time, we don’t know which types it will or won’t protect. 

 

What Dr. Harper said did come to fruition. The newest HPV vaccine is called Gardasil 9, because it is supposed to protect against nine strains of HPV. If you look at the titer data in the Gardasil 9 package insert on pages 28-33, the manufacturer provides a titer comparison of Gardasil 9 to the original formulation of Gardasil. The titer levels shown are similar, following the third dose of vaccine. What's missing in that comparison though is a listing of the titer levels in subsequent years. The only titer levels listed were those measured one month after receipt of the final vaccine doses, which were given at either month 6 or 12 (depending on the various schedules tested).

 

Safety

Separate from the effectiveness testing, is how the vaccines were tested for safety. In Part 1 of this series, I explained that for a person to learn which side effects participants were monitored for during the clinical trials, you need to review the vaccine package inserts provided by the manufacturers. Most HPV vaccine clinical trials monitored participants for only minor, short term reactions, listed below:

  • Pain

  • Erythema (redness of the skin)

  • Swelling

  • Rash

  • Urticaria (hives)

  • Pruritus (undesirable feeling on skin, which provokes desire to scratch)

  • Hematoma (collection of blood outside of the blood vessel)

  • Myalgia (muscle pain)

  • Arthralgia (joint pain)

  • Fatigue

  • Fever

  • Headache

  • Nausea

  • Vomiting

  • Diarrhea

  • Abdominal pain

  • Death
     

In the Cervarix insert, it states that all trial participants were monitored for some of the above listed reactions during the 7 days following vaccination. Participants could also report any other events during the 30 days following vaccination. For the original formulation of Gardasil, it explains that participants were given a vaccination report card, to record any of the symptoms listed above during the 14 days following vaccination. In the Gardasil 9 testing, the manufacturer describes that participants were specifically monitored for the above events for 5 days, and could report any other events in the 14 days following vaccination. An important point to note, is that these vaccines were not compared to a genuine saline placebo. In the clinical trials, the vaccines were either compared to their vaccine ingredients, or to each other.


The HPV Controversies and Investigative Reporting

With that background, let's now move into a discussion about the concerns that have been raised about the HPV vaccines, which include:

  1. the safety testing was inadequate

  2. the vaccine review and approval was fast-tracked

  3. some vaccine recipients are reporting debilitating, life altering illnesses

  4. some vaccine recipients are reporting impaired fertility

  5. the marketing of this vaccine has been very misleading


In Part 1 of this series I provided an important quote by Dr. Lucija Tomlijenovic. She has her PhD and is a vaccine researcher. Her quote was (emphasis mine):

...if one looks at the manufacturer's studies, they are often not designed to detect serious adverse events...There was a study done by a group of researchers, sponsored by GlaxoSmithKline, and they were looking at Cervarix [HPV vaccine]...and the authors acknowledged that none of the studies evaluated had been designed to detect auto-immune diseases. So obviously, you're not going to find what you're not looking for. And in spite of this obvious flaw, they conclude that there is no evidence that Cervarix is associated with increased risk for autoimmune diseases. And this is absurd, because you haven't looked for it. The study has not been designed to detect auto-immune diseases.

 

Also in Part 1 of this series, I explained that the CDC acknowledges that long term studies, looking at long term health outcomes in the vaccinated population, which could more accurately determine safety, have never been conducted. On their website they state:

Observing vaccinated children for many years to look for long-term health conditions would not be practical, and withholding an effective vaccine from children while long-term studies are being done wouldn’t be ethical.

 

Slate, a mainstream media group conducted their own eight month investigation into the Gardasil trials. The article written following this investigation was titled "What the Gardasil Testing May Have Missed." In this very important review, Slate corroborates the statement made by Dr. Tomlijenovic, that HPV studies were not designed to detect serious events like autoimmune diseases. 

 

But before highlighting Slate's report, it's important to first show how pro-vaccine Slate is. In a different Slate article, they stated (emphasis mine):

There are two sides to almost every story, and sometimes we publish both of them. That’s true even for science...But three areas of science are beyond scientific debate even though they are still debated by a lot of people. Evolution and climate change are two... The other is vaccines.

 

And, in a follow-up article titled, "Why is Slate Questioning Gardasil," written as a companion piece to "What the Gardasil Testing May Have Missed," a Slate writer re-iterated their very pro-vaccine stance, by saying the following:

"I was vaccinated with Gardasil in 2007, right after the vaccine was first approved. If I were faced with the choice today, I would still choose to get vaccinated with Gardasil...That’s because the decision around vaccination is a decision that involves weighing the evidence on potential benefits versus potential harms, and to my eye, the potential benefits greatly outweigh the potential harms.

 

I assume this companion piece was written in an effort to do damage control, because any publicly made vaccine critical sentiment usually leads to being branded anti-vax, and anti-science, which if you're a reporter is often a death sentence for your career. Despite Slate's very pro-vaccine stance, this investigation did show them that not only did the Gardasil research fail to serve the public's interest, but those failures could cause serious harm to public safety and therefore those failures NEED to be corrected. In "Why is Slate Questioning Gardasil," they stated (emphasis mine):

So why run this story? From my perspective, this story has important ramifications for public health. Because even if it turns out that Gardasil does not cause autoimmune disorders in anyone (which is possible), the fact remains that these trials were designed in a way that meant they would probably be unable to reliably assess this potential relationship. And to me, that’s worrying because clinical trials, particularly those used to assess medicine that will be used on large numbers of people prophylactically, ought to be able to make such assessments. And if we’ve been failing on this front, we should know that, so we can correct for it. This is how science is supposed to work.

 

...there’s a (legitimate) fear that this story could be used to bolster a case that vaccines are bad and untrustworthy....That’s possible. It’s also, in my opinion, a terrible reason to not run an excellent and nuanced piece of journalism about something that is true and, indeed, something that is in the public’s interest to know.

 

The main theme of "What the Gardasil Testing May Have Missed," is that the years-long pre-licensing testing failed the public completely, because the testing WAS NOT designed in a way that would allow for the identification of serious long term effects. 

 

Some highlights taken out of Slate's investigative report, which are arranged out of order for coherence, are as follows (emphasis mine):

An eight-month investigation by Slate found the major Gardasil trials were flawed from the outset... and that regulators allowed unreliable methods to be used to test the vaccine’s safety. While these flaws do not mean Gardasil caused the rare crippling illnesses reported by the media, they are troubling. Public health officials use trials like these both to determine safety and... to reassure the public when concerns like the ones about Gardasil arise. A flawed study design can complicate both tasks.

 

...To track the safety of its product, the drugmaker used a convoluted method that made objective evaluation and reporting of potential side effects impossible during ALL but a few weeks of its yearslong trials. At all other times, individual trial investigators used their personal judgment to decide whether or not to report any medical problem as an adverse event—essentially, as a potential side effect worth evaluating further. Other health issues went on a worksheet for “new medical history,” reserved for conditions that bore no relation to the vaccine. This study design put the cart before the horse, asking investigators to decide which symptoms might be side effects, rather than tracking everything in the same way.

 

...In all the trial locations, Merck also chose to restrict the reporting of adverse events—what the study protocol calls the “clinical follow-up for safety”—to just 14 days following each of the three Gardasil injections in the trial. Illness occurring outside these narrow time slots again was relegated to a single line on the [new] medical-history worksheet, whereas for each adverse event, several assessments would need to be carried out and reported. 

 

..[One trial participant] told me she brought up her symptoms with study personnel at every visit during the four-year trial. She even told them her illness had forced her to quit school. But no one seemed to take her seriously: “They keep saying, ‘This is not the kind of side effects we see with this vaccine.’ ”...

 

...[She] and I read the definition of “serious adverse experience” on the worksheets that investigators had to fill out at each visit following a vaccination. It included events resulting in “persistent or significant disability/incapacity,” meaning a “substantial disruption of a person’s ability to conduct normal life functions.” On all the forms, the only checked box was the one that said “None.” Was this an error? Arguably not, because [her] symptoms, as recorded by the study personnel, began three to four weeks after her second shot—outside the protocol’s mandatory follow-up for safety.

 

...[Another trial participant], who is currently employed under a special agreement for people with chronic illness, says she told study personnel about her problems during the trial; her records mention none of them.

 

...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. Deirdre Little explained in her lecture how Gardasil was fast tracked through the FDA review and approval process, when this vaccine didn't actually meet the FDA's fast tracking criteria.

 

On the FDA's website, they provide the criteria that a new drug must meet, in order to qualify for fast tracking. The FDA website states the following (emphasis mine):

Fast track is a process designed to facilitate the development, and expedite the review of drugs to treat serious conditions and fill an unmet medical need...Filling an unmet medical need is defined as providing a therapy where none exists or providing a therapy which may be potentially better than available therapy.

 

...If there are available therapies, a fast track drug must show some advantage over available therapy, such as:

  • Showing superior effectiveness, effect on serious outcomes or improved effect on serious outcomes

  • Avoiding serious side effects of an available therapy

  • Improving the diagnosis of a serious condition where early diagnosis results in an improved outcome

  • Decreasing a clinical significant toxicity of an available therapy that is common and causes discontinuation of treatment

  • Ability to address emerging or anticipated public health need

 

Dr. Harper and Dr. Little have both explained that regular pap screening is highly effective at preventing cervical cancer. In the Huffington Post article, Dr. Harper states that pap screening has never disabled or killed anyone, which she explains cannot be said for HPV vaccination. She elaborates further on the risks of HPV vaccination, saying (emphasis mine):

  • Duration of [vaccine] efficacy is key to the entire question. If duration is at least fifteen years, then vaccinating 11-year-old girls will protect them until they are 26 and will prevent some precancers, but postpone most cancers. If duration of efficacy is less than fifteen years, then no cancers are prevented, only postponed.

  • Safety: There is at least one verified case of auto-immune initiated motor neuron disease declared triggered by Gardasil [presented by neurologists at the 2009 American Neurological Association meeting in Baltimore, Maryland). There are serious adverse events, including death, associated with Gardasil use.

  • No population benefit in reduction of cervical cancer incidence in the United States with HPV vaccination as long as [pap] screening continues.

  • Incidence rate of cervical cancer in the United States based on [pap] screening is 7/100,000 women per year.

  • Incidence rate of cervical cancer if women are only vaccinated with Gardasil is 14/100,000 per year (twice the rate of cervical cancer if young women vaccinated with Gardasil do not seek Pap testing at 21 years and the rest of their life).

  • Incidence rate of cervical cancer with Cervarix vaccination is 9/100,000 per year— better than with Gardasil, but still more than with screening alone.
     

HPV vaccination cannot eliminate the need for pap screens, because if pap screens were eliminated, rates of cervical cancer would increase from 7 diagnoses for every 100,000 people today, to 9 or 14 diagnoses in every 100,000 people, depending on which vaccine was used. That reality makes pap screening the more effective cancer prevention strategy. In addition to that, pap screens also have never disabled or killed anyone, unlike HPV vaccination, which means that on both fronts, pap screening remains the superior and more advantageous medical practice, not vaccination. And therefore, according the FDA's own criteria, the HPV vaccine should never have been fast tracked through their review and approval process in the first place.

 

In Dr. Little's lecture, she explained:

We know that 1 in 3 fast tracked agents are withdrawn from the market due to adverse effects - that’s if [the fast tracked agent] had a six month approval time. Gardasil, as we know, had a six month approval time.

 

Dr. Little also spoke 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, studies that 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. If they had, and if that data showed fewer emergency visits and hospitalizations in the vaccinated population, that data would provide safety reassurance. Unfortunately, these researchers refused to conduct a comparison and like Government and manufacturer researchers who came before, they've assumed that the unvaccinated/never vaccinated populations experienced the same rates of ER visits and hospitalizations. Because of that, the researchers concluded that despite 10% of vaccine recipients requiring emergency care in the 42 days following vaccination, in their opinion, the HPV vaccine adverse events were "minimal" and the vaccine is safe.

 

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 for the Canadian study mentioned above. 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 (HPV4 is 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 made in Part 1 of this series, that vaccine makers and the Heath Authority assume that vaccine side effects must be short lasting. They make this assumption with no scientific data to back up their claim.

 

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 into this study, 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 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 made in this Kaiser Autoimmunity review, 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" (people who actually were heavy smokers but had quit smoking one month prior), and compared those estimated rates of disease 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 manufacturers and Government Health agencies contribute to this level of poor quality research, because they believe that real comparisons of real long term health outcomes between vaccinated and never vaccinated populations just isn't needed. 

 

Recently Published HPV Research that is Concerning

Recently, an economist, Gayle DeLong, published research in the Journal of Toxicology and Environmental Health. She and her colleagues had noticed that birth rates declined between 2008 and 2010. As economists, they speculated at that time that this decline in birth rate was due to the recession. However, when the economy improved but birth rates continued declining DeLong decided to investigate further, utilizing data published by the CDC following the National Health and Nutrition Examination Survey. This survey represented 8 million women, ages 25-29 years old, residing in the US between 2007 and 2014. DeLong's analysis of the Government data shows that pregnancy rates in married women, the group most likely trying to conceive, differed depending upon the vaccination status of the women. Married women who had been vaccinated against HPV, were more likely to have not been pregnant, compared to married women who had not been vaccinated against HPV. Her analysis of the data also showed that if she grouped the vaccinated women according to number of HPV doses they received, one dose, two doses or all three doses, the higher dosed groups had even lower rates of pregnancy. To quote from her paper, it says:

For married women, the difference in prevalence of pregnancy between exposure to the HPV vaccine (50.1%) and unexposed group (76.9%) was −26.2%. If all the married women had received the HPV shot, the number of those women who had ever been pregnant would have diminished by 1 million...

 

...One common misperception regarding regression analysis is that it may be used to determine causality. Regressions demonstrate associations, not causations. Although the analysis presented here shows a relationship between vaccine injection and lowered probability of ever being pregnant for females aged 25–29, the conclusion that vaccines were the basis for reduced probability cannot be made.

 

To conclude, I'd like to remind you that the HPV vaccines are marketed as a prevention for cervical cancer, despite never having been tested or proven as such. The manufacturers themselves explain that for every 100,000 Canadians, only seven women will be diagnosed with cervical cancer. Whereas, studies like the Canadian one which evaluated ER visits following vaccination, that study concluded that 10% of HPV vaccine recipients (that's 10,000 people for every 100,000 vaccinated) will need to visit an ER, and 0.5% of them (500 of every 100,000 vaccinated) will require hospitalization, in the 42 days following vaccination. Again, to be clear, that study could not determine whether or not Gardasil caused those ER visits and hospitalizations, but Gardasil may be doing just that. 

 

An HPV critical study published in July 2017 had the following to say, "This article critically reviews HPV vaccine serious adverse events described in pre-licensure randomized trials and in post-marketing case series...Two of the largest randomized trials found significantly more severe adverse events in the tested HPV vaccine arm of the study." The study explained that Cervarix vaccination resulted in a higher number of deaths, 14 deaths in 2,881 Cervarix recipients compared to 3 deaths in 2,871 "placebo" recipients (the placebo was the aluminum adjuvant contained within Cervarix, not saline). For general comparison purposes,  14 deaths in the 2881 Cervarix recipients, compared to 2 cervical cancer deaths in a population of 100,000, warrants further investigation. The Government should have insisted Gardasil be tested against a genuine saline placeboo, to ensure that more kids weren't dying from adverse effects of the vaccine, compared to the number of women  killed annually by cervical cancer. 

 

Another HPV critical study analyzed Swedish Government data, and arrived at the conclusion that HPV vaccination may actually be causing cervical cancer rather than preventing it. Before discussing those findings, it's important to first explain that this research was published on April 30, 2018, and was later retracted. The retraction letter explains that the author, out of fear, lied about his name and chose to publish under a pseudonym. As per this medical journal's policy, an author must publish under their true identity (maybe that is a requirement of all medical journals, I'm not sure). Despite the author's deception with his name, the publisher, the Indian Journal of Medical Ethics, has allowed the retracted paper to remain visible on their website, noting that the science and content within the article was found to be correct. A notation has since been added to the research paper, which states, "Under the current circumstances where publication of any information critical of vaccines can have serious personal repercussions, the author has chosen to publish under this pseudonym."

 

This research states (emphasis mine):

The Centre for Cervical Cancer Prevention (NKCx) in Sweden has noted in its annual report of 2017, which includes data upto 2016, a substantial increase in the incidence of invasive cervical cancer, especially during the years 2014 and 2015.

 

...The efficacy of HPV-vaccines has been evaluated by studying premalignant cell changes in the cervix called CIN2/3 and cervical adenocarcinoma in situ or worse. The efficacy was calculated for individuals who have not been exposed to HPV 16 and 18. These individuals are called naı̈ve. The vaccine is efficacious only in individuals not previously exposed to HPV 16 and 18 (naıv̈e individuals). If an individual has already been exposed to HPV 16 and 18, no new antibodies are made. Therefore, the vaccine will not work for non-naı̈ve individuals. HPV 16 and 18 are responsible for about 70% of all cervical cancers. It is therefore crucial to give the vaccine to naı̈ve individuals. During their review of Gardasil by the FDA, the efficacy of the vaccine was also evaluated on individuals who were exposed to the oncogenic HPV strains before vaccination since individuals who are non-naı̈ve will also receive the va