Chapter 6: Article 3
Previously, you learned it's critically important to ask, "What types of health outcomes are the focus of vaccine safety clinical trials?"
The 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 - bruise)
Myalgia (muscle pain)
Arthralgia (joint pain)
Fatigue
Fever
Headache
Nausea
Vomiting
Diarrhea
Abdominal pain
Death
Another critically important question to ask is, "How long were participants monitored for during the testing?"
Each vaccine is different. The Cervarix vaccine monitored participants 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, participants were monitored for the symptoms listed above during the 14 days following vaccination. In the Gardasil 9 testing, the manufacturer monitored the participants for the above events for 5 days after vaccination, and participants could report any other events in the 14 days following vaccination. An important point to note, these vaccines were not compared to a saline placebo. In the clinical trials, the vaccines were either compared to each other, or some of the vaccine ingredients.
With that background, let's discuss the concerns that have been raised about the HPV vaccines, which include:
the safety testing was inadequate
the vaccine review and approval was fast-tracked
some vaccine recipients are reporting debilitating, life altering illnesses
some vaccine recipients are reporting impaired fertility
the marketing of this vaccine has been very misleading
In Ch5: Article 3, I introduced you to Dr. Lucija Tomlijenovic. She has her PhD and is a vaccine researcher. In an interview she alerted us, saying (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...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 that article, 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.
Slate is extremely pro-vaccine. In a previous article they state (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," 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.
...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 from 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.
...To track the safety of its product, the drugmaker used a convoluted method that made objective evaluation and reporting of potential side effects impossibleduring ALL but a few weeks of its yearslong trials.
...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.
...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 list 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 advantageover 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.
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.
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.
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 - 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 to the FDA's own criteria, the HPV vaccine should never have been fast tracked through their review and approval process.
Did the FDA's haste to review and approve this drug quickly, cause them to prioritize vaccine approval over public safety. The next article digs deeper into that question, looking at concerning safety signals.
CONTINUE to Ch6: Article 4
Article Sources
Radio interview available on Youtube with HPV expert, Dr. Diane Harper Here
One More Girl Documentary excerpt - statement by Dr. Harper Here
Huffington Post Interview with Dr. Harper Here
Lecture on HPV by Dr. Deirdre Little Here
Gardasil Package Insert Here
Gardasil 9 Package Insert Here
Cervarix Package Insert Here
Statement by Dr. Lucija Tomlijenovic that the Cervarix vaccine studies were not designed to detect autoimmune diseases Here
CDC - vaccinated long term health outcomes have never been studied Here
Slate - What the Gardasil Testing May Have Missed Here
FDA - Fast Track Process Here