In December 2017, Slate magazine published an astonishing article about the human papillomavirus (HPV) vaccine Gardasil, revealing how the safety trials for this controversial vaccine actually “weren’t designed to properly assess safety.”1 Gardasil is supposed to prevent infection by certain strains of HPV virus, which in rare cases may cause cervical cancer if left untreated.
However, trial data from Merck shows that Gardasil vaccinations may actually increase your risk of cervical cancer by 44.6 percent if you have been exposed to HPV strains 16 or 18 prior to vaccination.2 The U.S. Food and Drug Administration has made this document inaccessible, but we’ve saved a copy of it. In his Slate article, investigative journalist Frederik Joelving recounts the story of Kesia Lyng, a 30-year-old Danish woman who, at the age of 19, participated in a clinical trial for Merck’s Gardasil vaccine.
“Lyng’s grandmother had died of cervical cancer the year before, so when a letter arrived offering her $500 to take part in a crucial international test of Gardasil, the decision was easy,” Joelving writes. “She got her first shot of the vaccine at Hvidovre Hospital in Copenhagen on September 19, 2002. The symptoms snuck up on her shortly after her second shot on November 14.
They never abated. It wasn’t until 2016 that she received her diagnosis — chronic fatigue syndrome (CFS) … In recent years, Lyng has become suspicious that there is a connection between her disease and her Gardasil immunization. Her ailments evoke descriptions found in hundreds of news stories from women who also received the vaccine, as well as several medical case reports from around the world.”
HPV Vaccine Linked to Serious Side Effects, Including Death
Reported side effects of Gardasil vaccination include immune-based inflammatory neurodegenerative disorders, suggesting something is causing the immune system to overreact in a detrimental way, sometimes fatally.3,4 The dangers of high immunogenicity was addressed in my 2015 interview with Lucija Tomljenovic, Ph.D., a research scientist at the University of British Columbia. In it, she explains that by triggering an exaggerated inflammatory immune response, vaccine adjuvants end up affecting brain function.
In collaboration with a team led by professor Yehuda Shoenfeld, a world expert in autoimmune diseases who heads the Zabludowicz Autoimmunity Research Centre at the Sheba Hospital in Israel, Tomljenovic has demonstrated how the HPV vaccine can cause brain autoimmune disorders. It was these findings that prompted the Japanese government to remove the HPV vaccine from its list of recommended vaccines.5 The vaccine injury law firm Sadaka Associates also claims that:6
“Medical researchers have accused drug regulators and manufacturers of concealing the real dangers of the HPV vaccine. Many girls have suffered life-threatening injuries as the result of the vaccine. The HPV vaccine has also caused death … The drug regulators have also been accused of adding aluminum to the placebo in order to manipulate scientific data. Even though aluminum was used in the placebo, scientists have confirmed that the HPV vaccine has been linked to death.
There was a study done that involved 2,881 girls who receive the vaccine. Fourteen of the girls who received the vaccine died. Three of the girls who received the placebo died. There was a team of researchers at the National Institute of Cardiology that also found that there is a link between HPV vaccine and life-threatening reactions.
They looked at 28 studies that involved girls who had been given the HPV vaccine. They also looked at 16 randomized trials. They found that girls were given a placebo with aluminum in 14 of the randomized trials.
If aluminum is placed in a placebo, then a person is more likely to have an adverse reaction. Spanish researchers found that girls who receive the HPV vaccine are 10 times more likely to react to it. Canadian scientists found that 10 percent of the girls who were vaccinated had to be hospitalized due to a reaction. These girls had to be hospitalized within 42 days of receiving the vaccination.”
Overstated and Unproven Effectiveness
A 2012 systematic review7 of pre- and post-licensure trials of the HPV vaccine also concluded that the vaccine’s effectiveness is both overstated and unproven. According to the authors, the review revealed:
“… evidence of selective reporting of results from clinical trials (i.e., exclusion of vaccine efficacy figures related to study subgroups in which efficacy might be lower or even negative from peer-reviewed publications). Given this, the widespread optimism regarding HPV vaccines long-term benefits appears to rest on a number of unproven assumptions (or such which are at odd with factual evidence) and significant misinterpretation of available data.
For example, the claim that HPV vaccination will result in approximately 70 percent reduction of cervical cancers is made despite the fact that the clinical trials data have not demonstrated to date that the vaccines have actually prevented a single case of cervical cancer (let alone cervical cancer death), nor that the current overly optimistic surrogate marker-based extrapolations are justified.
Likewise, the notion that HPV vaccines have an impressive safety profile is only supported by highly flawed design of safety trials and is contrary to accumulating evidence from vaccine safety surveillance databases and case reports which continue to link HPV vaccination to serious adverse outcomes (including death and permanent disabilities).”
Gardasil Safety Trials Were Not Designed to Detect Safety Problems
It’s precisely these kinds of design flaws that are highlighted in the December 17, 2017, Slate article.8 Joelving reports that Merck has repeatedly “issued reassurances about the thorough randomized trials the vaccines were subjected to before approval.”
The public was told that the three HPV vaccines marketed in the U.S. were tested on tens of thousands of individuals around the world, without any compelling evidence of serious side effects having emerged. While that reads well on paper, the shocking truth appears to be that these trials were never designed to detect and evaluate serious side effects in the first place. According to Joelving:
“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. Drug regulators tend to look much more seriously at potential side effects that surface during a pre-licensure study, which is what Lyng participated in, rather than after a product has already been found to be safe and been put on the market.
But regulators never learned of Lyng’s plight. In fact, her repeated complaints of debilitating symptoms were not even registered in the study as potential side effects … Lyng’s experience was not unique. Interviews with five study participants and more than 2,300 pages of documents obtained through freedom-of-information requests from hospitals and health authorities suggest inadequacies built into Merck’s major clinical tests of Gardasil.”
Joelving describes these inadequacies in great detail, showing how Merck made the vaccine appear far safer than it actually is by using “a convoluted method that made objective evaluation and reporting of potential side effects impossible during all but a few weeks of its yearslong trials.” Serious adverse events were only recorded during a two-week period post-vaccination.
Moreover, during this narrow window of time, trial investigators “used their personal judgment to decide whether or not to report any medical problem as an adverse event.”
Side Effects Simply Marked Down as Medical History
Importantly, and shockingly, most of the health problems that arose after vaccination were simply marked down as “medical history” rather than potential side effects — a tactic that basically ensured that most side effects would be overlooked. No record was made of symptom severity, duration or outcome.
Even with this gross reporting flaw, at least one Gardasil trial of the new nine-valent vaccine reported nearly 10 percent of subjects experienced “severe systemic adverse events” affecting multiple system organ classes, and over 3 percent suffered “severe vaccine-related adverse events.”9 The 2012 systematic review10 of Gardasil pre- and post-licensure trials mentioned earlier isn’t the only report out there that has offered up severe criticism of Merck’s trial tactics. Joelving writes:
“In an internal 2014 EMA report11 about Gardasil 9 obtained through a freedom-of-information request, senior experts called the company’s approach ‘unconventional and suboptimal’ and said it left some ‘uncertainty’ about the safety results. EMA trial inspectors made similar observations in another report, noting that Merck’s procedure was ‘not an optimal method of collecting safety data, especially not systemic side effects that could appear long after the vaccinations were given.'”
Study Subjects Betrayed
In other words, when Merck says Gardasil has been extensively studied for safety, it’s referring to studies set up in such a way that data on potential side effects were actually excluded. If side effects are not included in the data collection, how can you rightfully claim that no significant problems exist? Sadly, shoddy and incomplete documentation of adverse events, and follow-up periods that are too short to detect problems, can have tragic ramifications, and this is what appears to have happened with the release of Gardasil.
Joelving’s investigation reveals at least five other Danish women went on to develop debilitating health problems during the Gardasil trial. One developed severe fatigue, persistent flu-like symptoms, and had to be admitted to the hospital for a serious infection shortly after one of her vaccinations. All of her symptoms were marked down as “medical history” and were not processed as adverse events.