Scientific Misconduct and Maladministration Accusations over HPV Vaccine Safety in Europe

October 18, 2016

The Nordic Cochrane Center in Denmark issued a complaint earlier this year to the European Medicines Agency over its safety review of HPV vaccines (Gardasil and Cervarix) and their causal association with autoimmune disorders, specifically CRPS (Complex Regional Pain Syndrome) and POTS (Postural Orthostatic Tachycardia Syndrome), which dismissed any connection to the vaccines. The Nordic Cochrane Center did not feel that the EMA’s response addressed their complaint sufficiently. They are now accusing the EMA of scientific misconduct, illegitimate practices and maladministration and have sent a detailed complaint to the European Ombudsman (the ‘Complaint’), which will now require a legal investigation.

The downward spiral of the HPV vaccine program in Europe has been a progressively steady one over the last three years. Vaccine proponents would like you to believe that the decline in uptake rates is because of online rumors and media hype over the “coincidental” occurrence of autoimmune disorders in young girls around the time of vaccination. I remain at a loss, however, to explain away the peculiar destiny of girls being ambulanced to hospital from school immediately following a vaccination as a mere coincidence, which is what they are suggesting. The hype over declining rates in Ireland recently was deemed to be of such a concern that the WHO called an emergency meeting with the Irish health authority to discuss it. Think about that for a minute.

The WHO, along with the Global Advisory Committee on Vaccine Safety (GACVS), are doubling down on this “coincidence” idea and now, incredibly, are attributing reports of adverse reactions to an entirely new phenomenon referred to as “immunization anxiety reactions” (IARs). GACVS believes that the prevalence of “IARs” is largely influenced by social media, an inadequacy of health authorities to psychologically prepare the vaccine, and inaccurate media reporting of new vaccination programs (such as HPV). Language like “clusters” and “outbreaks” is used to describe the frequency of incidence of this newly identified “condition.” Common symptoms have also been described on the WHO’s website, I can only assume so that the idea will gather momentum amongst doctors, eager to find something with which to label patients. This “condition” has replaced the idea that these girls are suffering from what officials used to label “mass psychogenic” or “mass hysterical” reactions to the vaccine, according to this paper. The author suggests that the idea of “IARs” is more acceptable and less stigmatizing for young people. Even though this “condition” is not recognized in the medical literature, GACVS believes it should be studied further so that such “outbreaks” can be prevented and therefore, negative press and social media reports of adverse events can be thwarted, so as not to disrupt vaccination programs in the future. In none of the papers or the reports from GAVCS that I have read, did the authors make reference to vaccine injury as being a reality. There was only the desire to explain away the idea of it. And that’s scientific?

Evidence of this is mounting. In fact, just a few days ago a national radio news show in Ireland, hosted by MD Ciara Kelly, discussed the issue at length. She was heard with her guest, Dr. David Robert Grimes, an Oxford-educated scientist (not an MD), laughing at the idea of HPV vaccine injury and indeed mocking the injured girls of R.E.G.R.E.T. and their families, saying that their experiences were psychogenic. Dr. Grimes emphatically stated that serious side effects “simply DO NOT EXIST” (emphasis mine, but it sounded like he was shouting). They didn’t present a balanced opinion on the show due to the theory of “false balance.” This means that an opposing view (or testimonies of injury) would be considered misinformation in their opinion because the only ones opposing the vaccine were anti-vax groups and those who didn’t want to face up to the idea that their kids would be having sex, a puritanical viewpoint in Dr. Grimes’ opinion. They equated anyone with an opposing view with flat earthers, saying that they didn’t deserve to be heard on the same platform as the presenter and her guest. I don’t know where to begin with any of that.

This is the mentality being adopted by most public health (private wealth) “acronym agencies” throughout the world in order to dismiss the notion that HPV vaccines are causing autonomic disorders in epidemic proportions in teenagers. The problem for those who suffer a reaction is proving causation, which is the major trump card held by the medico-pharma-governmental establishments which promote vaccination. They all have a vested financial interest in cementing the idea of the absolute safety of HPV vaccines as an undeniable fact in the minds of the masses. Questioning that “fact” makes you an “anti-vaxer” or indeed, a “quack” if you happen to have spent ten years in medical training but by some anomaly have maintained your critical thinking skills. Either way, the notion of real risk must be suppressed at all costs because there are always lives at stake, in theory.

WHO slide indicative of the attitude toward HPV vaccine injuries

But what’s really at stake is money, and a whole lot of it. And when I say “money,” I don’t just mean the $2 billion dollars Merck and GSK generate from the sale of HPV vaccines each year, I mean the threat of costly lawsuits. The only side effects the pharmaceutical companies will allow to be causally linked to the vaccines are mild, short-term injection-site reactions and fainting (syncope). This allows vaccine pundits to be confident when they say that there are no long-term proven effects from the vaccine. Admitting anything more will open them up to litigation. Not in the U.S. of course, as you cannot sue a vaccine maker for any long-term ill health effects or death. Vaccine “lawsuits” settled in the U.S. in “Vaccine Court,” are done so on a no-fault basis. The going rate for a dead child following Gardasil (or any vaccine): $250,000.

A lawsuit outside of the U.S., however, would allow for the process of discovery, which would mean sensitive information could potentially be forced out into the public arena – and the dominoes would start to fall. It could mean that tens of thousands of people will line up to sue Merck and GSK for damages. In turn, governments all over the world could potentially sue them for fraud for persuading them to adopt a vaccine program which risked the health of their most valuable asset, their fertile teenage population.

Therefore, proving causality between the vaccine and the illnesses reported as post-market adverse events is the single biggest threat to the viability of the HPV vaccine program worldwide. It is the backdrop for this issue brewing in Europe. So when you hear online bullies shouting at these innocent girls from the peanut gallery, “There’s no evidence that your injuries are from the vaccine!” think about what these geniuses are saying.

Comparison of reported adverse effects of Gardasil vs. all other vaccines in Denmark as noted in the report from the Uppsala Monitoring Centre

So what are injured girls and their parents to do? Who will believe them?

The Cochrane Nordic Center has taken up the baton in Europe as watchdog for the people on this issue, as it has become more than apparent to anyone who looks beneath the surface that there are so many questions unanswered with regard to HPV vaccines. It is becoming abundantly clear that an urgent independent investigation is warranted, despite the “acronym agencies” continuing to dictate the age-old narrative that the “benefits outweigh the risks.” As the Complaint states

There is enough evidence to substantiate a suspicion of serious harms, which is what motivated the DHMA to call for an investigation. The EMA’s unwarranted certainty has been met with disbelief and has resulted in a dramatic decline in vaccine uptake, the exact opposite of what the EMA wanted. In Fyn in Denmark, the uptake of the vaccine decreased from 74% to 31% in just one year.

Denmark is the epicenter of the HPV vaccine free fall in Europe. In 2013, The Danish Health and Medicines Agency (DHMA) first reported a signal to the EMA of a suspected connection between POTS and Gardasil (the HPV vaccine of choice in Denmark at the time). However, the EMA concluded after looking at the evidence presented to them that they could “neither confirm or deny” a link to the vaccine.

Reports continued to flood to the five “HPV centers” around Denmark, which had been set up to manage the intake of these girls and take medical histories. However, there is no official treatment protocol at these centers and no recognition by the DHMA that their symptoms relate to the vaccine. There have been 2,300 adverse drug reactions (ADRs) officially reported. This growing patient population with new unexplained conditions prompted a national investigation by a mainstream TV network which released a hard-hitting investigative documentary in early 2015, adding yet more pressure on the DHMA to take action.

A study soon followed from Frederiksberg Hospital by Dr. Louise Brinth, who reported on 53 patients, who claim that their symptoms were linked to vaccination with Gardasil. Information was also coming from the WHO Uppsala Monitoring Centre, who reported on three safety signals coming from its database which could not be swept under the “IAR” rug. The DHMA was then pressed once again to present this new information to the EMA in July 2015, resulting in a formal request to reevaluate the risk profile of the HPV vaccine.

The results of those 53 case studies are staggering:

Fifty-two out of 53 patients (98%) reported that their activities of daily living were seriously affected and 40 (75%) had had to quit school or work for more than two months due to their symptoms.

Headache: 53 (100%)
Orthostatic intolerance: 51 (96%)
Syncope: 24 (45%)
POTS:  28 (53%)
Fatigue: 51 (96%)
Cognitive dysfunction: 47 (89%)
Disordered sleep: 45 (85%)
Visual symptoms: 37 (70%)
Blurring of vision: 44 (83%)
Gastrointestinal symptoms: 48 (91%)
Neuropathic pain: 35 patients (66%)
Motor symptoms: 35 (66%)
Dyspnoea [labored breathing] (: 35 (66%)
Skin disorders: 34 (64%)
Voiding dysfunction: 31 (59%)
Limb weakness: 30 (57%)
Vascular abnormalities: 27 (51%)
Irregular periods: 15/31 not on pill (48%)
Sicca symptoms [dry eyes and mouth]: 21 (40%)
Hyperventilation: 18 (34%)

The EMA conducted an investigation into the connection between the HPV vaccines and POTS and CRPS, even though the Brinth case studies did not include CRPS, over a few months from August 2015 to November 2015 after which it issued a draft report. Then the following January, they confidentially concluded in a binding and secretive decision that HPV vaccines were not causally associated with POTS and CRPS, a headline that ran in (biased) media outlets all over the world who were eager to sing it from the rooftops.

The DHMA may have appeared to flip-flop on this issue, but ultimately it embraced the EMA’s decision and continues to recommend vaccinating with the HPV vaccine, despite the coincidental (there’s that word again) timing of the removal of Gardasil as the vaccine of choice in January 2016. Denmark now recommends Cervarix, which is a bivalent vaccine (unlike Gardasil, it does not claim to prevent genital warts).

The DHMA insists this was purely a commercial decision on their part and had nothing to do with mounting reports of injuries due to Gardasil. Chief Medical Doctor Jesper Mehlsen at Synkopecenter at Frederiksberg Hospital, who himself treats injured girls and has conducted studies on this issue, is quoted in this article as saying (tongue in cheek?)

“It cannot be because of the side-effects which one claims don’t exist with Gardasil, because in the United Kingdom one has before experienced precisely the same side-effects with Cervarix”.

So we should not expect the patient reports to stop, just cessation of the mounting reports of side effects from Merck’s brand, Gardasil. This will deprive the world of vital information since Denmark is one of the few countries where researchers are actively monitoring the side effects in patients from this drug. Regardless of the brand name, uptake of the HPV vaccine continues to decline and now rests around 24%, down from a high of 80% when the vaccine was first introduced.

Patient groups in Denmark, like Ireland, are not going away quietly since their respective health agencies continue to deny help for their girls and deny a causal link between their members’ injuries and Gardasil. These patient groups, along with the help of some prominent politicians in Denmark, were responsible for bringing this issue to the attention of the Cochrane Nordic Center in 2015, which has resulted in the legitimization of their concerns.

The Cochrane Complaint has laid some heavy charges on the EMA, which are now answerable to the European Ombudsman, something they have faced before as the Complaint explains in detail. Specifically, the agency is being charged with maladministration due to failures to disclose of conflicts of interest, failure to disclose the names of rapporteurs, and illegitimate redactions when specific information was requested. They are accused of not acting in an open and accountable way to the public, of not looking at all the research, including the very credible research conducted by Dr. Brinth, the very research which prompted the inquiry. The EMA dismissed (unscientifically) many of the cases she presented in her research study. Indeed, Dr. Brinth was so enraged after the draft report was issued in November 2015, that she penned this rather detailed responsum.

The Complaint explains in detail how the EMA appeared to be operating on a consensus basis to arrive at their conclusion. The Complaint correctly noted that consensus is the very antithesis of science and is seen as political. This is not in the best interest of the public as it goes against the mission of the agency, which is

. . . to foster scientific excellence in the evaluation and supervision of medicines, for the benefit of public and animal health in the European Union (EU).

The complaint also focuses on the manufacturer’s clinical trials and questions the failure of the EMA to critically evaluate any of the studies they presented by accepting the manufacturers’ reports at face value. They correctly ask the question many of us have been asking around the world: Why did the EMA not question the use of a neurologically toxic adjuvant as the control in the Gardasil clinical trials? It is the same toxic adjuvant as the one in the vaccine. This has the effect of masking any safety signals, and Cochrane correctly charges the EMA with scientific misconduct based on this issue alone.

The complaint also questions the secrecy around the report’s author and why rapporteurs were asked to sign a lifelong secrecy agreement surrounding the details of the inquiry. The EMA is being accused of illegitimately using laws and codes to hide behind so that details of the consensus-reaching process can never be made public.

The EMA is accused of being under undue influence of the pharmaceutical industry, as evidenced by undisclosed conflicts of interest and the fact that the text in the official report is almost identical that of the drug companies. The EMA is accused of “spin” and of not conducting sufficient research into the background rates of CRPS and POTS, making the research that they did conduct scientifically invalid.

The EMA admitted that evidence from observed versus expected analyses cannot confirm a causal association due to the inherent limitations in such data, but then, logically, the EMA cannot provide any reassurance either for the opposite hypothesis, which is that the HPV vaccines are not harmful.

However, the EMA may be on the hook over this one and eventually made accountable, something the world has been deprived of thus far with regard to this issue. The Cochrane group have made it known in this complaint that they have in their possession, an internal document detailing the EMA review process, which was leaked to them to aid in their enquiries. We do not know who provided this unofficial document to the Cochrane Nordic center, but I think the world will soon be very glad that they did. Whistleblowers are so vitally important on this issue. Their impact cannot be understated and is reflected in the very real and present danger they face in coming forward. It may be the only way we will ever get the truth out to the public since the almighty pharmaceutical industry wields so much power.

Distribution of “coincidental” Gardasil-related diagnoses in Denmark over time

You can read the entire 256 pages here, which came from a “private source” and was released by the complainants in this comprehensive explanatory article here. It is worth noting that the EMA did conclude “a causal association with injection site trauma and CRPS” but not with the vaccine. Read that again. For some reason that important association was omitted from the official report. There are other leaked reports contained in the article above, most notably the details behind the WHO Uppsala Monitoring Center which noted a stark difference in reported HPV-related reactions than all other vaccines combined in the female age range of 12-17 years (as shown in the chart included earlier in this blog). Other information was obtained via FOI requests and from the EMA itself. Overall, it paints a picture of incomplete reporting to the public and an atmosphere of cover-up that must now be addressed.

This inside information, now released for everyone to examine, was used to compare the official report with what went on behind closed doors. The Complaint highlights these inconsistencies and reveals the scientific bias with which their review was conducted. This Complaint is now in the hands of the European Ombudsman. What we can expect is for each accusation to be addressed and that cannot happen soon enough. The ombudsman’s office is the highest law in the land for European agencies who face accusations of misconduct. It is the only recourse for scientists and researchers on this issue. We are very thankful to the patient groups and researchers in Denmark for their tireless efforts in bringing the public’s attention to the plight of the most likely thousands of HPV-vaccine-injured girls in Europe. In the words of the Cochrane Nordic group, which echoes how some of us feel about comparable agencies in the U.S. and their shortcomings

EMA does not focus on science but on politics. When people sit in a room together and know that it is expected of them that they reach consensus, it is not surprising that consensus is actually reached. Those who have differing views will feel a pressure to agree with the majority, and it is well-known from countless studies in psychology that such group pressure and group think can make people agree to things that directly contrasts with what they actually think about the subject. Science is about encouraging people to air their different interpretations of the data openly, as this is how science is best advanced; it is the very heart of science. In our view, the EMA’s processes, which lead to secrecy about differing views, mean that the EMA does not enjoy legitimacy. As the EMA’s most important work is to assess the benefits and harms of drugs, it is to be regarded as a scientific institution. The EMA is NOT a policy setting body, but that is how it behaves.

This is only the beginning of the unraveling of the HPV vaccination program in Europe. It will not happen overnight. It has been three years since the first complaint was made to the EMA. Three years of continued reports of harm to teenage girls all over Europe, indeed the world. Since the Precautionary Principal for some reason, is not applied to this drug, this insanity will continue. In the meantime, the alarm continues to be raised by injured girls and their families speaking out. We continue to be impressed by their tenacity and bravery.

We can no longer allow our daughters — and now our sons, too — to be sacrificed for the greater-good-that-isn’t with regard to HPV vaccines. The European Ombudsman is about to find out, and share with the world, that the fox is indeed guarding the henhouse. The jig is up.

~ ShamROCK

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