Prestigious Cochrane Challenges the European Medicines Agency about HPV Vaccines Harms
The Cochrane Nordic Center’s Director, Peter C Gotzsche, MD, MSc, filed a formal Complaint with the European Medicines Agency (EMA) May 26, 2016 regarding the EMA’s 40-page Assessment Report (Nov. 11, 2015) about the safety of the HPV vaccines, which are “supposed to decrease deaths from cervical cancer.”
The Cochrane complaint cited ten serious concerns about EMA’s handling of information in its report; however, I will discuss only those which I find relatively intriguing:
- Whether the EMA has been open and accountable to citizens and has respected citizens’ rights to know uncertainties related to the safety of the HPV vaccines.
- Whether the extreme secrecy, with lifelong confidentiality agreements, which the EMA imposed upon its working group members and scientific experts, is needed; is legitimate; is in the public interest; and guarantees that the administration enjoys legitimacy.
- Whether the redactions the EMA imposed on documents it delivered to the citizens according to Freedom of Information requests were needed; were legitimate; are in the public interest; and guarantees that the administration enjoys legitimacy.
- Whether the EMA behaves in a manner that guarantees that the administration enjoys legitimacy when the agency uses experts with financial ties to the manufacturers, in particular considering that it is always possible to find experts without such conflicts.
Widget not in any sidebars
Personally, I find the above four complaints also could be filed with, and against, the U.S. CDC and FDA, since it seems that the EMA probably is patterning its HPV vaccine information and vaccine safety profiles and protocols after the same practices as the U.S. patent holders of the HPV vaccine, the U.S. Health and Human Services, as explained below:
As if this is not enough, the United States Department of Health and Human Services, via the National Institutes of Health, Office of Technology Transfer receives royalties on each HPV vaccine sold worldwide. This happens because technologies used in the production of HPV vaccines were developed at NIH and subsequently patented by them. For three of the last five years, HPV vaccines based on recombinant papillomavirus capsid proteins have ranked #1 based on royalties from product sales. [….]
The major patent holder (National Cancer Institute/NCI), the regulator (FDA) and the vaccination policy maker (CDC) are all divisions of the Department of Health and Human Services (DHHS). These self-dealings typically benefit some administrators, not the government or tax payers. For example, Dr. Julie Gerberding, as the Director of the CDC, [2002-2009] approved the use of Gardasil for cervical cancer prevention as a public health policy is now the president of Merck’s Vaccine division promoting the sales of Gardasil.  [CJF emphasis]
The Nordic Cochrane’s complaint stems from HPV vaccine adverse reactions and serious harms peer reviewed articles published by Louise Brinth, MD, PhD, taken from the Danish Syncope Unit at the Frederiksberg Hospital in Copenhagen, describing serious neurological harms after HPV vaccinations.
The symptoms reported included chronic fatigue syndrome (CFS), postural orthostatic tachycardia syndrome (POTS), and chronic regional pain syndrome (CRPS) reported as reactions triggered by components in the HPV vaccine or the vaccine adjuvant.
However, the EMA’s report seemingly rejects the above suspected harms, while not investigating them thoroughly, as would be the expected safety protocol. Interestingly though, there was an internal report, which was confidential, that had been leaked and tells a different story. The Cochrane complaint states that Dr Brinth did not know about that leaked confidential internal report when she wrote her paper.
Much is discussed in the 19-page Cochrane complaint, which can be read here. However, what I want to highlight are the deliberate obfuscations that apparently frame vaccine politics and policies not only at U.S. federal health agencies and probably within the EMA. Recall the CDC fraud exposé documentary VAXXED.
I think I need to remind readers that this Cochrane complaint originates out of Denmark, a country where the CDC/FDA are involved in having been defrauded by Dr Poul Thorsen whose autism research U.S. federal health agencies promote to this day as a preeminent study that vaccines do not cause autism despite CDC epidemiologists Verstraeten  and Thompson  research claiming the MMR vaccine causes autism, but which CDC reworked effectively to negate.
Thorsen, furthermore, is the subject of a 22-count indictment [2, 3, 4] but Danish authorities can’t seem to cooperate either in finding him or turning him over to U.S. authorities for prosecution. I wonder why. Vaccinology espionage?
What I want to point out and “drive home” in the Cochrane complaint are the “Many redactions by the EMA in its documents are not legitimate.” [Pg. 8] That’s a process that seems to be endemic to vaccine manufacturers’ ‘safety’ studies. I quote from the complaint:
Various people have obtained redacted documents from the EMA through Freedom of Information requests. As we have access to the unredacted version of the EMA’s confidential 256-page internal document (4), we can see which bits the EMA has redacted. We give some examples of redactions that we find unreasonable (our comments are in brackets):
- Names of contact people at the EMA for the rapporteur and co-rapporteurs.
- Case numbers of patients for which harms were reported.
- Country names for individual cases.
- Numbers of reported harms for individual countries, names of countries where there is an excess incidence of reported harms, and number of doses of the vaccine used in individual countries.
- While it is indicated that some harms reports come from the Danish Syncope Centre, it is redacted that the centre is located at Frederiksberg Hospital.
- The publication identifier for an article in press.
I refer readers to the complaint pdf to read the Cochrane comments that are in brackets.
Uncertainties in the science that did not make it to the official report
There was much genuine uncertainty about what the science tells us and whether further research is needed, and there was also a lot of disagreement in the EMA’s working group that is not apparent in the official report. [And there are 2 pages of examples cited in the complaint]
Are the vaccines safe?
According to the firms they are safe. Initially, the vaccine was compared with a placebo group being vaccinated with physiological serum, whereby the number of adverse reactions was much higher and much more serious than in the control group. After comparing 320 patients in the saline placebo group a quick move was made to an aluminum-containing placebo, in order to be able to only evaluate the effects of the active substance. However, this distorted the comparison, because no one voluntarily wants to be vaccinated with toxic aluminum, as this is not really necessary, when inoculation with a harmless saline solution can be done. The difference between Gardasil and the saline placebo group were, however, already noticeable. Here we can refer to the Vioxx scandal, where the adverse reactions in fact were known, but concealed by the firm. Here also the difference between the vaccine and the saline placebo is concealed in all publications, as the table below clearly shows. For serious adverse reactions one suddenly takes the saline and aluminum group together, perhaps to cover up the major differences between these two groups. [CJF emphasis]
[Is that an example of deliberate and unethical fraudulent ‘study’ practice to skew vaccine ‘safety’ concerns in favor of the manufacturer’s claims?]
Conflicts of interest
According to the laws of public administration in several European countries, people should never be in a position where they are being asked to evaluate themselves. For example Danish law states (our translation):
“Anyone who works in the public administration is disqualified in relation to a particular case if he or she has a special or financial interest in the outcome … The person who is disqualified in relation to a case does not make decisions, participate in decision making or otherwise assist in the consideration of the case.”
The complaint goes on to discuss certain issues, but here’s what I think is key:
It is clear from its confidential document that the EMA relied heavily on the companies to come up with honest answer to highly complicated questions, and that the work of the EMA’s various assigned experts was not to control what the companies had done, but merely to discuss it. We find that his procedure provides poor protection of public health, particularly considering that there are so many egregious examples that companies have cheated by omitting major harms – including deaths – in their reports to the authorities (6,10). We find it unacceptable that the EMA did not check the veracity of the MAH’s [marketing authorization holders] work. [How interesting!]
Further along in the complaint this, characterized as misleading, appears:
We find it totally unprofessional and misleading to the extreme to suggest that the HPV vaccine can prevent all deaths from cervical cancer. Such a claim would not have been tolerated by the EMA if it had come from one of the manufacturers. The different vaccines don’t protect against infection from all HPV strains, only from 70%, 80% and 90% of the strains, respectively, and the vaccines are not 100% effective against the targeted strains.
We also find it inappropriate to use experts with financial ties to the manufacturers, as it is always possible to find experts without such conflicts.
On page 15 of the complaint, this about conflicts of interest:
4 We are aware that some of the top officials at the EMA have failed to declare their conflicts of interest in relation to the work they do at the EMA, although they have a legal obligation to do so. For example, the EMA’s director, Guido Rasi, declared on 20 July 2015 that he had no conflicts of interest (14). On a form called “EMA Public Declaration of Interests,” he replied “none” to all four questions, also to question 4, which is: “Other interests or facts whether or not related to the pharmaceutical industry which you consider should be made known to the Agency and the public, including matter relating to members of your household.”
However a Guido Rasi, which we assume is the same person, holds a number of patents, some of which were filed or approved in 2012 or 2013, and where the applicant was a drug company (Applicant: SciClone Pharmaceuticals, Inc.; Inventors: Guido Rasi, Enrico Garaci, Francesco Bistoni, Luigina Romani, Paolo Di Francesco) (15). As they go back less than five years, we believe he should have declared them, according to EMA’s regulations concerning the handling of declared interests of its employees (16).
Dr Gotzsche ends the complaint with some laudable “gems,” which I cite in part:
The EMA’s procedures for evaluation the safety of medical interventions – where the companies are by and large their own judges – need to be fundamentally reworked and all procedures and information should be made transparent to the public. [….]
You can’t handle the truth about vaccines (Ad)
The secrecy imposed by the EMA is not in the public interest. [….]
Public health is about the promotion of health and prevention of disease and disability through the organized efforts of society. This entails protection from harms and involves progression of knowledge in open collaboration. As far as we can see, the actions of the EMA in this case indicates that the agency is more concerned about protecting its own previous decisions and the vaccine than about protecting the citizens and giving them the option of choosing for themselves whether or not they would like to get vaccinated against HPV. Some people will prefer to avoid the vaccine, even if the risk of serious harm is very small, and some will prefer screening instead. It is not within the powers of regulatory authorities to deny citizens’ right to make informed choices about their own health by withholding important information. The citizens need honest information about the vaccine and the uncertainties related to it; not a paternalistic statement that all is fine based on a flawed EMA report.
To which I say, “Dr Gotzche’s immediate remarks above should be applicable not only to EMA but also to the U.S. CDC/FDA and public health agencies approving and regulating vaccines in every country on the Planet. Also, let’s not forget so-called “do-gooder” NGOs like the Bill and Melinda Gates Foundation, GAVI (Global Alliance for Vaccines and Immunizations), and more specifically, the World Health Organization with its penchant for pushing vaccines, plus pandemics to enforce mandated vaccinations.” Remember the 2009 Swine flu pandemic that really didn’t pan out? 
Finally, the vaccine industry’s habitual skewed ‘science’, dirty politics, and vested financial interests have been called on the carpet of accountability by one of the most respected INDEPENDENT health researching teams: Cochrane! Let’s see how EMA and big pharma neutralize the long overdue challenge to the HPV vaccine medical-scientific boondoggle, plus Cochrane’s credibility of “Trusted evidence; Informed decisions; Better health” .
Thank you, Dr Gotzche, plus the four co-signers of the complaint, for calling “check mate” on the EMA regarding the HPV vaccines—something obviously long overdue. However, may I respectfully suggest taking on the U.S. CDC/FDA about the HPV vaccines, as that’s where you probably will find the head of the vaccine beast that sends out spawn to pollute medical science and ruin healthy lives.
Photo credit: jetheriot via Visual Hunt / CC BY
Cochrane Nordic EMA Complaint pdf
Peter C Gotzsche 2013 book: Deadly Medicines and Organized Crime, How big pharma has corrupted healthcare
Catherine J Frompovich (website) is a retired natural nutritionist who earned advanced degrees in Nutrition and Holistic Health Sciences, Certification in Orthomolecular Theory and Practice plus Paralegal Studies. Her work has been published in national and airline magazines since the early 1980s. Catherine authored numerous books on health issues along with co-authoring papers and monographs with physicians, nurses, and holistic healthcare professionals. She has been a consumer healthcare researcher 35 years and counting.
Catherine’s latest book, published October 4, 2013, is Vaccination Voodoo, What YOU Don’t Know About Vaccines, available on Amazon.com.
Her 2012 book A Cancer Answer, Holistic BREAST Cancer Management, A Guide to Effective & Non-Toxic Treatments, is available on Amazon.com and as a Kindle eBook.
Two of Catherine’s more recent books on Amazon.com are Our Chemical Lives And The Hijacking Of Our DNA, A Probe Into What’s Probably Making Us Sick(2009) and Lord, How Can I Make It Through Grieving My Loss, An Inspirational Guide Through the Grieving Process (2008)
Catherine’s NEW book: Eat To Beat Disease, Foods Medicinal Qualities©2016 Catherine J Frompovich coming in Summer 2016