HPV Vaccine Controversy
In a damning 19 page complaint, which unsurprisingly has not been broadcast by mainstream media, the Nordic arm of the respected Cochrane organisation has slammed the European Medicines Agency (EMA) over their handling and lack of transparency with HPV vaccine safety.
Cochrane went so far to call it ‘outright scientific misconduct’.
Although the complaint is being made in Europe, the information could very easily apply to many countries where citizens are not being properly informed about the concerns related to HPV vaccines.
Firstly, it’s important to understand who the two parties involved in this complaint are.
Who Is Cochrane?
Cochrane is a highly respected, international organisation who offer the highest standard in evidence-based health care resources. They gather and summarise the best evidence available from research, then publish their reviews online, to help people make informed choices about their treatment.
Over the last 20 years, Cochrane have provided a trustworthy and independent resource for medical information and research, with a massive network of 37,000 researchers, professionals, and others, in 130 countries.
Most importantly, Cochrane’s work is free from commercial or conflicting funding, which means the organisation is a very rare and highly valuable source of unbiased research, for medical professionals and patients alike.
What Is The EMA?
According to the EMA’s website:
“The Agency is responsible for the scientific evaluation, supervision and safety monitoring of medicines developed by pharmaceutical companies for use in the EU”.
In November 2015, the EMA published a report on the safety of HPV vaccines, which are supposed to reduce deaths from cervical cancer.
So Why Did Cochrane Complain?
Cochrane had many serious concerns, not only about the EMA’s report, but about details from an internal draft report, which was leaked, revealing shocking omitted information.
Some of the concerns addressed are:
- The EMA has not been open and accountable about uncertainties regarding the safety of HPV vaccines, nor has it respected the rights of citizens to be informed of the concerns about the vaccines
- The EMA asked the vaccine manufacturers to search in their own databases for side effects of the vaccine, and did not check the company’s work for accuracy
- The EMA has not upheld professional and scientific standards when evaluating the safety of HPV vaccines
- There has been unfair treatment of Danish whistleblower, Doctor Louise Brinth, who raised concerns about possible serious harms from the HPV vaccines (read her report, here).
- The Danish Health and Medicines Authorities have not been fairly treated when raising concerns about possible serious harms from HPV vaccines
- The EMA has imposed extreme secrecy and life-long confidentiality agreements on its working group members and scientific experts, which might not be in the public’s interest
- Several EMA staff, including its director, appear to have undeclared conflicts of interest
- There is a lack of transparency in declaring names and conflicts of interest of experts consulted
What Health Complaints Are Being Reported?
Parents and patients have reported a wide range of health complaints, from fatigue to death.
However, much to their frustration, doctors have often dismissed their concerns, telling them their symptoms (or a death) are difficult to link to the vaccine, and are simply coincidental.
What we do know is mostly lifestyle factors increase the risk of cervical cancer. For example, smoking, hormonal contraceptive pills, and not using condoms during sex.
You can read a very informative article about HPV and its side effects.
From observations made around the world, HPV vaccines are suspected of causing several conditions, including chronic fatigue syndrome, postural orthostatic tachycardia syndrome (an autonomic dysfunction where patients experience an abnormally high heart rate response when upright, referred to as POTS), and chronic regional pain syndrome (CRPS).
It’s believed many cases go undiagnosed, due to the fact that these conditions are difficult to diagnose, and their causes are not well understood.
The hypothesis is that an autoimmune reaction is triggered by either the active ingredient of the vaccine, or the adjuvant. An adjuvant is a substance designed to enhance the body’s immune response to an antigen. A common adjuvant is aluminium, which is a known neurotoxin.
The EMA’s report appears to reject these suspected harms. However, only months before the report, they claimed the relationship between HPV vaccines and the reported conditions could neither be confirmed nor denied.
The leaked internal report is even more suspicious. It shows specific details have been omitted, including significant disagreements and observations.
Do Authorities Know The Truth About The HPV Vaccine’s Adverse Reactions?
Weak and fraudulent drug reporting is nothing new. There have been several well known cases in the media – the Vioxx and Diane 35 scandals, for example, where manufacturers were completely aware of the adverse reactions prior to the medications becoming available to the public.
This seems to be the case with the HPV vaccine. There are no independent studies, which is of major concern.
Many pharmaceutical companies have been sued for giving misleading information, or for manipulating or falsifying data.
A big problem is, any ‘slap on the wrist’ fines pharmaceutical companies receive are simply small change, when you consider the global expenditure on HPV vaccines alone to date is $AU37 billion ($US28 billion).
Cochrane points out countless past examples of drug companies hiding serious, and even fatal, harms from authorities. Sadly, it’s nothing new. But it’s not just the manufacturers who are pulling the wool over our eyes.
Data manipulation is the subject of the recently released documentary, Vaxxed. It’s not an anti-vaccination documentary as media outlets (who often haven’t even seen it) are reporting. Instead, it exposes the manipulation of data being performed to hide undesirable results, which has taken place as high up as the Centers for Disease Control and Prevention (CDC).
The World Health Organization has also been accused of vaccine data manipulation. Doctor Sin Hang Li, a pathologist who lectured at Yale University, spoke out about ‘blatant violation of public trust,’ for manipulating data related to the HPV vaccine’s safety.
Are HPV Vaccines Safe?
The million dollar question. Of course, the manufacturers claim they are safe, and the EMA say they are safe too.
But with no independent research, who is there to say otherwise?
Doctors are telling us HPV vaccines are safe, and we should have them. But could their recommendations be based on information which might be only as useful as the promotional and marketing materials?
Something the EMA kept secret from the public is most alarming.
During studies, the original placebo used for the HPV control group was a saline solution. But the number of adverse reactions were far more serious and more common than in the control group.
After 320 patients were given the saline placebo, the decision was made to switch to a placebo containing aluminium. This meant researchers could only evaluate the effects of the active substance in the vaccine, and not the whole vaccine. It makes it harder to identify all the effects of having a HPV vaccine.
Alarm bells should be ringing loud and clear.
Saline was all that was necessary for an effective placebo. Nonetheless, the two placebo groups were lumped together in the report. This is completely unscientific, and only leads us to believe it was done to dilute the attention of side effects from the whole vaccine.
Their actions glaringly alert us to the fact that:
a) There are legitimate, serious concerns about vaccine safety
b) Pharmaceutical companies cannot be trusted (especially when left to do their own safety research and reporting)
These are two big issues pro-choice advocates have been raising for years.
Concerns About EMA’s Scientific Advisory Group (SAG)
Cochrane has serious concerns about the EMA’s SAG, including:
- The SAG is bound to a lifelong secrecy clause, preventing members from discussing their disagreements in public
- The EMA keeps secret who their SAG is, and what conflicts of interest it has
- Some of the SAG members have financial conflicts of interest with companies who sell HPV vaccines, which means they are not independent
- Enerica Alteri from the EMA has said that the HPV vaccine can prevent most, if not all deaths from cervical cancer, whereas Cochrane finds it extremely unprofessional and misleading to state such a thing. The vaccines do not protect against infection from all HPV strains, and vaccines are not 100% effective against the targeted strains
- The EMA’s rapporteur, Julie Williams, co-authored with 16 others a paper that stated the authors had no competing interests. However the funding declaration on that very paper revealed numerous financial conflicts of interest with pharmaceutical companies.
HPV Vaccine and Premature Ovulation Failure
Cochrane’s complaint also refers to how the American College of Physicians found 89 cases of premature ovarian failure (which results in the loss of the normal function of the ovaries before the age of 40) in those who had HPV vaccines. There were 86 cases for Gardasil and 3 for Cervarix, and no reports for other vaccines.
The College was so alarmed by the findings that it distributed an alert in January 2016, in an effort to generate awareness amongst doctors and the public.
In spite of this, there is barely a mention of it in the EMA report, which simply states, “Adverse events related to potential immune-mediated disease (piMD) following vaccination with Cervarix, as well as primary ovarian failure, are currently under close surveillance and in-depth discussed with PBRER”.
Cochrane points to a similar situation in 2009-2010, when doctors were first to alert the scientific community to the adverse events from the Pandemrix vaccine for influenza. They noticed the occurrence of narcolepsy, where people had a specific tissue type.
Of course, these doctors were ridiculed, which commonly occurs when anyone – even doctors – dare question the safety and effects of drugs and vaccines. Several years later, it is now accepted that Pandemrix can cause narcolepsy (immune-mediated), even several years after vaccination.
We must stop the discrediting, attacking and even deregistering of open-minded medical professionals who question vaccines. They are not dangerous. They are educated professionals who care about easing the pain and suffering of those who have sustained an injury or condition after having a vaccination.
In her response to the EMA’s paper, Doctor Louise Brinth says, “I have been contacted by quite a few fellow doctors, researchers from Denmark as well as from other countries. Many of them tell me that they have the same suspicion, they see the same pattern – but most of them tell me that they are afraid to speak up. I find that we have established a culture where it is not acceptable to have a critical approach towards vaccines”.
What If The Suggested HPV Harms Are True?
In their complaint to the EMA, Cochrane states, “Should the concerns over possible harms of the HPV vaccine be confirmed, the trust in the EMA, and in vaccines in general, may be damaged beyond repair”.
“Our societies should no longer accept that assessments of drug safety are left to companies with huge financial interests and to a drug agency that receives 80% of its funding from the drug industry”.
Cochrane ends the report by saying: “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”.
Pharmaceutical companies continue to be untrustworthy, and to publish untrustworthy research and safety data; Cochrane is highly respected. Who are you going to believe?
Before you make a decision, below is a must watch Danish documentary about HPV vaccines, which contains english subtitles. The title “De vaccinerede piger” translates to ‘the vaccinated girls’.
You might want to read Cochrane’s full complaint.
For more information about HPV legal action around the world, and related support groups:
- R.E.G.R.E.T (Reactions and Effects of Gardasil Resulting in Extreme Trauma) Support Group – Ireland
- Japanese Victims Of Cervical Cancer Vaccine To Sue Vaccine Makers and The State
- HPV Safety Concerns (Blog post of Doctor Neville Wilson)
- Australian Woman Leading Class Action Against Gardasil