CHS,- This world exclusive report by CHS follows the decision by health authorities in Japan to withdraw their recommendation for human papilloma virus [HPV] vaccines because of high levels of serious adverse reactions in Japanese women and girls. Japanese girls will still be able to be vaccinated at no charge, but from now on they will be informed by healthcare providers that the health ministry does not recommend the vaccines.
Cervarix and Gardasil HPV vaccines were found to cause substantially higher rates of adverse reactions than other vaccines: Cervix vaccine issues trigger health notice Japan Times Jun 15, 2013 National Kyodo.
One report claims the rate of serious adverse reactions which Japanese women experienced after Cervarix injections are 52 times the rate of those reported after annual influenza vaccines: Urgent Request from Japan: Help Stop HPV Vaccinations July 27, 2013 By Norma Erickson SaneVax, Inc.
The UK media fail to report this kind of news affecting millions of British school children and families despite affecting their own families and networks of relatives in the UK. Journalism is a dying profession. So don’t buy newspapers or believe TV news reports. The UK’s BBC has become the British Government’s press office.
British Parents Not Told Their Children Are Not At Risk of Cervical Cancer
The targeted vaccination group of 12-year-old British schoolgirls are at no risk of contracting cervical cancer. Cervical cancer is an extremely rare disease. The risk is normally zero up to age 20. The risk of serious adverse reactions from the vaccine is therefore infinitely higher. In the UK the disease is so rare there are just 3 deaths in every 100,000 women of all ages as figures from Cancer Research UK show. What is worse is that by the time there is any risk for these schoolgirls any effect from the vaccine [if there ever was one] would have worn off yet these young women may then think they are protected and fail to undergo routine screening when they will still need it regardless of the vaccine.
By the time there is any risk of mortality for these 12 year-old schoolgirls it is extremely low. The risk of death from cervical cancer in the age range 20-24 is 3 in every million women of that age range. The disease does not normally affect schoolgirls. The highest number of deaths occur in women in their late seventies.
How UK Health Officials Tampered With the Adverse Reaction Reporting Systems
In the UK the Medicines Healthcare Products Regulatory Agency [MHRA] first interference was to encourage health professional not to report adverse reactions. This was done in formal advice issued in the name of Chief Executive Professor Sir Kent Woods telling health professionals that reactions can be “psychogenic” – or in simpler terms a figment of 12 year old schoolgirls’ imaginations and nothing to do with the vaccines [see more below for full details].
Next the data from over 6000 reports of suspected adverse reactions was systematically altered resulting in the MHRA declaring the vaccine safe when it was not.
The third thing the MHRA staff did was to fix the final figures to make the rate of adverse reactions appear lower by substituting the number of doses given for the number of children receiving the vaccine. Tampering with statistics by basing rates of adverse reactions on doses given reduced the numbers of adverse reactions per child by three times. This is because each child was to receive three doses of the vaccine. So whilst 6 million doses may have been given that represented only around one third of that figure in children receiving the vaccine – resulting in the rates of adverse reactions reported being calculated as 300% lower than they were per child.
In other words if all children received all three doses then the crucial figure was not the number of doses but the number of children who suffered reactions compared to the total number of children.
The MHRA was headed at the time by Chairman Professor Alasdair Breckenridge [retired December 2012] and Professor Sir Kent Woods [MHRA Chief Executive but shortly expected to retire after 10 years service].
Questions For Heads Of UK Drug Regulatory Agency – MHRA
The first question for Professors Breckenridge and Woods is – if Japanese women suffered adverse reactions at a rate 52 times higher for GSK’s Cervarix vaccine than for flu vaccine how can possible adverse reactions just be figments of childrens’ imagination and so are not to be reported by medical professionals? [“psychogenic” was how Woods put it more formally – see his official advice to medical professionals – more below].
Clearly, that cannot be the case. Not only that but Woods and Breckenridge cannot claim to be ignorant of those facts. They must know that is the position. Nearly half of all reports included what the MHRA categorised as “psychogenic” symptoms which the MHRA say are “all in the mind” and could not therefore be caused by the vaccine. A full list in a spreadsheet can be downloaded here: 130728 Single list of all Cervarix Yellow Card Reports or browsed at the end of this article.
Here are just a few examples:
- convulsions [which are serious reactions with risks of serious brain injury];
- grand mal convulsions;
- circulatory collapse;
- acquired colour blindness;
- head banging;
- foaming at mouth;
- transient blindness;
- transient deafness;
The next question is: who instructed staff of the UK’s Medicines Healthcare Products Regulatory Agency [MHRA] systematically to tamper with the reporting systems and with data in reports of adverse reactions by medical professionals to Cervarix HPV vaccines given to millions British Schoolgirls from December 2008 to July 2012?
And the next question is who instructed that none of the adverse reaction reports should be followed-up and conditions of the childreninvestigated? There is little point having drug safety monitoring if the data obtained from it is ignored. The MHRA hid the conditions in those cases which were reported.
Official Excuses for Withdrawal of GSK’s Cervarix HPV Vaccine Do Not Stand Up
In 2012 GSK’s Cervarix HPV vaccine was replaced by Merck’s Gardasil HPV vaccine. At the time this was claimed to be a result of competitive tendering. However it is a requirement that the Department of Health is required to ensure vaccine supply is not from a sole source. This requirement was made following criticism in the English Parliament and by the UK National Audit Office over problems caused previously by the failure of a sole source of supply of a different vaccine.
Professor Sir Kent Woods Instructs Medical Professionals Not To Report Adverse Reactions.
In advice dated 2nd September 2008 issued by the UK MHRA in Professor Kent Woods name Professor Woods primed health professionals to expect the most common adverse reactions would be “psychogenic”. Professor Woods then advised medical professionals not to report an adverse reaction if it “may” be psychogenic.
“Psychogenic” means that the symptom of the adverse reaction is to be treated as “all in the minds” of the British schoolgirls receiving GSK’s Cervarix vaccine – that is: the result of emotional or mental stress from the administration of the vaccine.
In other words – and feminists please take note – the male dominated MHRA was telling medical professionals to dismiss adverse reactions in schoolgirls because women are prone to that sort of thing – you know – women are silly, emotional and prone to hysteria and mass hysteria.
This advice was not only counterproductive but unscientific and improper from a drug safety perspective. Professors Woods and Breckenridge must know that.
Adverse reactions to all pharmaceuticals are heavily under-reported. Because of that medical professionals are constantly and generally encouraged to file adverse reaction reports to improve drug safety monitoring. Professor Woods’ advice was encouraging them not to.
An adverse reaction reporting system relies on the spectrum of adverse events to be reported so that it is possible to identify the “signal” of a previously unidentified adverse drug reaction against the background of known adverse reactions and reports.
By encouraging medical professionals to expect and then not to report suspected “psychogenic” reactions would result in reactions which were not psychogenic being identified as such and which would then not be reported following Professor Kent Woods’ advice. This would also make drug safety monitoring much less effective because if there were truly any “psychogenic” reactions, then subsequent analyses of the data could assist to identify which were likely to have been and which were not so likely or were not. But the less data one has makes the task more difficult.
MHRA Systematically Tampered with 6000 reports of Adverse Reactions To Declare The Vaccine Safe
From April 2008 up to 31st July 2012, the MHRA received a total of 6213 reports of suspected adverse reactions documenting 14,300 symptoms or 2 1/2 symptoms per report. Nurses contributed more than two-thirds of all reports. Over 6 million doses of the vaccine were administered.
The way the reports of suspected adverse reactions to GSK’s Cervarix vaccine were tampered with was to ensure the underlying conditions indicated by the reported symptoms could not be identified. In addition, no clinical follow-up was carried out on any Cervarix Yellow Card report of a suspected adverse reaction.
To diagnose an individual it is essential to consider all symptoms suffered by that individual and carry out a clinical assessment on a case-by-case basis. For example, how do you know if you might have flu? If you have fever, cough, headache, aching muscles and tiredness then you may have flu.
What the MHRA did was to carry out a paper analysis of the Yellow Card reports. They separated out the symptoms reported for each individual so that it would be impossible for anyone to identify the underlying conditions each individual suffered. SOURCE: MHRA 29 July 2010 “Suspected Adverse Reaction Analysis”
Here are the 5 categories each symptom was separated into:
A. Injection-site reactions
B. Allergic reactions
C. ‘Psychogenic’ events
D. ‘Other recognised’ reactions
E. not currently recognised
So if we consider by analogy a disease most people know about, flu, if this approach was applied to infectious disease reports each symptom would be split up and put into one or more of these categories. As the symptoms are no longer linked together it is impossible to say whether anyone was suffering from ‘flu or any other disease. There would be no way of telling.
Thus, the MHRA set about hiding the numbers and types of suspected ADRs suffered by British schoolchildren. This was not a conspiracy but fact – that is what the MHRA did.
If this approach were adopted to reporting infectious diseases generally the public could have no idea which diseases are present in the population at any time. There can be numerous infections diseases circulating simultaneously.
For example, a symptom of encephalitis is headache – in the period Sept 08 to 29 July 2010 information from MHRA recorded that in 4703 Yellow Card reports there were 848 reports which included headache as one of the reported symptoms and which might therefore be of encephalitis. A “quick and dirty” analysis of the MHRA data issued at that time shows that of just 5 of the 32 symptoms of encephalitis at least 2300 reports include at least one symptom of encephalitis.
But this is what the MHRA said having carried out no clinical investigation or analysis of any of the Yellow Card reports:-
The four cases of encephalitis reported so far, amongst the number of girls immunised, do not exceed the numbers normally expected in the absence of vaccination. There is therefore no suggestion at present that the vaccine can cause encephalitis.”
SOURCE: MHRA 29 July 2010 “Suspected Adverse Reaction Analysis“
- MHRA only recorded a report as suspected encephalitis if those specific words appear on the Yellow Card report
- and confirms MHRA did not consider what underlying conditions are indicated by the symptoms reported on the Yellow Cards
Most reports were by school nurses who are likely only to report the symptoms and not diagnose underlying conditions.
School Head Teachers & Governors
It is obvious from these figures that UK parents are obliged under their Children Act 1989 legal duties to refuse consent. This also puts head teachers and school governors in a remarkable position for putting children at risk by allowing these vaccination programmes to take place on school premises. Under English law they stand legally in “loco parentis” – in the place of the parents whilst children are under their care in school.
School Nurses & Other Medical Professionals.
Obviously medical practitioners bear a heavy duty of disclosure to obtain informed consent but they are not fulfilling it. Additionally, it is obvious that anyone proposing to have this vaccine needs to be screened for 1) pre-existing medical conditions putting them at risk and 2) risk of adverse reactions based on prior clinical history. That is not being done.
Properly informed consent is not being obtained – which legally can give rise to claims for “battery” – not simply negligence and easier to prove.
Parents are being told their 13-year-old girls may be given the vaccine even if the parents refuse consent. Girls of this age might be subject to pressure to persuade them even if parents have refused consent. There are reasons why this may not be lawful under “Gillick competence”.
Via Child Health Safety
Full list of MHRA reported symptoms of adverse reactions to GSK´s Cervarix HPV Vaccinr published at CHS Website