Vaccinations in School / Informed Consent

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Dear Department of Health,
I was recently given a form by my twin daughters asking for consent to administer the HPV vaccine in school, I decided not to, and so ticked the 'do not consent ' box,I then went on to read the attached leaflet and discovered as follows:

a) If I do not consent the Nurse can override my decision and vaccinate my children if they show an interest in having this done.

b) The leaflet explaining to parents the side effects of this vaccine said that the worse case scenario would be a headache and nausea , or a raised rash at the site of injection, and thats it.

I called the primary health team and asked to speak to them regarding overriding my decision, they confirmed that they could do this and this law was passed in the European Courts some two or more years ago. I asked them to tell me what information they give these children before they make a decision, I also asked if they could tell me where I could find the information/document that shows thgat the Nurse administering the vaccine is now the legal guardian of my child and is acting loco parentis, then I asked who would be responsible for my child if she had an adverse reaction and was physically/mentally disabled as a result, my questions were not answered. I get a phone call from my child's school to obtain consent for a paracetamol to be administered for a headache, and yet the Ministry of Health deem my twelve year old twins mature enough to make a decision about their health that could possible make them disabled, or worse, kill them.

My requests are obvious, but for clarity here they are.

1) I would like to know exactly as per nationwide protocol what is deemed to be informed consent when overriding a parents decision not to have their child vaccinated.

2) If the information given to the child is the same as it is on the leaflet, Nausea and a Headache at worst , then at the point of that child giving permission based on that information, who is responsible for the outcome if the outcome is more serious than above stated given that the parent didn't give consent and the child has not been given enough information to make that decision for herself.

3) I would like to see the European Court Rulings , it would be great if I could have this in lay terms pointing out the stipulations of informed consent. If there is a link to it, that would be great.

4) What measures have been taken since this ruling to alert the general population that their rights as parents to make the best decisions on behalf of their children has been taken away from them. A link to adverts would be great if you have them to hand.

5) Lack of informed consent that resulted in serious injury would be called medical negligence/ Assault? Could you clarify this for me?

Thank you for your time.

Yours faithfully,

Emma Flavell

Steve Hinks left an annotation ()

Emma,
you are absolutely correct to resist this. Please feel free to contact me on steve@hinksfamily.co.uk for information. Our daughter and my family have been devastated by our daughters severe reaction to this vaccine. See my Whatdotheyknow requests and also the many public comments on NHS Choices HPV vaccine pages (there are several pages).

I attach below the text of a 'Health Professionals Assurance of HPV Vaccine Safety. If you email me I will send you a file copy.

Health Professional’s Assurance of HPV Vaccine Safety

I accept that consent must be:
Voluntary – the decision to either consent or not to consent to treatment must be made by the person themselves, and must not be influenced by pressure from medical staff, friends or family.
Informed – the person must be given all of the information in terms of what the treatment involves, including the benefits and risks, whether there are reasonable alternative treatments and what will happen if treatment does not go ahead.
Capacity – the person must be capable of giving consent, which means they understand the information given to them, and they can use it to make an informed decision.
Children under the age of 16 are not deemed to be automatically legally competent to give consent. The courts have determined that such children can be legally competent if they have 'sufficient understanding and maturity to enable them to understand fully what is proposed'.
A young person who has the capacity to consent to straightforward, relatively risk-free treatment may not necessarily have the capacity to consent to complex treatment involving high risks or serious consequences.
I have received specific training in immunisation and attended regular updates. I am able to demonstrate competence, current evidence-based knowledge and understanding of the core areas of knowledge:
1. The aims of immunisation: national policy and schedules
2. The immune system and how vaccines work
3. Vaccine preventable diseases
4. The different types of vaccines used and their composition
5. Current issues and controversies regarding immunisation
6. Communicating with patients and parents 7. The aims of immunisation: national policy and schedules
8. The immune system and how vaccines work
9. Vaccine preventable diseases
10. The different types of vaccines used and their composition
11. Current issues and controversies regarding immunisation
12. Communicating with patients and parents

I am familiar with the Medicine Guide for Gardasil HPV vaccine available on NHS Choices web site: http://www.nhs.uk/medicine-guides

This states that Gardasil HPV vaccine is not suitable for everyone and some people should not use it. Other people should only use it with special care. Before you have the vaccine it is important that the person giving you this vaccine knows if you have any medical history.

Your prescriber may only prescribe this medicine with special care or may not prescribe it at all if you:
- are allergic or sensitive to or have had a reaction to any of the ingredients in the medicine
- have a high temperature
- have a weakened immune system
- have blood clotting problems
- have blood problems

I am also aware from the SPC (manufacturer’s Summary of Product Characteristics) http://www.medicines.org.uk/emc/medicine... that Gardasil contains amorphous aluminium hydroxyphosphate sulphate adjuvant (0.225 milligrams Al) – a known neurotoxin.

Risks:
I am able to explain the MHRA Yellow Card reporting system of adverse reactions following immunisation and that the following information is available from the MHRA:

Reports of serious adverse reactions, including deaths (4), have been 92 per 100,000 (approx. one hundred times more than most common vaccines).

Benefits:
Manufacturer Merck states “vaccination is not a substitute for routine cervical screening. Since no vaccine is 100% effective and Gardasil will not provide protection against every HPV type, or against existing HPV infections, routine cervical screening remains critically important”.

Cervical cancer risk factors:
Human Papillomavirus (HPV) Infection: types 16, 18, 31, 33, 35, 39, 45, 51, 52, 56, 58, 59 (convincing evidence) and types 26, 53, 66, 67, 68, 70, 73 82 (probable evidence), family history of cervical cancer, age, sexual and reproductive history, socioeconomic status, smoking, HIV infection, in utero DES exposure, long-term use of oral contraceptives.
HPV Gardasil vaccine has efficacy of approx. 97% for preventing just 4 types of HPV: 6, 11, 16 and 18.
The vaccine is only proven to be effective for several years.
The typical period for cervical cancer to develop is 10 – 20 years.
In the UK the mortality rate for cervical cancer has reduced from 8 per 100,000 to 2 per 100,000 since 1971 without any contribution from the HPV vaccine. If this continues there will be no deaths within 7 years.
Regardless of the legal entity under which I normally practice medicine, I am issuing this statement in both my business and individual capacities and hereby waive any statutory, Common Law, international treaty, and any other legal immunities from liability lawsuits.
I am on the professional register of the Nursing and Midwifery Council/General Medical Council or equivalent. Registration number:
Name (print): Profession:
Signed: Date:

Steve Hinks left an annotation ()

Emma,
please also obtain a copy of the manufacturers 'Medicine Guide' which can be found on the NHS Choices website. It will tell you that this medicine is not suitable for everyone, some people should never have it. Your vaccinator should know your medical history. It gives all of the known side effects (there are many more) and also that some side effects can be SERIOUS.

Department of Health and Social Care

Thank you for contacting the Department of Health.
This is an acknowledgement - please do not reply to this email.
Where a reply is appropriate, we aim to send one within 18 working days,
or 20 working days if your query is a Freedom of Information request or
complaint.
If you have contacted the Department of Health about a current health or
social care campaign, please visit the [1]GOV.UK website, the UK
Government’s official information website, where a response may have been
published.

If your enquiry is about a medical matter, please contact NHS 111 or visit
[2]NHS Choices, or contact your GP surgery.

For general health information you may also find it helpful to refer to
[3]GOV.UK, which includes the Department of Health's [4]'What we
do' section.
Please note that the Department of Health does not process complaints
about the NHS or social services. If you wish to make a complaint about a
healthcare professional, an NHS organisation or a social care provider,
please visit the [5]'Complaints procedure' page on the GOV.UK website.
 
You can find out more about the Department’s commitments from our
[6]Personal Information Charter.

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Department of Health and Social Care

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Caron Ryalls left an annotation ()

Emma, these are the types of questions the Dept of Health do not like to be asked and so will decline to answer if they have the opportunity.

I would suggest you ask your MP to write to the Dept of Health on your behalf, as there is a duty to respond to MP questions. This does not guarantee an appropriate response, but they will have to provide more than the general waffle provided for this FOI request.

Otherwise, try to phrase your questions more specifically eg ask for documents, correspondence etc that relate to discussions of informed consent, or ask how many complaints have been received by parents who have had their refusal to consent overridden and ask for the documentation relating to those complaints etc.

My daughter has been left with severe chronic health problems after having her HPV vaccine 4 years ago - the issue of proper informed consent in relation to the HPV vaccination is something I'm currently researching, along with many other families with similarly affected daughters. Currently, parents are not warned about the serious adverse reactions that can occur with the HPV vaccination and instead are being told it's very safe and any reactions are minor and short lasting. This is not our experience.

Dear Department of Health,

Please pass this on to the person who conducts Freedom of Information reviews.

I am writing to request an internal review of Department of Health's handling of my FOI request 'Vaccinations in School / Informed Consent'.

To whom it may concerm

I am a busy mother of four, I do not have time to play semantics and I am not inclined to waste copious amounts of time fighting for answers I am entitled to have and you are required to give.
So please, just answer my questions instead of trying to find flaws in my wording that will enable you to avoid answering.

On the basis of time and patience limitations I will now employ a professional to word a new FOI on my behalf.

I guess I wont be buying those Kurt Geiger Boots after all.

Emma Flavell
A full history of my FOI request and all correspondence is available on the Internet at this address: https://www.whatdotheyknow.com/request/v...

Yours faithfully,

Emma

Department of Health and Social Care

Thank you for contacting the Department of Health.
This is an acknowledgement - please do not reply to this email.
Where a reply is appropriate, we aim to send one within 18 working days,
or 20 working days if your query is a Freedom of Information request or
complaint.
If you have contacted the Department of Health about a current health or
social care campaign, please visit the [1]GOV.UK website, the UK
Government’s official information website, where a response may have been
published.

If your enquiry is about a medical matter, please contact NHS 111 or visit
[2]NHS Choices, or contact your GP surgery.

For general health information you may also find it helpful to refer to
[3]GOV.UK, which includes the Department of Health's [4]'What we
do' section.
Please note that the Department of Health does not process complaints
about the NHS or social services. If you wish to make a complaint about a
healthcare professional, an NHS organisation or a social care provider,
please visit the [5]'Complaints procedure' page on the GOV.UK website.
 
You can find out more about the Department’s commitments from our
[6]Personal Information Charter.

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Communications via the GSi may be automatically logged, monitored and/or
recorded for legal purposes.

References

Visible links
1. https://www.gov.uk/government/announceme...
2. http://www.nhs.uk/
3. https://www.gov.uk/government/organisati...
4. https://www.gov.uk/government/organisati...
5. https://www.gov.uk/government/organisati...
6. https://www.gov.uk/government/organisati...

Department of Health and Social Care

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Our ref: DE00000910155 
 
Dear Ms Flavell, 
 

Please find the Department of Health's response to your recent Freedom of
Information request attached.

Yours sincerely,
 
Jonathan Young
Freedom of Information Officer
Department of Health

 

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Steve Hinks left an annotation ()

Although the MHRA publicly claim that this vaccine is safe and deny ANY serious adverse reactions, when asked by Freedom of Information Act request they admit 21,156 adverse reactions have been reported including 8 with fatal outcome. They also acknowledge that 32% are classed as serious and that only 1-2% of adverse reactions and c.10% of serious adverse reactions are reported. We are being deceived. This has been supported by a most serious complaint by Cochrane to the EMA with allegations of withholding the truth! see: http://nordic.cochrane.org/sites/nordic....

Steve Hinks left an annotation ()

The European Medicines Agency (EMA) recently reviewed safety of this vaccine and concluded that it is safe! They stated ‘reviews of the reports (of serious adverse rections) did not show a consistent pattern regarding time-to-onset following vaccination! They have totally ignored the evidence provided by the UK Association of HPV Injured Daughters (AHVID) which reported that a questionnaire completed by 94 member families indicated that:
• 27 girls (31% ) had adverse reactions on the same day as the vaccination, many of them suffrering immediately, within minutes.
• 12 girls (14%) had adverse reactions after just 1 dose
• 19 girls (22%) had adverse reactions after just 2 doses (some of these had reactions also to the 1st dose
• 14 girls had adverse reactions after the 3rd dose (and some of these had earlier reactions)
• At least 4 girls (4%) had adverse reactions after each of 3 doses. Health professionals had indicated that the vaccine is safe and the adverse reactions suffered were not recognised as side effects of the vaccine. Initial symptoms were often ‘generally unwell, flu-like, tired, aches and pains’. With each dose the severity increased and day-by-day the severity increased. With some it was eventually several weeks before these symptoms developed into collapse with total fatigue and sleeping up to 23 hours each day.