When your 12-year-old daughter comes back from school with the consent form for HPV vaccine in hand, and you have to make the decision on her behalf, all the issues around informed consent come sharply into focus. My older two daughters — now adults — missed the boat on this one.
My youngest two daughters, however, face a new predicament — one that’s only been on offer to humans for a decade: the HPV vaccine. Should or shouldn’t they be exposed to a genetically engineered vaccine, hailed as the best shot at cervical cancer prevention?
It’s an issue we’ve reported on before, so we won’t duplicate information we’ve already provided. Following is a selection of some of our previous pieces (in reverse chronological order) on the HPV vaccine and informed consent:
18/01/17 – Its official: HPV vaccine, the most dangerous vaccine yet
07/09/16 – HPV vaccine propaganda
20/01/16 – HPV vaccine ‘cover-up’ allegations
16/12/15 – Grassroots pressure against HPV vaccine grows
04/11/15 – Swedish cover-up HPV vaccine side effects- and more
10/06/15 – ANH Feature: HPV vaccine: should you or shouldn’t you?
Signing on the dotted line
My daughter came home with 3 papers in hand. One was a letter from NHS England with the subject “Good news – Beating cervical cancer”. The second was a “Vaccination consent form” that offers the parent or guardian two choices:
- I want my daughter to receive the full course of HPV vaccinations; or:
- I do not want my daughter to have the HPV vaccine
[the consent options are bolded as above]
At the bottom of the form is a statement that says, “Any side effects following the HPV vaccination should be reported to the school nurse or your GP”. This is interesting as I have now met with many young girls who have developed severe reactions, which were reported to schools or GPs and were rapidly dismissed as not being linked.
The third item that my daughter brought home from school was a folded leaflet entitled “Beating cervical cancer” that is also available electronically.
The big question for my family earlier this week was: what information was being provided, and was this sufficient to make an informed consent?
The reality is that the information my daughter was given, information that’s intended to help guide us in this very important decision, amounts to — in my personal view — a sales pitch for Merck (the vaccine’s manufacturer).
It couldn’t be described as anything approaching the provision of all relevant, currently known information about the likely benefits and risks of HPV vaccination. It also gave away nothing about other options available, should we choose to not go down the vaccination route for my daughter.
Yet, my daughter also has a legal right to accept vaccination in the event that we, as parents don’t provide our consent. In the UK, as school nurses are the primary party administering vaccines, they also — somewhat incredibly in our view — have the right to vaccinate against the will of parents or guardians if they have assessed the potential recipient of the vaccine as Gillick competent. With only 12 years of life in the tank, a sales pitch thrown at them and a mass of information withheld, is the original subject matter — contraceptives/birth control — decided by the House of Lords in 1986 (Gillick v West Norfolk and Wisbech AHA ) really of relevance to HPV vaccination?
Our petition (please sign if you agree with it and haven’t already done so) spelt out the definition of informed consent: “Informed consent means that all relevant information should be available before someone is asked to decide about their own, or their child’s, vaccination. This should include the known benefits and risks, as well as any alternatives, to the proposed treatment.” We linked this explanation to a legal primer to remind readers of the legal importance of providing information about alternatives to the proposed treatment.
What they haven’t told us
We could write a book about this, but everyone’s time challenged. So here’s a summary:
- Vaccinate all Year 8 (12-year-old) girls to save 400 lives in the UK. How do we know? The leaflet and consent form all imply that being vaccinated will protect against HPV-related cancers, when in fact it’s too early to see if the vaccine works long-term to create a population-wide reduction in cancer that matches the mathematical models that are loaded with assumptions. Using these models, the UK NHS predicts that “400 lives could be saved a year” from cervical cancer if nearly the entire adolescent female population is vaccinated. But this is a prediction based on many assumptions including the prolonged immunogenicity of the vaccines. This has to be questioned further given the changes being made to the vaccine. The earlier, bivalent vaccine appeared to have around twice the persistence (approx. 8 years) compared with the quadrivalent vaccine, now in its final period of use in the UK as part of the national vaccination programme, in which the immune response wanes after just 4 years. What about the long-term efficacy of the latest Gardasil9 (already in use in the USA, and soon to be released in the UK), which targets not 2 or 4, but 9 sub-types of HPV? Surely temporary effects on immunogenicity cannot be translated to long-term protection against HPV-related cancers? And surely data from the old vaccine shouldn’t be applied to the new vaccine(s)? Decades worth of data from use of a given vaccine on young girls would be required to draw such conclusions.
- Unknown effectiveness. The effectiveness of the vaccine in reducing HPV-related cancers is assumed to be equivalent to the capacity for the vaccine to neutralise HPV antibodies, notably for high-risk HPV types (HR HPV). Given the transient nature of immunogenicity to HPV antibodies (e.g. 1-5 years), the potential for viral load acquired from birth (e.g. from the mother), as well as sexual activity prior to vaccination, it is wrong to assume an antibody response in the short-term is equivalent to cancer protection in the long-term.
- Health authorities mute on options other than vaccination. No information is provided to adults or adolescent children being targeted for vaccination on other options (see below) to protect against HPV-related cancers, other than vaccination. This is astounding given the many years of information available from cervical screening including knowledge that cervical abnormalities from Pap smear tests commonly normalise in time suggesting effective natural immunity.
- HPV is extremely common in humans and rarely leads to cancer. Parent, guardians and children have been led to believe that the so-called high-risk HPV types (16 and 18) are always pathogenic, when in fact infection with these and other sub-types of HPV is extremely common in young people, and only in a small proportion does cancer manifest.
- Data on health risks sanitised by health authorities. Information on agreed adverse effects based on trial data by vaccine manufacturers is considerably less in the UK than it is in the USA (see Infographic below). This information probably significantly under-represents the actual risks which continue to be a subject of controversy, mainly because it is very difficult to causally link adverse events that occur within a few days of vaccination with the particular adverse event. In the UK, there are thousands of reports of girls feeling “seriously ill” after routine HPV vaccination. The Association of Vaccine Injured Daughters is an example of grassroots effort by families of girls who have suffered serious, debilitating and sometimes permanent effects shortly following HPV vaccination. Similar grassroots actions have sprung up in many other countries including Japan, Denmark, India and elsewhere.
- The HPV vaccine is a genetically modified vaccine. If you read the smallprint on the patient information leaflet that can be downloaded, but is rarely read by the recipient, parent or guardian, you will find the active virus-like particles are made using “recombinant DNA technology” from yeast. Many laypeople won’t be aware that recombinant DNA technology is a form of genetic engineering (GE) or genetic modification (GM). Across the EU, including the UK, and increasingly in other parts of the world, it is mandatory to declare GM ingredients in foods. In the case of medicines, which entirely bypass the gastro-intestinal tract and are injected directly into muscles and then absorbed by the bloodstream, shouldn’t the public be clearly informed that the HPV vaccine is a GM vaccine?
- The aluminium additive in the vaccine creates adverse effects. The ingredients list also includes aluminium hydroxide which is used to increase the reactivity (‘reactogenicity’) of the genetically modified virus-like particles. As Drs Tomljenovic, Shaw and others at the University of British Columbia have found, rather than being assumed to be a safe additive, aluminium used as an adjuvant in vaccines is far from safe and has the “potential to induce serious immunological disorders in humans. In particular, aluminum in adjuvant form carries a risk for autoimmunity, long-term brain inflammation and associated neurological complications and may thus have profound and widespread adverse health consequences”. The presence of aluminium adjuvants accounts for the high rate of serious adverse effects in control groups in drug licensing studies.
- HPV, a sexually transmitted virus. The NHS leaflet on HPV accompanying the consent form says that HPV is “very common” and that it is ‘caught’ “through intimate sexual contact with another person who already has it.” Given this recognition of HPV as a sexually transmitted infection (STI), the leaflet does not categorise HPV infection as an STI alongside other STIs such as syphilis, gonorrhoea or HIV. More importantly, it provides no advice to parents, guardians or children on protected sex or on support that helps children to avoid very early sexual activity. Case-control studies reveal that the risk of cervical disease increases significantly among women whose male partners had a greater number of sex partners and HPV infection, presumably because viral load, not just presence or absence of the virus or antibodies to it, is an important determinant.
- Modified vaccine means altered risk/benefit profile. In the UK Cervarix and Gardasil (in both bivalent and quadrivalent forms) have been available since the launch of the government sanctioned national immunisation programme 10 years ago. Safety and effectiveness data are assumed to be equivalent for all vaccines, despite evidence to the contrary. This amounts to the public being seriously misled. The UK is shortly to start vaccinating with Gardasil9 which targets 9 rather than 4 HPV types. Since receiving the letter from the school a few days ago, we have made extensive enquiries and cannot get confirmation from any source in NHS England or my local authority whether it is anticipated that my daughter would be vaccinated with the quadrivalent version or Gardasil9 this Autumn. In fact, in asking for information from all available helplines, none of the operators understood the question, believing the vaccine had always been the same one.
Read the Full Article at Alliance for Natural Health International
This article (Are Parents Fully Informed of Risks of HPV Vaccine Before Consenting?) was originally published on Health Impact News and syndicated by The Event Chronicle.