Founder, executive and scientific director, Alliance for Natural Health International
Scientific director, Alliance for Natural Health USA
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. Like all women preceding our current generation of youngsters, their ability to live alongside human papilloma viruses (HPVs) is sealed by millions of years of evolution alongside these viruses and other microbes, the vast majority of which are non-pathogenic and many of which are beneficial or commensal.
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:
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
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.
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?
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.
Infographic: are UK citizens being short-changed on safety data?
Comparing safety data on patient information leaflets for quadrivalent Gardasil in the UK and USA.
In order to be true to the concept of informed consent, parents and guardians should be given more information about options available. These might be as follows:
Option 1 – The HPV vaccine option: Go for the two vaccine shots, the second shot being between 6 and 24 months after the first. Accept any associated risks from adverse events and as adults, maintain cervical screening (Pap tests). As noted by Dr Stella Heley of the Victorian Cytology Service in Melbourne, Australia, Pap test abnormalities will still be seen in many vaccinated women because of HPV exposure prior to them receiving the HPV vaccine.
Option 2: The no HPV vaccine option: Help build natural immunity through healthy diet and appropriate lifestyle, minimise any risk of sexual activity prior to puberty, and regular cervical screening for women over 30.
Option 3: Cervical cancer screening only (for women over 30). Even the smallprint in the the UK Gardasil patient information leaflet states “Vaccination is not a substitute for routine cervical screening. You should continue to follow your doctor’s advice on cervical smear/Pap tests and preventative and protective measures.” The US GARDASIL leaflet states: “GARDASIL does not eliminate the necessity for women to continue to undergo recommended cervical cancer screening“.
The unknown consequences of tampering with our virobiome
Finally, let me speculate a little – as an ecologist and health scientist. Health authorities like to make out that the science on cervical cancer, HPV and the HPV vaccine is a done deal. That couldn’t be further from the truth.
We know surprisingly little about the importance, benefit and harm associated with interactions between viruses and humans.
The pattern of research in this field seems to be following a similar trajectory to that of our knowledge of bacteria and humans. Fifty years ago, with the advent of antibiotics, it was usual to consider all bacteria as potentially pathogenic and fair targets for antibiotics. We now appreciate the problems associated with antibiotic over-use, their impact on the gut microbiome and the creation of antibiotic resistant 'superbugs'. We also understand that we can’t live without trillions of beneficial and commensal bacteria in our gut microbiome. This microbiota includes non-bacterial microorganisms, including viruses and fungi.
Science is beginning to point towards viruses not being solely the ‘bad guys’. As genetic sequencing technologies develop, we are just beginning to understand the relevance of our virobiome and virobiota, which are closely associated with bacteria, including those several trillion that reside in a healthy gut that has not been hit with antibiotics.
And here’s the rub, and one of my most deep-rooted concerns. Distorting this co-evolution by way of a prophylactic, genetically modified vaccine loaded with aluminium could trigger the development of more pathogenic strains of HPV. A detailed study of the ecological and evolutionary dynamics of HPV led by Paul Orlando and colleagues at the University of Illinois in Chicago and published in 2011 concluded that “the elimination of HR HPV through vaccines may alter the evolutionary trajectory of the remaining types and promote evolution of new HR HPV types.” Therefore, it is perfectly within the realms of possibility that our prophylactic vaccine campaigns targeting HR HPV strains could result in a new dawn of super-viruses.
Equally, this interference within an ever wider range of viral strains that have co-evolved alongside humans could impact the development and maturation of our immune systems more generally. Who are we to assume that our immune systems can develop fully and properly without the viral, bacterial and fungal elements of our microbiome? Contrary towhatis commonly reported, the natural history of HPV commonly involves the transfer of HPV from mothers to their babies, a process that has clearly existed prior to the dawn of humankind.
So - let’s look before we leap. And most importantly, let’s make sure we have as much of the available and relevant data as possible in front of us before we make decisions about the welfare of our most precious assets, our young daughters – or sons.
Governments have a long way to go on this front and we need to stand shoulder to shoulder and hold them to account for withholding information.
Get the word out!
Please forward this widely, including to your loved ones, friends and political representatives, ensuring that s/he does more to ensure that information required for properly informed consent is made readily available to parents, guardians and children prior to consent being given.