The Australian Commission on Safety and Quality in Health Care reported in 2014 that 60 per cent of adult Australians have low health literacy, arguing that they may not be able to effectively exercise their choice or voice when making healthcare decisions.
The Commission defines individual health literacy as the skills, knowledge, motivation and capacity of a person to access, understand, appraise and apply information to make effective decisions about health and health care and take appropriate action.
This finding is particularly concerning when one considers that vaccination rates in Australia are at very high levels and have been for some time.
In effect, a significant majority of people who are consenting to vaccination for themselves or on behalf of their children are doing so without the requisite knowledge and skills.
Ironically, the Commission suggests that low health literacy is responsible for low Influenza vaccine uptake, but if that were true, we would expect vaccine uptake to be low across the board.
The government, and mandatory vaccination lobby groups such as Dana McCaffery – Whooping Cough Awareness, Stop the AVN, Northern Rivers Vaccination Supporters, and Light for Riley take advantage of this state of affairs, as evidenced by the types of comments made to their social media pages.
Arguably, these groups actively prey on the uninformed.
For example, it is not unusual to see hateful comments on their social media pages to the effect that Whooping Cough has made a comeback because of the so-called ‘anti-vaxers’; comments which, noticeably, go uncorrected.
Such is the misinformation perpetuated by these groups, particularly with respect to Whooping Cough, the term the ‘McCaffery Inference’ has been coined to describe Toni and David McCaffery’s attribution of blame for their daughter’s death, by reference to the infamous childcare drop off in a area, neighbouring an area with lower vaccination rates than South Sudan. It could just as easily be the Hughes Inference.
The McCaffery Inference will be the subject of a subsequent article.
The type and amount of information provided during the consent to vaccination process is woefully inadequate. This is particularly so for the 60% of adults who lack the requisite knowledge and skills to make effective decisions about health and health care options.
In the video linked below, former National Centre for Immunisation Research and Surveillance (NCIRS) Director, Professor Peter McIntyre, defends this inadequate provision of information by asserting that a lot of parents don’t want a whole lot of detailed information.
Whilst it may be true that a lot of parents don’t want a whole lot of detailed information, health care practitioners have a legal duty to provide sufficient information, whether or not parents request it.
The leading Australian legal authority on consent to medical procedures is the High Court case of Rogers v Whitaker [1992] HCA 58.
Consent will be considered valid if the patient has been advised in broad terms of the nature of the procedure to be performed.
… the consent necessary to negative the offence of battery is satisfied by the patient being advised in broad terms of the nature of the procedure to be performed … (para 15)
A failure to warn about the risks of a medical procedure does not operate to invalidate consent but may ground a claim in negligence.
… an allegation that the risks inherent in a medical procedure have not been disclosed to the patient can only found an action in negligence and not in trespass … (para 15)
A health practitioner has a duty to warn a patient of a material risk inherent in the proposed treatment.
… a risk is material if, in the circumstances of the particular case, a reasonable person in the patient’s position, if warned of the risk, would be likely to attach significance to it or if the medical practitioner is or should reasonably be aware that the particular patient, if warned of the risk, would be likely to attach significance to it … (para 16)
Most defects in consent to vaccination in Australia involve a negligent failure to warn of material risks.
1. Only side-effects identified in pre-licensure clinical trials are included in the warnings given to potential vaccine recipients or their parents/guardians. However, as we know, clinicals trials don’t usually use representative samples and actively exclude people with certain health conditions, so it is no wonder that clinical trials rarely identify serious side-effects, other than the odd case of anaphylaxis and sore arms.
2. Adverse events identified in post-marketing (post-licensure) surveillance are not included in the warnings given to potential vaccine recipients or their parents/guardians, yet as we know, the sample sizes used in clinical trials are insufficient to detect the rarer, and usually more serious side-effects which inevitably emerge in post-marketing surveillance data.
A good example of this is the case of a young Tasmanian girl who was recently hospitalised with Kawasaki Disease, two days post-vaccination.
Even though there is high degree of probability that her condition was caused by the vaccination she received (Menactra Meningococcal ACWY), parents who take there children to be vaccinated against Meningococcal ACWY this week, will not receive a warning that Kawasaki Disease has been reported following receipt of that vaccine.
Nor will they receive a warning about all of the other serious, and sometimes life-threatening adverse events that have been identified in post-marketing surveillance unless they ask for a copy of the manufacturer’s Product Information (PI) sheet or Product Insert, where these are listed. See pages 11 and 12 of the Menactra PI.
3. Vaccine recipients or their parents/guardians are not advised that there may be a significant lag time between vaccination and manifestation of a disease arising from vaccination, resulting in massive under-reporting of post-marketing adverse events. This is particularly true with respect to autoimmune conditions. See Federal law acknowledges lag time of up to two months between vaccination and onset of autoimmune disease.
4. A learned intermediary, the Australian Technical Advisory Group on Immunisation (ATAGI) often makes vaccine recommendations which vary from the vaccine manufacturer’s warnings and instructions for appropriate use.
Arguably, all of the above factors are relevant in determining material risks to which vaccine recipients or their parents/guardians might attach significance, so should be included as warnings during the consent process. The provision of adequate warnings would reduce vaccine injury litigation to zero.
The provision of adequate warnings would also eliminate the need for a No Fault Vaccine Injury Compensation Scheme, on the basis that a right to compensation does not arise from the materialisation of a risk which a vaccine recipient had been prepared to accept. See Wallace v Kam [2013] HCA 19 (para 32).
As it currently stands in Australia, vaccine recipients are being injured as a result of a materialisation of a risk which they did not accept, because they were not warned.
The provision of adequate information and warnings does not require amendments to legislation. All that would be required is the will of our elected leaders to ensure this happens.
