Re: Philippines measles outbreak is deadliest yet as vaccine scepticism spurs disease comeback
Stephen O’Dea’ s observations about an association between MMR vaccination and Guillain Barre syndrome (GBS ), based on personal experience, will add to the concern felt by many observers of the UK vaccination scene that the implications of this association have been insufficiently discussed.
The Patient Information Leaflet ( PIL) for the MMR vaccine states that the GBS can be a side effect of the MMR vaccine, albeit of unknown frequency. The PIL identifies numerous other side effects with potentially serious outcomes.
The Montgomery decision in the UK Supreme Court, in 2015, regarding informed consent, “ ..replaces the previous tests founded in Bolam...” and means that doctors have a duty to ensure that patients are aware of “material risks .“ The Medical Defence Union guidance further explains that whether a risk is material ” ..doesn’t only depend on how frequently it occurs.” (1)
Does this not suggest that the parents of every child should be advised of the risk of GBS, ( and the other serious side effects ) before they can give valid informed consent to the MMR ?
The UK Green Book ( Immunisation against infectious disease ) was last updated by Public Health England in 2014. The chapter on consent still quotes the Bolam case - which was replaced, four years ago, as a legal precedent, by the Montgomery decision . (2)
This is a remarkable oversight, considering that the Green Book is considered an authoritative guide to immunisation practice, for professionals in primary care.
A BMJ Analysis article, in 2017, on the effects of the Montgomery decision, pointed out that “ the legal and ethical position is clear: doctors must not withhold information simply because they disagree with the decision the patient is likely to make if given that information.” (3)
The BMJ Analysis suggested that litigation decisions were already mentioning the influence of the Supreme Court ruling.
Last year the High Court ruled that although a surgeon had used reasonable care and skill in carrying out an operation which resulted in serious harm to a patient, because the patient had not been informed, when giving consent, about the rare complication subsequently suffered, valid consent had not been obtained. The patient was awarded £4.4 million. (4)
Although the media, including the BMJ, make much of patients’ and parents‘ alleged “vaccination hesitancy”, should we not be concentrating on providing comprehensive factual information on benefits and risks, “ from the perspective of a reasonable person in the patient’s position,“ (1) as UK law dictates ?
Only then, as UK law makes clear, can people give valid informed consent.
Rapid Response:
Re: Philippines measles outbreak is deadliest yet as vaccine scepticism spurs disease comeback
Stephen O’Dea’ s observations about an association between MMR vaccination and Guillain Barre syndrome (GBS ), based on personal experience, will add to the concern felt by many observers of the UK vaccination scene that the implications of this association have been insufficiently discussed.
The Patient Information Leaflet ( PIL) for the MMR vaccine states that the GBS can be a side effect of the MMR vaccine, albeit of unknown frequency. The PIL identifies numerous other side effects with potentially serious outcomes.
The Montgomery decision in the UK Supreme Court, in 2015, regarding informed consent, “ ..replaces the previous tests founded in Bolam...” and means that doctors have a duty to ensure that patients are aware of “material risks .“ The Medical Defence Union guidance further explains that whether a risk is material ” ..doesn’t only depend on how frequently it occurs.” (1)
Does this not suggest that the parents of every child should be advised of the risk of GBS, ( and the other serious side effects ) before they can give valid informed consent to the MMR ?
The UK Green Book ( Immunisation against infectious disease ) was last updated by Public Health England in 2014. The chapter on consent still quotes the Bolam case - which was replaced, four years ago, as a legal precedent, by the Montgomery decision . (2)
This is a remarkable oversight, considering that the Green Book is considered an authoritative guide to immunisation practice, for professionals in primary care.
A BMJ Analysis article, in 2017, on the effects of the Montgomery decision, pointed out that “ the legal and ethical position is clear: doctors must not withhold information simply because they disagree with the decision the patient is likely to make if given that information.” (3)
The BMJ Analysis suggested that litigation decisions were already mentioning the influence of the Supreme Court ruling.
Last year the High Court ruled that although a surgeon had used reasonable care and skill in carrying out an operation which resulted in serious harm to a patient, because the patient had not been informed, when giving consent, about the rare complication subsequently suffered, valid consent had not been obtained. The patient was awarded £4.4 million. (4)
Although the media, including the BMJ, make much of patients’ and parents‘ alleged “vaccination hesitancy”, should we not be concentrating on providing comprehensive factual information on benefits and risks, “ from the perspective of a reasonable person in the patient’s position,“ (1) as UK law dictates ?
Only then, as UK law makes clear, can people give valid informed consent.
1 https://www.themdu.com/guidance-and-advice/guides/montgomery-and-informe...
2 https://www.gov.uk/government/collections/immunisation-against-infectiou...
3 https://www.bmj.com/content/357/bmj.j2224
4 http://www.bailii.org/ew/cases/EWHC/QB/2018/164.html
Competing interests: No competing interests