Philippines measles outbreak is deadliest yet as vaccine scepticism spurs disease comeback
BMJ 2019; 364 doi: https://doi.org/10.1136/bmj.l739 (Published 14 February 2019) Cite this as: BMJ 2019;364:l739
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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
Stephen O'Dea [1] raises some interesting points. In my letter yesterday [2] I was pointing to the paradox that whereas there was immunity from measles for life in the days when virtually everyone caught it, the vaccine only offers imperfect and waning immunity [3]. Another problem is that vaccinated mothers may no longer hand on measles anti-bodies to their infants [4,5], which makes them a vulnerable group. Apart from anything else it is very hard to see how herd immunity from vaccines could ever be remotely obtainable, even if 95% [6] of children or 100% were vaccinated.
We are told that this is the worst outbreak yet [6], which is perhaps out of line with the WHO projection of 110,000 deaths globally in 2017 [7]. I also recall the former Italian Health Minister, Beatrice Lorenzin, who was appointed at the White House to head the Global Health Security Agenda in 2014 [8] declaring that 270 children died in a recent outbreak of measles in London while regretting misinformation on the web [9]. Who is to say who is not telling the truth anymore?
[1] Stephen M O'Dea, 'Re: Philippines measles outbreak is deadliest yet as vaccine scepticism spurs disease comeback', 25 February 2019, https://www.bmj.com/content/364/bmj.l739/rr
[2] John Stone, 'Re: US measles, vaccine mandates and totalitarian pharmocracy', 25 February 2019, https://www.bmj.com/content/363/bmj.k5246/rr-2
[3] Kontio M, Jokinen S, Paunio M, Peltola H, Davidkin I, 'Waning antibody levels and avidity: implications for MMR vaccine-induced protection', Infect Dis. 2012 Nov 15;206(10):1542-8. doi: 10.1093/infdis/jis568. Epub 2012 Sep 10.
[4] Sandra Waaijenborg, Susan J. M. Hahné, Liesbeth Mollema, Gaby P. Smits, Guy A. M. Berbers, Fiona R. M. van der Klis, Hester E. de Melker, and Jacco Wallinga, 'Waning of Maternal Antibodies Against Measles, Mumps, Rubella, and Varicella in Communities With Contrasting Vaccination Coverage', J Infect Dis. 2013 Jul 1; 208(1): 10–16.
[5] Zhao et al, 'Low titers of measles antibody in mothers whose infants suffered from measles before eligible age for measles vaccination' Virol J. 2010; 7: 87., Published online 2010 May 6. doi: 10.1186/1743-422X-7-87
[6] Owen Dyer, 'Philippines measles outbreak is deadliest yet as vaccine scepticism spurs disease comeback',
BMJ 2019; 364 doi: https://doi.org/10.1136/bmj.l739 (Published 14 February 2019)
[7] World Health Organization, 'Measles', 29 November 2019, https://www.who.int/news-room/fact-sheets/detail/measles
[8] John Stone, 'Re: MEPs devise strategy to tackle vaccine hesitancy among public -Echoes of WMD', 26 March 2018, https://www.bmj.com/content/360/bmj.k1378/rr
[9] John Stone, 'Re: Compulsory vaccination and growing measles threat - Prof Melegaro's response', 21 October 2017, https://www.bmj.com/content/358/bmj.j3429/rr-7
Competing interests: No competing interests
With so many recently published articles on the deaths caused by measles and such, and the blame being placed squarely at the feet of parents who object to having their children vaccinated; I wonder why the stories fail to present any quantitative data regarding the number of victims who were vaccinated, verses those who were not. It leaves me wondering if these figures might possibly be embarrassing as to the effectiveness, or lack thereof, in providing effective protection from the targeted disease.
I feel constantly at odds with both working in the industry, but also having family history of Guillain-Barré syndrome, where in each case onset has followed with 3-5 days after MMR immunisation. For me the dangers of GBS outweigh the possible hazards of wild contraction of Measles (Which I and my siblings survived well as children).
Scepticism will continue to rise unless real data shows a benefit at a personal level, for running whatever perceived risks may be at stake for receiving vaccines. What I look for, but fail to see is real death rate data on deaths from the vaccinated population verses the unvaccinated population.
Competing interests: No competing interests
Re: Philippines measles outbreak is deadliest yet as vaccine scepticism spurs disease comeback
Informed Consent, as clarified in Montgomery vs Lanarkshire Health Board 2015, requires all potential adverse events associated with a treatment, including vaccination, to be made known to the patient before any treatment commences. One has to wonder, with the significant awards being made to patients in cases where informed consent has not been secured, why any party would place themselves at risk by not ensuring that on each and every occasion, the correct legal requirements have been met and informed consent secured. A £4.4m award reflects the serious nature of the failure to obtain informed consent and is indicative of how seriously courts view the lapse in procedure.
In the case of vaccination, the pharmaceutical industry has stated that the Patient Information Leaflet (PIL) be read by the patient before treatment commences.
A May 2018 Public Health England, Patient Group Direction (PGD) (valid until April 2020), “to facilitate the delivery of publicly funded immunisation in line with national recommendations” for HPV vaccine administration, after setting out the step by step procedure for administering the vaccine etc, states on page 11, that staff should………………….
“Offer marketing authorisation holder's patient information leaflet (PIL) provided with the vaccine”. (1)
The PIL is the most comprehensive, product specific information created by the manufacturer, and should be made available before vaccination takes place. The ‘offering’ of the PIL is indicative of a casual act of a haphazard nature which is not compliant with either the provisions in Montgomery or the PIL itself and is devoid of any direct instruction as to timing. Surely in view of the legal requirements, the instruction to staff should be to “provide”, not offer, the PIL to the patient, and to do so before administering the vaccine.
In addition, the PGD directs staff, when assessing Gillick competence in young people, to a DH Reference Guide.
“For children under the age of 16 years being offered HPV vaccine, those assessed as Gillick competent can self-consent (see DH Reference guide to consent for examination or treatment). (2)
The Guide, published in July 2009, refers to “valid consent” (not informed consent) and relies on the House of Lords case Chester vs Afshar (2004), on the legal aspects of consent. The Guide advises that…………..
“It is a general legal and ethical principle that valid consent must be obtained before starting treatment or physical investigation, or providing personal care, for a person.”
In 2015, the Judgement in Montgomery dispensed with any notions of “general” and “ethical” principles with regard to consent and clearly defined the legal requirements.
Why then has PHE not protected Healthcare Staff by ensuring that in the past 4 years, guidance on informed consent has been updated with regard to the judgement in Montgomery?
One answer may lie in the decade old Guide itself where it is acknowledged that “further legal developments” re consent may occur after the 2009 guidance has been issued but that responsibility for keeping up to date with any changes, lies with the individual HCP's.
“Case law on consent has evolved significantly over recent years. Further legal developments may occur after this guidance has been issued, and all healthcare practitioners must remember their duty to keep themselves informed of legal developments that may have a bearing on their practice. Legal advice should always be sought if there is any doubt about the legal validity of a proposed intervention".
The responsibility on HCP’s to keep themselves appraised of current law on the issue of consent, along with the responsibility for ensuring informed consent is obtained from patients, in view of the severity of the penalties for failing to do so, is huge.
It appears that despite the Courts affirming the legal significance of informed consent and inflicting severe penalties on those who fail to respect and secure it, HPE are content to rely on an outdated Green Book(3) and a significantly outdated Reference Guide when directing staff on the subject of consent.
(1) https://www.england.nhs.uk/south-east/wp-content/uploads/sites/45/2018/0...
(2) https://www.gov.uk/government/publications/reference-guide-to-consent-fo...
(3) Dr Noel Thomas, https://www.bmj.com/content/364/bmj.l739/rapid-responses
Competing interests: No competing interests