Vaccination uptake: access is still biggest barrier, experts warn
BMJ 2019; 366 doi: https://doi.org/10.1136/bmj.l5576 (Published 17 September 2019) Cite this as: BMJ 2019;366:l5576All rapid responses
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BOILING FROG PRINCIPLE: PATIENT SAFETY AND VACCINES
Recent comments by Elisabeth Mahase, Helen Haskell, Stuart Fletcher, Noel Thomas , John Stone and JK Anand about patient safety and vaccines prompt the following reflections about an old metaphor:
The Boiling Frog Principle is a metaphor for the fact that we fail to appreciate the pathology that results from environmental hazards which creep gradually upon us. I first learned about the BFP during the infant formula controversy of the 1970s and early 1980s. It was especially apt in the US where the marketing of proprietary infant formula had been so successful and where so few infants were breastfed. During this period I published epidemiologic research that raised awareness of the benefits of breastfeeding in developed nations, and of the morbidity associated with formula feeding. (Cunningham: Pediatrics 1972;50:823. J Pediatr 1977;90:721…et al.) I well remember the initial response of pediatric colleagues, most of whom could not believe that formula was inferior to human milk.
It now strikes me that we have a similar situation with vaccinations. Our immunization programs have gradually expanded over the last 70 years, and distribution of large numbers of vaccines to children is virtually universal. There have been some notable successes, but our knowledge of long-term vaccine effectiveness and adverse effects is quite limited. We have taken on faith that, as a whole, immunization programs have done much more good than harm, but we do not know with any precision where the overall balance between risks and benefits really lies when every vaccine is given to every child. With universal vaccination it is likely that we are unaware of existing hazards, just as we were unaware of the hazards of infant formula. The list of potential vaccine adverse effects may be long, but I think of certain ‘mystery diseases’: Kawasaki disease, SIDS, autism, and acute flaccid myelitis/AFM. These have been associated with vaccination, but because of the way vaccines have been developed, tested, licensed and marketed there has been no opportunity to do the unbiased and properly controlled trials to support or exclude a causal role for vaccines—notwithstanding the observational studies used to assert non-causality in these diseases.
Many vaccine authorities will find the foregoing suggestions outrageous, but they will make good sense to those who have studied “non-specific vaccine effects.” DPT vaccine, for example, is associated with an increase in all-cause mortality in poor countries, even though it prevents the target diseases. BCG and measles vaccines, on the other hand, have been associated with decreased all-cause mortality, well beyond their specific prevention of TB and measles. In these examples a non-specific, or ‘heterologous’ effect on the immune system is postulated. The BMJ has published articles about NSVE going back more than 25 years and has been exceptional in bringing the subject to light, including studies by Peter Aaby, Christine Benn, Frank Shann, Paul Fine, Andrew Pollard, and others. They have called for randomized trials of different vaccine schedules in the hope that the optimal schedule can be found, minimizing the harms and maximizing the benefits of NSVE, while also providing specific protection against the target diseases. These authorities, at least, have not taken the safety of current immunization schedules completely for granted.
Properly controlled trials have become more and more important with every new vaccine. Natasha Crowcroft and her colleagues emphasize that new technologies bring considerable uncertainty about safety and effectiveness, requiring many years for adverse events caused by vaccines to be identified and confirmed. (BMJ 2015;350:h308)
The foregoing medical opinions have been reinforced by one legal scholar, who has called for an overhaul of US vaccination laws. I paraphrase what Efthimios Parasidis says about the National Childhood Vaccine Injury Act of 1986: Just as the health benefits of vaccines cannot be seriously questioned, the shortcomings of the legal framework governing immunizations cannot be ignored. The Vaccine Act was established when there were fewer vaccine doses, when health information technology was in its infancy, and when lawmakers heavily favored corporate welfare and deregulation over consumer protection. The result is that manufacturers have enjoyed robust immunity from tort claims for vaccine-related injuries. Furthermore, once a vaccine is approved and marketed, a manufacturer does not have a statutory obligation to actively collect and analyze safety and efficacy data, and is under no obligation to update vaccine formulas in light of new scientific advancements. Parasidis proposes that the requirements for adverse event reporting and post-market analysis of vaccine safety and efficacy be toughened. He also proposes that the law be recalibrated to remove the nearly insurmountable barriers in Vaccine Court to fair compensation for vaccine injuries. (Parasidis, “Recalibrating Vaccination Laws.” Boston University Law Review 2017;97:2153)
The boiling frog metaphor is a whimsical but serious warning against complacency and easy assumptions about patient safety and potential environmental hazards, medical or non-medical.
ALLAN S. CUNNINGHAM 19 September 2019
Competing interests: No competing interests
One thing health officials urgently need to attend to is Christopher Exley's new paper 'An aluminium adjuvant in a vaccine is an acute exposure to aluminium' which uses as an example the aluminium exposure from Infanrix Hexa vaccine [1].
[1] Christopher Exley, 'An aluminium adjuvant in a vaccine is an acute exposure to aluminium', Journal of Trace Elements in Medicine and Biology, Available on-line 18 September 2019, https://www.sciencedirect.com/science/article/pii/S0946672X19304201?via%...
Competing interests: No competing interests
Like most doctors who have ever worked in public health, I am keen on MEASLES vaccination.
But, I am one of the few who would like to know the genetic types of the wild virus prevalent in ENGLAND and whether the vaccine virus in use here is able to produce immunity against the virus type most likely to attack the non-immune, non-vaccinated. Please note - there is a difference between the terms IMMUNE and VACCINATED.
Awaiting a clear answer.
Competing interests: No competing interests
This is something that's been close to my heart nearly all my life. Vaccines are there with the best intentions, but they can and do go wrong and can have life-destroying effects. The media are pushing hard to make these mandatory but are either misinformed or blatantly ignore the facts. Where there is a risk, there should be a choice. Simple as that. Mandatory vaccination does not fit in a democratic society. They are not 100% safe nor 100% effective, so who is to take responsibility if anything goes wrong? Are the drug companies willing to contribute to a fund to help families? Is it the responsibility of the tax payer? Or are we to just let the parents and families of damaged children bear the brunt of these devastating reactions?
Competing interests: No competing interests
By an ironic coincidence this article [1] is published on 17 September 2019 which is World Health Organization Patient Safety Day in which we are told that " No one should be harmed in healthcare" and citizens of the world are enjoined to "Speak up for patient safety!" [2]. This is something I have been doing for two decades, yet those who speak up over vaccine safety are relentlessly met with hostility and even persecution by the WHO, the mainstream media and the governments of the world - notably the British government, its politicians and its officials. While the evidence base for vaccine safety is highly problematic [3,4] there can also be no presumption that the people who speak up daily and in large numbers on social media are not telling the truth.
In all probability tens of millions of vaccine products are presently administered in the UK every year, yet to the best of my knowledge not a single instance of harm has ever been spontaneously acknowledged by the National Health Service or the British government. This is neither credible or conscionable.
It is World Health Organization Patient Safety Day and I am speaking up for patient safety. When people speak up for patient safety over vaccines as with anything else they surely deserve respect. There is no difference: why should there be?
[1] Elisabeth Mahase, 'Vaccination uptake: access is still biggest barrier, experts warn', BMJ 2019; 366 doi: https://doi.org/10.1136/bmj.l5576 (Published 17 September 2019)
[2] WHO, 'World Patient Safety Day 2017', https://www.who.int/campaigns/world-patient-safety-day/2019
[3] John Stone, 'Re: Response to John Stone (2019 Jul 24)', 29 July 2019, https://www.bmj.com/content/365/bmj.l4291/rr-37
[4] John Stone, 'Refusing public dialogue is not (a) sign of strength', 2 September 2019, https://www.bmj.com/content/366/bmj.l5219/rr-2
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Competing interests: No competing interests
Re: The Boiling Frog Principle: patient safety and vaccines
I am grateful to Allan Cunningham [1]. To illustrate the point last year the European Parliament press room reported [2]:
"MEPs say it is unjustifiable that the cost of a full vaccines package for one child is 68 times more expensive in 2014 compared to 2001."
while failing to note how much the schedule expanded. Off the top of my head we have had added to the UK childhood schedule since 2014 influenza vaccines, Meningitis B vaccine, Hepatitis B vaccine, HPV vaccine for boys. The MEPs' calculation may also not have included vaccines in pregnancy (influenza, DTaP). It is likely that cost of vaccinating a single child has escalated by now well beyond IO0 times since 2001. Whatever you think of Andrew Wakefield he surely put a finger on a raw industry nerve when he questioned the triple vaccine MMR in 1998. What would happen if people continued to think they could pick and choose?
The European Parliament did also express some caution:
"MEPs stress that increased transparency in evaluating vaccines and their adjuvants, in the funding of independent research programmes and the possible side-effects of vaccines would contribute to restoring confidence in vaccination.
" They point out that researchers must declare any conflict of interest. Those subject to a conflict of interest should be excluded from evaluation panels. The confidentiality of deliberations of the European Medicines Agency’s (EMA) evaluation panel should also be lifted, and scientific and clinical data be made public."
Nevertheless we may wonder how much governmental and institutional progress has been made in regard to these pious concerns in the intervening months (now exactly a year and a half ago).
[1] Allan S Cunningham, 'The Boiling Frog Principle: patient safety and vaccines', 19 September 2019, https://www.bmj.com/content/366/bmj.l5576/rr-3
[2] 'Health Committee MEPs warn against dropping vaccination rates', European Parliament Press Room 20 march 2018, https://www.europarl.europa.eu/news/en/press-room/20180319IPR00021/healt...
Competing interests: No competing interests