US government website for collecting adverse events after vaccination is inaccessible to most users
BMJ 2017; 357 doi: https://doi.org/10.1136/bmj.j2449 (Published 19 May 2017) Cite this as: BMJ 2017;357:j2449
All rapid responses
Dr Anand [1] may not have been aware of an earlier paper of which Dr Puliyel is also co-author [2]
'Polio programme: let us declare victory and move on'. This is the abstract:
"It was hoped that following polio eradication, immunisation could be stopped. However the synthesis of polio virus in 2002, made eradication impossible. It is argued that getting poor countries to expend their scarce resources on an impossible dream over the last 10 years was unethical. Furthermore, while India has been polio-free for a year, there has been a huge increase in non-polio acute flaccid paralysis (NPAFP). In 2011, there were an extra 47,500 new cases of NPAFP. Clinically indistinguishable from polio paralysis but twice as deadly, the incidence of NPAFP was directly proportional to doses of oral polio received. Though this data was collected within the polio surveillance system, it was not investigated. The principle of primum-non-nocere was violated. The authors suggest that the huge bill of US$ 8 billion spent on the programme, is a small sum to pay if the world learns to be wary of such vertical programmes in the future."
There may be a mighty assumption, for instance on the part of the western media, that resistance to WHO programmes is always ignorant or ill-informed, and we may misunderstand geo-politics as a result. I also note the paper by Oller et al 'HCG Found in WHO Tetanus Vaccine in Kenya Raises Concern in the Developing World'. There are legitimate questions to be answered, and some deeply troubling cultural dimensions to all of this. The WHO should be answerable to the world community, and not just stand on its dignity.
[1] JK Anand, 'Re: US government website for collecting adverse events after vaccination is inaccessible to most users. Puliyel and Naik’s views' 9 July 2018, https://www.bmj.com/content/357/bmj.j2449/rr-18
[2] Vashisht N & Puliyel J, 'Polio programme: let us declare victory and move on' Indian J Med Ethics. 2012 Apr-Jun;9(2):114-7. https://www.ncbi.nlm.nih.gov/pubmed/22591873
[3] Oller et al, '
HCG Found in WHO Tetanus Vaccine in Kenya Raises Concern in the Developing World', OALibJ> Vol.4 No.10, October 2017, https://www.scirp.org/Journal/PaperInformation.aspx?PaperID=81838
Competing interests: No competing interests
That the doctors in public health (in England) are silent, is understandable. Their spirit is in chains - the Department of Health likes people to be “on message”.
But there ARE academic public health physicians - and the universities do not gag staff (I believe).
Would they care to publish a rejoinder to Puliyel and Naik?
As for the WHO, of course it should propagate the facts. For if it doesn’t, its credibility will be in tatters. There are parts of this world where, reportedly, polio vaccinators’ lives are in jeopardy because of misinformation.
If, on totally unrelated vaccines, paediatricians like Puliyel are ignored by the WHO, by the academics, the sceptics’ voices will be strengthened,
Competing interests: No competing interests
More than a year since Puliyel and Legge [1] wrote to this column I note the new paper by Puliyel and Naik 'Revised World Health Organization (WHO)’s causality assessment of adverse events following immunization—a critique' [2]. Puliyel and Naik note:
"After licensure, deaths and all new serious adverse reactions are labelled as ‘coincidental deaths/events’ or ‘unclassifiable’, and the association with vaccine is not acknowledged. The resulting paradox is evident.
The definition of causal association has also been changed. It is now used only if there is ‘no other factor intervening in the processes'. Therefore, if a child with an underlying congenital heart disease (other factor), develops fever and cardiac decompensation after vaccination, the cardiac failure would not be considered causally related to the vaccine. The Global Advisory Committee on Vaccine Safety has documented many deaths in children with pre-existing heart disease after they were administered the pentavalent vaccine."
They note ironically:
"AEFI reporting is said to be for vaccine safety. Child safety (safety of children) rather than vaccine safety (safety for vaccines) needs to be the emphasis."
Is it not time the WHO explained themselves? Painting with a broad brush cannot excuse the iatrogenic harm on the way. These are real lives and they are not being respected.
[1] Puliyel &Legge, 'Re: Enhancing Community Confidence in Vaccines Safety' 10 June 2017, https://www.bmj.com/content/357/bmj.j2449/rr-6
[2] Puliyel & Naik, 'Revised World Health Organization (WHO)’s causality assessment of adverse events following immunization—a critique'. https://f1000research.com/articles/7-243/v2
Competing interests: No competing interests
If the fallout from the vaccine programme is unmeasured and damage common, where would this show? One answer might be the burden of special educational needs (SEN).
In an earlier Rapid Response I pointed to the possibility of a rate of 10,000 new cases of ASD in London a year based on a BBC report, which would represent around 10% of young children [1], no doubt falling heavily on the population of boys.
Yesterday, another statistic came my way. In an article in Schoolsweek from June we read [2]:
"Released last week, the government data shows pupils with special needs statements or Education Health and Care Plans who are waiting for a school place rose from 1,710 in 2016 to 4,050 this year – an increase of 2.3 times."
This is presumably for England. What might not be immediately obvious is that this not only a very large rise it is also a very large number. A similar rise next year would give an above 1% figure for all children entering the education system being on a waiting list for Special Educational Needs places, on top of those who are being accommodated within an already stretched system.
I also note the recently published study by Leslie et al [3]:
"Results...Subjects with newly diagnosed AN (anorexia nervosa) were more likely than controls to have had any vaccination in the previous 3 months [hazard ratio (HR) 1.80, 95% confidence interval 1.21–2.68]. Influenza vaccinations during the prior 3, 6, and 12 months were also associated with incident diagnoses of AN, OCD (obsessive compulsive disorder), and an anxiety disorder. Several other associations were also significant with HRs greater than 1.40 (hepatitis A with OCD and AN; hepatitis B with AN; and meningitis with AN and chronic tic disorder)."
But irrespective of specific causes we seem to have no health officials interested or concerned to investigate the swelling and unsustainable burden of SEN engulfing our society, which is fundamentally a medical problem loaded onto the educational and social systems.
[1] John Stone, 'US government website for collecting adverse events after vaccination is inaccessible to most users' 29 May 2017 http://www.bmj.com/content/357/bmj.j2449/rr-5
[2] Jess Stauffenberg, 'Pupils with special needs waiting for school place more than doubles', http://schoolsweek.co.uk/pupils-with-special-needs-waiting-for-school-pl...
[3] Leslie, Kobre, Richmand , Guloksuz, Leckman, 'Temporal Association of Certain Neuropsychiatric Disorders Following Vaccination of Children and Adolescents: A Pilot Case–Control Study', https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5244035/
Competing interests: No competing interests
I have always had great respect for Viera Scheibner's views and knowledge [1], but I would like to stress that I am coming at this matter from a different angle. I do not have any absolute views on vaccination, but I am a critic of the vaccine programme and the behaviour of the vaccine lobby, which has become absolutist and dictatorial. And one question I would ask - as European countries move to mandate hosts of vaccine products for infants - is what we know about this class of product which absolves virtually all them from ordinary public scrutiny or doubt?
The events which are engulfing this continent, not to mention Australia, are simultaneous with a complaint made to the European ombudsman about the conduct of the European Medicines Agency over HPV vaccines [2,3], and while the HPV vaccines may not presently be on the infant list or mandated the complaint does raise questions about safety and knowledge of the role of aluminium adjuvants which are also commonly used in such infant vaccines as Infanrix Hexa [4], Prevenar [5] and Bexsero [6] and by implication it poses questions about how all vaccines are monitored, and the objectivity of the regulators. And yet we have a position of apparent doctrinal infallibility and over-reaching powers enforced by governments with apparent zero understanding of the issues.
When it comes to MMR the position is no more satisfactory. Successive Cochrane Reviews of MMR safety have stated [7,8,9]:
"The design and reporting of safety outcomes in MMR vaccine studies, both pre- and post-marketing, are largely inadequate."
A pertinent question here is what these studies might have found if they had been "adequate" instead of "inadequate"? Why are their no better studies?
Beyond this there is the extreme intolerance by the lobby of anyone who raises any issues at all which might affect the reputation of their products, and pre-empts all reasonable discussion and scrutiny. They adopt a precisely opposite strategy to one which in normal human relations would raise confidence and trust. Meanwhile, the pressure for the eradication of dissent comes from the lobby and not spontaneously from the public [10]. Frankly, disaster beckons if we go on like this.
[1] Viera Scheibner, 'Re: US government website for collecting adverse events after vaccination is inaccessible to most users' 13 July 2017, http://www.bmj.com/content/357/bmj.j2449/rr-14
[2] Stephane Foucart http://www.lemonde.fr/planete/article/2016/12/09/papillomavirus-les-auto...
[3] Gøtzsche P, Jørgensen K, Jefferson J, Auken M , Brinth L, 'Complaint to the European ombudsman over maladministration at the European Medicines Agency (EMA) in relation to the safety of the HPV vaccines', http://nordic.cochrane.org/sites/nordic.cochrane.org/files/public/upload...
[4] http://ca.gsk.com/media/537989/infanrix-hexa.pdf
[5] https://www.medicines.org.uk/emc/medicine/22689#COMPOSITION
[6]http://www.medicines.org.uk/emc/medicine/28407/SPC/Bexsero+Meningococcal...
[7] Jefferson T, Price D, Demicheli V, Bianco E, 'Unintended events following immunization with MMR: a systematic review' 2003 https://www.ncbi.nlm.nih.gov/pubmed/12922131
[8] Demicheli V, Jefferson T, Rivetti A, Price D., 'Vaccines for measles, mumps and rubella in children', 2005 https://www.ncbi.nlm.nih.gov/pubmed/16235361
[9] Demicheli V, Rivetti A, Debalini MG, Di Pietrantonj C, ''Vaccines for measles, mumps and rubella in children', 2012.
[10] John Stone, 'The Shadow War on Disease: Arbitrary, Oppressive and Unaccountable medicine' , 9 July 2017, http://www.bmj.com/content/357/bmj.j2449/rr-13
Competing interests: No competing interests
The shadow war on disease: Arbitrary, oppressive and unaccountable medicine.
The biggest potential natural scourge of humanity is scurvy (Hess 1920). This is so because humans are primates who do not produce their own vitamin C unlike other animals and rely on its sufficient intake from the ingested food.
The staple diet in the medieval Europe (the Old World) was bread and some meat, no vegetables and fruit.
The resistance to infectious disease was low and hence infectious disease used to decimate the whole communities.
The mass urbanisation of the European cities from the poor agricultural areas starting in the late Middle Ages created masses of people living in squalor and crowded conditions, lack of hygiene, scurvic and malnurished.
Thanks to two horticultural revolutions (Hunger and history 1985), people started growing and consuming vegetables such as cabbage (and especially its fermented form sour kraut) for the markets and later on potatoes and tomatoes, all rich in vitamin C. The life expectancy went from 25 to 70 years and the general health vastly improved. Natural infectious diseases such as measles became mild diseases with low morbidity and mortality and others, such as smallpox, disappeared completely naturally.
The history of smallpox was characterised by the efforts of preventing it, which goes back to the old Egypt and variolation. Lady Montague brought variolation to England from Turkey (in 1718) and it was exploited by Edward Jenner in the late seventeen hundreds (Craig 2010). This practice was based on a mistaken effort to introduce the puss from the smallpox pustules into healthy people, which resulted in spreading smallpox and causing epidemics and the victims developing paralysis, as found in the Egyptian mummies of children.
Characteristically, the first outbreaks of paralysis in NewYork in the early years of the twentieth century occurred in the European immigrants. As they stepped of the rickety ships, hungry, mal- and undernourished and exhausted in New York Harbour, they were injected with smallpox vaccine. No wonder they became ill and many developed provocation paralysis, especially the children. There was no evidence of contagion (Bolduan 1916).
The on and off story of smallpox vaccination ended when the WHO decided to proclaim smallpox eradicated due to the role of vaccination in causing and spreading the disease. According to Arita and Gromyko (1982) the benefits of smallpox vaccination were outweighed by its dangers, and the vaccination could be discontinued.
There was a long pause in mass vaccination efforts until mid 1950s. The new era started with the mass vaccination against polio and measles.
In the mid fifties, the first, injectable, Salk polio vaccine was tested on 1.8 million American children. Within days reports of paralysis occurring in the vaccinated children hit the media (Francis Report).
This was the motivation behind developing the oral polio vaccine by Sabin. However, reports of paralysis occurring in children given the oral vaccine continued. A new term was introduced: VAPP, a vaccine associated paralytic poliomyelitis. Also, the disease was redefined; a disease with residual paralysis which resolves within 60 days changed into a disease with paralysis persisting for more than 60 days. Since more than 90% of cases resolve within 60 days, that seemingly eradicated poliomyelitis (Law 2010).
Measles vaccine was ready to be mass administered from 1963 in the US and gradually thereafter elsewhere. However, vaccination failed to eradicate measles by 1967 as promised by Langmuir (1962) and Sencer et al. (1967) and to this day, despite intensive (in the US mandatory) vaccination efforts.
Outbreaks of measles and all “vaccine-preventable” diseases in the fully vaccinated have continued.
Further menace appeared: cancers occurring in small children linked to SV40 simian virus, ongoingly contaminating polio vaccines (Kops 2000) and deadly bronchiolitis caused by chimpanzee coryza virus (renamed respiratory syncytial virus) and brain-eating amoebae misdiagnosed as meningitis (Scheibner 2012a,b,c.d).
In my opinion based on medical research, there are no vaccine advantages and all vaccination should be discontinued forthwith,
Presently, vaccination proponents are pushing for more and more mandatory vaccinations in many countries and even by the politicians whose own children were vaccine affected. When I suggest that they institute mandatory vaccination of all politicians, I meet with a resounding silence.
The same applies to the majority of journalists.
The politicians refuse to vaccinate themselves, but they are enforcing vaccination of children, while showing gaping ignorance of biology, natural sciences and bacteriology and virology, vaccines and immunology. In the 21st century, the ignorant people are making decisions about the health and lives of millions of people!
They nonsensically blame the healthy unvaccinated children for vaccine caused outbreaks in the vaccinated and the innocent parents and other carers for vaccine reactions.
Smith (2014) asked “Are some diets “mass murder”? I ask ”Are vaccines “mass murder”? The answer is, sadly, and reluctantly, “Yes”.
I agree with John Stone that we are not seeing a reasoned, tolerant debate, but an industry with ever more [deadly] products to market, exerting its muscle [brazenly] through a complicit government against a reluctant and justifiably increasingly sceptical [and justifiably concerned] public, while dumping all grave consequences on it. By compensating at least some [though not all vaccine-injured] they admit that vaccines are dangerous and even deadly. Such behaviour is unconscionable.
While they list serious vaccine injuries, including autism and deaths in product information, elsewhere they spread outrageous and calculated misinformation. They demonise innocuous and easily manageable natural infectious diseases which are beneficial by priming and maturing the immune system and represent developmental milestones.
Having measles prevents tumours, sebaceous skin diseases, immunoreactive diseases and degenerative diseases of bone and cartilage and heals renal and other diseases (Albonico et al.1990; Ronne 1985; Scheibner 2013; Humphries 2015 demonstrate the benefits of having natural measles).
Who could justify denying children such obvious and documented benefits of natural infectious diseases?
References
Hess. 1920. Scurvy, past and present. Lippincott, Philadelphia. 280pp
Scheibner 2012. Smallpox was declared eradicated, yet still infects humans today. Vaccinationcouncil.org. 4 February 2012.
Bolduan 1916. What we have learnt from the New York epidemic of poliomyelitis. Read before Annual Meeting of the Massachusetts Association of the Boards of Health, New York City.
Wyatt. 2011. The 1916 New York City epidemic of poliomyelitis: where did the virus come from? Open Vaccine Journal 4: 13-17.
Arita and Gromyko 1982. Surveillance of orthopox infection and associated research, in the period after smallpox eradication. Bull WHO; 60(3): 367-375.
Hunger and history. (Edited by Rotberg snd Rabb). 1985. Cambridge University Press, 325pp.
Craig. 2010. Smallpox vaccine: Origin of vaccine madness. Vaccinationcouncil.org.26.2. 2010: 10pp.
Francis et al. 1955. An evaluation of the 1955 poliomyelitis vaccine trials. Sponsored by National Foundation for infantile paralysis, April 12, 1955.
Law. 2012. Assaulting alternative medicine: worthwhile or witch hunt? BMJ rapid response;10 March 2012.
Langmuir 1962. Medical importance of measles. Am J Dis Childhood; 163: 54-56.
Sencer et al. Epidemiologic basis for eradication of measles in 1967. Public Health Reports; 82(3): March 253-256.
Kops. 2000. Oral polio vaccine and human cancer: a reassessment of SV40 as a contaminant based upon legal documents. Anticancer Res; 26:4745-4750.
Scheibner 2012a.b.c.d. Polio eradication:a complex end game. BMJ 2012.rapid responses 24August (a); 26 August (b); 27 August (c) and 3 August (d).
Girardi, Sweet and Hilleman. 1960. Factors influencing tumour induction in hamsters by vacuolating virus, SV 40. Proc Soc ExpBiol &Med; 109: 649-660.
Scheibner 2017. Measles in older children and adults. BMJ 2017; 356 doi: https://doi.org/10.1136/bmj.j426 (Published 16 February 2017),
Smith 2014. Are some diets “mass murder”? BMJ 2014;349 doi: https://doi.org/10.1136/bmj.g7654 (published 15 December 2014.
Albonico et al. 1990. Vaccination campaign against measles, mumps and rubella. A constraining project for a dubious future? Working group of doctors for selective MMR vaccination.
Ronne 1985. Measles virus infection without rash in childhood is related to disease in adult life. Lancet 5 January: 1-5.
West 1966. Epidemiological studies of malignancies of the ovaries. Cancer; July:1001-1007.
Scheibner 2013. Measles vaccines. Part II: Benefits of contracting measles. Vaccinationcouncil.org: 1-4.
Humphries 2013. Dissolvingillusions.com.
Competing interests: No competing interests
It might not be inappropriate to remark here on the extraordinary historical circumstances of this correspondence [1], and the events of the last days. On Wednesday a report in the Independent newspaper stated [2]:
"The BMA is calling for evidence to be submitted to the UK Government on “the potential advantages and disadvantages of childhood immunisation made mandatory under the law”."
However, I can find no evidence on the BMA's website that it made such a call or that the government is holding such a consultation - presumably no one would know who to write to. This was followed on Friday by a call in the Guardian to make vaccination compulsory [3]. Rather than suggesting we have an informed, reasoned public debate the editorial consisted of a rant against "anti-vaxxers", and there was a photograph protestors in Italy (of which I am told there are huge numbers) demonstrating against country's new laws, where the government has mandated 12 vaccines for infants and young children. In a somewhat similar vein last week that great bastion of liberty, The Spectator, published an article by Seth Berkley, CEO of Gavi, calling for vaccine industry critics, again labelled "anti-vaxxers" to be excluded from social media [4].
What we are not seeing is a reasoned, tolerant debate but an industry with ever more products to market [5] exerting its muscle through government against a reluctant and justifiably increasingly sceptical public.
The VAERS database is one of the great black holes in the middle of vaccine science. Since it was instituted in 1990 it has registered approximately 600,000 reports (in fact the number of reports has gone up by 3,575 since I wrote here on 26 May [6,7]. None of the reports gets accreditation as a genuine injury - in fact that never even happens if a case gets compensated, but because it is only a passive reporting database with little publicity it is probably only a small fraction of actual cases. The reality of vaccines is that they are messy products and their harms are never systematically followed up, while mainstream hostility and opprobrium is reserved for anyone who speaks up - which is one powerful means of biasing data collection. It should be stressed that at no point do public bodies, or even courts acknowledge vaccine injury as such. Moreover, in the United Kingdom the Department of Works and Pensions were recently found in the High Court to have been denying compensation claims employing flawed and logically absurd assessment criteria [8] which may go back to the founding of the Vaccine Damage Payment Unit in 1979.
In this regard it is dismaying watching all the strong arm tactics, which have nothing to do with evidence, and what seems to be no better bad faith bullying being used to elevate vaccine science to the status of global infallibility. This is a sinister and unwarranted development.
[1] Peter Doshi, 'US government website for collecting adverse events after vaccination is inaccessible to most users' BMJ 2017; 357 doi: https://doi.org/10.1136/bmj.j2449
[2] Katie Foster, 'France to make vaccination mandatory from 2018 as it is 'unacceptable children are still dying of measles', The Independent, 5 July 2017, http://www.independent.co.uk/news/world/europe/france-vaccination-mandat...
[3] Editorial: 'The Guardian view on vaccination: a matter of public health' , The Guardian 7 July 2017, https://www.theguardian.com/commentisfree/2017/jul/07/the-guardian-view-...
[4] Seth Berkley, 'Anti-vaxxers have embraced social media; we paying for fake news with real lives' Spectator Health 28 June 2017, https://health.spectator.co.uk/anti-vaxxers-have-embraced-social-media-w...
[5] ADITEC Project Description http://www.aditecproject.eu/about-aditec/project-description.html
[6] http://www.medalerts.org/vaersdb/findfield.php?TABLE=ON&GROUP1=AGE&EVENT...
[7] John Stone, 'Re: US government website for collecting adverse events after vaccination is inaccessible to most users', 26 May 2017, http://www.bmj.com/content/357/bmj.j2449/rr-3
[8] 'Ministers lose fight to stop payouts over swine flu jab narcolepsy cases', The Guardian 27 February 2017, https://www.theguardian.com/science/2017/feb/09/ministers-lose-fight-to-...
Competing interests: No competing interests
VAERS has only obfuscated understanding rates of vaccine-related injuries. Active safety studies with biomarkers are needed and diagnostics such as urine dipsticks for malondialdehyde are getting along in production for this kind of use. We have billions being spent on individualized medicine everywhere else but here in the administration of vaccines. It's an anethem to the Hippocratic oath to vaccinate people without an understanding of adversomics. If we are going to continue to ignore differential risks to individuals for vaccines while pursuing pharmacogenomics and tailored medicine everywhere else, then we should at least accurately document the injured in war on disease. Just as the DOD doesn't want concussion sensors on soldiers, the military of medicine at the CDC doesn't want to document reality in vaccine injury....and when they occasionally get close we find whistleblowers muzzled. Trust lost, never to be regained.
Competing interests: No competing interests
While I am sure everyone will be delighted that the VAERS website has been restored to working order, the wider issues of the fallout of the vaccine programme and its honest measurement, remain to be addressed. How can we just plough on when NDDSs are at unprecedented and unsustainable levels? I am sure there may be other contributory factors than the ever-expanding vaccine programme, but no one wants to look at any of them or even admit that the problem exists. Meanwhile, the statistics are real and the implications utterly terrifying.
Competing interests: No competing interests
Re: US government website for collecting adverse events after vaccination is inaccessible to most users - an apology
Mr Stone (today’s rapid response) is right. I apologise for having missed Vashisht and Puliyel’s paper in the Indian Journal of Medical Ethics.
The “non-polio” paralyses in the United Kingdom are worth the attention of academic virologists and those public health physicians who are not bound by the Official Secrets Act.
If I may suggest a starting point: April 1974.
The old MOs H had been exterminated and new animals called community physicians had been created. There were also medical officers of environmental health/proper officers for the control of notifiable disease. Confusing? Yes, to most people. Including doctors.
However, the virological laboratory services were still intact and they used to send specimens to Colindale.
Might I suggest that records of virus identification in non-polio paralytic disease be examined and published?
Competing interests: No competing interests