Vaccine Damage

Bulletin of the World Health Organization

Published online 21 March 2011

http://www.who.int/bulletin/volumes/89/5/10-081901/en/index.html


No-fault compensation following adverse events attributed to vaccination: a review of international programmes

Clare Looker a & Heath Kelly a

a. Victorian Infectious Diseases Reference Laboratory, Locked Bag 815, Carlton South, Vic., 3053, Australia.

Correspondence to Clare Looker (e-mail: Clare_Looker@hotmail.com).

(Submitted: 10 August 2010 – Revised version received: 01 February 2011 – Accepted: 03 February 2011 – Published online: 21 March 2011.)

Bulletin of the World Health Organization 2011;89:371-378. doi: 10.2471/BLT.10.081901


Arguments for schemes


Arguments supporting vaccine-injury compensation include political and economic pressures, litigation threats, increasing confidence in population-based vaccine programmes and ensuring sustainability of vaccine supply. However, compensation schemes are also based on underlying principles of fairness and justice.


If there is no formal compensation scheme, the only source of compensation is through the courts, usually under the law of tort. Tort law requires a claimant to prove that he or she has suffered a wrong due to another person’s negligence or deliberate harm. The problem with this process, in the case of vaccination, is that there is often no clearly negligent party. A court-based approach to compensation can be inequitable and unpredictable, resulting in high monetary awards for some, while those who do not seek legal recourse receive nothing.


In the USA, before 1987, those injured by vaccines had no choice but to take their chances in the court system and seek recovery for their injuries directly from the manufacturer.34 Without a compensation system, it became difficult for vaccine manufacturers to predict their exposure to lawsuits. Accordingly, manufacturers and their insurers increased prices based on worst-case estimates.35 This led to exponential price rises, vaccine shortages and a reduction in vaccine research. Furthermore, several small vaccine manufacturers left the market.35


A vaccine-injury compensation scheme removes the uncertainty of tort liability for manufacturers and provides a more fair, efficient and stable approach for injured parties. Litigation is an expensive and restricted avenue that is inaccessible for many vaccine recipients. Furthermore, compensation schemes avoid the polarization of drug companies against vaccine recipients through litigation and the associated negative media coverage.36


Many countries that have implemented compensation schemes have done so as an expression of community solidarity.4 Ethicist Michelle Mello argues that solidarity means members of a community do not bear the risks of vaccination alone.37 Vaccine injuries can be severe and complex, and are often suffered by children who require a lifetime of care and may not qualify for other benefits under accident insurance schemes.3 In a vaccination programme, the injured and uninjured pay unequal shares of the social cost of producing the social good of herd immunity.37 Mello argues that, in line with principles of fairness and solidarity, mechanisms are needed to prevent the uninjured (unintentionally) “free-riding” on the injured...

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History of the UK’s Vaccine Damage Payment Scheme

Jack-Ashley-006


The History of the UK’s Vaccine Damage Payment Scheme (Passed into Law in 1979)

Honorary Secretary of The Association of Parents of Vaccine Damaged Children, Writes:

'Just imagine that in 1962 you have been blessed with a happy, healthy baby daughter and that overnight she is transformed into one that could never be normal and who suffers permanent mental handicap and convulsions. Then as you sought explanations and challenged the Government's refusal of compensation, you were warned that you were damaging the vaccine programme and told to keep quiet. How, in that deferential age, would any woman react? Rosemary Fox refused to condone this lamentable ethos, defied convention and began a campaign for compensation.' 
Rt. Hon. Lord Ashley of Stoke, C.H.

***

Rosemary-Fox


Rosemary Fox MBE Writes:

History of the UK Campaign for Vaccine Damaged Children

On 31st January 1974 Jack Ashley MP, (later to become Lord Ashley of Stoke) made an historic speech in the House of Commons about children who had been damaged by routine immunisation programmes. It was historic because, although such damage had been recorded for at least 50 years, no Government had ever thought it necessary either to tell parents about the risk to some of their children, or to make some special provision for those who suffered damage as a result. Supporting Jack Ashley's speech in the House of Commons was a group of nearly 300 families (later to increase to 630) who formed The Association of Parents of Vaccine Damaged Children (The Association) to campaign for recognition of the sacrifice their children had made in the interests of public health, and to look for some special provision for them. Supporting Jack Ashley also were many Members of Parliament representing the families concerned. The Association's "Case for Compensation", which told of the tragedy which had befallen them and their children, had been widely distributed to Ministers and Members of Parliament. Their demands were simple - they wanted an acknowledgment that vaccination caused the damage to their healthy children and special provision over and above the existing State provision to enable them to provide a better standard of care.

The Royal Commission

Disquiet about thalidomide children at the time had resulted in the setting up of the Royal Commission on Civil Liability and Compensation for Personal Injury (Pearson) . The Association gave evidence to the Royal Commission about the need for special provision for vaccine damage. Their arguments were strongly supported by the leading Medical Associations and Royal Colleges involved in the study, following which the Commission recommended that "The Government should be strictly liable in tort for severe damage suffered by anyone as a result of vaccination recommended in the interests of the community". Liability in tort envisaged a settlement by the Court and generally covered cases claiming negligence but Pearson suggested that those who could show "on the balance of probabilities" that vaccination caused their damage should be entitled to compensation and subject to "these matters of causation and fact" there should be no defences.

The Ombudsman

Following the Royal Commission enquiry The Health Service Ombudsman also became involved when The Association reported complaints from a few parents whose children were wrongly immunised that they were not given enough information to make an informed choice and following a detailed study the Ombudsman issued a report confirming that the Department of Health had to"accept a large measure of responsibility .. for not recognising earlier the desirability of alerting parents, as they had now done." It was after this that leaflets giving parents details of the vaccines they were being offered for their children, with some reference to possible risk factors, began to be routinely available. Three vital components of the campaign led to the Government decision to make some recompense to vaccine damaged children for the injuries they had suffered in the interests of public health -

1) Jack Ashley's Parliamentary Campaign Speech on 31 January 1974

Vaccine 'Risk To Children' Telegraph 1/2/1974

2) The Report of the Parliamentary Commissioner for Administration (the Ombudsman) in October 1977 confirming the responsibility of the Department of Health for the proper organisation of immunisation

3) The Report of the Royal Commission on Civil Liability and Compensation for Personal Injury in March 1978.

http://hansard.millbanksystems.com/commons/1978/mar/16/civil-liability-royal-commissions-report

The Vaccine Damage Payment Act 1979

http://www.legislation.gov.uk/ukpga/1979/17/contents

Having considered all these reports the Government agreed that some recompense was due to vaccine damaged children. They set up "The Vaccine Damage Payment Scheme" in 1978 which was followed by the Vaccine Damage Payment Act in 1979 to pay £10,000 to each vaccine damaged child who had been damaged to the extent of 80%, claims had to be made within 6 years in order to qualify. The then Secretary of State David Ennals said while announcing the Act that "this was not the end" which provided the basis for an ongoing campaign for better provision, which was to last for 21 years until June 2000.

The very long delay from February 1979 to June 2000 in getting the payment increased was due to the Conservative Government's statement after their election in 1979 that all disabled people should be treated equally, whether - as they said - they were damaged by vaccination or damaged by disease because they had not been vaccinated. It was obvious from such a statement that Conservative Ministers understood little about the principles involved or the need to accept responsibility for injuries resulting from the health programmes which the State promoted. In addition to providing time for continuous letter lobbies to Members of Parliament, a number of whom made direct representations to the Government, the 21-year delay provided time for parents to look for other solutions, one of which was legal action.

Legal Action

A steering committee of Solicitors was set up by the parents and some Court cases went ahead, one in Ireland which was successful because there was evidence that the vaccine manufacturer (Wellcome) had distributed a batch of vaccine which was not properly tested; one in Scotland which failed and 2 at the High Court in London which not only failed but also produced the legal argument that proof of causation would be required before any legal action was likely to succeed. Since as yet no scientific formula for determining vaccine damage has been produced by medical scientists, these were the last cases to be heard. Since legal aid is no longer available for such cases [as at November 2007] there is unlikely to be any new development in the matter of compensation in the forseeable future.

The European Commission of Human Rights

Meanwhile it was thought that the European Commission of Human Rights might provide an answer and a case based on Article 2 of the European Convention - "protection of everyone's right to life" and Article 8 - "right to respect for private and family life" went to the Commission in August 1975. It was to take 3 years before the Commission replied that since there was no "intention to deprive people of their lives " Article 2 did not apply and neither did Article 8. The General Election in 1997 produced a Labour Government and gave the first hint of possible success for the parents' campaign. Frank Field MP was appointed Minister of State for Welfare Reform and in reply to an Association query he said that "the Government was well aware of the long-standing concern about vaccine damage and would examine the Payment Scheme critically in the light of these concerns". That was the breakthrough after which it was just a question of keeping up the pressure with the help of Members of Parliament.

Other Campaigns

At that very late stage one or two new campaigns began. A small group of parents who felt that The Association's Case for Compensation was not demanding enough started to talk about large lump sums of compensation for the families and annual large payments for those who were damaged, payments which they said should be made by the vaccine manufacturers as well as the Government. While such a campaign might be popular with many parents caring for their damaged children, it was important to stress that without proof of causation it would be impossible to launch any legal action and without legal action there would be little one could do to force anyone to listen to their demands. The Association was particularly concerned not to raise false hopes among parents who might be misled into thinking that large sums of compensation would be easily available. The vaccine manufacturers had been asked to help and had refused. The Government had made its offer and had no plans to increase it.

Vaccine Damage Payments

The statement from Frank Field was the breakthrough and from that statement onwards, constant letter lobbying of supporting Members of Parliament, Debates in the House of Commons and public lobbies attended by some of the parents kept pressure on the Government until finally in June 2000 Alistair Darling, Secretary of State, announced that the Payment would be increased to a total of £100,000 and would cover disability up to 60%. This would give a sum of £68,000 to those who had received the original £10,000 - the year 2000 value of which was worked out as £32,000. The office set up to deal with the payments is the Vaccine Damage Payment Unit. This office had dealt with payments under the 1979 Payment Act and has continued to deal with applications for the increased payment. Figures show that after the introduction of the increased payment there were 1020 applications, of which 362 related to claims originally refused because of the 80% disability rule and now able to claim again and 658 were new claims. The rate of success of all claims was very low - only 11 out of 753 claims succeeded and there is some evidence that the difficulty in obtaining medical records to support claims is one of the causes.

Payments are made under a Deed of Trust which sets out various examples of how the money could be spent or invested for the disabled person and the Trustees are given discretion. As most of the recipients of the Vaccine Damage Payment are in receipt of Disability, Mobility, Income Support and other allowances from their local DHSS offices, there was initial concern about how the Payment might affect these benefits. To deal with this the Vaccine Damage Payment Unit issued a leaflet for the information of the DHSS officers. This confirmed that provided the Payment was not being used to cover any of the benefits already covered by the DHSS payments, the Payment was to be ignored. This more than anything made it clear that it was a Top Up payment specifically designed to pay for anything the Parent/Trustees considered necessary to improve the life of their vaccine damaged child.

A number of the older vaccine damaged men and women (the scheme goes back to 1946) live in small community homes with caring staff and the cost of this provision can be up to £50,000 a year, including staff costs and housing costs. Families who have opted for such provision feel that there will be continuity of care and that when they die their "children" will be secure and well provided for. Where families continue to care for their vaccine damaged "child" at home they have social security payments but these would not cover extra help or respite care on anything like the scale of the provision in community homes and these parents naturally feel that they have been left to cope alone. Perhaps a more positive campaign to the Pharmaceutical Companies, whose products were after all the cause of the damage, would be to ask them to set up a Special Fund to which parents could apply for extra help, similar to the funds which are set up by various profitable businesses and corporations.

http://www.legislation.gov.uk/uksi/2002/1592/contents/made

Overview of the Campaign for Vaccine Damaged Children

For the first time in the UK hundreds of parents with children disabled by vaccination had the opportunity to discuss their fears and join in action to get special provision for them. For the first time also in the UK the principle of Government liability for injuries arising from its health promotion programmes was established. The responsibility of the Health Department to provide clear information to parents about vaccination and the vaccines in use was established. Although legal liability for vaccine damage was not established the campaign provided a wealth of legal opinion and argument for use in any new attempt to investigate the possibility of such action.

The Association's campaign did not look for the large scale compensation which some parents who wanted to set up their own permanent care arrangements felt should have been included. Neither did it target the vaccine manufacturers as it was felt that this would involve a lengthy legal action the success of which would depend on proof of causation. Pharmaceutical Companies could follow the lead of other Business Organisations by setting up a fund to which parents could apply for help. Neither did the campaign seek medical accident compensation which would have required evidence of negligence in the immunisation procedure. Association parents never thought that doctors were negligent. Rather they thought that the Government should have at all times taken steps to provide against the possibility of injury arising from its vaccination programmes.

The question now is whether there is anything more which can be done by those dissatisfied with the present arrangements. Without proof of causation of vaccine damage and proof of negligence there does not seem to be any possibility of successful legal action.

Further Information

For full details of the campaign for vaccine damaged children read "Helen's Story" by Rosemary Fox, published by John Blake, copies from WH Smith, Waterstones, or Amazon

http://www.amazon.co.uk/s/ref=nb_sb_noss?url=search-alias%3Dstripbooks&field-keywords=Helen%27s+story+by+rosemary+fox

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Pressure mounts for inquiry into MMR furore BMJ 2004; 328 doi: https://doi.org/10.1136/bmj.328.7438.483-a (Published 26 Febr…


How can vaccines cause damage?

29 February 2004

Alan Challoner MA (Phil) MChS, Retired. LL18 5UR

It seems to be unduly restrictive to keep any enquiry about Wakefield
and the MMR/Autism factor to his paper. What the public is demanding by
its concerns about the MMR vaccine and its possible ill effect on
children, is not only for research to be stepped up but also for previous
research to be compiled and analysed in an attempt to come to genuine
conclusions. By genuine I mean those that are not just subservient to
epidemiological policy of mass vaccination to create herd immunity.

Below are just a few examples of work that has been done. Much of is
probably not in public knowledge. Even more striking is the argument put
forward by the pro-vaccine adherents that there is no evidence that
vaccines cause harm.

How can vaccines cause damage?

No vaccine is perfectly safe. An adverse event can be said to be
caused by a vaccine (i.e., a true reaction) if it is associated with a
specific laboratory finding and a specific clinical syndrome or both.
Alternatively, a clinical or epidemiological study is needed to find out
whether the rate of a given syndrome in vaccinated individuals exceeds
that expected among unvaccinated controls.

Immune panels and other laboratory tests, medical histories, and the
supporting medical literature support a causal association, with increased
risks among those children who are sick or have recently been sick.

Vaccination may damage children in several ways. Live or attenuated
virus vaccination can actually produce the infection that the vaccine is
supposed to prevent.

A second mechanism of damage comes from neurotoxic materials found
sometimes in vaccines. Thimerosol is the most widely discussed, since it
contains mercury.

The third, and probably the most important theory of vaccine damage,
relates to allergic reactions and the development of an autoimmune
response, stimulated by the vaccine and its adjuvant. Vaccines always
contain adjuvants, which are substances known to amplify the body's
response to the vaccine. These adjuvants are known to sometimes cause
allergic and autoimmune responses on their own.

The US Center for Disease Control (as its name implies) represents
one answer to these questions, while the National Vaccine Information
Center (NVIC) champions the rights of individual families to refuse
vaccines. The NVIC makes a very important, sometimes neglected point:

"Vaccination is a medical procedure which carries a risk of injury or
death. As a parent, it is your responsibility to become educated about the
benefits and risks of vaccines in order to make the most informed,
responsible vaccination decisions."

A similar statement can be made about any medical procedure. There
area also possible, but unproven links between MMR vaccine and juvenile
diabetes multiple vaccines and autism, and OPV and Gulf War syndrome. Time
and further research will tell if these proposed relationships are real
[1]

The DPT Vaccine

There is a large amount of evidence showing that the DPT vaccines in
use up to the end of the 20th C., and still in use in some places, was the
cause of brain damage in some children.

As early as 1948, Randolph Byers and Frederick Moll, of Harvard
Medical School and the Federal Drug Administration, carried out tests on
DPT vaccines at Children's Hospital in Boston and concluded that severe
neurological problems could follow the administration of DPT vaccines. The
results of the tests were published in Pediatrics.

In 1976, Dr. Charles Manclark, a FDA scientist, remarked that "the
DPT vaccine had one of the worst failure rates of any product submitted to
the Division of Biologics for testing."

According to the testimony of the Assistant Secretary of Health,
Edward Grant, Jr., before a U.S. Senate Committee on May 3rd, 1985, every
year, 35,000 children suffer neurological damage related to the DTP
vaccine.

In 1990, a Workshop on Neurologic Complications of Pertussis and
Pertussis Vaccination [2] was convened. It concluded that pertussis
vaccines are not standardised between manufacturers, that vaccines are not
standardised by each manufacturer from one batch to another, that there is
no inherent difficulty in assigning cause and effect to the vaccine and
subsequent permanent neurological damage, that there was sufficient
experimental data to implicate both endotoxin and pertussis toxin in
adverse neurological reactions to pertussis vaccine, and that there was a
consensus between neurologists that the seizures following pertussis
vaccination could not accurately be described as "febrile convulsions"
because they are not necessarily benign. Incredibly, in the face of their
own conclusions, they released a report that concluded, "there is no
demonstrated association between DPT vaccination and SIDS, because sudden
death after pertussis vaccination is too rare to be detectable in the
context of presently available series." There are 10,000 cases of SIDS in
the United States each year. The conspiracy runs deep. In the 1990 Journal
of the American Medical Association an editorial clearly labelled vaccine-
induced encephalopathy "a myth", ironically accusing the American
Association of Pediatrics (AAP) "and other well-meaning physicians" of
"joining forces with parents groups and lawyers." Ironic, because the AAP
was the one who recommended in 1992 that babies in the United States
should be given five doses of pertussis vaccine. It is interesting how the
AAP changed their tune within two years. The end result of this insanity
led to the formation of the National Vaccine Injury Program.

Another bit of irony is that finally in 1992, the Institute of
Medicine admitted that, "the evidence is consistent with a causal relation
between DPT vaccine and acute encephalopathy, defined in the studies
reviewed as encephalopathy, encephalitis or encephalomyelitis, and the
evidence indicates a causal relation between DPT vaccine and anaphylaxis,
between the pertussis component of DPT vaccine and protracted,
inconsolable crying." In other words, brain damage in progress.

These are but a minuscule of the evidence available on the DPT
vaccine, but show just how evidence can be hidden from the general public
in the guise public protection issues.

DPT & Autism

Megson [3] proposed that autism is linked to the disruption of the G-
alpha protein, affecting retinoid receptors in the brain. A study of sixty
autistic children suggested that autism could be caused by inserting a G-
alpha protein defect, particularly the pertussis toxin found in the D.P.T.
vaccine, into genetically at-risk children. This toxin separates the G-
alpha protein from retinoid receptors. Those most at risk report a family
history of at least one parent with a pre-existing G-alpha protein defect,
including night blindness, pseudohypoparathyroidism, or adenoma of the
thyroid and/or pituitary gland.

Megson proposed that natural vitamin A could reconnect the retinoid
receptors critical for vision, sensory perception, language processing and
attention.

Megson proposed that treating autistic children with natural cis -
forms of Vitamin A could have the effect of reconnecting the hippocampal
retinoid receptor pathways, critical for vision, sensory perception,
language processing and attention.

Megson noted that many autistic children needed natural, unsaturated
cis forms of Vitamin A found in sources such as cold water fish (salmon,
or cod liver), kidney, and milk fat, foods not commonly available in the
modern diet. Instead, children depend on Vitamin A Palmitate, found in
commercial infant formula and low fat milk. Unfortunately, absorption of
Vitamin A Palmitate requires an intact gut mucosal microvilli surface at
the right pH, in the presence of bile for metabolism. Since many autistic
children already had damaged mucosal surfaces due to unrecognized wheat
allergy or intolerances, their capacity to absorb vitamin A is
questionable.

Megson also argued that live viral measles vaccine depleted children
of their existing supply of Vitamin A, negatively impacting retinoid
receptors. Natural Vitamin A, in the cis form, is important for activation
of T and B cells for long-term immune memory. Measles, mumps and rubella
titers are either significantly elevated or negative, in spite of one or
two doses of the vaccine given to many of these children. Fish oils
contain one retinoid metabolite, alpha 14 hydroxyretroretinol that has a
role in T-cell activation, vision and growth of lymphoblasts.

The MMR and other vaccines

T. Zecca , et al. at the New Jersey Medical School's Children's
Hospital of New Jersey in Newark compared rubeola virus in autistic and
normal children. Among 16 children diagnosed with autism followed in their
clinical practice, they found a 3-fold increase in rubeola titers over
expected normal range. A Wilcoxon Kruskal Wallas test comparing 13 rubeola
titers from normal children revealed a statistically significant p-value
of 0.005.

The following facts are significant:

a) The incidence of Autism has increased significantly in the last
decade.
b) There is every reason to believe that this trend will continue.
c) No one has proved that MMR vaccine plays a role in autism.
d) No one has proved conclusively that it does not.
e) Serious studies by independent researchers are desperately needed, to
look into all aspects of this dreadful disease. [4]

Until recently, most vaccines presented antigens according to the
same principals as they were 200 years ago- when vaccines consisted of the
whole micro-organism, alive or killed. The new generation of vaccines
contains other defined antigens, called "subunit vaccines". Newly
developed genetic technology gives us the means to produce the defined
antigen in large enough amounts to generate a low price.

However, accessory technologies are required to make these defined
antigens immunogenic, including new approaches for the optimum physical
presentation of the antigen and the addition of adjuvants. An effective
adjuvant formulation provides the antigen with both an optimal physical
presentation and a boost to create immune recognition and reaction. A
construction aimed at fulfilling these requirements is called an ISCOM, or
"immuno-stimulatory complex". [5]

The concept of immuno-modulation is also important to modern
vaccination principles. It includes the induction of specific antibodies
of desired isotypes and IgG subclasses, the induction of selected T-helper
cell responses as classified by the resulting cytokine production, the
induction of cytotoxic T-cell responses, and the distribution of the
immune response to various lymphatic sites - for example, mucosal
surfaces. Any of these factors may be important to obtain protective
immunity - the ultimate goal for a vaccine.

In addition to the efficacy of eliciting a protective immune
response, there is concern about the toxicity of adjuvants. A number of
adjuvants evoke strong immune responses, and are widely used in research,
but are unsuitable for human and animal vaccines because of these toxic
side effects. Several substances have been tried for adjuvant activity and
safety. Still, even today, adjuvants and adjuvant formulations, which
combine both immuno-enhancing capacity and low toxicity, are lacking.

[1] http://www.healing-arts.org/children/vaccines/index.htm#return

[2] http://www.vaclib.org/basic/trufax/v6.html

[3] Megson, M. N. Is autism a G-protein defect reversible with
natural vitamin A? Unpublished research available from Dr. Mary Megson,
7229 Forest Ave, Suite 211, Richmond, VA 23226.

[4] F. Edward Yazbak, MD, FAAP. Pro & Con Research on MMR, Autism
Connection Compared.
http://www.healing-arts.org/children/autism-
overview.htm#MMR%20Vaccine%20and%20Autism

[5]Uppsala University, Sweden. Uppsala Biomedical Centre. Vaccine
Research at the Virology Department.

Competing interests:
Father of vaccine damaged daughter

Competing interests: No competing interests


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jackie@jabs.org.uk © John Fletcher 2012