Category Archives: Complaints

Complaint to the Speaker of NZ Parliament Concerning the Health Select Committee Report

On June 13, 2011 a complaint relating to factual errors and omissions in the Report of the Health Select Committee (following its Inquiry into how to improve immunisation completion rates) was sent by email to the Speaker of the New Zealand parliament Dr The Right Honourable Lockwood Smith.

The complaint was also copied to the Attorney General Christophen Finlayson and the Auditor General Lyn Provost.

An acknowledgment that the complaint has been received has bee received from the executive assistant to the Speaker and from the health sector manager of the Office of the Auditor General.

On June 17,  the following reply was received from the Speaker:

 

Dear Ms Smith

Thank you for your email of 14 June regarding the Health Committee’s report on its inquiry into how to improve completion rates of childhood immunisation.

The conduct of a select committee is a matter for the committee to determine. The Speaker has no authority to investigate the process followed by a committee or the nature of its report.

If you wish to raise your concerns about the inquiry then you should do so with the Health Committee. The committee can be written to as follows:

Health Committee
c/- Clerk of the Committee
Parliament Buildings
WELLINGTON 6160

Alternatively, you can email your concerns to select.committees@parliament.govt.nz and they will be forwarded to the committee.

My kind regards.

Yours sincerely

Dr The Rt Hon Lockwood Smith
SPEAKER

 

 

 

The complaint is below:

 

Katherine Smith
PO Box 44-128
Point Chevalier
Auckland 1246

To the Right Honourable Lockwood Smith, Speaker of the House

Dear Sir,

I would like an investigation into the Report of the Health Select Committee Inquiry into how to increase immunisation completion rates.  There are a number of significant problems with the Report, as detailed below:

1)  The names of most of the people/organisations that contributed written and/or oral submission to the Inquiry are not included in the Report.  Neither is there any sort of summary of key concerns and/or recommendations of any of these people/organisations with the exception of a select few, as detailed below.  This conceals the fact that the Report does not represent a large body of the evidence presented to it.

2)  The Report lacks referencing. Despite the fact that the Inquiry concerned a medical topic (vaccination) for which there is an abundance of peer reviewed medical and scientific literature, there is no referencing to any studies from peer reviewed journals in the entire Report.  Moreover, when the Report is reporting on information presented to it, there is frequent use of the term “we have been told” but no attempt to identify to person/organisation upon whose testimony the author(s) of the Report are relying.  This makes it impossible for the reader to follow up for themselves any statements that may appear to be inaccurate by following up by reading the written submissions provided by that person/organisation. Occasionally a few submitters are mentioned by name – such as Dr Nikki Turner who works for the Immunisation Advisory Centre (IMAC) – but this is the exception rather than the rule.

3)  The Report lacks concern about potential conflicts of interest on the part of people/organisations providing submissions. The Immunisation Advisory Centre (IMAC) of which Dr Nikki Turner is the Director that used to include the logos for five major vaccine companies on its website which it acknowledged as sponsors. (This website page can be emailed upon request.)  This acknowledgment was removed from the site after it was publicised.  The site now acknowledges the Ministry of Health as a major funder but also that the organisation receives “minimal funding” from “private industry” – presumably pharmacetical companies. [http://www.immune.org.nz/?t=1021]IMAC declares that despite receiving funding from “private industry” it does not have any conflict of interest, but this is contestable.  The Report states that it was “very impressed with Dr Nikki Turner’s “Six star plan” to increase vaccination rates.  It does not acknowledge  Dr Turner’s employment by an organisation that receives funding from “private industry”.

4) The report contains significant factual errors/omissions as detailed below:

NB: Text in blue is copied from the Report.  Text in black is my commentary.  Links to references are underlined.

The benefit of immunisation

We heard about the many benefits that immunisation brings to individuals, and to the New Zealand population which include:

* individual immunity
* herd immunity
* lower healthcare costs

Comments:

Individual immunity: While in some cases vaccination does appear to provide at least temporary immunity against some infections, during the course of the Inquiry, the Health Select Committee also heard about the harm that vaccination has caused to individuals.  In developing vaccination  policy, the risk of harm from vaccination must be weighed against the potential benefits.

Herd immunity: During the course of its Inquiry into increasing vaccination rates, the Health Select Committee was presented with evidence that suggests that the theory of “herd immunity” is faulty, as there are numerous instances of outbreaks of so-called “vaccine preventable” illnesses among highly vaccinated populations.    The Report from the Inquiry makes no mention of this but presents herd immunity as if it were a proven benefit.

Here are a few examples from the medical literature that show that high vaccination rates do not necessarily create “herd immunity”.  (The Health Select Committee was presented with substantially more evidence than this small sampling.)

* “Despite high vaccination levels, explosive measles outbreaks may occur in secondary schools due to 1) airborne measles transmission, 2) high contact rates, 3) inaccurate school vaccination records, or 4) inadequate immunity from vaccinations at younger ages.”

– Chen RT, Goldbaum GM, Wassilak SG, Markowitz LE, Orenstein WA. An explosive point-source measles outbreak in a highly vaccinated population. Modes of transmission and risk factors for disease.  Am J Epidemiol 1989 Jan;129(1):173-82

* “An outbreak of measles occurred in a high school with a documented vaccination level of 98 per cent.”

–  Nkowane BM, Bart SW, Orenstein WA, Baltier M. Measles outbreak in a vaccinated school population: epidemiology, chains of transmission and the role of vaccine failures.  Am J Public Health 1987 Apr;77(4):434-8

* “This outbreak demonstrates that transmission of measles can occur within a school population with a documented immunization level of 100%.”

–  Measles outbreak among vaccinated high school students, Illinois.  MMWR Morb Mortal Wkly Rep 1984 Jun 22;33(24):349-51

The fact that vaccinations often fail to prevent infections is tacitly acknowledged by the medical system by increasing the number of shots for a specific disease in the hope that this will improve their efficacy. (Even if this strategy proves ultimately fruitless, which it probably will, adding additional doses of vaccine benefits manufacturers as they sell product.)  In the case of measles, for instance, these (and similar) reports of vaccine failure led to the recommendation that children receive two shots of measles vaccines, rather than one.  (Currently in NZ, children are recommended to have one MMR vaccine at the age of 15 months followed by a second MMR at 4 years.)

Similarly, NZ children whose parents choose to following Ministry of Health recommendations will now receive four doses of a vaccine against pertussis, five doses of inactivated  polio vaccine (up from four in 2004).

To quote from a study on pertussis vaccination:

“Not even countries with immunisation rates of 90-95% have managed to eradicate pertussis or prevent disease in infants below the age of immunisation.”

Acta Paediatr Scand. 1984 Jul;73(4):417-25.
These examples should suffice to demonstrate the “herd immunity” supposedly conferred upon a population by high vaccination rates does not necessarily prevent cases of “vaccine preventable” disease – even in those who are vaccinated.

Moreover, even if it were possible to eliminate all cases of vaccine-preventable diseases, the  subgroups within childhood population who are at most risk of developing infections would still suffer ill health – caused by exposure to other microorganisms and the deprived circumstances in which they live.  It is significant that many of the microbes against which NZ children are routinely vaccinated such as pneunoccocus, diptheria, haemophilus influenzae and until recently meningoccocal B infections can be carried in the nasopharynx without causing disease. In a healthy individual the immune system is quite capable of  keeping these potentially pathogenic organisms – and many more – in  check.  A focus on infection prevention that primarily relies on vaccinations (even if those vaccinations were 100% effective – which they are not) is inadequate because children living in poor conditions will remain vulnerable to infections caused by other microorganisms due to inadequate nutrition, clothing, housing etc.

Lower Healthcare Costs: The Health Select Committee Report claims that vaccination can result in “lower healthcare costs” – without providing any sort of reference for this claim.  However, vaccination can increase the risk of some chronic conditions that are expensive to treat.  Asthma, associated with pertussis vaccination is the leading cause of hospitalisation for NZ children, according to the Asthma Society. (One in four NZ children has asthma.)  Regressive autism (often accompanied by bowel disease) is another vaccine-linked condition that is likewise debilitating and expensive to assess and treat (as well as straining the special education budget.) Diabetes, also linked to vaccination, is likewise expensive.

Asthma:
The following link is to a NZ study which found a 23% rate of asthma in vaccinated children compared to 0% asthma rate in un-vaccinated children.
http://www.ncbi.nlm.nih.gov/pubmed/9345669

Autism: Links to scientific papers concerning autism and vaccination may be found at the following URL:
http://www.callous-disregard.com/research.htm

Diabetes:  Vaccination has been shown to increase the risk of both type 1 and type 2 diabetes: http://www.vaccines.net/1TOPEDJ.pdf
http://www.vaccines.net/newpage11.htm

These are just a small sampling of the evidence that demonstrates the potential of vaccination to cause health problems and add to health care costs.  Vaccination has also been linked to many other serious conditions including demyelinating diseases such as multiple sclerosis. (See:  http://www.ncbi.nlm.nih.gov/pubmed/10430433 )

Without an honest acknowledgement of the burden of chronic disease caused by vaccination, and an attempt to assess the costs of  providing medical care (and other services that may be required such as special education, social welfare support, state housing etc) to people whose health has been damaged by vaccination, it is impossible to know whether or not NZ’s vaccination policy is actually lowering healthcare costs – or increasing them.  There is no evidence in its Report that the Select Committee attempted to do any sort of assessment of the medical costs due to vaccine injury before making the statement that one of the benefits of vaccination is “lower healthcare costs”.

To continue to quote from the Report:

Immunisation against specific diseases

Measles

We understand that if immunisation against measles ceased, measles infection would be expected to increase to pre-vaccine levels. The Immunisation Advisory Centre estimates that this would result in between 5,000 and 6,000 hospitalisations for measles, and 20 to 60 deaths annually.

Comment:  Deaths from measles were very low even before the single measles vaccine was introduced to the NZ schedule in 1969, as may been seen from the graph at this link:
http://www.beyondconformity.org.nz/_literature_85243/Disease_Decline_Measles_deaths_graph

Moreover, the risk of mortality from measles could be significantly reduced if intravenous vitamin C were used to treat the disease in children who were not coping normally with this usually mild-moderate infection. Measles is listed in Curing the Incurable by Thomas Levy, MD (ISBN 1-4010-6963-0 ) as being “Curable and Preventable” with vitamin C and includes some of Klenner’s case histories including that of an uneventful recovery of a child suffering from measles encephalitis (inflammation of the brain).  Prompt treatment of encephalitis, regardless of the cause, is important since the condition may result in death or survivors may be brain damaged.

For more information on the use of IVC in infections see: http://orthomolecular.org/library/jom/1999/articles/1999-v14n03-p143.shtml
Table 1: Measles disease and vaccine risks

Disease

A highly contagious viral illness causing fever, cough, and rash

Comment: This is essentially correct although conjunctivitis is also a common symptom.

Risks of disease
Otitis media (7 percent) Pneumonia (6 percent) Acute encephalitis (0.1
percent)

Comment: These are commonly cited figures for complications of measles infections. However, without any references it is difficult to say whether or not this is accurate.

Subacute sclerosing panencephalitis (one per 100,000)

Comment: This is another unreferenced assertion. On page 19 of its booklet “Childhood Immunisation” [ISBN: 978-0-478-19201-8] the NZ Ministry of Health cites a figure of 1-4 cases of SSPE per 100,000; however the  Ministry of Health does not include references in the information materials they prepare for parents.  However, without references it is difficult to know which of these two figures is more accurate.

Case fatality rate of one to two per 1,000

Comment: This is another unreferenced figure.  I would be interested to know the source. According to the Ministry of Health’s own Immunisation Handbook (2006) In the last large measles epidemic in NZ, there were an estimated 40-60,000 cases and seven reported deaths.  This represents a considerably lower risk of death from measles than the 1-2 per 1000 cited above.  In the 1997 measles epidemic there were more than 2000 cases and no deaths.  The claim of a case fatality rate of 1-2 per 1000 does not appear to be accurate for modern NZ conditions.
Maternal measles associated with an increased risk of premature labour, miscarriage, and low-birth-weight infants


Comment:
This is accurate.  However  prior to mass vaccination, maternal measles was very rare as most women had had a natural measles infection in childhood and thereby usually developed lifelong immunity.

Risks of vaccine

Mild local or systemic reaction (14.2 percent)
Aseptic meningitis (one per
100,000)
Encephalitis (one per million)
Anaphylaxis (<1 per million)

Comment: These are again unreferenced figures so it is difficult to know how much credence to give most of them.

However, the figure of fewer than 1 per million for anaphylaxis (life threatening allergic reaction) is demonstrably wrong.  For primary MMR vaccination, according to the British Medical Journal, the risk of anaphylaxis is one in 20,000.  (See: Cuts F. Revaccination against measles and rubella. BMJ 1996: 312:589-590 )

For children receiving a booster dose of the vaccine, the risk of anaphylaxis appears to be much higher again. School age children vaccinated in  New York reported that five children of 2,789 who had received an MMR booster shot developed anaphylaxis. (Fortunately all survived thanks to the timely administration of epinephrine and diphenylhydramine.)  This equates to an anaphylaxis rate of 1 in 558 children. This is a far cry from less than 1 in 1,00,000. (See:  Kalet A, Berger, DK, Bateman WB, Dubitsky J, Covitz K Allerigc reactions to MMR vaccine Pediatrics 1992; 89: 168-9 )

To continue to quote from the Report:

Rubella

We were told that stopping rubella vaccination in New Zealand would reduce the population’s immunity. Pregnant women would then be at risk of contracting rubella and passing congenital rubella syndrome on to their infants.

Table 2: Rubella disease and vaccine risks

Disease

A highly contagious viral illness causing fever, rash, lymphadenopathy, and foetal malformations

Risks of disease

85 percent of infants infected during the first trimester of pregnancy will be born with some type of birth defect, such as deafness, eye defects, heart defects, and mental retardation, among others.
One in two adolescents and adults have arthralgia
One in 6,000 develop encephalitis

Comment:  It is true that rubella infections during pregnancy carry a serious risk of birth defects for the baby.  However, prior to mass vaccination, congenital rubella syndrome was rare because most women had had a natural rubella infection during childhood and were therefore immune to the infection as adults.

Risks of vaccine

Mild local or systemic reaction (14.2 percent)
Aseptic meningitis (one per
100,000)
Encephalitis (one per million)
Anaphylaxis (<1 per million)

Comment: In NZ, the MMR (measles, mumps, rubella) vaccine is used for those who want to be vaccinated against measles and rubella, so it is instructive to look at the potential side effects of the MMR vaccine most commonly used in NZ as details on the manufacturer’s datasheet.  A brief look at the list of adverse effects reported after MMR vaccination shows how the tables relating to both measles and rubella vaccination side effects in the Report of the Health Select Committee’s Inquiry has omitted most of the potential side effects of the MMR vaccine usually used in NZ.  Omitted adverse effects are underlined and highlighted in red.

The following list is from the datasheet for the vaccine MMR-II manufactured by MSD.

“Common

“Burning and/or stinging of short duration at the injection site.

“Occasional

“Body as a whole: Fever (101°F [38.3°C] or higher).

“Skin: Rash, or measles-like rash, usually minimal but may be generalised. Generally, fever, rash, or both appear between the 5th and the 12th days.

“Rare

“Body as a whole: Mild local reactions such as erythema, induration and tenderness; sore throat, malaise, atypical measles, syncope, irritability.

“Cardiovascular: Vasculitis

“Digestive: Parotitis, nausea, vomiting, diarrhoea.

“Haematologic/Lymphatic: Regional lymphadenopathy, thrombocytopaenia, purpura.

“Hypersensitivity: Allergic reactions such as wheal and flare at injection site, anaphylaxis and anaphylactoid reactions, as well as related phenomena such as angioneurotic oedema (including peripheral or facial oedema) and bronchial spasm, urticaria in individuals with or without an allergic history.

“Musculoskeletal: Arthralgia and/or arthritis (usually transient and rarely chronic [see below]), myalgia.

“Nervous/Psychiatric: Febrile convulsions in children, afebrile convulsions or seizures, headache, dizziness, paresthesia, polyneuritis, polyneuropathy, Guillain-Barré syndrome, ataxia, aseptic meningitis (see below) measles inclusion body encephalitis (MIBE) (see “Contraindications). Encephalitis/encephalopathy have been reported approximately once for every 3 million doses. In no case has it been shown that reactions were actually caused by vaccine. The risk of such serious neurological disorders following live measles virus vaccine administration remains far less than that for encephalitis and encephalopathy with wild-type measles (one per two thousand reported cases).

“Respiratory System: Pneumonia, pneumonitis (see Contraindications), cough, rhinitis.

“Skin: Erythema multiforme, Stevens-Johnson syndrome, vesiculation at injection site, swelling, pruritis.

Special senses: Forms of optic neuritis, including retrobulbar neuritis, papillitis, and retinitis; ocular palsies, otitis media, nerve deafness, conjunctivitis.

“Urogenital: Epididymitis, orchitis.

“Other: Death from various, and in some cases unknown, causes has been reported rarely following vaccination with measles, mumps, and rubella vaccines; however, a causal relationship has not been established in healthy individuals (see Contraindications). No deaths or permanent sequelae were reported in a published post-marketing surveillance study in Finland involving 1.5 million children and adults who were vaccinated with M-M-R II during 1982 to 1993.

“Arthralgia and/or arthritis (usually transient and rarely chronic), and polyneuritis are features of infection with wild-type rubella and vary in frequency and severity with age and sex, being greatest in adult females and least in prepubertal children.

“Chronic arthritis has been associated with wild-type rubella infection and has been related to persistent virus and/or viral antigen isolated from body tissues. Only rarely have vaccine recipients developed chronic joint symptoms.

“Following vaccination in children, reactions in joints are uncommon and generally of brief duration. In women, incidence rates for arthritis and arthralgia are generally higher than those seen in children (children: 0-3%; women: 12-20%), and the reactions tend to be more marked and of longer duration. Symptoms may persist for a matter of months or on rare occasions for years. In adolescent girls, the reactions appear to be intermediate in incidence between those seen in children and in adult women. Even in older women (35 to 45 years), these reactions are generally well tolerated and rarely interfere with normal activities.

“Post-marketing surveillance of the more than 200 million doses of M-M-R and M-M-R II that have been distributed worldwide over 25 years (1971 to 1996) indicates that serious adverse events such as encephalitis and encephalopathy continue to be rarely reported.

“There have been reports of subacute sclerosing panencephalitis (SSPE) in children who did not have a history of infection with wild-type measles but did receive measles vaccine. Some of these cases may have resulted from unrecognised measles in the first year of life or possibly from the measles vaccination. Based on estimated nationwide measles vaccine distribution, the association of SSPE cases to measles vaccination is about one case per million vaccine doses distributed. This is far less than the association with infection with wild-type measles, 6-22 cases of SSPE per million cases of measles. The results of a retrospective case-controlled study conducted by the Centres for Disease Control and Prevention suggest that the overall effect of measles vaccine has been to protect against SSPE by preventing measles with its inherent higher risk of SSPE.

“Cases of aseptic meningitis have been reported following measles, mumps, and rubella vaccination. Although a causal relationship between the Urabe strain of mumps vaccine and aseptic meningitis has been shown, there is no evidence to link Jeryl LynnTM mumps vaccine to aseptic meningitis

“Panniculitis has been reported rarely following administration of measles vaccine.”

Source:  http://www.medsafe.govt.nz/profs/Datasheet/m/MMRIIinj.htm

Comment: MSD does not list autism as a possible adverse effect following MMR vaccination – possibly because this might expose the company to lawsuits from families in which previously healthy, normal  children have developed autism following MMR vaccination.  However there is considerable evidence that MMR vaccination may contribute to autism in some children.

To quote from one study:“These results show that primary pediatric MMR vaccination in children is associated with a marked increase in serious neurological disorders in comparison to DTwcP vaccination.  The increase is statistically significant for cerebellar ataxia, autism, mental retardation and permanent brain damage following primary pediatric MMR vaccination in comparison to DTwcP vaccination. The results are remarkable considering that DTwcP vaccination has been found by the scientific and medical communities to be responsible for permanent neurological sequalae in children.”

http://image.guardian.co.uk/sys-files/Society/documents/2003/05/20/MMRresearch.pdf

References to studies that discuss the biological basis for the development of autism following MMR vaccination may be found at the following links:

http://www.springerlink.com/content/l8020r2547565j37/
http://www.ncbi.nlm.nih.gov/pubmed?term=12145534

http://www.callous-disregard.com/research.htm

There is not one mention of autism in the entire report of the Health Select Committee even though vaccine-induced autism is blighting the lives of many NZ children and their families – and two mothers whose formerly normal children developed autism following vaccination took the time to share their experiences with the Health Select Committee – both in writing and in person.

Quoting from the Report again:

Pertussis

We understand that if the vaccination programme against pertussis (also known as whooping cough) were stopped pertussis would be likely to rise to pre-immunisation levels.

Table 3: Pertussis disease and vaccine risks

Disease

A highly contagious bacterial infection causing whooping cough and vomiting

Risks of disease

90 percent risk of contracting pertussis for non-immune infants
20 percent of all adults and adolescents being infected at any one time
0.1—-0.3 percent risk of permanent neurological damage for patients with paroxysmal cough
Case fatality of 0.05 percent in hospitalised infants

Comment: These figures are again unreferenced so there is no way of checking their accuracy.  However, assuming that the statement “20 percent of all adults and adolescents being infected [with pertussis] at any one time” is correct, this shows that vaccination programmes have not been successful in preventing the disease, since most of these adolescents and adults will have been vaccinated in childhood.


Risks of vaccine

Mild local or systemic reaction (0.8—62 percent)
Rare serious adverse events: severe local reaction (0.8—-8.0 percent)
Convulsions (0.00007 percent)
Persistent screaming
(<0.005 percent)
Hypotonic hyporesponsive episode (<0.003 percent)
Anaphylaxis (<0.00001 percent)

Comment: Again these are unreferenced figures so it is hard to know how much credence to give them.  They do differ from figures in the booklet “Immunisation Choices” which states that “In overseas trials of acellular pertussis [vaccine] less than one and up to two recipients per 10,00 had fits or ‘shock-collapse’”

In NZ, children whose parents choose vaccination are now routinely given a combination shot called Infanrix-Hexa which contains antigens for pertussis, diptheria, tetanus, hepatitis B, haemophilus influenzae and polio at the ages of six weeks, three months and five months.

The following information is quoted from the datasheet of Infanrix-hexa which can be downloaded from Medsafe’s website at  the following link: http://www.medsafe.govt.nz/profs/Datasheet/I/Infanrixhexainj.pdf

Information highlighted in red and underlined are side effects of the vaccine that were not disclosed in the section of Pertussis vaccine side effects in the Report prepared following the Health Select Committee’s Inquiry into how to increase vaccination completion rates.

“Undesirable effects

“Clinical trials:

“The safety profile presented below is based on data from more than 16,000 subjects. As has been observed for DTPa and DTPa-containing combinations, an increase in local reactogenicity and fever was reported after booster vaccination with Infanrixhexa with respect to the primary course. Frequencies per dose are defined as follows:

“Very common:   10%                          Common:          1% and < 10%
Uncommon:        0.1% and < 1%         Rare:                  0.01% and < 0.1%
Very rare:            < 0.01%

“Infections and infestations
Uncommon: upper respiratory tract infection

“Metabolism and nutrition disorders
Very common: appetite lost

“Psychiatric disorders
Very common: irritability, crying abnormal, restlessness
Common: nervousness

“Nervous system disorders
Uncommon: somnolence
Very rare: convulsions (with or without fever)

“Respiratory, thoracic and mediastinal disorders
Uncommon: cough**
Rare: bronchitis

“Gastrointestinal disorders
Common: vomiting, diarrhoea

“Skin and subcutaneous tissue disorders
Common: pruritus**
Rare: rash
Very rare: dermatitis, urticaria**

“General disorders and administration site conditions
Very common: pain, redness, local swelling at the injection site (≤ 50 mm), fever
38°C, fatigue
Common: local swelling at the injection site (> 50 mm)*, fever >39.5°C, injection site reactions, including induration
Uncommon: diffuse swelling of the injected limb, sometimes involving the adjacent joint*

“Post-Marketing Surveillance:

“Blood and lymphatic system disorders: Lymphadenopathy, thrombocytopenia

“Immune system disorders:
Allergic reactions (including anaphylactic and anaphylactoid reactions)

“Nervous system disorders:
Collapse or shock-like state (hypotonic-hyporesponsiveness episode)

“Respiratory, thoracic and mediastinal disorders:
Apnoea**[see section “special Warnings and special Precautions for use” for
apnoea in very premature infants (≤ 28 weeks of gestation)]

“Skin and subcutaneous tissue disorders
Angioneurotic oedema**

“General disorders and administration site conditions:
Extensive swelling reactions, swelling of the entire injected limb*, vesicles at the injection site

“* Children primed with acellular pertussis vaccines are more likely to experience swelling reactions after booster administration in comparison with children primed with whole cell vaccines. These reactions resolve over an average of 4 days.

“**observed with other GSK DTPa-containing vaccines

“Experience with hepatitis B vaccine:

“Paralysis, neuropathy, Guillain-Barré syndrome, encephalopathy, encephalitis and meningitis have been reported during post-marketing surveillance following GlaxoSmithKline Biologicals’ hepatitis B vaccine in infants < 2 years old.  The causal relationship to the vaccine has not been established.”

Comment: Looking at the data more closely, it is apparent that the table in the Report fail to disclose a large number of adverse effects following pertussus vaccination using Infanrix-Hexa.  There are also discrepancies in the risk of some of the adverse events when the frequency of side effects on the chart is on the Report is compared with the information on the datasheet provided by Infanrix-Hexa’s manufacturer:

For example, according to the Report the frequency of “Convulsions” after pertussis vaccination is “(0.00007 percent)”.
The datasheet prepared by Infanrix-Hexa’s manufacturer states that the risk of convulsions is < 0.01%

The datasheet  for Infanrix-Hexa states that “over 16,000″ “subjects” (presumably babies and children) received Infanrix-Hexa in clinical trials.  A rate of 0.00007% of convulsions is equivalent to a rate of 7 in ten million.

The claim of 0.00007% convulsions following vaccination against pertussis using Infanrix-Hexa is obviously not credible.  For the purposes of the calculations below, I will assume that between 16,000 and 17,000 people received the vaccine in the trials and use the higher figure (17,000) as the basis for calculations.

Even if 17,000 “subjects” received three doses each of Infanrix-hexa and one person had a single convulsion that would equate to a 1/17,000 (0.00588 %) rate of convulsions (if the number of people in the trial were used as the benchmark for the frequency of adverse effects.)  If the number of doses of vaccine (51,000, assuming that each person in the trial received all three doses of Infanrix-Hexa vaccine) were used as the basis for calculations, and one single person of the estimated 17,000 who received the vaccine suffered a single episode of convulsions, this equates to a convulsion rate of 1 in 51,000 or 0.00196%.

So, the figure for “convulsions” of “0.00007 %” stated in the Report of the Health Select Committee cannot possibly be true of Infanrix-Hexa.

Infanrix-Hexa’s datasheet does not give a frequency for the rate at which “hypotonic-hyporesponsive” effects (essentially life-threatening collapse) have been noted following the post market surveillance following the completion of the clinical trials involving Infanrix-Hexa.  Moreover the different terms used to describe other reactions i.e. “persistent screaming” in the Report compared to “crying abnormal”  on the datasheet make it difficult to make any valid comparisons about the relative frequency of these events.  However, it should be noted that “persistent screaming” following vaccination and  an abnormal high pitched cry can be symptoms of encephalitis (inflammation of the brain) and the fact that the the datasheet includes “crying abnormal” as being “very common” (occurring in 10% of vaccinees) is worrying since some of these recipients may be suffering from vaccine-induced encephalitis which has the potential to cause lasting brain damage.)  The table in the Report produced by the Health Select Committee gives a figure for “persistent screaming” of  “<0.005%”.

It seems fair to assume that the source of the unreferenced data for the Health Select Committee’s report was not Infanrix-Hexa’s datasheet.

If this was not the case, it is appropriate to ask the questions:

1)  What was the source of the data?

2)  Why was the datasheet for Infanrix-Hexa NOT used as the source for the data presented on the risks of pertussis vaccination in the Report of the Health Select Committee?  According to the NZ Immunisation Schedule downloadable from IMAC’s website, Infanrix-Hexa has been the pertussis-antigen containing vaccine used in NZ babies under the age of one year since September 2008.  It is usually administered at 6 weeks, 3 months and 5 months.  In my opinion the side effect profile pertaining to this specific vaccine should have been listed on the Report of the Health Select Committee.

NB:  There are two other pertussis-antigen containing vaccines that are offered to NZ children, according to the NZ Immunisation Schedule downloadable from IMAC’s website. One is “Infanrix-IPV” – which is on the NZ vaccination schedule for four year olds.  According to the datasheet provided by  its manufacturer (which can be downloaded from Medsafe’s website) Infanrix-IPV was tested on “more than 2,200 subjects”.  This low number of participants in the trials of this vaccine means that data pertaining to the trials of this vaccine could not have been used as a source for the data presented in the table relating to pertussis vaccination side effects that is included in the Report of the Health Select Committee.

The other pertussis antigen-containing vaccine offered to children in NZ is called “Boostrix” which is on the vaccination schedule for 11 year olds. According to its datasheet (which may be downloaded from the following link on Medsafe’s website at the following link: http://www.medsafe.govt.nz/profs/Datasheet/b/Boostrixinj.pdf ) Boostrix was tested on 839 children aged 4-9 and 1931 children, adolescents and adults aged from 10 years upwards.  The total of participants in the trials (2770) means that the datasheet for Boostrix cannot be the source for the data about pertussis vaccination side effects included in the Health Select Committee’s Report.

3) If the data pertaining to the three pertussis-antigen containing vaccines that are actually on the NZ childhood vaccination schedule weren’t used as a source of the data, what was the source of the data?

4)  What was the intention of the person/organisation who/which supplied the information about pertussis vaccination to the Health Select Committee?  Was there an intention to mislead the Health Select Committee about the side effects of pertussis vaccination by listing only six possible side effects of pertussis vaccination and failing to disclose most of the side effects that are acknowledged by the manufacturers of the pertussis-antigen containing vaccines that injected into NZ children?

5) The Chairman of the Health Select Committee is a doctor who would almost certainly have known that vaccination with pertussis-antigen containing vaccines entails considerably more risks than the six side effects included on the Report of the Health Select Committee.  The fact that the Report produced under his leadership omitted many of the side effects of pertussis vaccination using the vaccine (Infanrix-Hexa) routinely injected into NZ babies is troubling.  Perhaps Dr Hutchison is simply incompetent and relied upon data supplied by another party without checking references.  Or were the omissions (regarding pertussis vaccination side effects) in the Report intentional, in which case it must be asked whether or not this was an attempt to mislead parliament and the NZ public?

Quoting from the Report again:

Polio

We were told that if the polio vaccination was stopped and a traveller brought the disease to New Zealand unimmunised people would be susceptible to infection.

Table 4: Polio disease and vaccine risks

Highly contagious gastrointestinal infection for which humans are the only reservoir

Risk from disease

While many infections cause no symptoms, about one in 20 hospitalised patients will die and half of all surviving patients are permanently paralysed.

Comment:  Paralysis and deaths from polio could almost certainly be prevented in anyone who develops a symptomatic polio infection by the timely administration of sufficiently high dosages of intravenous vitamin C.  See: http://orthomolecular.org/library/jom/1999/articles/1999-v14n03-p143.shtml
The text of the article published in the July 1949 issue of the Southern Journal of Medicine and Surgery in which Dr Klenner reported on his cured polio patients may be read here:   http://www.sparks-of-light.org/polio-vit-c.html

Risk from vaccine

Local redness (one in three); pain (one in seven); swelling (one in 10); fever, crying, and decreased appetite (one in ten)

Comment:  In addition to these six side effects, there are many others detailed on the datasheet for  the injectable polio vaccine Ipolinj:

“Adverse Reactions
“Clinical Trial Experience

“The local reactogenicity of IPOL was evaluated in two multicentre randomized clinical trials involving a total of 395 patients, and local reactions were uncommonly to very commonly reported:

“Injection site redness: in 0.7% to 2.4% of subjects in each trial
“Injection site pain: 0.7% to 34%
“Injection site mass: 0.4%

“In a multicentre, randomized, phase III study involving 205 children, cases of fever >38.1°C were reported (in 10% of children after the first dose, in 18% after the second dose and in 7% after the third dose).

“In another multicentre randomized phase III study involving 324 children, it was concluded that IPOL combined or associated with DTP vaccines was as well tolerated as DTP vaccine alone.

“In primary immunisation of infants (2 to 12 months) most studies investigated the safety of IPV (IPOL) with combined vaccines, especially with DTPa. Systemic safety assessment of these studies showed that irritability is the most frequent (13.6 to 37.1%); drowsiness (1.5 to 23%) second most frequent; diarrhoea (2.1 to 9.4%); vomiting (0.7 to 7.6%) and fever over 39°C (0.5 to 3.0%).

“Clinical trials supporting the use of IPV as a booster in toddlers showed that cases of fever > 38.1°C range from 12 to 29% and fever over 39°C range from 2.7 to 5.2% and irritability is the second most frequent event.

“Data from Post-Marketing Surveillance

“These frequencies are based on spontaneous reporting rates and have been calculated using number of reports and estimated number of vaccinated patients. Adverse events are very rarely reported (<0.01%) during post-marketing surveillance. However, the exact frequency cannot be precisely calculated.

“IPOL is rarely injected alone in childhood immunisation schedules.

“The most frequently reported adverse events are local reactions and fever (respectively around 20% to 10% of adverse events reported).

“Blood and lymphatic system disorders:

• Very Rare (<0.01%)
Lymphadenopathy.

“General Disorders and Administration Site Conditions:

• Very Rare (<0.01%)
Injection site reactions such as injection site oedema, injection site pain, injection site rash or injection site mass within 48 hours following the vaccination and lasting one or two days
Transient mild fever (pyrexia) within 24 to 48 hours following the vaccination.

“Immune System Disorders:

• Very Rare (<0.01%)
Reaction of type I hypersensitivity to one component of the vaccine such as allergic reaction, anaphylactic reaction or anaphylactic shock.

“Musculoskeletal and Connective Tissue Disorders:

• Very Rare (<0.01%)
Mild and transitory arthralgia and myalgia within a few days after the vaccination.

“Nervous System Disorders:

• Very Rare (<0.01%)
Short-lasting convulsions, fever convulsions, within a few days following the vaccination
Headache
Transient and mild paraesthesia (mainly of limbs) within two weeks after the vaccination

“Psychiatric Disorders:

• Very Rare (<0.01%)
Within the first hours or days following the vaccination and shortly resolving:
Agitation
Somnolence
Irritability

“Skin and Subcutaneous Tissue Disorders:

• Very Rare (<0.01%)
Rash
Urticaria“

However the polio-virus-containing vaccine most commonly used in NZ babies, is Infanrix-Hexa.  It is also the vaccine (as discussed above) used in the primary vaccination series for pertussis in NZ babies.

I have already discussed how most of the potential side effects of Infanrix-Hexa (as they relate to pertussis vaccination) in a previous section.  Please refer to that section and you will see how the majority of possible side effects from polio vaccination (when Infanrix-Hexa is used, as is generally the case for NZ babies) have been omitted from the list of side effects in the Report of the Health Select Committee.


Conclusion:

I believe that New Zealanders deserve to know who it was who supplied this misleading information (regarding side effects following pertussis, measles, rubella and polio vaccination) to the Health Select Committee and whether the person(s) concerned have any conflict of interest (such as employment in a pharmaceutical company or organisation that receives funding from vaccine companies, for example) that may have had a bearing on the advice that they gave to the Health Select Committee – or whether they are simply incompetent.

Moreover, irrespective of the source of this information, my submission to the Inquiry included information about vaccine side effects from the manufacturers datasheet for the MMR-II.   (The MMR-II is the MMR (measles, mumps and rubella) vaccine manufactured by MSD – which is the MMR vaccine usually administered to NZ children.) Any of the members of the Health Select Committee who read my submission would have known that the information in the Report about the side effects of vaccination for measles, mumps and rubella is, to put it nicely, incomplete.  Producing a table of side effects that omits most possible side effects is misleading – since it gives the impression that the vaccine is much less than risky than the disease.

When I appeared in person before the Health Select Committee (as part of the Inquiry into how to increase vaccination completion rates) I asked for a show of hands as to who had read my submission. Just under half of the members raised their hands, so at least some of the members apparently read my submission.  Moreover, as I have previously stated, the chairman of the Health Select Committee is a doctor, and he would surely have realised that the information in the tables concerning vaccines side effects was incomplete. What went on during the writing of the Report that meant that no one corrected this erroneous information before the Report was published on the parliamentary website?

There is an old saying “A half truth is a whole lie”. In my opinion, the omission of the vast majority of the possible vaccination side effects appears to be part of an agenda to “manufacture consent” for acceptance of the recommendations in the report.  The information presented about the risks of the disease and the vaccine would give anyone who was not familiar with the issues surrounding vaccination an erroneous impression about the relative risks of the disease compared to the vaccine and would lead them to conclude that vaccination is far safer than the actual disease.

This is debatable, to say the least.

Many of the recommendations in the Report are coercive and, if instituted would erode parents’ rights to make decisions pertaining to the care of their children.  Some of the recommendations in the Report also appear to discriminate against children on the basis of their vaccination status, that is, which vaccines they have had and at what age.


Particular recommendations of concern are:

*  The recommendation that the government direct the Ministry of Health to consider linking “existing parental benefits” to vaccination. (See Page 6 of the Report.)

*  The recommendation that the government make children’s enrollment at school and early childhood centres dependent on parents producing proof of their children’s vaccination status.  If the government accepts the recommendations in the report, it appears that parents will be forced to choose whether their child has no vaccinations – or all vaccinations on the schedule – in order to be able to supply the documentation necessary to enroll their child in a school or early childhood education centre.  (See Page 6 of the Report.) This is obviously an assault on parents’ rights to make decisions pertaining to their children’s healthcare.

*  The recommendation to the government “that it implement Dr Nikki Turner’s ‘Six Star’ plan where there is a clear evidence base for doing so within the resources available.” [emphasis added] (See Page 6 of the Report.)

A number of the proposals in  Dr Turner’s “Six star” plan appear to be designed to coerce parents to make an all or nothing choice when it comes to vaccination.

*   Eligibility for the 20 Hours Free Early Childhood Education subsidy may also be restricted to children who have had all recommended vaccinations (or whose parents have decided against vaccination and have a “current declination form”) according to Page 33 of the Report.

* It is also possible that parents who do not comply with this “all or nothing” approach to vaccination (for example those who want their children to have some vaccines, but not others) may face financial penalties such as loss of government child benefits if, when their child turns two years old they cannot supply a “completed immunisation certificate or a declination form”. (See Page 34 of the Report).

These recommendations are coercive and represent an attack on parents’ rights to make healthcare decisions for their children.  They also impact on freedom of religion – since the rubella viruses in the MMR-II and Priorix MMR vaccines are cultured on cell lines derived from aborted human foetal tissue, making this vaccine morally unacceptable to many parents who are otherwise supportive of vaccination.  (See:  http://www.medsafe.govt.nz/profs/Datasheet/m/MMRIIinj.pdf
http://www.medsafe.govt.nz/profs/Datasheet/p/Priorixvac.pdf
http://www.rtl.org/prolife_issues/LifeNotes/pdf/Vaccines.pdf )

These parents might be forced to decide against vaccination entirely if vaccination were to become the all or nothing decision it appears that the author(s) of the Report would prefer.

In a democracy such as New Zealand we are dependent on the integrity of the members of parliament in the Select Committee process to honour their obligations to produce a Report that is factually accurate and faithfully represents the information that has been presented to the Select Committee in the course of their Inquiry.  It appears that in the case of this Inquiry, this has not happened and indeed the factual errors and omissions in the Report also suggest that there may have been an intention to mislead parliament (and the NZ public) on the part of whichever person(s)/organisation(s) provided information relating to vaccination side effects.  The fact that this mis-information regarding vaccination side effects was included in the Report of the Health Select Committee also raises serious questions regarding the competence and/or honesty of the author(s) of the Report – particularly the Chairman, given that he is a doctor and would likely have known that the information was inaccurate.

I hope that you will give this issue the urgent attention that it deserves.

Yours sincerely,

Katherine Smith