INFORMED CONSENT & CHILDHOOD IMMUNISATION IN NEW ZEALAND
In March 2011 the report of the Health Committee on the Inquiry into how to improve completion rates of childhood immunisation was presented to Parliament and published. The Health Committee was chaired by MP Paul Hutchison and was briefed by the Chief Coroner on the coronial process, and also had briefings from Michael Tatley on the adverse reaction process, and from Professor Peter Gluckman on how to improve completion rates of childhood immunisation.
The Health Committee called for public submissions on the inquiry and received 53 submissions. They also heard 24 submissions at meetings in Auckland and Wellington. It is clear from both the language used in the report and from the recommendations that the opinions of the experts prevailed and that the submissions and testimonies from concerned parents were completely disregarded by the Committee.
Chapter 5 of the report is headed “Community concerns, informed consent, and conscientious objection issues.” It is rather disturbing that the term ‘conscientious objection’ is now being used when discussing community concerns and in reference to parents who choose not to have their children vaccinated, or agree to some of the scheduled vaccines but not others.
The chapter begins with a paragraph or two on “attitudes” and of course it is referring to the attitudes of parents and not those of health professionals or health agencies.
“We received many submissions expressing fear of immunisation, distrust of the agencies that provide vaccinations, and scepticism about the information provided by the Government about immunisation. We heard stories of babies, children, and young people with ill health, and impairment, and even dying, and about their families’ belief that these events were linked to immunisations. We were disturbed about the unsatisfactory information flow between agencies and the families in this process.
We were told that about four to six per cent of parents actively decline immunisation, and that a significantly higher proportion lack confidence in immunisation.”
Thus the problem was identified as being an “unsatisfactory information flow” rather than the possibility that occasionally there is a severe adverse reaction to a vaccine.
The Ministry of Health advised the Health Committee that “it is useful to differentiate between the groups that do not immunise” because “this part of the population is not homogeneous.” The report states that the Ministry is “interested in taking a new approach, dividing the population into segments according to behaviour and motivation rather than ethnicity or location. This would help the Ministry to target its communication and interventions appropriately.”
According to the MOH the segment of the population who do not immunise their children consists of:
• those who are willing but who
experience financial or transport difficulties in getting their children immunised
• those who are “unmotivated”
• those who are “distrustful,” and
• those who are opposed to immunisation.
The section of this chapter under the heading “Informed consent” begins with the statement that:
“The information given to parents is a key influence on their attitudes to immunisation. The New Zealand system depends upon parents making an active, informed decision to immunise their children. We consider that it is very important that parents are given helpful, evidence-based information, to balance the common belief that immunisation is an individual parent’s choice and only affects children.”
Dr Nikki Turner told the Committee that some parents question the need for immunisation, are concerned about the safety of vaccines, and attribute the absence of these diseases to other factors, including hygiene, natural immunity, and unproven products. She said that families and communities sometimes do not understand the evidence behind the immunisation programme and part of the problem is that the evidence is poorly explained to them. Parents also rely on personal experience and anecdotal evidence.
The Committee’s response to this is a recommendation to the government “that the Ministry of Health ensure that it publishes up-to-date, readily accessible evidence-based data on the positive and adverse effects of immunisation so that informed consent can be made from a robust evidence base.” This could be taken as an admission that the Ministry has not been providing such information, something that communities, parents and health groups have complained about for many years.
The media came in for its fair share of criticism in the report as well. An unnamed person told the committee that “a large proportion of media reporting abut immunisation contains inaccurate material that creates fear and discourages immunisation.” Of course when it works the other way there are no complaints. The report also noted that after extensive – some would call it excessive – “media coverage of outbreaks of swine flu, there was an increase in the number of people who sought seasonal influenza vaccinations.”
The committee agreed with Dr Turner that media organisations need access to “articulate and knowledgeable immunisation experts. New Zealand images and stories relating to immunisation should be made available to the media and health promoters, to guide the way that immunisation is presented in the media, and in education materials.”
Translated this means that graphic pictures of babies harmed by meningococcal B on the front page of the NZ Herald is fine, but photos of children whose parents believe were harmed or died as a result of a vaccine are not.
The report goes on to say that “organised groups and vocal individuals circulate material containing negative messages about immunisation” and that an unnamed individual (probably the same one) told them “the same concerns about immunisation have been present since the eighteenth century, with changes reflecting only the progress in vaccines and information technology.” Translation – some parents are still mindlessly trotting out arguments from the 18th century, and use the internet to do it.
The fact some babies and children have been seriously, and in some cases permanently, harmed by vaccines was obviously something that the committee refused to consider despite the evidence presented to them. This is most unfortunate for the parents of these children who were once again faced with yet another health agency that refuses to believe them.
While the report contains a brief acknowledgement of the need for informed consent, its recommendations will result in coercive methods being used to bully parents into agreeing to vaccinate their children. They are thus more about obtaining informed compliance rather than informed consent. For example, the committee recommended that the ministry should “ensure that all contracts for immunisation services oblige the contracted party to promote immunisations, and the evidence behind it. We consider that all health care professionals should be prevented from undermining the national immunisation programme.”
So just how are they going to do that?
Other recommendations include:
We recommend to the Government that the Ministry of Health strengthen the legal and contractual requirements for health professionals involved in maternity care to provide scientifically credible immunisation information, in contexts including antenatal classes.
We recommend to the Government that the Ministry of Health build websites about immunisation with content written by, and designed for, antenatal educators, lead maternity carers, and well-child providers.
We recommend to the Government that it fund free antenatal classes for all first-time parents, and ensure that scientifically credible information about immunisation is provided to them.
Such recommendations are based on the assumption that there are never any risks associated with vaccines, that the pharmaceutical industry is totally reliable when it comes to testing the safety of their products, and that parents are not capable of making decisions about the scientific evidence.
But even more importantly, they simply do not fulfil the requirements of the Code of Consumers’ Rights.
PREGNANT WOMEN & BABIES TO GET H1N1 VACCINE
Last winter New Zealand experienced an outbreak of Influenza A (H1N1), also known as swine flu because it is endemic in pigs. Despite early fears that this particular variety of swine flu may be more severe than the usual seasonal outbreaks of influenza, subsequent events revealed that the majority of people experienced fairly mild symptoms, and some of those infected had no obvious symptoms.
Over 3,200 people were officially diagnosed with the H1N1 virus, although officials have estimated that between 10 – 25% of New Zealanders caught the virus. Twenty people died; a much lower mortality rate than that caused by previous seasonal flu viruses. The groups found to be most severely affected by the H1N1 virus were infants under one year of age, Maori and Pacific people, pregnant women and those with other pre-existing conditions such as heart and lung diseases. (1)
As autumn approaches the Ministry of Health is gearing up for another round of this particular variety of flu. Based on both the New Zealand experience and that of countries in the northern hemisphere who are nearing the end of their winter flu season, those deemed to be most at risk are pregnant women, infants, those who are very obese, those who have heart disease, diabetes, cancer or chronic respiratory diseases such as asthma. The Ministry is currently rolling out a vaccination campaign for the new H1N1 vaccine known as Celvapan (produced by Baxter Healthcare Ltd) to priority groups, including pregnant women and infants over the age of 6 months.
Those who will be eligible for free vaccination with Celvapan are pregnant women, those who are “morbidly obese,” and all children between six months and five years of age who are enrolled in an eligible practice. An eligible practice is one which has 50% or more of their enrolled children under 6 years identified as high needs (Maori, Pacific, high deprivation). (2)
This particular vaccination campaign will run from March 2010 till 30 June 2010.
Information on Ministry of Health and related websites state that the Ministry is expecting a resurgence of the H1N1 flu to begin in autumn rather than winter. The campaign will therefore begin with what is referred to as the Early Protection Programme in which Celvapan will be offered to frontline health workers and those most at risk of more severe outcomes from the H1N1 virus. Two doses of the vaccine at least three weeks apart will be required, and Celvapan began being offered to these priority groups on 1 February 2010.
The usual seasonal influenza vaccination programme begins in March and is a trivalent vaccine that is intended to protect against the H1N1 virus, the Influenza A H3N2 virus, and the Influenza B/Brisbane virus. Only one dose is required.
Celvapan was approved for use in New Zealand in January 2010. It is an inactivated whole virion vaccine and is produced by growing the virus in cultured mammalian cells. The whole virus is then killed using formalde-hyde and ultraviolet light and harvested to prepare the vaccine. Unlike other seasonal influenza vaccines, Celvapan does not contain any egg protein. (3)
Medsafe, a business unit of the Ministry of Health, has evaluated the safety data from clinical trial and post-marketing safety data and decided that “the vaccine has an acceptable safety profile.” (3) Of course, what is acceptable to the Ministry of Health and what is acceptable to parents may be very different.
What is even more concerning is that the clinical trial experience for children is extremely limited. The Ministry information pack states that “The analysis of safety data from a snapshot of the safety data base involving 146 subjects aged six months to 17 years of age (including 20 children aged 3-8 years and 20 toddlers and infants aged 6 – 35 months) suggests a favourable safety profile with regard to systemic and local reactions. No serious adverse events were reported for any of the children up to 7 days after the first vaccination.”
Again the issues of such a small sample being used to provide both so-called safety data and the reporting of systemic and local reactions are of major concern. The European Medicines Agency website reveals a list of adverse reactions that many parents would find completely unacceptable. They include nervous system disorders (headache, dizziness, fainting, tingling, prickling or burning sensations on the skin, a loss of sensitivity), gastrointestinal disorders (nausea, vomiting, diarrhoea, abdominal pain), flu-like symptoms (fever, chills, headache, fatigue), musculoskeletal disorders (muscle or joint pain, muscular weakness), and temporary facial paralysis, facial palsy, etc. A full list of the reported reactions to Celvapan is available on the European Medicines Agency website. (4)
In New Zealand the safety of all medicines or vaccine is monitored by the Centre for Adverse Reactions Monitoring (CARM), Medsafe, and the Medicines Adverse Reactions Com-mittee (MARC). However, it is notoriously difficult, if not impossible, to prove that an adverse reaction was caused by a particular vaccine, as the recently reported death of a healthy 18-year-old New Zealand young woman and the chronic illness of other teens following the course of injections with the HPV vaccine Gardasil goes to prove. (5)
The Ministry states that Celvapan may be used in pregnant women:
“There have been clinical trials that show the efficacy of Celvapan. Although, as is the case with most trials, pregnant women were not included in the trials, there is no reason to think that the vaccine should not be as effective for women during pregnancy.
Because Celvapan is a new vaccine there are no safety data specifically about use during pregnancy. However, previous influenza vaccines have been shown to be safe during pregnancy and Celvapan has been use in pregnant women in other countries. Pregnant women need to be informed of this information as part of the informed consent process.” (3) (emphasis added)
However, it appears that the Ministry of Health has already begun sending out information packs to health providers and maternity hospitals that include a poster but no information for women. The Health & Disability Commissioner has been notified.
Given the Ministry’s tendency to over-promote vaccines with a zeal comparable to that exhibited by the pharmaceutical industry, it is perhaps not that surprising that they haven’t got around to producing anything other than a poster. This despite the fact that parents have repeatedly voiced their wish to have information that provides adequate information on the risks, benefits and side effects of all vaccines. In the wake of the fallout following the Ministry of Health’s MeNZB vaccination campaign which failed to mention that the vaccine only lasted for a few years, the Ministry has once again failed to produce the full disclosure of information that meets the requirements of the Code of Consumers’ Rights and that parents want.
3. “Early Protection Immunisation Programme: Information Pack.” Ministry of Health. January 2010.
Adverse reactions to the H1N1 Vaccine in Children
For a very informative interview with Professor Peter Collingnon from Western Australia on the adverse reactions – high fever, convulsions, and the death of one young child in Australia – to the H1N1 vaccine in children go to:
Some of the facts about the H1N1 Vaccine
Despite predictions of an early return of Influenza A (H1N1) flu, as autumn fades into winter, New Zealand has yet to see the start of its seasonal flu season.
As reported in the March issue of the AWHC newsletter, the Ministry of Health embarked on an influenza campaign in February which saw a roll out of first the H1N1 (swine) flu vaccine, followed by the trivalent influenza vaccine that this year aims to protect against the H1N1 virus, as well as the Influenza A (H3N2) virus and the Influenza B/Brisbane virus.
Unlike flu vaccination campaigns in previous years, the MOH is especially targeting pregnant women, as well as children who are deemed to be in the at risk group. This includes Maori and Pacific children, children with chronic conditions including neurological conditions and respiratory conditions, eg asthma, as well as those who live in very poor areas.
Having recently upgraded the numbers of those who died in last years H1N1 flu epidemic from 20 to 35 (1), the Ministry is now rolling out a vaccination campaign without having produced information for pregnant women faced with deciding whether to have the vaccine, or for parents who are wondering whether to get their young children vaccinated.
The lack of information has been exacerbated by the reports from Australia of the death of a toddler from a febrile convulsion that occurred after the administration of the flu vaccine, and the hospitalisations of hundreds of other children who experienced a very high fever and convulsions.
As a result of the unexpectedly high incidence of febrile convulsions in young children Australia has decided to suspend its vaccination programme for all children under 5 years while they further consider their data. (2)
Some facts about these vaccines
New Zealand has now used up its stocks of FluVax, the flu vaccine linked to the incidence of high fever and convulsions in young children both here and in Australia. (3)(4)
There is, however, no clinical data to support or refute the theory that FluVax causes more severe reactions than any of the other flu vaccines currently in use. (4) In fact there is unlikely to be any difference between FluVax and the other two flu vaccines currently in use in NZ – Vaxigrip and InfluVac – as all three vaccines were manufactured to produce immunity to the same three strains of influenza. (3)
Fever is a known side effect of the influenza vaccine. It is particularly common in children under 3 years of age who are given the flu vaccine and can lead to febrile convulsions. (5)
Other common side effects of the flu vaccine include headache, inflammation of the nose, dizziness, vertigo, joint pain, muscle pain, sore throat, sweating, fever, chills, fatigue and malaise – similar to those of the flu. (6)
The studies that were published by CSL, the manufacturer of FluVax, earlier this year revealed that a third of children who received the lower dose of the vaccine developed a high fever and in about 15% of these children it was over 38.5 degrees. There were other side effects as well such as vomiting and malaise. (7)
People/children who have an allergy to eggs or egg protein should not have the flu vaccine as the vaccine virus is grown in hen’s eggs. (8)
It takes about two weeks to develop antibodies to the flu viruses in the seasonal flu vaccine after being vaccinated. (9)
Seasonal flu vaccines are only about 50% effective when given to an entire population. (7) For healthy adults under the age of 65 years the flu vaccine is about 80% effective. However, in people over the age of 65 years and in children the flu vaccine is relatively ineffective. (9) The flu vaccine is nowhere as near as good as any of the other vaccines in use (7) which means many of those who have been vaccinated may still get the flu.
Internationally there is extremely poor data on the impact of the flu vaccine on children, particularly very young children. Professor Peter Collingnon, an infectious diseases physician and microbiologist in Australia, recommended that prospectively collected data on large numbers of people be collected, so parents can make an informed decision on whether to get their child vaccinated with the flu vaccine. (7)
Speaking on National Radio at the end of April, Professor Collingnon said he was very surprised that when it became apparent very early on that the mortality rate for H1N1/swine flu for the vast majority of people was much lower than ordinary seasonal influenza, health authorities around the world did not change their plans.
Given that a healthy adult under the age of 30 with no risk factors like heart or lung disease had less than a one in a million chance of dying from swine flu, it did not make sense to continue with plans to urgently manufacture a vaccine and then proceed to vaccinate whole populations. He is particularly concerned at the lack of data there is on seasonal flu vaccines, and suggested that before a new flu vaccine is rolled out to millions of people a pilot should be set up with around 20 GP practices with practice nurses. All those who get injected with the latest flu vaccine could be given a card to fill in, or in the case of children for their parents to fill in, and they are all followed up for a week or two. This would enable health authorities to obtain good information in a timely fashion on the first 5,000 to 10,000 people vaccinated with the latest flu vaccine, he said. (7)
It would also enable parents faced with difficult decisions around having the vaccine themselves or having their children vaccinated to make an informed choice.
3.Nikki Turner on National Radio’s Nine to Noon programme on 28 April 2010 – www.radionz.co.nz/national/programmes/ninetonoon/20100428
5.www.immune.org.nz/site_resources/Professionals/Health_professional_notes_on_flu_vaccine_and_febrile_convulsions.pdf 6. “Early Protection Programme Information Pack.” Ministry of Health. January 2010.
7. Prof. Peter Collingnon on National Radio’s Nine to Noon programme on 28 April 2010 – www.radionz.co.nz/national/programmes/ninetonoon/20100428
Influenza vaccination: policy vs evidence
Public health analysis and comment on the evidence for influenza vaccination that appeared in 2006 in the British Medical Journal – http://www.bmj.com/cgi/content/full/333/7574/912
CONFLICTS OF INTEREST
WHO and the pandemic flu “conspiracies”
Key scientists advising the World Health Organization on planning for an influenza pandemic had done paid work for pharmaceutical firms that stood to gain from the guidance they were preparing. These conflicts of interest have never been publicly disclosed by WHO, and WHO has dismissed inquiries into its handling of the Influenza A/H1N1 pandemic as “conspiracy theories.” Deborah Cohen, features editor at the British Medical Journal and Philip Carter, a journalist at The Bureau of Investigative Journalism in London, investigate: