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October 18, 2004

New Zealand Meningococcal Vaccine Campaign - Facts Disregarded: Risk Expert

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New Zealand is preparing to vaccinate 1.15 million healthy children against the meningococcal virus, using a vaccine produced by Chiron Corp. that has been neither proved safe nor effective.

According to Ron Law, a risk analys expert, the campaign is based on fear and ideology rather than facts, proportionality, risk analysis or common sense.

Apparently the pilot vaccination project, used to "establish the safety" of the vaccine has caused a number of adverse reactions. But no one knows exactly how many or how serious, because the data was not properly collected or evaluated. So the vaccine is now officially safe (let's not look at a few cases of anyway to-be-expected side effects) and is ready to roll out to over a million kids.

However, despite the Minister of Health's pronouncement that the "epidemic" is not abating, the latest statistical evidence shows that mortality from Meningococcal disease declined dramatically over the last few years, well before even the experimental use of the vaccine this year. The Minister has been accused of "sexing up" the numbers of the disease during a parliamentary debate.

Is it not time the real efficacy of vaccination campaigns be honestly examined, including incidence of the disease vaccinated against before and after any vaccination drive? With Chiron's UK-produced anti-influenza vaccine cutting available doses in the US in half, it should be interesting to see whether this has any influence on the overall incidence of influenza in the US this coming winter season.

Here is Ron Law's challenge to the New Zealand health authorities:

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Ministry of Health's Meningococcal Report Raises Further Questions


Ron Law
Risk & Policy Analyst
Beyond Alternative Solutions


"The Ministry of Health's report on adverse events following MeNZB vaccination raises as many questions as it provides answers," says risk and policy analyst, Ron Law

Does the MOH report include the two deaths reported following vaccination in trial participants?

What was the illness of the child referred to in the MOH report that was 'unrelated to the MeNZB vaccine?'

Why has the Ministry of Health changed the normal adverse event reporting protocol and is now only considering known and predetermined adverse events? This is unprecedented and is not good science.

Why has the Ministry of Health by-passed internationally agreed classification systems regarding causality?

Without knowing the circumstance of the accidental death, is it possible that the vaccine could have psychological adverse effects which increase accidents, or even suicide? This fact was denied and covered up by regulators and drug companies regarding SSRI antidepressants for 13 years; the truth has only recently been disclosed.

Does the MOH report include a baby about 1 year old who died soon after vaccination and on whom an autospy was done. Was this dead child admitted to Hospital? If not, was the death considered by the MOH?

Does the MOH report include a girl who went into anaphylactic shock after the vaccination and was taken to hospital in an ambulance.

There is no mention in the report of an epileptic boy who had not had a seizure for three years but who had a Grand Mal seizure after the vaccine.

Does the report consider seizures other than febrile seizures? Discounting other seizures is not good science as other seizures are potential indicators of far more serious reactions than those caused by fever.

Does the MOH report include a pre-schooler who was in bed for two weeks with vomiting and diarrhoea post vaccination? That extent of illness in a pre-schooler, and bad enough to keep them bedridden, surely constitutes very serious illness, specially at that age.

Did the report consider the fact that one school [at least] had a reported c300 children absent following vaccination (all at once)?

Reports circulating say that the official spin is that they had 'the flu.'

How many of these children were tested for the flu virus? If none, why not? If they were, then what were the results? If not, why not?

Has any school in NZ ever had 300 kids away on one day/week all because of flu. And if it was for real, then there should be some investigation....

An analysis of the ESR weekly flu surveillance reports suggests that there were notifications of flu like illness in East/Sth Auckland at the time of the vaccinations, but that these were not supported by laboratory confirmation tests. What caused this rapid rise in flu like illness?

Flu was not an expected adverse effect of the vaccine.

Sentinel GPs are distributed on a population density basis of approximately 1 per 50,000. Sentinel General Practices carry out both disease and virological surveillance. The influenza case definition is "an acute respiratory tract infection characterized by an abrupt onset of two of the following: fever, chills, headache and myalgia" -- all symptoms of the MeNZB vaccine.

This data is either collected by phone, or forwarded by fax each Friday. Consultation rates are calculated using the number of consultations as the numerator and the sum of the patient populations, reported by the participating practices, as the denominator.

The national level of Influenza Like Illness activity is described using a set of threshold values: a weekly rate of 50-249 consultations per 100,000 patient population is considered indicative of normal seasonal activity; 250-399 indicates higher than expected activity, and >= 400 indicates an epidemic level of disease.

The rates as reported by the ESR weekly surveillance reports do not support a flu epidemic as being the cause of the absentees in Sth Auckland schools. The weekly reports of confirmed cases indicate normal levels of flu.

If it wasn't flu, what was it? And why has the Public Health system failed to undertake due diligence?

There must be something terribly wrong with that community if that many children got any illness all at once. And even if it was a large school say 1,200 - 1,500 wouldn't having a quarter to a fifth of the school away at the same time set off alarm bells? Especially when there is no evidence of flu in the region.

Wouldn't that normally be front page headlines in our daily newspapers?

Another question worth exploring is, "Why are there no pharmaco-vigilance experts on the monitoring committee?"

Dr O'Hallahan's statement on Friday that "CARM notes that the number of reports suggests that the rate of vaccine events following MeNZB˙ vaccination, resulting in health professional concern enough to generate a report, is low," is patently absurd, defies logic and provides no reassurance.

In 1999 the Ministry of Health was found by the Regulation Review Select Committee, chaired by Jonathon Hunt, and including Associate Health Minister Damien O'Connor [who bought the complaint on behalf of industry] to have abused its powers when introducing mandatory warning labels on bee products.

As noted in the Committee's report, the sum of the Ministry's evidence against bee pollen and propolis was;

"The Ministry of Health has also considered the health risks of bee pollen and propolis products. Reports in New Zealand and Australia have linked bee pollen and propolis products to adverse reactions. Four adverse reactions to bee pollen have been reported to CARM in New Zealand since November 1993. There is at least one case of an allergic reaction to bee pollen and propolis products where there was no previous history of asthma or allergy. This supports warning statements that apply to the general population."

(Reference)

In six years there had been three adverse reaction reports -- none confirmed -- and the Ministry deemed that the evidence was so compelling that mandatory warning labels were imposed ... despite the Regulation Committee Chair, Jonathon Hunt, bringing this matter to the attention of Parliament, and moving that the regulations be revoked, and despite a five-person independent scientific review endorsing the select committee's findings, they never were [due to an election, the motion lapsed.]

Paradoxically, under Damien O'Connor's watch, they now have been inculcated into special food standards...

(Reference)

There had been three adverse reaction reports to CARM in six years regarding bee pollen, and the Ministry of Health deemed these products to be so hazardous that they required the harshest warning labels on any food, anywhere in the world.

There have been 88 adverse reaction reports to CARM regarding MeNZB vaccine in less than 2 months, and the Ministry deems that to be evidence of safety warranting no further action -- this is nothing more than spin-doctored Pseudo-science.

The media are also reminded that the Minister of Health, Annette King, in announcing the unconditional release of MeNZB [despite the rhetoric, no age restrictions were gazetted for MeNZB...] stated, "The epidemic has shown no signs of abating, but now the vaccine has received approval we can begin to fight back."

(Reference)

Having proven that the epidemic is already well and truly abating, and has been for some time, [a fact that the Minister still denies] the only grounds for continuing with the mass vaccination of 1.15 million healthy children with an experimental drug, is to keep up the perception of risk of disease, and the perception of the safety of the vaccine.

A key pro-vaccine immunologist in New Zealand [who, incidentally was also a member of the expert scientist group that concluded that the M