Meningococcal Report Raises Further Questions

Mon, 18 Oct 2004

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 Grande 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 has 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 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." http://www.lawschool.vuw.ac.nz/vuw/content/display_content.cfm?school=law& id=1508

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.] http://www.sci.fi/~apither/files/BeeSciRev.pdf

Paradoxically, under Damien O'Connor's watch, they now have been inculcated into special food standards... http://www.nzfsa.govt.nz/policy-law/legislation/food-standards/nz-food-sta ndards-2002-bee.pdf

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." http://www.beehive.govt.nz/ViewDocument.cfm?DocumentID=20259

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 MOH failed to undertake meaningful risk analysis of bee products,] says on his website...

"If parents have no fear of vaccine, but fear of disease, the argument in favor of vaccination is clear-cut. If they have no fear of vaccine, but also no fear of disease, there may be inertia. When they have no fear of disease, but fear of vaccines, parents are likely to refuse immunization." http://osms.otago.ac.nz/immunet/whorwe2.htm

This is a key factor in the current debate... the Ministry of Health is doing its utmost to rewrite the facts regarding the real level of disease, as well as moving heaven and earth to 'prove' an experimental drug is safe.

If it was as simple as monitoring a few case records and getting them reviewed by hand-picked independent experts (two of whom are colleagues of the meningococcal research team) then pharmaceutical companies would not have to spend millions on safety tests, and Vioxx would still be a safe drug.

The Ministry of Health's spin is nothing more than Pseudo-science; it walks all over best practice, and rewrites the facts.

I will be forwarding under separate cover a graph of the rise and fall of meningococcal disease... the evidence speaks for itself and should be celebrated... bear in mind that the graph relates to total notified cases... if deaths just related to meningococcal B were released by the Ministry, then the story would be much less horrific than that painted by the Ministry.

Given the evidence regarding both risks and the fact that the epidemic is well and truly past its peak, the precautionary principal would suggest that the vaccination programme be halted. At best it will save 1 or 2 lives, at worst it will immunise people against immunisation in the future.

Competing interest.

Ron Law practiced as a medical scientist for more than 20 years, lectured in business management for 8 years, is a member of the New Zealand Risk Management Society, and was a member of the Ministry of Health expert working group that advised the Director General of Health on the Reporting and Management of medical injury in the New Zealand health system. http://www.moh.govt.nz/moh.nsf/0/008deb2fa836ba68cc256ad000804456/$FILE/Cl inicalExcellence-WorkingPartyReport.pdf

The report of the working party concluded that the economic impact of preventable medical injury in New Zealand was between $2 and $3 BILLION per year. If the working group had used the economic impact cost that the Ministry of Health did to justify the meningococcal B mass vaccination program, then the costs would have been some 4 BILLION dollars per year based on the results of the Prime Minister's Husband's $1.5 Ministry of Health and HRC funded research.

If these figures sound absurd, an Australian government taskforce concluded that, based on similar economic impact figures used by the Ministry of Health to justify the meningococcal mass vaccination experiment, preventable medical injury costs the Australian economy $33 BILLION per year. [report on file.]

In a letter dated 15 January 2003, the Minister of Health stated, "mortality data from 1998 attributes only 4 deaths to medical injury in that year." Professor Davis' report studied medical injury in New Zealand hospitals in 1998.

The Minister went on to say, "The Ministry of Health publication, 'the Burden of Disease and Injury in New Zealand,' ...did not focus on deaths from medical injuries because it is not a major category." [Letter on file.]

Can some brave reporter please ask the question: Why has a disease that has caused fewer than 0.05% of deaths in New Zealand in the past decade get $250 million in special government funding for a mass immunisation experiment using a drug which has had zero efficacy testing undertaken, when at the same time a major cause of preventable injury in New Zealand is denied by the Minister of Health?

If a proportionate amount of money was invested in reducing preventable medical injury was dedicated on reducing the carnage within the healths system, then the government would be spending some $37.5 Billion reducing medical injury in the health system... and that's assuming it works and prevents ten deaths per year.

By 2003, the death rate had declined 75% to only 5 deaths of all ages caused by meningococcal B. The economic impact was based on 20 lives saved in the target age group per year.

The vaccination campaign is predicated on fear, and ideology; it has not been based on proportionality, risk analysis, commonsense, or the facts.

ENDS

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