Ten Questions to Ask the MOH about MeNZB(tm)

Ten Questions to Ask the MOH about MeNZB(tm)

Ron Law, Risk & Policy Analyst

Barbara Sumner Burstyn, Free-lance writer/columnist

1. In its press release dated 11 April 2005, the MOH referred to the Independent Safety Monitoring Board as being, "Independent Safety Experts." http://www.scoop.co.nz/stories/GE0504/S00036.htm

What expertise in pharmaco-vigilance do each of the five members of the Independent Safety Monitoring Board set up to monitor the MeNZB(tm) vaccination programme have?

2. What does the term "Independent" mean in the context of the title "Independent Safety Monitoring Board" when three of the five members of that Board have collectively and/or individually received several million dollars in research grants from the Health Research Council during the past few years?

3. What does the term "Independent" mean in the context of the title "Independent Safety Monitoring Board" when members of that Board include colleagues and research partners of key MeNZB(tm) researchers?

4. Can the Ministry of Health confirm that the Minister's expert Medicines Assessment Advisory Committee said, as recorded in the 5 April 2004 minutes, that it "was concerned that there was no efficacy data for the proposed vaccine, and were not convinced that the efficacy and safety monitoring during roll out was sufficient to maintain public safety and confidence"?

5. On 3 August 2004 Medsafe wrote to the Director of the MeNZB(tm) vaccination programme, Dr Jane O'Hallahan, confirming to her that a condition of the provisional license of the MeNZB(tm) vaccine was that informed consent forms for parents/guardians must "clearly identify concerns about efficacy." Why has the Ministry of Health failed to comply with that condition by not conveying those concerns to parents/guardians?

6. Why is the Ministry of Health using total cases and deaths to justify a strain specific vaccine? For example, in 2003 and 2004 less than half of deaths were due to the epidemic strain, and yet we are being told that all 220 plus deaths since the beginning of the epidemic justify the use of the MeNZB(tm) vaccine. Another example being used to falsely promote the vaccine is the fact that of the 3 deaths due to meningococcal disease so far this year, two deaths were of middle aged people, not able to be vaccinated, and the 5 year old who was fully "protected" by the MeNZB(tm) vaccine died from Meningococcal C. Have any of the three deaths this year been due to the epidemic strain of bacteria? Why is the MOH using non epidemic strain data to justify a strain specific vaccine?

7. Why are parents and children being told that everyone has to be vaccinated for the vaccine to work properly, implying herd effect, when the Ministry knows that the vaccine does not stop the spread of meningococcal bacteria?

8. Why is the Ministry of Health telling doctors that there has been a 50% decline in meningococcal disease in Manukau-Counties since the MeNZB(tm) vaccine was rolled out when most of that decline had occurred before the vaccine was introduced and the rolling 12 month totals show that the vaccine has not increased the rate of decline? Why is the Minister of Health telling members of the public that the low 2004 meningococcal figures was due, in part, to the MeNZB(tm) vaccine, when no such evidence exists?

9. Why does the Ministry of Health keep exaggerating meningococcal disease figures due to all types and use these to justify a strain specific vaccine? For example, in a publication for doctors published in January 2005, the Ministry excludes 2004 data which would have revealed a significant decline in case and death numbers, and states that case rates are between 9 and 12 per 100,000 when that case rate for all strains in 2004 was 8.4 per 100,000, and confirmed cases of the epidemic strain were 4.6 per 100,000, barely above epidemic levels of 3 per 100,000?

10. Given that the Privacy Commissioner has told the Ministry of Health that parents and guardians must be advised in writing that school rolls are being downloaded into Ministry of Health databases, why are schools being told that they have no choice and parents/guardians not told at all? Is it legal for school rolls to be downloaded into Ministry of Health databases without parents' or guardians' consent?