Health Ministry Answers Questions About MeNZB

ORIGINAL REFERENCE:
Ten Questions to Ask the MOH about MeNZB(tm)
Ron Law, Risk & Policy Analyst
Barbara Sumner Burstyn, Free-lance writer/columnist

1. 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?

Answer: The Health Research Council, which set up the board, has information on this at www.hrc.govt.nz

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?

Answer: The Health Research Council, which set up the board, has information on this at www.hrc.govt.nz

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?

Answer: The Health Research Council, which set up the board, has information on this at www.hrc.govt.nz

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"?

Answer: These statements used in the article don't relate to the final dossier submitted as the results from the clinical trial were submitted in a rolling manner. The 6 July 2004 MAAC minutes stated; Clinical data have been discussed by the VSC on 5 April 2004 and a recommendation that the data supported provisional consent subject to satisfactory manufacturing and quality data. (p2)

And The committee was satisfied that the outstanding Part II data queries will be answered and that the monitoring that has been proposed for the clinical introduction of the vaccine will be able to identify safety and efficacy concerns.(p3)

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?

Answer: The Ministry has complied with all of the conditions necessary for this programme. The consent form, signed off by Medsafe, and signed by consenting parents / guardians and other published information for parents says the vaccine will not protect everyone but most people will be protected. eg the consent form states "We expect that most people who receive three doses will be protected against this common strain of meningococcal B disease. Protection is expected to last for a few years but the exact period is unknown."

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?

Answer: The Ministry is using epidemic strain data to explain the need for an epidemic-strain meningococcal vaccine. New Zealand has seen 5688 cases of meningococcal disease since the epidemic began, and since 1997 when we have been able to identify the strain, an average of 76% of all cases have been strain specific and 71% of deaths have been cause by this strain.

This strain causes a disproportiantely large number, not only of deaths, but also permanent injuries such as amputations, brain damage and deafness.

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?

Answer: The goal of the Meningococcal B Immunisation Programme is the rapid control of the meningococcal disease epidemic in New Zealand. To do this, we have to give as many young people as possible the vaccine that targets the 76% of cases caused by a single strain. It is logic that the more people immunised, the more people protected. This concept does not infer herd immunity - simply individual protection for an increased number of people.

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?

Answer: The Ministy has not used the 50% figure and we're not sure where it comes from. What we have said is that the introduction of the MeNZB vaccine will continue to impact positively in a reduction of notified cases of the epidemic strain during 2005.

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?

Answer: New Zealand has seen 5688 cases of meningococcal disease since the epidemic began, and since 1997 when we have been able to identify the strain an average of 76% of all cases have been strain specific and 71% of deaths have been cause by this strain. 2004 meningococcal disease data was still being reviewed by the Institute of Environmental Science and Research Limted in January 2004. It is standard practice for all disease case records to be reviewed before data is finalised and then reported. The correct and finalised data for 2004 was a total rate of notified meningococcal disease at 9.2 cases per 100,000 for all strains, with a rate of 7.3 per 100,000 for confirmed cases. Even if you multiply the confirmed rate of disease in 2004 by the percentage of cases that were the epidemic strain, you still don't get 4.6 cases per 100,000. Mr Law also does not acknowledge that a similar percentage of cases that could not be confirmed to determine the strain of the disease by laboratory testing will also be the epidemic strain. The epidemic has not abated. It is projected to run for another 6-10 years if it is allowed to carry on unchecked. Prior to 1991 we would expect approximately 50 cases per year, 2004 with 342 cases is still extremely high by international standards.

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?

Answer: The school roll data is not recorded directly on the NIR (which is a Ministry database), but the School Based Vaccination System managed by DHBs. Immunisation event data is then transferred to the NIR.

Legal opinions from both the Ministry of Education and the Ministry of Health supported the release of the school rolls to the Public Health services carrying out the vaccinations. The process was also discussed with both the Office of the Privacy Commissioner and the Office of the Ombudsman.

The Privacy Commissioner advised us that before school rolls can be provided to Public Health Nurses, schools will need to inform parents and children that the rolls will be used in this manner. School newsletters would be an appropriate way to inform parents. A letter to all Principals in New Zealand includes advice about the use of school rolls and the need to inform parents through newsletter regarding the provision of school rolls to

PHNs (sent 20 February 2003 and 14 July 2004). As clearly stated in the information about the NIR - "For those who do not want to be immunised and do not what this information recorded on the National Immunisation Register it is possible to 'opt off.'

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