Investigation: The Meningococcal Gold Rush

http://www.scoop.co.nz/mason/stories/HL0502/S00064.htm


Investigation: The Meningococcal Gold Rush

Monday, 7 February 2005, 10:01 am
Article: Barbara Sumner Burstyn

EXECUTIVE SUMMARY: New Zealand's meningococcal disease story, as
unravelled through analysis of previously secret documents obtained under
the Official Information Act, reveals that the New Zealand government,
media and public have been mislead and manipulated by officials, advisors
and scientists alike.

As a result of this manipulation, the government has committed an
unprecedented 200 million taxpayer dollars to a mass vaccination experiment
of 1.15 million New Zealand children with an untested and experimental
vaccine. Despite being reassured by a bevy of pro-vaccine and vaccine
manufacturer sponsored experts and none-less than the Minister of Health
herself that the MeNZB(tm) vaccine is thoroughly tested and proven to be
safe and effective, we reveal that Chiron's MeNZB(tm) vaccine was never
used in the trails used to approve its license. We reveal that despite
assurances, there is no evidence that the MeNZB(tm) vaccine will actually
work as promised.

We believe that the magnitude of policy, regulatory and scientific
misconduct is such that not only should vaccination with this vaccine be
halted forthwith, but that the meningococcal vaccination program should be
independently audited and the circumstances surrounding the development and
implementation of the program subjected to a full Royal Commission of
Inquiry.



The Meningococcal Gold Rush


By Barbara Sumner Burstyn
& Ron Law

In January 2002 the Minister of Health Annette King announced that "$100
million-plus" had been set aside to fund development and implementation of
a vaccine to combat New Zealand's unique strain-specific meningococcal
group B bacterium [1]

By May that year, following Ministry of Health negotiations with the
preferred contract supplier, Chiron Corporation, that figure had become "a
commitment of up to $200 million." [2] By September 2004 the sum of $250
million was being mentioned in parliament. [3]

In a July 7 2004 press release Ms King described the development and
approval of the MeNZBT vaccine as 'fantastic news.' She went on to explain
that the MeNZBT vaccine had been "specifically developed with scientists
from biotechnology company Chiron Corporation." Cabinet was told in 2001,
immediately prior to approving the signing of the Chiron contract, that the
deal included the "development of a unique or 'orphan' vaccine." [4]

Chiron's own press release declared they [Chiron] had specifically
developed the vaccine. [5] The company quoted Ms King congratulating them
"for their effort and dedication to this project."

But documents received under the Official Information Act reveal that the
MeNZBT vaccine was not developed by Chiron Corporation. It was developed by
the Norwegian Institute of Public Health. Chiron had bought the rights to
mass manufacture and market the Norwegian meningococcal B vaccines in
November 1999, nearly two years before the New Zealand government signed
the initial contract with the company. [27]

Last March, in replying to a question in the House from National MP Dr
Lynda Scott, the Minister of Health declared that $10.7 million has been
spent on the development of the group B meningococcal vaccine. [49] While
Cabinet papers, released under the Official Information Act, had most
financial details censored as being commercially sensitive, it would appear
that of the total $200 million cost, Chiron will net around a cool $140
million for developing and supplying the already developed vaccine. [28]

From the Norwegian perspective, the off-loading of their Norwegian specific
vaccine to Chiron must have been a godsend given it had likely invested
over a hundred million $US in double blind, placebo controlled studies
involving 170,000 people and over 2,000 doctors and nurses for a vaccine
that was never licensed for use in mass vaccination. (New Zealand's
preliminary trials involved about 1,500 people and cost at least $7.8
million). In parliament on 19 October 2004 Ms King stated "[the Norwegian
Government decision not to approve their vaccine for use] was ... based on
the evidence they had, that it did not stack up in terms of cost-benefit,
so they did not continue with it."

However The Lancet medical journal reported in 1991 that the Norwegian
Institute of Public Health found that the large and robust clinical trials
proved the vaccine to have insufficient efficacy to justify its use in a
mass vaccination program. [6] The Lancet paper also contained data showing
that the epidemic was waning naturally by the completion of the trails. The
incidence had declined from peak levels by about 50%, similar to the
natural decline that had occurred in New Zealand when the vaccine was
approved.

A further press release by Chiron declared, "Since the signing of the
initial 2001 agreement with the New Zealand Ministry of Health, Chiron has
supplied vaccine for clinical studies conducted in collaboration with the
Ministry of Health and the University of Auckland." [7] While they are
technically right, the inference in New Zealand has always been that the
vaccine for the trials was strain-specific and created expressly by Chiron
Corporation to combat New Zealand's 'unique' meningococcal group B
bacterium.

Financial and development questions aside, the documents received under the
Official Information Act reveal that not only was the vaccine not developed
by Chiron, but the vaccine used in the clinical studies in New Zealand was
not even made, as claimed, by Chiron. The vaccine used in the studies was
both developed and, according to minutes of the MAAC vaccine subcommittee,
manufactured by the Norwegian Institute of Public Health.

This raises a serious issue. In answer to another question by National's Dr
Lynda Scott (28 May 2003) the Minister of Health said, "New Zealand will
not acquire the intellectual property rights (to the vaccine) because New
Zealand does not have manufacturing experience in producing Outer Membrane
Vesicle (OMV) vaccines. If this were indeed possible, repeated clinical
trials would need to happen in New Zealand for the production of MeNZB.
When a vaccine is produced at a new manufacturing site, it is deemed for
clinical reasons a new vaccine and would require a full clinical
investigation and licence application." [50]

Therefore, by the Minister's own standards, Chiron should be conducting new
clinical trials on its own MeNZBT vaccine in New Zealand. After all, the
vaccine currently being deployed in this country is not the same as the one
used in the trials. It is made by a different organisation, in a different
laboratory, and in a different country to that of the trial vaccine.
Despite this, Chiron has been given a licence based on a vaccine made by
Norway in direct contradiction to the Minister's own statements.

Of the two trial groups that have been tested with the Chiron produced
MeNZBT vaccine, the minutes of the Minister's MAAC vaccine sub-committee
noted that one involved a total of ten adults. The number of 8-12 year old
children involved in the other group is still unknown, but is unlikely to
be more than a handful. [10]

The documents also show that when Chiron finally manufactured and tested
its MeNZBT vaccine in its Italian factory, it was so late in the trial
process that the Minister's MAAC Vaccine Sub-Committee notes that no
results of either of the tests were completed when they recommended the
vaccine be approved for general release.

The expert committee's conclusion was that, "the current data supplied
provides very limited data on its effectiveness," and "evidence of efficacy
is not compelling." They went on to say, "the Committee was concerned that
there was no efficacy data for the proposed [MeNZBT] vaccine, and were not
convinced that the efficacy and safety monitoring during the roll out was
sufficient to maintain public safety and confidence." [29] The Ministry of
Health's Dr Jane O'Hallahan has admitted that the MeNZBT vaccine would be
rolled out 'without efficacy data.'

The MAAC vaccine subcommittee noted that not a single study of Chiron
manufactured vaccine had been completed. MAAC also declared "there are a
number of issues relating to the manufacturing and quality data that are to
be addressed by Chiron."

The very next day the Minister approved Chiron's MeNZBT vaccine. In a press
statement announcing the approval the Minister said, "MedSafe is assured
that the vaccine is safe and effective given all the information currently
available to it." [9]

One can only marvel at the speed and efficiency of government agencies that
are able to resolve such outstanding issues in a single day. This is
especially pertinent given that on the same day MedSafe extended by 18
months [30] the about-to-expire use-by date of over 300,000 doses of the
vaccine that had been produced in commercial quantities by Chiron, months
in advance of the completion of trials and licensing, [37]

To add to the complexity of the issue, at the same time as MAAC was citing
manufacturing and quality data issues, regulators in the United States,
Britain and Brazil were cognizant of manufacturing and quality problems at
Chiron's plant in the UK, and the same Italian plant used to manufacture
the MeNZBT vaccine. Subsequently British regulators cancelled Chiron's UK
factory license due to breaches of 'Good Manufacturing Practice' resulting
in 50 million doses of flu vaccine being dumped in August. At this time
Chiron has been unable to rectify the manufacturing problems.

As has been pointed out by the Ministry the MeNZBT was not made in the
Liverpool factory. It was made in Chiron's Italian factory. However, this
same factory produced the more than four million doses of MMR vaccine
deployed in Brazil, that were recalled due to several hundred serious
adverse reactions, including anaphylaxis. [43]

To put the Ministry's attitude to Chiron into perspective it may be useful
to recall the situation surrounding the Minister's response in 2003 to
complementary medicines made by Pan Laboratory. Pan breached Good
Manufacturing Practice in the case of a pharmaceutical product that caused
serious adverse effects. Three months later, this resulted in the mandatory
recall and destruction of over 1,600 unaffected supplements at a cost to
industry of some $400 million in Australia and New Zealand. Industry
sources reveal that one New Zealand company lost 20 million dollars alone
due the New Zealand Minister's recall, despite having independent analysis
proving that their product was up to standard. The Minister's response was
so definitive that she ordered the destruction of all recalled goods.

Further documents received under the Official Information Act reveal that
while the country has been sold on the need for three vaccinations to bring
any immune response up to a suitable level, the Ministry's own unpublished
cost benefit analysis was based on five doses. [11]

Referred to by the Minister as an, 'independent economic evaluation of the
anticipated economic benefits [of the vaccine]" [38] the analysis was
undertaken by the faculty that stood to gain many millions of dollars of
research funding from Cabinet approval of the vaccination program. The
authors included senior meningococcal vaccine researchers and their
colleagues at Auckland University. Puzzlingly, neither the report [nor the
Minister] disclosed this important fact to Cabinet; the report falsely
declared, "Competing Interests: None."

Another cost benefit analysis by Treasury in 2001 showed that the
cost-to-benefit ratios were seven times those normally used by Pharmac to
approve funding of prescription medicines [12] and that was before the
significant declines in disease and deaths that have occurred naturally.

An Honours student at Canterbury University also did a cost benefit
analysis. Whilst presented at the New Zealand Association of Economists
conference in Wellington in June 2004, [45] the paper has not been posted
on the website as is usual practice but has been 'temporarily withdrawn'
from public purview. This is considered unusual as the Audit Office says
the paper is in public domain once presented. The paper is said to have
revealed that the MeNZBT vaccination program did not stack up economically
and, like the Auckland District Health Board, questioned the program's
rationale. [46] A university source has revealed that the paper was removed
to protect the interests of the student after the University received a
threatening letter 'advising against publication.' We are aware of the
student's name and have been asked not to make it public as to do so could
jeopardize their career options. We are also informed that the student was
approached by officials from other government departments and congratulated
for raising questions they were not allowed to.

Other MOH accounting is also dubious. The need for a new strain-specific
vaccine was based on 5,000 plus cases of epidemic strain meningococcal B.
This number has appeared in published scientific abstracts at conferences
including San Francisco, Milwaukee, Boston, Mexico and Auckland. But source
documents show that less than 50 percent of 'total' cases have been
confirmed as being of the epidemic meningococcal B strain targeted by the
MeNZBT vaccine.

The 5,000 plus figure includes cases caused by at least six other strains
of meningococcal bacteria, as well as unconfirmed 'suspected' cases. Even
this figure is in question as a MOH commissioned report suggests that
between 10 and 25 percent of notified cases are likely to have been falsely
diagnosed. [31] Nevertheless, Cabinet was falsely told that, "the current
epidemic has been caused by a single strain of group B meningococcal
bacterium." [14]

The World Health Organisation states that if the death rate for
meningococcal disease is less than 5 percent then it is likely that cases
have been over-diagnosed. [32] The death rate in New Zealand in 2003 and
2004 has been 2.3 percent for all types combined. Data from the Minister
shows the epidemic strain targeted by the MeNZBT vaccine has averaged a
death rate of just 1.4 percent for the past two years.

There are other anomalies between the Minister's figures and those reported
to Cabinet. Cabinet was told that meningococcal disease would kill 20 New
Zealanders per year for the next ten years, and that the MeNZBT vaccine
would avert 13.6 deaths per year. Yet since 2001, total deaths for all age
groups have declined naturally by about 70 percent while case numbers have
dropped by 48 percent. [13] Deaths due to the strain of bacteria targeted
by the MeNZBT vaccine have declined by 76% since peak levels in 2001. A
look at death rates across all strains of the disease show a natural
decline in the disease burden and follow somewhat the disease cycle decline
experienced in Norway, Cuba, Ireland and numerous other countries. [16]
[51] (Graph One) In short, the total case numbers are at their lowest
levels since 1994, and death rates due to meningococcal disease are at
their lowest levels since 1991, the year the 14-year epidemic began.
Puzzlingly, in the 7 July 2004 press statement Ms King said, "The epidemic
has shown no signs of abating."

The Minister has refused to release age related deaths for the epidemic
strain. But our best estimates are that the vaccine, if it proves
effective, will prevent at most 1 or 2 deaths per year in under 20 year
olds out of approximately 700 who die each year from all causes. In other
words 0.2% of all deaths in the under 20's might be prevented. Put another
way, if the government applied the same cost-benefit analysis to preventing
the other 99.8% of deaths, it would be spending over $100 billion.

The numbers game extends to international medical conferences. At the
Chiron sponsored, Seventh Annual Conference on Vaccine Research in
Virginia, USA in May 2004, the MOH meningococcal vaccine program director,
Dr Jane O'Hallahan was an invited speaker. Her abstract reads in part,
"With the epidemic claiming up to one life every two weeks in a nation of
four million people, this collaborative group is working against the
clock." [21]

At the time the abstract would have been written, the death rate had fallen
to one death every four weeks from all forms of meningococcal disease and
one death every three months from the epidemic strain of bacteria

In another anomaly, in 2001 the Ministry of Health told Cabinet [33],
through a document requesting funding for the Meningococcal B vaccine, that
the vaccine would most likely cause herd immunity. "[The preferred] option
also has the benefit of likely herd immunity. This is expected but cannot
be quantified." The document contains other allusions to expectation of
herd immunity. Later in the document the Minister's Office memo
categorically stated that herd immunity had been achieved in meningococcal
vaccination programs in the United Kingdom and Cuba.

But the United Kingdom program used a Meningococcal C vaccine, and the
Cuban study used a B/C combo, vaccines that are totally different in their
make-up. Meningococcal B vaccines cannot be made using the same process as
meningococcal C vaccines as they would induce antibodies that attack the
brain. It is generally understood to be scientific fraud to compare
different entities as if they were the same.

There is also no compelling scientific evidence that the Cuban vaccination
program conferred herd immunity. Reference to herd immunity in the medical
literature is predicated on no natural decline in case numbers pre and post
vaccination, and that the entire decline is due to the vaccine, and that
the vaccine reduces carriage and spread of the bacteria. The incidence of
meningococcal B was in steep natural decline at the time the Cuban
immunization program began. [34, see Graph Two] We can find no credible
evidence in the scientific literature that suggests that Meningococcal B
vaccines reduce the carriage and spread of the bacteria and hence have a
herd effect.

It is also of interest that the MeNZBT researchers themselves now
acknowledge that there is no body of evidence that MeNZBT-type vaccines
confer herd immunity. [35] Outer membrane vaccines such as the MeNZBT
vaccine do not reduce carriage or the spread of meningococcal bacteria. The
only grounds for raising the prospect of herd immunity by the officials
would appear to be to amplify the potential benefits of the meningococcal
vaccine in an attempt to convince Cabinet that Treasury had been too
conservative in their assessments. [52] (Graph Two)

Perhaps a paper given by the Ministry of Health's Dr O'Hallahan at a
meningococcal disease conference in Norway in 2002 goes some way to
explaining this type of pressure. Entitled, "How to harness the political
will and implement an OMV vaccine solution to combat a devastating
epidemic," the paper appears to have outlined ways to convince a government
to become involved in funding a new vaccine. [44] Another blatant example
of the use of the 'harnessing of political will' can be seen in the 2001
Cabinet papers when Cabinet gave approval for the $200 million project.
Paragraph 87, the last paragraph before the recommendations section, simply
states, "Large public and media reaction is expected if campaign does not
go ahead."

The choice of Chiron Corporation as the exclusive manufacturer of the New
Zealand vaccine also raises a number of questions. Cabinet papers show that
Ministry officials rejected competitor options and entered into the initial
contract with Chiron knowing that Chiron would only produce the vaccine if
they got the contracts to both manage the trials and supply the vaccine for
the clinical trials and the roll-out. [17] This raises conflict of interest
issues as Chiron effectively controlled weather or not the government paid
it for 3-4 million doses of its vaccine.

Papers released under the Official Information Act reveal that the Ministry
of Health and its advisors discarded a competitor of Chiron's from
consideration as a supplier of a meningococcal B vaccine because their
vaccine was a B/C combo. This rejected supplier manufactured the Cuban
vaccine. Having discarded a competitive supplier because the vaccine was a
combo, the Ministry of Health and Chiron then used that discarded
competitor's efficacy data and the alleged herd effect from the Cuban
studies of the discarded vaccine to justify the licensing and use of
Chiron's untested MeNZBT vaccine in New Zealand. [17]

Having apparently already acquired the rights to the Norwegian
meningococcal B vaccines, combined with the Ministry's discarding of a key
competitor, Chiron appears to have held all the cards.

Paradoxically, Chiron's publicly stated intentions are to produce a
combined meningococcal B and C vaccine. Government papers show that trials
have been undertaken in New Zealand using Chiron's meningococcal C vaccine
MenjugateT combined with the Norwegian vaccine.

Chiron's MenjugateT vaccine was also used as the control in a MeNZBT trial
of infant's in New Zealand. The infants were given MenjugateT vaccine as a
so-called 'placebo.' [18] This fact is not mentioned in the MAAC minutes
but was disclosed in a paper presented by Chiron at a scientific conference
in Japan in October 2004.

This raises serious questions regarding informed consent. Were parents and
guardians aware that Chiron was undertaking what would appear to be
unapproved trials of a vaccine that is not licensed for use in New Zealand
nor the USA?

In October 2004 Chiron stated that the FDA had requested further
information regarding its application to license MenjugateT in the USA.
[19] Since then, Chiron has withdrawn their USA application for approval of
MenjugateT on the premise that they want to introduce a combo vaccine with
a broader market appeal. This seems to be a puzzling move, however, given
that they had recently completed phase III clinical trials on MenjugateT;
it seems odd that if the trial results had been positive that Chiron would
not have proceeded with its application.

So, what are Chiron's motives? Aside from simple commercial opportunism,
there is wide market appeal for a New Zealand financed and trailed vaccine.
New Zealand's Environmental Science and Research (ESR) annual report this
year commented, 'the trials are definitely of international interest
because the same strain is now causing problems in Europe, although not yet
at an epidemic level . It's of huge international interest." [22] Chiron's
competitor Aventis said recently that meningitis B must be the next vaccine
target in the US. [3].

Secondly as the meningococcal B vaccine gold rush gains momentum there is
significant competitive pressure to gain dominance in this field. The WHO
noted in a report on the state of the art of vaccines, that research
institutes have formed alliances with pharmaceutical companies. The Cuban
Finlay Institute and GlaxoSmithKline, Norwegian Institute of Public Health
and Chiron, and the Dutch RIVM and Wyeth have formed alliances. Other
companies such as Microscience (USA) are also researching novel
meningococcal B vaccines, as is Aventis. [23]

Within days of Chiron's MeNZBT vaccine being approved in New Zealand, the
U.S. Treasury Department granted GlaxoSmithKline a first-of-its-kind
license to market the Cuban vaccine against meningococcal B bacteria. [24]
Interestingly, Chiron has licensed its competitor, Aventis, to market its
MenjugateT vaccine in Europe.

Despite all of this, pharmaceutical companies themselves acknowledge that
the meningococcal B bacterium is uniquely resistant to vaccination. [25] In
fact in 2000 Chiron's Dr Rappuoli stated that, "Conventional research
approaches to develop effective vaccines against different strains of group
B meningococcus have failed." In 2002 Dr Rappuoli reported that despite
years of effort, biomedical scientists failed to find a protective molecule
that would induce immunity to type B meningococcal disease. [39]

Perhaps this is why Chiron has recently commenced clinical trials of a
genetically engineered broad-spectrum meningococcal B vaccine. This begs
the question; is New Zealand's foray into the international vaccine game
little more than a form of naive and cynical political manipulation.

From Chiron's perspective, given the recent comment by Merrill Lynch that
"with only one of Chiron's three businesses doing well" growth was likely
to slow, the $140 million it is being paid for "developing and trialling" a
vaccine made by someone else, then being handed a license to supply 3.5
million doses to a guaranteed market must seem convenient. Especially given
they have been spared the expense of Phase III trials.

While Chiron's withdrawn MenjugateT made it to Phase III trials [48] the
New Zealand Minister vetoed the idea of Phase III trials for MeNZBT saying
it was agreed that the amount of safety and efficacy information on the
Norwegian specific vaccine produced in Norway for Norway could be bridged
to the New Zealand clinical trials.

Phase III trials are generally considered to be the place where the true
effectiveness and safety of a vaccine becomes known. The Minister added
that additional trials would have added little value given the comparable
information already available. She went onto say this approach allowed the
rapid introduction of the vaccine. [40]

This tactic is akin to Vioxx being approved based on Celebrex data; that
because there was only a minor difference in the two drugs, the adverse
effects and benefits would be the same. The fact that the Norwegian vaccine
designed for their epidemic was never approved for routine use in its own
country because it wasn't effective enough seems to have slipped from
memory here.

It should also be noted that it was only through extensive phase III
testing that it was proven that Vioxx and Celebrex are lethal drugs
responsible for tens of thousands of deaths in the US and several hundred
at least in Australasia. Is the reason for the Minister's dismissal of
Phase III trialing because such testing might have undermined the political
and public momentum for the MeNZBT vaccination program?

While Chiron's motives may be transparent, it is the roles of New Zealand
researchers and medical regulators that are of primary concern.

Numerous countries are beginning to ask about the alliances between
science, research, regulators and the pharmaceutical industry and the
conflicts of interest those alliances create. Specifically there are
significant connections and conflicts of interest between the corporation
holding the trademark on the MeNZBT vaccine and researchers and regulators
in New Zealand. The fact that the government gave away ownership of the
intellectual property is one mystery. The Chiron funded conference
mentioned earlier is a prime example of how one medical professional is
building a reputation and career courtesy of a company whose product she is
meant to be trialing in an unbiased way.

Potentially dangerous conflicts of interest extend to the MeNZBT adverse
event monitoring system. This system is overseen by hand picked pro-vaccine
specialists. In two cases these specialists are colleagues of the
meningococcal B researchers. This 'independent' monitoring board has
developed a method that only considers known adverse events, discounting
deaths following meningococcal vaccination as due to 'accident' or 'other
unrelated illness'. It should be noted that the Minister has not denied the
two deaths reported to have occurred during the trials. [42] They were
dismissed as being not relevant to the vaccination trial. This is at odds
with good pharmaco-vigilance practice.

There is the question of why the appointed champion of the meningococcal B
vaccine program is also on the MAAC vaccine sub-committee that recommended
the approval of the vaccine - in spite of concerns about manufacturing and
quality of the vaccine and lack of evidence of efficacy. This final MAAC
meeting was convened with less than a days notice. The majority of members
had not seen the clinical data so the champion of the meningococcal B
vaccine program then participated in the final full MAAC meeting to brief
the experts before they made their decision. The minutes note that this
extensive input 'had no influence on the final decision.'

The minutes of a second MAAC vaccine subcommittee meeting held the day
before the final full MAAC meeting in July are apparently so contentious
that the Minister has refused to release them under the Official
Information Act stating that to do so would discourage full and frank
discussions. Interestingly, no mention is made of this meeting in the final
MAAC minutes.

Then there are the ethical questions surrounding the Ministry of Health
downloading school rolls into its new National Immunisation Register to
capture all children's ID information. Was informed consent granted for
that? [26]

The questions surrounding the MeNZBT vaccine continue to mount. Given that
government documents reveal that it was a vaccine made in Norway and not
Chiron's Italian made MeNZBT vaccine that was used in the New Zealand
trials, and given that a virtually un-tested vaccine rolled out 'without
efficacy data" is now in general use, the primary question may be: is the
Chiron MeNZBT vaccine now being used in the current mass vaccination of
1.15 million young New Zealanders itself an uncontrolled medical experiment?

On December 7 2004 Merrill Lynch said that Chiron Corporation "may become
the vaccine supplier of last resort, given its manufacturing problems and
tarnished reputation." [47] With hind-sight, maybe it already has.

Perhaps a recent comment in the New York Times goes some way to explaining
the ideology behind it all. In a debate before the US Advisory Committee on
Immunization Practices an immunization expert, discussing the introduction
of a new meningococcal vaccine said, "Frightening parents about the
consequences of failing to vaccinate their children will most likely be
part of the campaign. For that task, meningococcal meningitis is ideal."

In New Zealand the Ministry of Health has done more than frighten the
public. They appear to have participated in a new orchestrated litany of
lies and a massive breach of the public trust.

*********

FOOTNOTES:
The Meningococcal Gold Rush: References
Barbara Sumner Burstyn, Ron Law
February 2005


1. http://www.beehive.govt.nz/ViewDocum...cumentID=12906

2. http://www.beehive.govt.nz/ViewDocum...cumentID=14056

3. http://www.clerk.parliament.govt.nz/...Hansard/Final/
FINAL_2004_09_15.htm#_Toc84652997

4. Memorandum to Cabinet Health and Education Committee: Request for Group
B Meningococcal Vaccination Campaign Funding. Office of the Minister of
Health, 2001, Para 3 -

5. http://www.chironvaccines.com/company/
vaccines_Press_Area_7_July_2004.php

6. Lancet. 1991 Nov 2;338(8775):1093-6

7. http://www.chiron.com/investors/pres...ase070704.html,
July 8 2004

8. MAAC VSC Minutes, 5 April 2004

9. MAAC Minutes, 6 July 2004

10. MACC VSC Minutes, 5 April 2004

11. An Economioc Evaluation of Vaccination against Meningococcal Disease,
2001, Milne et al

12. Cabinet Memorandum, December 2001

13. Minister of Health, Answers to Parliamentary Question 16087 (2004) and
PQ 16985 (2004).

14. Cabinet Memorandum, December 2001)

15. The Minister provided figures in answer to PQ 16087 (2004) that deaths
from the targeted strain had dropped from a high of 17 in 2001 to 4 in
2003. ESR figures provided under the OIA said there were 5 deaths in 2003.
Estimates are that there have been 4 deaths for all ages due to the
targeted strain in 2004.

16. MOH website, and answers to PQ 16087 (2004) Deaths due to all strains
of the disease declined to 13 in 2003 and 8 in 2004 for all ages. In 2003
and 2004 there have been 5 and 4 deaths respectively due to the epidemic
strain of meningococcal B.

17. Cabinet Memorandum, December 2001

18. Trial V60P50

19.
http://www.chironvaccines.com/compan...tober_2004.php

20.
http://www.nytimes.com/2004/05/26/in...TE_NOTE.html?e
x=1103086800&en=3c3708deef7992a5&ei=5070

21. http://www.nfid.org/conferences/vaccine04/abstracts.pdf

22. MOH, (2004) The Epidemiology of Meningococcal Disease in New Zealand

23. State of the Art of New Vaccines: Research & Development Initiative for
Vaccine Research, World Health Organization, Geneva, April 2003

24.
http://www.medicc.org/Medicc%20Revie...s_from_cuba.ht
ml

25. "Chiron Vaccine is building on its technical expertise in developing
the meningococcal vaccines to develop a recombinant vaccine against
serogroup B. Sequence variation of surface-exposed proteins and
cross-reactivity of the serogroup B capsular polysaccharide with human
tissues have hampered efforts to develop a successful vaccine." Quote from
Chiron's website,
http://www.chironvaccines.com/compan...line_Men_B.php

26. Quote from MeNZB Update the majority of our schools "have now received
upgrades to their own school roll systems that will enable a '1' button
push to produce the required roll extracts for the upcoming campaign."
http://www.imac.auckland.ac.nz/new/m...nzbge04_04.pdf
http://www.simpl.co.nz/News/Press/PressRel_2.aspx
http://www.moh.govt.nz/moh.nsf/0/e2f...264?OpenDocume
nt

27. [Chiron to Co-Develop Combination Meningitis B/C Vaccine With the
Norwegian Institutes of Public Health; Company Gains Access to Meningitis B
Vaccine, Nov 1999,
http://stg.syndnet.thomsonfn.com/Inv...y.aspx?partner
=5425&storyId=74296]

28. http://www.chiron.com/investors/shar...r/2003_10K.htm

29. Ref: Minutes MAAC VSC 5 April 2004

30. http://www.nzherald.co.nz/index.cfm?ObjectID=3577033

31. ( http://www.moh.govt.nz/moh.nsf/f8726...5666d000c8888/
3691822b313276c7cc256aa000182d53/$FILE/MeningococcalDiseaseRates-PrinterVers
ion.pdf)

32. http://www.who.int/emc-documents/men...oemcbac983.pdf

33. Memorandum to Cabinet Dec 2001

34. (Rodríguez, AP. et al, .Impact of Antimeningococcal B Vaccination . Mem
Inst Oswaldo Cruz, Rio de Janeiro, Vol. 94(4), Jul./Aug. 1999).

35. Proceedings of the Meningococcal Vaccine Strategy World Health
Organization Satellite Meeting, 10 March 2004, Auckland NZ; published in
NZMJ, Aug 2004.

36. http://www.moh.govt.nz/moh.nsf/238fd...56669006aed57/
17b9ed43b23631d3cc256b52000a00e2?OpenDocument

37. Chiron Press Release, January 2004

38. Ref: Answer to PQ 17136 (2004). Rt Hon Winston Peters to the Minister
of Health (24 November 2004

39. Moxon and Rappuoli, 2002

40. 17975 (2004) Published - Health - Normal Reply Question: Have any
Phrase III Clinical studies been undertaken on the MeNZB (tm) vaccine? If
so, when and what were the results?
Portfolio: Health. Minister: Hon Annette King, Date Lodged:09/12/2004

41. http://www.medsafe.govt.nz/Profs/adverse/Minutes111.htm

42. MOH website - ISMB report, October 2004

43. New York Times, 28 Aug 2004;
http://query.nytimes.com/gst/abstrac...B8EDDA10894DC4
04482 and later reports.

44. O'HALLAHAN, J. How to harness the political will and implement an OMV
vaccine solution to combat a devastating epidemic Meningococcal Vaccine
Strategy, Ministry of Health, Auckland, New Zealand. Thirteenth
International Pathogenic Neisseria Conference held at the Norwegian
Institute of Public Health, Oslo, Norway; Sept. 1-6, 2002

45. The New Zealand Association of Economists (Inc) 45th annual conference,
2004 Programme, 30 June - 2 July 2004. Eradicating meningococcal disease in
New Zealand: Is it worth it? To whom? And who decides? Name of author
withheld.

46. Letter dated 24 June 2002, on file

47. http://www.forbes.com/markets/2004/1...ketscan18.html

48.
http://www.fdanews.com/cgi-bin/udt/i....id=wbi-dpa&st
ory.id=32122

49. PQ 2100 (2004). Dr Lynda Scott to the Minister of Health (9 March
2004): How much money has been spent on meningitis programmes and where has
this money been spent, specified by programmes and allocated funding?

Hon Annette King (Minister of Health) replied: Between 1 December 1997 and
31 December 2003, a total of $21.7 million (GST inclusive) has been spent
on the Meningococcal Vaccine Strategy. Of this, $10.7 million has been
spent on the development of the group B meningococcal vaccine, $7.8 million
on conducting clinical trials, and $0.7 million on planning and preparation
for the national immunisation rollout programme. A further $2.5 million has
been spent on operational funding to support what will be New ZealandÆs
largest immunisation programme.

50. PQ 5241 (2003). Dr Lynda Scott to the Minister of Health (28 May 2003):
Will New Zealand acquire the intellectual property rights to the
meningococcal
vaccine that is being trialled?

Hon Annette King (Minister of Health) replied: No. New Zealand will not
acquire the intellectual property rights because New Zealand does not have
manufacturing experience in producing Outer Membrane Vesicle (OMV)
vaccines. If this were indeed possible, repeated clinical trials would need
to happen in New Zealand for the production of MeNZB. When a vaccine is
produced at a new manufacturing site, it is deemed for clinical reasons a
new vaccine and would require a full clinical investigation and licence
application.

51. Graph One - The Rise And Fall Of Meningococcal Disease In NZ


52. Graph Two - The Experience In Cuba



***** ENDS *****

© Barbara Sumner Burstyn, Ron Law February 05