Meningococcal Gold Rush III: post-MeNZB(tm) Vaccine Update

RELATED MATERIAL:
See also... Source Documents In .PDF Format
For earlier coverage see...
Investigation: The Meningococcal Gold Rush - 7 February 2005
And...
The Meningococcal Gold Rush - Second Edition - 30 May 2005

"Most rewardingly we are seeing the early, promising reduction in cases of disease and vaccine effectiveness calculations confirm an effective vaccine. Conclusions: this calculated gamble has paid off - we are in the process of controlling an epidemic using a designer vaccine."
- Ministry of Health, Director of the Meningococcal Vaccination Programme, Dr Jane O'Hallahan, the Ninth Annual Conference of Vaccine Research, Baltimore, MD
May 2006

In this Meningococcal Gold Rush III post-MeNZB(tm) vaccine update we present fresh evidence revealing apparent scientific misconduct relating to the recently concluded meningococcal vaccination program and associated research.

This new evidence reveals major deviations from ethics-committee approved methodology and shows that the vaccine manufacturer Chiron denied other members of the research team access to data preventing independent analysis. Documents (View Source Documents In .PDF Format) show that the MeNZB(tm) vaccine studies appear to have been manipulated to provide desired outcomes, especially in the infant studies ^[1]

These documents reveal Chiron has exclusively controlled the data analysis and refused to provide the electronic dataset to the principal investigator for independent verification. This so concerned Professor Diana Lennon of Auckland University, that she voiced her alarm to the Ethics Committee in writing. Professor Lennon was of the belief that the Ministry of Health had also been denied access to the electronic dataset.

However, in her letter of reassurance 'To The People of New Zealand' in response to our Meningococcal Goldrush investigative reports the Director General of Health Dr Karen Poutasi declared that 'the vaccine was tested according to international standards.' The newly received documents predate this statement. They reveal that senior Ministry of Health officials were aware of Professor Lennon's concerns. This suggests that if the Director General herself did not know that her statements were false, her senior advisors did.

We have been provided with two letters and fragments of a third letter written by Professor Lennon in March 2005. They state that, to facilitate vaccine licensure two MeNZB(tm) study reports had been signed off by her, without her having seen the data. Professor Lennon states that reports of two other MeNZB(tm) studies were provided to the licensing committee without her, as principal investigator, having seen them until after licensure was granted. Professor Lennon claims that Chiron also denied the Ministry of Health access to the datasets.

Professor Lennon derides the public claims of the Ministry of Health about peer review and partnership when she states, "In no case has the electronic dataset been available to the Investigator and Statistician to verify the company's results. This is in face of a publicly declared partnership between the University of Auckland, Chiron Vaccines and the Ministry of Health for the production of clinical trial data by the University of Auckland for licensure of the vaccine and epidemic control."

These alarming revelations provide some insight into the fact that false information was provided to MAAC, the Minister of Health's vaccine licensing committee. The minutes of the MAAC Vaccine subcommittee meeting that approved the vaccination of young babies (released following intervention by the Ombudsman) contains contradictory data. In fact the figures are so at odds that there have been up to four published versions of the numbers of trial participants and the number included in Chiron's analysis of immune response. In any other scientific arena such discrepancies would render the trial results invalid and result in investigations of scientific misconduct.

In addition, we have obtained a document that reveals that only 38 percent of those infants [supposedly] enrolled in the study were included in Chiron's analysis. Further, the document shows that Chiron excluded babies that failed to produce an antibody response from their analysis for both the young infant and older infant groups. This is akin to a school claiming a 100 percent pass-rate in NCEA assessments after excluding students who failed. This is an extreme deviation from the methodology approved by the ethics committee that stated that all infants completing the study would have blood taken for analysis.

Further deviations from the approved methodology have also been uncovered. According to both the MAAC minutes and Chiron's Medsafe approved MeNZB(tm) datasheet 55 percent of the young infants had a 'greater than four fold increase in antibodies' after a third dose of vaccine.

However, the documents clearly show that contrary to other studies, Chiron did not use a fourfold increase in antibodies as the endpoint; instead the documents obtained suggest an endpoint of slightly more than two-fold was used. Chiron's datasheet and the MAAC data excluded babies who had no increase in antibody levels and included the 5 percent of infants with already raised antibody levels at the beginning of the study to determine the 55 percent response figure. In other words the data has been deliberately 'managed' to produce a positive outcome despite the trials mandated threshold for vaccine effectiveness barely being reached. Available data suggests that the actual response rate was somewhat less than the 50 percent pass mark.

Given the above we are not surprised to learn that Professor Lennon raised her serious concerns about the integrity of the study results, and despite being the principal investigator and guarantor of the integrity of the MeNZB(tm) research, we note that her name has been excluded from the authorship of the recently published research.

Also worth noting is that while a fourth dose of MeNZB vaccine was recently approved for the youngest infants on the basis that their antibody levels dropped off quickly after the third dose, an even larger 'decay' [to use the Ministry of Health's term] occurred in antibody levels in the older infants study. This was never made public. Seven months following the third dose of MeNZB only 12.5 percent of the older infant group had so-called protective levels of antibodies compared to 14 percent of the younger infants.

We ask why, if the Ministry of Health believes that the MeNZB vaccine works did they not recommend a fourth dose for older infants?

Also revealed in the disclosed documents is evidence that the Ministry of Health was attempting to change the agreed protocol for storage of research documents in an apparent move to dump Professor Lennon and Auckland University as the lead researchers as early as March 2005. Documents also reveal that within days of an apparent plastering over of relationships, the Ministry of Health was applying to a different ethics committee for approval to undertake effectiveness studies.

We have also been informed that the Ministry of Health has now sub-contracted that research out to a department of the Wellington Medical School that is the recipient of a $500,000 Ministry of Health sponsorship deal that appears to have been negotiated with researchers now leading the rushed effectiveness studies, the results of which are to be announced at a function at Chiron's facilities in Italy next Monday.

With regard to the canned effectiveness study at Auckland University, we have been leaked Ministry of Health data that shows that the MeNZB(tm) vaccine can not be credited with the ongoing decline in meningococcal disease in the Auckland Region as claimed by the Ministry. The data reveals that for the six months Dec 2005 - May 2006 there have been just as many cases of the epidemic strain of meningococcal disease in fully vaccinated children (1.1 per 100,000) as there have been in partially and unvaccinated children (1.2 per 100,000).

In our earlier reports we revealed numerous undisclosed conflicts of interest relating to a key Ministry of Health advisor. The Ministry of Health refused to release Dr Stewart Reid's CV under the Official Information Act. Following the intervention of the Ombudsman the Ministry has released a heavily censored copy. This new document reveals further disturbing undisclosed conflicts of interest relating to relationships with drug companies, and raises questions as to why the Ministry of Health will not release the full CV. The fragments of the CV released reveal no particular qualifications regarding vaccinology and raises serious questions about the involvement in future policy and public health decision making of persons with non-relevant experience and so many competing interests. We also question where the pressure not to release the full CV has originated and how a public servant and the Ministry can justify the censorship?

In addition this key Ministry of Health advisor appears to be in breach of international publication ethics policies. These policies require all authors to declare competing interests. Whilst listed as an author on a number of published MeNZB(tm) articles, including two recent articles in the New Zealand Medical Journal, a plethora of competing interests have not been declared.

Our documents suggest strongly that MeNZB(tm) data has been manipulated and deliberately falsified in order to gain vaccine approval.

The documents (View Source Documents In .PDF Format) reveal the following:

• The principal investigator Professor Dianna Lennon was refused access to data and detailed analysis of at least four data sets.


• The principal investigator signed off two studies without having seen the actual data so that she could verify the results.


• The principal investigator only sited two studies AFTER they had been used to approve the licensing of the vaccine.


• Infants that did not respond to the MeNZB vaccine were excluded from Chiron's analysis to determine immune response used to license the vaccine and 'sell' the vaccine to the public.


• The MOH have changed conditions of the research agreement in a breech of the ethical committee approval.


• A key driving force in the meningococcal vaccine program has numerous competing interests that should have been declared but weren't, including involvement with pharmaceutical companies.


• Discrepancies that cast grave doubts over the independence of the Minister of Health's Medicines Assessment Advisory Committee that recommended licensing of the MeNZB(tm) vaccine.


• The Ministry of Health has canned an effectiveness study being undertaken by the principal investigator and awarded another effectiveness study to a University Department that it provides sponsorship to the tune of $500,000.


• The Ministry of Health is now making false claims regarding the effectiveness of the MeNZB vaccine.

This new evidence, backed by the Ministry of Health's own documents including those received under the OIA, supports our earlier calls for a Royal Commission of Inquiry into circumstances surrounding the policy, research and implementation of a medical experiment involving over 1 million children.

FOOTNOTES:
[1] V60P5 and V60P6

Correspondence to Ron Law, juderon @ gmail.com
Barbara Sumner Burstyn is a free-lance writer based in the Hawkes Bay. She is interested in issues of accountability.

Ron Law's career spans twenty years as a medical laboratory scientist, including 10 years as a clinical biochemistry lecturer, 5 years as a university business management lecturer, including research methodology, 4 years as executive director of a trade association, and more recently as an independent risk & policy analyst. Ron has a masters degree in international business studies and an applied theology degree. Ron was appointed by the Ministry of Health as a member of the expert group that advised the Director General of Health on the reporting and management of medical injury in New Zealand's healthcare system.
© Barbara Sumner Burstyn, Ron Law July 2006

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