MeNZB(tm) Claims Don't Stack Up

Press Release
MeNZB(tm) Claims Don't Stack Up
Ron Law & Barbara Sumner Burstyn

"Claims made by the Chair of the Minister's medicines assessment advisory committee that MeNZB(tm) concerns were answered in Chiron's final dossier don't stack up," say risk & policy analyst Ron Law, and writer/researcher Barbara Sumner Burstyn. [Dr Robson's statement is at http://www.immunise.moh.govt.nz/mediareleases/090605.html]

According to the minutes of the Tuesday 6 July 2004 MAAC meeting, it is possible that only two members of the eleven members of the full MAAC committee had actually seen the data considered. [Minutes attached]

The minutes do not mention a contentious meeting of the vaccine subcommittee held the day before, but only refer to the 5 April 2004 meeting that Dr Robson now says was out of date.

Something does not stack up.

The Minister of Health has refused to release the minutes of the secret Monday 5 July vaccine subcommittee meeting stating that to do so would restrict her advisers expressing, "free and frank expression of opinions..." [Letter attached]

According to Professor Robson, the committee had no concerns about the clinical data in the final dossier.

We find that a puzzling statement given the fact that the minutes of the Tuesday 6 July meeting that approved MeNZB(tm) was so hurriedly organised that less than half a day's notice was given, that three members could not be contacted, and that committee members had not received the clinical dossier that Professor Robson says they had considered.

The minutes of the final [Tuesday] meeting do not mention the secret and contentious meeting held the day before, but state, "Clinical data have been discussed by the VSC on 5 April and a recommendation made that the data supported provisional consent subject to satisfactory manufacturing and quality data."

The minutes of the final meeting also note that the quality and manufacturing data was still to be addressed. The vaccine was licensed under the fast-track provisions of s23 of the medicines act the very next day.

The minutes of the final meeting state: "The Committee noted that not all members had seen the clinical data due to the short notice of the teleconference. The Chairman invited Dr Reid to join [the] teleconference to provide an overview of the trials and the safety-monitoring programme."

The minutes claim that Dr Reid's involvement had no influence on the committee's decision. We find that statement puzzling; if that was the case, why did Professor Robson need to include Dr Reid's input into the final decision-making process?

The minutes record the following:

"Conflict of Interest: When Dr Reid joined the teleconference, he stated that he had a conflict of interest as he has been a member of the Meningococcal B Vaccine Project Committee for the past five years. Dr Reid was not involved in the decision concerning the licensure of the vaccine.

The conflict of interest was noted but did not influence the discussions or decision."

We note that it is not recorded in the minutes that Dr Reid was, according to Chiron's Clinical Trial Application V60P4, received under the Official Information Act, its principal clinical investigator in his capacity as a member of the MAAC vaccine subcommittee. [pages 2 & 13 of clinical trial application attached.]

Given the above, we believe that it is in the interests of our nations 1.15 million children who are being subjected to a mass State medical experiment to know the details of the "free and frank expression of opinions..." that occurred on the Monday 5 July 2004 MAAC vaccine subcommittee were. The Minister must release those minutes to verify statements made in defence of the MeNZB(tm) vaccine.

We believe that the people of New Zealand have a right to know why the final meeting of the Minister's expert advisory committee was so rushed that less than 24 hours notice was given, three members could not be contacted, and perhaps only two of the seven members who could attend had seen the clinical data that they were assessing.

Why was such an important decision about such a contentious issue taken so lightly?

Why, if the MAAC was satisfied with the safety and efficacy of the vaccine, did Medsafe write to Dr Jane O'Hallahan on 3 August, 2004, four weeks AFTER the MeNZB(tm) vaccine and say,

"The Vaccine Sub-committee (VSC) met on 5 April 2004 to discuss the clinical issues associated with the vaccine. The minutes of that meeting note that the VSC agreed that a letter be sent to the Director of the Meningococcal Vaccine Strategy team advising that as a condition of provisional consent of this product the following would be required to be carried out by the Meningococcal Vaccine Strategy Team and reported back to Medsafe:

Informed consent formes be provided to person about to be vaccinated (or parent/guardian in the case of children under age of 15 years). These forms clearly identify concerns about efficacy..." [Letter attached]

Why, did Medsafe not make mention of the 5 July MAAC VSC meeting?

Why has the Chairman of that Committee now made the public statement that, "The Medicines Assessment Advisory Committee (MAAC) is satisfied that the development programme for MeNZB provided the committee with appropriate data to demonstrate the safety and efficacy of the vaccine." when the publicly available minutes of its meetings and Medsafe's letter shows that it was not?

Our information is that there was a significant "free and frank expression of opinions..." at the Monday 5 July 2004 vaccine sub-committee meeting, and that most of that revolved around [lack of] transparency of process and concern that there was actually no efficacy data regarding the MeNZB(tm) vaccine...

The safety of 1.15 million children surely takes precedence over the saving of face of an advisor or two?"

"Given the above, the Minister must now release the minutes of the 5 July MAAC VSC meeting so that the people of New Zealand can decide the truth for themselves," say Law & Sumner Burstyn

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