[ MenZB vaccine NZ] Medical License Breached

[back] MeNZB vaccine (meningococcal)
http://www.whale.to/vaccine/medical_..._breached.html

Medical License Breached
Monday, 28 July 2008, 11:45 am
Press Release: Ron Law
http://www.scoop.co.nz/stories/GE0807/S00141.htm


Medical License Breached
Media Release
Ron Law
Risk & Policy Analyst

"The Minister of Health needs to explain to the public why the Ministry of
Health deliberately withheld information from parents that was a condition
of the license of the experimental drug, MeNZB," says risk & policy analyst
Ron Law.

Documents received under the Official Information Act show that on August 3
2004, the Ministry of Health's Director of the MeNZB campaign was advised,
in writing, (see attachment) that a condition of the MeNZB license required
the consent form to be amended to include the fact that the Minister's own
expert advisory committee was so concerned about the lack of efficacy
information relating the the experimental drug, MeNZB, that a condition of
the license to use MeZNB was that parents were advised of that concern.

Can the Minister please explain to the parents of New Zealand children why
Dr O'Hallahan ignored that important condition of the license?

Can the Minister also explain upon what basis one of Chiron's own
researchers, Dr Stewart Reid, writing in his capacity as a GP and an
"Advisor to the Meningococcal Vaccine Strategy," wrote a document (see
attachment) that was contrary to the findings of the Minister's own
committee (which he took part in) when he reassured health professionals,
"Key Message: The MeNZB vaccine targets the epidemic strain of meningococcal
disease in New Zealand and offers a high level of protection against the
epidemic strain that is expected to last for several years."... and "In
summary - The MeNZB vaccine targets the epidemic strain of meningococcal
disease in New Zealand and offers a high level of protection against the
epidemic strain that is expected to last for several years.?"


Attached:
Medsafe_Instruction_to_MOH_re_efficacy___3_Aug_200 4.pdf

On Mon, 28 Jul 2008 08:46:07 +0100, "JOHN" wrote:

Ron Law
Risk & Policy Analyst

Would this self appointed "Risk & Policy Analyst" of "Juderon
Associates" and "Beyond Alternative Solutions" be the same Ron Law, a
food supplement lobbyist, business management lecturer, and
ex-Director of the NZ "Nutritional Foods Association" who is also an
anti-vaccination campaigner and is railing against his "supplements"
being subject to quality control and proven efficacy standards?

(What is a non-nutritional food - McDonalds?)

Peter Parry wrote:
On Mon, 28 Jul 2008 08:46:07 +0100, "JOHN" wrote:

Ron Law
Risk & Policy Analyst

Would this self appointed "Risk & Policy Analyst" of "Juderon
Associates" and "Beyond Alternative Solutions" be the same Ron Law, a
food supplement lobbyist, business management lecturer, and
ex-Director of the NZ "Nutritional Foods Association" who is also an
anti-vaccination campaigner and is railing against his "supplements"
being subject to quality control and proven efficacy standards?

(What is a non-nutritional food - McDonalds?)

Is it the best argument you can make - to divert attention from
the message to the messenger and attack the messenger?

He could be a child rapist but the referenced document indeed shows
that there was a concern about vaccine efficacy, and that one of the
conditions for the vaccine approval was:

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

http://img.scoop.co.nz/media/pdfs/08...Aug_200 4.pdf

"Mike" wrote in message news:4Nujk.276$iM5.107@trnddc07...
Peter Parry wrote:


Is it the best argument you can make - to divert attention from
the message to the messenger and attack the messenger?


All these quackpopts have in the way of argument, Parry seems to specialise
in it

On Tue, 29 Jul 2008 01:56:16 GMT, Mike wrote:

Peter Parry wrote:

Is it the best argument you can make - to divert attention from
the message to the messenger and attack the messenger?

By the messenger I presume you mean Ron Law rather than John? John
has a habit of trying to imply his quotations are made by people with
rather better qualifications than they actually posses and Law is
somewhat more than an unbiased messenger as the two references made
by John simply refer to articles written by Ron Law. Laws claims
also appear to be misleading if not completely false.

He could be a child rapist but the referenced document indeed shows
that there was a concern about vaccine efficacy, and that one of the
conditions for the vaccine approval was:

That letter does not impose a condition and appears to have been taken
out of context. The VSC met on the 5th Apr 2004

http://www.medsafe.govt.nz/hot/paper...s05apr2004.htm

Those minutes record:-

"That the application for Meningococcal B (MeNZB) vaccine be
approved... approval is subject to the following [extract]:

That a patient information sheet is to be reviewed by the VSC, as the
information should indicate that this vaccine cannot guarantee
protection as it is not effective against all serotypes of
Meningococcus.

Apr 06.2004
After email discussion among the VSC members it was decided that
Medsafe should not be involved in deciding what is or is not required
for informed consent, as this is outside the VSC jurisdiction and it
is more appropriate for the ethics committees.
However, it was recommend that the VSC should flag that in their
opinion informed consent should be obtained and leave the detail for
an ethics committee who would consider the consent form for
vaccination in schools."

A consent form was subsequently produced.

Their report was considered by the Medicines Assessment Advisory
Committee Meeting on the 6th Apr 2004
http://www.medsafe.govt.nz/hot/paper...06July2004.htm

Their minutes record :-

"The Chairman advised the Committee that the object was to decide if
there was sufficient evidence to confirm the Vaccine Sub-Committee
recommendation for approval under Section 23 of the Medicines Act
1981.

The Chairman noted that the quality and manufacturing data (Module 3,
with Module 2 summaries) relating to the Meningococcal B vaccine
(MeNZB) produced by Chiron S.r.L. have been assessed by the Medicines
and Healthcare Products Regulatory Authority (MHRA) and discussed with
the National Institute of Biological Standards and Control UK (NIBSC).

Clinical data have been discussed by the VSC on 5 April 2004 and a
recommendation made that the data supported provisional consent
subject to satisfactory manufacturing and quality data."

"The Committee discussed the current levels of disease in the Auckland
region and noted that the benefits of the vaccine appear to be clear
when viewed in this context."

"The Committee raised the question of informed consent and the
Chairman confirmed that this is not a regulatory issue."

So it appears that the claim Law is making is not true, no such
condition as he claims was attached to the licence and the licence
was not breached.

"The committee recommended section 23 approval for the Meningococcal B
Vaccine and agreed that the benefits out weighed the risks. " One
would have thought a "Risk and Policy Analyst" would understand
risk/benefit calculations.

The full timeline for approval is on the Medsafe website at
http://www.medsafe.govt.nz/hot/paper...enzb/menzb.asp

the Medsafe data sheet for MeNZB is at
http://www.medsafe.govt.nz/Profs/Dat...m/MeNZBvac.htm