Matters Arising from the NZ Pharmacovigilance Centre
Chris McCashin made this Official Information request to Ministry of Health
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From: Chris McCashin
Dear Ministry of Health,
Meetings of the Medicines Adverse Reactions Committee (MARC)
Please provide the following since the start of 2021 including the Out of Session Meeting - 20 January 2021 relating to the Medicines Adverse Reactions Committee (MARC)
Meetings 185 - 192 and to include the following
Ultimately I am looking for all of the information MARC received from CARM and then the work completed by MARC which I believe relate to Sections 2.0 and Sections 3.0 of the minutes.
2.0 Matters Arising from the New Zealand Pharmacovigilance Centre
CARM Quarterly Reports and fatal reports for which CARM assessed the causality to be at least possible, Reports of Cases of Injuries etc etc, all of the information presented to MARC by CARM
3.0 Pharmacovigilance Issues
Matters referred to MARC under Section 36 of the Medicines Act 1981
I am specifically looking for all of the above relating to the Covid-19 vaccine. Such things arising from the Medsafe Reports include but limited to being the 4 Causal Deaths relating to the Covid-19 vaccine, all of the associated heart issues, pregnancy - suspect there should be a number of things given the safety signals that have been reported by Medsafe.
Can you also please provide the standards for Section 36 of the Medicines Act 1981.
Ultimately want all of the Matters Referred to MARC by Medsafe
Following on from that can you please provide all of the Recommendations and Associated Reporting completed by MARC.
As noted above - I am specifically asking for information relating to the Covid-19 vaccine and not all the other reports referring to the other Medicines.
Can you also please provide the total number of matters referred to MARC by Medsafe associated with the Covid-19 vaccine.
Yours faithfully,
Chris
From: OIA Requests
Kia ora Chris
Thank you for your request for official information received on 30 January
2023:
I would like to OIA information about Medsafe.
Meetings of the Medicines Adverse Reactions Committee (MARC)
Please provide the following since the start of 2021 including the Out of
Session Meeting - 20 January 2021 relating to the Medicines Adverse
Reactions Committee (MARC)
Meetings 185 - 192 and to include the following
Ultimately I am looking for all of the information MARC received from CARM
and then the work completed by MARC which I believe relate to Sections 2.0
and Sections 3.0 of the minutes.
2.0 Matters Arising from the New Zealand Pharmacovigilance Centre CARM
Quarterly Reports and fatal reports for which CARM assessed the causality
to be at least possible, Reports of Cases of Injuries etc etc, all of the
information presented to MARC by CARM
3.0 Pharmacovigilance Issues
Matters referred to MARC under Section 36 of the Medicines Act 1981
I am specifically looking for all of the above relating to the Covid-19
vaccine. Such things arising from the Medsafe Reports include but limited
to being the 4 Causal Deaths relating to the Covid-19 vaccine, all of the
associated heart issues, pregnancy - suspect there should be a number of
things given the safety signals that have been reported by Medsafe.
Can you also please provide the standards for Section 36 of the Medicines
Act 1981.
Ultimately want all of the Matters Referred to MARC by Medsafe
Following on from that can you please provide all of the Recommendations
and Associated Reporting completed by MARC.
As noted above - I am specifically asking for information relating to the
Covid-19 vaccine and not all the other reports referring to the other
Medicines.
Can you also please provide the total number of matters referred to MARC
by Medsafe associated with the Covid-19 vaccine.
The reference number for your request is: H2023019684.
As required under the Official Information Act 1982, Manatū Hauora will
endeavour to respond to your request no later than 20 working days after
the day your request was received. If you'd like to calculate the
timeframe, you can use the Ombudsman's online calculator here:
[1]http://www.ombudsman.parliament.nz/
If you have any queries related to this request, please do not hesitate to
get in touch.
Ngā mihi
[2]www.health.govt.nz
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From: OIA Requests
Kia ora Chris
Please find attached a letter regarding your request for information
Ngā mihi
OIA Services Team
Manatū Hauora | Ministry of Health
M[1]inistry of Health information releases
U[2]nite against COVID-19
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From: Chris McCashin
Dear OIA Requests,
A follow up on this to ensure I am not missing anything.
The current Pfizer Covid-19 vaccine has "provisional' approval until 3 November 2023 - Yes - No?
There have been four confirmed deaths from the Covid-19 vaccine - Yes - No?
Despite these deaths the current risk management plan does not identify death as a risk - Yes - No?
The current risk management plan notes there is missing information in pregnancy and breastfeeding - despite this missing information the vaccine was recommended by agencies for pregnant woman? Yes - No?
There have been reports of spontaneous abortion and miscarriage to CARM following administration - Yes - No?
The four deaths caused by the Covid-19 vaccine have never been discussed / considered by Medicines Adverse Reactions Committee Meeting (MARC)? Yes - No? To put into perspective numerous other Medicines that have caused death have, but not the Covid-19 causality deaths following review of all the meeting minutes as far as I can tell since the roll out.
The initial meeting discussing the Covid-19 vaccine quoted by Medsafe that "safety specification for this product is currently inadequate and does not accurately reflect known risks". Despite this information Medsafe allowed this vaccine to be mandated with reliance on "robust post-market" information gathering being of the utmost importance.
Knowing that "robust post-market" information was required the regulator Medsafe / Health authorities vaccinated the control group? Yes - No
Therefore there are no data points that can be relied on by the regulator? Yes - No
There are "15 deaths that could not be assessed due to insufficient information". Despite being a first world country our regulator can approve a medicine but does not then have the ability / tools to determine if the person died of the vaccine. Yes - No
New Zealand suffered 18% excess mortality the year this vaccine was rolled out - Yes - No
There is not one person in any and all of the regulatory authorities that has the ability to determine if fifteen people (some of these very young) died from a medication that is known to cause death. Doctors, Health Professionals, Medsafe, Ashley Bloomfield, Pfizer representatives, Minister of Health, Coroner, internet searches. So just to confirm - Medsafe can approve a medicine but then don't have the ability to determine if that medicine that they approved killed that person? Yes - No
Can yo also please provide all of the Post Marketing studies provided to Medsafe by Pfizer.
If these are not available can you provide dates these reports were received.
Is Medsafe aware that FDA, CDC and tried to bury trial information and post-marketing Pfizer reports for 75 years - does Medsafe have any inclination as to why this might be? Maybe it is reflective of our current dataset?
Yours sincerely,
Chris McCashin
From: OIA Requests
Kia ora
Thank you for your request for official information. The reference number
for your request is: H2023020017
As required under the Official Information Act 1982, Manatū Hauora will
endeavour to respond to your request no later than 20 working days after
the day your request was received. If you'd like to calculate the
timeframe, you can use the Ombudsman's online calculator
here: [1]http://www.ombudsman.parliament.nz/
If you have any queries related to this request, please do not hesitate to
get in touch.
Ngā mihi
OIA Services Team
M[2]inistry of Health information releases
U[3]nite against COVID-19
****************************************************************************
Statement of confidentiality: This e-mail message and any accompanying
attachments may contain information that is IN-CONFIDENCE and subject to
legal privilege.
If you are not the intended recipient, do not read, use, disseminate,
distribute or copy this message or attachments.
If you have received this message in error, please notify the sender
immediately and delete this message.
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References
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1. http://www.ombudsman.parliament.nz/
2. https://www.health.govt.nz/about-ministr...
3. https://covid19.govt.nz/
hide quoted sections
From: OIA Requests
Kia ora Chris
Please find attached a letter regarding your request for information
Ngā mihi
OIA Services Team
Manatū Hauora | Ministry of Health
M[1]inistry of Health information releases
U[2]nite against COVID-19
****************************************************************************
Statement of confidentiality: This e-mail message and any accompanying
attachments may contain information that is IN-CONFIDENCE and subject to
legal privilege.
If you are not the intended recipient, do not read, use, disseminate,
distribute or copy this message or attachments.
If you have received this message in error, please notify the sender
immediately and delete this message.
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References
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Chris McCashin left an annotation ()
Unfortunately when the data / reports are provided follow up questions are required and then they just obfuscate or trot out Medsafe / Pfizer propaganda / talking points. Their own data is atrocious for a "medication" for a virus that was never a threat to a young healthy person and anybody that followed this new that. Yet our regulators are the only people that can't be agile and change advice based on thousands of injuries, suspect deaths (from their own dataset) and so therefore they are aware their own processes from day one were corrupted. The cover up is always worse than the crime and that is why I suspect they are approving this for under 5's to really muddy the waters and trying and hide / muddle up all the data that they have. And as far as I can see if you get past the first 21 days then our regulators aren't even considering if an illness outside this window is related to an "experimental" shot.
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R Bailey left an annotation ()
You need to ask for the names of people / depts who are responsible for creating the data you want and then request their files.
Asking questions will get you nowhere.
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