Assessment bias toward new medicines - Ivermectin and Pfizer antiviral PF-07321332

Adam Irish made this Official Information request to Ministry of Health

Response to this request is delayed. By law, Ministry of Health should normally have responded promptly and by (details and exceptions)

From: Adam Irish

Dear Ministry of Health,

I request under the official information act the following information:

What systems are in place to ensure that Pharmac doesn't suffer from confirmation bias, group think or a preference towards new medications vs existing licensed expired medicines that aren't supported for an application, due to them being inexpensive.

For example it appears that Pharmac rely on an application for approval of medicines for a different, and if a medicine is out of patient a private pharmaceutical company would have a much larger incentive to make a new drug than prove the efficacy of a preexisting in-expense drug. And as such would not put in an application or do additional research to make the case for it. The pharmaceutical companies would also have a direct incentive to actively discredit or promulgate mistrust of studies that weren't to their financial interests and create a public narrative to support that.

Can New Zealanders have confidence that large pharmaceutical companies which sponsor and fund a significant amount of US media have not deliberately promulgated a narrative of mistrust around the drug Ivermectin. As this looks like it would be financially ruinous to its new Pfizer antiviral, PF-07321332, can New Zealand have confidence that the US media and its media narrative that the drug is just a 'horse medicine' or only for the treatment of parasites has not negatively influenced its assessment as a useful drug in combating Covid-19.

And is our application based system fit for purpose, or does it relies too much on private companies initiating the process. How much do our Pharmac assessors and the Ministry rely on just maintaining a status quo based on overseas decisions where their assessments and scientific assessments may not be completely impartial?

The new Pfizer antiviral, PF-07321332 appears to have the same function as a protease as Ivermectin but as Ivermectin is out of patient and significantly cheaper this could be significantly more adventitious. Has an updated assessment taken place on either of these drugs and are they approved for use in the treatment of Covid-19?

The information in the below video is gathering more attention:
https://www.youtube.com/watch?v=ufy2AweX...

In it Dr. John Campbell appears to be making some compelling claims for the use of Ivermectin, has Pharmac and the Ministry of Health assessed the studies he has cited in relation to an assessment of Ivermectin?

Yours faithfully,

Adam

Studies also below:

https://www.frontiersin.org/articles/10....

https://www.pfizer.com/news/press-releas...

https://www.ncbi.nlm.nih.gov/pmc/article...
https://bnf.nice.org.uk/medicinal-for..

https://pubs.rsc.org/en/content/articleh...

https://www.nature.com/articles/s42003-0...

https://pubs.rsc.org/en/content/articleh...

https://pubs.acs.org/doi/abs/10.1021/acs...

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From: OIA Requests

Kia ora,

 

Thank you for your Official Information Act (the Act) request. This is
an automatic reply to let you know we received it.

 

Due to the COVID-19 global pandemic response, the Ministry is experiencing
significantly higher volumes of queries and requests for information. We
will endeavour to acknowledge your request as soon as possible. Further
information about COVID-19 can be found on our
website: [1]https://www.health.govt.nz/our-work/dise...

 

In accordance with the Act, we'll let you know our decision within no more
than 20 working days. If you'd like to calculate the timeframe, you can
use the Ombudsman's online calculator
here: [2]http://www.ombudsman.parliament.nz/

If you have any questions while we're processing your request, please let
us know via [3][email address]

 

Ngā mihi  

OIA Services Team  

   

[4]Ministry of Health information releases  

[5]Unite against COVID-19 

 

 

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References

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1. https://www.health.govt.nz/our-work/dise...
2. http://scanmail.trustwave.com/?c=15517&a...
3. mailto:[email address]
4. https://www.health.govt.nz/about-ministr...
5. https://covid19.govt.nz/

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From: OIA Requests


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Kia ora Adam,

 

Thank you for your request for official information. The Ministry's
reference number for your request is: H202116879.

 

Please be advised that due dates for requests received from 29 November
2021 onwards take into account the following periods:

 

Christmas (25 December 2021)

Summer Holidays (25 December to 15 January)

New Year's Day (1 January 2022)

Day after News Year's Day (2 January 2022)

 

Your request has been logged and you can expect a reply no later than 17
January 2022 as required under the Official Information Act 1982.

 

Due to the COVID-19 global pandemic response, the Ministry is experiencing
significantly higher volumes of queries and requests for information. If
we are unable to respond to your request within this time frame, we will
notify you of an extension of that time frame.

 

If you have any queries related to this request, please do not hesitate to
get in touch.

 

Ngā mihi

 

OIA Services

Government Services

Office of the Director-General

Ministry of Health

E: [1][email address]

 

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From: OIA Requests


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Kia ora Adam,

Thank you for your request for official information received on 29
November 2021 for:

 

“What systems are in place to ensure that Pharmac doesn't suffer from
confirmation bias, group think or a preference towards new medications vs
existing licensed expired medicines that aren't supported for an
application, due to    them being inexpensive.

 

For example it appears that Pharmac rely on an application for approval of
medicines for a different, and if a medicine is out of patient a private
pharmaceutical company would have a much larger incentive to make a new
drug than prove the efficacy of a preexisting in-expense drug. And as such
would not put in an application or do additional research to make the case
for it. The pharmaceutical companies would also have a direct incentive to
actively discredit or promulgate mistrust of studies that weren't to their
financial interests and create a public narrative to support that.

 

Can New Zealanders have confidence that large pharmaceutical companies
which sponsor and fund a significant amount of US media have not
deliberately promulgated a narrative of mistrust around the drug
Ivermectin. As this looks like it would be financially ruinous to its new
Pfizer antiviral, PF-07321332, can New Zealand have confidence that the US
media and its media narrative that the drug is just a 'horse medicine' or
only for the treatment of parasites has not negatively influenced its
assessment as a useful drug in combating Covid-19.

 

And is our application based system fit for purpose, or does it relies too
much on private companies initiating the process. How much do our Pharmac
assessors and the Ministry rely on just maintaining a status quo based on
overseas decisions where their assessments and scientific assessments may
not be completely impartial?

 

The new Pfizer antiviral, PF-07321332 appears to have the same function as
a protease as Ivermectin but as Ivermectin is out of patient and
significantly cheaper this could be significantly more adventitious. Has
an updated assessment taken place on either of these drugs and are they
approved for use in the treatment of Covid-19?

 

The information in the below video is gathering more attention:

[1]https://scanmail.trustwave.com/?c=15517&...

 

In it Dr. John Campbell appears to be making some compelling claims for
the use of Ivermectin, has Pharmac and the Ministry of Health assessed the
studies he has cited in relation to an assessment of Ivermectin?”

 

Your request asks for information which is more closely connected with the
functions of the Pharmaceutical Management Agency (Pharmac). For this
reason, the Ministry of Health has decided to transfer your request to
Pharmac under section 14(b)(ii) of the Act. You can expect a response from
Pharmac in due course.

 

Please be advised that Pharmac have previously published OIA responses
regarding ivermectin and these may address some of the questions raised in
your request.

 

·         29 November 2021:
[2]https://pharmac.govt.nz/about/what-we-do...

·         17 September 2021:
[3]https://pharmac.govt.nz/about/what-we-do...

·         1 September 2021:
[4]https://pharmac.govt.nz/about/what-we-do...

 

Under section 28(3) of the Act you have the right to ask the Ombudsman
to review any decisions made under this request. The Ombudsman may be
contacted by email at: [5][email address] or by calling 0800
802 602.

 

If you have any queries related to this request, please do not hesitate to
get in touch.

 

Ngâ mihi,

 

OIA Services Team

 

[6]Ministry of Health information releases

[7]Unite against COVID-19

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References

Visible links
1. https://scanmail.trustwave.com/?c=15517&...
2. https://scanmail.trustwave.com/?c=15517&...
3. https://scanmail.trustwave.com/?c=15517&...
4. https://scanmail.trustwave.com/?c=15517&...
5. mailto:[email address]
6. https://www.health.govt.nz/about-ministr...
7. https://covid19.govt.nz/

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From: Web Enquiry

Kia ora Adam

 

Your request has been transferred from the Ministry of Health to Pharmac
for response. Our reference number for your request is 2021-22-067.

 

As required under the Official Information Act 1982 (OIA), we will respond
to your request within 20 working days. You should receive a response on
or before 27 January 2022 (please note the period from 25 December to 15
January inclusive is not considered ‘working days’ under the OIA).

 

If a large amount of information has been requested, we may need to extend
this date (this is provided for in section 15A of the Act). We will advise
you if such an extension is necessary.

 

Please feel free to contact us if you require any further assistance.

 

Ngâ mihi

 

 

Melody Willis ([1]she/her) | Government Services Advisor

___________________________________________________________________

Te Pâtaka Whaioranga | Pharmac | PO Box 10 254 | Level 9, 40 Mercer
Street, Wellington

P: +64 4 460 4990 |[2]www.pharmac.govt.nz

 

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