Printed from https://fyi.org.nz/request/17158-molnupiravir-for-horses-zebras-donkeys-offspring-born-with-no-teeth-skull-missing on April 24, 2024 02:18

Molnupiravir for Horses, Zebras & Donkeys - offspring born with no teeth & skull missing

Micky Turner made this Official Information request to Pharmaceutical Management Agency

The request was successful.

From: Micky Turner

Dear Pharmaceutical Management Agency,

Pharmac just pre-ordered 60,000 treatment doses of Molnupiravir.

In regards to Molnupiravir - can you please provide the following information:

1. All written communication between Pharmac and Merck
2. All trial and study information Pharmac used to inform your decision to fund the drug
3. All written communication with any people who have extensively studied the active ingredient in EIDD-2801 and believe it could be mutagenic

There seem to be numerous valid concerns around the safety of this drug.
___________________________________________________________________

It would not be unusual for BARDA to consider a drug like EIDD-2801. But Bright notes in his complaint that "similar experimental drugs in this class had been shown to cause reproductive toxicity in animals, and offspring from treated animals had been born without teeth and without parts of their skulls."

Raymond Schinazi, an Emory University chemist who has extensively studied the active ingredient in EIDD-2801 but has no connection to DRIVE, notes that his former pharmaceutical company, Pharmasset, abandoned it in 2003 after discovering its mutagenic properties. Schinazi says the small chemical tweaks made to increase the ingredient's bioavailability and transform it into EIDD-2801 are unlikely to change its mutagenicity. "Thank goodness someone is raising the red flag," about EIDD-2801, Schinazi says. "You don't develop a drug that's mutagenic. Period."

https://www.science.org/news/2020/05/ema...

___________________________________________________________________

The fact that 2 trials in India were abandoned early due to finding no efficacy is also concerning.

Yours faithfully,

Micky Turner

Link to this

From: Web Enquiry
Pharmaceutical Management Agency

Kia ora Micky

 

Thank you for your email.

 

Your request has been received and logged. Our reference number for your
request is: 2021-22-050.

 

As required under the Official Information Act 1982, we will respond to
your request within 20 working days. You should receive a response on or
before 10 November 2021.

 

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.

 

Ngā mihi

 

 

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

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Link to this

From: Web Enquiry
Pharmaceutical Management Agency

Attachment 2021 22 050 2021 11 08 OIA response letter Information about the decision to fund molnupiravir for COVID 19.pdf
118K Download View as HTML

Mōrena Micky

 

Please find a response to your request for information about molnupiravir
attached to this email.

 

We will be in contact with a further response to your request as soon as
possible and without undue delay.

 

Please feel free to contact us if you have any further queries in the
meantime.

 

Ngā mihi

 

 

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

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Link to this

From: Web Enquiry
Pharmaceutical Management Agency

Tēnā koe Micky

 

In our letter to you of 8 November 2021, we noted that we needed more time
to consult about the release of communications and information related to
questions 1 and 2 of your request. As such, we extended the time limit for
your request to 8 December 2021.

 

We have now decided to release the documents we hold to you, with a small
amount of information to be withheld. However, we need more time to
finalise these documents for release. We will provide you with these
documents as soon as possible and without undue delay.

 

Please note you have the right, by way of complaint under section 28(3) of
the OIA to an Ombudsman, to seek an investigation and review of our
decision.

 

Please feel free to contact us if you have any questions about this. We
will be back in touch with you soon.

 

Ngā mihi

 

 

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

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From: Micky Turner

Dear Melody,

Ok, thank you for the update.

Cheers - Micky

Link to this

From: Web Enquiry
Pharmaceutical Management Agency

Attachment 2021 22 061 2021 12 10 OIA response letter Early treatment options for COVID 19.pdf
116K Download View as HTML

Kia ora Micky

Please find a response for your request for information attached with this email.

Ngā mihi
Simon

Simon Mitchell | Senior Policy Advisor
Pharmac | Te Pātaka Whaioranga | PO Box 10 254 | Level 9, 40 Mercer Street, Wellington

This e-mail message and any accompanying attachments may contain confidential information. If you are not the intended recipient, please 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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From: Micky Turner

Hi Simon,

Thanks for your honest response.

I note the information is actually for a different OIA request (this is the Molnupiravir one).

Can you please send that response to this request so we can close it off:
https://fyi.org.nz/request/17559-covid-1...

Cheers - Micky

Link to this

From: Web Enquiry
Pharmaceutical Management Agency

Attachment 2021 22 050 2021 12 15 OIA response letter Information about the decision to fund molnupiravir for COVID 19.pdf
130K Download View as HTML

Attachment 2021 22 050 OIA request documents for Q1 All written communication between Pharmac and Merck.pdf
3.9M Download View as HTML

Attachment 2021 22 050 OIA request documents for Q2 All trial and study information Pharmac used to inform your decision to fund the drug.pdf
1.6M Download View as HTML

Kia ora Micky

Please find our response for your request for information about molnupiravir attached with this email.

Ngā mihi

Melody Willis (she/her) | Government Services Advisor

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Link to this

From: Micky Turner

Thanks Melody,

I appreciate you taking the time to put that information together!

What should be very concerning to the New Zealand public - is that Merck were not willing to publicly disclose their clinical data demonstrating safety and efficacy.

They have only released that information to Pharmac after insisting a Non-Disclosure Agreement was signed.

In light of the Indian trials which were abandoned due to showing no efficacy and the potential high risk mutagenic dangers of the drug - also in light of Merck's checkered history - Molnupiravir is not a drug that I personally would touch until fully independent large clinical randomized trials have proven it's safety and efficacy.

But that ultimately is a decision every individual should make for themselves based on fully 'informed consent'. The problem being - if Merck is not willing to disclose their clinical data in full - it is impossible for any member of the public to give fully informed consent.

Kindest regards - Micky Turner

Link to this

From: Web Enquiry
Pharmaceutical Management Agency

Thank you for emailing Pharmac enquiries.

* [1]View a list of all currently funded medicines (the Pharmaceutical
Schedule)
* [2]View the progress of funding applications on the Application
Tracker
* [3]Read our latest COVID-19 update

We will endeavour to get back to you within two working days.
 
 Ngā mihi,
 
 Pharmac Enquiries

This e-mail message and any accompanying attachments may contain
confidential information. If you are not the intended recipient, please do
not read, use, disseminate, distribute or copy this message or
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