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Kia ora

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

Ngā mihi

Melody Willis (she/her) | Government Services Advisor
___________________________________________________________________
Te Pātaka Whaioranga | Pharmac | PO Box 10 254 | Level 9, 40 Mercer Street, Wellington
P: +64 4 460 4990 | www.pharmac.govt.nz

-----Original Message-----
From: J Bruning <[FOI #21102 email]>
Sent: Friday, 11 November 2022 11:33 am
To: Web Enquiry <[email address]>
Subject: Official Information request - Rolling reviews of safety & efficacy of (non-mRNA gene therapy) COVID-19 treatments

[You don't often get email from [FOI #21102 email]. Learn why this is important at https://aka.ms/LearnAboutSenderIdentific... ]

Dear Pharmac,

Please provide me with the following information that is held by Pharmac, that Pharmacology and Therapeutics Advisory Committee (PTAC) or the COVID-19 Treatments Advisory Group:

1. Ronapreve, Baricitinib, Remdesivir, Tocilizumab, Molnuprivar, Paxlovid.

Please provide me with:
(a) The clinical trial data ID numbers used to claim efficacy and safety; and the date that the particular safety and efficacy data for these drugs were supplied.
(b) Any evaluations of reviews published in the scientific literature that have analysed the (i) safety and (ii) efficacy of these drugs post release onto the market. This includes for prevention of hospitalisation and death as well as efficacy claims by the manufacturer.
(c) All reviews of the scientific literature to understand state of knowledge on drug-drug interactions of these drugs in order to triangulate the claims of the manufacturer.
(d) All current information regarding drug-drug interactions held with Pharmac for these drugs.

2. In July the Ministry of Health released a report:
Ministry of Health (2021, Jul 9) COVID-19 Science Updates. Report https://www.health.govt.nz/system/files/...

(The manufacturers December 2020 concern that multimorbid and immune-challenged populations would not respond sufficiently (imparied efficacy) was corroborated by scientific evidence confirmed waning and breakthrough of COVID-19 vaccines by May 2021. Evidence that the mRNA genetic vaccines that encoded a spike protein into the human body were not as safe and effective was published by May 2021. Principles of administrative law require officials to make all relevant considerations - therefore legally, it would be presumed that Pharmac would look to drugs with a long history of safe use, so as to protect New Zealand's most vulnerable populations).

(a) Please provide evidence of rolling reviews undertaken to evaluate the evidence in the peer reviewed literature of any of the treatments listed in this Science Update Report.

(b) Please supply all emails, reports and memos discussing vitamin D in relation to the scientific evidence relating to immune health, pneumonia, lower respiratory tract infections and other COVID-19 related pathophysiological symptoms considered by the COVID-19 Treatments Advisory Group.

3. Please advise the Access Criteria Assessment process for off-patent/repurposed drugs and nutrient formulations for treatment of COVID-19.

4. Does (a) Pharmac, Pharmacology and Therapeutics Advisory Committee (PTAC) or the (b) COVID-19 Treatments Advisory Group:

(i) recognise that nutrients and drugs with a long history of safe use, where the safety profile is well established; where off-patent use is cheaper than new medicines; carry a different cost-benefit profile than new medications?

(ii) Recognise the implications of the Cochrane review that RCTs are an overly strict requirement and quite unnecessary to demonstrate efficacy. Instead, observational studies are an equally valid study design.
Ref: Anglemyer A et al (2014) Healthcare outcomes assessed with observational study designs compared with those assessed in randomized trials. Cochrane Database of Systematic Reviews 2014, Issue 4. Art. No.: MR000034. DOI:
10.1002/14651858.MR000034.pub2.

Yours faithfully,

J Bruning

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