From: Woodcock, Janet [/O=EXCHANGELABS/OU=EXCHANGE ADMINISTRATIVE GROUP
(FYDIBOHF23SPDLT)/CN=RECIPIENTS/CN=7B0453354A9A42 7DBOA66A86C7A36F3D-JANET. WOODC]

Sent: 2/6/2021 9:08:34 AM
To: Stan Young (ae.
Subject: RE: off the wall

PS a lot of things kill viruses in cells in vitro but don’t work in people: dose, tissue penetration, pharmacokinetics, other
factors. HCQ is one of those, in vivo probably not enough in the cells at a safe dose. jw

From: Stan Young (yyy

Sent: Friday, February 5, 2021 6:02 PM

To: Woodcock, Janet <Janet.Woodcock@fda.hhs.gov>
Subject: Re: off the wall

Janet: Is Merck giving an opinion? Do they have data? RCT? Do they have a more expensive solution?
(conspiracy theory? see 1 below)

Both could be right. Ivermectin by itself might not be effective. The zinc-doxycycline-ivermectin**
combination is reported to be effective in India. How effective? Maybe enough for public health, say 50%, but
not a magic bullet like I hear that antibody infusion is.

(1)We have been and are in a world of smoke and mirrors. Lancet had to withdraw an HCQ paper that looked
very impressive (HCQ was not effective and caused deaths) as the data appeared to have been made up. Who
has the time and money to make up a study good enough to fool Lancet? Was Lancet in on the game?

**here is the storyline, as I understand it. Zinc kills viruses, but typically can not get into cells on its own. An
interaction with HCQ or ivermectin lets zinc get into the cells where the zinc kills the virus. An antibiotic is
added (wrongly, I think) as it is ppeumonia that does most of the killing of humans with flu. COVID kills
differently.

Stan and Pat Young |

On Friday, February 5, 2021, 2:54:19 PM EST, Woodcock, Janet <janet.woodcock@fda.hhs.gov> wrote:

. Merck has just said they think ivermectin very unlikely to provide benefit (they invented it). Doxy,
zinc?? Doubtful. Agree NC probably as you say!! jw

From: Stan Young

Sent: Friday, February 5, 2021 2:51 PM

To: Woodcock, Janet <Janet.Woodcock@fda.hhs.gov>
Subject: off the wall

Janet:

I've studied the literature fairly well now. I'm sure your statisticians have also. I think the case for zinc,
doxycycline, ivermectin is strong, observational and RCTs.


Wishing you and yours well. Best — John

John P. Hussman, Ph.D.
Director, Hussman Foundation

Key Points:
(additional charts, references, and links below):

. Pandemic trajectory: While post-inauguration improvements in containment practices will certainly be helpful,
the recent shift in the trajectory of the pandemic suggests that U.S. fatalities are actually likely to peak close to January
20, suggesting the urgency of more immediate containment efforts, if even more comprehensive public health
messaging relating to limits on group size and unmasked conversation in indoor public airspace. A conservative estimate
of the current trajectory (which short-run figures exceed) suggests the potential for U.S. fatalities to reach 385,000 by
January 20, with a subsequently declining pace still potentially contributing to 530,000 U.S. fatalities by March 15.
Having modeled the trajectory of the pandemic since early February, probably the most striking aspect, from a
mathematical perspective, is how profoundly sensitive this trajectory can be to small improvements or relaxations in the
estimated “tightness” of containment behavior. Charts below.

. Repurposed therapeutics: Expanded guidance regarding repurposing of FDA-approved therapeutics may be
helpful, particularly those that are well-tolerated, supported by clinical evidence, and are informed by consideration of
relevant targets in the COVID-19 pathway. | have advocated similar guidance since March, and | recognize the temerity
of this proposal in the absence of definitive RCTs. By restricting the guidance to well-tolerated candidates supported by
multiple lines of evidence, | trust that the FDA might find an acceptable balance between safety and potential benefit.

° I’ve attached a draft example of well-tolerated, pathway-informed therapeutics that might be suggested
as “options to discuss with your physician.”
° The EUA for barcitinib (which might reasonably be extended to ruxolitinib) was welcome. If there is a

short list of candidates that | believe could be beneficial in limiting damage from extravasation of inflammatory
leukocytes, it would include doxycycline (except in pregnancy), which might also be protective against vascular damage
(possibly in synergy with a low-dose NOS/ROS inhibitor).

° Please dismiss these views if they run counter to evidence to which | might not have access, or if your
clinical experience with any of these therapeutics differs from my inferences. My research background includes
biological pathways of complex disease with a focus on translational targets, but | am not a clinician.

. Vaccine-related considerations:

° Antigen design: The leading mRNA vaccine candidates, based on a full-length spike stabilized in pre-
fusion conformation, are encouraging as they are not strictly reliant on the spike receptor binding domain, and such
designs have been reported to increase the breadth and potency of neutralizing antibodies in studies of SARS-CoV and
MERS-CoV candidates. Designs allowing greater access to the immunodominant S-RBD can be expected to induce
neutralizing antibodies but could potentially be more permissive of antibody-escape mutations and certain forms of
immune-enhancement via Fc-receptor interactions. The final section of my attached paper on clinical worsening
discusses some of these considerations. All of these reservations can be dismissed, of course, based on sufficient clinical
evidence, so my objective is only to suggest points for examination.

° Bell’s palsy: My impression is that certain rare, temporary vaccine side-effects such as Bell’s palsy
(idiopathic facial paralysis) may be related to a brief inflammatory response that may feature an elevated neutrophil-
lymphocyte ratio. Elevated NLR is a marker in Bell’s as well as COVID-19, and the coronavirus spike itself can promote an
inflammatory response including macrophage and neutrophil chemokines. In response to such rare side-effects, NLR
might be examined as a clinical marker, and short-term corticosteroid use coupled with an antiviral medication (possibly
even remdesivir in this context) could be a mitigating strategy, ideally after seroconversion. Please see additional
references below.

° Dose sparing: My understanding is that the incidence curve for the Pfizer vaccine largely mirrors placebo
in the initial 10 days, and then flattens dramatically. Table 13 (p 32) indicates 52% efficacy (~ 1-39/82) even between
dose 1 and 2, already exceeding the 50% target endpoint, with 90.5% efficacy in the 7-day period following the second
dose. Moreover, most vaccine-associated cases appear to have occurred during the initial 10 days following dose 1. The


Adrian

From: "Adam, Stacey (FNIH) [T]" <sadam@fnih.org>
Date: Wednesday, January 20, 2021 at 10:48 AM
To: "Adrian Hernandez, M.D." <adrian.hernandez@duke.edu>, Amanda Windham <awindham@duke.edu>,

Lauren Cohen </auren.w.cohen@duke.edu>, "Chen, Helen" <gingchen@deloitte.com>

Cc: Janet Woodcock <Janet.Woodcock@fda.hhs.gov>, "Lane, Cliff (NIH/NIAID) [E]" <) 0 e:, Eric
Hughes <eric.hughes@novartis.com>, "Read, Sarah (NIH/NIAID) [E]" ye, "Appell, Evan"
<eappell@deloitte.com>, "Sorosa, Alex" <asorosa@deloitte.com>, "Nasr, Hana" <hanasr@deloitte.com>, "Dr
Eric Perakslis, Ph.D." <eric.perakslis@duke.edu>, Tyrus Rorick <tyrus.rorick@duke.edu>, Dana Carluccio
<dana.carluccio@roseliassociates.com>, Rose Li Central Account <FNIH@roseliassociates.com>, "Wholley,
David (FNIH) [T]" <dwholley@fnih.org>

Subject: Summary of the Potential Pragmatic Trial Discussion with PCORnet

Dear ACTIV and PCORnet Teams,

Please find attached the summary and action items from our call yesterday for everyone’s reference. In addition, please
find the meta-analysis on ivermectin that | referred to yesterday at this website: https://ivmmeta.com/.

We will be back in touch to arrange the larger meeting once | know when the ACTIV leads have availability to discuss.

Thanks,
Stacey

Stacey J. Adam, PhD
Director, Cancer

Research Partnerships
Foundation for the National Institutes of Health
Direct: (301) 435-8364 | Mobile:

fnih.org
11400 Rockville Pike, Suite 600, North Bethesda, MD 20852

| fing io)
SENIH 3%


From: Stan Young (ie.
Sent: 1/20/2021 7:37:07 PM

To: Woodcock, Janet [/o=ExchangeLabs/ou=Exchange Administrative Group
(FYDIBOHF23SPDLT)/cn=Recipients/cn=7b0453354a9a427db0a66a86c7a36f3d-Janet.Woodc]
Subject: Re: Congratulations

Janet: Thanks for the note. Stan

Stan and Pat Young) 7”

On Wednesday, January 20, 2021, 5:52:06 PM EST, Woodcock, Janet <janet.woodcock@fda.hhs.gov> wrote:

No but the group previously known as “Operation Warp Speed”/therapeutics, BARDA, and NIH/ACTIV are working hard to
get a pragmatic trial set up fast, | am helping as | can. jw

From: Stan Young <

Sent: Wednesday, January 20, 2021 5:08 PM

To: Woodcock, Janet <Janet.Woodcock@fda.hhs.gov>
Subject: Congratulations

Janet:
Good to see that you are acting FDA Commissioner.

You must be busy. Is someone at FDA looking into ivermectin for COVID?

Stan and Pat Young Po


Thank you. | understand that part of the reason the drug has not been pursued is thatit was considered that there are
enough studies already underway. | would like to bring to your attention that the studyin Philadelphia that has been
listed with clinicaltrials.gov at MMhas not yet begun because
the investigators have been waiting foran IND from the FDA for nearly 5 months already. | wonderif there is any way to
facilitate them getting the INDrapidly so that theirstudy can begin during the current surge in casesin Philadelphia?
Any assistance with this would be greatly appreciated.

Sincerely,

Alexis Lieberman, MD

On Nov 12, 2020, at 10:23 AM, Woodcock, Janet <Janet. Woodcock @fda.hhs.gov> wrote:

Thank you. We have considered this drug before, will refer these references to the assessment team for further
evaluation. Janet Woodcock

on Original Message—---

From: Alexis Lieberman <

Sent: Wednesday, November 11, 2020 5:58 PM

To: Woodcock, Janet <Janet. Woodcock @fda.hhs.gov>

Subject: Information re Covid treatment

Dear Dr. Woodcock,

As a practicing pediatrician in Philadelphia, | am writing to request that you use your role on the Covid task force to
advocate for an immediate, large-scale RCT forivermectin early in disease. | include summaries of studies done sofaron
ivermectin that pointtoits promise.

As you know, Ilvermectinis an anti-parasitic drug that is used widely throughout the world and is generally very well -
tolerated with only very RARE side effects in those who do not have parasites, primarily limited to allergicreactions. The
drug is proposed to prevent the virus from getting into the nucleus of the human cell. While the initial Monash in-vitro
study used very high doses and the early Surgisphere study was discredited, since that time, there have been adozen
positive clinical studies. Sure ly there is enough evidence now to warranta large-scale, government-funded RCT.

This inexpensive, off-patent drug will not make money for any drug company. Therefore, it falls to the government to
take steps to funda trial. | implore you to advocate for this!

STUDIES AND LINKS REGARDING IVERMECTIN:

10/29/30. India: Two doses of ivermectin, given 72 hours apart, prophylactically, was associated with a 73% reduction of
COVID-19 infection among healthcare workers for the following one-month, ina case control study of 186 pairs.
https://www.medrxiv.org/conte.../10.1101/2020.10.29.20222661v1

10/26/30: Baghdad, Iraq: A recent study done Baghdad compared COVID patients who took ivermectin or did not.In
this, 10% of the non-Ivermectin group progressed to severe disease well only 4% of the ivermectin group did. In that
same study there was a 27% mortality rate for those who did not take over motion versus 18% and those who did.
https://www.medrxiv.org/cont.../10.1101/2020,10.26.20219345v1...

9/28/20: Bangladesh: In this retrospective study, they compared patients who received Ivermectin with those who
receive the standard of care. They found that 46% of the standard of care patients required oxygen and 8% we nt tothe
intensive care unit. This was compared to those who did receive ivermectin, in which 9% required oxygen and only 1%
wentto the intensive care unit. https://www.trialsitenews.com/mymensingh-medical-college-r...,

8/28/20: Preventive study from Egypt showing for the first time a large reduction in covid contraction for family
members taking prophylactic dose of lvermectin when there is aninfected person in the same household. Household
contacts who did not take ivermectin had a 58% rate of contracting Covid, compared to only 7% of those who did take
ivermectin.

https://clinicaltrials. gov/.../61/NCT04422561/Prot_SAP_000.pdf

8/26/20: Bangladesh. 400 patients were randomized to either receive ivermectin or placebo. In that study 18% of the
placebo patients progressed to clinical deterioration while only 9% of those withivermectin deteriorated. In that study
they also compared percentage of patients who had early clinical improvement within a week, and of those without
Ivermectin, 44% improved quickly while of those with Ivermectin, 60% improved quickly.
https://clinicaltrials.gov/.../31/NCT04523831/Prot_ICF_000.pdf

7/8/20 Baghdad, lraq: This study compared hospitalized patients with mild to moderate symptoms who tookivermectin
or did not. Those who did not hada hospital stay of 12 days on average, vs 7% in those who did take ivermectin.
https://www.medrxiv.org/.../10.../2020.07.07.20145979v1.full.pdf



To: Adam, Stacey (FNIH) [T] <sadam@fnih.org>
Subject: RE: [EXTERNAL] ACTIV-6

Thx they seem to want to help with agent selection jw

From: Adam, Stacey (FNIH) [T] <sadam@fnih.org>
Sent: Thursday, April 22, 2021 8:31 AM

To: Woodcock, Janet <Janet. Woodcock@fda.hhs.gov>
Subject: RE: [EXTERNAL] ACTIV-6

CAUTION: This email originated from outside of the organization. Do not click links or open attachments unless you recognize the
sender and know the content is safe.

Hi Janet,

As Francis and a number of NIH colleagues are on here as well, | will consult with them and make sure that someone is
on point to send a response.

Thanks,
Stacey

Stacey J. Adam, PhD
Associate Vice President
Research Partnerships

Direct: (301) 435-8364 | Mobile: SES

From: Woodcock, Janet <Janet.Woodcock@fda.hhs.gov>
Sent: Thursday, April 22, 2021 8:06 AM

To: Adam, Stacey (FNIH) [T] <sadam@fnih.org>

Subject: FW: [EXTERNAL] ACTIV-6

Maybe best for you to respond? jw

From: Stephen Ditmore ee

Sent: Thursday, April 22, 2021 12:44 AM

Tol 2 austin, Christopher P (NIH) <I ®>;| Woodcock, Janet

<Janet.Woodcock@fda.hhs.gov>; Kim, Peter (NIH/NIAID) <5; Hall, Matthew D (NIH)
; Harrigan, Rachel (OS) <Rachel.Harrigan@hhs.gov>; |

¢
Cc: Kim, Peter S (NIH) <. ; research.support.services@vumc.org; dukectsi@dm.duke.edu;
Renee.Pridgen@duke.deu; Joseph E. Varon </>; marc rendell <rendell@asndi.com>; Pierre Kory

<| Marik, Paul E. <MarikPE@evms.edu>; Ngo, Binh <Binh.Ngo@med.usc.edu>; Denise Brennan-
ieder < ; Daniel Griffin <I yyy; Mika Turkia <turkia@nic.fi>
Subject: [EXTERNAL] ACTIV-6

CAUTION: This email originated from outside of the organization, Do not click links or open attachments unless you recognize the
sender and know the content is safe.

Dr. Francis Collins, Director, NIH

Dr. Michael Gregory Kurilla, Director, Division of Clinical Innovation, NCATS
Dr. Matthew Hall, Division of Preclinical Innovation, NCATS

Dr. Janet Woodcock, Acting Commissioner, FDA



From: Woodcock, Janet [/O=EXCHANGELABS/OU=EXCHANGE ADMINISTRATIVE GROUP
(FYDIBOHF23SPDLT)/CN=RECIPIENTS/CN=7B0453354A9A42 7DBOA66A86C7A36F3D-JANET. WOODC]

Sent: 6/22/2021 12:46:06 PM
To: LARRY ROSENFELD [ i
Subject: RE: [EXTERNAL] Treatment for covid

There is an EUA for Regeneron and hundreds of thousands of doses have been administered to early, high
risk patients. Ivermectin is under study. Janet Woodcock

o---- Original Message-----

From: LARRY ROSENFELD 4 ©),

Sent: Monday, June 21, 2021 11:26 PM

To: woodcock, Janet <Janet .woodcock@fda.hhs.gov>
Subject: [EXTERNAL] Treatment for covid

CAUTION: This email originated from outside of the organization. Do not click links or open attachments
unless you recognize the sender and know the content is safe.

Why aren’t physicians prescribing
Regeneron and Ivermectin for early stage covid? There is evidence that these medications are effective
to prevent viral replication. What is the F D A doing to save lives during this pandemic?


On Friday, March 19, 2021, 6:44:19 PM EDT, Amar Bhat <admin@reaganudall.org> wrote:

{x] The picture can't be displayed.

You are receiving this message because you are noted as a participant in the Therapeutics

workstream of the COVID-19 Evidence Accelerator. This communication provides a recap of the



Dr. Stephen Hahn
Commésioner of Food and Drugs
Food and Drug Administration

Dr. Patrizia Cavazzoni
Acting Director, Center for Drug Evaluation and Research
Food and Drug Administration

Dr. Christopher Austin

Director

National Center for Advancing Translational Sciences
National Institutes of Health

CTAP officiabs and others as deemed appropriate.
Please consider this an open, shareable communication.

Dear Dr. Woodcock et. al.:

Evidence supporting the efficacy of ivermectin for the treatment of COVID-19 continues to come to light. At
this point, the need is not for the initiation of further research, but for the evaluation of available data to
inform national guidance on ivermectin's use. Documentation is now available at:

. Ivermectin-press-conference-material

. Epidemiologic-analyses-on-covidi19-and-ivermectin

. Ivermectin-in-the-prophylaxis-and-treatment-of-COVID-19 (manuscript)

. Meta-analysis-of-COVID-19-therapeutics (slide presentation)

We request an FDA advisory committee be convened without delay to evaluate ivermectin use for the
treatment of COVID-19, as Dr. Pierre Kory suggested at time 44:15 of a recent FLCCC press

conference, and that the members of the Front Line Covid-19 Critical Care Alliance (FLCCC) be
recognized as stakeholders with standing to advance the case for ivermectin in a transparent, open forum,
wekoming other organizations into the process as opportunities present. We understand the gatekeeper role
of the FDA, and are not experienced in these matters, so would appreciate the support of the National
Center for Advancing Translational Sciences (NCATS) and all other relevant government agencies.

After an admittedly hasty reading of Emergency Use Authorization of Medical Products and Related

A riti idance for Ii ry an her Stakeholders, we wonder if our most immediate concerns
could be addressed as described starting on page 30 under IV. EMERGENCY USE OF ELIGIBLE FDA-

APPROVED MCMs WITHOUT AN EUA. Your counsel in these matters will be most appreciated. For
reference, a previous message to Dr. Peter Kim is quoted below.

Sincerely,

Paul E. Marik MD, FCCP, FCCM
Eastern Virginia Medical School

Department of Internal Medicine
Chief, Pulmonary and Critical Care Medicine

Norfolk, VA


This may be of no interest whatsoever, and this is just an informal observation for you to ignore as you see fit.

As | have been developing patient-physician focussed models of drug development (aligned with the CPI), | happened
across this initiative here. The lady behind it is Tess Lawrie. | had a Zoom call with her today and she has some very
interesting ideas on building evidence of a drugs’ potential in terms of safety, efficacy and quality.

| will leave that with you in case the initiative that Tess is fronting would be useful information within FDA.

With kind regards,

Hedley

Hedley Rees

Managing Consultant PharmaFlow Ltd
T: +44 1656 655664

M: ©) 6)

Author

Book: Supply Chain Management in the Drug Industry: Delivering Patient Value for Pharmaceuticals and
Biologics (2011) - Read Me

Book: FIND IT, FILE IT, FLOG IT: Pharma’s Crippling addiction and How to Cure It (2015) - Read me

Book: Taming the BIG PHARMA MONSTER by Speaking Truth to Power — (2019) - Read me

Book: What Patients Need to Know About Pharmaceutical Supply Chains — (2021) — Read me

Video: Supply Chain Management in the Drug Industry: Delivering Patient Value for Pharmaceuticals and
Biologics (2011) — Watch it

Video: MEDICINES FOR THE 21%‘ CENTURY: Safe, Better, Cheaper (2019) — Watch it


It has been a while since we shared with you the British Ivermectin Recommendation Development (BIRD) meeting
recommendation and Evidence-to-Decision Framework. | am therefore writing to enquire where you are in the process
of evaluating the evidence we sent on this essential drug for covid-19.

| would also like to share with you a link to the UK-based team’s systematic review and meta-analysis on ivermectin for
covid-19 that underpins the BIRD recommendation: https://osf.io/k37ft/

This manuscript, which is now available on a preprint website, successfully underwent a four-peer review process for a
high-impact factor journal. All four reviewers were satisfied that their queries were addressed. Our systematic review is
the fifth review of ivermectin for the treatment and prevention of ivermectin (KORY et al

2021 https://t.co/B3MRnPAWSR; HILL et al 2021 https://t.co/r8fQigblgu; COBOS-CAMPOS et al

2021 https://t.co/EDRx8vyqoe; BRYANT et al 2021 https://t.co/u148ZUsyvy; NARDELI et al., 2021 - attached). As you
know, systematic reviews are considered the highest level of evidence on effects of an intervention. All five systematic
review teams are in agreement that the effect that ivermectin could have on reducing mortality and morbidity related to
covid-19 is substantial. All reviewers, with the exception of Hill et al, agree that ivermectin could have a significant
impact on the pandemic.

In addition, you will have seen from the BIRD Evidence to Decision framework previously shared, that the values,
resource, equity, acceptability and feasibility criteria all favour the implementation of ivermectin for covid-19 as soon as
possible.

You should know that the World is waiting on your team to act in the global public's interest and approve ivermectin
without further delay.

We look forward to some news.

Kind regards,
Tess Lawrie, on behalf of the BIRD Steering Group and recommendation panel

Dr. Theresa Lawrie
Evidence-based Medicine Consultancy Ltd
e-bmce.co.uk

On 5 Mar 2021, at 15:58, Tess Lawrie <tess@e-bmc.co.uk> wrote:
Dear Dr, Stein,
I trust that you are well and thank you for acknowledging receipt of last week’s email.

We have since written an executive summary and | attach it here for your information, with an updated BIRD
proceedings document. They are still draft documents as endorsements keep flooding in and we intend to publish
these with the final document. There are also the results of a public participation survey to be included. Again,
please don’t hesitate to contact me if you have any queries about the large body of accumulated evidence on
ivermectin use for covid-19.

Kind regards,
Tess

Dr. Tess Lawrie, on behalf of the BIRD Steering Group and Recommendation Development Panel
Director
Evidence-based Medicine Consultancy Ltd


> ~


From: Stephen Ditmore 1OY6))

Sent: 3/5/2021 7:33:58 AM

To: (9) Austin, Christopher P (NIH) [/o=Exchangelabs /ou=Exchange Administrative Group
(FYDI BOHF23SPDLT)/cn=Reci pients /cn=1194Sb8d0caf49bc84e09171ec167 b3a-HHS-austinc]; Woodcock, Janet
[/o=Excha ngela bs /ou=Exchange Administrative Group
(FYDIBOHF23SPDLT)/cn=Recipients /cn=7b0453354a9a42 7db0a66a86c7a36f3d-Janet.Woodc]; Kim, Peter
(NIH/NIAID) ()() Hall, Matthew D (NIH) [/o=ExchangeLabs/ou=Exchange Administrative Group
(FYDI BOHF23SPDLT)/cn=Reci pients /cn=80fd9cb35d7 3417388. 9464421 74Scbf-HHS-hallma -]; Harrigan, Rachel (OS)
[/o=ExchangeLabs /ou=Exchange Administrative Group
(FYDIBOHF23SPDLT)/cn=Recipients /cn=7a035d32ebba4e64a02797bcfa74c1a0-HHS-Rachel.]

ce: Kim, Peter S (NIH) [/o=ExchangeLabs /ou=Exchange Administrative Group
(FYDIBOHF23SPDLT)/cn=Recipients/cn=2876661346ba 42d7a684f7d3aeSc5b4c-HHS-peter.k]
Subject: [EXTERNAL] Stages of COVID-19 (Griffinet.al.) andresponseto the NIH/NCATS Antiviral Summit

CAUTION: This email originated from outsideof the organization. Do not clicklinks or open attachments unless you recognize the
sender and know the content is safe.

Dr. Francis Collins, Director, NIH

Dr. Christopher Austin, Director, NCATS

Dr. Matthew Hall, Division of Preclinical Innovation, NCATS
Dr. Janet Woodcock, Commissioner, FDA

Dr. Rachel Harrigan, OWS

Dr. Peter S. Kim, NIAID

Dear Distinguished NIH and NDA leaders;

This letter follows on two previous messages praising ACTIV and BLAZE outpatient trials and Dr.
Peter Kim's Therapy for Early COVID-19, A Critical Need. We applaud the NIH-CoV2
Therapeutics Antiviral Summit as well.

Encouraged by Dr. Woodcock's reply to our first letter, in which she agreed that a common
nomenclature for the stages of COVID-19 is needed, it gives us great pleasure to inform you
that The Importance of Understanding the Stages of COVID-19 in Treatment and
Trials, Dr. Daniel Griffin, lead author, is now available.

While in many respects the NIH-CoV2 Therapeutics Antiviral Summit, was a smashing success,
an invitation was extended by Dr. Collins to say what's missing that would help forward COVID-19
therapeutics development. We'd like to address that topic.

At 4:15:35 in the video Dr. Richard Whitley makes a point worth emphasizing: that a drug, like any
product, should be formulated with the intended use and method of administration in mind. Ina
situation in which speed of manufacture & distribution (and low cost) are critical, it would be a great
shame to overlook opportunities to utilize existing therapeutics because we are jaded by high profile
failures, even as we come to understand COVID-19 disease much better. We have not exhausted the
available options by any means, and there's much we still don't know because the poor outcomes of
some trials reflect a failure to administer antivirals promptly enough.

The need for speed in COVID-19 testing and administration of an antiviral therapeutic to infected
individuals, whether for treatment's sake or as part of a clinical trial, separates the COVID-19
experience from our battle with HIV/AIDS. The two have in common, however, the need for trials



problem for hospitals and doctors when it comes to Covid: Zero liability for hospitals but only
if they follow govt-approved treatments:

“The PREP Act specifies four types of covered countermeasures:

(i) a qualified pandemic or epidemic product; (ii) a “security countermeasure”; (iii) a drug, biological product,
or device that the U.S. Food and Drug Administration (FDA) has authorized for emergency use; and (iv) a
respiratory protective device”

So if a doctor or hospital does something that the FDA didn’t specifically authorize for
emergency use, then the hospital wouldn’t get protection against liability. And this is likely
part of why most hospitals and doctors are against Ivermectin. They have been granted
complete protection from liability anytime they are treating any Covid patient, so long as they
use only treatments that have emergency use authorization.

In effect the Federal Government is practicing medicine for individual patients, and all patients,
telling doctors what they can and cannot do.

https://crsreports.congress.gov/product/pdf/LSB/LSB10443

From: Steve Kirsch

Sent: Thursday, < PM

To: Chris.loftus@uhsinc.com; yyy sa.miller@uhsinc.com

Cc: 4 <M: Vikas Sukhatme (vsukhatme@emory.edu) <vsukhatme@emory.edu>;
Pierre Kory - FLCCC (pkory@flccc.net) <pkory@flccc.net>; Vidula Sukhatme (vidula@global-
cures.org) <vidula@global-cures.org>

Subject: *EXTERNAL* Gavin de Becker's father denied ivermectin and died: why?

Hi Chris and Lisa,

I'm a writer at TrialSiteNews and I'm writing an op-ed about ivermectin being denied for
hospitalized patients.

As I'm sure you are aware, ivermectin has an average 65% mortality benefit when used late in
disease. There have been a total of 12 studies, all but one showing a positive benefit. The one
negative study, the Shahbaznejad et al paper had a very high p-value as there was just a single
death and it was a patient who was about to die at baseline.

So in denying a potentially life saving treatment, I'm sure this was based on solid data and
consideration of all available evidence.

| was wondering what data the hospital relied upon that would lead you to conclude that the
treatment was more likely to hurt the patient than to help the patient?


From: Tom Brown

Sent: 3/18/2021 11:50:21 AM
To: Woodcock, Janet [janet.woodcock@fda.hhs.gov]
Subject: [EXTERNAL] Ivermectin

CAUTION: This email originated from outside of the organization. Do not click links or open attachments unless you recognize the
sender and know the content is safe.

I think it's been a long time since you were a real doctor. Maybe you could show some courage and take a real
look at this drug as a treatment for Covid-19.

Do something good with your "position of authority" for a change. Get out of the pocket of the
pharmaceutical companies.

Just a thought.

Tom Brown

Do the right thing, and do it right now.



From: Adam, Stacey (FNIH) [T] [sadam@fnih.org]

Sent: 4/22/2021 9:54:15 AM

To: Woodcock, Janet [/o=ExchangeLabs/ou=Exchange Administrative Group
(FYDIBOHF23SPDLT)/cn=Recipients/cn=7b0453354a9a427db0a66a86c7a36f3d-Janet.Woodc]

Subject: RE: [EXTERNAL] ACTIV-6

CAUTION: This email originated from outside of the organization. Do not click links or open attachments unless you recognize the
sender and know the content is safe.

Thank you thought for looping me into the request. | really appreciate it!
Stacey

Stacey J. Adam, PhD
Associate Vice President
Research Partnerships

Direct: (301) 435-8364 | Mobile: 22

From: Woodcock, Janet <Janet. Woodcock @fda.hhs.gov>
Sent: Thursday, April 22, 2021 9:10 AM

To: Adam, Stacey (FNIH) [T] <sadam@fnih.org>

Subject: RE: [EXTERNAL] ACTIV-6

Of course jw

From: Adam, Stacey (FNIH) [T] <sadam@fnih.org>
Sent: Thursday, April 22, 2021 9:02 AM

To: Woodcock, Janet <Janet.Woodcock@fda.hhs.gov>
Subject: RE: [EXTERNAL] ACTIV-6

CAUTION: This email originated from outside of the organization. Do not click links or open attachments unless you recognize the
sender and know the content is safe.

Hi Janet,

You are correct, but of course we are mostly completed in our prioritization for the first rounds, so | need to see how
NIH/ACTIV wishes to handle/message this to them.

Thanks,
stacey

Stacey J. Adam, PhD
Associate Vice President
Research Partnerships

Direct: (301) 435-8364 | Mobile: Se

From: Woodcock, Janet <Janet.Woodcock@fda.hhs.gov>
Sent: Thursday, April 22, 2021 8:37 AM



From: Bernstein, llisa [IBernstein@aphanet.org]

Sent: 9/1/2021 5:16:52 PM

To: Woodcock, Janet [/o=ExchangeLabs/ou=Exchange Administrative Group
(FYDIBOHF23SPDLT)/cn=Recipients/cn=7b0453354a9a427db0a66a86c7a36f3d-Janet.Woodc]; Solomon, Steven M
[/o=ExchangeLabs/ou=Exchange Administrative Group
(FYDIBOHF23SPDLT)/cn=Recipients/cn=e49ac6a056dc4f299ea269945e962e82-SSOLOMON]; Cavazzoni, Patrizia
[/o=ExchangeLabs/ou=Exchange Administrative Group
(FYDIBOHF23SPDLT)/cn=Recipients/cn=c42abd33834044ecbaa03d075cc0a5d2-Patrizia.Ca]

Subject: ({EXTERNAL] APhA/ASHP/AMA joint statement against ivermectin

CAUTION: This email originated from outside of the organization. Do not click links or open attachments unless you recognize the
sender and know the content is safe.

Today, APhA, AMA, and ASHP joined together to help FDA and the public health community in efforts to
prevent the prescribing and dispensing of ivermectin for COVID-19. Pasted below is the press
release. Thanks so much for all that you and my former colleagues are doing during these tough times.

https://www.pharmacist.com/APhA-Press-Releases/ama-apha-ashp-call-for-immediate-end-to-prescribing-
dispensing-and-use-of-ivermectin-to-prevent-or-treat-covid-19-outside-clinical-trials

Thanks. Be well.
ilisa

ILISA BG BERNSTEIN, PharmD, JD, FAPhA

Senior Vice President, Pharmacy Practice and Government Affairs
American Pharmacists Association

2215 Constitution Avenue, NW

Washington, DC 20037

202-429-7533 (0) | PPM)

www.pharmacist.com

PRESS RELEASE PUBLISHED ON WEDNESDAY, SEPTEMBER 1, 2021

AMA, APhA, ASHP Call for Immediate End to Prescribing, Dispensing, and Use of Ivermectin to Prevent
or Treat COVID-19 Outside Clinical Trials

WASHINGTON, DC — The American Medical Association (AMA), American Pharmacists Association (APhA),
and American Society of Health-System Pharmacists (ASHP) strongly oppose the ordering, prescribing, or
dispensing of ivermectin to prevent or treat COVID-19 outside of a clinical trial.

Ivermectin is approved by the U.S. Food and Drug Administration (FDA) for human use to treat infections
caused by internal and external parasites. It is not approved to prevent or treat COVID-19. Ivermectin is also
available to treat certain veterinary conditions; medications formulated or intended for use in animals should
not be used by humans. We are alarmed by reports that outpatient prescribing for and dispensing of ivermectin
have increased 24-fold since before the pandemic and increased exponentially over the past few months. As
such, we are calling for an immediate end to the prescribing, dispensing, and use of ivermectin for the
prevention and treatment of COVID-19 outside of a clinical trial. In addition, we are urging physicians,
pharmacists, and other prescribers — trusted healthcare professionals in their communities — to warn patients



Figure 2. Cumuiative Incidence Curves for the First COVID-19 Occurrence After Dose 1, Dose 1
All-Available Efficacy Population

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John P. Hussman, Ph.D.
Director, Hussman Foundation

>\7 HUSSMAN
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6021 University Blvd, Suite 490 | Ellicott City, MD 21043
443.465.4814 | hussman@hussmanfoundation.org



From: Flahive, James [/O=EXCHANGELABS/OU=EXCHANGE ADMINISTRATIVE GROUP.
(FYDIBOHF23SPDLT)/CN=RECIPIENTS/CN=570655C122F 24177BAGE9AC768A6F731-JAMES.FLAHI]

Sent: 3/4/2021 2:14:46 PM

To: Barclay, Lisa (OS) [/o=ExchangeLabs/ou=Exchange Administrative Group
(FYDIBOHF23SPDLT)/cn=Recipients/cn=18c6508b15a249799140fcd8d9ddc1ac-HHS-Lisa.Ba]; Despres, Sarah (OS)
[/o=ExchangeLabs/ou=Exchange Administrative Group
(FYDIBOHF23SPDLT)/cn=Recipients/cn=8e5f3d3f26584babb7b48c3cac8bba82-HHS-Sarah.D)

cc: Woodcock, Janet [/o=ExchangeLabs/ou=Exchange Administrative Group
(FYDIBOHF23SPDLT)/cn=Recipients/cn=7b0453354a9a427db0a66a86c7a36f3d-Janet.Woodc]; Tierney, Julia
[/o=ExchangeLabs/ou=Exchange Administrative Group
(FYDIBOHF23SPDLT)/cn=Recipients/cn=1160d300bc4248b790ded292a082e9a8-Julia.Tiern]; Fristedt, Andi
[/o=ExchangeLabs/ou=Exchange Administrative Group
(FYDIBOHF23SPDLT)/cn=Recipients/cn=8ebcdc6531394636a5 afcb39 1a6c0cc3-Andi.Friste]; Abernethy, Amy
[/o=ExchangeLabs/ou=Exchange Administrative Group
(FYDIBOHF23SPDLT)/cn=Recipients/cn=c84171967c724ee799bb2658197086bc-Amy.Abernet]; Raza, Mark
[/o=ExchangeLabs/ou=Exchange Administrative Group
(FYDIBOHF23SPDLT)/cn=Recipients/cn=5811a7d72ee34aa78ff3c8ccb59f92ee-MRaza]; Anderson, Erika
[/o=ExchangeLabs/ou=Exchange Administrative Group
(FYDIBOHF23SPDLT)/cn=Recipients/cn=98606928b9a64edfb25abale3573fdfe-Eranders]; Roth, Lauren
[/o=ExchangeLabs/ou=Exchange Administrative Group
(FYDIBOHF23SPDLT)/cn=Recipients/cn=52bfd08572694f269a20c508f3c04a03-Lauren.Roth]; Helms Williams, Emily
[/o=ExchangeLabs/ou=Exchange Administrative Group
(FYDIBOHF23SPDLT)/cn=Recipients/cn=873be46f1b1a4d2b8df3fe6713 7cbdc8-HELMSWILLIA]; Rebello, Heidi
[/o=ExchangeLabs/ou=Exchange Administrative Group
(FYDIBOHF23SPDLT)/cn=Recipients/cn=2834ce193ca949799ef063e34a2cfa0b-Heidi.Rebel]; Felberbaum, Michael
[/o=ExchangeLabs/ou=Exchange Administrative Group
(FYDIBOHF23SPDLT)/cn=Recipients/cn=4819a643ca2945cdb1a2631b83e69673-Michael.Fel]; Tobias, Lindsay
[/o=ExchangeLabs/ou=Exchange Administrative Group
(FYDIBOHF23SPDLT)/cn=Recipients/cn=a4766773c717470bbc55d204b5f067b2-Lindsay.Sto]; Caccomo, Stephanie
[/o=ExchangeLabs/ou=Exchange Administrative Group
(FYDIBOHF23SPDLT)/cn=Recipients/cn=950c32cebc4b4f80b302cS50cf3 1c8524-Stephanie.C]

Subject: Internal confidential deliberative Night Note for Friday, 3/5

° Consumer Update: Why You Should Not Use Ivermectin to Treat or Prevent COVID-19


Amol Kothalkar, a physician in Buldhana India has treated hundreds of patients with this protocol and swears by it. The
protocol is based on solid science and published studies. Not only does it work in studies published in peer reviewed
journals, and in clinical practice all over the world, but it works on the ground in India. Dr. Kothalkar will tell you these
methods are transformative. He will tell you it is unethical to withhold these drugs.

steve

From: Arjun Bhagat

Sent: Thursday, May 20, 2021 9:46 AM

Ce: Steve Kirsch
Subject: Introduction

Hi Gurpal and Steve,

| have talked to both of you, so you have context. This email is to get you both connected.

As discussed, Steve, please send over some of your white paper(s) which you think would allow the professionals to
understand what you are suggesting/propagating. Once they have had a chance to read it all, and if they have

questions, they can reach out to you for further clarifications or details.

| really hope we can get some traction on this, and save lives in Punjab as soon as possible.

Cheers,

Arjun


From: Woodcock, Janet [/O=EXCHANGELABS/OU=EXCHANGE ADMINISTRATIVE GROUP
(FYDIBOHF23SPDLT)/CN=RECIPIENTS/CN=7B0453354A9A42 7DBOA66A86C7A36F3D-JANET. WOODC]

Sent: 1/13/2021 1:02:09 PM
To: Alexis Lieberman [
Subject: RE: Information re Covid treatment

FDA is not a funding agency. NIH, BARDA etc for these sorts of trials. And it takes a long time. The ACTIV coalition at
NIH has looked at ivermectin numerous times and have not picked it up. jw

From: Alexis Lieberman <i>

Sent: Wednesday, January 13, 2021 12:13 PM

To: Woodcock, Janet <Janet.Woodcock@fda.hhs.gov>

Subject: Re: Information re Covid treatment

It’s the funding that is an issue. Can the FDA fund? If so, | can do the rest.

Alexis Lieberman

On Jan 13, 2021, at 11:12 AM, Woodcock, Janet <Janet.Woodcock@fda.hhs.gov> wrote:

You can get a group of clinicians and a company to provide drug and placebo, write a protocol, get an IND from FDA and
get IRB clearance. Not so easy. Jw

From: Alexis Lieberman <

Date: January 13, 2021 at 11:09:00 AM EST

To: Woodcock, Janet <Janet.Woodcock@fda.hhs.gov>

Subject: Re: Information re Covid treatment

What can | do to help set up that pragmatic trial that you mentioned?

Alexis Lieberman

On Jan 13, 2021, at 10:54 AM, Woodcock, Janet <Janet.Woodcock@fda.hhs.gov> wrote:

I spy is for critical patients. Not sure that is the best test case. Jw

From: Alexis Lieberman
Date: January 13, 2021 at 10:01:16 AM EST
To: Woodcock, Janet <Janet.Woodcock@fda.hhs.gov>, Robert Malone Lye

Subject: Re: Information re Covid treatment

Is it too late to set up that study now? | am in contact w Robert Malone — he is trying to figure out funding for such a
study, as he has an open arm in the |-Spy trial. Are you and he talking about it?

Alexis Lieberman


Rationale

Ivermectin is an antiparasitic drug that is approved by the Food and Drug Administration (FDA) for the treatment of
onchocerciasis and strongyloidiasis. lvermectin is not FDA-approved for the treatment of any viral infection. In general,
the drug is well tolerated. It is currently being evaluated as a potential treatment for COVID-19.

Antiviral and Anti-Inflammatory Effects of Ivermectin

Reports from in vitro studies suggest that ivermectin acts by inhibiting the host importin alfa/beta-1 nuclear transport
proteins, which are part of a key intracellular transport process that viruses hijack to enhance infection by suppressing
the host antiviral response.*” In addition, ivermectin docking in vitro may interfere with the attachment of the severe
acute respiratory syndrome coronavirus 2 (SARS-CoV-2) spike protein to the human cell membrane.?

Ivermectin has been shown to inhibit the replication of SARS-CoV-2 in cell culture. However, pharmacokinetic and
pharmacodynamic studies suggest that ivermectin doses up to 100-fold higher than those approved for use in humans
would be required to achieve the plasma concentrations necessary to duplicate the drug’s antiviral efficacy in vitro.*>
Even though ivermectin appears to accumulate in lung tissue, with the doses used in most clinical trials, predicted
systemic plasma and lung tissue concentrations are much lower than 2 uM, the half-maximal inhibitory concentration
(ICs) against SARS-CoV-2 in vitro.©”

Ivermectin demonstrates potential anti-inflammatory properties in some in vitro studies,** properties which have been
postulated to be beneficial in the treatment of COVID-19."°

Clinical Data

Since the last revision of the Ivermectin section of the Guidelines, the results of several randomized trials and
retrospective cohort studies of ivermectin use in patients with COVID-19 have been published in peer-reviewed journals
or made available as preliminary, non-peer-reviewed reports. Some clinical studies showed no benefits or worsening of
disease after ivermectin use,**** whereas others reported shorter time to resolution of disease manifestations attributed
to COVID-19,>"* greater reduction in inflammatory markers, ‘°”” shorter time to viral clearance, *”*° or lower mortality
rates in patients who received ivermectin than in patients who received comparator drugs or placebo.’2167#

However, most of the studies reported to date had incomplete information and significant methodological limitations,
which make it difficult to exclude common causes of bias. The missing information and limitations include the following:

. The sample size of most of the trials was small.
. Various doses and schedules of ivermectin were used.
. Some of the randomized controlled trials were open-label studies in which neither the participants nor the

investigators were blinded to the treatment arms.

. In addition to ivermectin or the comparator drug, patients also received various concomitant medications (e.g.,
doxycycline, hydroxychloroquine, azithromycin, zinc, corticosteroids), confounding assessment of the true efficacy or
safety of ivermectin.

. The severity of COVID-19 in the study participants was not always well described.
. The study outcome measures were not always clearly defined.

Because of these limitations, the Panel cannot draw definitive conclusions about the clinical efficacy or safety of
ivermectin for the treatment of COVID-19. Results from adequately powered, well-designed, and well-conducted clinical
trials are needed to provide more specific, evidence-based guidance on the role of ivermectin for the treatment of
COVID-19.

References

1. Yang SNY, Atkinson SC, Wang C, et al. The broad spectrum antiviral ivermectin targets the host nuclear transport
importin alpha/beta1 heterodimer. Antiviral Res. 2020;177:104760. Available at:
https://www.ncbi.nim.nih.gov/pubmed/32135219.

2. Arévalo AP, Pagotto R, Pérfido J, et al. lvermectin reduces coronavirus infection in vivo: a mouse experimental
model. bioRxiv. 2020;Preprint. Available at: https://www.biorxiv.org/content/10.1101/2020.11.02.363242v1.



Date: Mon, Nov 30, 2020 at 12:47 AM

Subject: Praise and concurring recommendations for Kim et.al.; Therapy for Early COVID-19, A
Critical Need; JAMA Viewpoint, November 11, 2020

To: <SUNUNNNNNNNNN®>, Kim, Peter (NIH/NIAID) <i>

Cc: Woodcock, Janet <Janet.Woodcock@fda.hhs.gov>, Harrigan, Rachel (HHS/IOS)
<Rachel.Harrigan@hhs.gov>, Marik, Paul E. <MarikPE@evms.edu>, Joseph E. Varon

<I yyyyye®>,, Ngo, Binh <Binh.Ngo@med.usc.edu>, marc rendell <rendell@asndi.com>,
Pierre Kory <i mmew’>

Peter S. Kim, MD, corresponding author
Therapeutics Research Program, Division of AIDS
National Institute of Allergy and Infectious Diseases
National Institutes of Health,

5601 Fishers Ln, Bethesda, MD 20892

Drs. Janet Woodcock, Rachel Harrigan, and Robert Califf are copied on this email.
Please forward to co-authors (including Dr. Fauci), collaborators and colleagues.

Dear Dr. Kim:

We take great encouragement from your recent letter, Therapy for Early COVID-19, A Critical
Need, which we support wholeheartedly. By that letter, along with the clarity of the

Bamlanivimab EUA instructions, you and your colleagues are making it clear that antiviral
therapeutics will be most effective when administered early in the course of SARS-CoV-2 infection.

We offer our comments as friendly, concurring suggestions from grateful allies, and are happy to do
whatever we can to help spread the word among diinicians and policy makers. We have experienced
first-hand that some clinicians remain predisposed to deny treatment before symptoms worsen. We
are also concerned about reliance on I.V. administration of therapeutics further straining our
hospitals and their personnel. A goal of outpatient COVID-19 therapeutics should be to relieve that
strain by providing solutions that can be implemented in community based settings.

Quoting (for reference) from your letter, Therapy for Early COVID-19, A Critical Need:

Several antivirals approved or in development for other viral infections, such as HIV,
hepatitis C virus, and ebolaviruses, are under investigation for early treatment of
COVID-19. These investigations have not yet yielded clinically actionable results;
however, many trials are ongoing. Examples of antivirals in trials for early
treatment of COVID-19 are MK-4482 (EIDD-2801), an orally bioavailable


From: h.rees@ pharmaflowltd.com <h.rees@pharmaflowltd.com>
Sent: Tuesday, May 11, 2021 12:14 PM

To: Woodcock, Janet <Janet. Woodcock@fda.hhs.gov>

Subject: RE: [EXTERNAL] UK Initiative on COVID-19

CAUTION: This email originated from outside of the organization. Do not click links or open attachments unless you recognize the
sender and know the content is safe.

Thanks Janet — good to hear you are driving it — there seems to be a growing body of evidence out there now!

All good here, hope same with you.

Really believing now that COVID has raised public awareness of the crucial importance of the manufacturing supply
chain in properly satisfying the needs of patients for safe, effective, high quality (and affordable) drugs. | have covered
your work in the final chapter of What Patients Need to Know About Pharmaceutical Supply Chains, titled ‘ROADMAP TO
A BETTER FUTURE’.

Drug Development for Research Scientists is next on the agenda — hopefully you will consider contributing some
thoughts, short or long as you like?

Finally, Industrial Pharmacy kindly published a two part article of mine on COVID supply chains in the last fall, see both
editions here:

Part 1 https://www.dropbox.com/s/edbj61w6op195j2/IP66%20FIP%20Sept%202020.pdf?dl=0

Part 2 https://www.dropbox.com/s/2v2rfezipq8oyue/IP67_2_FIP.pdf?dl=0

That's it from me!
With kind regards,

Hedley

From: Woodcock, Janet <Janet. Woodcock@fda.hhs.gov>
Sent: 11 May 2021 15:50

To: h.rees@pharmaflowltd.com
Subject: RE: [EXTERNAL] UK Initiative on COVID-19

Thanks, ACTIV at FNIH/NIH at my urging is launching a large simple trial with ivermectin as the first agent. Hope you are
well. jw

From: h.rees@ pharmaflowltd.com <h.rees@pharmaflowltd.com>
Sent: Tuesday, May 11, 2021 5:53 AM

To: Woodcock, Janet <Janet. Woodcock@fda.hhs.gov>

Subject: [EXTERNAL] UK Initiative on COVID-19

CAUTION: This email originated from outside of the organization. Do not click links or open attachments unless you recognize the
sender and know the content is safe.

Dear Janet,



From: Steve Kirsch

Sent: 5/20/2021 10:59:37 AM

To: Woodcock, Janet [/o=ExchangeLabs/ou=Exchange Administrative Group
(FYDIBOHF23SPDLT)/cn=Recipients/cn=7b0453354a9a427db0a66a86c7a36f3d-Janet.Woodc]

Subject: Re: [EXTERNAL] outpatient treatments must be delivered early, but rarely do patients present within 48 hrs of
symptoms!

CAUTION: This email originated from outside of the organization. Do not click links or open attachments unless you recognize the
sender and know the content is safe.

Thanks. That is a KEY insight. This is why so many people have died.
Have u read my op-ed on TrialSiteNews yet? Long but tells the story really well.

Sent from my iPhone

On May 20, 2021, at 6:47 AM, Woodcock, Janet Janet. Woodcock@fda.hhs.gov> wrote:

Don’t know. jw

From: Steve Kirsch ye

Sent: Thursday, May 20, 2021 9:44 AM

To: Woodcock, Janet <Janet.Woodcock@fda.hhs.gov>

Subject: Re: [EXTERNAL] outpatient treatments must be delivered early, but rarely do patients present within 48 hrs of
symptoms!

CAUTION: This email originated from outside of the organization. Do not click links or open attachments unless you recognize the
sender and know the content is safe.

As in show me the phase 3 study data driven | presume?
If | show him 50 phase 2 lower quality studies all consistent it won’t move needle?

Sent from my iPhone

On May 20, 2021, at 6:41 AM, Woodcock, Janet <Janet.Woodcock@fda.hhs.gov> wrote:

Very unlikely to happen, he is completely data-driven. jw

From: Steve Kirsch

Sent: Thursday, May 20, 2021 1:43 AM

To: Woodcock, Janet <Janet.Woodcock@fda.hhs.gov>

Subject: [EXTERNAL] outpatient treatments must be delivered early, but rarely do patients present within 48 hrs of
symptoms!



From: Stan Young

Sent: 3/19/2021 6:20:17 PM

To: Woodcock, Janet [/o=ExchangeLabs/ou=Exchange Administrative Group
(FYDIBOHF23SPDLT)/cn=Recipients/cn=7b0453354a9a427db0a66a86c7a36f3d-Janet.Woodc]

Subject: Re: [EXTERNAL] ivermectin

CAUTION: This email originated from outside of the organization. Do not click links or open attachments unless you recognize the
sender and know the content is safe.

good. make the data public.

Stan and Pat Young)

On Friday, March 19, 2021, 5:36:07 PM EDT, Woodcock, Janet <janet.woodcock@fda.hhs.gov> wrote:

Yes very close but like everything in government hair-pulling-out slow! jw

From: Stan Young

Sent: Friday, March 19, 2021 5:03 PM

To: Woodcock, Janet <Janet.Woodcock@fda.hhs.gov>
Subject: [EXTERNAL] ivermectin

CAUTION: This email originated from outside of the organization. Do not click links or open attachments unless you
recognize the sender and know the content is safe.

Janet: Any progress on a large, simple RCT? Stan

Stan and Pat Young



The veterinary division of FDA obviously has 100’s of millions of animals worth of safety data on this drug. | have fed it

to 9 dogs over 35 years. WHO probably has the human safety data. Likely the most knowledgeable living researcher
ttornte] sed away) is Prof. Hugh Taylor in Melbourne, who led the research effort at
JHU.

Dr. Vagelos would almost certainly be an expert or spokesperson for FDA because the human ivermectin donation
program was one of his crowing achievements at Merck

Coronavirus Can be Stopped in 48 Hours Using a Simple Anti-Parasitic Drug: Monash University
News18 News185 April 2020

Amid a barrage of research on finding treatment for new coronavirus, Australian scientists have found that a common
anti-parasitic drug killed SARS-CoV-2 virus, growing in cell culture, within 48 hours in lab settings. lvermectin is an FDA-
approved anti-parasitic drug that has also been shown to be effective in vitro against a broad range of viruses including
HIV, dengue, influenza and Zika virus.

Published in the journal Antiviral Research, the study from Monash University showed that a single dose of Ivermectin
could stop the coronavirus growing in cell culture -- effectively eradicating all genetic material of the virus within two
days. “We found that even a single dose could essentially remove all viral RNA by 48 hours and that even at 24 hours
there was a really significant reduction in it," said study lead author Dr Kylie Wagstaff.

Dr Wagstaff, however, cautioned that the tests conducted in the study were in vitro and that trials needed to be carried
out in people. "Ivermectin is very widely used and seen as a safe drug. We need to figure out now whether the dosage
you can use it at in humans will be effective - that's the next step," Wagstaff informed. In times when we're having a
global pandemic and there isn't an approved treatment, “if we had a compound that was already available around the
world then that might help people sooner".

“Realistically it's going to be a while before a vaccine is broadly available," she said. Although the mechanism by which
Ivermectin works on the virus is not known, it is likely, based on its action in other viruses, that it works to stop the virus
‘dampening down' the host cells' ability to clear it. Dr Wagstaff made a previous breakthrough finding on Ivermectin in
2012 when she identified the drug and its antiviral activity with Monash Biomedicine Discovery Institute's Professor
David Jans, also an author on this paper. Professor Jans and his team have been researching Ivermectin for more than 10
years with different viruses.

Dr Wagstaff and Professor Jans started investigating whether it worked on the SARS-CoV-2 virus as soon as the
pandemic was known to have started. The use of Ivermectin to combat COVID-19 depends on pre-clinical testing and
clinical trials, with funding urgently required to progress the work, the researchers

noted. https://in.news.yahoo.com/coronavirus-stopped-48-hours-using-103100205.html?soc_srce=social-sh&soc_trk=fb
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From: Woodcock, Janet [/O=EXCHANGELABS/OU=EXCHANGE ADMINISTRATIVE GROUP
(FYDIBOHF23SPDLT)/CN=RECIPIENTS/CN=7B0453354A9A42 7DBOA66A86C7A36F3D-JANET. WOODC]

Sent: 12/27/2020 11:47:48 AM
To: Steve Kirsch
Subject: RE: appropriate contact at CDC

Yes | believe it is co-chaired by Cliff Lane and another doc. jw

From: Steve Kirsch

Sent: Thursday, December 24, 2020 2:44 PM

To: Woodcock, Janet <Janet.Woodcock@fda.hhs.gov>
Subject: RE: appropriate contact at CDC

Apparently, it is the NIH panel that creates the guidelines for the CDC:
https://www.covid19treatmentguidelines.nih.gov/panel-roster/

From: Woodcock, Janet <Janet. Woodcock @fda.hhs.gov>
Sent: Thursday, December 24, 2020 6:28 AM

To: Steve Kirsch

Subject: RE: appropriate contact at CDC

No | don’t have any connections there, sorry. Janet W

From: Steve Kirsch FY

Sent: Wednesday, December 23, 2020 5:15 PM

To: Woodcock, Janet <Janet.Woodcock@fda.hhs.gov>
Subject: FW: appropriate contact at CDC

Got a contact?

From: Austin, Christopher (NIH/NCATS) [E] </>

Sent: Wednesday, December 23, 2020 2:14 PM
To: Steve Kirsch
Subject: RE: appropriate contact at CDC

| don’t unfortunately sorry

From: Steve Kirsch Te"

Sent: Wednesday, December 23, 2020 5:07 PM

To: Austin, Christopher (NIH/NCATS) [E] <9

Subject: appropriate contact at CDC

The CDC has very out of date info on Ivermectin and has no info on fluvoxamine on their website.

Do you know who we could reach out to there that you can refer me so | don’t end up in a black hole?

Thanks.

steve


cc: Colvis, Christine M (NIH) [/o=ExchangeLabs/ou=Exchange Administrative Group
(FYDIBOHF23SPDLT)/cn=Recipients/cn=d3bb5ce5 263c4206885ede0146e96813-HHS-christi]; Jansen, Kathrin
{kathrin.jansen@pfizer.com]; Lowy, Douglas (NCI) ©), Young, John [john.young.jy3@roche.com]; Biggs,
Mary [biggs.mary@gene.com]; Butcher, Tina [tina_butcher@merck.com]; Demarcus [demarcus@email.unc.edu];
Macone, Erin [erinm@amgen.com]; Melencio, Cheryl L (NIH) [/o=ExchangeLabs/ou=Exchange Administrative Group
(FYDIBOHF23SPDLT)/cn=Recipients/cn=baa3813b343d4f4cb949f1b990023053-HHS-cmelenc]; Salathin, Carla
{carla.salathin@novartis.com]; Menetski, Joseph M (NIH) [/o=ExchangeLabs/ou=Exchange Administrative Group
(FYDIBOHF23SPDLT)/cn=Recipients/cn=d8ed7bcfcbc04f338026fde223a907ae-HHS-jmenets]; Dana Carluccio
(dana.carluccio@roseliassociates.com]; Rose Li Central Account [FNIH@roseliassociates.com]; Lucas Smalldon
(Lucas.Smalldon@roseliassociates.com]; jennifer.j.palmer@pfizer.com; Mollica, Linda /US
{Linda.Mollica@sanofi.com]; Qashu, Felicia M (NIH) [/o=ExchangeLabs/ou=Exchange Administrative Group
(FYDIBOHF23SPDLT)/cn=Recipients/cn=3f0b7 1ff369f40f9bd47c1a2968585c1-HHS-felicia]; Patterson, Amy (NIH)
[/o=ExchangeLabs/ou=Exchange Administrative Group
(FYDIBOHF23SPDLT)/cn=Recipients/cn=a842e9e8e9e84d7b8736ddaa333145d0-HHS-amy.pat]; Rubin, Daniel B.
[/o=ExchangeLabs/ou=Exchange Administrative Group
(FYDIBOHF23SPDLT)/cn=Recipients/cn=aff2818c53624c0c9c406ea1ae161987-RUBIND]; Marston, Hilary D (NIH)
[/o=ExchangeLabs/ou=Exchange Administrative Group
(FYDIBOHF23SPDLT)/cn=Recipients/cn=87f32347b819459fb55d2b7e2baccSeb-HHS-hilary.]; Chen, Helen
(qingchen@deloitte.com]; Wung, Peter /US [Peter.Wung@sanofi.com]; Hoots, Keith K (NIH)
[/o=ExchangeLabs/ou=Exchange Administrative Group
(FYDIBOHF23SPDLT)/cn=Recipients/cn=2ebb64d11ebd42f4bb63f192e1e388ac-HHS-hootswk]; Groesch, Mary E (NIH)
[/o=ExchangeLabs/ou=Exchange Administrative Group
(FYDIBOHF23SPDLT)/cn=Recipients/cn=78d9da47 15154e1eabcf9d0178d06b88-HHS-mary.gr]; Shipp, Allan C (NIH)
[/o=ExchangeLabs/ou=Exchange Administrative Group
(FYDIBOHF23SPDLT)/cn=Recipients/cn=04e31be85c264b16bef9602845846e60-HHS-allan.s]; Kindzelski, Andrei L
(NIH) [/o=ExchangeLabs/ou=Exchange Administrative Group
(FYDIBOHF23SPDLT)/cn=Recipients/cn=202c4c81c85749ee80ee895d3b4e4132-HHS-kindzel]; Hone, David M (Dave)
CIV DTRA J9 (USA) ®®); Reisler, Ronald B CTR USARMY DOD JPEO CBRND (USA)
[ ©. Walker, Paula J (NIH) [/o=ExchangeLabs/ou=Exchange Administrative Group
(FYDIBOHF23SPDLT)/cn=Recipients/cn=5230079373904be5a42bac56b97a1a3e-HHS-walkerp]; Sorosa, Alex
[asorosa@deloitte.com]; Lumsden, Joanne M (NIH) [/o=ExchangeLabs/ou=Exchange Administrative Group
(FYDIBOHF23SPDLT)/cn=Recipients/cn=b4248b5d666d46f8a4b522b21c7a6d4d-HHS-joanne.]

Subject: The COVID-19 Treatment Guidelines Panel’s Statement on the Use of Ivermectin for the Treatment of COVID-19
https://bit.ly/2N69NqB

Dear ACTIV TX-Clinical WG,

Following onto our discussion yesterday, please find below the current treatment guidelines for ivermectin.
Thanks,

Stacey

The COVID-19 Treatment Guidelines Panel’s
Statement on the Use of Ivermectin for the Treatment
of COVID-19

Last Updated: January 14, 2021

Recommendation

. The COVID-19 Treatment Guidelines Panel (the Panel) has determined that currently there are insufficient data
to recommend either for or against the use of ivermectin for the treatment of COVID-19. Results from adequately
powered, well-designed, and well-conducted clinical trials are needed to provide more specific, evidence-based
guidance on the role of ivermectin for the treatment of COVID-19.


From: Freire, Maria (FNIH) [T] [mfreire@fnih.org]

Sent: 6/18/2020 5:27:44 PM

To: Woodcock, Janet [/o=ExchangeLabs/ou=Exchange Administrative Group
(FYDIBOHF23SPDLT)/cn=Recipients/cn=7b0453354a9a427db0a66a86c7a36f3d-Janet.Woodc]

Subject: RE: Ivermectin

Nope, | was wrong. They are using the regular dose: 0.2mg/Kg. | have reached out to colleagues to see if the results still
stand. What | can tell you is that the ivermectin supply is Peru is being wipped out because it is being use as a
prophylactic. I’ll pass along any more information. M.

From: Woodcock, Janet <Janet. Woodcock @fda.hhs.gov>
Sent: Thursday, June 18, 2020 4:45 PM

To: Freire, Maria (FNIH) [T] <mfreire@fnih.org>

Subject: RE: lvermectin

Yes would like to know if possible. Thanks. jw

From: Freire, Maria (FNIH) [T] <mfreire@fnih.org>
Sent: Thursday, June 18, 2020 4:43 PM

To: Woodcock, Janet <Janet. Woodcock@fda.hhs.gov>
Subject: RE: lvermectin

| will try to find out from my Peruvian contacts. My guess — only a guess — is that they would have been pretty high
doses. M.

From: Woodcock, Janet <Janet. Woodcock @fda.hhs.gov>
Sent: Thursday, June 18, 2020 4:36 PM

To: Freire, Maria (FNIH) [T] <mfreire@fnih.org>

Subject: RE: lvermectin

I'm following up. Certainly is a very safe drug, not sure what levels achieved in vivo. jw

From: Freire, Maria (FNIH) [T] <mfreire@fnih.org>
Sent: Thursday, June 18, 2020 11:44 AM

To: Woodcock, Janet <Janet.Woodcock@fda.hhs.gov>
Subject: RE: Ivermectin

David tells me there is a paper that just came out about the in vitro activity. I’ve not seen it but pretty dramatic
results. M.

From: Woodcock, Janet <Janet.Woodcock@fda.hhs.gov>
Sent: Thursday, June 18, 2020 10:08 AM

To: Freire, Maria (FNIH) [T] <mfreire@fnih.org>

Subject: RE: Ivermectin

Thanks for the information. Have not forgotten what you told me about this. wj

From: Freire, Maria (FNIH) [T] <mfreire@fnih.org>
Sent: Thursday, June 18, 2020 10:00 AM


From: Woodcock, Janet [/O=EXCHANGELABS/OU=EXCHANGE ADMINISTRATIVE GROUP
(FYDIBOHF23SPDLT)/CN=RECIPIENTS/CN=7B0453354A9A427DBOA66A86C7A36F3D-JANET.WOODC]
Sent: 3/16/2021 1:28:05 PM

To: Tess Lawrie [tess@e-bmc.co.uk]
Subject: RE: [EXTERNAL] URGENT: The BIRD meeting proceedings and recommendation on covid-19 prevention and
treatment

Thank you for writing. We are very aware of the wide use of ivermectin, including for scabies. The concern about animal
use is that people are dosing themselves with doses intended for animals and getting serious toxicities. This is not good.

Ivermectin use for COVID-19 has been evaluated multiple times by experts in the US, not just at the FDA.

Janet Woodcock

From: Tess Lawrie <tess@e-bmc.co.uk>

Sent: Tuesday, March 16, 2021 12:33 PM

To: Woodcock, Janet <Janet.Woodcock@fda.hhs.gov>

Subject: Fwd: [EXTERNAL] URGENT: The BIRD meeting proceedings and recommendation on covid-19 prevention and
treatment

CAUTION: This email originated from outside of the organization. Do not click links or open attachments unless you recognize the
sender and know the content is safe.

Dear Janet Woodcock,

lam sharing with you the correspondence that | have had with Peter Stein and colleagues with regard to the use of
ivermectin for the treatment and prevention of covid. | am concerned that they have not yet seen the evidence that we
sent to them on the 26th February, as the FDA’s official position on ivermectin continues to be that there is no evidence
to support its use and that ivermectin is intended for animals. The latter is particularly misleading and derogatory, given
that ivermectin is widely used in humans around the world, including among the elderly in the US for the treatment of
scabies. In addition, the FDA (and NIH) continues to refer to the in vitro Caly study to support the erroneous notion that
ivermectin cannot be effective against covid at regular doses - there are at least 22 RCTs and 5 systematic reviews that
show that ivermectin could have a significant impact on the pandemic and, in particular, reduce deaths.

l ask you to pay particular attention to the country example of India, which is four times more populous that the US, and
where ivermectin is freely distributed in many states.

| attach the documents that | have shared to date with members of your organization and trust that you will read them
with soon, so that we can agree to start saving lives with this cheap, safe and effective generic medicine. Honestly, what
does the FDA have to lose?

Sincerely,
Tess

Dr. Theresa Lawrie
Evidence-based Medicine Consultancy Ltd
e-bme.co.uk



>>>>>>_-----Original Messagi

>>> Fron: John valle: il) UNE.
>>>>>> Sent: Thursday, Ma

>>>>>> To: Steve Kirsch SOS

>>>>>> Subject: Re: IVM + FLV

>>>>>>

>>>>>> Walgreen’s has Fluvoxamine ready. You said Prozac was even better
>>>>>> so my plan was to see if Cvs will just fill Prozac while I wait
>>>>>> and if they seem to be holding it up I’11 go to Walgreen’s where
>>>>>> Fluvoxamine is already waiting for me now.

>>>>>>

>>>>>> Sent from my iPhone

>>>>>>
>>>>>>>> On May 6, 2021, at 6:12 AM, Steve Kirsch Errore:
D>>>>>>

>>>>>>> were you able to get the meds from the US pharmacies?
D>>>>>>

>>>>>>>> -----Original Message-
>>>>>>>> From: John Halbleib Famer eel

>>>>>>>> Sent: Thursday, May 6

>>>>>>>> To: Steve Kirsch ee we,

>>>>>>>> Subject: Re: IVM + FLV

>>>>>>>>

>>>>>>>> All symptoms are less now. Cough almost gone, full body unwell
>>>>>>>> feeling way less including the “I feel like I should have a
>>>>>>>> fever but don’t” feeling. The tongue thing had felt like I
>>>>>>>> burnt my tongue without actually having done that and has
35555555 lessened a lot and may be gone

>>>>>> soon.

>>>>>>>>

>>>>>>>> I told Dr Apter I took a Covid Test (NAAT) and he had already
>>>>>>>> said even if it comes back negative the safest thing was still
>>>>>>>> to continue treatment. It did comeback negative from a test on
>>>>>>>> May 3 and I have continued IVM and FLU with a prescription of
>>>>>>>> Prozac electronically sent also to finish up after Fluvoxamine is gone.
>>>>>>>>

>>>>>>>> I’ve lost some sleep in recent days and haven’t 100% had my
>>>>>>>> wits about me but later I have a story to tell of how the 60
>>>>>>>> Minutes Segment influenced me to push for a friend’s mother in
>>>>>>>> Egypt to get Fluvoxamine for her Covid diagnosed back in March.
>>>>>>>> Spoiler alert...she successfully made her way through despite
>>>>>>>> some scary

>>>>>> vulnerabilities.

>>>>>>>>

>>>>>>>> 1°11 tell the whole story later,

>>>>>>>>

>>>>>>>> Thank you,

>>>>>>>> John

>>>>>>>>
>>>>>>>> Sent from my iPad

D>p>p>>>

>>>>>>>>>> On May 6, 2021, at 12:35 AM, Steve Kirsch Me wrote:
D>>>>>>>>

>>>>>>>>> you should be getting better and better each day?

D>>>>>>>>

>>>>>>>>> were you able to fill the prescriptions???

>>>>>>>>>

D>DDDaa>a> -Original Message

D>>>>>>>>>> John Halbleib <

>>>>>>>>>> Wednesday, Ma! 2021 PM

SSSSSSE55 Tor steve Kirsch <n mie

>>>>>>>>>> Subject: Re: IVM + FLV

D>>>>>>>>>

>>>>>>>>>> Doing well, thanks. Exchanged emails with Robert also.
>>p>>>>>>>

>>>>>>>>>> Sent from my iPhone

D>>>>>>>>>

>>>>>>>>>>>> On May 5, 2021, at 4:59 PM, Steve Kirsch li wrote:
>>>>>>>>>>>

>>>>>>>>>>> How are you doing?


Best,

Miguel Antonatos, MD
Board Certified Internal Medicine Physician

On Wed, May 19, 2021 at 7:06 PM Dr. Syed Haider <thedoc@drsyedhaider.com> wrote:
No, | don't prescribe doxycycline to anyone.

On Wed, May 19, 2021 at 12:49 AM Steve Kirscll wrote:

do you prescribe this up front for your patients? if so, how much of a difference does it make?


From: Stan Young [

Sent: 1/21/2021 1:48:32 PM

To: Woodcock, Janet [/o=ExchangeLabs/ou=Exchange Administrative Group
(FYDIBOHF23SPDLT)/cn=Recipi ents /cn=7b0453354a9a427db0a66a86c 7a 36f3d-Janet.Woodc]

Subject: Florida study

Attachments: Rajter 2020 ivermectin propensity.pdf

Janet: The attached study looks good to me. Florida. Observation, but there was careful control of confounders.
Someone might ask for the data set. Small n=~280. If you all are able to get the data set, I'm willing to give it a
look also.

Stan and Pat Young Po


From: Woodcock, Janet [/O=EXCHANGELABS/OU=EXCHANGE ADMINISTRATIVE GROUP
(FYDIBOHF23SPDLT)/CN=RECIPIENTS/CN=7B0453354A9A42 7DBOA66A86C7A36F3D-JANET. WOODC]

Sent: 3/5/2021 8:01:19 AM

To: Kimberly, Brad [/o=ExchangeLabs/ou=Exchange Administrative Group
(FYDIBOHF23SPDLT)/cn=Recipients/cn=08bc909ed76d49868a5ff92¢3c70fb72-Bradley.Kim]

Subject: RE: JW TWEETS: Ivermectin // BABY FOOD

Good thanks jw

From: Kimberly, Brad <Brad.Kimberly@fda.hhs.gov>

Sent: Friday, March 5, 2021 8:00 AM

To: Woodcock, Janet <Janet.Woodcock@fda.hhs.gov>

Cc: Felberbaum, Michael <Michael.Felberbaum@fda.hhs.gov>; Hetlage, Daniel <Daniel.Hetlage@fda.hhs.gov>; Rebello,
Heidi <Heidi.Rebello@fda.hhs.gov>; Robb, Melissa <Melissa.Robb@fda.hhs.gov>; Thorpe, Valarie
<Valarie.Thorpe@fda.hhs.gov>; Tierney, Julia Julia. Tierney@fda.hhs.gov>

Subject: JW TWEETS: Ivermectin // BABY FOOD

Good morning... two items for your review this AM. Thanks! --Brad

CU: IVERMECTIN

Using any treatment for #COVID19 that’s not approved or authorized by the FDA can be highly dangerous and
potentially lethal. Don’t do it! [QRT @US_FDA]

TOXIC METALS IN BABY FOOD

We take exposure to toxic elements in the food supply extremely seriously, especially when it comes to
protecting the health & safety of the youngest and most vulnerable. We’re committed to reducing exposure to
the greatest extent feasible & further advance progress in this area. [QRT @DrMayneFDAFood]

Brad Kimberly

Director, Social Media

Office of Media Affairs
Office of Extemal Affairs

U.S. Food and Drug Administration
Tel: 240-402-1002 | Cell:

brad. kimberly@fda.hhs.gov

ry U.S. FOOD & DRUG

ADMINISTRATION

BOoOoO~


CAUTION: This email originated from outside of the organization. Do not click links or open attachments unless you recognize the
sender and know the content is safe.

Dear Dr. Woodcock,
Considering the potential public health value, including potential benefit in early / home use treatment of COVID-19,
safety history and profiles of current OTC products, might it be now appropriate for ivermectin and nitazaxanide, and

even hydroxychloroquinine, to be available OTC in the US?

https://covid19criticalcare.com/wp-content/uploads/2020/11/FLCCC-Alliance-I-MASKplus-Protocol-ENGLISH.pdf

With sincere respect,

Roxolana Horbowyj, MD, FACS



From: Woodcock, Janet [/O=EXCHANGELABS/OU=EXCHANGE ADMINISTRATIVE GROUP
(FYDIBOHF23SPDLT)/CN=RECIPIENTS/CN=7B0453354A9A42 7DBOA66A86C7A36F3D-JANET. WOODC]

Sent: 5/10/2021 2:18:32 PM
To: Cole Sommers [| 2,
Subject: RE: [EXTERNAL] Why aren't we using Ivermectin for covid?

Thank you. | am familiar with the ivermectin data. | believe it soon will be tested in a large trial to get a definitive idea
of its effectiveness in early treatment. Janet Woodcock

From: Cole Sommers < 8

Sent: Monday, May 10, 2021 2:11 PM

To: Woodcock, Janet <Janet.Woodcock@fda.hhs.gov>

Subject: [EXTERNAL] Why aren't we using Ivermectin for covid?

CAUTION: This email originated from outside of the organization. Do not click links or open attachments unless you recognize the
sender and know the content is safe.

Dear Dr. Woodcock,

lam sure that you are aware of the numerous studies showing the efficacy of lvermectin in both the
prophylaxis and treatment of covid-19.

| recommend that you to review the meta analysis by Dr. Tess Lawrie as well as the work of Paul
Marik, MD.
Countries that have adopted Ivermecitn have seen a large decrease in both cases and CFR.

We need all the tools in the tools shed to battle this terrible pandemic. That includes mass
vaccinations as well as safe and effective early treatment such as Ivermectin. People are dying that
simply don't have to die.

If you are not familiar with all of the literature on Ivermectin | will be happy to send it to you.

We must think our way out of this pandemic using first principles reasoning and work up form known
medical principles rather than reasoning form analogy.

Thank you,
Cole Sommers

"Your Deeds Are Your Monuments"

NULLIUS IN VERBA



From: Graaf, P.H. van der [p.vandergraaf@lacdr.leidenuniv.nl]
Sent: 3/8/2021 8:13:11 AM

To: Carl Peck [| ny Schmith [gschmith@nuventra.com]
cc: Yaning Wang ; Nick Holford [n.hol ford@auckland.ac.nz]; Mike Eldon
[ ; Woodcock, Janet [/o=Exchangelabs/ou=Exchange Administrative Group

(FYDIBOHF23SPDLT}/cn=Recipi ents /cn=7b0453354a9a427db0a66a86c7a36f3d-Janet.Woodc); Zhao, Liang

[/o=Excha ngeLabs/ou=Exchange Administrative Group

(FYDIBOHF23SPDLT)/cn=Recipi ents /cn=c1a1570c185440e69410afc0312b4ef1 -Zhaol]; cpteditor@ascptorg
Subject: [EXTERNAL] RE: Validation

CAUTION: This email originated from outside of the organization. Do not click links or open attachments unless you recognize the
sender and know the content is safe.

Dear all,
Thanks for the interesting thoughts.

| agree with Ginny that we should wait for more data to come out. The point that the standard dose was unlikelyto
work has already been made, but of course this doesn’t mean that a higher dose/exposurewill be efficacious.

Best wishes,

Piet

Piet van der Graaf, PharmD PhD

Senior Vice President, Quantitative Systems Pharmacology

Professor of Systems Pharmacology
Editor-in-Chief Clinical Pharmacology & Therapeutics

CERTARA®

Canterbury Innovation Centre, University Road, Canterbury, CT2 7FG, United Kingdom

ok 1227 931625
6ooode

Registered in England & Wales, Certara UK Limited no. 4217235. Registered office: One London Wall, 6th Floor, London, EC2Y SEB

From: Carl Peck <>
Sent: 07 March 2021 23:28

To: Ginny Schmith <gschmith@nuventra.com>

Ce: Yaning Wang <n Graaf, P.H. van der<p.vandergraaf @lacdr.leidenuniv.nl>; Nick Holford
<n.holford@auckland.ac.nz>; Mike Eldon <)>; Janet Woodcock <Janet. Woodcock @FDA.GOV>;
Liang Zhao <Liang.Zhao@fda.hhs.gov>

Subject: Re: Validation


Mar 27, 2020 — The FDA's Center for Veterinary Medicine has recently become aware that some consumers
may mistake chloroquine phosphate used to treat disease in aquarium fish for FDA-approved drugs (used to
treat malaria and certain other conditions in humans) that are being studied as a COVID-19 treatment for
humans.

Man Dies, Wife Hospitalized From Ingesting Fish Tank ...

www.pharmacypracticenews.com » Covid-19 > Article

Mar 25, 2020 — ... chloroquine phosphate in the mistaken belief the additive, commonly used by aquariums to
clean fish tanks, was a prophylactic for COVID-19 ...

Man dies after ingesting fish tank cleaner containing...

www.beckershospitalreview.com > public-health » man...

Mar 24, 2020 — A man in Arizona is dead and his wife is in critical care after the couple ingested a non-
medication form of chloroquine phosphate to stave off ...

Josh

On Sun, Mar 7, 2021 at 8:33 PM Stephen Ruberg < pe. wrote:
Thanks Carl.

I just saw 60 Minutes tonight and the story of fluvoxamine for COVID-19 - PATIENTS WITH MILDER
SYMPTOMS.

Another drug being re-purposed for treatment. Positive Ph 2 results (N=152 and p=0.009), but | am skeptical.
Lots of caveats for the trial. I should have a Blog paper posted on this by tomorrow AM.

https7//jamanetwork.comy/journals/jama/fullarticle/2773 108

In short, my prior is 0.01 (or 1%) chance that the drug works ... and honestly, that may be optimistic.

Using my favorite Bayesian formula for calculating a posterior probability, I get a posterior that the drug works
of 0.081. Yes, that's right. 8% chance that it truly works.

We will see as the larger follow-on trial is due to finish in a month or so.

On Sun, Mar 7, 2021 at 3:07 PM Carl Peck < PO wrote:
FYI - on value of clin pharn/pharmacometrics in Covid Rx R&D.

Carl

Begin forwarded message:

From: Carl Peck < me),
Subject: Validation
Date: March 7, 2021 at 12:03:37 PM PST


From: Adam, Stacey (FNIH) [T] [sadam@fnih.org]

Sent: 11/17/2020 12:02:42 PM

To: Woodcock, Janet [/o=Exchangelabs/ou=Exchange Administrative Group
(FYDIBOHF23SPDLT)/cn=Recipi ents /cn=7b0453354a9a427db0a 66a 86c7a 36f3d -Janet.Woodc]

Subject: RE: Ivermectin and anIND

I know. The results out of Perusoldher. They did not originally sell ourreviewers... ©

Stacey J. Adam, PhD
Director, Cancer
Research Partnerships

Direct: (301) 435-8364 | Mobile: 22

From: Woodcock, Janet Janet. Woodcock @fda.hhs.gov>
Sent: Tuesday, November 17, 2020 11:55 AM

To: Adam, Stacey (FNIH) [T] <sadam@fnih.org>

Subject: RE: lvermectinand an IND

Yes if possible. You know Maria is veryinterested inthis. jw

From: Adam, Stacey (FNIH) [T] <sadam@fnih.org>
Sent: Tuesday, November 17, 2020 11:51 AM
To: Woodcock, Janet <Janet. Woodcock @fda.hhs.gov>; Kilgore, Nicole RCIV USARMY (USA)

Subject: RE: lvermectinandan IND
Thanks, Janet,

As with Cyclosporin, would you like ACTIV to review this for prioritization? We did so twice already, butin earlier rounds
when the data was not so developed. Would you like us to take another look?

Thanks,
Stacey

Stacey J. Adam, PhD
Director, Cancer
Research Partnerships

Direct: (301) 435-8364 | Mobic: SII ee

From: Woodcock, Janet <Janet. Woodcock @fda.hhs.gov>
Sent: Tuesday, November 17, 2020 9:25 AM

To: Kilgore, Nicole R CIV USARMY (USA) <)>; Adam, Stacey (FNIH) [T] <sadam@fnih.org>
Subject: FW: Ivermectin and an IND

Potentially more information on Ivermectin use. Janet W

From: Marik, Paul E. <MarikPE@EVMS.EDU>
Sent: Tuesday, November 17, 2020 8:01 AM


Further, due to the urgency related to the communication and dissemination of this recommendation that is aimed at saving
thousands of lives daily, please forgive the limitations of the draft proceedings document attached. Information on the
process and methods can be found among the annexes. An Executive Summary is being finalised and will be available on
Monday.

We look forward to hearing from you soon and would be happy meet with you via teleconference if you think this will be
helpful.

Please do not hesitate to contact us with any questions.
Kind regards,
Dr. Tess Lawrie, on behalf of the BIRD Steering Group and Recommendation Development Panel

Evidence-based Medicine Consultancy Ltd
e-bmc.co.uk


To: Ginny Schmith <gschmith@nuventra.com>

Cc: Yaning Wang ee Piet Van Der Graaf
<p.vandergraaf@lacdr.leidenuniv.ni>, Nick Holford <n.holford@auckland.ac.nz>, Mike Eldon
Sa ee star sanet Woodcock <Janet Woodcock@FDA.GOV>, Liang Zhao
<Liang.Zhao@fda.hhs .gov>

Ginny, I just noted the piece below in Steve Shafer’s Daily COVID Update *(3/6/21):

"Ivermectin was the drug du jour for several months for COVID, at least on talk radio. A study in JAMA
found that “among adults with mild COVID-19, a 5-day course of ivermectin, compared with placebo, did not
significantly improve the time to resolution of symptoms. The findings do not support the use of ivermectin
for treatment of mild COVID-19, although larger trials may be needed to understand the effects of ivermectin
on other clinically relevant outcomes”

(see https?//Idry.ms/b/s!AuO yHP_aTly7s8JfmXPkeKdzWjS VFA?e=Enmi7 w)."

The above may validate your excellent CPT paper "The Approved Dose of Ivermectin Alone is not the
Ideal Dose for the Treatment of COVID-19”

Similarly, RCT’s have confirmed Yaning Wang’s equally excellent paper "Connecting hydroxychloroquine
in vitro antiviral activity to in vivo concentration for prediction of antiviral effect: a critical step in
treating COVID-19 patients “, which concluded:

"Under the assumption that in vivo cellular accumulation is similar to that from the in vitro studies, the
calculated free lung concentrations that would result from proposed dosing regimens are well below the in
vitro EC50/EC90 values, making the antiviral effect against SARS-CoV-2 not likely achievable with a safe
oral dosing regimen. Well-designed clinical trials that leverage full understanding of drug pharmacology and
disposition, as well as disease pathogenesis, will be necessary to definitively determine whether the
tisk/benefit balance is favorable for a given treatment."

Perhaps you should collaborate with Yaning to write a piece for CPT showing how good clin pharm and
pharmacometrics can avert wasting resources on poorly thought out hypotheses.

Carl

Make it a stellar day,

Steve Ruberg, PhD
President, Analytix Thinking
Bringing Data to Life


>

> can you or anyone at the FDA?
>
> -steve


From: Steve Kirscl

Sent: 5/12/2021 12:46:36 AM

To: Woodcock, Janet [/o=ExchangeLabs/ou=Exchange Administrative Group
(FYDIBOHF23SPDLT)/cn=Recipients/cn=7b0453354a9a427db0a66a86c7a36f3d-Janet.Woodc]

Subject: [EXTERNAL] there is better supply of IVM in a third world country

CAUTION: This email originated from outside of the organization. Do not click links or open attachments
unless you recognize the sender and know the content is safe.

this is ridiculous don't you think?

-Original Messag
Fron: Zohn ab ei, <i uN
Sent: Tuesday, May 11,

To: Steve Kirsch <stk@ml0.io>

Subject: Re: IVM + FLV

I will press and see what answers they come up with.
So far:

os said they didn’t have either medicine in stock and were out and checking with walgreen’s was a good
idea.

Walgreen’s told me they'd call Cvs and let me know when they were ready. Walgreen’s only got back to me
two days later about Fluvoxamine and the pharmacist had no record of the Ivermectin at all and said
“she’d have someone call Cvs.” I’ve not heard back since.

Sent from my iPad

> On May 11, 2021, at 9:18 PM, Steve Kirsch D....:

>
> can you press them on it. I'm curious how it goes. I will write this up as a case study.
>

> so NONE of the pharmacies could provide you with ivermectin? what are they telling you?

po tetera Original Message-----

>> From: John Halbleib <

>> Sent: Tuesday, May 11, 2021 8:51 PM
>> To: Steve Kirsch <stk@m10. io>

>> Subject: Re: IVM + FLV

>> Walgreen’s Pharmacy never followed up on Ivermectin.
>
>> Sent from my iPad

>
>>>> On May 7, 2021, at 5:45 PM, Steve Kirsch a ...-:

>>
>>> were you able to get both drugs?
>>>

>>>> -----Original Message-=---—

>>>> From: John Halbleib es

>>>> Sent: Thursday, May 6 124 AM

>>>> To: Steve Kirsch Ios

>>>> Subject: Re: IVM + FLV

>>>>

>>>> Walgreen’s texted saying Fluvoxamine was ready with no mention of
>>>> Ivermectin so my guess is they’re holding that one up.

>>>

>>>> I had 9 IvM pills to start and have taken 7 so far. I didn’t get
>>>> the impression that the pharmacies were going to let me have it.
>>>>

>>>> I could go and try Costco and Safeway. I’m a Kaiser Member but
>>>> would expect them to be the most uncooperative of all.

>>>>
>>>> Sent from my iPhone

>>>>

S>5>>> On May 6, 2021, at 9:06 AM, Steve Kirsch yyeee- wrote:
>>>>>

>>>>> how is the ivermectin fill going?
>>>>>


ribonucleoside inhibitor that was originally developed for influenza (NCT04575597);
SNGOO1, a nebulized formulation of interferon-B1a developed for viral infections in
patients with chronic obstructive pulmonary disease (NCT04385095); and camostat
mesylate, a serine protease inhibitor approved for treatment of chronic pancreatitis
and postoperative reflux esophagitis (NCT04353284).

We view your candidates favorably. Having said that, we would add three:

. favipiravir
. interferon gamma
. ivermectin

Of the six (your three+ours), only one, ivermectin, is currently FDA approved. Please open and
glance at Dr. Marik's attached slides. A partial bibliography of the studies cited appears below.

Ivermectin is available as generic in part due to the generous policies of Merck. While we would
welcome Merck advancing ivermectin for COVID-19, Merck has taken a financial interest in MK-4482
(EIDD-2801), so we believe someone else must be identified who will assess the evidence for
ivermectin efficacy, champion the finalizing of research, and make necessary applications on an
expedited basis.

The evidence for ivermectin efficacy far exceeds that for either famotidine or hydroxychloroquine,
two previously FDA approved orally available medications that have received scrutiny. We join front-
line intensivist Drs. Marik, Kory, and Varon in asking that our health authorities act on the evidence
concerning ivermectin, as attached and as supported

by Dr. Kory's interview at https://youtu.be/n2MlliaLCOA. Whether it's BARDA, NIAID, ACTIV,
OWS, NCATS, or a private foundation, someone needs to be found to advance ivermectin in the
public interest.

Under current circumstances, preponderance of the evidence, not proof, should be the applicable
standard for an EUA or a broad phase 3 IND from the FDA. If necessary, risk can be quantified;
actuarys do it routinely. If some risk taking is likely to minimize harm from the disease, that fact
should be incorporated when discussing means and methods, including standards for FDA approval.

Finally, there is the matter of clinical trial design under the circumstance we now find ourselves,
which is dire. There is no question double-blind placebo controlled clinical trials are the evidentiary
gold standard, but they fail to offer patient and clinician control concerning the individual patient's
wish to be treated, or not. RCTs do not allow us to both scale up, and compare treatments, in the
way we need to. Attempting to do so will result in an enormous number of people who desire
treatment receiving placebo, and medical staff time going into administering it. Having said all that,
observational trials are unlikely to generate the quality data we need to inform our decisions. There
is middle ground: active control clinical trials (ACTs). Former FDA Commissioner Robert Califf,
MD has spoken favorably of the potential of such trials, which would allow both randomization and
integration with clinical practice. We have cc'd Dr. Califf on this message so that he might
comment. Because ivermectin is already approved and widely available, it's adoption as a
background therapy would open possibilities in active control clinical trial design so we can dispense
with having to deny patients needed treatment because they were allocated placebo.

With respect to existing FDA approved agents, we've swung and missed twice in the cases of
hydroxychloroquine and famotidine. While that may be discouraging, no batter returns to the dugout


Pierre Kory, MD, MPA

Pulmonary and Critical Care Medicine
Aurora St. Luke's Medical Center
Mitwaukee, WI

Joseph Veron, MD, FACP, FCCP, FCCM, FRSM
United Memorial Medical Center

University of Texas School of Medicine
Houston, TX

Binh Ngo, MD

Associate Professor

Keck Medical School of USC
Los Angeks, CA

Marc Rendel, MD

Medical Director

Rose Saker Medical Research Foundation
Newport Beach, CA

Stephen Ditmore
Health Reporter
Parkchester Times
Bronx, NY

On Mon, Nov 30, 2020 at 12:47 AM Stephen Ditmore < > wrote:

Peter S. Kim, MD, corresponding author
Therapeutics Research Program, Division of AIDS
National Institute of Alergy and Infectious Diseases
National Institutes of Heakh,

5601 Fishers Ln, Bethesda, MD 20892

{ (b) (6)

Drs. Janet Woodcock, Rachel Harrigan, and Robert Calff are copied on this email.
Please forward to co-authors (including Dr. Fauci), collaborators and colleagues.


From: Steve Kirsch (b) (6)

Sent: 12/8/2020 12:00:17 AM

To: Woodcock, Janet [/o=ExchangeLabs/ou=Exchange Administrative Group
(FYDIBOHF23SPDLT}/cn=Recipi ents /cn=7b0453354a9a427db0a66a86c 7a 36f3d-Janet.Woodc); Austin, Christopher P
(NIH) [/o=ExchangeLabs/ou=Exchange Administrative Group
(FYDIBOHF23SPDLT)/cn=Recipi ents /cn=11945b8d0caf49bc84e0917 1ec167b3a-HHS-austinc]

ce: Hall, Matthew D (NIH) [/o=ExchangeLabs/ou=Exchange Administrative Group
(FYDIBOHF23SPDLT}/cn=Recipi ents /en=80fd9cb35d73417388a946a42174Scbf-HHS-hallma-]
Subject: HSGAC hearingon repurposed drugs

Wow. These people are absolutely incompetent. they are doing a huge disservice here.

From: Steve Kirsch

Sent: Monday, December 7, 2020 8:57 PM

To: Mulkins, Christopher (HSGAC) <Christopher_Mulkins @hsgac.senate.gov>

Ce: Petry, Megan (HSGAC) <Megan_Petry @hsgac.senate.gov>; Tsilker, Yelena (HSGAC)
<Yelena_Tsilker@hsgac.senate.gov>; Ryan, Corban (HSGAC) <Corban_Ryan@hsgac.senate.gov>; McLeod, Josh (HSGAC)
<Josh_McLeod @hsgac.senate.gov>; Rosenstock, Shani (HSGAC) <Shani_Rosenstock@hsgac.senate gov>; Ashish Jha -
Harvard (ashish_jha@brown.edu) <ashish_jha@brown.edu>

Subject: RE: why there isn't an EUA for fluvoxamine

| saw the list of witnesses foryour hearing. It seems to be a mix of ivermectin, HCQ, favipiravir, and anti-vax.

None of those drugs those witnesses will talk about has anywhere close to the p value and quality of evidence as
Fluvoxamine. That’s why it was the lead story in JAMA when it was published. More importantly, the patients report
that this drug turns covidintoa “mildcold”. While thatis anecdotal, itis verifiable in a VERY large cohort. | know
because | talked to the physician treating all the cases. He just reported the peoplewho previously opted out are all
changing their minds and optingin.

Ivermectinis arguably the second best drug. Thereis only one RCT published in a peer reviewed journal on|vermectin
(Podder etal) and that was far smaller than the fluvoxamine trial (less than half the size). here’s whatit said:

There were 30 patients in the control arm and 32 patients in the intervention arm. Total recovery time from the onset of
symptoms to complete resolution of symptoms of the patients in the intervention arm was 10.09 + 3.236 days, compared to
11.50 + 5.32 days in the control arm (95% CI -0.860,3.627, p>. 05) and was not significantly different. The mean recovery time
after enrolment in the intervention arm was 5.31 4 2.48 days, which also did not differ significantly from the control arm of 6.33
+ 4,23 days (95% CI — 0.766, 2.808, p> 0.05). Results of negative repeat RT- PCR were not significantly different between
control and intervention arms (control 90% vs intervention 95%, p>.05). Conclusion: Ivermectin had no beneficial effect on
the disease course over usual care in mild to moderate COVID-19 cases.

Most doctors basically only use high quality data, so there is really no comparison here. There are certainly alot more
studies onlvermectin, butagain, theseis dismissed by doctors if it isn’t double blind RCT publishedina peer reviewed
journal. The lvermectin metaanalysis wasn’t published in a journal, wasn’t peer reviewed. |lasked the 12 medical
experts on the CETF SAB what they thought of the metaanalysis and they said Garbage IN, Garbage out. It is not
debatable: the highest quality evidence for ivermectin said IT HAS NO BENEFIT.

’mvery familiar with Favipiravirand | love the Fujifilm people. We are great friends. Butthe factis that drug doesn’t
work either. |was very disappointed but itis what it is. That’s why the UCLA trial never got started. the PI lostinterest
because the data showed there was nothing there, This data is all in plain sight.

You are focusing your entire hearing on junk science and you are giving repurposed drugs a bad name. Instead of
helpingthe cause and saving lives, you are hurtingit by featuring these drugs where the highest quality evidence shows


the Carter Center, I’ve got enough familiarity with the pleiotropic effects of mectizan (ivermectin) to be unsurprised by
various reports of benefit in COVID-19, with few side effects. Though adequate RCTs are lacking, both of these —
particularly doxycycline — make sense for consideration or additional investigation among the repurposed therapeutics
above.

Hope this helps! (especially for a fellow Northwestern alum). Best - John

John P. Hussman, Ph.D.
Director, Hussman Foundation

24, HUSSMAN

FOUNDATION

6021 University Blvd, Suite 490 | Ellicott City, MD 21043
443.465.4814 | hussman@hussmanfoundation.org

From: Woodcock, Janet [mailto:Janet.Woodcock@fda.hhs.gov]

Sent: Monday, December 14, 2020 6:33 PM

To: John P, Hussman, Ph.D.

Subject: RE: COVID-19: Pandemic trajectory; Repurposed therapeutics; Vaccine considerations (antigens, rare
occurence of Bell's palsy, dose sparing, immune correlates); Public health messaging

Thanks very much. | will circulate again with your permission. It does appear that the monoclonal neutralizing
antibodies are not helpful in late disease.

Given the immune pathology, what do you think about cyclosporine as a repurposed agent? | getting a lot of push on
that one! Thanks jw

From: John P. Hussman, Ph.D. Sy yyyyyyee>

Sent: Thursday, December 10, 2020 11:53 AM

To: Auchincloss, Hugh (NIH) si‘ Woodcock, Janet <Janet.Woodcock@fda.hhs.gov>; Bozick,
Brooke A (NIH) (SOO >; Harris, Kara M (NIH) SOO >; Conrad, Patricia L (NIH)
<I>; CVH <cvh@vanhollen.org>; Tricia_Russell@vanhollen.senate.gov; Burrow, David
<David.Burrow@fda.hhs.gov>; Cruse, Alonza <Alonza.Cruse@fda.hhs.gov>; INO;

‘mom @martinomalley.com' <mom@martinomalley.com>; Kenny Thompson Jr. (Ty ye
SL pstavin@partners.org; Clemmens, Michael

(mclemmens@aahs.org) <mclemmens@aahs.org>; Jarrell, Bruce (bjarrell@umaryland.edu) <bjarrell@umaryland.edu>;
Ford, Henri (hford@med.miami.edu) <hford@med.miami.edu>; jeffrey.duerk@miami.edu; Jay Perman
(jperman@usmd.edu) <jperman@usmd.edu>; Chris Elias (chris.elias@gatesfoundation.org)
<chris.elias@gatesfoundation.org>; Chris Karp (Chris.Karp@gatesfoundation.org) <Chris.Karp@gatesfoundation.org>;
Pericak-Vance, Margaret A. <MPericak@med.miami.edu>

Cc: Brooke Steinau <bsteinau@hussmanfoundation.org>; John P. Hussman, Ph.D. <hussman@hussmanfoundation.org>
Subject: COVID-19: Pandemic trajectory; Repurposed therapeutics; Vaccine considerations (antigens, rare occurence of
Bell's palsy, dose sparing, immune correlates); Public health messaging

Good morning all,

Given the recent acceleration in the trajectory of COVID-19 fatalities, and the likelihood that widespread vaccination
may not be achieved until mid-year, | am writing to share a few perspectives that may be useful in the interim. As with
all of these periodic notes since February, they are offered as input for consideration, in hope that some part of this may
be helpful in your own thinking, or that of your staff, on one or more of these issues.

With gratitude for all of your dedicated efforts on so many fronts of this pandemic.


From: Woodcock, Janet [/O=EXCHANGELABS/O U=EXCHANGE ADMINISTRATIVE GROUP
(FYDIBOHF23SPDLT)/CN=RECI PIENTS/CN=7B0453354A9A427 DBOAG6A86C7A36F3D-J ANET.WOODC]

Sent: 12/7/2020 8:33:51 AM

To: Cavazzoni, Patrizia [/o=ExchangeLabs/ou=Exchange Administrative Group
(FYDIBOHF23SPDLT)/cn=Recipi ents /cn=c42abd33834044ecbaa03d075cc0a5d2 -Patrizia.Ca]

Subject: RE: To the FDA and NCATS concerningivermectin for the treatment of COVID-19

Thx jw

From: Cavazzoni, Patrizia <Patrizia.Cavazzoni @fda.hhs.gov>

Sent: Monday, December 7, 2020 8:34 AM

To: Hahn, Stephen <SH1@fda.hhs.gov>; Woodcock, Janet Janet.Woodcock@fda.hhs.gov>
Cc: Lenihan, Keagan <Keagan.Lenihan@fda.hhs.gov>

Subject: RE: To the FDA and NCATS concerningivermectin for the treatment of COVID-19

| will referto CDER ExecSec
Patrizia

From: Hahn, Stephen < m6),
Sent: Monday, December 7, 2020 8:24 AM

To: Woodcock, Janet <Janet. Woodcock @fda.hhs.gov>
Ce: Cavazzoni, Patrizia <Patrizia.Cavazzoni @fda.hhs.gov>; Lenihan, Keagan <Keagan.Lenihan@fda.hhs.gov>

Subject: Re: To the FDA and NCATS concerningivermectin for the treatment of COVID-19

Keagan

Would you refer to ExecSec?
Thx

Steve

Sent from my iPhone

On Dec 7, 2020, at 8:04 AM, Woodcock, Janet <Janet. Woodcock @fda.hhs.gov> wrote:

Per request below. OWS and ACTIV have evaluated several times. jw

From: Stephen Ditmore <| Wye),
Sent: Sunday, December 6, 2020 2:03 PM
To: Woodcock, Janet <Janet. Woodcock @fda.hhs.gov>

Ce: Paul E. <MarikPE@evms.edu>; Joseph E. Varon< pe.. Binh <Binh.Ngo@med.usc.edu>; marc
rendell <rendell@asndi.com>; Pierre Kory < ©). Harrigan, Rachel (OS) <Rachel.Harri an@hhs.gov>;

Kim, Peter (NIH/NIAID) <! .,: robert.califf@duke.edu
Subject: To the FDA and NCATS concerning ivermectin for the treatment of COVID-19

Dr. Janet Woodcock
Director, Center for Drug Evaluation and Research
Food and Drug Administration

Please forward to:


From:
Sent:
To:

Adam, Stacey (FNIH) [T] [sadam @fnih.org]
1/15/2021 1:08:59 PM
Garner, Carl [garner_carlos_o@lilly.com]; Bozzette, Sam A (NIH) [/o=ExchangeLabs/ou=Exchange Administrative
Group (FYDIBOHF23SPDLT)/cn=Recipients/cn=8054ed74996e46c2a49cb3 1ec22af84b-HHS-sam.boz]; Butterton, Joan
{joan_butterton@merck.com]; De Claro, R. Angelo [/o=ExchangeLabs/ou=Exchange Administrative Group
(FYDIBOHF23SPDLT)/cn=Recipients/cn=25c463 1cbb7144d4a22d53cSe5fcfdce-DECLAROR]; Draghia-Akli, Ruxandra
(RDraghia@ITS.JNJ.com]; Eisner, Mark [eisner.mark@gene.com]; Gottesdiener, Keith
1). Eric Hughes [eric.hughes@novartis.com]; Judy Currier

{jscurrier@mednet.ucla.edu]; Kim, Elizabeth [elkim@deloitte.com]; LaVange, Lisa [lisa.lavange@unc.edu]; Levy,
Elliot [elliott|@amgen.com]; Mellors, John W [jwm1@pitt.edu]; Menon, Sandeep [Sandeep.M.Menon@pfizer.com];
Parker, Ashley S (NIH) [/o=ExchangeLabs/ou=Exchange Administrative Group
(FYDIBOHF23SPDLT)/cn=Recipients/cn=3f43b948b59f4e679535a8a3ebc91167-HHS-ashley.]; Patel, Naimish
(naimish.patel@sanofi.com]; Peppercorn, Amanda [amanda.f.peppercorn@gsk.com]; Poole, Mike
(Mike.Poole@gatesfoundation.org]; Proschan, Michael A (NIH) [/o=ExchangeLabs/ou=Exchange Administrative
Group (FYDIBOHF23SPDLT)/cn=Recipients/cn=820d5 10db037432ab1ffafcd070ee409-HHS-proscha]; Read, Sarah W
(NIH) [/o=ExchangeLabs/ou=Exchange Administrative Group
(FYDIBOHF23SPDLT)/cn=Recipients/cn=72ca09ea60c74100a908211e1f7 cSf6a-HHS-readsa-]; Santos, Michael R (NIH)
[/o=ExchangeLabs/ou=Exchange Administrative Group
(FYDIBOHF23SPDLT)/cn=Recipients/cn=5d410c16ad784c24a4ee47599cafec85-HHS-msantos]; Shen, Yuan Li
[/o=ExchangeLabs/ou=Exchange Administrative Group
(FYDIBOHF23SPDLT)/cn=Recipients/cn=697e41cd393a4 fbab78fe028b77a20fb-SHENYU]; Stein, Peter
[/o=ExchangeLabs/ou=Exchange Administrative Group
(FYDIBOHF23SPDLT)/cn=Recipients/cn=d30a87acb0184261961264ba984b0a51-Peter.Stein]; Wholley, David N (NIH)
[/o=ExchangeLabs/ou=Exchange Administrative Group
(FYDIBOHF23SPDLT)/cn=Recipients/cn=784 115e9182043d48eaa9e91761c4330-HHS-dwholle]; Buchman, Tim G (OS)
[/o=ExchangeLabs/ou=Exchange Administrative Group
(FYDIBOHF23SPDLT)/cn=Recipients/cn=3b2ac13394e34125b8f9d36dcebd3157-HHS-Tim.Buc]; Collins, Sylva
[/o=ExchangeLabs/ou=Exchange Administrative Group
(FYDIBOHF23SPDLT)/cn=Recipients/cn=751351605a0a41flab9 7cb8a8753b432-Sylva.Colli]; Amanda Peppercorn
[amanda.peppercorn@gmail.com]; Higgs, Elizabeth S (NIH) [/o=ExchangeLabs/ou=Exchange Administrative Group
(FYDIBOHF23SPDLT)/cn=Recipients/cn=0ac36dd643c04994b3 16 1baf825cbfc3-HHS-ehiggs-]; Koroshetz, Walter J
(NIH) [/o=ExchangeLabs/ou=Exchange Administrative Group
(FYDIBOHF23SPDLT)/cn=Recipients/cn=4d97701b01894e15a53709b9df3e08e7-HHS-koroshe]; Timothy Burgess
(timothy.burgess@usuhs.edu]; Reineck, Lora A (NIH) [/o=ExchangeLabs/ou=Exchange Administrative Group
(FYDIBOHF23SPDLT)/cn=Recipients/cn=311c3ebe3a4c491db44fbf671e535f76-HHS-lora.re]; Aggarwal, Neil R (NIH)
[/o=ExchangeLabs/ou=Exchange Administrative Group
(FYDIBOHF23SPDLT)/cn=Recipients/cn=a7e4ee23a27e4699ad 1d5fb0e4e240ce-HHS-neil.ag]; Rosenberg, Yves D
(NIH) [/o=ExchangeLabs/ou=Exchange Administrative Group
(FYDIBOHF23SPDLT)/cn=Recipients/cn=5a312ca63150451cb98005b27b4a0f8b-HHS-rosenbe]; Goff, David C (NIH)
[/o=ExchangeLabs/ou=Exchange Administrative Group
(FYDIBOHF23SPDLT)/cn=Recipients/cn=1fa2747f2f704a3ba1637f2febe8bc67-HHS-david.g]; Brown, Jeremy (NIH)
[/o=ExchangeLabs/ou=Exchange Administrative Group
(FYDIBOHF23SPDLT)/cn=Recipients/cn=6e502731145c4045b5 e088df526a7 10b-HHS-jeremy.]; Gadbois, Ellen L (NIH)
[/o=ExchangeLabs/ou=Exchange Administrative Group
(FYDIBOHF23SPDLT)/cn=Recipients/cn=680ebce054324eff90ecfff770987437-HHS-gadbois]; Culp, Michelle A (NIH)
[/o=ExchangeLabs/ou=Exchange Administrative Group
(FYDIBOHF23SPDLT)/cn=Recipients/cn=93cef0fSbf33475c8e44a8b2a2516251-HHS-michell]; Jacqueline Kirchner
Jacqueline.Kirchner@gatesfoundation.org]; Beigel, John H (NIH) [/o=ExchangeLabs/ou=Exchange Administrative
Group (FYDIBOHF23SPDLT)/cn=Recipients/cn=db2bc96f962b4661b0494e9fa6ca6bcf-HHS-jbeigel]; Phillips, L Revell
CIV DTRA RD (USA) ®) Petrovick, Martha - 0449 - MITLL [petrovick@ll.mit.edu];

®®<izemore, Christine F (NIH) [/o=ExchangeLabs/ou=Exchange Administrative Group
(FYDIBOHF23SPDLT)/cn=Recipients/cn=d39a40f80fd64c1081df4a43500560b6-HHS-christi]; Lane, Henry C (NIH)
{/o=ExchangeLabs/ou=Exchange Administrative Group
(FYDIBOHF23SPDLT)/cn=Recipients/cn=d904337536cf41719032a9359alec2ab-HHS-CLANE-n]; Woodcock, Janet
[/o=ExchangeLabs/ou=Exchange Administrative Group
(FYDIBOHF23SPDLT)/cn=Recipients/cn=7b0453354a9a427db0a66a86c7a36f3d-Janet.Woodc]


Frank Fortin
American Pharmacists Association

ffortin@aphanet.org
Amy Ruth Cole

ASHP
aruthcole@ashp.org

Thanks. Be well

ILISA BG BERNSTEIN, PharmD, JD, FAPhA

Senior Vice President, Pharmacy Practice and Government Affairs
American Pharmacists Association

2215 Constitution Avenue, NW

Washington, DC 20037

202-429-7533 (O) | NIP (my
www.pharmacist.com

et APhA

American Pharmacists Association



(b) (6)

From: IAN GRANT-WHYTE [

Sent: 6/29/2021 1:47:10 AM

To: Woodcock, Janet [/o=ExchangeLabs/ou=Exchange Administrative Group
(FYDIBOHF23SPDLT)/cn=Recipients/cn=7b0453354a9a427db0a66a86c7a36f3d-Janet.Woodc]

ce: Berlin, Robert [robert.berlin@fda.hhs.gov]

Subject: [EXTERNAL] It is reasonable to try just about anything as long as the risk for harm is very low.

Attachments: ETOH.COVID.ARTICLE.8.21.2020.edited. final.8.28.20 (1) (1) (1) (1) (1) (4) (1) (2) (3) (1) (4) (2) (6) (2) (2) (4) (4) (4) (3)
(4) (1) (7) (1) (1) (2) (3) (3).docx

CAUTION: This email originated from outside of the organization. Do not click links or open attachments unless you recognize the
sender and know the content is safe.

==

Judith Tharp, MD

E 1G ine

Doesn't "prove" that Ivermectin helped, but in the course of an ongoing epidemic
capable of severe illness and complication, almost any treatment must be called
experimental (empirical). The way | look at it, it is reasonable to try just about
anything as long as the risk for harm is very low. You can't wait for a randomized
controlled study in the middle of a raging pandemic. Analysis of possible
benefit/no-benefit from Ivermectin can be done later, but that will depend on
adequate record-keeping and reporting.



To: Kessler, David (HHS/IOS) <David.Kessler @hhs.gov>; Collins, Francis (NIH/OD) [E] yee: Fauci,
Anthony (NIH/NIAID) [E] >; Bugin, Kevin (FDA/CDER) <kevin.bugin@fda.hhs.gov>; Teyhen, Deydre
(HHS/1OS) Sy Adam, Stacey (FNIH) [T] <sadam@fnih.org>

Subject: FW: [EXTERNAL] URGENT: The BIRD meeting proceedings and recommendation on covid-19 prevention and
treatment

Another good reason to get ACTIV 6 up and running. Solid evidence still lacking. jw

From: Tess Lawrie <tess@e-bmc.co.uk>

Sent: Friday, February 26, 2021 10:59 AM

To: Abernethy, Amy <Amy.Abernethy@fda.hhs.gov>; Anderson, Erika <Erika.Anderson@fda.hhs.gov>; Yiannas, Frank
<Frank.Yiannas@fda.hhs.gov>; james.sigg@fda.hhs.gov; Tyler, James <James.Tyler@fda.hhs.gov>; Tierney, Julia
<Julia.Tierney@fda.hhs.gov>; Hinton, Denise <Denise.Hinton@fda.hhs.gov>; Raza, Mark <Mark.Raza@fda.hhs.gov>;
Abdoo, Mark <Mark.Abdoo@fda.hhs.gov>; Araojo, Richardae <Richardae.Araojo@fda.hhs.gov>; McMeekin, Judith
<Judith.McMeekin@fda.hhs.gov>; Rebello, Heidi <Heidi.Rebello@fda.hhs.gov>; Roth, Lauren
<Lauren.Roth@fda.hhs.gov>; Tantillo, Andrew <Andrew.Tantillo@fda.hhs.gov>; Vasisht, Kaveeta
<Kaveeta.Vasisht@fda.hhs.gov>; Felberbaum, Michael <Michael.Felberbaum@fda.hhs.gov>; Mair, Michael
<Michael.Mair@fda.hhs.gov>; Mettler, Erik <Erik.Mettler@fda.hhs.gov>; Miller, Elizabeth
<Elizabeth.Miller@fda.hhs.gov>; Rogers, Michael <Michael.Rogers@fda.hhs.gov>; Cavazzoni, Patrizia
<Patrizia.Cavazzoni@fda.hhs.gov>; Marks, Peter <Peter.Marks@fda.hhs.gov>; Mayne, Susan
<Susan.Mayne@fda.hhs.gov>; Pazdur, Richard <Richard.Pazdur@fda.hhs.gov>; Jeffrey.shuren@fda.hhs.gov; Slikker,
William <William.Slikker@fda.hhs.gov>; Solomon, Steven M <Steven.Solomon@fda.hhs.gov>; Mitch.zeller@fda.hhs.gov;
Stein, Peter <Peter.Stein@fda.hhs.gov>; Woodcock, Janet <Janet. Woodcock @fda.hhs.gov>; Sally.chloe@fda.hhs.gov
Ce: claire Mock-Mufioz de Luna <claire@e-bme.co.uk>; Ketan Gajjar Andy Bryant
<andy.bryant@newcastle.ac.uk>; Tony Tham ; Scott Mitchell <scott.mitchell@gov.gg>; Tina

Peers
Subject: [EXTERNAL] URGENT: The BIRD meeting proceedings and recommendation on covid-19 prevention and
treatment

CAUTION: This email originated from outside of the organization. Do not click links or open attachments unless you recognize the
sender and know the content is safe.

Dear Dr. Stein and FDA Colleagues,

We are writing to share with you the evidence to decision framework of the British lvermectin Recommendation Development
(BIRD) Meeting that was held on Saturday 20th February 2021 via Zoom from Bath, United Kingdom. The expert panel of
health and allied professionals and other stakeholders included representatives from 16 countries, namely Argentina,
Australia, Belgium, Botswana, Canada, France, Hungary, India, Ireland, Japan, Peru, Nigeria, South Africa, The Philippines,
United States, United Kingdom. The ethos of the BIRD meeting was that of scientific rigour and transparency in the spirit of
international collaboration towards a common goal — that of saving lives.

The recommendation was developed according The WHO Handbook of Guideline Development (2014). BIRD panel conclusions
are that ivermectin should be approved immediately for prevention and treatment of covid-19.

The BIRD recommendation on covid-19 prevention and treatment

The British Ivermectin Recommendation Development Panel recommends ivermectin for the prevention and treatment of
covid-19 to reduce morbidity and mortality associated with covid-19 infection and to prevent covid-19 infection among those
at higher risk.

The BIRD Steering Group has taken heed of the WHO statement on ‘Developing global norms for sharing data and results
during public health emergencies’ that states that ‘public disclosure of information of relevance to public health emergencies
should not be delayed’, and also notes the' very great risks' that can occur from ‘withholding data and results arising from
analyses’. We are, therefore, sharing this evidence-to decision framework within just a few days of the BIRD meeting to avoid
delay.



My prayer is that you are honest. | am praying for your strength.

Sincerely,
Karla Q. Harris
Baltimore MD

A Guide to Home-Based COVID Treatment
https://aapsonline.org/covidpatientquide/
The 411 on COVID - Ask Your Doc'!

https://www.youtube.com/watch?v=QAHi3IX30GM&t=928s
https://www. youtube.com/watch?v=d8058HB8uYE&t=429s



Sent: 3/13/2021 8:45:38 AM
To: Geoffrey Taylor [| (0) (6)
Subject: RE: [EXTERNAL] Ivermectin

Thank you for writing. The USG has known about the interest in ivermectin since last summer, and we have
been reviewing data as it becomes available. What you read was FDA legal-speak roughly meaning that there
are not any applications in-house, in other words, we don't have a data submission. We are not allowed to
say whether or not we are reviewing applications for investigational drugs due to confidentiality
concerns. I would not expect an application to be submitted for ivermectin, just as we did not get one
for dexamethasone although corticosteroids have become standard of care in the US for the severe stage of
COVID-19. I knew about the Ivermectin Recommendation group, although I have not reviewed their analysis
in detail.

Obviously an oral product with good anti-viral activity and good safety would be a tremendous boon in
this disease. There has been concern that at usual tolerated doses intracellular concentrations are not
high enough with ivermectin to achieve this goal. There is an effort ongoing to formally test ivermectin
in an adequately powered trial here in the us.

At the moment we have monoclonal antibodies that are highly effective in inhibiting disease progression
and have been shown (although not fully FDA reviewed) in two independent trials to cut hospitalization
and death by greater than 75% when administered early to high risk outpatients. There are obvious
problems in administration of monoclonals but hundreds of thousands of infusions have been done..

We hope that oral direct antivirals will emerge into efficacy trials soon.

Janet Woodcock

-----Original Message-----

From: Geoffrey Taylor 4 6),

Sent: Saturday, March 13, 2021 7:50 AM

To: Woodcock, Janet <Janet.Woodcock@fda.hhs.gov>
Subject: [EXTERNAL] Ivermectin

CAUTION: This email originated from outside of the organization. Do not click links or open attachments
unless you recognize the sender and know the content is safe.
Janet

I just read the following from a March 8 FDA release: “ The FDA said initial research is underway, but
the agency has not yet reviewed any data to support the use of ivermectin to treat or prevent COVID-19.”

If that is true, and the FDA, unlike the NIH, hasn’t reviewed any data after sixteen successful human
trials of ivermectin that I know of, the first reporting in May 2020, then that is a matter of the utmost
concern. It is truly sad for the very large numbers of US residents who have passed away, their friends
and their families. And it is ongoing.

One metaanalysis, which I have just seen, records another 35 trials.

One reason people would turn to veterinary formulations, is that they are precluded by the authorities
from being prescribed a cheap drug with a long history of very safe use.

So I pose the question: Cui bono?

Best wishes
Geoff Taylor, Perth

I am a member of the British Ivermectin Recommendation Development group, which held a worldwide Zoom
meeting three weeks ago, with representation from every continent, and now has placed its recommendations
before the UK medicines authority.


From: Steve Kirsch Ca)

Sent: 1/25/2021 11:11:19 AM

To: Woodcock, Janet [/o=ExchangeLabs/ou=Exchange Administrative Group
(FYDIBOHF23SPDLT)/cn=Recipients/cn=7b0453354a9a427db0a66a86c7a36f3d-Janet.Woodc]

Subject: why some IVM outpatient studies showed no response

Of course.... All the studies I’ve seen were given an inadequate dose!
Once infected, the recommended dose is .2mg/kg each day for at least 3 days and ideally 5 days.
The problem was dosing was wild west until the FLCCC came out with their protocol guidelines.

Not following the guidelines is just like what happened with the Marik Sepsis Protocol. The RCTs did NOT follow the
protocol (it must be given within 6 hours or it WILL fail) so they couldn’t replicate his results (because they spent 24
hours to enroll) and there was NO effect. Marik was labelled a quack. Marik went 150 or so sepsis patients in a row on
his sepsis protocol and never lost a single one. NOBODY is that “lucky”. To this day, this is not generally known and we
lose 10M people a year to unnecessary death due to it.

It you look at the studies with 3 -5 days of IVM at adequate dose | think you'll find they are all effective. I'll check with
Paul.

-steve

From: Woodcock, Janet <Janet.Woodcock@fda.hhs.gov>

Sent: Monday, January 25, 2021 4:55 AM

To: Steve Kirsch ky

Subject: RE: Ivermectin is being treated unfairly by the NIH panel

There have been studies in outpatients that are not encouraging. Nevertheless we are trying to set up a pragmatic
trial. Janet W

From: Steve Kirsch < og

Sent: Monday, January 25, 2021 1:49 AM

To: Woodcock, Janet <Janet. Woodcock@fda.hhs.gov>
Subject: Ivermectin is being treated unfairly by the NIH panel

Has anyone filed for an EUA for IVM?.

If | had to pick another highly effective drug for COVID, that would be it. The NIH guidelines panel did a very poor job on
this drug and they VERY BADLY misinterpreted one of the studies and downgraded IVM to neutral. | don’t think we need
more data on this. We just need another set of eyes to clearly look at the data that is out there and if they have any
questions, they should email pierre or paul who are the two world experts on using this drug for COVID. They wrote a
great response to the NIH which any evaluator should study.

It’s not just me that believes that. Emory Med School Dean is a strong proponent of IVM and do so after a great deal of
study. More recently, an independent researcher who does Cochrane reviews, Tess Lawrie in the UK, did her own
independent assessment of the evidence and was so stunned by what she found she’s been working unpaid to try to
convince other scientists of the merit of this drug, e.g., watch at Gminutes at

https://www.youtube.com/watch ?v=rHPkR6QRcCc&feature=youtu.be.

This drug is getting treated unfairly. Is there any way you can help right that wrong?


against the use of ivermectin outside of FDA-approved indications and guidance, whether intended for use in
humans or animals, as well as purchasing ivermectin from online stores. Veterinary forms of this medication
are highly concentrated for large animals and pose a significant toxicity risk for humans.

The U.S. Centers for Disease Control and Prevention (CDC) and the FDA have issued advisories indicating
that ivermectin is not authorized or approved for the prevention or treatment of COVID-19. The National
Institutes of Health, World Health Organization, and Merck (the manufacturer of the drug) all state there is
insufficient evidence to support the use of ivermectin to treat COVID-19. The Infectious Diseases Society of
America Guidelines on the Treatment and Management of Patients with COVID-19 also recommend
against the use of ivermectin outside of a clinical trial.

Use of ivermectin for the prevention and treatment of COVID-19 has been demonstrated to be harmful to
patients. Calls to poison control centers due to ivermectin ingestion have increased five-fold from their pre-
pandemic baseline. A recent CDC Health Alert Network Advisory recommends that healthcare professionals
should counsel patients against use of ivermectin as a treatment for COVID-19, including emphasizing the
potentially toxic effects of this drug, including “nausea, vomiting, and diarrhea. Overdoses are associated with
hypotension and neurologic effects such as decreased consciousness, confusion, hallucinations, seizures,
coma, and death.”

For more information, we encourage patients and healthcare providers to consult the FDA’s Consumer
Update on Why You Should Not Use Ivermectin to Treat or Prevent COVID-19 and the CDC Health Alert
Network Advisory on the Rapid Increase in Ivermectin Prescriptions and Reports of Severe Illness Associated
with Products Containing Ivermectin to Prevent or Treat COVID-19.

Patients are encouraged to talk to their physicians, pharmacists, and other prescribers about currently
available therapies authorized or approved for the treatment or prevention of COVID-19. The most effective
ways to limit the spread of COVID-19 are to get vaccinated, wear a face mask, stay at least six feet from others
in public places, wash hands frequently, and avoid large crowds of people. Our organizations strongly urge
eligible unvaccinated individuals to get vaccinated.

AMA COVID-19 Resource Center for Physicians
APhA COVID-19 Resource Center
ASHP COVID-19 Resource Center

About the American Medical Association

The American Medical Association is the physicians’ powerful ally in patient care. As the only medical
association that convenes 190+ state and specialty medical societies and other critical stakeholders, the AMA
represents physicians with a unified voice to all key players in health care. The AMA leverages its strength by
removing the obstacles that interfere with patient care, leading the charge to prevent chronic disease and
confront public health crises and, driving the future of medicine to tackle the biggest challenges in health care.
About the American Pharmacists Association

The American Pharmacists Association is only organization advancing the entire pharmacy profession. Our
expert staff, and strong volunteer leadership, including many experienced pharmacists, allow us to deliver vital
leadership to help pharmacists, pharmaceutical scientists, student pharmacists and pharmacy technicians find
success and satisfaction in their work, while advocating for changes that benefit them, their patients and their
communities. For more information, please visit www.pharmacist.com.

About ASHP

ASHP is the collective voice of pharmacists who serve as patient care providers in hospitals, health systems,
ambulatory clinics, and other healthcare settings spanning the full spectrum of medication use. The
organization’s 58,000 members include pharmacists, student pharmacists, and pharmacy technicians. For 79
years, ASHP has been at the forefront of efforts to improve medication use and enhance patient safety. For
more information about the wide array of ASHP activities and the many ways in which pharmacists advance
healthcare, visit ASHP’s website, ashp.org, or its consumer website, SafeMedication.com.

Contacts:

AMA Media & Editorial

media@ama-assn.org


United States, United Kingdom. The ethos of the BIRD meeting was that of scientific rigour and transparency in the spirit of
international collaboration towards a common goal — that of saving lives.

The recommendation was developed according The WHO Handbook of Guideline Development (2014). BIRD panel conclusions
are that ivermectin should be approved immediately for prevention and treatment of covid-19.

The BIRD recommendation on covid-19 prevention and treatment

The British lvermectin Recommendation Development Panel recommends ivermectin for the prevention and treatment of
covid-19 to reduce morbidity and mortality associated with covid-19 infection and to prevent covid-19 infection among those
at higher risk.

The BIRD Steering Group has taken heed of the WHO statement on ‘Developing global norms for sharing data and results
during public health emergencies’ that states that ‘public disclosure of information of relevance to public health emergencies
should not be delayed’, and also notes the' very great risks' that can occur from ‘withholding data and results arising from
analyses’. We are, therefore, sharing this evidence-to decision framework within just a few days of the BIRD meeting to avoid
delay.

Further, due to the urgency related to the communication and dissemination of this recommendation that is aimed at saving
thousands of lives daily, please forgive the limitations of the draft proceedings document attached. Information on the
process and methods can be found among the annexes. An Executive Summary is being finalised and will be available on
Monday.

We look forward to hearing from you soon and would be happy meet with you via teleconference if you think this will be
helpful.

Please do not hesitate to contact us with any questions.
Kind regards,
Dr. Tess Lawrie, on behalf of the BIRD Steering Group and Recommendation Development Panel

Evidence-based Medicine Consultancy Ltd
e-bmc.co.uk


My apologies again, Mr. Kirsch, fornot being able to stay on the call this morning. Really appreciate yourtime and
insight!

Chris

From: Steve Kirsch Oe@>

Sent: Thursday, December 3, 2020 10:32 AM

To: Mulkins, Christopher (HSGAC) <Christopher_Mulkins@hsgac.senate.gov>

Ce: Petry, Megan (HSGAC) <Megan_Petry@hsgac.senate.gov>; Tsilker, Yelena (HSGAC)

<Yelena_ Tsilker@hsgac.senate.gov>; Ryan, Corban (HSGAC) <Corban_Ryan@hsgac.senate.gov>
Subject: i'm on the call now....<music waiting for organizer>

From: Mulkins, Christopher (HSGAC) <Christopher_Mulkins@hsgac.senate.gov>

Sent: Wednesday, December 2, 2020 4:48 PM

To: Steve Kirsch yy e>

Cc: Petry, Megan (HSGAC) <Megan_Petry@hsgac.senate.gov>; Tsilker, Yelena (HSGAC)

<Yelena_ Tsilker@hsgac.senate.gov>; Ryan, Corban (HSGAC) <Corban_Ryan@hsgac.senate.gov>
Subject: RE: Connection

We have a conflictat 10, but can do 10:30. We can use [IO and the passcode of IM Looking forward to
the discussion tomorrow.

Chris

From: Steve Kirsch) yO@@>

Sent: Wednesday, December 2, 2020 6:29 PM

To: Mulkins, Christopher (HSGAC) <Christopher_Mulkins@hsgac.senate.gov>

Cc; Petry, Megan (HSGAC) <Megan_Petry@hsgac.senate.gov>; Tsilker, Yelena(HSGAC)

<Yelena_ Tsilker@hsgac.senate.gov>; Ryan, Corban (HSGAC) <Corban_Ryan@hsgac.senate.gov>
Subject: RE: Connection

Importance: High

I’m free from 9am EST to 11am EST... would 10am EST work?

From: Mulkins, Christopher (HSGAC) <Christopher_Mulkins@hsgac.senate.gov>

Sent: Wednesday, December 2, 2020 2:52 PM

To: Steve Kirsch Me>

Ce: Petry, Megan (HSGAC) <Megan_Petry@hsgac.senate.gov>; Tsilker, Yelena (HSGAC)

<Yelena Tsilker@hsgac.senate.gov>; Ryan, Corban (HSGAC) <Corban_Ryan@hsgac.senate.gov>
Subject: RE: Connection

Thanks Josh. Appreciate the connection, Moving you to bcc to save you inbox.

Mr. Kirsch, would be great to connect. | have copied my colleagues here as well. Would you have time tochat
tomorrow?

Thanks,
Chris

From: McLeod, Josh (HSGAC) <Josh_McLeod @hsgac.senate.gov>
Sent: Wednesday, December 2, 2020 5:37 PM



From: YouTube <noreply@youtube.com>
Sent: Friday, February 5, 2021 4:21 AM

To: Steve Kirsch
Subject: New comment on "COVID-19: Platelets, serotonin, SSRIs, and cyproheptadine"

New comment on "COVID-19: Platelets, serotonin, SSRIs, and cyproheptadine"

E39 YouTube

Al Ma commented on your video

COVID-19: Platelets, serotonin, SSRIs,
and cyproheptadine

AlMa
Great information. Thank you for sharing!

REPLY
MANAGE ALL COMMENTS

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ov


one in Japan. These studies should be complete or nearly completed soon, although we have yet to see any public
release of their results.

4. Given the impending availability of preclinical NIAID testing data and the data from the existing clinical studies—
which would provide further and better controlled experimental results to more definitively either reinforce or
contradict the suggestions from the earlier case studies that ivermectin might be an effective treatment for COVID-19--
the team from ACTIV that studies antiviral agents decided to defer further consideration of the agent until those data
are available and able to be reviewed. (see attached slides review meeting and agent review summary)

5. Furthermore, since this review by the ACTIV antiviral team, data has very recently emerged in the scientific
literature and from some other presentations to the ACTIV team that suggest that the effects of ivermectin might in fact
not be antiviral, but could be instead related to host-targeted/immune-modulatory mechanisms of action. In
consequence of this, the ACTIV TX-Clinical WG co-chairs have recommended that the data on ivermectin be yet again
further reviewed by the ACTIV team that evaluates immune modulators to make doubly sure whether there is any value
in the agent from that perspective, given that group’s specific scientific expertise. This review is expected to take place
by January 15.

As you know, ACTIV has reviewed literally hundreds of drugs since its inception in April in order to select those agents
that are most promising for further study, and as a result has numerous immune modulators, antiviral drugs (including
monoclonal antibodies), anti-inflammatory agents, and anti-thrombotics currently in clinical testing in the various ACTIV
master protocols. While we are still assessing whether ivermectin is at all effective in treating COVID-19 and why, the
ultimate question is of course whether ivermectin is sufficiently more effective against COVID19 than those treatments
already being tested through ACTIV or other potential treatments we are in the process of assessing, and therefore why
it should be worth not just the considerable cost of such testing in terms of USG financial resources, but probably more
importantly why it could be worth the additional allocation of increasingly scarce resources to conduct crucial clinical
trials of COVID-19 agents within our already overburdened U.S. healthcare system.

Please let me know if you have further questions. Thanks, David


From: Woodcock, Janet [/O=EXCHANGELABS/OU=EXCHANGE ADMINISTRATIVE GROUP
(FYDIBOHF23SPDLT)/CN=RECIPIENTS/CN=7B0453354A9A42 7DBOA66A86C7A36F3D-JANET. WOODC]

Sent: 7/1/2021 3:12:56 PM
To: Paul Elias Alexander
Subject: RE: [EXTERNAL] Real World Evidence and non-randomized research.

Thanks. To my knowledge, there is no reliable evidence that hydroxychloroquine is effective in treating or preventing
COVID-19 and we are testing ivermectin. Janet W

From: Paul Elias Alexander yyy

Sent: Thursday, July 1, 2021 10:24 AM
To: Woodcock, Janet <Janet.Woodcock@fda.hhs.gov>; Marks, Peter <Peter.Marks@fda.hhs.gov>
Subject: [EXTERNAL] Real World Evidence and non-randomized research.

CAUTION: This email originated from outside of the organization. Do not click links or open attachments unless you recognize the
sender and know the content is safe.

Hi Dr. Woodcock, good morning. I have read your good publication with Dr. Marks on using real world evidence
and also Dr. Friedan's paper on using non-randomized research. I also know of the CURES ACT 2016 section 3022
that confines and constrains the FDA to use real world non randomized evidence to make regulatory decisions. ‘All
evidence is fair game’!

Short of randomized controlled evidence that is time consuming and costly to mount especially within the throes of
a pandemic emergency, then we have to consider real world evidence, anecdotal evidence, case series...everything.

Via the precautionary principle we do all we can to not cause harm and to yield some benefit, until more is known.
Tf a drug or drugs have even the modest of possible benefit, and no harms, then we are obligated to consider it.
‘First do no harm’. We have these drugs with regulatory approval, used for 70 years, for other conditions, sate,
effective, available etc., then why not use it if it ‘could’ help. If it can possibly help, should we not at least try? This is
the mind boggling issue, these drugs 'may well work’. Why not try it?

Thus I am arguing that you consider HCQ and IVM ete. from this lens. Can you? Let us remove the prior politics
from this situation and try to consider these as a way to save lives. Always. ‘This has been politicized and biased
wrongfully and people are scared and do not want to believe in other things. They have been confused and told
things that make no sense. It seems that our premier agencies are not being served by the persons assessing the
therapeutics and many often are conflicted.

We can treat our way out of this along with vaccines (if not harmful). I am against these vaccines for children,
anyone under 30...

I wrote to you as the top most decision-makers. | ask careful consideration.
Happy 4th of July, 2021! In the greatest nation.

Best,

Paul E. Alexander, PhD.

Health Research Methodologist

Evidence-Based-Medicine
Ciinical epidemiologist



Maybe time to trust the data on the table and save some lives? ©

-steve

From: Dr. Syed Haider <thedoc@drsyedhaider.com>
Sent: Sunday, March 14, 2021 12:44 PM

To: Steve Kirsch |

Subject: Re: Fluvoxamine status?

No one was hospitalized on ivm and fluvoxamine.

This is a change from before when using just ivermectin. | saw at least 2 patients hospitalized in the month before
starting fluvoxamine out of a small cohort of about 20 acute cases, so 10% hospitalizations.

However another patient would normally have been hospitalized because their O02 sat dropped to the low 80s, but they
insisted on staying home and getting home oxygen rather than going to a hospital where they would not have had
access to the appropriate treatment.

Also no one has gotten worse after starting the two meds. Again a definite change from ivermectin alone when at least
20% worsened after starting, especially those who came after day 5 of illness.

So far | have not seen anyone who started in the first week of illness stay sick longer than 2 weeks - this is also a change
from ivermectin alone. At least 10% of patients starting ivermectin alone between days 5 and 7 are still sick after day 14.

-Syed

©) 6)
On Sun, Mar 14, 2021, 2:47 PM Steve Kirsch > wrote:

Anyone on the combo hospitalized?
Anyone get worse after starting?

Sent from my iPhone
On Mar 14, 2021, at 11:43 AM, Dr. Syed Haider <thedoc@drsyedhaider.com> wrote:
There were a few patients | didn't prescribe it to because they were already on another SSRI. Oldest was probably 88

and she is doing great on it and feeling better, the youngest was in their mid 20s and also did well.

My general impression is that it is rare for patients not to feel much better within 3 days of starting. Occasionally they
have very mild lingering symptoms for a week.

One patient so far had an adverse reaction with headaches and nerve pain, which is one of the rare side effects and
went away when she stopped fluvoxamine.

Everyone | prescribed it to did take it with ivermectin. It helps that it is usually covered by insurance if you prescribe the
100mg tabs and tell them to take 1/2 tab twice a day, and if not it is cheap enough to pay out of pocket.

This is not the case with other things like steroid inhalers, which are too expensive if not covered and colchicine which
is often not covered outside of gout and then also too expensive.

-Syed


Did TOGETHER assess ivermectin?

From: Woodcock, Janet <Janet.Woodcock@fda.hhs.gov>

Sent: Friday, September 10, 2021 10:55 AM

To: rihrih wfuma.org <rihrih@wfuma.org>

Subject: RE: [EXTERNAL] Consider human-use OTC ivermectin &

Did this include the TOGETHER results? Very small numbers of events in many of these studies. jw

From: rihrih wfuma.org <rihrih@wfuma.org>

Sent: Friday, September 10, 2021 9:17 AM

To: Woodcock, Janet <Janet. Woodcock@fda.hhs.gov>

Subject: Re: [EXTERNAL] Consider human-use OTC ivermectin &

CAUTION: This email originated from outside of the organization. Do not click links or open attachments unless you recognize the
sender and know the content is safe.

Thank you - figures 1 and 2 here list studies and outcomes:

https://covid19criticalcare.com/wp-content/uploads/2021/09/Response-to-Elgazzar.pdf



On Jan 13, 2021, at 8:38 AM, Woodcock, Janet <Janet.Woodcock@fda.hhs.gov> wrote:

Thank you. It is certainly being evaluated by the scientific teams at ACTIV and OWS, so it is not ignored. | wish | had set
up a large pragmatic outpatient screening study at the outset of this, we have a number of approved oral agents that it
would be good to test. Thanks for writing. Janet W

From: Alexis Lieberman < Oo,
Sent: Tuesday, January 12, 2021 10:00 PM

To: Woodcock, Janet <Janet. Woodcock@fda.hhs.gov>
Subject: Re: Information re Covid treatment

Dear Dr. Woodcock,

lam writing again to urge that the FDA allow the use of ivermectin for Covid. Since | wrote in November, multiple other
positive studies have been completed. Unfortunately, studies are not being completed in the United States as the
monoclonal antibody studies have exclusivity contracts with the emergency departments that are doing research. | am
aware that there has been a recent FDA review of the international studies showing that ivermectin reduces morbidity
and mortality in for Covid especially when used as postexposure prophylaxis and early in disease. The sooner the FDA
endorses this drug, the sooner a broad swath of physicians will use it. This drug, in addition to a wide vaccine strategy,
has the potential to transform the pandemic in the United States.

Thank you,

Alexis Lieberman, MD

On Nov 11, 2020, at 5:58 PM, Alexis Lieberman < > wrote:

Dear Dr. Woodcock,

As a practicing pediatrician in Philadelphia, | am writing to request that you use your role on the Covid task force to
advocate for an immediate, large-scale RCT for ivermectin early in disease. | include summaries of studies done so far on
ivermectin that point to its promise.

As you know, Ivermectin is an anti-parasitic drug that is used widely throughout the world and is generally very well-
tolerated with only very RARE side effects in those who do not have parasites, primarily limited to allergic reactions. The
drug is proposed to prevent the virus from getting into the nucleus of the human cell. While the initial Monash in-vitro
study used very high doses and the early Surgisphere study was discredited, since that time, there have been a dozen
positive clinical studies. Surely there is enough evidence now to warrant a large-scale, government-funded RCT.

This inexpensive, off-patent drug will not make money for any drug company. Therefore, it falls to the government to
take steps to fund a trial. | implore you to advocate for this!

STUDIES AND LINKS REGARDING IVERMECTIN:

10/29/30. India: Two doses of ivermectin, given 72 hours apart, prophylactically, was associated with a 73% reduction of
COVID-19 infection among healthcare workers for the following one-month, in a case control study of 186 pairs.
https://www.medrxiv.org/content/10.1101/2020.10.29.20222661v1

10/26/30: Baghdad, Iraq: A recent study done Baghdad compared COVID patients who took ivermectin or did not. In
this, 10% of the non-lvermectin group progressed to severe disease well only 4% of the ivermectin group did. In that
same study there was a 27% mortality rate for those who did not take over motion versus 18% and those who did.
https://www.medrxiv.org/content/10.1101/2020.10.26.20219345v1?fbclid=lwAROM7sh3HnP3rDMS5FRyiM34RsBFWBoX
DcRfP3Nz4Yaw9la7YAo8FMmE4rGY

9/28/20: Bangladesh: In this retrospective study, they compared patients who received Ivermectin with those who


From: Woodcock, Janet [/O=EXCHANGELABS/OU=EXCHANGE ADMINISTRATIVE GROUP
(FYDIBOHF23SPDLT)/CN=RECIPIENTS/CN=7B0453354A9A42 7DBOA66A86C7A36F3D-JANET. WOODC]

Sent: 4/11/2021 1:19:28 PM
To: Steve Kirsch [| (>) 6)
Subject: RE: [EXTERNAL] ivermectin will be tested in ACTIV-6

Yes | can’t comment. jw

From: Steve Kirsch < Pe,

Sent: Sunday, April 11, 2021 11:09 AM
To: Woodcock, Janet <Janet.Woodcock@fda.hhs.gov>
Subject: [EXTERNAL] ivermectin will be tested in ACTIV-6

CAUTION: This email originated from outside of the organization. Do not click links or open attachments unless you recognize the
sender and know the content is safe.

hah.... | have it on VERY good authority that IVM is being tested in ACTIV-6.

| bet you know that too (just can't tell me due to secrecy reasons).

> From: Woodcock, Janet <Janet. Woodcock @fda.hhs.gov>

> Sent: Sunday, April 11, 2021 6:35 AM

>To: Steve Kirsch < og

> Subject: RE: [EXTERNAL] Ivermectin: better outcomes in the ivm cohort in
> 49/49 studies

>
> Hopefully this will be tested in a large RCT very soon. jw
>

> -----Original Message-----

> From: Steve Kirsch < Ee.

> Sent: Saturday, April 10, 2021 2:51 PM

> To: Woodcock, Janet <Janet.Woodcock@fda.hhs.gov>

> Subject: [EXTERNAL] Ivermectin: better outcomes in the ivm cohort in 49/49
> studies

>

> CAUTION: This email originated from outside of the organization. Do not click
> links or open attachments unless you recognize the sender and know the

> content is safe.

>

>

> 49 studies, 45 of which published in peer reviewed journals, 25 are RCTs.

>

> In 100% of these, the cohort that included the ivermectin ALWAYS did better.
> NOT A SINGLE COUNTER EXAMPLE (including the very flawed JAMA study).

>

> Nobody | talked with can cite a single instance where a drug with 49/49

> batting average was found to be a dud.



CAUTION: This email originated from outside of the organization. Do not click links or open attachments unless you recognize the
sender and know the content is safe.

This is the reality... patients present late. (see below)
If we can get patients EARLY, zero deaths and hospitalizations. LOTS of treatments will work... flv only, ivm only, etc.
How can we get Dr. Fauci to deliver this message? (hint, hint)

-steve

From: Dr. Syed Haider <thedoc@drsyedhaider.com>
Sent: Wednesday, May 19, 2021 5:29 PM

To: Steve Kirsc!

; David Seftel <dseftel@enablebiosciences.com>

Subject: Re: doxycycline?

Within 2 days | have not seen anyone fail to improve. Coming to me within 2 days happens rarely, and even
then getting the meds from the pharmacy can be a hurdle, which is why patients should have these
medications on hand and ready to go.

On Wed, May 19, 2021 at 8:24 PM Steve Kirsch <M wrote:

do you have 100% success rate when FLV + IVM are given within 2 days of symptoms?
Looks like if 5 days or more success rate is only a 50% reduction.
Timing is EVERYTHING.

Only 3 failures reasons: started LATE, bad drug, patient didn’t take meds.

From: Miguel Antonatos, MDI) EP
Sent: Wednesd 5:21 PM
To: Steve Kirsch

Cc: Syed Haider (thedoc@drsyedhaider.com) <thedoc@drsyedhaider.com>
Subject: Re: doxycycline?

Yes | prescribe doxycycline but not upfront only for certain situations when a patient is not improving with
ivermectin/fluvoxamine after 8-10 days then | recommend adding an antibiotic and my preference is doxycycline.



use, disclosure, copying or distribution is strictly prohibited. If you are not the intended recipient, please contact the
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From: Woodcock, Janet [/O=EXCHANGELABS/OU=EXCHANGE ADMINISTRATIVE GROUP
(FYDIBOHF23SPDLT)/CN=RECIPIENTS/CN=7B0453354A9A42 7DBOA66A86C7A36F3D-JANET. WOODC]

Sent: 12/20/2020 1:45:35 PM
To: Wholley, David (FNIH) [T] [dwholley@fnih.org]
Subject: RE: Further Summary on Ivermectin ACTIV Review

Thanks, very helpful. wj

From: Wholley, David (FNIH) [T] <dwholley@fnih.org>

Sent: Saturday, December 19, 2020 9:35 PM

To: Woodcock, Janet <Janet.Woodcock@fda.hhs.gov>

Cc: Adam, Stacey J (NIH) <sadam@fnih.org>; Freire, Maria C (NIH) <mfreire@fnih.org>; Collins, Francis S (NIH)

Subject: FW: Further Summary on Ivermectin ACTIV Review

Hi Janet—there have been a number of inquiries from the Hill regarding ivermectin. Thought you should know about
the information regarding ACTIV review of this agent that we have sent to Francis earlier this evening. Thanks, David

From: Wholley, David (FNIH) [T]

Sent: Saturday, December 19, 2020 8:42 PM

To: Collins, Francis (NIH/OD) (E] < oe,

Cc: Adam, Stacey (FNIH) [T] <sadam@fnih.org>; Freire, Maria (FNIH) [T] <mfreire@fnih.org>
Subject: Further Summary on Ivermectin ACTIV Review

Hi Francis,

In case it is of use in your interactions with Senator Johnson or other future inquiries, below and attached is a complete
description of the review of ivermectin by the ACTIV team, courtesy of Stacey Adam of course. If OK with you | would
like to share this with Janet Woodcock so everyone is in sync. David

1 Ivermectin was first reviewed in Wave 1. It made it through the initial triage of 400 agents by ACTIV and was
scored in the antiviral subteam of the Therapeutics Clinical Working Group assigned to look at such agents. It scored
moderately well due to the anecdotal data from its use in the clinic in Peru and other countries, and several early,
though inadequately powered and inconclusive, case studies. However, the preclinical data for ivermectin’s mechanism
of action were very weak, and since none of the clinical information was from controlled trials, the review team felt
more information was needed in order to place it into a large confirmatory trial. In addition, the group felt there were
higher priority repurposed agents to pursue at the time (a continuing theme; see attached slides for review meeting
summary)

2. Inhaled ivermectin was reviewed in Wave 2. But in this instance the formulation that was submitted to ACTIV for
consideration was significantly lacking in the PK/PD data needed to suggest that it would indeed be effective in

patients. It did not score well in the clinical antiviral subteam, so the ACTIV Preclinical Working Group then took it up to
see if there could be a match for preclinical testing resources in NIAID. The prior/ongoing studies for both the inhaled
and the oral formulation of ivermectin; these are currently pending and will be reviewed by ACTIV as soon as they are
available (see attached slides review meeting and agent review summary).

3. Oral ivermectin was reviewed by the ACTIV team yet again, as part of our 3 Round of Wave 3 review of
agents. (It is worth noting here that these reviews are part of a very urgent but also intensive effort, having taking place
virtually on a weekly basis since May, often on weekends.) At this point, the group determined that the preclinical data
showing any potential antiviral mechanism of action of ivermectin was still weak, and that they would be far more
comfortable waiting to see the results of the NIAID preclinical studies that were set up through the ACTIV Preclinical WG
(and which are still ongoing). In addition, it was noted that a number of Phase 2 randomized clinical trials across the
world had been begun by other groups: at least one here in the US (UPenn), one in the EU (sponsored by Gates), and


After they pointed his error out on Twitter, Hernandez then corrected his paper, republished it to
medrxiv, but by cherry picking studies, left his conclusion intact. He basically worked backwards from
the conclusion he wanted. That's the ONLY way you can show IVM doesn't work.

So ONLY study that proved his point reversed, and he doesn't change the conclusions. Are you kidding
me?!?! NOBODY IS BUYING ANY OF THIS. Except your committee.

There have been ZERO takers to my $2M offer. NOBODY CAN DEFEND YOU. NOBODY IN THE WORLD. I've even
reached out to IVM bashers pleading with them to take my money. They never respond. Hard to give away $2M
nowadays.

I request that you change both guidelines for FLV and IVM to "FOR" IMMEDIATELY as your failure to do so
is costing tens of thousands of lives every day.

If you want to also change the guidelines on HCQ for use *EARLY* that would also correct another error. I
argue that 29 positive studies, 0 negative studies is compelling in my op-ed in TSN as noted above.

we have a lot of data on HCQ in practice. Telemed and numerous clinical practices across the US have been
using hydroxychloroquine for most of the year to treat early outpatient Covid and have treated more than
120,000 Americans by now: 70,000 in one telemed group, 20,000 in another; 20,000 in a large Texas
practice; 4,000 in a southern California practice; 3,000 in another Texas practice, 3,000 by Dr. Zelenko,
etc., with literally a handful of deaths in total. Estimated that 40% of these patients have been high-
risk. So something like 50,000 patient lives saved by HcQ, a drug that your Guidelines say should be
avoided, even for early treatment (except in clinical trials). After 29 positive clinical trials for
early treatment, isn't it time to call this one based on expert opinion.

The effect size of HCQ is clearly lower than IvM and FLV. The HCQ real-world data FURTHER aids the case
of FLV and IvM.

Surely you are aware of the Precautionary Principle since it was used to justify mask wearing. See
https: //www. bmj .com/content/369/bmj .m1435

If not, let me summariz in a pandemic, if an intervention causes no harm, and MIGHT be helpful, we
should use it. Ivermectin is arguably one of the safest drugs every created. Fluvoxamine is also
extremely safe when properly prescribed per FDA guidelines on interactions. There is no evidence that
when given EARLY, either of these drugs causes harm.

As further evidence that the precautionary principle applies, please listen to this one-minute video of
the head of the WHO COVID-19 response: https://twitter.com/skynews/status/1238504143104421888?lang=en.

You and your committee are doing exactly the opposite. You are afraid to take any action because you are
afraid of making a mistake. You should be focused on minimizing the number of deaths.

I have been urging you to do the right thing for at least 5 months now.
My patience is at an end.

If you fail to immediately change the guidelines to reflect reality, I will ramp up my efforts to expose
the truth so that lives can be saved. I have the capital to do that.

I will start by making this email public. It is being bcc'ed to three dozen key influencers. You will be
asked to explain why you did nothing to the US Congress and the mainstream media. Failing to correct
these mistakes will destroy the credibility of the NIH Guidelines.

Please let me know **TODAY** what you plan to do. This isn't a tough call. If you cannot figure it out in
a few hours, I think you should resign.

All of this data has been hiding in plain sight for months and neatly summarized for you on cl9early.com.
It has been obvious for at least 7 months for both drugs when I started calling publicly for the use of
both drugs. It's about time for you to do the same.

If you have any questions, you can email me or call me at 650-279-1008.

I look forward to hearing back from you. TODAY.

Thank you for your attention to this urgent matter.

-steve


From: Woodcock, Janet [/O=EXCHANGELABS/OU=EXCHANGE ADMINISTRATIVE GROUP
(FYDIBOHF23SPDLT)/CN=RECIPIENTS/CN=7B0453354A9A42 7DBOA66A86C7A 36F3D-JANET. WOODC]
Sent: 4/6/2020 10:25:37 AM

To: Hugh Taylor [h.taylor@unimelb.edu.au]; Jonathan Javitt [jjavitt@neurorxpharma.com]; Alfred Sommer
[asommer@jhu.edu]

cc: Andy Harris [/ ©) (6)

Subject: RE: Ivermectin CoronaVirus Data

Thank you. jw

From: Hugh Taylor <h.taylor@unimelb.edu.au>

Sent: Monday, April 6, 2020 5:14 AM

To: Jonathan Javitt <jjavitt@neurorxpharma.com>; Woodcock, Janet <Janet.Woodcock@fda.hhs.gov>; Alfred Sommer
<asommer@jhu.edu>

Ce: Andy Harris < we,

Subject: Re: lvermectin CoronaVirus Data

Thanks Jonathan,

It is good to hear from you and | trust that you and your family are all safe and well.
For background | have attached the recent paper and a few thoughts of mine.

| hope this helps some, but | would be happy to try to answer any further questions.
Best wishes,

Hugh

Professor Hugh R Taylor AC,

Immediate Past President, The International Council of Ophthalmology,

Melbourne Laureate Professor, Harold Mitchell Chair of Indigenous Eye Health Melbourne School of Population and
Glebal Health, University of Melbourne, 207 Bouverie Street, Carlton, 3053. Ph: +61 3 8344 9320 Mobile (6)

www.iehu.unimelb.edu.au
‘| respectfully acknowledge Traditional Owners and Custodians of the Country on which | work’

From: Jonathan Javitt <jjavitt@ neurorxpharma.com>
Date: Monday, 6 April 2020 at 6:30 pm

To: "Woodcock, Janet" <Janet.Woodcock@fda.hhs.gov>, Hugh Taylor <h.taylor@unimelb.edu.au>, Al Sommer

<asommer@jhu.edu>
Ce: Andy Harris < OO),

Subject: Ivermectin CoronaVirus Data

Adding Al Sommer to this thread. Al was head of the International Center for Epidemiology and Preventive
Ophthalmology when the human Ivermectin work was done.

Dear Janet,

Please forgive me if I’m telling you things you already know.

If | can be helpful in any way, please use me. | have zero financial connection to Ivermectin. | was involved with
Executive leadership at Merck in the 1980’s when Hugh Taylor at Johns Hopkins proved that Ivermectin eradicates

Onchocerciasis in Humans and Merck donated sufficient lvermectin to eradicate human onchocerciasis and, therefore,
River Blindness.


To: Woodcock, Janet <Janet.Woodcock@fda.hhs.gov>
Subject: [EXTERNAL] Your opinion, please

CAUTION: This email originated from outside of the organization. Do not click links or open attachments unless you recognize the
sender and know the content is safe.

You'll no doubt find this interesting:

https://pubmed.ncbi.nlm.nih.gov/33065103/



Thave no idea about legal/political things. Why not just give (physicians) permission in 25/50 states? Pair them
so that the states within a pair are similar, then randomly assign within pairs.

I know a bit about NC, their reporting of positives, of people with symptoms, of those admitted to hospitals, of
deaths is both slow and, in my opinion, not very reliable.

Stan and Pat Young


From: Steve Kirsch
Sent: Wednesday, February 17, 2021 11:27 AM
To: David Boulware <boulw001@umn.edu>

Ce: Glenn Bunting (Util lee’

Subject: RE: Timeline?

Did you talk to them? Find out any info???

From: David Boulware <boulw001@umn.edu>
Sent: Wednesday, February 17, 2021 6:03 AM
To: Steve Kirsch <

Subject: RE: Timeline?

CNN is going to do story on repurposed meds for COVID, regardless of whether | am involved or not.


{x] ‘The picture can't be displayed.

Source: Johns Hopkins Coronavirus Resource Center

Click Here for Therapeutics Lab Meeting Summaries



From: Carl Peck { NEN]

Sent: 3/8/2021 3:16:39 PM
To: Ginny Schmith [gschmith@nuventra.com]
cc: Piet Van Der Graaf [p.vandergraaf@lacdr.| eidenuniv.nl]; Yaning Wang [LO Nick Holford

[n-holford@auckland.ac.nz]; Mike Eldon [9 9; woodcock, Janet

[/o=Exchangelabs/ou=Exchange Administrative Group

(FYDIBOHF23SPDLT)/cn=Recipients/cn=7b0453354a9a427db0a66a 86c7a 36f3d-Janet.Woodc]; cpteditor@ascpt.org
Subject: [EXTERNAL] Fwd: Validation

CAUTION: This email originated from outside of the organization. Do not click links or open attachments unless you recognize the
sender and know the content is safe.

Ginny,
Apparently, FDA has weighed in - see below.

Carl

Begin forwarded message:

From: Joshua Galanter <galanter.joshua@gene.com>
Subject: Re: Validation

Date: March 8, 2021 at 10:13:59 AM PST

To: Stephen Ruberg </ iae

Ce: Carl Peck <9) 9 @®>, Daniela Drago <drago@innovareg.com>, Joshua Galanter
<galanter.joshua@gene.com>, Christine Gamett <Christine.Gamett@fda.hhs.gov>, Charles Gombar

<charlie.gombar@gatesfoundation.org>, Charlie Grudzinskas <)>, Diane
K Jorkasky <)>, Jaime Kenyon <jaime.kenyon@ucsf.edu>

The FDA has weighed in...

https :/Avww.fda.gov/cons umers/consumer-updates/why-you-should-not-use-i vermectin-treat-or-
prevent-covid-19

There seems to be a growing interest in a drug called ivermectin to treat humans with
COVID-19. Ivermectin is often used in the U.S. to treat or prevent parasites in animals. The
FDA has received multiple reports of patients who have required medical support and been
hospitalized after self-medicating with ivermectin intended for horses.

Echoes of when people were using chloroquine for fish tanks.

FDA Letter to Stakeholders: Do Not Use Chloroquine...
www.fda.gov > product-safety-information > fda-letter-...



From: Adam, Stacey (FNIH) [T] [sadam@fnih.org]

Sent: 2/26/2021 1:55:47 PM

To: Woodcock, Janet [/o=ExchangeLabs/ou=Exchange Administrative Group
(FYDIBOHF23SPDLT)/cn=Recipients/cn=7b0453354a9a427db0a66a86c7a36f3d-Janet.Woodc]

Subject: RE; [EXTERNAL] URGENT: The BIRD meeting proceedings and recommendation on covid-19 prevention and
treatment

CAUTION: This email originated from outside of the organization. Do not click links or open attachments unless you recognize the
sender and know the content is safe.

Thank you!

Stacey J. Adam, PhD
Director, Cancer
Research Partnerships

Direct: (301) 435-8364 | Mobile: I!

From: Woodcock, Janet <Janet. Woodcock @fda.hhs.gov>

Sent: Friday, February 26, 2021 1:44 PM

To: Adam, Stacey (FNIH) [T] <sadam@fnih.org>

Subject: RE: [EXTERNAL] URGENT: The BIRD meeting proceedings and recommendation on covid-19 prevention and
treatment

I’m working on that. jw

From: Adam, Stacey (FNIH) [T] <sadam@fnih.org>

Sent: Friday, February 26, 2021 1:31 PM

To: Woodcock, Janet <Janet.Woodcock@fda.hhs.gov>

Subject: RE: [EXTERNAL] URGENT: The BIRD meeting proceedings and recommendation on covid-19 prevention and
treatment

CAUTION: This email originated from outside of the organization. Do not click links or open attachments unless you recognize the
sender and know the content is safe.

Thanks, Janet,

rc:

Thanks,
Stacey

Stacey J. Adam, PhD
Director, Cancer
Research Partnerships

Direct: (301) 435-8364 | Mobile: JIE

From: Woodcock, Janet <Janet.Woodcock@fda.hhs.gov>
Sent: Friday, February 26, 2021 1:12 PM



From: Steve Kirsch

Sent: 5/28/2021 12:47:29 PM

To: Lane, Henry C (NIH) [/o=ExchangeLabs/ou=Exchange Administrative Group
(FYDIBOHF23SPDLT)/cn=Recipients/cn=d904337536cf41719032a9359a1ec2ab-HHS-CLANE-n]

ce: Daniel O'Connor [doconnor@trialsitenews.com]

Subject: [EXTERNAL] **URGENT** What you are doing is unethical and costing THOUSANDS of lives every day

Importance: High

CAUTION: This email originated from outside of the organization. Do not click links or open attachments
unless you recognize the sender and know the content is safe.

Hi Cliff,

I'm sure you know by now that Together showed that both IVvM and FLV work. Gates Foundation knows. The WHO
knows and they aren't saying anything.

You may even know that the numbers from the washU trial showed the same effect size. Waiting an extra day
for drug delivery dramatically lowers the effect size which is why it was lower in this trial, but still
above the 20% threshold Francis Collins mentioned on 60 Minutes.

These drugs MUST be given EARLY for the largest effect. Wait 5 days before treatment and efficacy goes
down. Every virologist knows that.

The public must be told to take these drugs ASAP. You can't find a single doctor who has used these drugs
who will tell you otherwise. Not one.

there isn't a shred of evidence that both drugs are neutral or net harmful. NO study shows that. I simply
cannot find a single doctor anywhere in the world who have used these drugs that believes these drugs are
neutral or harmful.

You can change the NIH Guidelines for these two drugs based on expert opinion easily. You don't even need
a vote, as we learned from Peter Yim's efforts where the NIH refused to disclose whether there was a vote
on ivermectin and none of the panelists would say anything.

Keeping whether or not there was a vote secret, even after a FOIA request, is NOT IN THE PUBLIC
INTEREST. How do you explain avoid answering even a single question like that?

I offered $2M to anyone in the world who could provide a decent argument that the NIH or WHO guidelines
either 1) fit the evidence or 2) minimized # of lives lost.

https: //trialsitenews .com/if-you-can-prove-that-the-nih-and-who-got-thei r-treatment-guidelines-right-you-
could-win-2m/

Guess what? NOT ONE SINGLE TAKER. I even make it easy. There were two independent ways to win: you could
prove it EITHER way. NO TAKERS. Nobody qualified even attempted to enter.

This article published 2 days ago in TSN show even more evidence.

https: //trialsitenews.com/five-rcts-recently-pub1ished-in-mainstream-scientific-journals-that-confi rm-
major-statistically-signi ficant-benefits-of-ivermectin-against-covid-19-as-reported-in-several-prior-
rets/

How do you explain all this? All these studies are positive and your recommendations are NEUTRAL?

NEUTRAL is when half the studies are positive, half are negative. That's NEUTRAL. When you have 22
studies that are positive, with only 1 study which CALCULATED the effect size (and did not directly
measure it) with a VERY insigificant p value of .54 (mot .054), that's basically 22 positive studies and
one very statistically random result that was no better than a random guess. So the only negative study
was the lowest quality data in the lot. Clearly, that's the ONLY study you believe. That's ridiculous.

If you had a basketball team with a 22-0 win loss record, would you call that a winning team, losing
team, or neutral? I get it... that’s neutral.

I clearly point out in TSN op-ed discussing IVM, HCQ, and FLV that it is IMPOSSIBLE to justify that all
three drugs don't work. The hypothesis doesn't fit any of the facts. Apparently everyone agrees with my
analysis since nobody tried to get the $2M reward for showing I was wrong.

https: //trialsitenews .com/do-the-nih-and-who-covid-treatment-recommendati ons-need-to-be-fixed/

The only way to prove these drugs don't work is to transpose the treatment and control arm data to make
your study look correct as Adrian Hernandez attempted before he got caught just hours later:
https: //twitter.com/Covid19Ccrusher/status/1397214174766325765


(©) (6)

From: Geoffrey Taylor

Sent: 3/26/2021 6:51:27 AM

To: Woodcock, Janet [/o=ExchangeLabs/ou=Exchange Administrative Group
(FYDIBOHF23SPDLT)/cn=Recipients/cn=7b0453354a9a427db0a66a86c7a36f3d-Janet.Woodc]

Subject: (EXTERNAL] British lvermectin Recommendation Development Pane! - Response to EMA Statement on Ivermectin for
Covid-19

CAUTION: This email originated from outside of the organization. Do not click links or open attachments
unless you recognize the sender and know the content is safe.

Janet

I thought you might be interested.
Best wishes

Geoff Taylor

https://trialsitenews. com/british-ivermectin-recommendation-development-panel -response-to-ema-statement-
on-ivermectin-for-covid-19/


From: Woodcock, Janet [/O=EXCHANGELABS/OU=EXCHANGE ADMINISTRATIVE GROUP
(FYDIBOHF23SPDLT)/CN=RECIPIENTS/CN=7B0453354A9A42 7DBOAG6A86C7A36F3D-JANET.WOODC]

Sent: 2/17/2021 3:34:45 PM
To: Steve Kirsch [stk@m10.io]
Subject: RE: [EXTERNAL] fan mail

| hope a pragmatic trial can get going very soon, all are aligned. jw

From: Steve Kirsch <>

Sent: Wednesday, February 17, 2021 3:03 PM
To: Woodcock, Janet <Janet.Woodcock@fda.hhs.gov>
Subject: [EXTERNAL] fan mail

CAUTION: This email originated from outside of the organization. Do not click links or open attachments unless you recognize the
sender and know the content is safe.

Hah... see red...

From: David Boulware <boulw001@umn.edu>
Sent: Wednesday, February 17, 2021 10:37 AM

To: Glenn Bunting a. Steve Kirsch i
Subject: RE: Timeline?
It was Sanjay Gupta’s producer.

Also, FYI NIH is getting serious about repurposed drugs. Janet Woodcock has lit a fire.

DB

From: Glenn Bunting <)>

Sent: Wednesday, February 17, 2021 12:14 PM

To: David Boulware <boulw001@umn.edu>; Steve Kirsch yee
Subject: Re: Timeline?

Do we know who is doing it for what program?

From: David Boulware <boulw001@umn.edu>
Sent: Wednesday, February 17, 2021 9:36:03 AM

To: Steve Kirsch

Cc: Glenn Bunting </>

Subject: RE: Timeline?
Steve,
CNN story is about repurposed medicines overall, and the challenges of studying them.

They are aiming for next week and plan to cover multiple drugs — metformin, fluvoxamine, ivermectin.

DB


3. Lehrer S, Rheinstein PH. Ivermectin docks to the SARS-CoV-2 spike receptor-binding domain attached to ACE2. In
Vivo. 2020;34(5):3023-3026. Available at: https://www.ncbi.nlm.nih.gov/pubmed/32871846.

4. Guzzo CA, Furtek Cl, Porras AG, et al. Safety, tolerability, and pharmacokinetics of escalating high doses of
ivermectin in healthy adult subjects. J Clin Pharmacol. 2002;42(10):1122-1133. Available at:
https://www.ncbi.nim.nih.gov/pubmed/12362927.

5. Chaccour C, Hammann F, Ramon-Garcia S, Rabinovich NR. lvermectin and COVID-19: keeping rigor in times of
urgency. Am J Trop Med Hyg. 2020;102(6):1156-1157. Available at: https://www.ncbi.nlm.nih.gov/pubmed/32314704.
6. Arshad U, Pertinez H, Box H, et al. Prioritization of anti-SARS-CoV-2 drug repurposing opportunities based on

plasma and target site concentrations derived from their established human pharmacokinetics. Clin Pharmacol Ther.
2020;108(4):775-790. Available at: https://www.ncbi.nlm.nih.gov/pubmed/32438446.

7. Bray M, Rayner C, Noel F, Jans D, Wagstaff K. Ivermectin and COVID-19: a report in antiviral research,
widespread interest, an FDA warning, two letters to the editor and the authors' responses. Antiviral Res.
2020;178:104805. Available at: https://www.ncbi.nim.nih.gov/pubmed/32330482.

8. Zhang X, Song Y, Ci X, et al. lvermectin inhibits LPS-induced production of inflammatory cytokines and improves
LPS-induced survival in mice. Inflamm Res. 2008;57(11):524-529. Available at:
https://www.ncbi.nim.nih.gov/pubmed/19109745.

9. Ci X, Li H, Yu Q, et al. Avermectin exerts anti-inflammatory effect by downregulating the nuclear transcription
factor kappa-B and mitogen-activated protein kinase activation pathway. Fundam Clin Pharmacol. 2009;23(4):449-455.
Available at: https://www.ncbi.nlm.nih.gov/pubmed/19453757.

10. DiNicolantonio JJ, Barroso J, McCarty M. Ivermectin may be a clinically useful anti-inflammatory agent for late-
stage COVID-19. Open Heart. 2020;7(2). Available at: https://www.ncbi.nlm.nih.gov/pubmed/32895293.

11. Ahmed S, Karim MM, Ross AG, et al. A five-day course of ivermectin for the treatment of COVID-19 may reduce
the duration of illness. Int J Infect Dis. 2020;103:214-216. Available at:
https://www.ncbi.nim.nih.gov/pubmed/33278625.

12. Chachar AZK, Khan KA, Asif M, Tanveer K, Khaqan A, Basri R. Effectiveness of ivermectin in SARS-COV-2/COVID-
19 Patients. Int J of Sci. 2020;9:31-35. Available at: https://www.ijsciences.com/pub/article/2378.

13. Chowdhury ATMM, Shahbaz M, Karim MR, Islam J, Guo D, He S. A randomized trial of ivermectin-doxycycline
and hydroxychloroquine-azithromycin therapy on COVID19 patients. Research Square. 2020;Preprint. Available at:
https://assets.researchsquare.com/files/rs-38896/v1/3ee350c3-9d3f-4253-85f9-1f17f3af9551.pdf.

14, Soto-Becerra P, Culquichicén C, Hurtado-Roca Y, Araujo-Castillo RV. Real-world effectiveness of
hydroxychloroquine, azithromycin, and ivermectin among hospitalized COVID-19 patients: results of a target trial
emulation using observational data from a nationwide healthcare system in Peru. medRxiv. 2020;Preprint. Available at:
https://www.medrxiv.org/content/10.1101/2020.10.06.20208066v3.

15. Hashim HA, Maulood MF, Rasheed AW, Fatak DF, Kabah KK, Abdulamir AS. Controlled randomized clinical trial
on using ivermectin with doxycycline for treating COVID-19 patients in Baghdad, Iraq. medRxiv. 2020;Preprint. Available
at: https://www.medrxiv.org/content/10.1101/2020.10.26.20219345v1/.

16. Elgazzar A, Hany B, Youssef SA, Hafez M, Moussa H, eltaweel A. Efficacy and safety of ivermectin for treatment
and prophylaxis of COVID-19 pandemic. Research Square. 2020;Preprint. Available at:
https://www.researchsquare.com/article/rs-100956/v2.

17. Niaee MS, Gheibi N, Namdar P, et al. Ivermectin as an adjunct treatment for hospitalized adult COVID-19
patients: a randomized multi-center clinical trial. Research Square. 2020;Preprint. Available at:
https://www.researchsquare.com/article/rs-109670/v1.

18. Khan MSI, Khan MSI, Debnath CR, et al. lvermectin treatment may improve the prognosis of patients with
COVID-19. Arch Bronconeumol. 2020;56(12):828-830. Available at: https://www.ncbi.nim.nih.gov/pubmed/33293006.



From: Woodcock, Janet [/O=EXCHANGELABS/OU=EXCHANGE ADMINISTRATIVE GROUP
(FYDIBOHF23SPDLT)/CN=RECIPIENTS/CN=7B0453354A9A427DBOA66A86C7A36F3D-JANET.WOODC]
Sent: 5/14/2021 7:57:50 AM

To: h.rees@pharmaflowltd.com
Subject: RE: [EXTERNAL] UK Initiative on COVID-19 - brief update
Thx Janet W

From: h.rees@pharmaflowltd.com <h.rees@pharmaflowltd.com>
Sent: Friday, May 14, 2021 7:08 AM

To: Woodcock, Janet <Janet.Woodcock@fda.hhs.gov>

Subject: Re: [EXTERNAL] UK Initiative on COVID-19 - brief update

CAUTION: This email originated from outside of the organization. Do not click links or open attachments unless you recognize the
sender and know the content is safe.

Dear Janet,

Again, sending the attached privately, in case it may or may not be of interest. Also, a link to a recent press release from
the Front Line COVID-19 Critical Care Alliance:

https://covid19criticalcare.com/videos-and-press/ficcc-releases/flccc-alliance-statement-on-the-irregular-actions-of-
public-health-agencies-and-the-widespread-disinformation-campaign-against-ivermectin,

If you are curious why | am following this, it’s because the ‘ROADMAP TO A BETTER FUTURE’ has Healthcare
professionals, along with patients, front and center of drug development.

In the same way pilots are crucial in developing aircraft (and making sure they are safe for passengers),
physicians/doctors/clinicians should undertake an analogous role in medicines (IMHO). Jenner, Banting et al, Fleming,

Salk, were all medically qualified — and that is not the case today.

Me thinks the integration of the CPI, GMPs for the 2st Century and the principles of evidence based medicine would be a
potent combination, along with a strategic approach to building supply chains to patient markets.

Hope all is still good.
Kind regards,

Hedley

>)

Sent from my iPhone

On 11 May 2021, at 17:40, Woodcock, Janet <Janet. Woodcock@fda.hhs.gov> wrote:

Thanks! You’ve been productive. Janet W



From: Steve Kirsct ee

Sent: 3/14/2021 4:56:14 PM
To: Woodcock, Janet [janet.woodcock@fda.hhs.gov]
Subject: FW: [EXTERNAL] this just in.... real world result from a IVM prescriber who switched to the combo: FLV + IVM = 100%

success rate in 100 patients... WAY better than IVM alone

CAUTION: This email originated from outside of the organization. Do not click links or open attachments unless you recognize the
sender and know the content is safe.

Wow.... maybe some hope after all ©

From: Stein, Peter <Peter.Stein@fda.hhs.gov>

Sent: Sunday, March 14, 2021 1:29 PM

To: Steve Kirsch <stk@m10.io>

Subject: RE: [EXTERNAL] this just in.... real world result from a IVM prescriber who switched to the combo: FLV + IVM =
100% success rate in 100 patients... WAY better than IVM alone

Steve,
Received — appreciate your forwarding this information,
Peter Stein

From: Steve Kirsch

Sent: Sunday, March 14, 2021 4:08 PM

To: Woodcock, Janet <Janet. Woodcock @fda.hhs.gov>

Cc: Lane, Henry C (NIH) , Stein, Peter <Peter.Stein@fda.hhs.gov>; Francis Collins

Austin, Christopher P (NIH) Po Hall, Matthew D

Subject: [EXTERNAL] this just in.... real world result from a IVM prescriber who switched to the combo: FLV + IVM =
100% success rate in 100 patients... WAY better than IVM alone
Importance: High

CAUTION: This email originated from outside of the organization, Do not click links or open attachments unless you recognize the
sender and know the content is safe.

I just got this just now.... | had told Dr. Haider about fluvoxamine a few weeks ago and he agreed to add it to COVID
patients he treated with just IVM. He’s a teledoc so prescribes nationwide (to states he’s allowed to).

Boy, the FDA should be racing to approve at least fluvoxamine now if not both drugs, but our application has been at
FDA for over 6 weeks with no communication at all on the merits.

So now we have:

1) lenze trial: 100% success of 80 patients,
2) seftel trial: 100% of 77 patients,
3) Haider real-world prescribing to clients all over the country: 100% out of 100 patients.

Do you see a pattern yet? In the Seftel study alone, the p-value on the symptoms was 1e-14 with 100% effect
size. NOBODY has been able to explain a confounder. There isn’t a single observational study on large populations that
didn’t show a positive effect.


process refinements that result in the minimizing of time to treatment in an outpatient setting, if
undertaken, could be an enormous contribution of your study apart from or in addition to the
identification of an effective antiviral drug.

On the other hand, if what you're considering are anti-inflammatories and anticoagulants, it might be
better to wait until week 2. The centrality of timing relative to the specific therapeutic being
considered is a matter about which prominent physicians within our group, who might

disagree concerning other matters, speak with one voice, and about which we would urge you to
consider Griffin et. al, mentioned above. Many previous trials have made mistakes of timing. Trial
size and statistical sophistication cannot compensate if the timing of drug administration is improper
relative to disease course.

The U.S.N.I.H. and U.S. pharmaceutical companies have scored important wins with respect to mRNA
vaccines, and some would say monoclonal antibodies. We're grateful; the world is grateful. Yet even
in the area of vaccines, noted tropical disease specialist Peter Hotez recently said in an interview:

There were policy decisions focused exclusively around innovation, not sufficiently
considering which vaccines were going to be needed in resource poor countries.

Abroad, and here in the U.S., this pandemic is far from over. Our search for self-administered
outpatient therapeutics has not been successful to date (with the possible exception of recent
evidence for aspirin's efficacy in reducing progression to severe disease). But we do know more than
we did a year ago. Screening programs and independent researchers are pointing us toward possible
answers, and some are medicines with which physicians have had long

experience. Ivermectin remains in-the-running, and there are signals other medicines are
forthcoming. Comparative trials are needed; we have great hope ACTIV-6 will make a positive
contribution.

Sincerely,

Binh Ngo, MD

Associate Professor

Keck Medical School of USC
Los Angeles, CA

Marc Rendell, MD

Medical Director

Rose Salter Medical Research Foundation
Newport Beach, CA

Paul E. Marik MD, FCCP, FCCM

Eastern Virginia Medical School
Department of Internal Medicine

Chief, Pulmonary and Critical Care Medicine
Norfolk, VA

Pierre Kory, MD, MPA
Pulmonary and Critical Care Medicine
Aurora St. Luke's Medical Center


From: Steve Kirsch

Sent: 5/20/2021 10:37:48 PM

To: Woodcock, Janet [/o=ExchangeLabs/ou=Exchange Administrative Group
(FYDIBOHF23SPDLT)/cn=Recipients/cn=7b0453354a9a427db0a66a86c7a36f3d-Janet.Woodc]

Subject: [EXTERNAL] whoa! found out why hospitals deny ivermectin

CAUTION: This email originated from outside of the organization. Do not click links or open attachments unless you recognize the
sender and know the content is safe.

there have been 6 court cases on IVM and they all rule in favor of the plaintiff.

here’s why we think hospitals are denying treatments that can save lives... if hospitals stray off the reservation, they lose
liability protection (see red below).

So hospitals stay safe and people die unnecessarily.

Now just pretend you got hospitalized... even as head of the FDA and you knew all the studies are 100% positive for IVM
and effect size is >65%, you would not be able to get treatment. How would you feel about that? If it were me, I’d be
pretty upset, and probably die.

Is there a good way to fix this?

steve

From: 4

Zz
Sent: Thursday, May 20, 2021 6:44 PM
To: Steve Kirsch i Au
Cc: Pierre Kory - FLCCC (pkory@flccc.net) <pkory@flccc.net>
Subject: RE: Gavin de Becker's father denied ivermectin and died: why?

Just to you and Pierre, Steve.

First, Thank You so much. You’re more likely to get a reply than I. Though I confirmed
Loftus received my letter and received four phone messages, he never responded in any
way. And neither did the doctor. Amazing since I have power of attorney for medical stuff
involving my father.

Dr. Bhandari is the actual doctor responsible for treating my father at the Desert Springs
Hospital. She acknowledged by text that she received my letter ("Thank you for sending this
and will read it soon") but never replied to my emails or phone calls or texts.

You are welcome to call or text her, Steve: Here is her cellphone and email address: (2?

Perhaps this information can be valuable if you do an article: A likely reason the hospital and
doctor felt comfortable ignoring me outright is that the Federal Government has cured a giant



patients, is now available online and we invite you to take a look. Our appreciation to all who

contributed to this work and we look forward to our next publications.

This week, in our Therapeutics PA Accelerators-only meeting, we met to review and finalize the
approach to age coding and “small numbers” in our Natural History of Coagulopathy question set. In
the remdesivir portion of the meeting, we discussed some Aim 2 protocol changes to how we handle
patients with poor prognoses who were administered remdesivir as a last resort, as opposed those

who were administered remdesivir in the first two days after admission.
Next week will be our Accelerators-only meeting, Wednesday, March 24", 12-1pmET.

Post-Acute Sequelae of SARS-CoV-2 (PASC): We are preparing materials for the first larger
convening of the Post-Acute Sequelae of SARS-CoV-2 (PASC) Infection Working Group (planned for
March 25 at 3pmET). Preparation includes summarizing responses and themes from the survey

distributed last month. Additionally, we are collecting feedback on the updated concept proposal from
our Steering Committee. We will summarize the responses to the Accelerator survey and the concept

proposal and present to the PASC Working Group as our call to action.
Action Requests:

e Coagulopathy Accelerators: Please let Dr. Jeff Allen know if you would be interested in examining
the use of oral anticoagulants within your dataset as an addendum to the natural history work
underway.

e Remdesivir Accelerators: If you haven't already, please send in your Aim 1 tables so that we can
finalize our Aim 2 protocol.

e PASC: ff you are interested in joining the PASC Working Group, please email Dr. Alecia Clary.

e Evidence Accelerator Blog: if you have an idea for future post and/or would like to submit a post
for consideration, please let me know.

e Members of our Accelerators-only meetings are invited to join our Online Community Forum.
Questions or need a fresh link? Email me.

Finally, please let me know if you are no longer interested in COVID-19 Evidence Accelerator activity

and we will update our distribution list.

Regards,


Good points, Ginny.

Carl

On Mar 7, 2021, at 2:53 PM, Ginny Schmith <gschmith@nuventra.com> wrote:

Carl-

Thanks for the feedback. |am not sure there is a need foranother paper yet given the numberof articles and
commentaries on the subject, but | will leave that to Piet forhis opinion.

As forivermectin, our paper said that the approved dose (asingle 200 mcg/kg dose or about 16-20 mg) would not work,
but if the approved dose was administered daily, the lung concentrations would likely be 1/4" of the ICso. Unlike
hydroxychloroquine, ivermectin has a reasonable safety profile at the approved dose and doses up to 120 mg once
weekly or 60 mg/kg three times weekly have been well tolerated in asmall group of healthy subjects. Therefore, |
wonder whether higher doses of ivermectin (120mg once daily for5-7 days) would resultin efficacy in the treatment or
prevention of COVID. In our original paper, | did not highlight this because | did not want clinicians to start using high
doses off label without it being studied ina more well controlled clinical study situation. | know of several clinicians who
have asked Merck to doa studyat the higherdoses but were not successful in getting them to dothis. | also know of
several companies now trying to develop an inhaled version as well. | think a paper like you suggest would be better
afterwe hear from some of the studies with higher daily doses orinhaled administration.

Ginny

From: Carl Peck ¢ Oh
Sent: Sunday, March 7, 2021 3:04 PM
To: Ginny Schmith <gschmith@nuventra.com>

Cc: Yaning Wang < ©)@)>; Piet Van Der Graaf <p.vandergraaf@lacdr.leidenuniv.n|>; Nick Holford
<n. holford@auckland.ac.nz>; Mike Eldon ¢ PP; Janet Woodcock <Janet. Woodcock @FDA.GOV>;

Liang Zhao <Liang.Zhao@fda.hhs.gov>
Subject: Validation

EXTERNAL: This message originated from outside Nuventral

Ginny, | just noted the piece below in Steve Shafer’s Daily COVID Update *(3/6/21):

“Ivermectin was the drug du jour for several months for COVID, at least on talk radio. A study in JAMA found that
“among adults with mild COVID-19, a 5-day course of ivermectin, compared with placebo, did notsignificantly improve
the time to resolution of symptoms. The findings do not support the use of ivermectin for treatment of mild COVID-19,
although larger trials may be needed to understand the effects of ivermectin on other clinically relevant outcomes”
(see https://1drv.ms/b/s!AuOyHP_aTly7s8)fmXPke KdzWjSVFA?e=Enmi7w)."

The above may validate your excellent CPT paper "The Approved Dose of Ivermectin Alone is not the Ideal Dose for the
Treatment of COVID-19”


From: Steve Kirsch | (0) 6)

Sent: 2/9/2021 2:07:48 AM

To: Woodcock, Janet [/o=ExchangeLabs/ou=Exchange Administrative Group
(FYDIBOHF23SPDLT)/cn=Recipients/cn=7b0453354a9a427db0a66a86c7a36f3d-Janet.Woodc]

Subject: A good theory as to why kids have less problems with COVID (fyi)

just read the part in red

(6)
From: Farid Jalali

Sent: Monday, February 8, 2021 10:47 PM
To: Steve Kirsch <stk@m10.io>
Subject: Re: New comment on "COVID-19: Platelets, serotonin, SSRIs, and cyproheptadine"

Thanks Steve. | won’t get in the middle of conversation with Angela but you are correct and she is correct too. Kids
recover but a very small subset do not and we have no way to figure out yet who that subset is. However, the same
physiology applies to them as you said. One difference is the cd147 activation of platelets increases as people age, we
think so there may be far less platelet activation in kids due to this virus, presumably.

Your overall thought process is similar to many of us. Why do we have to go thru massive RCTs to prescribe a relatively
safe and well tolerated therapy with little harm to a healthy person with mild disease to prevent severe disease along a
pathway showing benefit in smaller trials. The upsides are decent and downsides are small. But unfortunately that’s not
how US approaches therapies. Many other countries don’t do it this way.

If a few doses of ivermectin or FLV prevents severe disease, great. If it doesn’t, not much was lost while trying.

When you compare that thought process to non-judicious use in this country (more rhan anywhere else) of Remdesivir
or plasma or tocilizumab (all with a large set of very very shaky data from the start until now) it really frustrates most of
us.

Let’s put it this way. Heparin saves lives. Proven now beyond shadow of doubt in very large RCTx3 in western world,
trials run by the boys and girls who frequent our conferences as keynote speakers. YET Our covid19 guidelines in US and
all major societies still recommend against full dose anticoagulant use with heparin.

The whole thing is just so bizarre and so frustrating. Many have died due to this attitude in this country.

On the cyproheptadine front, we are working with Canadian version of FDA to get the trial approved. Protocol written,
proposal detailed, and met with drug company who supplies it to the hospital to submit more info to Canadian FDA
equivalent,

land Phil will keep you updated.

Thanks
Farid

Sent from my iPhone

On Feb 8, 2021, at 10:12 PM, Steve Kirsch’ MEwrote:


-steve


From: Kurt Stockbauer [I ee 9

Sent: 7/23/2021 10:30:48 PM

To: Woodcock, Janet [/o=ExchangeLabs/ou=Exchange Administrative Group
(FYDIBOHF23SPDLT)/cn=Recipients/cn=7b0453354a9a427db0a66a86c7a36f3d-Janet.Woodc]

Subject: [EXTERNAL] Covid 19 protocol

CAUTION: This email originated from outside of the organization. Do not click links or open attachments unless you recognize the
sender and know the content is safe.

Do the right thing Janet Ivermectin should be part of US protocol!

India saw a dramatic fall in cases after the ICMR and AIIMS added Ivermectin to their protocols on
April 20, 2021. Daily COVID-19 cases, which peaked at 414,188, are now down to 84,332,

representing a drop of 80% overall in the country of India.

What seemed to be an impending humanitarian crisis at the end of April has now been brought under

control, not with mass vaccination, but instead with an inexpensive repurposed drug, Ivermectin.

Kurt



after two strikes, and there are two more at-bats before the half-inning is over. Let's take the rest of
our nine swings now, choosing wisely while acting with alacrity as we await widespread vaccination.

Sincerely,

Paul E. Marik MD, FCCP, FCCM

Eastern Virginia Medical School
Department of Internal Medicine

Chief, Pulmonary and Critical Care Medicine
Norfolk, VA

Pierre Kory, MD, MPA

Pulmonary and Critical Care Medicine
Aurora St. Luke's Medical Center
Milwaukee, WI

Joseph Veron, MD, FACP, FCCP, FCCM, FRSM
United Memorial Medical Center

University of Texas School of Medicine
Houston, TX

Binh Ngo, MD

Associate Professor

Keck Medical School of USC
Los Angeles, CA

Marc Rendell, MD

Medical Director

Rose Salter Medical Research Foundation
Newport Beach, CA

Stephen Ditmore
Health Reporter
Parkchester Times
Bronx, NY


From: Steve Kirsch

Sent: 5/21/2021 2:01:22 AM

To: Woodcock, Janet [/o=ExchangeLabs/ou=Exchange Administrative Group
(FYDIBOHF23SPDLT)/cn=Recipients/cn=7b0453354a9a427db0a66a86c7a36f3d-Janet.Woodc]

Subject: ({EXTERNAL] india is going to be a big RCT for IVM.

CAUTION: This email originated from outside of the organization. Do not click links or open attachments
unless you recognize the sender and know the content is safe.

Just three weeks after adding Ivermectin, Delhi now leads India out of the deadly second surge of the
COVID pandemic. Cases that had peaked at 28,395 on April 20 plummeted nearly 80% to just 6,430 on May 15.
Deaths peaked May 4, and now they are also down 25%

https: //www. thedesertreview.com/opinion/letters_to_editor/ivermectin-crushes-delhi-
cases/article_31f3afcc-b7 fa-1leb-9585-0f6a290ee105. htm]

since we know IVM doesn't really work per the NIH, I wonder what caused such a massive drop? Can anyone
at NIH explain that? Boy, I'd love to be a fly on the wall for THAT conversation.


4 Seet RCS, Quek AML, Ooi DSQ, et al. Positive impact of oral hydroxychloroquine and povidone-iodine throat spray for
COVID-19 prophylaxis: An open-label randomized trial. International Journal of Infectious Diseases. 2021;106:3 14-322.


From: Steve Kirsch

Sent: 5/20/2021 1:26:43 PM

To: Woodcock, Janet [/o=ExchangeLabs/ou=Exchange Administrative Group
(FYDIBOHF23SPDLT)/cn=Recipients/cn=7b0453354a9a427db0a66a86c7a36f3d-Janet.Woodc]

Subject: [EXTERNAL] We'll get Punjab and others to lead the way here...My op-ed will be published in Times of India!

CAUTION: This email originated from outside of the organization. Do not click links or open attachments unless you recognize the
sender and know the content is safe.

Hopefully, both the op-ed in the Times of India and changing treatment guidelines in Punjab will start to move the
needle.

Thanks for the insights on Dr. Fauci... Incredibly valuable

-steve

From: Steve Kirsch

Sent: Thursday, May 20, 2021 10:21 AM

To: yy; Sandhu Gurpal Jaya <
Cc: Amol Kothalkar
(vsukhatme@emory.edu) <vsukhatme@emory.edu>; Arjun Bhagat <’
Subject: COVID treatment

; Vikas Sukhatme

Thanks Arjun.

Nice to meet you Gurpal! If you can get this information to the right people, that would be wonderful. Vikas and | are
available 24x7 for questions and happy to speak with you at any time.

My goal is to have the COVID Treatment Guidance changed in Punjab, prove that that reduces the hospitalization and
death rate to near zero, and then repeat in other states in India.

The message we need to get incorporated is simple:
1) everyone should get treated for COVID **ASAP**. This is THE most important advice. Today, people wait too
long to be treated and even with perfect drugs, treatment can fail.

2) do not wait for symptoms if you have a positive test get treated. If you think you have a covid symptom, get
treated. SOONER IS ALWAYS BETTER.

3) NOBODY is exempt from treatment, all ages.

4) Have the drugs “on hand” so you can start immediately if you get sick

5) The two most important drugs are Fluvoxamine and ivermectin. Everyone should get at least these two drugs.
6) If you start late, you will need higher dosages of the core drugs and more drugs, e.g, 100mg BID of fluvoxamine
vs. 50mg BID if you are treated early

7) Lower dosing of fluvoxamine for teenagers and children

The treatment principles are explained in this document:
India op-ed

Why the WHO and NIH are wrong about ivermectin and fluvoxamine is explained in this long document
Do the NIH and WHO COVID treatment recommendations need to be fixed?

Dr. Sukhatme, Dean of the Emory School of Medicine, and other docs are available for a zoom call whenever you would
like to discuss.



From: Woodcock, Janet [/O=EXCHANGELABS/OU=EXCHANGE ADMINISTRATIVE GROUP
(FYDIBOHF23SPDLT)/CN=RECIPIENTS/CN=7B0453354A9A42 7DBOA66A86C7A36F3D-JANET. WOODC]
Sent: 12/15/2020 7:47:40 AM

To: John P. Hussman, Ph.D. [yee

Subject: RE: COVID-19: Pandemic trajectory; Repurposed therapeutics; Vaccine considerations (antigens, rare occurence of
Bell's palsy, dose sparing, immune correlates); Public health messaging

Thank you. I’ve tried to talk people into testing ivermectin formally but other agents keep getting prioritized
higher. Cys-A is being pushed by some but is placed lower for testing given other priorities. Appreciate your input. jw

From: John P. Hussman, Ph.D. yyy

Sent: Monday, December 14, 2020 11:19 PM

To: Woodcock, Janet <Janet.Woodcock@fda.hhs.gov>

Cc: John P. Hussman, Ph.D. <hussman@hussmanfoundation.org>; Brooke Steinau <bsteinau@hussmanfoundation.org>
Subject: RE: COVID-19: Pandemic trajectory; Repurposed therapeutics; Vaccine considerations (antigens, rare occurence
of Bell's palsy, dose sparing, immune correlates); Public health messaging

Thank you for your note. Of course — I’m glad for these to be circulated further, and hope that some part is helpful.

The finding that the mAbs aren’t helpful in late disease is understandable. By that point, my impression is that the
maladaptive inflammatory response dominates any cytopathic effect of the virus itself, and the pathology seems to
persist despite antibody response. Blunting the inflammatory tissue damage from infiltrating neutrophils and
macrophages (including thrombosis and damage to blood vessels from barrier degradation and extravasation) seems to
be important.

With regard to cyclosporine A, I’ve seen a number of letters to editors suggesting potential benefit, but only one small
trial (33274479) in COVID-19. There may be more | haven’t seen. While there are some in-vitro reports of SARS-CoV-2
inhibition, as well as inhibition of other hCoVs, my impression is that the main argument favoring cyclosporine is that it’s
been relatively well-studied in macrophage activation syndrome (secondary hemophagocytic lymphohistiocytosis HLH).
One protocol (HLH-2004 modified for adults) includes cyclosporine A in combination with glucocorticoids and etoposide
— the basic target being suppression and apoptosis of hyperproliferating T-cells.

As |am not a clinician, | would defer to intensivists in their choice of cyclosporine as part of a protocol to address
macrophage activation / cytokine storm. However, my impression is that in the context of COVID-19, inflammatory
monocytes/macrophages and neutrophils appear dominant. Severe patients already show lymphopenia (though
typically with virus-reactive T-cells among the depressed population that remains), so the main potential benefit of
cyclosporine would seem to be indirect reduction of cytokine transcription and possibly a reduction in ROS-induced
oxidative stress.

Despite the immunosuppressive effects of cyclosporine, there don’t seem to be broad reports of increased infection
resulting from short-term use, and it is already among clinical options for HLH. So the interest in cyclosporine seems
reasonable. The question is whether there are other reports of specific benefit in COVID-19.

In HLH that is refractory to glucocorticoids and cyclosporine, there are reports that more direct inhibition of cytokine
response may have potential benefit, including IL-1 blockade (e.g. anakinra) and IL-6 blockade (e.g. tocilizumab). As |
noted in my prior email, the EUA for barcitinib was welcome, and there are also favorable reports for ruxolitinib,
another JAK 1/2 inhibitor.

Finally, among well-tolerated options even in moderate cases, before the point of clinical deterioration, | do believe that
doxycycline (excluding pregnant patients) may have pleiotropic benefits, particularly in reducing inflammatory
extravasation and tissue damage (via MMP inhibition among other mechanisms). | suspect that this may be part of
what's going on in so-called “long-COVID.” Given that some of our global health work has been on river blindness with


incidence curve is effectively horizontal even between days 10-28, which can be best ascribed to the first dose. In the
absence of sufficient quantities of vaccine, a dose-sparing strategy might be considered, targeting a larger number of
single dose recipients initially, followed by a second dose upon broader availability. A single-dose arm might be initiated
immediately (perhaps publicly funded) if current data are insufficient to support that alternative. The results could, in
any event, be available for evaluation to address potential mid-year supply constraints.

° Immune correlates: It may be useful to evaluate the extent to which various vaccine candidates induce
T-cell responses (particularly in CD4+ populations, which may correlate with protection in elderly individuals), as well as
the induction of antibodies to conserved epitopes or predicted escape loci.

. Public health messaging: Given public fatigue for standard containment advice such as mask use, it may be
helpful to shift messaging toward not one or two but a “menu” of practices, each that acts as a temporary and partial
substitute for immunity, and each accompanied by a “why” —a logical relationship to one of the three drivers of
epidemic spread:

° 1) reducing the probability that contact with an infected person will result in transmission (mask use,
distancing, hygiene, fresh airflow, outdoor settings, limiting interactions and unmasked indoor conversation in public);
° 2) reducing the number of daily contacts (smaller and more stable groups, avoiding hub and super-
spreader events) and;

° 3) reducing the duration of infectivity (self-isolation, testing, contact-tracing).

° An updated draft of possible messaging is available to the transition team.

Charts, references, and links

1. U.S. 7-day COVID-19 fatalities and implied trajectory based on estimated containment as of 11/8/20. The chart
also shows the sensitivity of prospective 7-day U.S. fatalities to changes in containment practices after January 20, but
not prior to that date. The model is briefly described in the chart text. Additional charts and computational details are

available on request.

SARS-CoV-2 / COVID-19 actual and projected 7-day U.S. fatalities
neal “Second waves" can be produced by relaxing containment practices
while a large pool of active, infective cases is still present.

Containment practices include mask use; distancing; reduced conversation or forceful
exhalation, especially in unmasked, close-range, indoor settings such as restaurants;
increased fresh airflow; outdoor gatherings; limiting group size; avoiding "superspreaderTM
events; shorter interactions; self-isolation if affected or in recent contact with a case.

39.000

\

3.000

ey i

ed “ |
Jar30. Febe2Q Mian2 = Apr3O. May20 duet uh AupO. Sep2O Oce20 NovEO. Dee 30 lama ebRt Mord | Apeadt

—~Actual 7-day U.S. fatalities Baseline as of 11/08/20 ~~ 5% better practices after 01/20/20

——10% better practices after 01/20/20. —~20% better practices after 01/20/20 -—~-5% looser practices after 01/20/20

. , Model: SiR (susceptible, infected, recovered) modelparameterized to match U.S, fatality trajectory to-date,
10% looser practices after 01/20/20 pared on periedic estimation of an implicit containment factor ranging between0.0and 1.0 deseribing the
“ughtness” of containment behavior. @hussmanip

2. Impact of the current pandemic trajectory on potential U.S. fatalities, which can be strongly modified by changes
in containment behavior.


Daily new confirmed COVID-19 deaths per million people ye
Shown is the rolling 7-day average. Limited testing and challenges in the attribution of the cause of death means that the number -
of confirmed deaths may not be an accurate count of the true number of deaths from COVID-19.

10

4 United States

0 India

Mar 1, 2020 Apr 30, 2020 Jun 19,2020 Aug 8, 2020 Sep 27, 2020 Nov 16, 2020 Jan 5, 2021 Mar 15, 2021

Ss cc BY

SE COVID-

is Hopkins

Tess

Dr. Theresa Lawrie
Evidence-based Medicine Consultancy Ltd
e-bme.co.uk

Begin forwarded message:

From: Tess Lawrie <tess@e-bmc.co.uk>

Subject: Re: [EXTERNAL] URGENT: The BIRD meeting proceedings and recommendation on covid-19 prevention and
treatment

Date: 15 March 2021 at 16:30:33 GMT

To: Tess Lawrie <tess@e-bmc.co.uk>

Cc: "Stein, Peter" <Peter.Stein@fda.hhs.gov>, "Cavazzoni, Patrizia" <Patrizia.Cavazzoni@fda.hhs.gov>, "Farley, John"

<John.Farley@fda.hhs.gov>

Dear Dr Stein and Colleagues,


From: Woodcock, Janet [/O=EXCHANGELABS/OU=EXCHANGE ADMINISTRATIVE GROUP
(FYDIBOHF23SPDLT)/CN=RECIPIENTS/CN=7B0453354A9A42 7DBOA66A86C7A36F3D-JANET. WOODC]

Sent: 1/15/2021 11:47:50 AM

To: Robert Califf, M.D. (TG)

Subject: RE: Congrats!

Say ivermectin or fluvoxamine for COVID19 outpatients. jw

From: Robert Califf, ivaeR(b) ()

Sent: Friday, January 15, 2021 11:47 AM

To: Woodcock, Janet <Janet.Woodcock@fda.hhs.gov>
Subject: Re: Congrats!

Totally virtual? What’s the topic?

rmc

From: Janet Woodcock <Janet.Woodcock@fda.hhs.gov>

Date: Friday, January 15, 2021 at 8:01 AM
To: "Robert Califf, M.D." (a)
Subject: RE: Congrats!

) (5)

From: Robert Califf, M.0. (QQ)

Sent: Thursday, January 14, 2021 2:10 PM
To: Woodcock, Janet <Janet.Woodcock@fda.hhs.gov>
Subject: Congrats!

D) (9)

rmc


This new Consumer Update provides information on how some consumers are looking at unconventional treatments,
not approved or authorized by the FDA, to treat or prevent COVID-19. Using any treatment for COVID-19 that’s not

approved or authorized by the FDA can be highly dangerous, even lethal. There seems to be a growing interest in a drug
called ivermectin to treat humans with COVID-19. Ivermectin is often used in the U.S. to treat or prevent parasites in

animals. The FDA has received multiple reports of patients who have required medical support and been hospitalized
after self-medicating with ivermectin intended for horses.



From: Woodcock, Janet [/O=EXCHANGELABS/OU=EXCHANGE ADMINISTRATIVE GROUP
(FYDIBOHF23SPDLT)/CN=RECIPIENTS/CN=7B0453354A9A42 7DBOA66A86C7A36F3D-JANET. WOODC]

Sent: 1/20/2021 3:17:26 PM
To: Freire, Maria (FNIH) [T] [mfreire@fnih.org]
Subject: RE: Soo happy!

Oh dear! | am determined to get some of these repurposed drugs evaluated! jw

From: Freire, Maria (FNIH) [T] <mfreire@fnih.org>
Sent: Wednesday, January 20, 2021 3:08 PM

To: Woodcock, Janet <Janet.Woodcock@fda.hhs.gov>
Subject: Re: Soo happy!

Yes, you are probably crazy but the agency desperately needs you! It can’t be fun given what is going on but you are the
right person.

Thanks for looking into ivermectin. It would be great to have an answer. ain Peru right now and they dispense it like
candy. The other day the headline in Spanish was “FDA approves Ivermectin for COVID treatment” and cited
ScienceDirect. The medical community was elated and felt vindicated. Well, not so fast. When | went to the source
article, the headline in English was “FDA-approved drug ivermectin inhibits replication of SARS-CoV-2”. Go try to explain
the translation glitch - | nearly got skinned alive.

Hang in! M.

From: "Woodcock, Janet" <Janet.Woodcock@fda.hhs.gov>
Date: Wednesday, January 20, 2021 at 1:43:19 PM

To: "Freire, Maria (FNIH) [T]" <mfreire@fnih.org>

Subject: RE: Soo happy!

Thanks, and great to hear from you. Hope you are well. I’m probably crazy to do this, but | think the Agency needs me at
this point.

We are trying to put together a pragmatic trial that can include ivermectin. I’ll do everything | can to help get that up
and funded.

TX jw

From: Freire, Maria (FNIH) [T] <mfreire@fnih.org>
Sent: Wednesday, January 20, 2021 1:39 PM

To: Woodcock, Janet <Janet.Woodcock@fda.hhs.gov>
Subject: Soo happy!

Janet, | am SO happy you will be interim FDA Commissioner. If there is anything | can do to help, let me know.

The world owes you a HUGE debt of gratitude- not only for all your work at FDA but for your super-human efforts at
OWS. THANK YOU!

Onward! Maria


and treatment to proceed simultaneously, in parallel. For this to occur it is imperative that we involve
primary care physicians and community-based outpatient clinics. What's missing, in our view, are:

. Clinics and Urgent Care Centers as primary sites of outpatient trials and treatment. In the
case of SARS-CoV-2 the need for speed suggests that the personnel making the phone calls to inform
patients of their positive test results should inform them of their treatment and clinical trial options
on the spot. To do otherwise is to risk missing the window of opportunity.

. Therapeutics intended for distribution by pharmacists that reflect the latest medical thinking
without hewing slavishly to pharmaceutical company commercial interest.

. The voices of clinicians. While the NIH-CoV2 Therapeutics Antiviral Summit was very
good as far as it went, clinicians, including those with deep experience working in outpatient settings,
need to be part of the dialogue for the enterprise of translational medicine to succeed.

If we may be allowed a criticism of the summit, the self-congratulations around the approval of
remdesivir, a drug with which many clinicians are deeply unimpressed,

justifiably rankled some. Success in the lab does not always translate to success in medical
practice. While we all want good science, we also want pragmatic science. Enthusiasm would
have been more justified for monoclonal antibody therapies. Broad implementation remains a
struggle, but we are seeing positive outcomes when antibodies are administered early.

A follow-up summit is called for, this time featuring clinicians at the vanguard. We hope that Dr.
Griffin, his co-authors and others might work with NCATSin planning panels. Besides discussion of
specific repurposed agents for early outpatient treatment, panels could be devoted to alternative
clinical trial design and to how epidemiological evidence is understood. Such a follow-on summit,
emphasizing access to treatment and involving clinicians, would be in keeping with the Biden

Administration's Executive Order on Improving and Expanding Access to Care and
Treatments for COVID-19.

Concerning the matter of epidemiological evidence, positive and negative, the famotidine experience,
PPI's, and ivermectin could be discussed ina single panel. The bringing together of Dr. Christopher
Almario of Los Angeles and of Dr. Pierre Kory of the FLCCC, for example, could be very thought
provoking. They have brought forth evidence of harm in one case, benefit in the other, that is real
despite not being in the form of gold standard clinical trials.

The lack of clear guidance from U.S. health authorities in the area of COVID-19 outpatient
therapeutics has consequences, from inflated exuberance about hydroxychloroquine to premature
antibiotics prescription justified by a ‘pneumonia’ diagnosis. Scientific recommendations can be made
on the basis of preponderance of the evidence; failure to do so often results in poorer medicine.

We've included our previous letter to Dr. Peter Kim, below, because we believe the six therapeutics
named in it present a solid starting point for discussion. A particular point worth making where two
drugs are of the same class, such as favipiravir (T-705) and molnupiravir (EIDD-2801), is that an
immediate EUA for favipiravir would allow it to be utilized as an active control. Molnupiravir trials
could be expanded to include ACTs, allowing reseach to proceed even as people are being treated.

While we expect the core group preparing the panels should be U.S. persons, there are physicians
from other nations it would be useful to hear from as the US re-joins the WHO. The WHO
SOLIDARITY trial has expressed interest in initiating more early outpatient RCTs, but that would be
pointless using the list of therapeutics they have already researched, which is less up-to-date than
the six discussed in the letter below (Dr. Kim's three plus our three). We also need to better evaluate


6/30/20 Dominican Republic Data:

https://www.trialsitenews.com/president-of-dominican-repub.../

6/28/20 Bangladesh Data (mild to moderate cases, comparison with hydroxychloroquine/azithromycin). This study is not
statistically significant but showed a trend of recovery in eight days with ivermectin versus nine without.
https://www.trialsitenews.com/ivermectin-study-reveals-fan.../

6/10/20 Florida Data (first U.S. data, on hospitalized patients). This is a retrospective intensive care unit study in which
those who did not receive ivermectin had a25% mortality rate while those who did receive ivermectin had a 15%
mortality rate. It has since been publishedin a peer-reviewed journal.
https://journal.chestnet.org/.../S0012-3692(20)34898.../fulltext

5/2/20 Peru Data: areas of the country where ivermectin was used have alower case rate and lower fatality rate than
areas where ivermectin was not used.

https://www.docdroid.net/J8wuZ!b/ivermectin-studyesen-pdf

3/2020: Australian study that showed that high doses of ivermectin killed the Covid virus ina test tube study.
https://research.monash.edu/.../the-fda-approved-drug-ivermec...

The FLCC, a US based group of colleagues with over 200 years of combined experience in Critical Care and Emergency
Medicine, as well as long-standing shared interests in developing effective treatments for critical illnesses including
sepsis, isa working group devoted to creating a treatment protocol against COVID-19.

They developed an inpatient Covid protocol which has lead toa mortality rate of 4-10%, compared to the world average
of 23%.

They have now developeda prophylactic and early outpatient combination treatment protocol for COVID-19 called I-
Mask+.

https://covid19criticalcare.com/.../FLCCC-IVERMECTIN-Protocol...

This protocol recommends ivermectin, vitamins Cand D, Zinc, melatonin and, for adults only, aspirin.

Their rationale is based on multiple studies as well as real-world evidence comparing countries using ivermectin, such as
Peru, Brazil and Haiti, to those not usingit, such as the Dominican Republicand the US.

Here is the introductory video from FLCC:

https://vimeo.com/473929788/382c386d60

Thank you for yourconsideration,

Alexis Lieberman, MD

Advocare Fairmount Pediatrics

Paul E. Marik MD, FCCP, FCCM|

Eastern Virginia Medical School |

Department of Internal Medicine|

Chief, Pulmonary and Critical Care Medicine|
825 Fairfax Ave, Rm 575, Norfolk, VA 23507 |

® 757.446.8910| & 757.446.5242 |

& marikpe@evms.edu] &l www.evms.edu|

Teaching. Discovering. Caring.


Therapeutics Parallel Analysis Workgroup

[x] The picture can't be displayed.

We are pleased to announce that the first manuscript of the Therapeutics Parallel Analysis work group
has been published. The article, COVID-19 Evidence Accelerator: A parallel analysis to describe

the use of Hydroxychloroquine with or without Azithromycin among hospitalized COVID-19



From: Stan Young

Sent: 3/24/2021 9:36:13 PM

To: Amar Bhat [abhat@reaganudall.org]

cc: Woodcock, Janet [/o=ExchangeLabs/ou=Exchange Administrative Group
(FYDIBOHF23SPDLT)/cn=Recipi ents /cn=7b0453354a9a427db0a 66a 86c7a36f3d -Janet.Woodc]

Subject: [EXTERNAL] Re: COVID-19 Therapeutics/Vaccines Evidence Accelerator Weekly Update

Attachments: ivermectin meta-analysis.pdf; Ivermectin NIH.docx; Ivermectin Patel 2020.pdf

CAUTION: This email originated from outside of the organization. Do not click links or open attachments unless you recognize the
sender and know the content is safe.

Amar: The attached items relate to ivermectin. The two studies look quite sound to me.

Stan and Pat Young)”

On Monday, March 22, 2021, 9:40:09 AMEDT, Amar Bhat <abhat@reaganudall.org> wrote:

Stan,

So far, we haven't had any discussions regarding ivermectin. | have seen in press, etc. some references to use of
ivermectin, but we have not scheduled any discussions regarding repurposing of ivermectin for COVID-19 so far. If you
would like to suggest something (along with potential presenters), please let me know.

Regards,
Amar

Amar Bhat, PhD
Reagan-Udall Foundation for the FDA

uv: ns

From: Stan Young </>
Reply-To: "
Date: Friday, March 19, 2021 at 10:02 PM

To: Amar Bhat <abhat@reaganudall.org>
Subject: Re: COVID-19 Therapeutics/Vaccines Evidence Accelerator Weekly Update

CAUTION: This email originated from outside of the Foundation.

Amar: | follow lots of threads. Please point me to any reganudall thread on ivermectin. Stan

Stan and Pat Young)



Disclaimer: Any third-party material in this email has been shared for internal use under fair use provisions of U.S. copyright
law, without further verification of its accuracy/veracity. It dees not necessarily represent my views nor those of NIAID, NIH,
HHS, or the U.S. government.


From: Alexis Lieberman (NN?

Sent: 11/13/2020 7:32:42 PM

To: Woodcock, Janet [/o=Exchangelabs/ou=Exchange Administrative Group
(FYDIBOHF23SPDLT)/cn=Recipi ents /cn=7b0453354a9a427db0a66a86c7a36f3d-Janet.Woodc]

Subject: Re: Information re Covid treatment

Oral. It’s being run by Nina Gentile, and Joseph Herres. 0.2 mg/kg ivermectin up to 12 mg.
Alexis Lieberman
On Nov 13, 2020, at 2:11 PM, Woodcock, Janet <Janet.woodcock@fda.hhs.gov> wrote:

Is this study with an inhaled or oral formulation? Thanks jw

From: Alexis Lieberman

sent: Thursday, November 12, 2020 4:55 PM

To: woodcock, Janet <Janet.woodcock@fda.hhs.gov>
Subject: Re: Information re Covid treatment

Thank you. I understand that part of the reason the drug has not been pursued is that it was considered
that there are enough studies already underway. I would like to bring to your attention that the study in
Philadelphia that has been listed with clinicaltrials.gov at Albert Einstein Medical Center and Temple
University Hospital has not yet begun because the investigators have been waiting for an IND from the FDA
for nearly 5 months already. I wonder if there is any way to facilitate them getting the IND rapidly so
that their study can begin during the current surge in cases in Philadelphia? Any assistance with this
would be greatly appreciated.

sincerely,

Alexis Lieberman, MD

On Nov 12, 2020, at 10:23 AM, Woodcock, Janet <Janet.woodcock@fda.hhs.gov> wrote:

Thank you. we have considered this drug before, will refer these references to the assessment team for
further evaluation. Janet woodcock

----- Original Message--
From: Alexis Lieberman
Sent: wednesday, November 11, 2020 5:58 PM

To: woodcock, Janet <Janet.woodcock@fda.hhs.gov>
Subject: Information re Covid treatment

Dear Dr. woodcock,

As a practicing pediatrician in Philadelphia, I am writing to request that you use your role on the Covid
task force to advocate for an immediate, large-scale RCT for ivermectin early in disease. I include
summaries of studies done so far on ivermectin that point to its promise,

As you know, Ivermectin is an anti-parasitic drug that is used widely throughout the world and is
generally very well-tolerated with only very RARE side effects in those who do not have parasites,
primarily limited to allergic reactions. The drug is proposed to prevent the virus from getting into the
nucleus of the human cell. while the initial Monash in-vitro study used very high doses and the early
surgisphere study was discredited, since that time, there have been a dozen positive clinical studies.
surely there is enough evidence now to warrant a large-scale, government-funded RCT.

This inexpensive, off-patent drug will not make money for any drug company. Therefore, it falls to the
government to take steps to fund a trial. I implore you to advocate for this!

STUDIES AND LINKS REGARDING IVERMECTIN:

10/29/30. India: Two doses of ivermectin, given 72 hours apart, prophylactically, was associated with a
73% reduction of COVID-19 infection among healthcare workers for the following one-month, in a case
control study of 186 pairs.

https: //www.medrxiv.org/content/10.1101/2020.10.29.20222661v1

10/26/30: Baghdad, Iraq: A recent study done Baghdad compared COVID patients who took ivermectin or did
not. In this, 10% of the non-Ivermectin group progressed to severe disease well only 4% of the ivermectin
group did. In that same study there was a 27% mortality rate for those who did not take over motion
versus 18% and those who did.

https: //www.medrxiv.org/content/10.1101/2020. 10.26. 20219345v1?fbcl i d=IwAROM7sh3HnP3rDM5FRYiM34RSBFWBOXDCR
£P3NzZ4Yaw9Ta7 YAO8FMME4TGY


To: Woodcock, Janet <Janet. Woodcock@fda.hhs.gov>
Subject: lvermectin

Dear Janet,

Below is the curve | mentioned for the city of Iquitos, in the Peruvian Amazon. The health system collapsed almost
immediately; it was terrible. They had ivermectin and used it to treat patients. Clearly, these are empirical results, not a
clinical trial, but the source is reputable and the data comes from the Ministry of Health (MINSA). The use of Ivermectin
was approved by MINSA for COVID-19 treatment on May 8". The same has been reported for other regions in Peru and
in Honduras. BTW — Ivermectin fared rather well in the prioritization by the ACTIV WG in the second wave of potential
therapeutic compounds. Best, Maria

IMPACTO DEL USO DE LA IVERMECTINA EN LA REDUCCION DEL NUMERO DE FALLECIDOS

» _ N° DE FALLECIDOS POR COVID-19 POR FECHA DE
DEFUNCION. REGION LORETO, PERU - ANO 2020*
22 ~ Fuente de Datos: Centro Nacional de Epidemiologia, prevenciony
Control de Enfermedades (COC) del MINSA. Al 28 de Mayo del 2020.
ig. Se aclara que los reportes diarios de la Sala Situacional
del MINSA no solo corresponden a defunciones dda 1
anterior, sino que induye defunciones de otros dias, 4

Del 27 de Abril 9 de Mayo: Diversos

Evidente Cambio de Tendencia se produce
durante la semana del 4 al 10 de mayo

‘Del 3 al 9 de Mayo: Difusién del Documento “Inclusion de la tvermectina en ta primera linea
de accibn terapeutica para COVIO-19 :Se reporta una muy significativa disminuciénde ta
“asa de Letalidad con su uso". La reduccién en la Letalidad se describié en este documento,

8 de Mayo: Emisin de la R.M. 270-MINSA que aprobé Ia inclusion de la
Iwermectina como Tratamiento Especitico para COVID-19

ij. Re rence cones 12 de Mayo: Realizan aplicacin de inyeecones masvas conta el
18 extranjeros comunican ta grave situacién: COVID-19 en la ciudad de Iquitos.
‘ena ciudad de tquites por el
exponencaincremento decasos yet 20 de Mayo: ta Prensa Local y Nacional informa sobre la
creciente nimero de fallecidos. n ‘drastica disminucién en el nimero de casos en la ciudad
‘Muestran los cadaveres apilados y las de Iquitos, mostrando en video tas camillas sin uso
10 eas deldospital de quits con un

¢ ‘aplladas y acrimadas, también se muestra varias dreas
‘excesivoniimero de pacientes, vacias det Hospital de iquitos y solo3 pacientes.

Este brusca disminuciin en ef niimero
de fallecidos también se ha
presentado en otras regiones del Pera
Yyenel total Nacional.

‘Y de manera similar se ha presentado
en Hondurascon ef usodela
Ivermectina (dado como parte de un
grupade medicamentos).


Dr. Rachel Harrigan, OWS

Dr. Peter S. Kim, NIAID

Renee Pridgen, MHA, Duke Clinical Research Institute

General Questions, Duke Clinical & Translational Science Institute

Research Support Services, Vanderbilt Institute for Clinical and Translational Research

Dear Dr. Collins and colleagues,

Your recent announcement of the ACTIV-6 clinical trial, investigating repurposed COVID-19
therapeutics for early-stage disease, is the best reply our previous letters could have received. We
are excited at the prospect of having answers that will allow outpatient clinicians throughout the
United States and the world to effectively treat COVID-19. NCATS is the right agency to undertake
this; the participation of Duke and Vanderbilt is reason for further optimism.

We are a group of correspondents and co-authors of two recent papers:

The Importance of Understanding the Stages of COVID-19 in Treatment and Trials
Daniel O Griffin et al.

The Time to Offer Treatments for COVID-19
Binh Ngo et al.

In particular, Drs. Binh Ngo and Marc Rendell of Los Angeles, around whose efforts the rest of us
have formed, have been consistent seekers of repurposed outpatient COVID-19 antivirals. We
wonder if there is a way one or both might be nominated to advise the ACTIV-6 clinical trial.

While there's much to be said about where the US and the world stand concerning COVID-19
therapeutics, we'd like to take this opportunity to summarize our thoughts concerning:

Selection of agents

First, a question: Is it the intent of ACTIV-6 to focus on agents thought to have antiviral activity, or
should we take the word "symptoms" to imply something else?

Either way, we hope the need for answers concerning ivermectin is at or near the top of your agenda. The
volume of in vivo data from around the world, most of it supporting the hypothesis of ivermectin efficacy
against COVID-19, is considerable. Noted physicians in the U.S. and abroad, including members of our group,
stand ready to present that data & their meta-analysis of it. Ivermectin skeptics, some of them equally noted,
often question the quality of said data, leading to the necessity of a government or foundation funded clinical
trial such as ACTIV-6.

Other agents with antiviral activity we suggest might be included are budesonide, niclosamide, and nitric
oxide nasal spray.

The centrality of timing

If it's antivirals you wish to trial, we're concerned that a window of 7 days from symptom onset may
be excessive relative to the initiation of treatment. It's our understanding that the BLAZE trials
initiated therapy within a shorter time-frame, as did the COLCORONA study of colchicine (for other
reasons, since that is not an antiviral). In fact, many of us would suggest that procedure &


From: Adam, Stacey (FNIH) [T] [sadam @fnih.org]

Sent: 1/22/2021 3:36:41 PM
To: Adrian Hernandez, M.D. [adrian.hernandez@duke.edu]
ce: Woodcock, Janet [/o=ExchangeLabs/ou=Exchange Administrative Group

(FYDIBOHF23SPDLT)/cn=Recipients/cn=7b0453354a9a427db0a66a86c7a36f3d-Janet.Woodc]; Lane, Henry C (NIH)
[/o=ExchangeLabs/ou=Exchange Administrative Group
(FYDIBOHF23SPDLT)/cn=Recipients/cn=d904337536cf41719032a9359alec2ab-HHS-CLANE-n]; Eric Hughes
{eric.hughes@novartis.com]; Read, Sarah W (NIH) [/o=ExchangeLabs/ou=Exchange Administrative Group
(FYDIBOHF23SPDLT)/cn=Recipients/cn=72ca09ea60c74100a908211e1f7 cSf6a-HHS-readsa-]; Appell, Evan
{eappell @deloitte.com]; Sorosa, Alex [asorosa@deloitte.com]; Nasr, Hana [hanasr@deloitte.com]; Dr Eric Perakslis,
Ph.D. [eric.perakslis@duke.edu]; Tyrus Rorick [tyrus.rorick@duke.edu]; Dana Carluccio
(dana.carluccio@roseliassociates.com]; Rose Li Central Account [FNIH@roseliassociates.com]; Wholley, David N
(NIH) [/o=ExchangeLabs/ou=Exchange Administrative Group
(FYDIBOHF23SPDLT)/cn=Recipients/cn=784115e9182043d48eaa9e91761c4330-HHS-dwholle]; Lauren Cohen
{lauren.w.cohen@duke.edu]; Chen, Helen [qingchen@deloitte.com]

Subject: RE: Summary of the Potential Pragmatic Trial Discussion with PCORnet

Thanks, Adrian,

This is great news to hear. | am working right now to find time on Janet and Cliff’s calendars to plan the next larger
meeting as we have a couple of other interested groups that might be able to lead as well or collaborate with your team
to expand the reach of the trial. We would discuss this at the next meeting with all the groups.

Thanks for following up!

Best,
Stacey

Stacey J. Adam, PhD

Director, Cancer

Research Partnerships

Direct: (301) 435-8364 | Mobile:

From: Adrian Hernandez, M.D. <adrian.hernandez@duke.edu>

Sent: Friday, January 22, 2021 3:30 PM

To: Adam, Stacey (FNIH) [T] <sadam@fnih.org>

Ce: Woodcock, Janet (FDA/CDER) <Janet.Woodcock@fda.hhs.gov>; Lane, Cliff (NIH/NIAID) [E] < a.
Eric Hughes <eric.hughes@novartis.com>; Read, Sarah (NIH/NIAID) [E] < >; Appell, Evan
<eappell@deloitte.com>; Sorosa, Alex <asorosa@deloitte.com>; Nasr, Hana <hanasr@deloitte.com>; Dr Eric Perakslis,
Ph.D. <eric.perakslis@duke.edu>; Tyrus Rorick <tyrus.rorick@duke.edu>; Dana Carluccio

<dana.carluccio @roseliassociates.com>; Rose Li Central Account <FNIH@roseliassociates.com>; Wholley, David (FNIH)
[T] <dwholley@fnih.org>; Lauren Cohen <lauren.w.cohen@duke.edu>; Chen, Helen <qingchen@deloitte.com>
Subject: Re: Summary of the Potential Pragmatic Trial Discussion with PCORnet

Stacey

We met this afternoon with the PCORnet and PCORI leadership and everyone agrees this would line up with what we’ve
done before.

Let us know any next steps.


receive the standard of care. They found that 46% of the standard of care patients required oxygen and 8% went to the
intensive care unit. This was compared to those who did receive ivermectin, in which 9% required oxygen and only 1%
went to the intensive care unit. https://www.trialsitenews.com/mymensingh-medical-college-retrospective-study-
ivermectin-superior-to-standard-of-care-for-covid-19-patients/

8/28/20: Preventive study from Egypt showing for the first time a large reduction in covid contraction for family
members taking prophylactic dose of Ivermectin when there is an infected person in the same household. Household
contacts who did not take ivermectin had a 58% rate of contracting Covid, compared to only 7% of those who did take
ivermectin.

https://clinicaltrials.gov/ProvidedDocs/61/NCT04422561/Prot_SAP_000.pdf

8/26/20: Bangladesh. 400 patients were randomized to either receive ivermectin or placebo. In that study 18% of the
placebo patients progressed to clinical deterioration while only 9% of those with ivermectin deteriorated. In that study
they also compared percentage of patients who had early clinical improvement within a week, and of those without
Ivermectin, 44% improved quickly while of those with Ivermectin, 60% improved quickly.
https://clinicaltrials.gov/ProvidedDocs/31/NCT04523831/Prot_ICF_000.pdf

7/8/20 Baghdad, Iraq: This study compared hospitalized patients with mild to moderate symptoms who took ivermectin
or did not. Those who did not had a hospital stay of 12 days on average, vs 7% in those who did take ivermectin.
https://www.medrxiv.org/content/10.1101/2020.07.07.20145979Vv1.full.pdf

6/30/20 Dominican Republic Data:
https://www.trialsitenews.com/president-of-dominican-republic's-largest-private-health-group-discusses-the-success-
of-ivermectin-as-a-treatment-for-early-stage-covid-19/

6/28/20 Bangladesh Data (mild to moderate cases, comparison with hydroxychloroquine/azithromycin). This study is not
statistically significant but showed a trend of recovery in eight days with ivermectin versus nine without.
https://www.trialsitenews.com/ivermectin-study-reveals-fantastic-results-100-of-60-patients-better-in-an-average-of-

just-under-6-days/

6/10/20 Florida Data (first U.S. data, on hospitalized patients). This is a retrospective intensive care unit study in which
those who did not receive ivermectin had a 25% mortality rate while those who did receive ivermectin had a 15%
mortality rate. It has since been published in a peer-reviewed journal.
https://journal.chestnet.org/article/S0012-3692(20)34898-4/fulltext

5/2/20 Peru Data: areas of the country where ivermectin was used have a lower case rate and lower fatality rate than
areas where ivermectin was not used.
https://www.docdroid.net/J8wuZlb/ivermectin-studyesen-pdf

3/2020: Australian study that showed that high doses of ivermectin killed the Covid virus in a test tube study.
https://research.monash.edu/en/publications/the-fda-approved-drug-ivermectin-inhibits-the-replication-of-sars

The FLCC, a US based group of colleagues with over 200 years of combined experience in Critical Care and Emergency
Medicine, as well as long-standing shared interests in developing effective treatments for critical illnesses including
sepsis, is a working group devoted to creating a treatment protocol against COVID-19.

They developed an inpatient Covid protocol which has lead to a mortality rate of 4-10%, compared to the world average
of 23%.

They have now developed a prophylactic and early outpatient combination treatment protocol for COVID-19 called I-
Mask+.

https://covid19criticalcare.com/wp-content/uploads/2020/11/FLCCC-IVERMECTIN-Protocol.pdf



On Sat, Mar 13, 2021, 8:56 PM Steve Kirsch </> wrote:

Any restrictions on the Fluvoxamine where a patient wasn’t able to qualify for it? Youngest and oldest patients?

Sent from my iPhone
On Mar 13, 2021, at 3:38 PM, Dr. Syed Haider <thedoc@drsyedhaider.com> wrote:

Mostly standard FLCCC protocol of 0.2mg per kg for 2-5 days til feeling better.
Probably 25-50 active cases. I'll try to get follow up from all of them on their experience.
-Syed

On Sat, Mar 13, 2021, 6:07 PM Steve Kirsch <IM®> wrote:
What ivermectin dose? .2mg/kg for 3 to 5 days?

Were these with active covid cases or were they stockpiling?

From: Dr. Syed Haider <thedoc@drsyedhaider.com>
Sent: Saturday, March 13, 2021 2:53 PM

To: Steve Kirsch

Subject: Re: Fluvoxamine status?

Probably 100 at this point, but in telemedicine | don't get great follow-up from most patients, so can't really assess
the impact. Also everyone so far has been using it as an adjunct to ivermectin. There was just one patient who came
mentioning the 60 minutes segment and specifically requesting it in case they got sick.

-Syed

On Sat, Mar 13, 2021, 5:07 PM Steve Kirsch P| wrote:

How many prescriptions have you given total? Any uptake since the 60 minutes story aired last Sunday?

Sent from my iPhone


From: Woodcock, Janet [/O=EXCHANGELABS/OU=EXCHANGE ADMINISTRATIVE GROUP
(FYDIBOHF23SPDLT)/CN=RECIPIENTS/CN=7B0453354A9A42 7DBOA66A86C7A36F3D-JANET. WOODC]

Sent: 8/9/2021 7:11:10 AM
To: Stan Young
Subject: RE: [EXTERNAL] soy protein

Not so simple. | don’t think ivermectin works well enough It is a large simple no touch trial though. jw

From: Stan Young <

Sent: Sunday, August 8, 2021 11:00 PM

To: Woodcock, Janet <Janet.Woodcock@fda.hhs.gov>
Subject: [EXTERNAL] soy protein

CAUTION: This email originated from outside of the organization. Do not click links or open attachments unless you recognize the
sender and know the content is safe.

Janet: I've been following virus somewhat closely. I'm quite distrustful of CDC numbers. You mentioned that
you were considering an FDA experiment on ivermectin; large simple trial. What is going on there? Rank the
states by population. At random, one of each pair allows ivermectin. ?? Stan

Stan and Pat Young)



From: Michael Morrison hia)

Sent: 10/20/2021 11:51:44 AM

To: Woodcock, Janet [/o=ExchangeLabs/ou=Exchange Administrative Group
(FYDIBOHF23SPDLT)/cn=Recipients/cn=7b0453354a9a427db0a66a86c7a36f3d-Janet.Woodc]

Subject: Re: [EXTERNAL] Your opinion, please

CAUTION: This email originated from outside of the organization. Do not click links or open attachments unless you recognize the
sender and know the content is safe.

Thank you (or your staff) - sincerely - for your replies.

On Oct 20, 2021, at 7:53 AM, Woodcock, Janet <Janet.Woodcock@fda.hhs.gov> wrote:

NIH is doing a study on outpatient treatment with ivermectin. It isan RCT. Janet Woodcock

From: Michael Morrison

Sent: Tuesday, October 19, 2021 10:27 PM

To: Woodcock, Janet <Janet.Woodcock@fda.hhs.gov>
Subject: Re: [EXTERNAL] Your opinion, please

CAUTION: This email originated from outside of the organization. Do not click links or open attachments unless you recognize the
sender and know the content is safe.

Yet your FDA is why I’m being denied access to a profilaxis which has proven to be effective in other studies. My
pharmacist is refusing to fill a prescription by referring to your agency’s guidance.

Another NIH publication:

https://pubmed.ncbi.nlm.nih.gov/33592050/

“Two-dose ivermectin prophylaxis was associated with a 73% reduction of SARS-CoV-2 infection
among healthcare workers.”

Certainly an NIH follow up study is justified.

On Oct 19, 2021, at 8:30 AM, Woodcock, Janet <Janet.Woodcock@fda.hhs.gov> wrote:

Need to see results from RCTs, as the authors say. These types of studies are hypothesis generating, not
confirmatory. Janet Woodcock

From: Michael Morrison <
Sent: Monday, October 18, 2021 9:39 PM



This protocol recommends ivermectin, vitamins C and D, Zinc, melatonin and, for adults only, aspirin.

Their rationale is based on multiple studies as well as real-world evidence comparing countries using ivermectin, such as
Peru, Brazil and Haiti, to those not using it, such as the Dominican Republic and the US.

Here is the introductory video from FLCC:
https://vimeo.com/473929788/382c386d60

Thank you for your consideration,
Alexis Lieberman, MD
Advocare Fairmount Pediatrics


From: Woodcock, Janet [/O=EXCHANGELABS/OU=EXCHANGE ADMINISTRATIVE GROUP
(FYDIBOHF23SPDLT)/CN=RECIPIENTS/CN=7B0453354A9A42 7DBOA66A86C7A36F3D-JANET. WOODC]

Sent: 8/31/2021 7:44:13 AM

To: Ashley, Donald [/o=ExchangeLabs/ou=Exchange Administrative Group
(FYDIBOHF23SPDLT)/cn=Recipients/cn=40241a76230349cbb195ab1721092196-Donald.Ashi]

Subject: RE: [EXTERNAL] Fox News Ivermectin and Consumer Deaths from Reckless Medical Advice

Thx! jw

From: Ashley, Donald <Donald.Ashley@fda.hhs.gov>

Sent: Tuesday, August 31, 2021 7:41 AM

To: Woodcock, Janet <Janet.Woodcock@fda.hhs.gov>

Subject: FW: [EXTERNAL] Fox News Ivermectin and Consumer Deaths from Reckless Medical Advice

Janet: I'll arrange for an appropriate reply. Don

From: BRUCE JOHNSON < Lh

Sent: Monday, August 30, 2021 10:57 PM

To: Woodcock, Janet <Janet.Woodcock@fda.hhs.gov>; Ashley, Donald <Donald.Ashley@fda.hhs.gov>
Subject: [EXTERNAL] Fox News Ivermectin and Consumer Deaths from Reckless Medical Advice

CAUTION: This email originated from outside of the organization. Do not click links or open attachments unless you recognize the
sender and know the content is safe.

Why hasn’t the fda warmed Fox News of its reckless conduct with respect to invermectin?

Like below
https://www.fda.gov/news-events/press-announcements/coronavirus-covid-19-update-fda-warns-seller-marketing-
dangerous-chlorine-dioxide-products-claim

Bruce Johnson
©) 6)



(b) (6)

From: Larry Kayser
Sent: 9/3/2021 11:18:29 AM
To: Woodcock, Janet [/o=ExchangeLabs/ou=Exchange Administrative Group

(FYDIBOHF23SPDLT)/cn=Recipients/cn=7b0453354a9a427db0a66a86c7a36f3d-Janet.Woodc]
Subject: ({EXTERNAL] | am here again

CAUTION: This email originated from outside of the organization. Do not click links or open attachments unless you recognize the
sender and know the content is safe.

Good morning Dr. Woodcock,

I sit here still in amazement that we are approaching 100 days since the EUA submission for Aviptadil and not
a sound from the FDA apart from another declaration that it is safe. In the meantime, we pound away at
vaccines, shame people who don‘t want to get it for valid reasons and do virtually nothing to equip our
hospitals with any therapeutics that can give any kind of hope for critically ill patients while thousands die each
week and we are simply scolded for not getting the vaccination.

We still don’t have any reliable public data for vaccination side effects. We hear that Ivermectin is harming
people, yet there are many doctors who are using it despite the FDA refusal. Now we have lawsuits trying to
force hospitals to administer Ivermectin because people keep reading from places all around the world that
doctors are using it and it helps. We don’t even have a right to try for that drug so people take matters into
their own hands and do harm to themselves with wrong dosing or who knows what else they might be doing
wrong.

Now the FDA has granted right to try for Aviptadil, which I am grateful for. Why would the FDA grant
permission for them to try it at all if it is not worthy of an EUA in this time of emergency? It is simply beyond
my comprehension that the FDA does not know if Aviptadil is safe and “may be effective” at this point. I
cannot understand how this agency withholds this and other drugs that might be the only hope critically ill
people have to recover. Or that it might be used to prevent people from getting to that stage. The FDA has
again reiterated that it is safe, so it will not do serious harm to people. Yet here we sit week after week while
people die. I had another dear friend die yesterday. I tried to get the Right to Use application to him and his
doctors, but it takes too long for the overwhelmed medical staff to even respond, and very few doctors have
ever heard of Aviptadil, so they are understandably skeptical of the request. Somehow it has been deemed
safe and effective enough to be granted an EUA in Georgia, and I suspect some other Caucasus countries to
follow. But here we sit paralyzed while people keep dying.

I know that I will receive the standard reply that you cannot comment on drugs you have been involved
with. I simply don’t know where else to turn to vent my frustrations. I don’t think people who are sitting in
offices at the FDA or the CDC understand how deeply these agencies have broken trust with the American
people during this pandemic, and how this process has exposed the bureaucratic pace of the drug approval
process except of course for vaccines. So the strategy that has dominated our world is to get hundreds of
millions of shots into healthy people while we have so little emphasis and development on therapies for the
sick and dying. I have tried so hard in the last 18 months to not grow cynical about money, about large
Pharma control, about who is funding clinical trials...I am losing my battle with cynicism.

I know you can’t help. If you took the time to read this, thank you. If you have an assistant read it and
respond, I guess it really doesn’t matter.

Sincerely,
Larry



‘or oo Janet Janet. Woodcock @fda.hhs.gov>

Ce: Pierre Kory< me
Subject: lvermectin and an IND

Dear Drs. Lieberman and Woodcock:

| was sent this communication below. Two points in response.

1 As thisis a FDA approved drugan IND may not be required. Pleasesee the ACTS Vitamin Ctrial. As the product
used (IV Vitamin C) was FDA approved forthe treatment of “scurvy” the FDA provided a waiver of an IND.

2. There is now overwhelming evidence that lvermectin is useful for prophylaxis, postexposure Rx,

early symptomatictreatment and late treatment of COVID-19. Toignore this exceedingly safe, effective and cheap
medicationis immoral. URGENT actionis required.

Please see attachments and links below,

Kindly

Paul Marik. MD

U-Tube Channel
https://www.youtube.com/channel/UCz9Pvn1S5m4Rv1uY-aBYRVuw

https://www.trialsitenews.com/real -world-evidence-i-mask-protocol-ivermectin-key-for-prophylaxis-and-early-
treatment-of-covid-19/?fbclid=IwAR33nTE-TJ1fz087s12DNqWNOcTZ9YBz-m-Nt4haN WOvIKURRJBG6ZO911U

https://www.trialsitenews.com/why-isnt-ivermectin-being-widely-researched-and-utilized/

FLCCC
https://covid19criticalcare.com/

Here is a happy email exchange w the FDA

Thanks, | will definitely follow up. jw

Original Message—---

From: Alexis Lieberman

Sent: Monday, November 16, 2020 8:15 AM

To: Woodcock, Janet <Janet. Woodcock @fda.hhs.gov>

Subject: Re: Information re Covid treatment

Good morning, Dr Woodcock,

| wanted to follow up about the IND for the/ iM study. lalso learned thatthe?
(MB tudy and the [yyy tudy are each also waiting for an IND. While it looks like many trials are
occurringin the US forivermectin use for Covid, | believeonly the as an IND. The others are all
waiting. | greatly appreciate your assistance with this!

Alexis Lieberman, MD

On Nov 13, 2020, at 2:11 PM, Woodcock, Janet <Janet.Woodcock@fda.hhs.gov> wrote:

Is this study with an inhaled or oral formulation? Thanks jw

coe Original Message—---

From: Alexis Lieberman

Sent: Thursday, November 12, 2020 4:55 PM

To: Woodcock, Janet <Janet. Woodcock @fda.hhs.gov>

Subject: Re: Information re Covid treatment



And what error have the courts been making in deciding the ivermectin treatment cases for
the plaintiff?

Thanks in advance and | look forward to your response.

-steve


Milwaukee, WI

Stephen Ditmore
Health Reporter
Parkchester Times
Bronx, NY


week's activity and any requests for follow-up. If you are no longer interested in COVID-19 Evidence

Accelerator activity, please let us know and we will update our distribution list.

We had a great week here at the Evidence Accelerator with the start of our Vaccines workstream. On
Thursday, we expanded our discussions to include vaccine topics during our Therapeutics Lab
meeting. Going forward, we will continue to feature Vaccine-specific topics alongside our
Therapeutics topics, during joint Lab meetings on the 18! and 3 Thursdays, 3-4pmET timeslot.

Note that we will shortly be extending calendar invitations for all COVID-19 Evidence Accelerator Lab

meetings through the end of summer.

Upcoming Meetings

« Mar 24""— Therapeutics Parallel Analysis (Accelerators-only)

« Mar 25" — Post-Acute Sequelae of SARS-CoV-2 (PASC) Infection Working Group

« April 18‘ Therapeutics/Vaccines Lab meeting (Topics: Update on Alpha-1 blockers,
COVID-19 data resource)

Evidence Accelerator in the news:

e Harnessing a watershed moment for real-world data - Fierce Healthcare
e COVID-19 Diagnostics Market - Digital Journal
e« Shot inthe Arm: COVID-19 Boost to RWD - PharmaVOICE

Therapeutics/Vaccines Workstream

Thursday Afternoon “Lab” Meeting

As mentioned above, we had our inaugural meeting of the new Vaccines workstream. To start us off,
we had a wide-ranging conversation with Dr. Michael Osterholm of the Center for Infectious Disease
Research and Policy (CIDRAP) at the University of Minnesota, facilitated by Dr. Patrick Ryan of
OHDSI. In his remarks, Dr. Osterholm noted the need for nimbleness in responding to this public
health crisis, whether in regard to vaccine deployment or in tracking the spread of variants. He was
followed by Drs. Steve Anderson and Richard Forshee of FDA’s Center for Biologicals Evaluation


From: Woodcock, Janet [/O=EXCHANGELABS/OU=EXCHANGE ADMINISTRATIVE GROUP
(FYDIBOHF23SPDLT)/CN=RECIPIENTS/CN=7B0453354A9A42 7DBOA66A86C7A36F3D-JANET. WOODC]

Sent: 8/17/2021 2:16:27 PM
To: Adv Nadkarni [/ Ciba)
Subject: RE: [EXTERNAL] How state of Uttar Pradesh, India contained Delta Variant nCoV

Thank you for the information. Janet Woodcock

From: Adv Nadkarni <! gy

Sent: Tuesday, August 17, 2021 2:08 PM

To: Woodcock, Janet <Janet.Woodcock@fda.hhs.gov>

Subject: [EXTERNAL] How state of Uttar Pradesh, India contained Delta Variant nCoV

CAUTION: This email originated from outside of the organization. Do not click links or open attachments unless you recognize the
sender and know the content is safe.

Dear Dr. Woodcock,

Ihave the evidence from the respective State officials (India) on how Uttar Pradesh (UP), India with population
240 million contained the infections due to Delta variant nCoV that has the most efficient mutation ever, the
L452R (R=Arginine - Hydrophilic, Positively charged side chain with the highest pKa3 semi-essential amino
acid) in the RBD. The ACE2 is negatively charged.

In the first week of April 2021, when the Second wave in India shot up, a pilot program was conducted in the
City of Agra, UP, by the city's Chief Medical Officer Dr. Anshul Pareek. He gave Ivermectin 12 mg, | tablet a
day for 3 days to every person with mild/moderate symptoms, who was tested nCoV positive through RT/PCR
test. In addition, he also gave Ivermectin 12 mg to every family member and other persons who came in contact
with the person found nCoV positive. Dr. Pareek observed very good outcome, and that's when the Uttar
Pradesh state govt. decided to replicate this model state-wide which started in the 3rd week of April is still
being followed. For the last month, Uttar Pradesh has recorded less than 50 cases daily among its population of
240 million people. This model of using Ivermectin as a therapeutic and prophylactic agent was then used by
other states viz. Delhi, Madhya Pradesh, Gujarat, Uttarakhand, Bihar, Rajasthan, Punjab to my knowledge and
the evidence I have gained so far. You may check the results at https:/Avww.covid19india.org/

May be you can contact with the IDSP (Integrated Disease Surveillance Program) India officials and confirm
this information by yourself. I hope the information I shared with you is helpful to you in saving the people
from your country.

Best Regards,

Adv. Nadkarni, B.Sc.(Physics), MS (Computer Engg), MBA, LL.B.
India



Amar Bhat
Chief Operating Officer
Reagan-Udall Foundation for the FDA

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all Verizon LTE °< 9:17 AM Cue
f@ covid19criticalcare.com

On Sep 10, 2021, at 8:14 AM, Woodcock, Janet <Janet.Woodcock@fda.hhs.gov> wrote:

The current evidence of effectiveness of ivermectin and HCQ against COVID-19 is negative. The ACTIVE 6 trial is testing a
higher dose/longer duration of ivermectin in outpatients. I’m unaware of data on nitazaxanide. Janet Woodcock

From: rihrih wfuma.org <rihrih@wfuma.org>

Sent: Friday, September 10, 2021 6:43 AM

To: Woodcock, Janet <Janet.Woodcock@fda.hhs.gov>
Subject: [EXTERNAL] Consider human-use OTC ivermectin &


e-bmce.co.uk

<BIRD Proceedings 02-03-2021 v 1.5.1.pdf>
<BIRD Proceedings Executive Summary.pdf>

On 26 Feb 2021, at 16:42, Stein, Peter <Peter.Stein@fda.hhs.gov> wrote:

Dear Dr. Lawrie,

Thank you for forwarding this information — it’s much appreciated — and clearly
reflects your group’s thoughtful assessment. We'll certainly review what you’ve
provided.

Sincerely,
Peter Stein
Director, Office of New Drugs, CDER/FDA

From: Tess Lawrie <tess@e-bmc.co.uk>

Sent: Friday, February 26, 2021 10:59 AM

To: Abernethy, Amy <Amy.Abernethy@fda.hhs.gov>; Anderson, Erika <Erika.Anderson@fda.hhs.gov>; Yiannas, Frank
<Frank.Yiannas@fda.hhs.gov>; james.sigg@fda.hhs.gov; Tyler, James <James.Tyler@fda.hhs.gov>; Tierney, Julia
<Julia.Tierney@fda.hhs.gov>; Hinton, Denise <Denise.Hinton@fda.hhs.gov>; Raza, Mark <Mark.Raza@fda.hhs.gov>;
Abdoo, Mark <Mark.Abdoo@fda.hhs.gov>; Araojo, Richardae <Richardae.Araojo@fda.hhs.gov>; McMeekin, Judith
<Judith.McMeekin@fda.hhs.gov>; Rebello, Heidi <Heidi.Rebello@fda.hhs.gov>; Roth, Lauren
<Lauren.Roth@fda.hhs.gov>; Tantillo, Andrew <Andrew.Tantillo@fda.hhs.gov>; Vasisht, Kaveeta
<Kaveeta.Vasisht@fda.hhs.gov>; Felberbaum, Michael <Michael.Felberbaum@fda.hhs.gov>; Mair, Michael
<Michael.Mair@ fda.hhs.gov>; Mettler, Erik <Erik.Mettler@fda.hhs.gov>; Miller, Elizabeth
<Elizabeth.Miller@fda.hhs.gov>; Rogers, Michael <Michael.Rogers@fda.hhs.gov>; Cavazzoni, Patrizia
<Patrizia.Cavazzoni@fda.hhs.gov>; Marks, Peter <Peter.Marks@fda.hhs.gov>; Mayne, Susan
<Susan.Mayne@fda.hhs.gov>; Pazdur, Richard <Richard.Pazdur@fda.hhs.gov>;Jeffrey.shuren@fda.hhs.gov; Slikker,
William <William.Slikker@fda.hhs.gov>; Solomon, Steven M <Steven.Solomon@fda.hhs.gov>; Mitch.zeller@fda.hhs.gov;
Stein, Peter <Peter.Stein@fda.hhs.gov>; Woodcock, Janet <Janet. Woodcock @fda.hhs.gov>; Sally.chloe@fda.hhs.gov
Ce: claire Mock-Mufioz de Luna <claire@e-bmc.co.uk>; Ketan Gajjar <ketan.gajjar@nhs.net>; Andy Bryant
<andy.bryant@newcastle.ac.uk>; Tony Tham yyy: Scott Mitchell <scott.mitchell@gov.gg>; Tina
Peers <tina@drtinapeers.com>

Subject: [EXTERNAL] URGENT: The BIRD meeting proceedings and recommendation on covid-19 prevention and
treatment

CAUTION: This email originated from outside of the organization. Do not click links or open attachments unless you recognize the
sender and know the content is safe.

Dear Dr. Stein and FDA Colleagues,

We are writing to share with you the evidence to decision framework of the British lvermectin Recommendation Development
(BIRD) Meeting that was held on Saturday 20th February 2021 via Zoom from Bath, United Kingdom. The expert panel of
health and allied professionals and other stakeholders included representatives from 16 countries, namely Argentina,
Australia, Belgium, Botswana, Canada, France, Hungary, India, Ireland, Japan, Peru, Nigeria, South Africa, The Philippines,



9/28/20: Bangladesh: In this retrospective study, they compared patients who received Ivermectin with
those who receive the standard of care. They found that 46% of the standard of care patients required
oxygen and 8% went to the intensive care unit. This was compared to those who did receive ivermectin, in
which 9% required oxygen and only 1% went to the intensive care unit.

https: //www. trialsitenews .com/mymensingh-medical-col lege-retrospective-study-ivermectin-superior-to-
standard-of-care-for-covid-19-patients/

8/28/20: Preventive study from Egypt showing for the first time a large reduction in covid contraction
for family members taking prophylactic dose of Ivermectin when there is an infected person in the same
household. Household contacts who did not take ivermectin had a 58% rate of contracting Covid, compared
to only 7% of those who did take ivermectin.
https://clinicaltrials.gov/ProvidedDocs/61/NCT04422561/Prot_sAP_000.pdf

8/26/20: Bangladesh. 400 patients were randomized to either receive ivermectin or placebo. In that study
18% of the placebo patients progressed to clinical deterioration while only 9% of those with ivermectin
deteriorated. In that study they also compared percentage of patients who had early clinical improvement
within a week, and of those without Ivermectin, 44% improved quickly while of those with Ivermectin, 60%
improved quickly

https: Victinical trials. gov/ProvidedDocs/31/NCT04523831/Prot_IcF_000.pdf

7/8/20 Baghdad, Iraq: This study compared hospitalized patients with mild to moderate symptoms who took
‘ivermectin or did not. Those who did not had a hospital stay of 12 days on average, vs 7% in those who
did take ivermectin.

https: //www.medrxiv.org/content/10.1101/2020.07.07.20145979v1.full .pdf

6/30/20 Dominican Republic Data:
https: //www. trialsitenews .com/president-of-dominican-repub] ic's-largest-private-heal th-group-discusses-
the-success-of-ivermectin-as-a-treatment-for-early-stage-covid-19/

6/28/20 Bangladesh Data (mild to moderate cases, comparison with hydroxychloroquine/azithromycin). This
study is not statistically significant but showed a trend of recovery in eight days with ivermectin
versus nine without.

https: //www. trialsitenews .com/ivermectin-study-reveals-fantastic-results-100-of -60-patients-better-in-an-
average-of - just-under-6-days/

6/10/20 Florida Data (first U.S. data, on hospitalized patients). This is a retrospective intensive care
unit study in which those who did not receive ivermectin had a 25% mortality rate while those who did
receive ivermectin had a 15% mortality rate. It has since been published in a peer-reviewed journal.
https: //journal.chestnet.org/article/S0012- 3692 (20) 34898-4/fulltext

5/2/20 Peru Data: areas of the country where ivermectin was used have a lower case rate and lower
fatality rate than areas where ivermectin was not used.
https: //www.docdroid.net/J8wuz1b/ivermectin-studyesen-pdf

3/2020: Australian study that showed that high doses of ivermectin killed the Covid virus in a test tube
study.

https: //research.monash.edu/en/pub1ications/the-fda-approved-drug-ivermectin-inhibits-the-rep1ication-of-
sars

The FLCC, a US based group of colleagues with over 200 years of combined experience in Critical care and
Emergency Medicine, as well as long-standing shared interests in developing effective treatments for
critical illnesses including sepsis, is a working group devoted to creating a treatment protocol against
coviIp-19.

They developed an inpatient Covid protocol which has lead to a mortality rate of 4-10%, compared to the
world average of 23%.

They have now developed a prophylactic and early outpatient combination treatment protocol for CovID-19
called I-Mask+.

https: //covidi9criticalcare.com/wp-content/uploads/2020/11/FLCCC-IVERMECTIN-Protocol .pdf

This protocol recommends ivermectin, vitamins C and D, Zinc, melatonin and, for adults only, aspirin.

Their rationale is based on multiple studies as well as real-world evidence comparing countries using
ivermectin, such as Peru, Brazil and Haiti, to those not using it, such as the Dominican Republic and the
us.

Here is the introductory video from FLCC:
https: //vimeo.com/473929788/382c386d60

Thank you for your consideration,
Alexis Lieberman, MD
Advocare Fairmount Pediatrics


Research (CBER) who provided an overview of CBER’s system for vaccine safety surveillance,
working in tandem with other U.S. Government agencies such as CMS, CDC and the VA. CBER’s
slides are available on the Evidence Accelerator website. Finally, we were introduced to Heidi the

Hypothetical Patient and some of her “friends” by Dr. Donna Rivera of FDA’s Oncology Center of
Excellence. Participants of our Diagnostics Lab meetings will remember Heidi as our hypothetical
patient whose data journey helps us illustrate data flows (or lack-of-flow and interoperability) as

patients encounter the healthcare system.

Below is our data visualization highlight, showing current status in COVID-19 vaccine rollout in the
United States.


From: Steve Kirsch [| Co

Sent: 5/21/2021 1:08:20 PM

To: Lane, Henry C (NIH) [/o=ExchangeLabs/ou=Exchange Administrative Group
(FYDIBOHF23SPDLT}/cn=Recipi ents /cn=d904337536cf41719032a9359a1ec2ab-HHS-CLANE-n]}

cc: Woodcock, Janet [/o=ExchangeLabs/ou=Exchange Administrative Group
(FYDIBOHF23SPDLT)/cn=Recipi ents /cn=7b0453354a9a427db0a66a86c7a36f3d-Janet.Woodc]

Subject: [EXTERNAL] New data:Here's a way you cando the rightthing on IVM

CAUTION: This email originated from outside of the organization. Do not click links or open attachments unless you recognize the
sender and know the content is safe.

Cliff,

Cliff,

here’s a way for you to change your recommendation on ivermectin without backtracking.
PLEASE DO THIS ASAP.

Brazil isin total denial that early treatment works this. Sois Tamil Nadu.

thanks!

-steve

Four new randomized controlled trials (RCTs) forivermectin treatment (3) and prevention (1), below, have recently
appeared in mainstream scientific journals over the past six weeks. There are already some 20 of those RCTs for VM
treatment of COVID-19, and for those 8 which included serious cases, pooled mortality reduction was 78%, with
statistically significant benefits in 7 of these 8. What’s new here is that these four recent papers are the first of these
publishedin mainstream journals. Also, a major result on biological mechanism of IV Mactivity against SARS-CoV-2is
being finalized froma leading world virology lab —the Plis next door to a recent Nobel laureate.

Chaccour? - Patients in the ivermectin group recovered earlier from hyposmia/anosmia(76vs 158 patient-days; p<
0.001). Lesser reduction in viral load. [IVMas a single agent appears in many studies, clinical and animal, to have greater
reduction in morbidity v. infectivity; this may relate to greater shielding of NTDv. RBD region of viral spike protein]

Mahmud?-— Just one dose of IVM at 12 mg, plus doxy. Several clinical benefits at p=.001, including reductionin viral load.

Shahbaznejad? - Duration of symptoms and of hospitalization —IVMimproved by ~ p = .02 for each. Cough: p=0.02;
shortness of breath, p <0.05.

Seet*—IVM was given in just one low dose of 12 mg ina prevention study, with observation over 42 days. Three other
prevention regions were administered every day for 42 days. IVM did bestas to clinical benefits —it reduced
symptomatic COVID by 50% (p=.003) and acute respiratory symptoms by 50% (p=.012).

1. Chaccour C, Casellas A, Blanco-Di Matteo A, et al. The effect of early treatment with ivermectin on viral load, symptoms

and humoral response in patients with non-severe COVID-19: A pilot, double-blind, placebo-controlled, randomized clinical trial.
EClinical Medicine. 2021;32.

2 Mahmud R, Rahman MM, Alam I, et al. Ivermectin in combination with doxycycline for treating COVID-19. symptoms: a
randomized trial. Journal of International Medical Research. 2021; 49(5):030006052 1 1013550.

3. Shahbaznejad L, DavoudiA, Eslami G, et al. Effect of ivermectin on COVID-19: A multicenter double-blind randomized
controlled clinical trial. Clinical Therapeutics. 2021; https://doi.org/10.1016/j.clinthera.2021.04.007.



Dear Dr. Kim:

We take great encouragement from your recent etter, Therapy for Early COVID-19, A Critical Need
which we support whokheartedly. By that letter, along wth the clarity of the Bamlanivimab EUA

instructions, you and your colleagues are making t clear that antiviral therapeutics wil be most effective
when adminétered early in the course of SARS-CoV-2 infection.

We offer our comments as friendly, concurring suggestions from grateful allies, and are happy to do whatever
we can to help spread the word among clinicians and policy makers. We have experienced first-hand that
some clinicians remain predisposed to deny treatment before symptoms worsen. Weare ako concerned
about reliance on I.V. administration of therapeutics further straining our hospitals and their personnel. A
goal of outpatient COVID-19 therapeutics should be to relieve that strain by providing solutions that can be
implemented in community based settings.

Quoting (for reference) from your letter, Therapy for Early COVID-19, A Critical Need:

Several antivirals approved or indevelopment for other viral infections, such as HIV,
hepatitis C virus, and ebolaviruses, are under investigation for early treatment of COVID-
19. These investigations have not yet yielded clinically actionable results; however, many
trials are ongoing. Examples of antivirals in trials for early treatment of COVID-19 are MK-
4482 (EIDD-2801), an orally bioavailable ribonucleoside inhibitor that was originally
developed for influenza (NCT04575597); SNG0O01, a nebulized formulation of interferon-
81a developed for viral infections in patients with chronic obstructive pulmonary disease
(NCT04385095); and camostat mesylate, a serine protease inhibitor approved for
treatment of chronic pancreatitis and postoperative reflux esophagitis (NCT04353284).

We view your candidates favorably. Having said that, we would add three:
. favipiravir

. interferon gamma

° ivermectin

Of the six (your three+ours), only one, ivermectin, is currently FDA approved. Please open and glance
at Dr. Marik's attached slides. A partial bibliography of the studies cited appears below.

Ivermectin is avaiable as generic in part due to the generous polices of Merck. While we woud welcome
Merck advancing ivermectin for COVID-19, Merck has taken a financial interest in MK-4482 (EIDD-2801), so
we beleve someone ee must be identified who wil assess the evidence for ivermectin efficacy, champion
the finalizing of research, and make necessary appications on an expedited basis.

The evidence for ivermectin efficacy far exceeds that for either famotidine or hydroxychloroquine, two
previously FDA approved orally available medications that have received scrutiny. We join front-line


they have no effect andthen compounding thaterror by ignoring the only drug that is provenin both high quality
evidence and insubsequent use inthe field to be game changing for this disease.

lam baffled by your decision-making process.

-steve

From: Mulkins, Christopher (HSGAC) <Christopher Mulkins@hsgac.senate.gov>

Sent: Monday, December 7, 2020 11:14 AM

To: Steve Kirsch (6)

Ce: Petry, Megan (HSGAC) <Megan_Petry@hsgac.senate.gov>; Tsilker, Yelena (HSGAC)

<Yelena Tsilker@hsgac.senate.gov>; Ryan, Corban (HSGAC) <Corban_Ryan@hsgac.senate.gov>
Subject: RE: why there isn't an EUA for fluvoxamine

Steve, thanks so much for keeping usup to date on the Fluvoxamine developments. We very muchappreciate it. We
have decided totakea different tact with the hearing tomorrow, but we would very much like to know the progress in
regards to Fluvoxamineand its benefits for treating COVID patients.

Thanks again!
Chris

From: Steve Kirsct) oo

Sent: Friday, December4, 2020 4:02 AM

To: Mulkins, Christopher (HSGAC) <Christopher_Mulkins@hsgac.senate.gov>

Cc; Petry, Megan (HSGAC) <Megan Petry @hsgac.senate.gov>; Tsilker, Yelena (HSGAC)
<Yelena_Tsilker@hsgac.senate.gov>; Ryan, Corban (HSGAC) <Corban_Ryan@hsgac.senate.gov>
Subject: why there isn'tan EUA for fluvoxamine

Normally the drug maker has to apply. There are >12 manufacturers of the drug and none were cooperative. We had to
purchase the drug to do the study. There’s no money forthem to do apply.

There isa citizen’s route to apply foran EUA butitis slow andrarely used. | don’t know whol could hire forthis since
the talent all works full time for drug companies.

There is clearly sufficient body of evidence for an EUA. I’ve shown this evidence to top doctors and they all find it
compelling and would take the drugif they got sick. That’s well beyond the standard.

So this isa HUGE loopholeinthe system that needs to be addressed by HSGAC. In cases like this (genericdrugmany
manufacturers, pandemic), the FDA itself should assemble the case for the EUA.

So you now have two repurposed drugs, Fluvoxamine and lvermectin. Both have a 10X reductionin hospitalization rate.

If you don’t call me as a witness, may| suggest Dr. David Seftel or the Dean of the Medical School at Emory University?

From: Mulkins, Christopher (HSGAC) <Christopher_Mulkins@hsgac.senate.gov>

Sent: Thursday, December 3, 2020 8:37 AM

To: Steve Kirsch I yoe>

Cc: Petry, Megan (HSGAC) <Megan_ Petry@hsgac.senate.gov>; Tsilker, Yelena(HSGAC)

<Yelena Tsilker@hsgac.senate.gov>; Ryan, Corban (HSGAC) <Corban_Ryan@hsgac.senate.gov>
Subject: RE: i'mon the call now....<music waiting for organizer>



To: Mulkins, Christopher (HSGAC) <Christopher_Mulkins@hsgac.senate.gov>} 6)
Ce: Rosenstock, Shani (HSGAC) <Shani_Rosenstock@hsgac.senate.gov>
Subject: Connection

Chris,

Connecting you with Steve Kirsch, who created the COVID-19 Early Treatment
Fund https//www.treatearly.org/overview

We spoke with Steve earlier today and think he can provide valuable information in preparation for the hearing
Tuesday.

Thanks,
Josh


From: Gennaro D'Urso [gdurso@geneticnetworks.com]

Sent: 1/7/2021 4:23:27 PM
To: Gennaro D'Urso [gdurso@geneticnetworks.com]
Subject: Fwd: Automatic reply: Genetic Networks Update

From: Gennaro D'Urso <gdurso@genetionctworks. com>

Date: Thu, Jan 7, 2021 at 3:21 PM

Subject: Re: Automatic reply: Genetic Networks Update

To: Adam, Stacey (FNIH) [T] <sadam@fnih.org>

Ce: Chen, Helen <qingchen@deloitte.com>, Appell, Evan <eappell@deloitte.com>, Leland Hartwell

<Lee.Hartwell@asu.edu>

Dear Stacey,

Thank you so much for moving this forward. Lee and I would just like to emphasize how important it is to put
a meeting on the calendar to present our most recent results to the preclinical group.

We have heard through several of our contacts at different agencies throughout the govt that ivermectin is
getting a great deal of attention recently. We identified ivermectin early this year soon after the pandemic
occurred and identified a novel mode of action (MOA) for this drug. This MOA is shared with 7 other safe
drugs we identified using our proprietary platform, some of which demonstrate more potential promise than
ivermectin. We are now ready to disclose drug names for our best candidates and determine the next best
steps. There is no doubt in our minds that this work will result in saving many lives.

We would suggest a one hour meeting to hear our story.

If you can help to make that happen we would be grateful.

Sincerely,

Gennaro and Lee

1951 NW 7th Ave, Suite 300
Miami, FL 33136

www.geneticnetworks.com
1-888-844-9743

CONFIDENTIALITY NOTICE: This e-mail message from Genetic Networks, LLC (including all attachments) is for the
sole use of the intended recipient(s) and may contain confidential and privileged information. Any unauthorized review,


From: rihrih wfuma.org [rihrinh@wfuma.org]

Sent: 9/11/2021 11:02:10 AM

To: Woodcock, Janet [/o=ExchangeLabs/ou=Exchange Administrative Group
(FYDIBOHF23SPDLT)/cn=Recipients/cn=7b0453354a9a427db0a66a86c7a36f3d-Janet.Woodc]

Subject: Re: [EXTERNAL] Consider human-use OTC ivermectin &

CAUTION: This email originated from outside of the organization. Do not click links or open attachments unless you recognize the
sender and know the content is safe.

If that can benefit public health - sure.

R.

On Sep 11, 2021, at 10:03 AM, Woodcock, Janet <Janet.Woodcock@fda.hhs.gov> wrote:

That is a matter for the Center for Drug Evaluation and Research at the FDA to consider. Would you like me to direct
your inquiry to them? Janet Woodcock

From: rihrih wfuma.org <rihrih@wfuma.org>

Sent: Friday, September 10, 2021 4:58 PM

To: Woodcock, Janet <Janet.Woodcock@fda.hhs.gov>

Subject: Re: [EXTERNAL] Consider human-use OTC ivermectin &

CAUTION: This email originated from outside of the organization. Do not click links or open attachments unless you recognize the
sender and know the content is safe.

.. currently available data, as presented in the below figures, seems to support public use?

R.

On Sep 10, 2021, at 11:36 AM, Woodcock, Janet <Janet.Woodcock@fda.hhs.gov> wrote:

Yes must be later, and not published. jw

From: rihrih wfuma.org <rihrih@wfuma.org>

Sent: Friday, September 10, 2021 11:16 AM

To: Woodcock, Janet <Janet.Woodcock@fda.hhs.gov>

Ce: rihrih wfuma.org <rihrih@wfuma.org>

Subject: RE: [EXTERNAL] Consider human-use OTC ivermectin &

CAUTION: This email originated from outside of the organization. Do not click links or open attachments unless you recognize the
sender and know the content is safe.

https://jamanetwork.com/journals/jamanetworkopen/fullarticle/2779044



Similarly, RCT’s have confirmed Yaning Wang’ s equally excellent paper" Connecting hydroxychloroquine in vitro
antiviral activity to in vivo concentration for prediction of antiviral effect: a critical step in treating COVID-19
patients “, which concluded:

"Under the assumption that in vivo cellular accumulation is similarto that from the in vitro studies, the calculated free
lung concentrations that would result from proposed dosing regimens are well belowthe in vitro EC50/EC90 values,
making the antiviral effect against SARS-CoV-2 not likely achievable with a safe oral dosing regimen. Well-designed
clinical trials that leverage full understanding of drug pharmacology and disposition, as well as disease pathogenesis, will
be necessary to definitively determine whether the risk/benefit balance is favorable fora given treatment."

Perhaps you should collaborate with Yaning to write a piece for CPT showing how good clin pharm and pharmacometrics
can avert wasting resources on poorly thought out hypotheses.

Carl


| gonooo 4 SARS-CoV-2 / COVID-19 actual and projected U.S. fatalities .
given estimated containment "tightness" as of 11/8/20
$00,000 + es ee
| Discrete-time SIR (susceptible, infected, recovered) model with inferred
containment parameter to gauge “tightness of containment measures.
400,000
‘This chart assumes that current containment practices continue,
but changes in our actions can improve or worsen this trajectory.
300,000 + sis
| 200,000. + ~
100,000 +
Model: @hussmanip
Dota: Johns Hopkins CSSE
s2233 SEESEP ST RS EE SEPL RS SREP AERT
OC CeCeS ECE SEC ECCS CCS eee rere oe eee:
- =~ anm ee ae st “ ah a | . * oe TOMS
Projected U.S. fatalities (discrete-time SIR model with inferred containment parameter)
Prior baseline reflecting 10/12/20 epidemic trajectory
~—~-Actual U.S. fatalities
3. Cellular and molecular pathways of COVID-19 and potential points of therapeutic intervention (Hussman, 2020,

Frontiers in Pharmacology). Candidate therapeutics described in the paper include remdesivir, doxycycline, ivermectin,
dexamethasone, inhibitors of JAK1/2 and IL-6, as well as various prophylactics, but are investigational, not prescriptive.

4. Attachment: COVID19_RepurposedTherapeutics. Draft guidance (example) relating to repurposing of well-
tolerated, FDA-approved, pathway-informed therapeutics. Links to additional references are embedded in the PDF.

5. Attachment: Severe clinical worsening in COVID-19 and implications for antibody-based therapeutics. Currently
in review. Reflects recent edits (reordering of sections, additional headers).

6. Notes on Bell’s Palsy: Given that a high neutrophil-to-lymphocyte ratio (NLR) is a central feature of COVID-19
and also a correlate of Bell’s palsy (which also features disruptions of smell and taste), it is possible that NLR may be a
useful clinical marker in the evaluation of these cases. A few references in this regard: NLR 32364446, 33136021,
30545211; Spike protein induction of neutrophil/macrophage infiltration 16809289; Bell’s Palsy in association with
active COVID-19: 33159420, 32950319, 33006717, 33128540; Mitigation: NBK482290.

7. Pfizer mRNA vaccine: Cumulative incidence curve. Second dose administered after 3 weeks.


From: Woodcock, Janet [/O=EXCHANGELABS/OU=EXCHANGE ADMINISTRATIVE GROUP
(FYDIBOHF23SPDLT)/CN=RECIPIENTS/CN=7B0453354A9A42 7DBOA66A86C7A36F3D-JANET. WOODC]

Sent: 7/15/2021 10:10:30 AM
To: Karla [ Ch)
Subject: RE: [EXTERNAL] Thank You for Your Bold Move

Thank you for writing. We will look at all the evidence on ivermectin. Janet Woodcock

From: Karla < og

Sent: Thursday, July 15, 2021 9:31 AM

To: Woodcock, Janet <Janet.Woodcock@fda.hhs.gov>
Subject: [EXTERNAL] Thank You for Your Bold Move

CAUTION: This email originated from outside of the organization. Do not click links or open attachments unless you recognize the
sender and know the content is safe.

Dear Dr. Woodcock,

Thank you for your bold move in asking the independent Office of the Inspector General to investigate
how the FDA and representatives of Biogen interacted prior to the FDA’s approval of the company’s
Aduhelm (aducanumab) for Alzheimer’s disease.

| am writing to ask for your help, as the US is in need of another bold move. Currently, the FDA
recommends against the use of ivermectin to treat or prevent COVID-19
(https://Awww.fda.gov/consumers/consumer-updates/why-you-should-not-use-ivermectin-treat-or-
prevent-covid-19). This post also states, “The FDA has not reviewed data to support use of
ivermectin in COVID-19 patients to treat or to prevent COVID-19; however, some initial research is
underway.”

Dr. Woodcock, the data has been reviewed by the NIH which then upgraded its standing on
ivermectin from “not recommended” to “neutral.” The data has been reviewed through meta-analyses
by Dr. Tess Lawrie, a WHO independent research consultant, who then stated, “| independently
reviewed 27 studies presented by the Front Line COVID-19 Critical Care (FLCCC) alliance as
evidence of ivermectin’s effectiveness. The resulting evidence is consistent and

unequivocal. Ivermectin works well both in preventing COVID infections and in preventing deaths at
the same doses used to treat lice and other parasitic infections,”

(https://www. youtube.com/watch?v=M8RMBa1UfsE). The data has been reviewed through meta-
analysis by Dr. Andrew Hill from University of Liverpool, England, supported by The WHO Access to
COVID-19 Tools (ACT) Accelerator, who also found ivermectin produces large statistically significant
reductions in mortality, time to clinical recovery, and time to viral clearance

(https://www. youtube.com/watch?v=yOAh7GtvcOs).

Dr. Woodcock, | am asking you for another bold move. | am asking you to review the data presented
to the NIH January 6, 2021 (https://covid19criticalcare.com/wp-content/uploads/2021/01/FLCCC-
PressRelease-NIH-C19-Panel-FollowUp-Jan7-

2021.pdf https://Awww.youtube.com/watch?v=eeYoXGoh96w ). | am confident you too will find
ivermectin produces large statistically significant improvement in COVID-19 patients and that it would
be unconscionable to continue to withhold the FLCCC ivermectin protocols, as pediatric COVID-19
cases begin to surge, long-hauler COVID-19 cases continue to mount and COVID deaths are on the
rise.

| am asking you to immediately align the FDA position on ivermectin with that data.



the research and field experience of other nations that has already occurred with favipiravir,
ivermectin, and interferon gamma, the three therapeutics we would add to Dr Kim's list.

We do not mean to ignore drug categories other than antivirals, as those also may be important to
outpatient treatment. The COLCORONA study of colchicine is worth discussing for methodology,
execution, and result. There remains interest among clinicians in the uses of anticoagulants and
endothelial stabilizers like tissue plasminogen activator, defibrotide, and statins in treating COVID,
and we would all like to understand the latest forensics and research on the finding

of megakaryocytes in places other than bone marrow. Having said that, let's not fail to research
simpler solutions. Is it helpful to take aspirin and melatonin week 2? Until that's systematically
investigated, we won't know. Could such a study be incorporated into a multi-agent RCT? In this
instance, could matched pairing in the post-study analysis of an open label trial substitute for
randomization?

The common theme running through our commentary is outpatient COVID-19 therapeutics and the
role of the community based practitioner and pharmacist in addressing our current pandemic. Please
consider holding a follow-on summit with that focus.

Sincerely,

Binh Ngo, MD

Associate Professor

Keck Medical School of USC
Los Angeles, CA

Marc Rendell, MD

Medical Director

Rose Salter Medical Research Foundation
Newport Beach, CA

Paul E. Marik MD, FCCP, FCCM

Eastern Virginia Medical School
Department of Internal Medicine

Chief, Pulmonary and Critical Care Medicine
Norfolk, VA

Pierre Kory, MD, MPA

Pulmonary and Critical Care Medicine
Aurora St. Luke's Medical Center
Milwaukee, WI

Stephen Ditmore
Health Reporter
Parkchester Times
Bronx, NY

Saal Forwarded message ---------
From: Stephen Ditmore < >