FILED

MARY L. SWAIN
BUTLER COUNTY
CLERK OF COURTS
08/20/2021 03:30 PM
IN THE BUTLER COUNTY COMMON PLEAS COURT CV 2021 08 1206
CIVIL DIVISION

JULIE SMITH, as guardian ofJEFFREY SMITH,

3907 Charfield Lane
Hamilton, OH 45011
CASE NO.
Plaintiff,
vs
JUDGE:
WEST CHESTER HOSPITAL, LLC
DBA WEST CHESTER HOSPITAL
CIO GH&R Business Services, Inc.
312 Walnut Street, Suite 1800
Cincinnati, OH 45202

Defendant.

COMPLAINT FOR EMERGENCY MEDICAL DECLARATORY JUDGMENT

AND EMERGENCY INJUNCTIVE RELIEF
ORAL ARGUMENT REQUESTED

‘The Plaintiff,as Guardianof Jeffrey Smith,by and through undersigned counsel, states the
following for this Complaint for Emergency Medical Declaratory Judgment and Emergency
Injunctive Relief.
L_INTRODUCTION
1. Thisis a civil actionfor Emergency Declaratory and InjunctiveReliefbrought by
the Plaintiff, JULIE SMITH, whoisthe wife and guardian of, JEFFREY SMITH (“Jeffrey”); who
is currentlya patient in the Intensive Care Unit at West Chester Hospital, LLC, an Ohio nonprofit
limited liability company, dba West Chester Hospital, aka UC Health West Chester Hospital; and
1
who is diagnosed with COVID-19 and intubated.
2. Ms. Smith seeks a declaration that the Defendant honor her decision of treatment
as guardian pursuant to Dr. Fred Wagshul's medical order and prescription, requiring the
Defendant to administer Ivermectin to Jeffrey, and a declaration that the Defendant comply with
Dr. Wagshul’s medical orders for further prescriptions for Jeffrey in his battle with Covid-19.
3. Ms. Smith additionally seeks an order for such other,further and different reliefas
the Court deems just, equitable and proper.
IL_JURISDICTION AND VENUE
4. This Court has personal jurisdiction over the Defendant in that Defendant resides
and/or transacts or transacted business in the State ofOhio and in Butler County.
5. Venue is proper in this Court pursuant to Ohio Civ.R. 3(C)(3) in that substantially
allof the events that give riseto the claims in this action occurred in Butler County.
6. Ms. Smithis not secking monetary or compensatory damages ashercauseofaction
simply relates to the enforcement of her guardianship decision ofa reasonable courseoftreatment
for Jeffrey and the enforcement of his physician’s order and prescription; this Court has subject
matterjurisdiction over this matter and the partis.
LIL._PARTIES
7. The Plaintiff Julie Smith, isa citizenofthe Unites States of America, a resident of
the StateofOhio, is over the age of 18, and is a resident of Butler County; Ms. Smith is her
husband's, Jeffrey Smith's, guardian, and therefore has standing to bring this Complaint
8. The Defendant is a non-profit limited liability company in good standing and duly
registered with the Ohio Secretaryof State with an address of7700 University Drive, West Chester
2
Township, OH 45069.
9. The Defendant is the physical hospital where Jeffcy is a patient in the Intensive Care
Unit, diagnosed with COVID-19, breathing only with the assistance of a ventilator.
LV.
STATEMENT
OFFACTS
10. On July 9, 2021, Jeffrey tested positive for Covid-19.
11. On July 15, 2021, after excessively coughing and his oxygen stration dropping
dangerously Tow, Jeffrey was admitted to the Defendants hospital.
12. That same day, he was moved into the ICU and placed on a nasal cannula during the day
and a BIPAP at ight.
13. The Defendant treated Jeffrey with its Covid-19 protocol, which consistedofRemdesivir,
plasma, and steroids.
14. On July 27, 2021, and after a period of relative stability, Jeffrey's condition began to
decline; his oxygen level was dropping and he was unstable.
15. From July 26, 2021 through July 31, 2021, the Defendant proned Jeffry all night and
flipped him t0 his back during the day.
16. Jeffrey's condition continued to decline.
17. On August 1,2021, Jeffrey was sedated, intubated, and placed ona ventilator.
18. On August 3,2021, there was a Code Blue: theDefendantallowed the sedation drug to
completely run ou, causing Jeffrey to awaken, rip the air tbe out of his esophagus, disturbing andlor
breaking the feeding tube, which caused food particles and toxins to escape into his lungs; this caused him
to aspirate.
19. After the Code Blue, Jeffrey suffered infection afer infection and continues to suffer from
infections as a result of the aspiration.
20. Asof Augast 19,2021,the ventilator is at 80%, and he is suffering fromanotherinfection.
3
 21. Asa SI year old male, on a ventilator, Jeffreys chancesof survival have dropped to less
than 30%
22. Authis point, the Defendant has exhausted ts courseoftreatment and COVID- 19 protocol
in treating Jeffrey, which is unacceptable to Ms. Smith,
23 Ms. Smith investigated other formsoftreatmentfor COVID- 19.
24. Ms. Smith requested that the Defendant administer Ivermectin pursuant to its dosage
schedule.
25. The Defendant refused to administer Ivermectin despite its minimal downside and side
effects.
26. Ms. Smith offered to sign a release, releasing the Defendant, ts agents, assigns, any third
parties acting on ts behalf, and any doctors acting on its behalf, rom any and all lability in administering
the Ivermectin to her husband.
27. Despite the aforementioned, the Defendant refused and is unwilling to administer the
Ivermectin to Jeffrey.
28. As of August 19, 2021, Jeffrey has been on a ventilator for 19 days; he is on death's
doorstep; there isno furtherCOVID-19 treatment protocol for the Defendant to offer to Jeffrey; Ms. Smith
docs not want to sce her husband dic, and she is doing everything she can to give him a chance.
20. Ms. Smith sought the medical adviceofDr. Waghsul with regard to her husband's prior
medical history, current medical condition, and the usage of Ivermectin in treating Covid-19 and its afier
effects.
30. Dr. Wagshulis oneof theforemostexpertson using Ivermectin in treating Covid-19and a
founding member of the Frontline Covid-19 Critical Care Alliance; he supports the use of Ivermectin to
treat Jeffrey, and prescribed Ivermectin to him.
31. The Defendant refuses comply with Dr. Wagshul's medical order and prescription to
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administer Ivermectin to Jel.
32. Ms. Smithsecks adeclaratoryjudgment declaring that theDefendantfollow Dr. Wagshul's
order and prescription o administer Ivermectintothir mutual patient, JefTrey Smith; and adeclaration that
the Defendant comply with the guardian's reasonable wishes and directives for her husband. Ms. Smith
has no other option but to bring the instant declaratoryjudgment civil action.

V._CAUSE OF ACTION
As and for a CauseofAction Against the Defendant,
Ms. Smith alleges as follows:
33. Repeats and realloges cach and every allegation previously made as ifrestated herein.
34. Ms. Smith is the lgal guardianofher husband, Jeffry Smith.
35. Jeffrey is patient a the Defendants hospital with very litle chanceofsurvival,
36. Jeffrey has been diagnosed with COVID-19 and s currently in the Intensive Care Unit at
the Defendant's hospital; he s only breathing with the assistance ofa vnilator.
37. Despite requesting that the Defendant administer Ivermectin to Jeffrey, and despite Dr.
Wagshul's order and prescription, the Defendant hs refused andi unwilling to do so.
38. Despite Ms. Smith's offer 0 signa ull release, releasing and relieving the Defendant from
any and all lability concerning the administrationof Ivermectin to herhusband, the Defendant has refused
and is unwilling to do so.
39. Despite the Defendant exhausting its Covid-19 protocol with nothing lef to treat Jeffrey,
the Defendant refuses to administer Ivermectin to Jefliey based on upon Dr. Wagshul's order and
prescription
40. Asa result of the Defendants refusal to administer Ivermesin to JefTey pusuant 0 Dr.
Wagshul' order and prescription, Jefe, through Ms. Smith, has been damaged.
 41. Ms. Smith docs not have anadequateremedy at law toenforce her guardianshipwishes for
er husband and Dr. Wagshul's order and prescription.
42. Ms. Smith has not made any prior applications fortherelief requested herein.
43. Itis Ms. Smith'sbelief that she has made out a cause of ation for declaratory judgment.
VL._RELIEF SOUGHT
Based on the facts and the law, Ms. Smith is entitled to a declaratory judgment from this
Court (A) declaring and enforcing her guardianship decision for reasonable treatment for her
husband; and (B) declaring and enforcing Dr. Wagshuls order and prescription to administer
Ivermectin to Jeffrey Smith.
Ms. Smith respectfully requests that this Court enter an orderdeclaring that the Defendant
comply with (1) her reasonable requests as Jeffrey's guardian; and (2) Dr. Wagshul’s order and
prescription to administer Ivermectin to Jeffrey Smith.

WHEREFORE, Ms. Smith respectfully requests that this Court Order the following:
(A) Enter a judgment in favor of Ms. Smith on the Complaint in ts entirety and
against the Defendant;
(B) Entera judgment in favor of Ms. Smith, declaring that the Defendant comply
with Dr. Wagshul’s order and prescriptiontoadminister Ivermectin to their Joffrey Smith;
(C) Award Ms. Smith all relief allowed by law and equity, including, but not
limited to, declaratory, preliminary and permanent injunctive relief; and
(D) Ajudgment granting Ms. Smith such other, further and differentrelief that the
Court deemsjust, equitable and proper.

6
 Respectfully submitted,
1s Jonathan Davidson, Esq
Jonathan E. Davidson
Davidson Law Office Co, LPA
25. Third St., Suite 301
Hamilton, Ohio, 45011
(513) 868-7100
513-330-6969 (fax)
jdavidson@davidsonlaw.org
18 Jeffrey G. Stagnaro, Esq.
Jeffrey G. Stagnaro
Sharon J. Sobers
STAGNARO, SABA
& PATTERSON CO, LPA.
7373 Beechmont Avenue
Cincinnati, Ohio 45230
(513) 533-2981
(513) 533-2999
jgs@sspfirm.com
and
/s/ Ralph C. Lorigo, Esq.
Ralph C. Lorigo, Esq. (Pro Hac Vice Pending)
LAW OFFICE OF RALPH C. LORIGO
101 Slade Avenue
West Seneca, NY 14224
(716) 824-7200
Horigo@lorigo.com
Counselfor Plaintiff
Julie Smith, GuardianofJeffrey Smith

CERTIFICATE
OF SERVICE

‘The undersigned hereby certifies that on this dayof August, 2021, a copyof the foregoing
was filed with the Clerkof Courts by using the ECF System, which will senda noticeofelectronic
filing to all parties indicated on the electronic filing receipt, pursuant to Civ.R. S(B)2XD. All
other parties will be served by regular US Mail, postage prepaid pursuant to Civ.R. S(B)2)(0):
West Chester Hospital, LLC
dba West Chester Hospital
7700 University Drive
West Chester Township, OH 45069
C/O Registered Agent
GH&R Business Services, Inc.
312 Walnut Street
Suite 1300
Cincinnati, Ohio 45202

/s/ Jonathan Davidson, Esq

‘AttomeyforJulic Smith
Supreme Court No.: 0090093
and
[s/ Ralph C. Lorigo, Esq,
Ralph C. Lorigo, Esq. (Pro Hac Vice Pending)
Counselfor Plaintiff

s
 IN THE BUTLER COUNTY COMMON PLEAS COURT
CIVIL DIVISION
JULIE SMITH, as guardian of :
JEFFREY SMITH, :
CASE NO.
Plainift,
vs :
: JUDGE:
WEST CHESTER HOSPITAL, LLC ©
DBA WEST CHESTER HOSPITAL
Defendant. :

AFFIDAVIT OF JULIE SMITH IN SUPPORT OF HER MOTION SEEKING

EMERGENCY AND INJUCTIVE RELIEF

Julie Smith, having first been duly sworn, deposes and says as follows:
I. Tam the guardian of my husband, effrey Smith; this action is brought on his behalf
in my capacity a his guardian; attached hereto as Exhibit “A” is the Order, appointing me guardian
over my husband, Jeffey Smith.
2 Lam fully familiar with al of the facts and circumstances of this Motion; my
knowledge is based upon (A) my personal knowledges (B) my authority as guardian of my
husband; and (C) my review ofthe documents relevant to this Motion.
3. Imake this Affidavit in support of my Motion sccking an Order, compelling West
Chester Hospital, LLC, dba West Chester Hospital, its agents, assigns, or any third party acting on
its behalfocomplywith my husband's physician'sorder and prescription to administer vermeetin
to him
4. Forthe reasons set forth hecin, it i respectfully submitted that this Motion should

1
be granted in its entirety.
5. Jeffrey and I have been married for 24 years.
6. HeisaS1 year old healthy family man; he isa Verizon Wireless Network Engineer.
7. Jeffrey and I have thre children; he loves his children more than anything,
8. He enjoys fishing, hiking, and camping with our family.
9. He participates in Trail Life with our son
10. Hes faithful and loyal to a fault
11. Family is his everything; attached as Exhibit “B” is a recent picture of Jeffrey
before being admittedtothe Defendant’s hospital.
12. OnJuly 9, 2021, Jeffrey tested positive for Covid-19.
13. OnJuly 15, 2021, after excessively coughing and his oxygen saturation dropping
dangerously low, Jeffrey was admitted to the Defendant's hospital,
14. That same day, he was moved into the ICU and placed on a nasal cannula during
the day and a BIPAP at night.
15. The Defendant treated Jeffrey with their Covid-19 protocol, which consisted of
Remdesivir, plasma, and steroids.
16. On July 27,2021, and aftera periodofrelative stability, Jeffrey’s condition began
to decline; his oxygen level was dropping and was unstable.
17. From July 28, 2021 through July 31, 2021, the Defendant proned Jeffrey all night
and flipped him to his back during the day.
18. Jeffrey's condition continued to decline.
19. On August 1, 2021, Jeffrey was sedated, intubated, and placed on a ventilator.
20. On August 3, 2021, there was a Code Blue: the Defendant failed to refill the

2
sedation drug and it completely depleted, causing Jeffrey to awaken, rip the air tube out of his
esophagus, disturb and/or break the feeding tube, which caused food particles and toxins to escape
into his lungs; this caused him to aspirate.
21. After the Code Blue, Jefliey suffered infection after infection and continues to
suffer from infections asa result of the aspiration.
22. As of August 19, 2021, the ventilator continues to hover at or about §0%, and he
continues to suffer from infections.
23. Since August 1, 2021 and now for 19 days, Jeffrey has been on a ventilator in a
medically induced coma, aspirated, and suffered from numerous infections; he continues to suffer
and decline.
24. The Defendant has exhausted their Covid-19 treatment protocol; in other words,
the Defendant has nofurthertreatment options for Jeffrey, and his situation is truly “wait and sec”.
25. Asa 51 year old male placed on a ventilator, Jeffrey's chancesof survival have
dropped to less than 30%.
26. At this point, there is nothing more the Defendant can do, or will do, for my
husband.
27. However, Icannot give up on him, evenif the Defendant has. There is no reason
‘why the Defendant cannot approve or authorize other formsoftreatment so long as the benefits
outweigh the risks.
28. Running outofoptions, I began researching other Covid-19 treatment options.
29. Inmy research, I came across an article in the Chicago Tribunc about a woman who
was 68 years old, Covid-19 positive, in the ICU, and on a ventilator; like my husband, she was on
death's doorstep. (Exhibit “C”)

3
 30. After being admitted to Elmhurst Hospital for Covid-19, Ms. Nurije’s condition
rapidly, and consistently deteriorated. (Exhibit “C).
31. Like myself, Ms. Nurije’s daughter would not accept her mother’s fate by the
hospital's refusal to seekother treatment options,
32. Her mother’s primary care physician agreed to prescribe Ivermectin, and Ms.
Nurije’s daughter offered to sign a release and waiver, relinquishing the hospital of any liability.
Yet they adamantly refused to administer Ivermectin to Ms. Nurije. (Exhibit “D”),
33. Ms. Nurije’s daughter then obtained an Order from DuPage County Judge James
D. Orel, enforcing Dr. Crevier's order to administer Ivermectin to Ms. Nurije. (Exhibit “E”).
34. After Ms. Nurije was administered her first dose of Ivermectin, the ventilator was
reduced from 75% to 65%; this was the first sign of improvement in Ms. Nurije’s condition since
she was admitted over twenty days prior. (Exhibit “F)
35. Ms. Nurije is now outof the hospital and home.
36. Elmhurst Hospital appealed Judge Orel’s Order and the Appellate Court recently
dismissed the appeal in its entirety, but more importantly, upheld Judge Orel’s original order.
37. Talso came across an article in the Buffalo News about a woman who was 80 years
old, Covid-19 positive, in the ICU, and on a ventilator; like my husband, she was on death's
doorstep. (Exhibit “G),
38. Her children convinced the ICU doctor to administer Ivermectin as a Hail Mary
attempt to save her life; within 48 hours after the first dosage, she was transferred out of the ICU
and takenoff the ventilator. (Exhibit “G”).
39. However, once on the general Covid-19 floor and with different doctors, they
refused to continue with the remaining dosesofIvermectin; the family ended up obtaining a Court

a
Order from a New York State Supreme Court Justice, enforcing the primary care physician's order
to continue the doses of Ivermectin, and within two weeks, she was released from the hospital.
(Exhibit “G).
40. New York State Supreme Court Justice Henry Nowak’s Order is attached hereto as
Exhibit “H".
41. Talso discovered the story of Glenna Dickinson. (Exhibit “I”).
42. Ms. Dickinson's story is similar to so many suffering from Covid-19; she was
placed in the ICU and on a ventilator; she was on death's doorstep. (Exhibit “I").
43. Ms. Dickinson's physician prescribed Ivermectin for her, but Rochester General
Hospital refused to administrate it. (Exhibit I").
44. The family obtained an Order from Supreme Court Justice Frank Caruso, Ordering
Rochester General to comply with the physician's order and administer Ivermectin. (Exhibit “).
45. 1 continued to research Ivermectin, its use, and effect in treating Covid-19.
46. Myrescarch led me to the Front Line Covid-19 Critical Care Alliance (“FLCCC),
which is headed by Doctor Pierre Kory, a lung and ICU specialist
47. On December 8, 2020, Dr. Kory testified before Congress regarding his findings
on the use and success of Ivermectin in treating Covid-19, which can be found at
hitps://vimeo.com/490351508. (Exhibit “K”).
48. Myrescarch also led me to the latest attached medical articles and studies regarding
Ivermectin. (Exhibit “L").
49. The Broward County Study attached in Exhibit “L” is study of morc than 200
Severe Covid-19 patients, like my husband; in that study, of those who did not receive Ivermectin,
80% died;ofthose that received Ivermectin, only 30% died. (Exhibit “L).

5
 50. After conducting all of the research, I requested, numerous times, that the
Defendant, give my husband a chance and prescribe him Ivermectin.
51. The doctors and administration at the Defendant's hospital refused.
52. offered to sign a release and waiver, relinquishing the Defendantof any liability
ifit administered Ivermectin to my husband; however, the doctors and administration refused.
53. My husband's physician, Dr. Fred Wagshul, MD, a pulmonologist, and expert on
using Ivermectin in treating Covid-19, prescribed Ivermectin for my husband; the prescription is
attached hereto as Exhibit “M”; however, the Defendant will not administer it to my husband.
54. Dr. Wagshul is aware of my husband's past and current medical condition; Dr.
Wagshul would not prescribe Ivermectin ifhe believed it was unsafe.
55. As set forth in the attached Exhibits, Ivermectin has little to no downside.
56. My husband is on death's doorstep; he has no other options.
57. With absolutely nothing to lose, with litle to no risk, and with the Defendant likely
to begin palliative care, there is no basis for it to refuse Dr. Wagshul’s order and prescription to
administer Ivermectin to their mutual patient.
58. tis respectfully submitted that this Court give my husband a fighting chance.
59. tis further respectfully submitted that this Court enforce Dr. Wagshul’s order and
prescription to administer Ivermectin to my husband.
60. Its further respectfully submitted that this Court grant this Motion in its entirety.
61. Forall of the foregoing reasons, it is respectfully requested that the Court enter an
Order as follows:
A. An order compelling the Defendant and/or its agents to comply Dr.
Wagshul’s order and prescription to administer Ivermectin to my husband, their mutual patient;

6
 B. An order granting me such other, further and differentrelief that the Court
deemsus, equitable and proper.

JULIE Jus

Subscribed and sworn to before

meonthis Ap

Notary
Pyblic
SA ome ou
SU, alse
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7
EXHIBIT “A”
 =
FILED
20 AUG 19 PH I:
PROBATE COURT OF BUTLER COUNTY, OHIO 3
IN THE MATTER OF GUARDIANSHIP OF Jeffrey D. Smith Be
JUDGE JOHN ¥. FLCOMB
Case No. pG2108.0120 - -
EMERGENCY
LETTERS OF GUARDIANSHIP
wan Re. 2111.02
aren Julie Smith is appointed Guardian of
Jeffrey D. Smith 2a [X]incompetent [Jinor.
Guardianspowessare
A powers confer by the es of Oni an les of tis Court ver th wa’:
[reson ns cane [Kresonony [1]ese0nty
timited to. authorizeorapprove theprovisionfothewardofmedical,health.orother

otherwise.

Those uardansip powers, unt reve, re eran:

[5X] ntti time pris
[J oetinte time pero to
a scred.
The above-named Guardian hsth power cofard by lawto 0 and arom al ha duties of Guardian
Ho expenditures sai be a tout por Court authorization. /

NOTICE TO FINANCIAL INSTITUTIONS

Funds being hid in te nam of the within-ramed Ward shall nt b eeased 1 Guarlan without a Cout iter
lvecing lessof spcic fund and amounts terol.
CERTIFICATE OF APPOINTMENT AND INCUMBENCY
Tho abovs document is re copy ofthe gin! Keptbyme 3s custodianof is out. consuls th appinment
30 eters of author of th named guardian, who squalid and nn

0 0
Sean

FORM 15.4 LETTERS OF GUARDIANSHIP. FoF azn

EXHIBIT “B”
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EXHIBIT “C”
ann oecotcdo,EnsHosp sys long COI13pnbcontoversll vg ormoc-Chicagorun

After court order, Elmhurst Hospital says it’s allowing COVID-19

‘patientot receive controversial drug ivermectin
CeoB mons |Hy 4 201
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Shellman @chicagotribune.com.
EXHIBIT “D”
ana El Hosp
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DuPage Countyjudge orders Elmhurst Hospital to allow COVID-19

patient to receive controversial medication
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DugCounty dg on Monday orderedHimbstHosp to allow comatosefightwoman sf fom COVID-19 fo ecive

veeation th FoodandDragAdmit rationsayscon beunsafe,but hele appeszs bondto ccalt.
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ormallyvedto treat disease caved bypars worms.
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wort uPagoCounty gaodor GmaretHosp 1 lwCOVID-10patlnt 1 eceveconkoversialmecicaton -GogoTune
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thismedic ng
ation?Xf
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sohasbeeni he1CU foramonthand not impwhywoul ing
rovdthehospi talnotc ons ide
anotherm edicatio r
n?”
twastl notclear, however, whetherthehospitalwold alowFypeto rec eiv
themedic e Ozel sidheexpected
ation, the caseto
endto an appellate court, and whenheasked Monahan thehospi ofollowhisorder, the attorney replied, “Lill
wasgoingtal
tlktomy client”

AalautHospital spokesman declinedto commThepartie ent.s ardu e ourtTuesday.

fo returntoc
Likeoh purportedCOVID-19 treatmentsthathavenotgottengovecnment approval, iverme hasbeenmb cti n
rofledfn
controversy. Oneofits leadingproponents, Dr.PieceKory, aplmonary and etcalcaespecia testifiedinfavorofthe drug:
ls,
beforoa U.S. Senatecommitteelstyear,bt heseid Youlelatertackdowthe videoin whichhe madehis statement ,calling
itmedical misinformation.
Thatbrought achargeof ensarshi p onJohnson, aWisconsinRepublicanwhois onthe panel.YouTubedidnot
fromSen.R
respond to zequ est
orcommen t.
medicalournalalso xected a paperKoryco-wrote withfellowmembersofagroupcalledthe FrontLinentai COVID-19Critical
CaroAlliance, whichadvocatesfocthemedication,Thejournal'schief exec utiv
editorsa e paperco “aserieso
id he nedf
tong, unsupportedclaimsbasedonstudieswithinsufficientstatistical signfcae.”

othejournal latespublishedthe pape,tough,andKorysid iverme hnsprovecti n. Hehasrestedupward of

nitsworth
200COVID-19 patents iththedrugandseen “dramatic” resul ts, ndeolle
hosad, agn
aroundt es
heworldh avereportedsslax
finds.
‘Hosid govagenciest ern men
hatdoita tdrug's us againetCOVID19 arenotkeeping
pprovethe up withthe data.The data
havedonenothingbutdeepenandbecome more consistent.”
“The EDAdid notrespontotheTribune's requestforcommentbyprestime.
Clea tal involving themedication axeunderway, ndfn custpapers,thehospitalsadthejudge's decisiontoordertheuse
ofvermectinwas "houiedand wfaie”andshould have itedforevidencetobeprese nted.Bot Orelsaid givenFype'scondition,
isdecis ospeedy.
hadtobion
“161waitforan evdentioryhearing, shemightnotbearoun d”
hesad.
Jkeilman@chicagatribune.com
Twitter @JohnKeilian
EXHIBIT “E”
 WP00542.33
GUARDIANSHIP ORDER
TH GRUB COUTOF HERIGHTTOPICALCREE STATUS OF, ‘COUNTY OF DU PAGE
STATEOFILLINOIS

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EXHIBIT “F”
anne O13 trov og echoing glbtw xl
tsce
Water

COVID-19 patient shows improvement” after

receiving ivermectin following legal battle with
hospital
ay rtony Ponce | Pulsediy 4 | Coronas lag |FOK32Chg
COI-1patientshows improvement afer racing ermectin folowing court order to
After a short but tense legal battle, Edward-Elmhurst Hospital has agreed
one of its COVID-19
allow an outside doctor to administer ivermectin to
patients.

rd-Elmhurst Hospital
ELMHURST -After a short but tense legal battle, Edwa
in to one of its
has agreed to allow an outside doctor to administer ivermect
CovID-19,patients.

all 1 can tell right

“She looks calm, relaxed, she looks comfortable, so this is
e
now," said Desi Fype, who has been fighting for her mother, 68-year-old Nurij
not been FDA-
Fype, to receive ivermectin -- an anti-parasitic drug which has
approved to treat COVID.

spss
6 recipes rich in vitamin C
apes

DOWNLOAD THE FOX32 NEWS APP

Since Nurije was placed on a ventilator April 28th, and with her condition not
w the
improving, Desi has been fighting for Edward-Elmhurst Hospital to allo
drug to be used.
real COVID-10plotshows prema fr ecg mein olla aglow hosp
“At the point of me having nothing else to lose, and seeing that no other
treatment in the hospital was making her any better, | wanted to try
something different. Why not try to save her life Instead of seeing her
decline?" Desi said.

Whille ivermectin isn't FDA-approved, some doctors say it's proved to be

effective against COVID. Despite a judge's orders, the hospital had been
ed to let an
refusing to administer the drug until Monday night, when it agre
outside doctor give Nurije her first dose.

“was really really excited and hopeful to have this drug administered to my
hospital, her
mom as well, because from the day that she was admitted to the
condition kept only declining" Desi said.

"Today, after her first dose, the ventilator has been reduced from 75 percent
to 65 percent,” said Fype family attorney Ralph Lorigo. "That's an
improvement. Now she will get a dose of ivermectin every day until recovery.”

e's treatment,
Edward-Elmhurst Hospital has declined to comment on Nurij
citing privacy regulations.

himotrsmay otbepublished,broadest,reten,orreditbuted, G2021 FOX TeledsionStations

EXHIBIT “G”
 ose, wit sco LolNews| kre.om
rtoranzt © rod ais bsp fos pal C1

1h 7 ¢
o : Eo Gil! gE
bi rm k
LG #
i i
ie OR
fl) AI
{ pa 11
+ m

a CEdid
ase
N
[Es SR
TaLH ARE RRNA
SR ie GENER TW
FE SC vw Er
n a 20%
Judith Smentkiewicz, 80, of , was give
an ce of su rviv in g Co vi d- 19 wh en she was on d
ch
nt il at or at Mi ll ar d Fill io re Su burban Hospital,
ve
according to her children.
ly
Provided by Judith Smentkiewicz's fami

Dan Herbeck

Ep
 — — —
pa p
o r d e r e d M il l a r d F i l l m o r e
judge
b a n H o s p i t al la st w e e k to
Subur
ve a C ov i d - 1 9 p a t i e n t an
A gi
a l tr e a t m e nt , a n d h e r f a m ily
experiment
ey s s a y t h e y b e l i e v e t h a t
and attorn
. saved 80-year-old Judith
Smentkiewicz's life.

m e c t i n — a pi ll s o m e t i m e s
The drug Iver
t c h i l d r en w i t h h e a d li ce or
used to tr ea
d ca ts o f w o r m s — is n o t
to rid dogs an
e t a p p r o v e d b y t h e f e d eral
y
f o r u s e a g a i n s t C o v i d -
government
n and,
19. But Smentkiewicz's so
ll it “ a m i r a c l e d r u g ” i n th eir
daughter ca
court papers.
 ot 51
ofR sk wT
Ahoy tig cml sibleO

o he r attorney s, R a l p h C. Lo ri go
So d
and Jon F. Minear.

dy w a s o n a ve nt ilat or ,l it er al ly
“This la
de at hb ed , be fo re sh e w a s gi ven
on he r
is dr ug ,” Lo vi go to ld T h eB uf f alo
th
News about Smentkiewicz, a
aga re si de nt . “A s far as we 'r e
Cheektow
er ne d, th e ju dg e' s orde r save d this
conc
© woman'slife.”

go sa id o n e do ct or at th e ho sp it al
Lori
lo we d th e pa ti en t to b e gi ve n th e drug,
al
af te r sh e h a d b ee n gi ve n o n ed o se,
but
r do ct or at th e ho sp it al refused
anothe
lo w fu rt he r do se s. H e sa id fa mi ly
10 al
 e m
mt i
si ero
gn
b ers w e n t to co urt to fo rc e the
me m
th
hospital to resume treatmentwi
. Stat e S u p r e m e C o u r t J u d g e
Ivermectin
hem.
Henry A. Nowak sided with t

the
Dr. Thomas A. Russo, one of
gi on ’s le ad in g ex pe rt s o n infectious
re
es , said h e w a s gl ad to h e a r that
diseas
w i c z is d oi ng be tt er , b u t he
Smentkie
to
said people should never jump
lu si on s a b o u t Iv er me ct in or any
co nc
ts
other drug based on one patien
outcome.
 Co 0k wr aro ri.
hanat ii solos
this
“There are some indications that
a y ha ve s o m e me ri t in tr ea ti ng
drug m
vi d- 19 ... Ye s, it is po ss ib le th at it
Co
ut
helped this woman,” Russo said. “B
tr ia ls a n d te st in g are on going. W e
{he
show it
don’t have definitive data yet to
does help. Presently, it is not
vid- ~
recommended as a treatment for Co
19.”

ases
Russo is the chief of infectiousdise
e Un iv er si ty at Bu ff al o' s Ja co bs
at th
al
School of Medicine and Biomedic
nc es . H e ha s no involv ement in the
Scie
Smentkiewicz case.
 estvaso un BL
rig rd iil rp
Amst *

The patient’s son, Michael

c z , s a i d h o s p i t a l of fi ci al s
Smentkiewi
d h i m a n d hi s si st er ,M i c h e lle
had to l
n D e e . 3 1 t h a t th ei r m o t h e r ’s
Kulbacki, o
f su rv iv al — as a n 8 0 - y e a r -old
- chance o
19 p a t i e n t o n a ve nt il at or — was
Covid -
about 20%.

r s at t h e h o s pi t a l al so to ld
He said docto
y t h a t Sm en t k i e w i c z w o u ld
the farnil
b l y b e o n a ve nt il at or i n t h e
proba
Ca r e U n it fo r a t l e as t a mo n th.
Tntensive

d i d a lo t o f o u r o w n re s ea r ch, we
} “We
u t I v e rm e c t i n ... T h e re su lts
read abo
ou n d e d v er y p r o m i s i n g , a n d we
s
 oe 0 snvc as cto | LE
ore loi pe
Aernd *

c id e d w e h a d t o tr y s o m e thing
de
h a e l S m e n t k ie w i c z sa id .
different,” Mic
r e d t h e d o ct o r i n t h e I C U to
“We press u
t o he r. H e fi na ll y a g r e e d . ”
give it

m e n t k i e w i c z w a s g i v e n h er
On Jan. 2, S
e of I v e r m e c t i n , a n d a cc o rding
first dos
e r s fi le d b y e r fa mi ly , s he
to court pap
d e “ a c o m p l e t e t u r n a r o u nd.”
ma

4 8 ho u r s , m y m o t h e r w as
“In less than
t he ve nt il at or , t r an s f er r ed out
taken off
i v e C a r e U n i t , si tt in g u p on
of the Intens
a n d c o m m u n i c a t i n g , ” K u lbacki
her own
i
said in a courtaffidavit.

et tn WY
 —————
nee
r mo th e r w a s t r a n s f e rred to
But after he
w i n g a w a y f r o m t h e
another hospital
i n t h a t u n i t r e f u s e d to give
ICU, doctors
s o f t h e d r u g , a n d he r
her any more dose
kl y d e c l i n e d , t h e f a mi ly
condition quic
said in court papers.

u n d e d w h e n t he y r e f used
«we were asto
a n y m o r e d o s e s , ” M ichael
to give her
s a i d . “ T h a t ' s w h y I c alled
Smentkiewicz
o a n d w e t o o k t h eh o s pital
Ralph Lorig
to court.”

rt L o c al Jo ur na l i s m
Suppo
on m a k e s ou r r e p o rt i n g possible.
Your subscripti
 cont
Loot Nw Bf.
gio udashosp 1 vodpa Con AD smart wornan sco
Aigner"

a lei d a He al th , w h i c h o p e r a t es the
K
, op p o s e d t h e fa mi ly ’s r eq u est
hospital
ur t. L o r i g o sa id Ka le ida at t orney
in co
Judge
Michael J. Roach argued to
k th at d o c t o r s — a n d n ot the
Nowa
s h ou ld b e m a ki n g decisions
courts —
about medical care.

8, N o w a k o r d e r e d t heh o s p i tal
On Jan.
m m e d i a t el y a d m i n i s t e r t h e d rug
to “i
c t i n ” to S m e n t k i e w i c z , c o u rt
Tverme
papers show.
 e t l s no i
int”
e j u d g e al so to ld u s ve rb al ly that
«But th
th ’s f a m i l y d o c t o r w o u l d h a v e to
Judi
es cr ip ti on fo r Tv er me ct in ,
write a pr
L or i g o sa id . “ I n 4 6 y e a r s
which he did,”
ey , I' ve n e v e r s e e n a n o t h e r
as an attorn
e r e a fa mi ly h a d to ge t a c o urt
case wh
n t in u e a t re at m e n t t h a t had
order to co
b e e n st ar te d b y a ho spit al .”
. already

a e l P. H u g h e s , s p o ke s m an and
Mic h
st aff fo r K a l ei d a H e a l t h , s aid
chief of
he al t h c a re c o m p a n y is " a ware of
the
ly ’s po si ti on ," b u t h e d e c lined
this fami
sc us s de ta il s b e c a u s e o f fe deral
to di
y l a w s a n d b e c a u s e t h e c a s e has
privac
become "a legal matter."
 t e r wo
Fa.
h o s p i t al a t t o rn e y , d e c l i ned
Roach, the
n t , te ll in g a r e p o r t e r t o call
to comme
Hughes.

e n t k i e w i c z s a i d T h u r s day
Michael S m
m o t he r ’ s c o n d it i o n h a s
that his
g a i n s i n c e t h e I v e r m e ct in
fmproved a
{reatments resumed.

e ( W e d n e s d a y ) n i g h t . H er
«ghe called m
, b u t it w a s s o e x c i t i n g to
voice was raspy
c e, ” h e s a i d . “ S h e is s i t t i n g
hear her voi
d . Sh e ' s o f f t h e v en t il a t o r, but
up in be
c an u l a i n h er no s e, p roviding
she has a
supplemental oxygen.”
 p s C e a
pr e
d d e d t h a t a d o c t o r f r o m the
Tle a
l d h i m T h u r s d a y t h a t his
"hospital t o
r s t o h a v e " t u r n e d t h e
mother appea
h e r f i g h t a g ai n st t h e v i rus.
corner” in

S m e n tk i e wi c z s a i d h e also
Michael
p o w e r o f p r a y e r h e l p ed his
helieves the
mother.

b e e n ab l e t o s e e he r s ince
“We have no t
t ake n to t h e h o sp it a l b y
she was
n D e c e m b er 2 9 , a n d that
ambulance o
rd o n al l o f us,” he said.
ha s b e e n h a
l e w i n f r om al l o v e r t h e
“Family f
h e r e . O n N e w Y ea r ' s Eve,
country to be
h t of u s he l d a litt le p r a yer
about ei g
 p C ne a i e
pr e
h e r , ou t i n t h e h o s pi t al
service for
n t h o u g h w e c o u l dn ' t b e
parking lot. Eve
fe lt t h a t it wa s i m po rt ant
with her, we
e r ty , p r a y i n g f o r h e r. ”
© tobe on that prop

c t i n has s om e p a s s i o n a te
Iverme
s i n t h e m e d i c a l fi el d, b ut the
supporter
r u g A d m i n i s t r a t i o n s ays
U.S. Food & D
e t h e e n a p p r o v e d f o r
the drug has noty
t h i s c o u n t r y a s aC o v i d-19
use in
treatment.

t h e re ar e a p p r o v e d u ses for
“While
o p le a n d a n i m al s, it is
Tvermectin in pe
p p r o v ed fo r t h e p r e v e ntion or
not a
t of C o v i d - 1 9 , ” t h e f e d er al
treatme n
 }
a” ————y
s o n it s w e b s i t e . “ Y o u s hould
agency say
a ny m e d i c i n e t o t r e a t o r
not take
v i d - 1 9 u n l e s s it h a s b e e n
prevent Co
o u b y y o u r h e a l t h c a r e
prescribed to y
a c q u ir e d f r o m a l e g i t i mate
provider and
d di ti o n a l t e s t i n g is n e e d ed to
source ... A
th e r T y e r m e c t i n m ig h t be
determine whe
r o p r i a t e to pr e ve n t ort reat
ap p
.”
coronavirus orCovid-19

t o r s fe el t h e g o v e r n m e n t
Some doc
m o v e m u c h m o r e q u i c k ly to
should
er m e c t i n as a t r e a t m en t for
approve v
h a s k i l l e d n e a r l y 4 00 ,0 00
the virus that
Americans.
 i n e gl Co no n r s eu be
pr e
Dr. Pierre Kory, who heads an
so ci at io n of crit ic al ca re do ct ors,
as
fo re Co ng re ss in D e c e mb er,
testified be
fe de ra l ag en ci es to pr ev en t
asking
pits
needless deaths" by speeding u
g a n d rese ar ch o n Ivermect in .
testin

en tk ie wi cz 's fa mi ly de sc ri be s her as
Sm
red
an "amazing woman," &reti
dren as a
secretary who raised two chil
mo th er . T h e y sa id sh e st il l works
single
ve da ys a we ek , cl ea ni ng ho us es .
fi

o, w h o ur ge s caution un fi l the
Russ
t
government gets more data abou
Ivermectin, said he “absolutely”
wt ior sot otk worn sos os A
de rs tand s w h y Sm en tkie wicz ’s family
un
ors
was so insistent that Kaleida doct
give her the drug.

re
«I think we all can understand whe
fami ly wa s coming fr om ,” Ru ss o
this
said. “From their point of view,
desperate times call fordesperate
measures.”

Dan Herbeck
News reporter, Watchdog Team
EXHIBIT “H”
 K
CTERY 017087202112:491 EK YO. 800258/2023
C FESOREU E NT RECEIVED NSCER: 01/08/2071
woes 0c. WO, 31

Aan SpellTexmofthe Supreme.

: foftho CotintyofBslo
‘Cou,hold ian fBut i
Fido tho Cyo tilo,Now York
ontho BhdayofJanuasy2021.
sc,
PRESENT: HON. HENRY J. NOWAK '
Presiding Tustes

OFT
‘S YORR
NEWA ERIE
OF TY
K: COUN
‘SUPREME COURT
-—
MICHELLEKULBACKL, ORDERTO SHOW CAUSE
! Plaintiff,
v. TdéxNos
KALEIDAHEALTTH H, Son
KALBIDAHEAL FQUSUB NDATION,
MILLARD FILLMO RE URBANHOSPITAL,
Defenduts.
eee meet
bits
pon oviewing md lng the nex Affidavit of Michllo Kalbaold and he Exti
diay wid
tached threo, the Flint, Mickle Kibo, sécks an Onder grnilag hoc Imme
adniinister Iveriecti to !
canecgengyrefit (A) eompollng tho Defondaits d/o thle agints to
1) uh les :
elo, TihSennaonfo sds ht Covi 19, ad
furthor and diftesen ellos this Court may deem fst equitable sud proper.
:
GW, upon themotionofhoMishooKnlbackl, tshorchy
ofthe Supreme.Court, :
ORDERED, that tbo Defendants show chuso, at a special tom
Avene,
yf Honora, TENT NOWAK 5contin at igs
© ie end Satoof Now York,onho,3 cayofTana,
Bane, oho CityofBlo, CountyoftTonu
of 2290 Vine Mlevostlt
0 Me on ae soon Sheri a ms
ns
l ca bo head, why ths Cou ol d
nos e
021, S0
 2 ok vO. 800259/2021
CFEEDOER U E NTYCTERK UL/08/2021 12:49 RECEIVED NSCEF: 01/08/2071
WESCER DGC. ¥O. 11

.
an ddor as follows:
nts, agedts, and assigns fo
A. Au Ondor compelling the Defila ding ois dosagochart for
co
Sisto fs dnFeorsootnthS entidowioz; nd
Covid-19 tothee pata,Judi
chellouch orosa
r,fac
Kaothelb kdn
3. AnOdergranting the Mi
s Cour maydeem just,equitabl
ea nd
differentreliefasthi
‘prope;and it fipther :
e no t f s C ho
o u
De ,
nt s, sg os,
adn,
ORUBRE D,tapeni ng no
thisOrdortoShow Casoand its.
and aaythixd partiesaot ontheirbehalf,shall upon recdiptof
:
o r
ers t
me di
i n g
al s d n l
tho s
doug t
Tav erm in sooonding to its dosagsbhact for
oectr
sup pap
p .
iewdoz.
Covid-19to théirpatient,Judifh Smenti
D, tat tho sexv ico of fis Ond er fo Sho w Causo and supporting papers, a8
ORDE RE
idlent servios to the .
y , of ‘shall bo deemed food and suff
8
follows, befiro #:00 PM. on Jaanar

following: *
Foundation,
‘KaleidaHoelthandKaloidaHealth t
726 Eohpnge Street. .
NY 14210
‘Buffalo,
wd v
‘MillardFillmoreSubusbén Hospifal ry - |
:
1540Maple Road Zi
e, 14221
WilliamsvillNY

HON. HN J. NOWAK :
DATED: Fouary T, seal i
EXHIBIT “I”
 orm
wn ton perdi 10 rts lanl di ss ows

ne s ac l Znd-un y-h osp ako der ect o-r est cov id 1 5 a sith-orperimental
tps/bflonas co4011 Teb-b752-4B96600456 hen
ingore, 132339105
d WN Y ho sp it al or de re d to tr ea t Covid-19 patient with
2n
experimental drug
Dan Herbeck, Deldre Wills
Jan 24, 2021

LE UL

4 #
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# ¥

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! £
bp)
r 2
MW ty

ge ordered an experimental
CN
Lorigo says a sac ond Cov id1 0 pat ent has imp rov ed af a
tr Jud
torey Rlph C. aut hor ize d by the Foo d and Drug Administration. (Derek Gee/Buffalo News
file
eatment that has yet to be
photo)
Bsn
Dan Hrback, Deidre Willams
 ed Go p l a os 0
Pra nt plor ha s or de re d aWestern New
we ek s, a st at ej ud ge
F or thesecondtime inrecent ermectin as experiments treatmentfor
Yorlchospital to usethe drug Iv .
patient suff freomrCoi d-19g-
vin
Ca ru so on . Fr id ay or de re d aR oc he ster hospital to
Stato Supreme Court Justice Frank enna Dickinson, 65,ofAlbion.
Gl
<ontinme Ivermectin treatments to
ch es te r (G en er al Ho sp it al si nc e Ja n. 12 with
en in Ro
Tho OrleansCountywoman had be Jan. 17and had shown “no jmprovement” until
or
Covid-to,hailbeen put on a ventilat intensivecareunit doctor totreather with
ced:an‘
Jan. 20, when ber family convin lp h C. To ri go an d Jon F. Minear.
so n' s at to rn ey s Ra
Ivermectin, saidDickin
im pr ov em en ts u t th eh os pi ta lw as reluctant
ro ng
Within 12 hours, she had made a st rigosaid late Triday. “We got an oper from
Lo
10 continue giving her Tvermectn,” this v wo eman'ds life.”
so ,a nd he ma y ha ve s a
Judge Caru
u c c e s s
in f Auustlral y
li a an d se ve ra l other
Alfhoit uh gsh reportedlybeen used s ov by the United States
ed
no t ap pr
tion has said it
d-19, Iver me ct in is
countries to treat Covi
t: Th e U. S. Fo od & Dr ug Ad mi ni st ra
government as a Covid19 treatmen
i testing Ivermectfoinr that use.
ff al
d o Ne ws on F d , Ca ru so s a heiwads
n cout papers dbabyT ihenBu e Th om as Madejski.
x’ s ‘p er so na l ph ys ic ia n, Dr .
influencby ed an affidavit om Dickinso
fo r Co vi d- 19 on Ja n. 7 an d co nt in ued to get
tive
‘Made said Dickinson tested posi escrfriompMatde i o
js n
ki an d. atthe family’s
ap r
worseuntil the ICU staff — with
to thepatient.
in
insistence — gave Ivermect
ey we re 101d th at Di ck in so n' s es timated
idth
. Incourt papers, family members sad Covid patient on aventilator, were about 40%.
: ancesof survival, as a 65-year-ol
es ter Ge ne ra l ‘H os pita lt o “c om pl y” with Madejsld’s
; Caruso’ onde directed Roch no wg iv en to Di ck in so n every two days. Caruso’s !
, wh ic hi s
! prescriptifoonr Iver me ct in
ne sd ay , wh en fu rt he ra rg um en ts willbe heard,
ed
i
: onder ill be neffectuntil atleastW
 n s e c s r g so SA
anaot 1 tn pl e family had hoped, said
th
were not going as smoothly as
Saturday afternoon, things ’s attorneys were inthe pr
ocess
li e Kingdoll ar . Th e fa mi ly
Dickinson's daughter Nata ma kesure the hospital is
reques t fo r a co ur t or de r to
Saturday offiling another il e Dick inson: isin the hospital,
ep Ivermect ino n ha nd wh
required to obtain: and ke
Kingdollar said.
n ha nd when it agreed toadminister
noth av e Iv er me ct ino
The hospital pharmacy id
ined.
the drug, Kingdollarexpla
two
of th e‘ me di ca ti onfr om an outside pharmacy for
ough
‘Madejski had secured en tod th e ho spital Jast Tuesday, Kingdoll
ax
the family de li ve re
it
doses over two days, and.
said.
We dnesday, but Thursd ay a
se to th ehos pi tal on
mily delivered a third do se and didn’t
“The fa
ng do ll er , 52 5g sh e co ul d no t find th third do
‘ospital musecalled Ki
Ringdollar said.
now what happened to it,
n sa yi \g
ng th e ho sp it al pharmacy could not
Friday night, agai
Anuse called Kingdollar then ca
. ll edthe family's attorneys.
on, said Ki ng do ]Jl lax , wh o
find Dickinson's medicati
:fa ct th at th eymi sp la ce d her medication, and
ttled about the
“We are feeling a bit unse
llax said.
she wasmaking progress,” Kingdo
was
Dick inso n' s co nd it io i
n mproved.‘Herventilator
doses,
“A fter receivingthe fixsttwo s
o in
ftryto bringgher outofa
we re sta rti ng th e pr oc es
turned down, anddoctors
Kingdoll ar said.
medically induced coma,
tod the
were delivere
additional doses, which
‘Madejsk iultimately secured three ce rn edth at hermother's
|
t Ki ng do ll ar no wi sc on
i ‘hospital Saturday at 12:30 pm. Bu ministeredthe thirddose
lastThursday.
us e she was not ad
progress isjmpacted beca
er di d no t receat ihi e dose
vrd
| atifhe r mo th
ng‘Kingdollarfh
: But Madejski is reassuri a di ff er en ce as some doctorsprescri
be
nt make too su ch of
‘before Saturday, it should
:
her day, Kingdollar said.
: the medicine to be taken every ot
 G 8 po t p a l g c reso
an onyhop es os
ld re n, tu rn ed 65 last De ce mb er an dhad just retired.
Dickinson, who has four grandchi ee n ex po se d to abusiness partuer
aft er he r hu sb an d ba db
She contracted Covid-19 po se d
tot he vi ru s, Ki ng dollar said.
he ha d be en ex
ho was unaware at the timethat
to get better and T
ther
ju st genera ll y wo rr ie d. All Twant outofthis T want oy: mo
“Pm
antto be able to help other families," Kingdolar said.
a Go Fu nd Me pa ge to ‘e lpwi thhe r legal and medical
Dickinson's family has set up
expenses.
se s “v er y sim ila r” to th e ca so of Ju di th Smentldewicz,
Lorigo ssid Dickinson's ca
at e Su pr em e Co ur tJ ud ge, He nr y J. No wak, ordered
80, of Cheektowaga. Another St Ja n. 80 tr eather Covid-19 with
mo re Su bu rb an Ho sp it al on
offalofMillard Fill :
Ivermectin.
ti la to r an di nr ea ld ist res s,” ha ss ince improved to the
Smentliewicz, who was “on aven talan di s re cuperating in a
re le as ed fr om th e ‘ho spi
pointthatshehas been
rehabilitation facility, Lorigo said.
e
in f
fect io us di se as e tu esat he Univ ersity at Buffalo's
i
oe. Thomas A. Russo, chof nc es , sa id Tv er ll under
is sti
mectin
an d Biomed ical Sc ie
Jacabs Schoolof Medicine .
tment.
study as a potential Covid-19trea
t to sh ow it do es he lp ,” Ru ss o ca ut io nedlastweek.
tydon't have definitive dataye
y, iti s no t reco mmen de d as at re at me ntforCovid-19.”
«presentl
he r att orn eys , it 15 hi ghly un us ua l for ajudge to oxder a
According to Lorigo and of a patient.
a certain medicatito
on
Tospital or doctor to give
sit uations, Torigo said. “We
as put some patients in dire
‘But the Covid-19pandemich t the families of these
tt ak ei t Tig htl y to go to th e co ur ts in th ese two cases, Tu
did no d.
in
ha o be done,” the attorney sai
dtg
two women felt someth
 l Loc Now hod
tn|
amo 27
np bi womon elcxporOViImss
c loo
o l m
ba n e
ro ss gs pm en co
t ri tresmeatctice £1900080-391 Sd
gelatine
i 0708SbB06L ml
on w o m a n ge ts ex pe ri me ntal COVID treatment
Albi
ts condition has improved
GOURT ORDER: Family members say Dickdnsor
By SCOTT DESMIT iscom
adoamit@batavienev
Jou28,2008
3
EC
wis E(rer ml a
ma y
a0 [ .
i
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i

Ta pt

Ld

Dd Gla Dison
AOI
second
d for an Albi on Wo ma n who last week became the
ALBION — A: fundraisha ers been.establishe
D-19.
New Yo rk to ha ve a court-ordered treatment for COVI
person $n Western

ali zed in Ro ch es te r Jan . 12.and was on aventilator since Jan. 17.

Glenna Dickinson, 65,was hospit
on Fa ce bo ok, Dickinson's condit iondeteriorated.
go fu nd me acc oun t: and
According tofamil y posts on a
ctin, a drug used to treat children and avimals for lice.
Doctors began treatingher with Ivesme
ordere dthose treatments to continue.
Friday, a state Supreme Courtjudge
 esment|Loco News | hodallneuscring con
aneot —— - Alon man ge xprimentalCOVID

ke thi s mir acu lou s pro gre ss tha nks to lga lnt erv ent ion md anexperimental
theha ben abl to ma t or d” ber nc e, Nic oleM itc hel lwr ote on a gofundine
medicine being administered as asse t of con
u can ima gin e, the med ica l cos tsa ndl ega l exp ens es add ingup. The
ceo she established. “Asyo es the dos est hat are ke ep hein g Any donation
rlive. is
funily needstoxetain l a wto y e
ens r
ure he zec eiv
ou are not abl to don ate ple ase hel pby s h a r
her in
sto rytgo spread awareness and
greatly appreciated. Ify
saya prayes for her.Thankyou.”
inen use din sum ero us cas es acr oss the cou nty but has notbeen FDA-approved for
Ivermehact sbe
treatmentof COVID.
rde red doc tor s atM ill ard Fil lzi ore Sub urb an Hospital to treat
lier this month, judnT gre e Co un tyo
wit h Ive rme cti n. Th epa tie nt has sc e bee n rem ove dfr om a ventilator and
an 80-yearodwoman lo Nevws.
dischangetod aehabilitation facliy, according to TheBuffa
ts $7,000 goal.
ThefuntserforDickinsonhs sed abore $3,200 ofi
fu nd me .c om /f fa du dz 2? .
Tothe ipagt e, go to ht tp si /w go gn=p ico there
pA tm _S ou rc e= ci st om er Sa mp tm_ ca mp al
madcap. IrkSam
sheet

Scott
EXHIBIT “J”
 .

) DAL)
[Prat AtenSpal To ofthoSeems .
: outednadfrtoCountyof
Odes he TownofAllon,Now
Yo,outa21stdayofJenary 2021.
PRESENT: HON.FRANK.GARUSO.1S.Co
Treidiog Toston .
‘STATE
OFNEW YORK:COUNTY
OFORLEANS
SUPREMECODRT ;
‘ROBERTDICKINSON, ORDERTOSHOWCAUSE .
Plait,
« IndexNose] ~U4013
‘ROCHESTER GENERAL HOSPITAL,
'ROCHESTERREGIONAL BEALTE, .
Defadants,
Oooven sndlng hs nese Aiditof Robo Dimonsud thoAffton :
‘Dr:ThomasMaliend fo Bil achedfeo, hsPut,RobtDiclason,sekssn.
Ord granting himimmediateend emergencyrolief(A)compellingthe Defendantsand/ortheic
seats 1comply withpirmyom phyla,Dr,ThomasMade,orderresbiog
eameotiatotsi mupat,Cleo Dickson, osding 1Ha dag orCovi 19, ,
ancy 12mlligauns ondy1,Gy3,day ,a veyother day fos a deredbyDs. ,
Made},an (B)suchothe,father,nnddiff eof atioConcmaydeinust,oquitable, Co
| pope |
NOW,pon heMotionofMs.Dickinson, tsey ;
ORDERED,thttho Defeatsshowois t posalfxm of thoSup Con, :
before the Homorablo Prank Caruso atthe Coudhovse Jooatedat 1SouthMisi Streo,Site 3, :
Jee

by Miesrabi Teums:
op virtsally
{osteo ieConnyof Odes SistoNi YoonteJy offen,2021.
13.00100 frst comecb hi,vyti Countaon ct onaod
silo: ;
A.CompellingthDefsdctssnd ee pei complyWit
til save pal, Clea13
pimery cwo physician, Dr. Thomes Madejeki’s, order
Pring Ivanato .
Biiea,wnt fo i dowfx Coli 1,aly .
illu day doy,do 5 adveyoedy eee
onde by DraR ad
B.AnOc
catslof abisCont oy sch
rangMe,Dik tes,Seand
dean Jo,sible nd
prope ditefcr
ORDERED,thatpendingfuther orderoffhisCou, fheDefendants,its agents,and
igs,co ny hi pis ti lel,pon eslof OdeoShowCound
issupportingpepers,shall sailenforcepriscsc ghysion,DE:Thomas Madaek?'s, *
order md prescriptionto administer the drugTavermeotin tothelr mutuslpatient, Glenna.
Dlekinm, culingtolsdosage frCovi,sly12 ligaday, dy 3 day ,end -
every ti dayefoto cedbyDi.Md.
ORDRIED,fia hasevicsof isOc toShoveCoutoandsupportingpaper,shall !
“ .h
oumaconrbefor gnsase 2.9,202] andshallbndeemedgodmdsetsven .
to fhofollowing: i
|
‘Roshestor General Hospital
123Foca Avene i
14621
‘Rochester,NY i

‘Rochester Regional Health |

“i:Ge]Counsel :
10 rgHig. NY 14617 ' |
‘Rochosier,
pam: 12419 CARUSO, TC.

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EXHIBIT “K”
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“ABN &LINTREEACOTMVI9D CRITIC AL CARERALL IANCE
FLCCC ‘PROPHYLAXIS EN T PROTOC OL S FO CO VITS
ALLIANCE
ary of th e Clinical Tri als Fi de nc e for Ivermectin in COVID-19
One Page Summ he, By poll lind
201,
seqvesy |onl ie csCo} fel alsfom.
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 American Journal
ofTherapeutics 2, 299-6318 (2021) i
[OEE] |
Review of the Emerging Evidence Demonstrating the Efficacy
of Ivermectin in the Prophylaxis and Treatment of COVID-19 }
* Gianfranco Umberto Meduri, MD;? Joseph Varon, MD,
Pierre Kory, MD, |
Jose Iglesias, DO," and Paul E. Marik, MD® |

Background: AferCOVID9emergedon USshare,providersbegan releving heemergingbase

scence,tanlationsl, an clinical dat0 dentypotentially lective ratnenoptions. Iadelon,
maliceofboth novelsndrpueposed hrapeticagentswee edempicalyandsuid
tind] l.
hveFuld provid produce, efitve |
AresofUncrtanty:The thematalisedapts
proofof ficacyInreducingfryof ofCOVID19wih heecepion of oases in |
rodent to sever disease, Recently, evidence as cnerged that the oral antparaltc agen ve. |
meetinchilemameroo snl ard atfamnatory mechani wih tlset reporting |
giftoutcomebene,Givensoehave ntpas oc eve, sve cet Groups nid {
{ogUnltd Word Health Organization have underiaken, a systematic lob) fortto contact all. {
i clive alievestigatortorpidygatesth dt needfo gradeandpero cs ayes. |
DataSources:Datawerescuoedfrompublishedpeeeviewedstudies,manuscriptsposed topreprint |
server, xp nen,anresscldnilogilanysofeg wit reed db |
oncampus. |
Toone AOS Age A oT alontiad aot seca apr ido ||
ivermectin sre reposting repeated, lage magnitude improvements in cial outcomes.
Numecousprophylass rlsdemonstrate thatregula verminve eds 0 orgs reductions |
In eanamision. bulipl, Inge “naturel experiments” occured fn regonsthatnated “ver: |
mectin distbution” campaigas followed by tight, reproducisic, temporally associated ||
creas in cass count and ase tality rates compared with neacy regions Without such
3 campaigns. |
CondsionsMetalsbd18dl tl nant lsofhermes COV |
13have oundIre stacysgnroduc nord,ti cilrecovery, ndene to {|
b
vialdrove,Furherore,masfrom numero comvolepropylads6c ep grant
ofTennesseeelsScienceCaner,
Front Line Cou 19CrialCare Allee,Midion,Wi"Melis VA Medial Coter—Unierit y
Fuinanary, Cra] Cr, and Rese rls, Mnphi, 7; Lies ofTess ii Se Centr, Cries Coe Sek, ]
Hout, 3% Darrenof odio, cms School o ede, con Ff,NJnd“EseVig Mobic Scho, Division of |
Pulmonary andCiaCore, Nok VA.
§ GUMartscontribution herentof rkported it te recnesand esoffitstheMemphis VA Mods Cone, The ]
| cosy omydo pet ee US Dienof Vans As ve U3 Gren i
he utr ave vo coilsofrst o dere,
Por andG.U1.Mrhaecontrite uly oisvor. i
Studyoption design: . Koond G.. dur quite fd:PutMaria ose so,Analysisa reoofdots:
aslMark,P, Koy,and oe ke. Dri ofnasser Kor, Cineon: . U.Me adsah Varo,
OfLael Use: Ths vane cs dionofof bl seinCOVID of he FOAappesd elution ec. |
iissfo spies: ir Kory, MD, MPA, fain Covi10 Cra Core, 2002.5 NW, Sue 0, Wigton, D.C
200%.Enl ploryofcet |
Ti anopenccs atedined de te fers fheCreeComoAlriato-NonConnrcl-No Devas ics |1
DCCHY-NCND)ware prise 0didanddre he ork provided properlyced.Te ork vitecon any |
onordcommit lout persionfo rl
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toncpusfang of cnc Fly, nycls
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Indie atanc sonline napsscf COVID15pobn nie. i
Keywords: ivesmectio, COVID-19,infectiousdisease,pulmonaryinfection,respiratory ailuce {
= |
!
INTRODUCTION History of ivermectin |
nen 220,ontheonsetofthe spradiogpandemic, inIn1975, JapanProfesor Satoshi Omura theKiso institute
Isolatedanunusual |
many providessd.InsttutonsbegantoConny fromthesl ne agol cueSrsplmesbacker long hesoutenst 1
]
evi the apy emerging bai soc, bolton, const of Hoh, Japan. Our, lon
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|
optionsforCOVID15 Aldagh herbs ow smallond. ice fectedwiththe oundworn Hlgnosonnies i ||
increasingnumberof therapeutics showingsomeefficacy ygyrus. Campbell isolated theactivecompounds from
in important lirica outcomes, chi of which re corto. th bactalculture,namingthem “avermecins” and
nicsinmoderate 0sreeflrs, hewordcontnies thebate 5 eri forthecompounds sblly to |
{osuf from oworseningcrisswilthepolentaof clea mice ofworms? Despitedecadesofseuching
agp
overwheling hosp andteecaeunits seoundth world,th paniesmicoorgan remains.
(0CU). An of Fruny 21, 2020, the umber of desths theonysous of avert vee found.revelations Ivrmecin, a. ||
atidto COVIDA9 intheUnitedSaks reached decvativeof aveectin, thenproved
510248wilhrochan 9 million cvcass, ghst Orginal troduced 55 a vetrinary dro, fo0n ||
number todate. dditn, mutple uropeancoues made iti impact in human health, improving the
Fuh comporncing
i a
heseshrmingdevsopments prope wardwideeverice i ra istusedto est
!|
‘was waveofecenlypublished essfronthepeatc onchocercasi (ver blindness) inhumansin198,Tt |
domizedconmolldMinky conducted on medhints proved dee i many wee, goer tht 1 washighly |
eve cfctive for COVID9 Gt found a ack of afctive,broodspeceum,safe,wel tolerated,snd |
impactonmorllyin orp patientswilhthesoe coudbeensy acminiecod? Abhovgh i rateed |
of rmndesivir, hydeosychloroquine, lopiavie/cloca, fo tat 8 varey of intemal remaiode nfecions, it
interno,convenls, mopocoralandy ss ostknown 3 th seni miteof 2 global |
herpy 4Oneyeenothepandemic, the nly heapy dss liination campaigns tht has nearly lm |
considered “proven20 Honing
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anbparsicmediine wihknown avisandant cnt.One example esfh decidon byMarckow& |
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tha thnprovidedmorsthn 570
ingmorality.Althoughgrowing numbersofthestudies milliontreatments ntfist20years |
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Since 2012 a growing suber of cell suis have nation nd vialhudoss The20redvenmecin
demensedtat vemecinfosadvilpopes “ove,Ftme showedseesheal |
spitannso rmberof RNAvirus incon rm oti a won Sn To i
inothemechinioms ofacon vilload(53,158),wheresintheivermectinrented
influenza, Zia, HIV, Dergie,ondmostimporaollys
SARSCoV-227Insights mice |
bywhichiermectinboh muchowervi loswasmeasured
nerwihhecraneand wily fo ts hs Hei ted ic shows. @315% P<008), |
ploof SARSCoV-2 withinhuman elssre mount. nghtpatelogial dosage mah ht he difernces
ing. Cyet al fitreportedthtiverectinsigiicantly etethe versfromtheuninfoctdcontol mice were
Inkibls SARS.CoV-2 replication in ol ifure mode, notsatisily Sri.
dbservingthenea absenceof all violmall 8 hours TiasDoMelo at a”sen pastedtheresults of a ||
aftrexpose o ivcmedin, However, omequestioned studytheydidwith olde hamsters thatwernaa
whetherthischsevatin 3 ner llygiven alyinoculatedwith SARSCoV.2vis,and ttheime |
the abi toachleveslrtoeconcentatons sed ofte neon,theanimals loreceived single sub- |
intheirexperimentalmodeling standardoreve mas canonsjc of vemect a ados of04m/s |
ivedoses of termectn9 Itshouldbe edhateon day1.Coto!animal seetvedonlythephysiogic |
Concenmatons gine fosn hc calui odds soon They ound th. Iolo mots |
bea Ileresrblance tohumanphysiology venthe fermenrested Tumstrs: adramatic reduction in |
shmenceofanactive mimure semworkingaynergis. ancsmia(33%vs. 3%, P =009), whichwas also I]
olywi a rapeagentuh 2s in. so dependentin hatthmlehametrs cited 3 |
hemor,prolongeddurationsofexposefo ados reductionin nical coewhile the rated femalehan !
lywouldrequ afac ofthedosingJ short tea alle fo howanyignof ania.Theyslofound inthe ||
teem cllmodelexposure.Farhermore,mulecost: Sgroreductionsin cytokineconcentrations
Ingo allmate cherieofacon hel ipo he nealbinacs and emg of rerestedaims,desplte |
icles cbsrvesd,suchas the compettve ining th lackofapparent iferences inviral ters.
of Iveamecinwihthe ostrecplocbinding regionof Desple hesemountingnlghts ntothexingand |
SARSCoV-2 pleproen,asproposed n 6 molecular potentialmec ofactoof vemectnboi 35a
otiA ry FE tn, ts, epoca
was deniedsshaving he Highestormon highest thtsgnifcantresearchgopo emiandGat nayfur
trp |
bindingiis 0Gl pti ii dons hs cosd rir sicshouldbe rain 0 i|
ofSARS.CoV-2amon hundredsof oles olecvly eterdefineno oly hesemechanismsbutdo(0fur
exomined, withivermectinnotbeing theparticularfocus ther supportivermectin'sruleas aprophylacticagent, |
ofshadyin of hesests”Tis lh samemecha special intheoptimaldos and frequency required. |
isbywhichvilato
sim bywii on in puts,
particu Ge geTe Teliaadic st vemsstts" shinlmrony ||
SARS.CoV-2 vies,The igh bindingckivityof vee. PrOPeFies |
ntotheSARS.CaV-2speproteincould Ytbinding Given that file viral replication occurs i the later |
10 either the ACE? receptor or lc acd recepon, phases of COVID5,nrcan viras be cultured, and ||
|
espectivl, ihr prevencellacy ofheirs only in minorkty of sutopais can vial cytopathic
or preventing hemagglutination, a reomily proposed changes be found, the most likely pathophysio- ||
pathclogi mechaniom inCOVID19722 uemmecin logemechani is that identifiedby i efa where 11
Hastobeeshow fo bindfoor lceewith ruldple they showed that the nonviable RNA. fragments of |
sentialsrctralandrst proiesreguied by SAIS.CoV-2 lea 0 a high mortality and morbidly |
{hevin to eploste Finally, ivermectinshobindsto in COVIDI9. through the provocation of an ove. |
the SARSCoV2 RNA-dependent TNA polymerase whelmingand nfurious inflammatoryresporee.Based |
RAR)there init vialreplication
lee iedIn» ni mode feed onthes he tenghts and heclinicalbenefits of vermetin
hseofdiscus 1 beseemed blow, |
wilh a type 2 fully RNA cxonmvis sim o SATS: seems that the Increasingly wol-descbed in vito
‘CoV-2, (mousehepatitis vir),the responseto500 g/kg properties of ivermectin 8 an inhibitor of inflamma- 1
of nemocinverspocoTheaaynuded40 Hosarefa mre clinicallypotentthan previously rec T
octad rie, with 20 tate with fvermect, 20 wih ogaiaed.Thogrowing stofstulicsdemonstrating the |
Phosphatefredsie, an hen 16 ined conrl antinmmatoy properties of vecesincludeits: b
amine Amerie Fl ofThpets202) 269
 on Koryotal
abilitytonitcytokineproductionaterlpopolyse ac- group that included 1195 health care workers, they Hi
Charideexposure, downegulat transcriptionofNE. found thatove a 3-monihperiodtherewere ninfec |
KBan limithproduction ofbothnieaxe and tosrdamongewheress 705wokenwhotockweekly fo
prostaglandin E,55 iveamectinprophylass, 5% of he437controls
Exposure prophylexs studies of ivermectins ability ee ecore 11 OVID19 Hi lySemone |
to prevent trnamissionofCOVIDS acidiredid
amonghighiskhai creworkersbyaking
Dataarealsonowsvatbleshovinglageand atstally 12mg;onceweekly. ©TheCarvallo VERCARprotoce RCTbythe
sigpiicantdecnssesinthe anamisionof COVIDI3 was isosepariclytested n aprospectivewherethey
rong hums subjectsbasedandatafrom randomized Health Mini ofTucaman,Argentina, 1
Conta fil(RCTS)anc observationalconroled foundthatamong234 healthcareworkenythe erver-
2(OCIS)with 4ofthe 6(2ofthemRCTS)publishedin ton group thattook 12 mgonceweekly,any 3.4% con {
pesteviewedjoumal #46 racedCOVID-Svers214%ofcontrols,P< 0001 |
gaa and collesgues® at Berka University in Theneefo weckly dosingintheCarvallostudy over |
Egyptrndomized200 healthcae and houschaldcon. 24-monihperiodmayrtHavebeen recesarygiven
factsofpatientswithCOVID9 wheretheinterven. that,in recent RCTfromDhl Eangladeh,the tr:a
iongroupconsisted of 100patentsgiven ahigh dose ventiongroup( =59)look 12aonemonthlyfor
of 0 mg/kgonday 1 ond aseconddoseonday 7in similar &-manhperiodandalso reporteda largeand
addition to wearing personal protective equipment,r. siattcally significant decrease In infections compared
Whereasthecontrol groupof100contactworepe ithcontrol,69%versus 733%, P <045. Then,studyIn
sonal protective equipment alone, They seported & 2 large respective observational case-control
Tangeandsatsiclly Significant reductionin conacts fromIndl,Behera threportedtatamong 186 case
{esting positive by Reverse Tansceptase Polymerase control pais (v= 372) of health takencare workers, they |
Chain Reaction (FCT) when tested with ivermectin prophylaxis,identified 169 paricpants who had some ormof
versus controls, 2% versus 10%,P < 005. with 115 participantsthathad faken ver
“ShounanconductedanRCTat Zag Universityfn mec.Atematchedparanaly sis thyreportedthatin
Egypt,including340 (228testedand 112 control)fey theworkers whohad.taken 2doseIvermectinpro-
msmbersofpatientspasidve forSARS.CoV'2through phyla,theoddsratioforcontacting COVID was
PCR Ivermectin(sppros imatey
025mg/kg) was markedlydecreased(127,9%confidence interval(CY
admivistordtwice,onthedayoftheposkivetestand 015-051).Notably, anedeprophylaswasnotfound
72howslate.Alte atwo-week follow-up,aangeand 0beprotective in hi ty.Basedonbothteistudy
atialysignificantdasein COVID13sympoms India findingandtheEgyptian prophylad study,the All
monghouseholdmembers estedwihvernectinwas Insitute of Medical Scenes irstiuted a pro-
found, 74%versus58.4%, P <0201. phylaxisprotocol orthei healthcoeworkerswhere
Recently,Alumotalfrom Bangladeshpecormed a they now taketwo 03mg/bgdosesof vermetin72 |
prospective abservatioal study of 118 patents who hooks spatandrepeatthedose marily.
‘wereevenlysplitintothosewhovolunteeredfor either Datathatfurther illuminatesthepotentialprotective |
hetatment ocontrolans,descr 3.persasive roeof vemectin gaintCOVIDS comefrom ashidy |
pei
approach.Altrough
ER lined
thismethod,slongwithfh shady ofraving homeresides
between th 2groupswassohuge (673 ve. 733%, Dresden and52stafweetrated ith vemectnlthey
inFanewhich reported hat
<0001) and slrtotheotherprophylaxis sl resis the69 thisevent,7of
foundtatduring theperiod surounding (101%)Inths |
hatconfoundersaloneareunllly1 0expansuch a residesfllilwith COVID19
roult” Carv alaioperomned3progpect e ive group With an aersgeageof yea,eryoneresent
hservationstlwheretheygavehealthy volunleers required. gensupporofresidents and noresident died.In a
foermectinand.camageentndalyfor 23days and matchedcontolgroup fomsurounding
makhodthem tosimilarly hesthy controls whodid facies,theyfound22.7%ofr estsfl1 and 4%
nottaethemedicnes:©Ofthe229 studysubjects, 131 cid.
ere ated with 02 mgofivermectindropsakenby Furtherevidencesupportingtefcof vemmectin
mou 5 timesperday. Afee28days,noneofthose 32 pophylas agentwaspublished cently in he hier
Teceving ivermectin heprophylaxis group hd tested rforal Jordof Antico gn wher a group of
posiiue for SARS-COV-2versus 11.2%ofpatientinthe nsestchesnalyzeddla.using heprophylacticchemo-
Controlarm (2 < 0001).In 8muchlargerfollowup therapydatabankadrinisicrdbytheWHOalong wilh
prospeciv,observationalcontrolled ilby thesme case counts abnby Workdomeles, apublicdata
AmericJurslofThrpet ics
2021)26) nrameantierapeutics om
 Sumorstatig ho ice of orm a
Te — ut avr— — pr—
spn
82 7 2soe a vn
wm |
EE RnRE 1
2 mE |
Bop MEME pm ae |
FavoursMemactin FavoursControl |

EE mis So es abort fe of on pls oh Lope Simon: ls — a ||

Srl ensts SbSou dstein ffibid
rs desig oe obo orbs su Lys dndksev r I
peptone byang
meteae oe, heters foment popuaon,wht
oe ines Th hadori mld
seofNel,anpaps of Tod ||
ey
withaciv vemmectinmassdro ediminitation programs beganinmid-July, inNat they began onJune30th, |
nfposi ie eyht erin
otNic Hop
nearby,theyincorporated
cyofSr
vermectin ntotheir
hrs
reatment
||
thattheCOVID-19casecountswereignifcanllylow
becountieswithrecoil aveprograms, 10 8 hgh| protoess i te Mayafer heyweepariclalyhard |
en per ancy So poomodbythe Te BokTo
Sichbaci eeehd
govepotsk dtmba]pes ||
Ee ert eniots ote
ener a Sos a
do ot ot liwi
compa ||
aS Further data supportin aroleof ivermectinin g theirneighbo cites withoutsuchringcampaigns.
dt ao bef re ae Sol
hal Thde
ch. gen. To entsanon
© wer sn el § Bn i |
ee en or emg bac rat) tes mara Te
Ey ogo
pint igevo eg bsmis rma oes Clo staletohe fey of i
sented
rectin
‘Paraguay initiated “ivermectin distribution” campaigns ing, tp
ansh Canty? tdtot ea of or 0
‘Brazil the citiesof aja,Macapa,andNataldistributed patientswithmildoutpatient lineshavebeen completed,
i of om es kp 7 Re nd+c
—Compan cs un dors mon dione wih nd wits eros dittn
Tati,
-boon Noweoe nado munis meron Wowie mayevan ven ee
Ges a io po ues = or
Toot
Noth et — Ts a mmm Tok
Tot
Nernst No on es ww» ww rd
=
Sobre oir es tow
rp
ameionapetacm Amon raf hepsi 021) 280
 Ld Korot |
Table2. Change indent ats song neighboring regions in Bac. 1
%Change naverage desthaweck compared i
Hl
Region suo with 2weeksbefore
Souls SomaCorona EX
PARANA EA |
io Granda do Sul wn |
North Aap Ee i
AMAZONAS a {
par on |
North ast io Grande do Norte Zest
cennk a
Paros oo

eeme |
ot ors cotanes
for cy ek 4ted orci a cnn, th oer olor am
conducted in. Dhaka, Banach, and targeted 400 melhypre dnis
40mtwicepe dayolon
fned,via e |
alles wih 56 patients completingthestudy. In his cin C 1000 og ticeday, ine 75-125 mg/d, viamio
Study, 8 J manyoberoftheclical studiesfobexo. D3 5000IU day,agtomye in250mg/lfo & aye,and.
hen |
Viewed, ier ateacyline Goxycyine ) ormacrolide
ny acetaminop S00mg8needed.Alho ugh
nopatents |
antbio (uieof wosbudemyc
lvo asputol hereat. in ler groupproggesed adied, thetie(0recovery |
mentTheimportanc iniding anionsuch as wasirifcanlyshorein thefret eted group
SmylieoF asic unde;howeverbos (53digs ve.137day, P <0000) |
tetraydine and. macrllde sntbioc have recogiaed Chaceaur ct al conducted mal, double-blinded |
snfinfanmstory, imusormoddatory, and eve ani: RCT in Spain where they randomized 24 patents to |
alcfc(5-6). Alloughtheposted doinfomthis ivermectinversusplacsbo,andaltsoughtrey found
studydoesnospey amount ofmy lLupatons no difrencinPCRe positivity at day7,they dd find §
Versus hosplilled patients tated, imporiant cll tatsticallysignificantdecesssinvialloads, patient |
utcomeswenprofoundlyafcted,with
eme zased
nt tes daysofamosn(76ve. ia 155, P < 008), and paint
ofendimprov (607%va444%P<03)and dayswithcough (68va. 9, < 005) |
deavssed roteofdil deletion (87% ve 178%, AnotherRCT of ivrmctin sientn116 utptieis |
P<02),Giventhatmilly icpatents nlycom. wapecormedbyChowdhuryeanBanglades where
prisedthe studycoho,only 2 deathsweecbuarved theycompared a groupofG patents restedwithne a
bot theconta group). combination of fvemectin/do cjeyli
©.groupof0
Raviit performed doleblinded RCT of 115 patents tresed wilh hydrnychloroguine/dcnyeydine
poten, andallhoughtheprimary outcomeof PCR with aprimaryoutcomeoftime 0negative ICR
postivtyonday 6wasno diferent,thesecondary oat. Although they ound ro ifrence in this outcome, in
Eomeof moraywan0% vec 69% P =0190 a. the eatmentgroup, the timeto symplomate covery |
lolain Nigeiaaso perfor med
doublelndedRCT approachedsata significance(33days v.70 days, |
of 2patients,andincontrastto Ravikict heyfound a P = 0.7).Inanothersalle RCTof62patentbyPod |
significant difference Inviral clearancebetween both deretal,theyalso found ashorter time to symplomatic: }|
helow-dose ndhigh-dose rstmentgroups ndcon recovery hat aproschedsatsalsince 101 days
trolsin adosedependentfashion,» = 0065 Va 115daya, > 005, 95%C1, 036-367 i
“AnotherRCTbyHishim t69inDoghad, rag, Amedical gro intheDomanRepsrept a |
included10patentsequally divided;thecontolgroup cas sereof2435consecutive symplomatcoutpatients |
rcaivedstandardcareandte
ion atedgroupnudedo sein came in theemergency department,most |
Comboinat othcupatient ndhospalied patents, whom were digoosed using 8 cil sign. The {
heipistut ii apleh, pli nlp lomeet
inthe56paint ithmild-omodecateoutpatientI.
Ivernectin/d snd iandandof yline
oxyecaeandcom
patientswere esewih a Highdoe vemecin of 04.
Reaskably,oly 16ofthe266patients (055%)equired
|
|
paredoutcomeswithth48plnUestodwithsan ubsequent osplalaton with only singledeath i
Gadofcaeshone.Thestandardofcarein hi tial recoded |
Arionfar of herpes C02) 26) nmamenherspestcsom |
 Demonstating the Efccy ofarmoctn aos
anothercase seis 00 patentsinBangladesh, moranfindingws the rlylw oct teof in
lla wit combination of02mgements, 9% mad ngth betofacl
ersUstedwil vec pric allof | |
nddonyeyci ey oundthtno
Repay or ded, and a pons symploms Aice RCT patent
ne, reaned whom om Ta fod drsmatic eduction |
improved within 72 hours in mortality with ivermectin se Among muliple |
Rac se from Artin reported on a combi mecresentas (fren vermin dosing
tin protocol ht ues vec Spc, dos Shares wes used in he nervendonwhereas am, he he |
1
nclasane, and crrapadin. In the 10 ld lass average moray was soporte at 3%, il
patients, ol survived Similarly, a case series from average mortality within the standard care and pla-
Voie of 2 consecutively rested pases withfer. iho ar wis 185%, with odds aio OF) of i
meetin, all were reported to have recovered with an 0.18 (95% CI 006-055, P < 05). |
rage in 0 A covery of nly 36 days Scr ndSokprom prospective lof i
Clnicaldudivi
Sloe studies f 5th aficayyof emmectinin 100 Popa putin whercy they
ivermectinanddoxycycline,whereas rtd 0 wilh
the50controlswere. |
po amen;morsseverlyIhspl- Gosrepr
spla ized offermecin ven»plac coatingof vii 4 AMhovghna
Sidi ns rou, heme |
alizedanys
base nado 6 ETS, 5OCT,and adose Togifsay
patentsstudyis ment grouphd(10937 grantshoreBosal
asicaldoy ews47da 7 = OB, 1
helo RCTbs placedparswas performed nddorter 7ef operishiof npn, 67 |
concareno4S herghyIe
wih Rok haysvowedsbovehy dayTnwma 9 day, P= O01 bsp paiswas !
Eluatr nar atswerrome gkOCT.220 t BowlHest Hospi i |i
evanpce esman dete pais sch Cro | conductedbyRafe
roup of Wcptsoewilh oil an wsssn publ infhe for edict |
op rdetd of carewithondock OA 3hgvemactiplus
BOC) and 7oup lvl yd. ural bing 3 Ce (09.Teypromod
propensitymachi dnon288lpastivs OCT
conetve
ron 40 ogtiaondy 1 en300mgere Patan adcompared the tedwih
One.hud seventyueee
nly 5dae ho andar ofare.Trew
lysas overrtsof progrsion nh tinsets sedi sat chin10. is. wiv tin (0ovate in
remind gow(1% ve,22,§ < D000 wilh ido and 3 avdaseconddoveotdoy?)while ached 07 ||
ard 4Sen pei, Grogs Onder no
det any severly i pl, i gr 8 spin ortcompos, i, ry, an saisaly sgn
Intuod Inbth math sndrope
ted wi a singledom ofhydoryeloncine 04 mg/g Tos SOC, fot owes marlywas352%, among, were
fo 03)Pst, |||
hae group 4recived pis trated pas(507%vi.
SCInt sevrtyTivgn,
Comes etav rg, ih nis
he dfs
oeof progr
nut. inte.Wap
vole,moat)vas
wih sevedied
ofputersproudly pulmowhen |i
Fevers 30%andmorlty 2h vemos 0% (pSOLD, ed wilh erect CRE.SLT, compared P =0D01 115 |
!
“TheonelargelyoutpatientRCT conductedby Hashim~~Anotherlarge OCT inBangladesh
evinwedshoved pd 2hopin pails patents eat wih vest 8 sindrd Gore |
group.no ect doyleseo, hartconn of 13 pats Disp a gn
ers
it,hrsIn 1 sovrdysndof pullsardur11 groupaly
cl i cant gous higherproportion
eh Ue ihofpatenti el deo,oweshe Iveomtin |i
Everly1 pants(1 =2)weiced uc of oles COVIDterapswreoer wll
risin“cmsof ulin cay puis matched, yi the oxy deen was rst
SncBHGly
OCF |i
(hecon gro (5ThisdeinIe
mln i sve of fins beeen sk asic 4 hy ro nlp 1'smarked Sgn (05%vi,65% P < 009,To
0.3 Alogi
eterto eer |i
ledpanto.
Govtof Lore dep hsamall
hasbiogroupsacth amber nd
mmskid aydaa snot 500 pti’epoceddat henP04
includedeenokprovid,hey pi
4 pains nin, bene diac notes Popinlad pent ried wis singe dosof 115 ii
ehsnbt ot lechestlsigan For mg/kg vemecin,compared with 74coil,veal |
rts,des wa large reduc nth sofpro. abywaredced (4%vi 8.5%,HR0.2,55% CI |!
peinof ss9%vs. 510%, 7 = 036)and ot 013.039, F< 00001.
Frperanty, harewae a gedifcncs inmlly mechanical vedlation,mortally was.lo.redhced Simla, inthepainson
ngteseventy I ops dtrsched boi (15% v8.73%) Asll dyfomDaghdad,Ta |}
SatstalSniineOvs273%, ~0082) Another compared 16 vermis sand patini. wls 71
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FIGURE 2. Meta-analysisofthe outcoma of time to clinical recovery from controlled trials of ivermectin treatment in
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more updated and commensurateevidencebased practioner,resechers,pect,andpatientxepre- |
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mendaton of ivcmnecin
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with
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cbservaional role and the epidemiologic analyses
Wherethey was nuffin
found that he venmecinin seated to seglonal ivermectin vee. Afr a discusion
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to ecommendforoagainst COVID19 period, voto washeldonmaltiplespecsofthedata
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majoleadingpublichel agencies PFLA) developmentprocesses.The Panefound te eranof
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low-cost, wide avaiableanddeployable summary, based on the oa of the tals and |
‘suchas ivermectin. ‘epidemiologicevidencepresentedinthisreviewalong |
“ochunatly,agetesssporsocedby 2differentorgwith the preliminary finding of theUniald/WHO. |
izationshave roparkedon hisfotOnetom, spon
eta-analyisoftreatmentRCTs andthe gidelinerec-
er byteUndWHO ACK ArlrtorResour Frog, fvermectinshouldbegloballyand
omimendaio omth temationlBIDcoerce
systematically de-
md To bytheUnivesityofLiverpoolSenor and treatment of COVID-19. |
Fellow Dr. Andrew Hil, is performing a systematic ployed in theprevention
reviewandmet alysisfueslyon vermecin |
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 |i
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Journal Pre-proof =CHEST |

seo farmacinis Associatedwih Lowe Nortalyn Hospalad Patni win | 458: 80

COVID-13 (CON sty) ee
Sulans Capeloicz Rafer, W.0. chal S. Sherman, WD. FCCP, Neaz Fath, Eu
WD. Fablo Vogel, Pharm. , BPS, Jamie Sacks, Pharm.D. Jeanwlacaues Rafer, =| i
mo.
oi So0t2-3692020)34808. i
oot: hitps:/idai.org!10.1016/,chest 2020.10.08 |
Reforence: CHEST 3002 |
Toappoarin: CHEST i
IB
Received Date: 21 June2020 i
Revised Dato: 20 September 2020 |
Accopted Dat: 2October2020 |

Please ta ti rice as:Raflr JC, Sharman MS, Fatih N, Vogel F, Sacks J, ReferJJ Usoof i
vamactin's Assodtad wih Lower Marilyn Hospiazac Patents wih COVID-13 (CON stu), |
CHEST(2020), do: hips rg/1010161, chest2020.10.00
“This Is a PDFfileof an article that has undergone enhancements after acceptance, such as the addition !
ofacover ge and metadata, and formatingforeadabilty, but 5 ot ye the dato version of 1
‘record, This version wil undergo additional copyediting, typesetting and review before it is published
ins nl form,btwe are providing Th version to Gv early vistofthe rice, Please note tht, |
uring he production pro06s, erors may bo discovered which cou affect th content, and llega ||
‘Gsclamrs that apply to thekul pri,
©2020The Author(s). Published by Elsevier Inc under license from the American College of
Copyright i
Chest Physdans. |
|
|
 ii
I
[ne ——— |
Abst Wordcout: 00 |
|
Usoofvommeetnis AssociatedwithLoverMortalityinHospitalized Patintswih |
COVID-19 (CONstudy) |
JulianaCepelowiczRafter, MD. ||
Michael S.Sherman,M.D., FCCP |
‘Naaz Fatteh, M.D. . i
FabloVogel, Pharm. D. , BCPS' HK |
.
Jomo Sacks, Phare. 2 |
Jean-JacquesRajter, MD. CP + |
1.BonHethMtlCots,otLond, FL. ae |
2Dr UnsColleton tS) !
3 Ps maton Use ns |
Conesponding author: EV |
Jean-JacquesRafter, MD J
Browerd Health Medical Contr,FortLauderdale,
FL. |
Assistant Professor, Florida Intemational University, FL. |
ry
1000S. Andes Ave, #100
Emailsovidl9@psoflorids com
0”
|
|

Cottaftotesit in lve oscilners,sites, onsipliions |

lon Cdna MD: |i
Miche.Shcnan,MD:v0 !
NusaPuen, MDs one
Fablo Vogel, Pharm,D., BCPS.;none. i
JaiSacks, Phar,
D. none |
JemvlscquesRife,MD one |

Funding: None 1
Running head:Outcomes ofIvermectin us fn Covid-19infection i
i
 i
|
Abbreviation Lis !
OR:oddsato }
Cl confidence itervel |
BMI:bodymassindex |
MAP: mean atria prossure
SD:tdi dviation
QR: intergenic runge
NNT: numberneededto at
SARSCoV-2:sven aio espintoysynngcocnaies2., |
‘COVID:19:Coronavirus Discaso2019 oN
IRD: Institutional Review Board ed
FIO:FractionofInspired Oxygen 0 |

GF |
$F |
hospitalised COVID-19,survivl,mecha vation,sever pulioary
involvement, ivomesin,in-hosplal mortality,NNT.
ON
Sn
rns |I
end |
3 i
|1
|
|

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||
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i
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 |

Abstrct |
Background: ||
Iemseti was show fbiSARS.COV-2 replication nv, which has ed 0 of |
Tabetuss,but lilef has tbepreviously desorbed. |
Research Question: Docs veces benef optsCOVID-A9 as? |
‘StudyDesig andMethods: dy |
sod i
cutive tart hospitals inFlorida
patientshospitalized
‘Chartsofconse |
cfdCOV 5h 1, she ||
wero viewed, Hospi Fomiindosiog guidelines were provided
‘without ivemeeta |

botosm doin wep c'sdicrion,Thepi oto in

slo opt mol,Senda atc chadmorally acs i
esemmbnbembeoy w |
potent, and nist. ‘Sova pulmonary Involvement was definedas needorFO |
o Invasive venation astdyety. Logis rgrssion
250%, nonavasiva ventilation, |
and propensitysore tein weveused 0adsfo confounds. |
Results |
280paint, 173 brostdwithvrsect ad 107without ioretn, wer vied. |
Mostpatentsinbothgras lorected ydshoraqune andaahomyeln. |
A—————
OR052, C10:29-0.96, P=0.03). Mrtality wasalolowe among iver
25.29%, |

|
 |
||
ratopatswithsevropulzonayinvolvement (38.8%vs 807%,OR0.15, CL005- |
04,0000) Therewer gait diffsbn cuban es 06.1%v8 |
154%,0R3.11 (048- p=0.07)oleogt
1100) , Alleemuldvarato austenfr
h of tay. |
confounders sndmorality sk,the morality difticnc maidsigisnt (OR 027, |
1009080, p00), ) |
196 patents were nated nhepopstar.Moga sigaifiuntly |
99,
grou (133% v 24.5,OR 047,C0220005
Loverhermes 30 |
1125 (C103822.19 sitrik cht,wii bor sed ato£89 ||
(usa. S50 |
Interpretation: Le |
Ineo onmntvos sod ilovermarlyding sentof COVID-1, |
pty niitpy se Fd |
eddcon idng |

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 |
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Introduction
||
Ivemecinhasprovioulybeenstudied as therapeuticopionforvial infectionswith |
datashowingsomein-vitroactivityageiostabroad rengoofviruses,IncludingHIV, |
Dengus, Influenza
andZikavirus, likely through inhibitionofIMP w/pl-medinted. |
‘clear import ofviral proteins,“ Wagstaffal, demonstrated
that Ivermectin
wosa
showinga99.8%rei Aafer
potent invitoiniitor ofSARS-CoV-2, |
48 hours?Ths port nthe tent ofpyscon wvwsnlng COVIDA9
npn with vert dr Ape, 2020,PeCir gov, theca |
aCOVID-19, However,
cunt 37studies vesting thowsolcss fiero ||
eto tm AA est |
beensported, of en |
Intholate15708 vers develope aewcls fdr espsi |
intetons, TullyiedJaveterioaey idicie,it wos so0n found 0bose and |
ffi mses slybes ned et noses nd nd |
ofpeople worldwideaspartof aglobaldrugdonation program.
filariasis fn millions |
About3.7 billiondossofivermesti havebeen distibutedinmassdrugadlnsttion |
canupaigasgloballyovethepast 30yearsPresently, vemeetin aapprovedfo usoi
humans i sovealcounties toteatonchocercass ymphat lara songyloidiasis |
tt |
||
 |

Based onthedatadrug safetysheot for Ivermectin(NDA S0-742/5-022),sied ffects |

ersuncommonandfmited.Reportedsideeffectswithgrate than 1% acaurreace |
included,clovaton in ALTIAST (2%), nausea (24), diarhen (29%), desased leukocyte
count (3%), peripheral edema (3%) teckyourdia (39), dizziness (39),andprocitas (4%).
Apharmacokineticstudyof 166pavsats repatedsidoeffects of headech (6%), |
ms ast,
(1.8%)aad diarehea
dysmenonthen (5.5%), URIsympto |
Methods: Rel
Patents Ly I
Santon spol pss Bove ‘Health associated.
optoSuh Florida rt nme sionvi SARS.CV-2 ing |
codon ors ovis sity.The fied vas pov |
A JT
ey 4 ft i tertgD
sion FDA Bmerency Use Auboisd COVID-13 mel say forthedone |
OfSARS.CoV-2RNA. Patientsyoungerthan 18years old, regan,orincarcerated weco |
whohadatleast2
‘excludedfrom datacollectionbasedonIRErequirements. Patients |
‘separate admissionsplacingtheminboth groupswerealsoexcluded. {
Study procedures |

Recordsversabscacedby fourofhe sthrs sdaldtweessibsequntly review |

med Baseline da werecollectedatth timoofvormectin
byth leadauthor,
andconfir |
 i

administrationfo the ivermectingroup forth usualursgroupbaseline as alter at | i

hetimeofadministrationof ydeoxyehloroquine , nat sed, ath tive ofadmission. ||
Information collected includedCOVID- testing resuls patent demographics, rc-
andtheusoof
existing comorbid conditions, initialvita signs, laboratory results, |
contd, ycoyc romyoafade uin,
and horoq esr the sort snd i
to denity pteconfounds tween rugs. Sever ofplay ovement
oss oft dalton cgi vs |
ovat, Fonts wer onsidrd fv vorpulmo vole hey ied
an FIO;ofS0% or rete,high low fp — veatltion, or ntubation
nd mechanvr.Tons perryrt ncompssd ons |
we — FO aett |
up 0 6 Limin oflowtovin canals), indopendentof laboratory findings. |
Punts ers casgr lv sent groups based onwhetherthy caved |
Inthe vermetia group
atenytia during thehospitalization. Patients
ivermectin ||
ateas uo aldoseof ivermectina 200micograns/Klogram
ceived inaddon10 |
sua linllesc, Aseconddosocouldbo given a the discretionoftetreating

10,Thodecision topresertb Ivermectin hydcoxychloroquin, azthromnyei, oc ther

|
|
|
medications was a the discretion ofthe testing physicians, hewover hospital guidelines
wor atablishcfo th fousanddosing of theseages,These guidelinesincluded
baseline EKG and mandatorycardiacandQo monitoorrpaitinong receiving
1
|
ydroxyelloroguine (sone or incombination with aeltiromyeln) avoidance of |
itty patient’ baseline Qowes greater than 460used, and discontinuation of |
x y o h l o r oquiceninog evaton
hy d e o s
ifther was acon l inQT aif he pti’ |
cardiologist recommendeddiscontinuation. Oxygenand ventorysupport vero applied |
perth customarycare,Ep useaifvermcoetin was givea lotrCovID-19. in
Outcomes A |
“Theprimaryoutcomowesall-cause in-hospital Sy ——— |
“erie hp lv, sks hpi hd fom |
lve care ta avaling astrleod ality. Two consutv native bo
‘nasopharyngeasl wab specimens frsARS.Cov2, collec22
ted4hoursapart, were | |
essary orapat tbsce ots oaskilled nursing focilites,
Sondre htsppmolt ofls ih ves ply
{avoivemen, extubation aes fos ptt equi mechanical vel ng,of
ando |
r tho n
‘hospital stay. Lonogftsth ss
ay wes calculatedfromdayofadmitoet hei oday of }
dischargeorto patientdeath, |
Stataticn nsyss |
Univariate snlysis oft primary morality onanc nsbet,
arisom
dcompo ween |

_ - — — — "
restaatgroupswerodeeninedby Studea's est forparame continuous variables
re ——— — —
|

!
|
 |
|
Pearson ChiSquar testfo ategorlclvarisbls.Themethod ofHodges-Lebman was !
‘sedtoestimate medi differences with 5% confidence tervals. |
andbetween-groupdifferences, multvarisoanalysiswos
“Toadjust for confounders |
pectomedusingstepisobinarylogit ogress. Patent vaiabes neue in tho |
alysis ws aos, camerofdoes, hon ngdiscs, nto |
need fox
of ulmoayfelyemnt
dias, and bypertnsion, smoking sata, sveity !
‘mechanical vontilation at studyeutry, body mass index ay,Er — |
‘count absolut lymphocyte cout, and use fenton bivariate
oii on ring brn ss
Gsriowth95% confide tral wer
fromprevious sais. Adsted
malty {
‘computed to show level. tes dala and.
ys‘Wrobased onnonanissing
ising ds vor pied. Mingo19% vas fund for pip wi blood
elon, 54 itt, 076 rst pete ct. |
Woperformed asecondarysnalysisusingpopenslysromatching to reduce offs |
ofconfounding wasperformed
and kelhood ofselectionbias.Propeasty matahing |
usinganestestaulghbor lgortinwith1:1 matchingwithoutreplacement, andacaliper i
listane of essthen02, Veriblesfopropensitysoring included thoso variablesfom
hounvarist between groupsanalysisoftheunmatchedcohortthathad Pvaleloss !
than 0.2 (age, sox, pulmonary condition, hyperteuslan,HIV,soverepulmonary |
orazithromycin) Race,
tocortcastorolds, hydroxyehloroquine,
presentation, exposure :
|
|||
 |
In
‘whit coll count, solu ymphooyts coun,andneedormechanical veaUlaion priorto i
ornthedayofstudy airywere alsoaddedaspotenti! afc confounders, !
Alosswero2-idedand a pvalu <.05 wsconsideredstaticallyslaifcat. |
: ‘Statisticalanalyseswereconducted usingIBM SPSS v26 software (Armor,NY), R
and SPSS
forStatistical Computing, Viena, Austia),
software v3.5.3(RFoundation |
PS-matchiag software (sourceforgeact). AN | |
“Thisstudywasconductedin sods vith teamed DS of lin The |
rtot as pory tio Rovio BeBove Ht |
Host Sytam, protoss approval a202004BEC.Thears sume
Tris Ema Ses |
Sofiyottosay a
Results 0 |
Chants of pis |
307pats wereadintedforCOVID-19 ding thot period stud,4ptt |
veronotrovewed dustomultipleadmissions, 11didnothavoCOVID-19confirmedat |
ho ime ofthstudy, and12 weroexcludeddu to itor ageyoungerthan18years old,
pregnancy, or incarceration. The remaining cohort
of280 palit was comprised
of173
nate lth vermocinand 107 i thousualerogroup.Mostpatients eceivd asingle
doseofivermectin however 13patient eseived asesonddoseof vermecti for
ongoing sasosymploms at day 7ofresent, Followup data for all outcomes wero
 | |

availblethrough May 15h, 2020. Napalitwero lost afollow-up oe heprimary i

of
outcome. A the time of analysis,allpatients inboth groupshedmestheendpoiat |
0askilled fucility.OFthoseawaiting transfer,
orawaiting transfer
death, discharge alive, ||
inthecontrolgroup, on patientwas awaiting transfer hsicodue 0anwelated |
emit ls,and optsws vain give COVIOHY testopredvith |
ltdsgn. hoc group vepits wesin i ond, |
avalting anstertosiledfly, nd patsvod leyimproving.
elash etve repcomps somalsdpops |
= |
inhecfo,whens ossof hydnyorosine
wer mor prevent I
ad yreylooquieplusainvec ighorintheual sogrup. |
Fropensy srematching ed atotal of98matchedpairs.Aftermatching therewere.
inthe
0 asnlysign fencesbetwen hetwogroups, ghtptt |
‘propensitymatchedgon received
aseconddoseofivermeatin onday7, i

Unadjustedostcomesfo honumatchedcohort,andoutaormsinthopropensity watched {

cohort ao shownia Table 2, For tho unmatched cshor, averall motality wos
igaifianly lover the fvrmesingroupthan nthe usal cao group (15.0% v3 25.2%,
forivermestinand sual car espectivly, 3).Mortalitywasalsoloverforvet
{cated patentsnth subgroupofpaints with sover pulmonaryInvolvement (38.8% |
 |

andusualaro respeivly, 001).Onvalvaratoanalysis,

N
I|
v8. 80.7% for ivermectin
patentsteeiving oriosteolds had highermortality thanthosethatdidnot (00% va. | |
13.7%, OR 2.7 (147to 4.99;p=001);howover,corticosteroidsweremote likely tohave |
boonprescribedforsever pacts(58.6% v 22.4% forseversandnotsovere |
meet T—— |
reeseiteemnie etgts |
achedcohort fhgrou wel sd hsb ithevespulmonary |
involvement (Tablo 2). Ithematchedcohort, ems anabsolute
associated with |
kono 12 C1O39%22.1) nd pond mod tof |
[2 SH
89(C145263) o provontonedah. |
ofstayornextubationrates,ini mcda ated oor Ofnote, Taf
115pts vi hed onddoors tpt at th

Mativrato analy wes performed onthe mach coor austin ordemographic |

ctorand btween-group differences inmarilyrisks. Independent predictors fine
hospital mortality inched treatment group, age, severe pulmonarydiseasecatogory, nd
reduced lymplioeyo count (blo 3). As ace wes ot a siganpredictorafer
adjusonent, futheranalysiswasperformedwhich showedwhite tintsvero
signifioantlyoldc thanBlack(66.8vs $0.1years;mandifference7.7 years, CL3.0
|
 i
i

12,000) andHispanic patits (49.years,moandiffrence 17.0yeas, 19.6~ |

244, p<000). |
Discussion |
nthis culhospite eospeciveeohortstudy,woabseeved asignificant association |
This
forpaints admittedwithCOVID-19.
onimproved survival
‘with ivermectin |
silo as a msc ts ihsv ly dinThs |
verconfined se taroadsnsfo oabilios and ifs
ndings |
belwocagroups,andeso.ia propertysnr tlgor
Stott vttn on or
smoking, moro oeslone nln aprescatation, higher whita oadcel |
counts and ove lymphocyte co srgdssid makes or noitemortality. I
itr gybtpin, ed or L
inet hat fneins le Richiotlspr vl |
moralityof21%info‘York City cohort,with amortality of88% ininfubated |
intheircobortofhospitalized
‘pationts.*FeiZhou otalreported a28.2% mortality
badamortality of 96.9%." ncontrast
‘patients in Whar, Chin; thor intubated patents |
toAmba et al,wedidnot sco highermortality affect for hydroxychloroquine. This |
‘mayhavobeendue 0thosoul]mumberof patientswhowerenottreatedwiththose. |
agents;ourstdywas thusunderpoweredtodetec a differ inmodality rom ;
hydonyehloroquin treatment, Wo also hypothesizo that precautionary measures in he
 ||

Hospitls’ prtoso for hydeanychloroqin socoudaveprovented the from |

developing al anhythiss,Theso cludedbeslineEKGanddalyQT monitoringby |
Ieemety foany patient receivingyoryeloroquin orcombination hepy,
avoidsofathromysinifpatients baselineQT wasgreaterthan460ses, and.
discontinuationof bydroxychlotoqune ifher was aconsnngelevtoninQT or i
hits carols ommend nian,Incone fo chy tal, vo ||
dnd monlybenef ptt howerdssid on ue |

mlvaristo alysis, whic includedseveral severly vin,Ths ising

key cxplainblbyphysica’ hoist sari afcolonrids romost |
ete ewm— RS |
wa? Re ||
We i otcof gaelBicpensincomparisonto |
Whiteuesa ling forage, ri ports avesow owe sl is |
trong lack ndHispaio pont howeverPie ta sso Fond no cal ifs i
mortality. werosgaiiantly old, whichis
Inou hospital population, white paints
rflsivoofoualchunant rc andmayboresponsible fr th discrepancy.
We didnot observe a gnfiant diffrence hospital lng of tay betweenthogroups
(eed 7 daysfrboth groups) dspth lowermortality. Possibleexplanation cold
Include delay indischargingpation to thor fils (led musing fit, inpationt
 i
|
rohabs,tc) due o lag i obtainingrequired epostCOVID-19testingresults, Patents I]
inlengthofsay measurements.
‘Whodiedwere included i
sa ofmechanical ventilation asnotadopteda autconue of test, 5guidelinesond |
practicepattems foe intubation seria changed throug houty. We
thelengthofthostud |
wero unable todetermine 1CU lengthofstyandventilatoryfreedaysIn he 10U, as
veto onions ding hpi cd lay pets hs egos I
entstectumr— determine
andwecould:
‘room andother non ICU eaviroum |

1CU say. We didnotfind a lowermortality a— |

rentedwith veto hwev e, e sss esdifeences
ousstudywasoto }
er ow.Sly, etyoss
ollswas
a hovel lity inonsev |
r group.
intheivermectin
‘poweredtodetermine sheeciti rateswero highe |
Titties |
Interpretation 7° 3 > |
urs bassve non.Dueto he rospecive obsrvsins ts ofthe |
study, dospie adjustmentfoknown confounders nd propens ity wo
scoremating,
cannot excludothopossibilty ofnmensuredconfoundingfuctors, Althoughmareofthe
controlgroup wasenvolledin th firstweeksof hestudy,suggestingthepossibilty of |
timingbia,thismay bo fotby preferential treatment ofmo sovero patents with
ivermectin carly inthstudy dust low nal availabilty. We also didnot find
consistentlydiferentmortalityoucomeswith ting veeth shot durationoftls study.
 il

Wo alsodidnotfind avidencoof ramortal tebis,asolyoneofthecontrol paticats |

ed essthan S dysfomedmission,th averags im fomadmisiantodeathwas 11 |
days,andthevastmuoriy ofpatientsreceivedivermeotnin 2daysofless.Ifweomit |
) {topat int immortal tevfom he analysis, tho mortality diffrence
withpote |
romanssignificant inbothwamatohed (15.0% vo 24.5% fo Ivermectinand usualcare |
respectively, 05) ed td 124452505 or mest a ul te |
{espaively, <0.) coor. Mstofoueputtsstudied sabdhydorychloroquins I
oem nd eeeeos ottsdirs a
haanadd bon, hte moratywoud snbatterin both groups without i
thas agents, WT |
We have shown that mst tn vs ny associated withlower |
I
pulmonary ote ings
arotempere
toprtaton ofthoso find d by the limitations |
athretuspociv design nd he possiblity of confounding, Appropentedosing fr is i
tin load, arnpatints
indication notKnown;norar theeffectsofivermeonviral with |
ido isosso,Furtherstudios nappropriatelydesignedrandomizedtalsare |
recommendedbeforeanyconclusionscanbomad. |
|

AcimowleigementyAuthor contributions: ||
||
 i
| |
s dwardGracaly,Ph.D.for hissupportand advicewith tho
wish tothankDr,E
“Thoauthor |
statistical anatyss, snd Dr, WiliamRifkin orreviewingthemanusarpt |
Juli ana:leadauthor,had fullaccessto all ofthedatain thestudy,
CRafter,M.D |
ingt
ofmanuscrip
contributed wthstudydesign, data collection and itecpretaton, writ |
Mihsol .Sherman,M.D.»provideddata analysisand interpretation,andcontrbutedto |
writingofthomanusipt a |
Nooz Fatt, MD,»contibutedwith da ollotonsnd His 9
dasiancaletion
oth study
Fabio Voge,Pharm.D.-contibue |
Son,Pn. consvdfo icoleien ed di riz |
Jean-Jacques Rajtor, MD consenting ln, conssubstantiallytotho study
design, data snlysis and BT —

Refer: 74 b
1. Nov as
M,Campr D,RoquesMéds,otal. Sty of igh dos rman:
systematicroviewandmeta-analys is.
JAntimicrob ial Chetoter, 2020; 75: 821-834,
2. Boldssen V, Belmar MAM, Vesiakis N, Kein CD,Browd:spectrum agents for
faviviral infections: dengue, Zikaandbeyond.NatRevDegDiscov. 017; 16:565-586.
3. WagstaffKM, Svakumarsn H, Heaton SM,HurichD, Jus DA. Ivermeotin Isa
‘Speific Inhibi toraffMediatedNuclear import Ableto bib Replicatioofn
ofImport
HIV-1 and Denguo Virus. Blache J. 2012; 43851-56.
 i

4,CalyL, Druce JD,Caton MG, Jens DA, WagstaffKM,ThoFDA-approve drugd i

iverm ectin
inibisthereplic ationofSARS.CoV-2 ivito dutviralResearch 2020. |
178104787. Dol: 10.1 ofprt).
2020.104787(Epub ohosd
antivir016] ||
josn
5.Munoz,Bellester MR,AntonfRNta.Saftya ndpharockinctoprofiloof |
xeddosoIvrmeet withaninpovaiven 18wgtabletin alyadultvoluntees. PLoS |
Neg!TropDis2018 1201):0006020 ES | |
Rishon,Hi 1,Nosh M, ta,PrseningChinois,
‘Camorbidites, and Outcomes Among 5700 tneHall Wi COVIDA inthe
New ok lyAre. AVA iio i2 20,
woo emma. oF x
nT, Dt,CH kts mol |
ective e Lancet,
inpatientswithCOVID-19ivan,China: aretrospcohortstudy.Th |
Volume 395, oe1022: 28 Mich3 Apel202,Fges 105-1062
6 Mag aguol
1,Nerkadan§,Psi F.ota.Outomesofhyosychlocequng
usage in i
United States veterans hospitalized with Covid-19. Published online Apel 23, 2020. dol: |
itsoorg/10.10172020.04,1620065920. |
9. Horby P, LimWS,Emberson JR, ct l. RECOVERY Collaborative Group. |
Doxaothasono ishospitalizedpatientswithCovid-19-prli ncacy.
report,NEnglIMed
ished
onlineJuly7,
‘Publ 2020,Doi: 10.10S6/NEIMou2021426. i
SE REE |
i
I
10, Garg S, Kim L, Whitaker M, etal,HospitalizationRatesandCharacteristics of

“Patients Hospitalized with Laboratory-Confirmed Coronavirus Disease 2019 - COVID-

andmortality weekly report.
NET, 14 States, March 1-30, 2020. MMWR. Morbidity i

2020,65(15):458-464. 16 |
11.Price OC,AliceFL,Shyr ¥,eta.TosilizumabtretmeatforCytokineRelease i
CHEST
dr ilud ligtoes,
SynCOVIDASptss
ood
(2020), dol: hpsy/ dolorg/10.1016chest202006006. |
{ef |

oH |
RT |
“Take Home Polnt™ ER i
NE |
Question:fs ermecti assoclatedwithowermortality ateinpatients hospitalized |
wihcovoagr
Results: Retrosp ective
cohartstudyofconsecutivepati ents hospitalized with confirmed |
InSouth lari, Anayss showed statistically
SARS-CoV-2 at fou. hospital consortium |
with Ivermectin
lowermortally rates Inthe grouptreated
signiticant ,
ascomparedto. i
thegrouptreated vith “usual care” (15.0% versus 25.2%). |
|
Interpretation: Wermectinwas associated of
with lower martalty during treatment |
COVID-19, especialy npatientswh requiredhigher Inspired oxygenorventilatory ||
support
|
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Wotaanaiysi ofrandomized valsofvarmectin( eat SARS-CoV. nfacion i

|
|
Andrew Hill, Anna Garratt’, Jacob Lev’, Jonathan Falconer, Leah Elis’, Kaitlyn McCann’, 1
Victoria Pikington*, AmbarQavi’, Junzheng Wang®, Hannah Wentzef®

1 ogatnentct
NO Pramas andhp, rary ofthat ones
7 § |
2 Degirimnt of cios ase, Unorty Hoot of wae, Cora le Eo
OrberayHedi
5. Dovanansot Boge,UK
ora or,shims et, i
4. Basanonof
London, UK
DE Lomo nfclous leases, Cele and Wsimintr gainer NH i

&5. Coton
Foca orhisicne
ivr por aa eadColegerede
Londen, Scho,
UK Urry
708 of xt, UK I
Gorresponding author: QQ |
DrAncrow Hil PRD Go)
Department of Pharmacology and mrad
Unharsyot pos, Q Po
70 Pembroke Place %) |
IPR |
ens eng ;
© i
O i
i
go

O'The Autor) of2021.

DisonSocety Published byOxfordUniversity Press an behalf
Amen ofnftions
|||
This 2 Open Aces ntl dite underth tr of he CreativeCommons {
Atribution-NonCommercial-NoDerivs licence (http://creativecommons.org/licenses/by-ne-

ya
1
EE
'1nd/4.0/), which permits non-commercial reproduction and distributionof thework, in any

workcis properly cited. For commercial re-use, please contactjournalspermissions@oup.com |

Abstract i

Ivermectin is an antiparasitic drug being Investigated for repurposing against SARS-CoV-2. |

Ivermectin showed in-vitro activity against SARS-COV-2 at high concentrations. This meta- |
analysis investigated ivermectin in 24 randomized clinical trials (3328 patients) identified

Tn
‘andfasterviral clearance
byPCR. Viral clearance was treatment doss- and duration- |

wrew ormeterna
sae sos
dependent. In 11 randomized tialsofmoderatelsevere

————
infection,therewas a56%reduction H
|
|

A
‘were evaluated. Currently, WHO recommends the use of ivermectin only inside clinical trials. |
Anetwork of largeclinicaltrialsisInprogress tovalidate theresultsseen todate. |

Keywords; SARS-CoV, COVID-19, Ivermectin, Ropurposed |

or i
Xs |
©
oR 1
|
© :
£
||
Fo
|
. |
|
 |
Introduction
||

The SARS-GoV-2 pandemic continues to grow, with over 350,000 new nfacons and over
7,000 deaths rcordod worlds dally inMay2021 [1]. Protactive vaccines have been
developed, but curren supplies are o aw to overworidide demand n the coming |
months [2]. Researchers worldwide are ugenty looking for interventions to prover now |
itm rorsGnpect anontsotrom gto |
infected. x, |
5Q i |
nensete ov un regis
evaluating he potential of aroady existing medicines against Leds many ciical
|
rio ara Inprograssto r-purpose! drugs nomally Indicated. diseases. The known
safely profiles, shortened development melas, end wellgtabsied markets (wih low {
price points and higher capacity to defera scale) I sresdyexsing ||
‘compounds proposed for COVID-19 are particu Be Bntageous compared to new drug
significant sunival benef to dat: the &lcailgnd daxamethasona in the UK |
"RECOVERY rial 3], and the Inteidfin- (Ix) receptor antagonist drugs, tollzumab and 1
nines nb EAPCP HAG ECOVERS5,Otoan i
antimicrobials such os, ey ‘e, lophaniilonav, omdesivir and iteferon- f
beta, have shown no sg |benefit in two large, randomized trals 3, 6] despite |
Intal reportsofoffica the noad for caution when Interpreting carly cinical |
ial date. §

osama roby oH sas pron sea bort o 3

ent patents with COVID-19, while tocizumab and sarlmab Improve z
buona may havrl in mld facto 78. Hower, hare aremoapproved Eo
treatmentsfor patients with mild SARS-CoV-2 Infection, either
to prevent disease }
progression orreduce vial transmission, Treatments increasing viral clearance rate may i
reduce the riskofonward transmission bul this requires empirical demonstration. |
|

2 |1
 N|

|
Ivermectin is a well-established anti-parasitic drug used worldwide for a broad number of i
parasitesandaloforloical usaagarrosacea. Antal actly
ofvermactinhas been i
demonstrated recently for SARS-CoV-2inVeroSLAM cells [9]. However, concentrations i
required to inhibit viral replication In-vitro (ECe=2.2 - 2.8uM; ECoo=4.4uM) are not achieved i
systemically teroraladinistatonofthodrugto humans, 01. |

Th drug timated 0 acoumalat nung sues (267 mestha of plasma) [11], bt this
1s aso unikely to bo sufent to maintain target concaniratons for pulmonaryanligal
actly 10,12, Noluttanding, ermoctin susual prosant as amiu i
‘and although mainly excreted unchanged in humans, has two major 3].

reaner esesse pS —— pi
funy rsptt
an teepred ves. =) i
OF |
emerges
‘action In preclinical models of several other ! In-vitro studies have demonstrated
||
]!
that ivermectin suppresses production a atory mediators nitic oxide and |
‘prostaglandin E2 [14]. Furthermore? in (from which ivermectin is derived) : |
‘significantly impairs pro-inflammat ine secretion (IL-1B and TNF-a) and increases 8 |
secteon of th immuncrogu 1-10 15], ermectn also reduced TNF I,
and 1, and improved sub ashics hen
alethal dose of popolysaccharide 16]. :
Precinical evidence ess mmunomadatry andantflanmatory mechanisms
of action havo als erated in murine models [17, 18]. Final, in Syrian golden & |
reo OScova ammsamnveinsomata
anaheim lion
natn §i
ay Uttimataly, various potential mechanismsofaction for ivermecin against 3
Hs and are undergoing further Investigation, as recently summarised in a review & i
ariohz0l, ra
|
standard doses, of 0.20 mg for 1-2 days, emectin hasa good safelyprofleand |
as been dsbute {0 bilons of patients worduido In mass drug adinisbton programs.
recent meta-anayss found no sgnifcant diference in averse evens in those gven
3 |
 |
IIBn
||
Higher dosesof erect, ofupto2mgg,andthosereceiving longercourses, ofup 10 4 | |
days, compared to those receiving standard dosas (21. Ivermectin is nt licens for
pregnanto breastfeeding ween,o olen <15kg. The WHO Guidelines Group found
hatin 16 RCTs with 2407 patcpants vemectin improved mortally outcomes compared
with control but rated the quality of avalablo evidence as low or verylow (22). Current, the |
WHO does not racommend the use of ermectin outside cincal tas.
|
The bjecve ofthis A I |
from new published or unpublished randomized tals of Merman in SARS eton 3
{o Inform current guideings. ON i ||
£
Hothods “ |
Tho systamalic review and meta-analyss was conducted according to PRISMA guidelines. |
systematic soarch of PUBMED and EMBASE was conducted to dently randomized
control tials (RCTs) avaluating raatmentith vormoctin for SARS.-CoV-2 fected
patients. Cinical tials with no conirol am, or those ovalualng pravortion of infection wera
‘xcuded alongside non-randomlzad tials and case-control studies. Keydata extracted
Included bassline characteristics (ago, sex, Weight, xygon saturation, tage of infect),
changes In inflammatory markers, viral supprossionafertreatment, lca recovery, :
hosptalzation and survival. Data wors extracted and cross-checkedbytwo ndspendant |
roviewirs (HW and LE). |
i
Search sratagy and sation criteria 8
ROT were lige or Inclusion I theycompared an lvenmeciin-based rogimon vith a i |
comparator o standard of care (SOC) for te ealmen of SARS-CoV: infection, PRISMA 3 |
chal, PRISMA flow diagram, the search erm, and ncluson/exclusion rr used are :
datallod In Supplementary Figure 1, Supplementary Tables 1, 2and 3. § |
¥ i
|
Registydatabasos were searched up unl the 121h of May 2021.Cilcaltals. gov [23] was !
‘Searched using keywords COVID, SARS-CoV-2 and Ivermectintoidanty studies. The |
WHO International Clinical Trials Registry Platform (CTRP) was accessed via the COVID- |
NMA Intatv's mapping tool [24) and Stanford Unlvorsly's Coronavirus Antiviral Rosearch |
4 |
|
|
|
Database (CoV-RDB) [25] to identify additional rials listed on other national, and
Intemational registries. Literature searches via PubMed, Embase, and the preprint servers
Modul nd Rescrchcuar wereconduc o only plod sus. Oupsts |
registrations, non-randomised studies and prevention studies were excluded following i
dcusson bowen a aur. |
Adon to rssarch em conducting ula crcl il ors contacted and |
Teuto gua rman oommoclngn fom December 20201May2021, Al |
results available from eligible unpublished studies were also included in this systematic. i |
Toi §

Af ho cat is Inde nh meta-aayi wrs approved by loca acs

commits and all plns gave lormod consent,
The primary outcome was all-cause mortality from randomization 10 the endoffollow-up. | |
Secondary ccs indocdod io fora csrane, PCR negathy a day 7, lial I]
tocar, mo to cia econ, mechanical verlan, drat of hspalzaon and
recovery and hospitalization were also summarized for individual trials where endpoints 3 |
tan {

eT 3 |
condctd sing pubishd dla summaris.Forthamotaly ctcome, clr oo winat
Jost ane ath reported vere cute i i anys, Fubar, any boslaliston ~~ 3 |
Wit 12 hoursof randomization was excluded, Traament acts
wersogrossed ss ok |
rts (5) or bry aan nde lors I) conics cones Fo |
onc uae, wo poled tho ndviua ial ates using tefandom.ofc nvarss-
ranco model cont conectionof0. was aplod eam! am with no doce. |
Heterogenelty was evaluated by I. Tho significance troshold was sel at 5% (two-sided) and |
all analyses were conducted using Revman 5.3. A funnel plot for the mortality outcome was |
|
’
 |

croatd to assass publcation bias and small study effets; he p-value was ostimated rom |
Inogres.
asdHato orsmal cy af, I
Al studios Included in this analysis were assessed fo rs of bias using the Cochrane
Collaboration risk of bias standardized assessment tool [26]. The outcome of this
assessment Is given in Supplementary Table 3, Each study was assessed for risk of blas for
tha primary endpoint, viral load, and survival outcomes. The primary endpoint n the tras |
tended to be ciinical recovery which is more subjective and likely to be influenced by |
knowledge of estment arms, An assessment vas also cared out on more objective i |
endorsing sul and il lod wich ar los ly ound bys bis |
Vihere information vias ot avalabi in publshed papers, cca tral Investigators wero |
proschely contacted to fom th risk bias analysis.

se A
wd

24 RCTs Invohing a tollof3328 participantwb edin this meta-analysis.

The |
‘sample sizes
of aach il ranged from24 to A0Dipdrilpants.Of the 24 included studies, |
elght were published papers, inevere avglbly a pre-prini, sc vere unpublished resuits |
shard
for is ana,andono 5 hte va a ia rity webste. Eo
|

Investigated multi-day uptoseven

days(Table 18) [36-50] ,ofwhich four trialswere i
doseranging 25 Inthe include tae, ermaciin was largo invstiatad in 8
mildimoderatdp (15tial). Overall 18 trials were sither singleordouble-binded gz
mie os i5 |
3
x ration } i
i
An valuation ofthoquayoftho studies inched n this meta-analysis was conducted i
accordingto the Cochrane Colaboraton toloassess the isofbias across the folowing i
auomes: primary endpoints, il load, and sural Forth primary outcome assessment, |
6726 (25%) stucios wero assessedas igh isk
ofbias [Supplementary table SAL, However, |
inassessments
ofmore objective outcomes, includingviral load and mortality, the number of |
6 |
 Hi
high risk studies was lower. In the PCR assessment, 3/15 (20%) ofthe studies wero i
assassed as high ik [Supplementary Tabl 38] In the survival assessment, 1/11 (5) of |
the studies wor assessed as high isk of. [Supplementary Table GC). |

Effects on Inflammatory Markers |

romper to tt i me
toast(GAP), fariandderal 2 Four af ese asdang | |
nleaetutons nCoom Foterere ny |
ivermectinsignificantreduced frinlovels compared to onirl Ithe nt i |
population whi no signfcant ferenca was demonsirted nthe mil pation.
The Okumus ial 47] showed sgnficanygreaterreductions i fer 100 folow-
upfor vermoctin versus conta. Tho Ghaccour [35] and Armed3) ¥ Showed no
significant diffrence n ferrin count between Ivermedtin aSo jazzar [36] showed |
significant differences in d-dimer between ivermectin
ar oS Ih both the mildimoderate |
and sevaro populations, Okumus 47] showedsignfichhy dHbrances inc-dimeron day5
whist Ghacoour [36] found no signcant mor boueon ivermectin and
contol, but with smaller samplesize
Effects on Viral Clearanco dO i

A
undatectabie ona so 38), the umberofdays from randomization t negatity
|
(Tab 38), and ros such a5 yce me (01) valuos and dose-response 8
correlations (] os Kirt [43) and Okumus [47] trials Included viral load analysis only & |
os i opaT et
SR Co i |
we viral cloarance (26, 29, 34] i |
8 1
|
“The three studies randomizing patentstodiferant doses or durations of vermactn showed
apparentdoso-dopendentoffects on viral earance. Fis nth Babaol ris (v=60) 6],
ho Cm doso showed nds or fast viral dearance than tho 02mg dose. Second, |
40 Meat i (v=128) 26 tO igh dose of Wermacie 4s umricaly Higher |
|
7 |
 |!

ofpallntswithviral clearancebydayfive thanthe 0.2mghgdose.Third, inthe

percentage |
Abmed tia (v=72) 40], ermectin treatmentforie days lad o a higher porntage of i
patients with viral clearance at day 13 compared with one day of treatment. Finally, in |
Krolewiecki (n=45) 50], PKIPD coreitins shoved significantly aster val clearance for
patients with PK exposures above 180ngimL. {

evaluating doses of up ofive days of ermectin using dosesof0.4mgkg. AL reigns.

thore were statistically significant effecis on viral dlearance In al four el Pina §
meta-analysisofvial clearance vith subgroups ofdose duration, therepig niant |
koran
i etsn nv
ofvm ln Dc 300s
enn 84208Fr as ee Sh onri
studs, similar offects of vermectin on tme to viel lsran {Supplementry
Figure 2. Furthermore, In another analysis, vermectin sholygd viral dearanco at
day7 (Relative Risk 1.35 (95%C1 1.054.75]; oon |

Effects on Clinical Recovery and en |

entre tary orale, ssrcumin
TodTottwooct |
thesix als showed significantly, to
onivermectin compared
fsbter feto olinical racovery 8 |
control. Infour tials, hem signifcanty shorter duration of hospialzation |
compared contol |
SEP
In meta-analysis recovery with subgroups of dose duration, there were 8 |
significant di imo to clinical recovery n favour of ivermectin (Mean Difference - g |
a26%
1.58days {95%G132.80, 0.35]p=0.01,Figure 1C]. Aditonally,vrmectin showed 1 |

Ivermectin demonstrated a shorter durationofhospitalization compared to conrol (Mean

t |
|
Oiforonce 427 days 85% 8.60006) p=0.05, Figur 1E), Namectn was not assocised |
With a lower sk of ospilalizaton compared {0 conrol (RR 0.40 [SOI 0.14108] p=0.07, |
Figure 1F). However, this analysis involvedonly four tials In 704 pariicipants. In a sensitivity i
°
 |]
, 1
analysis includingany hospitalzastonwilh 12 hoursof randomizathtriowoenre 1
significant ower hospiasaton compared 0 contol (RR 0.32 [95% 0.13.0.80] p=0.01, |
Supplementary Figur3)e |

Effects on Survival |
aon and
#4 randomized ils reeportded that t least no parson had diedpostandomiz—
— —— —
———
‘were incl u
inth ed
analysis (Table 5). Acrossthese 11 trials In 2127 patients, were. I

o o n
ams. In a combined analysis using Inverse variance weighting, vormoctfi
s >s6%
tedetreatrea,. mae oraapnrosvement rvriovamlrgfb vs
3
b
mo = 43% Ther was a 70% im in su in thé{aubgrdup o |
e
mildimoder participan (RR 0.30 [85%C 0.15-0.58]; p=0.0¢
at ts al number of |
deathswassmall, the analysiswasbasedon 128deaths a resas nosignificant 1
difference between ivermectin and control in the sever Jb (0.58 [95%C1 0.25-1.32];
oo >
‘Consistent res e ol
weru rves
bset d astudies (RR 0.45 |
);in an
(9501 024-p0=0.6012,Supplapiinary Faure 4)Whenony low rs ofbias studies g
were included thisresult was al ned (RR 0.31 [96%Cl 0.10-0.90}; p=0.03, | A

RE
‘Supplementary Figure RE g|

binding and oir) Group showed consryistent survival benoft and no sgnlcant subgroup i |
el (Supplomonta Figures 6,7 and 8). 3 |
APES ans wpe entatryr septs se i |
effecipn theoveral eectsize (Supplem Tabla4). B |

tment aoc wer sink nsi offen ss, 0318 (Supers Fr

n
Afunnel plot for the mortality outcome showed no significant effects of publicatio bias: the i

9. |
9 |

|
 |

eens
0.57167) p=0.92, Figure 1H. However, hs estimate was basad on iv studies in 641
|
|
particpants includingonly 49 evens. ||
|
Discussion |

“This systomati rovaw and meta-analysis of 24 RCTs (n = 3328) 3 bo

vealdaerance moro
oatment reduces flammatory markers, achive UY |
oesovo
serrate
tentrom peos
do wile deosven. Topas
||
|
“The resuls from this analysis have emerged a ermectin Project Team
mostings batweenDecember 2020 and May20a {depondent esoarchteamswere |
‘conductingthetials re cnn to sharethelr data,whichwasoften |
unpubishad, to accelrate the spodbof raping and to ansur therfragmented rosearch, g |
widespread across the world, cou ut to global leaing. Viral clearance was
evaluated by Polymerase Of (PGR) assays inal the studios, Wa have only
ptt rr ce vismeta-analysis,The 24 RCTs ncododvera
dasigned and conductd indppéndontly,with rosuts combined in May 2021, However each |
Indica vag Sf] vid range ofopuaton types nad. Glial ecovery i
definitions ifg7ed tan tialsand therawereno ignfcan ferences on survival in g
sovoro patiipuntl 1
€ 5
oR G8dary En Erapine i2
‘Secofidary endpoints for some RCTs included blomarkers of disease severly. Some of 3
aioof ton ec SATS
ee oi arco etary
‘CoV infected ptiens. Previous meta-analyses have demonstrated that igh evel of |
‘GRP, ferrin, d-dimorand ymphocytapenia ro elted to COVID-19 severly and hyper- |
inflammation [6,52]. Studies ofIL recaptor antagonists have been shown to reduce CRP |
‘and d-dmer levels In patios with COVID-1G [5].
10
|
 |
ormactin may also haavole I shortarm prevention of SARS-CoV-2 Infection, {
suggested by plot studies (53, 541. This potential benefit as needs o be validated In larger
randomized tas.
|
Nechanlsm ofaction i |
he
i |
Att meofwh ring, knoviedg gapsprevent a aust conclusion about the mecharisomf : |
‘action of ivermectin. Ivermectin's broad-specirum antk-iral effects have bean proposed to be |
olted tos Impact on the NF-cB patiwey and via bing fo ho hast col import ofp ||
heterodimer, nuclear transport proteinstresponsible for nuclear entry of cargoas, and these |
effects in turnalsopreviv aplin
ral e cation. |

As discussed in the introduction, the current in-vitro ECan esimates (2.24, 24M and 284M |
ependtrnatgioonnsgon sag ara) RG. R) ar 5 ir irma |
concen followin norma oral dosing Even doses 8.5x ol the FDA recom ended |
200ug/kg of 1.7mglkg only reach plasma concentrationsof 0.28uM [55]. The Increased z 1
bloavallbilty in the fod sate and highar concentrations soen in ung tissue compared to &
low tah urn! published ECo resus.
pliailslbem i

However, ECs, results can vary greatly depending on lab methodology, cel iniealgey, vial :a |
quantifcation methods, the storf thae virus citured andthe Mulipoflinfection used. i i
“This Is an established phenomenon: viral polymorphisms of influenza demonstrated a 54ty0k! 5 |
‘variation In EC ofdig ent neuraminidaseassaysthat looked at the susceptiboiflfii eld
ffero i |
IsoolfaIntflueenzsa virus againstoseltamivir (56). Specifically in SARS-CoV-2, ECus for 8
previously repurposed drugs have varied significantly. Remdesivr, now licensed for SARS: i
GoV-2, performed >10 old better In RACE augmented AS49 cells (0.116 uM) than Vro E6.
(1.284) [57]. wheroas olher examples of repurposed drugs Ike sofosbuvi demonstrated
over 10-fod variation in ECswhen used In Vero E6 cells versus HUHT 58], Consequently, |
the EC so far demonstrated for ermealin against SARS-CoV-2 should be interpreted with |
auton sia uly 0 bone sat valu and abl 0 change ponding on hela |
El ||
 cll es
malnodlogy sod. In roassaysfo Nrmecth shad borepost or diferent ||
np ——— |
|
Limitations
Akey Imiaon fo this mia-analysisI he comparabiityofthe ta, with stucies difering in |
dosage, eatment dural, nd Incision rei. Furthermore, th standardof caro used n |
coon amfred bans. imtr,tlht vedciv canis | |
uchas ychasl oroquinen together
oopnaenavirverecombi vithhose tat |
used placebo or standard care. However, lopinavirtonavir and hydroxychloroquine have 3 |
ps ———————
‘shown no overall benefit or harm in large randomized trials and meta-analyses. (7, 58-61] |

cael placebo an active conrl showed no sigfcant diferenc between grocps.

||
Another limitation s that Ivermectin was given in combination with doxycycine in thee tials. i
Individual trials may not have power to detect treatment effects on rare endpoints such as
ul. Outcome measureswer no iandarizad;vial clearancews measured i most
is, buta ifr me pots anc ith ifrsnt PCR ol tresholds. The rally of
PCR testsfor quantification purposes has been the subject of substantive debate. Most £ |
audiosvereconducted inpopulationswith nly midimoderat nectionand some vials |
excluded patients with mulipls comorbidities. ||
Pol
coms pn nn mention 8 |
ascit recovery andosptal discharge. However, horisk ower orooo cndpolnis 5 |
suchasviol clarence andsurvival, We aveatiemptd 0contl orpublication isby i |
‘contacting each research team conducting the trials directly. This has generated more i |
toss thanveldboapparent fom a surveyofpublshed inca ils olybut mans that : |
many o the Includedvials have notbeen peer-re Review andviewed.
publicationofRCTs i |
ofkey
for clinical rals
generallytakes three tosixmonth.Ithasbecome common practice |
‘COVID-19 treatments fo be evaluated from pre-prints, such as for the WHO SOLIDARITY, |
RECOVERY and REMAP.CAPtil [457]. |
|
P |
 ||
i
“These RCTs have been conducted in a wide range of counries, often in low-resource |
condilons and overburdened healticro syst, Larger RCTs are curenty underway in |
‘Spain, South America, Afica and NoriAmerica, wihresusfromanatonal 5000 |
paricipants expectad in Summer 2021 (Supplementary Table 5. I
|
Dept tations, is analysis suggest acoso and duration dependent pact of
em on ateofvl cearanc, Theso ils evaluateda vide range of hemacln
dosing, fom 02mg or 1 day to 0.6m for days. This vide rangoofdosos alowed an
estimation of dose-dopandency on vial clearance but reduce the number of pants i |
Inca ht wore consistant iiitred he samo dos for he sam durin. Tho |
maximo efecto dosaof erect is no yet lear and nv lial als aro valualng
igherdose, up to 1.2mghg for S days. |

“The 56% survivalbk soo n tis meta-analyses base on 128 deaths, in 1 diferent
lic ra. This Is a sma toa numborofdeaths than the RECOVERY tial, which led to
te approvalof dexamethasone and s based on 1552 deaths. Hower, the observed
rival benef of 56% hn vermect s stronger han frother repurposed dru, reauking |
‘smallersample size to be demonstrated. Emerging mortallyresultsfrom larger studies of 2 i
Wermectn wil requir careful evaluation and maychangethe conusons fro the curt £ |
wis. |
ws |
‘example sofosbuvirdaclatasui, colchicine and remdeslvibutthe benefit was not seen later g
24 Te
roniT esr patoshoses roeret. 4 |
in survival, faster time to clinical recovery and signs of a dose-dependent effectofviral 5
a seme 1
valdated I larger confirmatory is. 3

5 |
|
 |
|
Acknowledgements |
Wo ou eto thankalth nicalsa,th esearchtasandthopatentswho |
participated Inthesestudies.

Funding:Ranwatr foundation |

enamels [ol
£
:
Paton Consent Statement: Af ho lil il ced nie OS - ||i
approvedby loca liscommitoas and al patients signod Info t

Ne |
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ODO |
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|
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Research COVID-{8 (RET
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andomized sted i study.0 ING. ii3 ||
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ik JANA. Publihed one March 0, 2021 do101001fama 20213071 {
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SA COVID-19 pants: vatabio
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ListofTables and figures |

Table 1: Trial Summarios |

|i
A: vormoct ils ith Dosing
onday 1only |
B: Ivermectin trials with multi-day dosing , |
°, 3
Tablo 2: Changesin farmatry Markers QO | |
Table 3: Efct of wrmectn on vial dearance &GO |
OF |
A Effects of armen on viral clearance (binary) OO |

- tenn |
2 I.
c se sha cp fs +of vol doarance I|
Table 4; Effects on on cinical recovery and hospitalization
||
i |
nTimetogliscnry
@ ioi |
2 |
B: ivermectin on duration of hospitalization & |
§ |
G:NumberofPatni witsiia covery byDy 7to 10pos tandorizaton ||
Table 5: Effectsofivermectin on survival i

a :
 |
I
|
bydose-duration.
plotoftimetoviral clearance
Figure 1A: Forest i
11
1
Figure 18: Foros lt of PCR negativity at day 7 Ki o al and Schwartzo al measured at |
day 6

dose rate.
toiis ecveryby
Figur 1:Forest ptf ||
Figure 1D: Forest lotof cna recovery (binary) by dosa curation x. ii ||
dose
Figure 15: Forest potfron hospi SR
¢ ||
Figura 1F: Forest plot
ofnew hospitalizationsIntrials on
|
|
OS |
| |
Figure 1:Forestplo ofsuralbyseverl Jo)

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‘Regloma Ofies Office No.2 &3, Kothari House, AR.Alaa Marg,Fort,Mumbil ~23,
||
asin |!
——————————————————————
May 25,2021 |
|
LEGAL NOTICE |
™ IN
Dr. Soumya Swaminathan |
Chief Scientist, |
‘World Health Organisation |
Avenue Appia 20 |
1211 Geneva, Switzerland I
|
Subject: 1. Running a disinformation campaign against |
Ivermectin by deliberate suppression of effectiveness of drug |
Ivermectin as prophylaxis and for treatment of COVID-19, |
despite the existence of large amounts of clinical data compiled |
and presented by esteemed, highly qualified, experienced medical |
doctors and scientists. 1

2. Tssuing statements in social media and mainstream media,

thereby influencing the public against the use of Ivermectin and
attacking the credibility of acclaimed bodies/institutes like ICMR

and AIMS, Delhi, which have included ‘Ivermectin’ in the

“National Guidelines for COVID-19 management’

- Page1of51
 |

Madam, i
1, the undersigned, serve the following legal notice upon you: |
1. Thislegal notice is divided in Bight sections: ||
Sr. Nos Particulars ParaNos
1. | Your views andstatementsagainst (he use| para 2 to 10, para
HH of Ivermectin for treatment of COVID-19.
Extensive studies and trials that prove| para 11 to 20, para bo
H effectivenessof Ivemmectin in treatment of |
COVID-19.
3. [Cases in ihe United Stalcs where older| para 21 {029 |
COVID-19 patients who were critically ill, |
either in comatose state or on ventilators, 1
who have successfully recovered afer
Ivermectin was included in their line of IN
treatment. Not to miss the crucial role of |
Couts, who intervened and directed the 1
‘hospitals to administer Ivermectin on such 1!
‘patients who were at the doorstepofdeath. i
Cognizance takenof the ‘Public Statement’| 42
para 38to
issued by FLCCC on the Imegular Actions
of Public Health Agencies and the
Widespread Disinformation Campaign
against Ivermectin,
Tvermeclin and TheNational Clinical | para 43 to 45
Guidelines for Covid-19 management”
issued by ICMR.

7NOs Page2of51
 Main grounds for issuance of (is legal | para 8 to 57 i

Falling standards of World Health |

Organization. |
‘Commendable work by select courageous| para 62 60 67 ||
‘medical doctors who have lived up to their |
Hippocratic Oath.

2. That, you have tweeted the following on May 10, 2021 on Twitter: |
“Safety and efficacy are important when using any drugfor a new |
indication. @WIO recommends against the use of Ivermectin for I
HCOVIDIY except within clinical trials https: //coldShDIWSIC |
—Soumya Swaminathan (@doctorsoumya) May 10, 2021” |
|
3. That, the above-mentioned tweet came soon after the announcement from the |
StateHealthMinister of Goa, India on May 10, 2021 that all the adults in Goa |
would be given the oral drug Tvermeetin (hereinafler referred to as |
“Ivermectin’) os a prophylactic (Preventive) measure, irrespective of their |
thereason
coronavirus stafus, in a bid to bring down mortality. He stated that |
‘behind such prescription was the study conducted by expert panels from the. |
UK, Ttaly, Spain and Japan, who found a statistically significant reduction in
‘mortality dueto Tvermectin. |

4. That, you have posted the above tweet in your official capacity as the Chief |
Scientist at the World Health Organisation (hereinafter referred to as WHO).

PI ho Page3 of 51 !
 5. That, you have includ ed tweethttps:
ahyperlinkinyour itco/dShDIWSt CW, i
‘which uponclickingtakesthereaderto a page onthewebsite ofpharmaceutical 1
company Merc, that displays & statement dated February 4, 2021 issued by ||
Mercktitled “MerckStatementon Ivermectinuseduring Covid Pandemic’ |
Refer Annexure 1. |
i
6.That, you have appeared on YouTube channel MOJO STORY on May 16, |
2021, wherein you have been interviewed by Ms. Barkha Dutt in a vlog titled |
“Fearsof “Prolonged Second Wave” says WHO Chief Scientist on India’s |
COVID Calamity’. |
The link to access this vog is as follows: |
ps.
youtube.cony/watc
htt h?v=N2INIYXeLIA I
That, in this viog, |
At 23:40 markup, Ms. Barkha Dutt has posed a question to you on |
toCovid-19patients
effectivenessof medicines curentlybeing administered |
in the absence of vaccines and she specifically asks your views on
Tvermectin to start with.

At24:28 markup, you have replied;

“You know, evidence-basedguidance and treatment, prevention is
really the way to goandwhat we havetriedat the WHO is to update
our guidance as often aspossible, based on the emerging data. So
we have something called like the Living Guideline that we update
whenever some new evidence comes out. So we got evidence on
Hydroxychloroguine, Lupinavir, Ritonavir, Interferon, Ivermectin
, Remdesivir and allofthese, the evidence does not support ts use,
you know, on a wide scalefor people infected with SARS CoV-2.

PIO a. Page 4 of51

 The one drug that has a big mortality benefit is simple |
Dexamethasone corticosteroids, given at the right stage of the |
disease because COVID-19 isa viral infection. As ofnow, we have
no antivirals that really actvery dramatically on this virus and they |
would need to be given in the early stage of the disease. We are | |
hoping there are some ant virals in development that will come |
very soon. So the early stage, you can use monoclonal antibodies, |
again still under research antivivals and the secondphaseof the |
disease that is the antiinflammatory that's where the lungs are |
getting blocked with infection and people's oxygen levels are
dropping and that's when steroids help and the anti-inflammatory |
drugs and the anti-IL-6 inhibitors, they help. That's when patients |
need oxygen. So what's Ifesaving, its oxygen, its corticosteroids i
given to moderateand severely ilpatients andperhaps the anti-IL-
6inhibitors. None of these other drugs which are widely being used
including antibiotics has...” (not audible as Ms. Barkha Dutt has
started her next question)

Ms, Barkha Dutt at 26:24 —..(sound interruption) Azithromycin, Ivermectin,

Fabiftu that are now being given set base template. You would say none of these:
noed to be given or should be given.

To which you have responded at 26:34 as under;

“There is no evidence that they have any impact on the disease

progression so 1 would rather spend those resources on giving people

good quality masks to wear, In the absenceofvaccines, masks are the
only vaccines. Everybody wears good quality masks, covering their nose
and mouth, that is going to make a big difference at the community level

Wo
D Page 5 of 51
 andofcourse spendresources on ramping upofoxygen andother supplies |
thatyou need in the hospital, getting the workforce there ready. You will |
have tosupplement the workforce because the existing doctorsand nurses |
are notgoing to be enough to cope with thekindof Toad that wehaveseen,
50 those are the kindofinvestments that need to be made andyou know
these drugs really that’s ot goingfo be the ones that have an impact.”

Ms. Barkha Dutt at 27:30— Ok Tkaow you are on limited time. Ijust have one |
‘more question on the drugs and then we will do the overall picture. Remdesivir
and Plasma Therapy. These are two, again the obsessive things that continue in
India. Your last word on thos. !

To which you have replied at 27:44 as under;

“Again, we had, don’t have WHO guidance onplasma therapy but
the trial which hasjust reported,theRecovery trial, in very large
umber ofpatients showed clearly thattheplasma therapy isofno
benefit. The ICMR trial, many months ago showed the same thing
in India. Soplasma therapy again, you know, there ispoorpatient
running around tying to get plasma for their relatives. I can
understand the desperation, both on thesideofpatients and heside |
ofdoctors,just to do something, do everythingpossiblejust to save
your loved ones but unfortunately, using these unproven therapies
doesn't help, you know to save lives. So what is really critical is the
axygen at the right timeand monitoringofpeople, makingsure they |
get omgen when they start de-saturating, they gel the
corticosteroids at the right time, they get the ICU care, the
ventilation, the supportive care at the right time, that’s really
importantand I think ongoing research, so again India has large
PIO a Page 6of 51
 |
numberofscientific institutions, there are a numberofearly leads
that different lab are talking about, allofthese need to go through |
the clinical rials andshould be tested osee whether they have, we
desperatelyneedbetter treatmentsfor this virus, we don’t have and | |
50 that should continue. But in the meantime, it is really the |
approach of testing, identifying people, following them wp,
‘monitoring them, geting them into care. Majorityofthepeople will
not eed to be hospitalized obviously they can be managed at home
but the ones whoneedto must ge there and that's the only way to
reduce the deaths that we have seen happening now." i

7. That, your act ofposingthesaidtwcet on May 10,2021 as well as responses

to the questions in the interview on MOJO STORY on May 16, 2021 |
against the use of Ivermectin _for treatment of COVID-19, are highly |
unconscionable, misleading and issued with ulteriorpurposes and deliberate :
intention to underplay the effectivencss of Ivermectin in treating the
COVID-19patientsaswellas its useas aprophylaxisandtodissuadepeople: |
Sromusing this drug bycreating doubts intheminds ofpeople around safety |
ofIvermectin. |

8.That, you have deliberately disregarded thefactthatthere is Joadsofdatato

prove that Ivermectin is a safe drug and has no harmful effets in general.
The drug Ivermectin which was discovered in 1975, has been around for
around 40 years and has also won the Nobel Peace Prize, The 2015 Nobel
Prize for medicine and physiology was shared between scientists which
included Trish parasitologist William C. Campbell and Japanese
‘microbiologist Satoshi Omura for discoveries that led to Ivermectin.
itp:/own.newscientistcom/article/dn2828 -brealdhrough-

0Jo Page7of51
 i
drugs-for-malavia-and-roundworm-win-medicine-nobell |

9. That, the Ivermectin is also recognized by WHO as oneoftheten essential I

‘medications. Around 3.7 billion dosagesof Ivermectinhavebeen given out |
in'last40years andthereis sullicientdatato prove its safety, That, you have
wilfully ignored the mountains of data that shows that Ivermectin is |
undeniably helpful asprophylactic in preventing contracting COVID-19 and |
there is compelling evidenceofits effectiveness in treating active COVID- |
19 in hospitalized patients.
|
10. That, you have intentionally ignored the research undertaken by several |
doctors, scientists and their associations and alliances, who had started early |
on the pandemic, fervently searching for medicine/drug that would help in |
treatment of COVID-19. Their work which includes discussions, paper | |
presentations, data on clinica trials, is readily available on the internet. |
|
11. That, youhave deliberately chosen toignore the work ofyour own brethren |
of diligent doctors, physicians and scientists ike the ‘Front Line COVID - |
19 Critical Care Alliance’ (hereinafter referred to as ‘FLCCC?) and the |
British IvermectinRecommendation Development (hereafterreferredto as |
“BIRD") Panel |

12. That, FLCCC is an allianceofexperienced and esteemed medical doctors i

and scientists, who have come together at the start of the COVID-19
‘pandemic and are working tirelessly in conducting research, studies and. i
Randomized Control Trial (hereafter refered toas RCTs). |

TOlo Page of 51 |
 The website of FLCCC has ocean of information regarding treatment i
protocol for COVID-19,s recommendations from esteemedandexperienced |
medical professionals, testimoniesofmedical doctorsandpatients who have |
benefitted from the work ofFCCCL, |
hetpsilcovid1Scriticaleare.com/

13. That, the FLCCC team consists ofexperienced, respectablephysicians and |

scientists who possess wealthofknowledge: |
1. Dr. Paul E. Marik, MD
2. Dr. Pierre Kory, MD
3. Dr. G. UmbertoMeda,MD
4. Dr.JosephVaron, MD | |
5. Dr. Jose Iglesias, MD |
6. Dr. Keith Berkowitz, MD
7. Dr. Fred Wagshul, MD |
8. Dr. Scott Mitchell, MBChB |
9. Dr. Bivind Vinjevoli, MD |
10. Dr. EricOsgood, MD.
Their profiles/Curriculum Vitae can be accessed on hitps://covid19eriti |
caleare.com/about/the-flcce-physicians/

14.That, Dr. Pierre Kory, MD., MP.A., has testified twice on behalf of |
FLCCC, in two senate hearings of United States of America (hereinafter |
refected to as “US/USA") since the pandemic started. Thefirst one on May
6, 2020 regarding recommendation of Corticosteroids to save lives of
critically ll patients. The videoofthis hearing is available on the FLCCC

PIO on Page 9 of 51
plies
 website under ‘Videos & Press section’ and under sub menu ‘Official |

Testimony’. |
hitps:/fcovid1eriticalcarecom/videos-and-pressofficial- |
testimony! |
‘The offical transcriptofthis hearing is attached as Annexure 2. |
|
15. That, Dr. Pierre Kory in his testimony on May 6, 2021 had advanced the |
case for use of corticosteroids at an appropriate time on critically ill |
COVID-19 patients, even when all the national and international !
organisations were against the use of corticosteroids. It is noteworthy that |
the results of the ‘Recovery Trial’ which came to be published in |
November 2020, hailed the effectiveness of Corticosteroids that led to |
intheprotocol. Sadly, six precious months were lost from
overnight change |
thetime that Dr. Pierre Kory had testified, till the results ofRecovery Trial # |

were published. |

16. That, Dr. Pierre Kory, on behalf of FLCCC, has testified before the US
Senate for the second time on December 8, 2020 regarding the wonder drug.
Ivermectin and ifs potential as prophylaxis and also for treating COVID-
19 patients. In ths testimony, he has justified the use of Ivermeetin for
treating COVID-1 patients based on 10 RCTs undertaken (at the time he
testified). The 28-minute videoof his testimony is availableonthe FCCCL
website under ‘Videos& Press’ section and under sub menu Official
Testimony’.
hitos://covid]criticaloare.com/videos-und-presg/official-testimony/

is attached as Annexure 3.
The official transcript ofthis hearing

PIU Page 10 of 51
 |

17. That, Dr. Pierre Kory, in the US Senate hearing on December 8, 2020, has |
expressed his dismay over how some leading public health organisations |
including US FDA (US Food and Drug Administation), CDC (Centers for |
Disease Control and Prevention), NIE (National Institute of Health) were |
losing time in acknowledging the power of Ivermectin in treatment of |
COVID-19. Dr. Pierre Kory, on behalf of FLCCC, had implored the

Senate to have a look at their manuscript which covered the results of 10 |

Randomised Control Trials. | |

Refer page 4ofthe Annexure 3 |

18. That, the manuscript ofFLCCC haspassed arigorouspeerreviewbysenior

scientists at the US FDA and Defence Threat Reduction Agency. The same |
has been published by the ‘American Journalof Therapeutics’ .
https:/fewrekalertorglpub.releases/2021-05/fece-Ipr050621.
php |]
|
19. That the website of FLCCChas aspecial page dedicated fothe Ivermectin. |
httpsilleovidiSeriticalcare.com/Ivermeetin -in-covid-19/ |

20. That, the BIRD Panel hes also conducted expansive studics and trials i
regarding effectiveness of Ivermectin as prophylaxis and for treatment of
COVID-19 patients.
BIRD panel includes dozens of multinational scientists and doctors who
have discussed the mounting data points and evidence supporting the use
of Ivermectin in COVID-19 cases. The large, diverse group has reviewed
tho ovidence associated with Ivermetin to potentially prevent and treat
COVID-19, with a goal of reaching a consensus and making
recommendations for further investigation and/or use.

01 Page 11 of 51
 |

The details of BIRD are available on htps:/bird-group.org/ |

||
Refer Aunexure 4for the details of secommendations by BIRD sent to
WHO. ||

Doctors for Life in Brazil have supported BIRD's position and conclusions
that contradict the WHO and claim there is much evidence to recommend
vermeatin for COVID-19, and each postponed day costs many lives.

The document can be accessed by clicking following link: |

hitps://bird-group.org/evidence-to-recommend-ivermectin/ |

BIRD Panel had organized the FIRST INTERNATIONAL

IVERMECTIN YOR COVID CONFERENCE on 24% and 25" April i
2021 | i
“The video is available on following link: |
bitps:/bivd-group.org/eonference-post-event! 1
ReferAnnexure 4 forthedetailsofrecommendations by BIRD sent to WHO.

21. That, it is disingenuous of you to have not acknowledged the cases of

miraculous recovery ofcritically ill COVID-19 patients in the US, who were
treated with Ivermectin, That, you have wilfully neglected the exemplary
‘work by FLCCC and all such physicians and scientists who have brought
back critically ll comatose and patients on ventilator from the doorsteps
ofdeath,

Do Page 12 of 51
 |
by theCourtsofLawwho passedordersto direot
22.That,thepatients were saved |
the concerned hospitals to administer Ivermectin, as US FDA has not yet |
approved Ivermectin for treatmentof COVID-19.
|
23. Tha, Ivermectin has saved the life of one 81 year old male COVID-19 |
patient names John W. Swanson, whose chances of survival were minimal. 1
Refer Annexure 5, anews article in Buffalo News dated April 9, 2021 titled |
“Judge orders Batavia hospital to treat coronavirus patient with |
|

|
Ivermectin *

coronavirus-patient-with-Tvermectin /article_53c8h32e-996c-11eb-87ct- |
2bd34f11d3c2 html {

|
‘The article states; I
|
“Swanson was on a ventilator and “on death’s doorstep.” at the i

United MemorialMedical Center when doctors there gave him one

doseofIvermectin on April 1, according to an affidavit filed in
court by attorneys for Swanson’s wife, Sandra. “After that one
dose, he started breathing on his own. He was taken off the |
ventilatorandwas making great progress,” saidattorney Ralph C.
Lorigo, who represents the Swanson family with Jon F. Minear.
“Then, the hospital refused to give him additional doses.” State |
Supreme Court Justice Frederick J. Marshall issued an order on |
April 2, directing the hospital to give Swansonfour more doses of
Ivermectin . Asoflate Friday afternoon, his attorneys described
Swanson as “stable.”

0Jo. Page 13 of 51
 i
24. That, another 80 year old critical COVID-19 patient named Judith il
‘Smentidewicz has had a miraculous recovery from the disease with the help |
of Ivermectin . !
Refer Annexure 6, a news article in Buffalo News titled ‘After | |

on
experimental Covid-19 treatment, 80-year-old woman thankful to be
||
hitps:/fouffalonews.com/news/locallafier-experimental-covid-19:
treatment-30-vear-old-woman-thanlful-to-be-homelarticle_dfac9da- |]
7204-11eb-bS44-2{0deSaeSd71 html |
‘The article states;
“AsJudith Smentkiewiczfoughtfor her life ina local hospital {
last month, she hadno idea that her struggle ith Covid-19 |
was the subject ofa heated court battle and stories in the
news media. Until afew days ago, the 80-year-old woman I
was unaware that herfamily’s lawyers had obtained a court
order enabling her to receive dosesofIvermectin, a drug
that has notyet been approved by thefederal government as
a Covid-19 treatment. Now that she’s back at her
Cheektowaga home and swell on the road to recovery, |
Smentkiewicz is amazed at everything that happened to her. |
saidshe has “absolutely no memory” ofafive-
Smentkiewicz |
dayperiod when she was on a ventilator atMillard Fillmore |
Suburban Hospital. According to family members, doctors |
there told them that her chances ofsurvival were about 20%. |
“I remember being taken to the hospital in an ambulance on |
Dec. 31, and being put on a stretcher in a hallway,” |
Smenthiewicz said. “Iknow theyput me on the ventilator that |

Ns Page 14 of 51 |
 day, but 1don't remember a single hing that happened until
Jan. 4, when Iwas takenoffthe ventilator and able (0 sit up :
in my bed. I'm kindofglad I don’t remember those days.” ||
Unapproved by FDA, Ivermectin useful as Covid-19
treatment, Tocal doctors say she now knows that her son,
Michael, and daughter, Michelle Kulbacki, insisted that |
doctors give Smentiewicz Ivermectin , a drug that has
helped Covid-19patients in other counties but has notyet |
‘been approvedas a Covid-19 treatment in the U. | |

She also realizes that, when doctors were reluctant 10 give |

her more than one doseofthe drug, her son and daughter |
hired attorneys Ralph C. Lorigo and Jon F. Minear to get a |
court order that enabled her fo get more doses. OnJan,8, |
State Supreme Court Justice Henry J. Nowa ordered the |
hospital to resune treatment with Ivermectin. After tha, b
Snetkienicz made a strong recovery, She was able to leave |
the hospital in mid-January.

She then spenta month in the HarrisHillNursingFacilityin |

Amherst, and on Tuesday, she returned home. “I am so
appreciativeofmyfamily, the lawyers, thejudge, the doctors,
and all these people who were prayingfor me andfighting
for me,” said Smentliewicz, speaking to a reporter in a
strong, clear voice. “I know had a lotof prayer warriors on
myside.”
“While she was on the ventilator, we prayedfor Mom. We
prayed to God, and the answer that came back fo us was
Ivermectin ,” Kulbacki said. “My brother was doing some
PNT Page 15 of 51
 research on his own and came up with the information about |
Ivermectin . Nothing else was helping our mother. We read |
that Ivermectin was helping other people and had no !
dangerous side effects. We decided we had to fry it.”
Kulbacki said her mother made “a complete turnaround” |
within daysof herfirst doses ofIvermectin
Smentkiewicz said she got “very good” care in the hospital |
and nursing home, and nowfeels she is “at about 85%” of |
where she was before she caught the virus. “I'm eating, |
walking, exercising, getting myselfdressed and making my I
own bed, getting bac fo normal Ife litle by littl,” she said. |
“Ifeel good, butIget outofbreathif I ry to do too much. |
I'm having a little trouble with balance and doing physical |
therapy twice a week.” For years, she has been active as a 1
volunteer at the Chapel in Cheeldowaga, where she babysits
young children while their parents attend Sunday services.
Smentkiewiczsaidshe is anxious to get back to that, and also
wants to expand her volunteer activites. “One thing Isawn
the nursing home was so many elderly people who just
wanted someone to come in, help them open their mail and
talicwith themfor a while,” she said. “I thinkIwould like to
go in as a volunteer and visit with people who need that.”
She added that thepublicity about her case will encourage
families of suffering Covidl9 patients to research the
possibility ofusingIvermectin to treat them.
Doctors recently told The News that Ivermectin has helped
many patients at two of the_region’s busiest Covid-19

TAD Page 16 of 51
 |

treatmentcenters-theElderwoodHealthCarefacilityin

ThomasMadejski,aformer presidentoftheNewYork State. |

Medical Society.said hehasalsowed Toermeetinas an |
effectivetreatmentfor Covid-19patients in Erie, Niagara
and Orleans counties. “It has very benign side effects, and |
that is one reason I have been offering it to patients,” said
Madejski, whosaid he was speaking onlyfor himself, and not
Jor the state medical society. Smentliewicz said she has no |
way of knowingif Ivermectin is a miracle drug. She said |
she is thankful she did not become one of the nearly |
500,000 Americans Killed by Covid-19. |
“I can’t say it will help everyone, but I definitely believe it i
helped me, with no side effects,” Smentkiewics said. “1feel |
that God kept me around forareason. He hada planfor me,”
she added. “ believe thatpart of thatplan is to getpeople
to take a closer look at Ivermectin.”

25. That, in third incident, a critically ill COVID-19 68 year old female
‘patient named Nurije Fype, who was in a state of medically induced coma,
at the Elmhurst Hospital in 2 comatose state and who was successful in
dodging death due to inclusionofIvermectin in her lineoftreatment.

Refer Annexure 7, an article published on Medical Brief titled “US judge

orders administration ofIvermectin to comatose patient dated May 12,
2021:

tps: ww medicalbrief
co zalarchiveshus-judge-orders-

PIO Page 17 of 51
 administration-of-Ivermectin -to-comatose-patient/ |
|
26. That, the caseofNurije Fype is a milestone in success of Ivermectin in |
he treatment of COVID-19. In this case, inspite of the court order to |
administer Ivermectin on Nurije Fype, the hospital had refused to act on |
the order. This left no option to the familyof Nurije Fype but to consider
filing a contemptofcourt petition against the Elmhurst hospital.
The article in Annexure 7 states that; |
“At request of herfamily an Illinoisjudge has ordered that a {
comatose woman sufferingfrom COVID-19 to be administered | |
Ivermectin , against the advice of her doctors, reports
the Chicago Tribune. |
NuriieFype, 68, has been in intensive care at the hospitalsince |
early April and is now on a ventilator, according to testimony |
at the court hearing. Her daughter, Desareta Fype, ispushing
forher mother to receive Ivermectin, a medication that the US |
Food and Drug Administration says may be unsafe. |
|
Anotherfederal agency, the National Institutes ofHealth, has |
taken a more measured stance, saying that while the drug is Lo
well-tolerated when usedfor its intendedpurposes, there isn’t ||
enough information to allow a recommendation “for or |
against” using it o treat COVID-19. |
Elmhurst Hospital's attorney, Joseph Monahan, said at the | |
hearing none of its doctors would agree to administer |
Ivermectin for COVID-19, and that an internal ethics panel | |
concluded its use couldn't bejustified. He argued that judges |
shouldn't overrule medical decisions. |
NOs Page 18 of 51 |
 {
“(The court) doesn’t have the authority to order a medical '
corporation to use particular medications, particularly when 1
it's an offlabel use, particularly when thefederal government i
has said it could be dangerous,” he said. |
Ie suggested Desareta Fype could transfer her mother to |
another facility where doctors would be willing to use the i
‘medication, but Judge James Orel seemed astonished at the i
suggestion. “Let me get this right: The hospital is willing to |
transfor a woman in a coma with COVID?” he said. "Is that |
what you're telling me?” ||
Judge Orel pointed to an affidavit from Fype's physician, Dr H
Willian Crevier, in which the doctor said he has used the drug 1
successfully for COVID-19 patientssince last year, If Elmhurst |
Hospital's doctors don’t want to use Ivermectin , Orel said, |
they should allow Crevier to administer it. |
“Why wouldn't this be triedifshe’s not improving?” Orel said. |
“Why does the hospital object toproviding this medication? If i
someone has been in the ICUfor a month and not improving, |
why would the hospital not consider another medication?” |
It was still not clear, however, whether the hospital would
allow Fype to receive themedication.Orelsaid he expected the |
case to head fo an appellate court, and when he asked |
Monahan ifthe hospital was going to follow his order, the |
attorney replied, “Iwilltalkfo my client,”
|{
|
TAO " Page 19 of 51 |
 I
For more deiails regarding Court hearing, click on link below; i
https:/ialsitenews.com/when-nothing-else-works:udges-ae-siding sith: |
Ivermectin |
On May 4, 2021, Judge Orel’s response was pointed.“Uf there’s a medicine out 1
there that can assist apatient and nothing else is workingand she’s regressing
10 the point of near death, then, yes, I balance the equities.” Meaning he |
weighed the evidence and sided with what many doctors call the “right to try”. |
“This rows is covered by FOX 32 News channel and the same can be viewed on |
following link: |

“COVID-19 patient shows ‘improvement’ after receiving Ivermectin |

following legal batle with hospital’ |
http://www youtube.com/watch?v=gEAOICEDYY. |
This video features patient Nurije Fype’s daughter Desareta Fype and their
Attorney Ralph Lorigo.
27.The news related to interventionof out in facilitating the administration of
Ivermectin on Nutje Fupe is covered in detail on following websites:
News dated May 1, 2021 titled ‘Court Battles Rage tosave Lives. Attorney:
“Put Hospital Chief in Jail
tps: www.beckershospitalreview. com/pharmacy/illinois-hospital-gives-
covid:19-patient-Tvermectin following-court-order. him]
News dated Api 16, 2021 titled ‘Ivermectin goes to Court and the NIB
relaxes ts prohibition’

0 on Page 20 of 51
 https: hwww.thedesertreview.com/opinion/leters_to_editor/Ivermectin _ - |
‘goes-to-court-and:the-nih-relaes-ts-prohibition/article_140b7300-59bf-
Lleb-b945-4f69ec28fdc0.html |
News dated April 21, 2021 fied “Ivermectin Wins in Court Again: For |
Human Rights’
https:/fwww.thedesertreview.com/opinion/letters_to_editor/Ivermectin _- |
wins-in-court-again-for-human-rights/article_98d26958-a13a-11eb-a698-
37¢06£532875. html |

28.That, Dr. Pierre Kory, who has expressed his anguish over refusal by the I
‘Blmburst Hospital to administer IvermectinonNurije Fupe, despite having a |
court order and the subsequent consideration to initiate contempt of court
proceeding by the patient's family, has been covered by FOX 32 on May 4, :
2021and the samecan be viewed on following |
tips: wn youtube. comvatch?v=eEF1eOcRlw)
In this video, Dr. Pierre Kory states;
“They are behaving indefensibly. I think the Judge is
dismayed, their horror at what they (hospital) are doing
matches mine. It is inexcusable”
https:/ftrialsitenews.com/court-battles-rage-to-save-lives-attorney-put-

hospital-chiefin-jail/
29."That, there are likely to be more cases of COVID-19 patients having
benefitted from using Ivermectin n their ineoftreatment. However, duc to
stricter laws in the USaroundpatient privacy, not all cases have made to the:
news and not all patients are forthcoming in sharing the details. But the.

0Jo Page 21 of 51
 testimonies of those who have dodged death and have survived, certainly bo
makeastrong case fo use Ivermectin. |

30.That, FLCC based on its objective studies and RCTs has prevailed upon
National Institute ofHealth (NTH) to change their guidance on Ivermectin
to “Neutral” on Tamuary 14, 2021, after rferencing the incrcased numbers of |
clinical tial that have been done with positive results since thei last update |
on August 27. They now recommend neither for nor against the use of |
Ivermectin for COVID-19. |
hitps://sww.covid]dtreatmentguidelines.nih gov/antiviral- |
therapy/Ivermectin / |

31.That, in Indis, Dr. Surya Kant Tripathi, Head of Respiratory Medicine ||

Department, King George Medical University, Lucknow, along with some |]
other health experts of India, has written a White Paper on Ivermectin, in |
which he has emphasized that this drug reduces the replication rateofthe |
infection by several thousand times. |
alm nihgov/omelartiol
hitps: /wrw.n cbi
es/PMCT434458/

32. That, the Whit paper byDr. Surya Kant, the studics undertaken by AIMS
~ Bhubaneswar and several other research and studies undertaken by
medical doctors aad scientists across the globe, have proved Ivermectin to
be effective as a prophylaxis and also inthe lineoftreatment for COVID-
1.

theFLCCC in ts Press Release on April 29, 2021 titled ‘Front Line

33. That |
COVID-19 Critical Care Alliance Statement on New Guidance on |

HO | Page 22 of 51
 Tvermectin from the All India Institute of Medical Science’ has praised |
the AIIMS for including Ivermectin in their national Covid-19 guidelines.
FCCL has expressed their gratitude towards AIIMS for having followed the |
science on Ivermectin in creating the new Guidelines. }
Refer Annexure 8.

34. That, FLCCC and BIRD have issued a “Joint Statement on Widespread
use of Ivermectin in India for Prevention and Early Treatment’ on i
May 3,2021.
hitps://orww.cinnews.com/pr_news/540334684/medical organizations |
inethe-ukey-s-join-the-govemment-of-india-to-recommend-Tvermectin i
to-end-the-covid-19-crisis !
|
https://covid]criticalcare.com/videos-and-press/flcce-releases/joint: |
statement-may-03-2021-joint-statement-on-widespread-use-of: |
Ivermectin -in-india-for-prevention-and-carly-reatment |

Refer Annexure 9

35. That, the Ivermectin has been widely used to treat Covid-19 in South
Africa, Czech Republic, Bolivia, Honduras, Peru, Slovakia, Zimbabwe |
Bangladesh, |
The Tink hitps://ivmstatus.com/ gives pictorial representation of global |
Ivermectin adoption for COVID-19. The status is updated rogulacly. |
|
36. That, in your interview on Mojo StoryonMay 16, 2021, while Ms. Barkha |
Dutt has asked you a pointed question at 22:40 whether to continue using. i
Remdesivir and Ivermectin, you have deliberately misled the audicnce by i

Afo. . Page 23 of 51
 not revealing the mountains of evidence on effectiveness of Ivermectin. |
You, instead of giving a balanced response, that was expected from 1
someoneofyour stature, have resorted tostrawmanargument and diverted in
the attention of people to areas totally unrelated to the specific question
‘posed to you, You have responded by saying; |
“There is no evidence that they have any impact on the disease |
progression so I would rather spend those resources on giving I
people good quality masks to wear. In the absenceofvaccines, 1
‘masks are the only vaccines. Everybody wears good quality masks, |
covering theirnose andmouth,that is going to make abigdifference |
at the community levelandofcourse spend resources on ramping |
upofoxygen and other supplies that you need in the hospital, |
getting the workforce there ready. You will have to supplement the |
workforce because the existing doctors andnurses are notgoing to |
‘be enough to cope with the kindof load that we have seen, so those
arethekindofinvestments thatneedto be made andyouknow these
drugs really that's not going t0 be the ones that have an impact.” {

37.That,inthesaid interview on Mojo Story, you havementionedaboutthe Living |

Guidelines issued by WHO on March 31, 2021. |
‘The Living Guideline can be accessed from the websiteofWHO: ]
> tps:/funwnwho inthews:roomfeature-siories/detail/vho-advises- |
that-vermectin -only-be-used-to-treat-covid-19-within-clinical-trials |
> Bttps:/mwwwho,intipublications/ifitem/WHO-2019-nCoV-
therapeutics-2021.1 |

Refer Annexure 10 for document titled “Therapeutics and COVID-19° i

0I" Page 24 of 51
 |
LIVING GUIDELINE DATED MARCH 31, 2021 issuedbyWHO.

38.MALAFIDES OF ‘WHO’ IN MISLEADING THE PUBLIC WITH |

TERIOR PURPOSES: ]

38.1. That, the LIVING GUIDELINE dated March 31, 2021 |

||
includes recommendations of WHO on several drugs |
including Ivermectin. The WHO panel has made a
recommendation not to use Ivermectin in patients with |
COVID-19 except in the context ofa clinical trial. |
The document also states the studies and finding of the |
Global Development Group (GDG), which supposedly |
served as the rationale for such recommendation regarding i
Ivermectin.
|
382. That, he explanation provided by WHO in the said Living |
Guideline dated March 31, 2021 is debunked by FLCCC by |
exposing the severe fallacies and bias on the past of WHO 1
whichwas pre-determined to block the cheap drug Ivermectin |
from being discovered as effective drug in prevention and {
treatmentofCOVID-19. |
Refer Annexure 11 - Public Statement dated May 12, 2021 issued by |
FLCCC titled Trregular Actions of Public Health Agencies and the |
Widespread Disinformation Campaign against Ivermectin’ |
|
|
|
|

0Jo. Page 25 of 51
 |
Refer the following link:
hitps:/Jeovid19eriticalcare.comvideos-and-press/floce-releases/tloce- |
alliance-statement-on-the-irregular-actions-of-public-health-agencics-and- I
the-widespread-disinformation-campaign-against-ivermectin/ |

39. That, the para 3 to 8 ofthe Public Statement dated May 12, 2021 issued by |
FLCC tiled “Irregular Actions of Public Health Agencies and the
‘Widespread Disinformation Campaign against Ivermectin’
read as under; ! |
“The following accounting and analysis of the WHO |
Ivermectin panel's highly irregular and inexplicable analysis
of the Ivermectin evidence supports but one rational |
explanation: the GDG Panel had a predetermined, i
nonscientific objective, which is to recommend against |
Ivermectin. This is despite the overwhelming evidence by |
respected experts calling for its immediate use (0 stem the i
pandemic. Additionally, there appears to be a wider effort to
employ what are commonly described as “disinformation |
tactics” in an attempt to counter or suppress any criticism of |
the irregular activity ofthe WHOpanel. |
The WHO Ivermectin Guideline Conflicts with the NIH |
Recommendation |
The FLCCCAlliance is a nonprofit, humanitarian organization |
made up of renowned, highly published, world-cxpert |
clinician-researchers whose sole mission over the past year |
has been to develop and disseminate the most effective |
treatment protocols for COVID-19. In the past six months, i

Nj Page26 of 51 |
 much of this effort has been centered on disseminating 1
knowledge of our identification of significant randomized, |
observational, and epidemiologic studies consistently i
) demonstrating the powerfil efficacy of Ivermectin in the |
prevention and treatment of COVID-19. Our manuscript |
detailing the depth and breadth of this evidence passed a |
rigorouspeer review by senior scientists at the USS Food and |
Drug Administration and Defense Threat Reduction Agency.
Recently published, our study concludes that, based on the |
totality of the evidence of efficacy and safety, Ivermectin |
Should be immediately deployed toprevent and treat COVID-
19 worldwide. |
Thefirst "vdlag! is the conflict betwe en 31, 2021,
theMarch I
WHO Ivermectin Panel's "against" recommendation and the |
NIE's earlier recommendationfrom February 12thof a more |
supportive neutral recommendation based on a lower amount |
ofsupportive evidenceofIvermectin's efficacy at that time. |
Twoflawed lines ofanalysis by the WHO appear to accountfor |
this inconsistent result |
1) The WHO arbitrarily and severely limited the extent and |
diversity of study’ designs considered (e.g, retrospective |
observational controlled trials (OCT), prospective OCTS, |
epidemiological, quasi-randomized, randomized, placebo- |
controlled, etc). |
2) The WHO mischaracterized the overall quality of the trial {
data to undermine the included studies. |
The Severely Limited Extent andDiversityof Ivermectin Data |
Considered by the WHO's Ivermectin Panel |

NOs: Page 27of 51

|
|
 The WHO Ivermectin Panelarbitrarily includedonlya narrow. ||
selectionof the available medical studies that their research
team had been instructed to collect when formulating their
recommendation, with virtually no explanation why they |
excluded such a voluminous amount of supportive medical |
evidence. This was made obvious at the outset due to the
following:
1) No pre-established protocol for data exclusion was \
published, which is a clear departurefrom standard practice |
in guideline development. |
2) The exclusions departed from the WHO's own original |
search protocol i required of Unitaid's Ivermectin research,
which collected a much wider arrayofrandomized controlled 1
trials (RCT). ||
Key IvermectinTrial Data Excludedfrom Analysis bl
1) The WHO excluded all “quasi-randomized” RCTs from |
consideration (two excluded trials with over 200patients that |
reported reductions in mortality). |
2) The WHO excluded all RCls where Ivermectin was !
compared to or given with other medications. Two such trials |
with over 750 patients reported reductions in mortality.
3) The WHO excludedfrom consideration7ofthe 23 available
Ivermectin RCTresults. Such irregularities skewed theproper
assessmentof important outcomes in at least the following
ways:
)Mortality Assessment
i) WHO Review: Excluded multiple RCTS such that only 31
total trials deaths occurred; despite this artificially meager

0Jo. Page 28of51

 sample, an estimateof up to a 91% reduction in the risk of |
death wasfound. |
1) Compared to the BIRD Review: Included 13 RCTs with 107 {
deaths observed andfound a 2.5% mortality with Ivermectin I
vs. 89% in controls; estimated reduction in risk of |
death=68%; highly statisticallysignificant, (p=007). |
b) AssessmentofImpacts on Viral Clearance
§) WHO Review: 6 RCT, 625 patients. The Panel avoided |
mentionofthe importantfinding ofa strong dose-response in | |
regard to this outcome. |
i) This action in (i) is indefensible given that their Unitaid |
researchteamfound thatamong 13 RCTS, 10 of the 13 reported. |
statistically significant reductions in time to viral clearance, |
with larger reductions with multiday dosing than single-day,
consistent with aprofound dose-response relationship.
©) Adverse Effects |
1) WHO: Only included 3 RCI studying this outcome. |
Although no statistical significance was found, the slight |
imbalance in this limited sample allowed the panel to !

fo
repeatedly document concerns for “harm” with Ivermectin

i) Compare (a) to the WHO's prior safety analysis in their

|
|

|
2018 Application for Inclusionof Tvermectin onto Essential
Medicines Listfor Indicationof Scabies:
(1) “Over one billion doses have been given in large-
scale prevention programs.” |
(2) “Adverse events associated with Ivermectin 1
treatment areprimarily minor and transient.”
|
|
I1a Page 29 of 51
 4) The WHO excluded all RCTs studying theprevention of COVID- i
19 with Ivermectin, without supporting rationale. Three RCls |
including almost 800patientsfoundan over 90% reduction in the risk. |
of infection when Ivermectin is taken preventively. |
5) The WHO excluded observational controlled rials (OCT), with 14 i
StudiesofIvermectin. These included thousandsofpatients, including |
those employing propensity matching, a technique shown to lead to |
similar accuracy as RCT. |
4) One large, propensity-matched OCT from the USfound that |
Ivermectin treatment was associated with a large decrease in |
oy |
1) 4 summary analysis of the combined data from the 14 ||
available Ivermectin OCTs found a large and statistically ||
significant decrease in mortality. |
) The WHOexcluded numerous publi shed
andpostedepide miologic
studies, despite requesting and receiving apresentationofthe results i
from one leading epidemiologic research team. These studiesfound: |
4) bn numerous cities and regions with population-wide Ivermectin |
distribution campaigns, lange decreases in both excess deaths and
COVID-19 casefatality rates were measured immediatelyfollowing |
the campaigns.
b) Counties with pre-existing Ivermectin prophylasis campaigns |
against parasites demonstrate significantly lower COVID-19 case |
counts and deaths compared to neighboring countries without such |
campaigns. |
Assessmentofthe Qualityof the Evidence Base by WHO Guideline i
Group 1
The numerous above actions mininizing the extentof the evidence

3 j
N Page30of51
 base were then compounded by the below efforts to minimize the |
qualityofthe evidence base: il
The WHO mischaracterized the overall quality ofthe included trials |
as "low" to "very low," conflicting with numerous independent expert
research groupfindings:
1) An international expert guideline group independently reviewed I
theBIRDproceeding and insteadfound the overall quality ofrials to |
be “moderate.” |
2) The WHO's own Unitaid systematic review team currently grade |
the overall quality as “moderate.” i
3) The WHOgraded the largest trial it included to support a negative ||
assessmentof Ivermectin’s mortality impacts as “low risk ofbias.” I
A large number ofexpert reviewers have graded that same trial as |
“high riskofbias,” detailed in an open letter signed by over 100 |
independentphysicians. !
We must emphasize this criticalfact:Ifthe WHO had more accurately !
assessed the quality ofevidence as “moderate certainty,” consistent |
with the multiple independent research teams above, Ivermectin |
would instead become the standard of care worldwide, similar to
what occurred after the dexamethasone evidence finding decreased
mortality was graded as moderate quality, which then led 10 its |
immediate global adoption in the treatmentofmoderate fo severe i
COVID-19 in Julyof2020.
Further, The WHO's own guideline protocol stipulates that quality
assessments should be upgraded when there is thefollowing:
1) alarge magnitudeofeffect (despite their data estimating a survival
benefitof81%, thelow number ofstudiesandevents includedallowed
them to dismiss thisfinding as “very low certainty”) or;

TI fo Page 31of51
 I
2) evidence ofa dose-response relationship. The WHO shockingly i
omits the well-publicized reports by their Unitaid research team ofa |
powerful dose-response relationship with viral clearance. |
In sum, the WHO's recommendation that “Ivermectin not be used
outside clinical trials” is based entirely upon: |
1) the dismissalof large amounts oftial data; |
2) the inaccurate downgradingof evidence quality; and |
a dose-response relationship with viral
3) the deliberate omission of 1
clearance. |
Consequently, these actionsformed the basis oftheir ability 10 avoid |
a recommendation for immediate global use. |
Even more surprising is that based on their “very low certainty” |
Jinding, the panel goes on to “infer” that “mostpatients would be |
reluctant to use a medication for which the evidence lef high ||
uncertainty regarding effects on outcomes they consider important,” Il
This statement is insupportable in lightofthe above actions. No |
patient could ever rationally consent to a trial in which they were |
acutely ill and would be subject to the possibility of receiving @ |
placebo, once informed of; the large amountofrelevant andpositive |
trials that the WIIO removedfrom consideration, their avoidance of |
reporting a large dose-response relationship, and their widely !
contradicted “very low certainty”gradingoflarge mortality benefits.
Such a trial would result in a historic ethical research violation,
causing both a widespread lossoflife and a resultant lossof trust in
PHA and research institutionsfor decades to come.
Themany methods employed by the WHO to distort the evidence base
and arrive at a non-recommendation are made even more suspicious
and questionable by thefollowing:

0Jo Page 32 of 51
Op
 |

1) The WHO GDG did not hold a vote on the useof Ivermectin . This |
highly irregular decision was purportedly based on the Tvermectin |
Panel's “consensus on evidence certainty.” ||
2) Unitaid Sponsors allegedly inserted multiple limitations and i
weakened the conclusions in fhe preprint, systematic review |
manuscript by the Unitaid research team, which has recently led to |
formal chargesofscientific misconduct. |
3) Recent WHO whistleblower complaintsofexternal influences in 1
other WHO Covid reports, as well as attempts by massive external |
funding organizations to increasetheirinfluence informulating WHO |
policies.
4) The findingof marked differences in the evidence bases used to 1
supportprior WHO/BIRD guideline recommendationsforIyermectin ||
in otherdiseases: |
4) WHO: Approved Ivermectin in the treatment of scabies |
based on 10 RCTS that included only 852 patients, despite it
being inferior to the standard ofcare.
b) EDA: Approved Ivermectin in the treatment of
strongyloidiasis based on 5 RCTs that included only 591
patients.
©) BIRD: Approved Ivermectin in March, 2021, for the
prevention and treatmentof COVID-19 based on 21 RCTs and
2,741 patients
Conclusion
As expert clinician-researchers in society, we are firmly committed to
ensuring that public health policy decisions derive from scientific
data. Disturbingly, after extensive analysis of the recent WHO
Ivermectin guideline recommendation, we could not arrive at a

Ho. Page 33 of 51
Dis
 |
credible scientific rationale to explain the numerous irregular, {
arbitrary, and inconsistent behaviors documented above. Further, |
after consultation with numerous physicians, guideline reviewers, |
legal experts, and veteran PHA scientists, we identified two major i
socio-political-cconomic forces that serve as the main barrier |
influences preventing Ivermectin 's incorporation into public health 1
policy in majorpartsof the world. They are: |
as “Big
1) The modernstructureandfunction of what wewilldescribe |
Science” and; |
2) The presenceof an active "Political-Economic Disinformation i.
Campaign.” |

40. That, the said Public Statement also states that (page 2); 1
“A similar conclusion has also been reachedby an increasing number
ofexpert groupsfrom theUnited Kingdom (UK), Italy, Spain, United
States (US), and a group from Japan headed by the Nobel Prize- i
winning discovererofIvermectin, Professor Satoshi Omura. Focused |
rebuttals that are backed by voluminous research anddata have been
sharedwith PHAS over thepast months. These include the WHO and
many individual members of its guideline_development group
(GD). the FDA, and the NIH, However, these PHAs continue to
Ignore or _disingenuously manipulate the _data_to_reach
unsupportable recommendations against Ivermectin treatment, We
ave forced to publicly expose what we believe can only be described
as a_ “disinformation” campaign astonishingly waged with full
cooperation of those authorities whose mission is to maintain the
integrity of scientific research and protect public health.”

PDo Page 34 of 51
 41.That, we as members of public, have taken cognizance of the said Public i
Statement dated May 12, 2021, issued by FLCCC and we call upon you to |
provide your respons as the Chief Scientist at WHO, to the fallacies pointed i
out by FLCCC regarding the Living Guideline of WHO dated 31.03.2021 i
based on the study conducted by Development Guideline Group regarding | |
Ivermectin. |

42. That, your failure to provide rebuttal to the contents mentioned in para 39
supra, shall be taken as acceptance of the fallacies in the Living Guideline I
Report of WHO dated 31.03.2021. i
|

43.That, “The Indian Council for Medical Research’ (horeafter referred to as

ICMR) which is the oneofthe oldest and largest medical bodies in the world 1
and which is the apex medical research organization, has listed the drug |
Ivermectin as a possible treatment option for mild Covid-19 patient under
‘home isolation in the ‘May Do’ category on April 22, 2021. The National
Clinical Guidelines for Covid-19 management are doveloped by All India |
Institute of Medical Sciences (hereinafter referred to as AIMS), Delhi and |
ICMRjoint taskdorce. Refer Annexure 12. |

44.That, the Ivermectin continues to be part of the National Protocol ssucd by i

the ICMR even at the timeofdrafting this legal notice. Refer Annexure 13 |
for the National Protocolas updatedon May 17, 2021. |

45. That, you aro a qualified medical doctor possessing the degree ofMBBS and
MDin Pediatrics from ATMS Delhi. You have serv edr General of
asDirecto
the ICMR and Secretaryofthe Departmentof Health Research (Ministry of

0i" Page 35 of 51
r=
 |
Health and Family Welfare) for the Government of India from August 2015 |
to November 2017. That, going by your educational qualifications and work |
experience, you are deemed to be competent enough to understand the |
significance of statements/protocols/notifications issued by the esteemed |
organizations of India like ICMR and ATIMS, which you yourself were |
associated withatsome point in time, But you have been repeatedly issuing 1
Statements against the use of Ivermectin with a malafide intention to i
misguide, mislead and create confusion in the minds of Indians in order to |
dissuade us from knowing about Ivermectin which has brought back fow |

i
critically ill COVID-19 patients from the doorsof death. !

46. That, while you have aftached the company statement issued by Merck in |
your feet on May 10, 2021, you have intentionally ignored the fect that |
Merck, which is the manufacturer of Ivermectin may have a conflict of |
interest in issuing the said statement against the use of Ivermectin in |
treatment of COVID-19 as mentioned in para 4, since Merck is in process of |
making its own COVID-19 drug and that clinical trials for the same are in |
|
progress.
Refer the following link: |
found-a-
tps: uhyp.org/segments/some-doctors-think-theyve |

heard-ofit/
|
An excerpt from the above news articlo titled ‘Some doctors think they’ve |
found a cheap, generic drug which treats COVID-19, So why hasn’t |
anyone heardofit?’ states; i

I» Page 36 of 51

plies
 “Merck, which originally developed Ivermectin but whosepatent on |
it expired, does not endorse its use for COVID-19 treatment. In a |
statement, a Merck representative said that “following detailed |
review ofthe evidence availablefor Ivermectin we calculatedthat the |
dose required to attain an antiviral effect would significantly exceed |
the doses known to be safe and well tolerated,” referencing the in |
vitro study. “We therefore concluded thatfurther research to evaluate |
the clinicalpotentialof Ivermectinfor the treatment ofSARS-CoV-2 |
was not warranted.” |
Merck is in the processofdeveloping its own new therapyfor |
in
COVID-19, which it wouldpresumablypatent. It is also involved |
vaccine trials.” ||
Merck has issued a statement January 25, 2021 regarding developmentofits |
two investigational therapeutic candidates for treatment of COVID 19. Refer 1
Annexure 14.

47. That the Ivermectini off-patont since 1996andtherefore it i available at a

cheap rate at present.

48. That, your malafides are proven through your act of attaching the public
statement of apharmaceutical company Merck dated February 4, 2021 instead
ofthe Report ofWHOdatedMarch 31, 2021in your tweet on May 10, 2021.
That, you were aware that the said WHO report on Living Guideline dated
March 31, 2021 is an eyewash as far a the recommendation on Ivermeetin is
concerned and hence you deliberately attached an older statement of Merck
dated February 4, 2021.

Nj Page 370f51
 i

49. That,itwas your malfeasance reflectinginthe tweet on May 10, 2021 agaiast |
the useof Ivermectin in desperate hope to dissuade peopleofIndia from |
discovering the effectiveness of Ivermectin and that they kecp fuling sick | |
asahuge market for several drugs which arebeing launched
and are available |
sow and which are in the pipeline and would bo launched soon once the
Emergency Use Authorisation (BUA) is granted for their public use.
|
50. That, you are wilfully spealiag sgainst theuseof Ivermectin for COVID-19 i
patients as you are aware that in the eventofIvermectin being declared as an |
existing and adequate drug’ fo treat COVID-19, the Emergency Use |
Authorisation (BUA) currently granted fo variety ofvaccines and drugs would
stand revoked and this vill severely impact the prospectsofnew vaccines and |
drugs being manufactured to combat COVID-19. |

51.That, you have abused your position 2s the Chief Scientist at WHO to
adversely influence the people including medical doctors and scientists, by
trying to impose upon them the fact that WHO does not support the use of
Ivermeetin either as prophylactic of in treatment of COVID-19.

52. It seems that you have deliberatly opted for deaths of peaple to achieve your
ulterior goals snd this is a sufficient ground for criminal prosecution against
you end also for initiating action for revocation of your degrees in medical
field,

53.Tha, it i highly unbecomingofyou as a physician and scientist, to insist on

Randomized Control Trials amidst pandemic, to ascertain the efficacy of
IvermeetinintreatmentofCOVID-19, Thisisequivalent to you taking astand

IJo Page 38 of 51

=
 |
|
that allows people to fall sick and probably die of COVID-19, but docs not }
allow them to take a drugwhichhas not only been proven to be safe with no |
‘harmful effects, buthasalsobeen proved to be effectiveas prophylaxisandin
treatment of COVID-19 in numerous cases across the globe. This isjuxtaposed |
tothe factthatpreciousfime was lostinconducting thesolidarity rialbyWHO |
that concluded that most of the drugs or therapies did mot work viz
Hydroxychloroquine, Remdesivir and the convalescent plasma.

54.You are deliberately ignoring the medical ethics and principles that you are |
bound to follow; |
1. The Declaration of Geneva of the World Medical Association
(WMA) binds the physician with the words, “The health and |
wellbeingofmy patient will be my first consideration,”
https://www.wma net/policies-post/wma-declaration-of-geneva/

2. Intemational Code of Medical Ethics declares that, “A physician

shall act in the patient’s best interest when providing medical
care”
tps: www.ywma.netfup-content/uploads/2006/09/nternational=
Code-of-Medical-Ethics-2006 pdf

3. Article 37 oftheWMAdeclaration ofHelsinki, titled: “Unproven

Interventions in Clinical Practice” It is paraphrased as “In the
treatment of an individual patient, whereproven interventions
do not exist, a physician may use an unproven interventionifin
the physician’s judgement it offers hope of saving life, re-
establishing health or alleviating suffering

PI ho Page 39of51
De
 DoF:
iips:/fwww. oma netfwp-content/uploads/2016/1 ||
0ct2013-IAMApdf |

55,That, you are called upon to read Article 37 of the WMA declaration of i
Helsinki mentioned in para 54 supra, at least a hundred times and provide a |
cogent explanation for:
1. Not supporting the useof Ivermectin in treatment of COVID-19, 1
isproven
given the fact that Iverme ctin to be safe with no harmful |
effects. I
1
2.guoring the presence of voluminous data that proves the
effectivencssofIvermectinnottoforge,t the oases wherepatients
have been taken off ventilator soon after Ivermectin was 1
administered(Refer para 21 to 28) !

56. That, your misleading tweet on May 10, 2021 against the usc of Ivermectin
had the effect of the State of Tamil Nadu withdrawing Ivermectin from the
‘protocol on May 11, 2021 just a day after the Tamil Nadu Government had
included the same for treatment of COVID-19 patients.
ttps://science.thewire.in/health/tn-revises-protocols-leaves-out-
Ivermestin-for-covid-patients/

57.That, the re-purpose drags which were included in the solidarity trials like
Remdesivir, hydroxychloroquine have proved to be ‘Ineffective’, so did the
convalescent plasma therapy. Your concerns around use of Ivermectin for
COVID -19 misplacedgiventhe fectthatIvermectin has no harmful
aretotally
side effects unlike corticosteroids and Remdesivir. Hence, resistance touseof

ls Page 40 of 51
 Ivermectin on flimsy grounds and that too by wilfully ignoring the |
‘vodata lum ino
thatproves venessof the drug,isnotatall tenable,
theeffectius |
rather it proves your malafides and ulterior purposes. |

: 58.That, the credibility and integrity of WHO has been severely eroded and |
continues towanewith cachpassing daydue toitsmiserable failu re
inhandling |
the pandemic. Also, the reports issued by WHO are increasingly been seen us i
biased and totally lacking in quality, authenticity and rational approach. The |
latest the reportregarding investigation into the originsofthe Corona Virus is |
also being questioned by the scientists’ community. As many as eighteen |
eminent scientists have written to WHO asking for detailed investigation. |
ws. com/articles/soiontists-call-for-decper-investigation-into-
ttps://wvw |
covid-19-origin-1 1620928801 |

“The above article states; |

“In a letter published Thursday in the journal Science, an
international group of 18 biologists, immunologists_and_other
scientists criticized the findingsof a report released in March by a
World Health Organization-led team into the pandemic’s origin and
called for a more extensive evaluationof the two leading hypotheses.
that the pandemic virus entered. the human population and began
spreading after escapingfrom a lab or afterjumping fo humansfrom
infected animals.

TheWHO-led team, whichincluded scientistsfrom China and several

other countries, reported no definitiveproofofeither hypothesis. Yet,
the scientists wrote, the team nevertheless concluded that an animal
origin for the pandemic was the likelier scenario and devoted only

\Dfo. Page dl of 51
NO
 |
||
ofa lab accident.”
four outofthe report's 313pages to thepossibility |

59. That, the WHO report published in March 2021 regarding the investigation |
into the origins of Corona virus is found to be severely lacking in many aspects, |
‘which is explained in following article;
https:/lscience.thewire. in/the-sciences/scientists-ltter-fuller-investigation-
‘origing-novel-coronavirus--lab-natural-spillover/ |

“The article sates;

“This was evidently a comment on the WHO's investigation into the | |
originsof the virus. Under the termsof referenceof this investigation, ]
the information, data, and samples for the study'sfirst phase were |
collectedandsummarised bya teamof Chinese scientists. The rest of |
the team only built on this analysis, which found no clear |
evidence either 1o support a natural spillover or a lab accident. |
However, the team said a zoonoticspilloverfrom an intermediate host |
was “likely to very likely,”and a laboratory incident was “extremely |
unlikely”. }
Even before the WHO report was released in March this year,
reports said in November 2020 that the WHO had ‘ceded control of
the investigation to China in a bid to gain access to the source of
coronavirus. The reports argued that the WHO was eager to “win
access and coordination”from China but achieved neither.”

60. That, several nations are callingout WIIO for its falling standards, biased
approach and is deliberate acts ofomission and commission that arc causing loss
of human lives.

i ho Page 42 of 51
 While the WHO flaunts itselflike ‘know it ll’, it is akin to the vain Emperor in
new clothes, while the entire world has realized by now that the Emperor (WHO)
has no clothes at all. |

61. That, you and WHO have inisled and misguided all the people throughout |
the pandemic, starting from the delay in raising alarm soon after SARS-CoV2 was |
detected in China, your failure to prevail over China in conducting an impartial 1
investigation into the origins of the virus, inordinate time consumed before
declaring Remdesivir, Hydroxychloroquine, convalescent plasma as ‘ineffective’ |
in treatment of COVID-19, ever changing theories around SARS-CoV2 being |
transmitted through droplets or it being air borne and many more. The world is ||
your absurd, arbitrary and fallacious approach in presenting
up tong
‘gradually waki |
concocted facts as “scientific approach’. As the famous quote ofAbrahamLincoln

“You can fool all the people someofthe time and some of the |
ot people all the time.”
foolallthe
peopleallthe time, butyou cann |
|
62. That, the teamofFLCCC have besceched all countries to use Ivermectin
which accordingto them is the only way to end this pandemic.

Refer the article below tilled ‘immediate global Ivermectin use can end Covid-
19 pandemic: Scientists’ published onlin onThee Free Press Journal on May 10,
2021:
https:/hwww.freepressiournal.in/health/immediate-global-Ivermectin_-
use-can-end-covid-19-pandemic-scientists

TOfo. Page 43of 51

Oj
 |
|
63. That, the article mentioned in para 55 states; !
“Peer reviewed by medical experts that included three US |
government senior scientists andpublished in the American Journal |
ofTherapeutics, the researchi the most comprehensive reviewofthe |
available data takenfrom clinical, in vitro, animal, and real-world {
studies. |

Led by theFront Line COVID-19 Critical Care Alliance (FLCCC), a |

group of medical and scientific experts reviewed published peer-
reviewed studies, manuscripts, expert meta-analyses, and |
epidemiological analyses of regions with Ivermectin distribution |
efforts all showing that Ivermectin is an effective prophylaxis and |
treatmentfor COVID-19.

"We did the work that the medical authorities failed to do, we
conducted the most comprehensive reviewof the available data on
Ivermectin," said Pierre Kory, MD, president and chief medical
officerofthe FLCCC. "We applied the goldstandard to qualify the
data reviewed before concluding that Ivermectin can end this
pandemic."

A focusof the manuscript was on the 27 controlled trials available in

January 2021, 15 of which were randomised controlled trials
(RCTS). Consistent with numerous meta-analyses of Ivermectin
RCTs sincepublished by expertpanelsfrom the UK, Italy, Spain and.
Japan, they found large, statistically significant reduction in
‘mortality, time to recovery and viral clearance in Covid-19 patients
treated with Ivermectin .

Pe Page 44 of 51

Oo
 |
. ||
||
"Our latest research shows, once again, that when the totality of the
evidence is examined, there is no doubt that Ivermectin is highly i
asasafeprophylaxis andtreatment
effective for Covid-19," said Paul
E. Marik,founding member of theFLCCC and Chief, Pulmonary and |
Critical Care Medicine at Eastern Virginia Medical School. {
|
Many regions around the world now recognise that Ivermectin is a
powerful prophylaxis and treatment for Covid-19. South Africa, ||
Zimbabwe, Slovakia, Coech Republic, Mexico, and India have 1
approved the drugfor use bymedicalprofessionals.
asseen in this lateststudy demonstrate that the Ivermectin
Theresults
distribution_campaigns repeatedly led to "rapid population-wide
decreases in morbidity and mortality."
"We are calling on regionalpublic health authorities and medical
professionals around the world to demand hat Ivermectin be
included in their standard of care right away so we can end this
pandemic once andforall," Marik noted.”

64. That, the work done by FLCCC, BIRD and similar groups, has ruffled the
feathers of many including WHO, whose inefficiencies and failures have
been exposed time and again.

65.That, there is a vicious attempt by some individuals including doctors,

scientists and leading public health organisations, to suppress all the news
regarding effectiveness of Ivermectin. This Syndicate has managed to
capture considerable portion of scientific and medical community, who

NO |. Page 45 of 51
 |
|

continuously discredit any reportshews around the effectiveness of |

Ivermectin in treating COvid-19 patients.
Such deliberate actions ure explained in detail in the Public Statement by
FLCC(ReferAnnexure 11, page 8 to 13) |

66.That the FLCCC and BIRD have shown exemplary courage in building a |
formidable foree to tackle the challenges in the form of disinformation, i
resistance and rebukefrompharma lobbies, powerful health institutions like |
WHO, NIH, CDC and regulators ike US FDA. |

67. That in the time of this crisis, there are fow doctors who are living up to ||
their Hippocratic Oath, by putting the patients” interest first and not being |
complicit in the agenda of spreading disinformation. These brave and |
courageous doctors, who are morally upright, have chosen to support the. |
truth rather than yielding meekly to authoritative and unscientific mandates.

These doctors are your very own brethren who are highly qualified,
experienced and more importantly humane end conscientious.

The FLCCC site hus a video dated April 19, 2020 that features following
brave doctors, who hav been forthcoming in declaring the effectiveness of
Ivermectin:
-M.D, FCCCM, FCCP
1. Dr. Paul E. Marik
Norfolk, Virginia :
2. Dr. Bruce Boras ~MD,
Key West, Florida
3. Dr. Keith Berkowitz ~M.D, MBA

NO Page 46 of 51
 |
New York |
4. Dr. Eric Osgood -MD. i
Trenton, New Jersey |
—PhD
5. Dr. Colleen Aldous |
Durham, South Africa |
6. Dr. AlexisLieberman M.D. |
Philadelphia, Pennsylvania |
7. Dr. RandyGrellner M.D. ||
Cushing, Oklahoma |
8. Dr. Jackie Stone M.D. |
Harare, Zimbabwe |
9. Dr. Syed Haider ~MD. !
Asheville, North Carolina !
10.Dr. Fred Wagshul ~M.D.
Dayton, Ohio
11.Dr. William Crevier—M.D. :
OrlandPark, Hiinois
12.Dr. Arezo Fathie ~ M.D.
Las Vegas, Nevada
13.Dr. Bruce Patterson ~ M.D.
Palo Alto, California
14. Dr.Miguel Antonatos — M.D.
Chicago, Illinois
15. Dr. Matt Erickson M.D.
Gainesville, Florida
16. Dr. Ram Yogendra~M.D.

mDo Page 47 of 51
 |

Pawtucket, Rhode Island. i

17. Dr. Tess Lawrie — MBBCH, PHD |
‘Bath,United Kingdom |
“The video can be accessed on Jlps://eovid]Seriticaleare.comlvideos-and-
press/flecc-alliance-videos/ I
|
“The description ofvideo reads thus:
‘They are truly adhering to their Hippocratic Oath and Putting patients ~ not |
profi fist. r
“These brave doctors are rising to the highest ideals of the i|
Hippocratic Oath theytookto save the livesofthe patients who 1
come intotheircare. These are the truest heroesof this ruthless |
pandemic. They have chosen to #followthescienceand save |
lives—and have refissed to be party to_the corruption that is
endemic among the world’s health authorities. There are more
brave doctors out there.”

That, Dr. Paul E. Maik, towards the endofthe video, states the following |
regarding Ivermectin ; |
i
“The statistics for us is, we know this can make a difference |
andsave lives, Anditseems like nobody really cares and wants |
10 listen to us. We have this massive force that is trying to |
silence us and yet wefeel we can't be silenced. We can't be, {
becauseyou know the truth will ultimately prevail”. i

68. That, the Constitution of India, as per Article ST A (h), casts a solemn duty |
upon me to develop scientific temper, humanism and the spirit ofinquiry and |

D
Mo Page 48 of 51 i
 |

reform. Therefore, I shall relentlessly pursue and question anything that is

||
found tobe unscientific, biased, arbitrary, flawed and irrational, especially in i
these times when several people are losing their lives, which could have been
saved but for the vicious attempts by a few to suppress vital information.

69. That, you are called upor: to:

(1) Provide your and WHO's response to ach and every finding shared
by FLCCC in their Public Statement issued on May 12, 2021 |
regarding (he fallacies in the Living Guideline issued by WHO on
March 31,2021 |

(2) Furnish the study papers, research, knowledge resources relied upon |
by you, based on which, you have tweeted against the use of i
Ivermectin on May 10,2021.

(3) Explain the rationale for attaching the notification of Merck dated
Teb 4, 2021 insteadofthe Living Guideline issued by WHO onMarch
31,2021,inyour tweet onMay 10, 2021.

(4) Explain with facts and figures that support your stand that
Ivermectin is not safe.

(5) Strictly refrain from sharing your views on Ivermectin for COVID-
19 til you address points 1,2, 3 and 4 above.

70. That, your failure to provide any response or a clear response to all of the
points in para 69, shall be deemed as acceptanceofall claims and allegations

he Page 49 of 51
 |
against you in this notice and we reserve all the rights to initiate legal action |
against you, which will be at your perl.

71. ‘This notice is issued by reserving our rights to initiate prosecution under |
sections 302, 304 (I), 8, 120 (B) and 34 and other provisions of the Indian |
Penal Code and under Disaster Management Act, 2005 in the appropriate ||
Courts of Law having jurisdiction for cach death cased due to your act of |
commission and omission.

Date: 25.05.2021

Place: Mumbai Die

Adv. Dipali N. Ojhia

Head - Legal Cell
Indian Bar Association
‘www.indianbarassociation.in

Copy to,
1. Hon’ble President of India
2. Hou'ble Prime Ministerof India
3. Hon'ble Governors of all StatesofIndia
4. Hon'ble Minister of Home Affairs
5. Hon'ble Minister of Health and Family Welfare
6. The Director, Intelligence Bureau
7. The Director, CB
8. Hon'ble Chief Ministers of all States of India

0a Page 50 of 51
Op
 ||
9. The Director General of Indian Council of Medical Research (ICMR)

10.The Director, All India Institute of Medical Sciences, Delhi (AIYMS)

11.The National President, Indian Medical Association
12. The Drugs Controllerof India |
13. The Director, The National Institute of Virology, Pune |
14. The Chairman, National Medical Commission (NVIC) |
15. South East Asia Office WHO, Delhi, India i
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