Exhibit 21 — Horse-Bleep: How 4 Calls on Animal Ivermectin Launched a False FDA-Media Attack (Document 12-21)

Summary

Exhibit 21 (Document 12-21) in Case 3:22-cv-00184, filed August 8, 2022 in TXSD, reproduces "Horse-Bleep: How 4 Calls on Animal Ivermectin Launched a False FDA-Media Attack on a Life-Saving Human Medicine," a Substack post by Mary Beth Pfeiffer and Linda Bonvie dated Oct 16, 2021. The authors write that the Mississippi health alert said "At least 70%" of recent poison control calls involved animal ivermectin, and that the AP and The New York Times later corrected the share of calls about ivermectin to about 2%. The post includes FDA emails, obtained under the Freedom of Information Act, in which Erica Jefferson tells Janet Woodcock the "Not a Horse" tweet reached 14.5M and that the Consumer Update was accessed 177k times in one day. It also cites a Northern New England Poison Control Center notice of 14 human exposures to ivermectin in 2021.

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Case 3:22-cv-00184 Document 12-21 Filed on 08/08/22 in TXSD Page 1 of 12

Exhibit 21
Case 3:22-cv-00184 Document 12-21 Filed on 08/08/22 in TXSD Page 2 of 12
j RESCUE with Michael Capuzzo Signin \v

Horse-Bleep: How 4 Calls on Animal Ivermectin Launched a False
FDA-Media Attack on a Life-Saving Human Medicine

Our investigative reporters dug up the FDA memos documenting the start of a

propaganda campaign, and got The New York Times to correct its false
reporting.

Mary Beth Pfeiffer and Linda Bonvie
Oct 16, 2021 Y "16 O 211

The Propaganda That Started The Big Lie:

U.S. FDA @ @US FDA - Aug 21
You are not a horse. You are not a cow. Seriously, y'all. Stop it.

fda.gov

Why You Should Not Use Ivermectin to Treat or Prevent COVID-19
Using the Drug ivermectin to treat COVID-19 can be dangerous and
even lethal. The FDA has not approved the drug for that purpose.

© 14k Td 72.6K © 117.8K

In a hokey tweet on August 21, the U.S. Food and Drug Administration told Americans the

obvious: “You are not a horse. You are not a cow. Seriously, yall. Stop it.”

Everyone knew what “it” was: an animal form of the drug ivermectin that folks were said to be
using, widely, for covid-19. Don’t, said FDA.
Case 3:22-cv-00184 Document 12-21 Filed on 08/08/22 in TXSD Page 3 of 12
Within two days, 23.7 million people had seen that Pulitzer-worthy bit of Twitter talk.
Hundreds of thousands more got the message on Facebook, LinkedIn, and from the Today

Show’s 3 million-follower Instagram account.

“That was great!” declared FDA Acting Commissioner Janet Woodcock in an email to her
media team. “Even I saw it!” For the FDA, the “not-a-horse” tweet was “a unique viral

moment,” a senior FDA official wrote to Woodcock, “in a time of incredible misinformation.”

There was one problem, however. The tweet was a direct outgrowth of wrong data—call it
misinformation—put out the day before by the Mississippi health department. The FDA did
not vet the data, according to our review of emails obtained under the Freedom of Information
Act and questions to FDA officials. Instead, it saw Mississippi, as one email said, as “an

opportunity to remind the public of our own warnings for ivermectin.”

The story behind the tweet that went ’round the world shows how a myth was born about
a safe, if now controversial, human drug that was FDA-approved for parasitic disease

in 1996 and bestowed the Nobel Prize in Medicine in 2015. It is a story in which the barest

grain of truth morphed into an anything-goes media firestorm.

It began with one sentence in a Mississippi health alert on reports to the state’s poison control
center: “At least 70% of the recent calls have been related to ingestion of livestock or animal
formulations of ivermectin purchased at livestock supply centers.” In the thick of a fierce covid
wave in the American South, no official at the FDA, or reporter for that matter, seemed to ask:
70 percent of what? Instead, government and media joined forces against a public health

threat that, in retrospect, was vastly exaggerated.

Amid dozens of articles that ensued, Rolling Stone told of Oklahoma hospitals so jammed

with ivermectin overdoses that gunshot victims had to wait for care—except it wasn’t true.

Twice, The New York Times printed corrections of the same false information from Mississippi,

which it described in one article and later removed, as “a staggering number of calls.”

The Associated Press, Washington Post and, twice, the The Guardian in London also corrected

its reporting on the alert.

The Times’ correction summed it up: “This article misstated the percentage of recent calls to
the Mississippi poison control center related to ivermectin. It was 2 percent, not 70
percent.” (The Times and Post both made corrections in direct response to our reporting for

this article.)
Case 3:22-cv-00184 Document 12-21 Filed on 08/08/22 in TXSD Page 4 of 12
In real numbers, six calls were received for ingestion of ivermectin. Four were for the

antiparasitic drug given to livestock.

If ivermectin reports had indeed been 70 percent of calls in the twenty days covered by the
alert, about 800 would have flooded the poison control line. Instead, eight came in. Two callers
sought information. Five had mild symptoms. One was advised to seek further care, according

to data from the Mississippi Poison Control Center.

Without question, people should not take drugs made for animals, given issues of dosing and

medical oversight, to name just two. That much is clear.

But in hopping on the Mississippi bandwagon, the FDA achieved a long-standing goal
separate from warning against livestock dewormer. It obliterated the line between the
ivermectin that saved millions from river blindness in Africa and the worm-killing animal
medicine that—“Stop it, y’all”—only the deluded would try. It turned ivermectin,

which doctors and health ministers in several countries say has saved many from covid-

19, into a drug to be feared, human form or not.

This highly effective bait-and-switch began last March with a webpage, to which the FDA
tweet linked, that conflates the two ivermectins. On one hand, the FDA tells of receiving

“multiple reports of patients who have required medical attention” after taking the animal
product. On the other, it describes the fate awaiting people who take large amounts of any

ivermectin, ending a long list with “dizziness, ataxia, seizures, coma and even death.” The

medical literature, nonetheless, shows ivermectin to be an extremely safe medicine.

So how big was the surge that FDA described as “multiple”? Four, an agency spokesperson
said just after the page went up. Three people were hospitalized, but it wasn’t clear if that was
for covid itself. When pressed for details, FDA cited privacy issues, and said in an email,

“Some of these cases were lost to follow up.”

This is how government gets away with some whoppers, and with the media’s help.

Below, FDA officials crow over the deception that was “the most popular post
we've ever had on Twitter:”
Case 3:22-cv-00184 Document 12-21 Filed on 08/08/22 in TXSD Page 5 of 12

View Zoom Share Rotate Markup
To: Woodcock Janet
Subject: RE: Sharing: FDA Ivermectin / COVID-19 Tweet Goes Viral
Date: Monday, August 23, 2021 3:29:22 PM

Attachments: image002.png

Hi Dr. Woodcock,

| just wanted to update you on some cool stats Brad just shared from the tweet today. Since we are a data driven agency, | thought you'd appreciate seeing
some visuals on the numbers.

e Currently, it’s the most popular post we've ever had on Twitter. There is a caveat with this statement given that today’s vaccine approval is on its heels.

e Allsaid, it looks like we gained a total of 11K followers across the accounts we posted these on. That's up 636.7% from the two days prior. That growth is
17.6K overall, including today’s vaccine approval social posts.

All in all, we're pleased with the response and the results here. It was also a perfect lead-in to today’s vaccine approval, meaning we reached thousands more
than we might have had we not picked up some additional followers that were drawn in by the tweet.

Please let us know if you have any follow up questions.

Erica
Profiles =
Reporting Period 1,681,379 10,881 6 16,099,564 565,755 3.5%
Compare to 1,670,404 1,477 2 739,636 11,100 1.5%

...and the FDA commissioner was thrilled:

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

Sent: Sunday, August 22, 2021 1:15 PM

To: Jefferson, Erica <Erica Jefferson@fda.hhs.gov>

Subject: RE: Sharing: FDA Ivermectin / COVID-19 Tweet Goes Viral

That was great! Even | saw it! Agree, we need to be creative and accessible! Excellent start! jw

(These excerpts are from emails obtained by Linda Bonvie under the Freedom
of Information Act.)

Within days of the tweet, headlines crowed, “Say ‘neigh’ to ivermectin,” while cable hosts and
comedians riffed on “horse paste.” USA Today, ABC News, The Hill, Slate and NPR picked up
the story. When CNN retweeted “not-a-horse,’ FDA was gleeful. “The numbers are racking up

and I laughed out loud,” wrote FDA Associate Commissioner Erica Jefferson in one email.
Case 3:22-cv-00184 Document 12-21 Filed on 08/08/22 in TXSD Page 6 of 12
On October 5, forty-six days after posting, the Mississippi health department “clarified” its
alert to say that 70 percent of ivermectin calls—not of all calls—were for the animal kind. The
image of dread, however, lives on in archived stories that often used nifty but hardly

accurate shorthand, like overdose or poisoning. In reality, ten of twenty-four ivermectin calls

to the Mississippi center from July 31 to Aug. 22—40 percent—merely sought information, our
reporting found, which is common to poison control centers. In 2019, poison control centers

logged more than 47,000 reports for acetaminophen and 83,000 for ibuprofen.

In this email obtained by Linda Bonvie under the Freedom of Information Act,
FDA officials celebrate reaching the “everyday” American with a tweet that
sparked a media firestorm of lies:

From: Jefferson, Erica <Erica.Jefferson@fda.hhs.gov>

Sent: Sunday, August 22, 2021 11:35 AM

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

Ce: Tierney, Julia <Julia.Tierney@fda.hhs.gov>; Safford, Melissa <Melissa.Safford@fda.hhs.gov>;
Rebello, Heidi <Heidi.Rebello@fda.hhs.gov>; Mulieri, Chris <Charles.Mulieri@fda.hhs.gov>;
Kimberly, Brad <Brad.Kimberly@fda.hhs.gov>; Walsh, Sandy <Sandy.Walsh@fda.hhs.gov>;
Felberbaum, Michael <Michael.Felberbaum@fda.hhs.gov>

Subject: Sharing: FDA Ivermectin / COVID-19 Tweet Goes Viral

Hi Dr. Woodcock,
| hope you are having a great weekend. | know we are all eager for tomorrow.

Separately and as you know, the OEA team and | have been meeting over the past several weeks to
discuss ways in which we can more effectively use our social media platforms to share important
public health information with consumers. I’m sure you saw some of the news coming out of
Mississippi on Friday regarding the use of ivermectin to treat / prevent Covid-19 and the increase in
adverse events (poisonings) the state highlighted as a result of its use. | expressed to the team late
Friday night that we take the opportunity to remind the public of our own warnings for ivermectin
and by early Saturday morning the social media team had posted the following tweet:

Needless to say, the direct, straight-forward and clever (humorous) communication, paired with a
follow-on tweet that provided additional answers to common questions about ivermectin, saw the
tweet quickly going viral and being shared across multiple social medium platforms (where it was
amplified by other influencers) and resulted in additional news coverage by: NYT, CNN, NBC News
and Rolling Stone to name a few. Notably, the official Today Show Instagram account (3 million
followers) also featured an original post on the account. We also took the opportunity to highlight a
Consumer Update on ivermectin, that was prepared and distributed earlier this year. I’m pleased to
report that as a result of the tweet, the update was accessed 177k times yesterday alone.

By comparison, the tweet currently ranks as our 2"? most popular tweet of all time in terms of the
number of people we’ve reached with the content:

J&J Pause tweet - 20.4M
Not a Horse tweet — 14.5M
Immunocompromised EUA FB - 10.8M
Case 3:22-cv-00184 Document 12-21 Filed on 08/08/22 in TXSD Page 7 of 12

J&J Pause tweet inside original tnread - 6.6M
Pfizer4Kidz tweet - 4.5M

As you know, | am committed to identifying unique (for FDA) ways for us to reach the “everyday”
American to “brand” FDA. | am grateful the OEA team is enthusiastically supportive of this goal and
in particularly, | want to recognize Brad, Chris and Sandy, for mobilizing quickly Friday night and
Saturday morning to create a unique viral moment at such a critical time for the FDA’s image and in
our fight against Covid-19. While we won’t always be able to take this approach (we are still a
government entity), we will seek to develop content that allows the agency to feel both accessible
and informative in a time of incredible misinformation. We will be meeting with OCC soon to discuss
our new recommended approach for social media engagement. We look forward to sharing more
about these efforts in the weeks ahead, including an ambition effort to counter much of the vaccine
information out there as we prepare to approve Comiraty.

Please let me know if you have any questions in the interim. Thanks for your support on our efforts

to evolve FDA’s communications with consumers.

Best,
Erica

Erica V. Jefferson (she/her)
Associate Commissioner for External Affairs
U.S. Food and Drug Administration

Tel: 240-702-3994

erica jefferson@fda.hhs.gov

Amid the hubbub, the Northern New England Poison Control Center posted a
notice September 15 stating it had “managed 14 human exposures to ivermectin in 2021,”
mostly in early September. “None of these patients experienced significant effects from the

ivermectin.” Other states—Illinois, lowa—have reported similar numbers.

This isn’t to minimize potential poisoning from the livestock drug. Mississippi officials told us
of two people hospitalized after their flawed alert, including one intubated and in cardiac

arrest. But like the FDA, Mississippi officials had no details.

The Associated Press issued this correction on their wildly inaccurate
reporting:
Case 3:22-cv-00184 Document 12-21 Filed on 08/08/22 in TXSD Page 8 of 12

JACKSON, Miss. (AP) — In an article published Aug. 23, 2021, about
people taking livestock medicine to try to treat coronavirus, The
Associated Press erroneously reported based on information
provided by the Mississippi Department of Health that 70% of
recent calls to the Mississippi Poison Control Center were from
people who had ingested ivermectin to try to treat COVID-19. State
Epidemiologist Dr. Paul Byers said Wednesday the number of calls
to poison control about ivermectin was about 2%. He said of the
calls that were about ivermectin, 70% were by people who had

ingested the veterinary version of the medicine.

In New Mexico, officials linked two deaths in September to ivermectin

poisoning, contending later the victims took the drug and died “after delaying treatment for
COVID-19.” The state’s acting health secretary, David Scrase, even said he was taking

a “calculated risk” in announcing the first death on September 9 though tests would likely take

weeks. No one questioned his widely reported conclusions.

This is the correction the New York Times was forced to make—twice—as a
result of inaccurate poison control reports from the Mississippi State
Department of Health:
Case 3:22-cv-00184 Document 12-21 Filed on 08/08/22 in TXSD Page 9 of 12

<4 Mail 8:13AM Thu Sep 30 <> © 96% am)
@ nytimes.com

While certain versions of ivermectin are prescribed to treat head
lice and other parasites in people, other formulations — which
come in forms such as liquid and paste — are commonly used in
the equine and livestock industries to combat worms and parasites.

In past years, Dr. Smolinske said, many of the incidents in New
Mexico involved children mistakenly taking chewable tablets
intended for dogs, but recently the poison centers had seen more
instances of people taking concentrated forms of the drug intended
for large animals.

“Most of our cases are of the horse or dewormer or pour-on
product, so they’re highly concentrated compared to those tablets
for dogs,” said Dr. Susan Smolinske, the director of the New Mexico
Poison and Drug Information Center.

Dr. Smolinske said misuse of the drug can cause drowsiness,
dizziness, tremors or even a coma. “It gets into the brain, and if you
take a high enough dose, it has difficulty getting out of the brain,”
she said.

Correction: Sept. 26, 2021

An earlier version of this article misstated the percentage of recent calls
to the Mississippi poison control center related to ivermectin. It was 2
percent, not 70 percent.

In the pandemic era, mainstream reporting is characterized by firmly drawn narratives. One is
that ivermectin is an unproven, possibly unsafe, treatment for covid, with several dozen
supporting trials largely dismissed as small, biased, and lacking rigor. We would argue that the

potential and effectiveness is far more nuanced and worthy of serious exploration.

This media landscape, which marginalizes, censors, and uses political or anti-vaccine labels,
set a perfect stage for the Mississippi-inspired onslaught of anti-ivermectin hype. Some of it
was true. Much was not, in particular the lasting image of peril of a drug celebrated as

“astonishingly safe for human use” in a 2011 article. Last March, a safety review of ivermectin

by a renowned French toxicologist could not find a single accidental overdose death in the
Case 3:22-cv-00184 Document 12-21 Filed on 08/08/22 in TXSD Page 10 of 12
medical literature in more than 300 safety studies of the drug over decades. The study was

performed for MedinCell, a French pharmaceutical company.

Since 1992, twenty deaths have been linked to inexpensive, off-patent ivermectin, according to
a World Health Organization drug tracker called VigiAccess. By contrast, since just the spring
of 2020, 570 deaths have been linked to remdesivir, an expensive, patented covid drug. The

question is why remdesivir is being used at all, with a WHO recommendation against it anda

new Lancet study finding “no clinical benefit.”

The other question is why ivermectin is not. The FDA tweet arrived just as ivermectin

prescriptions were soaring, up twenty-four-fold in August from before the pandemic. These

were legal prescriptions written by doctors who, presumably, had read the studies, learned

from experience, and decided for themselves. Indeed, 20 percent of prescriptions are written

off-label, namely for other than an approved use.

The effort to vilify ivermectin broadly has helped curb the legal supply of a safe drug. That’s

what drove people to livestock medicine in the first place.

Type your email...

Mary Beth Pfeiffer’s reporting and most recent book, LYME: The First Epidemic of Climate
Change, led her to covid-19. Both diseases have been denied and mismanaged in a corrupt health

care system. LYME was just released in paperback.

Linda Bonvie is an investigative journalist, freelance health and environmental writer, and co-

author of several books, including Chemical-Free Kids and, most recently, A Consumer’s Guide

to Toxic Food Additives.

QO 116 O 211 @ Share

A guest post by
Mary Beth Pfeiffer

| am an investigative journalist who is outraged by the government's abject failure
to stop COVID-19 by treating it early. Censorship and greed have fueled this
Case 3:22-cv-00184 Document 12-21 Filed on 08/08/22 in TXSD Page 11 of 12

pandemic. My articles: https://www.thefirstepidemic.com/new-index

@g,% Aguest post by
a Linda Bonvie

Investigative journalist, freelance health and environmental writer and co-author of
several books including "Chemical-Free Kids" and most recently "A Consumer's
Guide to Toxic Food Additives."

Write a comment...

SO Truth (Banned) Oct 17, 2021

Far-Right Health Care Companies Made Millions of Unproven Covid Remedies

https://is.gd/dtkrlO

Still pushing the Dewormer "Miracle" Covid cure, Mr. Ed?

| know you have no shame and are out for the money...

But labeling the FDA as the problem really takes the cake.
How much lower will you guys go just to make a buck?

The "Miracle" dewormer sales show will end soon...

But | am 100% sure you are working already on the next scam.
The Neverending American Story:

Why Americans Get Conned Again and Again

https://is.gd/1dXCqA
"It's a Miracle!!!" ©&
© 28 Reply

83 replies

Margaret Anna Alice Writes Margaret Anna Alice Through the... - Oct 16, 2021 Liked by Mary Beth Pfeiffer
Thank goodness we still have a few *actual* journalists like you guys—Mary Beth, Linda, and the
Capuzzos—left to conduct genuine investigative reporting and to hold the corporate spin machine

media accountable. Bravo for your tenacious detective work on this repugnant example of
Case 3:22-cv-00184 Document 12-21 Filed on 08/08/22 in TXSD Page 12 of 12

potentially lethal propaganda. | will definitely be referencing this in the upcoming article | will be
publishing on the scientific findings and deceptions surrounding ivermectin.

© 17. Reply

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© 2022 Michael Capuzzo & Teresa Capuzzo. See privacy, terms and information collection notice

~ Publish on Substack

RESCUE with Michael Capuzzo is on Substack — the place for independent writing


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