Exhibit (congressional letter on ivermectin, Oct. 5, 2021) — Apter v. HHS (S.D. Tex., 2022-08-08)

Record facts

U.S. District Court for the Southern District of Texas, Galveston Division · No. 3:22-cv-00184 · Doc. 12-28 · 2022-08-08 · Docket on CourtListener

Full text

Exhibit 28
Case 3:22-cv-00184   Document 12-28   Filed on 08/08/22 in TXSD   Page 1 of 7

WASHINGTON, DC  20510 
Congress of the United States 
 
 
 
October 5, 2021 
 
The Honorable Xavier Becerra 
Secretary 
Department of Health and Human Services 
200 Independence Ave, SW 
Washington, DC 20201 
 
Dr. Anthony S. Fauci  
Director  
National Institute of Allergy and Infectious Diseases  
5601 Fishers Lane  
Bethesda, MD 20892 
 
Rochelle P. Walensky, M.D., MPH 
Director 
Centers for Disease Control and Prevention 
1600 Clifton Road 
Atlanta, GA 30329 
 
Janet Woodcock, M.D. 
Acting Commissioner 
Food and Drug Administration 
10903 New Hampshire Ave 
Silver Spring, MD 20993 
 
Dear Secretary Becerra, Dr. Fauci, Dr. Walensky, and Dr. Woodcock: 
 
 
Throughout the COVID-19 pandemic, public health officials have not only ignored po-
tential early treatments, but at times seem to have participated in an aggressive campaign against 
the use of specific early treatment options.  Even though a basic tenet of medicine is:  early de-
tection allows for early treatment which produces better results; your agencies have overtly dis-
couraged the use of cheap and widely-available early treatments like ivermectin in favor of ex-
pensive new drugs like Remdesivir (which costs more than $3,000 per treatment).1  Despite the 
National Institutes of Health (NIH) funding a study examining the effectiveness of ivermectin as 
an early treatment for COVID-19, your agencies have already demonstrated your strong bias 
                                                 
1 See e.g. Tweet, @US_FDA, Aug. 21, 2021, available at https://twitter.com/us_fda/status/1429050070243192839 
(“You are not a horse. You are not a cow.  Seriously, y’all.  Stop it.”). Consumer Update, Why You Should Not Use 
Ivermectin to Treat or Prevent COVID-19, U.S. Food and Drug Administration, Sept. 03, 2021, available at 
https://www.fda.gov/consumers/consumer-updates/why-you-should-not-use-ivermectin-treat-or-prevent-covid-19. 
Sydney Lupkin, Remdesivir priced at more than $3,100 for a course of treatment, NPR, Jun. 29, 2020, available at   
https://www.npr.org/sections/health-shots/2020/06/29/884648842/remdesivir-priced-at-more-than-3-100-for-a-
course-of-treatment.  
Case 3:22-cv-00184   Document 12-28   Filed on 08/08/22 in TXSD   Page 2 of 7

October 5, 2021 
Page 2 
 
against this and other potential early treatment drugs.2  The Food and Drug Administration’s 
(FDA) mocking of ivermectin, conflating a widely-available human drug that was the basis for 
Nobel prize winning research, with its veterinary version, has cast doubt over the integrity of this 
study’s eventual results.3  We strongly believe you should explain to the American people why 
your agencies have failed to sufficiently examine and ensure access to a growing list of drugs be-
ing used by doctors who have had the courage to ignore NIH’s ongoing compassionless guide-
line of doing virtually nothing until COVID-19 patients are so sick they require hospitalization.4 
 
 
Physicians have utilized a variety of repurposed drugs and vitamins to treat COVID-19 
since the early days of the pandemic.  As the list of potential drugs grows, we are concerned by 
your lack of urgency to explore, research, and recommend use of those drugs.  In November and 
December 2020, Senator Ron Johnson, then-Chairman of the Senate Homeland Security and 
Governmental Affairs Committee, held two hearings with physicians discussing potential early 
treatments.5  At the November 19, 2020 hearing, Drs. Peter McCullough, Harvey Risch, and 
George Fareed testified about real world experience and metadata analysis of multi-drug treat-
ment protocols for early treatment of COVID-19.6  Dr. McCullough also described the four pil-
lars of pandemic response:  1) Contagion Control; 2) Early Home Treatment; 3) Hospital Treat-
ment; 4) Vaccines.7  At the December 8, 2020 hearing, Dr. Pierre Kory testified that “emerging 
publications provide conclusive data on the profound efficacy of the anti-parasite, anti-viral drug, 
anti-inflammatory agent called ivermectin in all stages of [COVID-19].”8 
 
                                                 
2 Large clinical trial to study repurposed drugs to treat COVID-19 symptoms, National Institutes of Health, Apr. 19, 
2021, https://www.nih.gov/news-events/news-releases/large-clinical-trial-study-repurposed-drugs-treat-covid-19-
symptoms.  See e.g. National Institute of Allergy and Infectious Disease (NIAID) Director Dr. Anthony Fauci re-
cently stated “[d]on’t do it; there’s no evidence that [ivermectin] works.”  ‘Don’t do it’: Dr. Fauci warns against us-
ing ivermectin to treat or prevent COVID-19, Boston.com, Aug. 29, 2021, https://www.boston.com/news/corona-
virus/2021/08/29/ivermectin-warnings-anthony-fauci-megan-ranney-fda/, CDC Health Advisory, Rapid Increase in 
Ivermecting Prescriptions and Reports of Severe Illness Associated with Use of Products Containing Ivermectin to 
Prevent or Treat COVID-19, CDC, Aug. 26, 2021, available at https://emer-
gency.cdc.gov/han/2021/pdf/CDC_HAN_449.pdf. 
3 See Press Release, The Nobel Prize in Physiology or Medicine, Oct. 5, 2015, available at https://www.no-
belprize.org/prizes/medicine/2015/press-release/, Ewen Callaway and David Cyranoski, Anti-parasite drugs sweep 
Nobel prize in medicine 2015, Nature, Oct. 5, 2021, https://www.nature.com/articles/nature.2015.18507; See e.g. 
Tweet, @US_FDA, Aug. 21, 2021, available at https://twitter.com/us_fda/status/1429050070243192839 (“You are 
not a horse. You are not a cow.  Seriously, y’all.  Stop it.”). Consumer Update, Why You Should Not Use Ivermec-
tin to Treat or Prevent COVID-19, U.S. Food and Drug Administration, Sept. 03, 2021, available at 
https://www.fda.gov/consumers/consumer-updates/why-you-should-not-use-ivermectin-treat-or-prevent-covid-19. 
4 COVID-19 Treatment Guidelines, National Institutes of Health, Sept. 29, 2021, available at 
https://files.covid19treatmentguidelines.nih.gov/guidelines/covid19treatmentguidelines.pdf. 
5 See Early Outpatient Treatment:  An Essential Part of a COVID-19 Solution:  Hearing Before the S. Comm. On 
Homeland Security and Governmental Affairs 116th Cong. (2020); and Early Outpatient Treatment:  An Essential 
Part of a COVID-19 Solution, Part II:  Hearing Before the S. Comm. On Homeland Security and Governmental Af-
fairs 116th Cong. (2020). 
6 Early Outpatient Treatment:  An Essential Part of a COVID-19 Solution:  Hearing Before the S. Comm. On Home-
land Security and Governmental Affairs 116th Cong. (2020). 
7 Id. 
8 Early Outpatient Treatment:  An Essential Part of a COVID-19 Solution, Part II:  Hearing Before the S. Comm. 
On Homeland Security and Governmental Affairs 116th Cong. (2020). 
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October 5, 2021 
Page 3 
 
 
Since these hearings, evidence of the potential of ivermectin and other repurposed drugs 
to treat COVID-19 has continued to accumulate.  For example, Mexico City and India’s Uttar 
Pradesh have both reportedly experienced positive outcomes after using ivermectin to treat indi-
viduals with COVID-19.9  Mexico City apparently saw reduced hospitalizations and Uttar Pra-
desh experienced lower positivity and fatality rates.10  Unfortunately, there appears to be a com-
plete lack of information or interest by U.S. public health agencies to examine what factors con-
tributed to these apparent positive outcomes.   
 
 
Your agencies have also taken steps to curtail the use of potential early treatments.  Even 
though an estimated 12 to 38 percent of doctor-office prescriptions are off-label treatment drugs, 
your actions have created a new industry standard that restricts doctors’ abilities to prescribe cer-
tain off-label treatments for COVID-19.11    
 
To justify your actions restricting access to COVID-19 drugs, your agencies claim that 
these treatments require randomized controlled trials (RCTs) before they can be deployed against 
the virus.12  As mentioned above, NIH is funding an RCT on ivermectin that you appear to have 
already prejudged.13  However, even in cases where an expensive and time-consuming RCT has 
proven a treatment’s safety and efficacy, health agencies have failed to take action.  For example, 
in April, following an RCT, the U.K. government authorized budesonide, an inhaled steroid to 
treat COVID-19 patients.14  Unfortunately, more than five months later, your agencies have not 
recommended budesonide to treat COVID-19 patients in the U.S.15 
 
By de facto requiring potential COVID-19 treatments go through RCTs or else be subject 
to your campaign of misdirection, you have dramatically tipped the scales in favor of expensive 
new drugs.  Manufacturers of generic drugs do not have the profit margins to afford expensive 
RCTs.  In the case of COVID-19, this strong bias against generic drugs has prevented early treat-
ments from being widely adopted and has cost an untold number of lives. 
 
                                                 
9 Presentation by Dr. Pierre Kory, President and Chief Medical Officer, Front Line COVID-19 Critical Care Alli-
ance, Sept. 2021 on file with staff; Maulshree Seth, Uttar Pradesh government says early use of Ivermectin helped 
to keep positivity, deaths low, Indian Express, May 12, 2021, https://indianexpress.com/article/cities/lucknow/uttar-
pradesh-government-says-ivermectin-helped-to-keep-deaths-low-7311786/. 
10 Id. 
11 Congressional Research Service, Off-Label Use of Prescription Drugs, Feb. 23, 2021, available at 
https://www.crs.gov/reports/pdf/R45792.  See e.g. Consumer Updates, Why You Should Not Use Ivermectin to 
Treat or Prevent COVID-19, U.S. Food and Drug Administration Sept. 03, 2021, available at 
https://www.fda.gov/consumers/consumer-updates/why-you-should-not-use-ivermectin-treat-or-prevent-covid-19. 
12 Letter from Andrew Tantillo, Acting Associate Commissioner for Legislative Affairs, U.S. Food and Drug Ad-
ministration, to Ron Johnson, U.S. Senator, Jan. 15, 2021, available at https://www.ronjohnson.sen-
ate.gov/2021/1/fda-response-letter-to-senator-johnson. 
13 Large clinical trial to study repurposed drugs to treat COVID-19 symptoms, National Institutes of Health, Apr. 19, 
2021, https://www.nih.gov/news-events/news-releases/large-clinical-trial-study-repurposed-drugs-treat-covid-19-
symptoms.   
14 Interim Position Statement, Inhaled budesonide for adults (50 years and over) with COVID-19, U.K. Department 
of Health and Social Care, Apr. 12, 2021, available at https://www.england.nhs.uk/coronavirus/wp-content/up-
loads/sites/52/2021/04/C1253-interim-position-statement-inhaled-budesonide-for-adults.pdf. 
15 COVID-19 Treatment Guidelines, National Institutes of Health, Sept. 29, 2021, available at 
https://files.covid19treatmentguidelines.nih.gov/guidelines/covid19treatmentguidelines.pdf. 
Case 3:22-cv-00184   Document 12-28   Filed on 08/08/22 in TXSD   Page 4 of 7

October 5, 2021 
Page 4 
 
It is beyond puzzling that the federal government continues to ignore foundational medi-
cal principles like early treatment or natural immunity, that federal agencies lack basic data re-
garding vaccine immunity and durability, and that agencies will highlight the relatively few ad-
verse events for one treatment—ivermectin—but largely ignore hundreds of thousands of ad-
verse events and over 15,000 deaths reported on VAERS for COVID-19 vaccines.16  As the 
number of breakthrough COVID-19 cases increase in the U.S. it is urgent that Americans have 
access to early treatment options. 
 
Rather than seriously consider evidence showing the potential of early treatments includ-
ing ivermectin, your agencies prefer to mischaracterize, conflate and misconstrue anything that 
goes against the mainstream narrative and the financial interests of the pharmaceutical industry.  
The American people deserve transparency from federal agencies and the most up-to-date infor-
mation regarding COVID-19 to inform their health decisions.  To better understand your 
agency’s positions regarding early treatments for COVID-19, we respectfully request the follow-
ing information: 
 
1. Since 1996, the combined number of reported deaths associated with ivermectin on both 
VAERS and FAERS totals 379, with 3,680 adverse events.17  In contrast, since December, 
2020, the worldwide total number of deaths associated with COVID-19 vaccines reported on 
VAERS is 15,386 and the worldwide total number of adverse events exceed 725,000.  In 
light of these numbers, please explain why the Centers for Disease Control and Prevention 
(CDC) and FDA believe that ivermectin presents a greater potential health risk, despite evi-
dence showing its success in treating COVID-19, than the COVID-19 vaccines that have 
been associated with vastly more adverse events and deaths.   
 
2. Please explain why your agencies have prejudged ivermectin’s potential effectiveness while 
the NIH’s phase 3 clinical trial of ivermectin remains ongoing.18 
 
3. When did CDC begin to draft the August 26, 2021 health advisory on ivermectin?19  Who 
made the decision to issue this health advisory?  What specific data prompted and was used 
to draft the advisory? 
 
4. Please provide a complete list of all early treatments (broken down by outpatient and inpa-
tient) for COVID-19 that the federal government has examined and the amount funded for 
each treatment. 
 
5. Please explain why budesonide has not been approved for COVID-19 patients in the U.S. 
 
Please provide this material as soon as possible but no later than 5:00 p.m. on October 19, 2021.  
Thank you for your attention to this urgent matter. 
                                                 
16 VAERS is the Vaccine Adverse Event Reporting System.   
17 FAERS is the FDA Adverse Event Reporting System.   
18 ACTIV-6: COVID-19 Study of Repurposed Medications, ongoing, estimated completion date Mar. 2023, availa-
ble at https://clinicaltrials.gov/ct2/show/NCT04885530. 
19 CDC Health Advisory, Rapid Increase in Ivermectin Prescriptions and Reports of Severe Illness Associated with 
Use of Products Containing Ivermectin to Prevent or Treat COVID-19, CDC, Aug. 26, 2021, available at 
https://emergency.cdc.gov/han/2021/pdf/CDC_HAN_449.pdf. 
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October 5, 2021 
Page 5 
 
 
 
 
 
 
 
 
 
 
Sincerely, 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Ron Johnson  
 
 
 
 
 
Tommy Tuberville 
 
United States Senator  
 
 
 
 
United States Senator 
 
 
 
 
 
 
 
Michael S. Lee 
 
 
 
 
 
Ted Cruz 
 
United States Senator  
 
 
 
 
United States Senator 
 
 
 
 
 
 
 
 
 
 
Andy Biggs 
 
 
 
 
 
 
Tom Tiffany  
 
Member of Congress  
 
 
 
 
Member of Congress 
 
 
 
 
 
 
 
 
 
 
 
Andy Harris, M.D.  
 
 
 
 
 
Paul A. Gosar, DDS  
 
Member of Congress  
 
 
 
 
Member of Congress 
 
 
 
 
 
 
 
 
Ralph Norman 
 
 
 
 
 
Randy K. Weber  
 
Member of Congress  
 
 
 
 
Member of Congress 
 
 
 
 
 
 
 
Scott Perry  
 
 
 
 
 
 
Warren Davidson 
 
Member of Congress  
 
 
 
 
Member of Congress 
Case 3:22-cv-00184   Document 12-28   Filed on 08/08/22 in TXSD   Page 6 of 7

October 5, 2021 
Page 6 
 
 
 
 
 
 
Andrew S. Clyde 
 
 
 
 
 
Bill Posey 
 
 
Member of Congress   
 
 
 
 
Member of Congress 
 
 
 
 
 
 
 
 
 
 
 
Bob Good 
 
 
 
 
 
 
Chip Roy 
 
Member of Congress  
 
 
 
 
Member of Congress 
 
 
 
 
 
 
Jody Hice 
 
 
 
 
 
 
Lauren Boebert 
 
Member of Congress  
 
 
 
 
Member of Congress 
 
 
 
 
 
 
 
Marjorie Taylor Greene 
 
 
 
 
Mary E. Miller 
 
Member of Congress  
 
 
 
 
Member of Congress 
 
 
 
 
 
 
Louie Gohmert 
 
 
 
 
 
Clay Higgins 
 
Member of Congress  
 
 
 
 
Member of Congress 
 
 
 
 
 
 
 
 
 
Case 3:22-cv-00184   Document 12-28   Filed on 08/08/22 in TXSD   Page 7 of 7

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