Declaration of Jeremy Snavely (Exhibit 2) — AAPS v. FDA

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EXHIBIT 2 
 
 
Case 1:20-cv-00493-RJJ-SJB   ECF No. 8-4 filed 06/22/20   PageID.138   Page 1 of 9

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IN THE UNITED STATES DISTRICT COURT 
FOR THE WESTERN DISTRICT OF MICHIGAN 
SOUTHERN DIVISION 
ASSOCIATION OF AMERICAN  
PHYSICIANS & SURGEONS, 
Plaintiff, 
 
 
v. 
FOOD & DRUG ADMINISTRATION; 
DR. STEPHEN M. HAHN, Commissioner 
of Food & Drugs, in his official capacity; 
BIOMEDICAL ADVANCED RESEARCH 
& DEVELOPMENT AUTHORITY; 
GARY L. DISBROW, Ph.D., Acting 
Director, Biomedical Advanced Research 
& Development Authority, in his official 
capacity; DEPARTMENT OF HEALTH & 
HUMAN SERVICES; and ALEX AZAR, 
Secretary of Health & Human Services, in 
his official capacity, 
 
Defendants. 
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No. 1:20-cv-00493-RJJ-SJB 
 
 
Hon. Robert J. Jonker 
DECLARATION BY JEREMY SNAVELY 
I, Jeremy Snavely, hereby declare that: 
1. 
I am over the age of 21 years and competent to make this declaration 
pursuant to 28 U.S.C. § 1746. I have not been convicted of a felony or a crime of 
dishonesty. 
2. 
I am the Business Manager and Director of Regulatory Affairs of 
Plaintiff Association of American Physicians & Surgeons (AAPS) in this action. 
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3. 
The issues raised in this case are germane to the mission of AAPS, 
whose motto is “omnia pro aegroto” (meaning “all for the patient”), as the 
interference with patient access to hydroxychloroquine and physicians’ ability to 
successfully prescribe are central to AAPS’s principles and reasons for existing. 
4. 
In my role at AAPS I frequently communicate with physician 
members of AAPS from across the United States, and based on these 
communications I have observed the following.  
5. 
 The actions by the U.S Food and Drug Administration (FDA) 
limiting the use of hydroxychloroquine (HCQ) have impeded the ability of AAPS 
members to practice patient-centered medicine. 
6. 
Multiple members of AAPS have communicated to AAPS their 
inability to prescribe hydroxychloroquine (HCQ) for a full regimen to treat or 
prevent COVID-19, including but not limited to physicians in Western Michigan, 
Georgia, New Jersey, Arizona, and Texas. 
7. 
The AAPS physician member who practices within the federal 
Western District of Michigan, identified as “Dr. John Doe” in the Complaint to 
protect him against retaliation, has been unable to successfully prescribe a full 
regimen of HCQ for patients in need of it, due to the FDA’s restrictions on HCQ.  
8. 
Numerous physician members of AAPS, including this “Dr. John 
Doe,” reasonably fear retaliation against them by state medical boards based on 
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Defendants’ irrational restrictions on HCQ along with the incorporation of the 
directive made to state medical boards by the Federation of State Medical Boards. 
9. 
As I have learned from this “Dr. John Doe,” patients of his have been 
additionally harmed by being denied access to a full regimen of the potentially 
lifesaving HCQ. 
10. 
A physician member of AAPS in Georgia informed AAPS of the 
following: “I’m continuing to be thwarted ...  in regards to prophylactic 
hydroxychloroquine for my nursing home patients. I had a nursing home … patient 
pass away last night.  The dead patient’s  roommate now is achy all over with a 
99.7 temp.”    
11. 
We have heard from physician members of AAPS in Texas and Maine 
who are under investigation by their state medical boards simply for 
recommending and/or prescribing hydroxychloroquine to patients.  
12. 
The Maine medical board included the FDA’s March 28 Emergency 
Use Authorization (EUA) letter restricting HCQ to hospitalized patients as 
evidence that the physician was somehow practicing in violation of Maine statutes. 
13. 
States issuing restrictions appear to be relying on guidelines issued by 
the Federation of State Medical Boards, which cite the FDA’s EUA as a rationale 
for the imposition of state-based restrictions. 
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14. 
In addition, AAPS members have communicated with me concerning 
the status of the remaining HCQ in the Strategic National Stockpile (SNS).   
15. 
Regarding the SNS, the Orlando Sun Sentinel reported on June 17, 
2020 the following: “As of Monday, the government has distributed 31 million 
tablets of hydroxychloroquine to state and local health departments, hospitals and 
research institutions; 63 million tablets remain, according to Carol Danko, a 
spokeswoman for the Department of Health and Human Services."   
16. 
A physician member of AAPS wrote to us to suggest that, “Hopefully 
[HHS] can issue [HCQ languishing in the SNS] in such a manner to those in need 
under medical care such as nursing home patients, other high risk [patients], [and] 
[p]eople in need of prophylaxis while working.” 
17. 
AAPS members are also concerned about the following conflicting 
statements issued by HHS related to the FDA’s June 15, 2020 revocation of the 
March 28, 2020 EUA for HCQ.  
18. 
HHS Secretary Azar stated in response to questions about the June 15 
revocation: “If a doctor wishes to prescribe it [HCQ], working with a patient, they 
may prescribe it for any purpose that they wish to do so. And this [the revocation] 
actually removes a potential barrier to that.” 
19. 
However an announcement on the HHS website about the revocation 
states: “Now, hydroxychloroquine sulfate and chloroquine phosphate can only be 
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used for the treatment of COVID-19 as part of an ongoing clinical trial.” 
https://www.phe.gov/emergency/events/COVID19/investigation-
MCM/Pages/hydroxychloroquine.aspx 
20. 
Separately, the FDA’s “Frequently Asked Questions on the 
Revocation of the Emergency Use Authorization for Hydroxychloroquine Sulfate 
and Chloroquine Phosphate” states, “FDA does not recommend using HCQ or CQ 
to treat hospitalized patients with COVID-19 outside of a clinical trial.” 
21. 
The above three statements from HHS entities present conflicting 
information about the ability of a physician to prescribe HCQ. 
22. 
The unavailability of HCQ is impeding the ability of AAPS members 
to attend our meetings. 
23. 
Our Workshop and Board Meeting scheduled for March 20 and 21, 
2020, were cancelled. To my knowledge, the last time AAPS cancelled an event 
was in 1945 due to WWII travel restrictions. 
24. 
The ability to hold the AAPS 77th Annual Meeting, scheduled for 
September 30 to October 3, 2020, is in jeopardy. Members have expressed to me 
their concern about travelling safely to the meeting and registration levels are 
trending significantly lower than in previous years.  
25. 
Pre-registrations for the AAPS Annual Meeting are currently more 
than 90% lower than over the same period in 2019.  
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26. 
Our scholarship program to bring Medical Students to our meetings is 
similarly negatively impacted.  
27. 
If HCQ were widely available as a prophylactic, and for early 
treatment, our members might be more comfortable attending our events. 
28. 
I have reviewed COVID-19 data published on the 
worldometers.info/coronavirus website, and reviewed reports concerning HCQ 
policies. Worldometer is an independent and self-financed team of developers with 
no political, governmental, or corporate affiliation.  I have found that HCQ use 
generally correlates with success in minimizing casualties from COVID-19: 
Country 
HCQ Policy 
Percentage 
COVID-19 
Deaths Per 
Case 
COVID-19 
Deaths Per 
Million in 
Population 
United Kingdom HCQ is discouraged 
and mostly 
unavailable
14% 
628 
Italy 
HCQ’s value was not 
known for the many 
initial casualties
14.5% 
573 
France 
HCQ is officially 
disfavored
18.5% 
454 
United States 
FDA interferes with 
access to HCQ
5.2% 
370 
Russia 
HCQ is encouraged 
1.4% 
56 
India 
HCQ is used 
prophylactically
3.2% 
10 
Turkey 
HCQ is used as early 
treatment
2.6% 
59 
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Country 
HCQ Policy 
Percentage 
COVID-19 
Deaths Per 
Case
COVID-19 
Deaths Per 
Million in 
Population
Israel 
HCQ is encouraged 
1.5% 
33 
South Korea 
HCQ is encouraged 
2.3% 
5 
 
29. 
In a similar manner, I have developed the following chart concerning 
HCQ and mortality from COVID-19, to illustrate the impact of 
allowing/encouraging or banning/discouraging use of HCQ: 
 
30. 
More than 25 articles since 1982 published in peer-reviewed medical 
journals have reported on the safety of HCQ, and these articles are included in the 
PubMed database as maintained by the United States National Library of Medicine 
at the National Institutes of Health. 
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