027 Appendix in Support filed by Public Health and Medical Professionals for Transparency re 26 Brief Memorandum in Support of Motion

Pfizer Documents (PHMPT/FDA)

Pfizer Bla Submission

Pfizer Court Documents

633

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 UNITED STATES DISTRICT COURT
NORTHERN DISTRICT OF TEXAS
PUBLIC HEALTH AND MEDICAL 
PROFESSIONALS FOR TRANSPARENCY,
Plaintiff,
-against-
FOOD AND DRUG ADMINISTRATION,
Defendant.Civil Action No. 4:21-cv-01058-P
APPENDIX IN SUPPORT OF BRIEF FOR TIMELY PRODUCTION
NOW COMES, Plaintiff Public Health and Medical Professionals for  Transparency and 
files this Appendix in Support of its Brief for Ti mely Productio n.
Exhibit Description Page No.
A Declaration of Peter McCullough, MD, MPH, 
President of Public Healt h and Medical Professionals 
for Transparency (PHMPT)App000001 –
App000003
B Declaration of Harvey Risch, MD, PhD App000004 –
App000102
C Declaration of Tom Jeffe rson, MD MRCGP FFPHM App000103 –
App000150
D Declaration of Peter McCullough, MD, MPH App000151 –
App000336
E Declaration of Aaron Siri, Esq. App000337 –
App000579
Unpublished Cases App000580 –
App000631Case 4:21-cv-01058-P   Document 27   Filed 12/07/21    Page 1 of 633   PageID 727Case 4:21-cv-01058-P   Document 27   Filed 12/07/21    Page 1 of 633   PageID 727
Page 2of 2 
 Dated: December 7, 2021
SIRI & GLIMSTAD LLP
Aaron Siri, NY Bar No. 4321790
Elizabeth A. Brehm, NY Bar No. 4660353Gabrielle G. Palmer, CO Bar No. 48948200 Park AvenueNew York, New York 10166Tel: (212) 532-1091Fax: (646) [email protected]
[email protected]
[email protected]
HOWIE LAW, PCJohn HowieTexas Bar Number: 24027239 2608 Hibernia StreetDallas, Texas 75204Tel: (214) [email protected]
Attorneys for Plaintiff
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Curriculum Vitae of Harvey A. Risch, M.D., Ph.D.
(Exhibit A to Ris ch Declaration) 
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Curriculum Vitae for:  H ARVEY  A. R ISCH, M.D., P H.D.
Professor of Epidemiology 
Yale School of Public Health, Yale School of Medicine 
Business Address: Yale School of Public Health 
60 College Street, LEPH 413 P.O. Box 208034, New Haven, CT  06520-8034 
Phone: (203) 785-2848;  Fax: (203) 785-4497 
E-mail: [email protected]
Education:
Date     School     Degree, Major
9/80-12/82 University of Washington Postdoctoral Fellow, Epidem iology 
9/76-8/80 University of Chicago Ph.D., Biomathematics 9/72-6/76 UC San Diego School of Medicine M.D., Medicine9/67-6/72 California Institute of Technology B.S. (Honors), Bio logy; Mathematics
Professional Appointments:
7/01- Professor of Epidemiology, Department of Chronic Disease Epidemiology, Yale 
School of Public Health, Yale School  of Medicine, New Haven, CT . 
1/12- Director, Molecular Cancer Epidemiology Laboratory and Sh ared Resource, Yale 
Comprehensive Cancer Center and Yale School of Public Health 
9/06-8/07 Lady Davis Visiting Professor, Department of Communit y Medicine and 
Epidemiology, Faculty of Medicine, Technion-Israel Institute of  Technology, Haifa, 
Israel
1/91-6/01 Associate Professor of  Epidemiology, Department of Ep idemiology and Public 
Health, Yale University School of Medicine. 
1/83-12/90  Epidemiologist-Biostatistician, Epidemiology Unit, National Cancer Institute of 
Canada, Toronto, Ontario. 
7/90-12/90  Associate Professor, Department of Preventive Medic ine and Biostatistics, University 
of Toronto, Toronto, Ontario ( Concurrent Appointment). 
1/83-6/90 Assistant Professor, Department of Preventive Medicin e and Biostatistics, University 
of Toronto, Toronto, Ontario ( Concurrent Appointment). 
9/80-12/82  Postdoctoral Fellow, Department of Epidemiology, Sc hool of Public Health and 
Community Medicine, University of Washington, Seattle, Washingt on. 
7/79-8/80 Postdoctoral Fellow, Department of Pathology, Univers ity of Chicago, Chicago, 
Illinois.
h-Index: 9 .  Publication citations: more than 4 ,000 research citations as of -XQH 22, 2021.
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Awards, Memberships, etc.:
NSF Undergraduate Research Fellowship, Department of Mathematic s, California Institute of
Technology, Pasadena (6/70-9/70) 
General Medicine Stipended Ext ernship, UC San Diego School of M edicine, La Jolla (6-9/73) 
Theoretical Biology Predoctoral Traineeship, University of Chic ago (9/76-6/79) 
Pathobiology Postdoctoral Trai neeship (GM 7190), University of Chicago (7/79-8/80) 
Cancer Epidemiology Postdoctoral Traineeship (CA 9168), Universi ty of Washington (9/80-12/82)
Member, Society for Epidemiologic Research (1982- ) Member, American Society of Preventive Oncology (1984- ) Full Member, Sigma Xi (1986- ) Fellow, American College of Epidemiology (1991- ); Member (1984 -91) 
Member, Yale Cancer Center (1992- ), Sections: Cancer Preventio n and Control; Gynecologic 
Oncology; Cancer Genetics 
“Best of the AACR Journals” for “ Aspirin Use and Reduced Risk of Pancreatic Cancer ,” one of 
the most highly cited Cancer Epidemiology, Biomarkers & Prevention (CEBP) articles 
published in 201 6 (April 2018) ( http://aacrjournals.org/h-a-risch-bio  ) 
The Ruth Leff Siegel Award for Excellence in Pancreatic Cancer Research (2018), $50,000 
(http://columbiasurgery.org/pancreas/ruth-leff-siegel-award  ) 
Member, Connecticut Academy of Science and Engineering  (2019- ) 
Highest attention paper ever published in the American Journal of Epidemiology (2020) 
(https://oxfordjournals.altmetric.com/details/82900954 ) 
Consortia: 
BEACON: Barrett's Esophagus and Esophageal Adenocarcinoma Conso rtium (2005- ) 
OCAC: Ovarian Cancer Association Consortium (International Cons ortium of Case-Control 
Studies of Ovarian Cancer) (2005- ) 
PanC4: Pancreatic Cancer Case-Control Consortium (2006- ); Elect ed Steering Committee 
Member (2008-2013, 2014-2017, 2018-2021) 
Panscan: Pancreas Cancer Genome-wide Association Study Consorti um (2008- ) 
CIMBA: Consortium of Investigat ors of Modifiers of BRCA1/2 (201 7- ) 
Research Interests:
Cancer epidemiology and etiology—Pancreas, Ovary, Lung, Breast,  Stomach, Bladder, etc. 
Cancer genetic epidemiology: polymorphisms, major genes; Hormona l factors and cancer; Occupa-
tional/environmental exposures and cancer; Diet and cancer; Helicobacter pylori and cancer
Epidemiologic methods; Causal inference; Cancer registration, c ontrol and prevention 
Teaching Experience:
Advanced Epidemiologic Research Methods (Yale University CDE 61 9a) (Course developer) 
Fundamentals of Epidemiology (Ya le University CDE/EMD 508) (Cou rse developer) 
Principles of Epidemiology II (Yale University CDE 516) (Course  developer) 
Research Methods in Epidemiology I  (University of Toronto CHL 4 102f) (Course co-developer) 
Research Methods in Epidemiology II (University of Toronto CHL 4105s) (Course developer) 
Cancer Epidemiology (Universit y of Toronto CHL 4103f; Yale Univ ersity CDE 532b) 
Trainees
PhD: Advisor to five students; dissertation committee member fo r 11 students. 
MPH or MSc: Advisor to 36 students. Postdoctoral Fellows: Advisor to 16 fellows.
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Visiting Faculty: Host to four visiting professors. 
Service Activity:
Grant Review Panels:
Health Canada, National Health Research and Development Program : Epidemiology, 
Occupational Health and Chronic Disease Panel (1987-91) 
NIH External Site Reviewer (1995) NIH Study Section Regular Member: Epidemiology and Disease Cont rol (EDC2) (1997) 
US Army MRMC Ovarian Cancer Research Program Integration Panel Membe r (1997-2002) 
American Cancer Society Extramural Grant Reviewer (1998)Chair, Epidemiology Grant Review Panel, National Cancer Institu te of Canada (2000-2) 
Dutch Cancer Society Extramural Research Grant Reviewer (2000, 2001, 2008) 
Cancer Council Australia Extramural Research Grant Reviewer (20 04)
Pancreatic Cancer Action Network-AACR Career Development Awards  Scientific Review 
Committee (2016-8) 
NIH Study Section Member: Epidemiology and Disease Control (EDC 2) (2000) 
NIH Study Section Member: Epidemiology Special Emphasis Panel ( ZRG4, 1998; ZRG1, 2001-3) 
NIH Study Section Member: Pancreas  SPORE Panel (ZCA1 GRB-V, 2002 -3) 
NIH Study Section Member: Small Grants Program for Cancer Epide miology Panel (ZCA1
SRRB-Q, 2003) 
NIH Study Section Member: Cancer Genetics Panel (CG) (2004, 200 6) 
NIH Study Section Member: Cancer Epidemiology, Prevention and C ontrol (NCI-E X1) (2005) 
NIH Study Section Member: Breast and Ovarian Cancer Genetics (Z RG1 ONC-U 03M) (2005) 
NIH Study Section Member: Gene-Environment Interactions (ZHL1 C SR-D S1 R) (2007) 
NIH Study Section Member: Epidemiology of Cancer Member Conflic ts (ZRG1 HOP-Q, 2009; 
ZRG1 PSE-B, 2010) 
NIH Study Section Member: Barrett's Esophagus Translational Res earch Network (ZCA1 SRLB-1
(O1) R, 2011) 
NIH Study Section Member: Core Infrastructure and Methodologica l Research for Cancer 
Epidemiology Cohorts (ZCA1 SRLB-9 (M2) B, 2013; ZCA1 TCRB-9 (J2)  R, 2014; ZCA1
SRBJ (O2) S, 2015) 
NIH Study Section Member: Cancer Management, Epidemiology, and Health Behavior (ZCA1 
SRLB-B (J1) S, 2013) 
NIH Study Section Member: Populati on Science (U01) (ZCA1 RTRB-Z  M1 R, 2016) 
Medical Research Council UK External Reviewer (2019)
Journal Editor:
Associate Editor, American Journal of Epidemiology  (1997-2014) 
Editor pro tem, American Journal of Epidemiology  (2002-2014) 
Member, Board of Editors, American Journal of Epidemiology  (2014-2020) 
Associate Editor, Journal of the National Cancer Institute  (2000- ) 
Editor, International Journal of Cancer  (2008- ) 
Journal Referee:
Alimentary Pharmacology & Therapeutics (2015- ) 
American Journal of Epidemiology (1986- ) American Journal of Medical Genetics (2004- ) American Journal of Obstetrics and Gynecology (2015- ) American Journal of Preventive Medicine (1988- ) 
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Annals of Epidemiology (1992- ) 
Annals of Oncology (2001- ) Annals of Surgical Oncology (2011- ) Biodemography and Social Biology (2018- ) Biometrics (1990- ) Blood Transfusion (2015- ) BMC Cancer (2007- ) BMC Public Health (2007- ) British Journal of Cancer (2003- ) Canadian Journal of Public Health (1987- ) Canadian Medical Association Journal (1983- ) Cancer (1996- ) Cancer Causes and Control (1992- ) Cancer Detection and Prevention (2003-2009) Cancer Epidemiology (2009- ) Cancer Epidemiology, Biomarkers and Prevention (1995- ) Cancer Genetics (2012- ) Cancer Research (1988- ) Carcinogenesis (2008- ) Clinical Cancer Research (2015- ) Clinical Gastroenterology and Hepatology (2007- ) Current Pharmacogenomics (2007- ) DNA and Cell Biology (2019- ) Environmental Pollution (2018- ) Epidemiology (1989- ) European Journal of Cancer (2001- ) European Journal of Epidemiology (1995- ) European Journal of Human Genetics (2008- ) Gastroenterology (2007- ) Gynecologic Oncology (1997- ) International Journal of Cancer (1995- ) International Journal of Epidemiology (1995- ) JAMA (1990- ) Journal for Nurse Practitioners (2018- ) Journal of Clinical Epidemiology (2006- ) Journal of Clinical Gastroenterology (2010- ) Journal of Clinical Medicine (2019- ) Journal of Epidemiology (2016- ) Journal of Infectious Diseases (2002- ) Journal of the National Cancer Institute (1992- ) Menopause (2011- ) Molecular Carcinogenesis (2009- ) Nature Clinical Practice Oncology (2005- ) Nature Scientific Reports (2016- ) New England Journal of Medicine (2017- ) Oncology Research (2001- ) Oncotarget (2017- ) Preventive Medicine (1994- ) 
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Reproductive Sciences (2008- ) 
Science (2004- ) Treatments in Endocrinology (2003- ) Tumor Biology (2015- ) World Journal of Gastroenterology (2013- ) 
Other Review and Service:
Society for Epidemiologic Resear ch Student Prize Paper Review C ommittee (1987, 1994) 
American Society for Clinical Oncology Cancer Prevention Curric ulum (2006) 
External Advisory Board Member, Multiple Myeloma Prevention Pro gram Project, Washington 
University (2014-2015) 
Mayo Clinic SPORE in Pancreatic Cancer External Advisory Commit tee (2018-2023) 
Connecticut Academy of Science a nd Engineering (CASE) Advisory Committee on Covid-19 
for Reopening Connecticut (2020) 
Academic and Professional Standing Committees:
Yale School of Public Health:
Doctoral (Admissions and Progress; 1991-1999) MPH (Academic Progress; 1991-1995) Computer (1999-2001) Medical Studies (2000-2005) Chair, Genetics and Public Health Interest Group (2003-2006) Chair, C.E.A. Winslow Medal Committee (2007-2010) Chair, Hildreth Memorial Fund Committee (2007-2012) The Honorable Tina Brozman Foundation Small Grant Proposal Revi ew Committee (2010) 
Chair, MPH Thesis Dean’s Prize Committee (2010- ) Chair, Department of Chronic Disease Epidemiology, Epidemiology  Competencies 
 Committee (2015- ) Committee for Academic and Professional Integrity (2018-2021) Education Committee (2019-) 
Yale School of Medicine:
Program in Investigative Medicine Doctoral Committee (1999-2007 ) 
Mentored Clinical Research Schol ar Program Advisory Board (2003 -2008) 
Yale Cancer Center: 
Rapid Case Ascertainment System Shared Resource (1995- ) American Cancer Society Institutional Research Award Review Com mittee (1996-2001) 
American College of Epidemiology: 
Education Committee (1996-2002) Policy Committee (1997-2003) 
Peer-Reviewed Research Publications:
Accepted for Publication or In-Press
Cartmel B, Hughes M, Ercola no EA, Gottlieb L, Li F, Zhou Y, Har rigan M, Ligibel JA, von 
Gruenigen VE, Gogoi R, Schwartz PE, Risch HA , Lu L, Irwin ML.  Randomized trial of 
exercise on depressive symptomatology and brain derived neurotr ophic factor (BDNF) in 
ovarian cancer survivors: The Women's Activity and Lifestyle St udy in Connecticut (WALC).  
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Gynecol Oncol 2021:S0090-8258(21)00195-5. doi: 10.1016/j.ygyno. 2021.02.036. PMCID: 
PMC Journal in Process.  In Press.
Zhang H, Greenwood DC, Risch HA , Bunce D, Hardie LJ, Cade JE.  Meat consumption and risk of 
incident dementia: cohort study of 493,888 UK Biobank participa nts.  Am J Clin Nutr 
2021:nqab028. doi: 10.1093/ajcn/nqab028. PMCID: PMC Journal in Process.  In Press.
Mocci E, Kundu P, Wheeler W, Arslan AA, Beane Freeman LE, Bracc i PM, Brennan P, Canzian F, 
Du M, Gallinger S, Giles GG, Goodman PJ, Kooperberg C, Le March and L, Neale RE, Shu 
XO, Visvanathan K, White E, Zheng W, Albanes D, Andreotti G, Ba bic A, Bamlet WR, Berndt 
SI, Blackford AL, Bueno-de-Mesquita B, Buring JE, Campa D, Chan ock SJ, Childs EJ, Duell 
EJ, Fuchs CS, Gaziano JM, Giovannucci EL, Goggins MG, Hartge P,  Hassan MM, Holly EA, 
Hoover RN, Hung RJ, Kurtz RC, Lee IM, Malats N, Milne RL, Ng K,  Oberg AL, Panico S, 
Peters U, Porta M, Rabe KG, Riboli E, Rothman N, Scelo G, Sesso  HD, Silverman DT, Stevens 
VL, Strobel O, Thompson IM, T jonneland A, Trichopoulou A, Van D en Eeden SK, Wactawski-
Wende J, Wentzensen N, Wilkens LR, Yu H, Yuan F, Zeleniuch-Jacq uotte A, Amundadottir 
LT, Li D, Jacobs EJ, Petersen GM, Wolpin BM, Risch HA , Kraft P, Chatterjee N, Klein AP, 
Stolzenberg-Solomon RZ.  Smoking modifies pancreatic cancer ris k loci on 2q21.3.  Cancer 
Res 2021:canres.3267.2020. doi: 10.1158/0008-5472.CAN-20-3267. PMCID: PMC Journal in 
Process.  In Press.
Corlin L, Ruan M, Tsilidis KK, Bouras E, Yu Y-H, Stolzenberg-So lomon R, Klein AP, Risch HA ,
Amos CI, Sakoda LC, Vodi ka P, Rish PK, Beck J, Platz EA, Michau d DS.  Two-Sample 
Mendelian Randomization Analysis of Associations Between Period ontal Disease and Risk of 
Cancer.  Accepted for Publication, JNCI Cancer Spectrum. PMCID: PMC Journal in Process.
Lakeman IMM, van den Broek AJ, Vos J, Barnes DR, Adlard J, Andr ulis IL, Arason A, Arnold N, 
Arun BK, Balmaña J, Barrowdale D, Benitez J, Borg A, Caldés T, Caligo MA, Chung WK, 
Claes KBM, GEMO Study Collaborator s-, EMBRACE Collaborators, Co llée JM, Couch FJ, 
Daly MB, Dennis J, Dhawan M, Domchek SM, Eeles R, Engel C, Evan s DG, Feliubadaló L, 
Foretova L, Friedman E, Frost D, Ganz PA, Garber J, Gayther SA,  Gerdes A-M, Godwin AK, 
Goldgar DE, Hahnen E, Hake CR, Hamann U, Hogervorst FBL, Hoonin g MJ, Hopper JL, 
Hulick PJ, Imyanitov EN, OCGN Investigators, HEBON Investigator s, kConFab Investigators, 
Isaacs C, Izatt L, Jakubowska A, James PA, Janavicius R, Jensen  UB, Jiao Y, John EM, Joseph 
V, Karlan BY, Kets CM, Konstantopoulou I, Kwong A, Legrand C, L eslie G, Lesueur F, Loud 
JT, LubiÑski J, Manoukian S, McGuffog L, Miller A, Gomes DM, Montagna M,  Mouret-
Fourme E, Nathanson KL, Neuhausen SL, Nevanlinna H, Yie JNY, Ol ah E, Olopade OI, Park 
SK, Parsons MT, Peterlongo P, Piedmonte M, Radice P, Rantala J,  Rennert G, Risch HA ,
Schmutzler RK, Sharma P, Simard J, Singer CF, Stadler Z, Stoppa -Lyonnet D, Sutter C, Tan 
YY, Teixeira MR, Teo SH, Teulé A, Thomassen M, Thull DL, Tischk owitz M, Toland AE, 
Tung N, van Rensburg EJ, Vega A, Wappenschmidt B, Devilee P, va n Asperen CJ, Bernstein 
JL, Offit K, Easton DF, Rookus MA, Chenevix-Trench G, Antoniou AC, Robson M, Schmidt 
MK, Consortium of Investigator s of Modifiers of BRCA1 and BRCA2 .  The predictive ability 
of the 313-variant-based polygenic risk score for contralateral  breast cancer risk prediction in 
women of European ancestry with a heterozygote BRCA1 or BRCA2 pa thogenic variant. 
Accepted for publication, Genet Med. PMCID: PMC Journal in Proce ss. 
2021
McCullough PA, Kelly RJ, Ruocco G, Lerma E, Tumlin J, Wheelan K R, Katz N, Lepor NE, Vijay 
K, Carter H, Singh B, McCullough SP, Bhambi BK, Palazzuoli A, D e Ferrari GM, Milligan GP, 
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Safder T, Tecson KM, Wang DD, McKinnon JE, O'Neill WW, Zervos M , Risch HA .
Pathophysiological Basis and Rationale for Early Outpatient Tre atment of SARS-CoV-2
(COVID-19) Infection.  Am J Med. 2021;134(1):16-22. doi: 10.101 6/j.amjmed.2020.07.003. 
PMCID: PMC7410805
Kho PF, Amant F, Annibali D, A shton K, Attia J, Auer PL, Beckma nn MW, Black A, Brinton L, 
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