2004P-0349: Citizen Petition Requesting Certain Actions with Respect to Vaccines and Other Drug Products, Containing Added Mercury, in Order to Reduce the Health Risk to Susceptible Fetuses, Newborns, Children, Adolescents and Adults

REF1

Declaration (pdf)

References (pdf)

Tab 1: FDA's Ongoing Response to the Issue of Caccines and Autism, Karen Midthun, M.D., FDA (pdf)

Tab 2: As Assessment of Thimerosal Use in Childhood Vaccines, Leslie K. Ball, Robert Ball & Douglas Pratt, Pediatrics 2001 (copyrighted material )

Tab 3: Joint Statement (concerning Thimerosal) of the American Academy of Pediatrics (AAP) and the U.S. Public Health Service (PHS), July 7, 1999 (pdf)

Tab 3-02: Joint Statement Concerning Removal of Thimerosal from Vaccine, Jun22, 2000 (pdf)

Tab 4: Prevention and Control of Influenza, Morbidity and Mortality Weekly Report, CDC April 25, 2003 (pdf)

Tab 5: Prevention and Control of Influenza, Morbidity and Mortality Weekly Report, CDC, July 23, 2006 (pdf)

Tab 6: Mercury Compounds, Technology Transfer Network Air Toxics Website, U.S. Environmental Protection Agency (pdf)

Tab 7: Mercury in Vaccines-Derived Products, Thimerosal in Vaccines, FDA (pdf)

Tab 8: Mercury in Plasma-Derived Products, Thimerosal in Vaccines, FDA (pdf)

Tab 9: Thimerosal-Containing Vaccines and Neurodevelopmental Disorders, Immunization Safety Review, Kathleen Stratton, Alicia Gable & Marie C. McCormick, Insttitute of Medicine (pdf)

Tab 10: Vaccine and Autism, Immunization Safety Review, Insttitute of Medicine (pdf)

Tab 11: Association Between Thimerosal-Containing Vaccine and Autism, A. Hviid, MSc, M. Stellfeld, MD, Jan Wohlfahrt, MSc & M. Melbye, MD, PhD, 2003 American Medical Association (copyrighted material)

Tab 12: Safety of Thimerosal-Containing Vaccines: A Two-Phased Study of Computerized Health Maintenance Organization Databases, T. Verstracten, MD; R.L. Davis, MD, MPHS; F. Destefano, MD, MPH; T.A. Lieu, MD, MPH; P.H. Rhodes, PhD; S.B. Black, MD; H. Shinefield, MD; & R.T. Chen, MD for the Vaccine Safey Datalink Team, Pediatrics 2003 (copyrighted material)

Tab 13: Thimerosal Exposure in Infants and Developmental Disorders: A Retrospective Cohort Study in the United Kingdom Does Not Support a Causal Association, N. Andrews, E. Miller, A. Grant, J. Stowe, V. Osborne & B. Taylor, Pediatrics 2004 (copyrighted material)

Tab 14: Thimerosal and the Occurrence of Autism: Negative Ecological Evidence From Danish Population-Based Data, Kreesten M. Madesen, MD; Marlene B. Lauristen, MD; Carsten B. Pedersen, Msc; Poul Thoresen, MD, PhD; Anne-Marie Plesner, MD, PHD; Peter H. Andersen, MD; & Preben B. Mortensen, MD, DMSc, Pediatrics 2003 (copyrighted material)

Tab 15: Autism and Thimerosal-Containing Vaccines: Lack of Consistent Evidence for an Association, Paul Stehr-Green DrPH, MPH, Peet Tull, Michael Stellfeld, MD, reben-Bo Mortenson, DrMedSC, Diane Simpson, MD, PhD, American Journal of Preventive Medicine 2003 (copyrighted material)

Tab 16: An assessment of the impact of thimerosal on childhood neurodevelopmental disorders, David A. Geier and Mark R. Geier, Pediatric Rehabilitation 2003 (copyrighted material)

Tab 17: A cmoparative evaluation of the effects of MMR immunization and mercury doses from thimerosal-containing childhood vaccines on the population prevalence of autism, David A. Geier and Mark R. Geier, 17: Med Sci Monit 2004 (copyrighted material)

Tab l8: Neurodevelopmental Disorders after Thimerosal-Containing Vaccines: A Brief Communication, and Mark R. Geier, The Genetic Centers of America (copyrighted material)

Tab 19: Thimerosal in Childhood Vaccines, Neurodevelopment Disorders, and Heart Disease in the United States, Mark R. Geier and David A. Geier, Journal of American Physicians and Surgeons 2003 (copyrighted material)

Tab 20: From Epideniology, Clinical Medicine, Molecular Biology, and Atoms, to Politics: A Review of the Relationship between Thimerosal and Autism, (Submitted to the Institue of Medicine, of the US National Academy of Sciences, January 2004), David A Geier, B.A., Mark R. Geier, MD, PhD (copyrighted material)

Tab 21: Pervasive Developmental Disorders in Montreal, Quebec, Canada: Prevalence and Links With Immunications, Eric Fombonne, MD, Rita Zaarian, MEd, Andrew Bennett, PhD, CPsych, Lynyan Meng, MSc and Diane McLean-Heywood, MA, Pediatrics 2006 (copyrighted material)

Tab 22: Thimerosal-Containing Vaccines and Autistic Spectrum Disorder: A Critical Review of Published Original Data, Sarah K. Parker, Benjamin Schwartz, James Todd and Larry K. Pickering, Pediatrics 2004 (copyrighted material)

Tab 23: Vaccines, Fourth Edition, Stanley, A. Plotkin, M.D., and Walter A. Orenstein, M.D., Paul A. Offit, M.D. (copyrighted material)

Tab 24: Udpate: Influenza Activity -- United States, 2003-04 Season, MMWR Weekly, CDC (pdf)

Tab 25: Dangerous Properties of Industrial Materials, Sixth Edition, N. Irving Sax (copyrighted material)

Tab 26: The Pharmacology of Mercury Compounds 6545: Dose-Response Relationships, Thomas W. Clarkson, Annual Review of Pharmacology 1972 (copyrighted material)

Tab 27: Chronic Oral Toxicities of Mercuri-Phenyl and Mercuric Salts, O. Garth Fitzhugh, Ph.D., Arthur A. Nelson, M.D., Ph.D., Eswin P. Laug, Ph.D. & Frieda M. Kunze, B.S., Industrial Hygiene and Occupational Medicine (copyrighted material)

Tab 28: Pesticides Studies in Man, Wayland J. Hayes, Jr., M.D., Ph.D. (copyrighted material)

Tab 29: Visine LR 1.0 oz carton label (pdf)

Tab 30: Allergan: FML (fluorometholone ophthalmic ointment) 0.1% sterile carton label (pdf)

Tab 31: Pharmaceutical Excipients Adverse Effects Associated with Inactive Ingredients in Drug Products (Part I), Larry K. Golightly, Susan S. Smolinske, Michael L. Bennett, Ear W. Sutherland III and Barry H. Rumack, Medical Toxicology 1988 (copyrighted material)

Tab 32: Trifluridine OphthalmicSolution 1% product information (pdf)

Tab 33: Blephamide (sulfacetamide sodium and prednisolone acetate) product information (pdf)

Tab 33b: Cortisporlin Ophthalmic Suspension Sterile (neomycin and polymyxin B sulfates and hydrocortisone ophthmalmic suspension USP), NDA50-169/S046 (copyrighted material)

Tab 34: Mercury in Drug and Biologic Products, CDER, FDA (pdf)

Tab 35: Retrograde degneration of neurite membrane structural integrity of nerve growth cones following in vitro exposure to mercury, Christopher C.W. Leong, Naweed I. Syed and Fritz L. Lorscheider. NeuroReport (2001) (copyrighted material)

Tab 36: Thimerosal Induces DNA Breaks, Caspase-3 Activation, Membrane Damage, and Cell Death in Cultrued Human Neurons and Fibroblsts, David S. Baskin, Hop Ngo, and Vladimir V. Didenko, Toxicological Sciences (2003) (copyrighted material)

Tab 37: Biochemical and molecular basis of thimerosal-induced apoptosis in T cells: a major role of mitochondrial pathway, S. Makani, S. Gollapudi, L el, S. Chiplunkar and S. Gupta, Genes and Immunity (2002) (copyrighted material)

Tab 38: Activation of methionine synthase by insulin-like growth factor-1 and lopamine: a target for neurodevelopmental toxins and thimerosal, M Waly, H Olteanu, R Banerjee, S-W Chol, JB Mason, BS Parker, S Sukumar, S Shim, A Sharma, JM Benzecry, V-A Power-Charnitsky and RC Deth, Molecular Psychiatry (2004) (copyrighted material)

Tab 39: A Comparative Study of the Effects of Mercury Compounds on Cell Viobility and Nucleic Acid Synthesis in HeLa Cells, Eddie S.E. Chao, John F. Gierthy and Gerald D. Frenkel, Biochemical Pharmacology Vol. 33, No. 12 (copyrighted material)

Tab 40: Cell culture model for acetaminophen-induced hepatocyte death in vivo, Robert H. Pierce, Christopher C. Franklin, Jean S. Campbell, Robert P. Tonge, Weichao Chen, Nelson Fausto, SIdney D. Nelson, Sam A. Bruschi, Biochemical Pharmacology 64 (2002) (copyrighted material)

Tab 41: Acetaminophen-Induced Oxidant Stress and Cell Injury in Cultured Mouse Hepatocytes: Protection by N-Acetyl Cysteine, Mary Lynn Bajt, Tamara R. Knight, John J. Lemaster and Hartmut Jaeschke, Toxicological Sciences (2004) (copyrighted material)

Tab 41-2: Cell culture model for acetaminophen-induced hepatocyte death in vivo, Pierce RH, Franklin CC, Campbell JS, Tonge RP, Chen W, Fausto N, Nelson SD, Bruschi SA, Biochem Pharmacol. (2002) (copyrighted material)

Tab 42: Neurotoxic effects of postnatal thimerosal are mouse strain dependent, M Homig, D Chian and WI Lipkin, Molecular Psychiatry (2004) (copyrighted material)

Tab 43: Dose-response study of thimerosal-induced murine systemic autoimmunity, S. Havarinasab, L. Lambertsson, J. Qvarnstrom, and P. Hultman, Toxicology and Applied Pharmacology (2004) (copyrighted material)

Tab 44: Critical Path Initiative; Establishment of Docket, Feder Register/Vol. 69, No. 78/Thursday, April 22, 2004/Notices (pdf)

Tab 45: Autistic Spectrum Disorders: Changes in the California Caseload An Update: 1999 Through 2002 (2003), California Department of Developmental Services (pdf)

Tab 46: Autism A.L.A.R.M., Project funded by a cooperative agreement between the American Academy of Pediatrics and the National Center on Birth Detects and Developmental Disabilities at the Center for Disease Control and Prevention (2004) (pdf)

Tab 47: Response to Bayer Petition on Mercury and Mercury Compounds, California Environmental Protection Agency (pdf)

Tab 48: A Case-Control Study of Mercury Burden in Children with Autistic Spectrum Disorders, Jeff Bradstreet, M.D., David A. Geler, B.A., Jerold J. Kartzinel, M.D., James B. Adams, Ph.D., & Mark R. Geler, M.D., Ph.D., Journal of American Physicians and Surgeons (2003) (copyrighted material)

Tab 49: Reduced Levels of Mercury in First Baby Haircuts of Autistic Childgren, Amy S. Holmes, Mark F. Blaxill, and Boyd E. Haley, International Journal of Toxicology (2003) (copyrighted material)

Tab 50: Outbreaks of Group A Streptococcal Abscesses Following Diphtheria-Tetanus Toxoid-Pertussis Vaccination, Harrison C. Stetler, M.D., et al, Pediatrics (1985) (copyrighted material)

Tab 51: (51) ANTIMICROBIAL EFFECTIVENESS TESING, USP29–NF24 Page 2499 (copyrighted material)

Tab 52: Teratogenicities of Ophthalmic Drugs: II. Teratogenicities and Tissue Accumulation of Thimerosal, Antonio R. Gasset, MD; Motokazu Itoi, MD; Yasno Ishii; Richard M. Ramer, PhD, Arch Ophthalmol/Vol 93, Jan 1975 (copyrighted material)

Tab 53: Predicted Mercury Concentrations in Hair From Infant Immunizations: Cause for Concern, Lyn Redwood, Sallie Bernard, David Brown, NeuroToxicology 22 (2001) (copyrighted material)

Tab 54: Developmental Neurotoxicology of Therapeutics: Survey of Novel Recent Findings, William Slickker, Jr., NeuroToxicology 21 (2000)

Tab 55: Clinical and Laboratory Observations: Iatrogenic exposure to mercury after hepatitis B vaccination in preterm infants, Gregory V. Stajich, PharmD, Gaylord P. Lopez, PharmD, ABAT, Sakei W. Harry, MBBS, MPH, and William R. Sexson, MD, The Journal of Pediatrics (200)

Tab 56: NIAID Studies on Thimerosal, Polly R. Sager, Ph.D., IOM (2004), NIH, HHS (copyrighted material)

Tab 57: Slides re Comparative Toxicokinetics of Methyl mercury (meHg) and Thimerosal in Infant Macca fascicularis, IOM (2004), NIH, HHS (copyrighted material)

Tab 58: Enhanced Toxicity for Mice of Pertussis Vaccines When Preserved with Merthiolate, E.A. Nelson and R.Y. Gottishall, Applied Microbiology (1967) (copyrighted material)

Tab 59: Problems Associated with the Use of Merthiolate as a Preservative in Anti-Lymphocytic Globulin, Martin F. Heyworth and Sidney C. Truelove, Toxicology (1979) (copyrighted material)

Tab 60: Merthiolate hypersensitivity and vaccination, L. Forstrom, M. Hannuksela, Merja Kousa and E. Lehmuskallio, Contact Dermatitis (1980) (copyrighted material)

Tab 61: Evaluation of the toxic action of prophylacitic and therapeutic preparations on cell cultures. III. The detection of toxic proprties in medical biological preparations by the degree of cell damage in the L132 continuous cell line, Kravchanko AT, Dzagurov SG, Chervonskaia GP, Mikrobiol Epidemiol Immunobio (1983) (copyrighted material)

Tab 62: Organic mercury compounds and their toxicity, K.A. Winship, MRCP, MFCM, DCH, Adv. Drug React. Ac. Pois. Rev. (1986) (copyrighted material)

Tab 63: Thiomersal allergy and vaccination reactions, Neil H. Cox and Angela Forsyth, Contact Dermatitis, (1988) (copyrighted material)

Tab 64: Pouch0vaginal fistulae after ileoanal anastomoses, David Seal, The Lancet (1991) (copyrighted material)

Tab 65: Vaccines Without Thiomersal: Why so Necessary, Why so Long Coming?, Albert-Jan van't Veen, Drugs (2001)

Tab 66: Self-Reported Changes in Subjective Health and Anthrax Vaccination as Reported by Over 900 Persian Gulf War Era Veterans, Walter R. Schumm, Earl J. Reppert, Anthony P. Jurich, Stephan R. Bollman, Farrel J. Webb, Carlos S. Castelo, Psychological Reports (2002) (copyrighted material)

Tab 67: Pathology of Chronic Alkylmercurial Poisoning in Swine, L. Tryphonas, D.V.M., Ph.D. and N.O. Nielsen, D.V.M., Ph.D., Am. J. Vet. Res. (1973) (copyrighted material)

Tab 68: Organ mercury levels in infants with omphaloceles treated with organic mercurial antiseptic, D.G. Fagan, J.S. Pritchard, T.W. CLarkson, and M.R. Greenwood, Archives of Disease in Childhood (1977) (copyrighted material)

Tab 69: The comparative toxicology of ethyl- and methylmercury, L. Magos, A.W. Brown, S. Sparrow, E. Bally, R.T. Snowden, and W.R. Skipp, Arch. Toxicol. (1985) (copyrighted material)

Tab 70: Intestinal Lymphocyte Populations in Children with Regressive Autism: Evidence for Extensive Mucosal Immunopathology, Paul Ashwood, Andrew Anthony, Alicia A. Pellicer, Franco Torrente, John A. Walker-Smith, and Andrew J. Wakefield, Journal of Clinical Immunology (2003) (copyrighted material)

Tab 71: Mercury and Autistic Gut Disease, Woody R. McGinnis, Environmental Health Perspectives (2001) (copyrighted material)

Tab 72: Is autism a G-alpha protein defect reversible with natural vitamin A?, N.N. Megson, Medical Hypotheses (2000) (copyrighted material)

Tab 73: In re: Cincinnati Radiation Litigation, Case No. C-1-94-126, U.S. District Court for the Southern District of Ohio, Western Division (1995) (pdf)

Tab 74: Kevin Albright, Petitioner v. Roger Oliver, Etc., et al., No. 92-833, Supreme Court of the United States (1994) (pdf)

Tab 75: Schmerber v. California, No. 658, Supreme Court of the United States, (1996) (pdf)