The Denial of Adverse Event Risk Following Immunization and the Loss of Informed Consent – A Perspective

References

  1. Andorno, R. “Global bioethics at UNESCO: in defence of the Universal Declaration on Bioethics and Human Rights” J Med Ethics. 2007 Mar; 33(3): 150–154.
  2. Vaccine Safety: Introduction to Vaccine Safety Science and Policy in the United States. October 2, 2017. https://www.icandecide.org/wp-content/uploads/2019/09/VaccineSafety-Version-1.0-October-2-2017-1.pdf
  3. Gillam C. SPIDER Bites CDC. October 17, 2016. https://www.huffpost.com/entry/spider-bites-cdc-ethics-c_b_12525012
  4. World Health Organization. “Causality assessment of adverse event following immunization (AEFI): user manual for the revised WHO classification” WHO/HIs/EMP/Qss, March 2013.
  5. Puliyel J, Phadke A. Deaths following pentavalent vaccine and the revised AEFI Classification. Indian Journal of Medical Ethics. October-December 2017.
  6. Guyer B, et al. Annual summary of vital statistics: trends in the health of Americans during the 20th century. Pediatrics. 2000 Dec;106(6):1307-17.
  7. Mogensen SW, et al. The Introduction of Diphtheria-Tetanus-Pertussis and Oral Polio Vaccine Among Young Infants in an Urban African Community: A Natural Experiment. EBioMedicine. 2017 Mar; 17: 192–198.
  8. Miller S. Re: The unofficial vaccine educators: are CDC funded non-profits sufficiently independent? BMJ. 2017;359:j5104.
  9. Puliyel J, et al. Infanrix hexa and sudden death: a review of the periodic safety update reports submitted to the European Medicines Agency. Indian Journal of Medical Ethics. 2018.
  10. MMWR Morb Mortal Wkly Rep. 2017 Mar 31; 66(12): 343–344.
  11. Chen RT, et al. Combination Vaccines: Postlicensure Safety Evaluation. Clinical Infectious Diseases. December 15, 2001;33(4):S327–S333.
  12. William E. Thompson, PhD, Senior Scientist, US Centers for Disease Control & Prevention, circa 2014 (as told to Dr. Brian Hooker in the documentary Vaxxed).
  13. Disclosure of Adverse Events in Pediatrics: COMMITTEE ON MEDICAL LIABILITY AND RISK MANAGEMENT, COUNCIL ON QUALITY IMPROVEMENT AND PATIENT SAFETY. Pediatrics. December 2016.
  14. Stipulated Order Confirming Non-Compliance with 42 USC 300AA-27C. www.icandecide.org/lawsuits.
  15. Baum C, Anello C. The spontaneous reporting system in the United States. In: Strom BL, ed. Phannacoepidemiology. New York, NY: Churchill Livingstone; 1989:107- 118.
  16. Schwartz KL, et al. Effectiveness of pertussis vaccination and duration of immunity. CMAJ. 2016 Nov 1; 188(16): E399–E406.
  17. Long GH. Acellular pertussis vaccination facilitates Bordetella parapertussis infection in a rodent model of bordetellosis. Proc Biol Sci. 2010 Jul 7;277(1690):2017-25.
  18. Pawloski LC, et al. Prevalence and molecular characterization of pertactin-deficient Bordetella pertussis in the United States. Clin Vaccine Immunol. 2014;21(2):119-25.
  19. Martin SW, et al. Pertactin-Negative Bordetella pertussis Strains: Evidence for a Possible Selective Advantage. Clinical Infectious Diseases. January 15, 2015;60 (2): 223–227.
  20. Gill C, Rohani P, Thea DM. The relationship between mucosal immunity, nasopharyngeal carriage, asymptomatic transmission and the resurgence of Bordetella pertussis. F1000Research. 2017;6(F1000 Faculty Rev):1568.
  21. Doshi P. The unofficial vaccine educators: are CDC funded non-profits sufficiently independent? BMJ. 2017;359:j5104.
  22. Doshi P. Pandemrix vaccine: why was the public not told of early warning signs? BMJ. 2018;362:k3948.
  23. Aluminum Toxicity in Infants and Children. Pediatrics. March 1996;97(3): 413-416.
  24. Mold, M, et al. Aluminium in brain tissue in autism. Journal of Trace Elements in Medicine and Biology. March 2018;46: 76-82.
  25. Shaw CA. Aluminum as a CNS and Immune System Toxin Across the Life Span. Neurotoxicity of Aluminum. 2018;53-83.
  26. Gherardi R., et al. Biopersistence and brain translocation of aluminum adjuvants of vaccines. Front. Neurol. 05 February 2015.
  27. Asin J, et al. Granulomas Following Subcutaneous Injection With Aluminum Adjuvant-Containing Products in Sheep. Veterinary Pathology. October 2018.
  28. Asin J, et al. Cognition and behavior in sheep repetitively inoculated with aluminum adjuvant-containing vaccines or aluminum adjuvant only. Pharmacological Research. In Press, https://doi.org/10.1016/j.phrs.2018.10.019.
  29. Hooker B, et al., Methodological Issues and Evidence of Malfeasance in Research Purporting to Show Thimerosal in Vaccines Is Safe. BioMed Research International. 2014.
  30. Risher JF, Tucker P. Alkyl mercury-induced toxicity: multiple mechanisms of action. Rev Environ Contam Toxicol. 2017;240:105-149.
  31. Burbacher TM, et al. Comparison of blood and brain mercury levels in infant monkeys exposed to methymercury or vaccines containing thimerosal. Environ Health Perspect. 2005;113(8):1015-1021.
  32. Rooney JP. The retention time of inorganic mercury in the brain—a systematic review of the evidence. Toxicol Appl Pharmacol. 2014;274(3):425-435.
  33. Geier D, et al. A review of Thimerosal (Merthiolate) and its ethylmercury breakdown product: specific historical considerations regarding safety and effectiveness. . 2007 Dec;10(8):575-96.
  34. Bradley M, et al. A Review of Mercury Bioavailability in Humans and Fish. International journal of environmental research and public health. February 10, 2017;14(2):169.
  35. Grandjean P, Landrigan PJ. Neurobehavioural effects of developmental toxicity. Lancet Neurol. 2014;13: 330-338.
  36. Rice DC. The U.S. EPA reference dose for methylmercury: sources of uncertainty. Environ Res. 2004;95:406-413.
  37. Guzzi G, et al. Effect of thimerosal, methylmercury, and mercuric chloride in Jurkat T Cell Line. Interdiscip Toxicol. 2012;5(3):159-161.
  38. Harry G. et al. Mercury concentrations in brain and kidney following ethylmercury, methylmercury, and Thimerosal administration to neonatal mice. Toxicol Lett. 2004;154(3):183-189.
  39. Classen JB. Review of evidence that epidemics of type 1 diabetes and type 2 diabetes/metabolic syndrome are polar opposite responses to iatrogenic inflammation. Curr Diabetes Rev. 2012 Nov;8(6):413-8.
  40. Khan AS. Investigating Viruses in Cells Used to Make Vaccines; and Evaluating the Potential Threat Posed by Transmission of Viruses to Humans. February 1, 2018. https://www.fda.gov/vaccines-blood-biologics/biologics-research-projects/investigating-viruses-cells-used-make-vaccines-and-evaluating-potential-threat-posed-transmission
  41. Kassim P, Eslick GD. Risk of intussusception following rotavirus vaccination: An evidence based meta-analysis of cohort and case-control studies. . 2017 Jul 24;35(33):4276-4286.
  42. Dubin, G, et al. Investigation of a regulatory agency enquiry into potential porcine circovirus type 1 contamination of the human rotavirus vaccine, Rotarix: approach and outcome. Hum Vaccin Immunother. 2013 Nov;9(11):2398-408.
  43. Chan VSW. Use of Genetically Modified Viruses and Genetically Engineered Virus-vector Vaccines: Environmental Effects. Journal of Toxicology and Environmental Health, Part A 2006;69(21):1971-1977.
  44. Rakowka SK, et al. Activation of the Immune System is the Pivotal Event in the Production of Wasting Disease in Pigs Infected with Porcine Circovirus-2 (PCV-2). Vet Pathol. 2001;38:31-42.
  45. Han HH. et al. “Serologic response to porcine circovirus type 1 (PCV1) in infants vaccinated with the human rotavirus vaccine, Rotarix™: A retrospective laboratory analysis” Hum Vaccin Immunother. 2017 Jan 2;13(1):237-244.
  46. Kuehn, BM. FDA: Benefits of Rotavirus Vaccination Outweigh Potential Contamination Risk. JAMA. 2010;304(1):30-31.
  47. Rizzo P, et al. Unique Strains of SV40 in Commercial Poliovaccines from 1955 Not Readily Identifiable with Current Testing for SV40 Infection. Cancer Research. December 1999;59 (24): 6103-6108.
  48. Gatti AM, Montanari S. New Quality-Control Investigations on Vaccines: Micro- and Nanocontamination. Int J Vaccines. 2016; 4(1): 00072.
  49. Obolski U. et al. Vaccination can drive an increase in frequencies of antibiotic resistance among nonvaccine serotypes of Streptococcus pneumoniae. PNAS. March 20, 2018; 115 (12): 3102-3107.
  50. Chan VS. Use of genetically modified viruses and genetically engineered virus-vector vaccines: environmental effect. Toxicol Environ Health. 2006 Nov;69(21):1971-7.
  51. Goldman GS, King, PG. Review of the United States universal varicella vaccination program: Herpes zoster incidence rates, cost-effectiveness, and vaccine efficacy based primarily on the Antelope Valley Varicella Active Surveillance Project data. Vaccine. 31(13): 1680-94.
  52. Goldman G. Miller N. Relative trends in hospitalizations and mortality among infants by the number of vaccine doses and age, based on the Vaccine Adverse Event Reporting System (VAERS), 1990–2010. Human & Experimental Toxicology, 2012; 31(10): 1012–1021.
  53. Mawson, AR, et al. Pilot comparative study on the health of vaccinated and unvaccinated 6- to 12-year-old U.S. children. J Transl Sci. 2017.
  54. Stratton K, et al. Adverse Effects of Vaccines : Evidence and Causality. Injury. 2011:0-24.
  55. US Institute of Medicine. The Childhood Immunization Schedule and Safety. 2013. https://www.ncbi.nlm.nih.gov/books/NBK206938/
  56. Crowe, JE. Genetic Predisposition for Adverse Events after Vaccination. The Journal of Infectious Diseases. July 2007;196 (2):176–177.
  57. Vadala M. et al. Vaccination and autoimmune diseases: is prevention of adverse health effects on the horizon? EPMA J. 2017;8(3):295-311.
  58. Rossingnol JF. Nitazoxanide: a first-in-class broad-spectrum antiviral agent. Antiviral Res. 2014 Oct;110:94-103.
  59. Rajčáni J. Szathmary S. Peptide Vaccines: New Trends for Avoiding the Autoimmune Response. The Open Infectious Diseases Journal. 2018; 10: 47-62.
  60. Arumugham V. Evidence that Food Proteins in Vaccines Cause the Development of Food Allergies and Its Implications for Vaccine Policy. J Develop Drugs. 2015; 4:4.
  61. The Siracusa Principles on the limitation and derogation provisions in the International Covenant on Civil and Political Rights. UN Doc E/CN.4/1984/4 (1984).
  62. Bi S. Klusty T. Forced Sterilizations of HIV Positive Women: A Global Ethics and Policy Failure. AMA J Ethics. 2015;17(10):952.
  63. Ethical issues with vaccination for the obstetrician–gynecologist. Committee Opinion No. 564. American College of Obstetricians and Gynecologists. Obstet Gynecol. 2013:121;1144–50.
  64. Kadrova A, et al. Isoprinosine in treatment of cervical intraepithelial neoplasia (CIN I-III) and cervical cancer (CC) in situ affected patients with human papillomavirus (HPV) 000308. International Journal of Gynecological Cancer. September-October 2005; 15: 136–137.
  65. Kerridge IH, Lowe M. Bloodletting: The story of a therapeutic technique. Med J Aust. 1995;163:631-633.
  66. Dubeau G. If only half of America Is properly vaccinated, where are the epidemics? The Hill. September 13, 2016.

K. Paul Stoller, MD, is a fellow of the American College of Hyperbaric Medicine and has an integrative medical practice in Santa Rosa, California. A pediatrician, he has documented the effectiveness of hyperbaric oxygen in reversing fetal alcohol syndrome in children (Pediatrics, 2005). He began working with patients of all ages with brain disorders in the late 1990s, including traumatic brain injury, stroke, cerebral palsy, multiple sclerosis, chemo-brain, autism, and Lyme. He is author of the book, Incurable Me: Why the best medical research never makes it into clinical practice (New York, Skyhorse, 2016). Dr. Stoller is available remotely for medical consultations, including consults on addiction medicine.
Website: www.hbotsf.org