1. THE VACCINATION DEBATE: Sorting Through the Bias and Fear Edwin Hofmann-Smith, PhD, ND Natural Childbirth and Family Clinic 10360 NE Wasco, Portland, OR 97220 503 252 8125

2. Public Health Point of View  Vaccination protects the individual AND OTHERS, potentially eliminates epidemics  Measles: 1/1000 death rate (pneumonia, encephalitis, nerve damage, etc.)  Cost of doctors, hospitals, etc. greater than cost of vaccines  Risks of vaccination less than risk of disease  One of the “greatest achievements of medicine/public health”. Smallpox, polio, diphtheria, measles, rubella, mumps, tetanus, all practically eliminated

3. Public health perspective  Pregnant mom picked up pertussis, her newborn got it, spent next five weeks in NICU, permanent lung damage  Child picks up measles in Switzerland, exposes plane full of people, many quarantined, some cases, no epidemic

4. Individual family’s perspective  Risk of disease may be minimal (since there are no epidemics)  Risk of vaccination is underestimated by officialdom  Don’t trust the vaccine authorities  Can control exposure (hep B, HPV)  Our situation isn’t typical, we eat healthy, use homeopathy,

5. BIAS  A preference or an inclination, especially one that inhibits impartial judgment  Helps us understand why there is such a wide divergence of opinions  For instance, did you believe the cigarette manufacturers when they say smoking doesn’t cause cancer?

6. BIAS: vaccine manufacturers  Obvious, everybody knows this  There are safeguards regarding conflict of interest, but revolving door is reality  Like military-industrial complex  Donate much money to political campaigns, lobbyists, media  Regulators get captured by regulatees. (It’s an axiom.)

7. BIAS: media  Advertising dollars are extremely persuasive  When was the last time you heard of a media outlet go against both government and advertisers?

8. BIAS: CDC/Federal Government  Vaccines for Children Program: Federal government supplies vaccines for free if clinic agrees to vaccinate according to the standard schedule  Tends to keep pediatricians in lock-step

9. BIAS: Vaccine Injury Compensation Program  Vaccine injury table - compensation only for accepted injuries with specific timing after vaccination  Large cost to program if additional injury added to table  Adversarial program - litigant must prove causation  Poling case - autism and seizures, “mitochondrial defect”

10. BIAS: scientific method  Hard to prove causation for adverse effects  Hard to prove causation if effect is delayed, infrequent, subtle, not obviously related to disease  Publication bias  Funding bias  Adverse effects research is a tough road

11. BIAS: Public health officers  Vaccination is one of the “greatest achievements of medicine”  Federal grants to states’ public health departments based on vaccination rates  Keeps public health departments motivated to push vaccination

12. BIAS: pediatric community  Don’t want to think that what they do every day could be harming (some) kids  Vaccinations are an integral part of practice, keep numbers up  Vaccine objectors are seen as uninformed “conspiracy theorists”  “Don’t worry, they’re completely harmless”

13. VACCINE APPROVAL  Try to balance cost of development with safety  Very brief followup in safety trials  Autoimmune and other adverse effects may take weeks to months to develop.  Generally look for immediate adverse effects, then rely on post-marketing surveillance

14. Vaccine adverse events reporting system  Reporting is required for serious effects  Anyone can report  Rate of reporting is between 1 and 10%

15. Vaccine safety datalink  Some managed care organizations report data on adverse effects, etc.  First hard evidence of an adverse effect from mercury (thimerasol)  Quickly advised removal of thimerosal

16. “SAFE”  “The U.S. Food and Drug Administration defines a safe product as ‘one that has acceptable risks, given the magnitude of the benefit expected in a specific population and within the context of alternatives available.’ Determining what degree of risk is 'acceptable' is a particular challenge for regulators and policy-makers” (and parents)

18. BIAS: Fear  Unknown contaminants  Stories of adverse effects have “legs”, not even necessarily true  Internet sites - no peer review, have “ax to grind”  Consequences are huge: lifetime of care for disabled child  Personal knowledge of vaccine-injured child

19. Mechanisms of adverse effects  Autoimmunity  Microglial activation  Unintended contamination: virus, DNA/RNA, enzymes (hypothesized)  Chemical toxicity: mercury/thimerosal, aluminum, formaldehyde

20. ASD and Developmental Disabilities  1/110 current rate of autism spectrum (CDC)  13% with developmental disabilities  ASD lifetime cost of care is $3.2 million  Medical care cost about 5 times more than normal kids  About 700,000 with ASD  50 - 60% of their parents believe illness was triggered by vaccination

21. ASD causation  Doctors treating ASD estimate 20-50% have clear-cut vaccine injury. Most parents blame vaccination.  MMR is worst one  Can be multiple illness/antibiotics  Gut flora probably involved in some  Some have bizarre immunological abnormality  Family history: autoimmune, neurological

22. Neurodevelopmental Disorders: Etiology  Mercury? - rates not dropping  Aluminum - not much research  Autoimmune - auto-antibodies not found in convincing frequency, no delay in some cases  Gut connection  Microglial activation

23. Hannah Poling case  Multiple ear infections (food allergy, antibiotics, immune dysfunction?)  Tympanostomy tubes  At 19 months, “We need to catch her up on her vaccinations”. Got 9 vaccines.  Prompt and profound decline  Mitochondrial defect

24. Mitochondrial dysfunction  Mitochondria as cellular “batteries”  They generate free radicals, also soak up free radicals by antioxidants  Free radicals damage the mitochondria  Genetic mitochondrial dysfunction? Unlikely.  Nitric oxide generates free radicals

25. Microglial/excitotoxin hypothesis for ASD  Proposed in 2003 by Russell Blaylock, MD  Microglia and astrocytes become activated when the systemic immune system becomes activated  Secrete inflammatory chemicals (cytokines), excitotoxins (glutamate and quinolinic acid), free radicals and lipid peroxidation products (damage mitochondria)  Similar to nitric oxide mechanism of CFS, etc. Can get stuck “on”

26. Nitric oxide and chronic disease  The proven mechanism of chronic fatigue syndrome, multiple chemical sensitivities, post-traumatic stress disorder, gulf war syndrome, etc. (Martin Pall)  Over production of nitric oxide (eg. in inflammation) leads to damaging free radicals, etc. and can lead to positive feedback loop.  Overproduction can be local. Autism has damage notably in cerebellum and frontal cortex.

27. Vitamin D hypothesis  Vitamin D has effects on about 10% of human genes  Rise in autism parallels recommendation of sun avoidance  More prevalent in dark-skinned, etc.  Pregnant women should get 4000 IU per day, babies 800IU/day

28. Aluminum toxicity  The calculated body burden of aluminum from vaccinations exceeds that from dietary sources, however, it is below the minimal risk level equivalent curve after the brief period following injection.  In young children, vaccines with aluminium hydroxide caused significantly more erythema and induration than plain vaccines (odds ratio 1·87) and significantly fewer reactions of all types (0·21)

29. Aluminum toxicity  Impairs mercury excretion  Impairs glutathione synthesis  Maximum dose per vaccine (850 mcg) not based on safety studies  Vaccines with aluminum: DTaP, Hib, Prevnar, Hep B, Hep A, HPV

30. US Recommended Vaccines  Hep B (3 doses); Polio (4 doses)  DTaP (5 doses); Rotavirus (3 doses)  Hib (3 or 4 doses); Pneumococcus (4 doses)  Varicella (2 doses); MMR (2 doses)  Hepatitis A (2 doses)  Total doses - 28  Total vaccines 42

31. Japanese schedule 2004  Polio: 3 shots starting around 3 months  DTaP: 3 shots starting around 3 months  Measles, rubella: age 1  Japanese encephalitis: 4 shots  BCG: 3 shots starting at 4 mo.  Total doses - 14  Total vaccines - 21

32. Timing  Immune system not mature till 1 year of age  Maternal antibodies protect against disease in the infant and inhibit antibody response, last about 6 months  Breast feeding protects against some diseases like Hib and PC

34. Hepatitis B  Childhood infection: usually asymptomatic but 25- 90% risk of chronicity  Chronic infection: liver cancer, cirrhosis  Common in Asia, Africa, Eastern Europe, Pacific Islanders, Central America, and the Carribean  Transmitted by contact with blood, semen and vaginal secretions

35. Chronic Acute Vaccination added in 1991

36. Hepatitis B vaccine  Risk of autoimmunity  Extremely low risk of disease - very weak justification for vaccination  Not recommended

37. Pertussis (whooping cough)  Increasing d/t lower vaccination rates  Newborns not protected (lack of maternal antibody)  Ordinary cough for a week then paroxysmal  Serious in babies: pneumonia, seizures, pulmonary hypertension

38. Pertussis vaccine  Start 3 - 6 months depending on exposure, etc.  Follow general recommendations: one shot at a time, not when sick or if gut is unhealthy, family history of neurological or autoimmune diseases, silicea 200C as preventive. Don’t repeat if reaction to first shot.  Recommended

39. Diphtheria  Bacteria cause sore throat and liberate a toxin  Very rare except some foreign countries  Recommended because can’t get pertussis vaccine without it. Available as DTaP, Tdap, etc.

40. Tetanus  Anaerobic bacterium found in soil, manure  Infection due to dirty wound causes generalized muscle spasm  Recommended: DTaP, Tdap  Can’t get pertussis vaccine without it

41. Polio  Disease eradicated from the Western Hemisphere, Europe, etc. No risk of disease  Vaccine is now relatively safe but not needed. Disease may be eradicated world-wide in future  Can vaccinate later before foreign travel

42. Haemophilus influenza type B  Bacterium is normal flora for nose and throat. Can become invasive and cause meningitis, pneumonia, cellulitis, epiglottis, etc.  Now rare due presumably to vaccination  Largely prevented by maternal antibody and breast feeding

43. Hib: not recommended  Have seen some neurological reactions, but none permanent  Risk of disease very low

44. Strep. pneumoniae (Prevnar)  More than 90 separate strains exist  Causes pneumonia, otitis media, sinusitis, sepsis, septic arthritis, meningitis, etc.  Vaccine is directed against the 13 worst strains  Now other strains are causing more disease (serotype replacement) and Staph carriage is increased

45. Prevnar: not recommended  Risk of disease is very low in the absence of specific risk factors like immune dysfunction  Breast feeding is protective  Serotype replacement  Vaccine is relatively reactogenic

46. Rotavirus  Almost all kids get this by the time they’re 5 years old  Vomiting 12 to 18 hours, then usually diarrhea  Self limited  37 deaths per year in US

47. Rotavirus vaccine  Live virus vaccine  Rotarix (GlaxoSmithKline) contains parts of a pig virus that doesn’t make pigs sick  Rota Teq (Merck) contains parts of a pig virus that kills baby pigs  Increase in intussusception with Rota Teq  Not recommended

48. Hepatitis A  Fecal-oral transmission  Very common in third world, rare in US  Usually asymptomatic in kids but more severe in adults  No chronic state  Vaccine relatively safe but not recommended unless a high risk group

49. Measles  Measles: 1/1000 death rate, neurological damage  Virtually eliminated in US d/t vaccine  Drop in vaccination rate associated with many-fold increase in cases

50. Measles vaccine  MMR is the most common vaccine trigger of autism, but usually was given with other vaccines and kid was already sick  Recommended to support public health effort  Give after age 2 - 3  Give 50 - 75,000 IU vitamin A, good vitamin D status, healthy, not with other vaccines

51. Mumps  Relatively mild disease  Self limited  Vaccine: can’t get it without measles and rubella  Recommended after age 2

52. Rubella  If pregnant mom contracts it in first trimester, fetus gets it and might die or have severe birth defects  Our public health approach - vaccinate all kids. Prevents epidemics. Successful.  Essentially eradicated from US

53. Rubella vaccine  15% of adolescent and adult women will get acute arthrisis, usually transient  Worse with wild virus infection  Can’t get it without M and M  Recommend: start after age 2  Don’t re-vaccinate if seronegative as adult

54. Varicella Zoster (Chickenpox)  Epidemics among young children  Occasional severe disease  Susceptibles like immuno-suppressed, chemotherapy at risk for severe disease  Carrier state with 30% getting shingles later  Exposure to children with chickenpox boosts immunity

55. CHICKENPOX (VARICELLA)  Disease is usually mild but virus persists  Asymptomatic re-activation of vaccine virus  Risk of shingles later in life less with vaccine? Likely.  Shingles vaccine necessary because less boosting of immunity from epidemics.  Risk of “serious” reaction to vaccine is 0.03 to 0.3%

56. Chickenpox vaccine program  Best information says, shingles less frequent and milder after vaccination than wild disease  Live virus, slight risk of mild disease after shot  Risks less after shot than from disease  Recommend after age two or three with usual preventive for live virus