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Drs. Simeonsson and Hillenbrand have no financial interests to disclose.

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Presentation on theme: "Drs. Simeonsson and Hillenbrand have no financial interests to disclose."— Presentation transcript:

1 Drs. Simeonsson and Hillenbrand have no financial interests to disclose.

2 The Risky Business of Vaccine Refusals NC Immunization Conference August 2009 Kristina Simeonsson, MD, MSPH Karin Hillenbrand, MD The Brody School of Medicine at ECU

3 “It is much easier to create doubt and damage a vaccine’s reputation than it is to restore it.” “It is much easier to create doubt and damage a vaccine’s reputation than it is to restore it.” Ashraft H; Lancet 2001

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5 Background: Parents Parents’ perceptions about the dangers of vaccines is key in their decision to have their child vaccinated Parents’ perceptions about the dangers of vaccines is key in their decision to have their child vaccinated Lack of disease awareness prompts greater reluctance to accept adverse reactions Lack of disease awareness prompts greater reluctance to accept adverse reactions Consumerism is on the rise Consumerism is on the rise Parents often trust information from the media, regardless of the source Parents often trust information from the media, regardless of the source

6 MMR Controversy in the United Kingdom 53% interviewed believed that equal evidence existed for both sides of the debate 53% interviewed believed that equal evidence existed for both sides of the debate Only 23% aware that bulk of evidence favors supporters of the vaccine Only 23% aware that bulk of evidence favors supporters of the vaccine Hargraves et al, Economics and Research Council, 2003

7 Background: Providers Providers vary in their delivery of information about vaccines may be uninformed, dismissive, disparaging Providers may send mixed messages publication of flawed studies invoke policies that conflict with our own science thimerosal removed rotavirus vaccine withdrawn

8 Dr. Bob

9 Background: Media Increased access to information and misinformation Increased access to information and misinformation Volume of non-science-based material exceeds that from reliable sources Volume of non-science-based material exceeds that from reliable sources Celebrity science Celebrity science 24/7 news is a business industry 24/7 news is a business industry Controversy and bad news attract a larger audience Controversy and bad news attract a larger audience Balanced coverage can mean giving equal time to “outlier views” Balanced coverage can mean giving equal time to “outlier views” Social networking Social networking

10 Pertussis Outbreak in Chapel Hill February 2009 Cases Of Whooping Cough Plague Chapel Hill-Carrboro Schools Cases Of Whooping Cough Plague Chapel Hill-Carrboro Schools Whooping Cough Outbreaks Show Vaccine’s Limits Whooping Cough Outbreaks Show Vaccine’s Limits

11 July 5, 1993 issue of The New YorkerThe New Yorker

12 Refusal versus Hesitancy Many parents express concerns about the safety of vaccines and should not automatically be categorized as being staunchly antivaccination Many parents express concerns about the safety of vaccines and should not automatically be categorized as being staunchly antivaccination

13 Communication Strategies Improve communication skills of public and private health leaders Improve communication skills of public and private health leaders Present information in perspective Present information in perspective Avoid obfuscation Avoid obfuscation Admit gaps in knowledge Admit gaps in knowledge Be available and candid in answering questions Be available and candid in answering questions Invest in research on what is truly driving parents’ questions and concerns Invest in research on what is truly driving parents’ questions and concerns Cooper LZ, Larson HJ, Katz SL. Pediatrics, 2008

14 Responding to Parent Concerns Explore and address parental concerns Explore and address parental concerns May need to discuss vaccines separately May need to discuss vaccines separately Provide parents with risk and benefit information necessary to make an informed decision Provide parents with risk and benefit information necessary to make an informed decision Correct an misinformation or misperceptions that exist Correct an misinformation or misperceptions that exist 25% of parents falsely believe that immune system could become weakened by too many vaccines 25% of parents falsely believe that immune system could become weakened by too many vaccines Diekema D and the Committee on Bioethics, Pediatrics 2005

15 Responding to Parent Refusals Give some vaccines if you can Give some vaccines if you can Revisit the immunization discussion at subsequent visits Revisit the immunization discussion at subsequent visits Good documentation of discussion of benefits of vaccine and risks of being unimmunized Good documentation of discussion of benefits of vaccine and risks of being unimmunized Sign a refusal waiver Sign a refusal waiver Avoid discharging a patient from practice solely because a parent chooses not to immunize Avoid discharging a patient from practice solely because a parent chooses not to immunize Diekema, Committee on Bioethics et al, Pediatrics 2005

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17 Healthcare Providers Can Make a Difference Healthcare providers are in a position to influence parents’ decisions to vaccinate their children Healthcare providers are in a position to influence parents’ decisions to vaccinate their children Concerned parents who considered their healthcare provider influential were more likely to have their child vaccinated (75%) than those who did not find their healthcare provider influential (50%) Concerned parents who considered their healthcare provider influential were more likely to have their child vaccinated (75%) than those who did not find their healthcare provider influential (50%) Smith PJ et al, Pediatrics 2006

18 Risk Communication Developed from the need to find more effective ways to communicate health risks Developed from the need to find more effective ways to communicate health risks Goal is to provide information about expected type and magnitude of an outcome from a behavior or exposure Goal is to provide information about expected type and magnitude of an outcome from a behavior or exposure The purpose of the message is to The purpose of the message is to empower decision-making

19 Sandman’s Model of Public Perception of Risk Hazard Scientific estimation of mortality or morbidity Outrage Factors that make the public worried, angry, frightened or otherwise upset

20 Not All Risks Are Created Equal Voluntary Voluntary Familiar Familiar Natural origin Natural origin Adult Adult Understood benefit Understood benefit Involuntary Exotic Manmade Children Questionable benefit Crisis and Emergency Risk Communication Centers for Disease Control and Prevention, September 2002

21 Principles of Emergency Risk Communication Stop trying to allay panic Stop trying to allay panic Emphasize there is a process in place Emphasize there is a process in place Don’t over reassure Don’t over reassure Acknowledge uncertainty Acknowledge uncertainty Acknowledge people’s fears Acknowledge people’s fears Express wishes Express wishes Give people things to do Give people things to do Acknowledge the shared misery Acknowledge the shared misery Give anticipatory guidance Give anticipatory guidance Address dreaded “what if” questions Address dreaded “what if” questions Be a role model and ask more of people Be a role model and ask more of people Be regretful Be regretful Crisis and Emergency Risk Communication Centers for Disease Control and Prevention, September 2002

22 Principles of Emergency Risk Communication Stop trying to allay panic Stop trying to allay panic Emphasize there is a process in place Emphasize there is a process in place Don’t over reassure Don’t over reassure Acknowledge uncertainty Acknowledge uncertainty Acknowledge people’s fears Acknowledge people’s fears Express wishes Express wishes Give people things to do Give people things to do Acknowledge the shared misery Acknowledge the shared misery Give anticipatory guidance Give anticipatory guidance Address dreaded “what if” questions Address dreaded “what if” questions Be a role model and ask more of people Be a role model and ask more of people Be regretful Be regretful

23 Emphasize a Process is in Place There is a process to monitor vaccine safety. There is a process to monitor vaccine safety. pre- and post-licensure vaccine safety surveillance pre- and post-licensure vaccine safety surveillance Vaccine trials Vaccine trials Vaccine Safety Datalink Vaccine Safety Datalink VAERS VAERS

24 Don’t Over Reassure Speak openly and honestly about the side effects and risks of vaccines Speak openly and honestly about the side effects and risks of vaccines

25 Acknowledge Uncertainty Offer what you know versus what you don’t know Offer what you know versus what you don’t know We don’t know the cause(s) of autism We don’t know the cause(s) of autism We know there is no link between MMR vaccine and autism We know there is no link between MMR vaccine and autism We know there is no link between thimerosal and autism We know there is no link between thimerosal and autism

26 Acknowledge People’s Fears Even when fear is unjustified… Even when fear is unjustified… it doesn’t respond well to being ignored it doesn’t respond well to being ignored It doesn’t respond well to criticism It doesn’t respond well to criticism It doesn’t respond well to statistics It doesn’t respond well to statistics

27 Give People Things to Do Encourage parents to review educational material that you trust and agree to discuss at next visit Encourage parents to review educational material that you trust and agree to discuss at next visit Provide references that are parent and provider friendly Provide references that are parent and provider friendly Refer parents to websites that are parent and provider friendly Refer parents to websites that are parent and provider friendly

28 Dr. Bob: Meet Dr. Brown

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30 Give Anticipatory Guidance If you are aware of future negative outcomes, let people know what to expect If you are aware of future negative outcomes, let people know what to expect Risks of disease Risks of disease Spread of disease to other vulnerable individuals Spread of disease to other vulnerable individuals Possibility of isolation / quarantine during outbreaks Possibility of isolation / quarantine during outbreaks

31 Be a Role Model and Ask More of People May want to mention that you are up to date on your vaccines… May want to mention that you are up to date on your vaccines… May want to mention that your children, grandchildren, nieces, nephews, etc. are vaccinated May want to mention that your children, grandchildren, nieces, nephews, etc. are vaccinated Ask people to help you provide a community where children are safer from diseases Ask people to help you provide a community where children are safer from diseases

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33 I don’t see the point. I had chickenpox when I was little... and polio doesn’t even exist any more.

34 No Benefit…? Vaccines are a victim of their own success! Vaccines are a victim of their own success! Never seen, rarely hear about Never seen, rarely hear about If we give a bunch of children vaccines, and no one catches anything, where’s the news in that? If we give a bunch of children vaccines, and no one catches anything, where’s the news in that? Risk of disease is low Risk of disease is low Risk from disease is low Risk from disease is low

35 Disease not that bad? It’s the measles folks, not Ebola. It’s an illness that before vaccination was treated with rest, chicken soup and time off in a dark room with high doses of Vitamin A and you all are making it sound like we’re all seconds away from dying in the worst outbreak of disease to hit mankind. THIS is why vaccine makers are trillionaires. Autism Blog: “Mary”, in response to article about outbreak of measles

36 Unprotected People "Invasive Hib Disease Kills Unvaccinated Toddler” January 2008, New York "Invasive Hib Disease Kills Unvaccinated Toddler” January 2008, New York "Pennsylvania man's death from diphtheria underscores the importance of vaccination for international travel” January 2004 "Pennsylvania man's death from diphtheria underscores the importance of vaccination for international travel” January 2004 “11-year-old Indiana girl dies after being brought to an emergency room in profound septic shock after a varicella zoster infection.” October 2002 “11-year-old Indiana girl dies after being brought to an emergency room in profound septic shock after a varicella zoster infection.” October 2002 "Influenza killed my beautiful 23-month-old daughter” December 2003, Colorado "Influenza killed my beautiful 23-month-old daughter” December 2003, Colorado “Mother with undiagnosed pertussis infects her three children... her newborn son dies of the disease.” June 2005 “Mother with undiagnosed pertussis infects her three children... her newborn son dies of the disease.” June 2005 “A mother loses her 6-year-old son to pneumococcal meningitis.” May 2001 “A mother loses her 6-year-old son to pneumococcal meningitis.” May 2001 “An infant born to refugee parents suffers multi-organ defects as a result of congenital rubella syndrome.” November 2005 “An infant born to refugee parents suffers multi-organ defects as a result of congenital rubella syndrome.” November 2005 Immunization Action Coalition

37 Counseling Parents Vaccine Information Statements (VIS) Vaccine Information Statements (VIS)

38 Do we still need vaccines? common diseases: serious sequelae common diseases: serious sequelae pertussis, pneumococcus, chickenpox, hepatitis pertussis, pneumococcus, chickenpox, hepatitis rare but persistent disease: drop in vaccine coverage will cause resurgence rare but persistent disease: drop in vaccine coverage will cause resurgence measles, mumps, rubella, H.flu B, tetanus measles, mumps, rubella, H.flu B, tetanus disease eliminated from US: “only a plane ride away” disease eliminated from US: “only a plane ride away” polio, diphtheria, (smallpox) polio, diphtheria, (smallpox)

39 Common

40 Rare but Persistent

41 Investigation halts the decline of vaccine in UK, but not enough to stop the return of disease Graphs from The Independent (London), 21 June 2008

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43 Eliminated…

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45 Polio Outbreak Dominican Republic and Haiti: 2000 Dominican Republic and Haiti: 2000 19 cases, vaccine-associated 19 cases, vaccine-associated all unimmunized or underimmunized all unimmunized or underimmunized

46 Five vaccines seems like a lot for such a young baby...

47 Too Many Vaccines? in a national survey of parents: 23% questioned the number of shots given to children 25% were convinced vaccines weaken the immune system

48 Do multiple vaccines overwhelm the immune system? vaccine antigens are a very small subset of the environmental exposures for the immune system vaccine antigens are a very small subset of the environmental exposures for the immune system ability to respond to extremely large numbers of distinct microbes ability to respond to extremely large numbers of distinct microbes able to generate protective immune responses to multiple vaccines at once able to generate protective immune responses to multiple vaccines at once vaccinated children get fewer infections (both vaccine-preventable and unrelated) vaccinated children get fewer infections (both vaccine-preventable and unrelated)

49 Are infants too young to get vaccines? newborns can mount an immune response from birth newborns can mount an immune response from birth multiple vaccines don’t affect response multiple vaccines don’t affect response diseases may affect young infants diseases may affect young infants

50 Hepatitis B: Risk of Carrier State after Acute Infection

51 Alternative and Delayed Schedules Schedules designed to delay vaccine administration incur risks: Schedules designed to delay vaccine administration incur risks: susceptible to disease for a longer time period susceptible to disease for a longer time period no evidence for benefit; unknown effect on efficacy no evidence for benefit; unknown effect on efficacy increased opportunities for known side effects increased opportunities for known side effects some single-ingredient vaccines not available some single-ingredient vaccines not available extra visits = extra time and cost extra visits = extra time and cost

52 I’d rather my child develop natural immunity. Isn’t it better?

53 Isn’t natural immunity better? YES... YES... immunity after disease follows a single infection; vaccine immunity may require several doses, and/or boosters immunity after disease follows a single infection; vaccine immunity may require several doses, and/or boosters

54 Isn’t natural immunity better? …and NO the cost is pain, discomfort and the potential for complications, disability, death vaccines are one of the safest most effective disease prevention tools known worldwide most deaths from vaccine-preventable diseases occur in children with healthy immune systems worldwide most deaths from vaccine-preventable diseases occur in children with healthy immune systems for some diseases immunity from vaccine is superior for some diseases immunity from vaccine is superior

55 I’m just not sure vaccines are safe.

56 Are Vaccines Safe? No vaccine (and no medication) is completely risk free No vaccine (and no medication) is completely risk free common mild side effects: pain, tenderness, redness common mild side effects: pain, tenderness, redness rare, serious side effects: anaphylaxis, thrombocytopenia rare, serious side effects: anaphylaxis, thrombocytopenia Act of commission or omission: active or passive role? Act of commission or omission: active or passive role? Because vaccines are given to healthy children, they must be as safe as possible: Because vaccines are given to healthy children, they must be as safe as possible: Benefit must clearly outweigh risk

57 Benefit vs. Risk: Hepatitis B Risk: Risk: anaphylaxis: 1 in 600,000 anaphylaxis: 1 in 600,000 no reported deaths no reported deaths Benefit: Benefit: 5000 deaths/yr; 10,000 with cirrhosis or cancer 5000 deaths/yr; 10,000 with cirrhosis or cancer severe and fatal consequences more common in the young severe and fatal consequences more common in the young 1 million people in US infected and asymptomatic 1 million people in US infected and asymptomatic prior to vaccine, 18,000 children/yr in US caught Hepatitis B from someone other than their mothers prior to vaccine, 18,000 children/yr in US caught Hepatitis B from someone other than their mothers

58 Benefit vs. Risk: Pertussis Risk: (DTwP) Risk: (DTwP) persistent crying: 1 in 100 persistent crying: 1 in 100 fever > 105: 1 in 330 fever > 105: 1 in 330 seizure with fever: 1 in 1750 seizure with fever: 1 in 1750 no deaths no deaths Benefit Benefit Japan stopped vaccination in 1975: Japan stopped vaccination in 1975: in the 3 years preceding, 400 cases of pertussis and 10 deaths in the 3 years preceding, 400 cases of pertussis and 10 deaths in the 3 years following, 13,000 cases and 113 deaths in the 3 years following, 13,000 cases and 113 deaths

59 Benefit vs Risk: Rotavirus Risk (RotaShield): Risk (RotaShield): 1 million children vaccinated 1 million children vaccinated 102 cases of intussusception: 1 in 10,000 102 cases of intussusception: 1 in 10,000 1 death 1 death Benefit Benefit US: 100,000 hospitalizations, 50-100 deaths/year US: 100,000 hospitalizations, 50-100 deaths/year per million children: 16,000 hospitalizations, 5-10 deaths per million children: 16,000 hospitalizations, 5-10 deaths most important cause of life-threatening diarrhea worldwide most important cause of life-threatening diarrhea worldwide >870,000 children under 5 years die each year >870,000 children under 5 years die each year

60 Change in risk/benefit

61 Monitoring for Safety Pre-licensure testing Pre-licensure testing Post licensure monitoring Post licensure monitoring Lot testing Lot testing Vaccine Adverse Event Reporting System (VAERS) Vaccine Adverse Event Reporting System (VAERS) Clinical Immunization Safety Assessment Centers (CISA) Clinical Immunization Safety Assessment Centers (CISA) Vaccine Safety Datalink (VSD) Vaccine Safety Datalink (VSD)

62 ` Vaccines are not completely safe, but they are as safe as we can make them, far safer than most medications, and better than the diseases they prevent

63 In 1736 I lost one of my Sons a fine Boy of 4 Years old, by the Small Pox...I long regretted bitterly and I still regret that I had not given it to him by Inoculation; This I mention for the Sake of Parents, who omit that Operation on the Supposition that they should never forgive themselves if a Child died under it; my example showing that the Regret may be the same either way, and that therefore the safer should be chosen. Benjamin Franklin Autobiography

64 MMR: Isn’t that the autism shot?

65 Can vaccines cause chronic diseases like… infantile spasms? (pertussis) infantile spasms? (pertussis) autism? (measles/MMR) autism? (measles/MMR) diabetes? (Hib, BCG) diabetes? (Hib, BCG) allergies and asthma? (pertussis, tetanus) allergies and asthma? (pertussis, tetanus) multiple sclerosis (Hep B, influenza, tetanus) multiple sclerosis (Hep B, influenza, tetanus) hemolytic anemia (DTP) hemolytic anemia (DTP) brain damage (polio, Hep B) brain damage (polio, Hep B) ITP (Hep B) ITP (Hep B) chronic arthritis (Hep B, Lyme) chronic arthritis (Hep B, Lyme) SIDS? (Hep B, pertussis) SIDS? (Hep B, pertussis) Autism and vaccines: Is there a link? Wednesday, December 11, 2002 Posted: 3:22 AM EST (0822 GMT)

66 MMR and Autism MMR and Autism Concern arises because: Concern arises because: MMR first given at 12-15 months MMR first given at 12-15 months first signs of autism often appear at 12-18 months first signs of autism often appear at 12-18 months most children in the US receive MMR, so most US children with autism have received MMR most children in the US receive MMR, so most US children with autism have received MMR BUT: BUT: sequence  consequence sequence  consequence evidence of autism actually present before vaccines given evidence of autism actually present before vaccines given multiple independent studies have shown no link between autism and MMR multiple independent studies have shown no link between autism and MMR no trend for an increase or decrease in autism as vaccination with MMR increases or decreases over time no trend for an increase or decrease in autism as vaccination with MMR increases or decreases over time

67 MMR and Autism Honda H, Shimizu Y, Rutter M. J Child Psych 2005.

68 Hepatitis B and SIDS

69 Refuting Evidence When disease follows vaccination, it occurs with a rate that can be predicted by chance alone When disease follows vaccination, it occurs with a rate that can be predicted by chance alone Cohort and case-control studies show no evidence of causality between vaccines and chronic disease Cohort and case-control studies show no evidence of causality between vaccines and chronic disease In some cases, vaccines are probably protective against these diseases In some cases, vaccines are probably protective against these diseases  Practitioners must be aware of popular media, public health information, and changing recommendations, and have access to valid alternative sources of information for parents.

70 Is this one of the vaccines that has mercury in it? Isn’t aluminum bad too?

71 Additives in vaccines preservatives preservatives adjuvants adjuvants stabilizers stabilizers manufacturing residuals manufacturing residuals antibiotics antibiotics formaldehyde formaldehyde egg protein egg protein yeast yeast Additives are present in very small amounts, but each is present for a reason Additives are present in very small amounts, but each is present for a reason

72 Preservatives: thimerosal mercury based preservative used since 1930’s mercury based preservative used since 1930’s mercury is neurotoxic mercury is neurotoxic FDA modernization act of 1997: assess Hg content of all food and drugs FDA modernization act of 1997: assess Hg content of all food and drugs ethyl mercury vs. methylmercury ethyl mercury vs. methylmercury no adverse effects EVER attributed to vaccine thimerosal no adverse effects EVER attributed to vaccine thimerosal except for some formulations of influenza, all routine pediatric vaccines in US now contain no thimerosal or only trace amounts except for some formulations of influenza, all routine pediatric vaccines in US now contain no thimerosal or only trace amounts

73 Adjuvants: aluminum adjuvants enhance the immune response adjuvants enhance the immune response aluminum salts only adjuvant in US aluminum salts only adjuvant in US aluminum is ubiquitous in the environment: a major component of the earth’s crush, and found in air, food, and water. aluminum is ubiquitous in the environment: a major component of the earth’s crush, and found in air, food, and water. breastmilk and formula contain aluminum breastmilk and formula contain aluminum safety well established safety well established

74 Stabilizers: gelatin stabilizers protect viruses from adverse conditions (freeze drying, heat) stabilizers protect viruses from adverse conditions (freeze drying, heat) all gelatin in vaccines is porcine all gelatin in vaccines is porcine risk of allergic reaction risk of allergic reaction most common identifiable cause of acute hypersensitivity reaction to vaccine most common identifiable cause of acute hypersensitivity reaction to vaccine extremely low, 1 in 2 million doses extremely low, 1 in 2 million doses

75 Antibiotics antibiotics prevent bacterial contamination during manufacturing process antibiotics prevent bacterial contamination during manufacturing process neomycin, polymyxin B, streptomycin, gentamicin; only neomycin is contained in vaccines in detectable quantities neomycin, polymyxin B, streptomycin, gentamicin; only neomycin is contained in vaccines in detectable quantities never clearly found to cause allergic reaction to vaccination never clearly found to cause allergic reaction to vaccination reaction is delayed type hypersensitivity: SQ nodule reaction is delayed type hypersensitivity: SQ nodule

76 Formaldehyde used to detoxify, sterilize used to detoxify, sterilize essential metabolite for DNA synthesis, but known to damage DNA in high concentrations essential metabolite for DNA synthesis, but known to damage DNA in high concentrations all humans have detectable formaldehyde in blood all humans have detectable formaldehyde in blood causes cancerous changes in cells in the lab; never shown to be a cause of cancer in man causes cancerous changes in cells in the lab; never shown to be a cause of cancer in man diluted during manufacture, but residual amounts found in some vaccines diluted during manufacture, but residual amounts found in some vaccines amount in vaccines considered safe amount in vaccines considered safe

77 Egg Protein egg allergy occurs in 0.5% of all kids and 5% of atopic kids egg allergy occurs in 0.5% of all kids and 5% of atopic kids influenza and yellow fever vaccines contain egg protein influenza and yellow fever vaccines contain egg protein if anaphylaxis to egg, vaccine is contraindicated if anaphylaxis to egg, vaccine is contraindicated MMR does not contain egg MMR does not contain egg

78 Yeast Hepatitis B made in Baker’s yeast Hepatitis B made in Baker’s yeast anaphylaxis occurs rarely after HepB vaccination (1 in 600,000) anaphylaxis occurs rarely after HepB vaccination (1 in 600,000) allergy to yeast not apparently the cause allergy to yeast not apparently the cause IgE to yeast never found in a recipient IgE to yeast never found in a recipient

79 These are NOT in vaccines... antifreeze antifreeze aborted human fetus cells aborted human fetus cells chick embryos chick embryos monkey kidneys monkey kidneys fetal bovine serum fetal bovine serum

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81 http://www.cdc.gov/CDCTV/GetThePicture/index.html

82 Summary Many parents have questions or concerns about childhood vaccines. Many parents have questions or concerns about childhood vaccines. Most parents have great faith in their child’s provider Most parents have great faith in their child’s provider Most parents readily accept recommendations about vaccination Most parents readily accept recommendations about vaccination Most parents weigh risk and benefit, and determine that vaccines are right for their child and for society Most parents weigh risk and benefit, and determine that vaccines are right for their child and for society When parents are concerned about vaccines, we must find out why and address their concerns When parents are concerned about vaccines, we must find out why and address their concerns

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