Risky Business: Talking to Parents about Vaccines

Risky Business: Talking to Parents about Vaccines NC Immunization Conference August 2011 Kristina Simeonsson, MD, MSPH Karin Hillenbrand, MDThe Brody School of Medicine at ECU

Educational Objectives • Recognize factors that contribute to the controversy surrounding vaccines • Incorporate principles of “risk communication” when discussing immunization with parents • Identify the most common concerns parents have about vaccines • Develop an approach for counseling the vaccine-hesitant parent

MMR Vaccine Gets a Bad Reputation • Wakefield “study” published in 1998 • Case series of 8 children whose symptoms of autism appeared within one month of receiving MMR vaccine

Determination of whether MMR vaccine causes autism requires four separate pieces of data

Offit PA, Coffin SE; Vaccine 2003

Background: Parents • 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 • Consumerism is on the rise • Parents often trust information from the media, regardless of the source

Parental Perspectives on Vaccine Freed et al, Pediatrics 2010

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

Wakefield Study Retracted • Case series was not consecutive • Data on timing of autistic features and gastrointestinal symptoms was altered • Study was funded by lawyers • Children were put through invasive procedures without appropriate consent

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

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

MMR Controversy in the United Kingdom More than 50% of parents interviewed believed that equal evidence existed for both sides of the debate Less than 25% were aware that bulk of evidence favors supporters of the vaccine Hargraves et al, Economics and Research Council, 2003

Refusal versus Hesitancy • Many parents express concerns about the safety of vaccines and should not automatically be categorized as being staunchly anti-vaccination

Parental Report of Level of Trust of Certain People for Vaccine Safety Information Freed GL et al, Pediatrics 2011

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

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

Risk Communication • 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 • The purpose of the message is to empower decision-making

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

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

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

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

Emphasize a Process is in Place • There is a process to monitor vaccine safety. • pre- and post-licensure vaccine safety surveillance • Vaccine trials • Vaccine Safety Datalink • Vaccine Adverse Event Reporting System

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

Acknowledge Uncertainty • Offer what you know versus what you don’t know • We don’t know the cause(s) of autism • We do know multiple independent studies have shown no link between autism and MMR • We do know multiple independent studies have shown no link between thimerosal and autism

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

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

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

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 your children, grandchildren, nieces, nephews, etc. are vaccinated • Ask people to help you provide a community where children are safer from diseases

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

Counseling Parents • Vaccine Information Statements (VIS) • available from CDC, • Immunization Action Coalition

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

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 Gellin BG, Maibach EW, Marcuse EK. Pediatrics. 2000.

Do multiple vaccines overwhelm 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 • able to generate protective immune responses to multiple vaccines at once • vaccinated children get fewer infections (both vaccine-preventable and unrelated)

Are infants too young to get vaccines? • newborns can mount an immune response from birth • serious diseases may affect young infants

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

YES... immunity after disease follows a single infection; vaccine immunity may require several doses, and/or boosters 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 Isn’t natural immunity better? • worldwide most deaths from vaccine-preventable diseases occur in children with healthy immune systems • for some diseases immunity from vaccine is superior

What about my right to decide? The Law in North Carolina GS 130A-152(a): Every child in this state shall be immunized… Parent shall have the responsibility… GS 130A-155(a): No child shall attend school, whether public, private, or religious, or a child care facility unless [immunized]…The principal or operator shall not permit the child to attend GS 130A-155.1: No person shall attend college…unless [immunized]

School Attendance NCAC 41A .0401 • Required vaccines • Diphtheria, tetanus, pertussis – 5 doses • Tdap: 6th grade; Td booster within 10 yrs: college • Polio – 4 doses • Measles, Mumps – 2 doses • Rubella – 1 dose • Varicella – 1 dose • Hepatitis B – 3 doses • H. influenzae B – 4 (3) doses

Exemptions NCAC 41A .0401 Medical (NC 130A-156) Religious (130A-157) There is no exception to these requirements for the case of a personal belief or philosophy or a parent or guardian not founded upon a religious belief.

Medical Exemption • permitted when a physician determines that an immunization may be harmful • must be written and signed by a NC licensed physician • must correspond to medical contraindications specified in NC Immunization rules, or receive an approved exception from the State Health Director • must maintain documentation in student’s permanent record

Religious Exemption • “bona fide religious objection” • no form for requesting religious exemption in North Carolina • parent must provide a written, signed statement of the bona fide beliefs and their opposition to immunization in the student’s permanent record • not required to be notarized, signed by a religious leader, prepared by an attorney, or submitted to the state for review

Religious Objection to Vaccines • Member of a religion that prohibits vaccination • Christian Science • Fetal tissues • some vaccines are made in human cell line cultures; some cell-line cultures originated from aborted fetal tissue obtained from legal therapeutic abortion in the 1960’s • Porcine additives • Islamic and Jewish law

Compulsory vs Mandatory Offit. Deadly Choices. 2011 • compulsory: people who refuse are forcibly vaccinated • right to refuse? • mandatory: people who refuse are denied social privileges (like attending school) • right to impose the risk on others?

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

Benefit vs. Risk:Hepatitis B • Risk: • anaphylaxis: 1 in 600,000 • no reported deaths • Benefit: • 5000 deaths/yr; 10,000 with cirrhosis or cancer • severe and fatal consequences more common in the young • 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

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

Risky Business: Talking to Parents about Vaccines