HISTORY OF THIMEROSAL CONCERN AND POLICY ACTIONS

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1 HISTORY OF THIMEROSAL CONCERN AND POLICY ACTIONS Gary L. Freed MD, MPH Margie C. Andreae MD Division of General Pediatrics Child Health Evaluation and Research (CHEAR) Unit University of Michigan

2 TOPICS REQUESTED TO BE ADDRESSED Provider assessments of parental concern for vaccine safety Provider self-perceptions of vaccine safety Variation in opinion over U.S. policy actions regarding thimerosal Rational for variation in international policy actions regarding thimerosal

3 PROVIDER PERCEPTIONS OF VACCINE SAFETY Survey study spring 2000 national random sample 750 PDs; 750 FPs response rate 70% Physician perceptions of parents Physician self-perceptions

4 RESPONDENTS Fam Phys Peds Practice Ownership Private/independent 64% 61% MD network 11% 11% Public/Other 8% 10% Number of Physicians On-Site % 23% % 42% 6+ 29% 35% Accept Medicaid 85% 81% Full time 89% 84% Male gender 70% 55% White race 90% 86%

5 FREQUENCY OF PARENTAL CONCERNS (% of physicians selecting sometimes or often) Short- and long term side effects that are currently included in Vaccine Information Statements. Neurologic effects (e.g., autism, multiple sclerosis) not currently in Vaccine Information Statements. Other chronic diseases (eg asthma, diabetes) not currently in Vaccine Information Statements. Fam Phys Peds p-val* 27% 40% % 35%.001 8% 12% NS SIDS/other unexplained death 6% 12%.001

6 PARENTAL VIEWS REGARDING VACCINE SAFETY (% of physicians selecting sometimes or often) Giving more than one vaccine at one time may harm a child s immune system. New vaccines are not fully tested; best to wait a few years before offering them Infants with family history of adverse reaction to specific vaccine should not receive that vaccine. The increasing prevalence of chronic disorders (eg diabetes, asthma) is related to greater number of vaccines that children receive today. Fam Phys Peds p-val* 15% 21%.02 24% 32%.02 40% 41% NS 9% 19%.001 Additives in vaccines may not be safe. 15% 17% NS

7 PARENTAL VACCINE REFUSALS At least one parental vaccine refusal in past year Fam Phys Peds p-val* 60% 92%.001 Increase in refusals over past year 8% 18%.01 Decrease in refusals over past year 18% 11%.01

8 PHYSICIAN EXPERIENCE WITH ADVERSE REACTIONS Over past 12 months Fam Phys Peds p-val Submitted no VAERS 95% 78%.001 Submitted > 3 VAERS 0% 3%.01 Increased VAERS 2% 4% NS

9 IMPACT OF ROTAVIRUS AND THIMEROSAL ISSUES Agreement with Statement: Parents are more concerned about vaccine safety as a result of rotavirus vaccine. I am more concerned about vaccine safety as a result of rotavirus vaccine. Parents are more concerned about vaccine safety as a result of thimerosal issues. I am more concerned about vaccine safety as a result of thimerosal issues. Fam Phys Peds p-value 12% 32%.01 32% 37% ns 18% 27%.01 24% 13%.01

10 ASSESSMENT OF U.S. PUBLIC POLICY PROCESS FOR THIMEROSAL Interviews with >15 individuals involved Government: CDC, FDA, EPA, NVPO, ACIP, Surgeon General AAP: COID, COEH, Board of Directors, staff AAFP Consultants

11 MOTIVATIONS FOR ACTIONS First and foremost, it is clear that all parties involved in this process acted in the manner they believed was in the best interest of children in the U.S. Even parties that differed most strongly never doubted the intent or purpose of those with whom they disagreed

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13 CONTROVERSIES IN POLICY PROCESS Rapidity of the process caught many off guard unclear rationale created perception of hasty decision-making Strong disagreement regarding actual vs theoretical risk (PHS, AAP, AAFP) Confusion created by 3 federal standards for mercury exposure

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15 CONSEQUENCES OF POLICY DECISION Impact of change on newborn hepatitis B immunization program initial decrease in newborn immunization failure of many hospitals to resume hepatitis B immunization Impact could have been anticipated policy trade-off should include scientific assessment of consequences

16 POTENTIAL PROCESS IMPROVEMENTS Development of process to bring multiple federal agencies together rapidly Creation of process to control and prioritize theoretical concerns of vaccines Proactive plan to work with media on unproven/theoretical vaccine safety concerns Decrease in confrontational approach to working through conflict and oversight

17 EUROPEAN PERSPECTIVE Risk perceptions and actions taken vary among nations in response to vaccine safety concerns Cross-national comparison of the way in which similar information was addressed

18 Subjects: EUROPEAN PERSPECTIVE France Greece Ireland Methods: Face to face interviews literature review internet search

19 Recommended Vaccines for Children Under 2 Years of Age Vaccine France Greece Ireland US BCG a!! DTP/DTaP!!!! Polio!!!! MMR!!!! Hib!!! Hep B!!!

20 RESPONSES TO THIMEROSAL ISSUE European Agency for the Evaluation of Medicinal Products (EMEA), July 1999 Although no evidence of harm caused by the level of exposure, it would be prudent to promote the general use of vaccines without thimerosal within the shortest possible timeframe vaccination should continue in accordance with national schedules

21 FRANCE No interruption in the vaccine program was necessary in response to thimerosal in vaccines Only vaccines containing thimerosal were hepatitis B and influenza Potential amount of mercury administered did not exceed WHO guidelines Concluded that any risk was both theoretical and low

22 GREECE No official statement issued Majority of vaccines were already thimerosal free Hepatitis B vaccine did contain thimerosal but despite official recommendations, was routinely given at >6 months of age Infrastructure of immunization policymaking and enforcement not strong

23 IRELAND Limited official action and public response Irish Medicines Board mentioned thimerosal issue in Aug 2000 newsletter All recommended vaccines delivered in the first two years of life already thimerosal-free Issue overridden by several other concurrent vaccine safety concerns

24 REASONS FOR DIFFERENCES IN INTERNATIONAL RISK ASSESSMENT Potential exposure to thimerosal was less than in US WHO mercury exposure guideline was less conservative Predominantly viewed as a theoretical risk Other vaccine safety concerns were more prominent

25 LESSONS LEARNED FROM INTERNATIONAL COMPARISON Direct comparison of policy actions only is not enough Underlying determinants of policy actions must be explored Utility of comparisons provide range of policy options available demonstrate impact of policy actions understand policy determinants