by SCOTT C. RATZAN, MD, MPA, MA Editor-in-Chief, Journal of Health Communication Yale University School of Medicine Tuf

1. Prudent policy-making and health communication amidst scientific uncertaintya presentation for the Science Board to the Food and Drug Administration Advisory Committee November 16, 2001 by SCOTT C. RATZAN, MD, MPA, MA Editor-in-Chief, Journal of Health Communication Yale University School of Medicine Tufts University School of Medicine George Washington University School of Public Health and Health Services For more information: sratzan@aol.com; www.journalofhealthcommunication.com

2. Status quo Describe conflicts – Industry, Government, Prestige organizations

3. The ten minute challenge • Background on Health/Risk Communication • Lessons from the UK BSE 1996- present • Thimerosal and vaccine risk --1999 • Recent challenges -- Anthrax 2001 • Ideas to consider

4. Our Goal: Health for the public good “Informed opinion and active cooperation on the part of the public are of the utmost importance in the improvement of health of the people.” World Health Organization Preamble to the Constitution

5. How do we generally make decisions ? • Scientific usual ideas: • The data speak for themselves • We can explain the issue with • statistical significance • Progress is incremental with • evidence-based hypothesis testing • The scientific method can solve • most dilemmas

6. How does the public make personal decisions? • The mouse is a little human • The plural form of the word • anecdote” is evidence • “They say” (e.g. the media) it • is unsafe becomes reality

7. How ought we make decisions ? • Passion is the mover to action, but • reason is the guide.” George Campbell • Evidence- based – hard and • social science • Goal driven for public beneficence • Reasonably with credible, • trustworthy, understandable, • emotional/cultural sensitivity

8. How should we make regulatory decisions that relate to health “progress?” Based on SOUND SCIENCE and EVIDENCE Our process adds VALUE from the deliberation, debate and dialogue Involves Policymakers, Experts, opinion leaders, and the Public inPARTNERSHIP

9. The standard “sound science and evidence” approach

10. The shifting paradigm: The Precautionary Principle and Biologic Plausibility Anthrax BSE- CJD link Thimeresol

11. Dealing with uncertainty: the Precautionary Principle and Biologic Plausibility • There are many different definitions that are sometimes contradictory • “It is better to be safe than sorry.” • “[It is] Acting to reduce risk in advance of a complete scientific understanding, by extension of evidence and in the exercise of reasonable foresight.” • Changing paradigm: guilty until proven innocent • the burden of proof shifts toward maintaining the status quo • scientific uncertainty (and hence subjective evidence) is in the equation • scientists and regulators require evidence with experimental design (e.g. RCT)

12. Does the process add VALUE with deliberation, debate and dialogue? • Communication about uncertainty – particularly for a broad consumer or public audience – should be developed through a process beginning with value judgments people make about risk information. • The science of risk communication "emphasizes the process of exchanging information and opinion with the public.” Source: 1996 National Research Council in Zorn, Marcia; Ratzan, Scott, compilers. Health risk communication. Bethesda (MD): National Library of Medicine (US); 2000 Oct. (Current bibliographies in medicine; no. 2000-7). 847 citations from January 1990 through October 2000, plus selected earlier citations. Available from:http://www.nlm.nih.gov/pubs/resources.html

13. How does the public deal with uncertainty? Factors important to the public in interpreting risk information Source: Vincent Covello, Center for Risk Communication

14. The Process: Policymakers, Experts, Opinion Leaders, and the Public inPartnership BSE Vaccines Anthrax

15. 1996 Regulatory Kakistocracy: Lessons from Bovine Spongiform Encephalopathy (BSE) “The biggest crisis the European Union ever had” Franz Fischler, European Commissioner for Agriculture “The worst crisis the British Government has faced since the Falklands” John Major “If one wanted to study the perils of imperfect policy-making, this case provides them all.” The Guardian Back cover of The Mad Cow Crisis: Health and the Public Good (S. Ratzan, Editor) University College London Press; NYU Press, 1998)

16. In the UK: The Science: How did the original 16 or now 100+ people get vCJD? There is no scientific proof that BSE can be transmitted to man by beef, but this is seen by SEAC as the most likely explanation, and all our control measures are based on the assumption that it is. [Official Report, 9 March 1999; Vol. 327, c. 86W.] (emphasis added)

17. Consequence of 1996: TRUST 1999 For each, do you generally trust them to tell the truth or not? Tell Truth Not tell truth Don’t know% % % Doctors 89 8 3 Teachers 88 7 5 Clergymen or priests 86 9 5 Television news readers 75 17 8 The Police 70 23 7 Ordinary wo/man in the street 58 26 16 Civil servants 52 35 13 Trade Union Officials 40 39 21 Government Scientists 38 46 16 Business leaders 35 49 16 Politicians generally 19 73 8 Government Ministers 17 71 12 Journalists 10 82 8 Source: Better Regulation Task Force/MORI 9-19 January 1999. Base: 1,015 adults aged 16+.

18. BSE- House of Lords report 2000 “The Government did not lie to the public about BSE. It believed that the risks posed by BSE to humans were remote. … Confidence in government pronouncements about risk was a further casualty of BSE.” ...Public confidence in scientific advice to Government has been rocked by a series of events, culminating in theBSE fiasco; and many people are deeply uneasy about the huge opportunities presented by areas of science including biotechnology and information technology.” (Emphasis added) Select Committee on Science and Technology Third Report , 2000

19. Thimerosal June-July, 1999 • June, 1999 the FDA revealed that some infants who receive multiple doses of vaccines containing thimerosal could be exposed to total amounts of mercury that exceed some federal guidelines. • July 1, 1999, the FDA sent a letter to vaccine manufacturers on requesting plans to remove thimerosal from vaccines or justify its continued use. • One week later the Public Health Service (including the FDA, NIH, CDC, HRSA) and the American Academy of Pediatrics issued two Joint Statements urged vaccine manufacturers to reduce or eliminate thimerosal in vaccines as soon as possible. • a recommendation to defer of the first dose of hepatitis B vaccine for infants born to hepatitis B virus surface antigen (HBsAg) negative women until age 2 to 6 months was also included. • Also in July, the European Agency for the Evaluation of Medicinal Products issued a statement promoting the use of vaccines without thimerosal for infants and toddlers within the shortest possible time frame. • July 1999: Hospitals in the USA stopped giving newborns the 1st dose of hepatitis B vaccine because of thimerosal concerns; many regardless of the mother’s HBsAg status

20. July-August – A Rippling effect on a Hep B vaccine that could prevent 5000 deaths/year • August, 1999: Hepatitis B vaccine without thimerosal was approved by the FDA • September, 1999 AAP and the U.S. Public Health Service have recommended that routine hepatitis B immunization for all newborn infants should be reintroduced immediately in hospitals in which this policy and practice had been discontinued MMWR. • September 1999: Hepatitis B vaccine without thimerosal as a preservative became available, but many hospitals elected not to resume routine neonatal hepatitis B immunization • 2000--CDC studies indicate that, soon after the AAP-U.S. Public Health Service statement was issued, most hospitals discontinued routine immunization of newborn infants of HBsAg-negative mothers

21. Reality of how thimerosal risk “played out” • Preliminary assessments of the impact of these policy changes on routine hepatitis B vaccination practices were conducted by public health officials in four states. • in Wisconsin many hospitals have not reinstated policies to ensure routine administration of hepatitis B vaccine to newborns despite the availability of preservative-free hepatitis B vaccine • in Oklahoma and Oregon the number of hepatitis B vaccine doses given to newborns has declined • In Michigan one unvaccinated infant died from fulminant hepatitis B. • Unfortunately, to date resumption of the birth dose has not occurred in many hospitals throughout the U.S. MMWR February 16, 2001 / 50(06);94-7 Impact of the 1999 AAP/USPHS Joint Statement on Thimerosal in Vaccines on Infant Hepatitis B Vaccination Practices

22. IOM’s Immunization Safety Review CommitteeOctober, 2001 • The evidence is inadequate to either accept or reject a causal relationship between thimerosal exposure from childhood vaccines and the neurodevelopmental disorders of autism, attention deficit hyperactivity disorder (ADHD), and speech or language delay. • While the available scientific data do not establish that these neurodevelopmental disorders are caused by thimerosal, at the same time, they do not establish that these neurodevelopmental disorders are not caused by thimerosal. • The hypothesis that exposure to thimerosal-containing vaccines could be associated with neurodevelopmental disorders was biologically plausible. • Additional studies are needed to establish or reject a causal relationship Immunization Safety review: Thimerosal and Neurodevelopmental disorders Institute of Medicine, October 1, 2001

23. Who does the public believe in questions of health? Trust Doctors at renowned university Local Doctors Surgeon General Doctors at CDC/NIH Doctors at local health department Friends/family Local officials State officials Media Federal officials Industry – Pharmaceutical + for profit Politicians Source Credibility

24. Mistrust Anthrax 2001: Communication Credibility Trust We are protecting the American public and taking all necessary steps 1, 2, 3….. Our surveillance system is in place and is working We will make smallpox vaccine for every American Reactive Proactive We will vaccinate every American for smallpox, anthrax “We have enough Cipro for everyone” We're prepared to take care of any contingency, any consequence that develops for any kind of bio-terrorism attack. 30 Sept01 We remain on a state of highest alert Don’t worry— All under control October 2001 It is the second wave of terrorism; related to Bin Laden and Al Qaeda 4Nov 01

25. Anthrax: The Initial retrospective analysis “We knew that communications would be important, but I don’t think we knew it would be this dominant in the response.” Dr. Scott Lillibridge, Director, Bioterrorism Preparedness and Response Program, Centers for Disease Control and Prevention New York Times, November 11, 2001

26. What is the common denominator of these examples? • Effective, ethical communication is a requisite • of scientific progress • Public health values need to be integrated in the • equation for decision-making • For example, a societal risk quotient of how scientific • decisions might diffuse, be interpreted and (re)acted • upon is valid evidence to consider. • “Pure” science without considering communication often • fulminates into a so-called unintended effect of scientific • research hindering progress.

27. How does this relate to the future with FDA? Scientific conclusions • If we embody an evidence-based approach by providing stringent scientific reassurance related to regulatory issues, we are not reassuring to the public(s) we seek to serve. Hence, suggesting such a strategy is not scientific. • As public decisions are value and trust driven, future activities should integrate health communication so that we are approaching public health decisions with a common rubric: “The most humane of the sciences and empiric of the arts.”

28. If every decision and deliberation by committees (and subsequently the FDA) have health impact - in many cases globally – there are five areas the committee could discuss to address emerging issues proactively ? • Could every advisory committee have an expert in health communication/public health who could add the science of how this most likely will “play out?” For example, could we institutionalize an internal (or external) evidence-based communication approach to assist in translating science into “perceptions and practice?” • Does the status quo consumer representation de facto create an adversarial relationship that thwarts scientific progress and public health? For example, could we use qualitative research (e.g. public opinion survey data) and/or other representatives as proxies for the public pulse? • Can we develop and apply a common metric to assist in decisions regarding safety, biologic plausibility, or the precautionary principle as it relates to public health?

29. Final Questions for the committee to consider • Can we integrate “societal risk” into decisions such that its assessment would include: • perceived urgency, • cost, feasibility and value of conducting more research, • number of persons potentially affected, • seriousness of the adverse event, • likelihood of the causal hypothesis being supported, • the harm/benefit probability of the hazard (e.g. vaccines/biologics vs. adverse effects), • the consequence(s) it may have on public health including diversion of resources and erosion of trust? • Could the FDA establish a coordinated communication program to inform the public and their intermediaries of how decisions are made under uncertainty as well of the “real” risk of regulated products. In other words, can the FDA help develop a health literate American public?

30. Health Communication: The most humane of the sciences and empiric of the arts