Ideal Risk Communication:

1
Prudent policy-making and health communication
amidst scientific uncertainty a
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_at_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 in PARTNERSHIP
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 fromhttp//www.nlm.n
ih.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 in Partnership
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
Dont 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 the BSE 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 mothers 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
IOMs Immunization Safety Review
CommitteeOctober, 2001

1. 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.
2. 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.
3. The hypothesis that exposure to
   thimerosal-containing vaccines could be
   associated with neurodevelopmental disorders was
   biologically plausible.
4. 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
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
Dont 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 dont 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