Hepatitis B Vaccination: Safety Issues

Communication:The Industry Perspective

Luc Hessel Hugues BogaertsAventis Pasteur MSD GlaxoSmithKline Biologicals

Viral Hepatitis Prevention Board MeetingGeneva, Switzerland, 13-14 March 2003

L Hessel, H. Bogaerts, VHPB meeting, Geneva, 13-14 March 2003.

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IntroductionIntroduction

• The Hepatitis B vaccine crisis has been the most important crisis for vaccine manufacturers in Europe

• It illustrates major changes in risk environment in vaccinology

• It had a profound impact on the way vaccine industry is managing risk assessment and communication

L Hessel, H. Bogaerts, VHPB meeting, Geneva, 13-14 March 2003.

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Presentation OutlinePresentation Outline

• Vaccine Manufacturers communication strategy during the Hepatitis B crisis

• Main pitfalls in communication• Lessons learnt• Consequences

– Understanding the environment– Dealing with uncertainty– Risk-assessment / crisis management /

communication– Vaccine advocacy and role of vaccine industry– Impact on clinical development and PMS

• Conclusion

L Hessel, H. Bogaerts, VHPB meeting, Geneva, 13-14 March 2003.

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Communication strategyCommunication strategy during the hepatitis B crisis during the hepatitis B crisis

Essentially reactive, « No Comment » despite willingness to communicate

• Internal considerations– Lack of preparation (data, messages,

communication skills and pathways)

• External constraints– DoH– AFSSAPS

• Legal issues– No comment on legal decisions

L Hessel, H. Bogaerts, VHPB meeting, Geneva, 13-14 March 2003.

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Pitfalls in Communication during Pitfalls in Communication during the hepatitis B crisisthe hepatitis B crisis

• Slow reactivity• Management of scientific communication to

media and lay public (specificity of vaccines)

• Difficult relationship with HA• Lack of consistency in messages• Lack of trust, confidence and credibility of

the industry (e.g. safety databases, epidemiological studies)

• Lack of « third parties » • Lack of defined communication strategy

L Hessel, H. Bogaerts, VHPB meeting, Geneva, 13-14 March 2003.

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Lessons learntLessons learnt

1996-1999

• Industry (and other internal and external stakeholders !) poorly prepared for crisis management

• “Fire fighting”, reactive strategies, “running behind the facts”

• An important learning period on what to do, how to manage / anticipate crises, with whom …

L Hessel, H. Bogaerts, VHPB meeting, Geneva, 13-14 March 2003.

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Lessons learntLessons learnt

From 1999• Vaccine issues (not only safety) are here to stay

and are part of our environment:dealing with uncertainty

• Support vaccination rather than vaccines• Industry & others partners are better prepared,

stronger, know more• Greater awareness = better anticipation• Audiences / partners better identified• Crisis management = team work !

L Hessel, H. Bogaerts, VHPB meeting, Geneva, 13-14 March 2003.

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ConsequencesConsequences

• Understanding the environment

• Risk assessment - Crisis management & Communication strategy

• “Vaccine advocacy”

• Impact on clinical development and post-marketing activities

• Role of the vaccine industry (EVM)

L Hessel, H. Bogaerts, VHPB meeting, Geneva, 13-14 March 2003.

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Understanding the EnvironmentUnderstanding the Environment

• Concern over vaccine safety is a major determinant of immunisation policy

• New technologies have revolutionized information & communication on health prevention

• Political environment: precautionary principle / zero-risk society / somebody should pay...

• Increasing level of scepticism by public & media about understanding of science

• Gap between public opinion and public policy • « traditional » vs « new players »

L Hessel, H. Bogaerts, VHPB meeting, Geneva, 13-14 March 2003.

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Traditional playersTraditional playersTraditional playersTraditional players

Health Authorities

Patients

IndustryHealthprofessionals

Scientific Media

L Hessel, H. Bogaerts, VHPB meeting, Geneva, 13-14 March 2003.

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New PlayersNew PlayersNew PlayersNew Players

Health Authorities

Patients

IndustryHealth professionals

Scientific MediaLay Media

PatientAction Groups

Lawyers

Internet

L Hessel, H. Bogaerts, VHPB meeting, Geneva, 13-14 March 2003.

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How does this affect vaccine How does this affect vaccine manufacturers ?manufacturers ?

How does this affect vaccine How does this affect vaccine manufacturers ?manufacturers ?

• Low credibility in risk communication:– «Conspiracy theory»– Conflicts of interest between public health impact

of vaccination and company’s profit

• External communication limited by regulatory and health authorities

• Liability / legal actions

• Need to permanently anticipate / manage critical situations

L Hessel, H. Bogaerts, VHPB meeting, Geneva, 13-14 March 2003.

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Dealing with uncertaintyDealing with uncertainty(internally and externally)(internally and externally)

• Do not wait to be confronted

• Listen to concerned people

• Put bounds on uncertainty

• Not all data are equally uncertain

• Say what is done to reduce uncertainty

• Do not hide behind uncertainty

• Explain your cautiousness

• Acknowledge if you have dragged you feet

L Hessel, H. Bogaerts, VHPB meeting, Geneva, 13-14 March 2003.

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Risk AssessmentRisk Assessment

Common features of vaccines scares• Causal link usually claimed with a disease or

condition of unknown or unclear etiology

• Association claimed by one investigator or a small group of investigators

• Association not confirmed by peers or subsequent research

• Claims made with no apparent concern for potential harm from public loss of confidence and refusal to vaccinate children

L Hessel, H. Bogaerts, VHPB meeting, Geneva, 13-14 March 2003.

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Crisis Management and Crisis Management and CommunicationCommunication

Preparing for a crisis

• Impossible to prepare for every crisis

• Each crisis is unique

• But some crisis preparation is essential

• More about attitudes (ethics, public health) than procedures

• Communication marketing

• Flexibility essential

L Hessel, H. Bogaerts, VHPB meeting, Geneva, 13-14 March 2003.

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Crisis Management and Crisis Management and CommunicationCommunication

Tools

Key messagesPosition papersQ&A’sIntranet-vaccine Issues Scientific articles and presentationsAlert / monitoring

Organisation

Multi disciplinary company team

One communication contact - clear process

Develop strategy & stick to it Media-trained

spokespersons Permanent / pro-active

L Hessel, H. Bogaerts, VHPB meeting, Geneva, 13-14 March 2003.

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Crisis Management and Crisis Management and CommunicationCommunication

Monitoring• Local company network monitors local

media (not specifically on issues) and alerts ad hoc– Lay press as crucial as specialised media

• New issues are picked up in scientific press and via relations with opinion leaders– potential issues may be “known” before

media attention

L Hessel, H. Bogaerts, VHPB meeting, Geneva, 13-14 March 2003.

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Crisis Management and Crisis Management and CommunicationCommunication

Internal communication• Intranet based

• one stop-shop for:– company position papers– links to third party organisations– press release– briefing documents– Q&A …

L Hessel, H. Bogaerts, VHPB meeting, Geneva, 13-14 March 2003.

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Crisis Management and Crisis Management and CommunicationCommunication

External communication• Mostly reactive versus media (depends on

and if litigation has started)• No press releases on legal actions against

industry• reliance on authorities CDC, WHO, VHPB,

immunisation advisory groups because poor credibility of industry

• Understanding does not necessarily bring support, whereas trust is associated with support

L Hessel, H. Bogaerts, VHPB meeting, Geneva, 13-14 March 2003.

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Vaccine AdvocacyVaccine Advocacy

Role of the vaccine industry• At the company level: importance of internal

stakeholders• Through vaccine industry associations• Partnership with HA and expert groups (CDC,

WHO, VHPB …)• Not limited to safety issues (supply)

L Hessel, H. Bogaerts, VHPB meeting, Geneva, 13-14 March 2003.

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Impact on vaccine developmentImpact on vaccine development

• Prelicensure:– Extensive safety studies

• Post-licensure– Pharmacoepidemiology

• Development of epidemiological surveillance– Vaccine and disease registries

• Overall increase in development costs and cost of compliance

L Hessel, H. Bogaerts, VHPB meeting, Geneva, 13-14 March 2003.

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ConclusionConclusionThe Way ForwardThe Way Forward

• Industry and 3rd parties in the vaccine community need to build partnership

• Retrospective databases (sometimes difficult to access) need to be identified and queried

• Prospective: post-marketing surveillance systems need to be set up: epidemiology, disease burden, side effects

• Adapt information pathways and messages to different audiences