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Viral Hepatitis Prevention Board Meeting Geneva, Switzerland, 13-14 March 2003

Hepatitis B Vaccination: Safety Issues Communication: The Industry Perspective Luc Hessel Hugues Bogaerts Aventis Pasteur MSD GlaxoSmithKline Biologicals. Viral Hepatitis Prevention Board Meeting Geneva, Switzerland, 13-14 March 2003. Introduction.

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Viral Hepatitis Prevention Board Meeting Geneva, Switzerland, 13-14 March 2003

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  1. Hepatitis B Vaccination: Safety IssuesCommunication:The Industry PerspectiveLuc Hessel Hugues BogaertsAventis Pasteur MSD GlaxoSmithKline Biologicals Viral Hepatitis Prevention Board MeetingGeneva, Switzerland, 13-14 March 2003

  2. Introduction • 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.

  3. Presentation 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.

  4. Communication strategy 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.

  5. Pitfalls in Communication during the 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.

  6. Lessons 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.

  7. Lessons 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.

  8. Consequences • 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.

  9. Understanding 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.

  10. Traditional players Health Authorities Scientific Media Patients Industry Health professionals L Hessel, H. Bogaerts, VHPB meeting, Geneva, 13-14 March 2003.

  11. New Players Scientific Media Health Authorities Lay Media Internet Patient Action Groups Patients Lawyers Industry Health professionals L Hessel, H. Bogaerts, VHPB meeting, Geneva, 13-14 March 2003.

  12. How does this affect vaccine 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.

  13. Dealing with uncertainty(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.

  14. Risk 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.

  15. Crisis Management and Communication 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.

  16. Crisis Management and Communication Tools • Key messages • Position papers • Q&A’s • Intranet-vaccine Issues • Scientific articles and presentations • Alert / 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.

  17. Crisis Management and Communication 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.

  18. Crisis Management and Communication 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.

  19. Crisis Management and Communication 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.

  20. Vaccine 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.

  21. Impact 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.

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

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