Bert Leufkens - Selling Sickness 2010

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Bert Leufkens - Selling Sickness 2010

  1. 1. Should regulators be involved?<br />Bert Leufkens, Chair Medicines Evaluation Board<br />
  2. 2. 8-10-2010<br />Selling sickness Leufkens<br />2<br />Declaration of interests<br />Professor of Pharmacoepidemiology, Utrecht Institute of Pharmaceutical Sciences, 0.4 FTE.<br />Chairman of the Dutch Medicines Evaluation Board (MEB), since mid 2007.<br />Co-opted member of CHMP PhVWP, 2006-2009; since 2009 co-opted member of CHMP. <br />Director WHO-Utrecht Collaborating Centre on Pharmaceutical Policy Analysis, since 2008.<br />This talk reflects my personal views; I am being inspired and challenged on a daily basis by many colleagues from these ‘environments’.<br />
  3. 3. 8-10-2010<br />Selling sickness Leufkens<br />3<br />Selling sickness is not a new phenomenon<br />
  4. 4. 8-10-2010<br />Selling sickness Leufkens<br />4<br />Incomplete innovation: two scenarios<br />
  5. 5. 8-10-2010<br />Selling sickness Leufkens<br />5<br />Orphanisation: the antibiotic pipeline is almost empty<br />ECDC/EMA, 2009<br />
  6. 6. 8-10-2010<br />Selling sickness Leufkens<br />6<br />Public health effects of medicines<br />Direct clinical effects (e.g. analgesics and pain relief, antivirals and AIDS survival, biologicals and infection risk, NSAIDs and GI bleeding).<br />Disease prevention (e.g. vaccines and childhood disease, statins and prevention of CV risk). <br />Effects on other medical interventions (e.g. PPIs and GI surgery, anaesthesia and surgery, cyclosporin and organ transplantation).<br />Society effects (e.g. contraceptives and demo-graphics, psychotropic drugs and transformation of the mental health system, disease mongering).<br />
  7. 7. 8-10-2010<br />Selling sickness Leufkens<br />7<br />Regulating marketing approval<br />Regulatory governance<br />Regulatory learning<br />
  8. 8. 8-10-2010<br />Selling sickness Leufkens<br />8<br />The soul of regulators: knights or knaves<br />Knights of safeguarding public health on behalf of the public, of idealism and altruism.<br />Knaves of procedures, of risk avoidance, of bureaucratic constructs and self-interest.<br />
  9. 9. 8-10-2010<br />Selling sickness Leufkens<br />9<br />Key questions in the lifecycle of a medicine<br />
  10. 10. 8-10-2010<br />Selling sickness Leufkens<br />10<br />Where can regulators contribute?<br />
  11. 11. 8-10-2010<br />Selling sickness Leufkens<br />11<br />Outcomes and making comparisons<br />societal effects<br />HTA<br />clinical outcome<br />biomarker<br />placebo standard treatment alternative scenario<br />
  12. 12. 8-10-2010<br />Selling sickness Leufkens<br />12<br />Low susceptibility <br />to misuse<br />Ranking evidence and susceptibility of misuse<br />Thyroid drugs<br />ICS for asthma<br />Insuline<br />Glaucoma drugs<br />High level of <br />evidence<br />Hypnotics<br />Growth hormone<br />Dementia drugs<br />Antibiotics<br />Expectorants<br />Proton pump inhibitors<br />Bégaud B, Bergman U, Eichler H-G, Leufkens HG, Meier PJ. Br J Clin Pharmacol 2002; 54: 528-34.<br />
  13. 13. 8-10-2010<br />Selling sickness Leufkens<br />13<br />Therapeutic indications in oncology over time<br />Tafuri G et al. Eur J Cancer 2010; 46: 471-5.<br />
  14. 14. 8-10-2010<br />Selling sickness Leufkens<br />14<br />Post-approval RCTs of etanercept, 2000–2008<br />Luijn JCF van et al. Scand J Rheumatol 2010;<br />
  15. 15. 8-10-2010<br />Selling sickness Leufkens<br />15<br />Are we serving patient’s interests by labelling new drugs as second line?<br />Schiller Y et al. Neurology 2008; 70: 54-65.<br />
  16. 16. 8-10-2010<br />Selling sickness Leufkens<br />16<br />Summarizing<br />The current regulatory system is marketing authorization holder (industry) driven.<br />Unless there is a safety issue or serious doubt about the B/R of a product (e.g. rosiglitazone).<br />The approved indication opens a window for appropriate, beneficial use and intended patient outcomes. <br />A ‘wrong’ indication opens also a window for off-label use, of not targeting the right patients, etc. (‘regulatory gap’).<br />Regulators are always too strict, too slow, too fast, too forgiven, too cozy, etc.<br />Transparency on how regulatory decisions are made is key for restoring trust from society (one of MEB’s priorities). <br />
  17. 17. 8-10-2010<br />Selling sickness Leufkens<br />17<br />Trust in the banking system has been badly shaken<br />
  18. 18. 8-10-2010<br />Selling sickness Leufkens<br />18<br />Critical regulatory features in three industries<br />
  19. 19. 8-10-2010<br />Selling sickness Leufkens<br />19<br />EMBO reports 2010; 11: 572-8.<br />
  20. 20. 8-10-2010<br />Selling sickness Leufkens<br />20<br />Health is not only about drugs: four scenarios<br />Crommelin D, Stolk P, Besancon L, Shah V, Midha K, Leufkens H. Pharmaceutical sciences in 2020. Nat Drug Discov 2010; 9: 99-100.<br />

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