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Teresa alves - selling sickness 2010


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Teresa alves - selling sickness 2010

  1. 2. Promotion to the public: European Disease Awareness Campaigns Teresa Leonardo Alves Selling Sickness Conference, 7 October 2010 Amsterdam, The Netherlands
  2. 3. <ul><li>Health Action International </li></ul><ul><li>An independent not-for-profit global network </li></ul><ul><li>Established in 1981 </li></ul><ul><li>Made up of patients, consumers, public interest NGOs, health care providers, academics, journalists and interested individuals </li></ul><ul><li>Working to increase access to essential medicines and to promote the rational use of medicines </li></ul><ul><li>HAI Europe: European office, based in Amsterdam </li></ul>
  3. 4. <ul><li>What this presentation covers </li></ul><ul><li>Relevant principles: </li></ul><ul><ul><li>European legislative framework for the advertising of prescription-only medicines </li></ul></ul><ul><ul><li>WHO Ethical Criteria for Medicinal Drug Promotion </li></ul></ul><ul><li>Disease awareness campaigns: </li></ul><ul><ul><li>Techniques and dissemination channels </li></ul></ul><ul><ul><li>Illustrative case studies </li></ul></ul><ul><li>Conclusions </li></ul><ul><li>Recommendations </li></ul>
  4. 5. New medicines, but not much advantage
  5. 6. <ul><li>In Europe... </li></ul><ul><li>5% of all hospital admissions are due to Adverse Drug Reactions </li></ul><ul><li>5% of all hospital patients suffer an Adverse Drug Reaction </li></ul><ul><li>ADRs are the 5th most common cause of hospital death </li></ul><ul><li>ADRs = 197,000 deaths/year </li></ul><ul><li>Societal cost = € 79 billion </li></ul>EU Commission, 2008
  6. 7. <ul><li>What is prohibited under current </li></ul><ul><li>EU Legislation? </li></ul><ul><li>EU Directive 2004/27/EC, amending the EU Directive </li></ul><ul><ul><li>Article 88 (a) prohibits advertising of prescription drugs to the public </li></ul></ul><ul><ul><li>Article 86 (2) allows information on diseases, as long as there is no direct or indirect reference to a specific product </li></ul></ul>
  7. 8. <ul><li>WHO Ethical Criteria on </li></ul><ul><li>Medicinal Drug Promotion </li></ul><ul><li>Definition of promotion </li></ul><ul><ul><li>All informational and persuasive activities by manufacturers and distributors, the effect of which is to induce the prescription, supply, purchase and/or use of medicinal drugs </li></ul></ul><ul><li>Information on health and diseases </li></ul><ul><ul><li>Scientific and educational activities should not be deliberately used for promotional purposes </li></ul></ul><ul><ul><li>While advertisements should take account of people’s legitimate desire for information regarding their health, they should not take undue advantage of people’s concern for their health </li></ul></ul>
  8. 9. <ul><li>WHO Ethical Criteria on </li></ul><ul><li>Medicinal Drug Promotion (II) </li></ul><ul><li>Relevant Indirect criteria </li></ul><ul><ul><li>All claims should be reliable, accurate, truthful, informative, balanced, up-to-date, capable of substantiation </li></ul></ul><ul><ul><li>No misleading or unverifiable statements or omissions likely to induce medically unjustifiable drug risks or give rise to undue risks </li></ul></ul>
  9. 10. Outdoors Alert to Allergy by Schering-Plough France, 2007
  10. 11. Internet Animation
  11. 12. Websites Live well online campaign by Eli-Lilly Portugal, 2010
  12. 13. Leaflets available at doctors’ practices and pharmacies Transdermal Contraception by Janssen Cilag Portugal, 2009
  13. 14. Postcards Spread the word campaign by Sanofi Pasteur, 2007
  14. 15. More than 6 weeks without smoking and no arguments yet. Stop smoking without drama, visit your doctor. Printed Media Stop Smoking without Drama by Pfizer, Portugal 2007
  15. 16. The quality of information that accompanies medicines can make the difference between “a poison and a cure”: between use that leads to better health and use that most likely to leads to harm.
  16. 17. Does the “information” provided in disease awareness campaigns lead to informed decisions? or Does it drive the choice for a specific product?
  17. 18. Ask your doctor...
  18. 19. <ul><li>Let’s look at evidence... </li></ul><ul><li>1. Do disease awareness campaigns increase sales? </li></ul><ul><li>2. How do current EU “information” campaigns stretch the limit of the law...and beyond? </li></ul>
  19. 20. - 't Jong GW et al. British Medical Journal 2004;328:931 Toenail Fungus TV Campaign by Novartis, The Netherlands Ethical Criteria definition of promotion: to stimulates sales
  20. 21. Increased Cardiovascular Risk by Pfizer, France
  21. 22. <ul><li>What is wrong with this message? </li></ul><ul><li>Focus on cholesterol lowering because of Pfizer’s cholesterol-lowering drug, Lipitor </li></ul><ul><li>The image is of a healthy looking woman in early middle age, a low risk demographic </li></ul><ul><li>In women without previous heart disease, benefits of statin use do not outweigh harm </li></ul>
  22. 23. Skip your period by Bayer Schering, The Netherlands 2007
  23. 24. <ul><li>What is wrong with this message? </li></ul><ul><li>Leaflet distributed at pharmacies </li></ul><ul><li>Direct reference to products which have been approved for specific indications </li></ul><ul><li>Positive comments about company’s medicines </li></ul><ul><li>Product is under FDA scrutiny: concerns about side-effects – Deep Venous Thromboembolism </li></ul><ul><li>In the US, company made unsupported claims in advertising and was heavily fined </li></ul>
  24. 25. Lust for Life Website Bayer, Ireland 2009
  25. 26. <ul><li>What is wrong with this message? </li></ul><ul><li>Disease awareness campaign or disease-mongering – testosterone for normal ageing </li></ul><ul><li>Not an effective treatment for tiredness, weight gain, depression, sexual problems </li></ul><ul><li>Increased risks of prostate cancer </li></ul>
  26. 27. Age of your arteries by Astra-Zeneca, Portugal 2007 “ John is 50, but his arteries are a lot older. What about your arteries, have you checked if they are OK for your age?”
  27. 28. <ul><li>What is wrong with this message? </li></ul><ul><li>Astra-Zeneca has a product to sell: rosuvastatin </li></ul><ul><li>Fear-mongering </li></ul><ul><li>Induces consumers to seek cholesterol testing and medical treatment </li></ul><ul><li>There is no evidence that at primary prevention level, in healthy subjects, with no history of cardiovascular disease, cholesterol testing and subsequent statin therapy is beneficial. </li></ul><ul><li>Serious ADRs detected: rhabdomyolysis, kidney toxicity, increased diabetes risk </li></ul><ul><li>Independent experts have observed that therapy harms outweigh benefits, even for patients with existing high cholesterol and at risk of heart disease </li></ul>
  28. 29. <ul><li>Unbranded pharmaceutical advertising </li></ul><ul><li>“ Disease-mongering” – expanded disease definitions in order to increase sales </li></ul><ul><li>Inaccuracies about disease prevalence, risks, potential treatment benefits, </li></ul><ul><li>Failure to comply with standards in WHO Ethical Criteria </li></ul><ul><li>Failure to comply with current EU Legislation </li></ul><ul><li>At risk: citizens’ safety and sustainability of health care costs </li></ul><ul><li>Regulatory response is generally inadequate </li></ul>
  29. 30. <ul><li>Conclusions </li></ul><ul><li>The public needs to know what the available treatment options are, the pros and cons of each, including the option not to treat. </li></ul><ul><li>The quality and promotional nature of the information provided in disease awareness campaigns funded by the pharmaceutical industry is disquieting. </li></ul><ul><li>A key concern about the reliance on pharmaceutical companies to provide this information is that the context in which the information is provided is biased towards supporting treatment with the sponsor’s product. </li></ul><ul><li>Unbranded disease awareness advertising represents a challenging regulatory grey area. </li></ul>
  30. 31. <ul><li>Recommendations </li></ul><ul><li>A thorough assessment of the content, public health and social implications of existing ‘disease-awareness’ campaigns by pharmaceutical companies in Europe is needed. </li></ul><ul><li>National Regulatory Agencies should set out criteria under which unbranded messages from pharmaceutical companies would be considered advertising, while conducting pre-screening of campaigns. </li></ul><ul><li>Social media outlets, such as Facebook, You tube, Twitter, Blogs, My Space and Wikipedia should be closely monitored to prevent disguised advertising of prescription medicines. </li></ul>
  31. 32. Acknowledgments Dr Barbara Mintzes Terri Beswick For more information... Please contact Teresa Alves at