Pakistan 2005: 12 day relief claim

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Pakistan 2005 1-2 day relief claim

• Excellent safety, side effect profile similar to
  placebo?
• USA 2004 warning of serious risks
• USA 2007 safety withdrawal

USA 2003 3 day relief claim
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Peru 2006
Canada 2005

• Same drug, same company, same unethical
  promotional campaign
• Unapproved use
• Illegal direct-to-consumer advertising
• Costly and not very effective

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Canada
France

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General principles - advertisements

• Minimum information
• WHO Ethical Criteria generic name, ingredients,
  approved uses, dose administration, adverse
  effects (including major or serious),
  precautions, contra-indications, warnings, major
  interactions, manufacturer info, reference to
  scientific literature as appropriate
• Wording and illustrations consistent with
  approved product information
• US FDA fair balance of information on harm and
  benefit in all parts of the advertisements
• Honoured in the breach

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(No Transcript)
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What is missing?

• Is a drug really needed?
• If it is, is this the best treatment?
• Is the existing scientific evidence presented in
  a balanced and comprehensive manner?
• Are references publicly available?
• What do images, headlines, graphs say and imply
  about this products benefits, harm, place in
  therapy (medical and non-medical messages)?

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Schering website Menopause and Hormones Accessed
October 2, 2006
Estrogen deficiency is therefore considered an
important risk factor for cardiovascular
disease. Misleading impression that estrogen
protects. No mention of cardiovascular risks of
hormone therapy.
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• Some interesting initiatives
• ADWATCH
• www.healthyskepticism.org

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AdWatch Healthy Skepticism - Australian ad
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What is the message?

• Use this first to avoid resistance
• delivers first time suggests 100 cure
• wants to recover in time busy young
  professionals want antibiotics for infections
• What doesnt the ad say?
• Patients desire for a quick recovery does not
  mean that antibiotics are indicated
• Amoxicillin/clavulanate has higher rates of
  diarrhoea, liver toxicity, than amoxicillin alone
• - http//healthyskepticism.org/adwatch/au/2004/au
  gmentin.php

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Concentration of spendingExample
direct-to-consumer advertising (DTCA)

• Most medicines NOT advertised
• New, expensive drugs, long-term use
• Large populations targeted generally healthier

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Source TNS Media Intelligence
US DTCA spending in 2006 - 4.7 billion
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42 million U.S. sleeping pill prescriptions in
2005
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ENHANCE trial completed 04/2006 but published in
2008 ezetimibe ineffective US DTCA 136 million
in 2006
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• Some interesting analytical techniques
  direct-to-consumer advertisng

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PRESENCE/ ABSENCE OF KEY INFORMATIONEducational
value of DTC ads in 18 major magazines,
1989-1998 (320 ads)
Bell et al. J Fam Pract 2000 49 1092-8
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Creating Demand for Prescription DrugsFrosch et
al, Annals Fam Med 2007 56-13

• TV ads classified based on previous analyses of
  print ads coded for
• Rational appeals info provided
• Positive and negative emotional appeals
• Humour, Sex, Nostalgia
• Inductive approach data classified by themes
• Role of medicines in characters lives
• Role of healthy lifestyle behaviours
• Team clinical psychology, communications,
  sociology, medicine, anthropology

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What messages are conveyed? systematic sample of
TV ads, 2006 (n38)
Frosch D et al. Ann Fam Med 2007 5 6-13
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Before anxious, unhappy, others concerned
After smiling, happy, loving hug from husband