Teresa alves - selling sickness 2010

Promotion to the public: European Disease Awareness Campaigns Teresa Leonardo Alves Selling Sickness Conference, 7 October 2010 Amsterdam, The Netherlands

Health Action International
An independent not-for-profit global network
Established in 1981
Made up of patients, consumers, public interest NGOs, health care providers, academics, journalists and interested individuals
Working to increase access to essential medicines and to promote the rational use of medicines
HAI Europe: European office, based in Amsterdam

What this presentation covers
Relevant principles:
European legislative framework for the advertising of prescription-only medicines
WHO Ethical Criteria for Medicinal Drug Promotion
Disease awareness campaigns:
Techniques and dissemination channels
Illustrative case studies
Conclusions
Recommendations

New medicines, but not much advantage

In Europe...
5% of all hospital admissions are due to Adverse Drug Reactions
5% of all hospital patients suffer an Adverse Drug Reaction
ADRs are the 5th most common cause of hospital death
ADRs = 197,000 deaths/year
Societal cost = € 79 billion
EU Commission, 2008

What is prohibited under current
EU Legislation?
EU Directive 2004/27/EC, amending the EU Directive
Article 88 (a) prohibits advertising of prescription drugs to the public
Article 86 (2) allows information on diseases, as long as there is no direct or indirect reference to a specific product

WHO Ethical Criteria on
Medicinal Drug Promotion
Definition of promotion
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
Information on health and diseases
Scientific and educational activities should not be deliberately used for promotional purposes
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

WHO Ethical Criteria on
Medicinal Drug Promotion (II)
Relevant Indirect criteria
All claims should be reliable, accurate, truthful, informative, balanced, up-to-date, capable of substantiation
No misleading or unverifiable statements or omissions likely to induce medically unjustifiable drug risks or give rise to undue risks

Outdoors Alert to Allergy by Schering-Plough France, 2007

Internet Animation

Websites Live well online campaign by Eli-Lilly Portugal, 2010

Leaflets available at doctors’ practices and pharmacies Transdermal Contraception by Janssen Cilag Portugal, 2009

Postcards Spread the word campaign by Sanofi Pasteur, 2007

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

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.

Does the “information” provided in disease awareness campaigns lead to informed decisions? or Does it drive the choice for a specific product?

Ask your doctor...

Let’s look at evidence...
1. Do disease awareness campaigns increase sales?
2. How do current EU “information” campaigns stretch the limit of the law...and beyond?

- '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

Increased Cardiovascular Risk by Pfizer, France

What is wrong with this message?
Focus on cholesterol lowering because of Pfizer’s cholesterol-lowering drug, Lipitor
The image is of a healthy looking woman in early middle age, a low risk demographic
In women without previous heart disease, benefits of statin use do not outweigh harm

Skip your period by Bayer Schering, The Netherlands 2007

Leaflet distributed at pharmacies
Direct reference to products which have been approved for specific indications
Positive comments about company’s medicines
Product is under FDA scrutiny: concerns about side-effects – Deep Venous Thromboembolism
In the US, company made unsupported claims in advertising and was heavily fined

Lust for Life Website Bayer, Ireland 2009

Disease awareness campaign or disease-mongering – testosterone for normal ageing
Not an effective treatment for tiredness, weight gain, depression, sexual problems
Increased risks of prostate cancer

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?”

Astra-Zeneca has a product to sell: rosuvastatin
Fear-mongering
Induces consumers to seek cholesterol testing and medical treatment
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.
Serious ADRs detected: rhabdomyolysis, kidney toxicity, increased diabetes risk
Independent experts have observed that therapy harms outweigh benefits, even for patients with existing high cholesterol and at risk of heart disease

Unbranded pharmaceutical advertising
“ Disease-mongering” – expanded disease definitions in order to increase sales
Inaccuracies about disease prevalence, risks, potential treatment benefits,
Failure to comply with standards in WHO Ethical Criteria
Failure to comply with current EU Legislation
At risk: citizens’ safety and sustainability of health care costs
Regulatory response is generally inadequate

Conclusions
The public needs to know what the available treatment options are, the pros and cons of each, including the option not to treat.
The quality and promotional nature of the information provided in disease awareness campaigns funded by the pharmaceutical industry is disquieting.
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.
Unbranded disease awareness advertising represents a challenging regulatory grey area.

Recommendations
A thorough assessment of the content, public health and social implications of existing ‘disease-awareness’ campaigns by pharmaceutical companies in Europe is needed.
National Regulatory Agencies should set out criteria under which unbranded messages from pharmaceutical companies would be considered advertising, while conducting pre-screening of campaigns.
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.

Acknowledgments Dr Barbara Mintzes Terri Beswick For more information... Please contact Teresa Alves at teresa@haiweb.org

Teresa alves - selling sickness 2010

by Gezonde scepsis on Oct 09, 2010

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