Direct-to-Consumer Advertising of Prescription Medicines

Direct-to-Consumer Advertising of Prescription Medicines

INTRODUCTION
CONTENTS
ACKNOWLEDGEMENTS
EXECUTIVE SUMMARY
ABBREVIATIONS
CHAPTER 1 TRENDS TOWARDS DIRECT-TO-CONSUMER ADVERTISING OF PRESCRIPTION MEDICINES
1.1 The rise of DTCA
1.2 Trends in healthcare
1.3 New trends in drug marketing

CHAPTER 2 TYPES OF DTC MARKETING
2.1 The nature of drug promotion
2.2 'True DTCA'
2.2.1 Television advertising
2.2.2 Radio
2.2.3 Print media
2.2.4 Internet
2.3 Quasi-DTCA
2.3.1 Articles and news features in the general media
2.3.2 Sponsorship of information materials
2.3.3 Disease awareness campaigns
2.3.4 Marketing of new drugs
2.3.5 Links with patient groups
2.4 Information gathering
2.5 Direct mailings

CHAPTER 3 DTCA ISSUES AND CONTROVERSIES
3.1 Issues surrounding DTCA
3.2 Impact on consumers
3.2.1 DTCA: promotion or education?
3.2.2 Information quality
3.2.3 Advertising of OTC medicines to consumers
3.2.4 Advertising to clinicians
3.2.5 Does promotion affect prescribing?
3.3 Impact of DTCA on the healthcare process
3.3.1 The clinician-patient relationship
3.3.2 Consumer choice, or medicalisation of everyday problems?
3.4 Impact on the healthcare system
3.4.1 Resource considerations
3.4.2 Corporate credibility

CHAPTER 4 FUTURE OPTIONS
4.1 Regulatory models
4.1.1 Government control of promotion
4.1.2 Self-regulation
4.1.3 A different model?
4.2 Policy options
4.2.1 'Yes, but'
4.2.2 'No, unless'
4.2.3 The bottom-line: health or profits?

REFERENCES

Acknowledgements
I would like to thank the following people for their time, energy and the clarity they brought to such a complex and contested area:

Laura Bradbard, Public Affairs Specialist, Centre for Drug Evaluation and Research, US Food and Drug Administration
Mark Duman, Project Officer, Promoting Patient Choice, The King's Fund, UK
Gloria Gibbons, Shire-Hall Communications
Nicola Gray, Community Pharmacist, Drug Usage and Pharmacy Practice Group, University of Manchester, UK
Ian Kramer, Deputy Chairman, UK Coalition of People Living with HIV and AIDS
Dr Joel Lexchin, Associate Professor, Department of Family and Community Medicine, University of Toronto, Canada
Richard Ley, The Association of the British Pharmaceutical Industry
Lucinda Maine, American Pharmaceutical Association, US
Andrea Mant, Associate Professor, School of Community Medicine, University of New South Wales, Australia
Neil McGregor-Paterson, Shire-Hall Communications
Barbara Mintzes, PhD student, Department of Health Care and Epidemiology, University of British Columbia, Canada
Nancy Ostrove, US Food and Drug Administration
Phillip Taylor, The Consumers' Association, UK
Professor Tom Walley, National Prescribing Centre, University of Liverpool, UK
The participants of the e-drug discussion group have also been invaluable in helping to shape the contents of the report. Thanks in particular go to:
Wendy Armstrong, Consumers' Association, Canada
Tim Dodd, Director of Pharmacy, Shaukat Khanum Memorial Cancer Hospital, Lahore, Pakistan
David Finer, Karolinska Institute, Stockholm, Sweden
Anne Holbrook, Associate Professor of Medicine, Division of Clinical Pharmacology, Centre for Evaluation of Medicines, McMaster University, Hamilton, Ontario, Canada
Peter Mansfield, Director, Medical Lobby for Appropriate Marketing (MaLAM), Australia
James McCormack, Associate Professor, Faculty of Pharmaceutical Sciences, St Paul's Hospital, Vancouver, Canada And, as ever, to Susan - thanks for advice and encouragement.

David Gilbert is Project Officer for Promoting Action on Clinical Effectiveness (PACE) at the King's Fund, London. He has worked on health and medicines issues at the Consumers' Association, Consumers in Europe Group (CEG) and Health Action International. He is Chair of a local mental health charity, Mind in Barnet and has an MSc in Health Psychology.

The views expressed in this report are the author's own.

EXECUTIVE SUMMARY
In the US this year, about $1 billion will be spent on direct-to-consumer advertising (DTCA) of prescription medicines. The financial benefits to the pharmaceutical industry will be profound, as might be the adverse consequences, in terms of inappropriate prescribing. As other countries look towards the US example, this report outlines the trends towards DTCA in industrialised countries, the different forms of DTCA and the major controversies it provokes. Looking towards the future, it suggests a range of policy options and relates regulatory action on advertising to the wider healthcare system.

Chapter 1 charts the inexorable rise of DTCA, the US experience through the moratorium years of 1983-1985 to the 1997 Food and Drug Administration (FDA) guidance that led to an explosion of DTCA. Meanwhile, worldwide changes in healthcare, economic pressures on governments and industry and the information age in medicine, all help to explain the emergence of new trends in drug promotion. The rise of consumerism provides the most enticing lure for industry marketing activities as firms target patients and the organisations that represent them.

Chapter 2 outlines the different types of DTCA, and looks at 'true-DTCA', appearing on television and radio, in the print media and on the Internet, and 'quasi-DTCA'. The last of these incorporates a variety of mechanisms by which promotional messages reach consumers, such as articles and news features in the general media, sponsorship of information materials, disease awareness campaigns, marketing of new drugs, links with patient groups, information gathering and patient mailings. The consequences of such activities are highlighted with examples from specific DTCA campaigns.

Chapter 3 investigates the issues and controversies surrounding DTCA. It looks at the arguments for and against DTCA and the likely impact of DTCA on consumers, the healthcare process and the wider healthcare system, for example whether DTCA is commensurate to 'educating' or 'empowering' consumers and what effect it might have on the clinician-patient relationship. In trying to answer these questions, the advertising of over-the-counter (OTC) drugs to consumers and prescription medicines to clinicians throws light on the quality of information consumers are likely to receive via DTCA. Wider issues are looked at, such as whether DTCA promotes choice or medicalises health problems. Also, the impact of DTCA on healthcare financing, and the relationship between DTCA and other issues relating to information provision are addressed.

Chapter 4 looks at future options and draws upon current regulatory models to offer four possible policy scenarios. These can be termed as a simple 'yes' or 'no' to DTCA; a 'yes, but' option that advocates a cautious embrace to DTCA, provided there are appropriate safeguards in place; or a 'no, unless' position which would build on and incorporate the 'yes, but' argument by proposing corresponding changes in other parts of the drug policy system - such as increased transparency in licensing decisions.

Whatever your preferred option however, the decisions about DTCA are likely to be driven by a high-level trade-off between governments and industry that have economic considerations rather than healthcare interests at their heart.

Industry Alert

Direct-to-Consumer Advertising of Prescription Medicines

Since US restrictions were relaxed in 1997, direct-to-consumer advertising (DTCA) has rapidly emerged as one of the most important means of maximising revenue for a new product in its patent-protected years.

Moreover, DTCA is no longer purely a US issue. Australia and Canada may soon follow the US example by relaxing advertising regulations, and it is only a matter of time before the EU re-examines its DTCA ban.

Direct-to-Consumer Advertising of Prescription Medicines from Scrip Reports presents you with a clear overview of the advantages and disadvantages of DTCA. It discusses the controversies which surround the issue so you can reach your own conclusions. It will enable you to: understand the evolving policy and regulatory context of DTCA; assess strategies implemented to maximise pharmaceutical sales; highlight consumer concerns which will need to be addressed; identify the restrictions placed upon DTCA.

Assess campaign details from 16 pharmaceutical companies

PUBLISHED: JUNE 1998
REF: BS968E
PAGES: 60+
PRICE: £143/$300/¥35,000