Lifestyle Drugs: Who will pay?

Lifestyle Drugs: Who will pay?

Viagra was the first of several products to be labelled a 'lifestyle drug': a drug that appears to lie at the ever shifting and socially constructed boundary between a 'lifestyle wish' and a 'health need'. In an era when healthcare costs within all industrialised countries are rising, how can access to such drugs be better managed or rationed?

Lifestyle Drugs: Who will pay? disentangles the different threads of the debate on lifestyle drugs. It assess the problems and controversies provoked and formulates a policy framework for tackling this new healthcare agenda. This report defines and clarifies the term 'lifestyle drug', highlights the major issues and enables you to draw your own conclusions about the future of lifestyle healthcare.

PUBLISHED: MAY 1999
REF: BS1020E
PAGES: 80+
PRICE: £250/$499/¥60,000

CONTENTS
LIST OF TABLES
ABOUT THE AUTHOR
ACKNOWLEDGEMENTS
EXECUTIVE SUMMARY
ABBREVIATIONS

CHAPTER 1 DRUGS AND LIFESTYLE - THE EMERGENCE OF A PROBLEM
1.1 What is a lifestyle drug?
1.2 Viagra (sildenafil)
1.2.1 Ever-widening use
1.2.2 Mixed blessings
1.2.3 Budget buster
1.3 Xenical (orlistat)
1.3.1 Management of obesity
1.3.2 Controversies in treatment for obesity
1.4 Propecia (finasteride)
1.4.1 Treating hair loss - a risky business
1.4.2 Advertising controversies
1.5 Seroxat (paroxetine) and drugs for mental health problems
1.5.1 Mental health awareness campaigns
1.6 Other lifestyle drugs
1.6.1 De facto lifestyle drugs
1.6.2 Displacing alternative approaches
1.6.3 Value judgements
1.6.4 Lifestyle drugs in the new millennium
1.7 Medicalisation - the creeping line
1.8 The role of industry in the rise of lifestyle drugs and medicalisation
1.8.1 Guidelines and treatment thresholds
1.8.2 New trends in drug promotion
1.8.3 Direct-to-consumer advertising
1.8.4 Disguised promotion

CHAPTER 2 DRUGS AND MONEY - FIRST ATTEMPTS TO FACE THE PROBLEM
2.1 The business of healthcare
2.2 The road to rationing - an overview
2.3 First steps on the road to rationing
2.3.1 France
2.3.2 Germany
2.3.3 New Zealand
2.3.4 Sweden
2.3.5 The UK
2.3.6 The US

CHAPTER 3 DRUGS AND POLITICS - NEXT STEPS TOWARDS SENSIBLE SOLUTIONS
3.1 Pharmaceutical regulatory policy
3.1.1 Better information
3.1.2 Cost-effectiveness
3.1.3 Balancing the system
3.1.4 Improved monitoring
3.2 Rationing revisited
3.2.1 A framework for decision-making
3.2.2 What's on the healthcare menu?
3.2.3 Countless day-to-day decisions
3.3 The unheard voice - patient, carer and public involvement
3.3.1 Why involve patients and the public?
3.3.2 How to involve patients and the public
3.3.3 A balanced approach
3.4 Bringing it all together - local and national medicines management
3.4.1 Central versus local decision-making
3.4.2 Support for implementation
3.5 One step back: the bigger picture

REFERENCES

LIST OF TABLES
Table 2.1 Healthcare prioritisation in Sweden
Table 2.2 Healthcare prioritisation in Oregon

EXECUTIVE SUMMARY
In the spring of 1998 in the US, the media picked up on Wall Street's predictions that Viagra (sildenafil) was close to being licensed. As with Prozac (fluoxetine), the expectations were intense. The resultant media blitz portrayed the 'new prescription for love' as 'revolutionary'. 'Hordes hot for impotence 'cure' awaiting FDA nod' was one headline (Scrip 2321, 27 March 1998 p16).

Across the Atlantic, French Government inspectors found a restaurant owner serving a 'beef piccata in Viagra sauce infused with fig vinegar and herbs'. The sauce contained a fifth of a 50mg tablet of Viagra, while in Italy, one newspaper observed: 'It is not clear whether (demand for the product) is because of different values or expectations in the land of the Latin lovers, or whether they really do have more medical problems' (Scrip 2341, 5 June 1998 p19).

Before the drug was licensed in the UK, a company offered 'Viagra by mail order - the wonder drug that everyone's talking about' (Scrip 2368, 9 September 1998 p3), while another sent unsolicited faxes to private numbers extolling the 'wonders' of Viagra: 'We don't sell it, we sift the fact from the fiction and let you decide', the fax said, giving a clinical trials review (mentioning Pfizer, its manufacturer) and 'how to get it', along with the address of a private London clinic where the drug was available.

Physicians were reported to be prescribing Viagra without seeing patients, via Internet websites in Austria, France, Spain and Sweden. Meanwhile an Asian black market was growing. In Hong Kong, three men were arrested for illegal marketing of nearly 500 tablets being sold for up to HK$400 ($52) each (Scrip 2340, 3 June 1998 p23). Japanese magazine readers were told how they could get Viagra from abroad (prior to it being licensed in the country). 'Proxy buyers' in the US, charging up to $190 for 10 tablets, could get hold of them and travel agencies also offered 'Viagra tours' to the US, during which customers could obtain the product for personal import.

This was the hype and the hope that greeted Viagra. But the heated debate had, and continues to have, a serious side.

The advent of Viagra for erectile dysfunction (ED) has ushered in a new pharmacological agenda. Though intended to treat a serious medical condition, Viagra has come to be identified as a 'lifestyle drug' - one that concerns a problem appearing to lie at the ever-shifting, and socially constructed, boundary between a 'lifestyle wish' and a 'health need'. The Viagra debate has also focused minds on whether, and to what extent, it is a good idea to treat so-called 'lifestyle' problems with a pill.

Other drugs - Xenical (orlistat) for obesity, Propecia (finasteride) for hair loss, and Seroxat (paroxetine) for social anxiety disorder (SAD) - raise similar clinical and cultural controversies. Many other treatments can also be considered lifestyle drugs, as they may come to be used as substitutes for personal effort or psychosocial interventions.

In an era of rising healthcare costs, there is a dilemma about whether the public purse can afford treatments that might appear to lie at the margins of medical necessity. Or, whether such interventions should be on the healthcare 'menu'. Lifestyle drugs are a highly visible catalyst to policy debates concerning the management of medicines in general, and healthcare prioritisation, or rationing, in particular.

This report disentangles the different threads of the debate on lifestyle drugs. By assessing the issues and controversies provoked, it formulates a policy framework for tackling this new pharmacological agenda.

Chapter 1 introduces the concept of lifestyle drugs and contains four case studies: Viagra (sildenafil, Pfizer) for ED, Xenical (orlistat, Roche) for obesity, Propecia (finasteride, Merck & Co) for hair loss and Seroxat (paroxetine, SmithKline Beecham) for SAD. It then looks at other drugs that might be considered as lifestyle drugs and places the issues within the context of the increasing 'medicalisation' of health problems. An assessment of the forces driving medicalisation leads to a reconsideration of the core business of health services and practical constraints surrounding the future provision of healthcare.

Chapter 2 seeks to understand how countries have sought to ration treatments and how they have tackled the issues surrounding lifestyle drugs. It outlines six country case studies - France, Germany, New Zealand, Sweden, the UK and the US - that illustrate a variety of approaches within the fields of pharmaceutical regulatory policy and healthcare prioritisation. These activities have some common characteristics, but reflect cultural and political differences. The reactive way in which countries have tackled the emergence of lifestyle drugs points towards the need to develop more coherent methods for tackling these issues.

Chapter 3 identifies four strands of public policy that need to be integrated as part of a future framework for lifestyle drugs. These are: improved pharmaceutical regulatory policies, rationing initiatives, patient and public involvement in priority setting, and medicines management activities. A coherent long-term strategy needs also to take into account the 'bigger picture' - the forces driving technological demand. Collective restraint on the part of all stakeholders, including the medical profession, the public and the pharmaceutical industry, is a key challenge for the future.