Lifestyle medicinesBMJ 2000; 321 doi: https://doi.org/10.1136/bmj.321.7272.1341 (Published 25 November 2000) Cite this as: BMJ 2000;321:1341
- David Gilbert, senior fellowa (, )
- Tom Walley, professor of clinical pharmacologyb,
- Bill New, independent health policy analystc
- a Office for Public Management, 252b Gray's Inn Road, London WC1X 8JT
- b Department of Pharmacology, University of Liverpool L69 3GF
- c 9 Countess Road, London NW5 2NS
- Correspondence to: D Gilbert
- Accepted 17 July 2000
Sildenafil and orlistat, prescribed for erectile dysfunction and obesity respectively, have been labelled as “lifestyle drugs” in the popular imagination. Although this description may trivialise serious medical conditions for which the drugs are indicated, it encapsulates concerns that some indications for these drugs might be regarded as issues of personal choice rather than illness. It is difficult to define what we mean by the term lifestyle drug since the perception of what is illness and what is within the sphere of personal responsibility rather than health care may depend on whether one is a potential patient or a potential “payer.” The perception may depend on social and cultural norms too,1 and it is also a function of how a medicine is used. For instance, most people would agree that the prescription of sildenafil for a healthy man unhappy with his sexual performance is a lifestyle use, but would consider differently the case of a diabetic man with neuropathy.
A working definition for this paper might be that a lifestyle drug is one used for “non-health” problems or for problems that lie at the margins of health and wellbeing (see table). A wider definition would include drugs that are used for health problems that might be better treated by a change in lifestyle; this definition might include drugs such as lipid lowering agents or proton pump inhibitors.
Lifestyle drugs are drugs used for non-health problems or for conditions that lie at the boundary between a health need and a lifestyle wish
These drugs threaten the financial sustainability of current health systems
Traditional approaches to regulating medicines are not effective for lifestyle drugs; coordinated action is needed to manage pharmaceutical policy nationally and locally
Greater public involvement is essential in establishing priorities
Lifestyle drugs may promote debate about appropriate directions of technological development
Where to draw the line between lifestyle purposes and legitimate medical use is debated vigorously. Lifestyle drugs are intended or come to be used for conditions that currently lie at the socially constructed boundary between lifestyle wishes and health needs. A lifestyle wish often becomes a health problem when a biomedical cause (for example, a biochemical or genetic factor) or a treatment is found for the “problem.” Lifestyle wishes are then portrayed as amenable to health care — medical intervention that can remove responsibility or control from the individual or society. Healthcare professionals may then “claim” the condition by defining the need for treatment at the level of collective policy making and at the individual doctor-patient level.8
As the availability of a treatment can convert a lifestyle wish into a health need, the pharmaceutical industry then becomes a key player in the process of medicalisation. While there is little doubt about the benefits of many modern drugs, there are concerns about how the pharmaceutical market operates. Drug development is often driven by potential profitability rather than by public health needs. Once a drug is available, industry campaigns may seek to redefine the illness in the minds of doctors and of potential patients, converting wishes into healthcare problems and then portraying these as primarily amenable to pharmaceutical treatment. Although advertising directly to consumers is proscribed in the European Union, companies are able to target patients indirectly through disease awareness campaigns, sponsorship of information materials, and press releases.
This redefining of illness may sometimes be appropriate. For example, one effect of the sildenafil controversy has been to reduce the taboo surrounding erectile dysfunction.
Who should pay?
A key element is whether these drugs should be paid for by public or private healthcare systems. As healthcare budgets are overstretched almost everywhere, funding these drugs inevitably means limiting other treatments. It was predicted that sildenafil and orlistat would cost the NHS £1.25bn9 and £500m-700m respectively, but actual costs so far are only a fraction of these amounts. Nevertheless, the unified budget held by primary care groups or trusts might be threatened by wide prescribing of lifestyle drugs, and this would undermine government reforms of the health service.
This issue, although obfuscated by politicians, is essentially one of rationing. The secretary of state for health said of sildenafil: “Impotence is in itself neither life threatening, nor does it cause physical pain, although it can in exceptional circumstances cause psychological distress. I do not consider it to be a priority for any additional NHS expenditure compared with, say … cancer, heart disease and mental health.”10 This blurs the margins of what is legitimate medical use by questioning what the state is willing to spend, and implies a degree of rigour in allocation of NHS resources that is often lacking.
The NHS already funds drugs which are neither life saving nor pain reducing but whose benefits to individuals and society mean they have become part of accepted medical practice. This applies, for example, to oral contraceptives.
In the past, the NHS has generally funded almost any licensed drug that is prescribed at a doctor's discretion. A few drugs have specific restrictions placed on their prescription or are excluded altogether, such as minoxidil for hair loss. This position has now been challenged by ministerial restrictions on sildenafil,11 and the National Institute for Clinical Excellence's (NICE) recommendation that zanamivir (Relenza) should not be prescribed within the NHS.12
The NHS now allows the prescription of sildenafil for certain conditions, while most other European countries have not funded it at all. In the United States, the views of healthcare providers have varied; some refuse to provide sildenafil while others have funded limited supplies or have introduced steep patient co-payments. Lifestyle drugs have thus become a catalyst to the rationing debate, raising questions about how to define the core business of health care and how to prioritise.13
Managing lifestyle drugs
Lifestyle drugs give rise to a crisis and an opportunity for health policy. By forcing us to rethink the notion of medical necessity, they can lead to ways of integrating policy and redesigning services. We need to establish clear principles and mechanisms now to deal with these issues since ad hoc solutions will be unacceptable in the future.
The drug licensing procedure is intended to ensure that drugs pass the tests of efficacy, safety, and quality; it is not concerned with the cost or cost effectiveness of a new drug or the need for it. In the United Kingdom, NICE may address these other issues, providing, in effect, a partial fourth hurdle to drug reimbursement in the NHS.
Health economics, although not a technical “fix” for lifestyle drugs, can play a part by defining measures of the quality of life and patient and citizen utilities. This use of patient defined quality of life allows lifestyle drugs to be measured in the same terms as other more traditional treatments … at least in theory. The difficulties of using the quality adjusted life year in this area have been well recognised, most recently in relation to a study of sildenafil, but there is difficulty in finding an alternative measure.14
Cost effectiveness alone is inadequate for decision making in the case of lifestyle medicines where the issues concern medical necessity and how this is defined. The already difficult role of NICE will become increasingly complex if it is to take the lead in this debate.
Managing the advice of a body such as NICE at a local level will require better monitoring of prescribing. It is currently difficult for prescribers to be made accountable for prescribing the right sort of drug for the right sort of indication because there are no information systems that can differentiate between the different conditions for which a drug is used.15 This is an important requirement if policy makers decide to reimburse for one use of a drug but not another. For example, omeprazole is widely used for unlicensed, vague indications that are perhaps related to lifestyle, and we are uncertain how effective are the restrictions on the prescription of sildenafil.
Overriding the technical challenges is the problem of defining health service priorities and determining whether certain services should be included or not. Rationing is a fact of life in all health services, though it is often implicit rather than explicit. In the United Kingdom, the reality of rationing has been clumsy and stumbling; until recently ministers refused to even use the word. Other countries have taken more innovative, though not always successful, approaches. 16 17 We believe that rationing should be explicit, systematic, and democratic.
Rationing needs to be considered at two levels: what should be rationed (that is, what package or range of treatments or services should be available) and who should receive priority for the available treatments? In considering what to ration, some argue for explicit definition of the package of services included and excluded from the NHS.18 Others argue against this, since there is no consensus about criteria or how decisions concerning what to include should be made.19 Experience in the US state of Oregon, where interventions were ranked in order to decide which should be included and excluded from the public health system, suggests that the number of services included in such an explicit package tends to expand.20
Moreover, blanket refusal to supply a lifestyle drug may harm specific patients, such as a diabetic man with erectile dysfunction. Therefore, the first collective level of rationing overlaps with the second individual level concerning which patients should be prioritised for treatment. Here we tend to focus on need related characteristics such as the extent of illness, effectiveness, or cost effectiveness. However, as discussed earlier, the point at which “need” ends and “want” begins is difficult to define. A funded treatment must come with a guideline of how and where it should be used. Whose value judgments in defining this should be considered?
Patient, carer, and public involvement
Rationing is a legitimate, though controversial, area for public debate, particularly so for lifestyle drugs. The stereotypical view is that the public is not sufficiently informed or sufficiently altruistic to pass judgment on difficult decisions. In Oregon, attempts to involve the public were largely unsuccessful; there was no real engagement with most of the population and special interest groups dominated. As a result the original list of priorities in Oregon required extensive revision.
The public is highly sensitive to how options are presented, and opinions can be easily swayed. However, systematic methods have been developed and used at local, national, and international level that allow informed public judgment on complex issues. These include citizens' juries,21 specially adapted focus groups,22 and deliberative opinion polls.
We believe that the general public — so often accused of exaggerated expectations, and at the same time politically marginalised in the process of healthcare decision making — may be the key to sensible solutions in the dilemma of lifestyle drugs. More formal, systematic ways of assessing their views on these issues should be developed.
The bigger picture
Options for the future might include continuing as at present: muddling through with covert rationing and suddenly throwing money at the problem when a (political) crisis occurs. We believe that a more rational approach requires the reorganisation or overt restriction of services. Changes in the supply of services need to be balanced by work on the demand for them — on managing expectations and, possibly, making patients more accountable for their own treatments.23
In fact, any call for restraint opposes the forces that are fuelling demand, such as modern medical technology, including the development and marketing of lifestyle drugs.24 The pharmaceutical industry should be a responsible partner in the rationing debate, but perhaps it is unrealistic to expect the industry to accept limits any more than we would expect this of the tobacco or the motor industries.
One solution favoured by some sections of the industry is to change the way healthcare systems are funded, with more income coming from private patient payments or co-payments. This model would need to incorporate safeguards that would preclude discrimination against poor people. However, limits are already in place to some extent, for example with regard to the supply of sildenafil for psychosexual disorders. For the moment, introducing a differential co-payment or prescription charge that depends on the clinical value of a drug is not considered politically acceptable here.25
The pharmaceutical market is currently concerned less with meeting health needs and more with the growth requirements of the industry. The goals of healthcare policy are in danger of becoming subsidiary to those of the pharmaceutical industry. A more sustainable approach would be to have an informed debate, led by societal interests, about what constitutes need and how this can be translated into useful products; how stakeholders more than shareholders can shape the future of health care. This would re-evaluate and reprioritise research and development activities in the long term, centred on an awareness of what health systems can and cannot afford. If this does not happen the pace of medicalisation and new technologies threatens to outstrip the capabilities of institutions and providers, both financially and organisationally, and may ultimately overwhelm societal control and central planning.
There is still time to step back from the headlong pursuit of technological possibility and medicalisation, to think carefully through an agenda for sustainable health systems and real joint working. This is a mighty challenge, but one that cannot be avoided if access and quality in health care are to be serious objectives. For the fact that we have to face this situation properly, we need to thank, or curse, the advent of lifestyle drugs.
Conflict of interest DG has written two policy reports for PJB Publications, publishers of Scrip, a pharmaceutical industry newsletter, and made a presentation to a recent seminar at the International University of Santander, Spain which was funded by Merk, Sharpe and Dohme.
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