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The role of the ‘lifestyle’ label and negative bias in the allocation of health resources for erectile dysfunction drugs: an ethics-based appraisal

A Corrigendum to this article was published on 02 March 2006

Abstract

There have been recent calls for the re-evaluation of health resource allocation for erectile dysfunction (ED) drugs. This paper discusses sociocultural prejudices associated with ED and its treatment, arising from the link with sexuality, the perception that ED is a ‘lifestyle’ issue and the belief that ED is part of the normal ageing process. These views diminish the perceived importance of sexual health, extending subjectively into the funding arena as a ‘negative bias’. Empirical data are presented, which demonstrate that ED can have significant psychosocial consequences, and that ED drugs are valuable quality-of-life interventions. The assumption that ED is an inevitable part of ageing is also analysed and found to be questionable. Health resource allocation decisions for ED drugs must be conducted with an awareness of the ethical and clinical complexities described in this paper, and with the sensibility that negative personal value judgments (on the part of policymakers) must be guarded against.

Introduction

Drugs for erectile dysfunction (ED) occupy a unique niche: the indication for treatment is both highly prevalent and non-life threatening, yet there are profound psychosocial consequences for some men. There is also a unique potential for ‘off-label’ use by men who do not have ED, as an enhancement of normal sexual function. In 1998, when a marketing license was granted for Viagra© (sildenafil citrate), these unusual characteristics led to a serious concern that funding for Viagra© would use a large proportion of available health resources. Eight years later, questions continue as to how sexual dysfunction drugs fit into society's view of the scope of health care: in June 2005, US Congress approved removal of coverage for ED drugs from Medicare and Medicaid while, conversely, in Britain, there have been continuing calls for the relaxation of controversial prescribing restrictions.1

This paper proposes that, apart from the traditional criteria used to determine the fate of new treatments in the funding arena (such as efficacy, safety, clinical outcomes, cost-effectiveness and economic data), for sexual dysfunction treatments there are other, more subtle factors involved, related to the drugs’ perceived ‘lifestyle’ indication and also to their function as a sexual treatment. For example, a US Congressman, as co-sponsor of the Bill supporting removal of ED drugs from Medicare coverage, stated on MSNBC News (February 2005), ‘We’re still taxing…young people to subsidize Grandpa's recreational sex.’2 In the New York Times, a notable bioethicist was quoted as stating, ‘These are essentially lifestyle drugs…this is not a good way to spend a limited amount of money, at a time when other medical needs are greater.’3 Since this ‘lifestyle’ label continues to resurface in the context of sexual dysfunction drugs, as a justification for restriction of funds for these drugs, the roots of these values and their implications in the health-care rationing field deserve further exploration.

‘Quality-of-life’ versus the ‘lifestyle’ label

Erectile dysfunction (defined as the inability to obtain and/or maintain penile erection sufficient for satisfactory sexual performance) is a symptom of many disease processes, which often have inter-relating organic, psychological, social or iatrogenic components and which can affect men at any age (Table 1).

Table 1 Risk factors for erectile dysfunction (ED)

The National Institutes of Health Consensus Panel stated in 1993 that ED can lead to ‘mental stress that affects…interactions with family and associates (and results in) fear, loss of image and self-confidence, and depression.’5 Empirical data support this statement. For example, the link between ED and depression is well established:6 Shabsigh and colleagues found, ‘a statistically significant increase in the incidence of depressive symptoms in men with ED (54%), compared with men without ED (21%), regardless of age, marital status or other co-morbidities.’7 ED has also been known to contribute to suicidal feelings.8

Furthermore, because sexual potency can be an important contributor to one's sense of masculinity and personal identity, ED is often associated with negative effects on both self-esteem and self-confidence.9 For single men, suffering from ED can affect partner-seeking behaviour,10 and in established relationships, sexual dysfunction has been shown to lead to a, ‘breakdown in emotional and sexual closeness, a sharing of thoughts and ideas, as well as a lower participation in social and recreational activities.’11 Sexual dysfunction within a marriage may be associated with ‘marital conflict, problems of commitment and intimacy, power struggles and lack of trust.’12 Indeed, in a recent UK-based survey, up to 28% of men with ED believed that their sexual dysfunction was directly responsible for the termination of their last relationship.10 For some couples, reproductive consequences are an additional source of concern, and where marital difficulties lead to divorce, there is an impact on quality of life affecting not just one person but also the entire family. While it should be acknowledged that the emergence of ED will have few adverse effects for some men, it is evident that, for others, ED will bring a far more negative psychosocial perspective, and at the extreme end of the spectrum, ED can contribute to suicidal intent.

Treatment for ED is known to improve quality-of-life parameters, including depression scores and marital relationships.6, 9, 13, 14 In one study, patients reported not only increased sexual well-being after treatment but also increased satisfaction ‘with life as a whole.’15 A treatment for ED is therefore of significant value to a sufferer's quality of life and may also be of value to his spouse and dependents.

The detection and treatment of ED also has a wider health benefit, which is often forgotten in the public sphere, but which is important. Studies have identified ED as a ‘marker’ of early or latent diabetes, hypertension, cardiovascular disease, hyperlipidaemia or depression, and ED is often the presenting symptom of these disorders.8, 16, 17 For example, of men referred with ED to a London clinic, ‘30% were at high cardiovascular risk and 17–37% had uncontrolled hyperlipidaemia, hypertension and/or diabetes.’17 Wilson et al.18 cite evidence that, ‘earlier detection of …diabetes and cardiovascular disease…as a result of patients presenting to primary care with ED, may result in more cost-effective management of these conditions.’

ED has also been noted to worsen a quality of life already diminished by comorbid illness: in a large study of men with Type II diabetes, those with ED had higher levels of depression and diabetes-specific health distress than those without ED, which translated to poorer acceptance of their diabetes and worse metabolic control.19

In the context of these data, the term ‘lifestyle’ represents a vague and inaccurate concept. Applying a ‘lifestyle’ label seems to imply that these drugs are used for a frivolous indication, that healthy sexual function is an ‘optional extra’ or a ‘luxury’ item, not essential to human well-being, and that one should be able to live one's life without being sexually fulfilled. The data presented above suggest otherwise.

ED drugs are indeed quality-of-life treatments, comparable in value and importance to many other life-improving interventions that have been funded, without question, by health-care agencies for years: examples include treatments for hearing loss, incontinence, insomnia or varicose veins; counselling for psychological problems; or certain quality-of-life indications for surgery (for instance, where the aim is to enable the continuation of sports). It could be argued that constructing special restrictions around access to ED drugs is unfair and inconsistent, when other life-improving treatments are left unscrutinized; this also sends out a signal that sexual disorders are not as important as other quality-of-life conditions, which can discourage sufferers from seeking help. A lack of regard for the value of sexual health was summarized by the First International Consultation on ED (1999): ‘The lack of interest by government…to invest resources in the field of sexual dysfunction’ and a ‘reluctance of the lay press to deal with issues of sexual health in a serious manner’ illustrate ‘a pervading belief…that sexual issues are of minor importance.’20

The sexual aspect

There is another facet to sexual dysfunction drugs that distinguishes these from other quality-of-life interventions and which makes their endorsement with health-care funds seem somehow more frivolous: the intimate association with sexuality affects society's perception of the drugs’ value and influences the relative importance of these drugs in a health care system.

Sexual behaviour is viewed as intensely personal and private, and ED often perceived as an embarrassing, taboo, even distasteful, subject. There is a common pervasive view in society that sexual function (unless for procreation) is ‘non-essential’, hedonistic or ‘recreational’. As such, sexual dysfunction seems to have little claim on limited funds. However, this perspective (that by funding ED drugs, society is endorsing what is essentially a selfish act, for one's own personal pleasure) ignores a broader understanding of the relevance of sexual intimacy to: the ability to procreate, the importance of psychological well-being, the stability of personal relationships and the integrity of families. These are important regardless of age. This ‘negative bias’ (to which the medical profession is not immune) overlooks the importance of ED drugs as an intervention that can make lives meaningful and which is comparable with other quality-of-life treatments in this respect.

It is likely that these intangible, deeply rooted sociocultural convictions result in a diminution of the perceived importance of sexual health, which extends subjectively into the funding arena as a negative bias against sexual dysfunction drugs. These ‘value judgments’ have been noted by other researchers. Mechanic warned that, in making resource allocation decisions, ‘It is important to guard against unconscious preferences reflecting class, sex, and other social biases.’21 Klein and Sturm22 stated, ‘There remain considerable inhibitions and prejudices about treatments involving sexual performance and potency.’ Stolk et al.23 called this phenomenon, ‘a ‘Calvinistic’ attitude towards sexuality.’ Titlow et al.,24 in analysing the process by which allocation decisions were made by insurers in the USA concluded that (regarding Viagra©), ‘Value judgements, rather than cost, seem to play a central, though largely unspoken, role in these coverage decisions.’

The ‘age’ question

An eminent member of the ‘President's Council on Bioethics’ stated recently, ‘If impotence occurs in the normal course of a human life, as a consequence of aging, these drugs should not be covered.’3 This exemplifies a common view that ED drugs are an antidote to a condition assumed to be a natural consequence of ageing and, as such, are less deserving of funds. The ‘medicalization’ of the ageing process seems to represent a challenge to the cultural perception that ED occurs as a natural part of existence, and should be simply accepted and endured. These views raise broader questions as to the legitimate goals of health care. Do interventions that improve quality of life deserve to be funded? More specifically, do interventions that improve one's sexual quality of life deserve to be funded? And, do interventions that improve the sexual quality of life for older people deserve to be funded?

First, the assumption that ED is a part of the ageing process needs to be examined. ED is known to increase proportionately with age: in the Massachussetts Male Aging Study, the prevalence of (complete) impotence tripled from 5 to 15% between the ages of 40 and 70.25 Furthermore, physiological changes with age have been identified, summarized in Table 2.

Table 2 Changes in sexual function in ageing men

Despite this, many experts consider that ED is not an inevitable consequence of advancing age.5, 6, 8, 26 The physiological changes listed in Table 2 show much interindividual variability and are by no means universal. Studies have not established a relationship between ED and the age-related decline in androgen levels.4 And whether or not these physiological parameters lead to ED is dependent on the effect of many other contributing factors that can occur at any stage in life, but which happen to occur more commonly in the later years: medication use, illness, or psychological, social and relationship changes. Whether or not ED is a normal, expected component of life is, therefore, still controversial and by no means clearcut.

Some commentators have proposed the (rather covert) exclusion of so-called ‘age-related’ ED from funding, using a strategy of reimbursement only for men with ‘ED caused by comorbid disease’:3 the aim of this is to distinguish ‘nondisease’ from disease. However, there are problems with this approach. An older man presenting with ED (but with no obvious clinical manifestations of concomitant disease) cannot be presumed to have ED simply as a function of his age. As is true for a younger man, and on the basis of the data that show that ED is an early symptom of other disease processes, the likelihood is that he has subclinical underlying pathology, or psychosocial problems, or some combination of (perhaps modifiable) contributing risk factors. From the clinical perspective, therefore, ‘age-related’ physiological changes in erectile function cannot easily be differentiated from those associated with early comorbid conditions. Such a policy also ignores the fact that the psychosocial consequences of this man's ED may well be comparable to those of a man with comorbid illness.

A theoretical perspective on the ‘age question’ can be obtained by consulting Norman Daniels’ influential ‘theory of justice for health care’.27 This model aims to define which interventions fit within the scope of health care and which do not, using a biomedical ‘normal-species-functioning’ premise. According to Daniels’ theory, sexual dysfunction creates a disadvantageous effect on, ‘Fair equality of opportunity: the opportunity to complete life projects and pursue important relationships,’ and as such, sexual dysfunction constitutes a ‘disease’ that can affect lives in important ways and which is comparable with other diseases which do so. Taken one step further, if sexual dysfunction were considered a normal part of ageing (akin to the menopause, for example), then dysfunction would be a departure from normal species functioning up to a certain age, after which it would become ‘expected’ as part of life and therefore (under the ‘fair opportunity model’) not a candidate for attention from a health-care system. However, if one accepts the argument that ED is not a normal, expected part of advancing age, the conclusion from applying this model (which excludes economic and social factors) is that sexual dysfunction treatments deserve funding, regardless of age.

Added to these clinical and theoretical complications, there are ethical objections to an ageist policy for ED drugs. If access to ED drugs was restricted for older men, this would suggest that healthy sexual function is not as important for older men as it is for their younger counterparts; it would suggest that the psychosocial consequences of ED for these men (e.g. depression and relationship effects) are somehow less meaningful, and it would imply that society does not respect the quality of their lives as much as younger men.

There are few studies exploring these particular issues in this age group, due in part to methodological difficulties. However, one recent community survey in Germany found that 83% of men aged 60–69 years, and 71% aged 70–80 years, reported regular sexual activity.28 Gott and Hinchcliff29 conducted a survey in Sheffield, England, in which, of those men and women aged 50–92 years who had a current sexual partner, all attributed at least some importance to sex, with many rating sex as ‘very’ or ‘extremely’ important. Sex was, ‘valued…as a way of expressing love for a partner, helping maintain their relationship, as well as for giving…pleasure and improving self-confidence.’ These data contradict the common view that sexual activity in the later years is neither commonplace nor important.

There are moral flaws inherent in a policy that rations by age. Grimley Evans30 described this as discrimination towards a vulnerable, largely uncomplaining population. It is apparent that such a policy, applied to ED drugs, would ignore important considerations of justice, fairness, dignity and respect.

Conclusions and recommendations

This paper demonstrates the unique ethical complexities involved in making resource allocation decisions for ED drugs. There exist prejudices arising from the diminished importance implied by both the ‘lifestyle’ label and the link with sexuality. There are also assumptions about ED and age that are questionable if one considers the complicated pathophysiology of ED and the relationship with concomitant disease processes. And specific moral objections exist to a policy of ageism for these drugs.

In the process of examining these issues, it has become evident that there is moral support to justify the funding of ED treatment on the grounds of beneficence and ‘fair opportunity’, that this is relevant across the age span and that there are health and social harms if dysfunction is left uninvestigated and untreated.

Precisely because these issues are complicated and subject to bias, any process that determines funds for these drugs must use sound ethical frameworks (which exist in the literature and are based on principles of rational deliberation, transparency and ‘fair-mindedness’)31 and decision-makers must be knowledgeable, aware of the complexities described in this paper, and conscious that negative personal value judgments can exist and must be guarded against. Evaluation should be conducted within the context that ED treatments occupy an important place in an array of quality-of-life interventions, all of which could be assessed for value ‘across the board’.

It must be acknowledged that difficult decisions have to be made in the real world of conflicting claims for health resources, and it is generally agreed that imposing limits on any aspect of treatment because of the finitude of budgets is an ethically justifiable position. Similarly, sociocultural factors can play a legitimate part in the determination of the relative importance of diseases in society. This paper does not intend to provide specific answers as to how health systems should manage the funding for these drugs: instead, the ethical ideals which exist in the context of ED treatments are laid out, to provide a more informed foundation on which allocation decisions can be made and to make a plea that basic ethical principles are not forgotten in the narrow-minded drive for economy. What is at stake is social justice and equality of access to treatment for men on limited incomes, and the valuable opportunity to screen this vulnerable group for early concomitant disease.

Decisions about ED drugs cannot be summed by a value judgment in a ‘sound-bite’. There is a lot more depth to consider. The author, a UK-trained General Practitioner, was part of the Viagra® Durg Development Team, Pfizer, UK (1996–1998), and wrote this paper as a Fellow in Medical Ethics, Department of Social Medicine, Harvard Medical School, USA (2004).

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Acknowledgements

For comments on an earlier draft of this paper and for their invaluable support, thanks are extended to: the 2003–2004 Fellows in Medical Ethics at Harvard Medical School; Mildred Z Solomon (Associate Clinical Professor or Social Medicine and Anaesthesia and Director of the Fellowship in Medical Ethics); Professors James Sabin and Norman Daniels (Harvard Medical School); and Professor Gorm Wagner (Copenhagen University Hospital).

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Correspondence to H Manson.

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Manson, H. The role of the ‘lifestyle’ label and negative bias in the allocation of health resources for erectile dysfunction drugs: an ethics-based appraisal. Int J Impot Res 18, 98–103 (2006). https://doi.org/10.1038/sj.ijir.3901409

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Keywords

  • erectile dysfunction
  • allocation of resources
  • drugs
  • ethics
  • ageing

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