Prescribing Viagra in an Ethically Responsible Fashion

Abstract

Sildenafil citrate (Viagra) and other newly released pharmaceuticals that assist erectile dysfunction may be one of the most important categories of drugs released in the past decade. Sildenafil is distinctive because it creates a new therapeutic relationship not only between patient and physician, but also with sexual partner(s). Physicians must first evaluate the patient comprehensively, addressing not only erectile function and sexual performance, but overall physical and mental health. Since the drug does impact others, an expanded model for informed consent needs to be considered. Three models to consider include the public health one, ethically justified limits on confidentiality, and a biopsychosocial one. The biopsychosocial model may be preferred because it expands the patient-physician dyad to directly include others. Physicians also need to distinguish between professional, role-related obligations and personal conscience when treating patients whose sexual beliefs and practices differ from their own. Other ethical issues include inappropriate prescribing over the Internet, dealing with unrealistic patient expectations, and fairness in paying for treatment for sexual conditions in both men and women. With these proposed guidelines, physicians can continue to provide steady, reliable guidance for patients while working with yet another scientific advance in medicine.

Keywords:

• informed consent
• medical ethics
• phosphodiesterase inhibitors
• piperazine
• sexual dysfunction

I. INTRODUCTION

Viagra (sildenafil citrate), and other newly released pharmaceuticals that assist sexual performance through enhanced erectile function, may be one of the most important categories of drugs released in recent years. In the area of therapeutics alone, the benefit to patients is substantial. First, erectile dysfunction is common, affecting up to 30 million men in the United States alone (Goldstein, 1998, pp. 1397–1404; Lue 2000, pp. 1802–1812). Although various devices and injections, or prostheses, have been available, patient acceptance has not been high, primarily because of discomfort and inconvenience. No effective oral drugs for erectile dysfunction have been previously available, and Viagra is the first to be FDA-approved. The popularity of the drug has been well documented, with over 6 million prescriptions being written in the first eight months of distribution alone, and sales exceeding 1 billion annually (Food and Drug Administration, 1998). Erectile dysfunction is also only one component of sexual dysfunction, described as disturbances in sexual desire and psycho-physiological changes associated with the sexual response cycle in men and women and found to be present in 43% of American women and 31% of men (Laumann, 1999, pp. 537–544).

Altogether, human sexual expression is vital and complex and includes the need to express love, physical release, reproduction, recreation, and to increase self-esteem (Bullard & Caplan, 1997, pp. 247–264). Therefore, the impact of sildenafil for the individual patient is not only physiologic, but broadly influences emotional, psychological, and behavioral components of the patient’s life and well being.

Because of the nature of sexual intercourse, sildenafil is distinctive in that it has a direct impact upon the sexual lives, health, and general well being of others, often identifiable others. Oral contraceptives, introduced during the 1960s, also have had a powerful effect beyond their pharmacological action by altering the sexual behavior of women, controlling conception, and allowing women and their partner(s) latitude and spontaneity in sexual relations. But sildenafil’s distinctiveness is that it augments, and may even allow, sexual intercourse to occur with another, thereby inexorably creating a distinctive therapeutic relationship not only between the patient and the physician, but indirectly with the sexual partner as well.

In this article, we will first consider the comprehensive evaluation and counseling of the patient by the physician before the drug is prescribed. Second, because the drug directly affects others, we will examine an expanded clinical model of decision making and informed consent. Third, we will consider the dilemma for the physician of professional judgement versus individual conscience when confronted with patients with sexual problems. Last, we will briefly consider a variety of related issues that have evolved in medical practice and society because of the drug and its use.

II. PATIENT EVALUATION AND COUNSELING

For the physician, the first ethical issue often arises in concert with the patient’s first inquiry about, or request for, the drug. This awareness has allowed patients, and even partners, to indirectly ask for assistance for their sexual performance and lives, by directly inquiring about the drug. “What do you think about this Viagra drug, doctor?” is often an easier question for the patient than: “Can we talk about the adequacy of my sexual life and performance?” This new behavior parallels the results of a poll of 500 US adults, the great majority of whom wanted to speak with their physician about sexuality, but believed the doctor would be both uncomfortable about, and discredit their concerns (Marwick, 1999, p. 2173). Because physicians are commonly remiss and uncomfortable in addressing issues of sexuality with their patients, this drug request now presents a powerful opportunity for the practitioner to begin an often neglected but necessary dialogue (Ende, Rockwell, & Glasgow, 1984, pp. 558–561; Merrill, Laux, & Thornby, 1990, pp. 613–617). To correct this omission, the practitioner should pursue the larger issue of sexuality by at least beginning the dialogue with something to the effect of: “Tell me about your current sexual activity.” If activity is ongoing, the next question can be: “Do you or your partner have any concerns or problems?” (Maurice, 1999). This opens the arena not only of physiology and function, but relations and relationships. In general, the complete sexual history can address the level of current activity; contact with men, women, or both; satisfaction with sexual experiences; contraception, if relevant; and prevention of sexually transmitted diseases, including HIV (Bullard, 1997, pp. 247–264; Merrill, Laux & Maurice, 1999; Thornby, 1990, pp. 613–617).

The latter, especially, raises traditional ethical concerns about protecting innocent others and justified limits on confidentiality when the patient declines to act in ways that minimizes risk to others. But prescribing sildenafil goes beyond these traditional ethical issues to raise at least some elementary questions about the status and expectations of the patient’s sexual partner(s) and the obligation to take a comprehensive approach to the decision as to whether to offer the drug.

For example, what are the expectations, and the anticipated effects, physiologically and emotionally, upon an elderly spouse whose husband is about to be reinvigorated sexually, although conjugal sexual activity has been dormant for years? In this case, the patient first should be encouraged to discuss the anticipated effects and ascertain the spouse’s reaction before the medication is prescribed. On the one hand, it is also possible that the areas opened up in this kind of discussion might exceed the clinician’s knowledge and experience in dealing with issues of human sexuality. On the other hand, such discussion affords the physician an excellent opportunity to gain more knowledge about the patient’s sexual behavior and its impact upon the partner(s). However, some physicians will feel inadequate to carry on a detailed discussion of this kind, and either further self-education, or referral to a psychiatrist, psychologist, or therapist who deals in sexual therapy is most appropriate in these cases.

The honesty with which a sexual history is related to a physician is dependent upon the trust and security felt by the patient in that therapeutic relationship. Since a sexual partner is usually not present in the examination room, the clinician must depend upon the patient’s veracity in describing relationships with others. If the patient believes that the practitioner might be disapproving or judgmental about relationships such as homosexuality, multiple sex partners, bisexuality, and partners outside of a spousal relationship, those behaviors will be downplayed or denied and effective evaluation and treatment will be impossible. In other words, the practitioner will have to use an indirect, non-threatening, supportive approach to questioning about, and responding to, the sexual history if truth is to be ascertained and the patient is to be truly benefited (Maurice, 1999).

Concerning therapeutic decision making, the most common clinical challenge for the physician is the temptation to simply prescribe the drug without adequately and comprehensively assessing the whole patient, the associated sexual relationships, and the resulting medical and ethical issues. In medical terms, male sexual dysfunction may relate to diabetes, heart disease, neurological disorders, pelvic surgery or trauma, side effects of medication, chronic diseases such as kidney or liver failure, hormonal imbalances, alcoholism and drug abuse, or heavy smoking. Psychological causes include stress or anxiety from work, concern about poor sexual performance, marital discord, unresolved sexual orientation, depression, and previous traumatic sexual experience (Bullard & Caplan, 1997, pp. 247–264; Maurice, 1999). By treating erectile dysfunction only, these important underlying conditions and issues may be ignored and sexual well being and overall health will not be benefited. For the patient, expectations may be exaggerated and unrealistic, aided by the naïve belief that sexual satisfaction and even intimate relations with others will be immediately and dramatically corrected or improved by the simple creation of a more rigid phallus. The patient, and even the partner(s), may also initially measure success only by the most obvious evidence, enhanced erectile function, and thereby ignore the more difficult underlying issues. Even worse, the non-selective use of the drug may delay and even prevent the necessary diagnosis and treatment of the underlying psycho-physiologic disorder, enabling the pathology to be sustained and even aggravated. For example, alcoholism is a typical disorder in which both erectile and general sexual dysfunctions are common. The physician would be seriously remiss if only erectile dysfunction was treated and the underlying disorders, including the primary diagnosis of alcoholism, were ignored.

For some conditions, such as depression, concomitant use of sildenafil with standard treatments such as psychotherapy or antidepressant medication may be both feasible and desirable. In this case, the practitioner may justifiably recommend sildenafil as a parallel therapy, since not only depression, but many anti-depressant medications are associated with both erectile and general sexual dysfunction (Balon, 1998, pp. 313–317). Moreover, a recent study showed that men with both erectile dysfunction and mild to moderate depressive symptoms who responded to sildenafil therapy significantly improved not only their sexual function, but their depressive symptoms and quality of life. In other words, when sexual function improved, so did mood (Seidman, Roose, & Menza, 2001, pp. 1623–1630).

III. AN EXPANDED MODEL FOR INFORMED CONSENT

The traditional approach to the informed consent process focuses upon the dyad of physician and patient, with others regarded as external or even described as “third parties”— language which reflects the view that they usually have a lesser role (Beauchamp & McCullough, 1984; Faden & Beauchamp, 1986). In clinical ethics, it is also accepted that when patients’ decisions have an impact upon other parties, the decision-making process justifiably takes account of these interests. Since the decision to take sildenafil has a direct effect upon a sexual partner, how should the informed consent process take his or her interests into account? There are three possible models to consider.

The first is a public health model, in which a patient’s decisions about management of his or her condition or disease are viewed in the context of its impact upon others (Beauchamp & McCullough, 1984). If the condition is reliably predicted to have an adverse effect upon others, the patient’s decision-making authority is rightly limited. Therefore, the patient is not free to exercise his or her autonomy to impact others who have not consented to being placed at risk for the adverse consequences of a harmful condition. In the case of sildenafil, however, this moral logic only partly applies. Sildenafil improves the patient’s sexual functional status, and ironically, it is the improved, and not the diseased status, that can put others at risk for adverse consequences to which they did not consent.

A second model for considering the interests of the patient’s sexual partner(s) is based upon ethically justified limits on confidentiality. These limits come into effect when the patient is engaging in behaviors that are reliably predicted to be dangerous to others (Beauchamp & McCullough, 1984). As a rule, taking sildenafil does not create predictably risky or dangerous consequences for the patient’s sexual partners, although some of those consequences may be unwelcome. One exception to this line of reasoning would be the patient with a sexually transmitted disease who requests sildenafil and intends to engage in unprotected sexual intercourse. In this case, decision making about the drug justifiably takes into account the interests of others. One approach is to explain to the patient that it is his or her obligation not to subject others, without their knowledge, to potentially dangerous adverse consequences of his improved sexual function.

Unfortunately, studies of patients with STDs such as AIDS, suggest that many individuals do not disclose their infected status to their sexual partners (Stein et al., 1998, pp. 253–257). However, another study has shown that notification of sexual partners by the health care professional is much more effective than voluntary notification by the patient (Landis, 1992, pp. 101–106). Moreover, notification of third parties by the health care professional can be understood ethically in terms of enforcing the patient’s obligation to prevent dangerous consequences for others. This approach is limited, however, to cases in which the patient who requests sildenafil has a serious sexually transmitted disease, does not intend to notify his or her sexual partner(s), and intends to engage in unprotected sexual intercourse.

The third model we would like to invoke is a biopsychosocial one. Introduced to balance biologic reductionism in clinical decisions, this model explains health and disease in terms of biologic, psychological, and social components (Engel, 1980, pp. 535–544). This model applies to decision making about sildenafil because important biopsychological interests of the patient’s sexual partners maybe at risk in unpredictable and perhaps harmful ways, for example, vaginal injury or increased stress from unwanted sexual overture. We believe the biopsychosocial model of the informed consent process is the optimal way to address the ethical problem of informed consent, in that it reaches beyond the dyad of the patient-physician relationship to include active involvement of the sexual partner, if possible, in shared decision making about the drug. In this way the partner can express and protect his or her interests directly.

This expanded model of informed consent allows the physician to explore with both the patient and sexual partner the anticipated changes in sexual function that can be expected with the use of the drug. This is especially important for long-standing relationships, in which the patient and partner have adjusted well and even happily to diminished or even non-existent sexual contact. It would also be to the advantage of the patient and partner to anticipate changes and problems for their relationship that the use of sildenafil might precipitate. The first limitation to this approach is that it would require the patient’s consent. Second, it presumes adequate skills in sexual counseling on the part of the physician. Third, it would be less practical in the case of multiple, or unknown, sexual partners.

In the dyadic model of consent, if the sexual partner were to object to the patient using sildenafil, this would not be regarded as a matter for the physician to directly address. The patient might have an obligation to address this matter, but not the physician, because consent is traditionally required from the patient, not “third parties.” With the expanded model of consent, however, such an objection would create a presumption against prescribing sildenafil, when the patient’s sexual partner, with the patient’s consent, was actively involved in the decision making process. This presumption would justify addressing the sexual partner’s concerns and helping the patient and partner to negotiate a mutually acceptable decision. To facilitate negotiation, the physician could propose a trial use of sildenafil, with both the patient and the partner’s experiences constituting the comprehensive evaluation. If the sexual partner’s concerns are biopsychosocially serious and cannot be negotiated, then refusing to write the prescription would be ethically permissible.

IV. THE ETHICS OF PERSONAL VERSUS PROFESSIONAL CONSCIENCE

A distinction between professional, role-related obligations and personal conscience is a third component when considering ethical issues in the use of sildenafil. When patients present for evaluation, they expect treatment by a true professional. Among other things, this means that the physician will not act with inappropriate bias toward the patient. At the same time, the physician, as an individual, may take moral exception to the patient’s beliefs and decisions on the basis of religious or other moral convictions that he or she holds, quite apart from being a physician (McCullough & Chervenak, 1994). It is also a generally accepted tenet of professional ethics that if a physician finds the clinical decisions of the patient to be morally objectionable, that clinician should not have to cooperate with those decisions. Again, this decision should be premised upon personal morality, as distinct from professional obligations, and referral to another physician should be feasible (McCullough & Chervenak, 1994).

As a professional, the physician should conduct the informed consent process in the same manner for every patient. When the patient articulates decisions or views that the physician finds morally objectionable, the objections based upon professional versus individual judgment should be distinguished. If the physician becomes aware that the patient wants sildenafil in order to engage in sexual relations that will degrade, debase, or humiliate another person, and will occur without consent, the physician has a professional obligation to express disapproval, and work with the patient to avoid such behavior. If the patient is recalcitrant, the physician always has the option of refusing to prescribe the drug. However, if the patient is a practicing homosexual, a situation to which the physician objects morally as an individual, and to such an extent that he or she is psychologically unable to function objectively as the physician, then the patient’s best interests cannot be upheld. In such a case, the physician should explain that or her she is not the most appropriate professional to provide treatment, and a referral should be arranged to a colleague who will not be uncomfortable on personal grounds with the patient’s relationships and practices.

At times, personal morality and good medical judgment may successfully overlap. For example, a patient may admit that he or she is desirous of obtaining sildenafil in order to begin and sustain an extramarital affair. The physician’s reluctance to prescribe the drug in this case does not have to be premised in the moral objection to the proposed affair, but the realization that the patient’s problems with his or her current spousal relationship may need to be addressed before mere sexual performance is enhanced.

V. OTHER ETHICAL ISSUES

Because of public fascination with the drug and its actions and impact upon sexual behavior, sildenafil quickly reached cult status across America and abroad. Capitalizing on the great demand and patient hesitancy to openly discuss sexual problems in an office, prescribing sildenafil over the Internet has increasingly occurred (American Medical Association, 2000, pp. 51–52). Since such prescribing is done without an examination, or even a face-to-face meeting, such practices are not congruous with accepted standards of care and are in violation of the AMA’s Code of Medical Ethics, as well as many state medical practice acts (Armstrong, Schwartz, & Asch, 1999, pp. 1389–1392; Ziegler, 1998, pp. 29–34).

In addition, many men, even with normal erectile and sexual function, have fantasized about the almost archetypal imagery of becoming “sexual supermen” through the use of the drug. Physicians should be alert to such attitudes and try to educate patients realistically about a medication that has no known benefit for men with normal sexual function.

Many women have also expressed both curiosity about, and interest in, sildenafil, and its potential impact upon their sexual lives. Although early studies suggested a possible benefit, this has not shown to date in controlled trials. If additional, larger studies confirm the presence of benefits, then many of the issues raised in this article will be more relevant for women.

Ethical concerns have also arisen about the appropriateness of coverage for drugs that enhance male sexual performance, when the same insurers have refused to cover contraceptive drugs and devices for women (Anonymous, 1998, p. 831; Ziegler, 1998, pp. 29–34). Appeals to fairness in the allocation of resources support criticisms of insurance plans or government health systems that pay for Viagra to begin paying for contraceptives for women.

VI. CONCLUSION

New medications such as sildenafil citrate not only represent bold pharmacological advances; they can dramatically change aspects of clinical practice. In the process, they present ethical challenges to physicians, patients, and others who may be directly or indirectly affected. At times, there is a tendency to think that such scientific advances outstrip the conceptual and clinical resources of contemporary medical ethics, presenting physicians in practice with new and unprecedented problems. We have shown in this article that contemporary medical ethics does possess the conceptual resources needed to provide physicians with an ethically justified, clinically applicable response to the ethical challenges that are raised by sildenafil and other drugs for erectile and sexual dysfunction that will follow in the near future. Physicians should always take a comprehensive approach to the evaluation and counseling of the patient and adjust the informed consent process to take account of the impact of clinical decisions on others whose interests might be harmed. In addition, the clinician should carefully distinguish between the limits imposed on clinical judgment and decision making by personal and professional conscience, and be attentive to related ethical issues. By doing so, physicians can provide steady, reliable guidance for patients in the midst of yet another scientific and technological advance in medicine and health care.

We note, in closing, that the biopsychosocial model of informed consent may apply in other clinical settings, for example, prescribing psychoactive drugs that can result in significant and perhaps unwelcome in changes in the patient’s relationships with intimate others. The wide application of the biopsychosocial model of informed consent is a matter worthy of further investigation.