Viewpoint: Interests, rights and standards of care in the context of globalized medicine

Authors


  • Ethics Symposium Part I: Should ideology be allowed to trump patient well-being?

Hille Haker, Richard A. McCormick Chair of Ethics, Loyola University Chicago, 6525 North Sheridan Road, Chicago, IL 60626, USA.
(fax: +17735082386; e-mail: hhaker@luc.edu).

Introduction

Historically, medical ethics responded to the ideological misuse of scientific (or pseudo-scientific) research and gave priority to the individual patient’s right to be respected in any medical intervention [1].1 This right has been confirmed in several guidelines, from the Helsinki Declaration to the European Oviedo Convention of Human Rights in Biomedicine and many professional ethics codices.

For most works on medical ethics, the right of patients is spelled out as respect for their interests, justified by freedom as the basis of autonomy, moral agency and a modern understanding of the individuals’ right to decide on issues related to their (good) lives. Physicians’ duties are constrained by patients’ freedom rights, namely their right to decision-making and nonintervention, and are therefore to justify any intervention in the light of the patients’ own understanding and concept of the ‘good life’. Successful communication (i.e. doctor–patient relationship) will result in the free and informed consent to a medical intervention – without it, the intervention would be considered morally wrong [3]. Over the last few decades, informed consent has become a kind of magic formula to guarantee patients’ rights.2 However, given the bureaucratic environment of modern medicine, it was not long before lack of time to engage in lengthy communication turned the thoroughly reflected ‘free and informed consent’ into a matter-of-fact standardized form, merely to be signed by the patient to make the operational sequences of medical action as effective as possible.

Interests or rights?

One could hold that the pragmatic application of the medical standard of free and informed consent can be remedied by creating more space for communication, further valuing the relationship between doctor and patient, visible ultimately on the physician’s pay cheque. But this would not solve the inherent problems of an interest-based medical ethics theory that has recently become the object of academic moral reasoning.

Some would argue that ‘interests’ and ‘rights’ are interchangeable terms. However, I believe that interests are linked to a patient’s subjective understanding of his/her good life, whereas rights are linked to a general concept of well-being that needs to be spelled out under the conditions of modern medicine and needs to be negotiated in the process of ethical deliberation in general.3 The concept of health rights that are meant to be applied in medical practice is one of the most difficult terms when considered from the ethical viewpoint: it lacks clarity in many ways and poses the following questions.

  • 1 What is the specific content and scope of these rights? And who decides ‘what counts’ as a right?
  • 2 What is the relation between the patient’s (morally justified) rights and (merely subjective) interests? Again, who decides?
  • 3 Who may (and can) claim these rights?
  • 4 Who is the addressee of the patient’s rights? And who then is the subject of duties and responsibilities?
  • 5 How are patients’ rights to be balanced with other standards or principles of medical ethics?

Interests-as-desires and interests-as-rights

Consider the following case. A 15-year-old girl approaches a physician with the aim of acquiring a breast enlargement. The physician considers this a nonjustified medical intervention, because it carries certain risks and hence does not serve her well-being. As a result, he refuses to treat her. The girl, however, argues that it is not only in her interest-as-desire but rather in her best interest, i.e. her right. She claims to suffer from psychological discomfort, because she is bullied by her peers. She assures the physician that she is aware of all the possible side effects and risks. She knows that she would have to pay for the treatment herself and is willing to do so.

May the girl claim to be treated if nobody other than herself will be harmed, and must the physician – who is needed for the procedure – respond to her request? In other words, may the physician correlate the girl’s interest – considered as interest-as-desire – with a more general concept of well-being, i.e. her best interest? How would he argue for his account? And who would need to be given priority in the final decision?

In the liberal interpretation of autonomy as self-determination or freedom to act, the physician must not impose his own values on the girl and take her interests as the principle for his own action.4 He must act in accordance with the principle of tolerance. Alternatively, according to the Kantian model of moral theory, autonomy may be considered a normative principle of morality on two conditions. The first condition is that there is an agent who can decide for herself, hence deserving respect for her freedom and dignity as moral agent (similar to the liberal interpretation); the second is that the moral agent agrees to make a reasonable argument for her claims [9]. According to this approach, the girl must carry out the test of universalization on the maxim of her action (the subjective principle of her interest-as-desire). Whereas universalization is the formal criterion of justification, well-being is the material side of it. Universalization enables us to ask two questions: whether a certain action serves our well-being, based upon a reasonable yet subjective analysis of our needs and desires, and whether this action could be imagined as a generalized practice, hence serving the well-being of any person in the same situation.5 The first question may very well be answered only by the agent herself; however, the second question integrates her action (or desire) into a more general practice (or process of reasoning about the good).6 Whereas in the Kantian approach the individual agent herself must undertake the ‘test of universalization’, discourse ethics suggests a deliberative concept of interactive or dialogical reasoning. In the latter approach, physicians, and in fact other health care professionals, play an important role in determining the content of well-being in the context of health, but they are bound to an ongoing hermeneutical process of dialogical ethical interpretation, understood as normative reasoning.

In my view, this Kantian-based moral stance is crucial to distinguish interests-as-desires from interests-as-rights. To determine what might count as desire or as right, the correlation between interest and well-being is critical. The ‘libertarian ethics’ approach that identifies medical services with any other service that the girl could purchase personalizes moral choices that cannot be distinguished from any other choices and does not consider the impact that medical practices have on social practices and social norms.

Underneath the adolescent girl’s interest to enhance her body, the ideology of a socially defined concept of beauty serves as a source of respect. Even though she expresses her interest as personal desire, it still functions as an internalized norm that the girl must fulfil to be recognized by her peers. Therefore, the physician’s refusal to help her may well result in frustration: she cannot live up to social expectations of a specific shape of her body. But could this underlying desire for recognition and respect justify cosmetic surgery as a right? It would be the physician’s task to disentangle the motives, values and norms underlying the girl’s request, but he would also need to question in what way the actions that he cannot justify on medical grounds fuel a social norm that puts adolescents increasingly at risk.7 Medical interventions are, consequently, part of a web of social practices that require responsible decisions and interactions, including the primacy of the adolescent’s health over social norms. A critical analysis of moral norms of well-being hence includes the critique of social norms related to health.

Research and the ‘standard of care’

The 2008 revised version of the Helsinki Declaration states in its Introduction:

“3. It is the duty of the physician to promote and safeguard the health of patients, including those who are involved in medical research. The physician’s knowledge and conscience are dedicated to the fulfilment of this duty.

4. The Declaration of Geneva of the World Medical Association (WMA) binds the physician with the words, “The health of my patient will be my first consideration,” and the International Code of Medical Ethics declares that, “A physician shall act in the patient’s best interest when providing medical care.”

In 2000, the WMA used the formula of the highest possible standard of care that should be made available to people participating in clinical research.8 In 2008, it emphasized again that this standard is not to be defined by national regulatory requirements.

“10. Physicians should consider the ethical, legal and regulatory norms and standards for research involving human subjects in their own countries as well as applicable international norms and standards. No national or international ethical, legal or regulatory requirement should reduce or eliminate any of the protections for research subjects set forth in this Declaration.”

Contrary to the WMA, however, in the last decade, with a rise in the number of medical trials in developing countries, the Nuffield Council on Bioethics, the US National Bioethics Advisory Commission and the Joint United Nations Programme on HIV/AIDS have moderated this high standard by stating that national standards could serve as sufficient, minimal ethical standards to respect patients’ rights.

The ‘best possible standard of care’ corresponds to the ‘best interest standard’ of the patient; it determines a physician’s action towards a patient. If this standard is dependent on national health standards, the rights of patients may easily be at risk. How could lower standards in medical trials, based on national legislation (or nonlegislation), be justified? It may be argued that the assumed outcome of a trial will still serve the well-being of all future patients, even though it might not have been carried out in countries with high standards of care. In accordance with utilitarian priority setting, the right of the individual may then be overridden by the well-being of all. In a second interpretation, however, the lower standard of care serves as an incentive for companies: the economic profit that is connected to progress in technologies justifies the lower standard of care because it is the only way to encourage companies to carry out trials at all. Medical ethics, in this interpretation, has given up the highest standards to serve the interests of the companies that wish to save costs.

Considered from a rights-based approach, however, both justifications would be clearly flawed: they potentially sacrifice the well-being of the individual for the future well-being of others or for scientific progress linked to economic gains. Both approaches put the moral burden on those individuals who might struggle for their right to the best possible standard of care. The above-mentioned guidelines and reports ultimately give priority to the (future) good-of-all over the (best-protected) well-being of the individual. ‘Trumping’ individual rights with an assumed good is, however, not in accordance with the principles of medical ethics that were developed in the second half of the 20th century, and it changes considerably the standards of the most important medical ethics guidelines. Medical ethics needs to reconsider the basis of patients’ right instead of succumbing to lower standards.

A second example addresses a culture-sensitive, yet rights-based approach in the context of HIV/AIDS trials, i.e. the microbicide trials that were carried out in several countries highly affected by HIV/AIDS. After almost a decade of hope that vaginal gels could complement the use of condoms in protecting women against HIV/AIDS, the clinical trial for a vaginal microbicide gel involving almost 10 000 women in East and Southern Africa was declared unsuccessful in December 2009.9 Although this is certainly a major setback in the struggle against HIV infection, the trial itself may serve as a test case for a culture-sensitive, dialogical implementation of ethical standards concerning medical research.

In the international setting of the microbicide trials, the concrete content of the ‘best interest’ standard was defined in communication with communal health service centres, adjusted via feedback forms from the participants and supervised by several authorities, including international ethics boards. The trials made it clear that in medical research, especially in developing countries, and particularly in the context of a sexually transmitted infectious disease, everything depends on trust. To build trust – and maintain it – intercultural interaction is needed to design the framework of trials in the implementation phase as well as during follow-up. As a result, the microbicide trials implemented a concept that takes serious the right of the participant to determine his or her good and yet connects it to standards of well-being that are based on the patients’ assumed interest in the best possible standard of care. The concrete measures, however, were determined in a process of (local) communication or discourse that provided the contextual interpretations needed during the trial.

Conclusion

Medical practice as much as medical trials reveals the conceptually necessary relation between interests, rights and well-being. In the case of medical treatments that do not concern others, the Kantian principle of autonomy is easily confused with a more cultural understanding of autonomy as self-determination of one’s own interests-as-desires. The replacement of the Kantian concept of autonomy by the cultural concept of autonomy as the extremely personalized pursuit of happiness has weakened medical ethics in general. Indeed, it leaves a gap where in traditional ethics the concept of the good has taken its place. New models of ethical deliberation are needed to maintain a critical stance on individual desires and social norms, to determine the content and the status of well-being in medical ethics.

In contrast to a ‘metaphysical’ or ‘naturalized’ concept of the good, the concept of well-being must take general human rights as seriously as the contexts of interpretation in which they are appropriated.10

Footnotes

  • 1

    For a short historical analysis of the underlying concepts, see reference [2].

  • 2

    This is because of the success of the popular bioethics book by Beauchamp and Childress [4].

  • 3

    This conflict is spelled out in the debates between preferential utilitarianism and deontological ethics, echoed in bioethics as debate between an interest-based and rights-based approach. For example, compare a utilitarian approach presented by Singer [5] or by Harris [6], with a human rights-based approach presented by Annas [7].

  • 4

    See reference [8] for this argumentation, which has since been echoed by others.

  • 5

    See reference [10] for the argument for freedom and well-being as necessary conditions of human agency.

  • 6

    See Korsgaard’s [11] interpretation of Kant, particularly of how an accordance of the subjective and generalized analysis can be reached.

  • 7

    An exploration of the implications of gendered standards of well-being, especially in the case of cosmetic surgery, would be needed for a thorough analysis.

  • 8

    The text was revised again in 2008; see http://www.wma.net/en/30publications/10policies/b3/index.html and reference [12] for discussion.

  • 9

    The Microbicide Trials Network announced on 14 December 2009: “The Microbicides Development Programme (MDP) announced the highly anticipated results of MDP 301 study testing the safety and effectiveness of 0.5% PRO 2000 on Monday, 14 December 2009. The clinical trial involving 9385 women in East and Southern Africa has demonstrated that a vaginal microbicide gel PRO 2000 (0.5%) whilst safe does not prevent HIV infection in women” (http://www.global-campaign.org/MDP301.htm).

  • 10

    See further discussion in reference [13].

Conflict of interest statement

No conflict of interest was declared.

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