Placebo Use Ethics Research Paper

1. History

Before modern medicine, many substances thought to have curative powers, e.g., arsenic, produced feelings of wellness, before perhaps killing the patient. Such placebo effects, due to ignorance of the physician and patient, were primary active ingredients of ancient medical practice. By the mid-1800s, Koch, Pasteur, and others demonstrated that specific bacteria could cause specific diseases, giving rise to specific pharmacologic and surgical interventions replacing nonspecific healing therapies. Placebo effects became ‘nuisance variables’ to be controlled for, and ethics considered when it was acceptable to use placebos instead of accepted treatment modes. Finally, placebo effects are being studied as interesting phenomena in their own right.

Their therapeutic value is increasingly recognized, and the ethics of failing to use placebos to produce beneficial results is being questioned. Today’s professionals produce placebo effects unwittingly, incidentally, or deliberately in research and practice in many fields including medicine, psychotherapy, and teaching. Today’s ideal professional would appropriately and deliberately combine the power of modern science and technology with the healing power of placebos. Unfortunately, impersonal cost-cutting programs may inadvertently eliminate such effective strategies.

2. Definitions And Uses

The ethics of placebo use depends on which definition or theory of placebos is employed.

2.1 The Pharmacological Paradigm

The term placebo, from Latin placere, ‘to please,’ was coined to mean a pharmacologically inert substance, e.g., a sugar tablet, deliberately disguised as medication. Thus defined, the placebo is used to satisfy complaining or malingering patients; placebo effectiveness was until recently considered proof of patient psychopathology or feigned illness. Today’s physician still employs placebos when the requested medication is inappropriate, but to satisfy concerns about lying to patients, may use very weak medications rather than inert substances.

Research on new treatments may yield ‘success’ simply as placebo effects. To control for this ‘noise’ researchers randomly assign both subjects and researchers to placebo and therapy groups. Double blind designs are used because researcher belief also influences results. The therapy is deemed successful if it yields better results than the placebo. (Without a placebo group, recovery due to treatment could not be distinguished from recovery due to spontaneous natural healing, as well as from expectancy effects.) To satisfy ethical requirements, researchers:

Inform subjects that they may receive placebos;

Specify the chance of receiving a placebo;

Use placebos only when genuinely uncertain about treatment effectiveness;

When inert substances might do harm, compare experimental treatment to baseline clinical data or current effective treatment;

Monitor subjects regularly for adverse effects and remove immediately from placebos if indicated;

Provide the placebo group with effective therapy later;

In double-blind studies, ensure that the code can be broken quickly to discover whether a placebo is causing a worsening condition;

Do not use placebos with highly vulnerable populations;

Use placebos resembling the active preparation so that patient and researcher cannot detect the difference.

Use of placebo control groups has, unfortunately, become such a hallmark of publishable research that placebo controls may be used when other approaches, e.g., comparison with current effective treatments, are as rigorous, often more appropriate, and put the subject’s interests first. Placebo control groups in psychiatric research on such vulnerable populations as persons suffering severe depression or schizophrenia have come under considerable scrutiny. Full comprehension and consent of the patient and next-of-kin concerning the possible use of a placebo, and careful surveillance of the patient, are crucial to ethical use of placebos when suicide or other forms of harm are plausible risks.

The pharmacological paradigm ignores sociocultural and interpersonal variables, expectations, learning, neurophysiology, and real therapeutic value of placebos. The malingering patient notion implies personality or demographic characteristics of placebo responders, but such characteristics have not been found.

2.2 Remembered Wellness

Newer conceptions and uses of placebos are highlighted in Benson and Friedman’s (1996) article. Under the right circumstances anyone might respond to a placebo. Placebos are not absence of treatment. What persons believe can diminish pain and objective symptoms of disease. The components of ‘remembered wellness’—the patient’s and physician’s positive beliefs and expectations, and a good relationship between the two parties—are one of medicine’s most powerful assets. Impersonal medical care and drug or surgical interventions are not effective in treating most diseases. Most visits to physicians stem from conditions related to stress and other psychosocial factors (Kroenke and Mangelsdorff 1989) which are responsive to placebo effects.

Such placebo effects based on ‘remembered wellness,’ accompanying standard therapies comprise effective care. For example, in an experiment using five standard therapies for angina pectoris, patients who believed in the therapy experienced about 80 percent relief from chest pain, reduced nitroglycerine usage, improved electrocardiogram, and increased exercise tolerance; skeptical patients experienced about half as much therapeutic benefit (Benson and McCallie 1977). In Canner (1980) among patients given placebos, less compliant patients had a 28 percent mortality rate after five years, while compliant patients had a 15 percent mortality rate.

Placebo use has evolved to entail warm, caring, sympathetic relationships that foster positive beliefs, combined with appropriate standard specific therapies. Thus defined, placebos are devoid of deception, and integral to quality of life, health, sound professional conduct, and empowerment and self-help. Under this conceptualization, it is reductionist scientific medicine coupled with impersonal managed care that is ethically questionable.

3. Theories Of Why Placebos Work

Three fundamental theories of placebo mechanisms are: conditioning (learning), hope and expectancy (cognition), and neurobiology (subjective experience). These three mechanisms are not mutually exclusive. Each provides ethical insights into placebo use.

3.1 Learning

Classical conditioning involves pairing an unconditioned stimulus (UCS), e.g., a charismatic, enthusiastic teacher who emphasizes the excitement and importance of a topic, with a neutral stimulus (a notparticularly exciting curriculum) which becomes the conditioned stimulus (CS) and evokes enthusiasm and dedication in the student. Pairing morphine (UCS) given to patients in great pain, causes the nurse and syringe to become conditioned stimuli (CS) for pain reduction. Placebo effects persist when only the CS is present and, following principles of partial reinforcement, continue undiminished if the UCS is reintroduced periodically, but eventually extinguish if the UCS is never reintroduced. For example, if a painkiller (UCS) having severe side-effects is interspersed with a placebo in an identical capsule (CS) and intermittent reintroduction of the UCS, the effect may be a continuously effective analgesic with diminished sideeffects. There is a powerful relationship between magnitude of UCS and response to the CS. For example, a massive dose of morphine (UCS) will result in a massive placebo (CS) effect. These principles of conditioned analgesia have been found with animals as well as humans.

Ethics requires disclosure of use of conditioning; e.g., following explanation of learning theory, the doctor might state that the UCS would be intermittent and that the client’s own relevant powers will serve to reduce pain. Conditioning produces expectancy, and memory of UCS effectiveness, as well as measurable neurological change.

3.2 Desire And Expectancy

Need or desire (e.g., for relief from pain) and expectation that a given therapy is effective will mediate placebo analgesia. These cognitive factors become associated with the CS and extend and support the role of learning. Authoritative professionals can create powerful hopes and expectations which can produce a placebo response without prior exposure to an objective UCS, though such exposure (combining conditioning with expectancy) increases expectancy.

Similarly, expectancy can result from learning about an agent’s therapeutic value, especially when one strongly desires that effect. Thus, persons desperate for relief are highly vulnerable to quackery, fraud, superstition, or cults, which may produce significant temporary relief through placebo effects. Conversely, anything expected to cause distress, sickness, or death (e.g., feared surgery, awkward physicians, institutions with poor reputations) can have a nocebo effect (Hahn 1997). Culturally based expectations, and good or bad relevant prior information or experiences, as well as aspects of the current therapeutic situation will create expectations and have placebo or nocebo effects. Positive expectations result in far superior outcomes of standard mediation surgery, education, and other interventions. The ethical professional uses expectancy effects to good ends, not to deceive people.

3.3 Neurobiology

If placebo effects are solely products of imagination, the ethics of placebo use concerns fooling people. However, as scientists discover how subjective ‘mind’ acts on the physical body, the ethics of placebo use changes. The functioning of neurons is involved in mental representation (e.g., the self, an image); subjective experience (e.g., pain, feeling of wellness); and bodily change (e.g., hormone secretion, healing); and the neural network, itself, is an objective physical entity. Thus, for example, injury causes pain, morphine reduces that pain, and placebos also alter neural representation of the injury (pain) in proportion to the preceding amount of morphine. Research has demonstrated neural substrates of placebo effects, especially analgesic effects, and imaging technology holds promise of rapid advancement in this area (see Fields and Price 1997).

Neurological models of placebo effects provide a framework for research on the role of language, culture, and environmental context in helping to reduce stress and pain, reversing disease processes, and healing injury. Future discoveries in this domain may lead to rewriting the ethics of placebo use.

4. Summary

Placebos have evolved from deception, and ‘noise’ that researchers control for, to phenomena studied in their own right. Research has shown that what persons think can affect objective (structurally or functionally measurable) changes in physiological functioning. Further theory and methodological developments promise the possibility of effective self-administered placebos—a new kind of self-help, and of radically new ethical considerations regarding placebo use.

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