1 - A New View of Nonmaleficence Case 1A The Patient Who Chooses Yoga, Colonics, and Reiki over Surgery A fifty-two-year-old woman is referred by her naturopath to a medical doctor for evaluation of an abnormal pap smear. Cervical biopsies reveal a premalignant condition, which, if left untreated, can progress and create lesions. The physician's recommendation is a hysterectomy, to be sure all the abnormality is removed.
The patient tells her physician that she plans to pursue yoga, colonics, and Reiki for three months, rather than surgery, and then have her condition evaluated. She does, however, want the physician to continue monitoring her care. The physician is reluctant to do so and is concerned about legal and ethical implications of remaining in the therapeutic relationship.
Case 1B The Parents Who Seek a Non-FDA-Approved Cancer Therapy A four-year old child is diagnosed with inoperable brain cancer. The child's parents wish him to receive a controversial therapy derived from human urine, but the therapy lacks FDA approval, and the child has not been approved for any clinical trials that might offer hope for receiving other relevant, experimental treatment. The FDA therefore insists that the child undergo standard radiation and chemotherapy; the parents, however, are reluctant to subject their child to the "harsh effects of these treatments." Further, the parents have met other parents whose children have successfully received and benefited from the controversial therapy, without experiencing toxicities or adverse side effects. The parents insist the decision belongs to the family, while the FDA insists it is merely following its congressional mandate to protect the public from interstate distribution of drugs not proven safe and effective.
The family physician feels it is her ethical obligation to treat the child with chemotherapy and considers seeking a court order to do so. Meanwhile, the state welfare agency initiates proceedings to declare the parents guilty of abuse and neglect and unfit for custody. The physician is called as a witness in the proceedings and has mixed feelings about the testimony she plans to present.
Preliminary Ethical Concerns about Using Complementary and Alternative Medical Therapies With the changing face of medicine and the burgeoning integration of complementary and alternative medical therapies into mainstream clinical practice, there is increasing interest in the ethical implications of providing, or
not providing, such therapies, as well as in the ethical parameters and principles that might guide the choices of physicians and other health care providers in the delivery of, or referral for, such therapies. For example, is it ethical for a physician to recommend specific herbs and other dietary supplements, special nutritional regimens, Chinese longevity exercises, and other therapies that are not proven safe and efficacious to the physician's satisfaction or are not sufficiently proven to receive general medical acceptance? Similarly, should the physician provide, or refer patients to other practitioners for, therapies such as chiropractic, acupuncture, naturopathy, massage therapy, homeopathy, nutritional care and herbal medicine, and various mind-body interventions when the physician has insufficient scientific evidence regarding the safety and efficacy of such therapies? On the flip side, when is it unethical to fail to recommend, deliver, or refer for therapies when there is some level of evidence for safety and efficacy?
Likewise, what should the clinician in mainstream practice say to a patient who insists on receiving such therapies? Is there a meaningful ethical distinction between recommending therapies and approving the patient's autonomous pursuit of such therapies (as opposed to discouraging the patient from using such treatments)? These questions become even more difficult with therapies when there are discrepancies between the belief systems of provider and patient. For example, should health care providers who are atheists pray with their patients--assuming scientific investigation suggests that prayer has some level of efficacy--and what kinds of conversations should providers have with patients regarding the efficacy, appropriateness, and medical understanding of prayer and other practices involving spiritual preferences? If evidence suggests that failing to pray (or provide other spiritual therapies) may diminish the therapeutic impact of the provider-patient relationship, what should the provider do?
For instance, what should the physician in case 1A say to her patient about the initial choice of yoga, colonics, and Reiki for several months instead of a hysterectomy? Should the physician in case 1B accede to the parents' wishes, terminate conventional treatment, and encourage the parents to pursue the option they deem most beneficial for their child? Or should the provider declare the parents unfit and face the possibility of separating a terminally ill child from his or her parents? How far does the state's role extend in intruding into family choices regarding different systems of medicine?
What kinds of conversations will satisfy informed consent? Which conversations will satisfy the conscience? Which, by enhancing the provider-patient dialogue and increasing communication, will reduce the risk of later malpractice exposure if the patient claims injury from insufficient disclosure? How does the provider handle paradigm shifts that challenge existing models, not only within the culture and the profession but also within his or her own being?
These questions begin to frame the broad question: When is it ethical for a physician to provide (or refuse to provide) a complementary and alternative medical therapy to a patient who either requests or demands a therapy that does not comport with the physician's best medical judgment for that patient? Again, on the other hand, when is it ethical for providers to refrain from even discussing therapies either desired by patients and their families or for which there is preliminary scientific evidence, when neither the provider nor the profession generally has accepted the safety, efficacy, clinical relevance, or even plausibility of such therapies (for example, homeopathy)? The exploration is grounded in larger questions, such as those of the role of safety and efficacy in provider decision making, the future parameters of clinical practice, and the health care provider's guiding role for the patient as such practices are more deeply integrated into mainstream health care and as such integration (in varying degrees) comports with or diverges from medical evidence and comfort.
These are, by and large, unanswerable questions--or at the least, questions requiring deeper investigation as the social order integrates the phenomena known, for the moment, as therapies encompassed by integrative and energy medicine. Moreover, the question of what is ethical can be used as a surrogate for a range of questions, including those that are legal, professional, moral, cultural, clinical, and personal.
Ethics is a broad field, encompassing theories, virtues, principles, and rules. Integrative and energy medicine, as previously defined, do not necessarily implicate new ways of conceptualizing the entire field of ethics. Therefore, the approach here is not systematic. In many cases, ethical considerations applicable to conventional and complementary and alternative medical therapies overlap. For example, health care providers have an ethical obligation to keep patient records and medical history confidential, whether the record involves prescription drugs or a history of specific dietary supplements. Similarly, both conventional and complementary and alternative medical providers have an obligation to refrain from invading the patient's physical body and personal boundaries in an assaulting manner, or their actions could be construed as battery. In this limited sense, complementary and alternative medicine covers no new ethical ground.
In some cases, the ethical conflicts arising within conventional medicine are heightened with complementary and alternative medical therapies. Specifically, complementary and alternative medicine often presents the clash between medical paternalism (the desire to protect patients' voluntary choices and to protect patients from foolish or ill-informed decisions) and patient autonomy. This conflict can be accentuated by patients' selection of therapies that lack medical acceptance (for example, colonics and Reiki) or that some consider medically dubious (for instance, the non-FDA-approved therapy in case 1B).
In still other cases, ethical considerations in integrative and energy medicine involve a logical extension of ethical principles in conventional care. For example, in conventional care, the obligation to obtain adequate informed consent from the patient requires disclosing the material risks and benefits of a particular modality and making note of risks and benefits that are speculative or unknown. "Material" refers to whether disclosure of the risks, benefits, and existence of a particular therapy would make a difference to the patient's decision to undertake or forgo a specific treatment plan. Presumably, no different duty applies with complementary and alternative medical therapies. In other words, the materiality standard also should govern the nature and scope of such disclosure in complementary and alternative medi-cine. If, for instance, gingko biloba improves dementia due to circulation problems and possibly Alzheimer's, then its risks and benefits should be disclosed for treatment of these conditions.
Finally, complementary and alternative medical modalities can raise ethical problems that challenge the provider's personal belief system in greater force than many conventional therapies. This is especially true when complementary and alternative medicine incorporates spiritual systems or operates along principles neither accepted nor proven in conventional scientific terms (such as the notion of energetic acupuncture meridians, involving neither a "placebo" effect nor a physiological one). For example, the physician in case 1A faces a patient who insists on delaying conventional care in favor of modalities with which the physician is not personally familiar and that have not or cannot be evaluated in terms with which the physician is familiar. On one hand, the patient's request creates an immediate moral and legal dilemma. The provider must assess liability exposure, as well as the possibility of unwittingly causing the patient injury. Viewed in other ways, however, the request creates the possibility for a transcultural dialogue, in which the patient's mental, emotional, and spiritual realities are tested against the provider's
perception of the obligation to safeguard the patient's welfare. This creates a larger conflict than the one between paternalism and autonomy. Specifically, the conflict may be not so much about whose choice should control as about what criteria should govern clinical evaluation of therapies foreign, and even repugnant, to prevailing biomedical models and/or governmental sensibilities.
Case 1B presents a similar conflict between professional standards and private ideals. Here, the provider faces a family that ardently and sincerely believes in reports of efficacy for a therapy the FDA considers not only untested but also possibly worthless and even dangerous. Not only the medical profession and a federal agency but also the machinery of the state have been brought to bear against the parents. The physician's own belief systems may preclude standing by the parents and defending their choice against these external forces. This conflict, again, may be framed as a choice not so much between a proven and an unproven therapy as between therapies accepted by majoritarian consensus within medicine and those accepted in the minds and hearts of patients. The choice thus can be framed as cultural as well as ethical. It is a power struggle.
One common ground in both case 1A and case 1B is that the patients' choices have spiritual and emotional components--for example, the decision to try yoga and Reiki or the choice to abandon chemotherapy in favor of a therapy whose mechanism is unknown but that seems to have helped other families. The provider is pitted against his or her own scientific principles, conscience, ethical obligations, and personal proclivities; the patient's wishes; the uncertainty inherent in pursuing the unknown; and the desire to help the patient avert unnecessary suffering and find the least harmful path back to health. Case 1B involves a patient with an incurable condition, but the scenario could be generalized, making decision making more variable.
The Effect of Overlapping and Competing Legal Concerns on Ethical Duties The ethical dilemma is complicated by overlapping and sometimes competing legal and liability considerations. This presents variations on the ways in which these obligations intersect in health care more generally. For instance, licensing and credentialing issues overlap with ethical concerns when physicians find their patients visiting providers who lack independent state licensure. The current list of non-licensed providers (in some states) includes lay homeopaths, counselors, herbalists, and spiritual healers. The extent to which lack of licensure makes the modality and the provider in question more or less acceptable receives further consideration elsewhere. Among other things, while the physician is on safer legal ground referring only to licensed complementary and alternative medical providers and using modalities that commonly are accepted among such providers, the need for (and scope of) licensure, certification, and other forms of credentialing vary by state and by profession.
For example, in many states (such as California and Massachusetts), there presently is no state licensure for massage therapists; yet the practice of massage therapy is not prohibited or is regulated by individual town ordinance. In many such cases, the practice of massage therapy is neither legal nor illegal--rather, it lies in the shadowy world of the unregulated (or under-regulated). The physician may feel such a provider might be helpful to the patient (for example, particularly for stress reduction) even though there are no state mandates regarding required training and education for the practitioner. In this situation, one might consider it ethical (in the sense of beneficence) to send the patient to the massage therapist, although the massage therapist's legal status may be unclear. By analogy, in case 1B, the physician may consider it ethical (in other words, beneficial) to help the patient obtain a nontoxic therapy other families have found effective for treatment of a child's inoperative brain tumor, but the treatment itself may be illegal.
In a converse situation, a practice involving complementary and alternative medicine may be legal but unethical. For example, many states do not license acupuncturists--or they allow physicians to practice acupuncture with a modicum of training. The physician may learn a smattering about needle placement in a weekend training course. This training, however, would be insufficient to qualify the provider as an expert in traditional oriental medicine. Therefore it may be legal but not ethical for the physician to purport to provide the patient with comprehensive acupuncture treatment. Parenthetically, the notion that physicians offering complementary and alternative medicine should have training on parity with that received by complementary and alternative medical providers offering the same treatment recently has received greater impetus from a report by the Select Committee on Science and Technology in the United Kingdom's House of Lords.
Liability issues also can raise situations in which legal and ethical obligations diverge. For example, in case 1A, one might consider it ethical for the physician to condone yoga, colonics, and Reiki for a period of three months rather than surgery. Indeed, to the extent that this, or some analogous scenario, is clinically tolerable, the physician's tolerance expresses respect for the patient's wishes, together with a "wait-and-see" attitude in which the physician continues to monitor the patient conventionally. But if the patient's condition deteriorates and the patient sues (arguing negligent care in the choice of treatment), the physician's tolerance of the patient's choice might lead to liability. If, on the other hand, the patient's condition improves, the physician would be free from liability (since malpractice liability requires a negligent action that causes the patient injury).
Continues...
Excerpted from Future Medicine: Ethical Dilemmas, Regulatory Challenges, and Therapeutic Pathways to Health Care and Healing in Human Transformation by Michael H. Cohen Copyright © 2003 by Michael H. Cohen. Excerpted by permission.
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