Brian D. Kavanagh, Laurie J. Lyckholm, and Jeremy Sugarman
The medical profession experienced a rise in socioeconomic stature in the United States during the 20th century.1 Physicians began to receive higher wages for their services and enjoy greater personal respect as providers of health. Although progress in medical science has improved the quality and duration of life for some patients with cancer and other serious illnesses, technical expertise alone does not fully account for the upsurge in the societal standing of medical doctors during the past 100 years.
High regard for physicians is contingent on the trust that doctors act unselfishly in a patient’s best interests, a role sometimes called moral fiduciary.2 Essential to this role are medical knowledge and a firm grasp of ethics. Derived from the Greek η´θο
(ethos), meaning character, ethics refers to the process of applying values and principles in professional interactions and particularly in medical decision making on behalf of patients. The curriculum of most medical schools now includes coursework in ethics, but many physicians practicing today completed their training without formal instruction in this topic. To foster an appreciation for the intellectual underpinnings of modern medical ethics, this chapter begins with an overview of scholarly approaches to ethics. Next is a discussion of selected proclamations and codes of ethics published by professional societies, federal commissions, and other authorities as guidelines for medical practice and research. Finally, common ethical issues in radiation oncology are addressed, including relevant medicolegal considerations.
CONCEPTUAL APPROACHES TO MEDICAL ETHICS
The term bioethics, coined in the early 1970s, refers to the academic inquiry and public policy movement addressing the application of science and medicine from a humanistic perspective.3 Medical ethics may be most accurately viewed as a branch of bioethics, but the terms are commonly used interchangeably. Among the more influential theoretical approaches to ethics that are used in bioethics are utilitarianism, deontology, casuistry, virtue theory, and principlism.
Utilitarianism is based on the premise that, in any situation, the best course of action is the one that produces the maximum net positive value (or least negative value). Utilitarianism can be applied to an individual patient’s case or to matters of health policy, in which decisions might be made to achieve the greatest overall benefit for the largest number of people.
Unlike utilitarianism, deontology is an ethical theory based on the morality of actions themselves rather than their net result. Deontology, sometimes called Kantianism in recognition of the influence of Immanuel Kant,4 calls for consistent standards of behavior at all times, regardless of the consequences. One simple example of the difference between utilitarianism and deontology is the issue of educating patients about their diagnosis, especially if the prognosis is very poor. Whereas a deontologist would always feel obliged to tell the truth even at the risk of causing distress, a utilitarian considers whether telling a patient the complete truth about the disease does or does not really benefit the patient. In practice, there is obviously a need to find the right balance between purely utilitarian and purely deontologic perspectives in a situation like this one. Respect for the patient’s autonomy, for example, is one of the prima facie ethical principles discussed further in the next section. Truth-telling is an integral component, and overriding this principle requires justification.
Casuistry is an approach to ethics that emphasizes inductive reasoning based on established precedents, and it is a common practice in both law and medicine. The proper course of action in any individual case is decided by recalling decisions made in prior similar cases. The major weakness of casuistry is the lack of a reference benchmark or settled opinion on novel technologies.
Virtue theory focuses on the character of moral agents, in this case physicians and other health care providers, focusing less on actions or outcomes. As such, virtue theory captures the way in which correct moral actions occur. For example, it is not only important to tell patients the truth about their diagnoses, but it is also critical to do so in a compassionate manner. In this case, the virtue is compassion. Accordingly, while virtue is a critical part of assessing moral action, virtues themselves have little guiding force.
Principlism is a system of applied ethics through which core principles ideally govern behavior in the absence of compelling reasons to override them. Principlism can be integrated with the other philosophical approaches already mentioned and serves as a unifying influence. Key features of principlism are addressed in the next section.
FIGURE 99.1. Early 19th-century engraving depicting a likeness of Hippocrates, closely resembling images of ancient coins found on the island of Cos bearing his likeness. (Courtesy of the National Library of Medicine.)
ETHICAL PRINCIPLES
A prima facie obligation may be defined as one that is “binding unless overridden or outweighed by competing moral obligations.”4 Four prima facie principles of bioethics are highlighted here: respect for autonomy, beneficence, nonmaleficence, and justice.
Respect for a patient’s autonomy is based on respect for the right to individual liberty. A patient’s voluntary decision to seek medical care or comply with referral to a specialist is the starting point of most patient–physician relationships, and competent patients should remain free to forgo therapy or change physicians at any time. The responsibility to respect patients’ autonomy is established not only in ethics but also in law. An example is the requirement to obtain a patient’s informed consent for proposed medical therapy. In a landmark case involving postmastectomy chest wall radiation therapy, a patient who sustained soft tissue necrosis won a lawsuit against her radiation oncologist for negligence and for lack of proper disclosure regarding possible treatment-related toxicity. The Kansas Supreme Court ruled that doctors should explain “in language as simple as necessary” the side effects associated with any recommended therapy.5
The principle of beneficence is intertwined with that of nonmaleficence. Some authors have offered nuanced distinctions between the two principles,4 but the key point is that physicians should act for the benefit of patients and should not harm their patients. Beneficence and nonmaleficence are typically concordant objectives, but sometimes an intervention that is helpful also entails a high risk of adverse treatment-induced sequelae. For example, administering high-dose morphine to a patient severely dyspneic from an incurable lung malignancy can relieve symptoms but at the same time risks fatally suppressing respiratory drive. Here the quality of remaining life might be improved by a measure that also hastens death. Such an action can sometimes be justified by the principle of double effect, the earliest expression of which is generally attributed to St. Thomas Aquinas.6 According to this concept, the benefit of an action might be valuable enough to outweigh a simultaneous significant risk of serious adverse event, as long as achieving benefit is the primary intent. High-dose chemotherapy, bone marrow transplant, and some high-complexity surgeries, such as Whipple procedures, are examples of cancer therapies in which potential burdens and risks might militate against potential benefits.
The principle of justice refers to fairness, typically the equitable distribution of health care resources. Justice-related questions often arise in regard to matters of public policy. Two examples are determining the means to allocate scarce organs for transplantation and selecting what types of research merit government funding. More globally relevant in the United States is the challenge of allocating federal dollars for health care. Distributive justice implies that persons ought to be afforded medical care according to their medical needs and the ability of the system to provide.
FORMAL OATHS AND CODES OF ETHICS
There are many published declarations of medical ethics authored by physicians. Not surprisingly, the tone and language of each reflect the social mores and sometimes historical events of the era in which it was composed.
The Hippocratic Oath
I will prescribe regimen for the good of my patients according to my ability and my judgment and never do harm to anyone
The Corpus Hippocraticum is a collection of medical treatises dating from around the fifth century BCE, believed to be the work of philosopher–physicians from the Greek island of Cos (Fig. 99.1). Contained within the Corpus is the well-known oath of Hippocrates, an ancient physician’s pledge of professionalism. Curiously, the oath is inconsistent with some other sections of the Corpus, perhaps because it was added later. Comments about abortion and surgery, for example, are at variance with teachings elsewhere in the collected works.7 Nevertheless, timeless themes are included, and the oath has survived in various modernized versions. The oath is often recited by medical students at the time of graduation—even if its contents are not always well remembered.8,9
Percival’s Medical Ethics
Hospital physicians and surgeons should minister to the sick, with due impressions of the importance of their office, reflecting that the ease, the health, and the lives of those committed to their charge depend on their skill, attention, and fidelity.
Thomas Percival (1740–1804) (Fig. 99.2) published Medical Ethics at a time when there were considerable tension among clinicians in his community.10 In the 1760s, Manchester, England, was a prosperous urban society that comfortably supported public health initiatives, including an infirmary serving as a charity hospital and teaching institution. But as the city grew and became crowded by the 1790s, tensions arose between rival groups in the medical community. Percival was prompted to draft a code of ethics after a contentious dispute about enlarging the infirmary’s staff, a threat to the controlling physician faction.11
When he began writing Medical Ethics, Percival was already a well-known writer and moralist whose A Father’s Instructions to His Children, published in 1775, included essays promoting personal virtues and social awareness to young readers. While completing Medical Ethics, Percival suffered devastating personal tragedies, bereaving the untimely deaths of two of his own sons. The finished work was dedicated to a third son studying medicine at the time.
Ultimately, Medical Ethics provided a template for the codes of ethics adopted by the American Medical Association (AMA) and other societies in the 19th century. Early 20th-century pundits criticized Percival’s work as merely a book of medical etiquetterather than medical ethics. However, revisionist historians have subsequently argued that although Percival focused on interprofessional relationships, he also taught that a physician’s duty toward the patient outweighs obligations of civility toward other health care professionals. Furthermore, Percival advanced the enlightened view that indigent patients should receive the same quality of care as affluent patients.12
FIGURE 99.2. Thomas Percival (1740–1804). (From Brockbank EM. Sketches of the lives and work of the honorary medical staff of the Manchester Infirmary, from its foundation in 1752 to 1830 when it became the Royal Infirmary. Manchester, UK: Manchester University Press, 1904, with permission.)
The American Medical Association Code of Ethics
The AMA first adopted a code of ethics at its inaugural meeting in 1847. The initial code was modeled on the work of Percival, but subsequent updates have reflected societal changes and technological progress. The 2004 version includes four components13:
a. Principles of Medical Ethics;
b. Fundamental Elements of the Patient–Physician Relationship;
c. Current Opinions of the Council on Ethical and Judicial Affairs; and
d. Reports of the Council on Ethical and Judicial Affairs.
The seven Principles are general instructions for a physician to maintain competence and integrity in the context of individual patient care and also in the larger view toward enhancing the standard of care in the community. The Fundamental Elements expand the concept of a collaborative interaction between physicians and patients, specifically mentioning the need for good communication and the need to protect patients’ confidentiality. The AMA here advocates that all patients have a right to “necessary care,” regardless of their ability to pay for that care, and that physicians should play a role in safeguarding this right. The Current Opinions and the Reports of the Council on Ethical and Judicial Affairs provide situational interpretations of the Principles and Fundamental Elements, and they are often referenced in legal proceedings.
The Nuremberg Code and the Declaration of Geneva
During World War II, odious crimes were committed by Nazi physicians who conducted horrific experiments on concentration camp prisoners who were coerced to submit. The Nuremberg Code was a formal response to these World War II–era human rights atrocities disguised as medical experiments.14 Issued from the military tribunal that tried some of the Nazi doctors who conducted these experiments, the Nuremberg Code acknowledges that medical investigations are important. However, for a medical experiment to be morally permissible, it must meet 10 criteria, paraphrased as follows:
• Voluntary consent of the human subject
• Necessity to yield results helpful to society
• Appropriate design based on knowledge of the disease under study
• Avoidance of unnecessary physical and mental suffering and injury
• Absence of reason to believe that death or disabling injury will occur
• Overall degree of risk in proportion to the nature of the problem to be solved
• Adequate precautions against the possibility of the subject’s injury, disability, or death
• Qualified persons conducting the study
• Unrestricted freedom of the subject to end the experiment if he or she reaches the physical or mental state where continuation of the experiment seems impossible
• Willingness of the investigator to discontinue the study at any time if there is reason to believe that continuing the experiment is likely to result in injury or death to the subject.
In the aftermath of the war, the international medical community was especially sensitized to the need for universal adherence to high standards of ethical behavior. The Declaration of Geneva was adopted in 1948 by the World Medical Association and has been updated since then. The text includes the physician’s vow to ignore “considerations of age, disease or disability, creed, ethnic origin, gender, nationality, political affiliation, race, sexual orientation, or social standing” in the treatment of a patient and to uphold “even under threat … the utmost respect for human life.”
Case Study
Despite publicity about the Nuremberg Code and the Geneva declaration, controversial large-scale, government-sponsored medical studies took place in the years following World War II. Experimentation on the effects of radiation exposure on humans was conducted in the United States during the Cold War, when fears of nuclear warfare prompted inquiry into the carcinogenic and other adverse health effects of environmental exposure to ionizing radiation. In response to public concern about thousands of federally funded studies conducted from the 1940s through 1970s without consent of the subjects, in 1994 President Bill Clinton established the Advisory Committee on Human Radiation Experiments (ACHRE). ACHRE was comprised of ethicists, radiation oncologists, and others with relevant expertise. It was charged with evaluating the experiments’ ethical and scientific standards and recommending actions to ensure that any mistakes of the past would not be repeated. ACHRE reviewed all available documentation and also conducted an oral history project in which scientists described prevailing sentiments regarding human research ethics during the era of interest.
ACHRE found that government officials and investigators were in some cases culpable “for not having had policies and practices in place to protect the rights and interests of human subjects who … could not possibly derive direct medical benefit.”15 One example was the observational study of uranium mine workers exposed to radon levels known to be hazardous, without warning and without efforts to reduce the radon levels by ventilating the mines. As a result, lung cancer developed in hundreds of workers, and appropriate compensation was recommended for the individuals affected.
The Belmont Report
In 1972 Jean Heller exposed the injustices of the U.S. Public Health Services (USPHS) Study of Untreated Syphilis in the Negro Male that was conducted in Tuskegee, Alabama.16 During a 40-year period beginning in the 1930s, 399 indigent African American sharecroppers with syphilis and 200 without syphilis were subjects in a natural history study of the disease. The men mistakenly believed that diagnostic blood tests and lumbar punctures composed treatment for their “bad blood” when in reality these were done solely to monitor the course of the infection. Moreover, years later when penicillin was discovered and found to be effective in the treatment of syphilis, it was withheld intentionally from the men. Subsequently, public awareness of the USPHS study likely contributed to enduring reluctance among some members of minority groups to participate in clinical trials,17,18 and the political backlash provoked action by the federal government.
The 1974 National Research Act established the National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research. The commission met at the Belmont Conference Center in Maryland to develop ethical guidelines for the conduct of biomedical and behavioral research. In 1979 the commission published Ethical Principles and Guidelines for the Protection of Human Subjects of Research, commonly known as the Belmont Report.19
In the Belmont Report, a clear distinction is made between medical research and clinical practice. The term practice describes interventions intended “to enhance the well-being of an individual patient … that have a reasonable expectation of success,” whereas research is “designed to test an hypothesis, permit conclusions to be drawn, and … contribute to generalizable knowledge.” Sometimes a clinician uses good judgment and departs from standard methods for the benefit of an individual patient in special circumstances. However, if major innovations are proposed as replacement for standard techniques, then a formal investigation should be conducted to assess safety and efficacy. The National Commission embraced a principlist perspective in drafting the report, emphasizing in particular respect for persons, beneficence, and justice. The Belmont Report’s definition of respect for persons incorporates respect for autonomy and special concern for individuals with diminished capacity to exercise their autonomy. Involving prisoners in research activity is cited as an example. Although it is inappropriate to deny prisoners the possible benefit of experimental interventions, any direct or indirect pressure on prisoners to participate in clinical studies must be avoided. For instance, a promise of clemency in return for study enrollment is unacceptable. The report also addresses the nature of justice in medical research, emphasizing that the process of selecting subjects for a research study must be carefully examined. Investigators should minimize the chance that socioeconomically disadvantaged groups are represented disproportionately as a result of a vulnerability to manipulation in the health care environment.
The American College of Radiation Oncology Code of Ethics
The American College of Radiation Oncology (ACRO) has published a code of ethics, contained within the organization’s bylaws, which is available for review at the organization’s website (www.acro.org). The principles expressed are concordant with accepted ethical standards and include respect of patient autonomy, the expectation that a radiation oncologist should always act in the best interests of the patient, and respect of patient confidentiality. The ACRO code also forbids deceptive billing arrangements, and members of ACRO who do not comply with the code of ethics are subject to disciplinary action by the organization.
National Electrical Manufacturers Association Code of Ethics
The makers of equipment and software used in the practice of radiation oncology are not required to demonstrate clinical efficacy of a new device or software through the same sort of clinical testing that is required by the U.S. Food and Drug Administration (FDA) for approval of a new drug or implantable medical device. Rather, most treatment devices are approved after demonstration of safety and substantial equivalence to an approved device that is already commercially available. A company that wishes to sell a new device submits a premarket notification to the FDA at least 90 days before commercial distribution is to begin, in accordance with Section 510(k) of the FDA Modernization Act of 1997. Because devices may be introduced into the market without proof of superiority in any given clinical situation, manufacturers may promote their products to physicians by emphasizing intuitively attractive features that might or might not provide meaningful clinical advantage to patients.
On January 1, 2005, members of the National Electrical Manufacturers Association (NEMA) adopted a code of ethics regarding interactions between makers of medical imaging and treatment equipment and physicians (www.nema.org). Individual sections of the NEMA code address member-sponsored product training and education, support for third-party educational conferences, sales and promotional meetings, arrangements with consultants, gifts, provision of reimbursement and other economic information, charitable donations, and research grants. The guidelines are essentially consistent with the AMA policy on gifts and applicable federal regulations. NEMA members are allowed to support educational conferences and advertise their wares in these venues, and also they may provide educational support for individual customers in the safe use of their products. However, hospitality provided by NEMA member at conferences and meeting should be “modest in value and … subordinate in time and focus to the purpose of the meeting.” When it is necessary to demonstrate nonportable equipment, members may pay for reasonable travel costs of attendees with a bona fide professional interest but not for their guests.20
COMMON ETHICAL ISSUES IN RADIATION ONCOLOGY
Doctors wear a lot of hats these days; besides the usual physician role, we are expected to be a researcher, financial counselor, administrator, gatekeeper, patient advocate in the medicolegal system, ethicist, and Lord knows what else.
—Thomas J. Smith21
Financial Relationships with Hospitals and Referring Physicians
Reimbursement for radiation oncology services or other procedure-intensive subspecialties can be a major revenue source for hospitals. At the same time, subspecialists depend on other physicians to refer patients for evaluation and management. These situations can tempt hospital administrators to reward subspecialists for practicing in their facility and might tempt the subspecialists to induce referrals with financial incentives. In either case, a conflict of interests emerges: Treatment recommendations can be influenced not only appropriately by patient-centered beneficence but also inappropriately by the physician’s interest in personal gain. In the United States, the Anti-Kickback Statute and the Stark Law make it illegal to engage in such unscrupulous medical business practices.
The Anti-Kickback Statute (42 U.S.C. §1320a-7b) includes criminal penalties for acts involving Medicare or state health care programs. Section (b) makes it a felony punishable by a fine up to $25,000 and up to 5 years in prison to solicit or receive “any remuneration (including any kickback, bribe, or rebate) directly or indirectly … in return for referring an individual to a person for … any item or service” reimbursed in whole or in part through Medicare or a state health care program. The Anti-Kickback Statute also bans other fraudulent transactions supported through the same funding sources.
Named for its leading congressional author, Rep. Pete Stark of California, the Stark Law (42 U.S.C. §1395nn; “Limitation on certain physician referrals”) bans other misconduct involving Medicare and Medicaid patients. The Stark Law prohibits a physician from referring a patient for a “designated health service” to a clinic or other facility with which the physician or an immediate family member of the physician has a financial relationship. Radiation therapy is considered a designated health service, but it is clarified that a request by a radiation oncologist for radiation therapy is considered integral to the consultation request from the (nonradiation oncologist) referring physician and does not constitute a self-referral per se in most situations. Sanctions for violations of the numerous Stark Law regulations may include civil prosecution.
Managed Care
By the early 1990s, more than 70% of Americans with health insurance were enrolled in some form of managed care plan22 in which patients are restricted in their choices of physicians and medical services for the purpose of limiting the cost of the health care.23 The idea has existed in the United States at least since the time of the Great Depression of 1929, when Dr. Michael Shadid of Oklahoma organized a prepay and copay system for surgical, medical, and dental services. To maintain profitability, managed care organizations influence the behavior of patients and physicians through strategies to minimize expenditures. Tactics directed toward patients are promotion of preventive medicine, limitation of access to medical specialists unless approved by a “gatekeeper” primary care physician, and restricted selection of physicians to those willing to accept lower reimbursements. Physicians are prompted to lower costs by capitation-based compensation packages and financial rewards to avoid excess resource utilization.
Managed care is ethically defensible insofar as it can provide equal access for participants and promote well-being through an emphasis on preventive medicine. However, managed care can also threaten the physician–patient relationship by undermining the patient’s autonomy and creating a conflict of interest for the health care provider.24 If the physician gatekeeper shares financial risk with the managed care organization, a patient with a difficult medical problem might be less likely to be referred to a specialist where higher costs would be expected to result.
Physicians’ attitudes about managed care reflect concerns about ethics. A survey of primary care physicians revealed that most of them believed that managed care has a negative impact on the patient–physician relationships by interfering with patients’ choices and compromising the physicians’ ability to put the patients’ interests first.25 Medical students and residents frequently receive negative messages about managed care from their faculty mentors.26
Oncology services are often still provided by managed care organizations through fee-for-service contracts with independent practitioners. Nonetheless, there remain challenging patient management issues with regard to delivering radiation therapy in the setting of managed care that include the sometimes fragmented care and inconvenience for the patient, whose managed care organization might have contracted with several centers for various aspects of oncology care, and the administrative burdens associated with obtaining documentation of preapproval for patients’ radiation treatments.27
Electronic Record-Keeping and Billing Practices
The principles of respect for autonomy and nonmaleficence oblige confidentiality in physician–patient communications. Publicizing private details of a patient’s condition can create social and economic harms for the patient. With the advent of electronic medical records and Internet communication, there is a greater need for vigilance in this respect.
In the United States, the Health Insurance Portability and Accountability Act of 1996 (HIPAA) empowered the Department of Health and Human Services to codify standards for storage and transmission of an individual patient’s health information. Penalties for violations vary in proportion to their severity. In the worst case of wrongful disclosure of information with intent to sell it, a fine of up to $250,000 and a prison term of up to 10 years can be imposed.
Submitting fraudulent claims to the government for reimbursement of health care services is illegal. The False Claims Act (31 U.S.C. §3729) provides that any person who knowingly presents fraudulent claims to the U.S. government may be fined $5,000 to $10,000 and may be liable for three times the amount of any damages sustained by the government.
Applications of New Technology
Innovative treatment-delivery technologies such as intensity-modulated radiation therapy and stereotactic body radiation therapy provide radiation oncologists freedom to exercise creativity in customizing treatment plans for each individual patient. Ideally, it is best that such innovations are tested in formal research protocols in which a clinical problem is identified and the new technology is proposed as a solution so that toxicity and efficacy can be monitored closely. A prospective clinical trial approved and monitored by an institutional review board affords the opportunity to advance knowledge in the field with ethical oversight.28 It is inappropriate to apply a novel, more expensive technology to generate higher revenue in the absence of a sound clinical rationale. The AMA code of ethics proscribes superfluous therapy of no benefit to the patient.29
Clinical Trial Conduct
Instances of flagrantly improper clinical research taint the annals of medical history. The USPHS study of syphilis mentioned earlier and the human radiation experiments conducted during the Cold War without the consent of the participants are dark reminders of the need for ethical oversight of research.
Obtaining a participant’s informed consent is of paramount importance in conducting most clinical research. Despite the recognized importance of informed consent, precisely how much information should be conveyed to a potential clinical trial participant is debatable. The Belmont Report offers this criterion: “the extent and nature of information should be such that persons, knowing that the procedure is neither necessary for their care nor perhaps fully understood, can decide whether they wish to participate” in the study. In certain situations the nature of a study requires that there is incomplete disclosure of information to the participant to sustain the integrity of the study. The Belmont Report condones such research only when “i) incomplete disclosure is truly necessary to accomplish the goals of the research, ii) there are no undisclosed risks to subjects that are more than minimal, and iii) there is an adequate plan for debriefing subjects, when appropriate, and for dissemination of research results to them.” The federal rules governing research (45 CFR 46) reflect these arguments.
Advances in the biosciences, such as stem cell research, cloning, and manipulations of the human genome, have been associated with contentious public debate. Federal government and professional policies on such matters have sometimes been constructed as a compromise between scientific opportunity and political ideology.30 Extra safeguards have been imposed in some settings; for example, the federal government requires an extra level of review for gene-transfer experiments.31
Genetics
The management of some cancer patients can involve assessment of genetic markers that might predict treatment response and also reveal a predisposition to the development of certain cancers among the patient’s family members. The National Society of Genetic Counselors has published a guideline concerning genetic cancer risk assessment, counseling, and testing.32 It is recommended that the process of obtaining informed consent for genetic testing should include, among other considerations, an explanation to the patient of possible implications on the ability to obtain health or disability insurance in the future.
Relationships with Industry Sponsors
Incentives from industry representatives to prescribe pharmaceuticals or purchase equipment threaten the fiduciary obligations physicians have to their patients. The AMA code of ethics allows that gifts of modest value with direct or indirect benefit to patients are acceptable.33 Examples include textbooks or unrestricted educational grants for students or fellows. Subsidies for “modest meals or social events held as part of a conference” are permissible, as are honoraria for lectures or legitimate consulting services. However, cash or other valuable incentives intended to influence the decision to use a company’s products are forbidden. Also unacceptable would be a blanket indemnification from liability for use of a product. Advertising items such as patient education pamphlets and anatomic models bearing a sponsor’s name are commonly found in radiation oncology clinics.34 Physicians should be aware of any real or perceived influence on the patient–physician relationships resulting from their tacit compliance with such marketing activities.
In recent years some pharmaceutical companies have been prosecuted for kickback schemes or other illegal enticements to physicians, and the civil and criminal penalties paid by the corporations held responsible have ranged up to hundreds of millions of dollars.35 Brennan et al.36 contend that voluntary self-regulation by physicians, industry, and government is an insufficient safeguard against the conflict of interests nurtured by close relationships between practicing doctors and sellers of pharmaceuticals and medical products. These authors argue that academic medical centers should set an example for the rest of the medical community by establishing policies that forbid gifts to physicians, funds for travel, unjustified consulting fees, participation in speakers’ bureaus, and the practice of “ghostwriting” medical articles, among other things. Substantial attention has focused on implementing policies related to these issues.37,38
CASE-SPECIFIC DILEMMAS: THE ROLE OF AN ETHICS CONSULTANT OR COMMITTEE
The radiation oncology–related ethical issues discussed thus far relate primarily to general practice and research guidelines. However, individual cases can also pose uncertainties regarding the proper choice of action for a specific patient.
Case Study
A 37-year-old woman undergoes modified radical mastectomy for a pathologic T3N2M0 breast cancer; postoperative chemotherapy and locoregional radiation therapy are recommended. The patient wishes to receive the therapy only if she can periodically interrupt it to alternate with what she calls a “natural herbal” therapy.
In this case, respect for a patient’s autonomy conflicts with what is believed to be in the patient’s best interests, but a physician cannot ethically abrogate the fiduciary responsibility to a patient simply for reasons of unfamiliarity with alternative medicine or prejudice against its worth.39 Similar situations may arise when patients are noncompliant with standard treatment recommendations because of a particular religious faith or cultural heritage. Although physicians must respect patients’ choices, there is no strict obligation for a physician to accept a particular individual as a patient, especially if there are foreseeable personal conflicts that might adversely affect the patient–physician relationship.40
Pediatric oncology also requires special considerations. Parents are the chief decision makers, but sometimes their wishes can seem discordant with the best interests of the child. In a different context, what should be done if the adult children of a patient with a heritable trait for malignancy inquire of the patient’s diagnosis, but the patient has instructed the physician not to reveal any information to them? The obligation to patient–physician confidentiality conflicts with a potentially overriding obligation toward the family members who might benefit from guidance toward screening.
In cases such as these in which it is difficult to choose between two defensible courses of action, individuals with experience in clinical medical ethics can provide the expertise needed to sort through the ethical, legal, and social issues involved.41
PALLIATIVE MEDICINE
Palliative medicine has become a well-established component of clinical practice, and numerous academic medical centers offer accredited fellowship programs in this field. Palliative medicine places emphasis on symptom management and on the goals of care, not only at the end of life but also in the treatment of serious illnesses. A palliative approach is ethically justified when fully aggressive therapy might be intolerable or futile.
Case Study
A 92-year-old woman presented with stage IVa maxillary sinus cancer. She complained of sinus fullness and a painful 4-cm neck node. Radical radiation therapy to the primary and neck was recommended, and the patient underwent placement of a percutaneous gastric feeding tube and full dental extraction. Midway through the course of treatment, the patient required a lengthy hospitalization for failure to thrive and severe mucositis.
In retrospect a less-aggressive course of radiation therapy intended to reduce the sinus and neck symptoms would have been a better choice for this patient, who was frail and unable to withstand intense treatment. Palliative medicine pays careful attention to a patient’s individual needs, quality of life, and a discussion of goals of care. A recent randomized study demonstrated improved quality of life and overall survival when palliative care was given early alongside standard cancer treatment for metastatic lung cancer.42 In many cases, aggressive symptom management and good communication among patient, family, and provider may result in better quality and, perhaps, quantity of life than would antineoplastic therapy that has little expectation of efficacy but significant risk of morbidity.43
ETHICS AND MEDICAL ERRORS
Soon after the discovery of x-rays by Wilhelm Röntgen more than 100 years ago, the first cases of malpractice involving the clinical use of radiation therapy were tried in the U.S. court system.44 During the early 20th century, severe dermatitis was a frequent plaintiff’s complaint—not surprising in view of the physical limitations of the low-energy machines available at the time.
In 1999, the Institute of Medicine published a report on medical errors, elevating the level of public awareness and stimulating inquiry into this topic.45,46 Estimates of the number of Americans who die each year as a result of medical error have ranged from 44,000 to 98,000,47,48 and the annual cost of preventable adverse events has been projected to be $17 billion to $29 billion.49 In addition to encouraging efforts to improve patient safety, the Institute of Medicine recommended the development of confidential self-reporting programs and legislation to prevent voluntary reporting from legal discovery.50
Physicians are often reluctant to discuss errors. It has been suggested that doctors and patients “harbor deep within themselves the expectation that the physician will be perfect.”51 Other reasons for reticence include uncertainty about whether an event really is an error, concern for the patient’s well-being, and fear of litigation.52 Each of these items warrants comment.
First, if a patient has an undesirable treatment outcome, careful review of the case can help distinguish error from untoward but unsurprising occurrence. For example, severe pneumonitis after breast radiation therapy is uncommon but not necessarily proof of negligence. Second, concern that disclosing an error causes a patient undue anxiety is contradicted by studies revealing that patients prefer physicians to acknowledge errors53 and they might even sue for lack of apology.54 Finally, in cases of alleged or suspected error leading to injury, the institutional risk-management service should usually be contacted for advice. However, fear of litigation should be mitigated by the fact that a low overall percentage of patients who suffer negligent injuries actually file malpractice claims.25,52
Nondisclosure of error can weaken the trust at the core of the patient–physician relationship. The argument for disclosure is especially strong when there is a specific preventive intervention that might lessen the severity of possible future injury. Nevertheless, the question still remains: Are physicians ethically obliged to disclose an error, even if there is no immediate harm to the patient?
Case Study
A patient with T3N1M0 squamous cell carcinoma of the left retromolar trigone received concurrent cetuximab plus intensity-modulated radiation therapy to the gross disease, with elective coverage of adjacent nodal echelons. The intent was to give 54 Gy to adjacent uninvolved lymph nodes at a rate of 1.8 Gy per day and 66 Gy to the gross disease at a rate of 2.2 Gy per day using a synchronous integrated boost technique, with all treatment completed in 30 fractions. After the spinal cord was contoured as an organ at risk, the structure was inadvertently deleted on all planning computed tomography slices below the level of the gross disease. As a result, when the intensity-modulated radiation therapy inverse planning software optimized the dose distribution according to the constraint of limiting the maximum dose to the spinal cord to 50 Gy, the entire cross-section of a 6-cm length of cervical spinal cord received the full prescription dose, with some areas of the cord located in a “hot spot” region receiving more than 70 Gy. The error was not detected until 1 week after the patient completed treatment, during a routine quality assurance check.
In this example, no injury has yet occurred, but the patient is at increased risk for radiation myelitis. Although there is currently no available proven preventive measure, if the escalated risk of myelitis is unknown to the patient, he or she might later undergo misguided management by another physician if symptoms develop. For instance, if the patient develops arm and leg weakness, a magnetic resonance imaging scan showing nonspecific enhancement and edema in the cervical spinal cord might be interpreted as evidence of metastatic intramedullary or epidural tumor rather than radiation change. Unaware of the prior treatment error, the patient would be unable to inform the other physician involved about the high risk for radiation injury. As a result, the patient might be given only minimal supportive care on the assumption of incurable recurrent disease rather than appropriate efforts toward rehabilitation.
Evans and Decker55 have offered practical suggestions on how to address the issue of a medical error in radiation oncology once the event has been recognized. They advise disclosure for any errors that result in a perceptible clinical effect, change in diagnosis or treatment course, or a chance of future harm. Their two-phase response recommendation involves initial attention to the patient’s immediate needs and an apology that avoids giving an impression of defensiveness. Later, after a more thorough analysis of the situation has been completed with the involvement of the hospital’s risk management team, a carefully prepared discussion with the patient and other interested parties can occur. Evans and Decker also encourage radiation oncologists to maintain a proactive process of practice self-review as one component of fostering a culture of safety and quality in patient care.
CONCLUSION
Society’s view concerning medical ethics has shifted over time to adapt to the forces of advancing knowledge. Ethical guidelines have sometimes been constructed as formal documents or mandated as law, but no single system comprehensively predicts and resolves all situational dilemmas. The core principles of medical ethics remain essential foundations for the practice of medicine.
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