Ethical Legal and Social Issues

The exciting potential of the work emanating from the Human Genome Project has led to unbounded enthusiasm about our ability to affect the health of the population through population screening for genetic cancer predisposition, through a more sophisticated understanding of the molecular profile of the cancer phenotype, and through new gene-targeted drug development. However, the recent expan sion of technology into the field of medical genetics has outstripped our ability to conceptualize the ethical and moral dimensions of the application of molecular genetics to the clinical setting of oncology. There are outstanding ethical issues that concern patients and their families, the healthcare profession, and society at large.

Most of the ethical debate for the public has centered on the ability to genetically characterize individuals for inherited cancer susceptibility syndromes. Limitations of test accuracy and the relative uncertainties about effective preventive strategies for those who test positive have led many to advise caution about the widespread adoption of genetic testing in the clinical setting. In fact, concern about the potential adverse consequences of genetic testing for cancer susceptibility has led to the view that genetic information is qualitatively different from other medical information because of its potential to be used in a discriminatory manner and its unique implications for family members. The public has expressed concern that the explosion of genetic information may result in an environment in which people will be labeled and disadvantaged in the workplace and in their ability to obtain insurance based on genetic information. In fact, the most common reason cited for not considering genetic testing for mutations in the BRCA1/2 genes is fear of insurance discrimination.8 Legislation for protection against discrimination based on genetic test results is incomplete and has not been thoroughly challenged in the court system. Responsibility to other family members is another concern voiced by individuals who undergo genetic testing. Privacy and confidentiality issues place the burden of communicating genetic test results with the proband, who may not have a sophisticated medical background and who may face difficult family dynamics in the communication process. The application of the new genetics to the diagnosis, characterization, and treatment of cancer has not generated as much concern and attention among cancer patients, who are often overwhelmed by their situation and the details of the treatments proposed to them. A good example of this is the increasing use of microsatellite instability (MSI) testing of colon tumors in the clinical setting without full disclosure to the patient that the testing may uncover a hereditary cancer syndrome in their family.

The promise of the new genetic technologies is emerging at a time when healthcare resources are shrinking and when access to care is not shared by all members of society. Although advances in technology will most likely lead to more cost-effective assays, the costs will still put a significant strain on the healthcare budget. Disparities in cancer care will grow as more advanced technologies are introduced into the treatment setting. The role of insurance companies in providing coverage for these new costs is unclear. The magnitude of insurance and/or employment risks from discrimination on the basis of genetic risk information is also a major concern for state and federal government agencies and the insurance industry.

There has been considerable debate about the issue of "genetic exceptionalism," that is, whether genetic testing is sufficiently different from other types of medical tests to warrant special considerations. Because of some of the unique aspects of genetic information, the standard of care has evolved to obtain formal informed consent for the conduct of a specific genetic test, even when done strictly for clinical management and not in the context of research. Unique components of the consent process are the acknowledgment of potential social and family implications of the test results, including the potential for discrimination based on genetic risk status, the symbolic meaning of heritage in our culture, the probabilistic nature of the test results, and the potential for lifetime classification of an individual as "at risk."9,10 Suggested components of the informed consent process are shown in Table 25.2. This process should take into account the participant's prior experiences, beliefs, attitudes, concerns, expectations, and motivations concerning genetic risk and should be handled with attention to confidentiality and the needs of other family members.

One special circumstance is the issue of genetic testing of children and adolescents. The ASHG and the American College of Medical Genetics, as well as ASCO, have suggested a series of points to consider in confronting this situation. The primary indication for genetic testing of a minor should be the provision of timely medical benefit. If the cancer occurs predominantly in childhood and risk reduction strategies and therapies are available, such as medullary thyroid cancer, there is justification for testing. Psychosocial benefits to competent adolescents, including reduction of uncertainty and anxiety, and contribution to life decisions may also be an indication. For those diseases, such as adult-onset cancers for which the medical and/or psychosocial benefits will not occur until adulthood, genetic testing should generally be deferred. The involvement and preparation of the family should be an integral part of this process. It is the responsibility of the provider to weigh the interests of the children and their families in their delivery of responsible genetic services.5,11

The ability to characterize individuals genetically facilitates the application of this technology on a global scale and, in addition to creating typologies of cancer susceptibility in the population, will permit the molecular definition of ancestry, ethnicity, intelligence, and other human features with the potential for misuse. All these issues call for public education about the issues the genetic revolution is raising and a general discourse on the use of genetics in the oncology setting.

TABLE 25.2. Components of informed consent for genetic testing.

Purpose of the test

The purpose of the genetic test must be clearly described.

Practical aspects of the test

Amount of blood to be drawn, length of time to receive results, other information to be collected, cost of

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