Ethical Challenges

History has shown that genetic information can be used for good or for bad purposes.

With the technological advances seen in the last several decades, genetic information now can be used to enhance cancer risk prediction, diagnosis, and treatment.

Personalized medicine relies heavily on the use of genetic information and tumor biomarkers to determine cancer molecular subtypes and to predict an individual’s response to particular therapies (McKinnon & Anderson, 2011).

Access

Access to Targeted Therapies

Fulfilling the promise of personalized medicine must take into account the question of access—that is, which members of society will actually have access to targeted therapies and whom will benefit most (Fleck, 2010).

There will likely be several levels of personalized care. If universal access is a goal, what level is acceptable? Is a tiered system ethical, where those who cannot afford to pay receive some level of service, while those who can afford the associated costs receive more comprehensive care? If the level of access will resemble that provided by our current healthcare system, this may be unacceptable to some people whose needs are not met.

Disparities in access to treatment, cancer-related health status, and health outcomes are the result of multiple factors in addition to genetics, including social factors such as income, education, occupation, geographic residence, etc. (Wolinsky, 2011). All are crucial considerations that must be taken into account by all stakeholders.

Risk prediction is an important component of personalized medicine, but it requires a fairly large sample of individuals. One of the most promising methods of risk prediction is achieved through the use of data collected by hospitals. This is called a "secondary use" of health data, since it is not being used for its original purpose of making a diagnosis about the patient from whom it was collected (Hawkins, 2010). There are additional potential secondary uses, including assessment of data for pharmacogenomic drug development, another important goal of personalized medicine.

Deconstructing a disease at its molecular level and developing an effective targeted therapy is a remarkable feat that once would have been viewed as science fiction. But today, personalized medicine is a reality for some patients and may soon become possible for many more. Accordingly, there is a crucial need for a well-equipped and appropriately trained professional workforce to help patients understand their choices.

Genetic counseling is a complex process intended to guide individuals through an intimate, life-altering, and sometimes painstaking decision-making process. The profession requires a highly-specialized knowledge and skill base to educate and help people effectively through multifaceted decisions about their own health and possibly the health of their relatives (Owens et al., 2009).

Because decision making after a cancer diagnosis can be extremely difficult, genetic counselors must be able to assist individuals effectively without seeking to fulfill their own agendas (Lebel, 2005). They should maintain an impartial and unbiased attitude about their patients’ personal beliefs, values, and goals. Genetic counseling should always accompany research that discloses genetic information.

Oncology nurses should have basic knowledge at least concerning genetics and genomics, since they serve at the front line of cancer research and are often the “go to” person for patients with questions and concerns. (Lea, Read, & Williams, 2011). Just as personalized medicine is evolving, so too will the roles and responsibilities of genetic counselors and the need for an adequate workforce of these professionals. There is concern that even healthcare providers in general may lack sufficient understanding about genetics, though many are still expected to provide genetic-related clinical information and services (Owens et al., 2009).

Privacy

Ensuring adequate protection of patient privacy is another crucial area that must be addressed before many people will be willing to take advantage of personalized medical care. Most agree that patients have a right to keep details about their health confidential from most people and entities. But how far does that right extend? Does it cover information about a person's genetic makeup? For example, if a patient’s genetic information is collected for use in risk profiling or diagnosis, should he or she be committed to allowing the use of the data for diagnosing and profiling others? When patients donate tissue for risk profiling, they are often asked for such permission. While this can be done without patient identifiers, this information is in effect “personally identifying,” so it can never be truly anonymous.

This means the need exists for a number of entities to have access to these biospecimens, including researchers, clinicians, and pharmaceutical companies.

While this may be necessary to enhance the benefit of personalized medicine, mass accessibility to biospecimens increases public concern about privacy and confidentiality (Hawkins, 2010).

There are three important safeguards needed concerning genetic information:

1. A thorough and transparent consent process about potential risks and benefits.
2. The ability to isolate genetic information from electronic health records (EHRs) during information exchange. The inclusion of such data in EHRs is crucial, but privacy concerns must be addressed.
3. Addressing the inadequate protection against genetic discrimination offered by the Genomic Information Nondiscrimination Act (GINA) (Francis, 2010).

Discrimination

One of the possible significant barriers to genetic testing is the fear of discrimination from an insurer, or even worse, an employer. This fear has been indicated in several polls, including a Harris Poll in 2002.

Many patients fear genetic discrimination using information obtained from an individual's genome. Genetic non-discrimination laws have been enacted in most US states, and at the federal level, by the Genetic Information Nondiscrimination Act (GINA).

GINA prohibits insurance companies and employers who offer group insurance from discriminating on the basis of potential genetic conditions for asymptomatic individuals. However, because it does not control insurance rates for those diagnosed with a genetic disease (Clayton, 2003), this is inadequate protection.

Even with this legislation in place, the fear of genetic discrimination prevents some individuals from undergoing genetic testing (Clayton, 2003). Some individuals even pay for testing themselves to prevent their insurers from learning which genetic tests they have had and result they’ve received.

Patients who are interested in donating their tissue must be sure to discuss any privacy concerns they may have with their doctors.

“Content Developed September 1, 2012”