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You Are Here: Home > Personalized Medicine > Ethics > The Promise > Patient Awareness Issues > Ethical Challenges |
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Ethics
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).
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Many people are without health insurance today,
and many more have insurance plans with only the
most basic coverage.
How can access to personalized medicine be
provided to everyone? Is access for everyone a
reasonable goal? Is it an attainable one? |
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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.
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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.
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If patients seek to know more about their
genetic makeup, what are the implications
for their family members?
Do family members have a right to learn
about the patient’s genetic results or the
choice to refuse receipt of such information?
Such questions need to be considered and
discussed before testing is performed. |
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Image courtesy of, www.genome.gov |
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Access to Data
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.
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In these cases, people other than patients and their medical
teams have access to patient genomic data to work on
solutions that may help others in the future. Policies must be
developed to allow such data sharing while protecting patient
confidentiality and preserving the right to opt-out of these
uses. |
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Access To Genetic Counseling
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.
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However, some people may not be willing and/or
capable of processing technical risk-assessment data
obtained from new ”omic” tests (Annes, Giovanni, &
Murray, 2010).
Decision-support tools will also be essential to guide
treatment decisions based on such test results, as the
psychological impact of this type of information may be
complex. |
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Image courtesy of, Wired magazine
Executive Editor, Thomas Goetz |
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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.
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Yet secure data sharing is absolutely necessary
to develop the field of personalized medicine
and the knowledge base around it. |
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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:
- A thorough and transparent consent process about potential risks and benefits.
- 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.
- 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.
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Along with the translation of personalized
medicine into clinical practice and the
currently inadequate protections in place
comes the possibility that insurance
companies will use genetic information to
deny or discontinue coverage in the future.
This is a very real concern that again must
be addressed by all stakeholders. |
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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” |
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