You Are Here: Home > Cancer Research > What We Know About Cancer > OMICS Revolution > Personalized Medicine - pg 5

Personalized Medicine - page 5

4) Public Policy and Ethical Issues

As with any significant undertaking, the challenges facing personalized medicine are not limited to the science behind it. A large number of public policy and ethical challenges exist that must be addressed before personalized medicine can become a reality.

Each of these challenges must be dealt with not by a single person or group, but by all of the stakeholders that are affected by it. Who are the stakeholders? That seems like an easier question than it actually is, but in general, the stakeholders are physicians, health care organizations like hospitals and health networks, private insurance providers, public insurance providers such as Medicare and Medicaid, pharmaceutical companies, state governments, the federal government, and, of course, patients.

Not all of these are affected by each issue, but solutions will only be possible when the affected stakeholders work together. We need to carefully study the many ethical, legal and social issues raised by this research. Such study is crucial in order to use genomic research to help patients and prevent misuse of new genetic technologies and information.

  • Privacy concerns

Protecting patient privacy is one of the most important things that must be done before ordinary people will be willing to take advantage of individualized medical care. Just about everyone agrees that patient's have a right to keep details about their health private from most people. (But how far does that right extend? Does it cover a person's genetic makeup?)

For example, if a person has this information collected for use in risk profiling or diagnosis, should that then automatically commit them to allowing their data to be used for diagnosing and profiling others? Tissue donated for risk profiling often asks for this right. While this can be done without identifiers, this information is, in effect, personally identifying, so it can never be truly anonymous.


Additionally, what about the privacy of other family members? Families share genetic information, and by knowing something about their risk, a person also learns about their relatives' risks.

Image courtesy of      

Personalized Medicine
Recently Diagnosed
Cancer 101
  • Autonomy

Patient autonomy is the right of a patient to choose what happens to them. The question of what uses of a patient's data are permissible, is not exclusively a question of privacy but also one of autonomy. Is it OK to require a person to allow their data to be used for risk profiling or diagnosis as a condition of performing the service for them?

  • Allowed usage

Risk prediction is an important part of personalized medicine, but it requires a fairly large sample of individuals on which to base the prediction. Moreover, the individuals used should be fairly similar to the patient (or patients) whose disease risk we want to estimate.

One of the most promising ways of doing this is by using data collected by hospitals. This is called a "secondary use" of health data since it is not being used for its original purpose - making a diagnosis about the patient from whom it was collected.

There are other potential secondary uses also, including using this data for pharmacogenomic drug development - another important goal of personalized medicine.

These secondary uses are not currently possible, and policies must be developed to allow this data sharing in such a way that protects a patient's confidentiality and their right to opt-out of these uses.

  • Psychological impact

For healthcare providers, personalized medicine offers the potential to improve the quality of care, through more precise diagnostics, better therapies, and access to more accurate and up-to-date patient data and sophisticated decision support tools.


Yet, some people may not be willing and/or capable of processing technical risk assessment data obtained from new omic tests.

Decision support tools will be essential to guide treatment decisions based on test results, as the psychological impact of this type of information may be large.

Physicians will also require a solid background in genomics and proteomics to make the best use of these sophisticated tools.

Image courtesy of Wired magazine
Executive Editor Thomas Goetz
  • Access to testing (cost)

Many people are without health insurance today, and many more have insurance plans that cover only the most basic things. How can we provide access to personalized medicine to everyone? Is access for everyone a reasonable goal? Is it an attainable one?

There will likely be a number of levels of personalized care, and if universal access is a goal, what level is acceptable? Is a tiered system where those who can't afford to pay on their own receive some level of service while those who can afford it get more comprehensive care ethically sound? It's something that looks much like our current health care system, but many people are unhappy with that model.

"Currently, less than 5% of all US private companies reimburse for genetic tests, indicating that the current health care delivery system may not be able to deliver effective personalized medicine". Quote from PricewaterhouseCoopers' Health Research Institute, (2009). [The new science of personalized medicine]

  • Access to results

Traditionally, genetic tests have been available only through healthcare providers such as physicians, nurse practitioners, and genetic counselors. Healthcare providers order the appropriate test from a laboratory, collect and send the samples, and interpret the test results so patients have the support they need when results are delivered.

Direct-to-consumer genetic testing refers to genetic tests that are marketed directly to consumers via television, print advertisements, or the Internet. This form of testing, which is also known as at-home genetic testing, provides access to a person's genetic information without necessarily involving a doctor or insurance company in the process.

Genetic testing provides only one piece of information about a person's health-other genetic and environmental factors, lifestyle choices, and family medical history also affects a person's risk of developing many disorders.

These factors are discussed during a consultation with a doctor or genetic counselor, but in many cases are not addressed by at-home genetic tests. More research is needed to fully understand the benefits and limitations of direct-to-consumer genetic testing.

  • Discrimination

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

Genetic discrimination is discriminating on the grounds of 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).

The GINA legislation prevents discrimination by health insurers and employers but does not apply to life insurance or long-term care insurance.



Site Design by: Studio457
CISN Home Page About Us Services CISN Home Page Contact Site Map CISN Home Page CISN Home Page