How Personalized Medicine Works


Ethical Considerations
While knowing you carry genes for a disease can be empowering, there’s a chance you’ll never develop the condition.
While knowing you carry genes for a disease can be empowering, there’s a chance you’ll never develop the condition.
iStockphoto.com/4774344sean

Would you want to know whether your genome contained information that suggested you were at a greater risk for cancer or disease, even if there's a chance it won't happen?

Knowledge can be empowering, but it can also create challenges when balancing health outcomes. In medical research, biomarkers are not always exact, and just because a person has a predisposition or the right combination of genes for a given health condition doesn't mean he or she will develop it.

For example, some forms of breast cancer are associated with specific genes. If a person knows he or she has the genetic makeup conducive to developing cancer, but it hasn't happened yet, should he or she take action such as having a mastectomy (surgical removal of the breast)? These are ethical debates researchers, doctors and patients are weighing together.

Data created from personalized medicine has become a source of ethical debate, too. To prevent employers and health insurance companies from discriminating against people based on genetic information, the U.S Congress passed the Genetic Information Non-Discrimination Act in 2008 [source: U.S. Equal Employment Opportunity Commission].

Then there's the issue of intellectual property, or determining who owns the rights to findings and data generated from personalized medicine. Because a company finds a biomarker for a specific illness, can that company patent it? That was a real concern just a few years ago, but according to the Supreme Court of the United States, genes with discovered links to disease cannot be patented [source: Liptak].

Author's Note: How Personalized Medicine Works

Looking to the future, I'm curious to see what will happen when personalized medicine and the Internet of Things collide: Will our thermostats monitor our biology in addition to the temperature?

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Sources

  • American Red Cross. "History of the Blood Transfusion." 2014. (Dec. 10, 2014) http://www.redcrossblood.org/learn-about-blood/history-blood-transfusion
  • Conger, Krista. "Whole-genome sequencing for clinical use faces many challenges, study finds." Stanford Medicine News Center. March 11, 2014. (Dec. 10, 2014) http://med.stanford.edu/news/all-news/2014/03/whole-genome-sequencing-for-clinical-use-faces-many-challenges-study-finds.html
  • Food and Drug Administration. "FDA Approves Kalydeco to Treat Rare Form of Cystic Fibrosis." Jan. 31, 2012. (Nov. 23, 2014) http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm289633.htm
  • Food and Drug Administration. "Paving the Way for Personalized Medicine: FDA's Role in a New Era of Medical Product Development." October 2013. (Nov. 23, 2014) http://www.fda.gov/downloads/ScienceResearch/SpecialTopics/PersonalizedMedicine/UCM372421.pdf
  • Food and Drug Administration. "Personalized Medicine: FDA's Unique Role and Responsibilities in Personalized Medicine." July 31, 2014. (Nov. 23, 2014) http://www.fda.gov/scienceresearch/specialtopics/personalizedmedicine/default.htm
  • Food and Drug Administration. Trastuzumab Product Approval Information – Licensing Action 9/25/98." June 8, 2012. (Dec. 10, 2014) http://www.fda.gov/Drugs/DevelopmentApprovalProcess/HowDrugsareDevelopedandApproved/ApprovalApplications/TherapeuticBiologicApplications/ucm080591.htm
  • Genetic Science Learning Center. "DNA Microarray." University of Utah Health Sciences. 2014. (Nov. 23, 2014) http://learn.genetics.utah.edu/content/labs/microarray/
  • Hayes, Daniel F. et al. "Personalized Medicine: Risk Prediction, targeted therapies and mobile health technology." BMC Medicine. Vol. 12. Issue 37. 2014. (Dec. 10, 2014) http://www.biomedcentral.com/1741-7015/12/37
  • Hresko, Andrew and Susanne Haga. "Insurance Coverage Policies for Personalized Medicine." Journal of Personalized Medicine. Vol. 2. Pages 201-206. 2012. (Dec. 10, 2014) http://www.mdpi.com/2075-4426/2/4/201
  • Krimsky, Sheldon. "Overview of Personalized Medicine." Personal interview. Dec. 9, 2014.
  • Liptak, Adam. "Justices, 9-0, Bar Patenting Human Genes." The New York Times. June 13, 2013. (Dec. 12, 2014) http://www.nytimes.com/2013/06/14/us/supreme-court-rules-human-genes-may-not-be-patented.html?_r=0
  • Mayo Clinic Staff. "Tinnitus." Mayo Clinic. Feb. 5, 2013. (Dec. 9, 2014) http://www.mayoclinic.org/diseases-conditions/tinnitus/basics/definition/con-20021487
  • News.com.au. "Patient Has 75 Percent of his Skull Replaced by 3-D-Printed Implant." March 8, 2013. (Nov. 23, 2014) http://www.news.com.au/technology/patient-has-75-per-cent-of-his-skull-replaced-by-3-Dd-printed-implant/story-e6frfro0-1226593075470
  • Oxford Performance Materials. "3-D Printed Skull Implant Ready for Operation." March 6, 2013. (Nov. 23, 2014) http://www.oxfordpm.com/news/article/2013-03-06_3-D-printed_skull_implant_ready_for_operation.php
  • Pollack, Steven and James Coburn. "FDA Goes 3-D." FDA Voice. Aug. 15, 2013. (Nov. 23, 2014) http://blogs.fda.gov/fdavoice/index.php/2013/08/fda-goes-3-d/
  • Pray, Leslie. "Personalized Medicine: Hope or Hype?" Nature Education. 2008. (Dec. 11, 2014) http://www.nature.com/scitable/topicpage/personalized-medicine-hope-or-hype-815
  • Stein, Rob. "Doctors Use 3-D Printing to Help a Baby Breathe." National Public Radio. March 12, 2014. (Dec. 8, 2014) http://www.npr.org/blogs/health/2014/03/17/289042381/doctors-use-3-d-printing-to-help-a-baby-breathe
  • Sykiotis, Gerasimos et al. "Hippocrates and Genomic Medicine." Archives of Medical Research. Vol. 37. Pages 181-183. 2006. (Dec. 10, 2014) http://www.arcmedres.com/article/S0188-4409%2805%2900227-4/abstract
  • The Jackson Laboratory. "Current Applications of Personalized Medicine." 2014. (Dec. 11, 2014) http://genetichealth.jax.org/personalized-medicine/what-is/applications.html
  • U.S. Equal Employment Opportunity Commission. "The Genetic Information Nondiscrimination Act of 2008." May 21, 2008. (Dec. 12, 2014) http://www.eeoc.gov/laws/statutes/gina.cfm
  • World Health Organization. "Diabetes." November 2014. (Dec. 11, 2014) http://www.who.int/mediacentre/factsheets/fs312/en/

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