Traditional clinical diagnosis and management focuses on the individual patient’s clinical signs and symptoms, medical and family history, and data from laboratory and imaging evaluation to diagnose and treat patients. This is often a reactive approach to treatment. In another word, treatment or medication starts after the signs and symptoms appear. For example, treatments for diabetes are aimed at improving insulin release from the pancreas and sensitivity of the muscle and fat tissues to insulin action.
Antibiotics were based on the observation that microbes produce substances that inhibit other species. The Human Genome Project (HGP) was declared complete in April 2003. The “Genome Era”, a term used to describe the period following the sequencing of the human genome, has foreboded fundamental revolution in the way of biomedical practice. Personalized medicine aims to use this increased genetic knowledge base to identify predisposition to disease and to tailor treatment to the individual based on an analysis of their genome.
In 2003, the Australian Law Reform Commission and the Australian Health Ethics Committee released a report recommending regulatory reform to ensure adequate protection of genetic information [1]. There have been significant developments in this area since that report was released, and the authors argue that it is time to reconsider the regulatory framework of personalised medicine in Australia. The authors identify a number of ethical concerns that need to be addressed if the promise of personalised medicine is to be fully realised.
Researchers are working toward a future where each of us will have the opportunity to get a blood test to have a complete analysis of the 20,000 coding-genes which is our personal genetic blueprint. This data will be stored in our personal electronic medical chart. It will tell your physician critical information. [2] At Duke Medicine, it is believed that personalized medicine should be defined by the following five principles, or the “5Ps. ” Personalized medicine is:
Predictive: Uses state-of-the-art molecular and diagnostic tools to precisely predict individual health risks and outcomes Personalized: Is informed by each person’s unique clinical, social, genetic, genomic, and environmental profile Preventive: Emphasizes wellness and prevention to stop disease before it progresses Preemptive: Incorporates action-oriented, individualized health planning Participatory: Empowers each patient to participate in their own care, with coordinated support from their health care team [3] Today, about 10% of labels for FDA-approved drugs contain pharmacogenomic information — a substantial increase since the 1990s but hardly the limit of the possibilities for this aspect of personalized medicine.
[4] Moving from concept to clinical use requires basic, translational, and regulatory science. On the basic-science front, studies are identifying many genetic variations underlying the risks of both rare and common diseases. These newly discovered genes, proteins, and pathways can represent powerful new drug targets, but currently there is insufficient evidence of a downstream market to entice the private sector to explore most of them. To fill that void, the NIH and the FDA will develop a more integrated pathway that connects all the steps between the identification of a potential therapeutic target by academic researchers and the approval of a therapy for clinical use.
This pathway will include NIH-supported centers where researchers can screen thousands of chemicals to find potential drug candidates, as well as public–private partnerships to help move candidate compounds into commercial development. The move towards personalised medicine can be seen as an evolutionary rather than revolutionary process. Although some personalised medicine approaches have already been introduced into practice in Europe, we are at an early stage of its implementation. Significant paradigm shifts will need to take place in major fields of medical research and health care for this innovative area to be fully exploited Reference [1] Chalmers D, Nicol D, Otlowski M, Critchley C. Personalised medicine in the genome era. 2013 Mar;20(3):577-94. [2] James C. Salwitz, MD.
The Future is Now: Personalized Medicine. 2012 http://www. cancer. org/cancer/news/expertvoices/post/2012/04/18/the-future-is-now-personalized-medicine. aspx [3] Geoffrey S. Ginsburg, MD, PhD, Huntington F. Willard, PhD. Genomic and personalized medicine: foundations and applications 2009. 154(6):277-87. [4] Frueh FW, Amur S, Mummaneni P. Pharmacogenomic biomarker information in drug labels approved by the United States Food and Drug Administration: prevalence of related drug use. Pharmacotherapy 2008;28:992-998 [5] Margaret A. Hamburg, M. D. , and Francis S. Collins, M. D. , Ph. D. Clinical relevance of genetic polymorphisms in the human CYP2C9 gene. 2010; 363:301-304.
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