Personalized Medicine (PM) is thought to be the next major advancement in the provision of healthcare. Once hospitals and healthcare practitioners acquaint themselves with evolving technologies in pharmacogenomics, pharmacogenetics, metabolomics, etc, they will be able to offer more effective services to the patients. For example, under this impending healthcare revolution, patients will be able to walk into a doctor’s office with a ‘smart card’ in hand, which contains encoded sequence of their genome. Armed with a complete and accurate understanding of a patient’s unique genome,the physician can then prescribe the right drug in the right dosage at the right time to effectively treat the health condition. Pharmacogenomics and pharmacogenetics, which are expected to be at the core of PM, combine to offer several advantages over conventional clinical methods. For example, while pharmacogenomics is limited to identifyng ‘inheritable response’ to medication across the whole genome, pharmacogenetics studies the effects of medication at the level of individual genes (the chart below outlines how it operates). The former also tries to reveal important links between genomic patterns and clinical responses. Such links are crucial sources of medical knowledge, as they empower clinicians to choose a particular treatment option based on individual patient condition as opposed to adopting a formulaic trial-and-error approach. (Hood, 2003, p.582)
The Human Genome Project (HGP), initiated and supported by former American President Bill Clinton was pivotal to subsequent breakthroughs in Personalized Medicine. With the help of advanced computing power, already more than 3 billion base pairs of DNA have been successfully mapped. With the completion of the HGP in 2003, new possibilities for PM have been opened up. Working expeditiously to make Personalized Medicine a reality in the near future are such organizations as the International HapMap Project, the NIH Encyclopedia of DNA Elements (ENCODE), the Roadmap Epigenomics Program, etc. (Cox, et. al., 2007, p.112)
In order to understand the scope and effectiveness of Personalized Medicine, let us take a hypothetical case. For instance, in the case of oncology treatment, where presently oral-intake medicines can cost hundreds (if not thousands) of dollars per year for the afflicted patient, understanding the intricate ‘genetic pathways’ (which is unique to each individual) is important in order to determine the probable efficacy of a particular therapy course. It is a sign of progress that in the United States today “there are 6 drugs for which FDA requires diagnostic genetic testing before prescription, about 30 for which a diagnostic test is recommended, and another 200 with pharmacogenomic information on the labels.” (Hesselgrave, 2010, p.16)
Moreover, traditional healthcare provision adopts an one-size-fits-all approach. Whereas, under Personalized Medicine, this practice will be dismantled and unique prognostic courses would be designed based on the patient’s genetic make up. Powerful technologies that try to understand the working of the human body down to the cellular level will be part of future PM treatments. These technologies include genomics, proteomics (the study of proteins), and metabolomics (the study of metabolites) amongst others. Metabolomics is of special interest to physicians as it has the potential to provide key information about individual patients. While the purpose of proteomics research is to identify abnormal protein patterns in patients, the purpose of metabolomic research is to identify abnormal metabolite patterns. Scientists are of the view that human bodies contain more than 3,000 metabolites that play a crucial role in proper growth and development of various organs. Apart from these primary metabolites there are secondary metabolites which strenghthen the immune system and helps reduce mental and physical stress. Of particular interest to the medical community are low-molecular-weight metabolites such as amino acids, carbohydrates, sugars and lipids, which can offer vital information about a patient’s health. (Bren, 2005)
By gaining the ability to study and understand organic processes behind metabolite generation, doctors will be able to draw up profiles of their patients. Since these profiles keep changing in response to the condition of the body, they can give clues to the most effective course of treatment. For example, the metabolite profile of patients change in reaction to the presence of a foreign body, with the intake of a drug, or in response to stressful stimuli. In essence, Metabolomics “is the evaluation of tissues and body fluids, such as urine, blood, plasma, saliva, and cerebrospinal fluid, for metabolite changes that may result from bodily responses”. (Bren, 2005) And metabolomic analysis can be conducted using methods such as Nuclear Magnetic Resonance(NMR) and Mass Sprectrometry (MS). While the speciality of NMR is to recognize and measure numerous metabolites in a body fluid extract, MS on the other hand can “display, quantify, and generate profiles of thousands of metabolites with more sensitivity than NMR. The profiles are then run through powerful computers that process, store, and generate data in a form for scientists to visualize and interpret.” (Woodcock, 2005, p.39)
The potential associated with metabolomics is quite substantive. To start with, it can make orally administered drugs a lot safer by recognising their likely toxicity in the patient. By using the genomic profiles of different ethnicities and racial groups, specially targeted drugs can be prescribed. Metabolomics also has the potential to predict a patient’s chances of acquiring health conditions in the future and also to ascertain quickly if a treatment course is producing the expected recovery. Its most important contribution would be in the area of preventative treatments, whereby high-risk individuals for a particular condition can be screened, cautioned and averted early. In conjunction with proteomics and genomics, metabolomics has the potential to transform the nature of healthcare. (Hemphill, 2010, p.12)
Finally, while Personalized Medicine offers unprecedented opportunities for patients and healthcare providers alike, in order to make it work, a concerted effort from pharmacists, lawmakers and government agencies is required. Under this new paradigm of health delivery, health outcomes of admitted patients is expected to improve while overall systemic costs are likely to decrease. In the United States, agencies such as the National Institute of Health (NIH) and the Department of Health and Human Services (HHS) have been at the forefront of conducting comparative clinical effectiveness trials for new technologies. The Health Reform Bill HR 3590 is another key step forward. These developments are on par with progress in Western European countries including Britain. (Ross, et. al., 2006, p.1)
References
Bren, L. (2005, November/December). Metabolomics: Working toward Personalized Medicine. FDA Consumer, 39,.
Cox, J., Campbell, A. V., & Fulford, B. (. (Eds.). (2007). Medicine of the Person: Faith, Science, and Values in Health Care Provision. London: Jessica Kingsley.
Health Care Re-gifting; Legislation Rightly Avoids Genetic Discrimination. (2007, April 11). The Washington Times, p. A17.
Hemphill, T. A. (2010). Gene Patents, the Anticommons and the Biotechnology Industry. Research Technology Management, 53(5), 11+.
Hesselgrave, B. (2010, June). PM and the Future of Pharmacy. Drug Topics, 154, 16+.
Hoh, Y. K., & Boo, H. K. (2007). Pharmacogenomics: Principles & Issues. The American Biology Teacher, 69(3), 143+.
Hood, E. (2003). Pharmacogenomics: The Promise of Personalized Medicine. Environmental Health Perspectives, 111(11), 580+.
Madows, M. (2005, November/December). Genomics and Personalized Medicine. FDA Consumer, 39,.
Ross, D. N., Entin, D. L., & Sanford, D. M. (2006). U.s. Biotech Industry Note. International Journal of Case Studies in Management (Online), 4(3), 1+.
Woodcock, J. (2005, November/December). Pharmacogenomics: On the Road to “Personalized Medicine”. FDA Consumer, 39.
Metabolomics – An Overview, article retrieved from <http://www.biomics.se/metabolomics/index.php> on March 2, 2011
Stahl, S.M.(2008), Essential Psychopharmacology, 3rd edition, Neuroscience Education Institute, Cambridge University Press, New York