Clinical OMICS

JAN-FEB 2018

Healthcare magazine for research scientists, labs, pathologists, hospitals, cancer centers, physicians and biopharma companies providing news articles, expert interviews and videos about molecular diagnostics in precision medicine

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Page 28 of 51 January/February 2018 Clinical OMICs 27 awareness of hospitals, other healthcare organizations, and physicians," he said. "It is not just academic medical cen- ters that are driving this. There are major healthcare orga- nizations that are recognizing [pharmacogenomics] is a differentiator for them in the market, so they want to start implementing it." Improved Safety, Improved Treatment Application of pharmacogenomics in the clinical setting promises to help reduce the rate of adverse drug reactions (ADRs) in patients for drugs post approval. While patients are encouraged to self-report to the FDA any adverse reac- tions to prescription medication use, there is no comprehen- sive reporting structure in the U.S. to accurately quantify either the rate of injury, or death, attributed to the use of prescription medications (excluding those related to over- dose or misuse). Despite this data gap, researchers have attempted to derive estimates of the toll taken by properly prescribed medications that end up harming patients. One often-cited study from 20 years ago published in the Journal of the Amer- ican Medical Association (Lazarou, et al.) estimated that each year roughly 106,000 people die in the U.S. due to an ADR. Other, more recent research pegs the number a bit higher— more than 125,000 annually. That's a rate roughly matched by the number of people who die each year from stroke, the fourth leading cause of death. While it is known that virtually every person has at least one genetic variant that affects drug response, these responses differ significantly from individual to individ- ual. Further complicating the process of pinpointing proper drug selection and dosing is the broad range of therapies available to treat patients. "The issue that we are trying to solve with pharmacog- enomics hasn't changed and never will change," said How- ard MacLeod, PharmD, director of the DeBartolo Family Personalized Medicine Institute at the University of South Florida Moffitt Cancer Center, in a 2016 National Human Genome Research Institute presentation. "That is we now have many different active therapies for the treatment of most diseases, and the changes that will occur will be that there will be even more therapeutic options for these dis- eases." One example cited by MacLeod is high blood pressure, which currently has more than 100 FDA-approved drugs, or drug combinations on the market for its treatment. Phy- sicians face the daunting task of which one to choose for a patient, with prescribing choices often based on a doctor 's familiarity with a specific drug, or choosing a drug that has worked well recently for a few patients. Quite often, the first drug doesn't work and the physician is faced with changing the treatment. "That really speaks to the need for something more pre- cise in how we choose from amongst the various medi- cines," MacLeod added. "We need to be thinking about how do we best choose from amongst the options. The reason we do that is there is so much variation in the response to most (continued on next page) Hero Images / Getty Images

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