Our current lack of ability to predict an individual patient’s treatment success for most diseases and conditions means that clinicians have no choice but to follow a less than optimal approach to prescribing drugs and other treatment options.
Margaret A. Hamburg, M.D. Commissioner of Food and Drugs
A patient being treated for high blood pressure, for example, might be placed on one of a number of blood pressure medications. The patient’s doctor makes a decision about what medication to prescribe based on only general information about what might actually work for that particular patient. If the medication does not work after a few weeks, the patient might be switched to another medication. This somewhat “trial-and-error” approach can lead to patient dissatisfaction, adverse drug responses and drug interactions and poor adherence to treatment regimens.
The goal of personalized medicine is to streamline clinical decision- making by distinguishing in advance those patients most likely to benefit from a given treatment from those who will incur cost and suffer side effects without gaining benefit.
The term “personalized medicine” is often described as providing “the right patient with the right drug at the right dose at the right time.” More broadly, “personalized medicine” may be thought of as the tailoring of medical treatment to the individual characteristics, needs and preferences of a patient during all stages of care, including prevention, diagnosis, treatment and follow-up.
Personalized medicine generally involves the use of two medical products – typically, a diagnostic device and a therapeutic product – to improve patient outcomes. A diagnostic device is a type of medical device. Diagnostic devices include both in vitro tests such as assays used in measurement of genetic factors and in vivo tests, such as electroencephalography (EEG), electrocardiography (EKG), or diagnostic imaging equipment.
Pharmacogenomics:
Pharmacogenomics (PGx), the study of variations of DNA and RNA characteristics as related to drug response, is one of the most exciting areas of personalized medicine today. The field arises from the convergence of advances in pharmacology (the science of drugs) and genomics (the study of genes and their functions). Patients typically have variability in response to many drugs that are currently available. It can be difficult to predict who will benefit from a medication, who will not respond at all, and who will experience adverse effects. PGx seeks to understand how differences in genes and their expression affect the body’s response to medications.
More specifically, PGx uses genetic information (such as DNA sequence, gene expression,
and copy number) for purposes of explaining interindividual differences in drug metabolism (pharmacokinetics) and physiological drug response (pharmacodynamics), identifying responders and non-responders to a drug, and predicting the efficacy and/or toxicity of a drug.
Advances in PGx have opened new possibilities in drug discovery and development. PGx has allowed for more tailored treatment of a wide range of health problems, including cardiovascular disease, cancer, and HIV/AIDS. FDA’s Center for Drug Evaluation and Research (CDER) has supported pharmacogenomics for more than a decade by providing regulatory advice, reviewing applications, and developing policies and processes centered on genomics and individualized therapeutics.
With the help of personalized medicine, the health care management paradigm will focus on prevention, moving from illness to wellness, and from treating disease to maintaining health. By improving our ability to predict and account for individual differences in disease diagnosis, experience, and therapy response, personalized medicine offers hope for diminishing the duration and severity of illness, shortening product development timelines, and improving success rates. At the same time, it may reduce healthcare costs by improving our ability to quickly and reliably select effective therapy for a given patient while minimizing costs associated with ineffective treatment and avoidable adverse events.
Read more at: FDA.gov
For more information on Personalized Medicine via Metabolic Validation Testing:
PGx Medical
Individualized Care – Personalized Medicine
info@pgxmed.com
405-509-5112