The Case for Personalized Medicine
Personalized Medicine Coalition
Shifting the emphasis in medicine from reaction to prevention: Personalized medicine introduces the ability to use molecular markers that signal disease risk or presence before clinical signs and symptoms appear, and it offers the opportunity to focus on prevention and early intervention rather than on reaction at advanced stages of the disease. In many areas, these clinical interventions can be life-saving.
For example, women with certain BRCA1 or BRCA2 gene variations have up to an 85 percent lifetime chance of developing breast cancer, compared with a 13 percent chance among the general female population. These women also have up to a 60 percent chance of developing ovarian cancer, compared with a 1.7 percent chance among the general female population. The BRCA1 and BRCA2 genetic test can guide preventive measures, such as increased frequency of mammography, prophylactic surgery, and chemoprevention.
Paving the Way for Personalized Medicine
FDA. U.S. Department Of Health And Human Services – U.S. Food And Drug Administration
The concept of personalized medicine is not new: The practice of medicine has always been about treating each individual patient, and clinicians have long observed that different patients respond differently to medical interventions. What is new is that paradigmatic developments in science and technology offer new promise for developing targeted therapeutics and tools for predicting who will respond to a medical therapy or who will suffer ill effects.
The purpose of this report is to describe the unique and special role and responsibility that the FDA has in helping to usher in the medical products that are central to this larger effort. The report describes the ways in which FDA has evolved its regulatory processes in response to – and in anticipation of – scientific developments that are critical for the development of personalized therapeutics and diagnostics.
Advances in the Pharmacogenomics of Adverse Drug Reactions
Susannah L. Collins / Daniel F. Carr / Munir Pirmohamed
Next-generation sequencing methodologies will help to continue this advancement. Many examples now exist of pharmacogenetic markers of ADRs. However, only a very small number have made the translation from discovery to clinical practice. Widespread uptake of pharmacogenetic typing into healthcare practice still faces significant hurdles, including determining the nature of the evidence that will be required, the availability and cost effectiveness of pre-prescription genotyping, and better education of the workforce.
Sample of Comprehensive Pharmacogenetic Report
Current Medication List: Warfarin, Codeine, Ibuprofen, Metoprolol, Aspirin, Simvastatin
Based on the patient’s genotype, a medication will have potentially reduced efficacy or increased toxicity, or the patient will have an increased risk for the indicated condition: Clopidogrel (Plavix).
Based on the patient’s genotype, guidelines exist for adjusting dosage or increased vigilance, or the patient will have a moderate risk for the indicated condition: Warfarin (Coumadin), Ibuprofen (Advil, Motrin), Celecoxib (Celebrex), Flurbiprofen (Ansaid), Fluvastatin (Lescol), Fosphenytoin (Cerebyx), Leflunomide (Arava), Meloxicam (Mobic), Phenytoin (Dilantin).
Based on this patient’s genotype, the medication can be prescribed according to standard regimens so the patient’s risk for the indicated condition is not increased: Codeine (Codeine; Fioricet with Codeine), Metoprolol (Lopressor), Simvastatin (Zocor).