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You may have heard or seen the term "personalized medicine" in news reports. This special issue of FDA Consumer takes a look at the basics underlying this emerging field and explores its potential effects on the future of health care.
When the Food and Drug Administration approved BiDil, a drug for the treatment of heart failure in African Americans, during the summer of 2005, it marked an initial step by the agency toward the promise of personalized medicine.
The approval of BiDil was based in part on the results of a study of more than 1,000 self-identified African Americans with severe heart failure who had already been treated with the best available therapy. The study, named the African-American Heart Failure Trial, found that black patients who used BiDil experienced a 43 percent reduction in death and a 39 percent decrease in hospitalization for heart failure.
Soon, researchers may be able to build on this first step to create more effective medicines with fewer side effects.
Meantime, scientists are working to detect early changes that are characteristic of a disease--while still at the molecular level. To read about their work and the promise it holds for the future, see our feature story titled "Paving the Way for Safer, More Effective Drugs, Food, and Medical Products."
The study of an individual' s gene structure is called genomics. The study of drugs--pharmacology--combined with genomics, is known as pharmacogenomics, the science that someday may allow doctors to use a patient' s genetic profile to predict a response to a drug.
Experts say pharmacogenomics is an exciting potential alternative to today's "one-size-fits-all" practice of medicine. Find out more in our feature titled "Genomics and Personalized Medicine."
The human genome published in 2003 contains about 35,000 genes that code for between 1 million and 5 million proteins. Many of those proteins are not new proteins; some either become other proteins or are modified during various bodily functions. The study of this elegant, continuous process is called proteomics. For more on this branch of the "-omics" and the search for the link between proteins and disease, see our feature titled "Proteomics: Moving Beyond the Human Genome."
As you might guess, all of this activity on the cellular level is part of something bigger. Digesting food, eliminating waste, breathing, and the circulation of blood through your body are all part of your metabolism. The molecules generated through metabolism are called metabolites.
Through the study of metabolites, called metabolomics, scientists can determine patterns that change when the body is fighting a disease or reacting to a drug. To find out more, read our feature titled "Metabolomics: Working Toward Personalized Medicine."
Scientists working in the -omics need powerful computers to handle all of the data generated by sophisticated devices and technologies on genes, proteins, and other materials. Read about some of these exciting technological developments in our feature story "Genomics and Medical Devices: A New Paradigm for Health Care."
We also take a look at scientists working with nanotechnology who create and use materials or devices at scales 1/1,000th the width of a human hair!
Raymond Formanek Jr.
Editor