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Personalized Medicine's Promise

By Nancy Weil, IDG News Service

June 10, 2005 | Within the next five years, pharmacogenomics will take stronger hold in medicine, with genetics becoming more key to drug development and providers moving toward a more personalized approach to healthcare, declared the FDA’s Lawrence Lesko in his keynote speech.

“I think we’re going to see some rapid changes” in how genetics is used in healthcare and drug development, said Lesko, director of the FDA Office of Clinical Pharmacology and Biopharmaceuticals, Center for Drug Evaluation and Research. The FDA is focused on the role of genetics and the emerging importance of pharmacogenomics, which are drugs developed using genetics, and is putting into place related guidelines and regulations, Lesko said, offering a timely overview of FDA initiatives in the area. In March, the agency released its long-awaited pharmacogenomics guidelines.

As for genetic testing, which is a linchpin of using genetics in drug development and healthcare, Lesko forecasted that standard test platforms would be adopted in the next few years, providing more complete testing to patients. As an offshoot of that progress, problems with interpreting test results will be lessened as vendors “are going to see a business here.” There already are point-of-care testing systems hitting the market, and those will become more widespread and reliable, as will predictive algorithms for test interpretation.

Guidelines for standards of care will also incorporate pharmacogenomics, Lesko said. Although in limited use, genetic testing can allow doctors to alter drug dosages based on a patient’s genomic information, which can reveal how well an individual will tolerate particular drugs.

Support for genetics-based medicine must come from insurance providers before “personalized medicine” becomes the norm, he said. Insurers are beginning to provide reimbursement for genetics testing and other elements of personalized medicine. Such medical care involves taking into account not only an individual’s genome sequence but also other aspects of the patient, including age, weight, and family history.

Ultimately, personalized medicine involves giving patients more control over their medical records and who has access to them. Increasingly, those records will be kept in digital form, he said. It also means that a team of providers, including doctors, specialists, laboratory staff, and pharmacists, will be involved in the process of determining care and medicine dosages.

Lesko said that the recent withdrawal of drugs with serious safety issues, including the painkiller Vioxx and Tysabri, has taught drugmakers and the FDA important lessons. It is now more widely accepted that determining toxicity across a wide population range is difficult to do. However, genetics-based medicine will help patients be better able to weigh the likely effects of a drug on them as individuals against possible risks.

That means that some older drugs that have been found to be toxic in a higher percentage of people than is acceptable can be “retooled” because genetic testing will help determine which patients can take such medicines without high risk. In some studies, certain drugs have been shown to have a “virtually nil” risk in patients with particular genetic compositions.

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