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Medicare-Funded Gene Test Could Propel Personalized Medicine Research
Our guest blogger is Michael Peroski, an undergraduate majoring in biochemistry and philosophy at Allegheny College and a former bioethics intern with CAP.
About two million patients take warfarin, or coumadin, each year to prevent blood clotting during medical procedures. But thousands of these patients experience bleeding complications due to inappropriate dosing of the blood thinner, and many die. From August 4th through September 3rd this year, the Centers for Medicare and Medicaid Services of the Department of Health and Human Services invited public commentary on whether Medicare should fund genetic tests to determine a patient’s warfarin response. Genetics, weight, sex, and age factors determine roughly 45-60 percent of the variance in response to warfarin, so these tests could prevent many adverse events. This possible change in policy might save thousands of lives and highlights the need for a more comprehensive approach to the field of personalized medicine.
Determining the appropriate amount of warfarin to administer to a patient is very difficult for physicians because there is a wide variance in response to the medication. The Food and Drug Administration approved a genetic test last year that allows physicians to better gauge how much warfarin to administer by checking two genes. Although the cost of these tests has dropped, the current price is approximately $500, which prohibits many seniors from benefiting from the best available care.
Some research indicates that using this genetic test might result in savings for the healthcare system. For example, Genelex reports, “cost effectiveness will be achieved if 33-47 percent of the anticipated number of bleeding events are avoided.” Doctor Raymond Woosley of the Critical Path Institute told U.S. News and World Report that “this test can save $1.1 billion in health-care costs and 18,000 lives a year.” There are methods for checking how a patient responds to warfarin, but as Wired explained, “In a perfect world, physicians would use both [the genetic tests and handheld devices like the Roche CoaguChek system that allow physicians to constantly monitor a patient’s blood] to aid in their decisions.”
If DHHS approves Medicare to fund this test, it could provide a push for the developing industry of pharmacogenomics. Moreover, this potential application of personalized medicine offers an alternative to conventional trail-and-error techniques by allowing physicians to tailor care to an individual’s unique clinical, genetic, and environmental information. This might well be the next medical frontier, but the field itself is in need of help due to genetic data that may not be ready for clinical application. In a recent Science Progress article discussing genomics, bioinformatics, and proteomics, Arthur Caplan explained:
This rapidly growing sector is riding an ill-grounded wave of hype that makes weak, next-to-useless correlations between gene markers and disease states without really having much idea what to tell its customers to do about the risk information that testing companies find.
To unleash the full potential of pharmacogenomics, the FDA and DHHS will need to make sure that the useful products get to the patients who need it and that the snake oil salesmen do not discredit the whole industry.
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