FDA OFFICIALS MAKE CASE FOR PERSONALIZED MEDICINE
The use of genetic testing to develop personalized dosing for medicines can save lives and potentially billions of dollars, a group of FDA officials says.
The agency officials recently conducted a case study of the anticoagulant warfarin to determine whether genetic testing would allow for more accurate dosing of the drug. The report, "Health Care Savings from Personalized Medicine Using Genetic Testing: The Case of Warfarin," found significant health and monetary benefits from the approach.
According to the study, genetic testing resulted in more optimal dosing of the drug, which could help Americans avoid 85,000 serious bleeding events and 17,000 strokes annually. Integrating genetic testing into warfarin therapy would reduce healthcare spending by an average of $1.1 billion each year, the study says.
The study was published Nov. 3 by the American Enterprise Institute (AIE)-Brookings Institution Joint Center for Regulatory Studies. The report's authors, Andrew McWilliam, Randall Lutter and Clark Nardinelli, are with the agency's Office of Policy and Planning. Lutter, the office's chief economist, is a former resident scholar at AEI. However, the think tank did not fund the study, and it does not represent the center's views, a Joint Center spokeswoman said.
The agency decided to have the Joint Center publish the study because doing so provides the report with "extra credibility" and qualifies it to be published in a peer-reviewed academic journal, an FDA spokeswoman said. Some journals will not accept studies that are not considered "original," and a study both conducted and published by the FDA may not meet that standard, she added.
The authors believe the study's results help make the case for greater use of genetic testing. "This analysis of warfarin illustrates that both public health improvements and significant reductions in healthcare spending may result from adoption of genetic information in clinical decisions about drug therapy," the report concluded.
The report is available at www.aei-brookings.org/admin/authorpdfs/page.php?id=1337 (http://www.aei-brookings.org/admin/authorpdfs/page.php?id=1337).