Personalized medicine — a concept in which an understanding of a patient’s genetic makeup is used to enhance treatment — has arrived at UF&Shands, the University of Florida Academic Health Center.
Under a new standard of care, UF doctors will help ward off heart attacks or strokes after heart procedures by taking a person’s genetic information into account before prescribing medications that prevent blood clots.
Starting today, patients at Shands at UF medical center who undergo a procedure that involves passing a thin tube into the left side of the heart to diagnose or treat heart disease will now be routinely screened for biological signals in their blood that give clues about how they might respond to a common anticlotting drug called clopidogrel, also sold as Plavix.
“In 2010, the Food and Drug Administration changed clopidogrel’s label to warn clinicians that it may not work for high-risk heart patients with certain genetic traits. But there hasn’t been a good way to get genetic information to doctors so they can use it during treatment,” said Julie A. Johnson, Pharm.D., director of the UF Clinical and Translational Science Institute’s Personalized Medicine Program and the UF College of Pharmacy’s Center for Pharmacogenomics. “Over the last year, we worked with stakeholders across our health system to tackle that challenge, and we are now able to deliver on the promise of personalized medicine.”
For patients, the screening is no different than a typical blood draw. The difference is that one sample will be sent to UF Pathology Laboratories to be tested for the presence of any of seven genetic variations that influence how the body responds to clopidogrel.
Results are typically available within 24 hours and are added to the patient’s electronic medical record. If the results suggest clopidogrel is not the best treatment option, the electronic medical record system will alert the cardiologist and recommend alternate drugs when a prescription is written.
“This helps us prescribe the right medication the first time and absolutely has the potential to reduce complications,” said R. David Anderson, M.D., an associate professor of medicine at UF and director of interventional cardiology and the cardiac catheterization laboratory at Shands at UF.
The new screening procedure is in keeping with the vision of the National Institutes of Health to use a patient’s genetic information to tailor their health care. To allow people to take advantage of personalized medicine without fear of genetic discrimination by health insurance companies or employers, the federal government enacted a law in 2008 known as the Genetic Information Nondiscrimination Act.
This initial use of personalized medicine at UF&Shands will help the roughly 1,500 patients per year treated at the cardiac catheterization lab, 40 percent of whom are likely to be prescribed clopidogrel. Over time, UF&Shands will expand the new approach to more patients.
But the UF CTSI’s Personalized Medicine Program doesn’t stop there.
“The model we’ve developed can provide a blueprint for other health systems that want to use evidence-based genetic information to improve patient care,” said David R. Nelson, M.D., director of the UF CTSI. “This is a major step toward being able to translate more than a decade of ground-breaking genomic research into better health.”
Starting in July, Stanford University will adopt the UF&Shands model. United under an NIH grant, UF and Stanford researchers also collaborated to develop a custom chip to collect and screen DNA samples for a total of 256 genetic variations that are suspected of influencing how the body responds to medications, including the seven relevant to clopidogrel.
UF Pathology Laboratories will use the new gene chip as part of a related research study that will begin in 2012. If patients choose to participate in the study, UF will store their additional 249 results in a secure database for future use in clinical care and research.
“Our patients are at the center of everything we do. This new capability is an extraordinary example of what happens when our health system and researchers work together to harness the latest medical knowledge and technology to provide the best possible care,” said David S. Guzick, M.D., Ph.D., UF senior vice president for health affairs and president of the UF&Shands Health System.
The UF CTSI Personalized Medicine Program’s creation and the collaboration with Stanford are funded by a grant of nearly $500,000 through the Clinical and Translational Science Awards program, which is led by the NIH’s National Center for Advancing Translational Sciences. Additional support is provided by a grant of more than $350,000 through the NIH Pharmacogenomics Research Network.
For now, NIH funding will cover the screening costs as this technology enters the clinic at UF&Shands. UF researchers will be studying the program as it rolls out to assess and optimize its cost-effectiveness and impact on patient care.