Medical treatment based on an individual’s genetics is the future of medicine, according to government, academic and industry panelists participating at a July 23 roundtable held by the House Energy and Commerce Committee.

Developed at the molecular level, personalized medicine is a growing practice area that holds tremendous promise for providing patients with cures to diseases that are tailored specifically to their genetic makeup, say advocates. Not only does this “precision” medicine have the potential to improve patient care and result in better outcomes by increasing the ability to predict which medical treatments will be safe and effective, but at the same time it can lead to a more efficient U.S. healthcare system and control costs by identifying the right drug for a patient.   

“Personalized medicine for the FDA is really about taking medical treatment and tailoring it to the individual characteristics, needs and preferences of each person,” says Jeffrey Shuren, M.D., director of the FDA’s Center for Devices and Radiological Health. “We think this is an opportunity we can move beyond just even treatment and start to focus more on prevention. The real linchpin here is having accurate and clinically meaningful diagnostic tests.”

In the future, argues Shuren, every patient will have their genome sequence stored in electronic health records to help diagnose them for the purposes of personalizing prevention or treatment. “Personalized medicine isn’t just about diagnostic tests to identify what the right drug is for you. It actually will be about personalized devices,” he says. “All of us have different anatomy. We have different physiology. And, you can actually make technologies to meet those needs.”

For instance, Shuren poins out that the FDA has already approved a repair for abdominal aortic aneurysms that can be tailored to a person’s unique anatomy, as well as software that analyzes brain waves to predict an individual’s response to psychotropic drugs.

Louis DeGennaro, Ph.D., interim president and CEO of the Leukemia and Lymphoma Society, believes that with advances in technologies over the next five to 10 years blood cancer patients will see diagnostics and therapies allowing them to “live long, productive lives.” However, Patrick O’Gara, director of clinical cardiology at Brigham and Women’s Hospital, makes the case that there is an enormous gap between the science of personalized medicine and its applications at the point of care for personalized tests and treatments.

“Cardiovascular medicine is decades behind oncology with respect to being able to identify single gene defects that could be the targets for small molecules,” warns O’Gara. “But, nevertheless, cardiovascular disease and stroke are the two major killers of men and women in the United States. We deal with chronic diseases more often than we deal with single gene defects...The average clinician is light years removed from the potential applicability of this science.”

Edward Abrahams, Ph.D., president of the Personalized Medicine Coalition, told the congressional committee that there are a number of barriers “between the science and the patient” including unclear government regulations, restrictive insurance reimbursement policies for diagnostics and therapeutics, and a lack of investment and incentives for manufacturers.

While healthcare experts recognize the potential value of personalized medicine, a national survey released July 22 shows that Americans do not fully understand this method of treatment and care. In the survey, commissioned by the Personalized Medicine Coalition, almost two-thirds (62 percent) have not heard of personalized medicine but the majority (65 percent) react positively when it is described to them and 7 in 10 (69 percent) are interested in learning more.

“It’s very important for us to focus as a community of care givers, interested in the health outcomes of our patients, on how we are going to educate clinicians and educate patients and families about the power of this technology and how it will impact our ability to identify various traits that over the course of decades--in combination with environmental factors--will lead to disease,” says O’Gara.


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