Given the ever-increasing advances in science and research related to genetics, it’s not surprising that discussions about personalized medicine among care providers and government officials are heating up.
Proponents of personalized medicine see potential cost-saving and patient safety benefits in targeting treatments to individuals. For example, costs incurred because of ineffective therapy for statins to treat cardiovascular disease currently run about $8 billion annually. Additionally, adverse drug reactions are the fourth leading cause of death, according to the FDA.
The U.S. government is exploring the concept of personalized medicine, and has committed to speeding drug development to ensure the safety of diagnostic and genetic tests associated with this burgeoning field. The National Institutes of Health (NIH) is developing programs where researchers can screen chemicals to find potential drug candidates and working to foster public-private partnerships to move more drug candidates into commercial development. The NIH also has created a voluntary genetic testing registry on the more than 2,000 genetic tests on the U.S. market.
Meanwhile, the FDA is developing new standards to establish which genetic information companies must show to prove their devices and/or drugs are effective, as well as re-labeling older drugs with genetic information. In March 2010, the agency issued a boxed warning for clopidogrel regarding diminished effectiveness of the drug in patients with decreased CYP2C19 function. The warning notes that genetic tests are available to help identify patients with genetic polymorphisms.
Despite the government interest, however, personalized medicine is not often incorporated on a broad scale into the treatment of patients due to various hurdles. While new science is outpacing old models of payment and regulation, genetic testing is not currently covered by public or private payors, making it accessible only to a select patient population. Also, limited interoperability between EHR systems, coupled with limited—albeit increasing—EHR adoption, makes it difficult to track and monitor outcomes and prove patient safety and cost savings.
A recent ACC CardioSurve survey of cardiologists found that only 7 percent of cardiovascular patients are being treated with personalized medicine. When it is being used, the cardiologists surveyed reported that it is most often for risk prevention (54 percent), genetic testing (53 percent) and lifestyle change (50 percent).
The primary driver of the short-term skepticism is the lack of patient outcome data related to the implementation of personalized medicine technologies (75 percent), followed closely by reimbursement concerns (68 percent). Lack of patient awareness and provider education also exists. According to survey participants, only 6 percent reported patients asking about personalized medicine, while 58 percent said they did not feel confident in their understanding of the field.
Moving forward, the best word to encapsulate personalized medicine is “potential.” Over the next decade, it is very likely that personalized medicine will play a larger role in patient care, including cardiovascular treatments. Cardiovascular organizations and professionals can lead the way in developing guidelines that address personalized medicine. We already have registry tools to track and measure outcomes and inform patients of risks, benefits and/or alternatives. Now we need to be on the front lines, educating other healthcare professionals and government agencies about personalized medicine’s potential.
Hippocrates was a harbinger of personalized medicine when he said, “It is more important to know what sort of person has a disease than to know what sort of disease a person has.” With the sequencing of the human genome and further research underway, we now have an opportunity to tailor the medical treatment we provide to each individual and ensure the right treatment for the right patient every time.
Dr. Lewin is CEO of the American College of Cardiology.