For those counting, today is day 3,273 since the sequencing of the human genome was completed.
Eric Green, director of the National Human Genome Research Institute, is among those counting. Medicine based on genomic information promises new advances for healthcare as technology gives clinicians new tools to make diagnostic and treatment decisions based on a genetic understanding of disease. Technological advances, Green noted, have already brought the cost of genomic sequencing to about $1,000. As the cost of this technology comes down, the tide of diagnostic advances is set to rise.
Green was among the speakers at a March 29 personalized medicine symposium at Duke University. Duke’s Center for Personalized Medicine coordinated the program entitled “At the Interface of Clinical Research and Clinical Medicine.” The symposium assembled a roster of personalized medicine experts from Duke as well as from around the country.
Dr. Victor Dzau, Duke’s chancellor for health affairs and CEO of Duke University Health System, said that personalized medicine will lead to better outcomes for patients and lower costs for the healthcare system. Development of new personalized medicine will lead to new partnerships between the public and private sectors as well as academia. “This is really the future of medicine; it’s not hyperbole,” Dzau said. Here are some highlights from the event.
Personalized medicine: it’s not just genomics. Genomics will play a big role in personalized medicine as doctors look to not only reduce side effects for patients, but also cut down on the trial-and-error approach to prescribing medicine. Dr. Murali Doraiswamy, professor of psychiatry and behavior science at Duke University Medical Center, said that the Mayo Clinic has been a leader in conducting pharmacogenomic testing on its psychiatric patients. Duke does not do so right now, but Doraiswamy said that such testing will become more common in the future. Dr. Adam Perlman, executive director of Duke Integrative Medicine, said that the practice of personalized medicine is nothing new. Chinese medicine, he said, has taken a personalized approach to patients for centuries. And some remain uncomfortable with the term “personalized medicine.” LabCorp (NYSE:LH) CEO David King, who is a board member of the Personalized Medicine Coalition, said that the word “personalized” is not quite right. “Individualized medicine” might be a better term. Ron Smith, senior vice president of the Physicians Pharmacy Alliance, said that the practice of personalized medicine does not have to be complex. Sometimes it’s as simple as getting people to take their medication, he said.
Cultural issues and change. Personalized medicine will mean changes in the ways that doctors are accustomed to working. Systems are resistant to change and healthcare is one very big, change-resistant system, said Dr. Marc Williams, director of the Genomic Medicine Institute of the Geisinger Health System in Danville, Pennsylvania. Williams said it takes a median of 17 years to fully implement evidence-based guidelines into clinical practice. That’s because of a culture that resists change. “In my experience, culture always trumps evidence,” Williams said. Personalized medicine does offer value. But new personalized medicine practices must have defined and measurable outcomes in order to define their value.
A Deep-dive Into Specialty Pharma
A specialty drug is a class of prescription medications used to treat complex, chronic or rare medical conditions. Although this classification was originally intended to define the treatment of rare, also termed “orphan” diseases, affecting fewer than 200,000 people in the US, more recently, specialty drugs have emerged as the cornerstone of treatment for chronic and complex diseases such as cancer, autoimmune conditions, diabetes, hepatitis C, and HIV/AIDS.
It’s about the patient. Dr. Amy Abernethy, director of the Duke Cancer Care Research Program, said that personalized medicine will lead to “a handshake between clinical research and clinical practice.” She envisions databases housing vast amounts of clinical data that will inform the treatment of an individual patient. And that patient’s information will become part of the databases to help inform the treatment of others. With the emergence of “big data,” doctors will need to learn how to use data in the practice of patient care, Abernethy said. Doctor/patient communication about personalized medicine will become important as new practices emerge, said Dr. Aimee Zaas, program director for Duke’s internal medicine residency program. Personalized medicine is introducing new concepts to clinicians, concepts that they’ll need to interpret and explain to their patients. If doctors have a hard time with these new concepts, imagine how patients must feel, Zaas said.
Paying for personalized medicine … and making personalized medicine pay off. Payers are welcoming the emergence of new tests that determine whether or not a drug a patient takes — and the insurers must pay for — actually works. Personalized medicine can give them that evidence. But so far, the introduction of personalized medicine has come with few guidelines. Most payers don’t yet have standards for the level of evidence required for reimbursement, Williams said. Personalized medicine will show return on investment by leading to better and more efficient healthcare, LabCorp’s King said. The challenge, he added, is defining “better.” “If personalized medicine works, it’s cost avoidance,” King said. “Avoidance doesn’t score at the Congressional Budget Office, it’s cost savings.”
