Personalized medicine needs a lot more exposition before it comes part of the mainstream, but a group of dedicated professionals is determined to make sure that it arrives as soon as possible.
The Washington-based Personalized Medicine Coalition has been spreading its message to receptive ears wherever they can find them. Coalition members recently appeared before the House Medical Technology Caucus to brief co-chairs Rep. Erik Paulsen (R-Minn,) and Rep. Anna Eshoo (D-Calif.) about the dynamics of personalized medicine and its benefits for the healthcare system, said Amy Miller, public policy director for the PMC.
“Healthcare reform raised the profile of personalized medicine on Capitol Hill but many members of Congress and congressional staffers wanted to better understand how personalized medicine can improve health outcomes, lower healthcare costs, and ultimately improve patient care,” she said.
Personalized medicine refers to the classifying of individuals into subpopulations that differ in their susceptibility to a particular disease or their response to a specific treatment. It allows healthcare providers to know which medical interventions will work for which patients, thus sparing the expense and side effects of treatment to those who will not benefit.
Advancements in genetic testing and genome sequencing are at the heart of the concept’s development, giving healthcare providers more latitude in profiling and treating patients, said John Klimek, senior vice president for the National Council for Prescription Drug Programs.
“In the past it was ‘one size fits all’ in the medication world, prescribing by height and weight,” he said. “Now it’s more personalized and with genetic testing we can see how a person will respond to different medications. There has been a lot of work in this area and over the past 10 years it has spiraled – getting deeper into a person’s biology since birth, revealing susceptibility to certain diseases.”
From the pharmacy perspective, having the specific details of a patient’s biology makes prescriptions much more accurate, dramatically reducing the chance of a patient being admitted to the hospital for an unforeseen negative reaction, Klimek said.
“It used to be that you’d give a patient an antibiotic to take care of an infection until you found out there was an allergy,” he said. “This serves the patient much better because you are custom fitting a drug regimen to biological composition.”
Experts show support
At the recent Capitol Hill briefing, Stephen Eck, MD, vice president and global head of medical oncology for Deerfield, Ill.-based Astellas Pharma Global Development, told legislators that personalized medical products are already being developed in the pharmaceutical sector, citing a Tufts Center for Drug Development study that shows such products comprise between 12 and 50 percent of current drug pipelines.
“The biopharmaceutical industry is committed to improving health outcomes by ensuring that the right patients receive the right therapies at the right time,” Eck said.
Amy Abernethy, MD, director of the Duke Cancer Care Research Program at Duke Cancer Institute, said she and other practicing oncologists face major challenges in integrating new understandings of the molecular basis for the disease, an ever-growing number of complex protocols for treatment decision-making, and patients’ personal values to determine the best treatment course for each cancer patient she encounters.
“Personalized medicine is not a vision for the future – when I see patients, they want and must get treatments that will work for them today,” she said.
By offering greater insight into a person’s biological makeup, personalized medicine can ensure that patients with different ethnic backgrounds and types of conditions have access to providers who understand the molecular basis for disease and the benefits of targeted therapies, said Donna Cryer, CEO of Washington-based CryerHealth and chair of the American Liver Foundation Board of Directors.
“Personalized medicine is the ultimate patient-centric solution, giving patients greater confidence in their diagnoses and treatment selection,” she said.
Getting ‘real’
The Personalized Medicine Coalition had 18 members when it came together in 2004 to develop policy and promote understanding of the concept. It has since grown to more than 220 members, demonstrating substantial growth over the past seven years.
Key obstacles to mainstream acceptance is within the regulatory and reimbursement climate, says PMC communications manager Gwen Gordon.
“There is not a clear path for products at the Food and Drug Administration and we’re not getting regulatory clarity for products and diagnostics,” she said. “Innovation in the field needs to be encouraged so that if a company makes an investment there is some assurance that it will get to market. Then once the product is approved, it should get reimbursed adequately.”
Yet despite the challenges that exist, “personalized medicine is becoming more real every day,” Gordon said. “From a product standpoint, we are seeing data we never had before from the pharmaceutical industry. The historical argument has been that the pharmaceutical industry is not committed because it divides their market. But based on the new products coming out, they are committed. From a policy standpoint, it is something government is definitely interested in. There is more recognition that personalized medicine is here to stay.”
