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AAAS Panel Mulls Real-World Implications of Personalized Medicine

WASHINGTON, DC (GenomeWeb News) – A varied group of stakeholders and interested parties sat down today for a public discussion of the current state and future of personalized medicine at the American Association for the Advancement of Science headquarters here.
The group, which included senior administrators from the National Institutes of Health and representatives from industry, health law and policy, and federal politics, participated in a panel called “Anticipating Personalized Medicine: A Roundtable Discussion." The panel was moderated by Health Affairs Editor and PBS NewsHour reporter Susan Dentzer and considered personalized medicine via hypothetical case studies of what this new technology means to a doctor treating breast cancer patients, and to the patients themselves.
Prodded by Dentzer to keep discussions about real-world applicability and foreseeable possibilities of personalized medicine, the panelists talked about the complexities of the tests themselves, about how the science can be pushed forward ethically, about the need for clinical trials, about health insurance policy, and about how new medical approaches will drive a business and regulatory environment.
A genetic test is not going to be the “end-all, be-all” of treatment, said Johns Hopkins University professor of genetic medicine Howard Levy. He sees personalized medicine in the near future, even in the distant future, as playing more of an advisory role for physicians.
“If medical professionals are going to order a test, it’s important we know what we’re going to do with the test,” particularly when deciding things such as breast cancer treatments, Levy said.
The panel was particularly focused on clinical trials. Without more clinical trials, where these exploratory genetic technologies can be proven, where can doctors and patients turn to help make decisions, wondered Annette Bar-Cohen, director of programs for the National Breast Cancer Coalition.
“We don’t yet have enough data from clinical trials about biomarkers on the whole,” she said. Above all, she would “encourage doctors to get patients into clinical trials.”
Charles Rotimi, director of the NIH Intramural Center for Genomics and Health Disparities, brought the issue of clinical trials back to the nation’s capital.
“Some studies are going to be meaningful, and some not so meaningful,” he admitted. “But we need to make the funds available.”
If that funding does come through, and researchers and companies begin conducting trials for every biomarker scientists can rustle out of the genome, will that begin to advance the field?
Greg Downing, program director of the Personalized Healthcare Office at the US Department of Health and Human Services, thinks it isn’t quite that simple.
“We need to establish some framework in which everything isn’t tested only in clinical trials,” Downing said.
“We also need more focus on biology, on infrastructure, and on the capacity to gather more data,” he said. “We hope that we could build a capacity and system that relies on information upgrades as we’re developing the science.”
Still others cautioned that a system focused on providing doctors with information about the latest personalized medical technologies may not be the best approach.
“There’s so much medical information out there that you could spend half your lifetime learning even half of what you need to know, and by the time you do you have forgotten half of it and the other half will be outdated,” said Hopkins' Levy.
Kavita Patel, deputy staff director of the Senate Health, Education, Labor, and Pensions Committee in the Office of Senator Edward Kennedy (D – Mass.), added another cautionary note regarding policy and lawmaking in the age of personalized medicine.
“A little technology can be a very dangerous thing to policy makers, and there can be a fine line in trying to deliver the science,” said Patel, who explained that Kennedy has renewed his commitment to increasing NIH and cancer research funding after being struck recently by a deadly and difficult-to-treat type of brain cancer called glioma.
“I would advise Senator Kennedy that we need to push for more funding,” she added, “but we also need to do a better job of pooling information about what we don’t know and do a better job of getting what we do know out there.”
Patel also believes that the question of health insurance will greatly impact personalized medicine. “People shouldn’t feel pressured to do one thing or the other because of the circumstances of financing their care, and that’s why Washington is struggling now over the issue of [health insurance] access,” she concluded.
Joanne Armstrong, senior medical director of the department of women’s health at Aetna, said insurers are watching personalized medicine closely. There are a number of things that “the big bad insurance companies like mine,” she joked, want to know when it comes to personalized medicine in the physician’s office.
“Services covered under health insurers are usually based on what is evidence-based, where information informs decision-making and improves health outcome and saves lives,” she explained.
Does the information come from peer-reviewed literature, from randomized clinical trials? Does the evidence offer specific indications of “how the test operates in the real world?” she asked. “Do you get the same results over and over again?” And, above all, what is the clinical validity and the clinical utility?
In a Q&A session, the panel continued to emphasize the imortance of funding, clinical trials, and the need to create an infrastructure that can handle and make accessible the vast amount of data expected to result from all of the new science.

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