Genomic Medicine: Can We Afford It?
CCGE Explores Cost, Access and Decision-Making
This article originally appeared in GenomeLife, Issue 6.
"Health care is the only industry to miss the Internet Revolution!"
So says the usually mild-mannered Kevin Schulman, Director of Duke's Center for Clinical and Genetic Economics (CCGE) and Vice Chair for Business Affairs in the Department of Medicine. Schulman's exasperation stems from the fact that he is exposed to the inadequacies of the US health care system every day by virtue of his research at the intersection of the clinical and economic aspects of medicine. And what he sees isn't pretty: 44 million Americans without health insurance, $1.6 trillion in health care expenditures in 2002 (and rising), overextended physicians, and a growing number of patients unable to absorb out-of-pocket costs. Innovation seems to have hit the skids, too, well beyond Schulman's complaint about health care's failure to embrace the Internet. Global pharmaceutical companies, for example, are confronting a dearth of new drugs in their pipelines and, while the FDA has tried to streamline its approval process, it still takes ten years and $800 million for a new drug to reach the US marketplace.
Schulman will admit that these are daunting problems, none of which has simple solutions. So where is the CCGE directing its attention? What is its mission? "We are, at our core, an outcomes research group," he says. "Our research themes cover three areas. The first is the cost effectiveness of new drugs and new technologies. The second is health services research, looking at access, among other things. And the third is focused on clinical decision-making."
In Schulman's view, most of what the CCGE does can be applied to genomics. With respect to cost-effectiveness, the connection is clear. Over the last few years, powerful new technologies like microarrays have arisen that can generate and utilize huge quantities of data resulting from the Human Genome Project. In part, the CCGE's efforts are devoted to assessing when genome-based diagnostics and therapeutics will hit the market and what barriers they will face. "Clearly, the economic aspects are going to be a core component of genome technology development."
CCGE Assistant Research Professor Shelby Reed evaluates the economics of new health services and therapies. She cautions that clinical applications of the genome sciences are still in their infancy and therefore, making predictions is difficult. "We really need to take a population-based approach and balance it with an individualistic approach," she says. "Once genome-based therapies can be targeted to selected patients, there can be an economic benefit."
Information, Please
While the price tag of the Genome Revolution is a major concern of the CCGE, it is not the only one. Implementation is also key. Even if practitioners had access to a long pipeline of patient-ready drugs and diagnostics, Schulman believes that our present health care system could not accommodate them. "Already physicians can't remember the 3000 drugs in the Physicians' Desk Reference. Now, if you're asking me, as a physician, to have to remember each of those at a genomic level and their relevant metabolic pathways, it's impossible."
Which brings us back to the Internet. What's necessary to make genome science a clinical reality, Schulman says, is a profound structural change in terms of information technology. "If we want to implement this technology, how are we going to reorganize the system so that we support information technology infrastructures and thereby support those [state-of-the-art] activities we want physicians to be doing?"
Information technology is only one facet of the broader question of innovation. Schulman acknowledges that there is no shortage of innovation on the science, technology and product development fronts, citing the numerous examples of high-throughput technology breakthroughs in genomics, neuroscience and drug discovery alone. Where he sees innovation lacking is in the management and delivery of clinical services. "We're dealing with hundred-year-old business models on that side," he says. "Will this technology be able to drive change in the system so that we're focusing more of our dollars on outpatient services and less on hospital care?"
Prescription for Innovation, Learning
Schulman doesn't pretend to have the answers nor is he necessarily even interested in cultivating them within the framework of the CCGE. "What I'd rather think about are incentives," he says. "The truth is there are a lot of people out there with great ideas, so how do we empower those people to try them? Rather than be prescriptive [about what should be done], I'd opt to be prescriptive about fostering innovation."
He believes that a core ingredient in that prescription must be training. He takes pride in the Health Sector Management Program (HSMP), which he runs within the Fuqua School of Business. Once focused primarily on hospital issues, Schulman has broadened the program's scope to include scrutiny of technology development, drug development, and medical devices as well as the process of bringing those products to market.
"We are trying to get students prepared for a health care industry that's very different from what it was in the past. Part of what I'm trying to do now is bring the resources we've created in the HSMP in terms of faculty, classes and expertise back across the university. My goal is more cross-fertilization with programs like the IGSP (for example, through the new Center for Genomic Medicine). I think you need that in order to train the next generation, because the training my generation received is just not appropriate for today's environment."