Health care’s central conundrum is individual variation: we develop drugs and medical devices based on the aggregate responses of large test populations, largely ignoring the important genetic variation from patient to patient because we lack the tools to address it. Billions are spent on treatments that bring little or no benefit or, worse yet, cause side effects that create other problems. For many serious illnesses, from severe depression to certain cancers, doctors and patients stumble their way toward better health without a map to guide them. Hence the need for a “genetic prescription system”—an approach, that is, that uses gene-based diagnostics to help people find better and safer treatments, resulting in improved health and more efficient spending without recourse to flawed one-size-fits-all government guidelines. Call it GPS for health care.

Companies and researchers are already embracing genetic prescription—for example, rushing to tailor chemotherapy drugs for cancer patients. The American Society of Clinical Oncology recently suggested that patients with metastatic colon cancer take a $300 test for a gene that causes tumor growth, estimating that the test might save $600 million a year by identifying patients who probably will derive no benefit from expensive drugs. Genomas (which one of us runs) and Hartford Hospital have developed PhyzioTypes, which identify patients genetically predisposed to experience side effects after taking certain drugs for mental illness and diabetes. The test helps physicians anticipate and manage side effects and match patients with safer drugs, more tolerable for long-term use. Another company, Genomic Health, has invented OncoType, which determines the likelihood that breast tumors will spread to other organs, sparing women with cancers unlikely to metastasize from having to suffer through harsh chemotherapy regimens.

Genetic prescription is clearly the wave of our health-care future, but two factors are slowing its development. The first is concern that federal health-care reform could focus too narrowly on cost reductions. Take the $1.1 billion set aside in the stimulus package for what’s known as comparative effectiveness research (CER). The legislation sets up a “federal coordinating council” to compare the clinical effectiveness of various drugs, devices, and procedures and then disseminate the findings to the public and to insurers. The impulse behind CER is a good one, but the council could easily become an American version of the UK’s National Institute for Clinical Effectiveness, which explicitly rations access to treatments based on a threshold for cost-effectiveness. The Institute generally agrees to pay for interventions that cost $60,000 or less per “Quality Adjusted Life Year” of benefit—meaning that British patients often can’t get access to costlier, cutting-edge drugs for cancer and Alzheimer’s disease. Such drugs are typically available in the U.S. and even in other European countries. Curtailing new drugs or technologies solely because of cost considerations would deter innovation at a time when we desperately need new treatments for debilitating diseases like Alzheimer’s. Further, CER tends to lag behind the scientific developments that make genetic prescribing so promising.

The second factor interfering with the progress of genetic prescription is confusion about how the FDA—the gatekeeper for all new medical products and devices—will treat gene-based drugs and devices. Will these products, designed to account for individual variation, have to undergo the same antiquated testing as the regular drugs, designed for large populations, whose manufacturers pay large sums for those tests? What kind of data should the agency require to validate the new products? To what extent will the FDA regulate laboratories conducting gene-based diagnostic testing, considering that at the moment, some are already being regulated by state agencies? The FDA’s Critical Path Initiative was supposed to develop a clear, rational framework to answer such questions, but it has been starved for funding and is crawling along at a snail’s pace. The FDA may even have to reorganize to deal more effectively with gene-based technologies, and it will need an infusion of new funding and expertise to take advantage of rapid developments in our understanding of human biology.

Prospective investors in gene-based health care need assurances that Washington won’t punish innovation and that there’s a clear pathway for FDA approval of these products and technologies. This will make it more likely, in turn, that public and private insurers will reimburse for better—not just cheaper—treatments. If policymakers let the opportunity slip away, our health-care system will be stuck treating patients with potentially obsolete drugs and devices—the equivalent of using a mariner’s astrolabe in the age of satellite-guided navigation.


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