While globalization, an aging population, and economic forces are pushing the trend toward personalized medicine, the US healthcare system is slow to adopt it, probably as a result of some combination of the financial issue mentioned in the Introduction, politics, regulation, economics, and ethics, rather than science — which, as we show in other sections of this issue, surged ahead in 2006.

The issues contributing to the slow adoption of personalized medicine include public concern that genetic information would be used against people by insurance providers and employers, for which a solution would be legislation to prohibit genetic discrimination; and the lack of financial incentive for drug developers (to which we alluded above), for which a solution might be to extend patent protection for pharmacogenomic drugs. Reimbursement for personalized medicine test/drug combinations (becoming known generically as “diapeutics” or “theranostics”), which will be expensive in the short term even though they promise to deliver overall economic benefits in the long run, is another issue.

Ethical questions include: What to do with patients who will demand a drug (perhaps because there is no alternative for them) even if tests show the drug will not work for them? Should the doctor prescribe it anyway? Should the payer refuse to reimburse for the drug? Another impediment to the spread of personalized medicine appears to be the doctor:

• Many doctors are unfamiliar with pharmacogenomic tests,
• Some doctors do not accept that the tests work, and
• Doctors generally are reluctant to change the habits of their practice,

though none of this applies to 40 psychiatrists at the Mayo Clinic who already in 2006 used genetic tests to help choose which drugs to prescribe. Doctors may also be helped by FDA guidelines promulgated in 2006 encouraging drug companies to include information about genetic tests to the labels of a few drugs. For example, the label for colon cancer drug Camptosar advises a lower starting dose for the 10 percent of people who have a particular version of a gene and are therefore susceptible to a serious decline in white blood cells if they take a higher dose.