Is a Health Industry Turf War Delaying the Next Medical Revolution?

Imagine a United States less united than today's, where each state has its own system for approving drugs and medical tests. Time for a prescription refill? Oops, you're on vacation in California, where the medicine you need is not approved. Hurt yourself and need a special kind of X-ray? Too bad, the state you live in does not allow that kind of test.

It sounds ridiculous, but this is the situation our nation is in for one of the hottest new tools in medicine, genetic tests. Gene tests conducted on a drop of blood can help predict what diseases a person is likely to get, fostering better preventive care and earlier diagnosis. For a growing number of diseases, gene tests can tell a patient which drug will work and which will not.

The moves by California and New York are the clearest evidence yet that a federal leadership gap now threatens to undermine the pending benefits of the genomics revolution.

But despite repeated calls by scientific and patient advocacy groups for the Bush administration to focus on this important emerging specialty, years have gone by without federal leadership. The Food and Drug Administration says it has the authority to regulate these tests -- to make sure they give accurate results and provide meaningful information -- but has largely steered clear of the complicated arena. The Federal Trade Commission, which has the responsibility for protecting Americans against false claims and consumer fraud, has effectively been AWOL on the gene test front, with the exception of a general "buyer beware" warning it put out in 2006. And despite repeated assurances that gene tests are a top priority, Health and Human Services Secretary Mike Leavitt has barely acknowledged receipt, back in April, of a long-awaited federal advisory report that called for HHS to take the reins on gene tests before this fast-moving specialty gets tainted by bad science and overzealous entrepreneurs.

Yesterday that lack of federal attention came sharply into focus with the revelation that California's public health department had sent "cease and desist" letters to more than a dozen gene test companies, including several direct-to-consumer companies that have recently begun to offer DNA tests through the mail. Health officials told the ventures they have two weeks to prove that they are in compliance with applicable state rules relating to such things as laboratory licensure and the status of the doctors or other professionals who are ordering and interpreting these pricey tests for clients.

It's tempting to see California's move as simply a responsible act by state officials concerned that consumers not get taken for a ride. And to be sure, there is room for concern. The tests offered by these companies -- most prominent among them are 23andMe, Inc. of Mountain View, California, and Navigenics, Inc. of Redwood Shores, California -- provide predictive information about future disease risks that is, by nature, preliminary, approximate, and difficult to interpret. Since by law consumers in some states cannot order these tests themselves, they are ordered by doctors affiliated with the testing companies, who do not know the clients/patients personally. And test results can be easily misinterpreted by clients if not explained by a trained genetic counselor or other professionals. Moreover, since there are some diseases for which there are no good treatments or preventives, there are questions of medical ethics, such as whether people are being too glibly encouraged to get information they may wish they never got.

At the same time, the gene test industry is the leading edge of a pending revolution in which diagnoses and treatments will, in many cases, be personalized to individuals' precise biological details. Already, the FDA has begun to approve drugs with gene test requirements or recommendations. In December, for example, the agency oversaw a label change for the drug carbamazepine -- which is used to treat epilepsy, bipolar ("manic depressive") disorder, and nerve pain -- to inform people of Asian ancestry that they should get a genetic test before starting therapy with the drug. People with a certain version of a gene, it turns out -- a gene that is particularly common in Asians -- have a significantly higher risk of developing an otherwise rare, but serious, skin reaction to the drug.