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

Personal Health

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.

Similarly, researchers reported last month that a lung cancer drug that has otherwise been disappointing appears to be very effective in the ten percent of patients who have a particular gene variant. Such discoveries can mean the difference between life and death for some patients, and can turn a drug that might have been thrown away by its developers into an overnight money-maker.

The problem is that state laws and regulations meant to protect patients and other users of gene tests vary considerably across the nation. Indeed, many of the same companies that got letters from California received similar letters not long ago from health authorities in New York State, which has perhaps the strictest medical test rules in the nation.

Now is the time for a clear guiding hand from the highest levels of the federal health bureaucracy.

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. "I can buy any number of medicines whose safety has been reviewed but I may not be able to get a test to say which drug is better for me," Kathy Hudson explains with apparent frustration. Hudson is the director of the Genetics and Public Policy Center in Washington D.C., which has produced a chart that shows the wide variation in state laws and regulations regarding gene test oversight.

One thing that this latest twist shows is that it is not enough to assure patients that the information gleaned from gene tests will not be used to discriminate against them in health insurance or employment. Congress secured that important human right this spring when it passed the Genetic Information Non-discrimination Act. But it took a dozen or so years for the legislation to pass, and the pace needs to pick up.

Consider that back in 2005, Secretary Leavitt responded to concerns about oversight of direct-to-consumer gene tests, saying he would "carefully consider" looking into the issue. More than a year ago, Leavitt announced that HHS was reviewing "existing structures for ensuring that genetic tests are accurate, valid and useful." Last September, he said, "work is moving ahead rapidly to support genomic medicine in particular and Personalized Health Care in general."

Meanwhile, tired of waiting, a number of gene test companies did their due diligence and launched, hoping that regulators would either ignore them or ultimately agree that they were in compliance with relevant laws and regulations. Washington remained silent.

In April, the Secretary's Advisory Committee on Genetics, Health and Society sent Leavitt a carefully researched report on oversight of genetic tests. Among other things, it recommended that the FDA use its authority to oversee the full range of genetic tests and that the Centers for Medicare & Medicaid Services, which oversees proficiency testing for various medical specialties, start a program of proficiency testing for gene test labs to make sure these fledgling enterprises really know what they are doing. It also recommended the launch of a variety of federal programs to help individuals know what they are getting into when they decide to get a genetic test.

To the great frustration of many, Leavitt has not even formally acknowledged receipt of the report, much less hinted at how he will respond.

The advisory committee's recommendations echo a report released by the Center for American Progress in April, "Genetic Non-discrimination: Policy Considerations in the Age of Genetic Medicine."

If HHS does not act, the CAP report says, then Congress should pass legislation requiring proficiency testing and FDA oversight. Two Senate bills already introduced, S. 976 and S. 736, could accomplish those goals. The CAP report also calls for a public registry of available gene tests to facilitate consumer education and government oversight. And it calls for the FTC and the FDA to collaborate toward creating advertising guidelines for gene testing companies, and for strict enforcement by the FTC of companies that violate those guidelines.

Without attention from the Bush administration, the fledgling field of genetic medicine could deteriorate into a war among companies and state governments, exacerbated by a turf war among doctors, medical geneticists and genetic counselors as they vie for control over this new and potentially profitable piece of the healthcare pie. Representatives of the major gene test companies quickly expressed a willingness yesterday to work with state government officials to draw up ground rules that can protect consumers and not stifle the nascent industry. Now is the time for a clear guiding hand from the highest levels of the federal health bureaucracy.

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