What's Your Sign Code?

It's better than astrology and all the rage. Genetic testing offered as a gamut of services, under marketing rubrics along the lines of "Discover Your True Self!" Some of this discovery is whimsical, for instance, the company 23andMe offers visitors to their website graphics and insight on the percentage of people in their company prone to wet ear wax, not flaky, determined by a dominant allele. Some tests are more diagnostic, claiming to promote health. Salugen touts the fantastic slogan "DNA Customized Nutrition" and offers vitamins with their DNA testing. The Genelex website says DNA testing can be used to fine tune the dose of prescription drugs used for treatment of diseases like depression, cancer and epilepsy. Its a burgeoning, unexplored, market. How will it evolve?

A couple of weeks ago, the California Department of Public Health sent cease-and-desist notices to 13 gene testing services, warning the companies not to offer tests to California consumers. New York state took similar action last November, sending notices to 31 companies. The California notice references a state code that makes it "unlawful for any person to own, operate, maintain, direct, or engage in the business of operating a clinical laboratory, as defined this chapter, unless she or she possesses a valid clinical laboratory licensed issued by the department." The department also objects to tests being ordered without a physician. Some companies have stopped selling services to customers in these states but others continue their business, undaunted, claiming that what they're offering is not subject to the states' rules.

The companies are doing more than selling to consumers though. In addition to offering genetic screens for curiosity or personal health, companies are moving to use the collected data to advance research. 23andMe is collaborating with the Parkinson's Institute to provide information from its customers to help understand that disease. This is in line with some of the company's long term goals, according to the San Francisco Chronicle:

"If 23andMe eventually succeeds in hosting large-scale communities of members with various illnesses, it can become a conduit for pharmaceutical companies that would pay the company to relay their offers to participate in clinical trials [co-founder Linda Avey] said."

Google and Microsoft are also in the process of setting up systems to gather large data sets from patients, a move that may help accelerate understanding of diseases. But there are many unanswered questions about the use and usefulness of the data.

Some say that federal regulation is so scarce and the barrier of entry so low that the direct to consumer industry invites fraudulent players. Others ask what such predictive tests can really predict? One woman interviewed by the journal Nature (453: 570-571) said her test results showed a 34% chance of becoming obese, compared to the average female her age who had 32% chance. Some researchers and public policy advocates ask whether the tests are a waste of money.

Even if the tests are predictive, will they encourage people to change their habits, or is that wishful thinking? Most people know that obesity increases your risk of heart attack, diabetes, cancer, etc. But despite straightforward evidence provided by daily surveillance in low cost mirrors, the western population suffers an epidemic of obesity not stanched by the most accessible information. Will more tests convince people to exercise and eat their vegetables?

Like many health conditions, obesity is not solely determined by genes. But while everyone acknowledges the influence of environment on disease probability, the extent of the influence is unknown. The same caveat applies to genetic influences. Huntington's disease is one disease largely determined by genetics, while autism and many others vary as to the genetic influence. Yet the proliferation of these companies encourages public perception that genetics is extraordinarily predictive of health outcomes.This can be problematic for individual consumers who could be misled about the importance of the data. The implications of incomplete information in the form of genomic data could also problematic when companies start collecting data for analysis.

Some genetic testing companies claim that the information they're providing to consumers is not diagnostic, only informational, they market the information as empowering to the consumer. But companies' collective enthusiasm for getting their hands on the forthcoming data belies their claims that the tests are solely for their customers' curiosity. The value of this information is far greater to the company that amasses collections of individual data than it is to any one individual. And once a company has data that represents recurring revenue potential, how is that information not just as fluid and salable as names, telephone numbers and addresses?

What are the implications of this? On the lighter side, imagine being besieged with junk mail about summer diet camps because at age nine, it's revealed that you show a propensity for Type II diabetes based on your mother's profile. Or imagine you pay to query your risk of arthritis and agree to have this data used by certain parties (identifying information stripped, of course). But then your emails begin to feature ads for joint balms or extra absorbent Q-tips. Can't imagine it?

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