Who determines whether you can have a genetic test done?

Here's an interesting aspect of the recent crackdown on genetic testing labs by the states of California and New York. Shari Roan of CNN asked:

Should a doctor's authorization be required for someone to obtain personal genetic testing? So far, California and New York state authorities say yes. But this debate is just beginning. The controversy is being played out this week on the many genetic medicine blogs.

She also asks, "what is the intent of personal gene testing?" and quotes from a couple of genetics blogs and a company that sells genetic testing on the Internet. She implies that one company not targeted replied by saying it "believes gene testing is a medical service and requires doctors to authorize tests." Here I'm quoting Roan, not the company identified in her article. Since the company does not require a doctor's prescription before it does testing--I was part of a class that did genetic testing for a student. Although his doctor knew about the testing, she didn't authorize it. Perhaps things have changed in the past year or so.

This blog has been discussing genetic testing for some time, but I have never considered before whether a person who wants to check out a specific question, or to check on relationships between family members, should be allowed to purchase a genetic test without going through a physician.

I was asked, and Hsien-Hsien Lei of Eye on DNA was also asked:

For an upcoming series on genetic testing, a major television network would like to interview a person who has ordered an online gene test to assess their future risk of getting certain diseases. Twelve complaints have been filed with the california Dept of Health and the New York State Dept of Health has sent letters explaining the legal ramifications of testing New York residents without the proper clinical laboratory permit. Most of these complaints are anonymous. Would anyone speak on-camera to their issues and share their personal experience ordering one of these tests and getting the results? Please call 917 991 3689 or write to Theodora12@gmail.com.

Daniel Macarthur, a researcher working in Sydney, Australia, on the genetic and evolutionary basis of variation in human muscle function wrote in GeneticFuture:

California has sent cease-and-desist letters to 13 direct-to-consumer genetic testing companies, "ordering them to immediately stop offering genetic tests to state residents." The companies haven't been named yet, although Navigenics has admitted to being among them, and is arguing that they are doing nothing wrong. Steve Murphy of Helix Health, who has been calling for tighter regulation of these companies for months, is predictably triumphal.

Naturally, this is just the beginning - to a large extent what's going on here is a turf war between proponents of the old-school medical regulation model and upstart advocates of the free information paradigm of the Google generation. Expect to see more regulatory punches thrown over the next few months, to Steve's continued delight.

Jason Kincaid, of TechCrunch, writes:

But what’s the big deal? Required state and federal certifications seem obvious given the sensitivity and personal nature of the data. But what about the mandated doctor’s note? It’s my DNA - shouldn’t I be able to read about it whenever I want?

Maybe not. The problem with this kind of casual DNA testing is that it almost trivializes the importance of genetic information. 23andMe considers itself as something of a novelty, providing lots of fascinating information that it says isn’t to be used to diagnose medical conditions.

Of course, the site still provides some probabilities of getting certain diseases. And while none of these sites are going to offer any life-shattering information (e.g. “You will die before you hit 30?), many health care professionals worry that any amount of genetic information could be misinterpreted. What happens when a patient finds out they have a lower-than-average risk of heart failure that leads them to neglect regular checkups? Then again, it’s my information - shouldn’t I be free to (mis)interpret it as I see fit?

The fact of the matter is that genetic testing will be commonplace within the next decade, and the outcome of these cases will be setting important precedents. New York and California may be misguided in their efforts to mandate a doctor’s approval, but we should remember that these are two unusually progressive states that don’t seem keen on hampering citizens’ rights. Regardless of the eventual outcome of these cases, there’s one important message we should take from their hesitation: tread lightly.

And Marcus Wolson, of Sci-Tech comments:

The crackdowns follow the launch of a batch of new DNA analysis services spawned by recent genetic discoveries. The mostly Web-based services will scan customers' genes to spot potential health risks, from cancer to lower back pain.

State and federal public health officials have urged consumers to be skeptical, pointing out that related research is in its earliest stages and doctors have little training in interpreting the results.

The federal Food and Drug Administration does not evaluate the tests for accuracy, though a federal panel recently recommended stepped-up oversight to ensure their validity.

Interesting discussions and insights. We'll see what happens next.

Marie Godfrey, PhD