Why You Shouldn’t Do Genetic Testing On Yourself
DNA testing has been in the news a lot lately. This week Jayann Sepich was in San Diego to promote DNA testing for felons upon arrest. Her daughter, Katie, was brutally raped and murdered while a grad student at New Mexico State University in 2003, and her body was set on fire and abandoned. Because she fought her attacker, Katie’s fingernails had traces of his blood and skin—DNA from that skin and blood were taken, but a match wasn’t made until three years later, when a man convicted of burglary had his DNA sampled. Although this man had been arrested for burglary three months after he murdered Katie, no DNA sample had been taken then, because the law said that only if a felon is convicted—not arrested– is a DNA sample taken. Jayann Sepich is trying to change that, to get states to adopt Katie’s Law—which says when a person is arrested for a felony–at the time of booking when fingerprints and mugshots are taken–the inside of their cheek is swabbed, and a DNA profile is extracted and entered into a database.
Largely because of her efforts, 23 states now have Katie’s Law on the books. Prop 69, California’s version of the law, passed in 2004. The ACLU though, has challenged the law’s constitutionality—they say it violated the “unreasonable search” protection of the Fourth Amendment and citizen’s fundamental right to privacy under the 4th Amendment.
Jayann was the guest of Life Technologies, a Carlsbad, Calif. company that manufactures forensic DNA kits. And although genetic testing helped find Katie Sepich’s murderer—forensic DNA tests are more like fingerprints, used for identification, and “provide identification while providing anonymity in terms of a person’s medical history,” wrote Tim Ingersoll, a spokesperson for Life Technologies, in an email.
A different animal, however, are consumer-friendly, over-the-counter genetic test kits–and they are generating controversy. On May 19th, the House Committee on Energy and Commerce sent a nasty letter to CEOs of three companies that make these kits—23andMe, Navigenics and Pathways Genomics Corp.
Here’s an excerpt from the letter:
The Committee is requesting information from the companies on several aspects of the tests: How the companies analyze test results to determine consumers’ risk for any conditions, diseases, drug responses, and adverse reactions; the ability of the companies’ genetic testing products to accurately identify any genetic risks; and the companies’ policies for the collection, storage, and processing of individual genetic samples collected from consumers.
According to Genomics Law Report:
The Committee appears to be interested in gathering information. Lots and lots of information. The letters are impressively broad in their scope, which is unsurprising given that this is the first publicly reported Congressional investigation into the current generation of DTC genetic testing companies.
Walgreens and CVS had announced agreements with Pathway Genomics to sell its genetic testing kit in their stores nationwide—and those kits claim the ability to test for more than 70 health issues, according to a story in Technology Review, including predispositions to Alzheimer’s, breast cancer and diabetes. But after the Committee started questioning the tests, the FDA began questioning the legality of selling them direct to consumers, and Walgreens decided to put its plans on hold.
The problem is one of a lack of consistency among states, in terms of regulating these tests. Although you can get tests like these online, something about having them poking out of the shelves of CVS and Walgreens made Congress and the FDA nervous, but the folks at the Genomics Law Report say a regulatory response to direct-to-consumer genetic test kits is way overdue anyway, so maybe the freakout is a good thing.
Letting consumers conduct genetic testing on themselves to determine what diseases they might be at risk for raises a lot of thorny issues, but one big concern is how consumers will use the information, and if they will even really understand it. Regulation may not be the best way to figure this out, since regulation doesn’t necessarily educate. It would be far better to work on improving the FDA’s and the general public’s understanding of just what the results of these tests mean and how best to use the information. And companies like Pathway Genomics need to increase their transparency, disclosing more thoroughly the limitations of their tests and services and make it clear that the results of a test—without some guidance, interpretation and context from a doctor—can be a dangerous thing.