Mike the Mad Biologist says the concern over regulation of direct-to-consumer genetic tests has been "overblown," and that FDA is doing the right thing in seeking to regulate them. Mike considers a recent article in the Huffington Post, which implies that FDA's move is solely predicated on the idea that patients can't "handle the truth," and that the information obtained from DTC tests is "dangerous" without a doctor's guidance. But Mike says it's not as simple as that. People aren't stupid, he says, but he does "see serious potential for bad outcomes; public health workers, though hard-earned experience, have learned that even seemingly simple things can go very wrong." Many people are misinformed about health ("Remember all the parents who didn't want their kids to get a flu shot?" Mike asks), and they have a tendency to hear only certain things, which means they could miss a lot of relevant information from a genetic test. Also, he adds, even physicians have more to learn. Not everyone is a geneticist, and MDs are going to need more training and reading materials so they can explain the relevant information to their patients, he suggests. FDA regulates all sorts of diagnostics, the blogger says, so why should this be any different? "I can see some downsides without regulation, and it doesn't hurt to examine if and what regulation would improve this technology for patients and doctors," he adds.
A Little Regulation Never Hurt Anybody
Jun 22, 2010