It seems like a life-changing innovation. Mail a swab with a bit of saliva off to a lab, and find out if you’re at risk for cancer, or Alzheimer’s, or some other genetically linked disease. What would you do with that information? Wouldn’t you want to know?
According to the Food and Drug Administration, however, it’s an idea that’s too good to be true.
The FDA came down hard on the company 23andme, which had offered just such a mail-order testing service. The company couldn’t ensure the reliability of its testing, the government contended. And without reliable test results, patients could seek unnecessary, possibly harmful treatments for non-existent conditions.
Two former Republican administration lawyers, David Rivkin and Andrew Grossman, don’t see it that way, however. For them, it’s about freedom of information: the government is trying to prevent patients from “knowing about their own health”.
Yes, they write in Tuesday’s USA Today, the field of genetic research is still developing, and the tests aren’t 100% reliable. “But that fact does not mean these services aren’t useful to consumers, particularly when combined with traditional diagnostics.”
“Rather than regulate by assuming that consumers are incapable of understanding their personal genetics,” they conclude, “the FDA should be thinking about the enormous opportunities to improve health offered by widespread, affordable genetic testing.”
“We need something like 23andme to help develop systems for letting people know how to deal with this genetic information, and for creating a world where people can actually start to deal with lots of health data”
Matthew Herper Forbes
MSNBC‘s Eric Rosenbaum agrees. “Look, health is no laughing matter, and the FDA is right to have concerns — especially given the predatory history of the medical and drug industry,” he writes. “Yet there’s a fine line between a regulator’s looking out for your best interest and one being a little overly paternalistic, or just behind the times.”
Forbes’ Matthew Herper would like to criticise the FDA’s decision, too, but he can’t. 23andme brought this on itself, he writes, by ignoring the government for six months.
“Either 23andme is deliberately trying to force a battle with the FDA, which I think would potentially win points for the movement the company represents but kill the company itself, or it is simply guilty of the single dumbest regulatory strategy I have seen in 13 years of covering the Food and Drug Administration,” he writes.
The government tried to work with the startup, he contends, but 23andMe made that impossible: “This is not the story of a big regulator choosing to squash a small company, but of a company that decided that it didn’t have to follow the rules.”
We need something like 23andme to help develop systems for letting people know how to deal with this genetic information, and for creating a world where people can actually start to deal with lots of health data. But outside of a crowd of libertarians and genoscenti, the company does not have the political support it needs for a fight against the FDA. And none of its high-minded ideals release it from the requirement the FDA wants to enforce: that a medical device has to work.
Mass-produced genetic testing is coming, and it’s going to get more reliable. If 23andme doesn’t deliver the breakthrough product, someone else will.
There are, however, two divergent views on what should happen next. Many medical professionals complain that the Internet has filled their examination rooms with self-diagnosing, second-guessing patients. If people can readily get their hands on details of their genetic makeup, that number could skyrocket.
Should the government have a firm hand in regulating the tests, possibly making them more expensive and less available? Or will people have cheap, easy, but largely unguided access to genetic data, and then have the freedom to act on that information as they so choose – even if their actions may not, in the end, be in their best interests?
What you don’t know won’t hurt you, as the saying goes. But what about what you do know?
- FDA tells 23andMe to halt sales of genetic test – USA TODAY (newestgadgetsinfo.com)