They sound so exciting. (Nearly) free genetic testing. (Nearly) painless blood tests. Blood tests that tell in moments whether someone has cancer. And they have millions, or billions, in venture capital to back them up. The only thing holding them back from bringing their services to the people? Government regulators.
Now, this story frequently gets told as a negative. “Big bad government hurting the people by keeping important medical advances from them.” But most of the time, that’s not the real story.
It’s almost impossible for regular citizens to evaluate and completely understand whether a new medical device or test is working. And because it’s so important – it’s literally about whether we live or die – it’s so important that we get it right. If we act on incorrect information, or even on correct information that we don’t have in the right context, it could change everything.
Even experts don’t always understand it. With Theranos, no one was even asking the questions.
As discussed in a recent Vanity Fair article about all the ways the media failed to protect the public from Theranos, “But it was a passage in that New Yorker profile, written by Ken Auletta, that led [John] Carreyrou to start questioning the validity of the company. In the piece, Auletta acerbically noted that the technology behind Theranos was “treated as a state secret, and Holmes’s description of the process was comically vague.” She told him, for instance, that one process occurred when “a chemistry is performed so that a chemical reaction occurs and generates a signal from the chemical interaction with the sample, which is translated into a result, which is then reviewed by certified laboratory personnel.” That doesn’t make sense to anyone and it can’t be evaluated.
And whether something gets funded is no promise of it working and protecting our health. Again, from Vanity Fair, “when the V.C.s asked how the technology worked, I was told, Holmes replied that it was too secret to share, even to investors. When they asked if it had been peer-reviewed, she insisted once again it was too secret to share—even to other scientists.”
Which means that even other doctors, who are hearing about this amazing technology that will improve their patients’ lives and reduce their pain, can’t determine whether it works. They need the FDA.
And this is not just a big deal with something is just an app. An app, even if it’s not really ready for prime time, won’t hurt anyone. It just won’t take off like the next Uber-for that it meant to be. But with these tests, we need the FDA to make sure that we’re relying on accurate medical information when we make our health decisions.
Thanks, FDA, for stepping up your work in medical devices in Silicon Valley. Because when they work, we want them. But not until they work.