A "misfire" is the way Eric Topol, MD, describes 23andMe's recent regulatory tussle with the FDA, which resulted in the Silicon Valley-based company halting sales for now of its health-related genetic test analysis.
Speaking with MPMN last week about heart attack-predicting nanosensors and other exciting cardiovascular development, Topol also delved into the question of whether the FDA, in trying to protect people, might squelch the innovation presently taking place.
"For $99, what they provide is an important, useful service," Topol says of 23andMe.
Topol, who is Scripps Health's chief academic officer and a practicing cardiologist often cited in the media, has cred when it comes to patient safety. While head of cardiology at Cleveland Clinic, he publicly spoke out, about the danger's of Merck's Vioxx painkiller.
Still, he also sees great potential for digital health technology, which spans everything from mobile health apps to genomics, to give us access to vastly more information about our health and the condition of our bodies in real time.
Here's what Topol had to say about the 23andMe case:
"I think this has been a misfire. I don't think there is a problem with 23andMe. I think the data they present is quite accurate, and the way they present it is educating the public. The problem they had is aggressive marketing, which caught the FDA off guard and got them to react in a pretty negative way. … I think it's going to get straightened out, and I think it's important to have entities like 23andMe that offer to help people get their pharmacogenetic data, their carrier information if they're planning to have a baby, susceptibility for different common conditions. It's reasonable data that can be actionable and useful, as well as ancestry data.
"For $99, what they provide is an important, useful service. They should have gotten their act together in the marketing side before taking on this regulatory body. But it will eventually, likely get resolved. …
"They want to form a database of millions of people, which would be helpful. …
"Some of the things the FDA wrote in their warning letter, that a woman could get a double-mastectomy by mistaken genotype. … First of all, I don't know any woman who would go have a double-mastectomy based on a 23andMe genotype. Secondly, the 23andMe for BRCA gene, that's only one common mutation. There are so many more. You have to get the sequence to know anything.
"The other example they gave, which was much more germane to cardiology, they talked about how somebody could have a bleeding event if they had their [dosage based on] warfarin-relevant genotype data. That's absurd. If you knew your 23andMe data on your warfarin before you ever got your first dose, that actually could make a really big difference in terms of getting the right, accurate dose, rather than the way it is done today. There's the empiric 10 milligrams, 10 milligrams, 10 milligrams until they start to bump their [international normalized ratio]. The way we do it today is much more risky than the way 23andMe would help."
