I just was threatened by Daniel MacArthur over at GenomesUnzipped that he was about to delete my comments.
He called it trivial. I think he is missing the tremendously simple point.
Why is the FDA mad as hell? Medical Claims.
Hell, they even told Mary Carmichael in the interview.
Alberto Gutierrez = AG
"AG: The concern is with everything."
"AG: The law requires us to clear devices or approve devices BEFORE they go into the marketplace when they make medical claims"
This to me is crystal clear. Make a medical claim. Get regulated.
Which is interesting. Because I would say some of what DTCG did was, infer medical claims without making outright claims- silly games . I happen to think that is a shitty way to sell something. But heck it is a way to create a discussion rather than instant regs.....
"AG: The question with 23andMe has been whether their claims were medical or not. The original claims they were making were very much on the edge."
"AG: We actually told them that WE(FDA) thought they were medical claims, but it was at least possible you could argue that they were not"
Do you get it? The judge thought they were medical claims, but let the company proceed. Giving it just enough rope to hang itself.......
The question here is clear. What is a medical claim?
Which boils down to: What is medical?
I can tell you what I do as a doctor.
I diagnose, treat, cure, palliate, prevent human suffering and advance human health.
If you are making claims to do any of those things, I would call it medicine.
This is very important to understand and I hope you VC are listening........
Diagnose, Treat, Cure, Palliate or Prevent human suffering.......and advance human health.
Words matter. Did you notice I didn't say disease. Because what's today's disease may not be tomorrow's.
And Vice Versa....
Is a priest a doctor? Well, they used to be.
Is a counselor practicing medicine, well, I would say yes, they are in the healthcare arena
Yes, it is now sinking in. That huge pit in your gut. The millions invested trying to game the system that is millenia old........
It will not work. DTCG has just proven that. And, do you think the vitamin industry has a chance over the next decade?
I will begin the deep dive into the FDA comments shortly. But rest assured, I just gave you some insight into what medical really means......
The Sherpa Says: There Daniel, there you have it. I have told you what medicine is. Now if you wish to argue against that go ahead bub.......