[glenra]

> if not for the FDA to come down on operations like Theranos, then who?

Theranos was committing fraud - selling investors a product that didn't exist. You don't need the FDA for fraud to be illegal, ordinary civil and financial law covers this.

If Theranos weren't defrauding investors and actually had a product that worked, it'd be up to the market to determine if that product were worth paying for. Since different customers have different risk profiles there's no one-size-fits-all best balance between safety, efficacy and cost - let people buy different products that choose different tradeoffs.

[IvyMike]

Theranos was in fact testing people, who received both false negative and false negative results.

From the article I link below:

> At its height, Theranos operated 40 “Wellness Centers” in Walgreens stores in Arizona and a single location in California, which were the source of much of its revenue. USA Today reported the metro Phoenix-area centers alone sold more than 1.5 million blood tests, which yielded 7.8 million tests results for nearly 176,000 consumers.

https://www.darkdaily.com/previously-high-flying-theranos-pr...

[sk5t]

> Theranos was committing fraud - selling investors a product that didn't exist

Well, the FDA is not the SEC--and Theranos was also providing patients with erroneous lab reports! This is more than a bit worse than wasting the time, money, and reputation, such that it may be, of Tim Draper, George Shultz, Henry Kissinger, et al.

[akiselev]

> You don't need the FDA for fraud to be illegal, ordinary civil and financial law covers this.

The FDA was literally made as the arbiter of what is and isn't fraud in medicine.