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by Thriptic 1912 days ago
Similarly, if the company won't validate their tech in peer reviewed journals, they are full of shit. I strongly suspected fraud years before it was acknowledged because Theranos was citing "trade secrets" for why they couldn't release any data about their tech. We don't do trade secrets in medicine or science, and this is precisely why.
1 comments

There’s no trade secret anywhere in US medicine? I can just walk in the factory and get a tour?
The FDA can (and will) audit anything and everything you do for approved drugs/treatments. There are no trade secrets in medicine. This is why companies patent things. You literally can’t hide information about something that’s about to be FDA approved.

As a result, the medical industry is less competitive than other industries. Also, it’s seen as ethically dubious to compete on saving lives. Instead, there’s a lot if in-licensing deals (see above re patents) as opposed to trade secrets.

You can’t hide it from the FDA, but not everything the FDA sees is available to the public and competitors.
There are vast amounts of data that you have to disclose to FDA that you are permitted to mark as not for public disclosure. If you ever FOIA records from FDA they are heavily redacted.
You can’t walk into the factory but certainly you can look at a patented drug and get a formula, for example. The Wikipedia article about Sovaldi (sofosbuvir - a Hepatitis C drug) contains the exact chemical formula.

Plus the clinical trial process is extensive. It would be much harder in the present regulatory regime to have a new BS prescription drug than a new BS testing startup, like this one or Theranos. (Old drugs are a little different - some were grandfathered into the current testing regime and evidence for their effectiveness is in some cases limited.)

Certainly there are trade secrets in medicine, but not everywhere.

Chemical formula != Steps to synthesize...
You are of course allowed to employ SOME obfuscation in research process, but you aren't allowed to shield your product and claims from scrutiny behind them. At the end of the day you have to validate that your product can do what you say it can do publicly through independent analysis, you have to run public trials against existing tech, and you have to explain how your tech works, which Theranos never did. They fought against scrutiny from the greater scientific community from day one; "just trust me it works" is not sufficient proof in science.

This is one reason why we have the patent structure, so people can publicly disclose data for validation purposes and still make a substantial profit.

Plenty of trade secrets in medicine in general (not just US). Parents need to lay out the process, but for some products (biological) the details matter immensely. That’s why even though some biologic drugs went off patent back in 2015 they are only launching the past year or two.