2 ms·

They might be a for profit company, but they haven't actually made a profit. I don't understand the mentality of your post. On the one hand, you seem to think

They might be a for profit company, but they haven't actually made a profit. I don't understand the mentality of your post. On the one hand, you seem to think that profit and public interest are mutually exclusive. They aren't. They are overlapping concerns, as in two circles on a venn diagram partially overlapping. On a personal level, you make an admonishing statement that the parent gave away their data for "neat" visualizations. I infer from this that you are saying they are giving away more than they got. The opposite of this would be profit (getting more than you gave). So you don't like 23andme because they want to get more than they give, and you admonish the parent because they gave more than they got. The FDA banned them from advertising, not because there was no scientific proof, but because they didn't know how to present the data in the way the FDA could understand. Regulatory agencies have their own lingo and methods and they are obscure, requiring the use of people who's sole job is to be the adapter between the regulators and everyone else. 23andme made a mistake likely out of ignorance regarding just how difficult it is to navigate regulatory waters. The FDA didn't grant them rights to marketing because they did anything new technically. It was because they are doing new things bureaucratically.

blub 11y ago
You are really grasping at straws to defend this company. I will do both of us a favor and skip the mental gymnastics about giving, getting and profit. But... the FDA didn't "understand" 23andme's data? And the company made an innocent mistake when it comes to presenting data? This letter from the FDA describes exactly what was and was not done and obliterates any arguments like the above: http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/2013/ucm376296.htm http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/2...
- DigitalJack 11y ago
  I work with regulating entities just like the FDA. I know what I'm talking about. I doubt you do. Especially if you think my post was so difficult to understand that it required mental gymnastics. Getting more than you give is the very definition of profit. It doesn't mean you don't give. It's a relative term. It is possible for both parties of an exchange to profit, from each party's point of view. The letter you posted was the last in a series, where the FDA, after numerous attempts to explain what they needed, gave up and pulled the plug. It's like a divorce, there are often many attempts at reconciliation before the plug is pulled, but if communication isn't working for whatever reason, the papers are served. And usually pretty easy to understand at that point.

blub 11y ago

You are really grasping at straws to defend this company. I will do both of us a favor and skip the mental gymnastics about giving, getting and profit. But... the FDA didn't "understand" 23andme's data? And the company made an innocent mistake when it comes to presenting data? This letter from the FDA describes exactly what was and was not done and obliterates any arguments like the above: http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/2013/ucm376296.htm http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/2...

DigitalJack 11y ago
I work with regulating entities just like the FDA. I know what I'm talking about. I doubt you do. Especially if you think my post was so difficult to understand that it required mental gymnastics. Getting more than you give is the very definition of profit. It doesn't mean you don't give. It's a relative term. It is possible for both parties of an exchange to profit, from each party's point of view. The letter you posted was the last in a series, where the FDA, after numerous attempts to explain what they needed, gave up and pulled the plug. It's like a divorce, there are often many attempts at reconciliation before the plug is pulled, but if communication isn't working for whatever reason, the papers are served. And usually pretty easy to understand at that point.