This is a question we all need to be asking whenever the government involves itself in anything. The latest thing that has set me off is the House poking it’s nose into a private business providing services to private individuals.
What bothers me even more are some of the comments:
Kim Slocum wrote:
For “Jason Frank”–the reason this stuff needs to be regulated pretty tightly is that the public needs to have confidence that 1. the test measures what it says it measures, 2. that results are reproducible batch to batch, and most importantly 3. that a positive or negative result from this tests actually correlates to something of clinical relevance. Given that this is an emerging field, I seriously doubt the manufacturer has provided data on any of these critical points and that’s the FDA’s (very legitimate) concern about the product.
It seems to be everyone’s default sentiment that government needs to be involved in regulating everything. Why? What on earth did we do before the government regulated a field? Well, we did research on it ourself. If we bought something that wasn’t what we thought it was, we could try to return it, or suck it up. Of what business is it of the government what I do with my money? And why is selling this service to people any business of the government? From what I can tell, they are not committing any kind of fraud, they are giving people (except for when mistakes are made) just what they say they are. And that emotional distress crap doesn’t fly if you got the wrong result. You should know what the chances of getting an incorrect result are before you buy the product, or if you can’t find out what they are, buyer beware.
Tags: FDA, genetic testing