Re:My deadly disease was just a 23andme bug
by refurb on Monday November 25, 2013 @06:43PM
(#6797946)
The difference between CT scans and 23 and Me is that CT scans have been tested and the rate of false-positives and false-negatives is generally known. In addition, the manufacturers of CT scanners are making claims based on this data.
What the FDA is upset about is that 23 and Me is making claims with no scientific basis. Sure, they are measuring gene's known to be associated with certain conditions, however, their tests have not been validated. That is the kicker.
The funny thing about this is that HN is notorious for its hatred of the pharmaceutical industry. If a drug company ever did what 23 and Me did, it would have been raided by US Marshall's and had it's door chained shut. The FDA has been incredibly patient with the company so far.
A simple ad that suggests patients might do better if they switch to Effexor XR, which, in fact, they might. The FDA sent a warning letter because the ad "contributes to the impression that patients who have failed previous antidepressant therapy can expect improvement when switching to Effexor XR when this has not been demonstrated by substantial evidence or substantial clinical experience."
This is not regulatory capture or anything of the sort. Pharmaceutical companies have been putting up with the high evidence hurdle for the last few decades. What makes 23 and Me think it can play by different rules?
What the FDA is upset about is that 23 and Me is making claims with no scientific basis. Sure, they are measuring gene's known to be associated with certain conditions, however, their tests have not been validated. That is the kicker.
The funny thing about this is that HN is notorious for its hatred of the pharmaceutical industry. If a drug company ever did what 23 and Me did, it would have been raided by US Marshall's and had it's door chained shut. The FDA has been incredibly patient with the company so far.
Take a look at what pharmaceutical companies have had to put up with: http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulat...
A simple ad that suggests patients might do better if they switch to Effexor XR, which, in fact, they might. The FDA sent a warning letter because the ad "contributes to the impression that patients who have failed previous antidepressant therapy can expect improvement when switching to Effexor XR when this has not been demonstrated by substantial evidence or substantial clinical experience."
This is not regulatory capture or anything of the sort. Pharmaceutical companies have been putting up with the high evidence hurdle for the last few decades. What makes 23 and Me think it can play by different rules?