The FDA scotched the Pathway and Walgreens partnership by asking Pathway to prove it didn't need FDA approval as a medical device. Someone should explain to me how gene tests are a medical device..I guess soap and bathroom scales are also medical devices (David Kessler once said the former was!) and should have FDA approval of some sort. Meanwhile, clinical labs that are part of programs designed to test, diagnose and sell quackish treatments abound...
www.sciencebasedmedicine.org/
The lame protectionist statement from the genetics counseling trade group sounds a lot like the whining from HIV clinics who opposed home HIV tests (protecting patients, not their monopoly on testing). "National Society of Genetic Counselors issued a statement saying that receiving genetic information without input from a doctor "increases the chance for misunderstanding or misinterpretation of results."
Really? Seems to me that it will lead people to contact doctors and make lifestyle changes...just as the spread of the home HIV test. Paternalism persists.
I guess the agency has nothing better to do...
articles.latimes.com/2010/may/13/business/la-fi-dna-kits-20100513
www.sciencebasedmedicine.org/
The lame protectionist statement from the genetics counseling trade group sounds a lot like the whining from HIV clinics who opposed home HIV tests (protecting patients, not their monopoly on testing). "National Society of Genetic Counselors issued a statement saying that receiving genetic information without input from a doctor "increases the chance for misunderstanding or misinterpretation of results."
Really? Seems to me that it will lead people to contact doctors and make lifestyle changes...just as the spread of the home HIV test. Paternalism persists.
I guess the agency has nothing better to do...
articles.latimes.com/2010/may/13/business/la-fi-dna-kits-20100513
