Archive for December, 2013
6 December 2013
As a follow-up to last week’s post, I can’t help but wonder about the future of the FDA, more than the future of medical genomic testing.
The FDA appears to have its beef not with sequencing, per se, but the hype of the interpretations of that sequencing. As far as genomic sequencing goes, it would be unreasonable for the FDA to prevent people from sequencing their own genes, and this is not what it’s doing for the time being. The real beef that the FDA has with 23andMe was the interpretation of that sequencing, taking what has been called a “paternalistic” role to vet / regulate the quality of information that could directly affect the actions taken by patients.
Along those lines, why not intervene and regulate online health info amalgamations like livestrong.com and WebMD.com? Is this not medical diagnostic hype? (see image)
This point was touched upon by Rahul Rekhi in The Guardian:
And what of services like WebMD – the hypochondriac’s haven – which offer patients checklists by which to self-diagnose their perceived symptoms? Do these not pose similar public health concerns? Yet, they persist largely uninhibited.
While half a million customers for 23andMe is nothing to laugh at, it still pales in comparison to the massive tide of people making significant personal health decisions based off ill-vetted pseudoscientific information on the internet. If the FDA wants to expand its reach and do the maximum public good, perhaps they should step in here, or perhaps the poorly regulated, multi-billion dollar supplements industry? An anti-cancer drug needs 15+ years and multiple stages of clinical trials and upwards of a billion dollars to show efficacy by our standards, but nothing is preventing snake oil salesmen from marketing homeopathic water to promote “vitality” to cancer patients.
Also, companies like 23andMe could easily make themselves over in countries without an overly paternalistic FDA. Its rather easy to sidestep regulatory oversight of transporting biological specimens (like cheek swabs) across international boundaries: one could have their genome sequenced in California and instantly uploaded the Cloud with something like Illumina’s BaseSpace and immediately have it analyzed by medical genomics teams in India, Singapore, etc.
The FDA has put its finger firmly in the hole in the dam, but it looks like the rising tide of genomic sequencing will soon spill it all over anyway. The plot thickens…