Re: [DIYbio] White House Petition to Reverse FDA decision to bar 23&Me from selling their DNA kits

It is not the FDA's job to produce the data to defend 23andme. It is the company's job. They knew this.  They were not "taken aback" or suddenly violated. Their CEO, should have received training on what he can and cannot say about their products on an interview or on marketing materials. And then again, maybe he decided to over-step anyway.

If you want to sell a diagnostic product, anything above a tongue depressor in the United States, you pretty much enter at least a Class IIa or Class IIb classification, and you go through the approval process. You can even call ahead and discuss strategy with the FDA if you so wish. 

Even now, that is all 23andme has to do. Sit down across the table from the FDA, convince them of the science as it stands and get the hold removed should their products be based on science as acceptable by today's standards. This process keeps a lot of people alive and healthy in the United States. 

These are the facts as they stand, and I am sure the White House will inform you thus as well. 

Sincerely,

Srihari

On Wed, Nov 27, 2013 at 8:46 AM, Joe Gorse <jhgorse@gmail.com> wrote:

Srihari,

If the FDA decides to produce a legitimate claim, I might be inclined to agree. Since all I have seen so far from the FDA is authority posturing and frivolous harm scenarios, all I can say is that they lack the data to make the claim that 23andMe should stop doing what they are doing. It appears that they have not clearly considered the harm which would be caused by doing nothing at all, which in this case is significantly greater than doing something which may not be completely accurate.

From the standpoint of risk vs reward, what 23andMe is doing is valuable even if their data is lossy. In this case, the value of any data (vs no data) should be clearly seen as a positive force to engage individuals to take more responsibility for their person health care whereas no data at all leaves us at the mercy of the current health care system. People will take this information and ask themselves, "What can I do to be or become healthy?" So they will go to their primary care physicians and ask, "What does this mean?" This can hardly be considered negative as some articles have been claiming.

For the down side of the false-positive, no physician in their right mind would make life-or-death therapeutic decisions based on a single genetic data point from 23andMe. Individuals are limited in their ability to act in drastic therapies without physicians so the worse case scenario for the lone individual is depression and incorrect supplements. Still in either case, the focus is on the individual's health and the outcomes are more than likely to be positive once it becomes a goal to be healthy.

The false-negative case is immaterial due to the fact that it leaves us in the same boat as we were before: at the mercy of the current healthcare system to detect, prevent, and repair us as needed. One could argue that it might give us a false confidence, though with placebo effect being relevant to medical interventions as well as this being a single point of data, I doubt a diabetic or cancer or Alzheimer patients will take a false-negative from 23andMe and say, "Well maybe I am not sick after all, I am going to stop taking my medicine."

We can hardly see any real negative in this scenario unless someone has something to lose (or unless you believe in the Angelina Jolie mastectomy hypothesis: crazed 23andMe customers cause havoc in hospitals and demand elective surgery), such as the established authorities and providers and vendors may have if they refuse to reform. What is at stake here is more than just a small squabble about accuracy, this is the future of medicine taking shape. I, personally, want the FDA to do better. Their rules tend to be made for pharmaceutical companies, which are who they primarily do business with so it has been reasonably come to be this way, but that hamper startups and individual scientists from contributing significantly to human therapies which can be used in the US.

The opportunity cost of not having more people engaged in productive research for human-relevant interventions is so great that it is becoming a moral imperative for our society as a whole. That is to say, the cost we incur by NOT testing more therapies for human interventions and disease rescue is greater than those saved by over-conservatively doing the same thing we have been doing before (and failing with) instead. If human life is indeed precious, then the sheer economic waste of inaction as those who succumb to disease pass on without altering the chances of survival for those who will suffer after them should be enough to convince even the most cool rational head that regulatory change is necessary and pressing.

So far, this 23andMe seems to be a case of regulation impeding instead of serving the interests of progress. Therefore the petition has my vote of confidence.

Cheers,

Joe Gorse

On Wed, Nov 27, 2013 at 10:30 AM, Srihari Yamanoor <yamanoor@gmail.com> wrote:

The best course for 23andme at this point is to tone down on their marketing claims, work with the FDA and seek appro

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