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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,SrihariOn Wed, Nov 27, 2013 at 8:46 AM, Joe Gorse <jhg...@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 GorseOn Wed, Nov 27, 2013 at 10:30 AM, Srihari Yamanoor <yama...@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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Joe,And you are missing my point. I am not opposed to 23andme selling any research tools they see fit and neither does the FDA. The only thing the FDA has done is made the discovery that they are indeed selling a diagnostic device as defined by the CFR. This brings them under their purview. This is not the first communication from the FDA to 23andme, so they could have and should have been better prepared.The FDA of the United States, as ill equipped as it is, because of a congress that succumbed to lobbying, is still at the very cutting edge of regulations that lead to two very key things - safe and effective devices, be they therapeutic or diagnostic. This agency is the one, global agencies, and now even the EU agencies are modeling themselves after; after having failed to succeed with any other regulatory pathway. Even in recent history, when Congressional lobbying led to poor oversight and fast approval of knee implants (you can read about it all in the news), it only ended up hurting patients, so I am very suspicious of the need to suspend oversight, especially given how many customers I have seen regularly prepare for, and get approvals.The notion that the FDA is modeling all of its activities after the pharmaceutical industry is summarily mythical, as the codes, the enforcement pathways and pretty much everything is quite divergent.
I also believe that it is a bit excessive to deem 23andme as having a solution that is far superior and unknown. When I was in graduate school, well before the company existed, Professors, CEOs and Researchers from everywhere came and talked about personalized medicine, diagnostic tools based on genes and such. Heck, that was so well personified by the "trichorder". The company may have executed and come up with a solution that now allows for a new market to be created, no one doubts that. But essentially they are in the body-fixing business, which is not new and not new for the FDA either. They may not have the "best" scientists and engineers out there, but they have pretty good ones.
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This is the delicate issue - the balance of patient rights vs. commercial profit making, both of which are needed. This is not the first time the FDA has had to deal with this emotionally titillating issue. Cancer patients and their loved ones have never been able to reconcile with the stance of experimental drug administration on patients with no other available treatments (and the ethical/business issues there can be the subject of tons of PhDs).I never used 23andme as I believe genes before data is sort of a cart before horse thing, but can you expand on the "patent me" point. I am interested, even if it needs an offshoot thread.
The FDA then establishes its ability to regulate this (remember, it's legally required to do this):
(...)
They then very helpfully point them to all the forms, documents, etc., necessary to satisfy the legal requirements:
(...)
There's even a helpful mailing address and fax number:
(...)
Honestly, this sounds like 23andme has been getting away with something for a while and the FDA is tired of giving them leeway."
I know that in US of A there's this vision of entrepreneurship as "distrupting" the rules that are perceived to be obsolete (see AirBnB or Uber), but sometimes people just push too far. There's a reason why FDA exists, and it's not only about making money to big pharma.
I hope that 23&Me folks get this issue cleaned up fast; they seem like a good people and company.
(also hi, first post here :))
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