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

Srihari,

Actually, I have to admit my ignorance here. What are PGEs? Something to do with prostaglandins?

Cheers,

Joe

On Wed, Nov 27, 2013 at 11:08 PM, Srihari Yamanoor <yamanoor@gmail.com> wrote:

Joe,

Let me ask you this question. How do you believe the FDA should classify the PGEs, and how should they regulate them?

The way I see it, as I have been reading more and more, in fact, looking at the letter, 23andme is making some really tall claims. They are trying to run serious medicine business as if it was a social media company. It doesn't seem inconceivable that there will be people who have some history of cancer or another chronic disease in their family history to read too much into this and take drastic, unintended consequences. Competitors are prone to follow their path, and the FDA will be left with a mess to handle if they don't act. 

By the way, something not being discussed, once devices and drugs come into the FDA purview, federal preemption takes over and companies, especially startups can defend themselves from spurious lawsuits, such as the ones torts try out. By the way, torts are paying attention to 23andme's current predicament, and that could compound their problem especially with the word tricks they are trying to play around the word "diagnostic". 

In addition, the FDA clearly considers apps/software as "devices". They do wish to regulate them, and will do so in some form or other. What might come as a surprise to many - most devices, from blood glucose monitors to radiofrequency generators have software in them, and that software is regulated to the extent that a specification needs to be laid out, a plan needs to be developed and adhered with, and controls need to be in place, just like design controls would be, for any device. Software updates too, are controlled, and cannot be performed without FDA approval. 

And before anyone gets very angry, I would like to remind everyone of two things - one, medical device and diagnostics companies do software control routinely, like the customers of the organization I work for. We, and in many cases they, have dedicated software teams that work quite well under commercial as well as regulatory pressures. People who develop apps should not have any issues doing this. 

Secondly, the moment something goes wrong; either with an app, a hip implant or an electric cigarette or a gene test, people will immediately blame the "government". At which point, Congress, will call a hearing and blast the FDA. You cannot really blame them for being paranoid. 

I do agree, that the FDA has the potential to over-reach, and this is really in the hands of Congress. Instead of trying to succumb to lobbying or scoring political points, they need to balance patient safety against profits when it comes to the FDA. They have been quite lacking in this, as with most other areas. 

Sincerely,

Srihari

On Wed, Nov 27, 2013 at 7:45 PM, Joe Gorse <jhgorse@gmail.com> wrote:

Srihari,

I am receiving your point loud and clear, that this is entirely 23andMe's fault for not playing within the current regulations, and as an engineer and entrepreneur I understand and agree with that part of the assessment. I would probably not have approached things as they did, but it is hard to say that without seeing the whole story which has yet to be told.

However, again, I must categorically disagree with the FDA's arbitrary assessment of this technology as "diagnostic" in order to pull rank on what amounts to a startup company. The criteria for the decision is based on open-ended policy which can be applied to anything, therefore the FDA is actively choosing to make this an issue. This creates a chilling effect for the startup industry and innovators like myself and many others who intend to enter the personal device healthcare market.

Imagine you are Apple and somebody writes a healthcare "diagnostic" App for the unlocked Cydia store. The FDA sees this and orders Apple to halt production and sales of iOS devices until they prove safety and effectiveness of their devices with this App. This would clearly be a dilitary and frivolous thing to do, and a death sentence for any startup company in Apple's shoes.

The leadership of the FDA is largely aware of these issues but claim they lack the resources and political climate, as you mentioned earlier, to address this type of reform head on (small business ~22:00).

The FDA also needs scientists to speak out and work with them to improve, which is why I am concerned when I hear such ardent black-and-white responses surrounding the 23andMe case. The WhiteHouse.gov petition is an appropriate forum for some of that feedback.

Cheers,

Joe

P.S. Full disclosure, I am not a 23andMe customer nor fan nor affiliate. I am more concerned with the idea of personal genomic data coming to market successfully.

On Wed, Nov 27, 2013 at 3:53 PM, Srihari Yamanoor <yamanoor@gmail.com> wrote:

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.

This is a bit of a straw man. Most, but definitely not "all" FDA, pathways are modelled as a result of a natural evolutionary cause-and-effect of serving pharmaceutical companies in the majority of the submissions for approval. The FDA is aware of this issue and has openly admitted it as of 2011. They have made good progress along these lines, but again it can always be improved.

The FDA is, effectively, a litigious shield for pharmaceutical companies. Prior to any significant tort reform, this is an essential function for big pharma to operate under any circumstances. To this end the FDA has primarily adapted itself to serve us in this fashion.

Just in case my tone was not neutral before, I would like to be clear that there is no value judgement from me one way or the other on this point. This just how it is and how it came to be. The information is to be used as a baseline for further action, including how best to interface with the FDA (through a pharmaceutical company or other known successful pathways) and improvement for the future.

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. 

"Body-fixing business" in the same way that LoseIt! works as an App for tracking calories on a smart phone or that supplements work from bodybuilding.com. The distinction is not yet clearly defined. Until a clear criteria can be used to actually technically describe the scope in a meaningful way, it might as well just be considered the roulette that it is.

It would also serve them well to play nice with the FDA, as their latest email suggests and create a path with perhaps lesser resistance for other companies. It is commonly known in the device industry that the "first-in-class" company always falls on the sword in one way or another.

And for all this hand-wringing and fan-clubbing, 23andme has the money and means to fix something, for which only they are to blame. 

Sincerely,

Srihari

On Wed, Nov 27, 2013 at 12:20 PM, Joe Gorse <jhgorse@gmail.com> wrote:

Srihari and Matthew,

Both of you are kind of missing the point. This is not about direct therapies which have the capability to cause harm (as have been often straw-manned in the larger conversation about this topic), but who has the right to screen your genetic information at a level consistent with consumer market rates.

The distinction between "diagnostic" and "research and education" purposes is significant. Nobody conducts research starting with expensive "diagnostics", not scientists and especially not engineers. We start with broad and low-cost screening to find the areas to focus on and go from there as a starting point. To consider this service a direct diagnostic that would lead straight into harmful therapy is fundamentally a stretch, to say the least.

I will reiterate my thesis from above, because this reinforces the larger point of this issue: what is the cost to society of not having this information available to the consumer at all, even if it may be flawed to some tolerance? If all of this information is known genetically about humans and mammals in the lab, why has virtually none of that made its way to a consumer affordable services which allow us to individually benefit from all that research which has occurred since Watson and Crick regarding the human genome?

The FDA is not currently equipped to handle this situation. Reform is obviously necessary for a multitude of reasons outside the scope of this particular conversation. Ignoring the weaknesses of the FDA will only cause things to get worse before reform can happen. This is clearly an area in which the FDA has room for improvement and there is a low barrier for doing it. They don't need additional labs or funding, just a hard look at their policy, the economics, and their mission to public.

Cheers,

Joe Gorse

On Wed, Nov 27, 2013 at 2:22 PM, Srihari Yamanoor <yamanoor@gmail.com> wrote:

Sorry my fault. Thanks for correcting me! Also, please note this article before considering signing the petition. Fans of 23andme might be doing more harm than good.  Read it carefully, and read the last paragraph. There is also another discussion going on at the Society of Participatory Medicine listserv.

http://www.fiercemedicaldevices.com/story/23andme-digs-fda-wants-test-market/2013-11-27

Sincerely,

Srihari

On Wed, Nov 27, 2013 at 10:49 AM, Matthew Harbowy <hbergeronx@gmail.com> wrote:

Except for the part where Srihari calls the 23andme CEO a "he", Srihari is dead right. They have admitted their guilt in not answering the FDA in a timely manner, silence being something that you just don't do if you want to retain your head on your shoulders. It's that simple.

I am certain the maker of elixir sulfanilamide was just trying to make a more palatable cough syrup, to "do good" and "improve human health" when they chose ethylene glycol as an excipient, and the result was many dead children, and among the first moves toward what has become the FDA. If you don't know the phrase "elixir sulfanilamide", go educate yourself right away. Science, not good intentions or a good sellable story, is the basis of interaction with the FDA. Science requires disclosing facts and evidence, not wishes.

Matt

On Wednesday, November 27, 2013, Srihari Yamanoor wrote:

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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