Digital Health Companies have to be careful, otherwise they could spoil the game for everyone

NOTE: It has been a busy few weeks and it is going to be a busy few months ahead. So, my blogging frequency is going to be erratic at best. It is a shame, because I wanted to write on the Prostate Awareness Month and then on Breast Cancer Awareness in October. However, Maker Faire Exhibits, Conference Presentations, Panels and Judging lie ahead for me, so please excuse the varied publishing schedule.

SyncThink

MedCity Newes reported on a warning letter from the FDA to a burgeoning company, SyncThink and they seemed to have responded promptly, as one would hope. However, the tailwinds still leave behind a trail of caution for companies going forward. Here's a quote from the MedCity Article:

SyncThink’s device Eye-Sync was cleared as a prescription device for the purpose of recording, viewing, and analyzing eye movements to help identify visual tracking impairment in human subjects, according to the letter.

However, it appears their overzealous marketing folks decided to go ahead and bump up the device to include concussion detection as a "feature". Why not? What with studies about the NFL, and various sports agencies deliberately ignoring issues have rendered many sportspeople with permanent ailments. Concussions also happen due to accidents, falls, etc., and thus the available market obviously spans a wide range of ages and gender is no bar. And yes, they can be life threatening. All this, of course, does not mean that you need to put the proverbial cart in front of the horse.

SyncThink of course claims it removed the materials that offended the FDA immediately from all of its marketing mechanisms.

Good, Right? Well...

A Trail of Bad and Unacceptable Behavior

The history of Digital Health is rife with examples of bad behavior.

Let's start with Not-AI/Maybe-AI/Most-Likely-ML

Actually this behavior spans all aspects of Healthcare, including, IBM Watson, according to a recent STAT article - promoted as a cancer therapy recommendation system, and sold prematurely resulting in a number of problems. This is something I have suspected for a while now, and it has been confirmed. Jumping the gun, declaring poor, dysfunctional Machine Learning products, worse than what a teenager can do with TensorFlow has become the order of the day for some companies. And to see IBM, glorified by Satell in one of the iconic books on Innovation do this is just sad. It should make you wonder about others.

Real AI is really not here. Excuse the pun. Google and IBM have friendly monsters that do a great job at Deep Learning. The actual independent decision making that would be the functional result of actual intelligence (not algorithmic analysis output), simply does not exist yet, at least in the public eye. And most of what you hear, is really just Machine Learning. More on this in a few blog posts before my December talk at the San Jose BIOMEDevice talk on AI in Medical Devices.

The problem with packaging stuff as AI?

It will always be the same. Overpromise, under-deliver, dilute your brand AND make it worse for the people that follow you. Just read my blog post on renal denervation, when I complete it and get it out later this week. The World Faires saw fewer contortionists in all of their existence, compared to people still, desperately trying to peddle renal denervation.

And while Scott Gottlieb wants to make the FDA business friendly and what not, two things to keep in mind - the FDA was created to avoid the kind of mortality and morbidity seen in Europe because all kinds of snake-oil merchants walked in and did whatever they wanted, and second, Europe, after about 50 years or so, has finally decided to take a more FDA-like approach.

So lying, fluffing or overstating, will get you trapped somewhere with regulatory problems. And, then, there will be the face-saving that all the other regulatory agencies will do by trying to get in on the game: bashing you.

My recommendation: Just don't do it.

But, let's go through one more example, before we get back to the recommendation that you have, hopefully heard since you were a child.

23-and-you-maybe, but not me!

Years ago, when 23andme came out, I was very irritated and wrote unequivocally about how they were going to make things hard for everyone. Why? All they could do was process your DNA. However, they marketed it in a way to make gullible people believe that as long as you joined the mania, and got your DNA mapped, suddenly a cure for just about anything to be found. Again marketing, with a serious disregard of facts. I am sure at least initially, they were not able to meet their price point profitably (this is just an assumption I make), and were hoping to ride the hype wave of people thinking suddenly, all they needed was Microsoft Excel (or Google Drive, given the company's origins) and compare their DNA with a bunch of friends - and lo!, the answer to everyone's problems would be laid bare with genetic certainty. Well...

Back then (and even now, and for at least a handful of years to come), even confirming a Single Nucleotide Polymorphism (SNP), where a single pair of nucleotides is off its hinges on the DNA ladder, took months to years to confirm. So, the company was essentially planning to capitalize on the desperation of the sick. Well, long story short, it took YEARS for the FDA to tell the company to go pound sand (too bad, neither the FDA, nor I are allowed to use more colorful language).

The company shockingly enough first tried to push back, and eventually gave in. Remarkable. And along the way, they slowed things down for everyone else, who could have behaved themselves, and gradually introduced a usable product, legally, when its time actually came.

My Recommendations:

1. The Valley (there really is only one here, contextually) is full of "people", who think the rule of law exists for others. They quaintly call such behavior: DISRUPTION. Ask Uber how that is working out. You might tell me, well, AirBnB broke the rules and bullied everyone, and got away with it. I ask you, what is likely: will you be the Uber of Concussion Detection or the AirBnB of it?

2. Regulations exist for a reason. No, not that you may flout them and find your own Lucy Koh (of the Apple/Samsung fame), sitting on the Federal Bench, just waiting to bite off more than he or she can chew! Again, your business plan can't be, "let's burn the bridge and when we need to cross one, get acquired".

3. Don't ruin it for others. When you flout regulations, or put out a terrible, immature product (read about what Medtronic did with Renal Denervation), you screw over quite a number of companies. People lose jobs, patients don't get the care. Do you really want to be the geniuses that got everyone in that swamp?

4. Following the rules is actually not that hard. Hire people with experience doing this. Go to RAPS, or the ASQ and look up good people. And I got good news for you: "Talented people in medical devices actually get paid terribly". Compared to the so-so CS grad you hired, only to have to give him bags of money, feed him and do his laundry, so he may write misogynist memos ruining your already flaky reputation because you funded 23andme!

5. Regulatory Agencies are almost always behind the curve. If you doubt me, go ask a Software Quality Engineer, what it takes to provide a software-update on an FDA approved product. But they learn. In the meanwhile, do not try to hoodwink them because they don't understand the gibber jabber of AI and so on and so forth. These are really smart people, and prone to anger (if you had to read and interpret text only pdfs all your life - and NO, your ML algorithm cannot do a better job, you'd be on the edge too). Play nice. Explain yourself to them. Show them your intentions are good. And work with them.

Doing all of the things I have stated are not going to earn you brownie points. You are expected to do them. There is a lot of change ahead with Digital Health, 3D Printing, 4D Printing (yes, it exists, mostly in labs), ML/DL/AI, IIoT and who knows what. It is important that when applying these technologies and paradigms to healthcare, good judgement, patience and care is essential.

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Reference:

1. On SyncThink: http://medcitynews.com/2017/09/fda-slaps-syncthink-warning-letter-concussion-detection-claims/?_hsenc=p2ANqtz-8nrGCq5sErFwlSoErAZCVWLTeQMaeWZlOm465jisv-uu2z4yqUt-sfcRu-YPPwD_LNPpWqAHnDZ-vxrsb-YPv7d0K6xA&_hsmi=56142139


2. IBM's Watson on STAT: https://www.statnews.com/2017/09/05/watson-ibm-cancer/?utm_source=STAT+Newsletters&utm_campaign=1793b79d98-Weekend_Reads&utm_medium=email&utm_term=0_8cab1d7961-1793b79d98-150030301

3. Image, Courtesy Pexels: https://www.pexels.com/photo/black-and-blue-electronic-tools-on-green-circuit-board-39290/

Genetic Screening is heavily misunderstood and therefore, it languishes, rightfully so!

I am going to write about one of my favorite topics, where I will, take somewhat of an antithetical position, and that is going to piss some of you off. If it does, it was meant to. If you are looking for a post that sings the praises of genetic screening, you are in the wrong place, but please do read on and find out exactly why. And no, I am not writing simply because genetic sequencing based ancestry ads have taken over my television with nauseating and stupid repetition focused on letting people know about their "ancestry" (which can be useful, yes, but more on that later). The reasons are deeper.

Now, I am all FOR genetic screening. Eventually, it will be the norm. This post is about WHY it is not being accepted by people at large yet, what is driving that, and the consequential desperation with which advertisements and strong-arming by physicians of their patients. A better understanding of these issues will clear the way for acceptance and genetic screening. So, let's take a dive.

1. Fear

Fear motivates humans in ways almost no other emotion can. Any time new technologies, methodologies, philosophies etc. emerge, people always respond with fear. And with something immensely personal, such as one's own genetic information, people will fear. In a society where science and scientific thinking is shunned and ignored, this is to be expected. So, education and awareness are not only important, they also take time.

And instead, it appears companies and physicians are jumping the gun, trying to push patients and parents, as in the case of a project titled BabySeq, that allows for babies' genetic codes to be sequenced, which apparently 93% of parents, have rejected.

To anyone who has been following clinical trial enrollment, especially in Oncology would not be surprised at this number. In fact, notwithstanding that genetic sequencing doesn't offer any immediate benefits, the numbers, at 7% of babies sequenced, is higher than, in some cases, where oncology trials only draw 5% of those eligible. Yes, a small number of patients would fear the possibility that they will get something other than the standard of care and might even perish. However, fear that a new treatment would fail or have unwanted side effects is probably what keeps a significant number of eligible patients off clinical trials.

A deeper understanding of how people react to new things and ideas, and what it would actually take to convince them to do adopt these things an ideas is essential.

2. Understanding the Non-Scientific Mind and the Non-Entrepreneurial Mind

Given that you are reading this blog, you and I think along the same lines - a mind with a high affinity towards science or entrepreneurship or both. We don't think alike, but, we embrace science, new technologies etc. more readily. When offered an opportunity to have my genetic screening done, I will do so readily, even though I fear, it may not reveal good news.

Much has been written about how entrepreneurs think, and to a large extent, how scientists think. But, consider those who do not readily embrace either, or both think. For them, something intangible, with a lack of immediate benefits, does not present an attractive proposition. They don't care that you can take the genetic information of hundreds of thousands or even millions of people and use "big data" and "machine learning" to glean insights.

When faced with such people, prudent strategies are required to create awareness and help them espouse genetic screening.

3. A million Henrietta Lacks?

If you are yet to hear of her, congratulations on living in a really airtight vacuum. However, as most of you know, her cancer cells were turned into an immortalized cancer line and innumerable research projects were carried out. Her family was never compensated for it. Now, when it comes to giving up their genetic codes, patients have to wonder if the benefits will be reaped by a handful of organizations.

It is clear that gene sequencing and the data analysis has the potential to allow for faster diagnoses and better treatments, the openness of the resulting analyses and findings should be paramount. This must be really hard for some companies to swallow, especially for one, started with the main aim of over-promise, under-delivery and essentially dominate the gene sequencing market, that had to be slowed down by the FDA, only to now peddle ancestry identification advertisements.

Yes, ancestry related data can further help point towards specific disease vulnerabilities among patients. However, as you know a lot of those types of studies have so far resulted in open information (stomach cancer risk in the Japanese population as an example), and this should continue. Give people assurances that you are not planning to profit off their data, and you will get much farther with gene sequencing, especially among healthy people and parents.

4. Genuine Legal Concerns

There are genuine legal concerns here. Will genetic data be properly blinded? Will insurance companies take advantage of the data to deny or reduce coverage? Will government agencies use the data to track babies or others?

This is more important to a lot of people than the fact that Penn was able to alter the treatment for 80% of the patients whose genetic sequencing had been completed. Finding out what the pain points are for people is key.

Real Solutions

Now that at least some of the major concerns surrounding gene sequencing have become apparent, doctors and organizations should implement solutions that are appropriate. Blind the data, prevent unauthorized access to patient information by third parties, including governments and insurance agencies, empower patients and the general population to have control over how and when the data is used, and prevent a random few from profiting off gene sequencing.

Make the future benefits of sequenced genetic information clear to people who think unlike scientists and/or entrepreneurs. And please keep off trivializing sequencing with nonsense such as ancestry. If you are going to use that angle, use it wisely, drawing a clear line to have that is actually beneficial.

Stepping into the shoes of others is critical, and this, I clearly believe is missing in the campaign to have people sequence their genes.

References:

1. Health IT News Article: http://www.healthcareitnews.com/news/precision-medicine-fight-brewing-between-clinicians-public-health?mkt_tok=eyJpIjoiTmpWbU0yWmhNR1kyTnpZNCIsInQiOiJ1T0lTMVdTTitQeHczUWxlOEtnczR1aWR2Mnc2allvbkd0cEVneU5NNzlwSnJSQzY4dkxzVmJPRHNQa04ybUhtQlVrRloyR2lpdER3VlRrQ1krM1hhdkVoRUJcL2FWZXlGbEZSMnVsRzV5Wk1VMFg4V3pGZVNYYzFPUVwvOXRGYjhkIn0%3D

2. Image, Courtesy WallpaperCave: http://wallpapercave.com/w/PYYchEd

Follow Up: How 23andme is getting some free spin doctorism...who's buying?

[Click on Post Title for Link to External Article]

I also want you to read this one from the same blog:

http://mndoci.com/blog/2008/06/17/the-right-to-get-yourself-genotyped/

And my original post here:

http://chaaraka.blogspot.com/2008/06/my-husband-had-all-this-money-lying.html

Here is my problem:

Most things are actually not your decision. This viewpoint that because it is your body you can do anything with it sounds like something you hear from irascible teenagers and pot smokers.

This is not about you at all!

This is also not about whether or not WebMD is organizing information the way you would appreciate it and how 23andme is better organized at rehashing the same information.

This is about vulnerability.

Of course they are not "telling" you that you should get yourself tested. But heck, they are implying it.

And if the Doctors know less than you about genetics (from the second blog I believe) - however believable that statement might be - it doesn't solve the basic problem.

The practice of medicine is mired by its own puff-able concept "Gold Standards". And even then, genetics hasn't gotten to the stage where insurance will pay enough and Doctors will pay attention. It will get there soon, not just yet.

But, we need to get back to the context.

Here is the problem with 23andme and its Redwood City look-alike:

1. We understand very little about how genetics actually work, even less about why SNPs occur, how they are triggered to start up or shut themselves and so on. Yeah, we know something...we have no clue about most other things.

2. In case this is news to you, people are gullible. The guy who's dad just died from Colon Cancer, the lady who's mom died of breast cancer. 23andme, believe it or not is a lovely, expensive trap for such people.

3. Let's go back to your Doctor thing. Let us say that family X did get their genes profiled. You admit yourself that based on your extensive survey and unfathomable depths of prescience, most Doctors have no clue what A,T,C,G and U do other than serving as alphabets. Given this situation, knowing that no insurance company wants to pay for the information, what is family X to do with the junky printouts 23andme sells them.

4. This may also be news to you. There is this group of people called hypochondriacs...

Oh my God! The things people say and imply. California sent those C&Ds at the appropriate time. Before we understand genetics, trying to randomly decode information at a perky price of $1000 or higher is as good as offering people to clone their dogs for them! (Apparently there is a huge market for them, and yeah, yeah, they are your dogs. God, someone call the SPCA - it's after all the dog's own genes...)

(Note: If 23andme were to do it for free at this point, I would have no problems! That would be a true contribution to science. Otherwise its like trying to get 1000 monkeys to come up with Shakespeare's plays, and asking the monkeys to pay for it as well)

And come on! Who are you fooling? If you walk down the street and described 23andme to random individuals on the street, how many would actually realize, admit or agree to your view that this is NOT about healthcare and that the Department of Public Health should just wait and watch.

Yes, 23andme and Navigenics are just that - snake oil merchants with deep pockets!

And if you are mad, maybe 23andme can figure out and help you remove the "mad" gene. I am sure they have good, well organized notes on why people get mad....

My husband had all this money lying around, so I thought I could do something medically useless in the field of medicine...how can that be

[Click on Post Title for Link to External Article]


wrong?

To quote: "Requiring that such tests demonstrate clinical "utility" could pose a particular problem if applied to 23andMe: The company has admitted its tests are not medically useful, as they represent preliminary findings, and so are merely for educational purposes."

Well, what have we here! So much money and they did not get their lawyers to do a simple fact check?

Demonstrating clinical utility could be a problem for a genetics test company?

Of course, all that really needs to happen is for Sergei to take a plane to Sacramento and convince people that demanding utilities in products is an absurdity:

"Our family has a tradition of creating half-functional products that we like to then display as the 'next best thing'.

Demanding fully functional or otherwise useful products interferes with our ideals to do business with no meaning, purpose or use and severely inhibits our ability to charge people for it!

If you don't stop making such demands immediately, we will buy California and sell it to someone else."

And so the story goes...

In reality though, if you look past the silliness, I do not have any sympathies for 23andme or Navigenics. Sailing on funds available through randomness or gullible Venture Capitalists, these firms set off to "create genetic profiles" that are "preliminary results only" and what not.

I am also not ga-ga over Navigenics "going through a doctor".

Its not like everyone with a Medical Degree has been sifted through the sieves of ethical practice.

We have barely understood that we have about 30,000 odd (or 40,000 odd was it?) genes in the human body.

We still theorize and struggle to explain why, our genetic scheme is only 1 - 2% different from that of the chimpanzee and that somehow fabulously makes us superior ( a very subjective opinion) as animals.

We have just finished realizing that our mitochondrial DNA - in statistical summary all of ours, meaning the 6 billion of us, almost shared the same mother once - meaning our entire race was nearly destroyed.

All this means one thing: we need to understand a lot more of the nuances of genetic interactions and how they are turned on and off before running around with a CD of our genetic code. Of course, whenever SNPs lead to disease, we can start working on those in the near future, but for most other complex genetic interactions, data provided by companies like 23andme would be useless.

Yes, indeed, it would be a great idea to cull genetic data from thousands of human beings. It would allow for statistical correlations (if we believe in statistics, that is) and eventually solid proof.

However, I have some serious problems with companies that want to charge people for things even they consider to be useless.

It is also an important lesson for entrepreneurs.

Sometimes funding is not enough.

Sometimes funding itself can make you shortsighted and lead you down the wrong path.

What 23andme or Navigenics have failed in doing will be a great stepping stone for the next company that comes in:

1. Research, research, research. Clearly understand what you are selling, understand who is buying and what they want and why the want it. Are they buying something because they want it, need it, or think they need it (like the practically useless ipods and iphones)?

2. Understand national, international and rather more importantly local regulations - especially if "local" happens to be California.

But don't stop there. Just because something is not being regulated right now does not mean you can run away with anything (or precisely, that something). States and Nations often start regulating an industry in the wake of new practices. Of course, most of this is driven by fear, sometimes unfounded, but you need to spend at least a little time thinking about this, especially when you are doing something "groundbreaking".

3. Be wary of where your funding comes from. While it is often harked that you need supportive investors, you also need independent investors who need to judge if your idea makes for an actual sale-able product or service.

4. Don't name something "educational" (refer back to the quote about 23andme) unless it is actually educational. Yes, genetic testing can be educational. But how can it be educational to potentially gullible customers who paid for something useless?