The Government is Trying to Plant a Chip in My Brain: An Autopsy of a Startup

December 9, 2017 jimflannery No comments exist
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The U.S. government just took its first step toward forcing microchips into people.  Naturally, they are doing it for your own protection.

To be more specific, two weeks ago, the FDA approved a new drug for bipolar disorder and schizophrenia which includes a digital sensor that allows health care providers (and government) to track whether or not the patient has taken their medication (source).

The new drug is called Abilify MyCite, which is a “re-packaging” of the drug Abilify which recently came off patent to now include this magical sensor.  Who is behind this?  The drug was developed through a  partnership between the pharmaceutical company Otsuka and medical device company Proteus Digital Health.  If Otsaku is an unfamiliar name, you may recognize Bristol-Myers Squibb, the company who sold Abilify in the US through a partnership (source).

This sensor technology has three parts: the sensor inside the pill, a patch worn on the body to monitor the presence of the sensor, and a smartphone app which reports the data collected by the patch.  This is the image Proteus has released showing what their sensor technology is capable of:

Proteus Digital Health and Abilify MyCite You can tell from the screenshot of their app that Proteu’s game plan is far more expansive than just this one application, they want to use ingestible sensors to track everything about your health using their chip/patch/app trio.

At first, I’m sure this all seems great and well-intentioned.   Millions of dollars and countless hours of effort was put into developing this fancy new technology to help “make the world a better place.”  I even noticed one of their co-founders, George Savage M.D., actually graduated from my alma mater Boston University with a biomedical engineering degree (same as I have).

As an entrepreneur and biomedical engineer, I’m going to speculate that Geroge’s thought process went something like this…..

Holy shit!  I’ve got this amazing idea for a technology that can help millions of people get the data they need to make good healthcare decisions easily, affordably, and efficiently: “ingestible sensors”.  I just need to find a way to raise a billion dollars to develop these sensors and get them into every pill in the pharmacy and these patches onto every body on the planet. 

This is the mindset the founder may have had back in 2001 when Proteus Digital Health was first founded.  And here we are 16 years later and they’ve done all the right things to defy the odds and finally bring a product to market!  I certainly commend that accomplishment.

If you follow the story of Proteus since 2001, you see their vision for a perfect future pivot along the way to accommodate reality.  Here’s what reality has looked like financially for Proteus Digital Health.  I pulled their investment history off CrunchBase:

Proteus Digital Health and Abilify MyCite

That’s a documented $400 million worth of investment over 16 years, not including the Series A and Series B rounds which are for undisclosed amounts.  Maybe there are some angel investors that came even sooner.

I really do commend the founders for all the effort and sweat and tears it must have taken to endure this long 16 year journey of taking was just an idea in 2001 to become a reality here in 2017.

With sincerity:

Dear Proteus,

The journey you are on must be incredibly stressful, with countless people counting on you to succeed.  You have many investors all expecting to get a huge return on their investment.  You may have family members expecting you to provide for them.  Maybe you’ve made sacrifices along the way, committing more hours to your work than your family, believing it will be worth it in the end for that big pay off one day.  Plus, there are all the people out there in the world who would benefit from your technology, counting on you to deliver.  I feel for the pressure you must be under.

Well… actually… probably nobody is actually “counting on” Proteus’ technology.  I mean… when was the last time you said to yourself, “I just wish there was an app that could detect whether I took my medication or not.”

Having been involved in startups (even one that was in the medical and biotech realm), I can imagine some of the journey Proteus has taken.  You start with this idea for a great technology.  You believe it will one day be used by every person on the planet.  But to get to that day, you need to find that first application for the technology to get your business launched.  You search tirelessly for an application where people “need” this type of technology, not just a place where it’s “cool”.

That’s the only way you can actually get investment money to go through all the development and testing and regulatory processes to take your idea from concept to reality.  You need a product that, if you are actually able to create it, will without question be adopted by the marketplace.

Based on their current home page, it looks like Proteus started off looking at applications for their ingestible sensors in Cardiovascular Disease and Infectious Disease.  These are places where adherence to proper medication consumption could genuinely make a huge impact in the health of people.  We’ve all heard that about antibiotics, right?  That when your doctor gives you a 7 day supply of antibiotics, you should take all 7 days worth, even if you’re feeling good after 3 days.

Apparently, applications for cardiovascular health and infectious disease are “cool”, but not “needed.”  Because somewhere along the way, Proteus Digital Health partnered up with Otsuka to solve a problem Otsuka had: they want to force people to take psychiatric medications.

When a patient is locked up in a psychiatric hospital (or prison) it’s easy monitor them and force medication on them.  The problem remains of how to ensure “compliance” outside of an institutional setting.

The popular solution to this problem is “Assisted Outpatient Treatment,” or AOT.  While this sounds nice, AOT is a euphemism for forced drugging and is legal in 47 states (not in Connecticut, Massachusetts, or Maryland).  Under AOT, people have to report somewhere to take their medication every day to prove they’re taking it.  In other scenarios, an extended-release drug is given every couple weeks.

With this wonderful new technology from Proteus Digital Health, people won’t even need to leave their home to allow the government to monitor whether or not they’ve taken their medication: they can monitor you remotely using an app.

To be very clear, this technology from Proteus is not merely a way to help a patient in case they have “forgotten” to take their medication.  There’s a much fancier piece of technology out there to help people who forget their medication:

Proteus Digital Health and Abilify MyCite

Sure, it’s a bit low-tech.  But it’s 100% effective in tracking whether or not someone took their medication each day.  There’s also zero possibility the batteries will run dry or that it will somehow malfunction when Apple releases the new iOS version.

This is not about helping forgetful patient – this is about compliance.  And compliance is about control.

I’m not trying to claim the folks at Proteus are evil-doers.  I’m sure the founders of Proteus have an immense amount of pressure on them and are doing everything they can to 1) get their investors a return on their investment, 2) get their life-changing technology to be used for real life-saving purposes, 3) make money, and 4) not be failures.

Yet, even with good intenions, the reality is that they’ve now entered the world of forced drugging.  I’m sure this was not the intention of Proteus in the beginning…. but this is absolutely the intention of their business partner, Otsaku.

With more sincerity:

Dear Proteus,

Damn, I feel for you.  You must have been so friggin’ excited when you signed that deal with Otsaku.  “Holy shit – we just partnered with one of the largest pharma companies in the world – we’re gonna change the world!” you must have thought as you signed the contracts.  It’s easy to not have seen through the bull shit to the reality that you were partnering up to to facilitate forced drugging of psychiatric patients. 

What do you do now?  You’ve raised $400 million dollars, you’re investors are all expecting 10X returns on their money, you’ve invested your life into this thing – what do you do? Just walk away?  You’ve likely signed into non-compete agreements which prevent you from working anywhere else in the healthcase industry for several years.  You could stay onboard and sabotage the project, you could probably be sued.  If you shut down, you’ve got 400-500 employees who will be out of work.  

Even if a single member is to quit the company, you will be replaced and the machine would keep on rolling.  You’ve created a fucking monster with a life of its own.  And now, it owns you.

I wish I had tangible action to give Proteus.  Just admit you made a mistake and walk away?  Sounds simple, but life is obviously complex.  I suppose the first step is acknowledging that you’ve got a problem.

It might sound like I’m picking on Proteus.  I’m trying to empathize with them but I’m afraid my anger is probably leaking through.  I do want to give them the benefit of the doubt as am ambitious startup with a promising technology trying to “make it”.

I have more genuine and deep-rooted grievances toward Otsaku, their pharma partner, who is a massive powerhouse of a pharmaceutical company that has been doing shitty things for a long time.  Like I mentioned, Abilify just came off patent, it’s been around for many years causing damage.

Otsaku’s revenues from Abilify were about $2 billion per year up until the product came off patent in 2016.  This data from Statistica:

Proteus Digital Health and Abilify MyCite

Just a taste of the Bristol-Myers Squibb / Otsaka douchebaggery: they pushed Abilify as a treatment for kids and for elderly patients with dementia, when neither use was approved by the FDA!  They got sued and settled for $20 million in 2016.  (source) Is $20 million not a big enough settlement?  In 2007, the same company settled a separate suit for similar illegal marketing practices $515 million (source)!

This is all for a drug, Abilify, which is now going to be able to be monitored remotely to make sure people are taking it.

Once upon a time, I was coerced into taking psychiatric medications to treat what doctors were convinced was a mental disorder.  Once someone is put on the medications, it is very difficult to get off them both for legal and physiological reasons.

One of the drugs I was put on was lithium.  Unlike all other psychiatric medications, lithium levels can be tested by a blood test, meaning you can detect whether or not someone takes their pills by checking their levels.  This information can then be used by courts to claim one is “non-compliant” for not taking their medications.

Many biological conditions can alter your lithium levels (for example sweating a lot during a workout or a day of hiking), but, in my experience, low lithium levels were generally assumed to mean you weren’t taking your medication.  After I got off lithium, I used to joke that the ‘chip the government put in my body had been removed.’

I repeated this joke after I quit smoking weed since courts can do blood tests for THC.  I bring this up because, again, the government could take a blood test and see a drug level in my system and make claims that I was a criminal for measured amounts of THC in the same way they could label me as non-compliant in the absence of lithium (which could also have criminal consequences).

The whole idea that the government would put microchips in us has been dismissed as a product of conspiracy theorists and paranoid schizophrenics.  Yet… there was also a time when “only crazy people” believed the government was tracking our digital and telecommunications activity.  This proved to be a fact in 2013 when Edward Snowden released details of the NSA mass surveillance practices (source).

It’s also a fact that millions of people have put chips inside their pets in case they lose them (source).  The security company BrickHouse in New York City claims they gets calls every single day from parents asking if they can putting tracking microchips in their children (source).  It’s also fact some humans have voluntarily had chips put inside them to control the locks on their homes or work (source) and the company Dangerous Things even sells a kit to chip yourself for less than $100 (source)!  You just need to get it “installed” by a tattoo artist.

If you still think forced-microchipping is far-fetched, just consider the simple facts: The FDA has approved Abilify MyCite.  There are $400 million dollars invested in Proteus (and probably more from Otsaku).  Those investors are looking for a 10x return on their investment, that’s $4 billion in profits they are expectingForced drugging has been around for decades… what could ever stop them from using the microchipped drugs?  Maybe me.

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