Author Topic: Electronics in medications? Wait, WTF?  (Read 1912 times)

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Offline hansTopic starter

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Electronics in medications? Wait, WTF?
« on: April 14, 2021, 09:21:29 pm »
Tonight, I found this: https://www.abilifymycite.com/about

FYI: Abilify is an antipsychotic drug for people that need to silence the storm inside their head. The problem is that this storm can convince patients that they forget whether they've taken them, or don't need/want/require the drug anymore (because it makes them feel too great/bad). The bottom line is, therapy efficacy of such medication is defined by therapy compliance. And so they created a pill that tracks whenever it has been taken, so the doctor can see whether you are honest about actually taking them.

To be honest I'm not surprised this exists. I think Mythbusters way back in the day did a myth about a digestion passable body core thermometer. I think Mike from mikeselectricstuff also did a teardown of a similar camera unit. However those were both plastic capsules that were designed not to give off medication chemicals or dissolve in the digestive system. Meanwhile, these pills apparently do.

At first I thought that maybe they have some special pill dispenser or strip that tracks when the user takes one. But that would be easily faked, as you can just throw the medication away. They actually want to know if you have taken it. The brochure (half way down the page), says it tracks pill ingestions using a body patch. But then I read the descriptions  (page 6):

Quote
The nonmedicated MYCITE® Patch gets a signal from the smart pill after you swallow it. Like an activity tracker, the Bluetooth®* patch logs your daily rest and activity (steps), sending the information to an app on your smartphone. The patch can stay on even through water and sweat and does not need to be taken off in the shower or during exercise.
So the patch is probably some small sealed Bluetooth sensor that logs a few metrics.
Quote
ABILIFY MYCITE® (aripiprazole tablets with sensor) is a smart pill that combines prescription medication with a tiny sensor the size of a grain of sand. The sensor is made entirely of natural ingredients found in most diets. It passes through your body naturally.

Wait, the sensor is made entirely of natural ingredients?! The last time I checked, people normally don't eat sand. So what would features or construction could they use from an 'organic' pill to do this kind of tracking? :-//

This withdrawn medical application, seems to suggest it does contain some kind of electronics: https://www.ema.europa.eu/en/medicines/human/withdrawn-applications/abilify-mycite

Disclaimer: I do not want to cross reference and certainly hope we don't diverge towards a 5G-chip vaccin discussion.
« Last Edit: April 14, 2021, 09:37:25 pm by hans »
 

Offline JohnnyMalaria

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Re: Electronics in medications? Wait, WTF?
« Reply #1 on: April 14, 2021, 10:10:32 pm »
Who said anything about it being made of sand?

Here's the patent: https://patents.google.com/patent/US20100185055A1/en
 
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Offline xrunner

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Re: Electronics in medications? Wait, WTF?
« Reply #2 on: April 14, 2021, 10:27:03 pm »
Who said anything about it being made of sand?

Here's the patent: https://patents.google.com/patent/US20100185055A1/en

From that link, interesting reading -

Quote
The activation component is a component that activates the signal generation element of the identifier to provide a signal, e.g., by emission or upon interrogation, following contact of the composition with a target physiological site of interest, such as the stomach. As reviewed in co-pending PCT application serial no. PCT/US2006/016370, activation of the identifier may be achieved in a number of different ways, where such approaches include, but are not limited to: battery completion, battery connection, etc. The different activation approaches disclosed in this co-pending application may be readily adapted to provide activation, as described herein, and as such are herein incorporated by reference in their entirety.

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Offline DrG

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Re: Electronics in medications? Wait, WTF?
« Reply #3 on: April 14, 2021, 10:32:24 pm »
Sounds to me like it is basically, a small and simple transmitter. The "battery" becomes active for a short period of time by contact with gastric fluids. The chip communicates with a patch worn near you stomach. The patch has BLE which communicates with your smartphone.

Embedded in the pill is a sensor that consists of a silicon chip with the logic circuit, along with two pieces of metal: copper and magnesium, Savage told Live Science. When the sensor is dropped into a solution of water or any other liquid that has polar molecules (such as the hydrochloric acid in the stomach, which dissolves the pill, leaving the sensor behind), the device will generate a current. The current is very small, but it's enough to run the chip.

"Technically, it's a partial power source," Savage said. "The patient becomes the battery."

Once activated, the chip — only 1 millimeter on a side, and 0.3 mm thick — sends a very simple signal, one that encodes only a single number. That number identifies the pill and tells the wearable, adhesive sensor — basically an adhesive bandage, Savage said — that it has been ingested.

The pill's signal isn't a radio signal, though, Savage said. The chip's logic circuit makes a small modulated current — a graph of the current levels would look like a sine wave. Since the human body is conductive, the wearable sensor can pick up the changes. The modulated current can encode ones and zeroes, similar to an FM signal, Savage said.

"It works in a similar way as an EKG," or electrocardiogram, Savage said. These machines pick up on changes in electrical current in the body to monitor heartbeats. The wearable sensor does the same thing, though the current is smaller, he said.

 from https://www.livescience.com/60963-how-does-digital-pill-work-abilify.html


No WTF here.

« Last Edit: April 14, 2021, 10:35:54 pm by DrG »
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Offline amyk

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Re: Electronics in medications? Wait, WTF?
« Reply #4 on: April 14, 2021, 11:57:09 pm »
I guess the WTF is "The sensor is made entirely of natural ingredients found in most diets."

Maybe if you count electrons, protons, and neutrons as "natural ingredients found in most diets"... which then begs the question, "most diets!?!?" :o
 
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Offline DrG

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Re: Electronics in medications? Wait, WTF?
« Reply #5 on: April 15, 2021, 12:29:25 am »
I guess the WTF is "The sensor is made entirely of natural ingredients found in most diets."

Maybe if you count electrons, protons, and neutrons as "natural ingredients found in most diets"... which then begs the question, "most diets!?!?" :o

What does the sensor contain that you think is not found in food?
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Offline ChristofferB

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Re: Electronics in medications? Wait, WTF?
« Reply #6 on: April 15, 2021, 07:17:37 am »
I have never eaten a carrot that didnt have at least one crunch from a leftover grain of sand.

It's definitely an analogy for non technical people.

Sand is basically silicon dioxide, and both it and silicon are nontoxic, and stable enough that they aren't notably dissolved at physiological conditions.

We have become fairly good at making bioorthorgonal stuff to put in the body that just passes through unnoticed.

It is a pretty cool product, though!

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Offline hansTopic starter

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Re: Electronics in medications? Wait, WTF?
« Reply #7 on: April 15, 2021, 03:01:22 pm »
I usually wash all my veggies till there is no sand left, so perhaps that's what they mean with "most diets" :)

I was more interested on how you can ingest an electronic apparatus, power it, and have it communicate something out/through the body, without having anything else besides body-friendly materials. Because my initial post was using the anecdotal "chips are just sand!" - but I thought most chips require much more than silicon alone (not even looking at packaging).

You can get your silicon substrate and N/P double/triple wells made out of silicon wafer for e.g. all the CMOS devices. However, you would also connect those CMOS devices through metal layers. You may need another chemicals to isolate the gate from source/drain. You may need bond pads to connect an 'antenna' or battery to it. Most batteries also use nasty chemicals, so can't 'package' a battery within the pill.

I think it's quite a fetch to say all of that compatible in the human body, but apparently they have been able to substitute all of it. Very cool tech.
 

Offline DrG

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Re: Electronics in medications? Wait, WTF?
« Reply #8 on: April 15, 2021, 03:39:07 pm »
I usually wash all my veggies till there is no sand left, so perhaps that's what they mean with "most diets" :)

I was more interested on how you can ingest an electronic apparatus, power it, and have it communicate something out/through the body, without having anything else besides body-friendly materials. Because my initial post was using the anecdotal "chips are just sand!" - but I thought most chips require much more than silicon alone (not even looking at packaging).

You can get your silicon substrate and N/P double/triple wells made out of silicon wafer for e.g. all the CMOS devices. However, you would also connect those CMOS devices through metal layers. You may need another chemicals to isolate the gate from source/drain. You may need bond pads to connect an 'antenna' or battery to it. Most batteries also use nasty chemicals, so can't 'package' a battery within the pill.

I think it's quite a fetch to say all of that compatible in the human body, but apparently they have been able to substitute all of it. Very cool tech.

So, as we all know, there is marketing hype, that can be technically accurate but not terribly significant in the absence of other information. IOW, it "sounds" better than it really is. So, for example...

The sensor, containing copper, magnesium and silicon (safe ingredients found in foods), generates an electrical signal when splashed by stomach fluid, like a potato battery, said Andrew Thompson, Proteus’s president and chief executive.
from: https://www.nytimes.com/2017/11/13/health/digital-pill-fda.html

So, some simple searching for;
what foods are high in silicon? https://www.ncbi.nlm.nih.gov/pmc/articles/PMC2744664/
what foods are high in magnesium? https://www.healthline.com/nutrition/10-foods-high-in-magnesium
what foods are high in copper? https://www.healthline.com/nutrition/foods-high-in-copper

and you will see all this therapeutic value for minerals, including silicon.

But, of course, you have to ask - well is this the exact same XXX as the XXX found in foods? Then, it becomes, well how much is in there compared to how much I need and get through diet and how much can cause problems?

For example, there is a birth control device that relies on copper https://www.mayoclinic.org/tests-procedures/paragard/about/pac-20391270 It is touted because there are no hormones....but some people are very sensitive to them and in some existing conditions, copper accumulation can be a real problem.

I don't know the answers in the case of aripiprazole and this monitoring system, but I would be shocked if the FDA application did not contain some information about those topics. I guess that is one of the first places I would look...the NDA application and all the supporting documentation.

The other thing is that I have not seen any evidence that its use increases patient compliance and in the little bit of reading I did, I don't think that the FDA has approved it saying that it has any effect on patient compliance - that could come later I suppose.

...just my two cents...
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Offline JohnnyMalaria

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Re: Electronics in medications? Wait, WTF?
« Reply #9 on: April 15, 2021, 03:52:17 pm »
At least one clinical trial is due to read-out soon:

https://clinicaltrials.gov/ct2/show/NCT03892889
 
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Offline hansTopic starter

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Re: Electronics in medications? Wait, WTF?
« Reply #10 on: April 15, 2021, 06:02:43 pm »
So, as we all know, there is marketing hype, that can be technically accurate but not terribly significant in the absence of other information. IOW, it "sounds" better than it really is. So, for example...

The sensor, containing copper, magnesium and silicon (safe ingredients found in foods), generates an electrical signal when splashed by stomach fluid, like a potato battery, said Andrew Thompson, Proteus’s president and chief executive.
from: https://www.nytimes.com/2017/11/13/health/digital-pill-fda.html

So, some simple searching for;
what foods are high in silicon? https://www.ncbi.nlm.nih.gov/pmc/articles/PMC2744664/
what foods are high in magnesium? https://www.healthline.com/nutrition/10-foods-high-in-magnesium
what foods are high in copper? https://www.healthline.com/nutrition/foods-high-in-copper

and you will see all this therapeutic value for minerals, including silicon.

But, of course, you have to ask - well is this the exact same XXX as the XXX found in foods? Then, it becomes, well how much is in there compared to how much I need and get through diet and how much can cause problems?

For example, there is a birth control device that relies on copper https://www.mayoclinic.org/tests-procedures/paragard/about/pac-20391270 It is touted because there are no hormones....but some people are very sensitive to them and in some existing conditions, copper accumulation can be a real problem.

That indeed is a valid question.

If you look up a regular multivitamin with 100% recommended daily allowance, most metals will be limited at tens of mg per day.
This study lists silicon as 24-33mg/day as being regular: https://academic.oup.com/ajcn/article/75/5/887/4689403
The paper also lists that a recommended daily allowance for silicon was not yet established, but they don't estimate it really that high.

Several tens of mg doesn't sound like a lot of material to work with.

Quote
I don't know the answers in the case of aripiprazole and this monitoring system, but I would be shocked if the FDA application did not contain some information about those topics. I guess that is one of the first places I would look...the NDA application and all the supporting documentation.

The other thing is that I have not seen any evidence that its use increases patient compliance and in the little bit of reading I did, I don't think that the FDA has approved it saying that it has any effect on patient compliance - that could come later I suppose.

...just my two cents...

Well the EU application was declined, because if such a device is intended to help people that forget medication or are constantly unaware of their own actions, then that system needs to be watertight. Not only do you want to know when people forget medication, you also want to know if they're taking more than they should. Looking at the patent they are just sending a very simple Manchester/n-Miller encoded tone to the patch. What happens if you take 3 pills at once? Does it detect 3 pills or detect none of them as multiple transmissions are happening at the same time? Any of those faulty conditions is in their own way a disaster.

I agree, it's hard to say if such a system would really help  in compliance. As a daily medication user for migraines, I sometimes also wonder if I have taken my medications; especially if I'm tapering up or down which requires 3-4 moments/day. There are obviously more straight forward approaches to that problem such as a medication box and mental tracking (e.g. counting back the days and doses on the packaging since you last remember), but that's arguably not enough automation.
« Last Edit: April 15, 2021, 06:05:38 pm by hans »
 

Offline tooki

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Re: Electronics in medications? Wait, WTF?
« Reply #11 on: April 15, 2021, 08:54:26 pm »
Wait, the sensor is made entirely of natural ingredients?! The last time I checked, people normally don't eat sand. So what would features or construction could they use from an 'organic' pill to do this kind of tracking? :-//
Then you didn’t check very well. Sand is mostly silicon dioxide, and silicon dioxide is a common food additive, probably most frequently encountered in powdered spices to keep them from clumping, as well as in pharmaceuticals in pill making. Hydrated silica (another form of silicon dioxide) is a common ingredient in toothpaste.
 
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Online coppercone2

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Re: Electronics in medications? Wait, WTF?
« Reply #12 on: April 15, 2021, 09:23:54 pm »
the future: cocaine has a cartel nanobot DLC
 
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Offline mindcrime

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Re: Electronics in medications? Wait, WTF?
« Reply #13 on: April 19, 2021, 11:29:45 pm »
Huh. Never expected to see this on EEVblog. I actually worked on this project about 6 years ago. But on the software side, not hardware. I never knew much about how the actual pill worked, and if I did I'd probably still be under NDA or something. I seem to vaguely recall hearing the term RFID being thrown around back then, but not sure if they literally meant the pill had an RFID tag in it, or if they were being metaphorical (or just wrong).

This was interesting stuff, but my understanding was that the manufacturer wanted to do this mostly to keep their branded Abilify in a monopoly position, as the original patents on the drug were about to expire. But apparently in the pharma world there's some tricky way to effectively "extend" a patent, which somehow has something to do with FDA approval (here in the USA anyway), where normally when a patent expires, that's just it, and anybody can step in and start using the tech as they see fit.

FWIW, the patch itself recorded the signals from the pill, as well as generic metrics like skin temperature, body position, heart rate, and a handful of other things. It paired with a phone using bluetooth (IIRC), and then the phone would stream the data up to a repository over IP. Then another process would push the data into a Hadoop cluster where analytics / BI stuff would run and process the data. The Hadoop cluster part is what I worked on, so I was a couple of "hops" away from the hardware.

Anyway, I probably can't say anything more than that, even if knew it.  Still, it's interesting to see this come up. I'd mostly forgotten about it, although at the time I was originally working on it, the whole thing struck me as really cool and having a lot of potential.
 
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Offline JohnnyMalaria

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Re: Electronics in medications? Wait, WTF?
« Reply #14 on: April 20, 2021, 12:01:02 am »
Huh. Never expected to see this on EEVblog. I actually worked on this project about 6 years ago. But on the software side, not hardware. I never knew much about how the actual pill worked, and if I did I'd probably still be under NDA or something. I seem to vaguely recall hearing the term RFID being thrown around back then, but not sure if they literally meant the pill had an RFID tag in it, or if they were being metaphorical (or just wrong).

This was interesting stuff, but my understanding was that the manufacturer wanted to do this mostly to keep their branded Abilify in a monopoly position, as the original patents on the drug were about to expire. But apparently in the pharma world there's some tricky way to effectively "extend" a patent, which somehow has something to do with FDA approval (here in the USA anyway), where normally when a patent expires, that's just it, and anybody can step in and start using the tech as they see fit.

FWIW, the patch itself recorded the signals from the pill, as well as generic metrics like skin temperature, body position, heart rate, and a handful of other things. It paired with a phone using bluetooth (IIRC), and then the phone would stream the data up to a repository over IP. Then another process would push the data into a Hadoop cluster where analytics / BI stuff would run and process the data. The Hadoop cluster part is what I worked on, so I was a couple of "hops" away from the hardware.

Anyway, I probably can't say anything more than that, even if knew it.  Still, it's interesting to see this come up. I'd mostly forgotten about it, although at the time I was originally working on it, the whole thing struck me as really cool and having a lot of potential.

That would be the Drug Price Competition and Patent Term Restoration Act of 1984

The right to a patent term extension based upon premarket regulatory review is the result of the Drug Price Competition and Patent Term Restoration Act of 1984, Public Law 98-417, 98 Stat. 1585 (codified at 21 U.S.C. 355(b), (j), (l); 35 U.S.C. 156, 271, 282)(Hatch-Waxman Act). The act sought to eliminate two distortions to the normal "patent term produced by the requirement that certain products must receive premarket regulatory approval." Eli Lilly & Co. v. Medtronic Inc., 496 U.S. 661, 669, 15 USPQ2d 1121, 1126 (1990). The first distortion was that the patent owner loses patent term during the early years of the patent because the product cannot be commercially marketed without approval from a regulatory agency. The second distortion occurred after the end of the patent term because competitors could not immediately enter the market upon expiration of the patent because they were not allowed to begin testing and other activities necessary to receive FDA approval before patent expiration. This second distortion is embodied in 35 U.S.C. 271(e)(1) which provides a safe harbor for otherwise patent infringing conduct that is solely for uses reasonably related to the development and submission of information under a Federal law which regulates the manufacture, use, or sale of drugs or veterinary biological products.

Bollocks, I say (to the first distortion).
« Last Edit: April 20, 2021, 12:03:13 am by JohnnyMalaria »
 


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