General > General Technical Chat

Electronics in medications? Wait, WTF?

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hans:

--- Quote from: DrG on April 15, 2021, 03:39:07 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.
--- End quote ---

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...

--- End quote ---

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.

tooki:

--- Quote from: hans on April 14, 2021, 09:21:29 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? :-//
--- End quote ---
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.

coppercone2:
the future: cocaine has a cartel nanobot DLC

mindcrime:
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.

JohnnyMalaria:

--- Quote from: mindcrime 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.

--- End quote ---

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


--- Quote from: https://www.uspto.gov/web/offices/pac/mpep/s2750.html ---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.
--- End quote ---

Bollocks, I say (to the first distortion).

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