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No More Skipping Your Medicine -- FDA Approves First Digital Pill

8:18 pm - 08/10/2012
The Food and Drug Administration has just approved a device that is integrated into pills and let’s doctors know when patients take their medicine – and when they don’t. Adherence to prescriptions is a serious problem, as about half of all patients don’t take medications the way they’re supposed to. But with patients doctors now becoming big brother, that statistic could change drastically.

The device, made by Proteus Digital Health, is a silicon chip about the size of a sand particle. With no battery and no sensor, it is powered by the body itself. The chip contains small amounts of copper and magnesium. After being ingested the chip will interact with digestive juices to produce a voltage that can be read from the surface of the skin through a detector patch, which then sends a signal via mobile phone to inform the doctor that the pill has been taken. Sensors on the chip also detect heart rate and can estimate the patient’s amount of physical activity. More than just a way for doctors to look over their patients’ shoulders, it will allow doctors to better assess if a person is responding to a given dose, or if that dose needs to be adjusted.

After clinical trials that began in 2009, the FDA approval follows approval from European regulatory approval in August 2010. Right now the FDA has only approved the chip for placebo pills, which were used in trials showing the chip to be safe and highly accurate. Proteus hopes to gain approval to use the digestible chip with other medicines. Andrew Thompson, chief executive of Proteus, says the chip has already been tested with treatments for tuberculosis, mental health, heart failure, hypertension, and diabetes.

The company is currently working with makers of metformin, a drug used to treat type 2 diabetes and the most commonly prescribed drug in the world. The company also plans on adding a wireless glucose meter to their device so that dosage amount and frequency can be correlated with changes in blood glucose levels.

The FDA approval could foster the development and approval of other ingestible sensors.

They would also like to digitize the drugs taken to treat neurological disorders. Disorders such as Parkinson’s Disease and Huntington’s Disease often require patients to receive drugs regularly – sometimes several times per day – and for extended periods of time. Ensuring that these patients are adhering to the prescribed regimen could greatly improve quality of life for some.

Transplant patients, who often have to take immunosuppressive drugs for long periods following surgery, could also potentially benefit from digitizing their medicine.

Ingestible body sensors have been discussed for a while now, but Proteus’ digital pills are the first ingestible sensor to be approved by the FDA, according to Nature. This first step toward regulated ingestible sensors will undoubtedly be followed by others. The Programmable Bio-Nano-Chip developed by Rice University scientists can detect heart disease or cancer from a saliva sample. If the chips were ever permanently implanted into the body, they could provide an early alarm system for these diseases long before symptoms are detected by the patient. Scientists at Tel Aviv University in Israel and Brigham & Women’s Hospital in Boston are developing a pill-sized robot that is remotely powered by an MRI machine to swim through the gut and look for the molecular signs of gastrointestinal cancer.

The first demonstration involved a placebo, but surely drug companies are eager to digitize their pills – and make sure patients empty out their prescriptions when they’re supposed to. Although possible, it is hard to imagine a complication would arise when the device is used with, say, Lipitor, that did not arise with the placebo. The usual FDA bottleneck could be loosened with the first incorporation into a bonafide drug.

The possible uses for ingestible sensors is as varied as the body itself. As with computer chips, ingestible chips will follow the exponential path of Moore’s Law and be able to sense more with less in the future. The FDA ruling could do much to get the technology on the fast track.

source @ forbes by Peter Murray

i get that this could be great for diseases like diabetes that could benefit from specific dosage calibration, but i am really worried about the implications of being constantly monitored by doctors, especially with stigmatized diseases like mental illness. i can't see this positively impacting the way that doctors communicate with their patients, especially regarding the patient's right to have control over their own treatment.

also, this kind of monitoring device becoming available could have a massive impact in other areas; war, politics, criminal justice systems, etc :/
koshkabegemot 11th-Aug-2012 05:06 am (UTC)
This kind of really freaks me right the fuck out.
fauxparadiso 11th-Aug-2012 05:10 am (UTC)
Insurance companies are gonna love this. Forget discrimination over pre-existing diseases; now it'll be about voiding policies because you don't follow prescriptions to a T.
seamouse 13th-Aug-2012 02:24 am (UTC)
yeah, i was kinda thinkin' that, too
roseofjuly 11th-Aug-2012 05:19 am (UTC)
As creepy as this probably sounds to many members of the community, I study adherence to HAART (anti-HIV meds) and am interested in adherence to mental health medication, and so I'm kind of excited about this. Current methods of adherence measurement are inadequate. On our most recent grant we actually investigated this chip as a way to measure adherence.

Not that I can't see the potential for misuse, but I'm really biased because for the past year the adherence community has been really excited about this.
arisma 11th-Aug-2012 06:22 am (UTC)
This would be incredibly bad for my mental health, and I'm pretty sure I'm not alone in that.
squeeful 11th-Aug-2012 05:20 am (UTC)
I have nothing more to say right now (goddam arthralgia) other than: apostrophes, how do they fucking work?
arisma 11th-Aug-2012 06:18 am (UTC)
Mte, all of it.
lux_roark 11th-Aug-2012 05:36 am (UTC)
I don't know about anyone else, but that would lead me to be paranoid about taking my medication. Not that I'm already paranoid enough as it is.
effervescent 11th-Aug-2012 05:41 am (UTC)
This really sounds creepy and not something that I would want to agree to. Maybe idk, better patient education and communication between them and their doctors would be something they could focus on.
tiddlywinks103 11th-Aug-2012 06:30 am (UTC)
roseofjuly 11th-Aug-2012 01:27 pm (UTC)
Well, they can guarantee the first one, since you can study how metallic components break down in stomach acids. I mean, no one can guarantee you won't have an uncommon allergic reaction to them, but then no one can guarantee that for any medical device.

But all the rest of what you say is very true...and a huge problem in the medical community. They'll test them in healthy adults (and most likely white and middle-class adults) and then get all happy and push them into poor populations (who are least likely to be adherent) and people with illnesses.
sparkindarkness 11th-Aug-2012 11:23 am (UTC)
How about a chip that reminds ME rather than my doctor? Despite my precautious I do forget to take my pills on occasion and Badness Happens - I'd love a reminder. But I don't want or nee my doctor to wag his finger at me
roseofjuly 11th-Aug-2012 01:29 pm (UTC)
The chip would potentially have that capability. If it could send signals to your physician, certainly they could create a device that could go off if it hasn't received the signal by some designated time.

(I just want to clarify that I'm not crusading for these chips - I think that they are interesting & useful for research purposes, but disastrous for private physician use, and I would NOT want to see them used that way.)
grey853 11th-Aug-2012 11:36 am (UTC)
Wow, talk about the potential for massive abuse against civil rights. I'm thinking in particular used to force people with mental illness or in the prison system to medicate against their will.

Lordy, it's like scifi in RL.

roseofjuly 11th-Aug-2012 01:29 pm (UTC)
They already do that.

(Not saying that that makes it ok. Just that that's already happening.)

Edited at 2012-08-11 01:30 pm (UTC)
moonbrightnites 11th-Aug-2012 01:03 pm (UTC)
I could see this being helpful as my (developmentally delayed) daughter grows older and eventually takes over her own medical care. I wouldn't want the results reported directly to her doctor but I'd like to know if she's taken her meds or not.

This would have been helpful for my schizophrenic uncle, too. He could rarely remember if he'd taken his meds or not (and a few days off of them meant disaster.)

also, this kind of monitoring device becoming available could have a massive impact in other areas; war, politics, criminal justice systems, etc

Agreed. I see a lot of potential for abuse, here.
mutive 11th-Aug-2012 02:07 pm (UTC)
Yeah, potential for abuse, but like you said, it could be super helpful in certain cases.

Heck, I could see wanting it for pills I take. I've always hated measuring them out into those little tins, and sometimes do forget if I've taken my prescription or not. (Esp. when I was on 3-4 medications, all taken 3 times a day.) Having a little beeper that said, "BTW, you're overdue..." would have been super helpful.)
silver_apples 11th-Aug-2012 02:13 pm (UTC)
Like others, I see many possibilities for misuse, followed by lawsuits. I'm not comfortable with the doctor tracking me like that. But my grandmother is in the early stages of Alzheimer's, and she'll forget to take pills because she doesn't remember they were ever prescribed. Having a way to monitor what she has taken would be helpful.

I think the key here would be agreement from the patients. Not just "do you want these pills or not", but the choice to take the pills with the chip or pills without the chip. Because I can see how someone with a lot of pills that need to be taken at different times, or part of a drug trial program, or with a history of addiction, might agree to the additional monitoring.
kaelstra 11th-Aug-2012 02:46 pm (UTC)
This is invasive as shit. DNW. It's MY body, I shouldnt have to eat mini-trackers just to reassure my doctor I'm doing what THEY want with my body.
makemerun 11th-Aug-2012 03:18 pm (UTC)
Terrifying, tbh.

Also, copper? Great. Since I'm severely allergic to metal, (as in, canned foods, high-iron cereal and potatoes make me sick, can't safely use an IUD allergic) I'm sure glad that my daily pill regimen will add more to my diet.
martyfan 11th-Aug-2012 10:59 pm (UTC)
I've never heard of a metal allergy! Is it all kinds of metal?
kitanabychoice 11th-Aug-2012 04:31 pm (UTC)
Even after reading this article and all the comments, I'm still coming down on the side of creepy for this. I get that in a lot of ways, this would be incredibly useful, but I just do not like the idea of even more monitoring of my body. Something about this just squicks me out to the core of my being.
checkerdandy 11th-Aug-2012 07:38 pm (UTC)
Our lab handles TB cases for our state, so I'm super excited about this. TB is scary and building resistance. Same with the super gonorrhea that's spreading. Maybe limiting chipping to anti-retrovirals, -biotitcs, -fungals, etc. would be helpful and not as scary to think about?
deathchibi 12th-Aug-2012 03:45 am (UTC)
I can see both sides of this. It is kind of invasive and a bit creepy. Companies could also abuse it.

But as someone who gets infections a lot because my asthma medications knock my immune system down, I do sorta welcome a system to help me make sure I'm taking everything in line. Because breathing is kickin' rad.
jenny_jenkins Absolutely out of the question11th-Aug-2012 08:40 pm (UTC)
Invasive, terrifying. The potential for abuse of this technology is absolutely terrifying.
qara_isuke 12th-Aug-2012 09:02 pm (UTC)
I am absolutely torn on this, like several other people.

On the one hand, the potentials for abuse are staggering. The invasion of privacy is also staggering.

But...I can also see the incredible potential for good. There are some very serious problems in my family that require consistent medication to handle. (Grandfather had Alzheimer's, aunt is very severely bipolar and is incredibly scary when off her meds, and her son is schizophrenic) I know that making certain people are taking their medications properly in those cases is very important, as it has a very real potential for danger when medication is missed or purposefully skipped.
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