FDA approves micro-chipped pill that tells doc if you took meds

Update Nov. 16, 2017:

The FDA has approved the first digital pill that tracks if and when patients have taken their medication. The drug is Abilify MyCite. In addition to treating schizophrenia, it can be used to treat bipolar I disorder and can be used as an add-on to treat depression.

The entire digital medical system is made up for four parts: the Abilify MyCite pill, a MyCite patch, the MyCite app and a web-based portal.

The Abilify pill includes an embedded ingestible senor that is the size of a grain of sand. After the Ingestion Event Marker (IEM) sensor hits stomach fluids, it generates a timestamped ID signal and sends a message to a wearable patch that the medication was taken. The patch, which is meant to be worn on the left rib cage and must be replaced once a week, wirelessly sends the recorded date and time to the mobile MyCite app.

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Some people with schizophrenia might be inclined to believe “they” are watching them, that “they” are tracking them, and ironically now “they” really might be via a “digital” pill that contains an ingestible sensor which gives doctors and caregivers the ability to track if and when a patient takes his medicine.

According to an announcement by Otsuka Pharmaceutical and Proteus Digital Health:

This is the first time an FDA-approved medication (ABILIFY) has been combined and submitted for approval with a sensor within the medication tablet (the Proteus ingestible sensor) to measure actual medication-taking patterns and physiologic response. This objective information is communicated to the patient – and with the consent of the patient – to the patient’s physician and/or caregiver.

The “first digital medicine” includes an ABILIFY pill “for serious mental illness” which is embedded with a Proteus “ingestible sensor;” it would work after being activated, aka powered up, by stomach juices. That ingested sensor would send a signal to a wearable Proteus patch.

The patch records and time-stamps the information from the ingestible sensor in addition to collecting other patient metrics, including rest, body angle and activity patterns. This information is recorded and relayed to patients on a mobile phone or other Bluetooth-enabled device, and only with their consent, to their physician and/or their caregivers.

The patient could see his info via the Discover app, a “secure and local software application on their mobile phone or device.” Healthcare professionals and caregivers could “drill down” into the patient’s data via the “secure” web-based Discover portal.

Neither the product nor its functionality changed, a Proteus spokesperson told MobiHealthNews. “The update merely officially clears Proteus to claim and market its product’s ability to quantify medication adherence, and demonstrates the FDA’s commitment to supporting a new category of medication adherence tracking technologies. The new clearance will help Proteus to sell clinical partners on the device and opens the door for other technologies to measure adherence in an FDA-cleared way.”

If approved by the FDA, it could be used for “measuring adherence in the treatment of adults with schizophrenia, acute treatment of manic and mixed episodes associated with bipolar I disorder, and as adjunctive therapy for the treatment of major depressive disorder in adults.”

The PR release claimed:

An estimated average of 50% of patients with chronic diseases in developed countries do not take medicines as prescribed, possibly limiting the effectiveness of those medicines. In the U.S., this may result in an estimated $100 billion-300 billion in avoidable healthcare costs due to direct costs such as unnecessary escalation of treatment as well as indirect costs. For example, patients suffering from chronic mental disorders such as schizophrenia are often required to take medication for long periods, and it is not unusual for these patients to discontinue taking their medication, or not take their medication as prescribed, which can lead to disease relapse and recurrence.

Apparently none of the experts are concerned that seriously mentally ill people may not be inclined to give consent. This could eventually lead to other pills taken for other common diseases such as hypertension or diabetes. If the FDA approves digitally recording patients’ ingestion of medication, and patients agree to share that info with doctors or caregivers, Proteus CEO Andrew Thompson said it could mean that “medicines could be tailored to each of us to reflect our unique medication-taking patterns, lifestyle and daily health choices.”

Proteus claims to be the first company which “combines ingestible, wearable, mobile and cloud computing.” Proteus announced in July 2015 that the FDA had “expanded the Indications for Use statement for the latest generation of its Ingestible Sensor technology, enabling the device to be used as an aid in the measurement of medication adherence. To the Company’s knowledge, this is the only device with an FDA-sanctioned claim for measuring medication adherence.”

Proteus Co-Founder and Chief Medical Officer Dr. George Savage added, “We believe that ingestible devices have the potential to speed clinical trials and improve the real-world effectiveness of medicines in community settings.”

So do you think this is cool or creepy? Would your opinion change if you were the one swallowing a microchip?