Pharmaceutical Big Brother Concerns Loom As FDA Approves Self Sensing Pill [Opinion]

What comes to mind as a great addition to pills taken by schizophrenia or bipolar patients? For most people that mental image probably does not include a digital tracker that tells a patch on the patient’s abdomen whether a medication was swallowed and reports that information to a smartphone along with a doctor and up to four other individuals. The Food and Drug Administration (FDA) thought it was a great idea, however, and approved it for the United States. Although the technology has existed for some time and has been successfully trialed, the Abilify MyCite FDA approval marks the first time a drug will be marketed with a digital ingestion tracking system. This controversial technology is making waves as patients argue that the mental health field is far from the best place to debut this potentially helpful technology.

Patients worldwide are aghast at the idea of reporting this information daily to their doctor and family members. Although Abilify MyCite’s co-manufacturer Proteus Digital Health has assured individuals that participation will be voluntary, there are fears that coercion may occur. Abilify is frequently prescribed to patients experiencing their first psychotic episode or patients leaving psychiatric facilities, and Abilify MyCite may become compulsory for them if they wish to leave or remain in their psychiatrist care. Even patients who voluntarily participated in the clinical trial were not convinced. Some patients said they would not repeat the experience if given the chance to again, while others experienced rashes from the patch.


Data leaks worldwide are a large concern with this digital medicine tracker. Since information is transferred to the physician and up to four other individuals, there is a threat that this knowledge could fall into the wrong hands. We do not know yet if any personal data will be contained in this transfer or if it will be just a number, but personal healthcare information hacking is a huge industry with serious consequences. Each incident of healthcare data breaches results in $2,500 out of pocket for the victims. There are also concerns about information leaked beyond physicians. Abilify is a mental health drug, and there is a potential for blackmail as patients may not wish for employers, spouses, or friends to know they are taking the medication.

FDA Tracking Pill Approval Smartphone Abilify
[Image by BravissimoS/Shutterstock]

Although the idea of Big Brother looms over users of this new technology, there is a great potential to build relationships between providers and patients. Continuous care is critical in mental health, and it can be difficult at times for patients to stay on their medications. Side effects or feeling like they are well and no longer need medication are both common reasons for going off of medicine without physician approval. If digital trackers are in place, physicians can call patients and speak with them early, potentially returning them to their care plan before any harm is done. There is also a potential for the patient to not want to displease or cause confrontations with family members or providers, leading them to continue taking much-needed medications when they might not have previously.

Manufacturers hope to solve many problems with Abilify MyCite. Abilify has been on the market since 2002 and is a reputable drug. The new version, Abilify MyCite, takes the current form of the medication and includes a sensor made of food safe ingredients, including magnesium and copper. The sensor simply generates an electrical signal to a Band-Aid-like device that sits on the patient’s abdomen, which can then report to a smartphone. The reasonably simple technology does not yet have a price tag.

[Featured Image by JPC-PROD/Shutterstock]