Abilify MyCite by Proteus Biomedical

Example of a digital medicine system Photo: Proteus Digital Health

The Food and Drug Administration has approved the first digital pill [1] for the US which tracks if patients have taken their medication. The pill called Abilify MyCite, is fitted with a tiny ingestible sensor that communicates with a patch worn by the patient — the patch then transmits medication data to a smartphone app which the patient can voluntarily upload to a database for their doctor and other authorized persons to see. Abilify is a drug that treats schizophrenia, bipolar disorder, and is an add-on treatment for depression.

The thinking behind this idea is founded upon the fact that compliance with doctors’ instructions has been identified as a key problem in medicine and healthcare. The World Health Organisation (WHO) estimates that 50 percent of patients do not take their medications correctly whilst the NHS report that the annual cost of unused medication is estimated to be up to £400 million. [2] [3]

The problem is compounded further for those patients who may be prescribed a series of drugs which need to be taken at different times. Moreover, with us all waking up to the profound implications that an ageing population represents in terms of healthcare provision, you can certainly begin to understand and appreciate the thinking behind the digital medicine systems. 

The Abilify MyCite features a sensor the size of a grain of sand made of silicon, copper, and magnesium. An electrical signal is activated when the sensor comes into contact with stomach acid — the sensor then passes through the body naturally. A patch the patient wears on their left rib cage receives the signal several minutes after the pill is ingested. The patch then sends data like the time the pill was taken and the dosage to a smartphone app over Bluetooth, and must be replaced every seven days. The patient’s doctor and up to four other people chosen by the patient, including family members, can access the information. The patient can revoke access at any time. [4]

The pill comes after years of research and is a venture between Japanese pharmaceutical company Otsuka and digital medicine service Proteus Digital Health, which makes the sensor. [5] [6]

By putting the power into the hands of patient, the system promises to allow the patient to better manage their own care and medication and empowered to be responsible for their own care. “What we know is that we’ve created many pharmaceuticals with great potential but much of that potential is not realised because these drugs are not being used properly,” said CEO Andrew Thompson [7]. A study that tested Proteus’ Lifenote system in a group of patients at elevated cardiovascular risk attending a cardiac prevention and rehabilitation program has shown promising potential for clinical use as a tool to encourage better medication-taking behaviour due to its ability to provide continuous patient-level feedback. [8]

Otsuka hasn’t indicated how much the digitized Abilify pills will cost yet. The WSJ reports the company plans to work with some insurers in covering the digitized pills with production planned to be ramped up only if it can find willing insurers. [9]

Whilst the idea of ingesting an intelligent pill might seem very new and cutting edge, once again, the basic idea has been around for a while now. Back in the 1980s, NASA developed ingestible thermometers in the 1980s to measure astronauts’ core temperatures. These thermometers have lately been adopted by some athletes. Other researchers have created cameras in pills to image the digestive system from the inside [10]. But clearly this represents a bit of a watershed moment as the product comes onto the open mass market.

Experts though, have expressed concerns over what the pill might mean for privacy. Some are worried that tracking pills will be a step towards punishing patients who don’t comply. Ameet Sarpatwari, an instructor in medicine at Harvard Medical School told The New York Times the digital pill “has the potential to improve public health. [But] if used improperly, it could foster more mistrust instead of trust.” [11] [12] Proteus adds that security safeguards would be used to protect transmitted data [13].

Similar issues arise with this technology as they do with biometrics and other forms of new technologies which help to identify us and in so doing offer the opportunity to challenge our freedom and dignity. Much of the marketing and publicity from Proteus speaks of the intelligent pills empowering the patient and not the professional, placing them at the heart of the design process. [14] However, where will the lines of engagement and responsibility be drawn in terms of data usage and storage? Certainly having the range of data available to patients offers the potential of informed decision making but could it also creep to empowering other professionals to start dictating what an individual can or cannot eat, activities which they can or cannot undertake or places they cannot or cannot visit, on the grounds of data which supports their advice. In the same way those specific groups can be identified for good, could it be used to discriminate against certain groups?

Whilst not wishing to vilify ‘big pharma’ unnecessarily, one cannot fail to see the lucrative incentives which this kind of intelligent pill could offer both the pharma and health insurance industry. Where the pharma industry currently lose many billions of dollars in sales from patients on long–term prescriptions who do not take their pills, being able to track the patient’s medication would be a significant help in saving money. Likewise, health insurance companies could stand to gain the advantage and potentially decline insurance cover on the knowledge of whether the patient has or has not kept up to date with taking their medication.

Clearly the long term success of this kind of technology must hinge on trust and accountability. We must not forget that all kinds of data is being generated, mined and stored already from all manner of different sources. This does not mean that we should take a laissez faire attitude towards it. Rather we need to readily engage and decide how this data is handled, entering into a trust relationship with those holding the data based on trust, choosing to use it in a way that empowers us rather than controls and inhibits us.  This is far easier said than done, giving the many examples of failed IT projects or data breaches which have hit the headlines. But whether we like it or not, this in many respects defines life today. Data generation is part of our lives now, we need to acknowledge and start engaging with the implications today.

Thus we return to Proteus’ message of ‘power to the patient’. Yet building on the trust concept and crucial to Abilify MyCites long term success must be how data is managed and stored so that it is not used without our knowledge. As this empowered patient which Abilify seeks to help us become, we need to ask ourselves how prepared are we for public disclosure of our information to become more apart of our daily lives? The man behind Google, Eric Schmidt, is famously quoted as saying, “If you have something that you don’t want anyone to know, maybe you shouldn’t be doing it in the first place” and sparked fierce debate. The Electronic Frontier Foundation responded: “Google, governments, and technologists need to understand more broadly that ignoring privacy protections in the innovations we incorporate into our lives not only invites invasions of our personal space and comfort, but opens the door to future abuses of power.”

These questions may well help to determine whether the developments Proteus and others are affording us point to the future of a bright new dawn or a dazzling but rude awakening.

References:

1.  https://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm584933.htm
2.  http://www.who.int/chp/knowledge/publications/adherence_report/en/
3. https://www.england.nhs.uk/five-year-forward-view/next-steps-on-the-nhs-five-year-forward-view/funding-and-efficiency/
4. https://www.proteus.com/press-releases/otsuka-and-proteus-digital-health-resubmit-application-to-fda-for-first-digital-medicine/
5. https://www.otsuka.co.jp/en/company/newsreleases/2017/20171114_1.html
6. https://www.proteus.com/
7. http://www.healthcareglobal.com/healthcare_technology/new-smart-pills-remind-patients-to-take-medication
8. https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5484791/
9. https://www.wsj.com/articles/fda-approves-worlds-first-digital-drug-1510621146?mg=prod/accounts-wsj
10. http://www.nature.com/news/say-hello-to-intelligent-pills-1.9823
11. https://www.theverge.com/2015/10/7/9466121/proteus-digital-pill-tracking-privacy-quantified-self
12. https://www.nytimes.com/2017/11/13/health/digital-pill-fda.html?_r=1
13. http://www.technologyreview.com/biomedicine/20434/page2/
14. https://www.bioethics.ac.uk/news/Intelligent-Pills-A-new-dawn-in-healthcare-.php