Is Proteus’s ingestible sensor really the “Holy Grail of Digital Health”

I normally find myself in close agreement with Dr David Lee Scher, Founder of DLS Healthcare Consulting and former cardiac electrophysiologist, but I find myself a long way off sharing his enthusiasm for embedding a radio transmitter into pills.

I thought it might be interesting to share my thoughts:

To remove any doubt: I have no problem appreciating the opportunity to use technology to improve medication adherence

I appreciate the huge advances in quality of care and understandings of disease that can be had if we know patients are taking their medications. I personally know carers who have contracted life threatening conditions as a result of their work with patients who failed to complete their medication courses. I understand there are many patients who have medical conditions that make it difficult for them to remember if/when they took a medication. I can also know that monitoring tech that is invisible and unintrusive increases the appeal of monitoring and helps to improve the outcomes of interventions and the quality of life enjoyed by patients.

We won’t be healthy because we are monitored

Now I’m not for a minute suggesting David is in this group but I notice a lot of technologists who seem convinced that accurate monitoring of what we do/eat is the holy grail of healthcare.

Despite the abundance of conflicting evidence it’s easy to see why the US Healthcare industry wants this to be true as it will create a massive business opportunity for health insurers and employers as care could be much more profitable and cheaper to provide if patients simply agreed to being monitored. To understand this you have to accept that with accurate evidence that a patient has failed to comply with what’s being prescribed to them, providers find it much easier to deny further cover/treatment (watch this 2010 presentation by Qualcomm’s Don Jones for more on this – FYI Qualcomm is the technology partner Proteus has worked with to develop the technology).

I can understand that some people favor this stick rather than carrot approach but I think the issues are a lot more complex than this and those who follow this line will soon enough find themselves getting dragged into a movement focused on “patient control” rather than “empowerment”.

For all it’s downsides I am quite grateful that there is this distinction between Veterinary and Human medicine.

Let’s be very clear about what this can and cannot do

In summary, this technology is a physiologic sensor incorporated into a medication pill. Stomach juices activate an energy source which is similar to a potato starch battery. The sensor then sends signals to a skin patch electrode which then wirelessly transmits information such as vital signs, body position, and verification of medication ingestion. The information is obtainable to designated persons (caregiver, clinician) via an app. It is, essentially, the quintessential digital technology…. ….2. This technology represents the crossroads of sensors, wireless, remote monitoring, and mobile. Physiologic sensors, wireless technologies, and mobile apps are the focus of dramatic developments recently. The Proteus ingestible sensor combines all of these features, demonstrating unique elegance and ingenuity

I think David’s confused about what the sensor is actually capable of and I’m not surprised as communications from Proteus can be somewhat confusing eg. it claims that “your body transmits the digital heart beat generated with the sensor” and consistently claims the sensor is “ingestible” while it appears to actually be “indigestible” (as I understand it comes out in your excretions).

The physiological data David is interested in isn’t being derived from the chip in the digestive tract of the patient but the sensor on the skin (sensors like this are being developed by a range of companies eg. Intelesens, and can obviously be used completely independently OR inconjunction with a radio pill).

In my opinion we can get a lot more valuable information by using technology to listen to patients rather than by putting i/o sensors into their stomachs.

The ultimate medication adherence tool

This technology is the ultimate medication adherence tool. Medication adherence has been a target of digital health technology development for many years, as it is estimated that up to $750 is spent on care and other expenses on non-adherent patients. From text messaging to digital pill bottle caps, technologies have been trying to come as close to an eyewitness of a person ingesting a medication as possible. This technology leaves no doubt about adherence

I think David’s jumped the starter gun here a bit. I’ve seen and learnt of patients in the community doing incredible things to “trick” care providers that they’re complying with their medication plans and can think of several easy ways that patients who want to will fool or navigate this adherence monitoring system too eg. by complaining that it irritates their stomach by effecting changes to their gastric juices, by telling their Doctor that they have concerns after reading in a tabloid of a patient who got stomach cancer or put on weight after taking these radio pills, attempts to create an “artificial” stomach with some acids, etc.

Ultimately, while far from being easy to do or control (and I’ve met both extremes of patient eg. ones who book an appointment with their Doctor because they’ve missed a single tablet through to ones who have their homes full of boxes of meds that they were supposed to have been taking), we have to strive to reach a point where patients want to follow their medication plans and work with their carers to achieve desirable outcomes.

3. This technology is clinical enough to put it on the radar for physicians. Most medical apps and digital technologies have not been taken seriously by clinicians because they are too simplistic and unproven. The ingestible sensor appeals to the scientific mind as well as addressing real clinical problems. If it is shown to decrease hospital readmissions, perhaps improve workflow, improve outcomes, and have no long-term adverse effects, it will no doubt be welcomed by healthcare providers worldwide

I think this is applying quite an unfair broad brush to clinicians. There isn’t a medical Doctor who hasn’t used Google or a Cellphone for their work, by 2009 20% of US Doctors were already using a mHealth app on their smartphone app, 3000 clinicians at the Ottawa Hospital are running round with iPads, Doctors at the Mayo Clinic are providing documented consults to patients remotely for years, here in the UK and Ireland Doctors have been conducting mobile video consults with patients since 2006, in Maine Trauma Surgeons use iPods to diagnose patients, etc.

In contrast to all this I can’t see how anyone thinks a radio transmitting pill will mark a line in the sand for adoption of healthcare tech by clinicians.

4. This technology provides a firm foundation for development of offshoot technologies. Like the development of NASA technologies and the ‘Star Wars’ initiative in the 80’s, this is a technology which will spawn ideas and developments in a few diverse directions resulting in the development of perhaps unrelated products and services. Examining all the ‘moving parts’ of this technology offers to me that kind of exciting promise

Whilst I don’t think anyone can disagree with the point that tech can spawn new ideas I can’t help but think that with 5.9 Billion individuals on the planet carrying a mobile already there is a bigger opportunity already emerging from a very different foundation altogether.

5. It is a technology with market appeal to clinicians first, consumers second. Most mobile apps to date have been targeted at consumers for various reasons. They do not require regulatory approval, they can be mass marketed, and they are not currently beholden to any standards. This technology has gone through vigorous approval processes by multiple agencies, addresses real clinical concerns, and may have a major impact on patient outcomes. So far only a few technologies have gone through this process. These are the technologies which will, by virtue of their potential impact on patients, be the ones to break barriers of adoption of digital health technologies

I think it’s important not to get carried away with what it means to have been approved by multiple agencies. Yes this “was recently approved by the FDA after having been approved a while ago by the CE of the EU” but this just means the firm has convinced the regulator that it complies with the essential requirements and that it is considered at this moment in time to be safe for humans to eat gastric acid powered electronic chips that can transmit radio signals.

Won’t external sensing get good enough?

I notice that cars and even the latest in passenger jet aircraft don’t yet monitor their fuel but rather the way it burns. So I really wonder if this is going to be required in a world where medication plans will be ever more personalised and mHealth app feedback systems will be capable of engaging patients so much more actively in their care.

Who’s in control?

In the comments David replies to Susan Perry’s comments about “patients worrying about an invasive tracking of their health” by stating that “As I understand it, Susan, the ‘tracking’ will be directed to any third parties by the patient“.

I also see that Proteus are claiming this on their materials but I cannot understand how the technology company that licenses this will have a control over this. If I’m an insurer surely this is going to be my precondition for adoption of the technology eg. so that I can say to patients “yes we’ll pay for this new expensive medication as long as you agree to have it tracked”.

Effectively that’s “directed by the patient” but in reality I can’t see how they are going to get much choice.

Who’s business model is this going to help: pharma or provider

Another problem I can see developing is that the data created from this chip in a pill might just make the care provider more powerful than the drug company. What if Kaiser Permanente – the worlds first big healthcare brand to take a mobile first strategy – introduced this in all drugs for patients with condition Y. Within a short space of time you could imagine that the provider would be in a position to tell the drug manufacturer that their med wasn’t actually as effective as their clinical trial evidence claimed, that they now have a data set which is larger and more convincing than their clinical trial data… …oh and from now on they won’t be using their product with patients as they’ve found generics that get better results… …now data like that could turn around the fortunes of a care provider (no wonder they talk of having a bright shiny line around our data and we don’t want anyone else getting inside that wall).

Perhaps we should fix the last mile problem before focusing on the last 30cm?

After sharing these thoughts (thanks Dragon 12!) I get the sense that there is an urgent need to deploy the mobile tech we already have to make medication adherence better before we even start to focus on this final leg of the problem (whether patients are putting their meds in their mouth or not).

Instead of trying to bring tech into the lives of patients let’s use it in ways that patients don’t have to concern themselves with to improve the packaging, add more actionable information (eg. by linking meds to rich mobile video content), create more engaging experiences (eg. by twinning it with engaging care experiences), getting more up to date information on meds into Doctors hands and making the face to face care experience more engaging (eg. where Doctors don’t make patients come in because that’s the only way they’ll get paid and where patients aren’t getting their concerns listened to because their Doctors are too preoccupied punching info into computers), etc, etc.

 

*** *** UPDATE 2 Feb 2016 *** ***

Join the discussion of radio embedded pills over in the Linkedin mHealth group:

mHealth discussion Pill reports when it has been digested

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3 Responses to Is Proteus’s ingestible sensor really the “Holy Grail of Digital Health”

  1. Thank you for this thoughtful post, David. I will state for the record that I am not in the group which seems “convinced that accurate monitoring of what we do/eat is the holy grail of healthcare.” There is a lot more to healthcare than quantification. However, technology which adds useful information not otherwise available is valuable when placed into context. The monitoring of patients should be clinically driven, not designed by insurers for economic business models as suggested by your link. Certainly not all patients or conditions warrant this kind of monitoring and it is not going to be imposed as a punishment. I agree with your skepticism about having this turn into stick vs carrot approach. Certainly we have seen an analogy with eavesdropping on cell phones after 9/11 with good motivations gone awry. I frankly did not even think of this side of the coin, and my positive feelings about this were from a caregiver perspective (my mother is dealing with cancer now).
    Regarding the technology itself, I did not mean to suggest that cardiac data could be transmitted from the ingested sensor in the digestive tract. The vital sign information combined with the ingested sensor can potentially give information regarding temporal relationship of ingestion to side effects or vital signs themselves. I worship William Osler who you referenced (I have a first edition copy of his biography written by Cushing). However, sensor monitors of vital signs offer far different (not necessarily better, but complimentary) information than a patient desicription.
    Regarding point #3, I would hardly compare the private practitioner or community hospital employed physician to the Mayo Clinic with regards to the level of engagement of mHealth technology. Using a smartphone is different that recommending a medical app to a patient or using one for remote monitoring of glucose levels.
    As far as providers using this data to discover conflict of efficacy data as provided by the drug company, I say, “Bring it on.” There needs to be post-market surveillance of drugs just as it is mandated for medical devices. Clinicians challenging Pharma with data is not a bad thing in my book.
    I again appreciate your thoughtful comments as well as your own dedication to putting digital health technologies on the map and in perspective.

  2. Hi David,

    Thanks for starting and joining me for this interesting discussion.

    I agree with your skepticism about having this turn into stick vs carrot approach. Certainly we have seen an analogy with eavesdropping on cell phones after 9/11 with good motivations gone awry

    I find a much better analogy in the automobile “Black Box” connected data recorder market. Insurers and auto manufacturers are bringing them in with promises that they’ll help reduce costs and reward low mileage/safe drivers. Behind the scenes we’ve already seen the data being used to deny insurance cover and by employers and authorities to track and incriminate individuals etc.

    I frankly did not even think of this side of the coin

    Neither did I until a few years ago when a MNO client asked for my opinion on an early M2M legal case involving data an employer had amassed on an employee through their use of a company car. It’s incredible how much data is being collected (number of occupants, journey details, speeds travelled, garages visited etc) and the implications it can have and that was before the tech is being put to use serving those who are vulnerable or technically naive.

    However, sensor monitors of vital signs offer far different (not necessarily better, but complimentary) information than a patient desicription

    I agree but when there is so little interest in doing the easy things (eg listening to patients) I’m fascinated by the health tech communities enthusiasm for doing the more difficult. Most Doctors aren’t getting a detailed history from their patients and the vast majority aren’t documenting this in the patients records (something that’s becoming very obvious to patients when they get provided with access to their health records). It’s a great starting point to be letting patients help their carers by taking on tasks like this.

    The vital sign information combined with the ingested sensor can potentially give information regarding temporal relationship of ingestion to side effects or vital signs themselves

    In >90% of patients you could achieve the same by asking them to press a button on the mobile they already have using a very basic app. No need for radio pills, bandaids, smartphones that can talk to bandaids, all the hassle/inconvenience that comes with distributing and supporting these technologies, etc.

    Regarding point #3, I would hardly compare the private practitioner or community hospital employed physician to the Mayo Clinic with regards to the level of engagement of mHealth technology

    I’ve actually seen more use of mHealth tech by Doctors in small practice than I’ve ever seen at the Mayo Clinic, Ottawa Hospital, Great Ormond St, UCH, Mass Gen, John Hopkins, St Mary’s London, Naval Hospitals, etc.

    For example there’s a Private Doctor in London who has a completely mobile based practice, I’ve worked with a private pediatrician who sends the parents of every patient a mobile video before they even meet, i know NHS GPs who provide Skype consultations on iPads and others that not only use SMS all the time but do most of their consultations over mobile phone calls, I know medical Doctor practices here in Europe that have no landline (only mobile) numbers, etc.

    Using a smartphone is different that recommending a medical app to a patient or using one for remote monitoring of glucose levels

    I agree. But I have noticed that when Doctors are familiar with using these technologies and they don’t have 20 tiers of bureaucracy to deal with, a very special thing happens: It becomes obvious long before you want to prescribe applications that if you have a patient who has access to the internet you can send them a URL via SMS to a video or relevant website.

    As far as providers using this data to discover conflict of efficacy data as provided by the drug company, I say, “Bring it on.” There needs to be post-market surveillance of drugs just as it is mandated for medical devices. Clinicians challenging Pharma with data is not a bad thing in my book

    I also think it’s a great thing, but to get an idea of the new territory we’re entering and the implications and issues look at the challenges faced by the ICD user group as they struggle to unlock data in the M2M medical device market. Obviously as soon as providers get the data the argument for denying it to patients becomes even thinner than it is already…

    I again appreciate your thoughtful comments as well as your own dedication to putting digital health technologies on the map and in perspective

    I have no doubt that it will be through such open discussions of points of view, concerns and issues that we’ll arrive at the positive futures we both want to see much quicker.

    PS. Really sorry to learn of your mother’s poor health, hope things improve for her and that you have colleagues there for you too.

    • FYI Natalie Bradford at the Centre for Online Health at the University of Queensland has published a paper on the “Feasibility and Accuracy of Medication Checks via Internet Video” that you might want to check out:

      http://www.ncbi.nlm.nih.gov/pubmed/22362831

      In brief it reports on the accuracy you could achieve through the use of a video link for double checking for medications and the opportunity this offers to improve the safety of home care.

      Very high levels of accuracy where acheived just using online webcams (imagine what you could do with Nokia’s PureView 41MP sensor camera with Carl Zeiss lens!) and that’s before using machine reading mobile AR tech.

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