Take two of these and call me in the morning”, was once the ritual utterance of the doctor at the bedside and for hundreds of years that was more or less the extent of the predictive power of our knowledge of the human body. Yet today, the extent of our ability to measure the human body and predict its behaviors has moved into unthinkable realms, and we need new rules to manage the ownership of that knowledge and the journeys that it takes.
Over the past few decades, we have imposed restrictions on who can access information about our bodies, but we are faced today with unimaginably greater complexity in managing this information that is beginning to be captured in real time and potentially across continents. We need a new global scheme for creating controls in what is currently a Wild West of medical information.
This is not a new problem per se. We have long understood that knowledge is power and first ownership of knowledge the ultimate power. From the oracle at Delphi to ultra-fast trading platforms, the power of first mover advantage has driven the journey of mankind. Great power and great wealth were granted the counts of Thurn and Taxis, who ran Europe’s first international mail system (Headrick, 2000), and Baron Reuters built his reputation on being the first in Europe to learn of the Lincoln assassination (Allen, 2007).
But from the very earliest times, philosophers have warned that our hunger for external knowledge and the power that it brings needed to be balanced by an even stronger thirst for understanding of both the boundless and bounded limits of the human psyche. “First know thyself” was one of the three maxims inscribed into the floor of the forecourt of the Temple of Apollo and whether you attribute it to Thales, Critias or Plato, it has stood for millennia as a warning against the hubris of mankind and as a call to examine carefully what we know and how we use that knowledge (Broad, 2007).
For better or for worse, we are standing at another one of the junctures predicted by the ancients, caused this time by the emerging confluence between nano-materials and modern sensing technologies. We need to look very carefully not so much at the increasing number of drones over our heads but the quiet expansion of drones inside our bodies. From the now well-established technologies by which our pacemakers send data about our hearts to server farms in North Dakota to the microchips buried inside pills that inform a health desk in Bangalore that we skipped yesterday’s medication, we are developing comprehensive technologies for monitoring our human bodies that are rapidly outgrowing the legal and ethical frameworks that exist today (Prisco, 2015).
Governments, non-profit hospitals and for-profit corporations are now gathering petabytes of information not just in the form of paper records about our health and illness but about our health behaviors and directly from therapeutic devices themselves. Every day, sensors are transmitting data about our real-time conditions to computers about our heart and metabolic health, hypertension and cholesterol levels. Google has developed a contact lens that can monitor our blood sugar levels (Diamandis, 2015).
Given Imaging has received approval from the FDA for a “pillcam”, an ingestible camera that can be used to take pictures of the colon for people who cannot be examined by other methods (Given Imaging Press Release, 2014). These newer levels of information are being added constantly to the existing layer of information about the drugs we are taking, our visits to the doctor, static images of our insides and visits to the hospital.
The newest techniques in nanotechnology have taken invasive therapies to a new level. At ETH Zurich, the Swiss Federal Institute of Technology, mechanical engineers have perfected nanobots that can swim through the eyes’ vitreous humors to deliver drugs directly to parts of the eye damaged by diseases such as macular degeneration (Prisco, 2015). Now, pills are being developed containing sensors that can confirm to the doctor’s computer database that the patient is in compliance and is taking his medication.
In September 2015, Otsuka Pharmaceuticals and Proteus Digital Health were granted approval to manufacture a version of schizophrenia treatment, Abilify, embedded with a small piece of magnesium and copper inside the pill (Zhang, 2015). When the pill falls into stomach juices, the two metals create a small voltage detectable by an adhesive sensor stuck on the torso. That sensor then sends information to a mobile phone app, and with the patient’s permissions, to his or her doctor.
Applications of this technology are being pioneered that can also monitor whether the medications being taken are in fact effective. According to the BBC, the cost of patients taking medicines incorrectly, taking the wrong medicines or taking them at the wrong dose is a problem that costs the US health care system as much as US$200 billion a year Graham, 2013). Other implantable technologies being researched include contraceptive devices that can be turned on and off with a remote control and capsule size circuits for obese patients that monitor fat levels and can be set to generate a substance that makes the patient feel full.
Ostensibly, the wider use of integrated, real time medical data with a potential to influence compliance and treatment efficacy would seem a net good, but the ethical issues involved are not hard to detect. Patient consent and transparency, information storage, retrieval and anonymity are all magnified in the context of implantable/ingestible devices, and the literature on these topics has been growing. The American Medical Association issued an opinion on implantable radio frequency identification (RFID) tags as long ago as 2007, and there have been many articles on the question of whether prosthetic enhancements from cochlear implants to laser surgery are ethically justifiable (Bacheldor, 2007).
Not surprisingly, many questions have also been raised about the ethical issues surrounding ingestible smart devices. Proteus itself was criticized for implants in Alzheimer’s patients allegedly without their consent (Cha, 2015). However, there appear to have been few, widely available discussions of the ethics involved in ingestibles. As we believe that these devices will potentially become ubiquitous in the coming years, there should be a broader examination of the pitfalls of this apparently highly useful technology.
There is, of course, a certain irony in concerns about how to protect humanity from the dangers of metabolic information at the individual level being abused in light of the enormous efforts under way to link all of the diverse sources of existing health information to create better health care. The sheer intractability of the many silos in which this information is currently housed is a huge barrier to identifying which drugs can most benefit sub-populations of people and which will be harmed by those same medications.
Some of these silos are technical, in the form of software and hardware platforms that are mutually “incomprehensible”. Some are due to the fact that so many valuable records are still in manual text form and can only be collated and read together by an individual human mind. Yet, others are cordoned off in thousands of legal jurisdictions with no available channels to share and interrogate their valuable contents.
This is excerpted from the full article. Click on the link to the journal below.
“Meeting Dr Jonah” appeared in The Journal of Business Strategy, Vol. 36 Issue: 1, 2016 pp.51 – 54, and is reprinted with permission from Emerald Publishing Group Ltd.