In 1966, writers and producers created a movie that depicted a miniature submarine that was injected into an important scientist to repair a clot in his brain. Starring Raquel Welch and Stephen Boyd, the SF thriller Fantastic Voyage entertained millions and may have given aspiring scientists some ideas for future medical devices.
We are not even close to being able to miniaturize a submarine manned with people to send through the body as the movie depicted, but we have seen some remarkable devices that can traverse, at least, the human gut. Previously this column highlighted the PillCam that photographs the small and large colon. Several years ago another device, the SmartPill, was released by the FDA.
The SmartPill contains sensors that can measure pH, temperature, and pressure and can transmit those measurements to an external data receiver. In doing so, it can assist physicians in assessing and diagnosing motility disorders such as gastroparesis and forms of chronic constipation by measuring gastric emptying time, small bowel transit time, and colonic transit time. Both of these devices pass through the gastrointestinal tract and end up as waste after their fantastic voyage.
Managed care companies have attempted for years to design programs to improve adherence to guideline-driven therapies, but their data typically consist of prescription fill data, which are, at best, flawed. Although it is hard to conceive of a time when patients will allow insurers to access ingestible event monitor type data, as we move toward ACOs and the patient- centered model, risk bearing entities will want more insight on how medication is taken and the consequences of poor adherence.
Ingestible event monitor
After four years of development and FDA review, the FDA in August provided a 510k approval for still another ingestible microchip device. Called the Ingestible Event Monitor, this digital pill is about the size of a grain of sand. It has traces of two metals which, upon contact with digestive juices, generate electricity that in turn powers the sensors and transmitter. Proteus Digital Health, a Redwood City company, created the device pictured below.
This monitoring system, by Proteus Digital Health, includes a mobile app, pills with embedded chips, and a patch that tracks body data.
This microchip is not something that is intended to be used alone. The idea is to create pills of traditional medications that contain this device. Once ingested and dissolved, the sensors can report several physical parameters including time of ingestion, temperature, heart rate, body position and even activity. The data are transmitted to a patch that is attached to the skin — a self-contained device with a battery that lasts about seven days. The patch relays data to an application on a smartphone that can record, plot, and analyze the data.
Of interest is that the patch, named Metria, is emerging as a burgeoning technology in and of itself. Proteus has plans to continue the development of Metria into a personal monitor that can measure calories burned, steps walked, sleep patterns and more. Using Avery Dennison Medical Solution’s waterproof adhesive and RDIF (radio frequency identification) technologies, this wireless monitor can be used during normal activities, including sweating and routine bathing.
The company clearly states that the patient controls access to the data. If allowed by the patient, using cell phone technology, the application can also alert physicians or caregivers that medication containing this microchip has been ingested.
Of importance is that this technology can assist patients by accurately tracking the time of their ingestion of medication. There is little information that is considered incontrovertible on adherence. Pill vial timer/recorders have been around for years, but the fact that a pill vial cap records the opening of the vial does not prove that the medication was actually ingested.
The World Health Organization in their 2003 landmark publication, Adherence to Long Term Therapies, Evidence for Action, estimates that up to half of all medication is not taken exactly as prescribed. This report also states that “significant cost-savings and increases in the effectiveness of health interventions … are attributable to low-cost interventions for improving adherence.” The WHO also specifically states that patients need to be “supported not blamed” for nonadherence.
The release of this technology by the FDA was followed by some very interesting comments in the blogosphere such as how interesting it might be should hackers get their hands on the chips, and how HIPAA standards might now apply to sewage treatment plants which would now house “dump-loads” of the personal health information. Others evoked the fear of Big Brother monitoring our every (bowel) movement! Obviously there were many skeptics!
But think about its use in monitoring compliance with medication for drug resistant tuberculosis where the public’s health can be damaged by nonadherence to therapy. Also, think about how this might revolutionize mental health treatment where many hospital admissions are attributed to “forgetfulness.” And what about its use in patients who are enrolled in clinical trials where nonadherence can lead to spurious data?
Obviously this is not just a tool for health care providers to spy on patients. The sensor can be imbedded into several medications that are taken together by the same patient. Each medication would have a specific “signature” to tell the clinician when each was taken. Computer algorithms could alert the patient if he or she forgot a needed medication. Consider patients on very complex medical regimes that are needed for good overall results. Control of diseases such as cancer, HIV, hepatitis C, and heart disease can rapidly deteriorate if patients miss even a few doses of primary or synergistic medications.
Another application could be to monitor, from afar, elderly patients who are attempting to maintain their independence. Parents could monitor their children’s adherence. Transplant patients likewise could benefit from monitoring their medication as well as from some of the physiologic measurements this device can provide. And don’t think just about missed medications; think about those suffering from Alzheimer’s disease who forgot they took their medication and “double up” resulting in unscheduled hospitalizations.
Perhaps the Ingestible Event Monitor will lead us on our own Fantastic Voyage into Tomorrow’s Medicine!
The author is a director in the value-based health department at Genentech. He has had no other industry affiliations in the past three years. The views expressed in Tomorrow’s Medicine are the author’s alone.