It sounds a little like science fiction — take a pill at home and your doctor is notified. Nevertheless, this may be the future of medicine and it’s been approved by the U.S. Food and Drug Administration. It was November 13, 2017, when the FDA announced the approval of the first digital pill — Abilify MyCite — for the treatment of schizophrenia, bipolar disorder and depression.1
The pill is designed to digitally track whether you’ve taken your medication and then send a compliance message to your smartphone and even your doctor if you approve of it doing so. Three years later the digital medication costs well over $1,500 for a 30-day supply, even through discount drug provider GoodRx.2
The cost is also nearly 30 times the cost of the generic pill for a 30-day supply. Schizophrenia affects approximately 1% of the population, yet a meta-analysis of 31 studies involving 51,925 people who were homeless found there is a significantly higher prevalence of schizophrenia, schizophreniform disorder and schizoaffective disorder in that population.3
The estimate of the prevalence of all psychotic disorders in the homeless population was 21.21%, and of schizophrenia alone was 10.29%. Plus, the number of individuals who are homeless with serious mental illness has been on the rise since the 1970s4 — which means that, even if the digital pill proved to successfully help manage a person’s schizophrenia and improve compliance, the cost of the technology may be far out of reach for those who need it most.
The Future of Medication May Arrive Soon: Digital Pills
The first digital pill system approved in 2017 required the individual to wear a sensor and used a cellphone app.5 According to Dr. George Savage, co-founder of Proteus Digital Health, maker of the first digital pill, the system was first conceived more than 200 years ago.
Within the digital pill is a sensor which includes copper and magnesium that operates similarly to a battery first developed 200 years ago. The compound in the pill generates a current, which runs a silicon chip. This sends a simple signal to the adhesive you wear on your stomach.
The system generates a current for only three minutes, just enough time to send the signal and for the sensor to gather the data. Information about the time you took your pill and your activity level is then sent to a cellphone app and, with your consent, onward to your doctor.
Although the system was unique, technology-driven and intended to improve drug adherence at the time it was conceived and developed, there was no evidence to prove it raised medication compliance.
More than three years later and under new leadership by EtectRx, which acquired Proteus when Proteus went into bankruptcy, there is renewed focus on determining whether it improves patient adherence.6 Now called the “ID Cap System,” the technology is set to make remote patient monitoring easier and to allow “real-time intervention” of doctors with their patients.
Digitals Pills Scheduled for an Upgrade
As CEO for etectRx, Valerie Sullivan talked about the differences between etectRx, Proteus and other companies in the market. Reiterating that her company is different because their focus is almost exclusively on patient compliance, including branding and clinical trials, Sullivan said:7
“This pandemic era we’re in has ramped up interest in telehealth generally. The remote patient monitoring that ID-Cap System enables can reduce clinical trial costs, eliminate non-adherence among patients and allow for real-time intervention with them.”
In early January 2021, MedCity News reported that etectRx teamed up with Pear Therapeutics to develop products combining the technology from both companies.8 They announced the initial project will be on medication related to mental health. In a phone interview with MedCity News, Sullivan commented on the “value in having patients see for themselves and feel empowered that when they take their medication, they feel better.”9
These digital pills will also contain wireless sensors embedded in the medication to communicate with a wearable lanyard device, as opposed to a patch stuck to your stomach. Pear and etectRx have not yet partnered with pharmaceutical companies to produce the technology for existing medications.
Digital Medicine May Be a Tough Pill to Swallow
Sullivan anticipates there may be some pushback from patients, doctors and even drug makers. Digital Commerce reported that British consulting firm L.E.K. Consulting found the technology may not be as well received as the digital pill companies hope.10
Although advocates believe the technology may improve outcomes by offering precise information about a patient’s use, experts anticipate it will be nearly a decade before these become routinely used in health care delivery.
L.E.K. believes among the biggest obstacles are the drug makers and the doctors. As Digital Commerce reported, Harsha Madannavar, managing director and partner at L.E.K., wrote in the report:11
“There is a degree of skepticism among pharmaceutical companies and some physicians. Pharmaceutical companies, like other large organizations, can be notoriously slow to integrate innovative technologies or platforms.
Physicians, particularly those in large hospital systems, have barely enough face time with patients and even less time to adapt to new care-delivery models or new decision-making paradigms.”
Speaking with a journalist from The New York Times, Ameet Sarpatwari from Harvard Medical School expressed concern about the technology, saying it “has the potential to improve public health, [but] if used improperly it could foster more mistrust, instead of trust.”12
Patients would be able to decide if their doctor and up to four other people could receive the data showing when the pills were taken. Patients would also have access to a cellphone app that could let them change their mind and block recipients later.
But some question whether this technology may also be an invasion of privacy and whether individuals may feel pressured to allow their doctors to monitor their medication. Dr. Peter Kramer, psychiatrist and author, believes digital technology may be ethical for a “fully competent patient,” but questions whether a digital drug may potentially become a “coercive tool.”13
Some experts believe that older adults, who wish to have help remembering to take their pills, may welcome these devices. Other potential uses for this type of technology can be expanded as well as incentivized by insurance providers to monitor opioid use and clinical trial participants, or to use as a condition for parole or release from a psychiatric facility.
On a different note, in 2019 Proteus announced it was testing a chemotherapy digital pill on patients with colorectal cancer.14 Again, the idea was to improve outcomes by ensuring medication adherence. The difference between this pill and the one for schizophrenia was it was not necessary for the chemotherapy pill to go through a round of regulatory approval based on the way in which the sensor was packaged within the capsule.
Technology Meant to Provide an Answer for Compliance
The chemotherapy drug was administered through Fairview Health Services in Minnesota, where the health care system paid Proteus in the hopes that it would help save them money by improving patient outcomes. The contract stated Fairview paid when the cancer patient took their chemotherapy as prescribed by their physician 80% of the time.
When patients didn’t meet the threshold, the digital pill company did not get paid. Despite plans to become a high-tech generic drug manufacturer, Proteus’ vision ended with its bankruptcy — with some experts saying the failure was on the part of the company and not the result of failed technology.15
Specifically, according to digital health venture fund and research group Rock Health, Proteus may have paid the price for a tactical choice by picking a “therapeutic area with a degree of difficulty that’s an eight or nine out of 10.”16 Even so, while the digital pill companies are taking aim at medication adherence, it may not be a fiscally responsible direction.
When medication is the only intervention sought, poor adherence can result in health complications and increased costs.17 This means that medication adherence and patient compliance are health care challenges the system seeks to overcome.
Data show some of the reasons why older adults do not adhere to their medication schedule include a lack of meaningful communication with health care providers, cost, fear of addiction, cognitive decline and medication side effects.18 That’s why chronic conditions, such as diabetes, high blood pressure, asthma and depression, require ongoing changes in lifestyle and nutrition to control the conditions.
The extent to which nonadherence affects patient outcomes varies widely across studies, having been reported as high as 92% and as low as 10%.19 Data show approximately 50% of non-adherence is intentional and the other half happens when patients are not aware they aren’t taking the medication as prescribed.
However, a team of doctors of pharmacy professionals believe that while medication adherence is a problem in Western medicine, it is not the only problem and may account for “only the third most frequent type of medication-related problem.”20 One pharmacist argues that science should not be solely aimed at compliance but, rather, adherence as a segment of medication optimization.21
Tied to medication optimization is adherence and a number of other factors that affect downstream costs such as adverse drug reactions, drug interactions, therapy failure and dosing problems.
Seek Out the Root of Your Health Condition
Many health conditions respond to lifestyle and nutritional choices. For instance, there are data to show people with schizophrenia who are low in vitamin D,22 folic acid and vitamin B1223 have more severe symptoms. In other words, there are nutraceutical interventions that help reduce symptoms of schizophrenia,24 depression,25 anxiety26 and many other health conditions.
Before becoming at risk for polypharmacy, or the use of multiple medications at one time to treat an ailment, and the side effects, seek out and work to correct the root of the health condition. Many times, there are lifestyle and nutritional changes you can make that have a significant impact on your overall health, and the symptoms or treatment of your health condition.
Prescription medications come with side effects, and oftentimes doctors prescribe a second medication to treat the side effects of the first. However, medications typically only mask symptoms and do not address the underlying condition, setting up a vicious cycle.
Although many pharmacy computers may flag drug interactions, the chemical complexity involved within your body when you’re taking multiple drugs make it challenging to avoid adverse reactions.
There are no magic pills — digital or otherwise — that fix symptoms or health conditions. In order to address your illness and restore your vigor, it is necessary to make changes to your lifestyle and your nutritional habits. Here are several articles to help you take a step toward achieving your health goals:
- The Science of Sleep and Sleep Deprivation
- Autophagy — How Your Body Detoxifies and Repairs Itself
- How to Make Fasting Easier, Safer and More Effective
- Incorporate the Nitric Oxide Dump