Are Digital Pills in Your Future?

New pills raise privacy and ethical concerns over their ability to send a signal to up to 5 people when taken
February 21, 2021 Updated: February 21, 2021

In November 2017, the FDA approved the digital pill Abilify MyCite to treat schizophrenia, depression, and bipolar disorder(1); a one-month supply costs $1,500, well out of range of affordability for many suffering from schizophrenia(2).

The pill includes a digital sensor that reacts with stomach acid when taken, sending a signal to a patch worn by the patient that then sends a signal to a smartphone app notifying up to five people that the pill was taken.

At the time of approval, concerns arose over how this new capability opened the door to various abuses, though there was little discussion of the worrying possibility of how such technology could be used by repressive governments.

The cost is nearly 30 times the cost of the generic pill for a 30-day supply. Schizophrenia affects approximately 1 percent 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 the homeless population.(3)

There were also questions at the time of approval over why a drug targeting schizophrenia was the first to include the technology, given that many people with this condition suffer delusions and paranoia. A drug that sends a signal from inside their body seems especially unattractive to this population.

The drug is the creation of Proteus Digital Health.(5) Although the system was 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, 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)

The new version of these digital pills will 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 haven’t 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)

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 minds and block recipients later. Of course, it isn’t inconceivable that future situations could emerge in which the patient didn’t get to make that choice themselves. The more benign scenarios include mental health patients who can be discharged from involuntary admissions based on drug regime adherence and possibly even parolees who must take specific drugs to be released from a psychiatric facility.

More common concerns around this technology are the potential 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.

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 that it wasn’t 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 that Fairview would be paid when cancer patients took their chemotherapy as prescribed by their physician 80 percent of the time.

When patients didn’t meet the threshold, the digital pill company didn’t get paid. Despite plans to become a high-tech generic drug manufacturer, Proteus’ vision ended with its bankruptcy. 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 don’t 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 percent and as low as 10 percent.(19) Data show approximately 50 percent of non-adherence is intentional and the other half happens when patients aren’t aware they aren’t taking the medication as prescribed.

However, a team of doctors and pharmacy professionals believe that while medication adherence is a problem in Western medicine, it isn’t 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 is data to show people with schizophrenia who are low in vitamin D,(22) folic acid, and vitamin B12(23) have more severe symptoms. In other words, there are nutraceutical interventions that help reduce symptoms of schizophrenia,(24) depression,(25) anxiety(26), 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.

Dr. Joseph Mercola is the founder of Mercola.com. An osteopathic physician, best-selling author, and recipient of multiple awards in the field of natural health, his primary vision is to change the modern health paradigm by providing people with a valuable resource to help them take control of their health. This article was originally published on Mercola.com

References

 

1 Food and Drug Administration, November 13, 2017

2 GoodRx, Abilify MyCite

3 BMC Psychiatry, 2019;19:370 

5 LiveScience, November 16, 2017

6, 7 Pharmaceutical Commerce, August 25, 2020 

8, 9 Med City News, January 14, 2021 

10, 11 Digital Commerce, March 29, 2018 

12, 13 The New York Times, November 13, 2017 

14 StatNews, January 17, 2019 

15, 16 Medical Futurist, July 21, 2020 

17 U.S. Pharmacology, 2012;37(4)

18 Pharmacy Times, 2011;4(59):12 Table 1 

19 Oman Medical Journal, 2011;26(3)

20 Journal of Managed Care and Specialty Pharmacy, 2016;22(5) 

21 The Digital Apothecary, November 1, 2019 

22 Schizophrenia Bulletin, 2018;44(6) 

23 CNS Drugs, 2014;28(7) 

24 Therapeutic Advances in Psychopharmacology, 2014;4(6) 

25 Journal of the American Osteopathic Association, 2020;120:100 

26 Nutrition Journal, 2010;9(42)