In the wake of back-to-back mass shootings in El Paso and Dayton last month, President Trump stated that millions of Americans posed a great threat to public safety, and that many in this group needed to be locked away.
“We must reform our mental health laws to better identify mentally disturbed individuals who may commit acts of violence, and make sure those people not only get treatment, but when necessary, involuntary confinement,” he said.
At a subsequent rally in New Hampshire, Trump spoke more explicitly about his plan: “We will be taking mentally deranged and dangerous people off of the streets so we won’t have to worry so much about them. A big problem.”
The idea of locking up those society calls “mentally ill” or “mad” has long been present in American society. Trump’s calls for locking up the “mentally deranged” presents us with a Back to the Future moment: the impulse to lock people up for public safety reasons is an age-old one, but it comes at a moment when digital technologies are making it easy to monitor an individual in our society. Indeed, there is now on the market a newly approved pill offering society the possibility of creating what might be called a digital asylum. Those deemed dangerous to society may be ordered to take an antipsychotic equipped with a sensor that will not only provide society with assurance that the person is taking the pill, it will provide other personal information to monitoring authorities. The haunted asylums of the past may be replaced by a Big Brother pill that has now arrived.
In 1751, when Quakers and other community leaders in Philadelphia petitioned the Pennsylvania Colonial Assembly to build a “hospital” that would house the “mad,” Benjamin Franklin wrote both of how hospital care could prove curative to many and of how there was a need to sequester the many lunatics “going at large [who] are a terror to their neighbors, who are daily apprehensive of the Violences they may commit.” When Pennsylvania Hospital opened in 1756, the “lunatics” were kept in gloomy, foul-smelling cells, and regularly “chained to rings of iron [or] restrained in hand-cuffs or ankle-irons.”
That societal impulse, to lock up those deemed mad for public safety reasons, has waxed and waned ever since. In the 1790s, Quakers in York, England reconceived of the mad as “brethren” and created a Retreat that sought to provide humane care consistent with that conception. American Quakers then established similar asylums in several states, and the notion that the “mad” were a threat to public safety waned, at least within the philosophy that governed the creation of those facilities.
In the late 1800s and first decades of the 20th century, eugenic ideas began to take hold in the United States, and those deemed “mentally ill” were put in large hospitals and regularly kept there for years in order to “segregate” them from the general population. However, this public policy was not driven by a societal worry that the “mentally ill” were a threat to public safety, but rather that they needed to be locked up to prevent the “mad” from passing on their “bad genes.”
In the wake of World War II, public support for eugenic ideas lessened, as it was these ideas that had fueled Nazi Germany, and thus the “public safety” rationale for locking people in mental hospitals waned. In the early 1960s, the emptying of the state hospitals began, with the public informed that a combination of outpatient care and antipsychotic medication could help the “severely mentally ill” live decent lives in community settings. During this decade and the next, there were even a number of popular novels and films that presented the patients in mental hospitals as heroic characters living in a mad society. In One Flew Over the Cuckoo’s Nest, it was those who ran the hospital who were seen as truly mad.
The tide began to turn again in the 1980s. Homeless individuals showed up on city streets, and while that was seen by many as a policy failure, one created by Reaganomics, E. Fuller Torrey began pushing for societal policies that would force the “mentally ill” to take their antipsychotic medication, and he used a “public safety” argument to make his case. People with schizophrenia off their medication were likely to commit horribly violent crimes, he said, and as he pushed states to pass laws that authorized forced treatment in community settings, he used instances of mass killings to bolster his argument in his media appearances. Without such legislation, he told 60 Minutes in 2013, our country would just have to accept such regular outbursts of random violence. “There are the consequences, when we allow people who need to be treated to go untreated,” he said.
The NRA has put Torrey’s claims to political use. Blaming “the mentally ill” for mass murders became a way to deflect attention away from laws that allow for easy purchase of assault weapons. “The truth is that our society is populated by an unknown number of genuine monsters — people so deranged, so evil, so possessed by voices and driven by demons that no sane person can possibly ever comprehend them,” said NRA President Wayne LaPierre after Sandy Hook. “They walk among us every day.”
This “dangerousness” narrative, of course, is countered by academics, advocates, and policy-makers who are familiar with the scientific literature, which tells of how there is no meaningful link between mass shootings and people said to have a “serious mental illness.” However, people with psychiatric diagnoses are at increased risk of being victims of violence. As Vanderbilt University researchers Jonathan Metzl and Kenneth McLeish wrote in a 2015 paper: “Blaming persons with mental disorders for gun crime overlooks the threats posed to society by a much larger population—the sane.”
While that response to the dangerousness narrative gets some play in the media, it doesn’t win the hearts and minds of a majority of the public. In a 2018 Post-ABC poll following the mass shooting at Parkland, 57% of respondents believed that “mass shootings were a result of failures to identify and treat individuals with mental health problems.” Seventy-seven respondents said they thought that “more effective mental health screening and treatment could have prevented the shooting at Marjory Stoneman Douglas High.”
In a sense, we are now back to where we were in 1751. Benjamin Franklin argued that new treatments could prove curative to many lunatics, and that the public needed to be protected from the “lunatics” because of their violent ways. That is, in essence, the same argument advanced by Torrey, with antipsychotics the curative agent of the day, and as for the language employed by LaPierre, who told of “monsters” walking free in our streets, his words were much harsher than any used by Franklin and his fellow Quakers.
A widespread belief that the “mentally ill” are responsible for much of the violence in our society presents several ‘policy’ questions. Who are the “seriously mentally ill?” How can they be identified? And once they are, how can their behaviors be monitored and “treatment” insisted upon that, at least in theory, will present them from acting in such violent ways?
The mental hospital long served as the confinement of choice. Compulsory outpatient treatment legislation has served as an extension of that confinement. And our society is now glimpsing a new possibility. The introduction of the first “digital pill” into the marketplace, Abilify MyCite, portends a Black Mirror-esque asylum that would reside within the human body: a digital version of the 18th century panopticon.
In 1791, English philosopher and social theorist Jeremy Bentham designed the panopticon, both a physical structure and a self-contained surveillance system. The panopticon’s circular design gave the guards, situated in the center, the ability to observe all inmates simultaneously. But the incarcerated persons could never ascertain if or when they were being watched:
“The Building circular — an iron cage, glazed — a glass lantern about the size of Ranelagh — The Prisoners in their Cells, occupying the Circumference — The Officers, the Centre. By Blinds, and other contrivances, the Inspectors concealed from the observation of the Prisoners: hence the sentiment of a sort of invisible omnipresence. — The whole circuit reviewable with little, or, if necessary, without any change of place.”
— Jeremy Bentham (1791). Panopticon, or The Inspection House
Bentham’s panopticon would become a central metaphor in the work of French philosopher Michel Foucault, and the emerging field of surveillance studies. Foucault’s theory of panopticism referred not just to a physical building, such as a prison, hospital, factory, or school, but to the ways that power and knowledge function across society, and how social control is exercised.
Foucault theorized that power is based on both the ability to observe others and the knowledge obtained through that observation. There is always an inherent power imbalance between the “omnipresent” and “invisible” watchers and their “permanently visible” subjects. As Foucault wrote in Discipline and Punish: The Birth of the Prison:
“Traditionally, power was what was seen, what was shown, and what was manifested . . . Disciplinary power, on the other hand, is exercised through its invisibility; at the same time it imposes on those whom it subjects a principle of compulsory visibility. In discipline, it is the subjects who have to be seen. Their visibility assures the hold of the power that is exercised over them. It is this fact of being constantly seen, of being able always to be seen, that maintains the disciplined individual in his subjection.”
In George Orwell’s dystopian novel Nineteen Eighty-Four, the physical infrastructure of the panopticon becomes the Telescreen, a device that “received and transmitted simultaneously,” functioning as a television, security camera, and microphone. The Thought Police used the Telescreens to continuously monitor persons deemed of interest to Oceania and to root out the presence of “Thoughtcrime” among them.
Orwell wrote of the Telescreens: “There was of course no way of knowing whether you were being watched at any given moment . . . you had to live . . . in the assumption that every sound you made was overheard, and, except in darkness, every movement scrutinised.”
In her 1984 poem “To Be a Mental Patient,” psychiatric survivor and cross-disability rights activist Rae Unzicker wrote:
“To be a mental patient is to be stigmatized, ostracized, socialized, patronized, psychiatrized.
To be a mental patient is to have everyone controlling your life but you. You’re watched by your shrink, your social worker, your friends, your family. And then you’re diagnosed as paranoid.
To be a mental patient is to live with the constant threat and possibility of being locked up at any time, for almost any reason.”
Unzicker told of a life lived under surveillance, and of suspicion. Psychiatry has its “Thought Criminals” too—those persons diagnosed with “serious mental illness” who will not admit to their illness, or comply with a doctor’s orders. Such individuals are pronounced as suffering from anosognosia, or “lack of insight.” They are not willing to observe themselves as ill, and therefore, to desire care; that is, to submit to medical authority.
Gail Susan Harris, my mother, came to be viewed as one of those “dangerous, noncompliant” types. My early childhood was spent inhabiting two distinct realities. The first reality was life with my mother when she was heavily medicated on Haldol. Most days, she was able to attend to my basic needs, but she was often sleeping, at times so sedated as to be nearly impossible to wake. I learned how to fend for myself, making cheese sandwiches and eating them in front of the TV as she slept.
The second reality was when she made the decision to flush her meds, a choice she would make over and over during the course of her short life. During these times, my mother would transform into a different person. She stopped sleeping as much. Her eyes went from dull and glazed to alert, flashing, darting this way and that. She let me in on a terrible secret, in hushed, conspiratorial tones: Nazi doctors were hiding among us in plain sight, and she was meant to expose the truth and save the world.
My mother’s fear of surveillance was all-encompassing. She would stop answering the telephone and would open the door to no one. One frigid winter day in 1979, convinced that the Nazis were monitoring her thoughts via the television screen, she heaved it out of our third-story apartment window. In such instances, our family would bring the police to break down the apartment door and forcibly take her to the Milwaukee County Mental Health Complex, the local public psychiatric institution. I’d end up either on a family member’s couch, or in foster care. This cycle would repeat, over and over, until the State finally took me away from her when I was five.
Reflecting on Unzicker’s experience, and my mother’s story, I can’t help but wonder: Maybe the very people who have been diagnosed with “paranoid schizophrenia” for insisting that they were being monitored and tracked by powerful government entities were not quite as “delusional” as everyone believed. Maybe they were actually prophets of a sort, picking up on dystopian realities yet to come.
In 2019, it can no longer be considered paranoid to say that they’re watching us. Whenever we are on the Internet, our behavior is being monitored, analyzed, and remembered. Cameras monitor our streets, our public spaces. Credit card companies track and analyze our spending habits. All of our health care visits and drug prescriptions become part of an electronic health record. The digital panopticon is in place, and “they” are discovering new ways to watch us, all the time.
At the 2018 meeting of an industry conference called HLTH, Otsuka Pharmaceutical CEO Kabir Nath and Proteus Digital Health CEO Andrew Thompson gave a presentation titled “The Future of Medicine.” They were there to tell about the world’s first digital pill, dubbed MyCite, which combines the antipsychotic drug Abilify with a sensor that reports whether the patient has taken a daily dose. When their turn to present came, the pair walked triumphantly onstage to the strains of Van Halen’s “Right Now.”
After waiting for the applause to die down, Nath, in an elegant, soothing baritone, told of the medical reality now at hand. “We’re excited to be here this afternoon to talk to you,” he said. “Not only about the fact that the future of medicine is digital . . . but that [the] future is here already.”
Otsuka is the manufacturer of Abilify (aripiprazole). Proteus developed the sensor technology, and when it was Thompson’s turn to speak, he provided the audience with what might be described as the official MyCite origin story, one that everyone could feel good about. He told of a collaborative partnership between the tech company and mental health service users that had led to its creation.
“We began working with mental health patients in 2009. We began with a deeply human-centered design process, where we partnered with patients who were bipolar or had schizophrenia. And then we worked with leading physicians who treat these patients, and we designed everything about our system around first, patient life flow, and then physician workflow. We learned a lot. And what we learned was that patients liked our solutions so much that they didn’t want to go back onto drug therapy after a three-month trial.”
In other words, MyCite is on the market today because psychiatric patients wanted it and industry listened. According to Thompson, these psychiatric patients set up tables at National Alliance on the Mentally Ill conferences, advocating for drug-makers and doctors to put microchips in their pills. This group’s passionate and vocal advocacy then attracted the attention of Otsuka Pharmaceutical, which reached out to Proteus Digital Health in 2012 to pursue a collaboration that would combine the “blockbuster” drug Abilify and Proteus’s sensor technology.
This drug-device combo is known as a Digital Medicine System (DMS). Each pill contains a tiny sensor no larger than a grain of sand, called an ingestible event marker (IEM), composed of trace amounts of minerals found in the human diet: copper, magnesium, and silicon. Upon contact with the gastric fluids, the sensor sends a signal to a wearable patch located on the user’s chest. The patch then conveys the “drug-adherence” data to an app on the patient’s smart phone, which in turn sends the data to a cloud-based server that can be accessed from a provider’s desktop.
The user can also designate up to four additional recipients of such data, including family, friends, or caregivers. However, the user cannot opt out of sharing their data with the medical provider. The data collected by the DMS includes not only whether a pill has been taken (within one minute with up 97% accuracy), but also activity level and physiological markers, such as heart rate and sleep.
“For the first time,” said Otsuka’s Nath, “physicians know something about what happens the 99% of the time that the patient is not under their direct control or care.”
In other words, an ever-present surveillance system. “It’s really important to understand that what we’re talking about when we talk about the world of digital is an end of statistics and probability, and the emergence of calculus and certainty,” he said.
What this means is that your doctor—and others—will now be able to know for sure whether you took your Abilify on schedule. And whether you are awake, and up and about. And all this in the first digital pill; one imagines that future Digital Medicine Systems will provide additional information about the activities of the “patient.” A MyCite app on the phone, for instance, could easily send GPS tracking information to the provider. The wearable patch, while ostensibly serving to tell of the digestion of a prescribed drug, could link every movement of that person to the Cloud.
When the FDA approved Abilify MyCite in November 2017, it became the world’s first FDA-approved “digital medicine.” As such, it was the first in a new “category of drugs” to be reviewed by the FDA, and this was the first new approval category added by the regulatory agency in 35 years. One industry-funded paper observed that it was “challenging to overstate” the clinical significance of this New Drug Application (NDA) approval, “given the rarity of new pharmaceutical categories.”
Even so, the question that had many scratching their heads was this: why would the first digital pill be an antipsychotic? Why not make it for a non-psychiatric illness? Even some leading psychiatrists were skeptical about this choice.
In a New York Times article titled “First Digital Pill Approved to Worries About Biomedical ‘Big Brother,’” Columbia University psychiatrist Paul Appelbaum said: “A system that will monitor their behavior and send signals out of their body and notify their doctor? You would think that, whether in psychiatry or general medicine, drugs for almost any other condition would be a better place to start than a drug for schizophrenia.”
Similarly, Virginia Commonwealth University psychiatrist James Levenson told The Washington Post: “Patients who have a lot of paranoia might be uncomfortable with the idea of a medicine that is transmitting signals. The patient may be afraid to take it.”
Or as late night talk show host Stephen Colbert joked: “Because nothing is more reassuring to a schizophrenic than a corporation inserting sensors into your body and beaming that information to people watching your every move.”
While the choice of an antipsychotic as the first digital pill may seem strange, there is an economic rationale for it. All you need to do is follow the money.
Proteus acquired the ingestible sensor technology around a decade ago. The immediate purpose of this technology was to increase medication adherence, which was understood to be a pressing medical need and thus a potentially big market.
Studies have found that rates of non-adherence tend to be uniformly high across the gamut of chronic health conditions, ranging anywhere from 30 to 50 percent. As a result, non-adherence to drugs is routinely cited as America’s “$300 billion health care problem.”
The New York Times called it “an out-of-control epidemic in the United States that costs more and affects more people than any disease Americans currently worry about.” Meanwhile, a 2018 study published in the Annals of Pharmacotherapy, examining drug-related morbidity and mortality, estimated that the cost of non-adherence may be as high as $528.4 billion annually, or equivalent to 16% of total US health care spending.
The medical community has been seeking to solve this problem for decades. Reliance on self-reports is generally inadequate, as people tend to overestimate their adherence rates. Pharmacy records don’t reveal whether individuals have actually taken the prescriptions they filled. Blood tests can detect the amount of a drug in someone’s system, but reveal nothing about daily adherence rates.
In institutional settings, such as hospitals and nursing homes, there is “direct observation therapy” (DOT), where staff watch to make sure patients take their pills. Higher-tech attempts at adherence solutions range from mobile phone reminders and alerts, to the Medication Event Monitoring System (MEMS), which consists of bottle caps equipped with electronic devices that can detect if a bottle has been opened. However, this system still can’t tell if a medication has actually been ingested into a human body.
The digital sensor technology offered an advance in “adherence monitoring” compared to all of these other efforts. And while Proteus has been testing it for a broad range of chronic illnesses, from a market perspective, it made sense for the company to focus on “serious mental illness” as its first commercial target.
According to one systematic literature review, people diagnosed with “schizophrenia” have among the highest non-adherence rates, said to hover in the 60-70 percent plus range, due to “insufficient efficacy, intolerable side effects, or for other reasons.” People diagnosed with bipolar disorder are also known to have high non-adherence rates. So the “seriously mentally ill” are seen as a problematic patient population.
In addition, the public has been primed to think that when people with a “serious mental illness” stop taking their antipsychotics, they are likely to relapse and become violent. As a result, there was already public support for legislation and other efforts that would ensure they took their drugs, which could help Otsuka introduce a digital pill to the market.
The medication-adherent product of choice for psychiatry has long been “long-acting injectable antipsychotics” (LAIs), which remain in the body for anywhere from 30 to 90 days. LAIs are said to eliminate the need for providers to conduct detailed adherence assessments at every visit, and reduce the chance of people going off their drugs during transitions from prison or hospital to the community. Families and caregivers also tend to like LAIs: they are seen as reducing or eliminating power struggles and the need for “grilling” around medication-taking or appointment-making.
However, LAIs may be disdained by some health care providers because of the difficulty in achieving accurate dosing, and perceptions of injectables as stigmatizing and coercive. People forced to take LAIs report considerable pain at the injection site, and often object loudly to this form of forced treatment.
Add these factors together, and Proteus could see a rationale for making an antipsychotic the first digital pill it would bring to market. People diagnosed with serious mental disorders regularly stopped taking their antipsychotic medication; the public had come to believe that medication compliance helped protect public safety; and the current method used to improve medication adherence, LAIs, was understood to have its limitations.
Equally important, Otsuka contacted Proteus in 2012 for a pressing reason of its own: its best-selling drug Abilify was set to go off patent in 2014. It needed to create a new patent-protected place in the market for Abilify, and turning it into a “digital” medicine offered the possibility of doing just that.
While speaking to the HLTH audience, Otsuka’s Nath spoke about the “patent cliff” and the threat it poses to the financial wellbeing of pharmaceutical companies.
“So people talk about drug pricing and they define drug pricing as the problem. Let me posit to you that it is not the problem. The Pharma business model, and especially the innovation model in the industry, is the problem. If it costs $5 billion to create a drug and then you have 10 years to make a return, then by definition the price of that drug is going to be high. Pharmaceuticals are a very risky business. R and D costs billions. It’s very hard to predict success. When you get a product approved, it can be very hard to get it paid for. Pricing must be high in this model, and by the way, your competitors in the bulk chemical industry are all waiting for a date certain when you lose your patent, and they can take over your business. It’s a very bad business model.”
While he did not mention Abilify by name, Nath surely had it in mind. From April 2013 to March 2014, Abilify had been the top-selling drug in the United States, with sales of $6.9 billion. Abilify accounted for nearly half of Otsuka’s revenues at that time.
In April 2015, the FDA approved the first generic aripiprazole. Abilify sales were about to fall off the cliff, and Otsuka was desperate to keep up the revenue stream from this drug. Adding a sensor to Abilify provided Otsuka with a way to fairly quickly bring a new patent-protected product to market.
As Thompson explained at the HLTH conference, the FDA has developed a “streamlined” approval process for products that are a “combination of a drug and a device.”
“To gain an approval for a digital medicine, there is a separate NDA process, a new NDA pathway through CDER. So you take an approved drug, you add the approved ingestible sensor, you test for stability, bio-equivalence and human factors. This takes about 20 to 30 months and it costs about $50 million. That may sound like a lot, but in case anyone isn’t aware of this, a regular pharmaceutical takes about 10 years and costs about $5 billion.
So you get a new NDA and new NDC code and new naming convention and you can create a new business with a much better product, with a very streamlined FDA pathway.”
Since Otsuka had already received FDA approval for Abilify in 2002, it was not required to test MyCite for therapeutic efficacy, or for drug-related side effects. And since Proteus had obtained FDA approval for its ingestible sensor in 2010, there wasn’t much additional safety testing of the digital monitoring system that was needed. All Otsuka and Proteus needed to show with their clinical trials was that patients could be instructed how to use it, that the patch wouldn’t have adverse safety effects, and that the digital sensor functioned as designed, which is to say that it sent a signal to the patch worn by the user that the drug had been consumed. Otsuka and Proteus did not even need to show that their product led to increased medication adherence.
As the FDA reviewers of MyCite trial data wrote, “The FDA’s conclusion is simply that the pill, patch, and app function as intended, and that most patients with schizophrenia, bipolar I disorder, and depressive disorder could successfully use the product.”
Otsuka priced its “digital pill” at $1650 a month, compared to $20 per month for generic oral aripiprazole. This cost, of course, will be mostly borne by the taxpayer, as the “seriously mentally ill” who are forced to take medications are usually covered by Medicaid. As Akin Gump, Otsuka America’s lobbying firm, wrote about their five-year collaboration: “As with all revolutionary medical products, success hinges on reimbursement by the Centers for Medicare and Medicaid Services.”
While researchers have pointed out the flimsy nature of the clinical trials that Otsuka and Proteus conducted to obtain FDA approval for MyCite, there has been little discussion in the general media about the ethics of promoting a digital pill to improve adherence to a medication that can cause a long list of adverse effects, and belongs to a class of drugs that impair a person’s cognition, deaden emotions, and reduce the possibility of long-term recovery. They may also cause early death.
Even over the short-term, Abilify and other “atypical antipsychotics” are known to cause metabolic dysfunction, parkinsonian symptoms, and brain shrinkage. Antipsychotics over longer periods of time may cause tardive dyskinesia, which is evidence of permanent damage to the basal ganglia. Studies in elderly populations show that they markedly increase the risk of death, and in a 2018 meta-analysis, UK researchers concluded that this heightened risk of death is apparent in general mental health studies too. They concluded: “Antipsychotic drugs precipitate excessive mortality across the spectrum. Prescribing of antipsychotic drugs for dementia or for other mental health care should be avoided and alternative means sought for handling behavioral disorders of such patients.”
There is now abundant evidence that regular antipsychotic use worsens long-term functional outcomes in persons diagnosed with psychotic disorders. Indeed, clinical practice guidelines in “first-episode psychosis” programs now stress the importance of judicious medication use and working collaboratively with service users and their social networks. The Open Dialogue approach pioneered in Finland incorporated those principles, and a 2015 paper exploring its success concluded that the single most important variable in a positive prognosis for “typical schizophrenia” was “a rare or low-dose use of antipsychotics.”
In a long-term study of schizophrenia patients in the United States, Martin Harrow found that the recovery rate was eight times higher for those off antipsychotic medication than for those who were medication compliant.
All of this is glossed over, or missing altogether, in public discussions about the “benefit” of laws and policies designed to make sure that the “seriously mentally ill” take their drugs. Also missing in this discussion is recognition of the fact that these drugs may induce akathisia, an extremely agitated state of mind and body, which is a risk factor for both suicide and interpersonal violence.
MIA’s recent report on “The Case Against Assisted Outpatient Treatment” details this risk that comes with use of antipsychotics:
“Patients suffering from akathisia described ‘violent urges to assault anyone near,’ and wanting to kill ‘the motherfuckers’ tormenting them in this way. A 1990 study determined that 50% of all fights on a psychiatric ward could be tied to akathisia. Yet another study concluded that moderate to high doses of haloperidol made half of the patients markedly more aggressive.”
And that was indeed the case for my mother.
My mother’s psychiatric record reads like a hellscape of violence, desperation, and despair. She was detained over and over by the police for things such as “bizarre and dangerous behavior,” “throwing herself in front of passing cars,” “laying down in the street,” “street-walking,” “smashing glass,” and “allegedly assaulting a neighbor.” Yet, she had no history of violence before being put on psychiatric drugs.
In 1986, my mother was enrolled in Wisconsin’s Medicaid-funded Community Support Program (CSP), as she met criteria with a diagnosis of “serious mental illness” and a high risk of re-hospitalization, given her past history. I have, in my possession, a gigantic accordion file with pages upon pages of yellowing case notes that attest to the weekly visits and careful observations, adherence assessments, and documentation of my mother’s lifestyle choices, behaviors, and habits. The words “compliant” or “noncompliant” are found on nearly every single page.
Eventually, the CSP began to “work” as intended. In the final two years of her life, my mother remained compliant with oral medications and was not re-hospitalized. By all “outcome metrics,” this was a win for my mother, who hated being shipped off to Milwaukee County Mental Health Complex. And it was a win for the family, who very much disliked dealing with her when she was “off her meds.” And it was a win for Wisconsin’s public mental system, which was saving thousands of dollars that would have been spent on her repeated institutionalizations.
However, this tallying up of the “benefits” didn’t account for the health consequences that came along with such medication adherence. The antipsychotics my mother was forced to take over the years likely contributed to her developing diabetes mellitus, which became another chronic condition that she was then expected to manage. Other medical issues my mom faced due to the drugs included restlessness and akathisia.
Cigarette smoking eased the worst of the drugs’ agitating adverse effects, and thus helped her cope with the akathisia. But the decades of smoking eventually led to her developing COPD. No one could compel my “unmotivated” mother to comply with a diabetic diet and to exercise, or to quit smoking. I suspect that making so-called “poor lifestyle choices” was the only avenue of resistance left to her.
As documented in my mother’s chart, on the night that she died in April 1996, she waved off a friend who wanted to call her an ambulance for her COPD-related breathing difficulties, saying she “just had a cold” and she’d be fine in the morning. The friend acquiesced to her wishes. Her final act was to refuse to go to the hospital for intubation, a simple medical procedure to open her airway, a procedure that would have saved her life, at least, for that night. While I miss her every day of my life, I believe that she was exercising what little choice she had left in a life dominated by nearly three decades of medical and psychiatric surveillance and control.
In the last case note appearing in my mother’s chart following her death, the RN spends several lines documenting my mother’s “compliance” with her meds, and her “noncompliance” with a diabetic diet or recommendations for the treatment of COPD.
The final line reads: Death appears to be of natural causes at this time, followed by a list of medications she was taking when she died. She was 46.
Although the FDA approved Abilify MyCite in November of 2017, Otsuka could not expect to immediately begin selling it. There was no existing market for this new category of drugs, and thus Otsuka has had to create one. In August of 2018, it entered into a collaboration with Magellan Health, with the “aim of providing real-world evidence to demonstrate the value of this drug-device combination product over time.”
Magellan Health is a Fortune 500 company. It is a large manager of behavioral health services, and it will first test this new product on Medicaid patients in the South. In their announcement of the collaboration, Otsuka and Magellan presented this roll-out as one that would bring “innovative technologies” to patients that rarely have access to them, with privacy protections in place too. “Patients can opt in if they want to try it, and Magellan will not have access to patients’ individual-level data on whether and at what time they ingested their pills,” STAT News reported.
In this preliminary test phase, it will be Otsuka that collects and analyzes all the data sent by the sensor. The data-collection process is in fact being presented and “branded” as an Otsuka product. The press release described how it will be done:
“The ABILIFY MYCITE System provides an opportunity for a connected care approach to treatment, and tracks if ABILIFY MYCITE (aripiprazole tablet with sensor) has been taken. The system is comprised of: the ABILIFY MYCITE tablet (an aripiprazole tablet embedded with an Ingestible Event Marker (IEM) sensor); the MYCITE® Patch (a wearable sensor); the MYCITE® APP (a smartphone application) and the MYCITE®Dashboard (a web-based portal for healthcare providers and caregivers).”
The press release makes it seem that the sensor will simply track whether the drug “has been taken.” For an individual, that is a data point of minuscule size. However, when Otsuka trumpets this technology as an advance in medical care, it tells a very different story. Then its device suddenly becomes one that can track a large number of real-time processes, which in turn generates huge amounts of data about each individual wearing the patch. As Dr. William Carson, President & CEO of Otsuka’s Pharmaceutical Development and Commercialization division, told Startup Health TV:
“The amount of data that Otsuka collected [in the MyCite trials] was more than all of the data that we’ve ever had in all of our clinical trials. And that really stands out, as it really makes you think. In the world that we’re in now, we have a wealth of data which will help us to understand patients better and help us to make sure that they are able to manage their medications.”
In addition to the Magellan collaboration, Otsuka is funding a trial of Abilify MyCite that will focus on recruiting military veterans living in the South. The study is called DIgital MEdicine Study (DIMES) for Adults With Schizophrenia, Bipolar I Disorder, or Major Depression Currently Using Aripiprazole, and is designed to measure differences in adherence rates between those who take Abilify as usual, and those who utilize the digital version. Recruitment is currently underway via the Durham VA Medical Center in North Carolina, and is planned for the Michael E. DeBakey VA Medical Center in Houston, Texas.
There is at least one other testing program in the works. In June of this year, Otsuka announced a collaboration with Thriving Mind South Florida (contracting as the South Florida Behavioral Health Network), a nonprofit organization supported by Florida’s Department of Children and Families. Thriving Mind then broke ground on a 280-bed jail diversion facility in Miami, funded by a blend of public behavioral health and criminal justice dollars. The collaboration and the eventual facility could provide Otsuka with an opportunity to demonstrate Abilify MyCite’s use in a captive population.
The eerie possibilities that await can best be seen in the above statement by Otsuka’s William Carson: the company collected more data in the MyCite studies than it “ever had in all of their clinical trials.”
Just how will that data be used in the future? And if the collection of enormous amounts of data is already possible with this first edition of a digital pill, what can we expect from subsequent generations of digital medicines?
“The use of smart pill technologies is described as an intervention to achieve medication adherence,” wrote Eric Swirsky and Andrew Boyd in a 2018 paper published in the American Journal of Bioethics. “However, this application of the digital pharmacopeia is more accurately described as surveilled compliance.”
And hence, the creation of the digital asylum. The American public has already embraced state laws that require the “seriously mentally ill” to take their medications; use of a digital pill would help monitor their compliance.
As early as 2012, when the idea of a digital pill first began taking hold in the public mind, Patricia Deegan, PhD, whose professional work has focused on giving service users voice and choice in their use of medications, raised an alarm about the potential coercive applications of digital pills:
“What should informed consent be like in the event that we are offered a ‘Police Pill’ or, phrased more benignly, an ‘Assisted Treatment Pill’? Who should control access to the personal information that is generated by such pills? What action should be taken based on the information that is collected by such pills? Should your employer be warned that you have not slept in 2 days? Should a psychiatrist or case manager come to our home if we have not swallowed prescribed medicine in a timely fashion? Should family members receive a notice if the microchip says that we have not been sleeping enough? Should our doctor or nurse adjust dosages of medication based on biometric information received from these ‘smart pills’?”
Moreover, it is easy to foresee the possibility that authorities will require people receiving government disability payments because of a psychiatric disorder to use the pill.
In a 2018 paper published in the American Journal of Bioethics, Dominic Sisti and Mélanie Terrasse noted that participation in “monitored medication adherence” programs could be dangled as an eligibility requirement for programs to access housing or other needed resources. This technology, they noted, could also be used for “big data policing”:
“It is also likely that mentally ill persons involved in the criminal justice system will be pushed to use treatment monitoring devices, and, therefore, disproportionately bear any unforeseen adverse consequences of these new technologies. This population is significantly more likely to be surveilled through methods such as neighborhood over-policing or ‘big data policing.’ Data from these devices may be repurposed for forensic aims, to evaluate individuals’ suitability and eligibility for particular rehabilitation or reentry programs, or to attempt to predict dangerousness.”
Trump, of course, spoke about how society needed to take “mentally deranged and dangerous people off the streets,” which was understood to be a call to return to rebuilding the asylums of old. But even at a cost of $1650 per month, digital Abilify may ultimately come to be seen as a more cost-effective way to control the lives of those deemed “mentally ill.” And it is because it can offer this control, that it will be seen as a superior alternative to long-acting injectables (LAIs).
Use of LAIs is an efficient and relatively low-cost method for assuring “medication adherence.” If that were the only purpose of Abilify MyCite, then it is difficult to see how it could become a commercial success. However, the fact that a prescription of Abilify MyCite requires the “patient” to wear a patch sending reams of data to the Cloud is what separates it from LAIs. The wearable patch is already able to provide huge amounts of real-time personal data, and it could easily be used to provide minute-by-minute monitoring of a person’s location. The digital pill offers systems and society the opportunity for 24-hour surveillance and control, and the possibility for corporations to profit from it.
For Proteus and Otsuka, Abilify MyCite is simply the first of the many digital pills they plan to bring to market. In an agreement signed in October 2018, Otsuka promised to pay Proteus $88 million in “related equity and other payments” for the “development and commercialization of digital medicines over the next five years.”
Proteus already has 31 digital medicines in its pipeline, including cancer medications and opioids, and is looking to expand into pre-exposure prophylaxis (PrEP) medications designed to prevent HIV transmission. In a 2018 address to the Royal College of Physicians in the UK, Proteus CEO laid out his vision for a futuristic world of digital health:
“Digital companies have been able to use phenotyping to create exquisitely tailored products and services. Amazon phenotypes how you shop and delivers precision commerce. The same will happen with medicines. Your care team will know how you take them, how your body responds and will deliver precision Digital Medicines.
On the device side we will move from fun toys to FDA-certified consumer friendly, medical grade wearables that deliver accurate, actionable health data.
Digital apps will be much more sophisticated and make use of sensors and analytics integrated into the consumer’s own mobile devices. These apps will store data and forward actionable insights to care teams based on AI, and provide engagement tools that support patients and their families.”
If Thompson is right—and Otsuka just bet $88 million that he is—then the digital medicine panopticon may be coming for us all.
If you have been part of an Abilify MyCite clinical trial or have otherwise used this digital medicine system, Mad in America would like to hear about your experience. Please contact the author or submit your story here.