From the Editor

The pill. The criticism. The question.

Readings have covered everything from new books to political speeches. This week, we consider a few thought-provoking pieces. Is there a common theme? Maybe this: the world of mental health care is changing – and fast.

In these three selections, we look at: the pill that talks to doctors and family, the criticism of digital health, the question about the true nature of schizophrenia.



Digital Pill

First Digital Pill Approved to Worries About Biomedical ‘Big Brother’

Pam Belluck

The New York Times, 13 November 2017

For the first time, the Food and Drug Administration has approved a digital pill — a medication embedded with a sensor that can tell doctors whether, and when, patients take their medicine.

The approval, announced late on Monday, marks a significant advance in the growing field of digital devices designed to monitor medicine-taking and to address the expensive, longstanding problem that millions of patients do not take drugs as prescribed.

Experts estimate that so-called nonadherence or noncompliance to medication costs about $100 billion a year, much of it because patients get sicker and need additional treatment or hospitalization.

Abilify’s digital pill collects data on compliance, as well as mood tracking (and, yes, there’s an app for that)

The author notes:

  • “Patients who agree to take the digital medication, a version of the antipsychotic Abilify, can sign consent forms allowing their doctors and up to four other people, including family members, to receive electronic data showing the date and time pills are ingested.”
  • The app can block recipients should the patient change his or her mind.
  • The first digital pill is for Abilify (the antipsychotic) but there would be potential use of this technology for medications treating chronic physical health conditions.

The article goes into detail on how it works:

The sensor, containing copper, magnesium and silicon (safe ingredients found in foods), generates an electrical signal when splashed by stomach fluid, like a potato battery, said Andrew Thompson, Proteus’s president and chief executive.

 After several minutes, the signal is detected by a Band-Aid-like patch that must be worn on the left rib cage and replaced after seven days, said Andrew Wright, Otsuka America’s vice president for digital medicine.

 The patch sends the date and time of pill ingestion and the patient’s activity level via Bluetooth to a cellphone app. The app allows patients to add their mood and the hours they have rested, then transmits the information to a database that physicians and others who have patients’ permission can access.

The author discusses the possible ethical implications, including patient privacy. Dr. Jeffrey Lieberman, Chairman of Psychiatry at Columbia University and New York-Presbyterian Hospital, argues: “Is it going to lead to people having fewer relapses, not having unnecessary hospital readmissions, being able to improve their vocational and social life? There’s an irony in it being given to people with mental disorders that can include delusions. It’s like a biomedical Big Brother.”

The digital pill has sparked much discussion. Some reaction from other publications:

“Continual adoption of new and innovative technological tools is ubiquitous. Technology will revolutionize behavioral healthcare and this advancement is simply the beginning of the digital transformation.” Dr. Michael Birnbaum, Director of the Early Treatment Program, Lenox Hill Hospital, New York, NY. (CNN)

“Many of these people do not recognize that they have a disorder, or they don’t like the side effects of medication, or they stop taking it once they feel better. And those things would not really be addressed by a pill with a sensor.” Dr. Dolores Malaspina, Psychosis Program at Icahn School of Medicine, Mount Sinai, New York, NY. (Time)

“The patient would have to give us permission to monitor compliance first. And this raises myriad ethical considerations such as informed consent, privacy issues, and data stewardship.” Dr. Orly Avitzur, Medical Director to Consumer Reports, Tarrytown, NY. (Consumer Reports)

A few thoughts:

  1. The digital pill is an interesting development.
  1. It’s always important to consider ethical concerns when weighing new treatments, but are these concerns somewhat overstated? If the patient consents to the digital pill, chooses the people who are notified about his or her compliance, and agrees to wear the relevant patch, how is that leading to “biomedical Big Brother?”
  1. The digital pill is cool – but is the real breakthrough drug for schizophrenia from 1972, not 2017? A recent JAMA Psychiatry study suggests it is. Check out this past Reading on antipsychotics drawing from Swedish national databases.


Digital Hype 

The Hype of Virtual Medicine

Ezekiel J. Emanuel

The Wall Street Journal, 10 November 2017

Will ‘virtual medicine’ transform the American health-care system? Will the latest computer-based technologies—apps, wearables, remote monitors and other high-tech devices—make Americans healthier? That’s the promise made by tech gurus, who see a future in which doctors and patients alike track health problems in real time, monitor changing conditions and ensure both healthy habits and compliance with drug and therapy regimens.

If it all sounds too good to be true, that’s because it is. Computer-enabled technology will indeed change the practice of medicine, but it will augment traditional care, not catalyze the medical revolution prophesied by Silicon Valley. Machine learning will replace radiologists and pathologists, interpreting billions of digital X-rays, CT and MRI scans and identifying abnormalities in pathology slides more reliably than humans. Remote observation of patients will be used in tele-intensive care units. And monitoring technologies will make it easier to treat patients at home, facilitating more out-of-hospital care.

But none of this will have much of an effect on the big and unsolved challenge for American medicine: how to change the behavior of patients.

Ezekiel J. Emanuel

So begins this lively essay by Dr. Ezekiel J. Emanuel, the Vice Provost and Chair of the Department of Medical Ethics and Health Policy at the University of Pennsylvania.

The author notes:

  • “According to the Centers for Disease Control and Prevention, fully 86% of all health care spending in the U.S. is for patients with chronic illness – emphysema, arthritis and the like… There is no reason to think that virtual medicine will succeed in inducing most patients to cooperate more with their own care, no matter how ingenious the latest gizmos.”
  • In a JAMA Internal Medicine paper, researchers compared different low-cost devices for encouraging patients to take their medication as prescribed for 50,000 participants, including pill bottles with digital timers and standard plastic pillboxes. “The high-tech pill bottles did nothing to increase compliance.”
  • A University of California study involving 1,500 with congestive heart failure were given high tech interventions like wireless blood pressure cuffs. The technology didn’t affect death rates.

He concludes:

The only interventions that seem to change the behavior of patients in a lasting way are financial incentives (mainly to stop smoking) and long-term, face-to-face relationships with nurses and health-care coordinators. These interventions are decidedly not high-tech. They are high-touch, and they remain our most effective prescriptions to treat chronic illnesses.

A few thoughts:

  1. This is a well argued piece.
  1. Dr. Emanuel makes good points. And he taps the literature well.
  1. Of course, it’s early. And it’s possible that some of these interventions will be more promising in a few years. It’s also possible that he’s been a bit selective with his literature review.
  1. For the record, CAMH’s Dr. David Goldbloom is unpersuaded. “I think he is wrong. Telephone coaching, for example, makes a difference in depression levels and return to work in RCTs. But I think he is right about the high-touch element. In fact, I just returned tonight from a trip to Cape Breton for the funeral of my last uncle, who dropped dead in the Sydney airport at age 86 (good way to go). While there, I got caught up with a second cousin of mine there who has schizophrenia; he is one of the lucky ones for whom clozapine has been a miracle drug with no major side effects. His pharmacy in Sydney has a volunteer driver who delivers his meds to him each day and stays there while he takes it. If there is going to be a bad storm, they bring him a couple of days’ worth at a time. He has never been better.”


Rethinking Schizophrenia

Schizophrenia – an anxiety disorder?

Jeremy Hall

The British Journal of Psychiatry, November 2017

Anxiety and affective symptoms are prominent features of schizophrenia which are often present in the prodromal phase of the illness and preceding psychotic relapses. A number of studies suggest that genetic risk for the disorder may be associated with increased anxiety long before the onset of psychotic symptoms. Targeting anxiety symptoms may represent an important strategy for primary and secondary prevention in schizophrenia.

The importance of anxiety in schizophrenia has long been recognised. Indeed, Sigmund Freud considered psychotic symptoms to arise as a defence against underlying states of heightened anxiety, and Bleuler highlighted affective disturbance among his fundamental symptoms of schizophrenia. An increasing number of studies now provide experimental evidence suggesting that heightened anxiety may be important in both the development of psychosis and psychotic relapses. This work highlights the fundamental importance of anxiety and affective symptoms in the disorder and the potential to target anxiety symptoms in primary and secondary prevention.

Jeremy Hall

So begins this Editorial by Prof. Jeremy Hall, Director and Research Theme Lead, Neurosciences & Mental Health Research Institute of Cardiff University.

The author makes several arguments:

  • This is a clinical connection between anxiety and schizophrenia. “There is strong evidence of significant comorbidity between schizophrenia and anxiety disorders.” He notes high rates social phobia, OCD, and GAD and schizophrenia, for example.He also notes high rates of anxiety in relapse (and the prodrome to relapse).
  • This is a genetic connection between anxiety and schizophrenia.

He closes with a call for action:

Relatively few studies have examined the potential for targeting anxiety and affective symptoms as a means to primary and secondary prevention in schizophrenia, but those studies that have taken this approach are encouraging and suggest that more systematic investigation of anti-anxiety treatments in the management of schizophrenia are warranted.

A few thoughts:

  1. This is a good and compelling Editorial.
  1. He makes reasoned arguments, particularly about the potential of prevention.
  1. But does the Editorial really live up to its provocative title?


Reading of the Week. Every week I pick articles and papers from the world of Psychiatry.