FDA Approves Antipsychotic with New Mechanism of Action for Treatment of Schizophrenia

I just noticed the FDA announcment of the approval of an antipsychotic with a new mechanism of action for the treatment of schizophrenia.

The drug is Cobenfy and it interacts with cholinergic rather than dopaminergic receptors. It has a number of side effects which are anticholinergic. This could lead to psychotic symptoms that consultation-liaison psychiatrists might get called to evaluate due to the anticholinergic delirium that could occur, which can mimic psychosis.

It’s easy to get alarmed about the Cobenfy side effects. I just remember all of the side effects of the one antipsychotic that has sometimes been the only effective treatment for patients with treatment resistant schizophrenia-clozapine.

Clozapine has been associated with agranulocytosis, seizures, bowel obstruction, prolonged cardiac conduction time leading to arrhythmias, liver toxicity and more. In fact, clinicians are required to enroll in a Risk Evaluation and Mitigation Strategy (REMS) program to prescribe it.

Patients who have schizophrenia and take clozapine are often admitted to general hospitals for treatment of medical problems which may or may not be directly related to clozapine itself. This requires close collaboration of internists and surgeons with consultation-liaison psychiatrists.

What do you do for patients who don’t respond to clozapine but are willing to take oral medication? There are augmenting strategies, some of which can be helpful although they could add to the side effect burden.

What do you do for a patient with treatment-resistant schizophrenia who refuses to take oral psychotropic medication? In some cases, it may be necessary to use injections of medications which also can have uncomfortable and even potentially life-threatening side effects. This difficult situation is complicated further by the lack of insight some patients have about their illness and the need for court orders to administer antipsychotics against their wishes.

I hope Cobenfy is a step forward for patients and their families.

Thoughts on the Homeless Mentally Ill

The homeless man who lives on the sidewalk outside our hotel reminds me of a couple of things. One is Dr. Gerard Clancy, MD who is University of Iowa Health Care Professor of Psychiatry, Professor of Emergency Medicine, and Senior Associate Dean of External Affairs.

I remember Gerry, who was in the department of psychiatry when I was a resident. I saw his picture in the newspaper and hearing about him riding a bicycle around Iowa City doing a sort of outreach to the homeless mentally ill.

I found an archived article mentioning him published in 1995 in the Daily Iowan. The story starts on the bottom of the front page, entitled “I.C. opens new doors for area’s mentally ill.” It continues on page 9A.

The story mentions Dr. Clancy and what was called then the Clinical Outreach Services and the Emergency Housing Program (EHP). The challenges then sound a lot like what they are now: long waiting lists for psychiatric evaluation and treatment, a lack of funding for the treatment of mental illness, and a lack of preventive care. The most common mental illnesses in the homeless mentally ill are chronic schizophrenia, schizoaffective disorder, and bipolar disorder. The idea of reaching out to them “on their own turf” as Clancy was quoted, was to help them feel more comfortable talking about their mental illness.

The housing situation for this population of those struggling with mental illness was dismal then and it’s still dismal.

The homeless guy I’ve been calling Bob lives on the sidewalk next to a busy street. It’s just my opinion that he’s mentally ill based on my observations of his behavior. I’ve never tried to talk to him. However, Bob gets visits from people who obviously have differing views about the way he lives.

Some of them do talk to him and, although I can’t hear their conversations, the actions tell me important things. Some bring him what I call “care packages,” often food, water, and other items. They may start by acting kind, although may get impatient with him. Others try to clean up his sidewalk, and may criticize him. The police occasionally visit and have so far not taken him into custody.

It looks like things have not changed much since 1995 regarding the homeless mentally ill based on what I write here about my observations. In fact, it’s easy to find current news stories that say things are getting worse.

At the beginning of this post, I said I found a couple of things. The other thing was a very thorough teaching presentation about the current state of formal outreach to this population. It’s available on the web as a power point presentation by another University of Iowa faculty, Dr. Victoria Tann, MD, entitled “Assertive Community Treatment 101.”

Dr. Tann is currently an IMPACT Team psychiatrist. It’s an excellent source of background on the history of this effort at outreach to the homeless mentally ill. It also summarizes what’s happening with the program now.

What About Bob?

The homeless guy camped next to the busy street just outside of our hotel is still here. I’m going to call him Bob because it’s awkward to keep calling him “the homeless guy.” I haven’t met Bob yet, but Sena got him some water. She had to give it to the hotel resident who so far is the only one who has been able to communicate with him.

Sena and I talked about what might be done for Bob. She noticed that his face was sunburned bad enough to cause the skin to peel off. Could a case be made for his being a danger to himself?

Of course, you could guess this issue would come up because I’m a retired psychiatrist. As an aside, I found an article published in the Daily Iowan early this year. The author interviewed several residents of a homeless camp who were displaced after a fire and subsequently the owners of the land closed the camp.

The homeless people at the camp were articulate and open to interview. Some of them were clearly choosing to be homeless and able to state how and why they did.

Bob might not be articulate enough to do that. He spends most of his time lying on the pavement with his blanket over him. It’s sometimes hard to tell if he’s out there until he moves. When he’s up, he usually stands up and waves his arms back and forth or sits on the grass. Occasionally, he moves in ways suggesting he’s acting out some kind of conversation with an invisible person.

A police officer stopped by, spoke briefly with Bob, and left. A woman stopped by and tried to help him clean up his room, so to speak. She picked up some of his trash and put it in a bag. She tried to get him to help, but he didn’t seem to understand.

What about Bob? Is he a danger to himself or others? Is he incapable of taking care of his basic self-care needs? Sooner or later, this would come up because the mental health laws would come into play. There are many homeless people out there living under bridges and camps. We’ve seen them when we go out for walks. Not all of them are definable as mentally ill.

There is guidance on the web about how to pursue a court-ordered psychiatric evaluation. I’m a retired psychiatrist and often was involved in those circumstances.

One way it works is that two people who are acquainted with the person go to the courthouse and complete paperwork to have someone ordered by a judge to be taken to the hospital for a mental health evaluation. If the judge signs an order, then typically the police would pick the person up and take them to the local emergency room. There aren’t vans with mental health professionals roaming the city looking for potential patients.

A psychiatrist performs a comprehensive mental health evaluation and later presents the report and testifies at a scheduled hearing. Attorneys are involved and give testimony for and against civil commitment. The patient also can speak. If the patient is court-ordered to inpatient treatment, that treatment is provided in the hospital usually. Periodic reports must be submitted to the court. Some people who are the objects of these interventions get better. Others don’t.

What’s missing here? You must at least know his real name to file for legal hold order. Although Sena says she saw Bob take out a cell phone, it’s not clear he knows how to use it or whether it even works. The only people who interact with him are those who are driving by and who show sympathy by buying food and water and other items for him. He usually tosses the empty water bottles in the parking lot where he sleeps. The police evidently didn’t think he needed an intervention from their perspective.

We don’t even know his real name. I haven’t tried to talk to him. I’ve never seen him act in a threatening way to anyone. Bob takes up one parking space and keeps his belongings within it. He usually lies under a blanket, often for several hours at a time. Bob doesn’t panhandle and I doubt he’s capable of that.

Am I Bob’s keeper?

Don’t Look in the Dictionary for Mental Health and Mental Illness

I read an interesting article in Clinical Psychiatry News the other day, written by Dinah Miller, MD in the Shrink Rap News column, “Psychiatry and semantics.” Dr. Miller’s point was that it’s sometimes hard to define terms when discussing mental illness and stress.

Can stress be defined as a mental illness? What the heck is the definition of mental illness? What does it mean to say that someone is depressed?

Way back in 2006, when I was an Associate Professor in psychiatry, I wrote an introductory article for a series of articles about stress for Psychiatric Times. The title was “Stress and the Psychiatrist: An Introduction.” I had a tough time defining stress also. In fact, the first 2 paragraphs of my article say it all:

“Defining “stress” and how it is expressed and managed in both psychiatrists and patients is a difficult proposition. This Special Report focuses on stress and the middle ground between the impulse to say there is no such thing as “stress” and the tendency to describe many explicit addressable issues under the monolithic term, “stress.”

I remember what my ward supervisor once told me about stress when I was a resident in psychiatry. I was presenting a case about a patient who was depressed and complaining about all the stress in her life. At that point, he barked testily, “There’s no such thing as stress!” He went on to direct me to be more specific in my interviewing techniques in an effort to identify the concrete problems that my patient was experiencing, instead of substituting a sort of shorthand (i.e., “lazy”) method of indicating the source of her depression. In his view, the term “stress” was being overused and it had become virtually meaningless.”

At the time I wrote that article, there was surprisingly little data about stress in psychiatrists. On the other hand, it was well known that psychiatrists are prone to stress, burnout, and suicide.

As I read my own article, I was surprised at how little things have changed over the years. In fact, they have gotten much worse. There is a lot of talk about The Great Resignation. Health care workers are leaving their jobs in droves, often due to the pressures of the pandemic.

I was and still am a fan of Stephen Covey’s wisdom:

Covey disparages the “Great Jackass” theory of management, in which the carrot-and-stick style of leadership dominates. Adopting a principle-centered leadership paradigm entails a commitment to change at the individual level, working from the inside out. This means building self-awareness, identifying one’s own vitally important goals, and creating a balance that includes a devotion to living, loving, learning, and leaving a legacy. In turn, this might lead to identifying a personal mission and a vision for an organization that empowers others to find their own motivation to service. Many of the problems that Covey finds in big business exist in the mental health care sector-low trust, low productivity, and environments in which the cultures of blame and victimization, political gamesmanship, and apathy spread. These are often the issues that get subsumed under the name of “stress” in academic departments, community mental health centers, and private practice groups.

Of course, despite how wise I sounded back then, I still ended up with burnout. It took a lot out of me, but it didn’t destroy me.  According to some figures, about 40%-60% of physicians are burned out.

One guy I admire a great deal is Dr. George Dawson, MD. He writes the blog Real Psychiatry. He has been fighting the pressures in the health care system for decades and signs that he’s still going strong are in the Psychiatric Times article “The Bureaucratic Takeover of American Psychiatry: George Dawson, MD, DFAPA.

The interviewer for that article, Dr. Awais Aftab, MD asked George what he thought about the system that psychiatrists must work in which tends to discount the effect of social adversity, poverty, and trauma on the psychiatric distress of their patients, yet corner them into a pill-prescribing role.

George replied, “I heard repeated stories about how child psychiatrists and pediatricians were expected to provide a miracle medical cure to address complex psychosocial problems.

As the number of prescriptions increased there was concern that children were being overmedicated and treated with inappropriate prescriptions like atypical antipsychotics. At that point a consultation line with a child psychiatrist was provided for these prescribers to discuss the prescriptions. At no point were the psychosocial parameters addressed and they still have not been addressed to this day.”

In response to Dr. Aftab’s question about George’s recommendations for how to address this situation:

“I have been writing and speaking about this in various capacities for the past 30 years. During this time very few physicians have been interested in a political fight. The only major figure in psychiatry I can recall is Harold Eist, MD, when he was the president of the American Psychiatric Association. Practically all other professional organizations are silent about managed care and pharmacy benefit managers as malignant forces. There is a lot written about burnout and how these companies waste physician time to the tune of billions of dollars a year. Nobody seems to talk much about all the free work physicians have to do to support the conflict-of-interest-driven decisions these companies make. There is some current interest in the Maintenance of Certification (MOC) issue that professional organizations have also ignored. But in general, nothing will happen until many more physicians get activated and unite. There is still the escapist dream out there that “I can still do private practice,” but that is vanishing fast.

After decades of elaborate planning and recommendations, I am back to the beginning. The course of action at this point is fairly simple. There has to be united agreement on the fact that managed care companies and pharmaceutical benefit managers work against the best interests of physicians and their patients. Once that recognition is there, a rational course of action may follow. But it does take physician professional organizations taking a clear stand against these business practices.

I do think there is a lot to be said for specialty clinics that are outside of the administrative scope of managed care companies. The first groups I noticed were radiologists and anesthesiologists. They were followed by surgical specialists. I do not see many large free-standing psychiatric practices. I think it is possible to practice with a group of like-minded psychiatrists and provide excellent care based on an agreed upon practice style that will result in greater degree of professional satisfaction than is possible as an employee of a managed care company. The required business expertise and planning is a deterrent to most but knowing what I know about the landscape today I would have tried it much earlier in my career.”

George announced his retirement in January this year. But he’s not done.

Dr. Miller suggests that we come up with a lingo that’s more precise to clarify what mental illness and mental health are and what our positions as practitioners and patients ought to be—and what we should do.

So that naturally led me to Allen Frances, MD, who wrote the book on the subject several years ago, “Essentials of Psychiatric Diagnosis: Responding to the Challenge of DSM-5.” Dr. Frances was also interviewed by Dr. Awais Aftab, MD, leading to the article “Conversations in Critical Psychiatry: Allen Frances, MD, published in May of 2019.

Dr. Frances says this about what he believes is “among the noblest of professions”:

 “I fear that too many psychiatrists are now reduced to pill pushing, with far too little time to really know their patients well and to apply the rounded biopsychosocial model that is absolutely essential to good care. We also have done far too little to educate the primary care doctors who prescribe 80% of psychiatric meds on the principles of cautious prescribing, proper indications, full consideration of risks, and the value of watchful waiting and tincture of time.

 I despair the diagnostic inflation that results from a too loose diagnostic system, aggressive drug company marketing, careless assessment, and insurance company pressure to rush to judgement. Diagnoses should be written in pencil, and under-diagnosis is almost always safer and more accurate than over-diagnosis. And, finally, I object to the National Institute of Mental Health (NIMH) research agenda that is narrowly brain reductionistic; it has achieved great intellectual masterpieces, but so far has not yet helped a single patient. So, in sum, I have loved being a psychiatrist, but wish we were better organized to end psychiatric suffering.”

Essentials of Psychiatric Diagnosis by Allen Frances

He rejects the dichotomy that mental illnesses are either diseases or problems in living as far too simplistic.  He deplores the tendency of the DSM 5 to confuse mental disorder with “everyday sadness, anxiety, grief, disappointments, and stress responses that are an inescapable part of the human condition.” He says the DSM should be only a tool to help guide clinicians’ judgment, not replace it.

So, let’s stop stressing ourselves out looking in the dictionary for definitions of mental health and mental illness.

with permission from the publisher Guilford Press