(Mis)informed Consent

December 20, 2011

Over the years, the practice of medicine has become less of an art, and more a process of crossing T’s and dotting I’s.  “Treating the chart” has become, in many ways, more important than treating the patient, and it seems that the pen—or, rather, the electronic medical record—has emerged as a more valuable tool than the stethoscope or reflex hammer.

For psychiatrists, one of the pesky little details of any office visit is obtaining “informed consent.”  Most commonly, this is the document—signed by the patient—stating that he/she has been fully informed of the reason they’re being prescribed a medication, the potential risks of taking said medication, and any possible alternatives.  Most private insurers and hospitals, and all Medicaid programs, require this documentation in the charts of patients seeing mental health specialists, and (at least in my experience) these documents are frequently sought in chart audits.

What do I mean by “pesky”?  Put briefly, the process of obtaining informed consent can be time-consuming, and some doctors worry that it might actually interfere with treatment.  In a 2004 survey, for instance, 44% of psychiatrists reported that “informed consent … increases patients’ anxiety.”  With respect to antipsychotics, nearly 20% of psychiatrists in the same study admitted “it is good practice to withhold information about tardive dyskinesia from some patients.”  As a result, patients are often poorly informed about the meds they take.  In a 2001 study of psychiatric inpatients in Scotland, fewer than half knew the reason they were receiving medication, the side effects of those medications, or even remembered getting an explanation from staff.  (But, according to the survey, far more than half were “happy to take all medications”!!)

I was recently asked for some suggestions on how to improve the medication-consent process in my outpatient clinic.  I must admit, the current process is atrocious.  Our forms are 10+ years old, with general descriptions of each class of medication (and, of course, they lack any drug introduced in the last decade); and they have that “photocopy of a photocopy” appearance, with faded margins and text at a crooked angle.  But hey, no big deal—they’re just papers to sign and stick in the chart, basically.  In the community clinic where I work part-time, the process is even more rudimentary: we have one generic form with no drug names or descriptions; the front-desk staff asks each patient to sign the form before each visit, and afterward I simply write in the name of the medication(s) I’ve prescribed.

In thinking of ways to improve the process, I’ve come to realize that it may provide an opportunity for some meaningful change in our treatment approach.

First of all, there’s no excuse for not describing the potential adverse effects of the drugs we use, but we must be cautious not to trivialize this process.  Most psychiatrists I know, for example, have a readymade “speech” about the potential for rash with Lamictal, or weight gain with Zyprexa, or sedation with Seroquel.  (See this post at Shrink Rap—and its comments—for more on this perspective.)  But if the patient hears this as just a “speech,” it’s less likely to be meaningful, just like the pre-flight safety lectures you hear on airplanes.  I advise my students and residents to pretend they’re prescribing to their spouse, parent, or child, and give all the information they would want to hear about each new drug.  (This includes how to stop the medication, too.)

Second, just as important as the potential adverse effects, I believe that patients need to hear more specific explanations of how the drug might actually provide some benefit.  All too often we give a feeble explanation like “this Prozac should make you feel better in a few weeks” or ” Valium might calm your nerves a bit” or “since you haven’t responded to your antidepressant, here’s some Abilify to help it along.”  We owe it to our patients (and to ourselves) to provide more detailed explanations.  To be sure, most patients don’t need to hear a molecular mechanism, complete with pKa values or details of CYP450 metabolism, but we ought to have this information in our heads, and we must know how we’re using this information to treat the patient in front of us.  When a patient asks how an antipsychotic might help their depression, or why an anticonvulsant might help stabilize their mood, we must give an answer.  (And if no good answer is possible, we need to rethink our treatment plan.)

Third, it is equally important to discuss treatment options with a patient.   When patients ask “is there anything else I can do or take?” the ensuing discussion might extend the appointment by a few minutes, but it always leads to a more collaborative dialogue (unless, of course, the patient is fishing for a Xanax prescription or a month’s supply of Seroquel to sell for cash).  A discussion of alternatives often gives an indication of what the patient wants, what the patient values, and how we can best promote the patient’s recovery.

Finally, the informed consent process really should be extended to non-psychiatrists who prescribe these agents.  Primary-care docs routinely prescribe antidepressants, benzodiazepines, psychostimulants, and mood stabilizers (and, of course, my personal favorite, “Seroquel for sleep”), without a discussion of risks, benefits, and alternatives, or (in most cases) a signed consent form.  Heck, even gastroenterologists prescribe Reglan, which is as likely to cause tardive dyskinesia as many of the antipsychotics we use in psychiatry, and pain specialists are fond of Cymbalta (an SNRI with some potentially nasty withdrawal effects) for “chronic pain.”  These providers should recognize the potential risks (and mechanisms) of psychotropics, just as psychiatrists do, and share them with their patients.

So even though we might look at obtaining informed consent as a “necessary evil,” we should instead look at it as a way to enhance treatment.  If nothing else, this would force us to think about what we do and why we do it.  It would enable us to honestly evaluate the true benefits and risks of what we prescribe, and maybe steer us in a different—and healthier—direction.

EMRs and Zombie Psychiatry

April 5, 2011

I consider myself to be a fairly tech-savvy guy.  I grew up in the 80s and computers have been a part of my leisure time, my academic life, and my work environment for as long as I can remember.  But using an electronic medical record (EMR) is testing my patience.

More importantly, it’s yet another example of an external influence which is changing the practice of psychiatry.  And not for the better.

I learned how to practice medicine from teachers who valued the essence of the interpersonal relationship between patient and doctor.  What attracted me to psychiatry in particular was the fact that in this field, these unspoken and unquantifiable aspects of the doctor-patient dyad are paramount, much more so than in any other medical specialty.  The patient’s subjective feelings about the therapeutic relationship—the patient’s unconscious transference of experience from past relationships into the present, for example—are as much a part of the therapeutic process as his or her verbal reports or directly measurable behavioral symptoms.  The “soul” of psychiatry lies in this nonverbal interaction.

Moreover, this relationship transcends time.  For as much as we like to bemoan the “15-minute med check” appointment, the truth is that fifteen minutes is plenty of time for an expert clinician to get an overall feeling for a patient—the “Gestalt” impression that informs the treatment process.  By the same token, a one-hour session by a poorly trained clinician is nothing more than data gathering.

EMRs are changing how we document information.  One could argue, correctly, that documentation has always been an important part of clinical care, and not directly related to the doctor-patient relationship.  However, a well-written note (not to mention the exquisitely detailed psychodynamic case formulations from years past) can convey a rich trove of information about a patient’s history, symptoms, underlying pathology, and future goals.

The type of information we document in an EMR, however, is different.  I’ve commented elsewhere that the ideal EMR for a psychiatrist would be a word processor and an encrypted hard drive.  Nothing more.  Just let me enter all the information that I think is relevant in a given session and save it for next time.

But EMRs weren’t designed for the psychiatrist or the patient.  They were designed for administrators, billing experts, lawyers, insurance companies, and others who care more about the quantifiable aspects of the interaction (the diagnosis, the medication prescribed, the presence/absence of discrete symptoms) than about the patterns of symptoms, the clinician’s subjective assessment, and the hypotheses underlying the patient’s behavior which are being actively tested in the therapeutic relationship.

The amount of time it takes me to document everything that is required for “correct billing” of my appointments (and to double-check everything, lest I get a call from my administrator the next day to “fix the chart”) takes up virtually the entire scheduled appointment time.

But my concern here is not about the time it takes, or even about the nuisance of having to click on a few dozen boxes during each patient encounter, or open six different documents—in different formats, in non-overlapping windows—to see what’s happened since a patient’s last visit.  (I like to think that I’m a quick enough learner to do all of that.)  My concern instead is with how I’m now starting to think of patients not as human beings with interesting and complicated histories which inform my care, but rather as collections of symptoms which change from visit to visit.

EMRs demand measurement and assessment of patients on scales that are, for the most part, arbitrary, and which may be completely “off the mark” vis-à-vis what’s really happening in a person’s life.  They ask us to quantify things that cannot be quantified, and distract our attention from what might be truly significant in the patient’s life at the time of the encounter.

Hey, maybe that’s okay.  After all, it’s the monthly visits by patient 2010-00224, dx code 296.34, that pay the bills.  And as long as I’ve checked the boxes next to “depressed mood” or “insomnia” or “feelings of guilt” (not to mention the other two-dozen boxes I need to check for his mental status exam and review of systems), and updated his problem list, and made sure I checked the box indicating he isn’t suicidal (never mind whether I actually asked him or not), that counts as “good” care.

But by this time, I’m not a psychiatrist.  Heck, I’m not even a human, I’m entranced, soulless, and following someone else’s commands.  A zombie.  And patient 2010-00224 deserves more than that.

Lessons of Rebecca Riley

February 2, 2011

I’ve been following the Rebecca Riley case in Massachusetts, although not as closely as I would like to, since I find the details so incredibly disturbing.  For those of you who aren’t familiar with it, four year-old Rebecca died in 2006 after an overdose of the psychotropic medications clonidine, Depakote, and Seroquel.  Her parents were convicted of murder in 2010 even though they argued that they were simply “following the instructions” of Rebecca’s child psychiatrist, Dr Kiyoko Kifuji of Tufts Medical Center.  Dr Kifuji had diagnosed Rebecca with bipolar disorder and prescribed three powerful medications to her, starting at the age of 2.

It has also come to light that Rebecca’s parents had exploited the social service system to obtain federal disability benefits for their three children– Rebecca and two older siblings, who were also diagnosed with bipolar disorder and ADHD by Dr Kifuji.  Also, Dr Kifuji’s medical license was suspended for two years after Rebecca’s death, although she eventually returned to practice medicine at Tufts, where she still sees patients.  Finally, Tufts settled a malpractice suit with the family last week for $2.5 million.

Many news stories disturb me, but this one makes me particularly angry, because all parties share part of the blame.  Obviously, I did not evaluate Rebecca myself (and, in the interest of full disclosure, I am not a child psychiatrist, nor have I even raised a two-year-old of my own), but the facts of the case, as I understand them, fill me with contempt for just about everyone involved.  Everyone that is, except for Rebecca.

The objects of my rage?  Let’s go down my list, one at a time:

  • Dr Kiyoko Kifuji – Even if we grant the possibility that bipolar disorder can be diagnosed in a two year-old (a questionable premise, even according to the experts), the evidence suggests that Dr Kifuji permitted Rebecca’s parents to give the medications as they saw fit (and agreed with their decisions to increase doses), authorized prescriptions over the phone without evaluating Rebecca, and was cautioned by pharmacies that Rebecca’s parents were going through meds more quickly than expected.  Social workers and a school nurse also alerted Dr Kifuji to the fact that Rebecca seemed oversedated and “like a floppy doll,” but Dr Kifuji allegedly made no adjustments to Rebecca’s treatment plan.
  • Michael and Carolyn Riley (Rebecca’s parents) – Seven abuse and neglect complaints were filed with the Massachusetts Dept of Children and Families, starting in 2002, alleging that the Rileys seemed unable to care for their children; apparently they, too, were also taking doses of medications that, at times, impaired their judgment.  Furthermore, it has come to light that everyone in the Riley family (except Rebecca) had applied for, and received, federal disability payments, in what appears to be a deliberate attempt to defraud the system to earn extra income.  They had filed an application for Rebecca, which was denied, but the Rileys appealed the decision.  However, after Rebecca’s death, in a jailhouse interview in September 2007, Carolyn Riley confessed to Katie Couric that she was not sure whether Rebecca had bipolar disorder after all: “maybe she was just hyper for her age.”
  • Massachusetts Department of Children and Families– While not directly responsible for Rebecca’s death, the warning signs were clearly visible that the Rileys were unfit to care for their children, including the abuse and neglect complaints noted above, as well as specific complaints from Rebecca’s therapist that, on a home visit, Carolyn Riley seemed “drugged and unable to care for [her] children.”  Agencies like this are incredibly overburdened and underfunded, but when they drop the ball, as they did in this case, lives may be at stake.
  • The psychiatric profession – As I’ve written on this blog, we as a discipline have not only expanded diagnostic criteria for mental illness (and are continuing to do so), but sometimes err on the side of over-diagnosis and over-treatment, rather than exploring alternate explanations for behavior or less potent treatment options.  One may argue that Dr Kifuji was practicing within the accepted standard of care.  Because I am not a child psychiatrist, I cannot comment on that, but there has been a 40-fold increase in diagnosis of childhood bipolar disorer from 1994 to 2003, which only a few in our profession have questioned or challenged.
  • The pharmaceutical industry – Drug companies are easy targets for frustration and rage, but in this case it could be argued that it was the inappropriate use of three commonly used (and frequently effective) medications which led to Rebecca’s death.  Two of the three medications she was taking (clonidine and valproic acid) are off-patent, so no one can accuse a drug company of “pushing” a medication on Rebecca for the sake of profit.  Nevertheless, efforts by Big Pharma to promote and expand the use of their medications can unfortunately bias some providers to overuse their agents, and the promotion of drugs while downplaying the risk of adverse effects is inexcusable.  (Even so, in my opinion, we doctors need to be held responsible for what we prescribe and why.)
  • Massachusetts Board of Registration of Medicine – Dr Kifuji entered a “voluntary agreement” to stop practicing psychiatry from February 2007 to September 2009.  The Board conducted an investigation into the case but “closed the complaint against Dr Kifuji without discipline.”  She has since returned to practice.  In my experience, I have seen state medical boards revoke licenses from doctors whose misbehaviors were not nearly as (allegedly) egregious as Dr Kifuji’s, or which involved only their personal lives and not patient care.  When I see the reports of this case and recognize that Dr Kifuji still practices psychiatry (in the same location and with the same patient population) I am concerned about the double standard being practiced by licensing bodies.
  • Tufts Medical Center – Obviously, Kifuji’s care was provided by an institution that also shares some responsibility for the ethical and beneficent provision of medical care. At the same time, it is shocking that Kifuji has retained her faculty position at Tufts.  Again, in my experience, hospitals and other institutions tend to be overly conservative when there is even the question of inappropriate behavior by one of their providers, if only to maintain good public relations.  Perhaps her employment will be terminated or limited now that a malpractice settlement has been reached, but it does strike me as one of those cases in which I see nothing that Tufts could gain by Dr Kifuji’s continued employment.
  • Malpractice Attorneys – Another easy (but valid) target.  Even assuming that malpractice was committed and the charges were valid, the fear of cases of this magnitude may make doctors less likely to treat the cases which actually do require aggressive care (and also contributes to defensive medicine, resulting in greater health care costs).  One might ask, however, whether the case, brought on behalf of Rebecca’s estate, had any merit, since her parents had already been convicted of her murder.  But as with most things in life, where there’s an opportunity for a payout, there are those who will spring into action:  A settlement of $2.5 million at 35% contingency fee, plus other expenses = $875K +.  And maybe the lawyer will be the guardian of funds, or set up a trust for Rebecca’s siblings, for an additional fee.  As a doctor wrote on a different website, “Three years of law school suddenly sounds like a better investment than medical school, internship, residency, and fellowship training.”

So many opportunities for Rebecca’s life to have turned out differently.  And so much blame to go around.  Unfortunately, the only one without any culpability at all is Rebecca herself.

The Tucson massacre – preventable?

January 12, 2011

Last Saturday’s tragic events in Tucson have called attention to the behavior of Jared Loughner, the perpetrator, as well as the political climate in which this horrific event occurred.  While it is likely too early to determine to what degree, if any, Loughner’s political views may have motivated this unspeakable act, information has come to light regarding his unusual behavior and unorthodox opinions, raising questions regarding his mental state.

Without direct observation of Loughner and his behavior, it would be risky to posit a diagnosis at this time.  Even though details are emerging, I do not yet know whether Loughner had been diagnosed with an illness, or whether he was taking medications.  But if it is determined by forensic experts that Loughner did indeed suffer from a psychiatric illness, one question that is certain to arise is:  Can a person with an illness that gives rise to unconventional views and a potential for violence be forcibly treated, so that events like this can be prevented?

[Before answering this question, two things should be emphasized:  First, mental illness very rarely causes violent behavior; and as a consequence, the function of psychiatric medication is not to prevent violence (indeed, see my earlier post).  Antipsychotic drugs can, however, minimize delusional and paranoid thoughts, and improve a person’s ability to negotiate the difference between reality and fantasy, and some mood stabilizers and antidepressants may lessen impulsivity and aggression, but we cannot assume that medications could have prevented Loughner’s act.]

Several landmark cases addressing this very issue have said no; patients retain the right to refuse treatment.  Patients can, however, be involuntarily committed to a hospital, but only when immediate intervention is required to prevent death or serious harm to themselves or to another person, or to prevent deterioration of the patient’s clinical state.  In California, the relevant section of the law is section 5150 of the Welfare and Institutions Code.  This allows a law enforcement officer or a clinician to involuntarily confine a person to treatment for a 72-hour period.  The criteria for a 5150 hold require the presence of “symptoms of a mental disorder” prior to the hold.  (Thus, self-injurious behavior as a result of alcohol intoxication does not qualify a person for a legal hold.)  All states provide some comparable form of brief involuntary commitment for those suspected of danger to self or others, or grave disability, as a result of a mental illness.

Even after hospital admission, though, patients have the right to refuse medications.  Medications can only be given involuntarily if a court determines, based on evidence presented by doctors, that a patient lacks the capacity to give informed consent (in California, this process is called a Riese hearing).

But what about cases that are less acute?  If Loughner’s behavior arose from a psychotic disorder such as paranoid schizophrenia (and his behavior does indeed have hallmarks of such a diagnosis) but not significant enough to require hospitalization, one might argue that adherence to an antipsychotic regimen may have prevented the extreme behavior we saw on Saturday.

He still could have refused.  A number of court decisions (discussed here) have established and affirmed this right.  Recent exceptions include Kendra’s Law in New York and Laura’s Law in California.  Kendra’s Law, enacted in 1999, allows courts to order seriously mentally ill individuals to accept treatment as a condition for living in the community.  It was originally designed to target those with a history of repeat hospitalizations that resulted from nonadherence to medications.  Patients can be ordered into assisted outpatient treatment if they are “unlikely to survive safely in the community without supervision” and have demonstrated either (a) acts of serious violent behavior toward self or others, or (b) at least two hospitalizations within the last 3 years, resulting from nonadherence to a treatment regimen.  Laura’s Law was signed into law in 2002 in California, although as of 2010 only two California counties have implemented it.  Studies reviewing the effects of these laws have found that patients in assisted outpatient treatment had fewer hospitalizations, fewer arrests and incarcerations, and had were less likely to be homeless or to abuse alcohol or drugs.

If Loughner had made threats of violence while engaged in treatment, another related decision, the Tarasoff duty, could have been invoked.  In the 1976 case of Tarasoff vs Regents of University of California (and a second ruling in 1982), it was determined that a physician or therapist who has reason to believe that a patient may injure or kill someone must warn the potential victim (the 1982 ruling broadened the decision to include the duty to protect, as well).  Thus, if a patient makes a threat against another person—and the clinician perceives it to be credible—he or she must warn the targeted individual, law enforcement, or take any other steps that are “reasonably necessary.”  

Clearly, there is a great deal of uncertainty and latitude in the above cases.  While the Tarasoff duty is clearly designed to prevent danger to others, it may potentially destroy the trust between doctor and patient and therefore hinder treatment; similarly, it is often difficult to determine whether a patient’s threats are credible.  In the case of a patient like Loughner, would antigovernment rhetoric prompt a warning?  What about threats to “politicians” in general?  The clinician’s responsibility is not always clear.

With regard to Kendra’s and Laura’s Laws, the meaning of “survival in the community” can be debated, and it is often arguable whether compliance with medications would prevent hospitalization.  Opponents argue that the best solution is more widespread (and more effective) voluntary outpatient treatment, rather than forced treatment.

As more information on this case comes to light, these issues are certain to be discussed and debated.  We must not rush to judgment, however, regarding motives and explanations for Loughner’s behavior and the
steps we could take (or could have taken) to prevent it.

Medical marijuana and psychiatry

January 9, 2011

Is marijuana really medicine?  I’m not arguing against the potential for marijuana to treat illness, nor do I mean to imply that marijuana is simply a recreational drug that has no place in medicine.  Instead, I simply wish to point out how the “medical” label, I feel, has been misused and co-opted in a way that reveals what “medicine” really is (and is not).

Let me state, for the record, that I have no position on medical marijuana.  I practice in California, a state in which it is legal to use marijuana for medicinal purposes.  Even though I do not prescribe it, I do not judge those who do, nor those who use it.  I agree that it can be helpful in a wide range of illnesses– sometimes even in the place of established medicines.  It is unfortunate that controlled studies on THC and other cannabinoid compounds– studies that could lead to new therapies– have not been performed.

Medical care usually follows a well-established outline: a patient with a complaint undergoes an examination by a provider; a diagnosis is determined; potential courses of treatment are evaluated; and the optimal treatment is prescribed.  Afterward, the patient follows up with the provider to determine the efficacy of treatment, any potential side effects, and interactions with other medications or therapies.  The frequency of follow-up is determined by the severity of the illness, and therapy is discontinued after it is no longer necessary, or becomes detrimental to the patient.

Unfortunately, none of this describes how medical marijuana is practiced.  Any patient can undergo an examination; the vast majority of such patients have already been using marijuana and explain that they find it helpful, and the provider issues a card stating that they “advise” the use of medical marijuana.  Not a prescription, but a card– which permits him or her to buy virtually any amount, of any type of cannabis desired.  Follow-up visits are typically yearly, not to evalaute response to treatment, but to issue a new card.

As a psychiatrist, I frequently see patients who tell me they have been prescribed marijuana for “anxiety” or “depression.”  Often, my evaluation confirms that they do indeed suffer from, say, a clinically relevant anxiety disorder or major depression.  However, when I know they are using another chemical to treat their symptoms (whether cannabis, alcohol, or a medication prescribed by another physician) it becomes my responsibility to determine whether it will interfere with treatment.  In most cases, it also makes sense to collaborate with the other provider to develop a treatment plan, much as a cardiologist might collaborate with a family physician to manage a patient’s coronary artery disease.  [Sometimes the treatment plan might be to continue marijuana because I believe psychiatric meds simply won’t have any effect.]

But efforts to communicate with marijuana prescribers often fail (and when I have been successful in communicating with such a prescriber, they’re usually surprised that I made the effort!).  Similarly, if I suggest to a patient that he or she consult with the marijuana prescriber to find a strain, or a delivery method, or a dosing interval, that would provide the best symptom relief, or the least interaction with conventional medications– they often react with shock.  “But I only see him once a year,” is the answer I receive.

Often I say to myself something like, “well, marijuana helps him, so I’ll let him continue using it; I’ll just ‘work around it’ unless it becomes a problem.”  The patient usually tells me that he wants to continue using marijuana “as needed,” but he also wishes to continue in treatment with me, taking the medications I prescribe and following through with any treatment I suggest.

It leads to an uncomfortable compartmentalization of care, in which I feel that I’m practicing “real” medicine, while simultaneously condoning his use of another substance, even though neither of us knows the true chemical content of this substance, doses might vary from day to day, and some might be shared with friends.  To top it all off, patients frequently report a greater response to marijuana than what I prescribe, and yet I ignore it?  This is not the way I was trained to practice medicine, and yet I do it almost every day.

The approval of “medical marijuana” has been, I believe, a successful campaign by proponents of marijuana legalization to take advantage of the fragmented and confused health care system to create a de facto social sanction of marijuana use, rather than (a) introducing it as a true “medicine” through the proper and accepted channels (clinical trials, FDA approval, etc) or (b) decriminalizing it into a legal drug, much like alcohol.  I can see the arguments in favor of either approach, but the “medical” label unfortunately undermines what we actually try to do in medicine.

On the other hand, if it works, maybe we ought to take a closer look at what we actually are trying to do in medicine.  If medicine worked all the time, there would be no need for medical marijuana, would there?

Violence, crime, and mental illness

January 7, 2011

Are people with mental illness more violent or aggressive, or more likely to commit crimes than those without mental illness?  Two recent papers investigate different aspects of this question.

In the January 2011 issue of Psychiatric Services, Fisher and colleagues investigate data from the Massachusetts Department of Mental Health, and found that people who had been diagnosed with a “severe and persistent psychiatric disorder” were two-thirds more likely than the general population to be arrested within a one-year period.  Arrest rates were significantly higher for all crimes, but particularly high for assault and battery on a police officer, a felony (odds ratio 5.96, or about 6 times more likely), and “crimes against public decency” (odds ratio 4.72).  While the data only reflect arrests (and not convictions, which would be fewer, since some charges were undoubtedly dropped), and say nothing about whether a person was actively involved in treatment at the time of his or her arrest, it does portray the severely mentally ill as more likely to engage with the criminal justice system.

A separate study, published last month in PLOS One, examined reports of medication-related adverse events to the FDA.  The authors looked at 484 drugs and the rates with which they had been associated with “violence-related symptoms.”  All medications had some such symptoms reported, but certain classes of drugs were associated with more frequent violent events than would occur by chance alone.  In particular, varenicline (Chantix) was most frequently associated with reports of violence, with a PRR (proportional reporting ratio) of 18.0.  (This means that the proportion of violent events by patients on Chantix was 18 times greater than the proportion of violent events reported for all other drugs).  Other medications shown to be associated with violent behaivor included antidepressants (average PRR = 8.4) and psychostimulants (average PRR = 6.9).  

It should be pointed out that the authors of the PLOS study have served as expert witnesses in criminal cases involving psychiatric drugs, and work for the Institute for Safe Medication Practices, a nonprofit group dedicated to exposing medication risks.  Furthermore, the reports of adverse events to the FDA may suffer from “attribution error”: when an adverse event like a violent act occurs, we search for possible causes, and medications– particulalry psychiatric meds– are frequent culprits, when in fact there may be no causal relationship.  Nevertheless, the large numbers of events, and the relative consistency within drug classes, should give us reason for concern.

But even with these limitations, these studies unfortunately show that criminal activity may indeed be more common among the mentally ill, and we need to exercise caution when using medications when the risk of aggression is high, to avoid making matters worse.


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