Perspectives

We were catching up during our 35th college reunion at our old fraternity house overlooking Cayuga Lake in Ithaca, N.Y. About 50 of us lived in the Tudor-style house, complete with secret basement room, and there was a ladder that allowed access to the relatively flat, painted aluminum roof. When the weather allowed, we climbed the ladder to sun ourselves on top of the house. We also flung water balloons at unsuspecting pedestrians with a sling shot device made by attaching rubber tubing to a funnel. The “funnelator” was very accurate to about 50 yards away. We were kids, and climbing that ladder meant fun, and we climbed it as often as we could.

Despite what many would have predicted when we graduated, my fraternity brothers became a very successful group of CEOs, vice presidents, doctors, lawyers, chairmen, and consultants. Our house was just off Cornell University’s campus at the top of Ithaca Falls, an idyllic setting on a beautiful June evening for my brothers to sit around, laugh about the old times, and philosophize about life. We recounted our life after college and reveled in each others’ accomplishments.

After climbing the roof ladder for fun, we had each climbed a different kind of ladder to success in our respective fields. We all really enjoyed the climb. I don’t think it is a coincidence that many of my brothers and I are now done climbing our ladders. Many of us are getting out of the rat race.

One of my friends is resigning as chairman of an academic ENT department. I remember his discipline in college, leaving the house after dinner every night to climb the hill where he studied in the quiet of Uris Library, which is attached to the iconic McGraw Tower. His hard work paid off with an acceptance to a prestigious medical school where he continued to excel. The author of more than 200 published manuscripts, with four senior-authored papers already this year, he is at the pinnacle of his academic success. Yet, he resigned.

Similarly, another of my fraternity brothers had recently resigned from his position as Senior Vice President and Chief Medical Officer for a large health care system. He would have been in line for the CEO position had he stayed. He has written well-received books on leadership and financial acumen for physicians. As a result, he is a frequent public speaker on similar topics. Yet, he resigned.

They were not the only ones resigning positions that others covet. I, too, resigned my position as Department Chairman earlier this year. None of us were fired, none of us were asked to leave, and none of us are burned out. So here we were, three accomplished physicians all resigning from powerful posts at the same time for what turns out to be similar reasons. Our priorities changed as our children moved out.

I would like to say that we all had the wisdom to know that our leadership skills were deteriorating and that we all wanted to get out while we are at the top of our game. Had Arthur Brooks written “Your Professional Decline Is Coming (Much) Sooner Than You Think” in The Atlantic (July 2019) before we made our decisions, I may have made that argument, but it would not have been true. All three of us feel like we have accomplished what we sought to achieve when we took our respective roles and now we wanted to leverage that experience into something different, if not better. None of us have settled into new roles yet, and all of us are still trying to define exactly what it is we want to do next, but all of us agree that we are no longer interested in driving ourselves to succeed at the expense of our family, friends, and relationships.

My fraternity brothers and I gushed with pride talking about our children and their success. Our progeny are starting their individual climbs up the ladder of opportunity in whatever field they have chosen. My friends and I, on the other hand, had already climbed a ladder and feel comfortable stopping. Or maybe we just want to start climbing a different ladder.

Dr. Kalaycio is editor in chief of Hematology News. He chairs the department of hematology and medical oncology at Cleveland Clinic Taussig Cancer Institute. Contact him at [email protected].

We were catching up during our 35th college reunion at our old fraternity house overlooking Cayuga Lake in Ithaca, N.Y. About 50 of us lived in the Tudor-style house, complete with secret basement room, and there was a ladder that allowed access to the relatively flat, painted aluminum roof. When the weather allowed, we climbed the ladder to sun ourselves on top of the house. We also flung water balloons at unsuspecting pedestrians with a sling shot device made by attaching rubber tubing to a funnel. The “funnelator” was very accurate to about 50 yards away. We were kids, and climbing that ladder meant fun, and we climbed it as often as we could.

Despite what many would have predicted when we graduated, my fraternity brothers became a very successful group of CEOs, vice presidents, doctors, lawyers, chairmen, and consultants. Our house was just off Cornell University’s campus at the top of Ithaca Falls, an idyllic setting on a beautiful June evening for my brothers to sit around, laugh about the old times, and philosophize about life. We recounted our life after college and reveled in each others’ accomplishments.

After climbing the roof ladder for fun, we had each climbed a different kind of ladder to success in our respective fields. We all really enjoyed the climb. I don’t think it is a coincidence that many of my brothers and I are now done climbing our ladders. Many of us are getting out of the rat race.

One of my friends is resigning as chairman of an academic ENT department. I remember his discipline in college, leaving the house after dinner every night to climb the hill where he studied in the quiet of Uris Library, which is attached to the iconic McGraw Tower. His hard work paid off with an acceptance to a prestigious medical school where he continued to excel. The author of more than 200 published manuscripts, with four senior-authored papers already this year, he is at the pinnacle of his academic success. Yet, he resigned.

Similarly, another of my fraternity brothers had recently resigned from his position as Senior Vice President and Chief Medical Officer for a large health care system. He would have been in line for the CEO position had he stayed. He has written well-received books on leadership and financial acumen for physicians. As a result, he is a frequent public speaker on similar topics. Yet, he resigned.

They were not the only ones resigning positions that others covet. I, too, resigned my position as Department Chairman earlier this year. None of us were fired, none of us were asked to leave, and none of us are burned out. So here we were, three accomplished physicians all resigning from powerful posts at the same time for what turns out to be similar reasons. Our priorities changed as our children moved out.

I would like to say that we all had the wisdom to know that our leadership skills were deteriorating and that we all wanted to get out while we are at the top of our game. Had Arthur Brooks written “Your Professional Decline Is Coming (Much) Sooner Than You Think” in The Atlantic (July 2019) before we made our decisions, I may have made that argument, but it would not have been true. All three of us feel like we have accomplished what we sought to achieve when we took our respective roles and now we wanted to leverage that experience into something different, if not better. None of us have settled into new roles yet, and all of us are still trying to define exactly what it is we want to do next, but all of us agree that we are no longer interested in driving ourselves to succeed at the expense of our family, friends, and relationships.

My fraternity brothers and I gushed with pride talking about our children and their success. Our progeny are starting their individual climbs up the ladder of opportunity in whatever field they have chosen. My friends and I, on the other hand, had already climbed a ladder and feel comfortable stopping. Or maybe we just want to start climbing a different ladder.

Dr. Kalaycio is editor in chief of Hematology News. He chairs the department of hematology and medical oncology at Cleveland Clinic Taussig Cancer Institute. Contact him at [email protected].

We were catching up during our 35th college reunion at our old fraternity house overlooking Cayuga Lake in Ithaca, N.Y. About 50 of us lived in the Tudor-style house, complete with secret basement room, and there was a ladder that allowed access to the relatively flat, painted aluminum roof. When the weather allowed, we climbed the ladder to sun ourselves on top of the house. We also flung water balloons at unsuspecting pedestrians with a sling shot device made by attaching rubber tubing to a funnel. The “funnelator” was very accurate to about 50 yards away. We were kids, and climbing that ladder meant fun, and we climbed it as often as we could.

Despite what many would have predicted when we graduated, my fraternity brothers became a very successful group of CEOs, vice presidents, doctors, lawyers, chairmen, and consultants. Our house was just off Cornell University’s campus at the top of Ithaca Falls, an idyllic setting on a beautiful June evening for my brothers to sit around, laugh about the old times, and philosophize about life. We recounted our life after college and reveled in each others’ accomplishments.

After climbing the roof ladder for fun, we had each climbed a different kind of ladder to success in our respective fields. We all really enjoyed the climb. I don’t think it is a coincidence that many of my brothers and I are now done climbing our ladders. Many of us are getting out of the rat race.

One of my friends is resigning as chairman of an academic ENT department. I remember his discipline in college, leaving the house after dinner every night to climb the hill where he studied in the quiet of Uris Library, which is attached to the iconic McGraw Tower. His hard work paid off with an acceptance to a prestigious medical school where he continued to excel. The author of more than 200 published manuscripts, with four senior-authored papers already this year, he is at the pinnacle of his academic success. Yet, he resigned.

Similarly, another of my fraternity brothers had recently resigned from his position as Senior Vice President and Chief Medical Officer for a large health care system. He would have been in line for the CEO position had he stayed. He has written well-received books on leadership and financial acumen for physicians. As a result, he is a frequent public speaker on similar topics. Yet, he resigned.

They were not the only ones resigning positions that others covet. I, too, resigned my position as Department Chairman earlier this year. None of us were fired, none of us were asked to leave, and none of us are burned out. So here we were, three accomplished physicians all resigning from powerful posts at the same time for what turns out to be similar reasons. Our priorities changed as our children moved out.

I would like to say that we all had the wisdom to know that our leadership skills were deteriorating and that we all wanted to get out while we are at the top of our game. Had Arthur Brooks written “Your Professional Decline Is Coming (Much) Sooner Than You Think” in The Atlantic (July 2019) before we made our decisions, I may have made that argument, but it would not have been true. All three of us feel like we have accomplished what we sought to achieve when we took our respective roles and now we wanted to leverage that experience into something different, if not better. None of us have settled into new roles yet, and all of us are still trying to define exactly what it is we want to do next, but all of us agree that we are no longer interested in driving ourselves to succeed at the expense of our family, friends, and relationships.

My fraternity brothers and I gushed with pride talking about our children and their success. Our progeny are starting their individual climbs up the ladder of opportunity in whatever field they have chosen. My friends and I, on the other hand, had already climbed a ladder and feel comfortable stopping. Or maybe we just want to start climbing a different ladder.

Dr. Kalaycio is editor in chief of Hematology News. He chairs the department of hematology and medical oncology at Cleveland Clinic Taussig Cancer Institute. Contact him at [email protected].

For a patient with a major mental illness, the road to wellness is long and uncertain. The medications commonly used to treat mood and thought disorders can take weeks to months to start providing benefits, and they carry significant risks for adverse effects, such as weight gain, sexual dysfunction, and movement disorders. Patients often have to take psychotropic medications for the rest of their lives. In addition to these downsides, there is no guarantee that these medications will provide complete or even partial relief.^2,3

Recently, there has been growing excitement about new treatments that might be “miracle cures” for patients with mental illness, particularly for individuals with treatment-resistant depression (TRD). Two of these treatments—ketamine-related compounds, and hallucinogenic drugs—seem to promise therapeutic effects that are vastly different from those of other psychiatric medications: They appear to improve patients’ symptoms very quickly, and their effects may persist long after these drugs have been cleared from the body.

Intravenous ketamine is an older generic drug used in anesthesia; recently, it has been used off-label for TRD and other mental illnesses. On March 5, 2019, the FDA approved an intranasal formulation of esketamine—the S-enantiomer of ketamine—for TRD.⁴ Hallucinogens have also been tested in small studies and have seemingly significant effects in alleviating depression in patients with terminal illnesses⁵ and reducing smoking behavior in patients with tobacco use disorder.^6,7

These miracle cures are becoming increasingly available to patients and continue to gain credibility among clinicians and researchers. How should we evaluate the usefulness of these new treatments? And how should we talk to our patients about them? To answer these questions, this article:

• explores our duty to our patients, ourselves, and our colleagues
• describes the dilemma
• discusses ways to evaluate claims made about these new miracle cures.

Duty: Protecting and helping our patients

The physician–patient relationship is a fiduciary relationship. According to both common law and medical ethics, a physician who enters into a treatment relationship with a patient creates a bond of special trust and confidence. Such a relationship requires a physician to act in good faith and in the patient’s best interests.⁸ As physicians, we have a duty to evaluate the safety and efficacy of new treatments that are available for our patients, whether or not they are FDA-approved.

We should also protect our patients from the adverse consequences of relatively untested drugs. For example, ketamine and hallucinogens both produce dissociative effects, and may carry high risks for patients who have a predisposition to psychosis.⁹ We should protect our patients from any false hopes that might lead them to abandon their current treatment regimens due to adverse effects and imperfect results. At the same time, we also have a duty to acknowledge our patients’ suffering and to recognize that they might be desperate for new treatment options. We should remain open-minded about new treatments, and acknowledge that they might work. Finally, we have a duty to be mindful of any financial benefits that we may derive from the development, marketing, and administration of these medications.

Dilemma: The need for new treatments

This is not the first time that novel treatments in mental health have seemed to hold incredible promise. In the late 1800s, Sigmund Freud began to regularly use a compound that led him to feel “the normal euphoria of a healthy person.” He wrote that this substance produced:

…exhilaration and lasting euphoria, which does not differ in any way from the normal euphoria of a healthy person. The feeling of excitement which accompanies stimulus by alcohol is completely lacking; the characteristic urge for immediate activity which alcohol produces is also absent. One senses an increase of self-control and feels more vigorous and more capable of work; on the other hand, if one works, one misses that heightening of the mental powers which alcohol, tea, or coffee induce. One is simply normal, and soon finds it difficult to believe that one is under the influence of any drug at all.¹

Continue to: The compound Freud was describing...

The compound Freud was describing is cocaine, which we now know is an addictive and dangerous drug that can in fact worsen depression.¹⁰ Another treatment regarded as a miracle cure in its time involved placing patients with schizophrenia into an insulin-induced coma to treat their symptoms; this therapy was used from 1933 to 1960.¹¹ We now recognize that this practice is unacceptably dangerous.

The past is filled with cautionary tales of the enthusiastic adoption of treatments for mental illness that later turned out to be ineffective, counterproductive, dangerous, or inhumane. Yet, the long, arduous journeys our patients go through continue to weigh heavily on us. We would love to offer our patients newer, more efficacious, and longer-lasting treatments with fewer adverse effects.

Discussion: How to best evaluate miracle cures

To help quickly assess a new treatment, the following 5 categories can help guide and organize our thought process.

1. Evidence

What type of evidence do we have that a new treatment is safe and effective? Psychiatric research may be even more susceptible to a placebo effect than other medical research, particularly for illnesses with subjective symptoms, such as depression.¹² Double-blinded, placebo-controlled studies, such as the IV ketamine trial conducted by Singh et al,¹³ are the gold standard for separating a substance’s actual biologic effect from a placebo effect. Studies that do not include a control group should not be regarded as providing scientific evidence of efficacy.

2. Mechanism

If a new compound appears to have a beneficial effect on mental health, it is important to consider the potential mechanism underlying this effect to determine if it is biologically plausible. A compound that is claimed to be a panacea for every symptom of every mental illness should be heavily scrutinized. For example, based on available research, ketamine’s long-lasting effects seem to come from 2 mechanisms^14,15:

• Activation of endogenous opioid receptors, which is also responsible for the euphoria induced by heroin and oxycodone.
• Blockade of N-methyl-D-aspartate receptors. N-methyl-D-aspartate receptor activation is a key mechanism by which learning and memory function in the brain, and blocking these receptors may increase brain plasticity.

Continue to: Therefore, it seems plausible...

Therefore, it seems plausible that ketamine could produce both short- and long-term improvements in mood. Hallucinogenic drugs are thought to profoundly alter brain function through several mechanisms, including activating serotonin receptors, enhancing brain plasticity, and increasing brain connectivity.¹⁶

3. Reinforcement

Psychiatric medications that are acutely reinforcing have significant potential for abuse. Antidepressants and mood stabilizers are not acutely rewarding. They don’t make patients feel good right away. Medications such as stimulants and opioids do, and must be used with extreme care because of their abuse potential. The problem with acutely reinforcing medications is that in the long run, they can worsen depression by decreasing the brain’s ability to produce endogenous opioids.¹⁷

4. No single solution?

A mental disorder is unlikely to have a single solution. Rather than regarding a new treatment as capable of rapidly alleviating every symptom of a patient’s illness, it should be viewed as a tool that can be helpful when used in combination with other treatments and lifestyle practices. In an interview with the web site STAT, Cristina Cusin, MD, co-director of the Intravenous Ketamine Clinic for Depression at Massachusetts General Hospital, said, “You don’t treat an advanced disease with just an infusion and a ‘see you next time.’ If [doctors] replace your knee but [you] don’t do physical therapy, you don’t walk again.”¹⁸ To sustain the benefits of a novel medication, patients with serious mental illnesses need to maintain strong social supports, see a mental health care provider regularly, and abstain from illicit drug and alcohol use.

5. Context matters

For a medication to obtain approval to treat a specific indication, the FDA usually require 2 trials that demonstrate efficacy. Off-label use of generic medications such as ketamine may have benefits, but it is unlikely that a generic drug would be put through a costly FDA-approval process.¹⁹

When learning about new medications, remember that patients might assume that these agents have undergone a thorough review process for safety and effectiveness. When our patients request such treatments—whether FDA-approved or off-label—it is our responsibility as physicians to educate them about the benefits, risks, effectiveness, and limitations of these treatments, as well as to evaluate the appropriateness of a treatment for a specific patient’s symptoms.

Continue to: Tempering excitement with caution

Our patients are not the only ones desperate for a miracle cure. As psychiatrists, many of us are desperate, too. New compounds may ultimately change the way we treat mental illness. However, we have an obligation to temper our excitement with caution by remembering past mistakes, and systematically evaluating new miracle cures to determine if they are safe and effective.

For a patient with a major mental illness, the road to wellness is long and uncertain. The medications commonly used to treat mood and thought disorders can take weeks to months to start providing benefits, and they carry significant risks for adverse effects, such as weight gain, sexual dysfunction, and movement disorders. Patients often have to take psychotropic medications for the rest of their lives. In addition to these downsides, there is no guarantee that these medications will provide complete or even partial relief.^2,3

Recently, there has been growing excitement about new treatments that might be “miracle cures” for patients with mental illness, particularly for individuals with treatment-resistant depression (TRD). Two of these treatments—ketamine-related compounds, and hallucinogenic drugs—seem to promise therapeutic effects that are vastly different from those of other psychiatric medications: They appear to improve patients’ symptoms very quickly, and their effects may persist long after these drugs have been cleared from the body.

Intravenous ketamine is an older generic drug used in anesthesia; recently, it has been used off-label for TRD and other mental illnesses. On March 5, 2019, the FDA approved an intranasal formulation of esketamine—the S-enantiomer of ketamine—for TRD.⁴ Hallucinogens have also been tested in small studies and have seemingly significant effects in alleviating depression in patients with terminal illnesses⁵ and reducing smoking behavior in patients with tobacco use disorder.^6,7

These miracle cures are becoming increasingly available to patients and continue to gain credibility among clinicians and researchers. How should we evaluate the usefulness of these new treatments? And how should we talk to our patients about them? To answer these questions, this article:

• explores our duty to our patients, ourselves, and our colleagues
• describes the dilemma
• discusses ways to evaluate claims made about these new miracle cures.

Duty: Protecting and helping our patients

The physician–patient relationship is a fiduciary relationship. According to both common law and medical ethics, a physician who enters into a treatment relationship with a patient creates a bond of special trust and confidence. Such a relationship requires a physician to act in good faith and in the patient’s best interests.⁸ As physicians, we have a duty to evaluate the safety and efficacy of new treatments that are available for our patients, whether or not they are FDA-approved.

We should also protect our patients from the adverse consequences of relatively untested drugs. For example, ketamine and hallucinogens both produce dissociative effects, and may carry high risks for patients who have a predisposition to psychosis.⁹ We should protect our patients from any false hopes that might lead them to abandon their current treatment regimens due to adverse effects and imperfect results. At the same time, we also have a duty to acknowledge our patients’ suffering and to recognize that they might be desperate for new treatment options. We should remain open-minded about new treatments, and acknowledge that they might work. Finally, we have a duty to be mindful of any financial benefits that we may derive from the development, marketing, and administration of these medications.

Dilemma: The need for new treatments

This is not the first time that novel treatments in mental health have seemed to hold incredible promise. In the late 1800s, Sigmund Freud began to regularly use a compound that led him to feel “the normal euphoria of a healthy person.” He wrote that this substance produced:

…exhilaration and lasting euphoria, which does not differ in any way from the normal euphoria of a healthy person. The feeling of excitement which accompanies stimulus by alcohol is completely lacking; the characteristic urge for immediate activity which alcohol produces is also absent. One senses an increase of self-control and feels more vigorous and more capable of work; on the other hand, if one works, one misses that heightening of the mental powers which alcohol, tea, or coffee induce. One is simply normal, and soon finds it difficult to believe that one is under the influence of any drug at all.¹

Continue to: The compound Freud was describing...

The compound Freud was describing is cocaine, which we now know is an addictive and dangerous drug that can in fact worsen depression.¹⁰ Another treatment regarded as a miracle cure in its time involved placing patients with schizophrenia into an insulin-induced coma to treat their symptoms; this therapy was used from 1933 to 1960.¹¹ We now recognize that this practice is unacceptably dangerous.

The past is filled with cautionary tales of the enthusiastic adoption of treatments for mental illness that later turned out to be ineffective, counterproductive, dangerous, or inhumane. Yet, the long, arduous journeys our patients go through continue to weigh heavily on us. We would love to offer our patients newer, more efficacious, and longer-lasting treatments with fewer adverse effects.

Discussion: How to best evaluate miracle cures

To help quickly assess a new treatment, the following 5 categories can help guide and organize our thought process.

1. Evidence

What type of evidence do we have that a new treatment is safe and effective? Psychiatric research may be even more susceptible to a placebo effect than other medical research, particularly for illnesses with subjective symptoms, such as depression.¹² Double-blinded, placebo-controlled studies, such as the IV ketamine trial conducted by Singh et al,¹³ are the gold standard for separating a substance’s actual biologic effect from a placebo effect. Studies that do not include a control group should not be regarded as providing scientific evidence of efficacy.

2. Mechanism

If a new compound appears to have a beneficial effect on mental health, it is important to consider the potential mechanism underlying this effect to determine if it is biologically plausible. A compound that is claimed to be a panacea for every symptom of every mental illness should be heavily scrutinized. For example, based on available research, ketamine’s long-lasting effects seem to come from 2 mechanisms^14,15:

• Activation of endogenous opioid receptors, which is also responsible for the euphoria induced by heroin and oxycodone.
• Blockade of N-methyl-D-aspartate receptors. N-methyl-D-aspartate receptor activation is a key mechanism by which learning and memory function in the brain, and blocking these receptors may increase brain plasticity.

Continue to: Therefore, it seems plausible...

Therefore, it seems plausible that ketamine could produce both short- and long-term improvements in mood. Hallucinogenic drugs are thought to profoundly alter brain function through several mechanisms, including activating serotonin receptors, enhancing brain plasticity, and increasing brain connectivity.¹⁶

3. Reinforcement

Psychiatric medications that are acutely reinforcing have significant potential for abuse. Antidepressants and mood stabilizers are not acutely rewarding. They don’t make patients feel good right away. Medications such as stimulants and opioids do, and must be used with extreme care because of their abuse potential. The problem with acutely reinforcing medications is that in the long run, they can worsen depression by decreasing the brain’s ability to produce endogenous opioids.¹⁷

4. No single solution?

A mental disorder is unlikely to have a single solution. Rather than regarding a new treatment as capable of rapidly alleviating every symptom of a patient’s illness, it should be viewed as a tool that can be helpful when used in combination with other treatments and lifestyle practices. In an interview with the web site STAT, Cristina Cusin, MD, co-director of the Intravenous Ketamine Clinic for Depression at Massachusetts General Hospital, said, “You don’t treat an advanced disease with just an infusion and a ‘see you next time.’ If [doctors] replace your knee but [you] don’t do physical therapy, you don’t walk again.”¹⁸ To sustain the benefits of a novel medication, patients with serious mental illnesses need to maintain strong social supports, see a mental health care provider regularly, and abstain from illicit drug and alcohol use.

5. Context matters

For a medication to obtain approval to treat a specific indication, the FDA usually require 2 trials that demonstrate efficacy. Off-label use of generic medications such as ketamine may have benefits, but it is unlikely that a generic drug would be put through a costly FDA-approval process.¹⁹

When learning about new medications, remember that patients might assume that these agents have undergone a thorough review process for safety and effectiveness. When our patients request such treatments—whether FDA-approved or off-label—it is our responsibility as physicians to educate them about the benefits, risks, effectiveness, and limitations of these treatments, as well as to evaluate the appropriateness of a treatment for a specific patient’s symptoms.

Continue to: Tempering excitement with caution

Our patients are not the only ones desperate for a miracle cure. As psychiatrists, many of us are desperate, too. New compounds may ultimately change the way we treat mental illness. However, we have an obligation to temper our excitement with caution by remembering past mistakes, and systematically evaluating new miracle cures to determine if they are safe and effective.

For a patient with a major mental illness, the road to wellness is long and uncertain. The medications commonly used to treat mood and thought disorders can take weeks to months to start providing benefits, and they carry significant risks for adverse effects, such as weight gain, sexual dysfunction, and movement disorders. Patients often have to take psychotropic medications for the rest of their lives. In addition to these downsides, there is no guarantee that these medications will provide complete or even partial relief.^2,3

Recently, there has been growing excitement about new treatments that might be “miracle cures” for patients with mental illness, particularly for individuals with treatment-resistant depression (TRD). Two of these treatments—ketamine-related compounds, and hallucinogenic drugs—seem to promise therapeutic effects that are vastly different from those of other psychiatric medications: They appear to improve patients’ symptoms very quickly, and their effects may persist long after these drugs have been cleared from the body.

Intravenous ketamine is an older generic drug used in anesthesia; recently, it has been used off-label for TRD and other mental illnesses. On March 5, 2019, the FDA approved an intranasal formulation of esketamine—the S-enantiomer of ketamine—for TRD.⁴ Hallucinogens have also been tested in small studies and have seemingly significant effects in alleviating depression in patients with terminal illnesses⁵ and reducing smoking behavior in patients with tobacco use disorder.^6,7

These miracle cures are becoming increasingly available to patients and continue to gain credibility among clinicians and researchers. How should we evaluate the usefulness of these new treatments? And how should we talk to our patients about them? To answer these questions, this article:

• explores our duty to our patients, ourselves, and our colleagues
• describes the dilemma
• discusses ways to evaluate claims made about these new miracle cures.

Duty: Protecting and helping our patients

The physician–patient relationship is a fiduciary relationship. According to both common law and medical ethics, a physician who enters into a treatment relationship with a patient creates a bond of special trust and confidence. Such a relationship requires a physician to act in good faith and in the patient’s best interests.⁸ As physicians, we have a duty to evaluate the safety and efficacy of new treatments that are available for our patients, whether or not they are FDA-approved.

We should also protect our patients from the adverse consequences of relatively untested drugs. For example, ketamine and hallucinogens both produce dissociative effects, and may carry high risks for patients who have a predisposition to psychosis.⁹ We should protect our patients from any false hopes that might lead them to abandon their current treatment regimens due to adverse effects and imperfect results. At the same time, we also have a duty to acknowledge our patients’ suffering and to recognize that they might be desperate for new treatment options. We should remain open-minded about new treatments, and acknowledge that they might work. Finally, we have a duty to be mindful of any financial benefits that we may derive from the development, marketing, and administration of these medications.

Dilemma: The need for new treatments

This is not the first time that novel treatments in mental health have seemed to hold incredible promise. In the late 1800s, Sigmund Freud began to regularly use a compound that led him to feel “the normal euphoria of a healthy person.” He wrote that this substance produced:

…exhilaration and lasting euphoria, which does not differ in any way from the normal euphoria of a healthy person. The feeling of excitement which accompanies stimulus by alcohol is completely lacking; the characteristic urge for immediate activity which alcohol produces is also absent. One senses an increase of self-control and feels more vigorous and more capable of work; on the other hand, if one works, one misses that heightening of the mental powers which alcohol, tea, or coffee induce. One is simply normal, and soon finds it difficult to believe that one is under the influence of any drug at all.¹

Continue to: The compound Freud was describing...

The compound Freud was describing is cocaine, which we now know is an addictive and dangerous drug that can in fact worsen depression.¹⁰ Another treatment regarded as a miracle cure in its time involved placing patients with schizophrenia into an insulin-induced coma to treat their symptoms; this therapy was used from 1933 to 1960.¹¹ We now recognize that this practice is unacceptably dangerous.

The past is filled with cautionary tales of the enthusiastic adoption of treatments for mental illness that later turned out to be ineffective, counterproductive, dangerous, or inhumane. Yet, the long, arduous journeys our patients go through continue to weigh heavily on us. We would love to offer our patients newer, more efficacious, and longer-lasting treatments with fewer adverse effects.

Discussion: How to best evaluate miracle cures

To help quickly assess a new treatment, the following 5 categories can help guide and organize our thought process.

1. Evidence

What type of evidence do we have that a new treatment is safe and effective? Psychiatric research may be even more susceptible to a placebo effect than other medical research, particularly for illnesses with subjective symptoms, such as depression.¹² Double-blinded, placebo-controlled studies, such as the IV ketamine trial conducted by Singh et al,¹³ are the gold standard for separating a substance’s actual biologic effect from a placebo effect. Studies that do not include a control group should not be regarded as providing scientific evidence of efficacy.

2. Mechanism

If a new compound appears to have a beneficial effect on mental health, it is important to consider the potential mechanism underlying this effect to determine if it is biologically plausible. A compound that is claimed to be a panacea for every symptom of every mental illness should be heavily scrutinized. For example, based on available research, ketamine’s long-lasting effects seem to come from 2 mechanisms^14,15:

• Activation of endogenous opioid receptors, which is also responsible for the euphoria induced by heroin and oxycodone.
• Blockade of N-methyl-D-aspartate receptors. N-methyl-D-aspartate receptor activation is a key mechanism by which learning and memory function in the brain, and blocking these receptors may increase brain plasticity.

Continue to: Therefore, it seems plausible...

Therefore, it seems plausible that ketamine could produce both short- and long-term improvements in mood. Hallucinogenic drugs are thought to profoundly alter brain function through several mechanisms, including activating serotonin receptors, enhancing brain plasticity, and increasing brain connectivity.¹⁶

3. Reinforcement

Psychiatric medications that are acutely reinforcing have significant potential for abuse. Antidepressants and mood stabilizers are not acutely rewarding. They don’t make patients feel good right away. Medications such as stimulants and opioids do, and must be used with extreme care because of their abuse potential. The problem with acutely reinforcing medications is that in the long run, they can worsen depression by decreasing the brain’s ability to produce endogenous opioids.¹⁷

4. No single solution?

A mental disorder is unlikely to have a single solution. Rather than regarding a new treatment as capable of rapidly alleviating every symptom of a patient’s illness, it should be viewed as a tool that can be helpful when used in combination with other treatments and lifestyle practices. In an interview with the web site STAT, Cristina Cusin, MD, co-director of the Intravenous Ketamine Clinic for Depression at Massachusetts General Hospital, said, “You don’t treat an advanced disease with just an infusion and a ‘see you next time.’ If [doctors] replace your knee but [you] don’t do physical therapy, you don’t walk again.”¹⁸ To sustain the benefits of a novel medication, patients with serious mental illnesses need to maintain strong social supports, see a mental health care provider regularly, and abstain from illicit drug and alcohol use.

5. Context matters

For a medication to obtain approval to treat a specific indication, the FDA usually require 2 trials that demonstrate efficacy. Off-label use of generic medications such as ketamine may have benefits, but it is unlikely that a generic drug would be put through a costly FDA-approval process.¹⁹

When learning about new medications, remember that patients might assume that these agents have undergone a thorough review process for safety and effectiveness. When our patients request such treatments—whether FDA-approved or off-label—it is our responsibility as physicians to educate them about the benefits, risks, effectiveness, and limitations of these treatments, as well as to evaluate the appropriateness of a treatment for a specific patient’s symptoms.

Continue to: Tempering excitement with caution

Our patients are not the only ones desperate for a miracle cure. As psychiatrists, many of us are desperate, too. New compounds may ultimately change the way we treat mental illness. However, we have an obligation to temper our excitement with caution by remembering past mistakes, and systematically evaluating new miracle cures to determine if they are safe and effective.

The future of psychiatry is bright, even scintillating. Disruptive changes are gradually unfolding and will proceed at a brisk pace. Psychiatric practice will be transformed into a clinical neuroscience that will heal the mind by repairing the brain. The ingredients of change are already in place, and the trend will accelerate.

Consider the following scientific, technical, and therapeutic advances that will continue to transform the psychiatric practice landscape.

Scientific advances

• Pluripotent cells. By dedifferentiating fibroblasts or skin cells and re-differentiating them into neurons and glia, the study of the structure and function of psychiatric patients’ brains can be conducted in a test tube. That will exponentially expand the knowledge of the neural circuitry that underpin psychiatric disorders and will lead to novel strategies for brain repair.¹
• CRISPR. This revolutionary advance in excising and inserting genes will eventually lead to the prevention of a psychiatric disease by replacing risk genes or mutations.¹
• Molecular genetics. The flurry of identifying risk genes, copy number variants (CNV), and de novo mutations using gene-wide association studies (GWAS) will facilitate gene therapy in psychiatric disorders.
• Neuroimmunology. The discovery of the role of neuroinflammation and oxidative stress (free radicals exceeding glutathione and other antioxidants) in neuropsychiatric disorders will ultimately lead to new insights into preventing the neurodegeneration associated with acute psychotic or mood disorders. Inhibiting the activation of microglia (the immune cells of the brain) is one example of innovative therapeutic targets in the future.²
• Recognizing the role of mitochondrial dysfunction as a pathogenic pathway to neuropsychiatric disorders such as depression, schizophrenia, bipolar disorder, and even the comorbid diabetes that is common among those psychiatric disorders will chart an entirely new approach to diagnosis and treatment.²
• The role of the microbiota and microbiome in psychiatric disorders has emerged as a fertile new frontier in psychiatry, both for etiology and as therapeutic targets.³
• The enteric brain in the gut, in close proximity with the microbiome, is now known to be a major source of neurotransmitters that modulate brain functions (dopamine, serotonin, and others). Consequently, it is implicated in psychopathology, rendering this “second brain” a target for therapeutic interventions in the future, in addition to the “cephalic brain.”⁴
• Biomarkers and endophenotypes. The rapid discoveries of biomarkers are setting the stage for the recognition of hundreds of biologic subtypes of complex neuropsychiatric syndromes such as schizophrenia, autism, depression, anxiety, and dementia. Biomarkers will steadily pave the road to precision psychiatry.^5,6

Technical advances

• Artificial intelligence is beginning to revolutionize psychiatric practice by identifying psychopathology via voice patterns, facial features, motor activity, sleep patterns, and analysis of writing and language. It will significantly enhance the early detection and diagnosis of neuropsychiatric disorders.⁷
• Machine learning. As with other medical specialties, this radical and important new technology is likely to generate currently unrecognized information and decision options for psychiatric practitioners in the future.⁸
• Neuromodulation. The future is already here when it comes to employing neuromodulation as a therapeutic technique in psychiatry. The past was prologue with the discovery of electroconvulsive therapy (ECT) 30 years ago, evolving into vagus nerve stimulation (VNS), and transcranial magnetic stimulation (TMS) over the past 2 decades. Their application will go beyond depression into several other psychiatric conditions. A flurry of other neuromodulation techniques are being developed, including cranial electrical stimulation (CES), deep brain stimulation (DBS), epidural cortical stimulation (ECS), focused ultrasound (FUS), low-field magnetic stimulation (LFMS), magnetic seizure therapy (MST), near infrared light therapy (NIR), and transcranial direct current stimulation (TDCS).⁹

Continue to: Therapeutic advances

Therapeutic advances

• Rapid-acting parenteral antidepressants are one of the most exciting paradigm shifts for the treatment of severe depression and suicidal urges. In controlled clinical trials, ketamine, scopolamine, and nitrous oxide were shown to reverse chronic depression that had failed to respond to multiple oral antidepressants in a matter of hours instead of weeks or months.¹⁰ This remarkable new frontier of psychiatric therapeutics has revolutionized our concept of the neurobiology of depression and its reversibility into rapid remission. The use of IV, intranasal, and inhalable delivery of pharmacotherapies is bound to become an integral component of the future of psychiatry.
• Telepsychiatry is an example of how the future has already arrived for psychiatric practice. Clinicians’ virtual access to patients living in remote areas for evaluation and treatment is certainly a totally new model of health care delivery when compared with traditional face-to-face psychiatry, where patients must travel to see a psychiatrist.
• New terminology for psychotropic agents is also an impending part of the future. The neuroscience-based nomenclature (NbN) will rename more than 100 psychotropic medications by their mechanisms of action rather than by their clinical indication.¹¹ Not only will this new lexicon be more scientifically accurate, but it also will avoid pigeon-holing drugs such as selective serotonin reuptake inhibitor antidepressants, which also are used to treat obsessive-compulsive disorder (OCD), anxiety, bulimia nervosa, and pain, or second-generation “atypical” antipsychotics, which are indicated not only for schizophrenia but also for bipolar mania and bipolar depression, and have been reported to improve treatment-resistant major depression, treatment-resistant OCD, borderline personality disorder, posttraumatic stress disorder (PTSD), and delirium.¹²
• Early intervention during the prodromal phase of serious psychiatric disorders is already here and will advance rapidly in the future. This will spare patients the anguish and suffering of acute psychosis or mania, hospitalization, or disability. It will likely reduce the huge direct and indirect costs to society of serious psychiatric disorders.¹³
• Repurposing hallucinogens into therapeutic agents is one of the most interesting discoveries in psychiatry. As with ketamine, a dissociative hallucinogen that has been rebranded as a rapid antidepressant, other hallucinogens such as psilocybin, lysergic acid diethylamide (LSD), and 3,4-methylenedioxy-methamphetamine (MDMA) are being investigated as therapeutic agents for depression, anxiety, and PTSD. They will become part of our expanding future pharmacotherapeutic armamentarium.¹⁴

It is obvious that parts of the future of psychiatry are already in place today, but other trends will emerge and thrill us clinicians. These advances will gradually but certainly alter psychiatric practice for the better, as the neuro­science of the mind expands and guides psychiatrists to more objective diagnoses and precise treatment options. The pace of advances in psychiatry is one of the most rapid in medicine.

So hold on: This will be a fascinating journey of creative destruction of traditional psychiatry.¹⁵ But as Emily Dickinson wrote: “Truth must dazzle gradually, or every man be blind.”

The future of psychiatry is bright, even scintillating. Disruptive changes are gradually unfolding and will proceed at a brisk pace. Psychiatric practice will be transformed into a clinical neuroscience that will heal the mind by repairing the brain. The ingredients of change are already in place, and the trend will accelerate.

Consider the following scientific, technical, and therapeutic advances that will continue to transform the psychiatric practice landscape.

Scientific advances

• Pluripotent cells. By dedifferentiating fibroblasts or skin cells and re-differentiating them into neurons and glia, the study of the structure and function of psychiatric patients’ brains can be conducted in a test tube. That will exponentially expand the knowledge of the neural circuitry that underpin psychiatric disorders and will lead to novel strategies for brain repair.¹
• CRISPR. This revolutionary advance in excising and inserting genes will eventually lead to the prevention of a psychiatric disease by replacing risk genes or mutations.¹
• Molecular genetics. The flurry of identifying risk genes, copy number variants (CNV), and de novo mutations using gene-wide association studies (GWAS) will facilitate gene therapy in psychiatric disorders.
• Neuroimmunology. The discovery of the role of neuroinflammation and oxidative stress (free radicals exceeding glutathione and other antioxidants) in neuropsychiatric disorders will ultimately lead to new insights into preventing the neurodegeneration associated with acute psychotic or mood disorders. Inhibiting the activation of microglia (the immune cells of the brain) is one example of innovative therapeutic targets in the future.²
• Recognizing the role of mitochondrial dysfunction as a pathogenic pathway to neuropsychiatric disorders such as depression, schizophrenia, bipolar disorder, and even the comorbid diabetes that is common among those psychiatric disorders will chart an entirely new approach to diagnosis and treatment.²
• The role of the microbiota and microbiome in psychiatric disorders has emerged as a fertile new frontier in psychiatry, both for etiology and as therapeutic targets.³
• The enteric brain in the gut, in close proximity with the microbiome, is now known to be a major source of neurotransmitters that modulate brain functions (dopamine, serotonin, and others). Consequently, it is implicated in psychopathology, rendering this “second brain” a target for therapeutic interventions in the future, in addition to the “cephalic brain.”⁴
• Biomarkers and endophenotypes. The rapid discoveries of biomarkers are setting the stage for the recognition of hundreds of biologic subtypes of complex neuropsychiatric syndromes such as schizophrenia, autism, depression, anxiety, and dementia. Biomarkers will steadily pave the road to precision psychiatry.^5,6

Technical advances

• Artificial intelligence is beginning to revolutionize psychiatric practice by identifying psychopathology via voice patterns, facial features, motor activity, sleep patterns, and analysis of writing and language. It will significantly enhance the early detection and diagnosis of neuropsychiatric disorders.⁷
• Machine learning. As with other medical specialties, this radical and important new technology is likely to generate currently unrecognized information and decision options for psychiatric practitioners in the future.⁸
• Neuromodulation. The future is already here when it comes to employing neuromodulation as a therapeutic technique in psychiatry. The past was prologue with the discovery of electroconvulsive therapy (ECT) 30 years ago, evolving into vagus nerve stimulation (VNS), and transcranial magnetic stimulation (TMS) over the past 2 decades. Their application will go beyond depression into several other psychiatric conditions. A flurry of other neuromodulation techniques are being developed, including cranial electrical stimulation (CES), deep brain stimulation (DBS), epidural cortical stimulation (ECS), focused ultrasound (FUS), low-field magnetic stimulation (LFMS), magnetic seizure therapy (MST), near infrared light therapy (NIR), and transcranial direct current stimulation (TDCS).⁹

Continue to: Therapeutic advances

Therapeutic advances

• Rapid-acting parenteral antidepressants are one of the most exciting paradigm shifts for the treatment of severe depression and suicidal urges. In controlled clinical trials, ketamine, scopolamine, and nitrous oxide were shown to reverse chronic depression that had failed to respond to multiple oral antidepressants in a matter of hours instead of weeks or months.¹⁰ This remarkable new frontier of psychiatric therapeutics has revolutionized our concept of the neurobiology of depression and its reversibility into rapid remission. The use of IV, intranasal, and inhalable delivery of pharmacotherapies is bound to become an integral component of the future of psychiatry.
• Telepsychiatry is an example of how the future has already arrived for psychiatric practice. Clinicians’ virtual access to patients living in remote areas for evaluation and treatment is certainly a totally new model of health care delivery when compared with traditional face-to-face psychiatry, where patients must travel to see a psychiatrist.
• New terminology for psychotropic agents is also an impending part of the future. The neuroscience-based nomenclature (NbN) will rename more than 100 psychotropic medications by their mechanisms of action rather than by their clinical indication.¹¹ Not only will this new lexicon be more scientifically accurate, but it also will avoid pigeon-holing drugs such as selective serotonin reuptake inhibitor antidepressants, which also are used to treat obsessive-compulsive disorder (OCD), anxiety, bulimia nervosa, and pain, or second-generation “atypical” antipsychotics, which are indicated not only for schizophrenia but also for bipolar mania and bipolar depression, and have been reported to improve treatment-resistant major depression, treatment-resistant OCD, borderline personality disorder, posttraumatic stress disorder (PTSD), and delirium.¹²
• Early intervention during the prodromal phase of serious psychiatric disorders is already here and will advance rapidly in the future. This will spare patients the anguish and suffering of acute psychosis or mania, hospitalization, or disability. It will likely reduce the huge direct and indirect costs to society of serious psychiatric disorders.¹³
• Repurposing hallucinogens into therapeutic agents is one of the most interesting discoveries in psychiatry. As with ketamine, a dissociative hallucinogen that has been rebranded as a rapid antidepressant, other hallucinogens such as psilocybin, lysergic acid diethylamide (LSD), and 3,4-methylenedioxy-methamphetamine (MDMA) are being investigated as therapeutic agents for depression, anxiety, and PTSD. They will become part of our expanding future pharmacotherapeutic armamentarium.¹⁴

It is obvious that parts of the future of psychiatry are already in place today, but other trends will emerge and thrill us clinicians. These advances will gradually but certainly alter psychiatric practice for the better, as the neuro­science of the mind expands and guides psychiatrists to more objective diagnoses and precise treatment options. The pace of advances in psychiatry is one of the most rapid in medicine.

So hold on: This will be a fascinating journey of creative destruction of traditional psychiatry.¹⁵ But as Emily Dickinson wrote: “Truth must dazzle gradually, or every man be blind.”

The future of psychiatry is bright, even scintillating. Disruptive changes are gradually unfolding and will proceed at a brisk pace. Psychiatric practice will be transformed into a clinical neuroscience that will heal the mind by repairing the brain. The ingredients of change are already in place, and the trend will accelerate.

Consider the following scientific, technical, and therapeutic advances that will continue to transform the psychiatric practice landscape.

Scientific advances

• Pluripotent cells. By dedifferentiating fibroblasts or skin cells and re-differentiating them into neurons and glia, the study of the structure and function of psychiatric patients’ brains can be conducted in a test tube. That will exponentially expand the knowledge of the neural circuitry that underpin psychiatric disorders and will lead to novel strategies for brain repair.¹
• CRISPR. This revolutionary advance in excising and inserting genes will eventually lead to the prevention of a psychiatric disease by replacing risk genes or mutations.¹
• Molecular genetics. The flurry of identifying risk genes, copy number variants (CNV), and de novo mutations using gene-wide association studies (GWAS) will facilitate gene therapy in psychiatric disorders.
• Neuroimmunology. The discovery of the role of neuroinflammation and oxidative stress (free radicals exceeding glutathione and other antioxidants) in neuropsychiatric disorders will ultimately lead to new insights into preventing the neurodegeneration associated with acute psychotic or mood disorders. Inhibiting the activation of microglia (the immune cells of the brain) is one example of innovative therapeutic targets in the future.²
• Recognizing the role of mitochondrial dysfunction as a pathogenic pathway to neuropsychiatric disorders such as depression, schizophrenia, bipolar disorder, and even the comorbid diabetes that is common among those psychiatric disorders will chart an entirely new approach to diagnosis and treatment.²
• The role of the microbiota and microbiome in psychiatric disorders has emerged as a fertile new frontier in psychiatry, both for etiology and as therapeutic targets.³
• The enteric brain in the gut, in close proximity with the microbiome, is now known to be a major source of neurotransmitters that modulate brain functions (dopamine, serotonin, and others). Consequently, it is implicated in psychopathology, rendering this “second brain” a target for therapeutic interventions in the future, in addition to the “cephalic brain.”⁴
• Biomarkers and endophenotypes. The rapid discoveries of biomarkers are setting the stage for the recognition of hundreds of biologic subtypes of complex neuropsychiatric syndromes such as schizophrenia, autism, depression, anxiety, and dementia. Biomarkers will steadily pave the road to precision psychiatry.^5,6

Technical advances

• Artificial intelligence is beginning to revolutionize psychiatric practice by identifying psychopathology via voice patterns, facial features, motor activity, sleep patterns, and analysis of writing and language. It will significantly enhance the early detection and diagnosis of neuropsychiatric disorders.⁷
• Machine learning. As with other medical specialties, this radical and important new technology is likely to generate currently unrecognized information and decision options for psychiatric practitioners in the future.⁸
• Neuromodulation. The future is already here when it comes to employing neuromodulation as a therapeutic technique in psychiatry. The past was prologue with the discovery of electroconvulsive therapy (ECT) 30 years ago, evolving into vagus nerve stimulation (VNS), and transcranial magnetic stimulation (TMS) over the past 2 decades. Their application will go beyond depression into several other psychiatric conditions. A flurry of other neuromodulation techniques are being developed, including cranial electrical stimulation (CES), deep brain stimulation (DBS), epidural cortical stimulation (ECS), focused ultrasound (FUS), low-field magnetic stimulation (LFMS), magnetic seizure therapy (MST), near infrared light therapy (NIR), and transcranial direct current stimulation (TDCS).⁹

Continue to: Therapeutic advances

Therapeutic advances

• Rapid-acting parenteral antidepressants are one of the most exciting paradigm shifts for the treatment of severe depression and suicidal urges. In controlled clinical trials, ketamine, scopolamine, and nitrous oxide were shown to reverse chronic depression that had failed to respond to multiple oral antidepressants in a matter of hours instead of weeks or months.¹⁰ This remarkable new frontier of psychiatric therapeutics has revolutionized our concept of the neurobiology of depression and its reversibility into rapid remission. The use of IV, intranasal, and inhalable delivery of pharmacotherapies is bound to become an integral component of the future of psychiatry.
• Telepsychiatry is an example of how the future has already arrived for psychiatric practice. Clinicians’ virtual access to patients living in remote areas for evaluation and treatment is certainly a totally new model of health care delivery when compared with traditional face-to-face psychiatry, where patients must travel to see a psychiatrist.
• New terminology for psychotropic agents is also an impending part of the future. The neuroscience-based nomenclature (NbN) will rename more than 100 psychotropic medications by their mechanisms of action rather than by their clinical indication.¹¹ Not only will this new lexicon be more scientifically accurate, but it also will avoid pigeon-holing drugs such as selective serotonin reuptake inhibitor antidepressants, which also are used to treat obsessive-compulsive disorder (OCD), anxiety, bulimia nervosa, and pain, or second-generation “atypical” antipsychotics, which are indicated not only for schizophrenia but also for bipolar mania and bipolar depression, and have been reported to improve treatment-resistant major depression, treatment-resistant OCD, borderline personality disorder, posttraumatic stress disorder (PTSD), and delirium.¹²
• Early intervention during the prodromal phase of serious psychiatric disorders is already here and will advance rapidly in the future. This will spare patients the anguish and suffering of acute psychosis or mania, hospitalization, or disability. It will likely reduce the huge direct and indirect costs to society of serious psychiatric disorders.¹³
• Repurposing hallucinogens into therapeutic agents is one of the most interesting discoveries in psychiatry. As with ketamine, a dissociative hallucinogen that has been rebranded as a rapid antidepressant, other hallucinogens such as psilocybin, lysergic acid diethylamide (LSD), and 3,4-methylenedioxy-methamphetamine (MDMA) are being investigated as therapeutic agents for depression, anxiety, and PTSD. They will become part of our expanding future pharmacotherapeutic armamentarium.¹⁴

It is obvious that parts of the future of psychiatry are already in place today, but other trends will emerge and thrill us clinicians. These advances will gradually but certainly alter psychiatric practice for the better, as the neuro­science of the mind expands and guides psychiatrists to more objective diagnoses and precise treatment options. The pace of advances in psychiatry is one of the most rapid in medicine.

So hold on: This will be a fascinating journey of creative destruction of traditional psychiatry.¹⁵ But as Emily Dickinson wrote: “Truth must dazzle gradually, or every man be blind.”

Editor’s note:  Career Choices features a psychiatry resident/fellow interviewing a psychiatrist about why he or she has chosen a specific career path. The goal is to inform trainees about the various psychiatric career options, and to give them a feel for the pros and cons of the various paths.

In this Career Choices, Saeed Ahmed, MD, Addiction Psychiatry Fellow at Boston University Medical Center/Boston University School of Medicine, talked with Paul S. Appelbaum, MD, Elizabeth K. Dollard Professor of Psychiatry, Medicine, and Law, and Director, Center for Law, Ethics, and Psychiatry, Department of Psychiatry, Columbia University Vagelos College of Physicians and Surgeons. Dr. Appelbaum is currently Chair of the DSM Steering Committee for the American Psychiatric Association, and Co-chair of the Standing Committee on Ethics of the World Psychiatric Association. He performs forensic evaluations in civil and criminal cases, and treats patients with a broad variety of illnesses, including depression, anxiety, and adjustment problems.

Dr. Ahmed: What made you pick the forensic psychiatry track, and how did your training lead you towards this path?

Dr. Appelbaum: I was a debater in high school and college, and a fair number of our topics dealt with legal issues, which I’d always found intriguing. However, on entering medical school, I had assumed that I would need to leave those interests behind me. During the first week of medical school, though, we were all asked to select a behavioral science elective for the semester, and on the list was “Law and Psychiatry.” I didn’t know what it involved, but it sounded interesting, so I signed up. The class was taught by Dr. Alan Stone, a professor at Harvard Law School and the most important figure in the academic study of legal issues in psychiatry. By the end of the first class—on the Friday afternoon of my first week in medical school—I was so excited by the things we were discussing that I pretty much decided this was what I wanted to focus on in my career.

Later in medical school, I joined a research project looking at violence on the inpatient psychiatric units, as a way of broadening my knowledge of the field. During residency—we’re talking about the late 1970s, which was a time of great legal ferment about regulation of psychiatric practice—I persuaded my attending psychiatrist to join me in studying patients who were exercising their newly granted right to refuse treatment. That’s how Dr. Tom Gutheil and I started working together, a collaboration that continues today, with the publication of the 5th edition of our text, Clinical Handbook of Psychiatry and Law. I was also able to get foundation funding to do a study of patients’ decision-making capacities, a topic that has remained a focus of my research to the present day. During my final year of residency, I was able to create a chief residency in legal psychiatry, which allowed me to take law school courses, pursue my research, and supervise the more junior residents in their forensic evaluations.

Today, most people headed toward careers in forensic psychiatry take a fellowship after residency, but [such fellowships] were few and far between in 1980. So I went to Alan Stone for advice, and he said, “Go work with Loren Roth in Pittsburgh for 5 years, and you’ll be able to do anything you want after that.” I tracked down Loren Roth, then the leading empirical researcher on issues related to law and psychiatry, explained that Alan Stone had said I should go work with him, and somehow it all worked out. My first faculty job was with his Law and Psychiatry Program at the University of Pittsburgh.

Dr. Ahmed: What are some of the pros and cons of working in forensic psychiatry?

Continue to: Dr. Appelbaum...

Dr. Appelbaum: It may sound at first as though forensic psychiatry is a narrow subspecialty of psychiatry. But the field is actually immense, and the diversity of experiences that it provides is one of the big pros of a career in forensic psychiatry. On the academic side of the field, topics of research interest include prediction and management of violence, involuntary commitment and treatment, informed consent and decisional capacity, privacy and confidentiality of psychiatric treatment, criminal responsibility, and correctional treatment. Clinically, forensic psychiatrists perform a variety of evaluations, ranging from competence to consent to treatment, testamentary capacity, emotional harms in tort cases, psychiatric malpractice, sexual harassment and work-related disability, to competence to stand trial, voluntariness of confessions, insanity defense, and pre-sentencing assessments. Indeed, after nearly 40 years in the field, I still occasionally get asked to do evaluations of a type that I’ve never done before. Increasingly, forensic psychiatrists are involved in treating offenders, both in correctional facilities and in outpatient settings. Most people trained in forensic psychiatry mix their forensic work with general clinical work, whether inpatient or outpatient. So the flexibility that the field offers to craft a career is one of its great advantages.

On the cons side, a career in forensic psychiatry can mean a life of what Alan Stone called “moral peril.” By that he meant that forensic psychiatrists face constant ethical challenges as they perform evaluations and provide testimony. One challenge is to stay grounded in the evidence base of psychiatry and resist the temptation to draw conclusions that may seem “right” but that go beyond what psychiatric knowledge can actually support. Making that challenge even more difficult in private forensic practice is knowing that the party for whom one is working has specific interests that they are hoping you will support, and very definite ideas about what they want your conclusions to be. It may be in your financial interest to accommodate them, but in the long run, your reputation is your most valuable asset. Staying honest both to one’s beliefs and to the broader evidence base in psychiatry is an ongoing challenge, but a critical necessity.

Dr. Ahmed: Based on your personal experience, what should one consider when choosing a forensic psychiatry program?

Dr. Appelbaum: Having supervised forensic psychiatry fellowships for roughly 30 years, I think one of the most important aspects of a training program is its breadth. Given the diversity of the field, a program with a limited number of training sites that focuses on a restricted set of evaluations (usually related to criminal law) will not offer a fellow an optimal training experience. Diverse placements with a variety of evaluations to be performed under the supervision of experienced forensic psychiatrists, and without excessive service demands, are key aspects of a top-notch program. In addition, not everything can be learned hands-on; didactic training is indispensable. Fellows should be offered sufficient background on legal issues and the research base in forensic psychiatry to ground their subsequent work. Finally, for many fellows their time in fellowship is the last opportunity they may have to engage in research or other scholarly projects under supervision, another valuable component of a training program. A good question to ask of any program: What are your former fellows doing now? If the answers don’t reflect the career path you hope to pursue, that’s not the program for you.

Dr. Ahmed: What are some of the career options and work settings for forensic psychiatrists?

Continue to: Dr. Appelbaum...

Dr. Appelbaum: One of the advantages of forensic psychiatry is the plethora of work settings available. People headed to private practice can often combine clinical practice with forensic work, a necessity when starting one’s career and waiting to establish steady referral pipelines. Psychiatrists with forensic training are in demand in correctional facilities (which often pay higher salaries than comparable jobs in psychiatric facilities), forensic hospitals, and court clinics. Opportunities for academic involvement include directing fellowship programs, teaching residents, and conducting research. With regard to research, although funding is harder to come by than, for example, for studies of the biology of major psychiatric syndromes, determined psychiatrists can often find ways of framing questions related to forensic issues so that they appeal to funders’ priorities. As one gains experience, opportunities for consultation for law enforcement agencies, intelligence agencies, and federal and state mental health agencies may be available. It is rare for a forensic psychiatrist to do just one of these things; most forensic psychiatrists engage in a mix of types of work, including general clinical work. The possibilities are manifold.

Dr. Ahmed: What are some of the challenges in working in this field?

Dr. Appelbaum: I talked already about some of the ethical challenges in forensic psychiatry. In addition, as a subspecialty that applies psychiatric knowledge to legal questions, forensic psychiatry requires its practitioners to stay up-to-date with both advances in psychiatry and changes in the law, not to mention variations across jurisdictions. This is not an area of specialization in which one can pay attention during fellowship and then coast through a career. In my view, it’s also critical for a good forensic psychiatrist to be an excellent clinician; forensic cases frequently offer diagnostic challenges that require the highest level of clinical skills to address. Finally, for people early in their careers, it can take a few years before they are well-enough known to get a steady flow of private forensic cases. So having a plan B during that career phase will be essential.

Dr. Ahmed: Where do you see forensic psychiatry going?

Dr. Appelbaum: Forensic evaluations will need to incorporate new assessment techniques and new knowledge—although not before they have been demonstrated to be valid and reliable. I can foresee increased use of specialized neuroimaging assessments, genomic and other “omic” testing, and measurement of other neurophysiologic parameters. As we know more about the etiology of psychiatric disorders, that will impact everything from evaluations of causation in emotional harms cases to conclusions about which divorcing parent may be better able to handle primary custody of a child. I think there will be exciting opportunities in the coming decades to integrate growing scientific knowledge about psychiatric illnesses into forensic psychiatry.

Continue to: Dr. Ahmed...

Dr. Ahmed: What advice do you have for those contemplating a career in forensic psychiatry?

Dr. Appelbaum: Residents thinking about undertaking training in forensic psychiatry should come to one of the annual meetings of the American Academy of Psychiatry and the Law, the major professional organization of forensic psychiatrists, which takes place every October. That will give them a good feel for the scope of the field and the types of work available. Many residencies offer rotations in forensic psychiatry, another opportunity to learn about the field, and even in programs that don’t, highly motivated residents are often able to arrange electives working with forensic psychiatrists in the community. Doing a research project in the area is another great way to learn more about the field. The more you know before you make a decision, the better that decision will be.

Editor’s note:  Career Choices features a psychiatry resident/fellow interviewing a psychiatrist about why he or she has chosen a specific career path. The goal is to inform trainees about the various psychiatric career options, and to give them a feel for the pros and cons of the various paths.

In this Career Choices, Saeed Ahmed, MD, Addiction Psychiatry Fellow at Boston University Medical Center/Boston University School of Medicine, talked with Paul S. Appelbaum, MD, Elizabeth K. Dollard Professor of Psychiatry, Medicine, and Law, and Director, Center for Law, Ethics, and Psychiatry, Department of Psychiatry, Columbia University Vagelos College of Physicians and Surgeons. Dr. Appelbaum is currently Chair of the DSM Steering Committee for the American Psychiatric Association, and Co-chair of the Standing Committee on Ethics of the World Psychiatric Association. He performs forensic evaluations in civil and criminal cases, and treats patients with a broad variety of illnesses, including depression, anxiety, and adjustment problems.

Dr. Ahmed: What made you pick the forensic psychiatry track, and how did your training lead you towards this path?

Dr. Appelbaum: I was a debater in high school and college, and a fair number of our topics dealt with legal issues, which I’d always found intriguing. However, on entering medical school, I had assumed that I would need to leave those interests behind me. During the first week of medical school, though, we were all asked to select a behavioral science elective for the semester, and on the list was “Law and Psychiatry.” I didn’t know what it involved, but it sounded interesting, so I signed up. The class was taught by Dr. Alan Stone, a professor at Harvard Law School and the most important figure in the academic study of legal issues in psychiatry. By the end of the first class—on the Friday afternoon of my first week in medical school—I was so excited by the things we were discussing that I pretty much decided this was what I wanted to focus on in my career.

Later in medical school, I joined a research project looking at violence on the inpatient psychiatric units, as a way of broadening my knowledge of the field. During residency—we’re talking about the late 1970s, which was a time of great legal ferment about regulation of psychiatric practice—I persuaded my attending psychiatrist to join me in studying patients who were exercising their newly granted right to refuse treatment. That’s how Dr. Tom Gutheil and I started working together, a collaboration that continues today, with the publication of the 5th edition of our text, Clinical Handbook of Psychiatry and Law. I was also able to get foundation funding to do a study of patients’ decision-making capacities, a topic that has remained a focus of my research to the present day. During my final year of residency, I was able to create a chief residency in legal psychiatry, which allowed me to take law school courses, pursue my research, and supervise the more junior residents in their forensic evaluations.

Today, most people headed toward careers in forensic psychiatry take a fellowship after residency, but [such fellowships] were few and far between in 1980. So I went to Alan Stone for advice, and he said, “Go work with Loren Roth in Pittsburgh for 5 years, and you’ll be able to do anything you want after that.” I tracked down Loren Roth, then the leading empirical researcher on issues related to law and psychiatry, explained that Alan Stone had said I should go work with him, and somehow it all worked out. My first faculty job was with his Law and Psychiatry Program at the University of Pittsburgh.

Dr. Ahmed: What are some of the pros and cons of working in forensic psychiatry?

Continue to: Dr. Appelbaum...

Dr. Appelbaum: It may sound at first as though forensic psychiatry is a narrow subspecialty of psychiatry. But the field is actually immense, and the diversity of experiences that it provides is one of the big pros of a career in forensic psychiatry. On the academic side of the field, topics of research interest include prediction and management of violence, involuntary commitment and treatment, informed consent and decisional capacity, privacy and confidentiality of psychiatric treatment, criminal responsibility, and correctional treatment. Clinically, forensic psychiatrists perform a variety of evaluations, ranging from competence to consent to treatment, testamentary capacity, emotional harms in tort cases, psychiatric malpractice, sexual harassment and work-related disability, to competence to stand trial, voluntariness of confessions, insanity defense, and pre-sentencing assessments. Indeed, after nearly 40 years in the field, I still occasionally get asked to do evaluations of a type that I’ve never done before. Increasingly, forensic psychiatrists are involved in treating offenders, both in correctional facilities and in outpatient settings. Most people trained in forensic psychiatry mix their forensic work with general clinical work, whether inpatient or outpatient. So the flexibility that the field offers to craft a career is one of its great advantages.

On the cons side, a career in forensic psychiatry can mean a life of what Alan Stone called “moral peril.” By that he meant that forensic psychiatrists face constant ethical challenges as they perform evaluations and provide testimony. One challenge is to stay grounded in the evidence base of psychiatry and resist the temptation to draw conclusions that may seem “right” but that go beyond what psychiatric knowledge can actually support. Making that challenge even more difficult in private forensic practice is knowing that the party for whom one is working has specific interests that they are hoping you will support, and very definite ideas about what they want your conclusions to be. It may be in your financial interest to accommodate them, but in the long run, your reputation is your most valuable asset. Staying honest both to one’s beliefs and to the broader evidence base in psychiatry is an ongoing challenge, but a critical necessity.

Dr. Ahmed: Based on your personal experience, what should one consider when choosing a forensic psychiatry program?

Dr. Appelbaum: Having supervised forensic psychiatry fellowships for roughly 30 years, I think one of the most important aspects of a training program is its breadth. Given the diversity of the field, a program with a limited number of training sites that focuses on a restricted set of evaluations (usually related to criminal law) will not offer a fellow an optimal training experience. Diverse placements with a variety of evaluations to be performed under the supervision of experienced forensic psychiatrists, and without excessive service demands, are key aspects of a top-notch program. In addition, not everything can be learned hands-on; didactic training is indispensable. Fellows should be offered sufficient background on legal issues and the research base in forensic psychiatry to ground their subsequent work. Finally, for many fellows their time in fellowship is the last opportunity they may have to engage in research or other scholarly projects under supervision, another valuable component of a training program. A good question to ask of any program: What are your former fellows doing now? If the answers don’t reflect the career path you hope to pursue, that’s not the program for you.

Dr. Ahmed: What are some of the career options and work settings for forensic psychiatrists?

Continue to: Dr. Appelbaum...

Dr. Appelbaum: One of the advantages of forensic psychiatry is the plethora of work settings available. People headed to private practice can often combine clinical practice with forensic work, a necessity when starting one’s career and waiting to establish steady referral pipelines. Psychiatrists with forensic training are in demand in correctional facilities (which often pay higher salaries than comparable jobs in psychiatric facilities), forensic hospitals, and court clinics. Opportunities for academic involvement include directing fellowship programs, teaching residents, and conducting research. With regard to research, although funding is harder to come by than, for example, for studies of the biology of major psychiatric syndromes, determined psychiatrists can often find ways of framing questions related to forensic issues so that they appeal to funders’ priorities. As one gains experience, opportunities for consultation for law enforcement agencies, intelligence agencies, and federal and state mental health agencies may be available. It is rare for a forensic psychiatrist to do just one of these things; most forensic psychiatrists engage in a mix of types of work, including general clinical work. The possibilities are manifold.

Dr. Ahmed: What are some of the challenges in working in this field?

Dr. Appelbaum: I talked already about some of the ethical challenges in forensic psychiatry. In addition, as a subspecialty that applies psychiatric knowledge to legal questions, forensic psychiatry requires its practitioners to stay up-to-date with both advances in psychiatry and changes in the law, not to mention variations across jurisdictions. This is not an area of specialization in which one can pay attention during fellowship and then coast through a career. In my view, it’s also critical for a good forensic psychiatrist to be an excellent clinician; forensic cases frequently offer diagnostic challenges that require the highest level of clinical skills to address. Finally, for people early in their careers, it can take a few years before they are well-enough known to get a steady flow of private forensic cases. So having a plan B during that career phase will be essential.

Dr. Ahmed: Where do you see forensic psychiatry going?

Dr. Appelbaum: Forensic evaluations will need to incorporate new assessment techniques and new knowledge—although not before they have been demonstrated to be valid and reliable. I can foresee increased use of specialized neuroimaging assessments, genomic and other “omic” testing, and measurement of other neurophysiologic parameters. As we know more about the etiology of psychiatric disorders, that will impact everything from evaluations of causation in emotional harms cases to conclusions about which divorcing parent may be better able to handle primary custody of a child. I think there will be exciting opportunities in the coming decades to integrate growing scientific knowledge about psychiatric illnesses into forensic psychiatry.

Continue to: Dr. Ahmed...

Dr. Ahmed: What advice do you have for those contemplating a career in forensic psychiatry?

Dr. Appelbaum: Residents thinking about undertaking training in forensic psychiatry should come to one of the annual meetings of the American Academy of Psychiatry and the Law, the major professional organization of forensic psychiatrists, which takes place every October. That will give them a good feel for the scope of the field and the types of work available. Many residencies offer rotations in forensic psychiatry, another opportunity to learn about the field, and even in programs that don’t, highly motivated residents are often able to arrange electives working with forensic psychiatrists in the community. Doing a research project in the area is another great way to learn more about the field. The more you know before you make a decision, the better that decision will be.

Editor’s note:  Career Choices features a psychiatry resident/fellow interviewing a psychiatrist about why he or she has chosen a specific career path. The goal is to inform trainees about the various psychiatric career options, and to give them a feel for the pros and cons of the various paths.

In this Career Choices, Saeed Ahmed, MD, Addiction Psychiatry Fellow at Boston University Medical Center/Boston University School of Medicine, talked with Paul S. Appelbaum, MD, Elizabeth K. Dollard Professor of Psychiatry, Medicine, and Law, and Director, Center for Law, Ethics, and Psychiatry, Department of Psychiatry, Columbia University Vagelos College of Physicians and Surgeons. Dr. Appelbaum is currently Chair of the DSM Steering Committee for the American Psychiatric Association, and Co-chair of the Standing Committee on Ethics of the World Psychiatric Association. He performs forensic evaluations in civil and criminal cases, and treats patients with a broad variety of illnesses, including depression, anxiety, and adjustment problems.

Dr. Ahmed: What made you pick the forensic psychiatry track, and how did your training lead you towards this path?

Dr. Appelbaum: I was a debater in high school and college, and a fair number of our topics dealt with legal issues, which I’d always found intriguing. However, on entering medical school, I had assumed that I would need to leave those interests behind me. During the first week of medical school, though, we were all asked to select a behavioral science elective for the semester, and on the list was “Law and Psychiatry.” I didn’t know what it involved, but it sounded interesting, so I signed up. The class was taught by Dr. Alan Stone, a professor at Harvard Law School and the most important figure in the academic study of legal issues in psychiatry. By the end of the first class—on the Friday afternoon of my first week in medical school—I was so excited by the things we were discussing that I pretty much decided this was what I wanted to focus on in my career.

Later in medical school, I joined a research project looking at violence on the inpatient psychiatric units, as a way of broadening my knowledge of the field. During residency—we’re talking about the late 1970s, which was a time of great legal ferment about regulation of psychiatric practice—I persuaded my attending psychiatrist to join me in studying patients who were exercising their newly granted right to refuse treatment. That’s how Dr. Tom Gutheil and I started working together, a collaboration that continues today, with the publication of the 5th edition of our text, Clinical Handbook of Psychiatry and Law. I was also able to get foundation funding to do a study of patients’ decision-making capacities, a topic that has remained a focus of my research to the present day. During my final year of residency, I was able to create a chief residency in legal psychiatry, which allowed me to take law school courses, pursue my research, and supervise the more junior residents in their forensic evaluations.

Today, most people headed toward careers in forensic psychiatry take a fellowship after residency, but [such fellowships] were few and far between in 1980. So I went to Alan Stone for advice, and he said, “Go work with Loren Roth in Pittsburgh for 5 years, and you’ll be able to do anything you want after that.” I tracked down Loren Roth, then the leading empirical researcher on issues related to law and psychiatry, explained that Alan Stone had said I should go work with him, and somehow it all worked out. My first faculty job was with his Law and Psychiatry Program at the University of Pittsburgh.

Dr. Ahmed: What are some of the pros and cons of working in forensic psychiatry?

Continue to: Dr. Appelbaum...

Dr. Appelbaum: It may sound at first as though forensic psychiatry is a narrow subspecialty of psychiatry. But the field is actually immense, and the diversity of experiences that it provides is one of the big pros of a career in forensic psychiatry. On the academic side of the field, topics of research interest include prediction and management of violence, involuntary commitment and treatment, informed consent and decisional capacity, privacy and confidentiality of psychiatric treatment, criminal responsibility, and correctional treatment. Clinically, forensic psychiatrists perform a variety of evaluations, ranging from competence to consent to treatment, testamentary capacity, emotional harms in tort cases, psychiatric malpractice, sexual harassment and work-related disability, to competence to stand trial, voluntariness of confessions, insanity defense, and pre-sentencing assessments. Indeed, after nearly 40 years in the field, I still occasionally get asked to do evaluations of a type that I’ve never done before. Increasingly, forensic psychiatrists are involved in treating offenders, both in correctional facilities and in outpatient settings. Most people trained in forensic psychiatry mix their forensic work with general clinical work, whether inpatient or outpatient. So the flexibility that the field offers to craft a career is one of its great advantages.

On the cons side, a career in forensic psychiatry can mean a life of what Alan Stone called “moral peril.” By that he meant that forensic psychiatrists face constant ethical challenges as they perform evaluations and provide testimony. One challenge is to stay grounded in the evidence base of psychiatry and resist the temptation to draw conclusions that may seem “right” but that go beyond what psychiatric knowledge can actually support. Making that challenge even more difficult in private forensic practice is knowing that the party for whom one is working has specific interests that they are hoping you will support, and very definite ideas about what they want your conclusions to be. It may be in your financial interest to accommodate them, but in the long run, your reputation is your most valuable asset. Staying honest both to one’s beliefs and to the broader evidence base in psychiatry is an ongoing challenge, but a critical necessity.

Dr. Ahmed: Based on your personal experience, what should one consider when choosing a forensic psychiatry program?

Dr. Appelbaum: Having supervised forensic psychiatry fellowships for roughly 30 years, I think one of the most important aspects of a training program is its breadth. Given the diversity of the field, a program with a limited number of training sites that focuses on a restricted set of evaluations (usually related to criminal law) will not offer a fellow an optimal training experience. Diverse placements with a variety of evaluations to be performed under the supervision of experienced forensic psychiatrists, and without excessive service demands, are key aspects of a top-notch program. In addition, not everything can be learned hands-on; didactic training is indispensable. Fellows should be offered sufficient background on legal issues and the research base in forensic psychiatry to ground their subsequent work. Finally, for many fellows their time in fellowship is the last opportunity they may have to engage in research or other scholarly projects under supervision, another valuable component of a training program. A good question to ask of any program: What are your former fellows doing now? If the answers don’t reflect the career path you hope to pursue, that’s not the program for you.

Dr. Ahmed: What are some of the career options and work settings for forensic psychiatrists?

Continue to: Dr. Appelbaum...

Dr. Appelbaum: One of the advantages of forensic psychiatry is the plethora of work settings available. People headed to private practice can often combine clinical practice with forensic work, a necessity when starting one’s career and waiting to establish steady referral pipelines. Psychiatrists with forensic training are in demand in correctional facilities (which often pay higher salaries than comparable jobs in psychiatric facilities), forensic hospitals, and court clinics. Opportunities for academic involvement include directing fellowship programs, teaching residents, and conducting research. With regard to research, although funding is harder to come by than, for example, for studies of the biology of major psychiatric syndromes, determined psychiatrists can often find ways of framing questions related to forensic issues so that they appeal to funders’ priorities. As one gains experience, opportunities for consultation for law enforcement agencies, intelligence agencies, and federal and state mental health agencies may be available. It is rare for a forensic psychiatrist to do just one of these things; most forensic psychiatrists engage in a mix of types of work, including general clinical work. The possibilities are manifold.

Dr. Ahmed: What are some of the challenges in working in this field?

Dr. Appelbaum: I talked already about some of the ethical challenges in forensic psychiatry. In addition, as a subspecialty that applies psychiatric knowledge to legal questions, forensic psychiatry requires its practitioners to stay up-to-date with both advances in psychiatry and changes in the law, not to mention variations across jurisdictions. This is not an area of specialization in which one can pay attention during fellowship and then coast through a career. In my view, it’s also critical for a good forensic psychiatrist to be an excellent clinician; forensic cases frequently offer diagnostic challenges that require the highest level of clinical skills to address. Finally, for people early in their careers, it can take a few years before they are well-enough known to get a steady flow of private forensic cases. So having a plan B during that career phase will be essential.

Dr. Ahmed: Where do you see forensic psychiatry going?

Dr. Appelbaum: Forensic evaluations will need to incorporate new assessment techniques and new knowledge—although not before they have been demonstrated to be valid and reliable. I can foresee increased use of specialized neuroimaging assessments, genomic and other “omic” testing, and measurement of other neurophysiologic parameters. As we know more about the etiology of psychiatric disorders, that will impact everything from evaluations of causation in emotional harms cases to conclusions about which divorcing parent may be better able to handle primary custody of a child. I think there will be exciting opportunities in the coming decades to integrate growing scientific knowledge about psychiatric illnesses into forensic psychiatry.

Continue to: Dr. Ahmed...

Dr. Ahmed: What advice do you have for those contemplating a career in forensic psychiatry?

Dr. Appelbaum: Residents thinking about undertaking training in forensic psychiatry should come to one of the annual meetings of the American Academy of Psychiatry and the Law, the major professional organization of forensic psychiatrists, which takes place every October. That will give them a good feel for the scope of the field and the types of work available. Many residencies offer rotations in forensic psychiatry, another opportunity to learn about the field, and even in programs that don’t, highly motivated residents are often able to arrange electives working with forensic psychiatrists in the community. Doing a research project in the area is another great way to learn more about the field. The more you know before you make a decision, the better that decision will be.

“Canst thou not minister to a mind diseased, pluck from the memory a rooted sorrow, raze out the written troubles of the brain, and with some sweet oblivious antidote cleanse the stuffed bosom of that perilous stuff which weighs upon the heart?”
– William Shakespeare, Macbeth

For many years, the United States has been experiencing a shortage of psychiatrists. Currently, there are only 28,000 to 33,000 psychiatrists in active patient care practice in the United States.^1,2 The lack of psychiatrists is pronounced in many areas of the country, including rural regions, some urban neighborhoods, and community health centers. In approximately half of US counties, there are no psychiatrists at all.³

While patients with mental illnesses often are treated in primary care settings, the need for qualified mental health clinicians remains acute. Two-thirds of primary care physicians report difficulty in referring patients for mental health care, due to the shortage of clinicians and long wait times for patients to be seen.⁴ In the Department of Veterans Affairs (VA), the shortage of qualified psychiatrists is even more acute, due to ongoing combat operations and an increased number of missions and manpower requirements to complete them, which also has increased veterans’ mental health needs during life after their service.⁵

The outlook for providing adequate numbers of psychiatrists in the future is even more concerning. Based on a population analysis, Satiani et al⁶ predicts an extreme shortage of psychiatrists for the next 30 years, with the availability of psychiatrists per population expected to reach an all-time low by 2024. Based on ratios from the Department of Health and Human Services, this would mean a shortage of 14,000 to 31,000 psychiatrists over the next 5 to 6 years alone. This is due primarily to the expected retirement of more than 25,000 psychiatrists age >55 during the next 5 years. With mental illness becoming the costliest medical condition in the United States, at $201 billion annually, the potential impact of this shortage is alarming.⁶

Addressing the shortage

Efforts aimed at increasing the number of psychiatrists, improving access to care, and improving efficiency of care have focused on expanding recruitment and training capacity in psychiatry residency programs, utilizing new models such as telepsychiatry and Assertive Community Treatment (ACT) teams, increasing the number of Certified Community Behavioral Health Clinics, and embedding psychiatrists in large primary care practices.⁷ Another avenue for addressing the psychiatrist shortage has been the training and hiring of more advanced practice clinicians, including physician assistants (PAs) and nurse practitioners (NPs). Approximately 11,000 PAs and NPs specialize in psychiatry in the United States; this number represents more than one-third of the current psychiatrist workforce. This substantially adds to the available mental health professionals who can assess, monitor, and treat mental health conditions, and creates an opportunity for further growth to help make up for the expected shortfall of psychiatrists. In an analysis of a data set that included information on 90% of physician practices in the United States, Martsolf et al⁸ found that in 2016, 28% of specialty practices employed advanced practice clinicians.

Physician assistants and NPs make up the largest group of non-physician mental health professionals who can prescribe medications. Physician assistant training is most closely aligned with the allopathic training model of physicians.⁹ Some typical duties of PAs working in a psychiatric setting are outlined in the Table.

How many PAs elect to specialize in psychiatry, compared with the percentage of physicians who choose psychiatry as a career? Data from the National Commission on Certification of Physician Assistants (NCCPA) revealed that in 2018 there were 1,470 PAs working in psychiatry, or approximately 1.5% of all PAs in practice.¹⁰ In comparison, approximately 5% of physicians complete residency training in psychiatry.²

Continue to: Although the need for more...

Although the need for more mental health professionals—especially those who can prescribe—is well documented, PA practice in psychiatry has been underrepresented, with PAs choosing to work in the field at a rate just over one-fourth that of physicians. While there is no clear explanation for the lack of PAs in psychiatry, PA programs’ training model has been to produce generalist clinicians who can work in numerous settings, particularly primary care. However, during the past several decades, PA practice choice has shifted largely from primary care to specialty care. In 1974, an estimated 68.8% of PAs worked in primary care settings (family medicine/general practice, general internal medicine, and general pediatrics), while the remainder worked in specialty areas.¹¹ In contrast, by 2018, only 25.8% of PAs worked in primary care settings.¹⁰ Despite more PAs choosing to work in medical specialties, the number choosing psychiatry remains very low. With the great need for well-trained mental health prescribers, the opportunity for growth in this area of medicine and increased salary incentive should serve as an impetus for PAs to consider psychiatry. Like their physician counterparts, PAs working in specialty areas of medicine tend to be paid more, sometimes substantially more.¹²

Training requirements

What is the level of training and experience for PAs who choose to work in psychiatry? Physician assistant program applicants generally come from a pre-med background with a Bachelor’s degree in a hard science, and often have medical experience as a nurse, paramedic, emergency medical technician, or other health profession. Physician assistants are trained in the same medical model of care as physicians, although their training is structured over an average 27-month cycle, with 1 year devoted to didactic education and 1 year or more devoted to clinical training.¹³ They are qualified to “go to work” soon after graduating and passing the NCCPA Physician Assistant National Certifying Examination (PANCE), and may require a state license. Upon graduation, PAs have received approximately 1,000 hours of didactic and 2,000 hours of clinical training across the general spectrum of medicine.

Physician assistants who choose to specialize in psychiatry may complete a residency/fellowship in psychiatry of approximately 1 year, and/or obtain the Certificate of Added Qualification (CAQ) in psychiatry from the NCCPA. Most PAs who work in psychiatry have done so through “on-the-job” training, where their knowledge and skills have expanded through working with their supervising physician(s) and gaining experience from their clinical practice and self-study. For many years, there were only 1 or 2 PA residency/fellowship opportunities in psychiatry in the United States for PAs wanting to acquire additional formal didactic and clinical knowledge and skills in psychiatry. Fortunately, there has been a growing number of PA residencies/fellowships in psychiatry. These programs are typically 1 year in length and can provide a PA who wants to specialize in psychiatry with an additional 300 to >500 didactic and 1,500 to 2,000 clinical hours of training in the assessment, diagnosis, and treatment of the spectrum of psychiatric conditions. Currently, there are 10 to 12 programs in the United States that offer this training to PAs, producing approximately 18 to 20 residency-trained psychiatric PAs each year. Almost one-half of PAs who are residency-trained in psychiatry are being trained in VA facilities and affiliated institutions sponsored by the VA Office of Academic Affiliations. Along with the PA’s basic education, the additional knowledge and skills acquired in residency prepare the PA to be a highly capable psychiatric clinician, with a combined 1,500 didactic and 4,000 clinical hours of training in general medicine plus psychiatry. The addition of the CAQ demonstrates the PA’s commitment to additional learning in psychiatry, as the added work experience requirements, the additional postgraduate continuing medical education requirements in psychiatry, and the psychiatry board exam clearly show dedication to a higher level of knowledge and skill in the specialty.

Because PAs have been trained as generalists who are able to work in any setting or specialty, they have a broad range of knowledge in medicine and surgery. This can be especially helpful when working in a psychiatric practice, where they can provide an added medical focus to patient care when needed. As more PAs are choosing to work in a specialty area for much or all of their practice, they are able to gain significant knowledge and skills in that specialty.

Getting more PAs into psychiatry

So what does the future hold for PAs in psychiatry? The increased need and opportunity in mental health will likely draw a higher percentage of PAs to this specialty. Hopefully, an increase in the number of PA psychiatry residencies or advanced mental health training opportunities, and the continued goal of obtaining the CAQ in psychiatry, will serve to increase the number of psychiatric PAs.¹⁴

Continue to:  The NCCPA has also recognized...

The NCCPA has also recognized the importance of increasing PA knowledge and integration in mental health care by establishing a PArtners in Mental Health Steering Committee, composed of leaders from the largest PA organizations, including the American Academy of Physician Assistants, the Accreditation Review Commission on Education for the Physician Assistant, the Physician Assistant Education Association, the Physician Assistant Foundation, and other PA and interprofessional members. The NCCPA’s PArtners in Mental Health Initiative: Stakeholders Report 2018 outlines an ongoing strategy to increase PA engagement in and awareness of mental health among the PA community and future providers via outreach to member organizations, state societies, PA programs, and those at the state and national level who legislate and reimburse PA services for mental health care.¹⁵ The Steering Committee’s recommendations include:

• enhancing PA educational approaches in mental health
• strengthening the PA practice environment to address mental health needs and foster integration
• promoting national campaigns to raise the profile of PAs addressing mental health across disciplines
• creating an organizational structure that incorporates current participants, offers backbone support to this movement, and plans for communication and financing.¹⁶

The role of PA educators

In the end, PA leaders and educators will play a substantial role in influencing future PAs to seek a career in psychiatry. Currently, psychiatry education varies among PA programs. Some offer robust didactic and clinical education and training, while other programs are limited in the number of hours of psychiatric didactic education, and may offer psychiatry clinical opportunities only in the context of a primary care setting, rather than in a dedicated psychiatric setting. Additionally, the mission of training PAs for generalist, primary care practice may limit many PAs from considering psychiatry because they do not necessarily view psychiatry as closely aligning with primary care generalist practice the way cardiology, pulmonology, gastroenterology, or other internal medicine specialties do.

In terms of PA postgraduate education, many PAs have completed residencies in surgical specialties or emergency medicine. Coincidentally, surgery and emergency medicine residencies are the most prolific of the postgraduate residency programs, adding a significant number of well-trained PAs to these specialties. The NCCPA also offers the CAQ for Cardiovascular and Thoracic Surgery, Orthopedic Surgery, and Emergency Medicine, which may attract PAs into these specialties, with or without completing a residency.

Because the NCCPA also offers the CAQ in Psychiatry, it would be reasonable and attractive for PAs who complete a psychiatry residency to obtain this certification. In fact, the PA psychiatry residency at our own institution trains our residents to be fully prepared and board-eligible to take the CAQ in Psychiatry upon completing residency. To date, every PA residency graduate who has completed our program and taken the CAQ in Psychiatry exam has passed and been awarded the CAQ in Psychiatry. They have proven themselves to the program and the NCCPA, and have impressed their employers with their clinical abilities and medical knowledge.

For psychiatrists, the addition of a well-trained or willing-to-be-trained PA to the practice can provide an economic advantage and strong team partnership that ensures optimal care for patients in this time of shortage of skilled mental health clinicians. The need is clear and will continue. Physician assistant educators must provide adequate didactic and clinical training in psychiatry to PA students, and support students interested in pursuing a career path in this specialty. Physician assistant organizations must meet the challenge of increasing the number of PAs in psychiatry, and encourage the establishment of additional post-graduate residency programs in psychiatry for PAs. Lastly, more PAs need to be made aware that psychiatry is an in-demand specialty that offers broad autonomy and rewarding clinical work.

Continue to: Bottom Line

Physician assistants (PAs) who choose to specialize in psychiatry will find enormous opportunity, as the need for well-trained and knowledgeable mental health providers is acute. Those PAs who obtain additional training and/or certification in psychiatry will be highly valued and sought-after, with an abundance of job opportunities. Physician assistant programs should continue to improve didactic and clinical training for their students in psychiatry, and encourage increased numbers of PAs to consider psychiatry as a career path.

Related Resources

• National Commission on Certification of Physician Assistants. Psychiatry Certificate of Added Qualifications. https://www.nccpa.net/psychiatry.
• Association of Physician Assistants in Psychiatry. http://psychpa.com/.

“Canst thou not minister to a mind diseased, pluck from the memory a rooted sorrow, raze out the written troubles of the brain, and with some sweet oblivious antidote cleanse the stuffed bosom of that perilous stuff which weighs upon the heart?”
– William Shakespeare, Macbeth

For many years, the United States has been experiencing a shortage of psychiatrists. Currently, there are only 28,000 to 33,000 psychiatrists in active patient care practice in the United States.^1,2 The lack of psychiatrists is pronounced in many areas of the country, including rural regions, some urban neighborhoods, and community health centers. In approximately half of US counties, there are no psychiatrists at all.³

While patients with mental illnesses often are treated in primary care settings, the need for qualified mental health clinicians remains acute. Two-thirds of primary care physicians report difficulty in referring patients for mental health care, due to the shortage of clinicians and long wait times for patients to be seen.⁴ In the Department of Veterans Affairs (VA), the shortage of qualified psychiatrists is even more acute, due to ongoing combat operations and an increased number of missions and manpower requirements to complete them, which also has increased veterans’ mental health needs during life after their service.⁵

The outlook for providing adequate numbers of psychiatrists in the future is even more concerning. Based on a population analysis, Satiani et al⁶ predicts an extreme shortage of psychiatrists for the next 30 years, with the availability of psychiatrists per population expected to reach an all-time low by 2024. Based on ratios from the Department of Health and Human Services, this would mean a shortage of 14,000 to 31,000 psychiatrists over the next 5 to 6 years alone. This is due primarily to the expected retirement of more than 25,000 psychiatrists age >55 during the next 5 years. With mental illness becoming the costliest medical condition in the United States, at $201 billion annually, the potential impact of this shortage is alarming.⁶

Addressing the shortage

Efforts aimed at increasing the number of psychiatrists, improving access to care, and improving efficiency of care have focused on expanding recruitment and training capacity in psychiatry residency programs, utilizing new models such as telepsychiatry and Assertive Community Treatment (ACT) teams, increasing the number of Certified Community Behavioral Health Clinics, and embedding psychiatrists in large primary care practices.⁷ Another avenue for addressing the psychiatrist shortage has been the training and hiring of more advanced practice clinicians, including physician assistants (PAs) and nurse practitioners (NPs). Approximately 11,000 PAs and NPs specialize in psychiatry in the United States; this number represents more than one-third of the current psychiatrist workforce. This substantially adds to the available mental health professionals who can assess, monitor, and treat mental health conditions, and creates an opportunity for further growth to help make up for the expected shortfall of psychiatrists. In an analysis of a data set that included information on 90% of physician practices in the United States, Martsolf et al⁸ found that in 2016, 28% of specialty practices employed advanced practice clinicians.

Physician assistants and NPs make up the largest group of non-physician mental health professionals who can prescribe medications. Physician assistant training is most closely aligned with the allopathic training model of physicians.⁹ Some typical duties of PAs working in a psychiatric setting are outlined in the Table.

How many PAs elect to specialize in psychiatry, compared with the percentage of physicians who choose psychiatry as a career? Data from the National Commission on Certification of Physician Assistants (NCCPA) revealed that in 2018 there were 1,470 PAs working in psychiatry, or approximately 1.5% of all PAs in practice.¹⁰ In comparison, approximately 5% of physicians complete residency training in psychiatry.²

Continue to: Although the need for more...

Although the need for more mental health professionals—especially those who can prescribe—is well documented, PA practice in psychiatry has been underrepresented, with PAs choosing to work in the field at a rate just over one-fourth that of physicians. While there is no clear explanation for the lack of PAs in psychiatry, PA programs’ training model has been to produce generalist clinicians who can work in numerous settings, particularly primary care. However, during the past several decades, PA practice choice has shifted largely from primary care to specialty care. In 1974, an estimated 68.8% of PAs worked in primary care settings (family medicine/general practice, general internal medicine, and general pediatrics), while the remainder worked in specialty areas.¹¹ In contrast, by 2018, only 25.8% of PAs worked in primary care settings.¹⁰ Despite more PAs choosing to work in medical specialties, the number choosing psychiatry remains very low. With the great need for well-trained mental health prescribers, the opportunity for growth in this area of medicine and increased salary incentive should serve as an impetus for PAs to consider psychiatry. Like their physician counterparts, PAs working in specialty areas of medicine tend to be paid more, sometimes substantially more.¹²

Training requirements

What is the level of training and experience for PAs who choose to work in psychiatry? Physician assistant program applicants generally come from a pre-med background with a Bachelor’s degree in a hard science, and often have medical experience as a nurse, paramedic, emergency medical technician, or other health profession. Physician assistants are trained in the same medical model of care as physicians, although their training is structured over an average 27-month cycle, with 1 year devoted to didactic education and 1 year or more devoted to clinical training.¹³ They are qualified to “go to work” soon after graduating and passing the NCCPA Physician Assistant National Certifying Examination (PANCE), and may require a state license. Upon graduation, PAs have received approximately 1,000 hours of didactic and 2,000 hours of clinical training across the general spectrum of medicine.

Physician assistants who choose to specialize in psychiatry may complete a residency/fellowship in psychiatry of approximately 1 year, and/or obtain the Certificate of Added Qualification (CAQ) in psychiatry from the NCCPA. Most PAs who work in psychiatry have done so through “on-the-job” training, where their knowledge and skills have expanded through working with their supervising physician(s) and gaining experience from their clinical practice and self-study. For many years, there were only 1 or 2 PA residency/fellowship opportunities in psychiatry in the United States for PAs wanting to acquire additional formal didactic and clinical knowledge and skills in psychiatry. Fortunately, there has been a growing number of PA residencies/fellowships in psychiatry. These programs are typically 1 year in length and can provide a PA who wants to specialize in psychiatry with an additional 300 to >500 didactic and 1,500 to 2,000 clinical hours of training in the assessment, diagnosis, and treatment of the spectrum of psychiatric conditions. Currently, there are 10 to 12 programs in the United States that offer this training to PAs, producing approximately 18 to 20 residency-trained psychiatric PAs each year. Almost one-half of PAs who are residency-trained in psychiatry are being trained in VA facilities and affiliated institutions sponsored by the VA Office of Academic Affiliations. Along with the PA’s basic education, the additional knowledge and skills acquired in residency prepare the PA to be a highly capable psychiatric clinician, with a combined 1,500 didactic and 4,000 clinical hours of training in general medicine plus psychiatry. The addition of the CAQ demonstrates the PA’s commitment to additional learning in psychiatry, as the added work experience requirements, the additional postgraduate continuing medical education requirements in psychiatry, and the psychiatry board exam clearly show dedication to a higher level of knowledge and skill in the specialty.

Because PAs have been trained as generalists who are able to work in any setting or specialty, they have a broad range of knowledge in medicine and surgery. This can be especially helpful when working in a psychiatric practice, where they can provide an added medical focus to patient care when needed. As more PAs are choosing to work in a specialty area for much or all of their practice, they are able to gain significant knowledge and skills in that specialty.

Getting more PAs into psychiatry

So what does the future hold for PAs in psychiatry? The increased need and opportunity in mental health will likely draw a higher percentage of PAs to this specialty. Hopefully, an increase in the number of PA psychiatry residencies or advanced mental health training opportunities, and the continued goal of obtaining the CAQ in psychiatry, will serve to increase the number of psychiatric PAs.¹⁴

Continue to:  The NCCPA has also recognized...

The NCCPA has also recognized the importance of increasing PA knowledge and integration in mental health care by establishing a PArtners in Mental Health Steering Committee, composed of leaders from the largest PA organizations, including the American Academy of Physician Assistants, the Accreditation Review Commission on Education for the Physician Assistant, the Physician Assistant Education Association, the Physician Assistant Foundation, and other PA and interprofessional members. The NCCPA’s PArtners in Mental Health Initiative: Stakeholders Report 2018 outlines an ongoing strategy to increase PA engagement in and awareness of mental health among the PA community and future providers via outreach to member organizations, state societies, PA programs, and those at the state and national level who legislate and reimburse PA services for mental health care.¹⁵ The Steering Committee’s recommendations include:

• enhancing PA educational approaches in mental health
• strengthening the PA practice environment to address mental health needs and foster integration
• promoting national campaigns to raise the profile of PAs addressing mental health across disciplines
• creating an organizational structure that incorporates current participants, offers backbone support to this movement, and plans for communication and financing.¹⁶

The role of PA educators

In the end, PA leaders and educators will play a substantial role in influencing future PAs to seek a career in psychiatry. Currently, psychiatry education varies among PA programs. Some offer robust didactic and clinical education and training, while other programs are limited in the number of hours of psychiatric didactic education, and may offer psychiatry clinical opportunities only in the context of a primary care setting, rather than in a dedicated psychiatric setting. Additionally, the mission of training PAs for generalist, primary care practice may limit many PAs from considering psychiatry because they do not necessarily view psychiatry as closely aligning with primary care generalist practice the way cardiology, pulmonology, gastroenterology, or other internal medicine specialties do.

In terms of PA postgraduate education, many PAs have completed residencies in surgical specialties or emergency medicine. Coincidentally, surgery and emergency medicine residencies are the most prolific of the postgraduate residency programs, adding a significant number of well-trained PAs to these specialties. The NCCPA also offers the CAQ for Cardiovascular and Thoracic Surgery, Orthopedic Surgery, and Emergency Medicine, which may attract PAs into these specialties, with or without completing a residency.

Because the NCCPA also offers the CAQ in Psychiatry, it would be reasonable and attractive for PAs who complete a psychiatry residency to obtain this certification. In fact, the PA psychiatry residency at our own institution trains our residents to be fully prepared and board-eligible to take the CAQ in Psychiatry upon completing residency. To date, every PA residency graduate who has completed our program and taken the CAQ in Psychiatry exam has passed and been awarded the CAQ in Psychiatry. They have proven themselves to the program and the NCCPA, and have impressed their employers with their clinical abilities and medical knowledge.

For psychiatrists, the addition of a well-trained or willing-to-be-trained PA to the practice can provide an economic advantage and strong team partnership that ensures optimal care for patients in this time of shortage of skilled mental health clinicians. The need is clear and will continue. Physician assistant educators must provide adequate didactic and clinical training in psychiatry to PA students, and support students interested in pursuing a career path in this specialty. Physician assistant organizations must meet the challenge of increasing the number of PAs in psychiatry, and encourage the establishment of additional post-graduate residency programs in psychiatry for PAs. Lastly, more PAs need to be made aware that psychiatry is an in-demand specialty that offers broad autonomy and rewarding clinical work.

Continue to: Bottom Line

Physician assistants (PAs) who choose to specialize in psychiatry will find enormous opportunity, as the need for well-trained and knowledgeable mental health providers is acute. Those PAs who obtain additional training and/or certification in psychiatry will be highly valued and sought-after, with an abundance of job opportunities. Physician assistant programs should continue to improve didactic and clinical training for their students in psychiatry, and encourage increased numbers of PAs to consider psychiatry as a career path.

Related Resources

• National Commission on Certification of Physician Assistants. Psychiatry Certificate of Added Qualifications. https://www.nccpa.net/psychiatry.
• Association of Physician Assistants in Psychiatry. http://psychpa.com/.

“Canst thou not minister to a mind diseased, pluck from the memory a rooted sorrow, raze out the written troubles of the brain, and with some sweet oblivious antidote cleanse the stuffed bosom of that perilous stuff which weighs upon the heart?”
– William Shakespeare, Macbeth

For many years, the United States has been experiencing a shortage of psychiatrists. Currently, there are only 28,000 to 33,000 psychiatrists in active patient care practice in the United States.^1,2 The lack of psychiatrists is pronounced in many areas of the country, including rural regions, some urban neighborhoods, and community health centers. In approximately half of US counties, there are no psychiatrists at all.³

While patients with mental illnesses often are treated in primary care settings, the need for qualified mental health clinicians remains acute. Two-thirds of primary care physicians report difficulty in referring patients for mental health care, due to the shortage of clinicians and long wait times for patients to be seen.⁴ In the Department of Veterans Affairs (VA), the shortage of qualified psychiatrists is even more acute, due to ongoing combat operations and an increased number of missions and manpower requirements to complete them, which also has increased veterans’ mental health needs during life after their service.⁵

The outlook for providing adequate numbers of psychiatrists in the future is even more concerning. Based on a population analysis, Satiani et al⁶ predicts an extreme shortage of psychiatrists for the next 30 years, with the availability of psychiatrists per population expected to reach an all-time low by 2024. Based on ratios from the Department of Health and Human Services, this would mean a shortage of 14,000 to 31,000 psychiatrists over the next 5 to 6 years alone. This is due primarily to the expected retirement of more than 25,000 psychiatrists age >55 during the next 5 years. With mental illness becoming the costliest medical condition in the United States, at $201 billion annually, the potential impact of this shortage is alarming.⁶

Addressing the shortage

Efforts aimed at increasing the number of psychiatrists, improving access to care, and improving efficiency of care have focused on expanding recruitment and training capacity in psychiatry residency programs, utilizing new models such as telepsychiatry and Assertive Community Treatment (ACT) teams, increasing the number of Certified Community Behavioral Health Clinics, and embedding psychiatrists in large primary care practices.⁷ Another avenue for addressing the psychiatrist shortage has been the training and hiring of more advanced practice clinicians, including physician assistants (PAs) and nurse practitioners (NPs). Approximately 11,000 PAs and NPs specialize in psychiatry in the United States; this number represents more than one-third of the current psychiatrist workforce. This substantially adds to the available mental health professionals who can assess, monitor, and treat mental health conditions, and creates an opportunity for further growth to help make up for the expected shortfall of psychiatrists. In an analysis of a data set that included information on 90% of physician practices in the United States, Martsolf et al⁸ found that in 2016, 28% of specialty practices employed advanced practice clinicians.

Physician assistants and NPs make up the largest group of non-physician mental health professionals who can prescribe medications. Physician assistant training is most closely aligned with the allopathic training model of physicians.⁹ Some typical duties of PAs working in a psychiatric setting are outlined in the Table.

How many PAs elect to specialize in psychiatry, compared with the percentage of physicians who choose psychiatry as a career? Data from the National Commission on Certification of Physician Assistants (NCCPA) revealed that in 2018 there were 1,470 PAs working in psychiatry, or approximately 1.5% of all PAs in practice.¹⁰ In comparison, approximately 5% of physicians complete residency training in psychiatry.²

Continue to: Although the need for more...

Although the need for more mental health professionals—especially those who can prescribe—is well documented, PA practice in psychiatry has been underrepresented, with PAs choosing to work in the field at a rate just over one-fourth that of physicians. While there is no clear explanation for the lack of PAs in psychiatry, PA programs’ training model has been to produce generalist clinicians who can work in numerous settings, particularly primary care. However, during the past several decades, PA practice choice has shifted largely from primary care to specialty care. In 1974, an estimated 68.8% of PAs worked in primary care settings (family medicine/general practice, general internal medicine, and general pediatrics), while the remainder worked in specialty areas.¹¹ In contrast, by 2018, only 25.8% of PAs worked in primary care settings.¹⁰ Despite more PAs choosing to work in medical specialties, the number choosing psychiatry remains very low. With the great need for well-trained mental health prescribers, the opportunity for growth in this area of medicine and increased salary incentive should serve as an impetus for PAs to consider psychiatry. Like their physician counterparts, PAs working in specialty areas of medicine tend to be paid more, sometimes substantially more.¹²

Training requirements

What is the level of training and experience for PAs who choose to work in psychiatry? Physician assistant program applicants generally come from a pre-med background with a Bachelor’s degree in a hard science, and often have medical experience as a nurse, paramedic, emergency medical technician, or other health profession. Physician assistants are trained in the same medical model of care as physicians, although their training is structured over an average 27-month cycle, with 1 year devoted to didactic education and 1 year or more devoted to clinical training.¹³ They are qualified to “go to work” soon after graduating and passing the NCCPA Physician Assistant National Certifying Examination (PANCE), and may require a state license. Upon graduation, PAs have received approximately 1,000 hours of didactic and 2,000 hours of clinical training across the general spectrum of medicine.

Physician assistants who choose to specialize in psychiatry may complete a residency/fellowship in psychiatry of approximately 1 year, and/or obtain the Certificate of Added Qualification (CAQ) in psychiatry from the NCCPA. Most PAs who work in psychiatry have done so through “on-the-job” training, where their knowledge and skills have expanded through working with their supervising physician(s) and gaining experience from their clinical practice and self-study. For many years, there were only 1 or 2 PA residency/fellowship opportunities in psychiatry in the United States for PAs wanting to acquire additional formal didactic and clinical knowledge and skills in psychiatry. Fortunately, there has been a growing number of PA residencies/fellowships in psychiatry. These programs are typically 1 year in length and can provide a PA who wants to specialize in psychiatry with an additional 300 to >500 didactic and 1,500 to 2,000 clinical hours of training in the assessment, diagnosis, and treatment of the spectrum of psychiatric conditions. Currently, there are 10 to 12 programs in the United States that offer this training to PAs, producing approximately 18 to 20 residency-trained psychiatric PAs each year. Almost one-half of PAs who are residency-trained in psychiatry are being trained in VA facilities and affiliated institutions sponsored by the VA Office of Academic Affiliations. Along with the PA’s basic education, the additional knowledge and skills acquired in residency prepare the PA to be a highly capable psychiatric clinician, with a combined 1,500 didactic and 4,000 clinical hours of training in general medicine plus psychiatry. The addition of the CAQ demonstrates the PA’s commitment to additional learning in psychiatry, as the added work experience requirements, the additional postgraduate continuing medical education requirements in psychiatry, and the psychiatry board exam clearly show dedication to a higher level of knowledge and skill in the specialty.

Because PAs have been trained as generalists who are able to work in any setting or specialty, they have a broad range of knowledge in medicine and surgery. This can be especially helpful when working in a psychiatric practice, where they can provide an added medical focus to patient care when needed. As more PAs are choosing to work in a specialty area for much or all of their practice, they are able to gain significant knowledge and skills in that specialty.

Getting more PAs into psychiatry

So what does the future hold for PAs in psychiatry? The increased need and opportunity in mental health will likely draw a higher percentage of PAs to this specialty. Hopefully, an increase in the number of PA psychiatry residencies or advanced mental health training opportunities, and the continued goal of obtaining the CAQ in psychiatry, will serve to increase the number of psychiatric PAs.¹⁴

Continue to:  The NCCPA has also recognized...

The NCCPA has also recognized the importance of increasing PA knowledge and integration in mental health care by establishing a PArtners in Mental Health Steering Committee, composed of leaders from the largest PA organizations, including the American Academy of Physician Assistants, the Accreditation Review Commission on Education for the Physician Assistant, the Physician Assistant Education Association, the Physician Assistant Foundation, and other PA and interprofessional members. The NCCPA’s PArtners in Mental Health Initiative: Stakeholders Report 2018 outlines an ongoing strategy to increase PA engagement in and awareness of mental health among the PA community and future providers via outreach to member organizations, state societies, PA programs, and those at the state and national level who legislate and reimburse PA services for mental health care.¹⁵ The Steering Committee’s recommendations include:

• enhancing PA educational approaches in mental health
• strengthening the PA practice environment to address mental health needs and foster integration
• promoting national campaigns to raise the profile of PAs addressing mental health across disciplines
• creating an organizational structure that incorporates current participants, offers backbone support to this movement, and plans for communication and financing.¹⁶

The role of PA educators

In the end, PA leaders and educators will play a substantial role in influencing future PAs to seek a career in psychiatry. Currently, psychiatry education varies among PA programs. Some offer robust didactic and clinical education and training, while other programs are limited in the number of hours of psychiatric didactic education, and may offer psychiatry clinical opportunities only in the context of a primary care setting, rather than in a dedicated psychiatric setting. Additionally, the mission of training PAs for generalist, primary care practice may limit many PAs from considering psychiatry because they do not necessarily view psychiatry as closely aligning with primary care generalist practice the way cardiology, pulmonology, gastroenterology, or other internal medicine specialties do.

In terms of PA postgraduate education, many PAs have completed residencies in surgical specialties or emergency medicine. Coincidentally, surgery and emergency medicine residencies are the most prolific of the postgraduate residency programs, adding a significant number of well-trained PAs to these specialties. The NCCPA also offers the CAQ for Cardiovascular and Thoracic Surgery, Orthopedic Surgery, and Emergency Medicine, which may attract PAs into these specialties, with or without completing a residency.

Because the NCCPA also offers the CAQ in Psychiatry, it would be reasonable and attractive for PAs who complete a psychiatry residency to obtain this certification. In fact, the PA psychiatry residency at our own institution trains our residents to be fully prepared and board-eligible to take the CAQ in Psychiatry upon completing residency. To date, every PA residency graduate who has completed our program and taken the CAQ in Psychiatry exam has passed and been awarded the CAQ in Psychiatry. They have proven themselves to the program and the NCCPA, and have impressed their employers with their clinical abilities and medical knowledge.

For psychiatrists, the addition of a well-trained or willing-to-be-trained PA to the practice can provide an economic advantage and strong team partnership that ensures optimal care for patients in this time of shortage of skilled mental health clinicians. The need is clear and will continue. Physician assistant educators must provide adequate didactic and clinical training in psychiatry to PA students, and support students interested in pursuing a career path in this specialty. Physician assistant organizations must meet the challenge of increasing the number of PAs in psychiatry, and encourage the establishment of additional post-graduate residency programs in psychiatry for PAs. Lastly, more PAs need to be made aware that psychiatry is an in-demand specialty that offers broad autonomy and rewarding clinical work.

Continue to: Bottom Line

Physician assistants (PAs) who choose to specialize in psychiatry will find enormous opportunity, as the need for well-trained and knowledgeable mental health providers is acute. Those PAs who obtain additional training and/or certification in psychiatry will be highly valued and sought-after, with an abundance of job opportunities. Physician assistant programs should continue to improve didactic and clinical training for their students in psychiatry, and encourage increased numbers of PAs to consider psychiatry as a career path.

Related Resources

• National Commission on Certification of Physician Assistants. Psychiatry Certificate of Added Qualifications. https://www.nccpa.net/psychiatry.
• Association of Physician Assistants in Psychiatry. http://psychpa.com/.

In this edition of “How I will treat my next patient,” I examine two recently published efforts to enlighten our sensitivity to the seriousness of immune-related adverse events (IrAEs) in patients on immune checkpoint inhibitors (ICIs) and the effect of delays in initiating systemic adjuvant therapy on the long-term outcomes of patients with resected pancreatic cancer.

IrAEs requiring hospitalization

Investigators led by Aanika Balaji of the Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins University, Baltimore, reviewed a 6-month audit of inpatient oncology admissions of solid-tumor patients who had ever received ICIs and ascertained the prevalence of hospitalization for management of IrAEs (J Oncol Pract. 2019 Aug 6. doi: 10.1200/JOP.18.00703). To determine that an IrAE had occurred they required: consensus among two oncologists, clinical improvement with immune-directed therapy, exclusion of alternative diagnoses or pathologic confirmation of an IrAE, or chronic management of an IrAE for more than 6 months.

The bottom line: They found a cumulative incidence of a confirmed IrAEs among hospitalized ICI-treated solid tumor patients of 23%. As expected, the majority (65%) were grade 3-4 in severity. In total, 91% required multidisciplinary management, and 65% improved or resolved. But 87% of patients never received an ICI again.

Patients with preexisting autoimmune disease (25% of patients, although they included hypothyroidism in that group) were not more vulnerable to an IrAE with ICI therapy (odds ratio, 1.0; 95% confidence interval, 0.3-4.0). Not unsurprisingly, the median age was higher for ICI-treated patients who were admitted for IrAEs than for those not admitted (68 years vs. 59 years; OR, 5.4; 95% CI, 1.6-17.8), and more admitted patients had received combination ICIs than single agents (OR, 6.8; 95% CI, 2.0-23.2).

The median time from beginning ICIs to an IrAE-related hospitalization was 64 days, and the median number of ICI doses was one, with a wide range for both days and doses. The authors were quick to comment that this is a small, academic, single-institution survey over a brief period of time and that the generalizability of the results is uncertain.

What this means in practice

This publication changes very little for most practicing oncologists, but it does reinforce that ICI therapy can cause unpredictable, severe IrAEs. Clinical markers for selecting patients at highest risk are imperfect. As with chemotherapy, the patients we worry about the most – older individuals and patients treated with drug combinations – are, in fact, the ones we should be worrying about the most.

In view of the potential severity and impact of IrAEs, research efforts should place equal priority on identifying biomarkers of toxicity, such as tumor mutation burden, and biomarkers of efficacy (JAMA Oncol. 2019 Aug 22. doi: 10.1001/jamaoncol.2019.3221). The potential financial and societal effects, as well as lost opportunity costs in the form of alternative therapies and early referral to hospice, demand no less, particularly in an era of value-based health care reimbursement.
 

Timing of adjuvant treatment

Sung Jun Ma, MD, department of radiation medicine at Roswell Park Comprehensive Cancer Center, Buffalo, N.Y., and colleagues analyzed data from the more than 7,500 stage I-II resected pancreatic cancer patients in the National Cancer Database, of whom more than 5,400 ultimately received adjuvant therapy (chemotherapy with or without radiation). The patients were treated during 2004-2015. Appropriately, the investigators focused on correlating survival duration with the interval between surgery and initiation of adjuvant therapy. Other endpoints would be hard to accurately measure and verify without detailed clinical information (JAMA Network Open. 2019 Aug 14. doi: 10.1001/jamanetworkopen.2019.9126).

They found that the best overall survival was associated with starting adjuvant treatment 28-59 days after surgery – not earlier (17% higher mortality) and not later (9% higher). Patients who did not start adjuvant treatment until more than 90 days post operatively still had an overall survival benefit (hazard ratio, 0.75; 95% confidence interval, 0.66-0.85; P less than .001), a more impressive hazard ratio than that seen for any particular interval between surgery and adjuvant treatment. Overall survival at 2 years was 47.2% versus 38% for the adjuvant therapy and surgery alone cohorts, respectively, with no overlap in the 95% confidence intervals.

As expected, longer delays to receive adjuvant treatment were associated with longer inpatient surgical stays, advanced age, black race, lower income, and a readmission for a postoperative complication within 30 days.

What this means in practice

This is another study that verifies that the patients we worry about most – older patients, those with a complicated recovery from surgery, and those with fewer supportive resources – are exactly the patients we should worry about most. It changes very little for most practicing oncologists. The analysis validates the importance of adjuvant therapy for patients who are able to receive it – whenever that is.

The data collection in this publication precedes recent improvements in adjuvant chemotherapy for resected pancreatic cancer, such as FOLFIRINOX or gemcitabine plus capecitabine. In an era of improved treatment, delays in initiating therapy may be less important since better treatment overcomes many prognostic variables that are significant for less effective therapy.

In my opinion, this large-data analysis is not really hypothesis-generating or practice-changing, but it does compel us to continue research efforts to improve surgical morbidity, identify better adjuvant and advanced disease regimens, and consider neoadjuvant treatment so that more than 72% of patients can receive all components of the multimodality treatment they need.
 

Dr. Lyss has been a community-based medical oncologist and clinical researcher for more than 35 years, practicing in St. Louis. His clinical and research interests are in the prevention, diagnosis, and treatment of breast and lung cancers and in expanding access to clinical trials to medically underserved populations.

In this edition of “How I will treat my next patient,” I examine two recently published efforts to enlighten our sensitivity to the seriousness of immune-related adverse events (IrAEs) in patients on immune checkpoint inhibitors (ICIs) and the effect of delays in initiating systemic adjuvant therapy on the long-term outcomes of patients with resected pancreatic cancer.

IrAEs requiring hospitalization

Investigators led by Aanika Balaji of the Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins University, Baltimore, reviewed a 6-month audit of inpatient oncology admissions of solid-tumor patients who had ever received ICIs and ascertained the prevalence of hospitalization for management of IrAEs (J Oncol Pract. 2019 Aug 6. doi: 10.1200/JOP.18.00703). To determine that an IrAE had occurred they required: consensus among two oncologists, clinical improvement with immune-directed therapy, exclusion of alternative diagnoses or pathologic confirmation of an IrAE, or chronic management of an IrAE for more than 6 months.

The bottom line: They found a cumulative incidence of a confirmed IrAEs among hospitalized ICI-treated solid tumor patients of 23%. As expected, the majority (65%) were grade 3-4 in severity. In total, 91% required multidisciplinary management, and 65% improved or resolved. But 87% of patients never received an ICI again.

Patients with preexisting autoimmune disease (25% of patients, although they included hypothyroidism in that group) were not more vulnerable to an IrAE with ICI therapy (odds ratio, 1.0; 95% confidence interval, 0.3-4.0). Not unsurprisingly, the median age was higher for ICI-treated patients who were admitted for IrAEs than for those not admitted (68 years vs. 59 years; OR, 5.4; 95% CI, 1.6-17.8), and more admitted patients had received combination ICIs than single agents (OR, 6.8; 95% CI, 2.0-23.2).

The median time from beginning ICIs to an IrAE-related hospitalization was 64 days, and the median number of ICI doses was one, with a wide range for both days and doses. The authors were quick to comment that this is a small, academic, single-institution survey over a brief period of time and that the generalizability of the results is uncertain.

What this means in practice

This publication changes very little for most practicing oncologists, but it does reinforce that ICI therapy can cause unpredictable, severe IrAEs. Clinical markers for selecting patients at highest risk are imperfect. As with chemotherapy, the patients we worry about the most – older individuals and patients treated with drug combinations – are, in fact, the ones we should be worrying about the most.

In view of the potential severity and impact of IrAEs, research efforts should place equal priority on identifying biomarkers of toxicity, such as tumor mutation burden, and biomarkers of efficacy (JAMA Oncol. 2019 Aug 22. doi: 10.1001/jamaoncol.2019.3221). The potential financial and societal effects, as well as lost opportunity costs in the form of alternative therapies and early referral to hospice, demand no less, particularly in an era of value-based health care reimbursement.
 

Timing of adjuvant treatment

Sung Jun Ma, MD, department of radiation medicine at Roswell Park Comprehensive Cancer Center, Buffalo, N.Y., and colleagues analyzed data from the more than 7,500 stage I-II resected pancreatic cancer patients in the National Cancer Database, of whom more than 5,400 ultimately received adjuvant therapy (chemotherapy with or without radiation). The patients were treated during 2004-2015. Appropriately, the investigators focused on correlating survival duration with the interval between surgery and initiation of adjuvant therapy. Other endpoints would be hard to accurately measure and verify without detailed clinical information (JAMA Network Open. 2019 Aug 14. doi: 10.1001/jamanetworkopen.2019.9126).

They found that the best overall survival was associated with starting adjuvant treatment 28-59 days after surgery – not earlier (17% higher mortality) and not later (9% higher). Patients who did not start adjuvant treatment until more than 90 days post operatively still had an overall survival benefit (hazard ratio, 0.75; 95% confidence interval, 0.66-0.85; P less than .001), a more impressive hazard ratio than that seen for any particular interval between surgery and adjuvant treatment. Overall survival at 2 years was 47.2% versus 38% for the adjuvant therapy and surgery alone cohorts, respectively, with no overlap in the 95% confidence intervals.

As expected, longer delays to receive adjuvant treatment were associated with longer inpatient surgical stays, advanced age, black race, lower income, and a readmission for a postoperative complication within 30 days.

What this means in practice

This is another study that verifies that the patients we worry about most – older patients, those with a complicated recovery from surgery, and those with fewer supportive resources – are exactly the patients we should worry about most. It changes very little for most practicing oncologists. The analysis validates the importance of adjuvant therapy for patients who are able to receive it – whenever that is.

The data collection in this publication precedes recent improvements in adjuvant chemotherapy for resected pancreatic cancer, such as FOLFIRINOX or gemcitabine plus capecitabine. In an era of improved treatment, delays in initiating therapy may be less important since better treatment overcomes many prognostic variables that are significant for less effective therapy.

In my opinion, this large-data analysis is not really hypothesis-generating or practice-changing, but it does compel us to continue research efforts to improve surgical morbidity, identify better adjuvant and advanced disease regimens, and consider neoadjuvant treatment so that more than 72% of patients can receive all components of the multimodality treatment they need.
 

Dr. Lyss has been a community-based medical oncologist and clinical researcher for more than 35 years, practicing in St. Louis. His clinical and research interests are in the prevention, diagnosis, and treatment of breast and lung cancers and in expanding access to clinical trials to medically underserved populations.

In this edition of “How I will treat my next patient,” I examine two recently published efforts to enlighten our sensitivity to the seriousness of immune-related adverse events (IrAEs) in patients on immune checkpoint inhibitors (ICIs) and the effect of delays in initiating systemic adjuvant therapy on the long-term outcomes of patients with resected pancreatic cancer.

IrAEs requiring hospitalization

Investigators led by Aanika Balaji of the Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins University, Baltimore, reviewed a 6-month audit of inpatient oncology admissions of solid-tumor patients who had ever received ICIs and ascertained the prevalence of hospitalization for management of IrAEs (J Oncol Pract. 2019 Aug 6. doi: 10.1200/JOP.18.00703). To determine that an IrAE had occurred they required: consensus among two oncologists, clinical improvement with immune-directed therapy, exclusion of alternative diagnoses or pathologic confirmation of an IrAE, or chronic management of an IrAE for more than 6 months.

The bottom line: They found a cumulative incidence of a confirmed IrAEs among hospitalized ICI-treated solid tumor patients of 23%. As expected, the majority (65%) were grade 3-4 in severity. In total, 91% required multidisciplinary management, and 65% improved or resolved. But 87% of patients never received an ICI again.

Patients with preexisting autoimmune disease (25% of patients, although they included hypothyroidism in that group) were not more vulnerable to an IrAE with ICI therapy (odds ratio, 1.0; 95% confidence interval, 0.3-4.0). Not unsurprisingly, the median age was higher for ICI-treated patients who were admitted for IrAEs than for those not admitted (68 years vs. 59 years; OR, 5.4; 95% CI, 1.6-17.8), and more admitted patients had received combination ICIs than single agents (OR, 6.8; 95% CI, 2.0-23.2).

The median time from beginning ICIs to an IrAE-related hospitalization was 64 days, and the median number of ICI doses was one, with a wide range for both days and doses. The authors were quick to comment that this is a small, academic, single-institution survey over a brief period of time and that the generalizability of the results is uncertain.

What this means in practice

This publication changes very little for most practicing oncologists, but it does reinforce that ICI therapy can cause unpredictable, severe IrAEs. Clinical markers for selecting patients at highest risk are imperfect. As with chemotherapy, the patients we worry about the most – older individuals and patients treated with drug combinations – are, in fact, the ones we should be worrying about the most.

In view of the potential severity and impact of IrAEs, research efforts should place equal priority on identifying biomarkers of toxicity, such as tumor mutation burden, and biomarkers of efficacy (JAMA Oncol. 2019 Aug 22. doi: 10.1001/jamaoncol.2019.3221). The potential financial and societal effects, as well as lost opportunity costs in the form of alternative therapies and early referral to hospice, demand no less, particularly in an era of value-based health care reimbursement.
 

Timing of adjuvant treatment

Sung Jun Ma, MD, department of radiation medicine at Roswell Park Comprehensive Cancer Center, Buffalo, N.Y., and colleagues analyzed data from the more than 7,500 stage I-II resected pancreatic cancer patients in the National Cancer Database, of whom more than 5,400 ultimately received adjuvant therapy (chemotherapy with or without radiation). The patients were treated during 2004-2015. Appropriately, the investigators focused on correlating survival duration with the interval between surgery and initiation of adjuvant therapy. Other endpoints would be hard to accurately measure and verify without detailed clinical information (JAMA Network Open. 2019 Aug 14. doi: 10.1001/jamanetworkopen.2019.9126).

They found that the best overall survival was associated with starting adjuvant treatment 28-59 days after surgery – not earlier (17% higher mortality) and not later (9% higher). Patients who did not start adjuvant treatment until more than 90 days post operatively still had an overall survival benefit (hazard ratio, 0.75; 95% confidence interval, 0.66-0.85; P less than .001), a more impressive hazard ratio than that seen for any particular interval between surgery and adjuvant treatment. Overall survival at 2 years was 47.2% versus 38% for the adjuvant therapy and surgery alone cohorts, respectively, with no overlap in the 95% confidence intervals.

As expected, longer delays to receive adjuvant treatment were associated with longer inpatient surgical stays, advanced age, black race, lower income, and a readmission for a postoperative complication within 30 days.

What this means in practice

This is another study that verifies that the patients we worry about most – older patients, those with a complicated recovery from surgery, and those with fewer supportive resources – are exactly the patients we should worry about most. It changes very little for most practicing oncologists. The analysis validates the importance of adjuvant therapy for patients who are able to receive it – whenever that is.

The data collection in this publication precedes recent improvements in adjuvant chemotherapy for resected pancreatic cancer, such as FOLFIRINOX or gemcitabine plus capecitabine. In an era of improved treatment, delays in initiating therapy may be less important since better treatment overcomes many prognostic variables that are significant for less effective therapy.

In my opinion, this large-data analysis is not really hypothesis-generating or practice-changing, but it does compel us to continue research efforts to improve surgical morbidity, identify better adjuvant and advanced disease regimens, and consider neoadjuvant treatment so that more than 72% of patients can receive all components of the multimodality treatment they need.
 

Dr. Lyss has been a community-based medical oncologist and clinical researcher for more than 35 years, practicing in St. Louis. His clinical and research interests are in the prevention, diagnosis, and treatment of breast and lung cancers and in expanding access to clinical trials to medically underserved populations.

When asked about my decision to choose pediatrics over the other specialty opportunities I was being offered, I have always answered that my choice was primarily based on my desire to work with children. That affinity certainly didn’t stem from my experience with my sister who is 7 years my junior. By her own admission, she was a bratty little thing and a major annoyance during my journey through adolescence. However, during the summers of high school and college I worked as a lifeguard, and one of my duties was to teach swimming classes. The joy and reward of watching children overcome their fear of the water and become competent swimmers left a positive impression, which was in stark contrast to the few classes of adult nonswimmers my coworkers and I taught. Our success rate with adults was pretty close to zero.

michaeljung/iStock/Getty Images Plus

If I was going to spend my time and effort becoming a physician, I decided I wanted to be working with patients with the high potential for positive change and ones who had yet to accumulate a several decades long list of bad health habits. I wanted to be practicing in situations well before the die had been cast.

With this background in mind, you can understand why I was drawn to a recent article in the Harvard Gazette titled “Social spending on kids yields the biggest bang for the buck,” by Clea Simon. The article describes a recent study by Opportunity Insights, a Harvard-based institute of policy analysts and social scientists (“A Unified Welfare Analysis of Government Policies” by Nathaniel Hendren, PhD, and Ben Sprung-Keyser). Using computer algorithms capable of mining large pools of data, the researchers looked at 133 government policy changes over the last 50 years and compared the long-term results of those changes by assessing dollars spent against those returned in the form of tax revenue.

The Harvard article quotes Dr. Hendren as saying, “The policies that have historically invested in kids tend to be the biggest bang for the buck.” This association was most impressive for children who came from lower-income families. This was especially true for programs that aimed at improving child health and increasing educational attainment.

Of course, these observations don’t come as a surprise to those of us who have accepted the challenge of improving the health of children. But it’s always nice to hear some new data that warms our hearts and reinforces our commitment to building healthy communities by focusing our efforts on its youngest members.

However, the paper did provide a finding that disappointed me. This big data analysis revealed that programs aimed at encouraging young people to attend college produced higher future earnings than did those focused on job training. I guess this shouldn’t be much of a surprise, but I believe we have been overemphasizing college track programs when we should be destigmatizing a career path in one of the trades. It may be that job training has been poorly done or at least not flexible enough to meet the changing demands of industry.

The investigators were surprised that their analysis demonstrated that policy changes targeted at children through their middle and high school years and even into college yielded return on investment at least as great if not greater than some successful preschool programs. Dr. Hendren responded to this finding by observing that “it’s never too late.” However, I think his comment deserves the loud and clear caveat, “as long as we are still talking about children.”

Dr. Wilkoff practiced primary care pediatrics in Brunswick, Maine, for nearly 40 years. He has authored several books on behavioral pediatrics, including “How to Say No to Your Toddler.” Email him at [email protected].

When asked about my decision to choose pediatrics over the other specialty opportunities I was being offered, I have always answered that my choice was primarily based on my desire to work with children. That affinity certainly didn’t stem from my experience with my sister who is 7 years my junior. By her own admission, she was a bratty little thing and a major annoyance during my journey through adolescence. However, during the summers of high school and college I worked as a lifeguard, and one of my duties was to teach swimming classes. The joy and reward of watching children overcome their fear of the water and become competent swimmers left a positive impression, which was in stark contrast to the few classes of adult nonswimmers my coworkers and I taught. Our success rate with adults was pretty close to zero.

michaeljung/iStock/Getty Images Plus

If I was going to spend my time and effort becoming a physician, I decided I wanted to be working with patients with the high potential for positive change and ones who had yet to accumulate a several decades long list of bad health habits. I wanted to be practicing in situations well before the die had been cast.

With this background in mind, you can understand why I was drawn to a recent article in the Harvard Gazette titled “Social spending on kids yields the biggest bang for the buck,” by Clea Simon. The article describes a recent study by Opportunity Insights, a Harvard-based institute of policy analysts and social scientists (“A Unified Welfare Analysis of Government Policies” by Nathaniel Hendren, PhD, and Ben Sprung-Keyser). Using computer algorithms capable of mining large pools of data, the researchers looked at 133 government policy changes over the last 50 years and compared the long-term results of those changes by assessing dollars spent against those returned in the form of tax revenue.

The Harvard article quotes Dr. Hendren as saying, “The policies that have historically invested in kids tend to be the biggest bang for the buck.” This association was most impressive for children who came from lower-income families. This was especially true for programs that aimed at improving child health and increasing educational attainment.

Of course, these observations don’t come as a surprise to those of us who have accepted the challenge of improving the health of children. But it’s always nice to hear some new data that warms our hearts and reinforces our commitment to building healthy communities by focusing our efforts on its youngest members.

However, the paper did provide a finding that disappointed me. This big data analysis revealed that programs aimed at encouraging young people to attend college produced higher future earnings than did those focused on job training. I guess this shouldn’t be much of a surprise, but I believe we have been overemphasizing college track programs when we should be destigmatizing a career path in one of the trades. It may be that job training has been poorly done or at least not flexible enough to meet the changing demands of industry.

The investigators were surprised that their analysis demonstrated that policy changes targeted at children through their middle and high school years and even into college yielded return on investment at least as great if not greater than some successful preschool programs. Dr. Hendren responded to this finding by observing that “it’s never too late.” However, I think his comment deserves the loud and clear caveat, “as long as we are still talking about children.”

Dr. Wilkoff practiced primary care pediatrics in Brunswick, Maine, for nearly 40 years. He has authored several books on behavioral pediatrics, including “How to Say No to Your Toddler.” Email him at [email protected].

When asked about my decision to choose pediatrics over the other specialty opportunities I was being offered, I have always answered that my choice was primarily based on my desire to work with children. That affinity certainly didn’t stem from my experience with my sister who is 7 years my junior. By her own admission, she was a bratty little thing and a major annoyance during my journey through adolescence. However, during the summers of high school and college I worked as a lifeguard, and one of my duties was to teach swimming classes. The joy and reward of watching children overcome their fear of the water and become competent swimmers left a positive impression, which was in stark contrast to the few classes of adult nonswimmers my coworkers and I taught. Our success rate with adults was pretty close to zero.

michaeljung/iStock/Getty Images Plus

If I was going to spend my time and effort becoming a physician, I decided I wanted to be working with patients with the high potential for positive change and ones who had yet to accumulate a several decades long list of bad health habits. I wanted to be practicing in situations well before the die had been cast.

With this background in mind, you can understand why I was drawn to a recent article in the Harvard Gazette titled “Social spending on kids yields the biggest bang for the buck,” by Clea Simon. The article describes a recent study by Opportunity Insights, a Harvard-based institute of policy analysts and social scientists (“A Unified Welfare Analysis of Government Policies” by Nathaniel Hendren, PhD, and Ben Sprung-Keyser). Using computer algorithms capable of mining large pools of data, the researchers looked at 133 government policy changes over the last 50 years and compared the long-term results of those changes by assessing dollars spent against those returned in the form of tax revenue.

The Harvard article quotes Dr. Hendren as saying, “The policies that have historically invested in kids tend to be the biggest bang for the buck.” This association was most impressive for children who came from lower-income families. This was especially true for programs that aimed at improving child health and increasing educational attainment.

Of course, these observations don’t come as a surprise to those of us who have accepted the challenge of improving the health of children. But it’s always nice to hear some new data that warms our hearts and reinforces our commitment to building healthy communities by focusing our efforts on its youngest members.

However, the paper did provide a finding that disappointed me. This big data analysis revealed that programs aimed at encouraging young people to attend college produced higher future earnings than did those focused on job training. I guess this shouldn’t be much of a surprise, but I believe we have been overemphasizing college track programs when we should be destigmatizing a career path in one of the trades. It may be that job training has been poorly done or at least not flexible enough to meet the changing demands of industry.

The investigators were surprised that their analysis demonstrated that policy changes targeted at children through their middle and high school years and even into college yielded return on investment at least as great if not greater than some successful preschool programs. Dr. Hendren responded to this finding by observing that “it’s never too late.” However, I think his comment deserves the loud and clear caveat, “as long as we are still talking about children.”

Dr. Wilkoff practiced primary care pediatrics in Brunswick, Maine, for nearly 40 years. He has authored several books on behavioral pediatrics, including “How to Say No to Your Toddler.” Email him at [email protected].

Many readers may be aware of large payments made by such companies as Johnson & Johnson to compensate women with a history of ovarian cancer who have claimed that perineal application of talc played a causative role in their cancer development. This column serves to review the purported role of perineal talc use in the development of ovarian cancer, and explore some of the pitfalls of observational science.

ThitareeSarmkasat/iStock/Getty Images Plus

Talc, a hydrated magnesium silicate, is the softest mineral on earth, and has been sold as a personal hygiene product for many decades. Perineal application of talc to sanitary pads, perineal skin, undergarments, and diapers has been a common practice to decrease friction, moisture build-up, and as a deodorant. Talc is chemically similar, although not identical, to asbestos and is geologically located in close proximity to the known carcinogen. In the 1970s, there were concerns raised regarding the possible contamination of cosmetic-grade talc with asbestos, which led to the development of asbestos-free forms of the substance. Given that a strong causal relationship had been established between asbestos exposure and lung and pleural cancers, there was concern that exposure to perineal talc might increase cancer risk.

In the 1980s, an association between perineal talc exposure and ovarian cancer was observed in a case-control study.¹ Since that time, multiple other observational studies, predominately case-control studies, have observed an increased ovarian cancer risk among users of perineal talc including the findings of a meta-analysis which estimated a 24%-39% increased risk for ovarian cancer among users.² Does this establish a causal relationship? For the purposes of legal cases, these associations are adequate. However, science demands a different standard when determining cause and effect.

It is not unusual to rely on observational studies to establish a causal relationship between exposure and disease when it is unethical to randomize subjects in a clinical trial to exposure of the potential harmful agent. This was the necessary methodology behind establishing that smoking causes lung cancer. Several factors must be present when relying on observational studies to establish plausible causation including an observable biologic mechanism, dose-effect response, temporal relationship, consistent effect observed in multiple study populations, and statistical strength of response. These elements should be present in a consistent and powerful enough way to balance the pitfalls of observational studies, namely biases.

A particularly problematic bias is one of recall bias, which plagues case-control studies. Case-control studies are a popular tool to measure a relationship between an exposure and a rare disease, because they are more feasible than the prospective, observational cohort studies that require very large study populations observed over very long periods of time to capture enough events of interest (in this case, cases of ovarian cancer). In case-control studies, researchers identify a cohort of patients with the outcome of interest (ovarian cancer) and compare this population to a control group of similar demographic features. They then survey directly or indirectly (through medical records) for the exposure of interest (perineal talc use).

Recall bias occurs when subjects who have the disease are more likely to have memory of exposure than do control subjects because of the natural instincts individuals have toward attribution. This is emphasized when there is public commentary, justified or not, about the potential risks of that exposure. Given the significant publicity that these lawsuits have had with companies that produced cosmetic talc, it is plausible that ovarian cancer survivors are more likely to remember and negatively attribute their talc exposure to their cancer than are subjects without cancer. Additionally, their memory of volume and duration of exposure generally is enhanced by the same pressures. The potential for this bias is eliminated in prospective, cohort observational studies such as the Women’s Health Initiative Observational Study which, among 61,576 women, half of whom reported perineal talc exposure, did not measure a difference in the development of ovarian cancers during their 12 years of mean follow-up.³

Given these inherent biases, how do studies examining the relationship between talc exposure and ovarian cancer stand up? The biologic mechanism of talc carcinogenesis is largely theoretical. As mentioned earlier, prior to the 1970s, there was some observed contamination of talc with asbestos likely caused by the geologic proximity of these minerals. Asbestos is a known carcinogen, and therefore possibly could be harmful if a contaminant of talc. However, it is not known if this level of contamination was enough to be achieve ovarian carcinogenesis. Most theories of talc carcinogenesis are based on foreign body inflammatory reaction via talc particle ascent through the genital tract. This is proposed to induce an inflammatory release of prostaglandins and cytokines, which could cause a mutagenic effect promoting carcinogenesis. The foreign body inflammatory mechanism is further supported by the observation of a decreased incidence of ovarian cancer after hysterectomy or tubal ligation.⁴ However, inconsistently, a protective effect of NSAIDs has not been observed in ovarian cancer.⁵

A recent meta-analysis, which reviewed 27 of the largest, best-quality observational studies, identified a dose-effect response with an increased risk for ovarian cancer with greater than 3,600 lifetime applications, compared with less than 3,600 applications.² The observed association between perineal talc exposure and increased risk of ovarian cancer appears to be consistent across a number of observational studies, including both case-control studies and prospective cohort studies (although somewhat mitigated in the latter). Additionally, there appears to be consistency in the finding that the risk is present for the epithelial subtypes of serous and endometrioid, but not mucinous or clear cell cancer. However, when considering the magnitude of effect, this remains somewhat small (odds ratio, 1.31; 95% confidence interval, 1.24-1.39) when compared with other better established carcinogenic relationships such as smoking and lung cancer where the hazard ratio is 12.12 (95% CI, 6.94-21.17).^2,6

If talc does not cause ovarian cancer, why would this association be observed at all? One explanation could be that talc use is a confounder for the true causative mechanism. A theoretical example of this would be if the genital microbiome (a subject we have reviewed previously in this column) was the true culprit. If a particular microbiome profile promotes both oncogenic change in the ovary while also causing vaginal discharge and odor, it might increase the likelihood that perineal talc use is reported in the history of these cancer patients. This is purely speculative, but it always is important to consider the potential for confounding variables when utilizing observational studies to attribute cause and effect.

Therefore, there is a consistently observed association between perineal talc application and ovarian cancer, however, the relationship does not appear to be strong enough, associated with a proven carcinogenic mechanism, or free from interfering recall bias such to definitively state that perineal talc exposure causes ovarian cancer. Given these findings, it is reasonable to recommend patients avoid the use of perineal talc application until further definitive safety evidence is provided. In the meantime, it should be noted that even though talc-containing products are not commercially labeled as carcinogens, many pharmaceutical and cosmetic companies have replaced the mineral talc with corn starch in their powders.
 

Dr. Rossi is assistant professor in the division of gynecologic oncology at the University of North Carolina at Chapel Hill. She had no relevant financial disclosures. Email her at [email protected].

References

1. Cancer. 1982 Jul 15;50(2):372-6.

2. Epidemiology. 2018 Jan;29(1):41-9.

3. J Natl Cancer Inst. 2014 Sep 10;106(9). pii: dju208.

4. Am J Epidemiol. 1991 Aug 15;134(4):362-9.

5. Int J Cancer. 2008 Jan 1;122(1):170-6.

6. J Natl Cancer Inst. 2018 Nov 1;110(11):1201-7.

Many readers may be aware of large payments made by such companies as Johnson & Johnson to compensate women with a history of ovarian cancer who have claimed that perineal application of talc played a causative role in their cancer development. This column serves to review the purported role of perineal talc use in the development of ovarian cancer, and explore some of the pitfalls of observational science.

ThitareeSarmkasat/iStock/Getty Images Plus

Talc, a hydrated magnesium silicate, is the softest mineral on earth, and has been sold as a personal hygiene product for many decades. Perineal application of talc to sanitary pads, perineal skin, undergarments, and diapers has been a common practice to decrease friction, moisture build-up, and as a deodorant. Talc is chemically similar, although not identical, to asbestos and is geologically located in close proximity to the known carcinogen. In the 1970s, there were concerns raised regarding the possible contamination of cosmetic-grade talc with asbestos, which led to the development of asbestos-free forms of the substance. Given that a strong causal relationship had been established between asbestos exposure and lung and pleural cancers, there was concern that exposure to perineal talc might increase cancer risk.

In the 1980s, an association between perineal talc exposure and ovarian cancer was observed in a case-control study.¹ Since that time, multiple other observational studies, predominately case-control studies, have observed an increased ovarian cancer risk among users of perineal talc including the findings of a meta-analysis which estimated a 24%-39% increased risk for ovarian cancer among users.² Does this establish a causal relationship? For the purposes of legal cases, these associations are adequate. However, science demands a different standard when determining cause and effect.

It is not unusual to rely on observational studies to establish a causal relationship between exposure and disease when it is unethical to randomize subjects in a clinical trial to exposure of the potential harmful agent. This was the necessary methodology behind establishing that smoking causes lung cancer. Several factors must be present when relying on observational studies to establish plausible causation including an observable biologic mechanism, dose-effect response, temporal relationship, consistent effect observed in multiple study populations, and statistical strength of response. These elements should be present in a consistent and powerful enough way to balance the pitfalls of observational studies, namely biases.

A particularly problematic bias is one of recall bias, which plagues case-control studies. Case-control studies are a popular tool to measure a relationship between an exposure and a rare disease, because they are more feasible than the prospective, observational cohort studies that require very large study populations observed over very long periods of time to capture enough events of interest (in this case, cases of ovarian cancer). In case-control studies, researchers identify a cohort of patients with the outcome of interest (ovarian cancer) and compare this population to a control group of similar demographic features. They then survey directly or indirectly (through medical records) for the exposure of interest (perineal talc use).

Recall bias occurs when subjects who have the disease are more likely to have memory of exposure than do control subjects because of the natural instincts individuals have toward attribution. This is emphasized when there is public commentary, justified or not, about the potential risks of that exposure. Given the significant publicity that these lawsuits have had with companies that produced cosmetic talc, it is plausible that ovarian cancer survivors are more likely to remember and negatively attribute their talc exposure to their cancer than are subjects without cancer. Additionally, their memory of volume and duration of exposure generally is enhanced by the same pressures. The potential for this bias is eliminated in prospective, cohort observational studies such as the Women’s Health Initiative Observational Study which, among 61,576 women, half of whom reported perineal talc exposure, did not measure a difference in the development of ovarian cancers during their 12 years of mean follow-up.³

Given these inherent biases, how do studies examining the relationship between talc exposure and ovarian cancer stand up? The biologic mechanism of talc carcinogenesis is largely theoretical. As mentioned earlier, prior to the 1970s, there was some observed contamination of talc with asbestos likely caused by the geologic proximity of these minerals. Asbestos is a known carcinogen, and therefore possibly could be harmful if a contaminant of talc. However, it is not known if this level of contamination was enough to be achieve ovarian carcinogenesis. Most theories of talc carcinogenesis are based on foreign body inflammatory reaction via talc particle ascent through the genital tract. This is proposed to induce an inflammatory release of prostaglandins and cytokines, which could cause a mutagenic effect promoting carcinogenesis. The foreign body inflammatory mechanism is further supported by the observation of a decreased incidence of ovarian cancer after hysterectomy or tubal ligation.⁴ However, inconsistently, a protective effect of NSAIDs has not been observed in ovarian cancer.⁵

A recent meta-analysis, which reviewed 27 of the largest, best-quality observational studies, identified a dose-effect response with an increased risk for ovarian cancer with greater than 3,600 lifetime applications, compared with less than 3,600 applications.² The observed association between perineal talc exposure and increased risk of ovarian cancer appears to be consistent across a number of observational studies, including both case-control studies and prospective cohort studies (although somewhat mitigated in the latter). Additionally, there appears to be consistency in the finding that the risk is present for the epithelial subtypes of serous and endometrioid, but not mucinous or clear cell cancer. However, when considering the magnitude of effect, this remains somewhat small (odds ratio, 1.31; 95% confidence interval, 1.24-1.39) when compared with other better established carcinogenic relationships such as smoking and lung cancer where the hazard ratio is 12.12 (95% CI, 6.94-21.17).^2,6

If talc does not cause ovarian cancer, why would this association be observed at all? One explanation could be that talc use is a confounder for the true causative mechanism. A theoretical example of this would be if the genital microbiome (a subject we have reviewed previously in this column) was the true culprit. If a particular microbiome profile promotes both oncogenic change in the ovary while also causing vaginal discharge and odor, it might increase the likelihood that perineal talc use is reported in the history of these cancer patients. This is purely speculative, but it always is important to consider the potential for confounding variables when utilizing observational studies to attribute cause and effect.

Therefore, there is a consistently observed association between perineal talc application and ovarian cancer, however, the relationship does not appear to be strong enough, associated with a proven carcinogenic mechanism, or free from interfering recall bias such to definitively state that perineal talc exposure causes ovarian cancer. Given these findings, it is reasonable to recommend patients avoid the use of perineal talc application until further definitive safety evidence is provided. In the meantime, it should be noted that even though talc-containing products are not commercially labeled as carcinogens, many pharmaceutical and cosmetic companies have replaced the mineral talc with corn starch in their powders.
 

Dr. Rossi is assistant professor in the division of gynecologic oncology at the University of North Carolina at Chapel Hill. She had no relevant financial disclosures. Email her at [email protected].

References

1. Cancer. 1982 Jul 15;50(2):372-6.

2. Epidemiology. 2018 Jan;29(1):41-9.

3. J Natl Cancer Inst. 2014 Sep 10;106(9). pii: dju208.

4. Am J Epidemiol. 1991 Aug 15;134(4):362-9.

5. Int J Cancer. 2008 Jan 1;122(1):170-6.

6. J Natl Cancer Inst. 2018 Nov 1;110(11):1201-7.

Many readers may be aware of large payments made by such companies as Johnson & Johnson to compensate women with a history of ovarian cancer who have claimed that perineal application of talc played a causative role in their cancer development. This column serves to review the purported role of perineal talc use in the development of ovarian cancer, and explore some of the pitfalls of observational science.

ThitareeSarmkasat/iStock/Getty Images Plus

Talc, a hydrated magnesium silicate, is the softest mineral on earth, and has been sold as a personal hygiene product for many decades. Perineal application of talc to sanitary pads, perineal skin, undergarments, and diapers has been a common practice to decrease friction, moisture build-up, and as a deodorant. Talc is chemically similar, although not identical, to asbestos and is geologically located in close proximity to the known carcinogen. In the 1970s, there were concerns raised regarding the possible contamination of cosmetic-grade talc with asbestos, which led to the development of asbestos-free forms of the substance. Given that a strong causal relationship had been established between asbestos exposure and lung and pleural cancers, there was concern that exposure to perineal talc might increase cancer risk.

In the 1980s, an association between perineal talc exposure and ovarian cancer was observed in a case-control study.¹ Since that time, multiple other observational studies, predominately case-control studies, have observed an increased ovarian cancer risk among users of perineal talc including the findings of a meta-analysis which estimated a 24%-39% increased risk for ovarian cancer among users.² Does this establish a causal relationship? For the purposes of legal cases, these associations are adequate. However, science demands a different standard when determining cause and effect.

It is not unusual to rely on observational studies to establish a causal relationship between exposure and disease when it is unethical to randomize subjects in a clinical trial to exposure of the potential harmful agent. This was the necessary methodology behind establishing that smoking causes lung cancer. Several factors must be present when relying on observational studies to establish plausible causation including an observable biologic mechanism, dose-effect response, temporal relationship, consistent effect observed in multiple study populations, and statistical strength of response. These elements should be present in a consistent and powerful enough way to balance the pitfalls of observational studies, namely biases.

A particularly problematic bias is one of recall bias, which plagues case-control studies. Case-control studies are a popular tool to measure a relationship between an exposure and a rare disease, because they are more feasible than the prospective, observational cohort studies that require very large study populations observed over very long periods of time to capture enough events of interest (in this case, cases of ovarian cancer). In case-control studies, researchers identify a cohort of patients with the outcome of interest (ovarian cancer) and compare this population to a control group of similar demographic features. They then survey directly or indirectly (through medical records) for the exposure of interest (perineal talc use).

Recall bias occurs when subjects who have the disease are more likely to have memory of exposure than do control subjects because of the natural instincts individuals have toward attribution. This is emphasized when there is public commentary, justified or not, about the potential risks of that exposure. Given the significant publicity that these lawsuits have had with companies that produced cosmetic talc, it is plausible that ovarian cancer survivors are more likely to remember and negatively attribute their talc exposure to their cancer than are subjects without cancer. Additionally, their memory of volume and duration of exposure generally is enhanced by the same pressures. The potential for this bias is eliminated in prospective, cohort observational studies such as the Women’s Health Initiative Observational Study which, among 61,576 women, half of whom reported perineal talc exposure, did not measure a difference in the development of ovarian cancers during their 12 years of mean follow-up.³

Given these inherent biases, how do studies examining the relationship between talc exposure and ovarian cancer stand up? The biologic mechanism of talc carcinogenesis is largely theoretical. As mentioned earlier, prior to the 1970s, there was some observed contamination of talc with asbestos likely caused by the geologic proximity of these minerals. Asbestos is a known carcinogen, and therefore possibly could be harmful if a contaminant of talc. However, it is not known if this level of contamination was enough to be achieve ovarian carcinogenesis. Most theories of talc carcinogenesis are based on foreign body inflammatory reaction via talc particle ascent through the genital tract. This is proposed to induce an inflammatory release of prostaglandins and cytokines, which could cause a mutagenic effect promoting carcinogenesis. The foreign body inflammatory mechanism is further supported by the observation of a decreased incidence of ovarian cancer after hysterectomy or tubal ligation.⁴ However, inconsistently, a protective effect of NSAIDs has not been observed in ovarian cancer.⁵

A recent meta-analysis, which reviewed 27 of the largest, best-quality observational studies, identified a dose-effect response with an increased risk for ovarian cancer with greater than 3,600 lifetime applications, compared with less than 3,600 applications.² The observed association between perineal talc exposure and increased risk of ovarian cancer appears to be consistent across a number of observational studies, including both case-control studies and prospective cohort studies (although somewhat mitigated in the latter). Additionally, there appears to be consistency in the finding that the risk is present for the epithelial subtypes of serous and endometrioid, but not mucinous or clear cell cancer. However, when considering the magnitude of effect, this remains somewhat small (odds ratio, 1.31; 95% confidence interval, 1.24-1.39) when compared with other better established carcinogenic relationships such as smoking and lung cancer where the hazard ratio is 12.12 (95% CI, 6.94-21.17).^2,6

If talc does not cause ovarian cancer, why would this association be observed at all? One explanation could be that talc use is a confounder for the true causative mechanism. A theoretical example of this would be if the genital microbiome (a subject we have reviewed previously in this column) was the true culprit. If a particular microbiome profile promotes both oncogenic change in the ovary while also causing vaginal discharge and odor, it might increase the likelihood that perineal talc use is reported in the history of these cancer patients. This is purely speculative, but it always is important to consider the potential for confounding variables when utilizing observational studies to attribute cause and effect.

Therefore, there is a consistently observed association between perineal talc application and ovarian cancer, however, the relationship does not appear to be strong enough, associated with a proven carcinogenic mechanism, or free from interfering recall bias such to definitively state that perineal talc exposure causes ovarian cancer. Given these findings, it is reasonable to recommend patients avoid the use of perineal talc application until further definitive safety evidence is provided. In the meantime, it should be noted that even though talc-containing products are not commercially labeled as carcinogens, many pharmaceutical and cosmetic companies have replaced the mineral talc with corn starch in their powders.
 

Dr. Rossi is assistant professor in the division of gynecologic oncology at the University of North Carolina at Chapel Hill. She had no relevant financial disclosures. Email her at [email protected].

References

1. Cancer. 1982 Jul 15;50(2):372-6.

2. Epidemiology. 2018 Jan;29(1):41-9.

3. J Natl Cancer Inst. 2014 Sep 10;106(9). pii: dju208.

4. Am J Epidemiol. 1991 Aug 15;134(4):362-9.

5. Int J Cancer. 2008 Jan 1;122(1):170-6.

6. J Natl Cancer Inst. 2018 Nov 1;110(11):1201-7.

PART I
Reports of sexual harassment and gender discrimination have dominated news headlines, and the #MeToo movement has brought the scope and severity of discriminatory behavior to the forefront of public consciousness. The #MeToo movement has raised national and global awareness of gender discrimination and sexual harassment in all industries and has given rise to Time’s Up initiative within health care.
Academic medicine has not been immune to workplace gender discrimination and sexual harassment as has been vastly reported in the literature and clearly documented in the 2018 National Academies of Sciences, Engineering, and Medicine report, which points out that … “the cumulative effect of sexual harassment is a significant and costly loss of talent in academic science, engineering, and medicine, which has consequences for advancing the nation’s economic and social well-being and its overall public health.”1 
With the increasing recognition that healthcare is an environment especially prone to inequality, gender discrimination and sexual discrimination, the Time’s Up national organization, supported by the Time’s Up Legal Defense Fund, launched the Time’s Up initiative for health care workers on March 1, 2019.2,3 The overarching goal of this initiative is to expose workplace inequalities; drive policy and legislative changes focused on equal pay, equal opportunity, and equal work environments; and support safe, fair, and dignified work for women in health care. 2,3
This article, presented over the next three issues of Vascular Specialist, will present data on the ongoing problem of sexual harassment in medicine, discuss why the problem is prevalent in academic medicine, and provide recommendations for mitigating the problem in our workplace.

Defining & Measuring Sexual Harassment
Although commonly referred to as “sex discrimination,” sexual harassment differs from sexual discrimination. Sex discrimination refers to an employees’ denial of civil rights, raises, job opportunities, employment or a demotion or other mistreatments based on sex. On the other hand, sexual harassment relates to behavior that is inappropriate or offensive. A 2018 report from the National Academies Press defined sexual harassment (a form of discrimination) as comprising three categories of behavior: gender harassment – verbal and nonverbal behaviors that convey hostility, objectification, exclusion, or second-class status about members of one sex; unwanted sexual attention – verbal or physical unwelcome sexual advances, which can include assault; and sexual coercion – when favorable professional or educational treatment is conditional based on sexual activity.1
During 1995-2016, more than 7,000 health care service employees filed claims of sexual harassment with the Equal Employment Opportunity Commission. While this number may seem large, the number of official reports severely undervalues the prevalence of sexual discrimination in U.S. health care.1 Prevalence is best determined using representative validated surveys that rely on firsthand experience or observation of the behavior(s) without requiring the respondent to label those behaviors.

Environments at Risk for Sexual Harassment 
Research reveals that academic settings in the fields of science exhibit characteristics that create high levels of risk for sexual harassment to occur. These environments historically are male dominated, tolerate sexually harassing behavior, and create a hierarchy in which men hold most of the positions of power and authority. Moreover, dependent relationships often exist between these gatekeepers and those subordinate to them, with gatekeepers directly influencing the career advancement of those subordinates.1
The greatest predictor of sexual harassment in the workplace is the organizational climate, which refers to the tolerance for sexual harassment and is measured on three elements: a lack of sanctions against offenders; a perceived risk to those who report sexually harassing behavior; and the perception that one’s report of sexually harassing behavior will not be taken seriously.1 Women are less likely to be directly harassed in environments that do not tolerate harassing behaviors or have a strong, clear, transparent consequence for these behaviors.  

Sexual Harassment in Academic Medicine
Academic medicine has the highest rate of gender and sexual harassment in the health care industry, with about 50% of female academic physicians reporting incidents of sexual harassment.1 A recent survey suggests that more than half (58%) of women surgeons experienced sexual harassment within just the previous year alone.4 The conditions that increase the risk of sexual harassment against women – male-dominated hierarchical environments and organizational tolerance of sexual harassment – still prevail in academic medicine. 
Higher-education environments are perceived as permissive environments in part because when targets report sexual harassment, they are retaliated against or there are few consequences for the perpetrator. Academic institutions are replete with cases in which the conduct of offenders is regarded as an open secret, but there are no sanctions for that bad behavior. These offenders often are perceived as superstars in their particular substantive area. Because they hold valued grants or national status within their specialty area, they often receive preferential treatment and are not held accountable for gender-biased and sexually harassing behavior. Interview data regarding sexual harassment in academic medicine reveals that interview respondents and other colleagues often know which individuals have a history of sexually harassing behavior. Both men and women warn colleagues of these perpetrators – knowing that calling out or reporting these behaviors is fruitless – and that the best manner for dealing with their behavior is to avoid or ignore it. This normalization of sexual harassment and gender bias was noted, unfortunately, to fuel similar behavior in new cohorts of medicine faculty.1 
Sexual harassment of women in academic medicine starts in medical school. Female medical students are significantly more likely to experience sexual harassment by faculty and staff than are graduate or undergraduate students. Sexual harassment continues into residency training with residency described as “breeding grounds for abusive behavior by superiors.”1 Interview studies report that both men and women trainees widely accept harassing behavior at this stage of their training. The expectation of abusive and grueling conditions during residency caused several respondents to view sexual harassment as part of a continuum that they were expected to endure. Female residents in surgery and emergency medicine are more likely to be harassed than those in other specialties because of the high value placed on a hierarchical and authoritative workplace. Once out of residency, the sexual harassment of women in the workplace continues. A recent meta-analysis reveals that 58% of women faculty experience sexual harassment at work. Academic medicine has the second-highest rate of sexual harassment, behind the military (69%), as compared with all other workplaces. Women physicians of color experience more harassment (as a combination of sexual and racial harassment) than do white women physicians.1 

Why Women Are Not Likely to Report Sexual Harassment
Only 25% of targets file formal reports with their employer, with even fewer taking claims to court. These numbers are even lower for women in the military and academic medicine, where formal reporting is the last resort for the victims. The reluctance to use formal reporting mechanisms is rooted in the “fear of blame, disbelief, inaction, retaliation, humiliation, ostracism, and the damage to one’s career and reputation.”1 Targets may perceive that there seem to be few benefits and high costs for reporting. Women and nonwhites often resist calling bad behavior “discrimination” because that increases their loss of control and victimhood.1 Women frequently perceive that grievance procedures favor the institution over the individual, and research has proven that women face retaliation, both professional and social, for speaking out. Furthermore, stark power differentials between the target and the perpetrator exacerbate the reluctance to report and the fear of retaliation. The overall effects can be long lasting. 

References:
1. National Academies of Sciences, Engineering, and Medicine. Sexual Harassment of Women: Climate, Culture, and Consequences in Academic Sciences, Engineering, and Medicine. The National Academies Press, Washington, DC; 2018. doi. 10.17226/24994.
2. Choo EK et al. From #MeToo to #TimesUp in Health Care: Can a Culture of Accountability End Inequity and Harassment? Lancet. 2019 Feb 9;393(10171):499-502.
3. Choo EK et al. Time’s Up for Medicine? Only Time Will Tell. N Engl J Med. 2018 Oct 25;379(17):1592-3.
4. Medicine Has Its Own #MeToo Problems. Can Time’s Up Healthcare Fix It? 

Dr. Mitchell is a vascular surgeon at Salem (Ore.) Hospital; Dr. Drudi is as vascular surgery resident at McGill University, Montreal; Dr. Brown is a professor of surgery at the Medical College of Wisconsin. Milwaukee; Dr. Sachdev-Ost is an associate professor of surgery at the University of Pittsburgh Medical Center.

PART I
Reports of sexual harassment and gender discrimination have dominated news headlines, and the #MeToo movement has brought the scope and severity of discriminatory behavior to the forefront of public consciousness. The #MeToo movement has raised national and global awareness of gender discrimination and sexual harassment in all industries and has given rise to Time’s Up initiative within health care.
Academic medicine has not been immune to workplace gender discrimination and sexual harassment as has been vastly reported in the literature and clearly documented in the 2018 National Academies of Sciences, Engineering, and Medicine report, which points out that … “the cumulative effect of sexual harassment is a significant and costly loss of talent in academic science, engineering, and medicine, which has consequences for advancing the nation’s economic and social well-being and its overall public health.”1 
With the increasing recognition that healthcare is an environment especially prone to inequality, gender discrimination and sexual discrimination, the Time’s Up national organization, supported by the Time’s Up Legal Defense Fund, launched the Time’s Up initiative for health care workers on March 1, 2019.2,3 The overarching goal of this initiative is to expose workplace inequalities; drive policy and legislative changes focused on equal pay, equal opportunity, and equal work environments; and support safe, fair, and dignified work for women in health care. 2,3
This article, presented over the next three issues of Vascular Specialist, will present data on the ongoing problem of sexual harassment in medicine, discuss why the problem is prevalent in academic medicine, and provide recommendations for mitigating the problem in our workplace.

Defining & Measuring Sexual Harassment
Although commonly referred to as “sex discrimination,” sexual harassment differs from sexual discrimination. Sex discrimination refers to an employees’ denial of civil rights, raises, job opportunities, employment or a demotion or other mistreatments based on sex. On the other hand, sexual harassment relates to behavior that is inappropriate or offensive. A 2018 report from the National Academies Press defined sexual harassment (a form of discrimination) as comprising three categories of behavior: gender harassment – verbal and nonverbal behaviors that convey hostility, objectification, exclusion, or second-class status about members of one sex; unwanted sexual attention – verbal or physical unwelcome sexual advances, which can include assault; and sexual coercion – when favorable professional or educational treatment is conditional based on sexual activity.1
During 1995-2016, more than 7,000 health care service employees filed claims of sexual harassment with the Equal Employment Opportunity Commission. While this number may seem large, the number of official reports severely undervalues the prevalence of sexual discrimination in U.S. health care.1 Prevalence is best determined using representative validated surveys that rely on firsthand experience or observation of the behavior(s) without requiring the respondent to label those behaviors.

Environments at Risk for Sexual Harassment 
Research reveals that academic settings in the fields of science exhibit characteristics that create high levels of risk for sexual harassment to occur. These environments historically are male dominated, tolerate sexually harassing behavior, and create a hierarchy in which men hold most of the positions of power and authority. Moreover, dependent relationships often exist between these gatekeepers and those subordinate to them, with gatekeepers directly influencing the career advancement of those subordinates.1
The greatest predictor of sexual harassment in the workplace is the organizational climate, which refers to the tolerance for sexual harassment and is measured on three elements: a lack of sanctions against offenders; a perceived risk to those who report sexually harassing behavior; and the perception that one’s report of sexually harassing behavior will not be taken seriously.1 Women are less likely to be directly harassed in environments that do not tolerate harassing behaviors or have a strong, clear, transparent consequence for these behaviors.  

Sexual Harassment in Academic Medicine
Academic medicine has the highest rate of gender and sexual harassment in the health care industry, with about 50% of female academic physicians reporting incidents of sexual harassment.1 A recent survey suggests that more than half (58%) of women surgeons experienced sexual harassment within just the previous year alone.4 The conditions that increase the risk of sexual harassment against women – male-dominated hierarchical environments and organizational tolerance of sexual harassment – still prevail in academic medicine. 
Higher-education environments are perceived as permissive environments in part because when targets report sexual harassment, they are retaliated against or there are few consequences for the perpetrator. Academic institutions are replete with cases in which the conduct of offenders is regarded as an open secret, but there are no sanctions for that bad behavior. These offenders often are perceived as superstars in their particular substantive area. Because they hold valued grants or national status within their specialty area, they often receive preferential treatment and are not held accountable for gender-biased and sexually harassing behavior. Interview data regarding sexual harassment in academic medicine reveals that interview respondents and other colleagues often know which individuals have a history of sexually harassing behavior. Both men and women warn colleagues of these perpetrators – knowing that calling out or reporting these behaviors is fruitless – and that the best manner for dealing with their behavior is to avoid or ignore it. This normalization of sexual harassment and gender bias was noted, unfortunately, to fuel similar behavior in new cohorts of medicine faculty.1 
Sexual harassment of women in academic medicine starts in medical school. Female medical students are significantly more likely to experience sexual harassment by faculty and staff than are graduate or undergraduate students. Sexual harassment continues into residency training with residency described as “breeding grounds for abusive behavior by superiors.”1 Interview studies report that both men and women trainees widely accept harassing behavior at this stage of their training. The expectation of abusive and grueling conditions during residency caused several respondents to view sexual harassment as part of a continuum that they were expected to endure. Female residents in surgery and emergency medicine are more likely to be harassed than those in other specialties because of the high value placed on a hierarchical and authoritative workplace. Once out of residency, the sexual harassment of women in the workplace continues. A recent meta-analysis reveals that 58% of women faculty experience sexual harassment at work. Academic medicine has the second-highest rate of sexual harassment, behind the military (69%), as compared with all other workplaces. Women physicians of color experience more harassment (as a combination of sexual and racial harassment) than do white women physicians.1 

Why Women Are Not Likely to Report Sexual Harassment
Only 25% of targets file formal reports with their employer, with even fewer taking claims to court. These numbers are even lower for women in the military and academic medicine, where formal reporting is the last resort for the victims. The reluctance to use formal reporting mechanisms is rooted in the “fear of blame, disbelief, inaction, retaliation, humiliation, ostracism, and the damage to one’s career and reputation.”1 Targets may perceive that there seem to be few benefits and high costs for reporting. Women and nonwhites often resist calling bad behavior “discrimination” because that increases their loss of control and victimhood.1 Women frequently perceive that grievance procedures favor the institution over the individual, and research has proven that women face retaliation, both professional and social, for speaking out. Furthermore, stark power differentials between the target and the perpetrator exacerbate the reluctance to report and the fear of retaliation. The overall effects can be long lasting. 

References:
1. National Academies of Sciences, Engineering, and Medicine. Sexual Harassment of Women: Climate, Culture, and Consequences in Academic Sciences, Engineering, and Medicine. The National Academies Press, Washington, DC; 2018. doi. 10.17226/24994.
2. Choo EK et al. From #MeToo to #TimesUp in Health Care: Can a Culture of Accountability End Inequity and Harassment? Lancet. 2019 Feb 9;393(10171):499-502.
3. Choo EK et al. Time’s Up for Medicine? Only Time Will Tell. N Engl J Med. 2018 Oct 25;379(17):1592-3.
4. Medicine Has Its Own #MeToo Problems. Can Time’s Up Healthcare Fix It? 

Dr. Mitchell is a vascular surgeon at Salem (Ore.) Hospital; Dr. Drudi is as vascular surgery resident at McGill University, Montreal; Dr. Brown is a professor of surgery at the Medical College of Wisconsin. Milwaukee; Dr. Sachdev-Ost is an associate professor of surgery at the University of Pittsburgh Medical Center.

PART I
Reports of sexual harassment and gender discrimination have dominated news headlines, and the #MeToo movement has brought the scope and severity of discriminatory behavior to the forefront of public consciousness. The #MeToo movement has raised national and global awareness of gender discrimination and sexual harassment in all industries and has given rise to Time’s Up initiative within health care.
Academic medicine has not been immune to workplace gender discrimination and sexual harassment as has been vastly reported in the literature and clearly documented in the 2018 National Academies of Sciences, Engineering, and Medicine report, which points out that … “the cumulative effect of sexual harassment is a significant and costly loss of talent in academic science, engineering, and medicine, which has consequences for advancing the nation’s economic and social well-being and its overall public health.”1 
With the increasing recognition that healthcare is an environment especially prone to inequality, gender discrimination and sexual discrimination, the Time’s Up national organization, supported by the Time’s Up Legal Defense Fund, launched the Time’s Up initiative for health care workers on March 1, 2019.2,3 The overarching goal of this initiative is to expose workplace inequalities; drive policy and legislative changes focused on equal pay, equal opportunity, and equal work environments; and support safe, fair, and dignified work for women in health care. 2,3
This article, presented over the next three issues of Vascular Specialist, will present data on the ongoing problem of sexual harassment in medicine, discuss why the problem is prevalent in academic medicine, and provide recommendations for mitigating the problem in our workplace.

Defining & Measuring Sexual Harassment
Although commonly referred to as “sex discrimination,” sexual harassment differs from sexual discrimination. Sex discrimination refers to an employees’ denial of civil rights, raises, job opportunities, employment or a demotion or other mistreatments based on sex. On the other hand, sexual harassment relates to behavior that is inappropriate or offensive. A 2018 report from the National Academies Press defined sexual harassment (a form of discrimination) as comprising three categories of behavior: gender harassment – verbal and nonverbal behaviors that convey hostility, objectification, exclusion, or second-class status about members of one sex; unwanted sexual attention – verbal or physical unwelcome sexual advances, which can include assault; and sexual coercion – when favorable professional or educational treatment is conditional based on sexual activity.1
During 1995-2016, more than 7,000 health care service employees filed claims of sexual harassment with the Equal Employment Opportunity Commission. While this number may seem large, the number of official reports severely undervalues the prevalence of sexual discrimination in U.S. health care.1 Prevalence is best determined using representative validated surveys that rely on firsthand experience or observation of the behavior(s) without requiring the respondent to label those behaviors.

Environments at Risk for Sexual Harassment 
Research reveals that academic settings in the fields of science exhibit characteristics that create high levels of risk for sexual harassment to occur. These environments historically are male dominated, tolerate sexually harassing behavior, and create a hierarchy in which men hold most of the positions of power and authority. Moreover, dependent relationships often exist between these gatekeepers and those subordinate to them, with gatekeepers directly influencing the career advancement of those subordinates.1
The greatest predictor of sexual harassment in the workplace is the organizational climate, which refers to the tolerance for sexual harassment and is measured on three elements: a lack of sanctions against offenders; a perceived risk to those who report sexually harassing behavior; and the perception that one’s report of sexually harassing behavior will not be taken seriously.1 Women are less likely to be directly harassed in environments that do not tolerate harassing behaviors or have a strong, clear, transparent consequence for these behaviors.  

Sexual Harassment in Academic Medicine
Academic medicine has the highest rate of gender and sexual harassment in the health care industry, with about 50% of female academic physicians reporting incidents of sexual harassment.1 A recent survey suggests that more than half (58%) of women surgeons experienced sexual harassment within just the previous year alone.4 The conditions that increase the risk of sexual harassment against women – male-dominated hierarchical environments and organizational tolerance of sexual harassment – still prevail in academic medicine. 
Higher-education environments are perceived as permissive environments in part because when targets report sexual harassment, they are retaliated against or there are few consequences for the perpetrator. Academic institutions are replete with cases in which the conduct of offenders is regarded as an open secret, but there are no sanctions for that bad behavior. These offenders often are perceived as superstars in their particular substantive area. Because they hold valued grants or national status within their specialty area, they often receive preferential treatment and are not held accountable for gender-biased and sexually harassing behavior. Interview data regarding sexual harassment in academic medicine reveals that interview respondents and other colleagues often know which individuals have a history of sexually harassing behavior. Both men and women warn colleagues of these perpetrators – knowing that calling out or reporting these behaviors is fruitless – and that the best manner for dealing with their behavior is to avoid or ignore it. This normalization of sexual harassment and gender bias was noted, unfortunately, to fuel similar behavior in new cohorts of medicine faculty.1 
Sexual harassment of women in academic medicine starts in medical school. Female medical students are significantly more likely to experience sexual harassment by faculty and staff than are graduate or undergraduate students. Sexual harassment continues into residency training with residency described as “breeding grounds for abusive behavior by superiors.”1 Interview studies report that both men and women trainees widely accept harassing behavior at this stage of their training. The expectation of abusive and grueling conditions during residency caused several respondents to view sexual harassment as part of a continuum that they were expected to endure. Female residents in surgery and emergency medicine are more likely to be harassed than those in other specialties because of the high value placed on a hierarchical and authoritative workplace. Once out of residency, the sexual harassment of women in the workplace continues. A recent meta-analysis reveals that 58% of women faculty experience sexual harassment at work. Academic medicine has the second-highest rate of sexual harassment, behind the military (69%), as compared with all other workplaces. Women physicians of color experience more harassment (as a combination of sexual and racial harassment) than do white women physicians.1 

Why Women Are Not Likely to Report Sexual Harassment
Only 25% of targets file formal reports with their employer, with even fewer taking claims to court. These numbers are even lower for women in the military and academic medicine, where formal reporting is the last resort for the victims. The reluctance to use formal reporting mechanisms is rooted in the “fear of blame, disbelief, inaction, retaliation, humiliation, ostracism, and the damage to one’s career and reputation.”1 Targets may perceive that there seem to be few benefits and high costs for reporting. Women and nonwhites often resist calling bad behavior “discrimination” because that increases their loss of control and victimhood.1 Women frequently perceive that grievance procedures favor the institution over the individual, and research has proven that women face retaliation, both professional and social, for speaking out. Furthermore, stark power differentials between the target and the perpetrator exacerbate the reluctance to report and the fear of retaliation. The overall effects can be long lasting. 

References:
1. National Academies of Sciences, Engineering, and Medicine. Sexual Harassment of Women: Climate, Culture, and Consequences in Academic Sciences, Engineering, and Medicine. The National Academies Press, Washington, DC; 2018. doi. 10.17226/24994.
2. Choo EK et al. From #MeToo to #TimesUp in Health Care: Can a Culture of Accountability End Inequity and Harassment? Lancet. 2019 Feb 9;393(10171):499-502.
3. Choo EK et al. Time’s Up for Medicine? Only Time Will Tell. N Engl J Med. 2018 Oct 25;379(17):1592-3.
4. Medicine Has Its Own #MeToo Problems. Can Time’s Up Healthcare Fix It? 

Dr. Mitchell is a vascular surgeon at Salem (Ore.) Hospital; Dr. Drudi is as vascular surgery resident at McGill University, Montreal; Dr. Brown is a professor of surgery at the Medical College of Wisconsin. Milwaukee; Dr. Sachdev-Ost is an associate professor of surgery at the University of Pittsburgh Medical Center.

I read with cautious optimism the Diversity Pledge and No–All Male Panel Policy recently announced by the Lancet Group.¹ This initiative comes at a crucial time, on the heels of a renewed interest and attention to gender inequities in medicine.

Despite 50-year-old federal legislation mandating that men and women receive equal compensation for equal work, pay inequities persist in all aspects of the workforce and medicine is no exception. In 2018, the American College of Physicians published a position paper acknowledging that, despite an increase in women in the active physician workforce and training positions, our numbers remain disproportionately low in leadership positions, with a mediocre track record for career advancement.² Inadequate mentorship, discrimination, gender bias, imposter syndrome and a lack of work-life integration have all been cited as contributing to the problem.

Consensus and commitment statements are important first steps in legitimizing a problem, but they do not always engender change. They run the risk of creating an “illusion of fairness” that lulls us into a sense of complacency that change is coming and yet it never does. This is why the Lancet Group’s pledge is so remarkable in its scope. Less than a year after the timely ACP position paper, the Lancet Group published a theme issue addressing the systematic concerns surrounding gender bias in medicine.

Recognizing that publications are prime currency in medicine, the Lancet Group has declared its commitment to increase the representation of women, minorities, and underrepresented geographic areas in editorial boards, peer review, and authorship. Since their #LancetWomen issue, 8 of their 18 journals have refreshed their editorial boards to include at least 50% female membership, with a goal of all 18 journals achieving this landmark by year’s end. That this change is being catapulted by a major publishing group suggests that a necessary cultural transformation is underway.

Today, women are entering the medical field in equal numbers to men. While some may argue that we have achieved gender diversity in medicine, we must not confuse this with gender equity, which remains a distant goal. This is a ripe time in medicine. We have momentum and an opportunity for change.

In an editorial comment to the ACP position paper, Molly Carnes, MD, drew an analogy to the Surgeon General’s report in 1964, which announced that smoking was detrimental to health. The report legitimized the already overwhelming evidence that smoking negatively impacted clinical outcomes and it served as a trigger to propel change.³ Similarly, we hope the ACP position has legitimized the research highlighting gender disparities in medicine and that the Lancet Group’s initiative is among the first of many changes to come.

This change must be embraced and executed by leadership across medical schools, universities, and professional societies. We must collectively pursue interventions and solutions to the multifaceted problem of gender inequity. After all, women have become an integral part of the medical workforce and we all need to work together to ensure both genders have sustainable careers.

Dr. Sosa is a benign hematologist at Fox Chase Cancer Center in Philadelphia. Her research interests are in thromboembolic disease, with a focus in racial and gender disparities.

References

1. Lancet. 2019 Aug 10; 394(10197): 452-3.

2. Ann Intern Med. 2018 May 15;168(10):721-3.

3. Ann Intern Med. 2018 May 15;168(10):741-3.

I read with cautious optimism the Diversity Pledge and No–All Male Panel Policy recently announced by the Lancet Group.¹ This initiative comes at a crucial time, on the heels of a renewed interest and attention to gender inequities in medicine.

Despite 50-year-old federal legislation mandating that men and women receive equal compensation for equal work, pay inequities persist in all aspects of the workforce and medicine is no exception. In 2018, the American College of Physicians published a position paper acknowledging that, despite an increase in women in the active physician workforce and training positions, our numbers remain disproportionately low in leadership positions, with a mediocre track record for career advancement.² Inadequate mentorship, discrimination, gender bias, imposter syndrome and a lack of work-life integration have all been cited as contributing to the problem.

Consensus and commitment statements are important first steps in legitimizing a problem, but they do not always engender change. They run the risk of creating an “illusion of fairness” that lulls us into a sense of complacency that change is coming and yet it never does. This is why the Lancet Group’s pledge is so remarkable in its scope. Less than a year after the timely ACP position paper, the Lancet Group published a theme issue addressing the systematic concerns surrounding gender bias in medicine.

Recognizing that publications are prime currency in medicine, the Lancet Group has declared its commitment to increase the representation of women, minorities, and underrepresented geographic areas in editorial boards, peer review, and authorship. Since their #LancetWomen issue, 8 of their 18 journals have refreshed their editorial boards to include at least 50% female membership, with a goal of all 18 journals achieving this landmark by year’s end. That this change is being catapulted by a major publishing group suggests that a necessary cultural transformation is underway.

Today, women are entering the medical field in equal numbers to men. While some may argue that we have achieved gender diversity in medicine, we must not confuse this with gender equity, which remains a distant goal. This is a ripe time in medicine. We have momentum and an opportunity for change.

In an editorial comment to the ACP position paper, Molly Carnes, MD, drew an analogy to the Surgeon General’s report in 1964, which announced that smoking was detrimental to health. The report legitimized the already overwhelming evidence that smoking negatively impacted clinical outcomes and it served as a trigger to propel change.³ Similarly, we hope the ACP position has legitimized the research highlighting gender disparities in medicine and that the Lancet Group’s initiative is among the first of many changes to come.

This change must be embraced and executed by leadership across medical schools, universities, and professional societies. We must collectively pursue interventions and solutions to the multifaceted problem of gender inequity. After all, women have become an integral part of the medical workforce and we all need to work together to ensure both genders have sustainable careers.

Dr. Sosa is a benign hematologist at Fox Chase Cancer Center in Philadelphia. Her research interests are in thromboembolic disease, with a focus in racial and gender disparities.

References

1. Lancet. 2019 Aug 10; 394(10197): 452-3.

2. Ann Intern Med. 2018 May 15;168(10):721-3.

3. Ann Intern Med. 2018 May 15;168(10):741-3.

I read with cautious optimism the Diversity Pledge and No–All Male Panel Policy recently announced by the Lancet Group.¹ This initiative comes at a crucial time, on the heels of a renewed interest and attention to gender inequities in medicine.

Despite 50-year-old federal legislation mandating that men and women receive equal compensation for equal work, pay inequities persist in all aspects of the workforce and medicine is no exception. In 2018, the American College of Physicians published a position paper acknowledging that, despite an increase in women in the active physician workforce and training positions, our numbers remain disproportionately low in leadership positions, with a mediocre track record for career advancement.² Inadequate mentorship, discrimination, gender bias, imposter syndrome and a lack of work-life integration have all been cited as contributing to the problem.

Consensus and commitment statements are important first steps in legitimizing a problem, but they do not always engender change. They run the risk of creating an “illusion of fairness” that lulls us into a sense of complacency that change is coming and yet it never does. This is why the Lancet Group’s pledge is so remarkable in its scope. Less than a year after the timely ACP position paper, the Lancet Group published a theme issue addressing the systematic concerns surrounding gender bias in medicine.

Recognizing that publications are prime currency in medicine, the Lancet Group has declared its commitment to increase the representation of women, minorities, and underrepresented geographic areas in editorial boards, peer review, and authorship. Since their #LancetWomen issue, 8 of their 18 journals have refreshed their editorial boards to include at least 50% female membership, with a goal of all 18 journals achieving this landmark by year’s end. That this change is being catapulted by a major publishing group suggests that a necessary cultural transformation is underway.

Today, women are entering the medical field in equal numbers to men. While some may argue that we have achieved gender diversity in medicine, we must not confuse this with gender equity, which remains a distant goal. This is a ripe time in medicine. We have momentum and an opportunity for change.

In an editorial comment to the ACP position paper, Molly Carnes, MD, drew an analogy to the Surgeon General’s report in 1964, which announced that smoking was detrimental to health. The report legitimized the already overwhelming evidence that smoking negatively impacted clinical outcomes and it served as a trigger to propel change.³ Similarly, we hope the ACP position has legitimized the research highlighting gender disparities in medicine and that the Lancet Group’s initiative is among the first of many changes to come.

This change must be embraced and executed by leadership across medical schools, universities, and professional societies. We must collectively pursue interventions and solutions to the multifaceted problem of gender inequity. After all, women have become an integral part of the medical workforce and we all need to work together to ensure both genders have sustainable careers.

Dr. Sosa is a benign hematologist at Fox Chase Cancer Center in Philadelphia. Her research interests are in thromboembolic disease, with a focus in racial and gender disparities.

References

1. Lancet. 2019 Aug 10; 394(10197): 452-3.

2. Ann Intern Med. 2018 May 15;168(10):721-3.

3. Ann Intern Med. 2018 May 15;168(10):741-3.