Commentary

By nature, my wife and I are risk-averse people. Our investment strategy is just a few baby steps short of hiding our money under the mattress. We have never tried marijuana, though to some extent this is because we were out of college and already married when its popularity surged across this country’s campuses. We do drink alcohol, which was so ubiquitous when we were teenagers that it seemed innocuous.

Given my personality, you can understand why I have trouble understanding why anyone would ever try heroin or any opiate. I realize that many of the young addicts don’t follow the news closely enough to realize the risks. But the epidemic of addiction is so entrenched here in rural Maine that they must have known someone who has died of an overdose.

By nature, my wife and I are risk-averse people. Our investment strategy is just a few baby steps short of hiding our money under the mattress. We have never tried marijuana, though to some extent this is because we were out of college and already married when its popularity surged across this country’s campuses. We do drink alcohol, which was so ubiquitous when we were teenagers that it seemed innocuous.

Given my personality, you can understand why I have trouble understanding why anyone would ever try heroin or any opiate. I realize that many of the young addicts don’t follow the news closely enough to realize the risks. But the epidemic of addiction is so entrenched here in rural Maine that they must have known someone who has died of an overdose.

By nature, my wife and I are risk-averse people. Our investment strategy is just a few baby steps short of hiding our money under the mattress. We have never tried marijuana, though to some extent this is because we were out of college and already married when its popularity surged across this country’s campuses. We do drink alcohol, which was so ubiquitous when we were teenagers that it seemed innocuous.

Given my personality, you can understand why I have trouble understanding why anyone would ever try heroin or any opiate. I realize that many of the young addicts don’t follow the news closely enough to realize the risks. But the epidemic of addiction is so entrenched here in rural Maine that they must have known someone who has died of an overdose.

Do we stand by our Hippocratic Oath when providing physician-assisted suicide?

Physician-assisted suicide (PAS) is a form of euthanasia in which a physician provides the patient with the pertinent information, and, in certain cases, a prescription for the necessary lethal drugs, so that the individual can willingly and successfully terminate his or her own life. The justification for PAS is the compassionate relief of intractable human suffering. Euthanasia and PAS are accepted practices in European countries such as the Netherlands, Belgium, and Luxembourg.

Critical role of mental health workers

Although PAS has been legalized in those five U.S. states, its support and cases have stalled in recent years, indicating serious ethical concerns, mostly because of multileveled challenges of combating and delineating cultural stereotypes, quantifying mental capacity, gauging quality of life, and deciding where to situate psychiatrists in the PAS decision.

The psychiatrist’s role is being debated. In the United States, opponents take issue with current PAS-legal state’s legislation regarding psychiatric evaluations. For example, Oregon stipulates a psychiatrist referral only in cases where a physician other than a psychiatrist believes the patient’s judgment is impaired. It’s agreed that psychiatrists have the best skill set to assess a patient’s perceptions. Other PAS-legal states require a psychiatrist or psychologist assessment before making the decision. Unfortunately, though, physicians have rarely referred these patients to psychiatrists before offering PAS as an option.

PAS opponents target standards by which concepts like “quality of life” or “contributing member of society” are judged – specifically, that “unbearable suffering” and its ramifications are ill defined – people whose lives are deemed “not worth living” (including the terminally ill) would be susceptible to “sympathetic death” via PAS that might result from PAS legalization. Opponents also argue that recognizing a suicide “right” contradicts that a significant number of suicide attempters have mental illness and need help. They say that legalizing PAS would enable mentally incapacitated people to commit the irreversible act based on their distorted perceptions without providing them the expected assistance from their profession.¹

The use of euthanasia or PAS gradually is trending from physically terminally ill patients toward psychiatrically complex patients. There are cases in which euthanasia or PAS was requested by psychiatric patients who had chronic psychiatric, medical, and psychosocial histories rather than purely physical ailment histories. In one study, Scott Y. H. Kim, MD, PhD, and his associates reviewed cases in the Netherlands in which either euthanasia or PAS for psychiatric disorders was deployed. The granted PAS requests appeared to involve physician judgment without psychiatric input.

The study reviewed 66 cases: 55% of patients had chronic severe conditions with extensive histories of attempted suicides and psychiatric hospitalizations, demonstrating that the granted euthanasia and PAS requests had involved extensive evaluations. However, 11% of cases had no independent psychiatric input, and 24% involved disagreement among the physicians.² PAS proponents and opponents support the involvement and expertise of psychiatrists in all of this.

Psychiatrists have long contended that suicide attempts are often a “cry for help,” not an earnest act to end one’s life. Legalizing PAS tells suicidal individuals that society does not care whether they live or die – a truly un-Hippocratic stance. The stereotypes tossed around in the PAS debate, which could mean life or death, need to be unpacked with specific criteria attached, rather than preconceptions.
 

Autonomy of patients and implications of PAS

In the PAS debate, there are serious life concerns exhibited by terminally ill/psychiatrically ill patients over losing their autonomy and becoming a burden to their families and caregivers. Stereotypes must be deconstructed, yes, but such patients generally have been considered to be rendered, by the sum effect of their illnesses, mentally incapable of making the decision to end their lives. Addressing this order of patient life concerns generally has been the realm of social workers, psychologists, and, in the most desirable cases, psychiatrists. Therefore, even in keeping with established practice, some form of competent psychiatric evaluation should be required before considering PAS as a viable option.

The call for this requirement is backed up by a study, which reported that 47% of patients who had considered or committed suicide previously were diagnosed with psychiatric disorders, and 15% had undiagnosed psychiatric disorders.³ Also, inventories of thwarted suicide attempters reveal that most lack the conviction to end their lives, and this obverse phenomenon is backed by a study that revealed that 75% of 96 suicidal patients were found to be ambivalent in their intent to end their lives. Suicide attempters simply may be trying to communicate with people in their lives in order to test their love and care.⁴ This indicates that those who attempt suicide are predominantly psychiatrically ill and prone to distorted perceptions, impaired judgment, frustration, escapism, and manipulative guilt.

Suicide is abhorrent to most human beings’ sensibilities, because humanity has an innate will to live.⁵ It is wrong to offer patients life-ending options when they might rejuvenate or ease into death naturally. With the debilitated or elderly, PAS could violate their human rights. If the attitude that they are a burden to society persists, then a certain segment of society might be tempted to avoid their intergenerational obligations to elders, particularly those elders presenting with concurrent mental illnesses. PAS would additionally fuel that problem. This would represent a profound injustice and gross violation of human dignity, while also serving as a denial of basic human rights, particularly the right to life and care.⁶

Conclusion

The complex physical, psychological, and social challenges associated with PAS and the difficulty in enforcing its laws necessitate more adept alternatives. Instead of conditionally legalizing suicide, we should ease patient suffering with compassion and calibrated treatment.^6,7

Terminally ill patients often suffer from depression, affecting their rationality. Adequate counseling, medical care, and psychological care should be the response to terminally ill patients considering suicide. If society accepts that ending a life is a reasonable response to human suffering that could otherwise be treated or reversed, then those with the most serious psychiatric conditions are destined to become more vulnerable. Therefore, physicians and psychiatrists should instead work harder to help patients recover, rather than participating in their quest for death.

Simplistic legal and regulatory oversight is insufficient, because the questions evoked by PAS are complicated by life, death, and ethics. Further research is needed to look into the mechanisms and morality of how psychiatrists and other physicians will make judgments and recommendations that are vital elements in developing regulatory oversight on PAS. Finally, future studies should look at which practices have been successful and which might be deemed unethical.
 

References

1. Clin Med (Lond). 2010 Aug;109(4):323-5.

2. JAMA Psychiatry. 2016;73(4):362-8.

3. “The Final Months: A Study of the Lives of 134 Persons Who Committed Suicide,” New York: Oxford University Press, 1981.

4. “Why We Shouldn’t Legalize Assisting Suicide, Part I.” Department of Medical Ethics, National Right to Life Committee.

5. “Working with Suicidal Individuals: A Guide to Providing Understanding, Assessment and Support,” Philadelphia: Jessica Kingsley Publishers, 2010.

6. “Always Care, Never Kill: How Physician-Assisted Suicide Endangers the Weak, Corrupts Medicine, Compromises the Family, and Violates Human Dignity and Equality,” Washington: The Heritage Foundation, 2015.

7. Ann Intern Med. 2012 Jan 3;156(1 Pt 2):73-104.

Dr. Ahmed is a 2nd-year resident in the psychiatry & behavioral sciences department at the Nassau University Medical Center, New York. Over the last 3 years, he has published and presented papers at national and international forums. His interests include public social psychiatry, health care policy, health disparities, mental health stigma, and undiagnosed and overdiagnosed psychiatric illnesses in children. Dr. Ahmed is a member of the American Psychiatric Association, the American Society of Clinical Psychopharmacology, and the American Association for Social Psychiatry.

Do we stand by our Hippocratic Oath when providing physician-assisted suicide?

Physician-assisted suicide (PAS) is a form of euthanasia in which a physician provides the patient with the pertinent information, and, in certain cases, a prescription for the necessary lethal drugs, so that the individual can willingly and successfully terminate his or her own life. The justification for PAS is the compassionate relief of intractable human suffering. Euthanasia and PAS are accepted practices in European countries such as the Netherlands, Belgium, and Luxembourg.

Critical role of mental health workers

Although PAS has been legalized in those five U.S. states, its support and cases have stalled in recent years, indicating serious ethical concerns, mostly because of multileveled challenges of combating and delineating cultural stereotypes, quantifying mental capacity, gauging quality of life, and deciding where to situate psychiatrists in the PAS decision.

The psychiatrist’s role is being debated. In the United States, opponents take issue with current PAS-legal state’s legislation regarding psychiatric evaluations. For example, Oregon stipulates a psychiatrist referral only in cases where a physician other than a psychiatrist believes the patient’s judgment is impaired. It’s agreed that psychiatrists have the best skill set to assess a patient’s perceptions. Other PAS-legal states require a psychiatrist or psychologist assessment before making the decision. Unfortunately, though, physicians have rarely referred these patients to psychiatrists before offering PAS as an option.

PAS opponents target standards by which concepts like “quality of life” or “contributing member of society” are judged – specifically, that “unbearable suffering” and its ramifications are ill defined – people whose lives are deemed “not worth living” (including the terminally ill) would be susceptible to “sympathetic death” via PAS that might result from PAS legalization. Opponents also argue that recognizing a suicide “right” contradicts that a significant number of suicide attempters have mental illness and need help. They say that legalizing PAS would enable mentally incapacitated people to commit the irreversible act based on their distorted perceptions without providing them the expected assistance from their profession.¹

The use of euthanasia or PAS gradually is trending from physically terminally ill patients toward psychiatrically complex patients. There are cases in which euthanasia or PAS was requested by psychiatric patients who had chronic psychiatric, medical, and psychosocial histories rather than purely physical ailment histories. In one study, Scott Y. H. Kim, MD, PhD, and his associates reviewed cases in the Netherlands in which either euthanasia or PAS for psychiatric disorders was deployed. The granted PAS requests appeared to involve physician judgment without psychiatric input.

The study reviewed 66 cases: 55% of patients had chronic severe conditions with extensive histories of attempted suicides and psychiatric hospitalizations, demonstrating that the granted euthanasia and PAS requests had involved extensive evaluations. However, 11% of cases had no independent psychiatric input, and 24% involved disagreement among the physicians.² PAS proponents and opponents support the involvement and expertise of psychiatrists in all of this.

Psychiatrists have long contended that suicide attempts are often a “cry for help,” not an earnest act to end one’s life. Legalizing PAS tells suicidal individuals that society does not care whether they live or die – a truly un-Hippocratic stance. The stereotypes tossed around in the PAS debate, which could mean life or death, need to be unpacked with specific criteria attached, rather than preconceptions.
 

Autonomy of patients and implications of PAS

In the PAS debate, there are serious life concerns exhibited by terminally ill/psychiatrically ill patients over losing their autonomy and becoming a burden to their families and caregivers. Stereotypes must be deconstructed, yes, but such patients generally have been considered to be rendered, by the sum effect of their illnesses, mentally incapable of making the decision to end their lives. Addressing this order of patient life concerns generally has been the realm of social workers, psychologists, and, in the most desirable cases, psychiatrists. Therefore, even in keeping with established practice, some form of competent psychiatric evaluation should be required before considering PAS as a viable option.

The call for this requirement is backed up by a study, which reported that 47% of patients who had considered or committed suicide previously were diagnosed with psychiatric disorders, and 15% had undiagnosed psychiatric disorders.³ Also, inventories of thwarted suicide attempters reveal that most lack the conviction to end their lives, and this obverse phenomenon is backed by a study that revealed that 75% of 96 suicidal patients were found to be ambivalent in their intent to end their lives. Suicide attempters simply may be trying to communicate with people in their lives in order to test their love and care.⁴ This indicates that those who attempt suicide are predominantly psychiatrically ill and prone to distorted perceptions, impaired judgment, frustration, escapism, and manipulative guilt.

Suicide is abhorrent to most human beings’ sensibilities, because humanity has an innate will to live.⁵ It is wrong to offer patients life-ending options when they might rejuvenate or ease into death naturally. With the debilitated or elderly, PAS could violate their human rights. If the attitude that they are a burden to society persists, then a certain segment of society might be tempted to avoid their intergenerational obligations to elders, particularly those elders presenting with concurrent mental illnesses. PAS would additionally fuel that problem. This would represent a profound injustice and gross violation of human dignity, while also serving as a denial of basic human rights, particularly the right to life and care.⁶

Conclusion

The complex physical, psychological, and social challenges associated with PAS and the difficulty in enforcing its laws necessitate more adept alternatives. Instead of conditionally legalizing suicide, we should ease patient suffering with compassion and calibrated treatment.^6,7

Terminally ill patients often suffer from depression, affecting their rationality. Adequate counseling, medical care, and psychological care should be the response to terminally ill patients considering suicide. If society accepts that ending a life is a reasonable response to human suffering that could otherwise be treated or reversed, then those with the most serious psychiatric conditions are destined to become more vulnerable. Therefore, physicians and psychiatrists should instead work harder to help patients recover, rather than participating in their quest for death.

Simplistic legal and regulatory oversight is insufficient, because the questions evoked by PAS are complicated by life, death, and ethics. Further research is needed to look into the mechanisms and morality of how psychiatrists and other physicians will make judgments and recommendations that are vital elements in developing regulatory oversight on PAS. Finally, future studies should look at which practices have been successful and which might be deemed unethical.
 

References

1. Clin Med (Lond). 2010 Aug;109(4):323-5.

2. JAMA Psychiatry. 2016;73(4):362-8.

3. “The Final Months: A Study of the Lives of 134 Persons Who Committed Suicide,” New York: Oxford University Press, 1981.

4. “Why We Shouldn’t Legalize Assisting Suicide, Part I.” Department of Medical Ethics, National Right to Life Committee.

5. “Working with Suicidal Individuals: A Guide to Providing Understanding, Assessment and Support,” Philadelphia: Jessica Kingsley Publishers, 2010.

6. “Always Care, Never Kill: How Physician-Assisted Suicide Endangers the Weak, Corrupts Medicine, Compromises the Family, and Violates Human Dignity and Equality,” Washington: The Heritage Foundation, 2015.

7. Ann Intern Med. 2012 Jan 3;156(1 Pt 2):73-104.

Dr. Ahmed is a 2nd-year resident in the psychiatry & behavioral sciences department at the Nassau University Medical Center, New York. Over the last 3 years, he has published and presented papers at national and international forums. His interests include public social psychiatry, health care policy, health disparities, mental health stigma, and undiagnosed and overdiagnosed psychiatric illnesses in children. Dr. Ahmed is a member of the American Psychiatric Association, the American Society of Clinical Psychopharmacology, and the American Association for Social Psychiatry.

Do we stand by our Hippocratic Oath when providing physician-assisted suicide?

Physician-assisted suicide (PAS) is a form of euthanasia in which a physician provides the patient with the pertinent information, and, in certain cases, a prescription for the necessary lethal drugs, so that the individual can willingly and successfully terminate his or her own life. The justification for PAS is the compassionate relief of intractable human suffering. Euthanasia and PAS are accepted practices in European countries such as the Netherlands, Belgium, and Luxembourg.

Critical role of mental health workers

Although PAS has been legalized in those five U.S. states, its support and cases have stalled in recent years, indicating serious ethical concerns, mostly because of multileveled challenges of combating and delineating cultural stereotypes, quantifying mental capacity, gauging quality of life, and deciding where to situate psychiatrists in the PAS decision.

The psychiatrist’s role is being debated. In the United States, opponents take issue with current PAS-legal state’s legislation regarding psychiatric evaluations. For example, Oregon stipulates a psychiatrist referral only in cases where a physician other than a psychiatrist believes the patient’s judgment is impaired. It’s agreed that psychiatrists have the best skill set to assess a patient’s perceptions. Other PAS-legal states require a psychiatrist or psychologist assessment before making the decision. Unfortunately, though, physicians have rarely referred these patients to psychiatrists before offering PAS as an option.

PAS opponents target standards by which concepts like “quality of life” or “contributing member of society” are judged – specifically, that “unbearable suffering” and its ramifications are ill defined – people whose lives are deemed “not worth living” (including the terminally ill) would be susceptible to “sympathetic death” via PAS that might result from PAS legalization. Opponents also argue that recognizing a suicide “right” contradicts that a significant number of suicide attempters have mental illness and need help. They say that legalizing PAS would enable mentally incapacitated people to commit the irreversible act based on their distorted perceptions without providing them the expected assistance from their profession.¹

The use of euthanasia or PAS gradually is trending from physically terminally ill patients toward psychiatrically complex patients. There are cases in which euthanasia or PAS was requested by psychiatric patients who had chronic psychiatric, medical, and psychosocial histories rather than purely physical ailment histories. In one study, Scott Y. H. Kim, MD, PhD, and his associates reviewed cases in the Netherlands in which either euthanasia or PAS for psychiatric disorders was deployed. The granted PAS requests appeared to involve physician judgment without psychiatric input.

The study reviewed 66 cases: 55% of patients had chronic severe conditions with extensive histories of attempted suicides and psychiatric hospitalizations, demonstrating that the granted euthanasia and PAS requests had involved extensive evaluations. However, 11% of cases had no independent psychiatric input, and 24% involved disagreement among the physicians.² PAS proponents and opponents support the involvement and expertise of psychiatrists in all of this.

Psychiatrists have long contended that suicide attempts are often a “cry for help,” not an earnest act to end one’s life. Legalizing PAS tells suicidal individuals that society does not care whether they live or die – a truly un-Hippocratic stance. The stereotypes tossed around in the PAS debate, which could mean life or death, need to be unpacked with specific criteria attached, rather than preconceptions.
 

Autonomy of patients and implications of PAS

In the PAS debate, there are serious life concerns exhibited by terminally ill/psychiatrically ill patients over losing their autonomy and becoming a burden to their families and caregivers. Stereotypes must be deconstructed, yes, but such patients generally have been considered to be rendered, by the sum effect of their illnesses, mentally incapable of making the decision to end their lives. Addressing this order of patient life concerns generally has been the realm of social workers, psychologists, and, in the most desirable cases, psychiatrists. Therefore, even in keeping with established practice, some form of competent psychiatric evaluation should be required before considering PAS as a viable option.

The call for this requirement is backed up by a study, which reported that 47% of patients who had considered or committed suicide previously were diagnosed with psychiatric disorders, and 15% had undiagnosed psychiatric disorders.³ Also, inventories of thwarted suicide attempters reveal that most lack the conviction to end their lives, and this obverse phenomenon is backed by a study that revealed that 75% of 96 suicidal patients were found to be ambivalent in their intent to end their lives. Suicide attempters simply may be trying to communicate with people in their lives in order to test their love and care.⁴ This indicates that those who attempt suicide are predominantly psychiatrically ill and prone to distorted perceptions, impaired judgment, frustration, escapism, and manipulative guilt.

Suicide is abhorrent to most human beings’ sensibilities, because humanity has an innate will to live.⁵ It is wrong to offer patients life-ending options when they might rejuvenate or ease into death naturally. With the debilitated or elderly, PAS could violate their human rights. If the attitude that they are a burden to society persists, then a certain segment of society might be tempted to avoid their intergenerational obligations to elders, particularly those elders presenting with concurrent mental illnesses. PAS would additionally fuel that problem. This would represent a profound injustice and gross violation of human dignity, while also serving as a denial of basic human rights, particularly the right to life and care.⁶

Conclusion

The complex physical, psychological, and social challenges associated with PAS and the difficulty in enforcing its laws necessitate more adept alternatives. Instead of conditionally legalizing suicide, we should ease patient suffering with compassion and calibrated treatment.^6,7

Terminally ill patients often suffer from depression, affecting their rationality. Adequate counseling, medical care, and psychological care should be the response to terminally ill patients considering suicide. If society accepts that ending a life is a reasonable response to human suffering that could otherwise be treated or reversed, then those with the most serious psychiatric conditions are destined to become more vulnerable. Therefore, physicians and psychiatrists should instead work harder to help patients recover, rather than participating in their quest for death.

Simplistic legal and regulatory oversight is insufficient, because the questions evoked by PAS are complicated by life, death, and ethics. Further research is needed to look into the mechanisms and morality of how psychiatrists and other physicians will make judgments and recommendations that are vital elements in developing regulatory oversight on PAS. Finally, future studies should look at which practices have been successful and which might be deemed unethical.
 

References

1. Clin Med (Lond). 2010 Aug;109(4):323-5.

2. JAMA Psychiatry. 2016;73(4):362-8.

3. “The Final Months: A Study of the Lives of 134 Persons Who Committed Suicide,” New York: Oxford University Press, 1981.

4. “Why We Shouldn’t Legalize Assisting Suicide, Part I.” Department of Medical Ethics, National Right to Life Committee.

5. “Working with Suicidal Individuals: A Guide to Providing Understanding, Assessment and Support,” Philadelphia: Jessica Kingsley Publishers, 2010.

6. “Always Care, Never Kill: How Physician-Assisted Suicide Endangers the Weak, Corrupts Medicine, Compromises the Family, and Violates Human Dignity and Equality,” Washington: The Heritage Foundation, 2015.

7. Ann Intern Med. 2012 Jan 3;156(1 Pt 2):73-104.

Dr. Ahmed is a 2nd-year resident in the psychiatry & behavioral sciences department at the Nassau University Medical Center, New York. Over the last 3 years, he has published and presented papers at national and international forums. His interests include public social psychiatry, health care policy, health disparities, mental health stigma, and undiagnosed and overdiagnosed psychiatric illnesses in children. Dr. Ahmed is a member of the American Psychiatric Association, the American Society of Clinical Psychopharmacology, and the American Association for Social Psychiatry.

On Oct. 25, 2016, the Food and Drug Administration issued a draft guidance document titled “Low Sexual Interest, Desire, and/or Arousal in Women: Developing Drugs for Treatment.” The document outlines FDA’s current thinking about how best to design phase III trials for drugs to treat these problems. The purpose of this guidance is to provide pharmaceutical companies with a road map of what the FDA recommends should be addressed in clinical trials designed for new drug approval.

The FDA makes it clear that this guidance is only a “recommendation,” reflecting the agency’s current thinking on this important issue, and is not a requirement (unless specific regulatory or statutory requirements are cited). That may well be, but this puts me in mind of my graduate school days when my advisor used to tell me that his suggestions for my dissertation were only “recommendations.” I knew, of course, that to ignore these recommendations was folly.

Dr. Kingsberg is chief of the division of behavioral medicine in the department of obstetrics and gynecology at MacDonald Women’s Hospital, part of the University Hospitals Cleveland Medical Center, Ohio. She is also a professor in the departments of reproductive biology and psychiatry at Case Western Reserve University, Cleveland. Dr. Kingsberg reported being a consultant or member of the scientific advisory board for Acerus, AMAG, Bayer, Emotional Brain, Endoceutics, NovoNordisk, Palatin, Pfizer, Shionogi, Sprout, TherapeuticsMD, Sermonix, Strategic Science & Technologies, and Valeant. Valeant is the manufacturer of the HSDD drug flibanserin.

On Oct. 25, 2016, the Food and Drug Administration issued a draft guidance document titled “Low Sexual Interest, Desire, and/or Arousal in Women: Developing Drugs for Treatment.” The document outlines FDA’s current thinking about how best to design phase III trials for drugs to treat these problems. The purpose of this guidance is to provide pharmaceutical companies with a road map of what the FDA recommends should be addressed in clinical trials designed for new drug approval.

The FDA makes it clear that this guidance is only a “recommendation,” reflecting the agency’s current thinking on this important issue, and is not a requirement (unless specific regulatory or statutory requirements are cited). That may well be, but this puts me in mind of my graduate school days when my advisor used to tell me that his suggestions for my dissertation were only “recommendations.” I knew, of course, that to ignore these recommendations was folly.

Dr. Kingsberg is chief of the division of behavioral medicine in the department of obstetrics and gynecology at MacDonald Women’s Hospital, part of the University Hospitals Cleveland Medical Center, Ohio. She is also a professor in the departments of reproductive biology and psychiatry at Case Western Reserve University, Cleveland. Dr. Kingsberg reported being a consultant or member of the scientific advisory board for Acerus, AMAG, Bayer, Emotional Brain, Endoceutics, NovoNordisk, Palatin, Pfizer, Shionogi, Sprout, TherapeuticsMD, Sermonix, Strategic Science & Technologies, and Valeant. Valeant is the manufacturer of the HSDD drug flibanserin.

On Oct. 25, 2016, the Food and Drug Administration issued a draft guidance document titled “Low Sexual Interest, Desire, and/or Arousal in Women: Developing Drugs for Treatment.” The document outlines FDA’s current thinking about how best to design phase III trials for drugs to treat these problems. The purpose of this guidance is to provide pharmaceutical companies with a road map of what the FDA recommends should be addressed in clinical trials designed for new drug approval.

The FDA makes it clear that this guidance is only a “recommendation,” reflecting the agency’s current thinking on this important issue, and is not a requirement (unless specific regulatory or statutory requirements are cited). That may well be, but this puts me in mind of my graduate school days when my advisor used to tell me that his suggestions for my dissertation were only “recommendations.” I knew, of course, that to ignore these recommendations was folly.

Dr. Kingsberg is chief of the division of behavioral medicine in the department of obstetrics and gynecology at MacDonald Women’s Hospital, part of the University Hospitals Cleveland Medical Center, Ohio. She is also a professor in the departments of reproductive biology and psychiatry at Case Western Reserve University, Cleveland. Dr. Kingsberg reported being a consultant or member of the scientific advisory board for Acerus, AMAG, Bayer, Emotional Brain, Endoceutics, NovoNordisk, Palatin, Pfizer, Shionogi, Sprout, TherapeuticsMD, Sermonix, Strategic Science & Technologies, and Valeant. Valeant is the manufacturer of the HSDD drug flibanserin.

Bertrand M. Bell, MD, Distinguished University Professor Emeritus at Albert Einstein College of Medicine, died at the age of 86 in his Manhattan home on October 4, 2016. For decades, Dr Bell was the Director of Ambulatory Care, which included the ED at Einstein’s teaching hospital, the Bronx Municipal (Jacobi) Hospital Center. But, as Dr Bell was aware for the last 25 years of his life, he would always be remembered for a committee he chaired the year he was on sabbatical from Einstein and Jacobi in 1987.

After the death of 18-year-old Libby Zion from a dangerous drug interaction, the New York State Commissioner of Health asked Dr Bell to chair an ad hoc committee to investigate the care of hospitalized patients by residents and to make recommendations regarding medication ordering and administration, the use of patient restraints, attending supervision, and resident work hours. The “Bell Commission,” as it came to be known, recommended that residents not be allowed to work more than 80 hours a week or more than 24 consecutive hours, and that attending physicians be present in the hospital 24/7. These recommendations were made part of the New York State Health Code in 1989 and adopted nationwide by the Accreditation Council for Graduate Medical Education in 1993. 

The Bell Commission changes in resident work hours were not enthusiastically received by all, with most of the criticism centering on a perceived lack of continuity in resident education resulting from the shortened work hours. Largely ignored, however, was the committee’s call for 24/7 attending supervision, which would have provided both continuity in patient care and enhanced resident education and experiences. Dr Bell was outspoken in defending his committee’s recommendations and his views on the inadequacies of graduate medical education (GME), occasionally infuriating those who disagreed with him.

Ironically, though the formal name of the Bell Commission was the “Ad Hoc Advisory Committee on Emergency Services,” the recommendations did not address prehospital care issues and probably affected emergency medicine (EM) residents less than they did residents from other specialties. Both the work-hour rules and mandated attending presence had already been implemented by many EM residency training programs from the time EM became a specialty in 1979, and were required of all EM programs by the end of the 1980s. (See “’My Patient’—More Than Ever,” Emerg Med. 2013;45[4]:1.)

Yet, Bert Bell may have had as profound an effect on the birth and survival of academic EM on the East Coast as did his committee’s recommendations on GME nationwide. Together with his ED Director, Sheldon Jacobson, MD, Bert secured for Einstein/Jacobi the first federally funded paramedic training program in New York State in 1974, followed a year later by the first EM residency in New York State, and one of the earliest in the nation. Bert also hired and trained nurse practitioners and physician assistants to care for patients in the ED and clinics, realizing their potential and the value of their contributions to patient care, years before others did.

The group of emergency physicians that Bert and Shelly assembled at Einstein/Jacobi in the 1970s included John Gallagher, Peter Moyer, Mark Henry, Gregg Husk, Paul Gennis, a young Wallace Carter, me, and several other EM pioneers. Bert instilled in all of us the importance of always placing patients first, providing quality medical education, standing up for what is right regardless of personal consequences, maintaining a sense of humor, and a love for life.

At Dr Bell’s funeral on October 7, the rabbi alluded to a description of the prophet Elijah, in describing Bert as a “holy troublemaker.” Bert Bell was a larger-than-life iconoclast whose name became an icon for graduate medical education reforms and whose patient care values will survive in future generations of physicians. 

Bertrand M. Bell, MD, Distinguished University Professor Emeritus at Albert Einstein College of Medicine, died at the age of 86 in his Manhattan home on October 4, 2016. For decades, Dr Bell was the Director of Ambulatory Care, which included the ED at Einstein’s teaching hospital, the Bronx Municipal (Jacobi) Hospital Center. But, as Dr Bell was aware for the last 25 years of his life, he would always be remembered for a committee he chaired the year he was on sabbatical from Einstein and Jacobi in 1987.

After the death of 18-year-old Libby Zion from a dangerous drug interaction, the New York State Commissioner of Health asked Dr Bell to chair an ad hoc committee to investigate the care of hospitalized patients by residents and to make recommendations regarding medication ordering and administration, the use of patient restraints, attending supervision, and resident work hours. The “Bell Commission,” as it came to be known, recommended that residents not be allowed to work more than 80 hours a week or more than 24 consecutive hours, and that attending physicians be present in the hospital 24/7. These recommendations were made part of the New York State Health Code in 1989 and adopted nationwide by the Accreditation Council for Graduate Medical Education in 1993. 

The Bell Commission changes in resident work hours were not enthusiastically received by all, with most of the criticism centering on a perceived lack of continuity in resident education resulting from the shortened work hours. Largely ignored, however, was the committee’s call for 24/7 attending supervision, which would have provided both continuity in patient care and enhanced resident education and experiences. Dr Bell was outspoken in defending his committee’s recommendations and his views on the inadequacies of graduate medical education (GME), occasionally infuriating those who disagreed with him.

Ironically, though the formal name of the Bell Commission was the “Ad Hoc Advisory Committee on Emergency Services,” the recommendations did not address prehospital care issues and probably affected emergency medicine (EM) residents less than they did residents from other specialties. Both the work-hour rules and mandated attending presence had already been implemented by many EM residency training programs from the time EM became a specialty in 1979, and were required of all EM programs by the end of the 1980s. (See “’My Patient’—More Than Ever,” Emerg Med. 2013;45[4]:1.)

Yet, Bert Bell may have had as profound an effect on the birth and survival of academic EM on the East Coast as did his committee’s recommendations on GME nationwide. Together with his ED Director, Sheldon Jacobson, MD, Bert secured for Einstein/Jacobi the first federally funded paramedic training program in New York State in 1974, followed a year later by the first EM residency in New York State, and one of the earliest in the nation. Bert also hired and trained nurse practitioners and physician assistants to care for patients in the ED and clinics, realizing their potential and the value of their contributions to patient care, years before others did.

The group of emergency physicians that Bert and Shelly assembled at Einstein/Jacobi in the 1970s included John Gallagher, Peter Moyer, Mark Henry, Gregg Husk, Paul Gennis, a young Wallace Carter, me, and several other EM pioneers. Bert instilled in all of us the importance of always placing patients first, providing quality medical education, standing up for what is right regardless of personal consequences, maintaining a sense of humor, and a love for life.

At Dr Bell’s funeral on October 7, the rabbi alluded to a description of the prophet Elijah, in describing Bert as a “holy troublemaker.” Bert Bell was a larger-than-life iconoclast whose name became an icon for graduate medical education reforms and whose patient care values will survive in future generations of physicians. 

Bertrand M. Bell, MD, Distinguished University Professor Emeritus at Albert Einstein College of Medicine, died at the age of 86 in his Manhattan home on October 4, 2016. For decades, Dr Bell was the Director of Ambulatory Care, which included the ED at Einstein’s teaching hospital, the Bronx Municipal (Jacobi) Hospital Center. But, as Dr Bell was aware for the last 25 years of his life, he would always be remembered for a committee he chaired the year he was on sabbatical from Einstein and Jacobi in 1987.

After the death of 18-year-old Libby Zion from a dangerous drug interaction, the New York State Commissioner of Health asked Dr Bell to chair an ad hoc committee to investigate the care of hospitalized patients by residents and to make recommendations regarding medication ordering and administration, the use of patient restraints, attending supervision, and resident work hours. The “Bell Commission,” as it came to be known, recommended that residents not be allowed to work more than 80 hours a week or more than 24 consecutive hours, and that attending physicians be present in the hospital 24/7. These recommendations were made part of the New York State Health Code in 1989 and adopted nationwide by the Accreditation Council for Graduate Medical Education in 1993. 

The Bell Commission changes in resident work hours were not enthusiastically received by all, with most of the criticism centering on a perceived lack of continuity in resident education resulting from the shortened work hours. Largely ignored, however, was the committee’s call for 24/7 attending supervision, which would have provided both continuity in patient care and enhanced resident education and experiences. Dr Bell was outspoken in defending his committee’s recommendations and his views on the inadequacies of graduate medical education (GME), occasionally infuriating those who disagreed with him.

Ironically, though the formal name of the Bell Commission was the “Ad Hoc Advisory Committee on Emergency Services,” the recommendations did not address prehospital care issues and probably affected emergency medicine (EM) residents less than they did residents from other specialties. Both the work-hour rules and mandated attending presence had already been implemented by many EM residency training programs from the time EM became a specialty in 1979, and were required of all EM programs by the end of the 1980s. (See “’My Patient’—More Than Ever,” Emerg Med. 2013;45[4]:1.)

Yet, Bert Bell may have had as profound an effect on the birth and survival of academic EM on the East Coast as did his committee’s recommendations on GME nationwide. Together with his ED Director, Sheldon Jacobson, MD, Bert secured for Einstein/Jacobi the first federally funded paramedic training program in New York State in 1974, followed a year later by the first EM residency in New York State, and one of the earliest in the nation. Bert also hired and trained nurse practitioners and physician assistants to care for patients in the ED and clinics, realizing their potential and the value of their contributions to patient care, years before others did.

The group of emergency physicians that Bert and Shelly assembled at Einstein/Jacobi in the 1970s included John Gallagher, Peter Moyer, Mark Henry, Gregg Husk, Paul Gennis, a young Wallace Carter, me, and several other EM pioneers. Bert instilled in all of us the importance of always placing patients first, providing quality medical education, standing up for what is right regardless of personal consequences, maintaining a sense of humor, and a love for life.

At Dr Bell’s funeral on October 7, the rabbi alluded to a description of the prophet Elijah, in describing Bert as a “holy troublemaker.” Bert Bell was a larger-than-life iconoclast whose name became an icon for graduate medical education reforms and whose patient care values will survive in future generations of physicians. 

The American Academy of Pediatrics has recently released a new policy for parents on safe sleep practices that in addition to the previous warnings about bed sharing and positioning includes the recommendation that an infant sleep in the same room as her parent for at least the first 6 months (Pediatrics. 2016 Oct;138[5]:e20162938). Apparently what prompted this new set of recommendations is the observation that deaths from sudden unexpected infant deaths (SUIDS) and sudden infant deaths (SIDS) has plateaued since the dramatic decline we witnessed in the 1990s following the Back-to-Sleep campaign.

Although the policy statement refers to “new research” that has become available since the last policy statement was released in 2011, I have had trouble finding convincing evidence in the references I reviewed to support the room sharing recommendation. In some studies, room sharing was the cultural norm, making it difficult to establish a control group. In one of the most frequently cited papers from New Zealand, the authors could not sort out the effects of prone sleeping and sleeping alone, and wonder whether both factors may be affecting risk “through a common mechanism” (Lancet. 1996 Jan 6;347[8993]:7-12).

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].

The American Academy of Pediatrics has recently released a new policy for parents on safe sleep practices that in addition to the previous warnings about bed sharing and positioning includes the recommendation that an infant sleep in the same room as her parent for at least the first 6 months (Pediatrics. 2016 Oct;138[5]:e20162938). Apparently what prompted this new set of recommendations is the observation that deaths from sudden unexpected infant deaths (SUIDS) and sudden infant deaths (SIDS) has plateaued since the dramatic decline we witnessed in the 1990s following the Back-to-Sleep campaign.

Although the policy statement refers to “new research” that has become available since the last policy statement was released in 2011, I have had trouble finding convincing evidence in the references I reviewed to support the room sharing recommendation. In some studies, room sharing was the cultural norm, making it difficult to establish a control group. In one of the most frequently cited papers from New Zealand, the authors could not sort out the effects of prone sleeping and sleeping alone, and wonder whether both factors may be affecting risk “through a common mechanism” (Lancet. 1996 Jan 6;347[8993]:7-12).

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].

The American Academy of Pediatrics has recently released a new policy for parents on safe sleep practices that in addition to the previous warnings about bed sharing and positioning includes the recommendation that an infant sleep in the same room as her parent for at least the first 6 months (Pediatrics. 2016 Oct;138[5]:e20162938). Apparently what prompted this new set of recommendations is the observation that deaths from sudden unexpected infant deaths (SUIDS) and sudden infant deaths (SIDS) has plateaued since the dramatic decline we witnessed in the 1990s following the Back-to-Sleep campaign.

Although the policy statement refers to “new research” that has become available since the last policy statement was released in 2011, I have had trouble finding convincing evidence in the references I reviewed to support the room sharing recommendation. In some studies, room sharing was the cultural norm, making it difficult to establish a control group. In one of the most frequently cited papers from New Zealand, the authors could not sort out the effects of prone sleeping and sleeping alone, and wonder whether both factors may be affecting risk “through a common mechanism” (Lancet. 1996 Jan 6;347[8993]:7-12).

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].

The study by Dr. Kesselheim and his colleagues is one of several recently aimed at reviewing the overall safety of generic drug switching. The FDA sponsored three clinical bioequivalence studies to determine the adequacy of average bioequivalence studies for ensuring safe conversion between different antiseizure products for patients with epilepsy. Taken together, these studies confirm that most patients can safely switch between generic formulations, even between tablets differing in appearance.

So why do patients and open series report seizures associated with formulation changes? Probably several things are happening:

• Patients want to find a reason for the near-random pattern of their seizures. Threshold cortical epileptogenic activity triggers seizures in near-random patterns, and their timing might be influenced by triggers such as missing doses, stress, and hormonal changes.

• Patients’ views of illness and treatments might influence their reporting of seizures and drug effects. This search for seizure explanations can even extend to pets with seizures.

• There is temporal variability in individual drug absorption and elimination. Food has a major effect on absorption of antiseizure medications and maximum concentration; this effect is particularly common with modified-release formulations. A small subgroup of patients in the FDA’s clinical bioequivalence studies had variability in concentrations during reexposure to the same product.

• A small group of patients may be outside the 90% confidence interval bioequivalence acceptance range and may experience product switching effects.

—Gregory L. Krauss, MD
Professor of Neurology
Johns Hopkins University, Baltimore

—Michael D. Privitera, MD
Professor of Neurology
University of Cincinnati

This commentary was adapted from Krauss GL, Privitera M. More data on the safety of generic substitution: yes, the blue tablet is OK? Neurology. 2016 Sep 28 [Epub ahead of print].

The study by Dr. Kesselheim and his colleagues is one of several recently aimed at reviewing the overall safety of generic drug switching. The FDA sponsored three clinical bioequivalence studies to determine the adequacy of average bioequivalence studies for ensuring safe conversion between different antiseizure products for patients with epilepsy. Taken together, these studies confirm that most patients can safely switch between generic formulations, even between tablets differing in appearance.

So why do patients and open series report seizures associated with formulation changes? Probably several things are happening:

• Patients want to find a reason for the near-random pattern of their seizures. Threshold cortical epileptogenic activity triggers seizures in near-random patterns, and their timing might be influenced by triggers such as missing doses, stress, and hormonal changes.

• Patients’ views of illness and treatments might influence their reporting of seizures and drug effects. This search for seizure explanations can even extend to pets with seizures.

• There is temporal variability in individual drug absorption and elimination. Food has a major effect on absorption of antiseizure medications and maximum concentration; this effect is particularly common with modified-release formulations. A small subgroup of patients in the FDA’s clinical bioequivalence studies had variability in concentrations during reexposure to the same product.

• A small group of patients may be outside the 90% confidence interval bioequivalence acceptance range and may experience product switching effects.

—Gregory L. Krauss, MD
Professor of Neurology
Johns Hopkins University, Baltimore

—Michael D. Privitera, MD
Professor of Neurology
University of Cincinnati

This commentary was adapted from Krauss GL, Privitera M. More data on the safety of generic substitution: yes, the blue tablet is OK? Neurology. 2016 Sep 28 [Epub ahead of print].

The study by Dr. Kesselheim and his colleagues is one of several recently aimed at reviewing the overall safety of generic drug switching. The FDA sponsored three clinical bioequivalence studies to determine the adequacy of average bioequivalence studies for ensuring safe conversion between different antiseizure products for patients with epilepsy. Taken together, these studies confirm that most patients can safely switch between generic formulations, even between tablets differing in appearance.

So why do patients and open series report seizures associated with formulation changes? Probably several things are happening:

• Patients want to find a reason for the near-random pattern of their seizures. Threshold cortical epileptogenic activity triggers seizures in near-random patterns, and their timing might be influenced by triggers such as missing doses, stress, and hormonal changes.

• Patients’ views of illness and treatments might influence their reporting of seizures and drug effects. This search for seizure explanations can even extend to pets with seizures.

• There is temporal variability in individual drug absorption and elimination. Food has a major effect on absorption of antiseizure medications and maximum concentration; this effect is particularly common with modified-release formulations. A small subgroup of patients in the FDA’s clinical bioequivalence studies had variability in concentrations during reexposure to the same product.

• A small group of patients may be outside the 90% confidence interval bioequivalence acceptance range and may experience product switching effects.

—Gregory L. Krauss, MD
Professor of Neurology
Johns Hopkins University, Baltimore

—Michael D. Privitera, MD
Professor of Neurology
University of Cincinnati

This commentary was adapted from Krauss GL, Privitera M. More data on the safety of generic substitution: yes, the blue tablet is OK? Neurology. 2016 Sep 28 [Epub ahead of print].

Many of my patients ask, “Why do you have fortune cookies on your desk?” Then, I offer them one. I considered having other treats, but decided on fortune cookies because of

Comfort. The cookie is a small treat for those who want one.

Diet. You don’t have to eat the cookie to enjoy it; you can still read the fortune. For patients who have an eating disorder, the cookie allows us to naturally transition the conversation to issues they are experiencing.

Cultural competency. I treat patients of many backgrounds. Some have never seen a fortune cookie (remember to warn them there is a fortune inside!). Others know the fortune cookie is not a Chinese invention, as it is popu­larly thought to be.¹

Impulsivity. Do patients grab a cookie immediately, wait for one to be offered, or ask for one?

At this point, I ask patients to tell me their fortune. This allows me to assess:

Fine motor skills. Do they have a hand tremor or weakness, or a problem with involuntary movement? How well do they open the individually wrapped cookie?

Problem solving. On the slip of paper in the cookie, fortunes are printed on one side; on the other side are lucky numbers and a Chinese phrase. Some patients fail to turn the slip of paper over; they look it and say, “There are only numbers on this piece of paper.”

Eyesight. Can they see without glasses? Did they bring their glasses? (By extension, I can gauge whether they need, and use, glasses when reaching for a pill bottle in the medicine cabinet.)

Literacy. Can they read their fortune aloud?

Last, I ask what the fortune means and how it might apply to them. This helps me understand their:

Mindset. Having them explain how the fortune applies to them can be helpful to understanding their thinking.

Thought process. I am looking for how they think: Abstractly? Concretely? How well do they ar­ticulate and explain the meaning of the fortune?

Many of my patients ask, “Why do you have fortune cookies on your desk?” Then, I offer them one. I considered having other treats, but decided on fortune cookies because of

Comfort. The cookie is a small treat for those who want one.

Diet. You don’t have to eat the cookie to enjoy it; you can still read the fortune. For patients who have an eating disorder, the cookie allows us to naturally transition the conversation to issues they are experiencing.

Cultural competency. I treat patients of many backgrounds. Some have never seen a fortune cookie (remember to warn them there is a fortune inside!). Others know the fortune cookie is not a Chinese invention, as it is popu­larly thought to be.¹

Impulsivity. Do patients grab a cookie immediately, wait for one to be offered, or ask for one?

At this point, I ask patients to tell me their fortune. This allows me to assess:

Fine motor skills. Do they have a hand tremor or weakness, or a problem with involuntary movement? How well do they open the individually wrapped cookie?

Problem solving. On the slip of paper in the cookie, fortunes are printed on one side; on the other side are lucky numbers and a Chinese phrase. Some patients fail to turn the slip of paper over; they look it and say, “There are only numbers on this piece of paper.”

Eyesight. Can they see without glasses? Did they bring their glasses? (By extension, I can gauge whether they need, and use, glasses when reaching for a pill bottle in the medicine cabinet.)

Literacy. Can they read their fortune aloud?

Last, I ask what the fortune means and how it might apply to them. This helps me understand their:

Mindset. Having them explain how the fortune applies to them can be helpful to understanding their thinking.

Thought process. I am looking for how they think: Abstractly? Concretely? How well do they ar­ticulate and explain the meaning of the fortune?

Many of my patients ask, “Why do you have fortune cookies on your desk?” Then, I offer them one. I considered having other treats, but decided on fortune cookies because of

Comfort. The cookie is a small treat for those who want one.

Diet. You don’t have to eat the cookie to enjoy it; you can still read the fortune. For patients who have an eating disorder, the cookie allows us to naturally transition the conversation to issues they are experiencing.

Cultural competency. I treat patients of many backgrounds. Some have never seen a fortune cookie (remember to warn them there is a fortune inside!). Others know the fortune cookie is not a Chinese invention, as it is popu­larly thought to be.¹

Impulsivity. Do patients grab a cookie immediately, wait for one to be offered, or ask for one?

At this point, I ask patients to tell me their fortune. This allows me to assess:

Fine motor skills. Do they have a hand tremor or weakness, or a problem with involuntary movement? How well do they open the individually wrapped cookie?

Problem solving. On the slip of paper in the cookie, fortunes are printed on one side; on the other side are lucky numbers and a Chinese phrase. Some patients fail to turn the slip of paper over; they look it and say, “There are only numbers on this piece of paper.”

Eyesight. Can they see without glasses? Did they bring their glasses? (By extension, I can gauge whether they need, and use, glasses when reaching for a pill bottle in the medicine cabinet.)

Literacy. Can they read their fortune aloud?

Last, I ask what the fortune means and how it might apply to them. This helps me understand their:

Mindset. Having them explain how the fortune applies to them can be helpful to understanding their thinking.

Thought process. I am looking for how they think: Abstractly? Concretely? How well do they ar­ticulate and explain the meaning of the fortune?

Pain was introduced as the “fifth vital sign” in the 1990s, ranking it as important a measure as blood pressure, heart and respiratory rate, and temperature.¹ The American Pain Society promoted this notion to increase awareness of pain treatment among health care professionals. Emphasizing its importance, the Veterans Health Administration in 1999 launched the “Pain as the 5th Vital Sign” initiative, which mandated a pain intensity rating at all clinical encounters.²

Interestingly, the Joint Commission standards never stated that pain needed to be treated as a vital sign. But many organizations started to require documentation of routine pain screening for all patients. Health care providers were instructed to inquire about pain and to treat it as an essential element of health history.

These changes were quite controversial. The additional measure, while important, competed with other priority screening needs, including diabetes, cancer, and hypertension. There was—and continues to be—quite the debate on whether pain actually can be measured and what impact that information has on the quality of care.

I do not intend to enter that debate here. Instead, I want to discuss what continues to be a conundrum for me: the paradox of pain management.

For many patients, especially those in acute or emergency care settings, the presenting complaint is pain. I would submit that for many the expectation is for pain to be immediately and permanently relieved. But is this a realistic goal?

I recall a lecture on pain management I attended years ago; at that time, the approach involved early identification and prompt, aggressive treatment. When asked “How much medication and for how long?” the lecturer used diabetes as a treatment model, stating, “You would increase insulin until the blood glucose was controlled—don’t be afraid to increase pain medication until the pain is controlled.” In the early days of pain management, that was the accepted norm. The possibility that a “zero” on the pain scale was unattainable for some patients was not considered.

Yet seemingly overnight, once pain was decreed a vital sign, health care providers were mandated to measure it and faced with the responsibility to treat it. This resulted in a vague 0-10 pain scale and providers who were inadequately educated on how to begin pain management. Unlike with diabetes or hypertension, there was no protocol, algorithm, or standard upon which to base a plan of care. Moreover, there was a lack of differentiation between pain that was a short-lived nuisance and pain that interfered with quality of life.

Faced with growing concern for undertreated pain in the US, however, many of us strove to achieve a balance of sufficient yet appropriate treatment. We struggled to determine how to relieve the pain our patients experienced without creating other problems, such as undesirable side effects, misuse, or addiction. That ­predicament, paired with the ever-increasing direct-to-consumer advertisements about pain relief and the insistence by (some, not all) patients that nonnarcotic pain medication is ineffective, bred the crisis of opioid overuse and addiction we now face.

But just as I chose not to debate the impact of pain measurement on quality of care, I also choose not to debate the existence of the opioid crisis. What I want to emphasize is that all policy changes have consequences. I reach out to you, my colleagues, for innovative ideas to strike the delicate balance of appropriate use of narcotics. How do we address the needs of patients whose pain is more than just an inconvenience and for whom daily use of a narcotic allows them to function—while also avoiding the pitfalls that we are now regularly warned about?

I have no doubt that each of us knows at least one person—a patient, a family member, a neighbor—for whom pain is a daily occurrence. But we must put that in perspective; not all pain is a barrier to physical and emotional functioning. Data suggest that a “33% to 50% decrease in pain intensity is meaningful from a patient’s perspective and represents a reasonable standard of intervention efficacy.”³ For those who deal with chronic pain, even a slight improvement is progress.

So, while the American Medical Association and the American Pain Society bicker about whether pain is the “fifth vital sign,” we must find a better means to resolve the discord in our society.⁴ Banning all opioid use is not the answer, but neither is considering narcotics the default treatment for pain.

We must remind our patients, our policymakers, and ourselves that identifying and assessing pain is not equated with writing an opioid or narcotic prescription. Nor will removing those medications from our formulary mitigate the crisis. We need to communicate a clear, consistent message that pain is real, that some pain is a fact of life, and that we will help our patients.

However, it is incumbent upon us to adopt a systematic yet personalized plan of care that is effective, cost conscious, culturally and developmentally appropriate, and safe—and that plan may or may not include prescribing narcotics. We have much work ahead of us in order to minimize the potential for misuse of these medications without impeding patients’ access to necessary health care.

Please share your thoughts on this conundrum by writing to [email protected].

Pain was introduced as the “fifth vital sign” in the 1990s, ranking it as important a measure as blood pressure, heart and respiratory rate, and temperature.¹ The American Pain Society promoted this notion to increase awareness of pain treatment among health care professionals. Emphasizing its importance, the Veterans Health Administration in 1999 launched the “Pain as the 5th Vital Sign” initiative, which mandated a pain intensity rating at all clinical encounters.²

Interestingly, the Joint Commission standards never stated that pain needed to be treated as a vital sign. But many organizations started to require documentation of routine pain screening for all patients. Health care providers were instructed to inquire about pain and to treat it as an essential element of health history.

These changes were quite controversial. The additional measure, while important, competed with other priority screening needs, including diabetes, cancer, and hypertension. There was—and continues to be—quite the debate on whether pain actually can be measured and what impact that information has on the quality of care.

I do not intend to enter that debate here. Instead, I want to discuss what continues to be a conundrum for me: the paradox of pain management.

For many patients, especially those in acute or emergency care settings, the presenting complaint is pain. I would submit that for many the expectation is for pain to be immediately and permanently relieved. But is this a realistic goal?

I recall a lecture on pain management I attended years ago; at that time, the approach involved early identification and prompt, aggressive treatment. When asked “How much medication and for how long?” the lecturer used diabetes as a treatment model, stating, “You would increase insulin until the blood glucose was controlled—don’t be afraid to increase pain medication until the pain is controlled.” In the early days of pain management, that was the accepted norm. The possibility that a “zero” on the pain scale was unattainable for some patients was not considered.

Yet seemingly overnight, once pain was decreed a vital sign, health care providers were mandated to measure it and faced with the responsibility to treat it. This resulted in a vague 0-10 pain scale and providers who were inadequately educated on how to begin pain management. Unlike with diabetes or hypertension, there was no protocol, algorithm, or standard upon which to base a plan of care. Moreover, there was a lack of differentiation between pain that was a short-lived nuisance and pain that interfered with quality of life.

Faced with growing concern for undertreated pain in the US, however, many of us strove to achieve a balance of sufficient yet appropriate treatment. We struggled to determine how to relieve the pain our patients experienced without creating other problems, such as undesirable side effects, misuse, or addiction. That ­predicament, paired with the ever-increasing direct-to-consumer advertisements about pain relief and the insistence by (some, not all) patients that nonnarcotic pain medication is ineffective, bred the crisis of opioid overuse and addiction we now face.

But just as I chose not to debate the impact of pain measurement on quality of care, I also choose not to debate the existence of the opioid crisis. What I want to emphasize is that all policy changes have consequences. I reach out to you, my colleagues, for innovative ideas to strike the delicate balance of appropriate use of narcotics. How do we address the needs of patients whose pain is more than just an inconvenience and for whom daily use of a narcotic allows them to function—while also avoiding the pitfalls that we are now regularly warned about?

I have no doubt that each of us knows at least one person—a patient, a family member, a neighbor—for whom pain is a daily occurrence. But we must put that in perspective; not all pain is a barrier to physical and emotional functioning. Data suggest that a “33% to 50% decrease in pain intensity is meaningful from a patient’s perspective and represents a reasonable standard of intervention efficacy.”³ For those who deal with chronic pain, even a slight improvement is progress.

So, while the American Medical Association and the American Pain Society bicker about whether pain is the “fifth vital sign,” we must find a better means to resolve the discord in our society.⁴ Banning all opioid use is not the answer, but neither is considering narcotics the default treatment for pain.

We must remind our patients, our policymakers, and ourselves that identifying and assessing pain is not equated with writing an opioid or narcotic prescription. Nor will removing those medications from our formulary mitigate the crisis. We need to communicate a clear, consistent message that pain is real, that some pain is a fact of life, and that we will help our patients.

However, it is incumbent upon us to adopt a systematic yet personalized plan of care that is effective, cost conscious, culturally and developmentally appropriate, and safe—and that plan may or may not include prescribing narcotics. We have much work ahead of us in order to minimize the potential for misuse of these medications without impeding patients’ access to necessary health care.

Please share your thoughts on this conundrum by writing to [email protected].

Pain was introduced as the “fifth vital sign” in the 1990s, ranking it as important a measure as blood pressure, heart and respiratory rate, and temperature.¹ The American Pain Society promoted this notion to increase awareness of pain treatment among health care professionals. Emphasizing its importance, the Veterans Health Administration in 1999 launched the “Pain as the 5th Vital Sign” initiative, which mandated a pain intensity rating at all clinical encounters.²

Interestingly, the Joint Commission standards never stated that pain needed to be treated as a vital sign. But many organizations started to require documentation of routine pain screening for all patients. Health care providers were instructed to inquire about pain and to treat it as an essential element of health history.

These changes were quite controversial. The additional measure, while important, competed with other priority screening needs, including diabetes, cancer, and hypertension. There was—and continues to be—quite the debate on whether pain actually can be measured and what impact that information has on the quality of care.

I do not intend to enter that debate here. Instead, I want to discuss what continues to be a conundrum for me: the paradox of pain management.

For many patients, especially those in acute or emergency care settings, the presenting complaint is pain. I would submit that for many the expectation is for pain to be immediately and permanently relieved. But is this a realistic goal?

I recall a lecture on pain management I attended years ago; at that time, the approach involved early identification and prompt, aggressive treatment. When asked “How much medication and for how long?” the lecturer used diabetes as a treatment model, stating, “You would increase insulin until the blood glucose was controlled—don’t be afraid to increase pain medication until the pain is controlled.” In the early days of pain management, that was the accepted norm. The possibility that a “zero” on the pain scale was unattainable for some patients was not considered.

Yet seemingly overnight, once pain was decreed a vital sign, health care providers were mandated to measure it and faced with the responsibility to treat it. This resulted in a vague 0-10 pain scale and providers who were inadequately educated on how to begin pain management. Unlike with diabetes or hypertension, there was no protocol, algorithm, or standard upon which to base a plan of care. Moreover, there was a lack of differentiation between pain that was a short-lived nuisance and pain that interfered with quality of life.

Faced with growing concern for undertreated pain in the US, however, many of us strove to achieve a balance of sufficient yet appropriate treatment. We struggled to determine how to relieve the pain our patients experienced without creating other problems, such as undesirable side effects, misuse, or addiction. That ­predicament, paired with the ever-increasing direct-to-consumer advertisements about pain relief and the insistence by (some, not all) patients that nonnarcotic pain medication is ineffective, bred the crisis of opioid overuse and addiction we now face.

But just as I chose not to debate the impact of pain measurement on quality of care, I also choose not to debate the existence of the opioid crisis. What I want to emphasize is that all policy changes have consequences. I reach out to you, my colleagues, for innovative ideas to strike the delicate balance of appropriate use of narcotics. How do we address the needs of patients whose pain is more than just an inconvenience and for whom daily use of a narcotic allows them to function—while also avoiding the pitfalls that we are now regularly warned about?

I have no doubt that each of us knows at least one person—a patient, a family member, a neighbor—for whom pain is a daily occurrence. But we must put that in perspective; not all pain is a barrier to physical and emotional functioning. Data suggest that a “33% to 50% decrease in pain intensity is meaningful from a patient’s perspective and represents a reasonable standard of intervention efficacy.”³ For those who deal with chronic pain, even a slight improvement is progress.

So, while the American Medical Association and the American Pain Society bicker about whether pain is the “fifth vital sign,” we must find a better means to resolve the discord in our society.⁴ Banning all opioid use is not the answer, but neither is considering narcotics the default treatment for pain.

We must remind our patients, our policymakers, and ourselves that identifying and assessing pain is not equated with writing an opioid or narcotic prescription. Nor will removing those medications from our formulary mitigate the crisis. We need to communicate a clear, consistent message that pain is real, that some pain is a fact of life, and that we will help our patients.

However, it is incumbent upon us to adopt a systematic yet personalized plan of care that is effective, cost conscious, culturally and developmentally appropriate, and safe—and that plan may or may not include prescribing narcotics. We have much work ahead of us in order to minimize the potential for misuse of these medications without impeding patients’ access to necessary health care.

Please share your thoughts on this conundrum by writing to [email protected].

The American Academy of Pediatrics released a new set of recommendations for the appropriate amount of screen time for children and adolescents in October 2016.

Among other changes, the AAP now recommends no screen time (except for video chatting) for infants and children up to 18 months old. For 18- to 24-month-olds, the AAP discourages screen time, recommending that parents introduce only selected “high-quality” programming and cowatch with their children. Likewise, for children up to 5 years old, the AAP urges parents to limit all screen time to 1 hour/day, half of its previous recommendation, and again recommends that parents cowatch with their children and use only reliable providers of quality content, such as the Public Broadcasting Service (PBS). For older children, the AAP does not set specific time limits, but recommends that parents collaborate with the children on a media plan that limits screen time so that it does not interfere with other important activities, including homework, social time, exercise, and sleep.

BunnyHollywood/iStockphoto.com

Dr. Swick is an attending psychiatrist in the division of child psychiatry at Massachusetts General Hospital, Boston, and director of the Parenting at a Challenging Time (PACT) Program at the Vernon Cancer Center at Newton Wellesley Hospital, also in Boston. Dr. Jellinek is professor emeritus of psychiatry and pediatrics, Harvard Medical School, Boston. Email them at [email protected].

The American Academy of Pediatrics released a new set of recommendations for the appropriate amount of screen time for children and adolescents in October 2016.

Among other changes, the AAP now recommends no screen time (except for video chatting) for infants and children up to 18 months old. For 18- to 24-month-olds, the AAP discourages screen time, recommending that parents introduce only selected “high-quality” programming and cowatch with their children. Likewise, for children up to 5 years old, the AAP urges parents to limit all screen time to 1 hour/day, half of its previous recommendation, and again recommends that parents cowatch with their children and use only reliable providers of quality content, such as the Public Broadcasting Service (PBS). For older children, the AAP does not set specific time limits, but recommends that parents collaborate with the children on a media plan that limits screen time so that it does not interfere with other important activities, including homework, social time, exercise, and sleep.

BunnyHollywood/iStockphoto.com

Dr. Swick is an attending psychiatrist in the division of child psychiatry at Massachusetts General Hospital, Boston, and director of the Parenting at a Challenging Time (PACT) Program at the Vernon Cancer Center at Newton Wellesley Hospital, also in Boston. Dr. Jellinek is professor emeritus of psychiatry and pediatrics, Harvard Medical School, Boston. Email them at [email protected].

The American Academy of Pediatrics released a new set of recommendations for the appropriate amount of screen time for children and adolescents in October 2016.

Among other changes, the AAP now recommends no screen time (except for video chatting) for infants and children up to 18 months old. For 18- to 24-month-olds, the AAP discourages screen time, recommending that parents introduce only selected “high-quality” programming and cowatch with their children. Likewise, for children up to 5 years old, the AAP urges parents to limit all screen time to 1 hour/day, half of its previous recommendation, and again recommends that parents cowatch with their children and use only reliable providers of quality content, such as the Public Broadcasting Service (PBS). For older children, the AAP does not set specific time limits, but recommends that parents collaborate with the children on a media plan that limits screen time so that it does not interfere with other important activities, including homework, social time, exercise, and sleep.

BunnyHollywood/iStockphoto.com

Dr. Swick is an attending psychiatrist in the division of child psychiatry at Massachusetts General Hospital, Boston, and director of the Parenting at a Challenging Time (PACT) Program at the Vernon Cancer Center at Newton Wellesley Hospital, also in Boston. Dr. Jellinek is professor emeritus of psychiatry and pediatrics, Harvard Medical School, Boston. Email them at [email protected].

The Centers for Disease Control and Prevention released results from the first nationally representative study on health risk behaviors of gay, lesbian, and bisexual (GLB) high school students in August 2016.

These data were collected through the Youth Risk Behavior Survey (YRBS) questionnaire. The YRBS questionnaire was developed in 1990 as a way to monitor health-related behaviors that contribute to the leading causes of mortality and morbidity in youth and young adults. Areas covered by the survey include behaviors related to unintentional injuries and violence, tobacco use, alcohol and other drug use, sexual behaviors, dietary behaviors, and physical activity. Data are collected every 2 years through national, state, territorial, tribal government, and local school-based surveys of representative samples of 9th-12th grade students.

Selected questionnaire results

Sexual identity

• 88.8% of students identified as heterosexual.

• 6.0% identified as bisexual.

• 3.2% were not sure.

• 2.0% identified as gay or lesbian.

Sexual behaviors

• 48% had had sexual contact with the opposite sex only.

• 4.6% had sexual contact with both sexes.

• 1.7% had had sexual contact with the same sex only.

• 45.7% had no sexual contact.

Mental health

Percent of students who reported making a suicide plan in the 12 months preceding the survey:

• 11.9% of heterosexual students.

• 27.9% of students not sure of sexual identity.

• 38.2% of gay, lesbian, bisexual (GLB) students.

Percent of students who attempted suicide in the 12 months preceding the survey:

• 6.4% of heterosexual students.

• 13.7% of students not sure of sexual identity.

• 29.4% of GLB students.

Sexual Behaviors

First sex before the age of 13:

• 3.4% of heterosexual students.

• 8.8% of students not sure of their sexual identity.

• 7.3% of GLB students.

Drank alcohol or used drugs before last sex:

• 20.0% of heterosexual students.

• 44.5% of students not sure of their sexual identity.

• 22.4% of GLB students.

Tested for HIV:

• 9.3% of heterosexual students.

• 12.8% of students not sure of their sexual identity.

• 18.2% of GLB students.

Substance use

Currently smoking cigarettes daily:

• 1.9% of heterosexual students.

• 7.0% of students not sure of their sexual identity.

• 4.0% of GLB students.

Current alcohol use:

• 32.1% of heterosexual students.

• 34.6% of students not sure of their sexual identity.

• 40.5% of GLB students.

Current marijuana use:

• 20.7% of heterosexual students.

• 26.0% of students not sure of their sexual identity.

• 32.0% of GLB students.

Used hallucinogenic drugs (such as LSD, acid, PCP, angel dust, mescaline, or mushrooms):

• 5.5% of heterosexual students.

• 15.7% of students not sure of their sexual identity.

• 11.5% of GLB students.

Ever used heroin:

• 1.3% of heterosexual students.

• 9.3% of students not sure of their sexual identity.

• 6.0% of GLB students.

Ever took prescription drugs without a doctor’s prescription:

15.5% of heterosexual students.

24.3% of students not sure of their sexual identity.

27.5% of GLB students.

Physical Activity

Did not participate in at least 60 minutes of physical activity on at least 1 day in past week:

• 12.6% of heterosexual students.

• 27.0% of students not sure of their sexual identity.

• 25.7% of GLB students.

Dr. Chelvakumar is an attending physician in the division of adolescent medicine at Nationwide Children’s Hospital and an assistant professor of clinical pediatrics at the Ohio State University, both in Columbus.

The Centers for Disease Control and Prevention released results from the first nationally representative study on health risk behaviors of gay, lesbian, and bisexual (GLB) high school students in August 2016.

These data were collected through the Youth Risk Behavior Survey (YRBS) questionnaire. The YRBS questionnaire was developed in 1990 as a way to monitor health-related behaviors that contribute to the leading causes of mortality and morbidity in youth and young adults. Areas covered by the survey include behaviors related to unintentional injuries and violence, tobacco use, alcohol and other drug use, sexual behaviors, dietary behaviors, and physical activity. Data are collected every 2 years through national, state, territorial, tribal government, and local school-based surveys of representative samples of 9th-12th grade students.

Selected questionnaire results

Sexual identity

• 88.8% of students identified as heterosexual.

• 6.0% identified as bisexual.

• 3.2% were not sure.

• 2.0% identified as gay or lesbian.

Sexual behaviors

• 48% had had sexual contact with the opposite sex only.

• 4.6% had sexual contact with both sexes.

• 1.7% had had sexual contact with the same sex only.

• 45.7% had no sexual contact.

Mental health

Percent of students who reported making a suicide plan in the 12 months preceding the survey:

• 11.9% of heterosexual students.

• 27.9% of students not sure of sexual identity.

• 38.2% of gay, lesbian, bisexual (GLB) students.

Percent of students who attempted suicide in the 12 months preceding the survey:

• 6.4% of heterosexual students.

• 13.7% of students not sure of sexual identity.

• 29.4% of GLB students.

Sexual Behaviors

First sex before the age of 13:

• 3.4% of heterosexual students.

• 8.8% of students not sure of their sexual identity.

• 7.3% of GLB students.

Drank alcohol or used drugs before last sex:

• 20.0% of heterosexual students.

• 44.5% of students not sure of their sexual identity.

• 22.4% of GLB students.

Tested for HIV:

• 9.3% of heterosexual students.

• 12.8% of students not sure of their sexual identity.

• 18.2% of GLB students.

Substance use

Currently smoking cigarettes daily:

• 1.9% of heterosexual students.

• 7.0% of students not sure of their sexual identity.

• 4.0% of GLB students.

Current alcohol use:

• 32.1% of heterosexual students.

• 34.6% of students not sure of their sexual identity.

• 40.5% of GLB students.

Current marijuana use:

• 20.7% of heterosexual students.

• 26.0% of students not sure of their sexual identity.

• 32.0% of GLB students.

Used hallucinogenic drugs (such as LSD, acid, PCP, angel dust, mescaline, or mushrooms):

• 5.5% of heterosexual students.

• 15.7% of students not sure of their sexual identity.

• 11.5% of GLB students.

Ever used heroin:

• 1.3% of heterosexual students.

• 9.3% of students not sure of their sexual identity.

• 6.0% of GLB students.

Ever took prescription drugs without a doctor’s prescription:

15.5% of heterosexual students.

24.3% of students not sure of their sexual identity.

27.5% of GLB students.

Physical Activity

Did not participate in at least 60 minutes of physical activity on at least 1 day in past week:

• 12.6% of heterosexual students.

• 27.0% of students not sure of their sexual identity.

• 25.7% of GLB students.

Dr. Chelvakumar is an attending physician in the division of adolescent medicine at Nationwide Children’s Hospital and an assistant professor of clinical pediatrics at the Ohio State University, both in Columbus.

The Centers for Disease Control and Prevention released results from the first nationally representative study on health risk behaviors of gay, lesbian, and bisexual (GLB) high school students in August 2016.

These data were collected through the Youth Risk Behavior Survey (YRBS) questionnaire. The YRBS questionnaire was developed in 1990 as a way to monitor health-related behaviors that contribute to the leading causes of mortality and morbidity in youth and young adults. Areas covered by the survey include behaviors related to unintentional injuries and violence, tobacco use, alcohol and other drug use, sexual behaviors, dietary behaviors, and physical activity. Data are collected every 2 years through national, state, territorial, tribal government, and local school-based surveys of representative samples of 9th-12th grade students.

Selected questionnaire results

Sexual identity

• 88.8% of students identified as heterosexual.

• 6.0% identified as bisexual.

• 3.2% were not sure.

• 2.0% identified as gay or lesbian.

Sexual behaviors

• 48% had had sexual contact with the opposite sex only.

• 4.6% had sexual contact with both sexes.

• 1.7% had had sexual contact with the same sex only.

• 45.7% had no sexual contact.

Mental health

Percent of students who reported making a suicide plan in the 12 months preceding the survey:

• 11.9% of heterosexual students.

• 27.9% of students not sure of sexual identity.

• 38.2% of gay, lesbian, bisexual (GLB) students.

Percent of students who attempted suicide in the 12 months preceding the survey:

• 6.4% of heterosexual students.

• 13.7% of students not sure of sexual identity.

• 29.4% of GLB students.

Sexual Behaviors

First sex before the age of 13:

• 3.4% of heterosexual students.

• 8.8% of students not sure of their sexual identity.

• 7.3% of GLB students.

Drank alcohol or used drugs before last sex:

• 20.0% of heterosexual students.

• 44.5% of students not sure of their sexual identity.

• 22.4% of GLB students.

Tested for HIV:

• 9.3% of heterosexual students.

• 12.8% of students not sure of their sexual identity.

• 18.2% of GLB students.

Substance use

Currently smoking cigarettes daily:

• 1.9% of heterosexual students.

• 7.0% of students not sure of their sexual identity.

• 4.0% of GLB students.

Current alcohol use:

• 32.1% of heterosexual students.

• 34.6% of students not sure of their sexual identity.

• 40.5% of GLB students.

Current marijuana use:

• 20.7% of heterosexual students.

• 26.0% of students not sure of their sexual identity.

• 32.0% of GLB students.

Used hallucinogenic drugs (such as LSD, acid, PCP, angel dust, mescaline, or mushrooms):

• 5.5% of heterosexual students.

• 15.7% of students not sure of their sexual identity.

• 11.5% of GLB students.

Ever used heroin:

• 1.3% of heterosexual students.

• 9.3% of students not sure of their sexual identity.

• 6.0% of GLB students.

Ever took prescription drugs without a doctor’s prescription:

15.5% of heterosexual students.

24.3% of students not sure of their sexual identity.

27.5% of GLB students.

Physical Activity

Did not participate in at least 60 minutes of physical activity on at least 1 day in past week:

• 12.6% of heterosexual students.

• 27.0% of students not sure of their sexual identity.

• 25.7% of GLB students.

Dr. Chelvakumar is an attending physician in the division of adolescent medicine at Nationwide Children’s Hospital and an assistant professor of clinical pediatrics at the Ohio State University, both in Columbus.