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Prenatal SSRI exposure’s effect on development
Unfortunately, the bottom line for most of these important questions is that we really don’t know as much as we probably should.
Just when we’ve read a convincing finding from a reputable journal that establishes a link between prenatal SSRI use and an untoward outcome, we see it disputed the next month. Why is this always happening, and why can’t we really know anything with certainty? Much of the confusion can be attributed to research methods and the obvious difficulty of using randomized, controlled trials to control for potential confounding factors. While statistical techniques have become increasingly sophisticated in addressing these confounding factors, they remain imperfect. For example, one of the most difficult challenges that remains is separating any effects of a medication from any effects caused by the condition it was designed to treat. Comparing women with the same underlying condition, some of whom are treated with a medication and some of whom are not, is a step forward, but there may be important reasons that one group decides to seek treatment and the other doesn’t. One clever research design that was employed to look at congenital anomalies in the offspring of women taking SSRIs accounted for siblings of these children who were born when their mother was not taking an SSRI. This study demonstrated that these women were more likely to have children with congenital malformations even when they weren’t taking the SSRIs.1 Other factors that render this literature difficult to interpret include small sample sizes when looking at specific SSRIs (many studies cluster them all), dose effects, timing (which trimester), duration of treatment, and method of recording compliance.
The potential link between SSRIs and autism has received a fair amount of attention lately, especially after a very well-designed study in 2016 suggested a significantly increased risk.10 However, as with many of the findings, this study was quickly disputed by other high-quality, well-powered research that found no increased risk after controlling for maternal illness.11,12
ADHD generally has not been found to be related to maternal SSRI use, although one study did find a link between ADHD and tricyclic antidepressants.12,13
In terms of other neurodevelopmental outcomes, there have been many negative studies examining IQ, nonverbal communication, as well as speech and motor skills.14,15,16 However, as with so many other outcomes, some other studies contradict these negative results. According to a recent, large cohort study, there may be some concern regarding SSRI exposure prenatally and an increase in speech disorders by age 14 years, as well as lower language competence at age 3 years.17,18 Likewise, mild motor abnormalities have been observed, with maternal depression severity as an independent but contributing factor.19
Several studies demonstrate a connection between prenatal SSRI exposure and childhood internalizing symptoms, such as depression and anxiety, independent of maternal depression.12,20 These findings must be balanced with our knowledge of the serious mental health conditions in offspring that are associated with untreated maternal illness, including both internalizing and externalizing disorders.21,22
How does one come to any firm conclusions to guide a primary care clinician’s practice and recommendations? Hopefully, the evidence will become clearer over time as we adopt more sophisticated designs and accumulate observations. A larger number of observations would allow us to decrease heterogeneity by studying subgroups according to type of SSRI and duration of exposure. Enhanced understanding of the role of genetic factors also may shed some light on individual variation as the serotonin transporter gene has been suggested as a potential moderator of sensitivity.23
Dr. Guth is an assistant professor in the department of psychiatry at the University of Vermont Medical Center and the University of Vermont Robert Larner College of Medicine, both in Burlington. She works with children and adolescents as well as women in the perinatal period. She has no relevant financial disclosures.
References
1. BMJ. 2015 Apr 17;350:h1798.
2. Can J Clin Pharmacol. 2009 Winter;16(1):e66-7.
3. J Matern Fetal Neonatal Med. 2008 Oct;21(10):745-51.
4. PLoS ONE. 2014 Nov; 9(11): e111327.
5. Pediatr Res. 2017 Jun 30. doi: 10.1038/pr.2017.156. [Epub ahead of print].
6. J Clin Psychiatry. 2017 May;78(5):605-11.
7. Acta Psychiatr Scand. 2010 Jun;121(6):471-9.
8. Am J Psychiatry. 2016 Feb 1;173(2):147-57.
9. J Perinatol. 2011 Sep;31(9):615-20.
10. JAMA Pediatr. 2016 Feb;170(2):117-24.
11. JAMA. 2017 Apr 18;317(15):1544-52.
12. J Am Acad Child Adolesc Psychiatry. 2016 May;55(5):359-66.
13. Paediatr Perinat Epidemiol. 2017 Jul;31(4):363-73.
14. Acta Obstet Gynecol Scand. 2015 May;94(5):501-7.
15. J Psychopharmacol. 2017 Mar;31(3):346-55.
16. CNS Drugs. 2005;19(7):623-33.
17. JAMA Psychiatry. 2016 Nov 1;73(11):1163-70.
18. BJOG. 2014. doi: 10.1111/1471-0528.12821.
19. BJOG. 2016 Nov;123(12):1908-17.
20. Pediatr Res. 2015 Aug;78(2):174-80.
21. Neuroscience. 2017 Feb 7;342:154-66.
22. Depress Anxiety. 2014 Jan;31(1):9-18.
23. Neuroscience. 2017 Feb 7;342:212-31.
Unfortunately, the bottom line for most of these important questions is that we really don’t know as much as we probably should.
Just when we’ve read a convincing finding from a reputable journal that establishes a link between prenatal SSRI use and an untoward outcome, we see it disputed the next month. Why is this always happening, and why can’t we really know anything with certainty? Much of the confusion can be attributed to research methods and the obvious difficulty of using randomized, controlled trials to control for potential confounding factors. While statistical techniques have become increasingly sophisticated in addressing these confounding factors, they remain imperfect. For example, one of the most difficult challenges that remains is separating any effects of a medication from any effects caused by the condition it was designed to treat. Comparing women with the same underlying condition, some of whom are treated with a medication and some of whom are not, is a step forward, but there may be important reasons that one group decides to seek treatment and the other doesn’t. One clever research design that was employed to look at congenital anomalies in the offspring of women taking SSRIs accounted for siblings of these children who were born when their mother was not taking an SSRI. This study demonstrated that these women were more likely to have children with congenital malformations even when they weren’t taking the SSRIs.1 Other factors that render this literature difficult to interpret include small sample sizes when looking at specific SSRIs (many studies cluster them all), dose effects, timing (which trimester), duration of treatment, and method of recording compliance.
The potential link between SSRIs and autism has received a fair amount of attention lately, especially after a very well-designed study in 2016 suggested a significantly increased risk.10 However, as with many of the findings, this study was quickly disputed by other high-quality, well-powered research that found no increased risk after controlling for maternal illness.11,12
ADHD generally has not been found to be related to maternal SSRI use, although one study did find a link between ADHD and tricyclic antidepressants.12,13
In terms of other neurodevelopmental outcomes, there have been many negative studies examining IQ, nonverbal communication, as well as speech and motor skills.14,15,16 However, as with so many other outcomes, some other studies contradict these negative results. According to a recent, large cohort study, there may be some concern regarding SSRI exposure prenatally and an increase in speech disorders by age 14 years, as well as lower language competence at age 3 years.17,18 Likewise, mild motor abnormalities have been observed, with maternal depression severity as an independent but contributing factor.19
Several studies demonstrate a connection between prenatal SSRI exposure and childhood internalizing symptoms, such as depression and anxiety, independent of maternal depression.12,20 These findings must be balanced with our knowledge of the serious mental health conditions in offspring that are associated with untreated maternal illness, including both internalizing and externalizing disorders.21,22
How does one come to any firm conclusions to guide a primary care clinician’s practice and recommendations? Hopefully, the evidence will become clearer over time as we adopt more sophisticated designs and accumulate observations. A larger number of observations would allow us to decrease heterogeneity by studying subgroups according to type of SSRI and duration of exposure. Enhanced understanding of the role of genetic factors also may shed some light on individual variation as the serotonin transporter gene has been suggested as a potential moderator of sensitivity.23
Dr. Guth is an assistant professor in the department of psychiatry at the University of Vermont Medical Center and the University of Vermont Robert Larner College of Medicine, both in Burlington. She works with children and adolescents as well as women in the perinatal period. She has no relevant financial disclosures.
References
1. BMJ. 2015 Apr 17;350:h1798.
2. Can J Clin Pharmacol. 2009 Winter;16(1):e66-7.
3. J Matern Fetal Neonatal Med. 2008 Oct;21(10):745-51.
4. PLoS ONE. 2014 Nov; 9(11): e111327.
5. Pediatr Res. 2017 Jun 30. doi: 10.1038/pr.2017.156. [Epub ahead of print].
6. J Clin Psychiatry. 2017 May;78(5):605-11.
7. Acta Psychiatr Scand. 2010 Jun;121(6):471-9.
8. Am J Psychiatry. 2016 Feb 1;173(2):147-57.
9. J Perinatol. 2011 Sep;31(9):615-20.
10. JAMA Pediatr. 2016 Feb;170(2):117-24.
11. JAMA. 2017 Apr 18;317(15):1544-52.
12. J Am Acad Child Adolesc Psychiatry. 2016 May;55(5):359-66.
13. Paediatr Perinat Epidemiol. 2017 Jul;31(4):363-73.
14. Acta Obstet Gynecol Scand. 2015 May;94(5):501-7.
15. J Psychopharmacol. 2017 Mar;31(3):346-55.
16. CNS Drugs. 2005;19(7):623-33.
17. JAMA Psychiatry. 2016 Nov 1;73(11):1163-70.
18. BJOG. 2014. doi: 10.1111/1471-0528.12821.
19. BJOG. 2016 Nov;123(12):1908-17.
20. Pediatr Res. 2015 Aug;78(2):174-80.
21. Neuroscience. 2017 Feb 7;342:154-66.
22. Depress Anxiety. 2014 Jan;31(1):9-18.
23. Neuroscience. 2017 Feb 7;342:212-31.
Unfortunately, the bottom line for most of these important questions is that we really don’t know as much as we probably should.
Just when we’ve read a convincing finding from a reputable journal that establishes a link between prenatal SSRI use and an untoward outcome, we see it disputed the next month. Why is this always happening, and why can’t we really know anything with certainty? Much of the confusion can be attributed to research methods and the obvious difficulty of using randomized, controlled trials to control for potential confounding factors. While statistical techniques have become increasingly sophisticated in addressing these confounding factors, they remain imperfect. For example, one of the most difficult challenges that remains is separating any effects of a medication from any effects caused by the condition it was designed to treat. Comparing women with the same underlying condition, some of whom are treated with a medication and some of whom are not, is a step forward, but there may be important reasons that one group decides to seek treatment and the other doesn’t. One clever research design that was employed to look at congenital anomalies in the offspring of women taking SSRIs accounted for siblings of these children who were born when their mother was not taking an SSRI. This study demonstrated that these women were more likely to have children with congenital malformations even when they weren’t taking the SSRIs.1 Other factors that render this literature difficult to interpret include small sample sizes when looking at specific SSRIs (many studies cluster them all), dose effects, timing (which trimester), duration of treatment, and method of recording compliance.
The potential link between SSRIs and autism has received a fair amount of attention lately, especially after a very well-designed study in 2016 suggested a significantly increased risk.10 However, as with many of the findings, this study was quickly disputed by other high-quality, well-powered research that found no increased risk after controlling for maternal illness.11,12
ADHD generally has not been found to be related to maternal SSRI use, although one study did find a link between ADHD and tricyclic antidepressants.12,13
In terms of other neurodevelopmental outcomes, there have been many negative studies examining IQ, nonverbal communication, as well as speech and motor skills.14,15,16 However, as with so many other outcomes, some other studies contradict these negative results. According to a recent, large cohort study, there may be some concern regarding SSRI exposure prenatally and an increase in speech disorders by age 14 years, as well as lower language competence at age 3 years.17,18 Likewise, mild motor abnormalities have been observed, with maternal depression severity as an independent but contributing factor.19
Several studies demonstrate a connection between prenatal SSRI exposure and childhood internalizing symptoms, such as depression and anxiety, independent of maternal depression.12,20 These findings must be balanced with our knowledge of the serious mental health conditions in offspring that are associated with untreated maternal illness, including both internalizing and externalizing disorders.21,22
How does one come to any firm conclusions to guide a primary care clinician’s practice and recommendations? Hopefully, the evidence will become clearer over time as we adopt more sophisticated designs and accumulate observations. A larger number of observations would allow us to decrease heterogeneity by studying subgroups according to type of SSRI and duration of exposure. Enhanced understanding of the role of genetic factors also may shed some light on individual variation as the serotonin transporter gene has been suggested as a potential moderator of sensitivity.23
Dr. Guth is an assistant professor in the department of psychiatry at the University of Vermont Medical Center and the University of Vermont Robert Larner College of Medicine, both in Burlington. She works with children and adolescents as well as women in the perinatal period. She has no relevant financial disclosures.
References
1. BMJ. 2015 Apr 17;350:h1798.
2. Can J Clin Pharmacol. 2009 Winter;16(1):e66-7.
3. J Matern Fetal Neonatal Med. 2008 Oct;21(10):745-51.
4. PLoS ONE. 2014 Nov; 9(11): e111327.
5. Pediatr Res. 2017 Jun 30. doi: 10.1038/pr.2017.156. [Epub ahead of print].
6. J Clin Psychiatry. 2017 May;78(5):605-11.
7. Acta Psychiatr Scand. 2010 Jun;121(6):471-9.
8. Am J Psychiatry. 2016 Feb 1;173(2):147-57.
9. J Perinatol. 2011 Sep;31(9):615-20.
10. JAMA Pediatr. 2016 Feb;170(2):117-24.
11. JAMA. 2017 Apr 18;317(15):1544-52.
12. J Am Acad Child Adolesc Psychiatry. 2016 May;55(5):359-66.
13. Paediatr Perinat Epidemiol. 2017 Jul;31(4):363-73.
14. Acta Obstet Gynecol Scand. 2015 May;94(5):501-7.
15. J Psychopharmacol. 2017 Mar;31(3):346-55.
16. CNS Drugs. 2005;19(7):623-33.
17. JAMA Psychiatry. 2016 Nov 1;73(11):1163-70.
18. BJOG. 2014. doi: 10.1111/1471-0528.12821.
19. BJOG. 2016 Nov;123(12):1908-17.
20. Pediatr Res. 2015 Aug;78(2):174-80.
21. Neuroscience. 2017 Feb 7;342:154-66.
22. Depress Anxiety. 2014 Jan;31(1):9-18.
23. Neuroscience. 2017 Feb 7;342:212-31.
Depression in adolescence
As many as 20% of children and adolescents experience a psychiatric disorder, with 50% of all lifetime psychiatric illnesses occurring by the age of 14 years. ADHD and depression are among the most common. The National Institutes of Health estimate that, in 2015, 3 million 12- to 17-year-old American children experienced a major depressive episode. Any illness that affects over 10% of adolescents will present regularly in the primary care provider’s office. It is important to know whom to screen and how to start treatment when your patient appears to be suffering from this serious but treatable condition.
While there are many screening instruments, it is important to be ready to ask patients diagnostic questions when your clinical suspicion of depression is high. In addition to asking about mood, sleep, appetite, energy, and the other DSM5 criteria of a major depressive episode, it is important to remember that teens with depression might present with irritability as much as sadness. While they lose interest in school, sports, or hobbies, they still may be distracted or cheered up by friends. And 
Explain to your patient (and their parents) that depression is very treatable, but most effective treatments take time. Psychotherapy usually works over several months, and even effective medications can take 6 weeks or more. But, without treatment, their symptoms may persist for over a year and can disrupt their healthy development.
This is also a good time to ask your patient about suicidal thoughts. Have they been imagining how their death would affect others? Wishing they could just sleep? Do they have a plan? Do they have access to a means of killing themselves? Do they feel attached or connected to family, friends, religion, or a goal? Explain to your patient that these thoughts are common symptoms of depression, and work with their parents to ensure that they are connected and safe when starting treatment.
Psychotherapy is considered the first line treatment for mild to moderate episodes of depression and should be used alongside medications in severe episodes. While structured therapies such as cognitive behavioral therapy or interpersonal therapy have a strong evidence base to support their use, the best predictor of an effective therapy appears to be a strong alliance between therapist and patient. So, help your patient to find a therapist, and explain the importance of finding someone with whom they feel comfortable. Suggest to your patients that they have three visits with a new therapist to see if it feels like a “good match,” before considering trying another.
Finally, antidepressant medications are first-line treatment for more severe episodes of depression and episodes in which significant suicidal ideation or functional impairment are present. If the symptoms are more severe, or if therapy alone has not been effective after 4-6 weeks, you might consider starting antidepressant treatment. Psychiatrists usually start with an selective serotonin reuptake inhibitor, typically of a medium half-life, at a low dose to minimize the chances of side effects. While real efficacy takes up to 6 weeks, there should be some improvement in energy within the first 2 weeks on an effective medication. If there is no change, the dose can be raised gradually as tolerated. It is important to tell patients and their families about common side effects (mild GI upset) and the more rare but dangerous ones (such as hypomania or an increase in the frequency or intensity of suicidal thoughts).
Even when you do not refer your patient to someone else for treatment of depression, it is important that you not be alone in their management. Work closely with their therapist or consider having a psychiatric social worker join your team to offer therapy in close connection with your management. You might also periodically consult with a child psychiatrist to address treatment and medication questions and identify needed resources. Staying in touch with parents or connected adults at school (with the appropriate permission) can be very useful with those patients you are more concerned about. The educated and attuned primary care provider can provide thoughtful first-line treatment of depression in young people and can be an important part of managing this public health challenge. It is always rewarding to help an adolescent overcome depression.
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].
As many as 20% of children and adolescents experience a psychiatric disorder, with 50% of all lifetime psychiatric illnesses occurring by the age of 14 years. ADHD and depression are among the most common. The National Institutes of Health estimate that, in 2015, 3 million 12- to 17-year-old American children experienced a major depressive episode. Any illness that affects over 10% of adolescents will present regularly in the primary care provider’s office. It is important to know whom to screen and how to start treatment when your patient appears to be suffering from this serious but treatable condition.
While there are many screening instruments, it is important to be ready to ask patients diagnostic questions when your clinical suspicion of depression is high. In addition to asking about mood, sleep, appetite, energy, and the other DSM5 criteria of a major depressive episode, it is important to remember that teens with depression might present with irritability as much as sadness. While they lose interest in school, sports, or hobbies, they still may be distracted or cheered up by friends. And
Explain to your patient (and their parents) that depression is very treatable, but most effective treatments take time. Psychotherapy usually works over several months, and even effective medications can take 6 weeks or more. But, without treatment, their symptoms may persist for over a year and can disrupt their healthy development.
This is also a good time to ask your patient about suicidal thoughts. Have they been imagining how their death would affect others? Wishing they could just sleep? Do they have a plan? Do they have access to a means of killing themselves? Do they feel attached or connected to family, friends, religion, or a goal? Explain to your patient that these thoughts are common symptoms of depression, and work with their parents to ensure that they are connected and safe when starting treatment.
Psychotherapy is considered the first line treatment for mild to moderate episodes of depression and should be used alongside medications in severe episodes. While structured therapies such as cognitive behavioral therapy or interpersonal therapy have a strong evidence base to support their use, the best predictor of an effective therapy appears to be a strong alliance between therapist and patient. So, help your patient to find a therapist, and explain the importance of finding someone with whom they feel comfortable. Suggest to your patients that they have three visits with a new therapist to see if it feels like a “good match,” before considering trying another.
Finally, antidepressant medications are first-line treatment for more severe episodes of depression and episodes in which significant suicidal ideation or functional impairment are present. If the symptoms are more severe, or if therapy alone has not been effective after 4-6 weeks, you might consider starting antidepressant treatment. Psychiatrists usually start with an selective serotonin reuptake inhibitor, typically of a medium half-life, at a low dose to minimize the chances of side effects. While real efficacy takes up to 6 weeks, there should be some improvement in energy within the first 2 weeks on an effective medication. If there is no change, the dose can be raised gradually as tolerated. It is important to tell patients and their families about common side effects (mild GI upset) and the more rare but dangerous ones (such as hypomania or an increase in the frequency or intensity of suicidal thoughts).
Even when you do not refer your patient to someone else for treatment of depression, it is important that you not be alone in their management. Work closely with their therapist or consider having a psychiatric social worker join your team to offer therapy in close connection with your management. You might also periodically consult with a child psychiatrist to address treatment and medication questions and identify needed resources. Staying in touch with parents or connected adults at school (with the appropriate permission) can be very useful with those patients you are more concerned about. The educated and attuned primary care provider can provide thoughtful first-line treatment of depression in young people and can be an important part of managing this public health challenge. It is always rewarding to help an adolescent overcome depression.
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].
As many as 20% of children and adolescents experience a psychiatric disorder, with 50% of all lifetime psychiatric illnesses occurring by the age of 14 years. ADHD and depression are among the most common. The National Institutes of Health estimate that, in 2015, 3 million 12- to 17-year-old American children experienced a major depressive episode. Any illness that affects over 10% of adolescents will present regularly in the primary care provider’s office. It is important to know whom to screen and how to start treatment when your patient appears to be suffering from this serious but treatable condition.
While there are many screening instruments, it is important to be ready to ask patients diagnostic questions when your clinical suspicion of depression is high. In addition to asking about mood, sleep, appetite, energy, and the other DSM5 criteria of a major depressive episode, it is important to remember that teens with depression might present with irritability as much as sadness. While they lose interest in school, sports, or hobbies, they still may be distracted or cheered up by friends. And
Explain to your patient (and their parents) that depression is very treatable, but most effective treatments take time. Psychotherapy usually works over several months, and even effective medications can take 6 weeks or more. But, without treatment, their symptoms may persist for over a year and can disrupt their healthy development.
This is also a good time to ask your patient about suicidal thoughts. Have they been imagining how their death would affect others? Wishing they could just sleep? Do they have a plan? Do they have access to a means of killing themselves? Do they feel attached or connected to family, friends, religion, or a goal? Explain to your patient that these thoughts are common symptoms of depression, and work with their parents to ensure that they are connected and safe when starting treatment.
Psychotherapy is considered the first line treatment for mild to moderate episodes of depression and should be used alongside medications in severe episodes. While structured therapies such as cognitive behavioral therapy or interpersonal therapy have a strong evidence base to support their use, the best predictor of an effective therapy appears to be a strong alliance between therapist and patient. So, help your patient to find a therapist, and explain the importance of finding someone with whom they feel comfortable. Suggest to your patients that they have three visits with a new therapist to see if it feels like a “good match,” before considering trying another.
Finally, antidepressant medications are first-line treatment for more severe episodes of depression and episodes in which significant suicidal ideation or functional impairment are present. If the symptoms are more severe, or if therapy alone has not been effective after 4-6 weeks, you might consider starting antidepressant treatment. Psychiatrists usually start with an selective serotonin reuptake inhibitor, typically of a medium half-life, at a low dose to minimize the chances of side effects. While real efficacy takes up to 6 weeks, there should be some improvement in energy within the first 2 weeks on an effective medication. If there is no change, the dose can be raised gradually as tolerated. It is important to tell patients and their families about common side effects (mild GI upset) and the more rare but dangerous ones (such as hypomania or an increase in the frequency or intensity of suicidal thoughts).
Even when you do not refer your patient to someone else for treatment of depression, it is important that you not be alone in their management. Work closely with their therapist or consider having a psychiatric social worker join your team to offer therapy in close connection with your management. You might also periodically consult with a child psychiatrist to address treatment and medication questions and identify needed resources. Staying in touch with parents or connected adults at school (with the appropriate permission) can be very useful with those patients you are more concerned about. The educated and attuned primary care provider can provide thoughtful first-line treatment of depression in young people and can be an important part of managing this public health challenge. It is always rewarding to help an adolescent overcome depression.
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].
Debunking false claims about mental illness and violence
On July 27, 2015, Lai Hang shot and killed her son, George, at the Valley Hotel in Rosemead, Calif. Ms. Hang had been diagnosed with terminal cancer a few months prior and was concerned about the future of her son. George was almost 18 and diagnosed with schizophrenia.
In thinking about why Ms. Hang chose this act, I can’t help but wonder about our role in perpetuating the myth that mental illness and violence go hand in hand.
Loss and tough adjustment
George had been born to Lai and Peter Hang, who moved to the United States in 1992 from the southeast Asian country of Laos to open a printing shop and pursue the “American dream.” In 2012, Peter Hang was diagnosed with metastatic cancer and died, a development that was a severe stressor for George.
Over a period of months, George reportedly started withdrawing from friends and acting differently. He destroyed things around the house, including a garden he had planted with a family friend. His grades slipped in school; he was getting report cards full of Fs. He subsequently was diagnosed with schizophrenia. Ms. Hang grew increasingly concerned about him in the context of the multiple highly publicized mass shootings attributed to patients with mental illness.
When George became more interested in Adolf Hitler after a school project on World War II, Ms. Hang’s fear intensified. Her concerns grew even more in the wake of reports of killings by James Holmes in Aurora, Colo.; Adam Lanza in Newtown, Conn.; and Elliot Rodger in the Santa Barbara County, Calif., town of Isla Vista. After the Charleston, S.C., church shootings of June 2015, George Hang reportedly became fixated on Dylann Roof. With increasing distress over her son, Ms. Hang wondered whether anything could have been done to stop those shooters.1
Politicians long have perpetrated the belief that patients with mental illness cause violence. Former President Barack Obama often linked mental illness to gun violence. For example, in a 2016 statement, he said: “While individuals with mental illness are more likely to be victims of violence than perpetrators, incidents of violence continue to highlight a crisis in America’s mental health system.”2
The recent election also was a prime example, with quotes such as: “This isn’t a gun problem; it’s a mental health problem ... these are sick people,” by now-President Donald Trump, and “We are not making sure that someone who is mentally ill can’t get access to a gun”3 by Ohio Gov. John Kasich.
The media also have promoted this view with headlines such as “Get the violent crazies off our streets,” and “They threaten, seethe and unhinge, then kill in quantity.” In one article, the writer contended: “In our newfound complacency, we had forgotten a particular kind of violence to which we are still prey … violence of the mentally ill.”4
How the evidence stacks up
Nonetheless, the scientific evidence contradicts those views. Most reviews on the topic come to conclusions similar to those of Debra A. Pinals, MD, and Lisa Anacker, MD, who recently wrote: “Despite media accounts to the contrary, persons with mental illness account for only a small percentage of persons who commit acts of violence ...”5
Jeffrey W. Swanson, PhD, who has spent his career examining these issues, studied more than 10,000 people with and without mental illness over 1 year, and found that serious mental illness was found in only 4% of the cases of violence. He found three factors that do predict the occurrence of violence: whether the perpetrator was male, poor, or abusing drugs.6 “That study debunked two myths,” Dr. Swanson, professor in the department of psychiatry and behavioral sciences at Duke University, Durham, N.C., reportedly said. “One: people with mental illness are all dangerous. Well, the vast majority are not. And the other myth: that there’s no connection at all. There is one. It’s quite small, but it’s not completely nonexistent.”7
Despite the consistent research on this topic, the voice of psychiatry has been muddled. Many have promoted this intuitive yet wrong narrative. In particular, this approach has been embraced by the Treatment Advocacy Center (TAC), a large nonprofit organization “dedicated to eliminating barriers to the timely and effective treatment of severe mental illness.”
In 2013, E. Fuller Torrey, MD, the executive director of TAC, contended in an interview “about half of … mass killings are being done by people with severe mental illness.” His solution is explicit: “The U.S. would have fewer mass killings if individuals with severe mental illnesses received proper treatment.”8 In a fact that implies tacit approval of Dr. Torrey’s problematic positions, three past presidents of the American Psychiatric Association currently serve on TAC’s board: Jeffrey A. Lieberman, MD; Steven S. Sharfstein, MD; and John A. Talbott, MD.
It is worrying that some psychiatrists have started sounding false alarms again when advocating for laws that support assisted outpatient treatment (AOT). In AOT, an individual meeting specified criteria for mental illness and potentially asserted to have a risk for violence is compelled by court order to comply with outpatient psychiatric treatment as a condition of remaining in the community.9 Some psychiatrists contend that “the relationship between deinstitutionalization and the increasing episodes of violent behavior by individuals with serious mental illness who are not being treated has been firmly established. Until we address the treatment issue and use proven remedies, such as assisted outpatient treatment … we should expect these episodes of violent behavior to continue,” they conclude.10
I am concerned about this issue, not only because of the stigma faced by our patients. I want to prevent our patients from realizing that behind their backs, outside of the office, we speak of them as dangerous and in need of involuntary confinement. I am concerned that patients will no longer trust psychiatrists if we describe them in such scary fashions without even the backing of science. If nonmaleficence is at the cornerstone of medical ethics, maybe as psychiatrists we could start by not falsely accusing our patients of being dangerous.
As Irvin D. Yalom, MD, famously said: “It’s the relationship that heals.” I cannot think of anything more important to my practice than cultivating genuine and meaningful relationships. I work as a psychiatrist with patients who have severe mental illness. They are dehumanized by the system, disenfranchised from society, and feared by the media. My role is to create a relationship that helps them overcome those obstacles.
References
1 Los Angeles Times. May 22, 2017
2 Obama White House Archives, Jan. 4, 2016
3 TheTrace.org. Sept. 1, 2015
4 The Guardian. Oct. 2, 2015
5 Psychiatr Clin N Am. 2016;39:611-21
6 Ann Epidemiol. 2015 May;25(5):366-76
7 The New Yorker. Nov. 19, 2014
8 60 Minutes. Sept. 27, 2013
9 Psychiatr Serv. 2016 Jul 1;67(7):784-6
10 CNS Spectr. 2015 Jun;20(3):207-14
Dr. Badre is a forensic psychiatrist in San Diego and an expert in correctional mental health. He holds teaching positions at the University of California, San Diego; and the University of San Diego. He teaches on medical education, psychopharmacology, ethics in psychiatry, and correctional care. Dr. Badre also mentors several residents on projects, including reduction in the use of solitary confinement of patients with mental illness, reduction in the use of involuntary treatment of the mentally ill, and examination of the mentally ill offender.
On July 27, 2015, Lai Hang shot and killed her son, George, at the Valley Hotel in Rosemead, Calif. Ms. Hang had been diagnosed with terminal cancer a few months prior and was concerned about the future of her son. George was almost 18 and diagnosed with schizophrenia.
In thinking about why Ms. Hang chose this act, I can’t help but wonder about our role in perpetuating the myth that mental illness and violence go hand in hand.
Loss and tough adjustment
George had been born to Lai and Peter Hang, who moved to the United States in 1992 from the southeast Asian country of Laos to open a printing shop and pursue the “American dream.” In 2012, Peter Hang was diagnosed with metastatic cancer and died, a development that was a severe stressor for George.
Over a period of months, George reportedly started withdrawing from friends and acting differently. He destroyed things around the house, including a garden he had planted with a family friend. His grades slipped in school; he was getting report cards full of Fs. He subsequently was diagnosed with schizophrenia. Ms. Hang grew increasingly concerned about him in the context of the multiple highly publicized mass shootings attributed to patients with mental illness.
When George became more interested in Adolf Hitler after a school project on World War II, Ms. Hang’s fear intensified. Her concerns grew even more in the wake of reports of killings by James Holmes in Aurora, Colo.; Adam Lanza in Newtown, Conn.; and Elliot Rodger in the Santa Barbara County, Calif., town of Isla Vista. After the Charleston, S.C., church shootings of June 2015, George Hang reportedly became fixated on Dylann Roof. With increasing distress over her son, Ms. Hang wondered whether anything could have been done to stop those shooters.1
Politicians long have perpetrated the belief that patients with mental illness cause violence. Former President Barack Obama often linked mental illness to gun violence. For example, in a 2016 statement, he said: “While individuals with mental illness are more likely to be victims of violence than perpetrators, incidents of violence continue to highlight a crisis in America’s mental health system.”2
The recent election also was a prime example, with quotes such as: “This isn’t a gun problem; it’s a mental health problem ... these are sick people,” by now-President Donald Trump, and “We are not making sure that someone who is mentally ill can’t get access to a gun”3 by Ohio Gov. John Kasich.
The media also have promoted this view with headlines such as “Get the violent crazies off our streets,” and “They threaten, seethe and unhinge, then kill in quantity.” In one article, the writer contended: “In our newfound complacency, we had forgotten a particular kind of violence to which we are still prey … violence of the mentally ill.”4
How the evidence stacks up
Nonetheless, the scientific evidence contradicts those views. Most reviews on the topic come to conclusions similar to those of Debra A. Pinals, MD, and Lisa Anacker, MD, who recently wrote: “Despite media accounts to the contrary, persons with mental illness account for only a small percentage of persons who commit acts of violence ...”5
Jeffrey W. Swanson, PhD, who has spent his career examining these issues, studied more than 10,000 people with and without mental illness over 1 year, and found that serious mental illness was found in only 4% of the cases of violence. He found three factors that do predict the occurrence of violence: whether the perpetrator was male, poor, or abusing drugs.6 “That study debunked two myths,” Dr. Swanson, professor in the department of psychiatry and behavioral sciences at Duke University, Durham, N.C., reportedly said. “One: people with mental illness are all dangerous. Well, the vast majority are not. And the other myth: that there’s no connection at all. There is one. It’s quite small, but it’s not completely nonexistent.”7
Despite the consistent research on this topic, the voice of psychiatry has been muddled. Many have promoted this intuitive yet wrong narrative. In particular, this approach has been embraced by the Treatment Advocacy Center (TAC), a large nonprofit organization “dedicated to eliminating barriers to the timely and effective treatment of severe mental illness.”
In 2013, E. Fuller Torrey, MD, the executive director of TAC, contended in an interview “about half of … mass killings are being done by people with severe mental illness.” His solution is explicit: “The U.S. would have fewer mass killings if individuals with severe mental illnesses received proper treatment.”8 In a fact that implies tacit approval of Dr. Torrey’s problematic positions, three past presidents of the American Psychiatric Association currently serve on TAC’s board: Jeffrey A. Lieberman, MD; Steven S. Sharfstein, MD; and John A. Talbott, MD.
It is worrying that some psychiatrists have started sounding false alarms again when advocating for laws that support assisted outpatient treatment (AOT). In AOT, an individual meeting specified criteria for mental illness and potentially asserted to have a risk for violence is compelled by court order to comply with outpatient psychiatric treatment as a condition of remaining in the community.9 Some psychiatrists contend that “the relationship between deinstitutionalization and the increasing episodes of violent behavior by individuals with serious mental illness who are not being treated has been firmly established. Until we address the treatment issue and use proven remedies, such as assisted outpatient treatment … we should expect these episodes of violent behavior to continue,” they conclude.10
I am concerned about this issue, not only because of the stigma faced by our patients. I want to prevent our patients from realizing that behind their backs, outside of the office, we speak of them as dangerous and in need of involuntary confinement. I am concerned that patients will no longer trust psychiatrists if we describe them in such scary fashions without even the backing of science. If nonmaleficence is at the cornerstone of medical ethics, maybe as psychiatrists we could start by not falsely accusing our patients of being dangerous.
As Irvin D. Yalom, MD, famously said: “It’s the relationship that heals.” I cannot think of anything more important to my practice than cultivating genuine and meaningful relationships. I work as a psychiatrist with patients who have severe mental illness. They are dehumanized by the system, disenfranchised from society, and feared by the media. My role is to create a relationship that helps them overcome those obstacles.
References
1 Los Angeles Times. May 22, 2017
2 Obama White House Archives, Jan. 4, 2016
3 TheTrace.org. Sept. 1, 2015
4 The Guardian. Oct. 2, 2015
5 Psychiatr Clin N Am. 2016;39:611-21
6 Ann Epidemiol. 2015 May;25(5):366-76
7 The New Yorker. Nov. 19, 2014
8 60 Minutes. Sept. 27, 2013
9 Psychiatr Serv. 2016 Jul 1;67(7):784-6
10 CNS Spectr. 2015 Jun;20(3):207-14
Dr. Badre is a forensic psychiatrist in San Diego and an expert in correctional mental health. He holds teaching positions at the University of California, San Diego; and the University of San Diego. He teaches on medical education, psychopharmacology, ethics in psychiatry, and correctional care. Dr. Badre also mentors several residents on projects, including reduction in the use of solitary confinement of patients with mental illness, reduction in the use of involuntary treatment of the mentally ill, and examination of the mentally ill offender.
On July 27, 2015, Lai Hang shot and killed her son, George, at the Valley Hotel in Rosemead, Calif. Ms. Hang had been diagnosed with terminal cancer a few months prior and was concerned about the future of her son. George was almost 18 and diagnosed with schizophrenia.
In thinking about why Ms. Hang chose this act, I can’t help but wonder about our role in perpetuating the myth that mental illness and violence go hand in hand.
Loss and tough adjustment
George had been born to Lai and Peter Hang, who moved to the United States in 1992 from the southeast Asian country of Laos to open a printing shop and pursue the “American dream.” In 2012, Peter Hang was diagnosed with metastatic cancer and died, a development that was a severe stressor for George.
Over a period of months, George reportedly started withdrawing from friends and acting differently. He destroyed things around the house, including a garden he had planted with a family friend. His grades slipped in school; he was getting report cards full of Fs. He subsequently was diagnosed with schizophrenia. Ms. Hang grew increasingly concerned about him in the context of the multiple highly publicized mass shootings attributed to patients with mental illness.
When George became more interested in Adolf Hitler after a school project on World War II, Ms. Hang’s fear intensified. Her concerns grew even more in the wake of reports of killings by James Holmes in Aurora, Colo.; Adam Lanza in Newtown, Conn.; and Elliot Rodger in the Santa Barbara County, Calif., town of Isla Vista. After the Charleston, S.C., church shootings of June 2015, George Hang reportedly became fixated on Dylann Roof. With increasing distress over her son, Ms. Hang wondered whether anything could have been done to stop those shooters.1
Politicians long have perpetrated the belief that patients with mental illness cause violence. Former President Barack Obama often linked mental illness to gun violence. For example, in a 2016 statement, he said: “While individuals with mental illness are more likely to be victims of violence than perpetrators, incidents of violence continue to highlight a crisis in America’s mental health system.”2
The recent election also was a prime example, with quotes such as: “This isn’t a gun problem; it’s a mental health problem ... these are sick people,” by now-President Donald Trump, and “We are not making sure that someone who is mentally ill can’t get access to a gun”3 by Ohio Gov. John Kasich.
The media also have promoted this view with headlines such as “Get the violent crazies off our streets,” and “They threaten, seethe and unhinge, then kill in quantity.” In one article, the writer contended: “In our newfound complacency, we had forgotten a particular kind of violence to which we are still prey … violence of the mentally ill.”4
How the evidence stacks up
Nonetheless, the scientific evidence contradicts those views. Most reviews on the topic come to conclusions similar to those of Debra A. Pinals, MD, and Lisa Anacker, MD, who recently wrote: “Despite media accounts to the contrary, persons with mental illness account for only a small percentage of persons who commit acts of violence ...”5
Jeffrey W. Swanson, PhD, who has spent his career examining these issues, studied more than 10,000 people with and without mental illness over 1 year, and found that serious mental illness was found in only 4% of the cases of violence. He found three factors that do predict the occurrence of violence: whether the perpetrator was male, poor, or abusing drugs.6 “That study debunked two myths,” Dr. Swanson, professor in the department of psychiatry and behavioral sciences at Duke University, Durham, N.C., reportedly said. “One: people with mental illness are all dangerous. Well, the vast majority are not. And the other myth: that there’s no connection at all. There is one. It’s quite small, but it’s not completely nonexistent.”7
Despite the consistent research on this topic, the voice of psychiatry has been muddled. Many have promoted this intuitive yet wrong narrative. In particular, this approach has been embraced by the Treatment Advocacy Center (TAC), a large nonprofit organization “dedicated to eliminating barriers to the timely and effective treatment of severe mental illness.”
In 2013, E. Fuller Torrey, MD, the executive director of TAC, contended in an interview “about half of … mass killings are being done by people with severe mental illness.” His solution is explicit: “The U.S. would have fewer mass killings if individuals with severe mental illnesses received proper treatment.”8 In a fact that implies tacit approval of Dr. Torrey’s problematic positions, three past presidents of the American Psychiatric Association currently serve on TAC’s board: Jeffrey A. Lieberman, MD; Steven S. Sharfstein, MD; and John A. Talbott, MD.
It is worrying that some psychiatrists have started sounding false alarms again when advocating for laws that support assisted outpatient treatment (AOT). In AOT, an individual meeting specified criteria for mental illness and potentially asserted to have a risk for violence is compelled by court order to comply with outpatient psychiatric treatment as a condition of remaining in the community.9 Some psychiatrists contend that “the relationship between deinstitutionalization and the increasing episodes of violent behavior by individuals with serious mental illness who are not being treated has been firmly established. Until we address the treatment issue and use proven remedies, such as assisted outpatient treatment … we should expect these episodes of violent behavior to continue,” they conclude.10
I am concerned about this issue, not only because of the stigma faced by our patients. I want to prevent our patients from realizing that behind their backs, outside of the office, we speak of them as dangerous and in need of involuntary confinement. I am concerned that patients will no longer trust psychiatrists if we describe them in such scary fashions without even the backing of science. If nonmaleficence is at the cornerstone of medical ethics, maybe as psychiatrists we could start by not falsely accusing our patients of being dangerous.
As Irvin D. Yalom, MD, famously said: “It’s the relationship that heals.” I cannot think of anything more important to my practice than cultivating genuine and meaningful relationships. I work as a psychiatrist with patients who have severe mental illness. They are dehumanized by the system, disenfranchised from society, and feared by the media. My role is to create a relationship that helps them overcome those obstacles.
References
1 Los Angeles Times. May 22, 2017
2 Obama White House Archives, Jan. 4, 2016
3 TheTrace.org. Sept. 1, 2015
4 The Guardian. Oct. 2, 2015
5 Psychiatr Clin N Am. 2016;39:611-21
6 Ann Epidemiol. 2015 May;25(5):366-76
7 The New Yorker. Nov. 19, 2014
8 60 Minutes. Sept. 27, 2013
9 Psychiatr Serv. 2016 Jul 1;67(7):784-6
10 CNS Spectr. 2015 Jun;20(3):207-14
Dr. Badre is a forensic psychiatrist in San Diego and an expert in correctional mental health. He holds teaching positions at the University of California, San Diego; and the University of San Diego. He teaches on medical education, psychopharmacology, ethics in psychiatry, and correctional care. Dr. Badre also mentors several residents on projects, including reduction in the use of solitary confinement of patients with mental illness, reduction in the use of involuntary treatment of the mentally ill, and examination of the mentally ill offender.
Physician liability in opioid deaths
Question: Regarding opioid deaths, which of the following is incorrect?
A. The term refers to accidental or intentional deaths caused mostly by heroin.
B. They are reaching epidemic proportions.
C. May form the basis for a wrongful death lawsuit.
D. May lead to loss of medical license.
E. The physician may face prosecution for homicide.
Answer: A. Opioids are a class of drugs that include the illegal drug heroin, as well as prescription drugs such as fentanyl, oxycodone, hydrocodone, codeine, and morphine. To be sure, opioid deaths occur in addicts from the deliberate or accidental use of heroin; but other opioids, especially painkillers, are also widely implicated. In addition, deaths have resulted from the careless, negligent, reckless, or wanton conduct of doctors who prescribe them without the proper indications or in inappropriate amounts, and then fail to provide careful follow-up.
Physicians may face both civil and criminal liabilities in such a situation. One remedy sought in wrongful death is a civil action, i.e., a malpractice lawsuit against the negligent doctor. The plaintiff is asserting that by violating community professional standards, the physician’s substandard conduct breached his duty of due care and was a proximate cause of the patient’s death. The evidentiary proof that is required to sustain such an allegation is “more probable than not” or “preponderance of evidence,” and expert medical testimony is typically necessary to establish the requisite standard of care and causation. Where there is gross negligence, i.e., egregious conduct that was reckless, the jury may award punitive damages.
Not infrequently, the wayward doctor faces triple liability: a civil lawsuit, state medical board action, and criminal prosecution for homicide. Given the publicity over soaring opioid death rates, one can expect aggressive prosecution of dealers and doctors alike.
This was not the first such case in Oklahoma. In 2014, a 71-year-old pain management doctor pleaded guilty to eight counts of second-degree murder in connection with several drug overdose deaths and will serve 8 years in prison. The doctor had reportedly prescribed more controlled drugs than any other physician in the state of Oklahoma. These drugs included hydrocodone, oxycodone, alprazolam, diazepam (Valium), and carisoprodol (Soma) – as many as 600 pills at a time. He allegedly accepted only cash payment for the office visits, and a review of his patient files revealed inadequate assessment of patient complaints or physical findings to justify the prescriptions.
Other states have been equally aggressive in prosecuting doctors over opioid deaths from reckless prescribing habits.
For the first time, New York in 2014 convicted a doctor of manslaughter in the overdose deaths of patients from oxycodone and alprazolam (Xanax). Some of the patients were prescribed as many as 500-800 pills over a 5- to 6-week period. The defendant, an anesthesiologist and pain management specialist, allegedly saw upward of 90 patients a day in his Queens weekend storefront clinic, charging them on a per-prescription basis. In his defense, he claimed that he was simply trying to help suffering people who misused medications and who misled him (“tough patients and good liars”).
Likewise, a Los Angeles–area doctor was recently convicted of second-degree murder for prescribing painkillers that killed three patients, and he was sentenced to 30 years to life in prison.
According to the Centers for Disease Control and Prevention, both drug overdose and opioid-involved deaths continue to increase in the United States.2 The majority of drug overdose deaths (more than 6 out of 10) involve an opioid, and the number has quadrupled since 1999.2 It has been estimated that more than 18,000 overdose deaths in 2014 involved prescription painkillers, while an additional 10,000 fatalities were attributed to heroin and 5,000 to fentanyl and other synthetic opioids. Overdose deaths exceed motor vehicle accidents as the leading cause of injury-related deaths. About 90 Americans die every day from an opioid overdose, and opioids have been forecast to kill 500,000 Americans over the next decade.
The CDC acknowledges that prescription opioids are a driving factor, noting that since 1999, the amount sold in the United States has nearly quadrupled, yet there has not been an overall change in the amount of pain that Americans report.
States such as Missouri, faced with the skyrocketing cost of treating the opioid epidemic, have sued the drug manufacturers, blaming them for their “campaign of fraud and deception.” At the same time, doctors have been deemed the “biggest culprit” for the opioid addiction epidemic, and one author has pointedly asserted that “by refusing to accept their inability to separate pain relief from addiction, physicians have long suffered the sin of hubris – and their patients have paid the price.”3
The U.S. Surgeon General recently took the historic step of writing to all American doctors asking for their help. And the American Medical Association has developed an educational module explaining the epidemic and how opioid misuse is linked to heroin addiction. The module also outlines risk-reducing steps when using opioids for pain relief.4
Dr. Tan is emeritus professor of medicine and former adjunct professor of law at the University of Hawaii, Honolulu. Some of the materials here have appeared in previous columns by the author. This article is meant to be educational and does not constitute medical, ethical, or legal advice. For additional information, readers may contact the author at [email protected].
References
1. Available at www.foxnews.om/health/2017/06/26/oklahoma-doctor-charged-in-opioid-deaths-5-patients.html. Accessed June 28, 2017.
2. Available at www.cdc.gov/drugoverdose/epidemic/index.html. Accessed June 28, 2017.
3. Available at www.thedailybeast.com/the-doctors-who-started-the-opioid-epidemic. Accessed June 27, 2017.
4. https://www.end-opioid-epidemic.org. Accessed July 5, 2017.
Question: Regarding opioid deaths, which of the following is incorrect?
A. The term refers to accidental or intentional deaths caused mostly by heroin.
B. They are reaching epidemic proportions.
C. May form the basis for a wrongful death lawsuit.
D. May lead to loss of medical license.
E. The physician may face prosecution for homicide.
Answer: A. Opioids are a class of drugs that include the illegal drug heroin, as well as prescription drugs such as fentanyl, oxycodone, hydrocodone, codeine, and morphine. To be sure, opioid deaths occur in addicts from the deliberate or accidental use of heroin; but other opioids, especially painkillers, are also widely implicated. In addition, deaths have resulted from the careless, negligent, reckless, or wanton conduct of doctors who prescribe them without the proper indications or in inappropriate amounts, and then fail to provide careful follow-up.
Physicians may face both civil and criminal liabilities in such a situation. One remedy sought in wrongful death is a civil action, i.e., a malpractice lawsuit against the negligent doctor. The plaintiff is asserting that by violating community professional standards, the physician’s substandard conduct breached his duty of due care and was a proximate cause of the patient’s death. The evidentiary proof that is required to sustain such an allegation is “more probable than not” or “preponderance of evidence,” and expert medical testimony is typically necessary to establish the requisite standard of care and causation. Where there is gross negligence, i.e., egregious conduct that was reckless, the jury may award punitive damages.
Not infrequently, the wayward doctor faces triple liability: a civil lawsuit, state medical board action, and criminal prosecution for homicide. Given the publicity over soaring opioid death rates, one can expect aggressive prosecution of dealers and doctors alike.
This was not the first such case in Oklahoma. In 2014, a 71-year-old pain management doctor pleaded guilty to eight counts of second-degree murder in connection with several drug overdose deaths and will serve 8 years in prison. The doctor had reportedly prescribed more controlled drugs than any other physician in the state of Oklahoma. These drugs included hydrocodone, oxycodone, alprazolam, diazepam (Valium), and carisoprodol (Soma) – as many as 600 pills at a time. He allegedly accepted only cash payment for the office visits, and a review of his patient files revealed inadequate assessment of patient complaints or physical findings to justify the prescriptions.
Other states have been equally aggressive in prosecuting doctors over opioid deaths from reckless prescribing habits.
For the first time, New York in 2014 convicted a doctor of manslaughter in the overdose deaths of patients from oxycodone and alprazolam (Xanax). Some of the patients were prescribed as many as 500-800 pills over a 5- to 6-week period. The defendant, an anesthesiologist and pain management specialist, allegedly saw upward of 90 patients a day in his Queens weekend storefront clinic, charging them on a per-prescription basis. In his defense, he claimed that he was simply trying to help suffering people who misused medications and who misled him (“tough patients and good liars”).
Likewise, a Los Angeles–area doctor was recently convicted of second-degree murder for prescribing painkillers that killed three patients, and he was sentenced to 30 years to life in prison.
According to the Centers for Disease Control and Prevention, both drug overdose and opioid-involved deaths continue to increase in the United States.2 The majority of drug overdose deaths (more than 6 out of 10) involve an opioid, and the number has quadrupled since 1999.2 It has been estimated that more than 18,000 overdose deaths in 2014 involved prescription painkillers, while an additional 10,000 fatalities were attributed to heroin and 5,000 to fentanyl and other synthetic opioids. Overdose deaths exceed motor vehicle accidents as the leading cause of injury-related deaths. About 90 Americans die every day from an opioid overdose, and opioids have been forecast to kill 500,000 Americans over the next decade.
The CDC acknowledges that prescription opioids are a driving factor, noting that since 1999, the amount sold in the United States has nearly quadrupled, yet there has not been an overall change in the amount of pain that Americans report.
States such as Missouri, faced with the skyrocketing cost of treating the opioid epidemic, have sued the drug manufacturers, blaming them for their “campaign of fraud and deception.” At the same time, doctors have been deemed the “biggest culprit” for the opioid addiction epidemic, and one author has pointedly asserted that “by refusing to accept their inability to separate pain relief from addiction, physicians have long suffered the sin of hubris – and their patients have paid the price.”3
The U.S. Surgeon General recently took the historic step of writing to all American doctors asking for their help. And the American Medical Association has developed an educational module explaining the epidemic and how opioid misuse is linked to heroin addiction. The module also outlines risk-reducing steps when using opioids for pain relief.4
Dr. Tan is emeritus professor of medicine and former adjunct professor of law at the University of Hawaii, Honolulu. Some of the materials here have appeared in previous columns by the author. This article is meant to be educational and does not constitute medical, ethical, or legal advice. For additional information, readers may contact the author at [email protected].
References
1. Available at www.foxnews.om/health/2017/06/26/oklahoma-doctor-charged-in-opioid-deaths-5-patients.html. Accessed June 28, 2017.
2. Available at www.cdc.gov/drugoverdose/epidemic/index.html. Accessed June 28, 2017.
3. Available at www.thedailybeast.com/the-doctors-who-started-the-opioid-epidemic. Accessed June 27, 2017.
4. https://www.end-opioid-epidemic.org. Accessed July 5, 2017.
Question: Regarding opioid deaths, which of the following is incorrect?
A. The term refers to accidental or intentional deaths caused mostly by heroin.
B. They are reaching epidemic proportions.
C. May form the basis for a wrongful death lawsuit.
D. May lead to loss of medical license.
E. The physician may face prosecution for homicide.
Answer: A. Opioids are a class of drugs that include the illegal drug heroin, as well as prescription drugs such as fentanyl, oxycodone, hydrocodone, codeine, and morphine. To be sure, opioid deaths occur in addicts from the deliberate or accidental use of heroin; but other opioids, especially painkillers, are also widely implicated. In addition, deaths have resulted from the careless, negligent, reckless, or wanton conduct of doctors who prescribe them without the proper indications or in inappropriate amounts, and then fail to provide careful follow-up.
Physicians may face both civil and criminal liabilities in such a situation. One remedy sought in wrongful death is a civil action, i.e., a malpractice lawsuit against the negligent doctor. The plaintiff is asserting that by violating community professional standards, the physician’s substandard conduct breached his duty of due care and was a proximate cause of the patient’s death. The evidentiary proof that is required to sustain such an allegation is “more probable than not” or “preponderance of evidence,” and expert medical testimony is typically necessary to establish the requisite standard of care and causation. Where there is gross negligence, i.e., egregious conduct that was reckless, the jury may award punitive damages.
Not infrequently, the wayward doctor faces triple liability: a civil lawsuit, state medical board action, and criminal prosecution for homicide. Given the publicity over soaring opioid death rates, one can expect aggressive prosecution of dealers and doctors alike.
This was not the first such case in Oklahoma. In 2014, a 71-year-old pain management doctor pleaded guilty to eight counts of second-degree murder in connection with several drug overdose deaths and will serve 8 years in prison. The doctor had reportedly prescribed more controlled drugs than any other physician in the state of Oklahoma. These drugs included hydrocodone, oxycodone, alprazolam, diazepam (Valium), and carisoprodol (Soma) – as many as 600 pills at a time. He allegedly accepted only cash payment for the office visits, and a review of his patient files revealed inadequate assessment of patient complaints or physical findings to justify the prescriptions.
Other states have been equally aggressive in prosecuting doctors over opioid deaths from reckless prescribing habits.
For the first time, New York in 2014 convicted a doctor of manslaughter in the overdose deaths of patients from oxycodone and alprazolam (Xanax). Some of the patients were prescribed as many as 500-800 pills over a 5- to 6-week period. The defendant, an anesthesiologist and pain management specialist, allegedly saw upward of 90 patients a day in his Queens weekend storefront clinic, charging them on a per-prescription basis. In his defense, he claimed that he was simply trying to help suffering people who misused medications and who misled him (“tough patients and good liars”).
Likewise, a Los Angeles–area doctor was recently convicted of second-degree murder for prescribing painkillers that killed three patients, and he was sentenced to 30 years to life in prison.
According to the Centers for Disease Control and Prevention, both drug overdose and opioid-involved deaths continue to increase in the United States.2 The majority of drug overdose deaths (more than 6 out of 10) involve an opioid, and the number has quadrupled since 1999.2 It has been estimated that more than 18,000 overdose deaths in 2014 involved prescription painkillers, while an additional 10,000 fatalities were attributed to heroin and 5,000 to fentanyl and other synthetic opioids. Overdose deaths exceed motor vehicle accidents as the leading cause of injury-related deaths. About 90 Americans die every day from an opioid overdose, and opioids have been forecast to kill 500,000 Americans over the next decade.
The CDC acknowledges that prescription opioids are a driving factor, noting that since 1999, the amount sold in the United States has nearly quadrupled, yet there has not been an overall change in the amount of pain that Americans report.
States such as Missouri, faced with the skyrocketing cost of treating the opioid epidemic, have sued the drug manufacturers, blaming them for their “campaign of fraud and deception.” At the same time, doctors have been deemed the “biggest culprit” for the opioid addiction epidemic, and one author has pointedly asserted that “by refusing to accept their inability to separate pain relief from addiction, physicians have long suffered the sin of hubris – and their patients have paid the price.”3
The U.S. Surgeon General recently took the historic step of writing to all American doctors asking for their help. And the American Medical Association has developed an educational module explaining the epidemic and how opioid misuse is linked to heroin addiction. The module also outlines risk-reducing steps when using opioids for pain relief.4
Dr. Tan is emeritus professor of medicine and former adjunct professor of law at the University of Hawaii, Honolulu. Some of the materials here have appeared in previous columns by the author. This article is meant to be educational and does not constitute medical, ethical, or legal advice. For additional information, readers may contact the author at [email protected].
References
1. Available at www.foxnews.om/health/2017/06/26/oklahoma-doctor-charged-in-opioid-deaths-5-patients.html. Accessed June 28, 2017.
2. Available at www.cdc.gov/drugoverdose/epidemic/index.html. Accessed June 28, 2017.
3. Available at www.thedailybeast.com/the-doctors-who-started-the-opioid-epidemic. Accessed June 27, 2017.
4. https://www.end-opioid-epidemic.org. Accessed July 5, 2017.
The burden of health care–associated C. difficile infection in a nonmetropolitan setting
Clostridium difficile infection (CDI) remains a major cause of health care–associated diarrhea in industrialized countries and is a common target of antimicrobial stewardship programs (ASPs).
While the burden of CDI has been well described in tertiary metropolitan hospitals, there is a lack of published evidence from regional and rural hospitals. Our recent study published in the Journal of Hospital Infection explores the effect of an ASP on health care–associated CDI rates and the impact of CDI on length of stay and hospital costs.
The ASP functioned alongside infection control practices, including isolation of patients with antimicrobial-resistant organisms (including C. difficile), hand hygiene, personal protective equipment, and terminal cleaning. Timely feedback emails to medical officers contained information on patient-specific risk factors for CDI, current and prior antimicrobials, and suggestions for CDI treatment. The effect of health care–associated CDI on length of stay and hospital costs was investigated using a group of matched controls, identified retrospectively using hospital performance data. Prior antimicrobial and proton pump inhibitor use were also measured and compared with background use.
The results of our study demonstrated a stable health care–associated CDI rate of around four cases per 10,000 occupied bed days over a 5-year period, similar to the average Australian rate. The length of time over which CDI rates could be effectively examined prior to the intervention was limited by changes to C. difficile stool testing methods. Median length of stay was 11 days greater, and median hospital costs were AU$11,361 higher for patients with health care–associated CDI (n = 91) than for their matched controls (n = 172). It is likely that the increase in costs was associated with additional length of stay but also with increased investigation and treatment costs. Among the group of patients with severe disease (n = 8), only four received oral vancomycin according to Australian guidelines, possibly because of under-recognition of severity criteria. The response rate to emails was low at 19%, showing that other methods are additionally necessary to communicate CDI case feedback.
Third generation cephalosporins and beta-lactamase inhibitor combinations were over-represented in the health care–associated CDI group, where narrower spectrum antimicrobials such as beta-lactamase sensitive penicillins were under represented. Rates of prior antimicrobial use and proton pump inhibitor use were broadly in agreement with the literature.
Our study demonstrated that, in the Australian nonmetropolitan setting, there was a high burden of health care–associated CDI in terms of hospital costs and length of stay, even though our health district experienced CDI rates that were similar to the Australian average. Challenges associated with the study included maintenance of consistent data collection across multiple hospital sites without comprehensive electronic medical records, provision of timely email feedback, and dissemination of study results.
Analysis of prior antimicrobial use has allowed us to identify targets for ongoing antimicrobial stewardship activities, and we also intend to provide further education on recognition of severity criteria. These activities can be supported through daily antimicrobial stewardship ward rounds. Future research could involve application of appropriateness criteria to prior and current antimicrobial use in CDI patients in order to identify avoidable cases and use of more advanced statistical techniques such as multistate modeling to determine differences in outcomes between cases and controls.
Stuart Bond, BPharm, DipPharmPrac, is an antimicrobial stewardship pharmacist based at Wollongong Hospital in New South Wales, Australia.
Clostridium difficile infection (CDI) remains a major cause of health care–associated diarrhea in industrialized countries and is a common target of antimicrobial stewardship programs (ASPs).
While the burden of CDI has been well described in tertiary metropolitan hospitals, there is a lack of published evidence from regional and rural hospitals. Our recent study published in the Journal of Hospital Infection explores the effect of an ASP on health care–associated CDI rates and the impact of CDI on length of stay and hospital costs.
The ASP functioned alongside infection control practices, including isolation of patients with antimicrobial-resistant organisms (including C. difficile), hand hygiene, personal protective equipment, and terminal cleaning. Timely feedback emails to medical officers contained information on patient-specific risk factors for CDI, current and prior antimicrobials, and suggestions for CDI treatment. The effect of health care–associated CDI on length of stay and hospital costs was investigated using a group of matched controls, identified retrospectively using hospital performance data. Prior antimicrobial and proton pump inhibitor use were also measured and compared with background use.
The results of our study demonstrated a stable health care–associated CDI rate of around four cases per 10,000 occupied bed days over a 5-year period, similar to the average Australian rate. The length of time over which CDI rates could be effectively examined prior to the intervention was limited by changes to C. difficile stool testing methods. Median length of stay was 11 days greater, and median hospital costs were AU$11,361 higher for patients with health care–associated CDI (n = 91) than for their matched controls (n = 172). It is likely that the increase in costs was associated with additional length of stay but also with increased investigation and treatment costs. Among the group of patients with severe disease (n = 8), only four received oral vancomycin according to Australian guidelines, possibly because of under-recognition of severity criteria. The response rate to emails was low at 19%, showing that other methods are additionally necessary to communicate CDI case feedback.
Third generation cephalosporins and beta-lactamase inhibitor combinations were over-represented in the health care–associated CDI group, where narrower spectrum antimicrobials such as beta-lactamase sensitive penicillins were under represented. Rates of prior antimicrobial use and proton pump inhibitor use were broadly in agreement with the literature.
Our study demonstrated that, in the Australian nonmetropolitan setting, there was a high burden of health care–associated CDI in terms of hospital costs and length of stay, even though our health district experienced CDI rates that were similar to the Australian average. Challenges associated with the study included maintenance of consistent data collection across multiple hospital sites without comprehensive electronic medical records, provision of timely email feedback, and dissemination of study results.
Analysis of prior antimicrobial use has allowed us to identify targets for ongoing antimicrobial stewardship activities, and we also intend to provide further education on recognition of severity criteria. These activities can be supported through daily antimicrobial stewardship ward rounds. Future research could involve application of appropriateness criteria to prior and current antimicrobial use in CDI patients in order to identify avoidable cases and use of more advanced statistical techniques such as multistate modeling to determine differences in outcomes between cases and controls.
Stuart Bond, BPharm, DipPharmPrac, is an antimicrobial stewardship pharmacist based at Wollongong Hospital in New South Wales, Australia.
Clostridium difficile infection (CDI) remains a major cause of health care–associated diarrhea in industrialized countries and is a common target of antimicrobial stewardship programs (ASPs).
While the burden of CDI has been well described in tertiary metropolitan hospitals, there is a lack of published evidence from regional and rural hospitals. Our recent study published in the Journal of Hospital Infection explores the effect of an ASP on health care–associated CDI rates and the impact of CDI on length of stay and hospital costs.
The ASP functioned alongside infection control practices, including isolation of patients with antimicrobial-resistant organisms (including C. difficile), hand hygiene, personal protective equipment, and terminal cleaning. Timely feedback emails to medical officers contained information on patient-specific risk factors for CDI, current and prior antimicrobials, and suggestions for CDI treatment. The effect of health care–associated CDI on length of stay and hospital costs was investigated using a group of matched controls, identified retrospectively using hospital performance data. Prior antimicrobial and proton pump inhibitor use were also measured and compared with background use.
The results of our study demonstrated a stable health care–associated CDI rate of around four cases per 10,000 occupied bed days over a 5-year period, similar to the average Australian rate. The length of time over which CDI rates could be effectively examined prior to the intervention was limited by changes to C. difficile stool testing methods. Median length of stay was 11 days greater, and median hospital costs were AU$11,361 higher for patients with health care–associated CDI (n = 91) than for their matched controls (n = 172). It is likely that the increase in costs was associated with additional length of stay but also with increased investigation and treatment costs. Among the group of patients with severe disease (n = 8), only four received oral vancomycin according to Australian guidelines, possibly because of under-recognition of severity criteria. The response rate to emails was low at 19%, showing that other methods are additionally necessary to communicate CDI case feedback.
Third generation cephalosporins and beta-lactamase inhibitor combinations were over-represented in the health care–associated CDI group, where narrower spectrum antimicrobials such as beta-lactamase sensitive penicillins were under represented. Rates of prior antimicrobial use and proton pump inhibitor use were broadly in agreement with the literature.
Our study demonstrated that, in the Australian nonmetropolitan setting, there was a high burden of health care–associated CDI in terms of hospital costs and length of stay, even though our health district experienced CDI rates that were similar to the Australian average. Challenges associated with the study included maintenance of consistent data collection across multiple hospital sites without comprehensive electronic medical records, provision of timely email feedback, and dissemination of study results.
Analysis of prior antimicrobial use has allowed us to identify targets for ongoing antimicrobial stewardship activities, and we also intend to provide further education on recognition of severity criteria. These activities can be supported through daily antimicrobial stewardship ward rounds. Future research could involve application of appropriateness criteria to prior and current antimicrobial use in CDI patients in order to identify avoidable cases and use of more advanced statistical techniques such as multistate modeling to determine differences in outcomes between cases and controls.
Stuart Bond, BPharm, DipPharmPrac, is an antimicrobial stewardship pharmacist based at Wollongong Hospital in New South Wales, Australia.
Don’t forget about Zika
Although the Zika virus isn’t making as many news headlines as it was last summer, ob.gyns. must not forget that it could still be in our waiting rooms.
Last year, new information on Zika emerged on a weekly, sometimes daily, basis. Today, ob.gyns. remain on the front lines of counseling and treating women whose pregnancies are at risk of being affected by the Zika virus and devastating birth defects associated with it.
The American College of Obstetricians and Gynecologists prioritizes preparing ob.gyns. to comprehensively address the Zika virus with patients. To support clinicians, ACOG regularly develops, updates, and issues guidance on the risk, prevention, assessment, treatment, and outcomes of the Zika virus. This includes a regularly updated Practice Advisory, as well as information to direct ob.gyns. to critical resources from the Centers for Disease Control and Prevention, such as the U.S. Zika Pregnancy Registry.
Last month, I participated in an ad hoc meeting of international experts and professional society representatives sponsored by the Gottesfeld-Hohler Memorial Foundation. The goal of this Zika think tank was to share ongoing studies and unpublished findings and to identify ways for the groups to collaborate to fight the virus. Zika experts from endemic and risk areas, such as Brazil, Colombia, Puerto Rico, Texas, and Florida, started the meeting with on-the-ground updates. The latest epidemiologic evidence is that there appear to be waves of Zika virus infections that occur across regions/countries, spreading to virus-naive areas. Although immunity may develop eventually, Zika appears to occur in epidemics and is likely to spread further in North and South America to naive regions. Much of the United States is at risk during mosquito seasons. This collaboration with the Gottesfeld-Hohler Memorial Foundation was just the beginning, and I look forward to working more with Zika experts from all over the world.
The health reform debate in Washington also will affect our ability to respond to the ongoing Zika crisis. Current proposals allow states to opt out of essential coverage requirements, such as contraception and maternity coverage. It also would limit the federal investment in Medicaid, resulting in cuts to benefits and provider reimbursement and hamstringing our ability to treat our low-income pregnant patients with Zika exposure.
As ob.gyns., we continue to be the most important source of information for patients, and our goals of providing the most up-to-date knowledge and aiding in informed decision making are more important than ever.
Dr. Harris is a gynecologist in Gainesville, Fla., and chair of ACOG District VII. She reported having no relevant financial disclosures.
Although the Zika virus isn’t making as many news headlines as it was last summer, ob.gyns. must not forget that it could still be in our waiting rooms.
Last year, new information on Zika emerged on a weekly, sometimes daily, basis. Today, ob.gyns. remain on the front lines of counseling and treating women whose pregnancies are at risk of being affected by the Zika virus and devastating birth defects associated with it.
The American College of Obstetricians and Gynecologists prioritizes preparing ob.gyns. to comprehensively address the Zika virus with patients. To support clinicians, ACOG regularly develops, updates, and issues guidance on the risk, prevention, assessment, treatment, and outcomes of the Zika virus. This includes a regularly updated Practice Advisory, as well as information to direct ob.gyns. to critical resources from the Centers for Disease Control and Prevention, such as the U.S. Zika Pregnancy Registry.
Last month, I participated in an ad hoc meeting of international experts and professional society representatives sponsored by the Gottesfeld-Hohler Memorial Foundation. The goal of this Zika think tank was to share ongoing studies and unpublished findings and to identify ways for the groups to collaborate to fight the virus. Zika experts from endemic and risk areas, such as Brazil, Colombia, Puerto Rico, Texas, and Florida, started the meeting with on-the-ground updates. The latest epidemiologic evidence is that there appear to be waves of Zika virus infections that occur across regions/countries, spreading to virus-naive areas. Although immunity may develop eventually, Zika appears to occur in epidemics and is likely to spread further in North and South America to naive regions. Much of the United States is at risk during mosquito seasons. This collaboration with the Gottesfeld-Hohler Memorial Foundation was just the beginning, and I look forward to working more with Zika experts from all over the world.
The health reform debate in Washington also will affect our ability to respond to the ongoing Zika crisis. Current proposals allow states to opt out of essential coverage requirements, such as contraception and maternity coverage. It also would limit the federal investment in Medicaid, resulting in cuts to benefits and provider reimbursement and hamstringing our ability to treat our low-income pregnant patients with Zika exposure.
As ob.gyns., we continue to be the most important source of information for patients, and our goals of providing the most up-to-date knowledge and aiding in informed decision making are more important than ever.
Dr. Harris is a gynecologist in Gainesville, Fla., and chair of ACOG District VII. She reported having no relevant financial disclosures.
Although the Zika virus isn’t making as many news headlines as it was last summer, ob.gyns. must not forget that it could still be in our waiting rooms.
Last year, new information on Zika emerged on a weekly, sometimes daily, basis. Today, ob.gyns. remain on the front lines of counseling and treating women whose pregnancies are at risk of being affected by the Zika virus and devastating birth defects associated with it.
The American College of Obstetricians and Gynecologists prioritizes preparing ob.gyns. to comprehensively address the Zika virus with patients. To support clinicians, ACOG regularly develops, updates, and issues guidance on the risk, prevention, assessment, treatment, and outcomes of the Zika virus. This includes a regularly updated Practice Advisory, as well as information to direct ob.gyns. to critical resources from the Centers for Disease Control and Prevention, such as the U.S. Zika Pregnancy Registry.
Last month, I participated in an ad hoc meeting of international experts and professional society representatives sponsored by the Gottesfeld-Hohler Memorial Foundation. The goal of this Zika think tank was to share ongoing studies and unpublished findings and to identify ways for the groups to collaborate to fight the virus. Zika experts from endemic and risk areas, such as Brazil, Colombia, Puerto Rico, Texas, and Florida, started the meeting with on-the-ground updates. The latest epidemiologic evidence is that there appear to be waves of Zika virus infections that occur across regions/countries, spreading to virus-naive areas. Although immunity may develop eventually, Zika appears to occur in epidemics and is likely to spread further in North and South America to naive regions. Much of the United States is at risk during mosquito seasons. This collaboration with the Gottesfeld-Hohler Memorial Foundation was just the beginning, and I look forward to working more with Zika experts from all over the world.
The health reform debate in Washington also will affect our ability to respond to the ongoing Zika crisis. Current proposals allow states to opt out of essential coverage requirements, such as contraception and maternity coverage. It also would limit the federal investment in Medicaid, resulting in cuts to benefits and provider reimbursement and hamstringing our ability to treat our low-income pregnant patients with Zika exposure.
As ob.gyns., we continue to be the most important source of information for patients, and our goals of providing the most up-to-date knowledge and aiding in informed decision making are more important than ever.
Dr. Harris is a gynecologist in Gainesville, Fla., and chair of ACOG District VII. She reported having no relevant financial disclosures.
Listening for golf balls
“What did the patient say about the golf ball?” I asked my student.
The student looked blank. “Golf ball?” he asked.
“The patient said a golf ball hit him.”
“He did?”
“I showed him a precancerous red spot on his forehead, and said I could freeze it off.”
“Yes,” said the student. “Now I remember.”
“Good. Now tell me why he said it.”
The student looked lost. “Because he really was hit by a golf ball?”
“Maybe he was,” I said. “But in his 60 years, he’s been hit by a lot of things. How can he be sure the golf ball hit just that spot? And anyhow, why tell me about it? He must have thought it was important for me to know. We discussed this the other day,” I reminded him.
“Because there was trauma?”
“That’s it,” I said. “One way patients understand why things happen to them is by saying that what got sick was hit by something. They assume trauma weakens and damages the body, and disposes it to being unhealthy.
“After all,” I went on, “I had told him his spot was caused by sun exposure. But he’s had sun exposure all over his face, so why would he get a sun spot only right there? His answer: Sun damages all skin, but the part the golf ball whacked is especially susceptible.
“Is he right? I have no idea, but it’s important – to him – to think so. Not so much for this spot – we’re going to treat it anyway – but because of what he said 2 minutes later about his left shin. Remember?”
The student did not.
“He had a raised brown spot on his leg,” I reminded him. “It was just a seborrheic keratosis, not even precancerous. But he said he was always picking it.”
“Yes, he did say that,” said the student.
“So again: Why did he think I needed to know?”
“Because picking is a form of trauma, which might cause the spot to turn into something?”
“Yes, indeed,” I said. “You should train yourself to listen to these offhand remarks that seem irrelevant to you. They are relevant to the patient, or he wouldn’t say them.
Sure enough, a little later the student and I met another patient coming for a skin check. A computer scientist from a local university, he displayed a big collection of cherry angiomas on his torso, front, and back.
Looking at his belly, he said, “I know where I got those.”
“Which ones?” I asked.
He pointed to a dense collection of red spots near his navel. “A soccer ball hit me there when I was a teenager in Colombia,” he said.
Later, the student and I discussed this man’s recollection. “What makes his observation striking,” I suggested, “is not just as another example of a patient blaming body changes on trauma. It’s that he did it in a way that even a smidgen of critical thinking – the kind he applies to his professional work all the time – would show that his hypothesis makes no sense. After all, he has dozens of red spots nowhere near where the soccer ball supposedly hit him.
“You would think a computer scientist would notice this, but when it comes to looking at our own health, even sophisticated scientific training may not help. Instead, the thinking is: “I’ve got these red spots. Something caused them. A soccer ball hit me down there. That must be it.”
Sometimes hearing what patients say doesn’t matter; we’re not going to remove the cherry angiomas. But sometimes it does, by telling us the real reason they want something removed, which may include some guilt about their own picking, guilt they can do without.
But you would have to listen for that nuance, and listening is hard. Mostly, in medicine and in life, we hear only what we expect to hear.
Dr. Rockoff practices dermatology in Brookline, Mass., and is a longtime contributor to Dermatology News. He serves on the clinical faculty at Tufts University, Boston, and has taught senior medical students and other trainees for 30 years. His second book, “Act Like a Doctor, Think Like a Patient,” is available at amazon.com and barnesandnoble.com. Write to him at [email protected]
“What did the patient say about the golf ball?” I asked my student.
The student looked blank. “Golf ball?” he asked.
“The patient said a golf ball hit him.”
“He did?”
“I showed him a precancerous red spot on his forehead, and said I could freeze it off.”
“Yes,” said the student. “Now I remember.”
“Good. Now tell me why he said it.”
The student looked lost. “Because he really was hit by a golf ball?”
“Maybe he was,” I said. “But in his 60 years, he’s been hit by a lot of things. How can he be sure the golf ball hit just that spot? And anyhow, why tell me about it? He must have thought it was important for me to know. We discussed this the other day,” I reminded him.
“Because there was trauma?”
“That’s it,” I said. “One way patients understand why things happen to them is by saying that what got sick was hit by something. They assume trauma weakens and damages the body, and disposes it to being unhealthy.
“After all,” I went on, “I had told him his spot was caused by sun exposure. But he’s had sun exposure all over his face, so why would he get a sun spot only right there? His answer: Sun damages all skin, but the part the golf ball whacked is especially susceptible.
“Is he right? I have no idea, but it’s important – to him – to think so. Not so much for this spot – we’re going to treat it anyway – but because of what he said 2 minutes later about his left shin. Remember?”
The student did not.
“He had a raised brown spot on his leg,” I reminded him. “It was just a seborrheic keratosis, not even precancerous. But he said he was always picking it.”
“Yes, he did say that,” said the student.
“So again: Why did he think I needed to know?”
“Because picking is a form of trauma, which might cause the spot to turn into something?”
“Yes, indeed,” I said. “You should train yourself to listen to these offhand remarks that seem irrelevant to you. They are relevant to the patient, or he wouldn’t say them.
Sure enough, a little later the student and I met another patient coming for a skin check. A computer scientist from a local university, he displayed a big collection of cherry angiomas on his torso, front, and back.
Looking at his belly, he said, “I know where I got those.”
“Which ones?” I asked.
He pointed to a dense collection of red spots near his navel. “A soccer ball hit me there when I was a teenager in Colombia,” he said.
Later, the student and I discussed this man’s recollection. “What makes his observation striking,” I suggested, “is not just as another example of a patient blaming body changes on trauma. It’s that he did it in a way that even a smidgen of critical thinking – the kind he applies to his professional work all the time – would show that his hypothesis makes no sense. After all, he has dozens of red spots nowhere near where the soccer ball supposedly hit him.
“You would think a computer scientist would notice this, but when it comes to looking at our own health, even sophisticated scientific training may not help. Instead, the thinking is: “I’ve got these red spots. Something caused them. A soccer ball hit me down there. That must be it.”
Sometimes hearing what patients say doesn’t matter; we’re not going to remove the cherry angiomas. But sometimes it does, by telling us the real reason they want something removed, which may include some guilt about their own picking, guilt they can do without.
But you would have to listen for that nuance, and listening is hard. Mostly, in medicine and in life, we hear only what we expect to hear.
Dr. Rockoff practices dermatology in Brookline, Mass., and is a longtime contributor to Dermatology News. He serves on the clinical faculty at Tufts University, Boston, and has taught senior medical students and other trainees for 30 years. His second book, “Act Like a Doctor, Think Like a Patient,” is available at amazon.com and barnesandnoble.com. Write to him at [email protected]
“What did the patient say about the golf ball?” I asked my student.
The student looked blank. “Golf ball?” he asked.
“The patient said a golf ball hit him.”
“He did?”
“I showed him a precancerous red spot on his forehead, and said I could freeze it off.”
“Yes,” said the student. “Now I remember.”
“Good. Now tell me why he said it.”
The student looked lost. “Because he really was hit by a golf ball?”
“Maybe he was,” I said. “But in his 60 years, he’s been hit by a lot of things. How can he be sure the golf ball hit just that spot? And anyhow, why tell me about it? He must have thought it was important for me to know. We discussed this the other day,” I reminded him.
“Because there was trauma?”
“That’s it,” I said. “One way patients understand why things happen to them is by saying that what got sick was hit by something. They assume trauma weakens and damages the body, and disposes it to being unhealthy.
“After all,” I went on, “I had told him his spot was caused by sun exposure. But he’s had sun exposure all over his face, so why would he get a sun spot only right there? His answer: Sun damages all skin, but the part the golf ball whacked is especially susceptible.
“Is he right? I have no idea, but it’s important – to him – to think so. Not so much for this spot – we’re going to treat it anyway – but because of what he said 2 minutes later about his left shin. Remember?”
The student did not.
“He had a raised brown spot on his leg,” I reminded him. “It was just a seborrheic keratosis, not even precancerous. But he said he was always picking it.”
“Yes, he did say that,” said the student.
“So again: Why did he think I needed to know?”
“Because picking is a form of trauma, which might cause the spot to turn into something?”
“Yes, indeed,” I said. “You should train yourself to listen to these offhand remarks that seem irrelevant to you. They are relevant to the patient, or he wouldn’t say them.
Sure enough, a little later the student and I met another patient coming for a skin check. A computer scientist from a local university, he displayed a big collection of cherry angiomas on his torso, front, and back.
Looking at his belly, he said, “I know where I got those.”
“Which ones?” I asked.
He pointed to a dense collection of red spots near his navel. “A soccer ball hit me there when I was a teenager in Colombia,” he said.
Later, the student and I discussed this man’s recollection. “What makes his observation striking,” I suggested, “is not just as another example of a patient blaming body changes on trauma. It’s that he did it in a way that even a smidgen of critical thinking – the kind he applies to his professional work all the time – would show that his hypothesis makes no sense. After all, he has dozens of red spots nowhere near where the soccer ball supposedly hit him.
“You would think a computer scientist would notice this, but when it comes to looking at our own health, even sophisticated scientific training may not help. Instead, the thinking is: “I’ve got these red spots. Something caused them. A soccer ball hit me down there. That must be it.”
Sometimes hearing what patients say doesn’t matter; we’re not going to remove the cherry angiomas. But sometimes it does, by telling us the real reason they want something removed, which may include some guilt about their own picking, guilt they can do without.
But you would have to listen for that nuance, and listening is hard. Mostly, in medicine and in life, we hear only what we expect to hear.
Dr. Rockoff practices dermatology in Brookline, Mass., and is a longtime contributor to Dermatology News. He serves on the clinical faculty at Tufts University, Boston, and has taught senior medical students and other trainees for 30 years. His second book, “Act Like a Doctor, Think Like a Patient,” is available at amazon.com and barnesandnoble.com. Write to him at [email protected]
Point/Counterpoint: Is intraoperative drain placement essential during pancreatectomy?
Yes, placing drains is essential.
It’s important to look at the evidence in the literature, starting with a randomized controlled trial of 179 patients from 2001 that showed no reduction in death or complication rate associated with use of surgical intraperitoneal closed suction drainage (Ann. Surg. 2001;234:487-94). Interestingly, even though this study showed there was no benefit to using drains, they address the use of closed suction drainage. The investigators were not claiming all drains are unnecessary.
Why drain placement? The argument for drains includes evacuation of blood, pancreatic juice, bile, and chyle. In addition, assessing drainage can act as a warning sign for anastomotic leak or hemorrhage, so patients can potentially avoid additional interventions.
A study from University of Tokyo researchers found three drains were more effective than one. In addition, the investigators argued against early removal, pointing out that the risk for infection associated with drains only increased after day 10. The researchers were not only in favor of drains but in favor of multiple drains (World J Surg. 2016;40:1226-35).
A multicenter, randomized prospective trial conducted in the United States compared 68 patients with drains to 69 others without during pancreaticoduodenectomy. They reported an increase in the frequency and severity of complications when drains were omitted, including the number of grade 2 or greater complications. Furthermore, the safety monitoring board stopped the study early because mortality among patients in the drain group was 3%, compared with 12% in the no-drain group. (Ann. Surg. 2014:259:605-12).
Another set of researchers in Germany conducted a prospective, randomized study that favored omission of drains. However, a closer look at demographics shows that about one-fourth of participants had chronic pancreatitis, which is associated with a low risk of fistula (Ann Surg. 2016;263:440-9). In addition, they found no significant difference in fistula rates between patients who underwent pancreaticojejunostomy or pancreaticoduodenectomy. Interestingly, the authors noted that surgeons were reluctant to omit drains in many situations, even in a clinical trial context.
Furthermore, a systematic review of nine studies with nearly 3,000 patients suggests it is still necessary to place abdominal drains during pancreatic resection, researchers at the Medical College of Xi’an Jiaotong University in China reported (World J Gastroenterol. 2015;21:5719-34). The authors cited a significant increase in morbidity among patients in whom drains were omitted (odds ratio, 2.39).
Perhaps the cleverest way to address this controversy with drains during pancreatic resection comes from researchers at the University of Pennsylvania. They looked at surgical risk factors to gain a more nuanced view. They used the Fistula Risk Score (FRS) to stratify patients and re-examined the outcomes of the multicenter U.S. study I cited earlier that was stopped early because of differences in mortality rates. The University of Pennsylvania research found that FRS correlated well with outcomes, suggesting its use as a mitigation strategy in patients at moderate to high risk for developing clinically relevant postoperative pancreatic fistula (J Gastrointest Surg. 2015;19:21-30). In other words, they suggest routine prophylactic drainage for patients at moderate to high risk but also suggest that there may be no need for prophylactic drainage for negligible to low risk patients.
I would like to conclude that drains appear essential in many cases, including for moderate to higher risk patients. We need to tailor our practices as surgeons regarding placement of drains during pancreatectomy or pancreaticoduodenectomy. Our goal remains to create opportunities for prolonged survival and better quality of life for our patients.
Dr. Dervenis is head of the Department of Surgical Oncology at the Metropolitan Hospital in Athens, Greece. He is also chair of the hepato-pancreato-biliary surgical unit. He reported no disclosures.
No, drain placement is not always necessary.
Drain placement is not essential during all pancreatectomies. The practice is so historically entrenched in our specialty that I need you to check your dogma at the door and take a look at the data with an open mind.
There are many, many retrospective studies that examine drainage versus no drainage. All of these studies have shown the same thing: There is no difference in many outcomes, including mortality. There may be a difference in terms of complicated, postoperative fistulae, which are difficult to manage in patients who have drains.
Another prospective randomized trial from Germany compared the reintervention rate, an endpoint I like, among 439 patients (Ann Surg. 2016;264:528-37). There was no statistically significant difference between the drain or no drain groups, further suggesting that drains are not essential in all cases.
We also need to take a closer look at the study Dr. Dervenis cited (Ann Surg. 2014:259:605-12). It’s true this trial was stopped early because of a higher mortality rate of 12% in the no drain group, but the difference was not statistically significant (P = .097). There was no difference in the fistula rate.
When you look at these data, there are a couple of conclusions you can reach. One conclusion is that a trial of 130 people designed for 750 found something uniquely different that had never been reported in any retrospective series, including one by the study’s senior author that demonstrated drains are essential (HPB [Oxford]. 2011;13:503-10). Another conclusion is that drains are not needed, and there is a very good chance this is a false positive finding. Look at the reasons the 10 participants died. I’m not sure a drain would have helped some of the patients without them, and some of the patients who had drains still died.
A study looking at practice at my institution, MSKCC, shows that drains are still used about half the time, indicating they are not essential. (Ann. Surg. 2013 Dec;258[6]:1051-8). Drains were more commonly used for pancreaticoduodenectomy and when the surgeon thought there might be a problem, such as a soft gland, difficult time in the OR, or a small pancreatic duct.
If you look at these data, this pans out in every retrospective study I’ve seen comparing drain versus no drain – the patients with drains tend to have higher morbidity. Among the 1,122 resection patients in the MSKCC study, those without operative drains had significantly lower rates of grade 3 complications and overall morbidity and fewer readmissions and lower rates of grade 3 or higher pancreatic fistula. Mortality and reintervention rates were no different.
I also looked at our most recent data, between 2010 and 2015. Now we are using intraoperative drains even less often. They are not considered essential at this point.
There are multiple retrospective and well-designed prospective, randomized trials that show no benefit to routine drainage following pancreatectomy. Acceptance of randomized clinical data is slow, particularly when it flies in the face of what you were taught by your mentors over the past 40 or 50 years. I encourage you to look at these data carefully and utilize them in your practice.
Dr. Allen is associate director for clinical programs at David M. Rubenstein Center for Pancreatic Cancer Research and the Murray F. Brennan chair in surgery at Memorial Sloan-Kettering Cancer Center in New York City. He reported no disclosures.
Yes, placing drains is essential.
It’s important to look at the evidence in the literature, starting with a randomized controlled trial of 179 patients from 2001 that showed no reduction in death or complication rate associated with use of surgical intraperitoneal closed suction drainage (Ann. Surg. 2001;234:487-94). Interestingly, even though this study showed there was no benefit to using drains, they address the use of closed suction drainage. The investigators were not claiming all drains are unnecessary.
Why drain placement? The argument for drains includes evacuation of blood, pancreatic juice, bile, and chyle. In addition, assessing drainage can act as a warning sign for anastomotic leak or hemorrhage, so patients can potentially avoid additional interventions.
A study from University of Tokyo researchers found three drains were more effective than one. In addition, the investigators argued against early removal, pointing out that the risk for infection associated with drains only increased after day 10. The researchers were not only in favor of drains but in favor of multiple drains (World J Surg. 2016;40:1226-35).
A multicenter, randomized prospective trial conducted in the United States compared 68 patients with drains to 69 others without during pancreaticoduodenectomy. They reported an increase in the frequency and severity of complications when drains were omitted, including the number of grade 2 or greater complications. Furthermore, the safety monitoring board stopped the study early because mortality among patients in the drain group was 3%, compared with 12% in the no-drain group. (Ann. Surg. 2014:259:605-12).
Another set of researchers in Germany conducted a prospective, randomized study that favored omission of drains. However, a closer look at demographics shows that about one-fourth of participants had chronic pancreatitis, which is associated with a low risk of fistula (Ann Surg. 2016;263:440-9). In addition, they found no significant difference in fistula rates between patients who underwent pancreaticojejunostomy or pancreaticoduodenectomy. Interestingly, the authors noted that surgeons were reluctant to omit drains in many situations, even in a clinical trial context.
Furthermore, a systematic review of nine studies with nearly 3,000 patients suggests it is still necessary to place abdominal drains during pancreatic resection, researchers at the Medical College of Xi’an Jiaotong University in China reported (World J Gastroenterol. 2015;21:5719-34). The authors cited a significant increase in morbidity among patients in whom drains were omitted (odds ratio, 2.39).
Perhaps the cleverest way to address this controversy with drains during pancreatic resection comes from researchers at the University of Pennsylvania. They looked at surgical risk factors to gain a more nuanced view. They used the Fistula Risk Score (FRS) to stratify patients and re-examined the outcomes of the multicenter U.S. study I cited earlier that was stopped early because of differences in mortality rates. The University of Pennsylvania research found that FRS correlated well with outcomes, suggesting its use as a mitigation strategy in patients at moderate to high risk for developing clinically relevant postoperative pancreatic fistula (J Gastrointest Surg. 2015;19:21-30). In other words, they suggest routine prophylactic drainage for patients at moderate to high risk but also suggest that there may be no need for prophylactic drainage for negligible to low risk patients.
I would like to conclude that drains appear essential in many cases, including for moderate to higher risk patients. We need to tailor our practices as surgeons regarding placement of drains during pancreatectomy or pancreaticoduodenectomy. Our goal remains to create opportunities for prolonged survival and better quality of life for our patients.
Dr. Dervenis is head of the Department of Surgical Oncology at the Metropolitan Hospital in Athens, Greece. He is also chair of the hepato-pancreato-biliary surgical unit. He reported no disclosures.
No, drain placement is not always necessary.
Drain placement is not essential during all pancreatectomies. The practice is so historically entrenched in our specialty that I need you to check your dogma at the door and take a look at the data with an open mind.
There are many, many retrospective studies that examine drainage versus no drainage. All of these studies have shown the same thing: There is no difference in many outcomes, including mortality. There may be a difference in terms of complicated, postoperative fistulae, which are difficult to manage in patients who have drains.
Another prospective randomized trial from Germany compared the reintervention rate, an endpoint I like, among 439 patients (Ann Surg. 2016;264:528-37). There was no statistically significant difference between the drain or no drain groups, further suggesting that drains are not essential in all cases.
We also need to take a closer look at the study Dr. Dervenis cited (Ann Surg. 2014:259:605-12). It’s true this trial was stopped early because of a higher mortality rate of 12% in the no drain group, but the difference was not statistically significant (P = .097). There was no difference in the fistula rate.
When you look at these data, there are a couple of conclusions you can reach. One conclusion is that a trial of 130 people designed for 750 found something uniquely different that had never been reported in any retrospective series, including one by the study’s senior author that demonstrated drains are essential (HPB [Oxford]. 2011;13:503-10). Another conclusion is that drains are not needed, and there is a very good chance this is a false positive finding. Look at the reasons the 10 participants died. I’m not sure a drain would have helped some of the patients without them, and some of the patients who had drains still died.
A study looking at practice at my institution, MSKCC, shows that drains are still used about half the time, indicating they are not essential. (Ann. Surg. 2013 Dec;258[6]:1051-8). Drains were more commonly used for pancreaticoduodenectomy and when the surgeon thought there might be a problem, such as a soft gland, difficult time in the OR, or a small pancreatic duct.
If you look at these data, this pans out in every retrospective study I’ve seen comparing drain versus no drain – the patients with drains tend to have higher morbidity. Among the 1,122 resection patients in the MSKCC study, those without operative drains had significantly lower rates of grade 3 complications and overall morbidity and fewer readmissions and lower rates of grade 3 or higher pancreatic fistula. Mortality and reintervention rates were no different.
I also looked at our most recent data, between 2010 and 2015. Now we are using intraoperative drains even less often. They are not considered essential at this point.
There are multiple retrospective and well-designed prospective, randomized trials that show no benefit to routine drainage following pancreatectomy. Acceptance of randomized clinical data is slow, particularly when it flies in the face of what you were taught by your mentors over the past 40 or 50 years. I encourage you to look at these data carefully and utilize them in your practice.
Dr. Allen is associate director for clinical programs at David M. Rubenstein Center for Pancreatic Cancer Research and the Murray F. Brennan chair in surgery at Memorial Sloan-Kettering Cancer Center in New York City. He reported no disclosures.
Yes, placing drains is essential.
It’s important to look at the evidence in the literature, starting with a randomized controlled trial of 179 patients from 2001 that showed no reduction in death or complication rate associated with use of surgical intraperitoneal closed suction drainage (Ann. Surg. 2001;234:487-94). Interestingly, even though this study showed there was no benefit to using drains, they address the use of closed suction drainage. The investigators were not claiming all drains are unnecessary.
Why drain placement? The argument for drains includes evacuation of blood, pancreatic juice, bile, and chyle. In addition, assessing drainage can act as a warning sign for anastomotic leak or hemorrhage, so patients can potentially avoid additional interventions.
A study from University of Tokyo researchers found three drains were more effective than one. In addition, the investigators argued against early removal, pointing out that the risk for infection associated with drains only increased after day 10. The researchers were not only in favor of drains but in favor of multiple drains (World J Surg. 2016;40:1226-35).
A multicenter, randomized prospective trial conducted in the United States compared 68 patients with drains to 69 others without during pancreaticoduodenectomy. They reported an increase in the frequency and severity of complications when drains were omitted, including the number of grade 2 or greater complications. Furthermore, the safety monitoring board stopped the study early because mortality among patients in the drain group was 3%, compared with 12% in the no-drain group. (Ann. Surg. 2014:259:605-12).
Another set of researchers in Germany conducted a prospective, randomized study that favored omission of drains. However, a closer look at demographics shows that about one-fourth of participants had chronic pancreatitis, which is associated with a low risk of fistula (Ann Surg. 2016;263:440-9). In addition, they found no significant difference in fistula rates between patients who underwent pancreaticojejunostomy or pancreaticoduodenectomy. Interestingly, the authors noted that surgeons were reluctant to omit drains in many situations, even in a clinical trial context.
Furthermore, a systematic review of nine studies with nearly 3,000 patients suggests it is still necessary to place abdominal drains during pancreatic resection, researchers at the Medical College of Xi’an Jiaotong University in China reported (World J Gastroenterol. 2015;21:5719-34). The authors cited a significant increase in morbidity among patients in whom drains were omitted (odds ratio, 2.39).
Perhaps the cleverest way to address this controversy with drains during pancreatic resection comes from researchers at the University of Pennsylvania. They looked at surgical risk factors to gain a more nuanced view. They used the Fistula Risk Score (FRS) to stratify patients and re-examined the outcomes of the multicenter U.S. study I cited earlier that was stopped early because of differences in mortality rates. The University of Pennsylvania research found that FRS correlated well with outcomes, suggesting its use as a mitigation strategy in patients at moderate to high risk for developing clinically relevant postoperative pancreatic fistula (J Gastrointest Surg. 2015;19:21-30). In other words, they suggest routine prophylactic drainage for patients at moderate to high risk but also suggest that there may be no need for prophylactic drainage for negligible to low risk patients.
I would like to conclude that drains appear essential in many cases, including for moderate to higher risk patients. We need to tailor our practices as surgeons regarding placement of drains during pancreatectomy or pancreaticoduodenectomy. Our goal remains to create opportunities for prolonged survival and better quality of life for our patients.
Dr. Dervenis is head of the Department of Surgical Oncology at the Metropolitan Hospital in Athens, Greece. He is also chair of the hepato-pancreato-biliary surgical unit. He reported no disclosures.
No, drain placement is not always necessary.
Drain placement is not essential during all pancreatectomies. The practice is so historically entrenched in our specialty that I need you to check your dogma at the door and take a look at the data with an open mind.
There are many, many retrospective studies that examine drainage versus no drainage. All of these studies have shown the same thing: There is no difference in many outcomes, including mortality. There may be a difference in terms of complicated, postoperative fistulae, which are difficult to manage in patients who have drains.
Another prospective randomized trial from Germany compared the reintervention rate, an endpoint I like, among 439 patients (Ann Surg. 2016;264:528-37). There was no statistically significant difference between the drain or no drain groups, further suggesting that drains are not essential in all cases.
We also need to take a closer look at the study Dr. Dervenis cited (Ann Surg. 2014:259:605-12). It’s true this trial was stopped early because of a higher mortality rate of 12% in the no drain group, but the difference was not statistically significant (P = .097). There was no difference in the fistula rate.
When you look at these data, there are a couple of conclusions you can reach. One conclusion is that a trial of 130 people designed for 750 found something uniquely different that had never been reported in any retrospective series, including one by the study’s senior author that demonstrated drains are essential (HPB [Oxford]. 2011;13:503-10). Another conclusion is that drains are not needed, and there is a very good chance this is a false positive finding. Look at the reasons the 10 participants died. I’m not sure a drain would have helped some of the patients without them, and some of the patients who had drains still died.
A study looking at practice at my institution, MSKCC, shows that drains are still used about half the time, indicating they are not essential. (Ann. Surg. 2013 Dec;258[6]:1051-8). Drains were more commonly used for pancreaticoduodenectomy and when the surgeon thought there might be a problem, such as a soft gland, difficult time in the OR, or a small pancreatic duct.
If you look at these data, this pans out in every retrospective study I’ve seen comparing drain versus no drain – the patients with drains tend to have higher morbidity. Among the 1,122 resection patients in the MSKCC study, those without operative drains had significantly lower rates of grade 3 complications and overall morbidity and fewer readmissions and lower rates of grade 3 or higher pancreatic fistula. Mortality and reintervention rates were no different.
I also looked at our most recent data, between 2010 and 2015. Now we are using intraoperative drains even less often. They are not considered essential at this point.
There are multiple retrospective and well-designed prospective, randomized trials that show no benefit to routine drainage following pancreatectomy. Acceptance of randomized clinical data is slow, particularly when it flies in the face of what you were taught by your mentors over the past 40 or 50 years. I encourage you to look at these data carefully and utilize them in your practice.
Dr. Allen is associate director for clinical programs at David M. Rubenstein Center for Pancreatic Cancer Research and the Murray F. Brennan chair in surgery at Memorial Sloan-Kettering Cancer Center in New York City. He reported no disclosures.
Don’t be bullied by patients threatening bad reviews
“I’m giving you a bad review on Yelp over this.”
He said that, and I honestly didn’t care.
When he called for the appointment, he told my staff he was on a PPO plan that I’m contracted with. But when he came in 2 weeks later, he had a completely different card: an HMO that I’ve never been affiliated with.
I’m an adult neurologist, and don’t see anyone under 18. If you’re an adult, you need to start taking responsibility for your actions. One of them should be knowing what your medical insurance is. This is your job. Not ours. When you tell us what your insurance is, we take you at your word.
But I’m here to help people, and he said he really needed to see me. So I offered to see him at my cash discount rate.
He said no.
I then said I’d see him, and bill it to his insurance to see if they paid anything, and we could work out what he still might owe after that. I was genuinely trying to help him.
Not surprisingly, he again said no.
Then he made me this counteroffer: See me for free, and I won’t post a negative online review about you.
Predictably, he left. And wrote the review on a rate-a-doc site.
Does the bad review bother me? Not at all. The nature of medicine is such that you can’t please everyone. And those you do please likely won’t write a review.
I come here each day to do my best to help people. Threatening me to start a medical relationship will find you going nowhere.
And taking responsibility for your own actions, like I tell my kids, is a big part of being a grownup.
Dr. Block has a solo neurology practice in Scottsdale, Ariz.
“I’m giving you a bad review on Yelp over this.”
He said that, and I honestly didn’t care.
When he called for the appointment, he told my staff he was on a PPO plan that I’m contracted with. But when he came in 2 weeks later, he had a completely different card: an HMO that I’ve never been affiliated with.
I’m an adult neurologist, and don’t see anyone under 18. If you’re an adult, you need to start taking responsibility for your actions. One of them should be knowing what your medical insurance is. This is your job. Not ours. When you tell us what your insurance is, we take you at your word.
But I’m here to help people, and he said he really needed to see me. So I offered to see him at my cash discount rate.
He said no.
I then said I’d see him, and bill it to his insurance to see if they paid anything, and we could work out what he still might owe after that. I was genuinely trying to help him.
Not surprisingly, he again said no.
Then he made me this counteroffer: See me for free, and I won’t post a negative online review about you.
Predictably, he left. And wrote the review on a rate-a-doc site.
Does the bad review bother me? Not at all. The nature of medicine is such that you can’t please everyone. And those you do please likely won’t write a review.
I come here each day to do my best to help people. Threatening me to start a medical relationship will find you going nowhere.
And taking responsibility for your own actions, like I tell my kids, is a big part of being a grownup.
Dr. Block has a solo neurology practice in Scottsdale, Ariz.
“I’m giving you a bad review on Yelp over this.”
He said that, and I honestly didn’t care.
When he called for the appointment, he told my staff he was on a PPO plan that I’m contracted with. But when he came in 2 weeks later, he had a completely different card: an HMO that I’ve never been affiliated with.
I’m an adult neurologist, and don’t see anyone under 18. If you’re an adult, you need to start taking responsibility for your actions. One of them should be knowing what your medical insurance is. This is your job. Not ours. When you tell us what your insurance is, we take you at your word.
But I’m here to help people, and he said he really needed to see me. So I offered to see him at my cash discount rate.
He said no.
I then said I’d see him, and bill it to his insurance to see if they paid anything, and we could work out what he still might owe after that. I was genuinely trying to help him.
Not surprisingly, he again said no.
Then he made me this counteroffer: See me for free, and I won’t post a negative online review about you.
Predictably, he left. And wrote the review on a rate-a-doc site.
Does the bad review bother me? Not at all. The nature of medicine is such that you can’t please everyone. And those you do please likely won’t write a review.
I come here each day to do my best to help people. Threatening me to start a medical relationship will find you going nowhere.
And taking responsibility for your own actions, like I tell my kids, is a big part of being a grownup.
Dr. Block has a solo neurology practice in Scottsdale, Ariz.
FDA has the resources to answer questions about medicines and pregnancy
There are about 6 million pregnancies in the United States each year, and it’s estimated that 50% of pregnant women take at least one medicine. Physicians play an important role in helping their pregnant patients make informed health choices, especially when it comes to the safe use of medications.
- Emphasize that patients should always talk to their health care provider before taking any medicines, herbs, or vitamins. The website provides tips on how to start the conversation with patients about what medicines, herbs, or vitamins to avoid when pregnant.
- Encourage patients to check the drug label and other information that comes with their medicine to learn about possible risks for women who are pregnant or breastfeeding.
- Assist pregnant patients with changing medications as needed.
- Advise pregnant patients if they need to take more or less of their medicines.
- Advise patients about medicines that can and cannot be used when they start breastfeeding.
- Encourage patients to talk about any problems they have with their medicine.
- Report any serious problems your pregnant patients have had after taking a medicine to the FDA. It falls to physicians to report to the FDA any cases of serious side effects, problems with product quality, and product-use errors or with any of the following products: human drugs, medical devices, blood products and other biologics (except vaccines), and/or medical foods.
- Encourage patients to enroll in a Pregnancy Exposure Registry, if applicable at the FDA website, which collects information on pregnancy outcomes in women who already are taking medications. Observational studies of the patients that physicians help enroll in a pregnancy exposure registry can improve drug safety information for medicines used during pregnancy and can be used to update drug labeling. The observational studies included with the registries can also help physicians make medicine recommendations for use during pregnancy. The list includes contact information for each registry. Physicians can check online to see if there is a registry for their patients’ medicine.
The FDA website also provides information about the Pregnancy and Lactation Labeling Final Rule, which requires changes to the content and format for information presented in prescription drug labeling. The changes are implemented to help health care providers assess risk versus benefit and in subsequent counseling of pregnant women and nursing mothers.
The FDA offers free medicine safety and pregnancy resources for pregnant women, including downloadable infographics; a Medicines Record Keeper brochure in English, Spanish 
Pregnancy is an exciting time for women, but they may have questions and concerns about how medicines they take will affect their babies. Our pregnancy website can help make a woman’s pregnancy happier and healthier.
Dr. Yao is the director of the division of pediatrics and maternal health, Office of Drug Evaluation IV, Center for Drug Evaluation and Research at the FDA, in Silver Spring, Md.
There are about 6 million pregnancies in the United States each year, and it’s estimated that 50% of pregnant women take at least one medicine. Physicians play an important role in helping their pregnant patients make informed health choices, especially when it comes to the safe use of medications.
- Emphasize that patients should always talk to their health care provider before taking any medicines, herbs, or vitamins. The website provides tips on how to start the conversation with patients about what medicines, herbs, or vitamins to avoid when pregnant.
- Encourage patients to check the drug label and other information that comes with their medicine to learn about possible risks for women who are pregnant or breastfeeding.
- Assist pregnant patients with changing medications as needed.
- Advise pregnant patients if they need to take more or less of their medicines.
- Advise patients about medicines that can and cannot be used when they start breastfeeding.
- Encourage patients to talk about any problems they have with their medicine.
- Report any serious problems your pregnant patients have had after taking a medicine to the FDA. It falls to physicians to report to the FDA any cases of serious side effects, problems with product quality, and product-use errors or with any of the following products: human drugs, medical devices, blood products and other biologics (except vaccines), and/or medical foods.
- Encourage patients to enroll in a Pregnancy Exposure Registry, if applicable at the FDA website, which collects information on pregnancy outcomes in women who already are taking medications. Observational studies of the patients that physicians help enroll in a pregnancy exposure registry can improve drug safety information for medicines used during pregnancy and can be used to update drug labeling. The observational studies included with the registries can also help physicians make medicine recommendations for use during pregnancy. The list includes contact information for each registry. Physicians can check online to see if there is a registry for their patients’ medicine.
The FDA website also provides information about the Pregnancy and Lactation Labeling Final Rule, which requires changes to the content and format for information presented in prescription drug labeling. The changes are implemented to help health care providers assess risk versus benefit and in subsequent counseling of pregnant women and nursing mothers.
The FDA offers free medicine safety and pregnancy resources for pregnant women, including downloadable infographics; a Medicines Record Keeper brochure in English, Spanish
Pregnancy is an exciting time for women, but they may have questions and concerns about how medicines they take will affect their babies. Our pregnancy website can help make a woman’s pregnancy happier and healthier.
Dr. Yao is the director of the division of pediatrics and maternal health, Office of Drug Evaluation IV, Center for Drug Evaluation and Research at the FDA, in Silver Spring, Md.
There are about 6 million pregnancies in the United States each year, and it’s estimated that 50% of pregnant women take at least one medicine. Physicians play an important role in helping their pregnant patients make informed health choices, especially when it comes to the safe use of medications.
- Emphasize that patients should always talk to their health care provider before taking any medicines, herbs, or vitamins. The website provides tips on how to start the conversation with patients about what medicines, herbs, or vitamins to avoid when pregnant.
- Encourage patients to check the drug label and other information that comes with their medicine to learn about possible risks for women who are pregnant or breastfeeding.
- Assist pregnant patients with changing medications as needed.
- Advise pregnant patients if they need to take more or less of their medicines.
- Advise patients about medicines that can and cannot be used when they start breastfeeding.
- Encourage patients to talk about any problems they have with their medicine.
- Report any serious problems your pregnant patients have had after taking a medicine to the FDA. It falls to physicians to report to the FDA any cases of serious side effects, problems with product quality, and product-use errors or with any of the following products: human drugs, medical devices, blood products and other biologics (except vaccines), and/or medical foods.
- Encourage patients to enroll in a Pregnancy Exposure Registry, if applicable at the FDA website, which collects information on pregnancy outcomes in women who already are taking medications. Observational studies of the patients that physicians help enroll in a pregnancy exposure registry can improve drug safety information for medicines used during pregnancy and can be used to update drug labeling. The observational studies included with the registries can also help physicians make medicine recommendations for use during pregnancy. The list includes contact information for each registry. Physicians can check online to see if there is a registry for their patients’ medicine.
The FDA website also provides information about the Pregnancy and Lactation Labeling Final Rule, which requires changes to the content and format for information presented in prescription drug labeling. The changes are implemented to help health care providers assess risk versus benefit and in subsequent counseling of pregnant women and nursing mothers.
The FDA offers free medicine safety and pregnancy resources for pregnant women, including downloadable infographics; a Medicines Record Keeper brochure in English, Spanish
Pregnancy is an exciting time for women, but they may have questions and concerns about how medicines they take will affect their babies. Our pregnancy website can help make a woman’s pregnancy happier and healthier.
Dr. Yao is the director of the division of pediatrics and maternal health, Office of Drug Evaluation IV, Center for Drug Evaluation and Research at the FDA, in Silver Spring, Md.