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Suicide rate higher than average for female clinicians

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Sun, 01/26/2020 - 11:07

The suicide rate for women who provide health care is higher than that of all women of working age, while male health care practitioners are less likely to end their lives than working-age men as a whole, according to the Centers for Disease Control and Prevention.

In 2016, the suicide rate for women classified as “healthcare practitioners and technical” – a category that includes physicians and surgeons, as well as chiropractors, physician assistants, and nurse practitioners – was 8.5 per 100,000 population, compared with 7.7 per 100,000 for all working women aged 16-64 years. That difference, however, was not statistically significant, Cora Peterson, PhD, and associates at the CDC said in the Morbidity and Mortality Weekly Report.

For females classified as “healthcare support” – medical assistants and transcriptionists, phlebotomists, and pharmacy aides – the suicide rate of 10.6 per 100,000 was significantly higher than that of all working women, the investigators noted.

The suicide rate for males in each of the two occupation categories was 23.6 per 100,000 population in 2016, lower than the rate of 27.4 per 100,000 for males of all occupations, they said, based on data from 32 states that participated in the 2016 National Violent Death Reporting System.



For males, the highest suicide rates in occupations meeting criteria for sample size were “construction and extraction” (49.4 per 100,000); “installation, maintenance, and repair” (36.9); and “arts, design, entertainment, sports, and media” (32.0). Among females, the highest rates were seen in “construction and extraction” (25.5 per 100,000), “protective service” (14.0), and “transportation and material moving” (12.5), with healthcare support next, Dr. Peterson and associates reported.

“Although relative comparisons of suicide rates in this manner are useful for prevention purposes, these results should not overshadow the essential fact that the suicide rate in the U.S. working-age population overall has increased by 40% in less than 2 decades. Therefore, all industry sectors and occupational groups can contribute to reducing suicide incidence,” they wrote.

SOURCE: Peterson C et al. MMWR. 2020 Jan 24;69(3):57-62.

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The suicide rate for women who provide health care is higher than that of all women of working age, while male health care practitioners are less likely to end their lives than working-age men as a whole, according to the Centers for Disease Control and Prevention.

In 2016, the suicide rate for women classified as “healthcare practitioners and technical” – a category that includes physicians and surgeons, as well as chiropractors, physician assistants, and nurse practitioners – was 8.5 per 100,000 population, compared with 7.7 per 100,000 for all working women aged 16-64 years. That difference, however, was not statistically significant, Cora Peterson, PhD, and associates at the CDC said in the Morbidity and Mortality Weekly Report.

For females classified as “healthcare support” – medical assistants and transcriptionists, phlebotomists, and pharmacy aides – the suicide rate of 10.6 per 100,000 was significantly higher than that of all working women, the investigators noted.

The suicide rate for males in each of the two occupation categories was 23.6 per 100,000 population in 2016, lower than the rate of 27.4 per 100,000 for males of all occupations, they said, based on data from 32 states that participated in the 2016 National Violent Death Reporting System.



For males, the highest suicide rates in occupations meeting criteria for sample size were “construction and extraction” (49.4 per 100,000); “installation, maintenance, and repair” (36.9); and “arts, design, entertainment, sports, and media” (32.0). Among females, the highest rates were seen in “construction and extraction” (25.5 per 100,000), “protective service” (14.0), and “transportation and material moving” (12.5), with healthcare support next, Dr. Peterson and associates reported.

“Although relative comparisons of suicide rates in this manner are useful for prevention purposes, these results should not overshadow the essential fact that the suicide rate in the U.S. working-age population overall has increased by 40% in less than 2 decades. Therefore, all industry sectors and occupational groups can contribute to reducing suicide incidence,” they wrote.

SOURCE: Peterson C et al. MMWR. 2020 Jan 24;69(3):57-62.

The suicide rate for women who provide health care is higher than that of all women of working age, while male health care practitioners are less likely to end their lives than working-age men as a whole, according to the Centers for Disease Control and Prevention.

In 2016, the suicide rate for women classified as “healthcare practitioners and technical” – a category that includes physicians and surgeons, as well as chiropractors, physician assistants, and nurse practitioners – was 8.5 per 100,000 population, compared with 7.7 per 100,000 for all working women aged 16-64 years. That difference, however, was not statistically significant, Cora Peterson, PhD, and associates at the CDC said in the Morbidity and Mortality Weekly Report.

For females classified as “healthcare support” – medical assistants and transcriptionists, phlebotomists, and pharmacy aides – the suicide rate of 10.6 per 100,000 was significantly higher than that of all working women, the investigators noted.

The suicide rate for males in each of the two occupation categories was 23.6 per 100,000 population in 2016, lower than the rate of 27.4 per 100,000 for males of all occupations, they said, based on data from 32 states that participated in the 2016 National Violent Death Reporting System.



For males, the highest suicide rates in occupations meeting criteria for sample size were “construction and extraction” (49.4 per 100,000); “installation, maintenance, and repair” (36.9); and “arts, design, entertainment, sports, and media” (32.0). Among females, the highest rates were seen in “construction and extraction” (25.5 per 100,000), “protective service” (14.0), and “transportation and material moving” (12.5), with healthcare support next, Dr. Peterson and associates reported.

“Although relative comparisons of suicide rates in this manner are useful for prevention purposes, these results should not overshadow the essential fact that the suicide rate in the U.S. working-age population overall has increased by 40% in less than 2 decades. Therefore, all industry sectors and occupational groups can contribute to reducing suicide incidence,” they wrote.

SOURCE: Peterson C et al. MMWR. 2020 Jan 24;69(3):57-62.

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Actor Alan Alda discusses using empathy as an antidote to burnout

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Wed, 05/06/2020 - 12:46

– Physicians and other medical professionals who routinely foster empathic connections with patients may be helping themselves steer clear of burnout.

That’s what iconic actor Alan Alda suggested during a media briefing at Scripps Research on Jan. 16, 2020.

Vidyard Video



“There’s a tremendous pressure on doctors now to have shorter and shorter visits with their patients,” said the 83-year-old Mr. Alda, who received the Public Welfare Medal from the National Academy of Sciences in 2016 for his work as a champion of science. “A lot of that time is taken up with recording on a computer, which can only put pressure on the doctor.”

Practicing empathy, he continued, “kind of opens people up to one another, which inspirits them.”

Mr. Alda appeared on the research campus to announce that Scripps Research will serve as the new West Coast home of Alda Communication Training, which will work in tandem with the Alan Alda Center for Communicating Science at Stony Brook (N.Y.) University, a nonprofit organization that Mr. Alda helped found in 2009.

“This will be a center where people can come to get training in effective communication,” Mr. Alda, who is the winner of six Emmy Awards and six Golden Globe awards, told an audience of scientists and medical professionals prior to the media briefing.

“It’s an experiential kind of training,” he explained. “We don’t give tips. We don’t give lectures. We put you through exercises that are fun and actually make you laugh, but turn you into a better communicator, so you’re better able to connect to the people you’re talking to.”

During a question-and-answer session, Mr. Alda opened up about his Parkinson’s disease, which he said was diagnosed about 5 years ago. In 2018, he decided to speak publicly about his diagnosis for the first time.

“The reason was that I wanted to communicate to people who had recently been diagnosed not to believe or give into the stereotype that, when you get a diagnosis, your life is over,” said Mr. Alda, who played army surgeon “Hawkeye” Pierce on the TV series “M*A*S*H.”

“Under the burden of that belief, some people won’t tell their family or workplace colleagues,” he said. “There are exercises you can do and medications you can take to prolong the time it takes before Parkinson’s gets much more serious. It’s not to diminish the fact that it can get really bad; but to think that your life is over as soon as you get a diagnosis is wrong.”

The first 2-day training session at Scripps Research will be held in June 2020. Additional sessions are scheduled to take place in October and December. Registration is available at aldacommunicationtraining.com/workshops.

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– Physicians and other medical professionals who routinely foster empathic connections with patients may be helping themselves steer clear of burnout.

That’s what iconic actor Alan Alda suggested during a media briefing at Scripps Research on Jan. 16, 2020.

Vidyard Video



“There’s a tremendous pressure on doctors now to have shorter and shorter visits with their patients,” said the 83-year-old Mr. Alda, who received the Public Welfare Medal from the National Academy of Sciences in 2016 for his work as a champion of science. “A lot of that time is taken up with recording on a computer, which can only put pressure on the doctor.”

Practicing empathy, he continued, “kind of opens people up to one another, which inspirits them.”

Mr. Alda appeared on the research campus to announce that Scripps Research will serve as the new West Coast home of Alda Communication Training, which will work in tandem with the Alan Alda Center for Communicating Science at Stony Brook (N.Y.) University, a nonprofit organization that Mr. Alda helped found in 2009.

“This will be a center where people can come to get training in effective communication,” Mr. Alda, who is the winner of six Emmy Awards and six Golden Globe awards, told an audience of scientists and medical professionals prior to the media briefing.

“It’s an experiential kind of training,” he explained. “We don’t give tips. We don’t give lectures. We put you through exercises that are fun and actually make you laugh, but turn you into a better communicator, so you’re better able to connect to the people you’re talking to.”

During a question-and-answer session, Mr. Alda opened up about his Parkinson’s disease, which he said was diagnosed about 5 years ago. In 2018, he decided to speak publicly about his diagnosis for the first time.

“The reason was that I wanted to communicate to people who had recently been diagnosed not to believe or give into the stereotype that, when you get a diagnosis, your life is over,” said Mr. Alda, who played army surgeon “Hawkeye” Pierce on the TV series “M*A*S*H.”

“Under the burden of that belief, some people won’t tell their family or workplace colleagues,” he said. “There are exercises you can do and medications you can take to prolong the time it takes before Parkinson’s gets much more serious. It’s not to diminish the fact that it can get really bad; but to think that your life is over as soon as you get a diagnosis is wrong.”

The first 2-day training session at Scripps Research will be held in June 2020. Additional sessions are scheduled to take place in October and December. Registration is available at aldacommunicationtraining.com/workshops.

– Physicians and other medical professionals who routinely foster empathic connections with patients may be helping themselves steer clear of burnout.

That’s what iconic actor Alan Alda suggested during a media briefing at Scripps Research on Jan. 16, 2020.

Vidyard Video



“There’s a tremendous pressure on doctors now to have shorter and shorter visits with their patients,” said the 83-year-old Mr. Alda, who received the Public Welfare Medal from the National Academy of Sciences in 2016 for his work as a champion of science. “A lot of that time is taken up with recording on a computer, which can only put pressure on the doctor.”

Practicing empathy, he continued, “kind of opens people up to one another, which inspirits them.”

Mr. Alda appeared on the research campus to announce that Scripps Research will serve as the new West Coast home of Alda Communication Training, which will work in tandem with the Alan Alda Center for Communicating Science at Stony Brook (N.Y.) University, a nonprofit organization that Mr. Alda helped found in 2009.

“This will be a center where people can come to get training in effective communication,” Mr. Alda, who is the winner of six Emmy Awards and six Golden Globe awards, told an audience of scientists and medical professionals prior to the media briefing.

“It’s an experiential kind of training,” he explained. “We don’t give tips. We don’t give lectures. We put you through exercises that are fun and actually make you laugh, but turn you into a better communicator, so you’re better able to connect to the people you’re talking to.”

During a question-and-answer session, Mr. Alda opened up about his Parkinson’s disease, which he said was diagnosed about 5 years ago. In 2018, he decided to speak publicly about his diagnosis for the first time.

“The reason was that I wanted to communicate to people who had recently been diagnosed not to believe or give into the stereotype that, when you get a diagnosis, your life is over,” said Mr. Alda, who played army surgeon “Hawkeye” Pierce on the TV series “M*A*S*H.”

“Under the burden of that belief, some people won’t tell their family or workplace colleagues,” he said. “There are exercises you can do and medications you can take to prolong the time it takes before Parkinson’s gets much more serious. It’s not to diminish the fact that it can get really bad; but to think that your life is over as soon as you get a diagnosis is wrong.”

The first 2-day training session at Scripps Research will be held in June 2020. Additional sessions are scheduled to take place in October and December. Registration is available at aldacommunicationtraining.com/workshops.

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The suicide wars

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Fri, 01/24/2020 - 10:28

Topic of suicide prevention causing divisions within psychiatry

At every swipe through my social media feeds, I’m greeted with another topic that has advocates clustered at the extremes. People align, and they align quickly in our strangely polarized world in which anyone who might sit in the middle lies low.

Dr. Dinah Miller

It seems we’re divided: On the left you are a CNN fan or you’re one of those soulless monsters who tunes in to Fox News. You’re pro-life or you’re a baby killer, advocating for late-term abortions or even the execution of live infants. When it comes to firearm regulation, one side says you’re a threat to the Constitution, while the other says that those opposed are responsible for the death of every person who was ever the victim of a discharged firearm. And those who feel strongly about a given topic often justify their attacks on those who disagree. Psychiatry is no stranger to this thinking, and we are the only medical specialty with organized “antipsychiatry” groups who oppose our work. I have been a bit surprised, however, that the topic of suicide prevention is one that has us divided within our own specialty.

Amy Barnhorst, MD, is a psychiatrist at the University of California, Davis, and the author of “The empty promise of suicide prevention: Many of the problems that lead people to kill themselves cannot be fixed with a little serotonin,” an op-ed piece that appeared in the New York Times on April 26, 2019. Dr. Barnhorst began her essay with the story of a patient who was hospitalized after a relative realized she was planning her suicide. That story had an ending that psychiatrists relish: A person with previously unrecognized and untreated bipolar disorder received care, including medication, and got better. This suicide was preventable, a life was saved, and this story followed a model we all hope is being replicated over and over.

Dr. Barnhorst went on to say that this was an outlier in her career, that most of the suicidal patients she sees are impoverished, homeless, addicted, and she wrote about how little the treatment setting has to offer: The idea that a pill would fix these problems is almost laughable. She suggests that there is more to suicide prevention than identifying prospective patients and getting them acute psychiatric care.

The decision to stop living is one that people arrive at by different paths, some over months, but many in a matter of minutes. Those people won’t be intercepted by the mental health system. We certainly need more psychiatric services and more research into better, faster-acting treatments for severe depression and suicidal thoughts, but that will never be enough.

We need to address the root causes of our nation’s suicide problem – poverty, homelessness, and the accompanying exposure to trauma, crime, and drugs. That means better alcohol and drug treatment, family counseling, low-income housing resources, job training, and individual therapy. And for those at risk who still slip past all the checkpoints, we need to make sure they don’t have access to guns and lethal medications.

Psychological autopsies done after suicides have indicated that more than 90% of people who die from suicide suffered from a mental illness, yet 54% of those who ended their own lives had never received a psychiatric diagnosis. There is a hopefulness that, if only we had more – more services, more therapy, more medication – then we could prevent suicide. Unfortunately, this line of thinking, with a “Zero Suicide” initiative, points a finger at those who survive: Suicide is preventable, so someone is to blame, if not a family member for missing the warning signs then the clinician who offered treatment that wasn’t good enough.

Along this line, the New York Times printed another opinion piece on Jan. 6 by Richard A. Friedman, MD, titled, “Why are young Americans killing themselves?” Dr. Friedman’s conclusion was more along the psychiatrist party line: “The good news is that we don’t have to wait for all the answers to know what to do. We know that various psychotherapies and medication are highly effective in treating depression. We just need to do a better job of identifying, reaching out to and providing resources for at-risk youths.”

Dr. Friedman goes on to propose universal screening at school, among other measures to identify those at risk. It is no surprise that Dr. Friedman’s article had more than 1,700 comments before commenting was closed by the Times. I have written about the pros and cons of screening adolescents for depression in a primary care setting, so putting the responsibility of identifying suicidal teenagers on school teachers seems like an ominous responsibility to add to a teacher’s obligations.

I did not read Dr. Barnhorst’s earlier op-ed piece as a condemnation of psychiatric care, but rather as a call to action and a reality check on the idea that psychiatry is the only answer to our suicide epidemic. More people than ever get treatment – from psychiatrists, from primary care doctors, from nonphysician prescribing clinicians, and from so many varieties of psychotherapists, and yet our suicide rates continue to rise.

In a post on the Psychology Today website, Sara Gorman, PhD, and Jack M. Gorman, MD, discussed Dr. Barnhorst’s article. “In the process of making her point, Barnhorst also manages to seriously trivialize the role of antidepressant medication in the treatment of depression and to imply that, given societal woes, there isn’t much we can do to try to prevent suicides – aside from limiting access to lethal means,” they wrote.

The Gormans were not alone in their objections; the day after the op-ed appeared in the New York Times, a well-respected psychiatry department chairman took on not just the content of the op-ed, but also the author, in his Twitter feed. He wrote, “@amybarnhorst doesn’t read scientific literature or skipped training. this article is wrong. #suicide is largely preventable, if proper measures taken n Rx provided. @nytimes please vet authors better @APAPsychiatric.” Dr. Barnhorst, also a voice on Twitter, added the wry response, “I skipped training.” When Twitter users responded that initial Twitter comment conveyed a lack of civility toward a colleague, the original Tweeter – I’m withholding his name with the hope that even writing about these interactions won’t put me on anyone’s enemy list – like many others sitting on the poles of these contentious topics, responded with the following, “All for civility except in the case of misinformation that puts lives at risk, especially when purveyed by a professional who wears the patina of credibility.”

If it’s not yet obvious, I don’t believe there is a simple answer to our suicide problem, nor do I think it puts lives at risk to point out that, so far, our treatments have not lowered suicide rates. The issue is complex and we have no perfect explanation as to why countries differ so greatly with regard to suicide. There are impoverished, war-torn countries with remarkably lower suicide rates, and nations with much stricter gun laws that have higher statistics. Honduras, deemed “the murder capital of the world,” has an enviable suicide rate of only 2.9 per 100,000.

If the solution were as simple as making medications more accessible, the answer might be an easy one (or at least worth trying) – make antidepressants available over-the-counter, a move that would both increase access and decrease stigma.

Some people are determined to end their own lives. They aren’t looking to see psychiatrists or to call hotlines, and they may well resort to an alternate method if any given one is not readily available. For these individuals, suicide may not be preventable, and we may be left to say that this tragic phenomena with its diverse causes should also lead us to explore the root causes of human misery and our cultural features that lead some people to end their own lives while others endure.

Clearly, there are those who have untreated psychiatric illnesses and who make impulsive and lethal decisions – access to care and means restrictions certainly save some lives. And while it is obvious to us as psychiatrists that anyone who is depressed or is having suicidal thoughts is deserving of a psychiatric evaluation and intervention, the truth remains that access to treatment in this country is limited by finances, by the availability of mental health professionals, and by stigma and shame. In the end, I don’t believe we have a single easy answer as to why suicide rates are rising or a singular response that will stop this tragic phenomena. The one thing I am certain of is that our efforts to prevent suicide should unite, and not fracture, our profession.

Dr. Miller is coauthor with Annette Hanson, MD, of “Committed: The Battle Over Involuntary Psychiatric Care” (Baltimore: Johns Hopkins University, 2016). She has a private practice and is assistant professor of psychiatry and behavioral sciences at Johns Hopkins, both in Baltimore.

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Topic of suicide prevention causing divisions within psychiatry

Topic of suicide prevention causing divisions within psychiatry

At every swipe through my social media feeds, I’m greeted with another topic that has advocates clustered at the extremes. People align, and they align quickly in our strangely polarized world in which anyone who might sit in the middle lies low.

Dr. Dinah Miller

It seems we’re divided: On the left you are a CNN fan or you’re one of those soulless monsters who tunes in to Fox News. You’re pro-life or you’re a baby killer, advocating for late-term abortions or even the execution of live infants. When it comes to firearm regulation, one side says you’re a threat to the Constitution, while the other says that those opposed are responsible for the death of every person who was ever the victim of a discharged firearm. And those who feel strongly about a given topic often justify their attacks on those who disagree. Psychiatry is no stranger to this thinking, and we are the only medical specialty with organized “antipsychiatry” groups who oppose our work. I have been a bit surprised, however, that the topic of suicide prevention is one that has us divided within our own specialty.

Amy Barnhorst, MD, is a psychiatrist at the University of California, Davis, and the author of “The empty promise of suicide prevention: Many of the problems that lead people to kill themselves cannot be fixed with a little serotonin,” an op-ed piece that appeared in the New York Times on April 26, 2019. Dr. Barnhorst began her essay with the story of a patient who was hospitalized after a relative realized she was planning her suicide. That story had an ending that psychiatrists relish: A person with previously unrecognized and untreated bipolar disorder received care, including medication, and got better. This suicide was preventable, a life was saved, and this story followed a model we all hope is being replicated over and over.

Dr. Barnhorst went on to say that this was an outlier in her career, that most of the suicidal patients she sees are impoverished, homeless, addicted, and she wrote about how little the treatment setting has to offer: The idea that a pill would fix these problems is almost laughable. She suggests that there is more to suicide prevention than identifying prospective patients and getting them acute psychiatric care.

The decision to stop living is one that people arrive at by different paths, some over months, but many in a matter of minutes. Those people won’t be intercepted by the mental health system. We certainly need more psychiatric services and more research into better, faster-acting treatments for severe depression and suicidal thoughts, but that will never be enough.

We need to address the root causes of our nation’s suicide problem – poverty, homelessness, and the accompanying exposure to trauma, crime, and drugs. That means better alcohol and drug treatment, family counseling, low-income housing resources, job training, and individual therapy. And for those at risk who still slip past all the checkpoints, we need to make sure they don’t have access to guns and lethal medications.

Psychological autopsies done after suicides have indicated that more than 90% of people who die from suicide suffered from a mental illness, yet 54% of those who ended their own lives had never received a psychiatric diagnosis. There is a hopefulness that, if only we had more – more services, more therapy, more medication – then we could prevent suicide. Unfortunately, this line of thinking, with a “Zero Suicide” initiative, points a finger at those who survive: Suicide is preventable, so someone is to blame, if not a family member for missing the warning signs then the clinician who offered treatment that wasn’t good enough.

Along this line, the New York Times printed another opinion piece on Jan. 6 by Richard A. Friedman, MD, titled, “Why are young Americans killing themselves?” Dr. Friedman’s conclusion was more along the psychiatrist party line: “The good news is that we don’t have to wait for all the answers to know what to do. We know that various psychotherapies and medication are highly effective in treating depression. We just need to do a better job of identifying, reaching out to and providing resources for at-risk youths.”

Dr. Friedman goes on to propose universal screening at school, among other measures to identify those at risk. It is no surprise that Dr. Friedman’s article had more than 1,700 comments before commenting was closed by the Times. I have written about the pros and cons of screening adolescents for depression in a primary care setting, so putting the responsibility of identifying suicidal teenagers on school teachers seems like an ominous responsibility to add to a teacher’s obligations.

I did not read Dr. Barnhorst’s earlier op-ed piece as a condemnation of psychiatric care, but rather as a call to action and a reality check on the idea that psychiatry is the only answer to our suicide epidemic. More people than ever get treatment – from psychiatrists, from primary care doctors, from nonphysician prescribing clinicians, and from so many varieties of psychotherapists, and yet our suicide rates continue to rise.

In a post on the Psychology Today website, Sara Gorman, PhD, and Jack M. Gorman, MD, discussed Dr. Barnhorst’s article. “In the process of making her point, Barnhorst also manages to seriously trivialize the role of antidepressant medication in the treatment of depression and to imply that, given societal woes, there isn’t much we can do to try to prevent suicides – aside from limiting access to lethal means,” they wrote.

The Gormans were not alone in their objections; the day after the op-ed appeared in the New York Times, a well-respected psychiatry department chairman took on not just the content of the op-ed, but also the author, in his Twitter feed. He wrote, “@amybarnhorst doesn’t read scientific literature or skipped training. this article is wrong. #suicide is largely preventable, if proper measures taken n Rx provided. @nytimes please vet authors better @APAPsychiatric.” Dr. Barnhorst, also a voice on Twitter, added the wry response, “I skipped training.” When Twitter users responded that initial Twitter comment conveyed a lack of civility toward a colleague, the original Tweeter – I’m withholding his name with the hope that even writing about these interactions won’t put me on anyone’s enemy list – like many others sitting on the poles of these contentious topics, responded with the following, “All for civility except in the case of misinformation that puts lives at risk, especially when purveyed by a professional who wears the patina of credibility.”

If it’s not yet obvious, I don’t believe there is a simple answer to our suicide problem, nor do I think it puts lives at risk to point out that, so far, our treatments have not lowered suicide rates. The issue is complex and we have no perfect explanation as to why countries differ so greatly with regard to suicide. There are impoverished, war-torn countries with remarkably lower suicide rates, and nations with much stricter gun laws that have higher statistics. Honduras, deemed “the murder capital of the world,” has an enviable suicide rate of only 2.9 per 100,000.

If the solution were as simple as making medications more accessible, the answer might be an easy one (or at least worth trying) – make antidepressants available over-the-counter, a move that would both increase access and decrease stigma.

Some people are determined to end their own lives. They aren’t looking to see psychiatrists or to call hotlines, and they may well resort to an alternate method if any given one is not readily available. For these individuals, suicide may not be preventable, and we may be left to say that this tragic phenomena with its diverse causes should also lead us to explore the root causes of human misery and our cultural features that lead some people to end their own lives while others endure.

Clearly, there are those who have untreated psychiatric illnesses and who make impulsive and lethal decisions – access to care and means restrictions certainly save some lives. And while it is obvious to us as psychiatrists that anyone who is depressed or is having suicidal thoughts is deserving of a psychiatric evaluation and intervention, the truth remains that access to treatment in this country is limited by finances, by the availability of mental health professionals, and by stigma and shame. In the end, I don’t believe we have a single easy answer as to why suicide rates are rising or a singular response that will stop this tragic phenomena. The one thing I am certain of is that our efforts to prevent suicide should unite, and not fracture, our profession.

Dr. Miller is coauthor with Annette Hanson, MD, of “Committed: The Battle Over Involuntary Psychiatric Care” (Baltimore: Johns Hopkins University, 2016). She has a private practice and is assistant professor of psychiatry and behavioral sciences at Johns Hopkins, both in Baltimore.

At every swipe through my social media feeds, I’m greeted with another topic that has advocates clustered at the extremes. People align, and they align quickly in our strangely polarized world in which anyone who might sit in the middle lies low.

Dr. Dinah Miller

It seems we’re divided: On the left you are a CNN fan or you’re one of those soulless monsters who tunes in to Fox News. You’re pro-life or you’re a baby killer, advocating for late-term abortions or even the execution of live infants. When it comes to firearm regulation, one side says you’re a threat to the Constitution, while the other says that those opposed are responsible for the death of every person who was ever the victim of a discharged firearm. And those who feel strongly about a given topic often justify their attacks on those who disagree. Psychiatry is no stranger to this thinking, and we are the only medical specialty with organized “antipsychiatry” groups who oppose our work. I have been a bit surprised, however, that the topic of suicide prevention is one that has us divided within our own specialty.

Amy Barnhorst, MD, is a psychiatrist at the University of California, Davis, and the author of “The empty promise of suicide prevention: Many of the problems that lead people to kill themselves cannot be fixed with a little serotonin,” an op-ed piece that appeared in the New York Times on April 26, 2019. Dr. Barnhorst began her essay with the story of a patient who was hospitalized after a relative realized she was planning her suicide. That story had an ending that psychiatrists relish: A person with previously unrecognized and untreated bipolar disorder received care, including medication, and got better. This suicide was preventable, a life was saved, and this story followed a model we all hope is being replicated over and over.

Dr. Barnhorst went on to say that this was an outlier in her career, that most of the suicidal patients she sees are impoverished, homeless, addicted, and she wrote about how little the treatment setting has to offer: The idea that a pill would fix these problems is almost laughable. She suggests that there is more to suicide prevention than identifying prospective patients and getting them acute psychiatric care.

The decision to stop living is one that people arrive at by different paths, some over months, but many in a matter of minutes. Those people won’t be intercepted by the mental health system. We certainly need more psychiatric services and more research into better, faster-acting treatments for severe depression and suicidal thoughts, but that will never be enough.

We need to address the root causes of our nation’s suicide problem – poverty, homelessness, and the accompanying exposure to trauma, crime, and drugs. That means better alcohol and drug treatment, family counseling, low-income housing resources, job training, and individual therapy. And for those at risk who still slip past all the checkpoints, we need to make sure they don’t have access to guns and lethal medications.

Psychological autopsies done after suicides have indicated that more than 90% of people who die from suicide suffered from a mental illness, yet 54% of those who ended their own lives had never received a psychiatric diagnosis. There is a hopefulness that, if only we had more – more services, more therapy, more medication – then we could prevent suicide. Unfortunately, this line of thinking, with a “Zero Suicide” initiative, points a finger at those who survive: Suicide is preventable, so someone is to blame, if not a family member for missing the warning signs then the clinician who offered treatment that wasn’t good enough.

Along this line, the New York Times printed another opinion piece on Jan. 6 by Richard A. Friedman, MD, titled, “Why are young Americans killing themselves?” Dr. Friedman’s conclusion was more along the psychiatrist party line: “The good news is that we don’t have to wait for all the answers to know what to do. We know that various psychotherapies and medication are highly effective in treating depression. We just need to do a better job of identifying, reaching out to and providing resources for at-risk youths.”

Dr. Friedman goes on to propose universal screening at school, among other measures to identify those at risk. It is no surprise that Dr. Friedman’s article had more than 1,700 comments before commenting was closed by the Times. I have written about the pros and cons of screening adolescents for depression in a primary care setting, so putting the responsibility of identifying suicidal teenagers on school teachers seems like an ominous responsibility to add to a teacher’s obligations.

I did not read Dr. Barnhorst’s earlier op-ed piece as a condemnation of psychiatric care, but rather as a call to action and a reality check on the idea that psychiatry is the only answer to our suicide epidemic. More people than ever get treatment – from psychiatrists, from primary care doctors, from nonphysician prescribing clinicians, and from so many varieties of psychotherapists, and yet our suicide rates continue to rise.

In a post on the Psychology Today website, Sara Gorman, PhD, and Jack M. Gorman, MD, discussed Dr. Barnhorst’s article. “In the process of making her point, Barnhorst also manages to seriously trivialize the role of antidepressant medication in the treatment of depression and to imply that, given societal woes, there isn’t much we can do to try to prevent suicides – aside from limiting access to lethal means,” they wrote.

The Gormans were not alone in their objections; the day after the op-ed appeared in the New York Times, a well-respected psychiatry department chairman took on not just the content of the op-ed, but also the author, in his Twitter feed. He wrote, “@amybarnhorst doesn’t read scientific literature or skipped training. this article is wrong. #suicide is largely preventable, if proper measures taken n Rx provided. @nytimes please vet authors better @APAPsychiatric.” Dr. Barnhorst, also a voice on Twitter, added the wry response, “I skipped training.” When Twitter users responded that initial Twitter comment conveyed a lack of civility toward a colleague, the original Tweeter – I’m withholding his name with the hope that even writing about these interactions won’t put me on anyone’s enemy list – like many others sitting on the poles of these contentious topics, responded with the following, “All for civility except in the case of misinformation that puts lives at risk, especially when purveyed by a professional who wears the patina of credibility.”

If it’s not yet obvious, I don’t believe there is a simple answer to our suicide problem, nor do I think it puts lives at risk to point out that, so far, our treatments have not lowered suicide rates. The issue is complex and we have no perfect explanation as to why countries differ so greatly with regard to suicide. There are impoverished, war-torn countries with remarkably lower suicide rates, and nations with much stricter gun laws that have higher statistics. Honduras, deemed “the murder capital of the world,” has an enviable suicide rate of only 2.9 per 100,000.

If the solution were as simple as making medications more accessible, the answer might be an easy one (or at least worth trying) – make antidepressants available over-the-counter, a move that would both increase access and decrease stigma.

Some people are determined to end their own lives. They aren’t looking to see psychiatrists or to call hotlines, and they may well resort to an alternate method if any given one is not readily available. For these individuals, suicide may not be preventable, and we may be left to say that this tragic phenomena with its diverse causes should also lead us to explore the root causes of human misery and our cultural features that lead some people to end their own lives while others endure.

Clearly, there are those who have untreated psychiatric illnesses and who make impulsive and lethal decisions – access to care and means restrictions certainly save some lives. And while it is obvious to us as psychiatrists that anyone who is depressed or is having suicidal thoughts is deserving of a psychiatric evaluation and intervention, the truth remains that access to treatment in this country is limited by finances, by the availability of mental health professionals, and by stigma and shame. In the end, I don’t believe we have a single easy answer as to why suicide rates are rising or a singular response that will stop this tragic phenomena. The one thing I am certain of is that our efforts to prevent suicide should unite, and not fracture, our profession.

Dr. Miller is coauthor with Annette Hanson, MD, of “Committed: The Battle Over Involuntary Psychiatric Care” (Baltimore: Johns Hopkins University, 2016). She has a private practice and is assistant professor of psychiatry and behavioral sciences at Johns Hopkins, both in Baltimore.

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FDA advisers set high bar for new opioids

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Tue, 07/21/2020 - 14:18

During an opioid-addiction epidemic, can any new opioid pain drug meet prevailing safety demands to gain regulatory approval?

On Jan. 14 and 15, a Food and Drug Administration advisory committee voted virtually unanimously against two new opioid formulations and evenly split for and against a third; the 2 days of data and discussion showed how high a bar new opioids face these days for getting onto the U.S. market.

The bar’s height is very understandable given how many Americans have become addicted to opioids over the past decade, more often than not by accident while using pain medications as they believed they had been directed, said experts during the sessions held on the FDA’s campus in White Oak, Md.

Among the many upshots of the opioid crisis, the meetings held to discuss these three contender opioids highlighted the bitter irony confronting attempts to bring new, safer opioids to the U.S. market: While less abusable pain-relief medications that still harness the potent analgesic power of mu opioid receptor agonists are desperately desired, new agents in this space now receive withering scrutiny over their safeguards against misuse and abuse, and over whether they add anything meaningfully new to what’s already available. While these demands seem reasonable, perhaps even essential, it’s unclear whether any new opioid-based pain drugs will ever fully meet the safety that researchers, clinicians, and the public now seek.

A special FDA advisory committee that combined the Anesthetic and Analgesic Drug Products Advisory Committee with members of the Drug Safety and Risk Management Advisory Committee considered the application for three different opioid drugs from three separate companies. None received a clear endorsement. Oxycodegol, a new type of orally delivered opioid molecule engineered to slow brain entry and thereby delay an abuser’s high, got voted down without any votes in favor and 27 votes against agency approval. Aximris XR, an extended-release oxycodone formulation that successfully deterred intravenous abuse but had no deterrence efficacy for intranasal or oral abuse failed by a 2-24 vote against. The third agent, CTC, a novel formulation of the schedule IV opioid tramadol with the NSAID celecoxib designed to be analgesic but with limited opioid-abuse appeal, came the closest to meaningful support with a tied 13-13 vote from advisory committee members for and against agency approval. FDA staff takes advisory committee opinions and votes into account when making their final decisions about drug marketing approvals.

In each case, the committee members, mostly the same roster assembled for each of the three agents, identified specific concerns with the data purported to show each drug’s safety and efficacy. But the gathered experts and consumer representatives also consistently cited holistic challenges to approving new opioids and the stiffer criteria these agents face amid a continuing wave of opioid misuse and abuse.

“In the context of the public health issues, we don’t want to be perceived in any way of taking shortcuts,” said Linda S. Tyler, PharmD,, an advisory committee member and professor of pharmacy and chief pharmacy officer at the University of Utah in Salt Lake City. “There is no question that for a new product to come to market in this space it needs to add to what’s on the market, meet a high bar, and provide advantages compared with what’s already on the market,” she said.

 

 

Tramadol plus celecoxib gains some support

The proposed combined formulation of tramadol and celecoxib came closest to meeting that bar, as far as the advisory committee was concerned, coming away with 13 votes favoring approval to match 13 votes against. The premise behind this agent, know as CTC (cocrystal of tramadol and celecoxib), was that it combined a modest dose (44 mg) of the schedule IV opioid tramadol with a 56-mg dose of celecoxib in a twice-daily pill. Eugene R. Viscusi, MD, professor of anesthesiology and director of acute pain management at Thomas Jefferson University in Philadelphia and a speaker at the session on behalf of the applicant company, spelled out the rationale behind CTC: “We are caught in a dilemma. We need to reduce opioid use, but we also need to treat pain. We have an urgent need to have pain treatment options that are effective but have low potential for abuse and dependence. We are looking at multimodal analgesia, that uses combination of agents, recognizing that postoperative pain is a mixed pain syndrome. Multimodal pain treatments are now considered standard care. We want to minimize opioids to the lowest dose possible to produce safe analgesia. Tramadol is the least-preferred opioid for abuse,” and is rated as schedule IV, the U.S. designation for drugs considered to have a low level of potential for causing abuse or dependence. “Opioids used as stand-alone agents have contributed to the current opioid crisis,” Dr. Viscusi told the committee.

In contrast to tramadol’s schedule IV status, the mainstays of recent opioid pain therapy have been hydrocodone and oxycodone, schedule II opioids rated as having a “high potential for abuse.”

Several advisory committee members agreed that CTC minimized patient exposure to an opioid. “This drug isn’t even tramadol; it’s tramadol light. It has about as low a dose [of an opioid] as you can have and still have a drug,” said member Lee A. Hoffer, PhD, a medical anthropologist at Case Western Reserve University, Cleveland, who studies substance use disorders. “All opioids are dangerous, even at a low dose, but there is a linear relationship based on potency, so if we want to have an opioid for acute pain, I’d like it to have the lowest morphine milligram equivalent possible. The ideal is no opioids, but that is not what happens,” he said. The CTC formulation delivers 17.6 morphine milligram equivalents (MME) per pill, the manufacturer’s representatives said. The Centers for Disease Control and Prevention defines a “relatively low” daily opioid dose as 20-50 MME.

Some committee members hailed the CTC formulation as a meaningful step toward cutting opioid consumption.

“We may be very nervous about abuse of scheduled opioids, but a schedule IV opioid in an opioid-sparing formulation is as good as it gets in 2020,” said committee member Kevin L. Zacharoff, MD, a pain medicine specialist at the State University of New York at Stony Brook. “Any opioid has potential for abuse, but this is a safer alternative to the schedule II drugs. There is less public health risk with this,” said committee member Sherif Zaafran, MD, a Houston anesthesiologist. “This represents an incremental but important approach to addressing the opioid crisis, especially if used to replace schedule II opioids,” said Brandon D.L. Marshall, PhD, an epidemiologist and substance abuse researcher at Brown University in Providence, R.I.

But despite agreement that CTC represented a new low in the MME of an opioid given to patients, several committee members still saw the formulation as problematic by introducing any opioid, no matter how small the dose.

“The landscape of tramadol use and prescribing is evolving. There’s been an exponential upturn in tramadol prescribing. It’s perceived [as] safer, but it’s not completely safe. Will this change tramadol abuse and open the door to abuse of other opioids? This is what got us into trouble with opioids in the first place. Patients start with a prescription opioid that they perceive is safe. Patients don’t start with oxycodone or heroin. They start with drugs that are believed to be safe. I feel this combination has less risk for abuse, but I’m worried that it would produce a false sense of security for tolerability and safety,” said committee member Maryann E. Amirshahi, MD, a medical toxicologist at Georgetown University and MedStar Health in Washington.

Several other committee members returned to this point throughout the 2 days of discussions: The majority of Americans who have become hooked on opioids reached that point by taking an opioid pain medication for a legitimate medical reason and using the drug the way they had understood they should.

“I’m most concerned about unintentional misuse leading to addiction and abuse. Most people with an opioid addiction got it inadvertently, misusing it by mistake,” said committee member Suzanne B. Robotti, a consumer representative and executive director of DES Action USA. “I’m concerned about approving an opioid, even an opioid with a low abuse history, without a clearer picture of the human abuse potential data and what would happen if this drug were abused,” she added, referring to the proposed CTC formulation.

“All the patients I work with started [their opioid addiction] as pain patients,” Dr. Hoffer said.

“The most common use and abuse of opioids is orally. We need to avoid having patients who use the drug as prescribed and still end up addicted,” said committee member Friedhelm Sandbrink, MD, a neurologist and director of pain management at the Veterans Affairs (VA) Medical Center in Washington.

What this means, said several panelists, is functionally clamping down a class-wide lid on new opioids. “The way to reduce deaths from abuse is to reduce addiction, and to have an impact you need to reduce opioid exposure.” said committee member Sonia Hernandez-Diaz, MD, professor of epidemiology at the Harvard School of Public Health in Boston.

“In this opioid crisis, we ask for data that we wouldn’t ordinarily ask for. I feel there are unanswered questions about the abuse potential [of CTC]. We have seen a recent reduction in oxycodone use, which is great, but also an increase in tramadol use. We should not be fooled. Tramadol is an opioid, even if it’s schedule IV,” Dr. Tyler said.

 

 

Two other opioids faced greater opposition

The other two agents that the committee considered received much less support and sharper skepticism. The application for Aximris XR, an extended release form of oxycodone with a purported abuse-deterrent formulation (ADF) that relies on being difficult to extract for intravenous use as well as possibly having effective deterrence mechanisms for other forms of abuse. But FDA staffers reported that the only effective deterrence they could document was against manipulation for intravenous use, making Aximris XR the first opioid seeking ADF labeling based on deterrence to a single delivery route. This led several committee members, as well as the FDA, to comment on the clinical meaningfulness of ADF for one route. So far, the FDA approved ADF labeling for seven opioids, most notably OxyContin, an extended-release oxycodone with the biggest share of the U.S. market for opioids with ADF labeling.

“For ADF, we label based on what we expect from the premarket data. We don’t really know how that translates into what happens once the drug is on the market. Every company with an ADF in their label is required to do postmarketing studies on the abuse routes that are supposed to be deterred. We see shifts to other routes. Assessment of ADF is incredibly challenging, both scientifically and logistically, because there has not been a lot of uptake of these products, for a variety of reasons,” said Judy Staffa, PhD, associate director for Public Health Initiatives in the Office of Surveillance & Epidemiology in the FDA’s Center for Drug Evaluation and Research. The company that markets OxyContin has been the first to submit to the FDA all of its required postmarketing data on ADF efficacy, and the agency is now reviewing this filing, Dr. Staffa said.

The data presented for Aximris XR appeared to generally fail to convince committee members that it provided a meaningful addition to the range of opioids with ADF designations already available, which meant that their decision mostly came down to whether they felt it made sense to bring a me-too opioid to the U.S. market. Their answer was mostly no.

“In the end, it’s another opioid, and I’m not sure we need another opioid,” said committee member Lonnie K. Zeltzer, MD, professor of pediatrics, anesthesiology, psychiatry, and biobehavioral sciences and director of pediatric pain at the University of California, Los Angeles “There are so many options for patients and for people who abuse these drug. I don’t see this formulation as having a profound impact, but I’m very concerned about adding more prescription opioids,” said Martin Garcia-Bunuel, MD, deputy chief of staff for the VA Maryland Health Care System in Baltimore. Another concern of some committee members was that ADF remains a designation with an uncertain meaning, pending the FDA’s analysis of the OxyContin data.

“At the end of the day, we don’t know whether any of the [ADF] stuff makes a difference,” noted Steve B. Meisel, PharmD, system director of medication safety for M Health Fairview in Minneapolis and a committee member,

The third agent, oxycodegol, a molecule designed to pass more slowly across the blood-brain barrier because of an attached polyethylene glycol chain that’s supposed to prevent a rapid high after ingestion and hence cut abuse potential. It received unanimous committee rejection, primarily because its safety and efficacy evidence had so many holes, but the shadow of opioid abuse permeated the committee’s discussion.

“One dogma in the abuse world is that slowing entry into the brain reduces abuse potential, but the opioid crisis showed that this is not the only factor. Some people have become addicted to slow-acting drugs. The abuse potential of this drug, oxycodegol, needs to be considered given where we’ve been with the opioid crisis,” said Jane B. Acri, PhD, chief of the Medications Discovery and Toxicology Branch of the National Institute on Drug Abuse.

“During the opioid epidemic, do we want to approve more opioids? If the [pain] efficacy is about the same as oxycodone, is better safety or abuse potential a reason to approve it? We need guidance [from the FDA] about what is ‘better enough.’ No opioid will ever be perfect; there will always be abuse and misuse. But what is good enough to justify bringing another opioid onto the market? What is a good enough improvement? I don’t have an answer,” Dr. Hernandez-Diaz said.

Adviser comments showed that the continued threat of widespread opioid addiction has cooled prospects for new opioid approvals by making FDA advisers skittish over how to properly score the incremental value of a new opioid.

“Do we need to go back to the drawing board on how we make decisions on exposing the American public to these kinds of agents?” Dr. Garcia-Bunuel asked. “I don’t think we have the tools to make these decisions.”

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During an opioid-addiction epidemic, can any new opioid pain drug meet prevailing safety demands to gain regulatory approval?

On Jan. 14 and 15, a Food and Drug Administration advisory committee voted virtually unanimously against two new opioid formulations and evenly split for and against a third; the 2 days of data and discussion showed how high a bar new opioids face these days for getting onto the U.S. market.

The bar’s height is very understandable given how many Americans have become addicted to opioids over the past decade, more often than not by accident while using pain medications as they believed they had been directed, said experts during the sessions held on the FDA’s campus in White Oak, Md.

Among the many upshots of the opioid crisis, the meetings held to discuss these three contender opioids highlighted the bitter irony confronting attempts to bring new, safer opioids to the U.S. market: While less abusable pain-relief medications that still harness the potent analgesic power of mu opioid receptor agonists are desperately desired, new agents in this space now receive withering scrutiny over their safeguards against misuse and abuse, and over whether they add anything meaningfully new to what’s already available. While these demands seem reasonable, perhaps even essential, it’s unclear whether any new opioid-based pain drugs will ever fully meet the safety that researchers, clinicians, and the public now seek.

A special FDA advisory committee that combined the Anesthetic and Analgesic Drug Products Advisory Committee with members of the Drug Safety and Risk Management Advisory Committee considered the application for three different opioid drugs from three separate companies. None received a clear endorsement. Oxycodegol, a new type of orally delivered opioid molecule engineered to slow brain entry and thereby delay an abuser’s high, got voted down without any votes in favor and 27 votes against agency approval. Aximris XR, an extended-release oxycodone formulation that successfully deterred intravenous abuse but had no deterrence efficacy for intranasal or oral abuse failed by a 2-24 vote against. The third agent, CTC, a novel formulation of the schedule IV opioid tramadol with the NSAID celecoxib designed to be analgesic but with limited opioid-abuse appeal, came the closest to meaningful support with a tied 13-13 vote from advisory committee members for and against agency approval. FDA staff takes advisory committee opinions and votes into account when making their final decisions about drug marketing approvals.

In each case, the committee members, mostly the same roster assembled for each of the three agents, identified specific concerns with the data purported to show each drug’s safety and efficacy. But the gathered experts and consumer representatives also consistently cited holistic challenges to approving new opioids and the stiffer criteria these agents face amid a continuing wave of opioid misuse and abuse.

“In the context of the public health issues, we don’t want to be perceived in any way of taking shortcuts,” said Linda S. Tyler, PharmD,, an advisory committee member and professor of pharmacy and chief pharmacy officer at the University of Utah in Salt Lake City. “There is no question that for a new product to come to market in this space it needs to add to what’s on the market, meet a high bar, and provide advantages compared with what’s already on the market,” she said.

 

 

Tramadol plus celecoxib gains some support

The proposed combined formulation of tramadol and celecoxib came closest to meeting that bar, as far as the advisory committee was concerned, coming away with 13 votes favoring approval to match 13 votes against. The premise behind this agent, know as CTC (cocrystal of tramadol and celecoxib), was that it combined a modest dose (44 mg) of the schedule IV opioid tramadol with a 56-mg dose of celecoxib in a twice-daily pill. Eugene R. Viscusi, MD, professor of anesthesiology and director of acute pain management at Thomas Jefferson University in Philadelphia and a speaker at the session on behalf of the applicant company, spelled out the rationale behind CTC: “We are caught in a dilemma. We need to reduce opioid use, but we also need to treat pain. We have an urgent need to have pain treatment options that are effective but have low potential for abuse and dependence. We are looking at multimodal analgesia, that uses combination of agents, recognizing that postoperative pain is a mixed pain syndrome. Multimodal pain treatments are now considered standard care. We want to minimize opioids to the lowest dose possible to produce safe analgesia. Tramadol is the least-preferred opioid for abuse,” and is rated as schedule IV, the U.S. designation for drugs considered to have a low level of potential for causing abuse or dependence. “Opioids used as stand-alone agents have contributed to the current opioid crisis,” Dr. Viscusi told the committee.

In contrast to tramadol’s schedule IV status, the mainstays of recent opioid pain therapy have been hydrocodone and oxycodone, schedule II opioids rated as having a “high potential for abuse.”

Several advisory committee members agreed that CTC minimized patient exposure to an opioid. “This drug isn’t even tramadol; it’s tramadol light. It has about as low a dose [of an opioid] as you can have and still have a drug,” said member Lee A. Hoffer, PhD, a medical anthropologist at Case Western Reserve University, Cleveland, who studies substance use disorders. “All opioids are dangerous, even at a low dose, but there is a linear relationship based on potency, so if we want to have an opioid for acute pain, I’d like it to have the lowest morphine milligram equivalent possible. The ideal is no opioids, but that is not what happens,” he said. The CTC formulation delivers 17.6 morphine milligram equivalents (MME) per pill, the manufacturer’s representatives said. The Centers for Disease Control and Prevention defines a “relatively low” daily opioid dose as 20-50 MME.

Some committee members hailed the CTC formulation as a meaningful step toward cutting opioid consumption.

“We may be very nervous about abuse of scheduled opioids, but a schedule IV opioid in an opioid-sparing formulation is as good as it gets in 2020,” said committee member Kevin L. Zacharoff, MD, a pain medicine specialist at the State University of New York at Stony Brook. “Any opioid has potential for abuse, but this is a safer alternative to the schedule II drugs. There is less public health risk with this,” said committee member Sherif Zaafran, MD, a Houston anesthesiologist. “This represents an incremental but important approach to addressing the opioid crisis, especially if used to replace schedule II opioids,” said Brandon D.L. Marshall, PhD, an epidemiologist and substance abuse researcher at Brown University in Providence, R.I.

But despite agreement that CTC represented a new low in the MME of an opioid given to patients, several committee members still saw the formulation as problematic by introducing any opioid, no matter how small the dose.

“The landscape of tramadol use and prescribing is evolving. There’s been an exponential upturn in tramadol prescribing. It’s perceived [as] safer, but it’s not completely safe. Will this change tramadol abuse and open the door to abuse of other opioids? This is what got us into trouble with opioids in the first place. Patients start with a prescription opioid that they perceive is safe. Patients don’t start with oxycodone or heroin. They start with drugs that are believed to be safe. I feel this combination has less risk for abuse, but I’m worried that it would produce a false sense of security for tolerability and safety,” said committee member Maryann E. Amirshahi, MD, a medical toxicologist at Georgetown University and MedStar Health in Washington.

Several other committee members returned to this point throughout the 2 days of discussions: The majority of Americans who have become hooked on opioids reached that point by taking an opioid pain medication for a legitimate medical reason and using the drug the way they had understood they should.

“I’m most concerned about unintentional misuse leading to addiction and abuse. Most people with an opioid addiction got it inadvertently, misusing it by mistake,” said committee member Suzanne B. Robotti, a consumer representative and executive director of DES Action USA. “I’m concerned about approving an opioid, even an opioid with a low abuse history, without a clearer picture of the human abuse potential data and what would happen if this drug were abused,” she added, referring to the proposed CTC formulation.

“All the patients I work with started [their opioid addiction] as pain patients,” Dr. Hoffer said.

“The most common use and abuse of opioids is orally. We need to avoid having patients who use the drug as prescribed and still end up addicted,” said committee member Friedhelm Sandbrink, MD, a neurologist and director of pain management at the Veterans Affairs (VA) Medical Center in Washington.

What this means, said several panelists, is functionally clamping down a class-wide lid on new opioids. “The way to reduce deaths from abuse is to reduce addiction, and to have an impact you need to reduce opioid exposure.” said committee member Sonia Hernandez-Diaz, MD, professor of epidemiology at the Harvard School of Public Health in Boston.

“In this opioid crisis, we ask for data that we wouldn’t ordinarily ask for. I feel there are unanswered questions about the abuse potential [of CTC]. We have seen a recent reduction in oxycodone use, which is great, but also an increase in tramadol use. We should not be fooled. Tramadol is an opioid, even if it’s schedule IV,” Dr. Tyler said.

 

 

Two other opioids faced greater opposition

The other two agents that the committee considered received much less support and sharper skepticism. The application for Aximris XR, an extended release form of oxycodone with a purported abuse-deterrent formulation (ADF) that relies on being difficult to extract for intravenous use as well as possibly having effective deterrence mechanisms for other forms of abuse. But FDA staffers reported that the only effective deterrence they could document was against manipulation for intravenous use, making Aximris XR the first opioid seeking ADF labeling based on deterrence to a single delivery route. This led several committee members, as well as the FDA, to comment on the clinical meaningfulness of ADF for one route. So far, the FDA approved ADF labeling for seven opioids, most notably OxyContin, an extended-release oxycodone with the biggest share of the U.S. market for opioids with ADF labeling.

“For ADF, we label based on what we expect from the premarket data. We don’t really know how that translates into what happens once the drug is on the market. Every company with an ADF in their label is required to do postmarketing studies on the abuse routes that are supposed to be deterred. We see shifts to other routes. Assessment of ADF is incredibly challenging, both scientifically and logistically, because there has not been a lot of uptake of these products, for a variety of reasons,” said Judy Staffa, PhD, associate director for Public Health Initiatives in the Office of Surveillance & Epidemiology in the FDA’s Center for Drug Evaluation and Research. The company that markets OxyContin has been the first to submit to the FDA all of its required postmarketing data on ADF efficacy, and the agency is now reviewing this filing, Dr. Staffa said.

The data presented for Aximris XR appeared to generally fail to convince committee members that it provided a meaningful addition to the range of opioids with ADF designations already available, which meant that their decision mostly came down to whether they felt it made sense to bring a me-too opioid to the U.S. market. Their answer was mostly no.

“In the end, it’s another opioid, and I’m not sure we need another opioid,” said committee member Lonnie K. Zeltzer, MD, professor of pediatrics, anesthesiology, psychiatry, and biobehavioral sciences and director of pediatric pain at the University of California, Los Angeles “There are so many options for patients and for people who abuse these drug. I don’t see this formulation as having a profound impact, but I’m very concerned about adding more prescription opioids,” said Martin Garcia-Bunuel, MD, deputy chief of staff for the VA Maryland Health Care System in Baltimore. Another concern of some committee members was that ADF remains a designation with an uncertain meaning, pending the FDA’s analysis of the OxyContin data.

“At the end of the day, we don’t know whether any of the [ADF] stuff makes a difference,” noted Steve B. Meisel, PharmD, system director of medication safety for M Health Fairview in Minneapolis and a committee member,

The third agent, oxycodegol, a molecule designed to pass more slowly across the blood-brain barrier because of an attached polyethylene glycol chain that’s supposed to prevent a rapid high after ingestion and hence cut abuse potential. It received unanimous committee rejection, primarily because its safety and efficacy evidence had so many holes, but the shadow of opioid abuse permeated the committee’s discussion.

“One dogma in the abuse world is that slowing entry into the brain reduces abuse potential, but the opioid crisis showed that this is not the only factor. Some people have become addicted to slow-acting drugs. The abuse potential of this drug, oxycodegol, needs to be considered given where we’ve been with the opioid crisis,” said Jane B. Acri, PhD, chief of the Medications Discovery and Toxicology Branch of the National Institute on Drug Abuse.

“During the opioid epidemic, do we want to approve more opioids? If the [pain] efficacy is about the same as oxycodone, is better safety or abuse potential a reason to approve it? We need guidance [from the FDA] about what is ‘better enough.’ No opioid will ever be perfect; there will always be abuse and misuse. But what is good enough to justify bringing another opioid onto the market? What is a good enough improvement? I don’t have an answer,” Dr. Hernandez-Diaz said.

Adviser comments showed that the continued threat of widespread opioid addiction has cooled prospects for new opioid approvals by making FDA advisers skittish over how to properly score the incremental value of a new opioid.

“Do we need to go back to the drawing board on how we make decisions on exposing the American public to these kinds of agents?” Dr. Garcia-Bunuel asked. “I don’t think we have the tools to make these decisions.”

During an opioid-addiction epidemic, can any new opioid pain drug meet prevailing safety demands to gain regulatory approval?

On Jan. 14 and 15, a Food and Drug Administration advisory committee voted virtually unanimously against two new opioid formulations and evenly split for and against a third; the 2 days of data and discussion showed how high a bar new opioids face these days for getting onto the U.S. market.

The bar’s height is very understandable given how many Americans have become addicted to opioids over the past decade, more often than not by accident while using pain medications as they believed they had been directed, said experts during the sessions held on the FDA’s campus in White Oak, Md.

Among the many upshots of the opioid crisis, the meetings held to discuss these three contender opioids highlighted the bitter irony confronting attempts to bring new, safer opioids to the U.S. market: While less abusable pain-relief medications that still harness the potent analgesic power of mu opioid receptor agonists are desperately desired, new agents in this space now receive withering scrutiny over their safeguards against misuse and abuse, and over whether they add anything meaningfully new to what’s already available. While these demands seem reasonable, perhaps even essential, it’s unclear whether any new opioid-based pain drugs will ever fully meet the safety that researchers, clinicians, and the public now seek.

A special FDA advisory committee that combined the Anesthetic and Analgesic Drug Products Advisory Committee with members of the Drug Safety and Risk Management Advisory Committee considered the application for three different opioid drugs from three separate companies. None received a clear endorsement. Oxycodegol, a new type of orally delivered opioid molecule engineered to slow brain entry and thereby delay an abuser’s high, got voted down without any votes in favor and 27 votes against agency approval. Aximris XR, an extended-release oxycodone formulation that successfully deterred intravenous abuse but had no deterrence efficacy for intranasal or oral abuse failed by a 2-24 vote against. The third agent, CTC, a novel formulation of the schedule IV opioid tramadol with the NSAID celecoxib designed to be analgesic but with limited opioid-abuse appeal, came the closest to meaningful support with a tied 13-13 vote from advisory committee members for and against agency approval. FDA staff takes advisory committee opinions and votes into account when making their final decisions about drug marketing approvals.

In each case, the committee members, mostly the same roster assembled for each of the three agents, identified specific concerns with the data purported to show each drug’s safety and efficacy. But the gathered experts and consumer representatives also consistently cited holistic challenges to approving new opioids and the stiffer criteria these agents face amid a continuing wave of opioid misuse and abuse.

“In the context of the public health issues, we don’t want to be perceived in any way of taking shortcuts,” said Linda S. Tyler, PharmD,, an advisory committee member and professor of pharmacy and chief pharmacy officer at the University of Utah in Salt Lake City. “There is no question that for a new product to come to market in this space it needs to add to what’s on the market, meet a high bar, and provide advantages compared with what’s already on the market,” she said.

 

 

Tramadol plus celecoxib gains some support

The proposed combined formulation of tramadol and celecoxib came closest to meeting that bar, as far as the advisory committee was concerned, coming away with 13 votes favoring approval to match 13 votes against. The premise behind this agent, know as CTC (cocrystal of tramadol and celecoxib), was that it combined a modest dose (44 mg) of the schedule IV opioid tramadol with a 56-mg dose of celecoxib in a twice-daily pill. Eugene R. Viscusi, MD, professor of anesthesiology and director of acute pain management at Thomas Jefferson University in Philadelphia and a speaker at the session on behalf of the applicant company, spelled out the rationale behind CTC: “We are caught in a dilemma. We need to reduce opioid use, but we also need to treat pain. We have an urgent need to have pain treatment options that are effective but have low potential for abuse and dependence. We are looking at multimodal analgesia, that uses combination of agents, recognizing that postoperative pain is a mixed pain syndrome. Multimodal pain treatments are now considered standard care. We want to minimize opioids to the lowest dose possible to produce safe analgesia. Tramadol is the least-preferred opioid for abuse,” and is rated as schedule IV, the U.S. designation for drugs considered to have a low level of potential for causing abuse or dependence. “Opioids used as stand-alone agents have contributed to the current opioid crisis,” Dr. Viscusi told the committee.

In contrast to tramadol’s schedule IV status, the mainstays of recent opioid pain therapy have been hydrocodone and oxycodone, schedule II opioids rated as having a “high potential for abuse.”

Several advisory committee members agreed that CTC minimized patient exposure to an opioid. “This drug isn’t even tramadol; it’s tramadol light. It has about as low a dose [of an opioid] as you can have and still have a drug,” said member Lee A. Hoffer, PhD, a medical anthropologist at Case Western Reserve University, Cleveland, who studies substance use disorders. “All opioids are dangerous, even at a low dose, but there is a linear relationship based on potency, so if we want to have an opioid for acute pain, I’d like it to have the lowest morphine milligram equivalent possible. The ideal is no opioids, but that is not what happens,” he said. The CTC formulation delivers 17.6 morphine milligram equivalents (MME) per pill, the manufacturer’s representatives said. The Centers for Disease Control and Prevention defines a “relatively low” daily opioid dose as 20-50 MME.

Some committee members hailed the CTC formulation as a meaningful step toward cutting opioid consumption.

“We may be very nervous about abuse of scheduled opioids, but a schedule IV opioid in an opioid-sparing formulation is as good as it gets in 2020,” said committee member Kevin L. Zacharoff, MD, a pain medicine specialist at the State University of New York at Stony Brook. “Any opioid has potential for abuse, but this is a safer alternative to the schedule II drugs. There is less public health risk with this,” said committee member Sherif Zaafran, MD, a Houston anesthesiologist. “This represents an incremental but important approach to addressing the opioid crisis, especially if used to replace schedule II opioids,” said Brandon D.L. Marshall, PhD, an epidemiologist and substance abuse researcher at Brown University in Providence, R.I.

But despite agreement that CTC represented a new low in the MME of an opioid given to patients, several committee members still saw the formulation as problematic by introducing any opioid, no matter how small the dose.

“The landscape of tramadol use and prescribing is evolving. There’s been an exponential upturn in tramadol prescribing. It’s perceived [as] safer, but it’s not completely safe. Will this change tramadol abuse and open the door to abuse of other opioids? This is what got us into trouble with opioids in the first place. Patients start with a prescription opioid that they perceive is safe. Patients don’t start with oxycodone or heroin. They start with drugs that are believed to be safe. I feel this combination has less risk for abuse, but I’m worried that it would produce a false sense of security for tolerability and safety,” said committee member Maryann E. Amirshahi, MD, a medical toxicologist at Georgetown University and MedStar Health in Washington.

Several other committee members returned to this point throughout the 2 days of discussions: The majority of Americans who have become hooked on opioids reached that point by taking an opioid pain medication for a legitimate medical reason and using the drug the way they had understood they should.

“I’m most concerned about unintentional misuse leading to addiction and abuse. Most people with an opioid addiction got it inadvertently, misusing it by mistake,” said committee member Suzanne B. Robotti, a consumer representative and executive director of DES Action USA. “I’m concerned about approving an opioid, even an opioid with a low abuse history, without a clearer picture of the human abuse potential data and what would happen if this drug were abused,” she added, referring to the proposed CTC formulation.

“All the patients I work with started [their opioid addiction] as pain patients,” Dr. Hoffer said.

“The most common use and abuse of opioids is orally. We need to avoid having patients who use the drug as prescribed and still end up addicted,” said committee member Friedhelm Sandbrink, MD, a neurologist and director of pain management at the Veterans Affairs (VA) Medical Center in Washington.

What this means, said several panelists, is functionally clamping down a class-wide lid on new opioids. “The way to reduce deaths from abuse is to reduce addiction, and to have an impact you need to reduce opioid exposure.” said committee member Sonia Hernandez-Diaz, MD, professor of epidemiology at the Harvard School of Public Health in Boston.

“In this opioid crisis, we ask for data that we wouldn’t ordinarily ask for. I feel there are unanswered questions about the abuse potential [of CTC]. We have seen a recent reduction in oxycodone use, which is great, but also an increase in tramadol use. We should not be fooled. Tramadol is an opioid, even if it’s schedule IV,” Dr. Tyler said.

 

 

Two other opioids faced greater opposition

The other two agents that the committee considered received much less support and sharper skepticism. The application for Aximris XR, an extended release form of oxycodone with a purported abuse-deterrent formulation (ADF) that relies on being difficult to extract for intravenous use as well as possibly having effective deterrence mechanisms for other forms of abuse. But FDA staffers reported that the only effective deterrence they could document was against manipulation for intravenous use, making Aximris XR the first opioid seeking ADF labeling based on deterrence to a single delivery route. This led several committee members, as well as the FDA, to comment on the clinical meaningfulness of ADF for one route. So far, the FDA approved ADF labeling for seven opioids, most notably OxyContin, an extended-release oxycodone with the biggest share of the U.S. market for opioids with ADF labeling.

“For ADF, we label based on what we expect from the premarket data. We don’t really know how that translates into what happens once the drug is on the market. Every company with an ADF in their label is required to do postmarketing studies on the abuse routes that are supposed to be deterred. We see shifts to other routes. Assessment of ADF is incredibly challenging, both scientifically and logistically, because there has not been a lot of uptake of these products, for a variety of reasons,” said Judy Staffa, PhD, associate director for Public Health Initiatives in the Office of Surveillance & Epidemiology in the FDA’s Center for Drug Evaluation and Research. The company that markets OxyContin has been the first to submit to the FDA all of its required postmarketing data on ADF efficacy, and the agency is now reviewing this filing, Dr. Staffa said.

The data presented for Aximris XR appeared to generally fail to convince committee members that it provided a meaningful addition to the range of opioids with ADF designations already available, which meant that their decision mostly came down to whether they felt it made sense to bring a me-too opioid to the U.S. market. Their answer was mostly no.

“In the end, it’s another opioid, and I’m not sure we need another opioid,” said committee member Lonnie K. Zeltzer, MD, professor of pediatrics, anesthesiology, psychiatry, and biobehavioral sciences and director of pediatric pain at the University of California, Los Angeles “There are so many options for patients and for people who abuse these drug. I don’t see this formulation as having a profound impact, but I’m very concerned about adding more prescription opioids,” said Martin Garcia-Bunuel, MD, deputy chief of staff for the VA Maryland Health Care System in Baltimore. Another concern of some committee members was that ADF remains a designation with an uncertain meaning, pending the FDA’s analysis of the OxyContin data.

“At the end of the day, we don’t know whether any of the [ADF] stuff makes a difference,” noted Steve B. Meisel, PharmD, system director of medication safety for M Health Fairview in Minneapolis and a committee member,

The third agent, oxycodegol, a molecule designed to pass more slowly across the blood-brain barrier because of an attached polyethylene glycol chain that’s supposed to prevent a rapid high after ingestion and hence cut abuse potential. It received unanimous committee rejection, primarily because its safety and efficacy evidence had so many holes, but the shadow of opioid abuse permeated the committee’s discussion.

“One dogma in the abuse world is that slowing entry into the brain reduces abuse potential, but the opioid crisis showed that this is not the only factor. Some people have become addicted to slow-acting drugs. The abuse potential of this drug, oxycodegol, needs to be considered given where we’ve been with the opioid crisis,” said Jane B. Acri, PhD, chief of the Medications Discovery and Toxicology Branch of the National Institute on Drug Abuse.

“During the opioid epidemic, do we want to approve more opioids? If the [pain] efficacy is about the same as oxycodone, is better safety or abuse potential a reason to approve it? We need guidance [from the FDA] about what is ‘better enough.’ No opioid will ever be perfect; there will always be abuse and misuse. But what is good enough to justify bringing another opioid onto the market? What is a good enough improvement? I don’t have an answer,” Dr. Hernandez-Diaz said.

Adviser comments showed that the continued threat of widespread opioid addiction has cooled prospects for new opioid approvals by making FDA advisers skittish over how to properly score the incremental value of a new opioid.

“Do we need to go back to the drawing board on how we make decisions on exposing the American public to these kinds of agents?” Dr. Garcia-Bunuel asked. “I don’t think we have the tools to make these decisions.”

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Common drug with lots of surprising side effects

Article Type
Changed
Wed, 01/22/2020 - 12:45

A 55-year-old woman comes to clinic for follow-up. She reports her family is worried that she isn’t getting enough sleep and is more tired than usual. The patient reports she is sleeping 8 hours a night and wakes up feeling rested, but she has noticed she has been yawning much more frequently than she remembers in the past.

Dr. Douglas S. Paauw

Past medical history: gastroesophageal reflux disease, hypertension, generalized anxiety disorder, hypothyroidism, and osteoporosis. Medications: amlodipine, lansoprazole, irbesartan, escitalopram, levothyroxine, and alendronate. Physical examination: blood pressure 110/70 mm Hg, pulse 60 bpm. Lower extremities: 1+ edema.

What is the likely cause of her increased yawning?

A. Amlodipine.

B. Alendronate.

C. Irbesartan.

D. Escitalopram.

E. Lansoprazole.

The correct answer here is escitalopram. Selective serotonin reuptake inhibitors in general are well tolerated. Given how commonly these drugs are used, however, there are a number of lesser-known side effects that you are likely to see.

In the above case, this patient has yawning caused by her SSRI. Roncero et al. described a case of yawning in a patient on escitalopram that resolved when the dose of escitalopram was reduced.1 Paroxetine has been reported to cause yawning at both low and high doses.2

In a review of drug-induced yawning, SSRIs as a class were most frequently involved, and sertraline and fluoxetine were implicated in addition to paroxetine.3 The serotonin-norepinephrine reuptake inhibitors duloxetine and venlafaxine have also been associated with yawning.4,5

Hyperhydrosis has also been linked to SSRIs and SNRIs, and both yawning and hyperhidrosis may occur because of an underlying thermoregulatory dysfunction.6

SSRIs have been linked to increased bleeding risk, especially increased risk of upper gastrointestinal hemorrhage. Laporte and colleagues showed an association of SSRI use and risk of bleeding in a meta-analysis of 42 observational studies, with an odds ratio of 1.41 (95% confidence interval, 1.27-1.57; P less than .0001).7 The risk of upper gastrointestinal (UGI) bleeding is further increased if patients are also taking NSAIDs.

Anglin et al. looked at 15 case-control studies and 4 cohort studies and found an OR of 1.66 for UGI bleeding with SSRI use, and an OR of 4.25 for UGI bleeding if SSRI use was combined with NSAID use.8 The number needed to harm is 3,177 for NSAID use in populations at low risk for GI bleeding, but it is much lower (881) in higher-risk populations.8 Make sure to think about patients’ bleeding risks when starting SSRIs.

An issue that comes up frequently is: What is the risk of bleeding in patients on SSRIs who are also on anticoagulants? Dr. Quinn and colleagues looked at the bleeding risk of anticoagulated patients also taking SSRIs in the ROCKET AF trial.9 They found 737 patients who received SSRIs and matched them with other patients not on SSRIs in the trial. All patients in the trial were either receiving rivaroxaban or warfarin for stroke prophylaxis. They found no significant increase risk in bleeding in the patients on SSRIs and anticoagulants.
 

Take-home points:

  • Yawning and hyperhidrosis are interesting side effects of SSRIs.
  • Bleeding risk is increased in patients on SSRIs, especially when combined with NSAIDs.

Dr. Paauw is professor of medicine in the division of general internal medicine at the University of Washington, Seattle, and he serves as third-year medical student clerkship director at the University of Washington. Contact Dr. Paauw at [email protected].

References

1. Neurologia. 2013 Nov-Dec;28(9):589-90.

2. Psychiatry Clin Neurosci. 2006 Apr;60(2):260.

3. Presse Med. 2014 Oct;43(10 Pt 1):1135-6.

4. Prog Neuropsychopharmacol Biol Psychiatry. 2009 Jun 15;33(4):747.

5. Ann Pharmacother. 2011 Oct;45(10):1297-301.

6. Depress Anxiety. 2017 Dec;34(12):1134-46.

7. Pharmacol Res. 2017 Apr;118:19-32.

8. Am J Gastroenterol. 2014 Jun;109(6):811-9.

9. J Am Heart Assoc. 2018 Aug 7;7(15):e008755.

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A 55-year-old woman comes to clinic for follow-up. She reports her family is worried that she isn’t getting enough sleep and is more tired than usual. The patient reports she is sleeping 8 hours a night and wakes up feeling rested, but she has noticed she has been yawning much more frequently than she remembers in the past.

Dr. Douglas S. Paauw

Past medical history: gastroesophageal reflux disease, hypertension, generalized anxiety disorder, hypothyroidism, and osteoporosis. Medications: amlodipine, lansoprazole, irbesartan, escitalopram, levothyroxine, and alendronate. Physical examination: blood pressure 110/70 mm Hg, pulse 60 bpm. Lower extremities: 1+ edema.

What is the likely cause of her increased yawning?

A. Amlodipine.

B. Alendronate.

C. Irbesartan.

D. Escitalopram.

E. Lansoprazole.

The correct answer here is escitalopram. Selective serotonin reuptake inhibitors in general are well tolerated. Given how commonly these drugs are used, however, there are a number of lesser-known side effects that you are likely to see.

In the above case, this patient has yawning caused by her SSRI. Roncero et al. described a case of yawning in a patient on escitalopram that resolved when the dose of escitalopram was reduced.1 Paroxetine has been reported to cause yawning at both low and high doses.2

In a review of drug-induced yawning, SSRIs as a class were most frequently involved, and sertraline and fluoxetine were implicated in addition to paroxetine.3 The serotonin-norepinephrine reuptake inhibitors duloxetine and venlafaxine have also been associated with yawning.4,5

Hyperhydrosis has also been linked to SSRIs and SNRIs, and both yawning and hyperhidrosis may occur because of an underlying thermoregulatory dysfunction.6

SSRIs have been linked to increased bleeding risk, especially increased risk of upper gastrointestinal hemorrhage. Laporte and colleagues showed an association of SSRI use and risk of bleeding in a meta-analysis of 42 observational studies, with an odds ratio of 1.41 (95% confidence interval, 1.27-1.57; P less than .0001).7 The risk of upper gastrointestinal (UGI) bleeding is further increased if patients are also taking NSAIDs.

Anglin et al. looked at 15 case-control studies and 4 cohort studies and found an OR of 1.66 for UGI bleeding with SSRI use, and an OR of 4.25 for UGI bleeding if SSRI use was combined with NSAID use.8 The number needed to harm is 3,177 for NSAID use in populations at low risk for GI bleeding, but it is much lower (881) in higher-risk populations.8 Make sure to think about patients’ bleeding risks when starting SSRIs.

An issue that comes up frequently is: What is the risk of bleeding in patients on SSRIs who are also on anticoagulants? Dr. Quinn and colleagues looked at the bleeding risk of anticoagulated patients also taking SSRIs in the ROCKET AF trial.9 They found 737 patients who received SSRIs and matched them with other patients not on SSRIs in the trial. All patients in the trial were either receiving rivaroxaban or warfarin for stroke prophylaxis. They found no significant increase risk in bleeding in the patients on SSRIs and anticoagulants.
 

Take-home points:

  • Yawning and hyperhidrosis are interesting side effects of SSRIs.
  • Bleeding risk is increased in patients on SSRIs, especially when combined with NSAIDs.

Dr. Paauw is professor of medicine in the division of general internal medicine at the University of Washington, Seattle, and he serves as third-year medical student clerkship director at the University of Washington. Contact Dr. Paauw at [email protected].

References

1. Neurologia. 2013 Nov-Dec;28(9):589-90.

2. Psychiatry Clin Neurosci. 2006 Apr;60(2):260.

3. Presse Med. 2014 Oct;43(10 Pt 1):1135-6.

4. Prog Neuropsychopharmacol Biol Psychiatry. 2009 Jun 15;33(4):747.

5. Ann Pharmacother. 2011 Oct;45(10):1297-301.

6. Depress Anxiety. 2017 Dec;34(12):1134-46.

7. Pharmacol Res. 2017 Apr;118:19-32.

8. Am J Gastroenterol. 2014 Jun;109(6):811-9.

9. J Am Heart Assoc. 2018 Aug 7;7(15):e008755.

A 55-year-old woman comes to clinic for follow-up. She reports her family is worried that she isn’t getting enough sleep and is more tired than usual. The patient reports she is sleeping 8 hours a night and wakes up feeling rested, but she has noticed she has been yawning much more frequently than she remembers in the past.

Dr. Douglas S. Paauw

Past medical history: gastroesophageal reflux disease, hypertension, generalized anxiety disorder, hypothyroidism, and osteoporosis. Medications: amlodipine, lansoprazole, irbesartan, escitalopram, levothyroxine, and alendronate. Physical examination: blood pressure 110/70 mm Hg, pulse 60 bpm. Lower extremities: 1+ edema.

What is the likely cause of her increased yawning?

A. Amlodipine.

B. Alendronate.

C. Irbesartan.

D. Escitalopram.

E. Lansoprazole.

The correct answer here is escitalopram. Selective serotonin reuptake inhibitors in general are well tolerated. Given how commonly these drugs are used, however, there are a number of lesser-known side effects that you are likely to see.

In the above case, this patient has yawning caused by her SSRI. Roncero et al. described a case of yawning in a patient on escitalopram that resolved when the dose of escitalopram was reduced.1 Paroxetine has been reported to cause yawning at both low and high doses.2

In a review of drug-induced yawning, SSRIs as a class were most frequently involved, and sertraline and fluoxetine were implicated in addition to paroxetine.3 The serotonin-norepinephrine reuptake inhibitors duloxetine and venlafaxine have also been associated with yawning.4,5

Hyperhydrosis has also been linked to SSRIs and SNRIs, and both yawning and hyperhidrosis may occur because of an underlying thermoregulatory dysfunction.6

SSRIs have been linked to increased bleeding risk, especially increased risk of upper gastrointestinal hemorrhage. Laporte and colleagues showed an association of SSRI use and risk of bleeding in a meta-analysis of 42 observational studies, with an odds ratio of 1.41 (95% confidence interval, 1.27-1.57; P less than .0001).7 The risk of upper gastrointestinal (UGI) bleeding is further increased if patients are also taking NSAIDs.

Anglin et al. looked at 15 case-control studies and 4 cohort studies and found an OR of 1.66 for UGI bleeding with SSRI use, and an OR of 4.25 for UGI bleeding if SSRI use was combined with NSAID use.8 The number needed to harm is 3,177 for NSAID use in populations at low risk for GI bleeding, but it is much lower (881) in higher-risk populations.8 Make sure to think about patients’ bleeding risks when starting SSRIs.

An issue that comes up frequently is: What is the risk of bleeding in patients on SSRIs who are also on anticoagulants? Dr. Quinn and colleagues looked at the bleeding risk of anticoagulated patients also taking SSRIs in the ROCKET AF trial.9 They found 737 patients who received SSRIs and matched them with other patients not on SSRIs in the trial. All patients in the trial were either receiving rivaroxaban or warfarin for stroke prophylaxis. They found no significant increase risk in bleeding in the patients on SSRIs and anticoagulants.
 

Take-home points:

  • Yawning and hyperhidrosis are interesting side effects of SSRIs.
  • Bleeding risk is increased in patients on SSRIs, especially when combined with NSAIDs.

Dr. Paauw is professor of medicine in the division of general internal medicine at the University of Washington, Seattle, and he serves as third-year medical student clerkship director at the University of Washington. Contact Dr. Paauw at [email protected].

References

1. Neurologia. 2013 Nov-Dec;28(9):589-90.

2. Psychiatry Clin Neurosci. 2006 Apr;60(2):260.

3. Presse Med. 2014 Oct;43(10 Pt 1):1135-6.

4. Prog Neuropsychopharmacol Biol Psychiatry. 2009 Jun 15;33(4):747.

5. Ann Pharmacother. 2011 Oct;45(10):1297-301.

6. Depress Anxiety. 2017 Dec;34(12):1134-46.

7. Pharmacol Res. 2017 Apr;118:19-32.

8. Am J Gastroenterol. 2014 Jun;109(6):811-9.

9. J Am Heart Assoc. 2018 Aug 7;7(15):e008755.

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ACP maps two potential paths to universal health care

Article Type
Changed
Wed, 05/06/2020 - 12:46

The American College of Physicians is recommending either a single-payer system or a public option within a regulated private insurance system to help deliver universal and affordable access to health care for all Americans.

“We came to the conclusion that two directions or approaches could get us to where we need to be,” ACP President Robert McLean, MD, said in an interview. “We need ... a system that provides universal, affordable access to care.”

After examining the evidence, ACP discarded one option: a direct market-based approach.

“Direct market-based approaches won’t work,” Dr. McLean explained. “If you look at where direct marketplace approaches ... have been implemented, they just will not get you to a place where you are going to get universal coverage, portability, essential benefits, and preexisting condition protection and administrative simplification.”

Dr. McLean highlighted two paths that could achieve universal coverage and better access to health care: a single-payer–financed system, or a publicly financed coverage option within a system of regulated private insurance.

It’s the first time ACP has endorsed a single-payer approach. The college supported the public option that wasn’t included as part of the Affordable Care Act. But ACP’s latest publicly financed proposal offers a deeper level of detail on how to make that option work in the context of a private insurance system.

While the health reform conversation may be a political, ACP doesn’t want to make it a partisan one. ACP’s policy recommendations represent a carefully researched series of ideas backed by evidence-based research, Dr. McLean said.

“There is a lot of nuance behind” the two recommendations, he noted, and those nuances are explored in a series of articles and editorials published Jan. 21 in Annals of Internal Medicine.

Sizing up single payer

The ACP acknowledges that for its single-payer system, the transition could be “politically difficult and strain the federal budget,” according to Ryan A. Crowley, senior analyst at ACP, and colleagues in an article outlining the organization’s vision. “Taxes would probably replace premiums, and private insurance would have a reduced role or be eliminated altogether.”

However, the authors note that a single-payer system could be designed to address concerns from a generally skeptical public, such as providing bulk funding or setting minimum standards to guide state operations. It also could include private insurance to provide supplemental coverage.

Even so, “adopting a single-payer system would be highly disruptive and could lead to price controls that would perpetuate flaws in the current Medicare payment system, including the undervaluation of primary care,” Mr. Crowley and colleagues wrote. “If prices are set too low, it could lead to shortages and longer wait times for services. Without sufficient cost controls, however, the cost of a single-payer system could be too high to be feasible.”

Pondering the public option

Given a single-payer plan’s potential challenges, ACP also is endorsing a public option model, which provides the choice of a government-sponsored health insurance plan to compete with existing private insurance options.

“Depending on its structure and implementation, a public choice (or public option) model available to all could help to achieve universal coverage, better access, and improved outcomes without the disruption of a single-payer approach,” the ACP authors noted.

The public option has its own drawbacks, they acknowledge. Those include an inability to achieve better savings on prescription drugs, compared with a single-payer system. The public option approach also doesn’t do away with the current administrative burden, and access issues related to narrow provider networks would persist.

Dr. McLean noted that a more highly regulated insurance market would be needed to help make the public option model work.

“Insurance companies don’t have regulation in a lot of things that they do,” Dr. McLean said. “We see that as quite problematic. They are kind of running amok at this point.”

Expanding the role of primary care

In either reform scenario, primary care would play a much greater role.

“We need to promote primary care,” Dr. McLean said. That includes better incentives to draw physicians to it. “We have to pay them enough,” he added.

The health care models will need to move away from higher pay to specialties for high-cost, high-volume procedural reimbursement. And they’ll need to recognize the need for placing a higher value on the cognitive services provided at the primary care level.

Also in need of change: physicians’ administrative burdens. Reforms need to address the burden created by value-based care and the poor application and misapplication of quality measures.

Migration to a single-payer environment could would make reducing the administrative burden a lot easier, Dr. McLean said. But it also could be done with a public option approach.

That’s where regulators can play a big role in working with insurers to help address administrative burden – streamlining prior authorization of procedures, the types of forms used, and other policies, Dr. McLean explained.

“The number of insurers and their ability to have their own rules and regulations [make it] incredibly complex for patients as well as physicians trying to figure out how to deliver the care that they need,” he noted.

Dr. McLean hopes that the ACP’s papers will spark conversation, particularly among legislators and regulators.

“The bottom line is we cannot afford to not do something bold,” he cautioned. “It is just not working. Our patients deserve better, and we can do better.”

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The American College of Physicians is recommending either a single-payer system or a public option within a regulated private insurance system to help deliver universal and affordable access to health care for all Americans.

“We came to the conclusion that two directions or approaches could get us to where we need to be,” ACP President Robert McLean, MD, said in an interview. “We need ... a system that provides universal, affordable access to care.”

After examining the evidence, ACP discarded one option: a direct market-based approach.

“Direct market-based approaches won’t work,” Dr. McLean explained. “If you look at where direct marketplace approaches ... have been implemented, they just will not get you to a place where you are going to get universal coverage, portability, essential benefits, and preexisting condition protection and administrative simplification.”

Dr. McLean highlighted two paths that could achieve universal coverage and better access to health care: a single-payer–financed system, or a publicly financed coverage option within a system of regulated private insurance.

It’s the first time ACP has endorsed a single-payer approach. The college supported the public option that wasn’t included as part of the Affordable Care Act. But ACP’s latest publicly financed proposal offers a deeper level of detail on how to make that option work in the context of a private insurance system.

While the health reform conversation may be a political, ACP doesn’t want to make it a partisan one. ACP’s policy recommendations represent a carefully researched series of ideas backed by evidence-based research, Dr. McLean said.

“There is a lot of nuance behind” the two recommendations, he noted, and those nuances are explored in a series of articles and editorials published Jan. 21 in Annals of Internal Medicine.

Sizing up single payer

The ACP acknowledges that for its single-payer system, the transition could be “politically difficult and strain the federal budget,” according to Ryan A. Crowley, senior analyst at ACP, and colleagues in an article outlining the organization’s vision. “Taxes would probably replace premiums, and private insurance would have a reduced role or be eliminated altogether.”

However, the authors note that a single-payer system could be designed to address concerns from a generally skeptical public, such as providing bulk funding or setting minimum standards to guide state operations. It also could include private insurance to provide supplemental coverage.

Even so, “adopting a single-payer system would be highly disruptive and could lead to price controls that would perpetuate flaws in the current Medicare payment system, including the undervaluation of primary care,” Mr. Crowley and colleagues wrote. “If prices are set too low, it could lead to shortages and longer wait times for services. Without sufficient cost controls, however, the cost of a single-payer system could be too high to be feasible.”

Pondering the public option

Given a single-payer plan’s potential challenges, ACP also is endorsing a public option model, which provides the choice of a government-sponsored health insurance plan to compete with existing private insurance options.

“Depending on its structure and implementation, a public choice (or public option) model available to all could help to achieve universal coverage, better access, and improved outcomes without the disruption of a single-payer approach,” the ACP authors noted.

The public option has its own drawbacks, they acknowledge. Those include an inability to achieve better savings on prescription drugs, compared with a single-payer system. The public option approach also doesn’t do away with the current administrative burden, and access issues related to narrow provider networks would persist.

Dr. McLean noted that a more highly regulated insurance market would be needed to help make the public option model work.

“Insurance companies don’t have regulation in a lot of things that they do,” Dr. McLean said. “We see that as quite problematic. They are kind of running amok at this point.”

Expanding the role of primary care

In either reform scenario, primary care would play a much greater role.

“We need to promote primary care,” Dr. McLean said. That includes better incentives to draw physicians to it. “We have to pay them enough,” he added.

The health care models will need to move away from higher pay to specialties for high-cost, high-volume procedural reimbursement. And they’ll need to recognize the need for placing a higher value on the cognitive services provided at the primary care level.

Also in need of change: physicians’ administrative burdens. Reforms need to address the burden created by value-based care and the poor application and misapplication of quality measures.

Migration to a single-payer environment could would make reducing the administrative burden a lot easier, Dr. McLean said. But it also could be done with a public option approach.

That’s where regulators can play a big role in working with insurers to help address administrative burden – streamlining prior authorization of procedures, the types of forms used, and other policies, Dr. McLean explained.

“The number of insurers and their ability to have their own rules and regulations [make it] incredibly complex for patients as well as physicians trying to figure out how to deliver the care that they need,” he noted.

Dr. McLean hopes that the ACP’s papers will spark conversation, particularly among legislators and regulators.

“The bottom line is we cannot afford to not do something bold,” he cautioned. “It is just not working. Our patients deserve better, and we can do better.”

The American College of Physicians is recommending either a single-payer system or a public option within a regulated private insurance system to help deliver universal and affordable access to health care for all Americans.

“We came to the conclusion that two directions or approaches could get us to where we need to be,” ACP President Robert McLean, MD, said in an interview. “We need ... a system that provides universal, affordable access to care.”

After examining the evidence, ACP discarded one option: a direct market-based approach.

“Direct market-based approaches won’t work,” Dr. McLean explained. “If you look at where direct marketplace approaches ... have been implemented, they just will not get you to a place where you are going to get universal coverage, portability, essential benefits, and preexisting condition protection and administrative simplification.”

Dr. McLean highlighted two paths that could achieve universal coverage and better access to health care: a single-payer–financed system, or a publicly financed coverage option within a system of regulated private insurance.

It’s the first time ACP has endorsed a single-payer approach. The college supported the public option that wasn’t included as part of the Affordable Care Act. But ACP’s latest publicly financed proposal offers a deeper level of detail on how to make that option work in the context of a private insurance system.

While the health reform conversation may be a political, ACP doesn’t want to make it a partisan one. ACP’s policy recommendations represent a carefully researched series of ideas backed by evidence-based research, Dr. McLean said.

“There is a lot of nuance behind” the two recommendations, he noted, and those nuances are explored in a series of articles and editorials published Jan. 21 in Annals of Internal Medicine.

Sizing up single payer

The ACP acknowledges that for its single-payer system, the transition could be “politically difficult and strain the federal budget,” according to Ryan A. Crowley, senior analyst at ACP, and colleagues in an article outlining the organization’s vision. “Taxes would probably replace premiums, and private insurance would have a reduced role or be eliminated altogether.”

However, the authors note that a single-payer system could be designed to address concerns from a generally skeptical public, such as providing bulk funding or setting minimum standards to guide state operations. It also could include private insurance to provide supplemental coverage.

Even so, “adopting a single-payer system would be highly disruptive and could lead to price controls that would perpetuate flaws in the current Medicare payment system, including the undervaluation of primary care,” Mr. Crowley and colleagues wrote. “If prices are set too low, it could lead to shortages and longer wait times for services. Without sufficient cost controls, however, the cost of a single-payer system could be too high to be feasible.”

Pondering the public option

Given a single-payer plan’s potential challenges, ACP also is endorsing a public option model, which provides the choice of a government-sponsored health insurance plan to compete with existing private insurance options.

“Depending on its structure and implementation, a public choice (or public option) model available to all could help to achieve universal coverage, better access, and improved outcomes without the disruption of a single-payer approach,” the ACP authors noted.

The public option has its own drawbacks, they acknowledge. Those include an inability to achieve better savings on prescription drugs, compared with a single-payer system. The public option approach also doesn’t do away with the current administrative burden, and access issues related to narrow provider networks would persist.

Dr. McLean noted that a more highly regulated insurance market would be needed to help make the public option model work.

“Insurance companies don’t have regulation in a lot of things that they do,” Dr. McLean said. “We see that as quite problematic. They are kind of running amok at this point.”

Expanding the role of primary care

In either reform scenario, primary care would play a much greater role.

“We need to promote primary care,” Dr. McLean said. That includes better incentives to draw physicians to it. “We have to pay them enough,” he added.

The health care models will need to move away from higher pay to specialties for high-cost, high-volume procedural reimbursement. And they’ll need to recognize the need for placing a higher value on the cognitive services provided at the primary care level.

Also in need of change: physicians’ administrative burdens. Reforms need to address the burden created by value-based care and the poor application and misapplication of quality measures.

Migration to a single-payer environment could would make reducing the administrative burden a lot easier, Dr. McLean said. But it also could be done with a public option approach.

That’s where regulators can play a big role in working with insurers to help address administrative burden – streamlining prior authorization of procedures, the types of forms used, and other policies, Dr. McLean explained.

“The number of insurers and their ability to have their own rules and regulations [make it] incredibly complex for patients as well as physicians trying to figure out how to deliver the care that they need,” he noted.

Dr. McLean hopes that the ACP’s papers will spark conversation, particularly among legislators and regulators.

“The bottom line is we cannot afford to not do something bold,” he cautioned. “It is just not working. Our patients deserve better, and we can do better.”

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Medscape survey points to generational differences in physician burnout

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Wed, 05/06/2020 - 12:46

Burnout among physicians appears to have decreased slightly in the past few years, but remains a significant problem for the medical profession, according to the Medscape National Physician Burnout & Suicide Report 2020: The Generational Divide.

olm26250/Thinkstock

A survey of more than 15,000 physicians revealed that 42% reported being burned out, down from 46% who responded to the survey 5 years ago. However, there are variations in the rates based on certain demographic factors such as specialty, age, and gender.

Urology sits at the top of the list as the specialty that is experiencing the highest rate of burnout, with 54% of urologists responding to the survey reporting burnout. Neurology and nephrology followed with rates of burnout at 50% and 49%, respectively. The next five specialties on the list all reported burnout rates of 46%: diabetes and endocrinology, family medicine, radiology, ob.gyn., and rheumatology. Pulmonology specialists reported a burnout rate of 41%. Gastroenterologists reported burnout rates of 37%.

The survey divided participants into three age categories – Millennial (ages 25-39 years), Generation X (ages 40-54 years), and Baby Boomer (ages 55-73 years). Both Millennials and Baby Boomers reported similar rates of burnout (38% and 39%, respectively) and those in Generation X reported a higher rate of burnout (48%).

This higher rate is not unexpected. The survey results cite Carol Bernstein, MD, of the Albert Einstein College of Medicine, New York, as noting that midcareer “is typically the time of highest burnout, which is where Gen Xers are in their career trajectory, suggesting a number of factors outside of work such as caring for children and elderly parents, planning for retirement, can play a role in contributing to burnout.”

Women also reported a higher rate of burnout, although the rate has dropped from the survey conducted 5 years ago. The rate of burnout among women reported for the 2020 survey was 48%, down from 51% reported 5 years ago. By comparison, the rate of burnout for men was 37% in 2020, down from 43% in 2015.

In terms of what is causing burnout, the biggest contributor is the bureaucratic tasks (charting and paperwork, for example) that physicians must complete, which 55% of respondents to the survey said was the leading cause of burnout. Next was spending too many hours at work (33%); lack of respect from administrators, employers, colleagues, and staff (32%); and the increased computerization of the practice, including the use of electronic health records (30%).

When broken down by age category, the bureaucratic tasks was tops in all three groups (57% for Millennials, 56% for Generation X, and 54% for Baby Boomers), but what ranks next differs slightly by age group. For Millennials, the next two factors were too many hours at work (38%) and lack of respect (35%). Generation X respondents cited the same two factors, both at 33%. Baby Boomers cited computerization as their second-highest factor (41%) and spending too many hours at work as the third-highest factor (31%).

The generations had different approaches to coping with burnout. Millennials (56%) reported sleep as their top-ranked coping strategy, while Gen Xers and Baby Boomers ranked exercise and personal isolation as their top choice. For these two older groups, sleep was ranked last, after other activities such as talking with family and friends.

The survey also asked about depression, and respondents reported a similar rate across all age groups (15%, 18%, and 16%, respectively). Among those who said they were depressed, the three age groups had similar rates of suicidal thoughts (21%, 24%, and 22%).

Perhaps the most striking finding of the survey is the number of physicians who would take a pay cut to achieve a better work-life balance. Among Millennials, 52% would accept a pay cut, compared with 48% of Generation X and 49% of Baby Boomers. A surprising number (36%, 34%, and 31%, respectively, reported that they would accept a $10,000-$20,000 pay cut to have a 20% reduction in work hours. [email protected]

*This story was updated on 1/22/2020.

SOURCE: Kane L et al. Medscape National Physician Burnout & Suicide Report 2020: The Generational Divide. Medscape. 2020 Jan 15.

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Burnout among physicians appears to have decreased slightly in the past few years, but remains a significant problem for the medical profession, according to the Medscape National Physician Burnout & Suicide Report 2020: The Generational Divide.

olm26250/Thinkstock

A survey of more than 15,000 physicians revealed that 42% reported being burned out, down from 46% who responded to the survey 5 years ago. However, there are variations in the rates based on certain demographic factors such as specialty, age, and gender.

Urology sits at the top of the list as the specialty that is experiencing the highest rate of burnout, with 54% of urologists responding to the survey reporting burnout. Neurology and nephrology followed with rates of burnout at 50% and 49%, respectively. The next five specialties on the list all reported burnout rates of 46%: diabetes and endocrinology, family medicine, radiology, ob.gyn., and rheumatology. Pulmonology specialists reported a burnout rate of 41%. Gastroenterologists reported burnout rates of 37%.

The survey divided participants into three age categories – Millennial (ages 25-39 years), Generation X (ages 40-54 years), and Baby Boomer (ages 55-73 years). Both Millennials and Baby Boomers reported similar rates of burnout (38% and 39%, respectively) and those in Generation X reported a higher rate of burnout (48%).

This higher rate is not unexpected. The survey results cite Carol Bernstein, MD, of the Albert Einstein College of Medicine, New York, as noting that midcareer “is typically the time of highest burnout, which is where Gen Xers are in their career trajectory, suggesting a number of factors outside of work such as caring for children and elderly parents, planning for retirement, can play a role in contributing to burnout.”

Women also reported a higher rate of burnout, although the rate has dropped from the survey conducted 5 years ago. The rate of burnout among women reported for the 2020 survey was 48%, down from 51% reported 5 years ago. By comparison, the rate of burnout for men was 37% in 2020, down from 43% in 2015.

In terms of what is causing burnout, the biggest contributor is the bureaucratic tasks (charting and paperwork, for example) that physicians must complete, which 55% of respondents to the survey said was the leading cause of burnout. Next was spending too many hours at work (33%); lack of respect from administrators, employers, colleagues, and staff (32%); and the increased computerization of the practice, including the use of electronic health records (30%).

When broken down by age category, the bureaucratic tasks was tops in all three groups (57% for Millennials, 56% for Generation X, and 54% for Baby Boomers), but what ranks next differs slightly by age group. For Millennials, the next two factors were too many hours at work (38%) and lack of respect (35%). Generation X respondents cited the same two factors, both at 33%. Baby Boomers cited computerization as their second-highest factor (41%) and spending too many hours at work as the third-highest factor (31%).

The generations had different approaches to coping with burnout. Millennials (56%) reported sleep as their top-ranked coping strategy, while Gen Xers and Baby Boomers ranked exercise and personal isolation as their top choice. For these two older groups, sleep was ranked last, after other activities such as talking with family and friends.

The survey also asked about depression, and respondents reported a similar rate across all age groups (15%, 18%, and 16%, respectively). Among those who said they were depressed, the three age groups had similar rates of suicidal thoughts (21%, 24%, and 22%).

Perhaps the most striking finding of the survey is the number of physicians who would take a pay cut to achieve a better work-life balance. Among Millennials, 52% would accept a pay cut, compared with 48% of Generation X and 49% of Baby Boomers. A surprising number (36%, 34%, and 31%, respectively, reported that they would accept a $10,000-$20,000 pay cut to have a 20% reduction in work hours. [email protected]

*This story was updated on 1/22/2020.

SOURCE: Kane L et al. Medscape National Physician Burnout & Suicide Report 2020: The Generational Divide. Medscape. 2020 Jan 15.

Burnout among physicians appears to have decreased slightly in the past few years, but remains a significant problem for the medical profession, according to the Medscape National Physician Burnout & Suicide Report 2020: The Generational Divide.

olm26250/Thinkstock

A survey of more than 15,000 physicians revealed that 42% reported being burned out, down from 46% who responded to the survey 5 years ago. However, there are variations in the rates based on certain demographic factors such as specialty, age, and gender.

Urology sits at the top of the list as the specialty that is experiencing the highest rate of burnout, with 54% of urologists responding to the survey reporting burnout. Neurology and nephrology followed with rates of burnout at 50% and 49%, respectively. The next five specialties on the list all reported burnout rates of 46%: diabetes and endocrinology, family medicine, radiology, ob.gyn., and rheumatology. Pulmonology specialists reported a burnout rate of 41%. Gastroenterologists reported burnout rates of 37%.

The survey divided participants into three age categories – Millennial (ages 25-39 years), Generation X (ages 40-54 years), and Baby Boomer (ages 55-73 years). Both Millennials and Baby Boomers reported similar rates of burnout (38% and 39%, respectively) and those in Generation X reported a higher rate of burnout (48%).

This higher rate is not unexpected. The survey results cite Carol Bernstein, MD, of the Albert Einstein College of Medicine, New York, as noting that midcareer “is typically the time of highest burnout, which is where Gen Xers are in their career trajectory, suggesting a number of factors outside of work such as caring for children and elderly parents, planning for retirement, can play a role in contributing to burnout.”

Women also reported a higher rate of burnout, although the rate has dropped from the survey conducted 5 years ago. The rate of burnout among women reported for the 2020 survey was 48%, down from 51% reported 5 years ago. By comparison, the rate of burnout for men was 37% in 2020, down from 43% in 2015.

In terms of what is causing burnout, the biggest contributor is the bureaucratic tasks (charting and paperwork, for example) that physicians must complete, which 55% of respondents to the survey said was the leading cause of burnout. Next was spending too many hours at work (33%); lack of respect from administrators, employers, colleagues, and staff (32%); and the increased computerization of the practice, including the use of electronic health records (30%).

When broken down by age category, the bureaucratic tasks was tops in all three groups (57% for Millennials, 56% for Generation X, and 54% for Baby Boomers), but what ranks next differs slightly by age group. For Millennials, the next two factors were too many hours at work (38%) and lack of respect (35%). Generation X respondents cited the same two factors, both at 33%. Baby Boomers cited computerization as their second-highest factor (41%) and spending too many hours at work as the third-highest factor (31%).

The generations had different approaches to coping with burnout. Millennials (56%) reported sleep as their top-ranked coping strategy, while Gen Xers and Baby Boomers ranked exercise and personal isolation as their top choice. For these two older groups, sleep was ranked last, after other activities such as talking with family and friends.

The survey also asked about depression, and respondents reported a similar rate across all age groups (15%, 18%, and 16%, respectively). Among those who said they were depressed, the three age groups had similar rates of suicidal thoughts (21%, 24%, and 22%).

Perhaps the most striking finding of the survey is the number of physicians who would take a pay cut to achieve a better work-life balance. Among Millennials, 52% would accept a pay cut, compared with 48% of Generation X and 49% of Baby Boomers. A surprising number (36%, 34%, and 31%, respectively, reported that they would accept a $10,000-$20,000 pay cut to have a 20% reduction in work hours. [email protected]

*This story was updated on 1/22/2020.

SOURCE: Kane L et al. Medscape National Physician Burnout & Suicide Report 2020: The Generational Divide. Medscape. 2020 Jan 15.

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Elizabeth Wurtzel helped clear the air on stigma

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Wed, 01/22/2020 - 15:07

When Elizabeth Wurtzel wrote “Prozac Nation,” an autobiographical account published in 1994 of her experience with depression and psychiatric medications, she helped shift the public dialogue about mental illness, and in doing so chipped away at the stigma that continues to haunt many of our patients.

Dr. Robert T. London

Ms. Wurtzel, who died recently at age 52, wrote about depression passionately and matter-of-factly.

As she stated in “Prozac Nation”: “Depression was the loneliest &*%$ thing on earth. There were no halfway houses for depressives, no Depression Anonymous meetings that I knew of. Yes, of course, there were mental hospitals like McLean and Bellevue and Payne Whitney and the Menninger Clinic, but I couldn’t hope to end up in one of those places unless I made a suicide attempt serious enough to warrant oxygen or stitches or a stomach pump.

“I used to wish – to pray to God for the courage and strength – that I’d have the guts not to get better, but to slit my wrists and get a whole lot worse so I could land in some mental ward, where real help might have been possible.”

Think of where the public consciousness was in 1994. Peter D. Kramer, MD, had started the conversation on Prozac a year earlier with his book, “Listening to Prozac,” Kurt Cobain died by suicide in 1994, and 2 years later President Bill Clinton signed the Personal Responsibility and Work Opportunity Reconciliation Act, a law that “reformed” welfare and some say made it more difficult for low-income Americans to secure psychiatric and addiction services (Milbank Q. 2005 Mar;83[1]:65-99).

Prozac, as we know, was the first SSRI on the market in the late 1980s and was hailed as a major medication breakthrough in the treatment of depression. It lacked the side effects of the tricyclic antidepressants of previous years and did not have the potentially dangerous food restrictions associated with monoamine oxidase inhibitors.

Interestingly, the major reviews of Ms. Wurtzel’s book, mainly written by men, were negative. Those reviews focused more on the lifestyle of Ms. Wurtzel, her introspection, and how difficult life was for her, rather than the importance of the book. To me, her writing skills were exceptional, as was her willingness to put her lifestyle and suffering on the line.

The literary critics failed to recognize the book’s importance in unmasking the massive denial of mental illnesses and what Ms. Wurtzel was trying to get across. There have been many successful male writers over the years whose lives were difficult and replete with emotional pain and suffering, and their work was lauded. Regardless of the reviews’ negativity, readers found her book open and enlightening, making it a bestseller – thus paving the way for better and more-open discussion of mental disorders. It also became a touchstone in discussions of antidepressants in the psychiatric literature (Lancet. 1998 Sep 26. doi: 10.1016/S0140-6736(98)08418-9; Lancet. 2015 Oct 1. doi: 10.1016/S2215-0366[15]00430-7; and Biol Psychiatry. 2018 Dec 1;84[11]:e73-5).



However, unfortunately, the stigma still exists on many levels, often starting with the medical profession itself. In my experience over the years in teaching and supervising medical students, many of those not interested in becoming a psychiatrist all too often could not wait for their psych rotation to be over. Generally, they did not take the rotation seriously. I’ve even heard students making light of the delusions and paranoia seen in the suffering of acutely ill patients.

We can take this even further within the profession. I have had many referrals from far too many extremely competent physicians, across many medical specialties, who would refer to their patient as “sort of crazy.” Those physicians want the best for their patients, clearly, in making the referral, but they need to change their thinking and, therefore, their vocabulary about mental disorders. I’d like to see these physicians be more respectful of our patients – just as I would be if I were referring a patient complaining of fatigue and joint pain to a general internist or rheumatologist.

I once knew a brilliant orthopedic surgeon who, when he made a referral, would sit down with the patient and clearly explain why they were not crazy but had an anxiety or a mood problem that he didn’t treat but had a person to refer to who could help. Likewise, I know an ophthalmologist who tells his patients with some emotional symptoms that they are experiencing a difficult situation and would benefit from help that he is not able to provide but could be resolved with another type of specialist who works with their “difficulties.” We clearly need more docs like this who go out of their specialty to explain what patients might need – despite the administrative burden exacted by EMRs on doctors’ time and energy.

As we grow more tolerant in our culture and eliminate distasteful words about people and groups, maybe we should try and avoid the word crazy – even in our general vocabulary. Furthermore, in social situations, while out to dinner with friends, at the gym, or even while in the workplace, just as we may refer to our primary care doc as the best or report we have the best cardiologist or dermatologist, we rarely hear someone being open about the best psychiatrist, psychologist, or therapist in the same manner.

“If ‘Prozac Nation’ has any particular purpose,” she wrote in the afterword, “it would be to come out and say that clinical depression is a real problem, that it ruins lives, that it ends lives, that it very nearly ended my life, that it afflicts many, many people, many very bright and worthy and thoughtful and caring people, people who could probably save the world or at the very least do it some real good.” Those people are our patients, and medicine should take the lead in working further to destigmatize mental illness.

Dr. London is a practicing psychiatrist and has been a newspaper columnist for 35 years, specializing in and writing about short-term therapy, including cognitive-behavioral therapy and guided imagery. He is author of “Find Freedom Fast” (New York: Kettlehole Publishing, 2019). He has no conflicts of interest.

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When Elizabeth Wurtzel wrote “Prozac Nation,” an autobiographical account published in 1994 of her experience with depression and psychiatric medications, she helped shift the public dialogue about mental illness, and in doing so chipped away at the stigma that continues to haunt many of our patients.

Dr. Robert T. London

Ms. Wurtzel, who died recently at age 52, wrote about depression passionately and matter-of-factly.

As she stated in “Prozac Nation”: “Depression was the loneliest &*%$ thing on earth. There were no halfway houses for depressives, no Depression Anonymous meetings that I knew of. Yes, of course, there were mental hospitals like McLean and Bellevue and Payne Whitney and the Menninger Clinic, but I couldn’t hope to end up in one of those places unless I made a suicide attempt serious enough to warrant oxygen or stitches or a stomach pump.

“I used to wish – to pray to God for the courage and strength – that I’d have the guts not to get better, but to slit my wrists and get a whole lot worse so I could land in some mental ward, where real help might have been possible.”

Think of where the public consciousness was in 1994. Peter D. Kramer, MD, had started the conversation on Prozac a year earlier with his book, “Listening to Prozac,” Kurt Cobain died by suicide in 1994, and 2 years later President Bill Clinton signed the Personal Responsibility and Work Opportunity Reconciliation Act, a law that “reformed” welfare and some say made it more difficult for low-income Americans to secure psychiatric and addiction services (Milbank Q. 2005 Mar;83[1]:65-99).

Prozac, as we know, was the first SSRI on the market in the late 1980s and was hailed as a major medication breakthrough in the treatment of depression. It lacked the side effects of the tricyclic antidepressants of previous years and did not have the potentially dangerous food restrictions associated with monoamine oxidase inhibitors.

Interestingly, the major reviews of Ms. Wurtzel’s book, mainly written by men, were negative. Those reviews focused more on the lifestyle of Ms. Wurtzel, her introspection, and how difficult life was for her, rather than the importance of the book. To me, her writing skills were exceptional, as was her willingness to put her lifestyle and suffering on the line.

The literary critics failed to recognize the book’s importance in unmasking the massive denial of mental illnesses and what Ms. Wurtzel was trying to get across. There have been many successful male writers over the years whose lives were difficult and replete with emotional pain and suffering, and their work was lauded. Regardless of the reviews’ negativity, readers found her book open and enlightening, making it a bestseller – thus paving the way for better and more-open discussion of mental disorders. It also became a touchstone in discussions of antidepressants in the psychiatric literature (Lancet. 1998 Sep 26. doi: 10.1016/S0140-6736(98)08418-9; Lancet. 2015 Oct 1. doi: 10.1016/S2215-0366[15]00430-7; and Biol Psychiatry. 2018 Dec 1;84[11]:e73-5).



However, unfortunately, the stigma still exists on many levels, often starting with the medical profession itself. In my experience over the years in teaching and supervising medical students, many of those not interested in becoming a psychiatrist all too often could not wait for their psych rotation to be over. Generally, they did not take the rotation seriously. I’ve even heard students making light of the delusions and paranoia seen in the suffering of acutely ill patients.

We can take this even further within the profession. I have had many referrals from far too many extremely competent physicians, across many medical specialties, who would refer to their patient as “sort of crazy.” Those physicians want the best for their patients, clearly, in making the referral, but they need to change their thinking and, therefore, their vocabulary about mental disorders. I’d like to see these physicians be more respectful of our patients – just as I would be if I were referring a patient complaining of fatigue and joint pain to a general internist or rheumatologist.

I once knew a brilliant orthopedic surgeon who, when he made a referral, would sit down with the patient and clearly explain why they were not crazy but had an anxiety or a mood problem that he didn’t treat but had a person to refer to who could help. Likewise, I know an ophthalmologist who tells his patients with some emotional symptoms that they are experiencing a difficult situation and would benefit from help that he is not able to provide but could be resolved with another type of specialist who works with their “difficulties.” We clearly need more docs like this who go out of their specialty to explain what patients might need – despite the administrative burden exacted by EMRs on doctors’ time and energy.

As we grow more tolerant in our culture and eliminate distasteful words about people and groups, maybe we should try and avoid the word crazy – even in our general vocabulary. Furthermore, in social situations, while out to dinner with friends, at the gym, or even while in the workplace, just as we may refer to our primary care doc as the best or report we have the best cardiologist or dermatologist, we rarely hear someone being open about the best psychiatrist, psychologist, or therapist in the same manner.

“If ‘Prozac Nation’ has any particular purpose,” she wrote in the afterword, “it would be to come out and say that clinical depression is a real problem, that it ruins lives, that it ends lives, that it very nearly ended my life, that it afflicts many, many people, many very bright and worthy and thoughtful and caring people, people who could probably save the world or at the very least do it some real good.” Those people are our patients, and medicine should take the lead in working further to destigmatize mental illness.

Dr. London is a practicing psychiatrist and has been a newspaper columnist for 35 years, specializing in and writing about short-term therapy, including cognitive-behavioral therapy and guided imagery. He is author of “Find Freedom Fast” (New York: Kettlehole Publishing, 2019). He has no conflicts of interest.

When Elizabeth Wurtzel wrote “Prozac Nation,” an autobiographical account published in 1994 of her experience with depression and psychiatric medications, she helped shift the public dialogue about mental illness, and in doing so chipped away at the stigma that continues to haunt many of our patients.

Dr. Robert T. London

Ms. Wurtzel, who died recently at age 52, wrote about depression passionately and matter-of-factly.

As she stated in “Prozac Nation”: “Depression was the loneliest &*%$ thing on earth. There were no halfway houses for depressives, no Depression Anonymous meetings that I knew of. Yes, of course, there were mental hospitals like McLean and Bellevue and Payne Whitney and the Menninger Clinic, but I couldn’t hope to end up in one of those places unless I made a suicide attempt serious enough to warrant oxygen or stitches or a stomach pump.

“I used to wish – to pray to God for the courage and strength – that I’d have the guts not to get better, but to slit my wrists and get a whole lot worse so I could land in some mental ward, where real help might have been possible.”

Think of where the public consciousness was in 1994. Peter D. Kramer, MD, had started the conversation on Prozac a year earlier with his book, “Listening to Prozac,” Kurt Cobain died by suicide in 1994, and 2 years later President Bill Clinton signed the Personal Responsibility and Work Opportunity Reconciliation Act, a law that “reformed” welfare and some say made it more difficult for low-income Americans to secure psychiatric and addiction services (Milbank Q. 2005 Mar;83[1]:65-99).

Prozac, as we know, was the first SSRI on the market in the late 1980s and was hailed as a major medication breakthrough in the treatment of depression. It lacked the side effects of the tricyclic antidepressants of previous years and did not have the potentially dangerous food restrictions associated with monoamine oxidase inhibitors.

Interestingly, the major reviews of Ms. Wurtzel’s book, mainly written by men, were negative. Those reviews focused more on the lifestyle of Ms. Wurtzel, her introspection, and how difficult life was for her, rather than the importance of the book. To me, her writing skills were exceptional, as was her willingness to put her lifestyle and suffering on the line.

The literary critics failed to recognize the book’s importance in unmasking the massive denial of mental illnesses and what Ms. Wurtzel was trying to get across. There have been many successful male writers over the years whose lives were difficult and replete with emotional pain and suffering, and their work was lauded. Regardless of the reviews’ negativity, readers found her book open and enlightening, making it a bestseller – thus paving the way for better and more-open discussion of mental disorders. It also became a touchstone in discussions of antidepressants in the psychiatric literature (Lancet. 1998 Sep 26. doi: 10.1016/S0140-6736(98)08418-9; Lancet. 2015 Oct 1. doi: 10.1016/S2215-0366[15]00430-7; and Biol Psychiatry. 2018 Dec 1;84[11]:e73-5).



However, unfortunately, the stigma still exists on many levels, often starting with the medical profession itself. In my experience over the years in teaching and supervising medical students, many of those not interested in becoming a psychiatrist all too often could not wait for their psych rotation to be over. Generally, they did not take the rotation seriously. I’ve even heard students making light of the delusions and paranoia seen in the suffering of acutely ill patients.

We can take this even further within the profession. I have had many referrals from far too many extremely competent physicians, across many medical specialties, who would refer to their patient as “sort of crazy.” Those physicians want the best for their patients, clearly, in making the referral, but they need to change their thinking and, therefore, their vocabulary about mental disorders. I’d like to see these physicians be more respectful of our patients – just as I would be if I were referring a patient complaining of fatigue and joint pain to a general internist or rheumatologist.

I once knew a brilliant orthopedic surgeon who, when he made a referral, would sit down with the patient and clearly explain why they were not crazy but had an anxiety or a mood problem that he didn’t treat but had a person to refer to who could help. Likewise, I know an ophthalmologist who tells his patients with some emotional symptoms that they are experiencing a difficult situation and would benefit from help that he is not able to provide but could be resolved with another type of specialist who works with their “difficulties.” We clearly need more docs like this who go out of their specialty to explain what patients might need – despite the administrative burden exacted by EMRs on doctors’ time and energy.

As we grow more tolerant in our culture and eliminate distasteful words about people and groups, maybe we should try and avoid the word crazy – even in our general vocabulary. Furthermore, in social situations, while out to dinner with friends, at the gym, or even while in the workplace, just as we may refer to our primary care doc as the best or report we have the best cardiologist or dermatologist, we rarely hear someone being open about the best psychiatrist, psychologist, or therapist in the same manner.

“If ‘Prozac Nation’ has any particular purpose,” she wrote in the afterword, “it would be to come out and say that clinical depression is a real problem, that it ruins lives, that it ends lives, that it very nearly ended my life, that it afflicts many, many people, many very bright and worthy and thoughtful and caring people, people who could probably save the world or at the very least do it some real good.” Those people are our patients, and medicine should take the lead in working further to destigmatize mental illness.

Dr. London is a practicing psychiatrist and has been a newspaper columnist for 35 years, specializing in and writing about short-term therapy, including cognitive-behavioral therapy and guided imagery. He is author of “Find Freedom Fast” (New York: Kettlehole Publishing, 2019). He has no conflicts of interest.

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Sleep problems linked to worsening PTSD in veterans

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Wed, 05/06/2020 - 12:46

Insomnia is a common problem for veterans with PTSD, and the frequency of sleep problems is associated with increasing severity of PTSD, according to a study published in of the Journal of Traumatic Stress.

Raymond C. Rosen, PhD, of the New England Research Institutes, Watertown, Mass., and coauthors wrote that exploration of the relationship between PTSD and insomnia is complicated by the fact that it can be difficult to separate out disturbed sleep from other elements of PTSD, and because of the presence of other comorbidities in veterans, such as depression and traumatic brain injury.

The cohort study involved 1,643 veterans – roughly equal numbers of women and men – of Iraq and Afghanistan. Around two-thirds of the cohort had a diagnosis of PTSD. The participants completed a self-administered survey online or by mail, and were also assessed in a telephone interview, then followed up within 2-4 years.

While the prevalence of sleep problems was high across the cohort, the study found that 74% of participants with PTSD at baseline said they had experienced sleep difficulties for at least half of the previous 30 days, and one-third had been prescribed for a sedative-hypnotic drug in the past year.

In comparison, veterans without PTSD had fewer sleep problems and were prescribed significantly fewer sedative-hypnotic drugs.

The prevalence of sleep problems was similar in men and women with PTSD, although women had significantly higher rates of sedative-hypnotic prescriptions than men (40.4% vs. 35%, P = .006). A similar gender difference in prescription rates was seen in individuals without PTSD.

The study found that, although there was only a weak association between the severity of PTSD symptoms at baseline and the frequency of sleep problems at follow-up, there was a stronger association in reverse. Veterans with a higher frequency of sleep problems at baseline showed a significant increase in PTSD symptoms at follow-up.

The authors commented that this was in line with previous studies finding a similar effect of sleep disturbance on PTSD severity, both in military personnel and civilians.

“From a neurobiological perspective, it has been proposed that chronic sleep loss can lead to emotional dysregulation or heightened autonomic arousal, which in turn may be a risk factor for PTSD in trauma-exposed individuals,” they wrote. “It has also been proposed that prior sleep disturbance may attenuate the effects of extinction learning, leading to more enduring or severe symptoms in trauma-exposed individuals with concomitant sleep disorders.”

Given this association, the authors called for more attention to be given to identifying, diagnosing, and treating sleep disorders in veterans with and without PTSD.

The authors noted that they did not have access to polysomnographic data for participants, and were also unable to assess the prevalence, frequency, or intensity of nightmares in the cohort.

The study was supported by the Department of Defense. Conflict of interest disclosures were unavailable.

SOURCE: Rosen RC et al. J Trauma Stress. 2020;32:936-45.

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Insomnia is a common problem for veterans with PTSD, and the frequency of sleep problems is associated with increasing severity of PTSD, according to a study published in of the Journal of Traumatic Stress.

Raymond C. Rosen, PhD, of the New England Research Institutes, Watertown, Mass., and coauthors wrote that exploration of the relationship between PTSD and insomnia is complicated by the fact that it can be difficult to separate out disturbed sleep from other elements of PTSD, and because of the presence of other comorbidities in veterans, such as depression and traumatic brain injury.

The cohort study involved 1,643 veterans – roughly equal numbers of women and men – of Iraq and Afghanistan. Around two-thirds of the cohort had a diagnosis of PTSD. The participants completed a self-administered survey online or by mail, and were also assessed in a telephone interview, then followed up within 2-4 years.

While the prevalence of sleep problems was high across the cohort, the study found that 74% of participants with PTSD at baseline said they had experienced sleep difficulties for at least half of the previous 30 days, and one-third had been prescribed for a sedative-hypnotic drug in the past year.

In comparison, veterans without PTSD had fewer sleep problems and were prescribed significantly fewer sedative-hypnotic drugs.

The prevalence of sleep problems was similar in men and women with PTSD, although women had significantly higher rates of sedative-hypnotic prescriptions than men (40.4% vs. 35%, P = .006). A similar gender difference in prescription rates was seen in individuals without PTSD.

The study found that, although there was only a weak association between the severity of PTSD symptoms at baseline and the frequency of sleep problems at follow-up, there was a stronger association in reverse. Veterans with a higher frequency of sleep problems at baseline showed a significant increase in PTSD symptoms at follow-up.

The authors commented that this was in line with previous studies finding a similar effect of sleep disturbance on PTSD severity, both in military personnel and civilians.

“From a neurobiological perspective, it has been proposed that chronic sleep loss can lead to emotional dysregulation or heightened autonomic arousal, which in turn may be a risk factor for PTSD in trauma-exposed individuals,” they wrote. “It has also been proposed that prior sleep disturbance may attenuate the effects of extinction learning, leading to more enduring or severe symptoms in trauma-exposed individuals with concomitant sleep disorders.”

Given this association, the authors called for more attention to be given to identifying, diagnosing, and treating sleep disorders in veterans with and without PTSD.

The authors noted that they did not have access to polysomnographic data for participants, and were also unable to assess the prevalence, frequency, or intensity of nightmares in the cohort.

The study was supported by the Department of Defense. Conflict of interest disclosures were unavailable.

SOURCE: Rosen RC et al. J Trauma Stress. 2020;32:936-45.

Insomnia is a common problem for veterans with PTSD, and the frequency of sleep problems is associated with increasing severity of PTSD, according to a study published in of the Journal of Traumatic Stress.

Raymond C. Rosen, PhD, of the New England Research Institutes, Watertown, Mass., and coauthors wrote that exploration of the relationship between PTSD and insomnia is complicated by the fact that it can be difficult to separate out disturbed sleep from other elements of PTSD, and because of the presence of other comorbidities in veterans, such as depression and traumatic brain injury.

The cohort study involved 1,643 veterans – roughly equal numbers of women and men – of Iraq and Afghanistan. Around two-thirds of the cohort had a diagnosis of PTSD. The participants completed a self-administered survey online or by mail, and were also assessed in a telephone interview, then followed up within 2-4 years.

While the prevalence of sleep problems was high across the cohort, the study found that 74% of participants with PTSD at baseline said they had experienced sleep difficulties for at least half of the previous 30 days, and one-third had been prescribed for a sedative-hypnotic drug in the past year.

In comparison, veterans without PTSD had fewer sleep problems and were prescribed significantly fewer sedative-hypnotic drugs.

The prevalence of sleep problems was similar in men and women with PTSD, although women had significantly higher rates of sedative-hypnotic prescriptions than men (40.4% vs. 35%, P = .006). A similar gender difference in prescription rates was seen in individuals without PTSD.

The study found that, although there was only a weak association between the severity of PTSD symptoms at baseline and the frequency of sleep problems at follow-up, there was a stronger association in reverse. Veterans with a higher frequency of sleep problems at baseline showed a significant increase in PTSD symptoms at follow-up.

The authors commented that this was in line with previous studies finding a similar effect of sleep disturbance on PTSD severity, both in military personnel and civilians.

“From a neurobiological perspective, it has been proposed that chronic sleep loss can lead to emotional dysregulation or heightened autonomic arousal, which in turn may be a risk factor for PTSD in trauma-exposed individuals,” they wrote. “It has also been proposed that prior sleep disturbance may attenuate the effects of extinction learning, leading to more enduring or severe symptoms in trauma-exposed individuals with concomitant sleep disorders.”

Given this association, the authors called for more attention to be given to identifying, diagnosing, and treating sleep disorders in veterans with and without PTSD.

The authors noted that they did not have access to polysomnographic data for participants, and were also unable to assess the prevalence, frequency, or intensity of nightmares in the cohort.

The study was supported by the Department of Defense. Conflict of interest disclosures were unavailable.

SOURCE: Rosen RC et al. J Trauma Stress. 2020;32:936-45.

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FROM THE JOURNAL OF TRAUMATIC STRESS

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Alan Alda, Scripps Research join forces to improve science communication

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Tue, 01/21/2020 - 13:01

– The first time that legendary actor Alan Alda conducted an interview for “Scientific American Frontiers” on PBS, an award-winning series that ran for more than a decade, he remembers learning a lesson in humility.

Doug Brunk/MDedge News
From left, actor Alan Alda, Dr. Laura Lindenfeld, executive director of the Alan Alda Center for Communicating Science, and Dr. Peter Schultz, president and CEO of Scripps Research.

“I wasn’t as smart as I thought I was,” he told a crowd of largely scientists and medical professionals who gathered in a small auditorium on the campus of Scripps Research on Jan. 16, 2020. “I didn’t realize the value of ignorance. I have a natural supply of it. I began to use it and say [to interviewees]: ‘I don’t understand what that means.’ Sometimes it would be basic physics and they’d look at me like I was a school child. I am a very curious person. What I discovered was, I was bringing out their humanity by my own curiosity, by the way I related to them, which I developed through studying improvisation as an actor, and relating as an actor to other actors.”

Mr. Alda, 83, appeared on the research campus to announce that Scripps Research is the new West Coast home of Alda Communication Training, which will work in tandem with the Alan Alda Center for Communicating Science at the State University of New York at Stony Brook, a nonprofit organization that Mr. Alda helped found in 2009.
 

Immersive training experience

“This will be a center where people can come to get training in effective communication,” said Mr. Alda, who is the winner of six Emmy Awards and six Golden Globe awards. “It’s an experiential kind of training. We don’t give tips. We don’t give lectures. We put you through exercises that are fun and actually make you laugh, but turn you into a better communicator, so you’re better able to connect to the people you’re talking to.”

To date, the Alan Alda Center for Communicating Science has trained more than 15,000 scientific leaders in the United States and other countries. The location at Scripps Research makes it more convenient for West Coast–based researchers and industry leaders to participate. “One of the things we wished, for years, we had was a place where we could train scientists and researchers and medical professionals all up and down the West Coast,” he said.

Recently, more than 30 of Scripps Research scientists participated in Mr. Alda’s training program, an immersive and engaging experience that helps participants learn to empathize with an audience and present their work in a way that connects with different stakeholders. The skills and strategies can help participants relate to prospective investors and philanthropists, government officials, members of the media, peers across scientific disciplines, and the general public.

Earlier in the day that he spoke on the Scripps campus, Mr. Alda encountered some of the Scripps researchers who had participated in that training. “One group of scientists came in and we shook hands,” he said. “They introduced themselves and said: ‘We’re working on infectious diseases.’ I said: ‘Oh my God; I just shook hands with you!’ No matter what I asked them, they had a clear way to express what they did. Then I realized they had studied with Alda Communications.”
 

 

 

Why communication matters

During the early stages of forming what became the Alan Alda Center for Communicating Science, one Nobel Prize winner at a major university dismissed the importance of improving the communication skills of young scientists. “He said to me: ‘We don’t have time for that; we have too much science to teach,’ ” said Mr. Alda, who played Army surgeon “Hawkeye” Pierce on the TV series “M*A*S*H”. “But communication is the essence of science. How can you do science unless you communicate with other scientists? There’s a stereotype that scientists are not as good at communicating as other people are. It’s true that they often speak a language that a lot of us don’t understand, but we all speak a language that is hard for other people to understand if we know something in great depth. We want to tell all the details; we want to speak in our special language because it makes us feel good.”

He underscored the importance of scientists being able to effectively communicate with the general public, “because the public needs to understand how important science is to their lives. It matters because at a place like [Scripps Research], understanding how nature works is put to work to keep our health secure.” Members of the public, he continued, “are busy living their lives; they’re busy working and bringing up their children. They haven’t spent 20, 30, 40 years devoted to a single aspect of nature the way scientists have. We can’t expect them to know as much as professional scientists, so we have to help them understand it. I hope we find ways to increase curiosity. I don’t know how to do that. I wish somebody would do a study on it, how you can take someone with a modicum of curiosity and help them enlarge it so it gives them the pleasure of discovering things about nature or understanding things about nature that other people don’t discover. Curiosity is the key to staying alive. That would bring us to a point of more people understanding science.”

Cultivating a sense of responsibility is another key to effective communication. “It’s the job of the person leading the discussion to make clear to the person listening,” Mr. Alda said. “You get the impression that ‘this person is my responsibility. I have to take care of them, so they understand what’s going on.’ ”
 

Parkinson’s disease diagnosis

During a question-and-answer session, Mr. Alda opened up about his Parkinson’s disease, which he said was diagnosed about 5 years ago. In 2018, he decided to speak publicly about his diagnosis for the first time.

“The reason was that I wanted to communicate to people who had recently been diagnosed not to believe or give into the stereotype that when you get a diagnosis, your life is over,” said Mr. Alda, who received the Public Welfare Medal from the National Academy of Sciences in 2016. “Under the burden of that belief, some people won’t tell their family or workplace colleagues. There are exercises you can do and medications you can take to prolong the time it takes before Parkinson’s gets much more serious. It’s not to diminish the fact that it can get really bad; but to think that your life is over as soon as you get a diagnosis is wrong.”

He added: “I’ve gone 5 years and I’m almost busier than I’ve ever been. I’m getting a lot accomplished and I look forward to I don’t know how many years. As long as I have them, I’m going to be grateful. It’s amazing how great it feels not to keep the diagnosis a secret.”

The first 2-day training session at Scripps Research will be held in June 2020. Additional sessions are scheduled to take place in October and December. Registration is available at aldacommunicationtraining.com/workshops.

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– The first time that legendary actor Alan Alda conducted an interview for “Scientific American Frontiers” on PBS, an award-winning series that ran for more than a decade, he remembers learning a lesson in humility.

Doug Brunk/MDedge News
From left, actor Alan Alda, Dr. Laura Lindenfeld, executive director of the Alan Alda Center for Communicating Science, and Dr. Peter Schultz, president and CEO of Scripps Research.

“I wasn’t as smart as I thought I was,” he told a crowd of largely scientists and medical professionals who gathered in a small auditorium on the campus of Scripps Research on Jan. 16, 2020. “I didn’t realize the value of ignorance. I have a natural supply of it. I began to use it and say [to interviewees]: ‘I don’t understand what that means.’ Sometimes it would be basic physics and they’d look at me like I was a school child. I am a very curious person. What I discovered was, I was bringing out their humanity by my own curiosity, by the way I related to them, which I developed through studying improvisation as an actor, and relating as an actor to other actors.”

Mr. Alda, 83, appeared on the research campus to announce that Scripps Research is the new West Coast home of Alda Communication Training, which will work in tandem with the Alan Alda Center for Communicating Science at the State University of New York at Stony Brook, a nonprofit organization that Mr. Alda helped found in 2009.
 

Immersive training experience

“This will be a center where people can come to get training in effective communication,” said Mr. Alda, who is the winner of six Emmy Awards and six Golden Globe awards. “It’s an experiential kind of training. We don’t give tips. We don’t give lectures. We put you through exercises that are fun and actually make you laugh, but turn you into a better communicator, so you’re better able to connect to the people you’re talking to.”

To date, the Alan Alda Center for Communicating Science has trained more than 15,000 scientific leaders in the United States and other countries. The location at Scripps Research makes it more convenient for West Coast–based researchers and industry leaders to participate. “One of the things we wished, for years, we had was a place where we could train scientists and researchers and medical professionals all up and down the West Coast,” he said.

Recently, more than 30 of Scripps Research scientists participated in Mr. Alda’s training program, an immersive and engaging experience that helps participants learn to empathize with an audience and present their work in a way that connects with different stakeholders. The skills and strategies can help participants relate to prospective investors and philanthropists, government officials, members of the media, peers across scientific disciplines, and the general public.

Earlier in the day that he spoke on the Scripps campus, Mr. Alda encountered some of the Scripps researchers who had participated in that training. “One group of scientists came in and we shook hands,” he said. “They introduced themselves and said: ‘We’re working on infectious diseases.’ I said: ‘Oh my God; I just shook hands with you!’ No matter what I asked them, they had a clear way to express what they did. Then I realized they had studied with Alda Communications.”
 

 

 

Why communication matters

During the early stages of forming what became the Alan Alda Center for Communicating Science, one Nobel Prize winner at a major university dismissed the importance of improving the communication skills of young scientists. “He said to me: ‘We don’t have time for that; we have too much science to teach,’ ” said Mr. Alda, who played Army surgeon “Hawkeye” Pierce on the TV series “M*A*S*H”. “But communication is the essence of science. How can you do science unless you communicate with other scientists? There’s a stereotype that scientists are not as good at communicating as other people are. It’s true that they often speak a language that a lot of us don’t understand, but we all speak a language that is hard for other people to understand if we know something in great depth. We want to tell all the details; we want to speak in our special language because it makes us feel good.”

He underscored the importance of scientists being able to effectively communicate with the general public, “because the public needs to understand how important science is to their lives. It matters because at a place like [Scripps Research], understanding how nature works is put to work to keep our health secure.” Members of the public, he continued, “are busy living their lives; they’re busy working and bringing up their children. They haven’t spent 20, 30, 40 years devoted to a single aspect of nature the way scientists have. We can’t expect them to know as much as professional scientists, so we have to help them understand it. I hope we find ways to increase curiosity. I don’t know how to do that. I wish somebody would do a study on it, how you can take someone with a modicum of curiosity and help them enlarge it so it gives them the pleasure of discovering things about nature or understanding things about nature that other people don’t discover. Curiosity is the key to staying alive. That would bring us to a point of more people understanding science.”

Cultivating a sense of responsibility is another key to effective communication. “It’s the job of the person leading the discussion to make clear to the person listening,” Mr. Alda said. “You get the impression that ‘this person is my responsibility. I have to take care of them, so they understand what’s going on.’ ”
 

Parkinson’s disease diagnosis

During a question-and-answer session, Mr. Alda opened up about his Parkinson’s disease, which he said was diagnosed about 5 years ago. In 2018, he decided to speak publicly about his diagnosis for the first time.

“The reason was that I wanted to communicate to people who had recently been diagnosed not to believe or give into the stereotype that when you get a diagnosis, your life is over,” said Mr. Alda, who received the Public Welfare Medal from the National Academy of Sciences in 2016. “Under the burden of that belief, some people won’t tell their family or workplace colleagues. There are exercises you can do and medications you can take to prolong the time it takes before Parkinson’s gets much more serious. It’s not to diminish the fact that it can get really bad; but to think that your life is over as soon as you get a diagnosis is wrong.”

He added: “I’ve gone 5 years and I’m almost busier than I’ve ever been. I’m getting a lot accomplished and I look forward to I don’t know how many years. As long as I have them, I’m going to be grateful. It’s amazing how great it feels not to keep the diagnosis a secret.”

The first 2-day training session at Scripps Research will be held in June 2020. Additional sessions are scheduled to take place in October and December. Registration is available at aldacommunicationtraining.com/workshops.

– The first time that legendary actor Alan Alda conducted an interview for “Scientific American Frontiers” on PBS, an award-winning series that ran for more than a decade, he remembers learning a lesson in humility.

Doug Brunk/MDedge News
From left, actor Alan Alda, Dr. Laura Lindenfeld, executive director of the Alan Alda Center for Communicating Science, and Dr. Peter Schultz, president and CEO of Scripps Research.

“I wasn’t as smart as I thought I was,” he told a crowd of largely scientists and medical professionals who gathered in a small auditorium on the campus of Scripps Research on Jan. 16, 2020. “I didn’t realize the value of ignorance. I have a natural supply of it. I began to use it and say [to interviewees]: ‘I don’t understand what that means.’ Sometimes it would be basic physics and they’d look at me like I was a school child. I am a very curious person. What I discovered was, I was bringing out their humanity by my own curiosity, by the way I related to them, which I developed through studying improvisation as an actor, and relating as an actor to other actors.”

Mr. Alda, 83, appeared on the research campus to announce that Scripps Research is the new West Coast home of Alda Communication Training, which will work in tandem with the Alan Alda Center for Communicating Science at the State University of New York at Stony Brook, a nonprofit organization that Mr. Alda helped found in 2009.
 

Immersive training experience

“This will be a center where people can come to get training in effective communication,” said Mr. Alda, who is the winner of six Emmy Awards and six Golden Globe awards. “It’s an experiential kind of training. We don’t give tips. We don’t give lectures. We put you through exercises that are fun and actually make you laugh, but turn you into a better communicator, so you’re better able to connect to the people you’re talking to.”

To date, the Alan Alda Center for Communicating Science has trained more than 15,000 scientific leaders in the United States and other countries. The location at Scripps Research makes it more convenient for West Coast–based researchers and industry leaders to participate. “One of the things we wished, for years, we had was a place where we could train scientists and researchers and medical professionals all up and down the West Coast,” he said.

Recently, more than 30 of Scripps Research scientists participated in Mr. Alda’s training program, an immersive and engaging experience that helps participants learn to empathize with an audience and present their work in a way that connects with different stakeholders. The skills and strategies can help participants relate to prospective investors and philanthropists, government officials, members of the media, peers across scientific disciplines, and the general public.

Earlier in the day that he spoke on the Scripps campus, Mr. Alda encountered some of the Scripps researchers who had participated in that training. “One group of scientists came in and we shook hands,” he said. “They introduced themselves and said: ‘We’re working on infectious diseases.’ I said: ‘Oh my God; I just shook hands with you!’ No matter what I asked them, they had a clear way to express what they did. Then I realized they had studied with Alda Communications.”
 

 

 

Why communication matters

During the early stages of forming what became the Alan Alda Center for Communicating Science, one Nobel Prize winner at a major university dismissed the importance of improving the communication skills of young scientists. “He said to me: ‘We don’t have time for that; we have too much science to teach,’ ” said Mr. Alda, who played Army surgeon “Hawkeye” Pierce on the TV series “M*A*S*H”. “But communication is the essence of science. How can you do science unless you communicate with other scientists? There’s a stereotype that scientists are not as good at communicating as other people are. It’s true that they often speak a language that a lot of us don’t understand, but we all speak a language that is hard for other people to understand if we know something in great depth. We want to tell all the details; we want to speak in our special language because it makes us feel good.”

He underscored the importance of scientists being able to effectively communicate with the general public, “because the public needs to understand how important science is to their lives. It matters because at a place like [Scripps Research], understanding how nature works is put to work to keep our health secure.” Members of the public, he continued, “are busy living their lives; they’re busy working and bringing up their children. They haven’t spent 20, 30, 40 years devoted to a single aspect of nature the way scientists have. We can’t expect them to know as much as professional scientists, so we have to help them understand it. I hope we find ways to increase curiosity. I don’t know how to do that. I wish somebody would do a study on it, how you can take someone with a modicum of curiosity and help them enlarge it so it gives them the pleasure of discovering things about nature or understanding things about nature that other people don’t discover. Curiosity is the key to staying alive. That would bring us to a point of more people understanding science.”

Cultivating a sense of responsibility is another key to effective communication. “It’s the job of the person leading the discussion to make clear to the person listening,” Mr. Alda said. “You get the impression that ‘this person is my responsibility. I have to take care of them, so they understand what’s going on.’ ”
 

Parkinson’s disease diagnosis

During a question-and-answer session, Mr. Alda opened up about his Parkinson’s disease, which he said was diagnosed about 5 years ago. In 2018, he decided to speak publicly about his diagnosis for the first time.

“The reason was that I wanted to communicate to people who had recently been diagnosed not to believe or give into the stereotype that when you get a diagnosis, your life is over,” said Mr. Alda, who received the Public Welfare Medal from the National Academy of Sciences in 2016. “Under the burden of that belief, some people won’t tell their family or workplace colleagues. There are exercises you can do and medications you can take to prolong the time it takes before Parkinson’s gets much more serious. It’s not to diminish the fact that it can get really bad; but to think that your life is over as soon as you get a diagnosis is wrong.”

He added: “I’ve gone 5 years and I’m almost busier than I’ve ever been. I’m getting a lot accomplished and I look forward to I don’t know how many years. As long as I have them, I’m going to be grateful. It’s amazing how great it feels not to keep the diagnosis a secret.”

The first 2-day training session at Scripps Research will be held in June 2020. Additional sessions are scheduled to take place in October and December. Registration is available at aldacommunicationtraining.com/workshops.

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