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Docs used permanent, not temporary stitches; lawsuits result
The first in what have come to be known as the “wrong stitches” cases has been settled, a story in The Ledger reports.
The former plaintiff in the now-settled suit is Carrie Monk, a Lakeland, Fla., resident who underwent total laparoscopic hysterectomy at Lakeland Regional Health Medical Center several years ago. (The medical center is managed by Lakeland Regional Health Systems.) D As a result, over the next 19 months, she experienced abdominal pain and constant bleeding, which in turn affected her personal life as well as her work as a nurse in the intensive care unit. She underwent follow-up surgery to have the permanent sutures removed, but two could not be identified and excised.
In July 2020, Ms. Monk filed a medical malpractice claim against Lakeland Regional Health, its medical center, and the ob-gyns who had performed her surgery. She was among the first of the women who had received the permanent sutures to do so.
On February 28, 2021, The Ledger ran a story on Ms. Monk’s suit. Less than 2 weeks later, Lakeland Regional Health sent letters to patients who had undergone “wrong stitch” surgeries, cautioning of possible postsurgical complications. The company reportedly kept secret how many letters it had sent out.
Since then, at least nine similar suits have been filed against Lakeland Regional Health, bringing the total number of such suits to 12. Four of these suits have been settled, including Ms. Monk’s. Of the remaining eight cases, several are in various pretrial stages.
Under the terms of her settlement, neither Ms. Monk nor her attorney may disclose what financial compensation or other awards she’s received. The attorney, however, referred to the settlement as “amicable.”
The content contained in this article is for informational purposes only and does not constitute legal advice. Reliance on any information provided in this article is solely at your own risk.
A version of this article first appeared on Medscape.com.
The first in what have come to be known as the “wrong stitches” cases has been settled, a story in The Ledger reports.
The former plaintiff in the now-settled suit is Carrie Monk, a Lakeland, Fla., resident who underwent total laparoscopic hysterectomy at Lakeland Regional Health Medical Center several years ago. (The medical center is managed by Lakeland Regional Health Systems.) D As a result, over the next 19 months, she experienced abdominal pain and constant bleeding, which in turn affected her personal life as well as her work as a nurse in the intensive care unit. She underwent follow-up surgery to have the permanent sutures removed, but two could not be identified and excised.
In July 2020, Ms. Monk filed a medical malpractice claim against Lakeland Regional Health, its medical center, and the ob-gyns who had performed her surgery. She was among the first of the women who had received the permanent sutures to do so.
On February 28, 2021, The Ledger ran a story on Ms. Monk’s suit. Less than 2 weeks later, Lakeland Regional Health sent letters to patients who had undergone “wrong stitch” surgeries, cautioning of possible postsurgical complications. The company reportedly kept secret how many letters it had sent out.
Since then, at least nine similar suits have been filed against Lakeland Regional Health, bringing the total number of such suits to 12. Four of these suits have been settled, including Ms. Monk’s. Of the remaining eight cases, several are in various pretrial stages.
Under the terms of her settlement, neither Ms. Monk nor her attorney may disclose what financial compensation or other awards she’s received. The attorney, however, referred to the settlement as “amicable.”
The content contained in this article is for informational purposes only and does not constitute legal advice. Reliance on any information provided in this article is solely at your own risk.
A version of this article first appeared on Medscape.com.
The first in what have come to be known as the “wrong stitches” cases has been settled, a story in The Ledger reports.
The former plaintiff in the now-settled suit is Carrie Monk, a Lakeland, Fla., resident who underwent total laparoscopic hysterectomy at Lakeland Regional Health Medical Center several years ago. (The medical center is managed by Lakeland Regional Health Systems.) D As a result, over the next 19 months, she experienced abdominal pain and constant bleeding, which in turn affected her personal life as well as her work as a nurse in the intensive care unit. She underwent follow-up surgery to have the permanent sutures removed, but two could not be identified and excised.
In July 2020, Ms. Monk filed a medical malpractice claim against Lakeland Regional Health, its medical center, and the ob-gyns who had performed her surgery. She was among the first of the women who had received the permanent sutures to do so.
On February 28, 2021, The Ledger ran a story on Ms. Monk’s suit. Less than 2 weeks later, Lakeland Regional Health sent letters to patients who had undergone “wrong stitch” surgeries, cautioning of possible postsurgical complications. The company reportedly kept secret how many letters it had sent out.
Since then, at least nine similar suits have been filed against Lakeland Regional Health, bringing the total number of such suits to 12. Four of these suits have been settled, including Ms. Monk’s. Of the remaining eight cases, several are in various pretrial stages.
Under the terms of her settlement, neither Ms. Monk nor her attorney may disclose what financial compensation or other awards she’s received. The attorney, however, referred to the settlement as “amicable.”
The content contained in this article is for informational purposes only and does not constitute legal advice. Reliance on any information provided in this article is solely at your own risk.
A version of this article first appeared on Medscape.com.
Jury decides against hospital and surgeon who died by suicide
, according to the New York Post and other news outlets.
In November 2014, New York Giants running back Michael Cox sustained severe lower-body injuries, including a broken leg and a damaged left ankle, after he was tackled in a game against the Seattle Seahawks. At the time, Cox was in the second year of a 4-year, $2.3 million contract with the Giants.
Later, he underwent treatment at New York City’s Hospital for Special Surgery (HSS), the oldest orthopedic hospital in the United States, which is consistently ranked among the best. Mr. Cox’s surgeon for the procedure was Dean Lorich, MD, then associate director of HSS’s orthopedic trauma service and chief of the same service at New York–Presbyterian Hospital, also located in New York City.
But here the story takes a grim turn.
Dr. Lorich’s surgery allegedly failed to fully repair Mr. Cox’s left ankle, which led to the player’s early retirement. In May 2016, Mr. Cox sued Dr. Lorich, HSS, and the New York–Presbyterian Healthcare System for unspecified damages. (Mr. Cox’s attorney at the time reportedly claimed that Dr. Lorich hadn’t properly treated the talus bone in the player’s ankle.) Roughly a year and a half later, in December 2017, police found Dr. Lorich unconscious and unresponsive in his Park Avenue apartment, a knife protruding from his torso. The medical examiner later ruled his death a suicide, though there was no indication of why the surgeon took his own life.
The malpractice suit against Dr. Lorich’s estate and the hospitals continued.
Last month, on September 23, a New York County Supreme Court jury reached its decision. It awarded the ex-NFL player $12 million in lost earnings, $15.5 million for future pain and suffering, and $1 million for past pain and suffering.
“The jury spoke with a clear and unambiguous voice that Mr. Cox received inadequate medical care and treatment and was significantly injured as a result,” announced Jordan Merson, Mr. Cox’s attorney. “We are pleased with the jury’s decision.”
But an attorney for the hospital and the Lorich estate has called the jury verdict “inconsistent with the evidence in the case.” The defendants will appeal the verdict, he says.
A version of this article first appeared on Medscape.com.
The content contained in this article is for informational purposes only and does not constitute legal advice. Reliance on any information provided in this article is solely at your own risk.
, according to the New York Post and other news outlets.
In November 2014, New York Giants running back Michael Cox sustained severe lower-body injuries, including a broken leg and a damaged left ankle, after he was tackled in a game against the Seattle Seahawks. At the time, Cox was in the second year of a 4-year, $2.3 million contract with the Giants.
Later, he underwent treatment at New York City’s Hospital for Special Surgery (HSS), the oldest orthopedic hospital in the United States, which is consistently ranked among the best. Mr. Cox’s surgeon for the procedure was Dean Lorich, MD, then associate director of HSS’s orthopedic trauma service and chief of the same service at New York–Presbyterian Hospital, also located in New York City.
But here the story takes a grim turn.
Dr. Lorich’s surgery allegedly failed to fully repair Mr. Cox’s left ankle, which led to the player’s early retirement. In May 2016, Mr. Cox sued Dr. Lorich, HSS, and the New York–Presbyterian Healthcare System for unspecified damages. (Mr. Cox’s attorney at the time reportedly claimed that Dr. Lorich hadn’t properly treated the talus bone in the player’s ankle.) Roughly a year and a half later, in December 2017, police found Dr. Lorich unconscious and unresponsive in his Park Avenue apartment, a knife protruding from his torso. The medical examiner later ruled his death a suicide, though there was no indication of why the surgeon took his own life.
The malpractice suit against Dr. Lorich’s estate and the hospitals continued.
Last month, on September 23, a New York County Supreme Court jury reached its decision. It awarded the ex-NFL player $12 million in lost earnings, $15.5 million for future pain and suffering, and $1 million for past pain and suffering.
“The jury spoke with a clear and unambiguous voice that Mr. Cox received inadequate medical care and treatment and was significantly injured as a result,” announced Jordan Merson, Mr. Cox’s attorney. “We are pleased with the jury’s decision.”
But an attorney for the hospital and the Lorich estate has called the jury verdict “inconsistent with the evidence in the case.” The defendants will appeal the verdict, he says.
A version of this article first appeared on Medscape.com.
The content contained in this article is for informational purposes only and does not constitute legal advice. Reliance on any information provided in this article is solely at your own risk.
, according to the New York Post and other news outlets.
In November 2014, New York Giants running back Michael Cox sustained severe lower-body injuries, including a broken leg and a damaged left ankle, after he was tackled in a game against the Seattle Seahawks. At the time, Cox was in the second year of a 4-year, $2.3 million contract with the Giants.
Later, he underwent treatment at New York City’s Hospital for Special Surgery (HSS), the oldest orthopedic hospital in the United States, which is consistently ranked among the best. Mr. Cox’s surgeon for the procedure was Dean Lorich, MD, then associate director of HSS’s orthopedic trauma service and chief of the same service at New York–Presbyterian Hospital, also located in New York City.
But here the story takes a grim turn.
Dr. Lorich’s surgery allegedly failed to fully repair Mr. Cox’s left ankle, which led to the player’s early retirement. In May 2016, Mr. Cox sued Dr. Lorich, HSS, and the New York–Presbyterian Healthcare System for unspecified damages. (Mr. Cox’s attorney at the time reportedly claimed that Dr. Lorich hadn’t properly treated the talus bone in the player’s ankle.) Roughly a year and a half later, in December 2017, police found Dr. Lorich unconscious and unresponsive in his Park Avenue apartment, a knife protruding from his torso. The medical examiner later ruled his death a suicide, though there was no indication of why the surgeon took his own life.
The malpractice suit against Dr. Lorich’s estate and the hospitals continued.
Last month, on September 23, a New York County Supreme Court jury reached its decision. It awarded the ex-NFL player $12 million in lost earnings, $15.5 million for future pain and suffering, and $1 million for past pain and suffering.
“The jury spoke with a clear and unambiguous voice that Mr. Cox received inadequate medical care and treatment and was significantly injured as a result,” announced Jordan Merson, Mr. Cox’s attorney. “We are pleased with the jury’s decision.”
But an attorney for the hospital and the Lorich estate has called the jury verdict “inconsistent with the evidence in the case.” The defendants will appeal the verdict, he says.
A version of this article first appeared on Medscape.com.
The content contained in this article is for informational purposes only and does not constitute legal advice. Reliance on any information provided in this article is solely at your own risk.
Rules for performing research with children
The road to hell is paved with good intentions – especially true in clinical research. A Food and Drug Administration press release notes, “Historically, children were not included in clinical trials because of a misperception that excluding them from research was in fact protecting them. This resulted in many FDA-approved, licensed, cleared, or authorized drugs, biological products, and medical devices lacking pediatric-specific labeling information.” In an effort to improve on this situation, the FDA published in September 2022 a proposed new draft guidance on performing research with children that is open for public comment for 3 months.
There is a long history of government attempts to promote research and development for the benefit of society. Sometimes government succeeds and sometimes not. For instance, when the U.S. federal government funded scientific research in the 1960s, it sought to increase the common good by promulgating those discoveries. The government insisted that all federally funded research be in the public domain. The funding produced a spectacular number of technological advancements that have enriched society. However, a decade later, the government concluded that too many good research ideas were never developed into beneficial products because without the ability to patent the results, the costs and risks of product development were not profitable for industry. By the late 1970s, new laws were enacted to enable universities and their faculty to patent the results of government-funded research and share in any wealth created.
Pharmaceutical research in the 1970s and 1980s was mostly performed on men in order to reduce the risk of giving treatments of unknown safety to pregnant women. The unintended consequence was that the new drugs frequently were less effective for women. This was particularly true for cardiac medications for which lifestyle risk factors differed between the sexes.
Similarly, children were often excluded from research because of the unknown risks of new drugs on growing bodies and brains. Children were also seen as a vulnerable population for whom informed consent was problematic. The result of these well-intentioned restrictions was the creation of new products that did not have pediatric dosing recommendations, pediatric safety assessments, or approval for pediatric indications. To remediate these deficiencies, in 1997 and 2007 the FDA offered a 6-month extension on patent protection as motivation for companies to develop those pediatric recommendations. Alas, those laws were primarily used to extend the profitability of blockbuster products rather than truly benefit children.
Over the past 4 decades, pediatric ethicists proposed and refined rules to govern research on children. The Common Rule used by institutional review boards (IRBs) to protect human research subjects was expanded with guidelines covering children. The new draft guidance is the latest iteration of this effort. Nothing in the 14 pages of draft regulation appears revolutionary to me. The ideas are tweaks, based on theory and experience, of principles agreed upon 30 years ago. Finding the optimal social moral contract involves some empirical assessment of praxis and effectiveness.
I am loathe to summarize this new document, which itself is a summary of a vast body of literature, that supports the Code of Federal Regulations Title 21 Part 50 and 45 CFR Part 46. The draft document is well organized and I recommend it as an excellent primer for the area of pediatric research ethics if the subject is new to you. I also recommend it as required reading for anyone serving on an IRB.
IRBs usually review and approve any research on people. Generally, the selection of people for research should be done equitably. However, children should not be enrolled unless it is necessary to answer an important question relevant to children. For the past 2 decades, there has been an emphasis on obtaining the assent of the child as well as informed consent by the parents.
An important determination is whether the research is likely to help that particular child or whether it is aimed at advancing general knowledge. If there is no prospect of direct benefit, research is still permissible but more restricted for safety and comfort reasons. Next is determining whether the research carries only minimal risk or a minor increase over minimal risk. The draft defines and provides anchor examples of these situations. For instance, oral placebos and single blood draws are typically minimal risk. Multiple injections and blood draws over a year fall into the second category. One MRI is minimal risk but a minor increase in risk if it involves sedation or contrast.
I strongly support the ideals expressed in these guidelines. They represent the best blend of intentions and practical experience. They will become the law of the land. In ethics, there is merit in striving to do things properly, orderly, and enforceably.
The cynic in me sees two weaknesses in the stated approach. First, the volume of harm to children occurring during organized clinical research is extremely small. The greater harms come from off-label use, nonsystematic research, and the ignorance resulting from a lack of research. Second, my observation in all endeavors of morality is, “Raise the bar high enough and people walk under it.”
Dr. Powell is a retired pediatric hospitalist and clinical ethics consultant living in St. Louis. Email him at [email protected].
The road to hell is paved with good intentions – especially true in clinical research. A Food and Drug Administration press release notes, “Historically, children were not included in clinical trials because of a misperception that excluding them from research was in fact protecting them. This resulted in many FDA-approved, licensed, cleared, or authorized drugs, biological products, and medical devices lacking pediatric-specific labeling information.” In an effort to improve on this situation, the FDA published in September 2022 a proposed new draft guidance on performing research with children that is open for public comment for 3 months.
There is a long history of government attempts to promote research and development for the benefit of society. Sometimes government succeeds and sometimes not. For instance, when the U.S. federal government funded scientific research in the 1960s, it sought to increase the common good by promulgating those discoveries. The government insisted that all federally funded research be in the public domain. The funding produced a spectacular number of technological advancements that have enriched society. However, a decade later, the government concluded that too many good research ideas were never developed into beneficial products because without the ability to patent the results, the costs and risks of product development were not profitable for industry. By the late 1970s, new laws were enacted to enable universities and their faculty to patent the results of government-funded research and share in any wealth created.
Pharmaceutical research in the 1970s and 1980s was mostly performed on men in order to reduce the risk of giving treatments of unknown safety to pregnant women. The unintended consequence was that the new drugs frequently were less effective for women. This was particularly true for cardiac medications for which lifestyle risk factors differed between the sexes.
Similarly, children were often excluded from research because of the unknown risks of new drugs on growing bodies and brains. Children were also seen as a vulnerable population for whom informed consent was problematic. The result of these well-intentioned restrictions was the creation of new products that did not have pediatric dosing recommendations, pediatric safety assessments, or approval for pediatric indications. To remediate these deficiencies, in 1997 and 2007 the FDA offered a 6-month extension on patent protection as motivation for companies to develop those pediatric recommendations. Alas, those laws were primarily used to extend the profitability of blockbuster products rather than truly benefit children.
Over the past 4 decades, pediatric ethicists proposed and refined rules to govern research on children. The Common Rule used by institutional review boards (IRBs) to protect human research subjects was expanded with guidelines covering children. The new draft guidance is the latest iteration of this effort. Nothing in the 14 pages of draft regulation appears revolutionary to me. The ideas are tweaks, based on theory and experience, of principles agreed upon 30 years ago. Finding the optimal social moral contract involves some empirical assessment of praxis and effectiveness.
I am loathe to summarize this new document, which itself is a summary of a vast body of literature, that supports the Code of Federal Regulations Title 21 Part 50 and 45 CFR Part 46. The draft document is well organized and I recommend it as an excellent primer for the area of pediatric research ethics if the subject is new to you. I also recommend it as required reading for anyone serving on an IRB.
IRBs usually review and approve any research on people. Generally, the selection of people for research should be done equitably. However, children should not be enrolled unless it is necessary to answer an important question relevant to children. For the past 2 decades, there has been an emphasis on obtaining the assent of the child as well as informed consent by the parents.
An important determination is whether the research is likely to help that particular child or whether it is aimed at advancing general knowledge. If there is no prospect of direct benefit, research is still permissible but more restricted for safety and comfort reasons. Next is determining whether the research carries only minimal risk or a minor increase over minimal risk. The draft defines and provides anchor examples of these situations. For instance, oral placebos and single blood draws are typically minimal risk. Multiple injections and blood draws over a year fall into the second category. One MRI is minimal risk but a minor increase in risk if it involves sedation or contrast.
I strongly support the ideals expressed in these guidelines. They represent the best blend of intentions and practical experience. They will become the law of the land. In ethics, there is merit in striving to do things properly, orderly, and enforceably.
The cynic in me sees two weaknesses in the stated approach. First, the volume of harm to children occurring during organized clinical research is extremely small. The greater harms come from off-label use, nonsystematic research, and the ignorance resulting from a lack of research. Second, my observation in all endeavors of morality is, “Raise the bar high enough and people walk under it.”
Dr. Powell is a retired pediatric hospitalist and clinical ethics consultant living in St. Louis. Email him at [email protected].
The road to hell is paved with good intentions – especially true in clinical research. A Food and Drug Administration press release notes, “Historically, children were not included in clinical trials because of a misperception that excluding them from research was in fact protecting them. This resulted in many FDA-approved, licensed, cleared, or authorized drugs, biological products, and medical devices lacking pediatric-specific labeling information.” In an effort to improve on this situation, the FDA published in September 2022 a proposed new draft guidance on performing research with children that is open for public comment for 3 months.
There is a long history of government attempts to promote research and development for the benefit of society. Sometimes government succeeds and sometimes not. For instance, when the U.S. federal government funded scientific research in the 1960s, it sought to increase the common good by promulgating those discoveries. The government insisted that all federally funded research be in the public domain. The funding produced a spectacular number of technological advancements that have enriched society. However, a decade later, the government concluded that too many good research ideas were never developed into beneficial products because without the ability to patent the results, the costs and risks of product development were not profitable for industry. By the late 1970s, new laws were enacted to enable universities and their faculty to patent the results of government-funded research and share in any wealth created.
Pharmaceutical research in the 1970s and 1980s was mostly performed on men in order to reduce the risk of giving treatments of unknown safety to pregnant women. The unintended consequence was that the new drugs frequently were less effective for women. This was particularly true for cardiac medications for which lifestyle risk factors differed between the sexes.
Similarly, children were often excluded from research because of the unknown risks of new drugs on growing bodies and brains. Children were also seen as a vulnerable population for whom informed consent was problematic. The result of these well-intentioned restrictions was the creation of new products that did not have pediatric dosing recommendations, pediatric safety assessments, or approval for pediatric indications. To remediate these deficiencies, in 1997 and 2007 the FDA offered a 6-month extension on patent protection as motivation for companies to develop those pediatric recommendations. Alas, those laws were primarily used to extend the profitability of blockbuster products rather than truly benefit children.
Over the past 4 decades, pediatric ethicists proposed and refined rules to govern research on children. The Common Rule used by institutional review boards (IRBs) to protect human research subjects was expanded with guidelines covering children. The new draft guidance is the latest iteration of this effort. Nothing in the 14 pages of draft regulation appears revolutionary to me. The ideas are tweaks, based on theory and experience, of principles agreed upon 30 years ago. Finding the optimal social moral contract involves some empirical assessment of praxis and effectiveness.
I am loathe to summarize this new document, which itself is a summary of a vast body of literature, that supports the Code of Federal Regulations Title 21 Part 50 and 45 CFR Part 46. The draft document is well organized and I recommend it as an excellent primer for the area of pediatric research ethics if the subject is new to you. I also recommend it as required reading for anyone serving on an IRB.
IRBs usually review and approve any research on people. Generally, the selection of people for research should be done equitably. However, children should not be enrolled unless it is necessary to answer an important question relevant to children. For the past 2 decades, there has been an emphasis on obtaining the assent of the child as well as informed consent by the parents.
An important determination is whether the research is likely to help that particular child or whether it is aimed at advancing general knowledge. If there is no prospect of direct benefit, research is still permissible but more restricted for safety and comfort reasons. Next is determining whether the research carries only minimal risk or a minor increase over minimal risk. The draft defines and provides anchor examples of these situations. For instance, oral placebos and single blood draws are typically minimal risk. Multiple injections and blood draws over a year fall into the second category. One MRI is minimal risk but a minor increase in risk if it involves sedation or contrast.
I strongly support the ideals expressed in these guidelines. They represent the best blend of intentions and practical experience. They will become the law of the land. In ethics, there is merit in striving to do things properly, orderly, and enforceably.
The cynic in me sees two weaknesses in the stated approach. First, the volume of harm to children occurring during organized clinical research is extremely small. The greater harms come from off-label use, nonsystematic research, and the ignorance resulting from a lack of research. Second, my observation in all endeavors of morality is, “Raise the bar high enough and people walk under it.”
Dr. Powell is a retired pediatric hospitalist and clinical ethics consultant living in St. Louis. Email him at [email protected].
How to remain apolitical with patients
It is assumed that psychiatrists in general, but particularly in academia, are progressive liberals. There is evidence to support this idea, with a survey finding that more than three-quarters of U.S. psychiatrists are registered Democrats.1
Other corroborating factors to our field’s progressive tendency include the publication of pseudo-political books like “The Dangerous Case of Donald Trump: 27 Psychiatrists and Mental Health Experts Assess a President” – without a well-known equivalent on the other side.
Additionally, psychiatry has in the recent past, rightfully spent significant effort examining the disproportional trauma faced by patients with underprivileged backgrounds, which is often seen as a political position. The American Psychiatric Association has itself taken a stance on the national debate about abortion to warn against the psychiatric consequences of the Dobbs v. Jackson Supreme Court decision despite the clear political statement it makes.
We understand a likely rationale for psychiatry’s liberal tendency. Most psychiatrists support political objectives that provide resources for the treatment of the severely mentally ill. In general, the psychosocial consequences of mental illness place a downward economic pressure on our patients that leads to poverty and its associated traumas that then tend to feedback to worsen the severity of the illness itself. It is thus natural for psychiatry to promote political causes such as progressivism that focus on the needs of economically and socially struggling communities. If one posits a natural role for psychiatry in promoting the interests of patients, then it is a short leap to psychiatry promoting the political causes of the underprivileged, often in the form of endorsing the Democratic party.
As a result, a proportion of patients come into psychiatric treatment with expectations that their providers will negatively judge them and possibly punish their conservative beliefs or Republican political affiliation. Herein lies a question – “Is psychiatry willing to make 46.9% of Americans uncomfortable?” How should psychiatry address the 46.9% of Americans who voted Republican during the 2020 presidential election? In our desire to support the disadvantaged, how political are we willing to get and at what cost? While we cannot speak for the field as a whole, it is our concern that a vast percentage of Americans feel alienated from talking to us, which is particularly problematic in a field based on mutual trust and understanding.
This problem may be particularly palpable to us, as we are psychiatrists in a large metropolitan area of California who often treat specialty populations like veterans and law enforcement. In one study, law enforcement officers were found to be twice as likely to be Republicans as civilians.2 Michael McHale, the president of the National Association of Police Organizations, spoke at the 2020 Republican Party’s national convention as documented in an article titled “Union leader tells Republican convention why cops back Trump.”3 Similarly, about 60% of veterans identify as Republicans.4
Within the first few sessions, when patients are most vulnerable and sensitive to the perception of being judged, we commonly get asked questions to test our political beliefs. Some patients will display clothing that suggests a political affiliation; those wardrobe arrangements are, at times, an attempt at testing our knowledge of their in-group. While a bright-red cap with a reminder to keep the United States “great” in capital letters may be an overt invitation to address the topic, other patients may have a small symbol of a rattlesnake to test our ability to recognize the “Don’t Tread on Me” Gadsden flag.
Alternatively, other patients will ask our opinion, or bring up news topics, to share their concerns and/or examine our response and reactions. We remember, in particular, a patient who subtly asked if they needed to be vaccinated to attend therapy visits in person as a leading statement into their conservative political beliefs. It is a reminder that many patients fear how we will judge them or where we will draw the line – “Is there something I, the patient, can say that will make him dislike me?”
While the concept of making all patients comfortable may feel abstract or trivial to some, the consequences can be very real. We remember a patient with severe depression and occasional suicidality, who required many months of treatment for him to reveal that he owned a gun. His conservative beliefs made him very resistant to discuss gun ownership with someone who is presumably liberal and has the power to restrict such ownership. However, after a frank discussion that our concerns about his gun were not constitutional or political but medical, the patient agreed to relinquish his gun, at least temporarily, a likely more important intervention than many in psychiatry.
The ramifications are also wider than most imagine. In California, a particularly liberal state, many consistently and reliably liberal patients have some conservative beliefs. Those beliefs are often closeted: a Democratic mother who doesn’t think her 3-year-old daughter should wear a mask in school; a Democratic woman who questioned the veracity of Amber Heard during the Johnny Depp defamation trial and feels guilty about her prior dedication to the #MeToo movement.
Patients may feel torn about those beliefs and may be apprehensive to discuss them despite a nagging need to express or examine them in a place without judgment.
that we attempted to highlight in this article. In particular, a vast proportion of Americans may feel alienated from treatment or may refuse to divulge clinically relevant information, and a large number of patients may enter psychiatric treatment with concerns that they will be judged.
Psychiatry is founded on the honest exchange of thoughts and feelings between patients and providers without the fear of harsh judgment and intellectual retaliation. Psychiatrists would be wise to consider those factors and their repercussions when choosing to take political positions and setting a frame of care with their patients.
Dr. Lehman is a professor of psychiatry at the University of California, San Diego. He is codirector of all acute and intensive psychiatric treatment at the Veterans Affairs Medical Center in San Diego, where he practices clinical psychiatry. He has no conflicts of interest. Dr. Badre is a clinical and forensic psychiatrist in San Diego. He holds teaching positions at the University of California, San Diego, and the University of San Diego. He teaches medical education, psychopharmacology, ethics in psychiatry, and correctional care. Dr. Badre can be reached at his website, BadreMD.com. He has no conflicts of interest.
References
1. Sanger-Katz M. Your surgeon is probably a Republican, your psychiatrist probably a Democrat. New York Times. 2016 Oct 6.
2. Ba B et al. Who are the police? Descriptive representation in the coercive arm of government. 2022 Mar 21.
3. Rainey J. Union leader tells Republican convention why cops back Trump. Los Angeles Times. 2020 Aug 26.
4. Igielnik R et al. Trump draws stronger support from veterans than from the public on leadership of U.S. military. Pew Research Center. 2019 July 10.
It is assumed that psychiatrists in general, but particularly in academia, are progressive liberals. There is evidence to support this idea, with a survey finding that more than three-quarters of U.S. psychiatrists are registered Democrats.1
Other corroborating factors to our field’s progressive tendency include the publication of pseudo-political books like “The Dangerous Case of Donald Trump: 27 Psychiatrists and Mental Health Experts Assess a President” – without a well-known equivalent on the other side.
Additionally, psychiatry has in the recent past, rightfully spent significant effort examining the disproportional trauma faced by patients with underprivileged backgrounds, which is often seen as a political position. The American Psychiatric Association has itself taken a stance on the national debate about abortion to warn against the psychiatric consequences of the Dobbs v. Jackson Supreme Court decision despite the clear political statement it makes.
We understand a likely rationale for psychiatry’s liberal tendency. Most psychiatrists support political objectives that provide resources for the treatment of the severely mentally ill. In general, the psychosocial consequences of mental illness place a downward economic pressure on our patients that leads to poverty and its associated traumas that then tend to feedback to worsen the severity of the illness itself. It is thus natural for psychiatry to promote political causes such as progressivism that focus on the needs of economically and socially struggling communities. If one posits a natural role for psychiatry in promoting the interests of patients, then it is a short leap to psychiatry promoting the political causes of the underprivileged, often in the form of endorsing the Democratic party.
As a result, a proportion of patients come into psychiatric treatment with expectations that their providers will negatively judge them and possibly punish their conservative beliefs or Republican political affiliation. Herein lies a question – “Is psychiatry willing to make 46.9% of Americans uncomfortable?” How should psychiatry address the 46.9% of Americans who voted Republican during the 2020 presidential election? In our desire to support the disadvantaged, how political are we willing to get and at what cost? While we cannot speak for the field as a whole, it is our concern that a vast percentage of Americans feel alienated from talking to us, which is particularly problematic in a field based on mutual trust and understanding.
This problem may be particularly palpable to us, as we are psychiatrists in a large metropolitan area of California who often treat specialty populations like veterans and law enforcement. In one study, law enforcement officers were found to be twice as likely to be Republicans as civilians.2 Michael McHale, the president of the National Association of Police Organizations, spoke at the 2020 Republican Party’s national convention as documented in an article titled “Union leader tells Republican convention why cops back Trump.”3 Similarly, about 60% of veterans identify as Republicans.4
Within the first few sessions, when patients are most vulnerable and sensitive to the perception of being judged, we commonly get asked questions to test our political beliefs. Some patients will display clothing that suggests a political affiliation; those wardrobe arrangements are, at times, an attempt at testing our knowledge of their in-group. While a bright-red cap with a reminder to keep the United States “great” in capital letters may be an overt invitation to address the topic, other patients may have a small symbol of a rattlesnake to test our ability to recognize the “Don’t Tread on Me” Gadsden flag.
Alternatively, other patients will ask our opinion, or bring up news topics, to share their concerns and/or examine our response and reactions. We remember, in particular, a patient who subtly asked if they needed to be vaccinated to attend therapy visits in person as a leading statement into their conservative political beliefs. It is a reminder that many patients fear how we will judge them or where we will draw the line – “Is there something I, the patient, can say that will make him dislike me?”
While the concept of making all patients comfortable may feel abstract or trivial to some, the consequences can be very real. We remember a patient with severe depression and occasional suicidality, who required many months of treatment for him to reveal that he owned a gun. His conservative beliefs made him very resistant to discuss gun ownership with someone who is presumably liberal and has the power to restrict such ownership. However, after a frank discussion that our concerns about his gun were not constitutional or political but medical, the patient agreed to relinquish his gun, at least temporarily, a likely more important intervention than many in psychiatry.
The ramifications are also wider than most imagine. In California, a particularly liberal state, many consistently and reliably liberal patients have some conservative beliefs. Those beliefs are often closeted: a Democratic mother who doesn’t think her 3-year-old daughter should wear a mask in school; a Democratic woman who questioned the veracity of Amber Heard during the Johnny Depp defamation trial and feels guilty about her prior dedication to the #MeToo movement.
Patients may feel torn about those beliefs and may be apprehensive to discuss them despite a nagging need to express or examine them in a place without judgment.
that we attempted to highlight in this article. In particular, a vast proportion of Americans may feel alienated from treatment or may refuse to divulge clinically relevant information, and a large number of patients may enter psychiatric treatment with concerns that they will be judged.
Psychiatry is founded on the honest exchange of thoughts and feelings between patients and providers without the fear of harsh judgment and intellectual retaliation. Psychiatrists would be wise to consider those factors and their repercussions when choosing to take political positions and setting a frame of care with their patients.
Dr. Lehman is a professor of psychiatry at the University of California, San Diego. He is codirector of all acute and intensive psychiatric treatment at the Veterans Affairs Medical Center in San Diego, where he practices clinical psychiatry. He has no conflicts of interest. Dr. Badre is a clinical and forensic psychiatrist in San Diego. He holds teaching positions at the University of California, San Diego, and the University of San Diego. He teaches medical education, psychopharmacology, ethics in psychiatry, and correctional care. Dr. Badre can be reached at his website, BadreMD.com. He has no conflicts of interest.
References
1. Sanger-Katz M. Your surgeon is probably a Republican, your psychiatrist probably a Democrat. New York Times. 2016 Oct 6.
2. Ba B et al. Who are the police? Descriptive representation in the coercive arm of government. 2022 Mar 21.
3. Rainey J. Union leader tells Republican convention why cops back Trump. Los Angeles Times. 2020 Aug 26.
4. Igielnik R et al. Trump draws stronger support from veterans than from the public on leadership of U.S. military. Pew Research Center. 2019 July 10.
It is assumed that psychiatrists in general, but particularly in academia, are progressive liberals. There is evidence to support this idea, with a survey finding that more than three-quarters of U.S. psychiatrists are registered Democrats.1
Other corroborating factors to our field’s progressive tendency include the publication of pseudo-political books like “The Dangerous Case of Donald Trump: 27 Psychiatrists and Mental Health Experts Assess a President” – without a well-known equivalent on the other side.
Additionally, psychiatry has in the recent past, rightfully spent significant effort examining the disproportional trauma faced by patients with underprivileged backgrounds, which is often seen as a political position. The American Psychiatric Association has itself taken a stance on the national debate about abortion to warn against the psychiatric consequences of the Dobbs v. Jackson Supreme Court decision despite the clear political statement it makes.
We understand a likely rationale for psychiatry’s liberal tendency. Most psychiatrists support political objectives that provide resources for the treatment of the severely mentally ill. In general, the psychosocial consequences of mental illness place a downward economic pressure on our patients that leads to poverty and its associated traumas that then tend to feedback to worsen the severity of the illness itself. It is thus natural for psychiatry to promote political causes such as progressivism that focus on the needs of economically and socially struggling communities. If one posits a natural role for psychiatry in promoting the interests of patients, then it is a short leap to psychiatry promoting the political causes of the underprivileged, often in the form of endorsing the Democratic party.
As a result, a proportion of patients come into psychiatric treatment with expectations that their providers will negatively judge them and possibly punish their conservative beliefs or Republican political affiliation. Herein lies a question – “Is psychiatry willing to make 46.9% of Americans uncomfortable?” How should psychiatry address the 46.9% of Americans who voted Republican during the 2020 presidential election? In our desire to support the disadvantaged, how political are we willing to get and at what cost? While we cannot speak for the field as a whole, it is our concern that a vast percentage of Americans feel alienated from talking to us, which is particularly problematic in a field based on mutual trust and understanding.
This problem may be particularly palpable to us, as we are psychiatrists in a large metropolitan area of California who often treat specialty populations like veterans and law enforcement. In one study, law enforcement officers were found to be twice as likely to be Republicans as civilians.2 Michael McHale, the president of the National Association of Police Organizations, spoke at the 2020 Republican Party’s national convention as documented in an article titled “Union leader tells Republican convention why cops back Trump.”3 Similarly, about 60% of veterans identify as Republicans.4
Within the first few sessions, when patients are most vulnerable and sensitive to the perception of being judged, we commonly get asked questions to test our political beliefs. Some patients will display clothing that suggests a political affiliation; those wardrobe arrangements are, at times, an attempt at testing our knowledge of their in-group. While a bright-red cap with a reminder to keep the United States “great” in capital letters may be an overt invitation to address the topic, other patients may have a small symbol of a rattlesnake to test our ability to recognize the “Don’t Tread on Me” Gadsden flag.
Alternatively, other patients will ask our opinion, or bring up news topics, to share their concerns and/or examine our response and reactions. We remember, in particular, a patient who subtly asked if they needed to be vaccinated to attend therapy visits in person as a leading statement into their conservative political beliefs. It is a reminder that many patients fear how we will judge them or where we will draw the line – “Is there something I, the patient, can say that will make him dislike me?”
While the concept of making all patients comfortable may feel abstract or trivial to some, the consequences can be very real. We remember a patient with severe depression and occasional suicidality, who required many months of treatment for him to reveal that he owned a gun. His conservative beliefs made him very resistant to discuss gun ownership with someone who is presumably liberal and has the power to restrict such ownership. However, after a frank discussion that our concerns about his gun were not constitutional or political but medical, the patient agreed to relinquish his gun, at least temporarily, a likely more important intervention than many in psychiatry.
The ramifications are also wider than most imagine. In California, a particularly liberal state, many consistently and reliably liberal patients have some conservative beliefs. Those beliefs are often closeted: a Democratic mother who doesn’t think her 3-year-old daughter should wear a mask in school; a Democratic woman who questioned the veracity of Amber Heard during the Johnny Depp defamation trial and feels guilty about her prior dedication to the #MeToo movement.
Patients may feel torn about those beliefs and may be apprehensive to discuss them despite a nagging need to express or examine them in a place without judgment.
that we attempted to highlight in this article. In particular, a vast proportion of Americans may feel alienated from treatment or may refuse to divulge clinically relevant information, and a large number of patients may enter psychiatric treatment with concerns that they will be judged.
Psychiatry is founded on the honest exchange of thoughts and feelings between patients and providers without the fear of harsh judgment and intellectual retaliation. Psychiatrists would be wise to consider those factors and their repercussions when choosing to take political positions and setting a frame of care with their patients.
Dr. Lehman is a professor of psychiatry at the University of California, San Diego. He is codirector of all acute and intensive psychiatric treatment at the Veterans Affairs Medical Center in San Diego, where he practices clinical psychiatry. He has no conflicts of interest. Dr. Badre is a clinical and forensic psychiatrist in San Diego. He holds teaching positions at the University of California, San Diego, and the University of San Diego. He teaches medical education, psychopharmacology, ethics in psychiatry, and correctional care. Dr. Badre can be reached at his website, BadreMD.com. He has no conflicts of interest.
References
1. Sanger-Katz M. Your surgeon is probably a Republican, your psychiatrist probably a Democrat. New York Times. 2016 Oct 6.
2. Ba B et al. Who are the police? Descriptive representation in the coercive arm of government. 2022 Mar 21.
3. Rainey J. Union leader tells Republican convention why cops back Trump. Los Angeles Times. 2020 Aug 26.
4. Igielnik R et al. Trump draws stronger support from veterans than from the public on leadership of U.S. military. Pew Research Center. 2019 July 10.
FDA panel recommends withdrawal of Makena for preterm birth
A federal advisory panel recommended the United States withdraw from the market an injection given to women at risk for giving birth prematurely. Many of its members argued this step is needed to allow further testing to see if this drug actually works.
The Food and Drug Administration has been seeking to pull the approval of hydroxyprogesterone caproate (17P) injection (Makena, Covis) since 2020, after the drug failed to show a benefit in the PROLONG study. This study was meant as a confirmatory trial for the accelerated approval the FDA granted Makena in 2011 based on promising results from an earlier small study, known as the Meis trial. The manufacturer, Covis, contends that the flaws in the PROLONG study made Makena appear ineffective.
The FDA asked its Obstetrics, Reproductive and Urologic Drugs Advisory Committee to review the evidence gathered to date on Makena at a hearing that ran from Oct. 17 to Oct. 19. At the conclusion, the FDA asked the committee to vote on whether the agency should allow Makena to remain on the market while an appropriate confirmatory study is designed and conducted.
The vote was 14-1 against this plan.
There needs to be another study as a “tiebreaker” to determine which of the previous Makena trials was correct, said FDA panelist Michael K. Lindsay, MD, MPH, who is also director of the division of maternal-fetal medicine for Grady and Emory University Hospital Midtown, Atlanta.
“I think there needs to be another trial,” Dr. Lindsay said. “If you can do the trial without the medication being FDA approved, then I am supportive of that.”
Members of the FDA panel noted the difficulties that would ensue if Covis attempted further study of Makena with the drug still approved, including difficulties in recruiting patients. Indeed, there were delays in recruiting patients for the PROLONG trial in part because Makena was perceived as the standard of care for pregnant women who had a prior spontaneous preterm birth. That led to efforts to enroll patients outside of the United States, particularly in Eastern European countries.
Panelist Cassandra E. Henderson, MD, of the New York-based Garden OB/GYN practice, was the dissenter in the 14-1 vote.
Withdrawing the approval of Makena may lead to increased use of pharmacy-compounded versions of this medicine, as women look for options to try to extend their pregnancies, she said.
“They may seek it in other ways and get something that we don’t have any control over, and we don’t know what the fetus may be exposed to,” Dr. Henderson said.
Dr. Henderson also said there should be greater discussion with patients about questions of potential “intergenerational risk” because of fetal exposure to the medicine. Covis could add a registry similar to the University of Chicago’s DES Program to its research program for Makena, she said.
Race-based argument
Covis has been fighting to keep the Makena approval by offering theories for why the PROLONG study failed to show a benefit for the drug.
Covis emphasizes the different racial make-up of patients in the two trials. Black women composed 59% of the Meis study population, compared with only 6.7% for the PROLONG study, Covis said in its briefing document for the hearing. The Luxembourg-based company also says that there may have been unreliable estimates of the gestational age in the PROLONG trial, which enrolled many subjects in Ukraine and Russia.
During deliberations among panelists on Oct. 19, Dr. Henderson emphasized a need to consider other factors that may have been involved and encouraged continued study of the drug in Black women. She dismissed the idea of a race-based difference being the explanation for the difference between the two trials, but instead stressed that race serves as a marker for inequities, which are known to increase risk for preterm birth.
“Targeting a population that is at risk, particularly Black women in the United States, may show something that would be beneficial” from Makena, Dr. Henderson said.
Other physicians have argued that this approach would actually put Black women and children at greater risk of an ineffective drug with potential side effects.
“The drug is not proven to work so keeping it on the market to be injected into Black women to see what subgroups it might work in essentially amounts to experimentation,” said Adam Urato, MD, chief of maternal-fetal medicine at MetroWest Medical Center in Framingham, Mass., during the public comment session of the hearing.
The vote marks the second time that the FDA’s advisers on reproductive health have told the agency that the evidence gathered on the drug does not support its use. An advisory committee also cast votes against the drug at a 2019 meeting.
The rate of preterm birth in Black women in 2020 was 14.4%, significantly higher than the rate of preterm birth in White or Hispanic women, 9.1% and 9.8%, respectively, according to the Centers for Disease Control and Prevention. The potential for harm to children from premature birth led the FDA to clear Makena through the accelerated approval pathway, said Patrizia Cavazzoni, MD, the director of FDA’s Center for Drug Evaluation and Research, in the opening session of the hearing.
“We once thought Makena was likely to be part of the answer to that problem,” Dr. Cavazzoni said. “Unfortunately we no longer do, based on the evidence available.”
A federal advisory panel recommended the United States withdraw from the market an injection given to women at risk for giving birth prematurely. Many of its members argued this step is needed to allow further testing to see if this drug actually works.
The Food and Drug Administration has been seeking to pull the approval of hydroxyprogesterone caproate (17P) injection (Makena, Covis) since 2020, after the drug failed to show a benefit in the PROLONG study. This study was meant as a confirmatory trial for the accelerated approval the FDA granted Makena in 2011 based on promising results from an earlier small study, known as the Meis trial. The manufacturer, Covis, contends that the flaws in the PROLONG study made Makena appear ineffective.
The FDA asked its Obstetrics, Reproductive and Urologic Drugs Advisory Committee to review the evidence gathered to date on Makena at a hearing that ran from Oct. 17 to Oct. 19. At the conclusion, the FDA asked the committee to vote on whether the agency should allow Makena to remain on the market while an appropriate confirmatory study is designed and conducted.
The vote was 14-1 against this plan.
There needs to be another study as a “tiebreaker” to determine which of the previous Makena trials was correct, said FDA panelist Michael K. Lindsay, MD, MPH, who is also director of the division of maternal-fetal medicine for Grady and Emory University Hospital Midtown, Atlanta.
“I think there needs to be another trial,” Dr. Lindsay said. “If you can do the trial without the medication being FDA approved, then I am supportive of that.”
Members of the FDA panel noted the difficulties that would ensue if Covis attempted further study of Makena with the drug still approved, including difficulties in recruiting patients. Indeed, there were delays in recruiting patients for the PROLONG trial in part because Makena was perceived as the standard of care for pregnant women who had a prior spontaneous preterm birth. That led to efforts to enroll patients outside of the United States, particularly in Eastern European countries.
Panelist Cassandra E. Henderson, MD, of the New York-based Garden OB/GYN practice, was the dissenter in the 14-1 vote.
Withdrawing the approval of Makena may lead to increased use of pharmacy-compounded versions of this medicine, as women look for options to try to extend their pregnancies, she said.
“They may seek it in other ways and get something that we don’t have any control over, and we don’t know what the fetus may be exposed to,” Dr. Henderson said.
Dr. Henderson also said there should be greater discussion with patients about questions of potential “intergenerational risk” because of fetal exposure to the medicine. Covis could add a registry similar to the University of Chicago’s DES Program to its research program for Makena, she said.
Race-based argument
Covis has been fighting to keep the Makena approval by offering theories for why the PROLONG study failed to show a benefit for the drug.
Covis emphasizes the different racial make-up of patients in the two trials. Black women composed 59% of the Meis study population, compared with only 6.7% for the PROLONG study, Covis said in its briefing document for the hearing. The Luxembourg-based company also says that there may have been unreliable estimates of the gestational age in the PROLONG trial, which enrolled many subjects in Ukraine and Russia.
During deliberations among panelists on Oct. 19, Dr. Henderson emphasized a need to consider other factors that may have been involved and encouraged continued study of the drug in Black women. She dismissed the idea of a race-based difference being the explanation for the difference between the two trials, but instead stressed that race serves as a marker for inequities, which are known to increase risk for preterm birth.
“Targeting a population that is at risk, particularly Black women in the United States, may show something that would be beneficial” from Makena, Dr. Henderson said.
Other physicians have argued that this approach would actually put Black women and children at greater risk of an ineffective drug with potential side effects.
“The drug is not proven to work so keeping it on the market to be injected into Black women to see what subgroups it might work in essentially amounts to experimentation,” said Adam Urato, MD, chief of maternal-fetal medicine at MetroWest Medical Center in Framingham, Mass., during the public comment session of the hearing.
The vote marks the second time that the FDA’s advisers on reproductive health have told the agency that the evidence gathered on the drug does not support its use. An advisory committee also cast votes against the drug at a 2019 meeting.
The rate of preterm birth in Black women in 2020 was 14.4%, significantly higher than the rate of preterm birth in White or Hispanic women, 9.1% and 9.8%, respectively, according to the Centers for Disease Control and Prevention. The potential for harm to children from premature birth led the FDA to clear Makena through the accelerated approval pathway, said Patrizia Cavazzoni, MD, the director of FDA’s Center for Drug Evaluation and Research, in the opening session of the hearing.
“We once thought Makena was likely to be part of the answer to that problem,” Dr. Cavazzoni said. “Unfortunately we no longer do, based on the evidence available.”
A federal advisory panel recommended the United States withdraw from the market an injection given to women at risk for giving birth prematurely. Many of its members argued this step is needed to allow further testing to see if this drug actually works.
The Food and Drug Administration has been seeking to pull the approval of hydroxyprogesterone caproate (17P) injection (Makena, Covis) since 2020, after the drug failed to show a benefit in the PROLONG study. This study was meant as a confirmatory trial for the accelerated approval the FDA granted Makena in 2011 based on promising results from an earlier small study, known as the Meis trial. The manufacturer, Covis, contends that the flaws in the PROLONG study made Makena appear ineffective.
The FDA asked its Obstetrics, Reproductive and Urologic Drugs Advisory Committee to review the evidence gathered to date on Makena at a hearing that ran from Oct. 17 to Oct. 19. At the conclusion, the FDA asked the committee to vote on whether the agency should allow Makena to remain on the market while an appropriate confirmatory study is designed and conducted.
The vote was 14-1 against this plan.
There needs to be another study as a “tiebreaker” to determine which of the previous Makena trials was correct, said FDA panelist Michael K. Lindsay, MD, MPH, who is also director of the division of maternal-fetal medicine for Grady and Emory University Hospital Midtown, Atlanta.
“I think there needs to be another trial,” Dr. Lindsay said. “If you can do the trial without the medication being FDA approved, then I am supportive of that.”
Members of the FDA panel noted the difficulties that would ensue if Covis attempted further study of Makena with the drug still approved, including difficulties in recruiting patients. Indeed, there were delays in recruiting patients for the PROLONG trial in part because Makena was perceived as the standard of care for pregnant women who had a prior spontaneous preterm birth. That led to efforts to enroll patients outside of the United States, particularly in Eastern European countries.
Panelist Cassandra E. Henderson, MD, of the New York-based Garden OB/GYN practice, was the dissenter in the 14-1 vote.
Withdrawing the approval of Makena may lead to increased use of pharmacy-compounded versions of this medicine, as women look for options to try to extend their pregnancies, she said.
“They may seek it in other ways and get something that we don’t have any control over, and we don’t know what the fetus may be exposed to,” Dr. Henderson said.
Dr. Henderson also said there should be greater discussion with patients about questions of potential “intergenerational risk” because of fetal exposure to the medicine. Covis could add a registry similar to the University of Chicago’s DES Program to its research program for Makena, she said.
Race-based argument
Covis has been fighting to keep the Makena approval by offering theories for why the PROLONG study failed to show a benefit for the drug.
Covis emphasizes the different racial make-up of patients in the two trials. Black women composed 59% of the Meis study population, compared with only 6.7% for the PROLONG study, Covis said in its briefing document for the hearing. The Luxembourg-based company also says that there may have been unreliable estimates of the gestational age in the PROLONG trial, which enrolled many subjects in Ukraine and Russia.
During deliberations among panelists on Oct. 19, Dr. Henderson emphasized a need to consider other factors that may have been involved and encouraged continued study of the drug in Black women. She dismissed the idea of a race-based difference being the explanation for the difference between the two trials, but instead stressed that race serves as a marker for inequities, which are known to increase risk for preterm birth.
“Targeting a population that is at risk, particularly Black women in the United States, may show something that would be beneficial” from Makena, Dr. Henderson said.
Other physicians have argued that this approach would actually put Black women and children at greater risk of an ineffective drug with potential side effects.
“The drug is not proven to work so keeping it on the market to be injected into Black women to see what subgroups it might work in essentially amounts to experimentation,” said Adam Urato, MD, chief of maternal-fetal medicine at MetroWest Medical Center in Framingham, Mass., during the public comment session of the hearing.
The vote marks the second time that the FDA’s advisers on reproductive health have told the agency that the evidence gathered on the drug does not support its use. An advisory committee also cast votes against the drug at a 2019 meeting.
The rate of preterm birth in Black women in 2020 was 14.4%, significantly higher than the rate of preterm birth in White or Hispanic women, 9.1% and 9.8%, respectively, according to the Centers for Disease Control and Prevention. The potential for harm to children from premature birth led the FDA to clear Makena through the accelerated approval pathway, said Patrizia Cavazzoni, MD, the director of FDA’s Center for Drug Evaluation and Research, in the opening session of the hearing.
“We once thought Makena was likely to be part of the answer to that problem,” Dr. Cavazzoni said. “Unfortunately we no longer do, based on the evidence available.”
IM residents rate cardiology low on work-life balance
Both male and female internal medicine (IM) residents prioritized work-life balance, such as stable working hours and family friendliness, when considering career choices, and cardiology was perceived to fall short in this area, an updated survey revealed.
Originally conducted in 2010, the survey aimed to understand IM residents’ professional development preferences and perceptions of cardiology as a specialty. That survey demonstrated a discordance between what residents valued in making a career choice and their perceptions of a career in cardiology.
The discordance remained in 2020, with residents even more likely than their predecessors to report negative perceptions of cardiology.
Compared with residents surveyed in 2010, respondents in 2020 placed higher value on all aspects of work-life balance and of having role models who demonstrated a successful balance. The value change was particularly notable for men.
“While our survey does not elucidate why this is, speculation could be made that this value on work-life balance is generational and prominent in the youngest generations entering all professional fields, not just medicine,” lead author Meghan York, MD, of Beth Israel Deaconess Medical Center, Harvard Medical School, Boston, told this news organization.
“There is also an interesting trend that dual-career couples are on the rise in the U.S.,” she said. “This may reflect that trend, [with] men in medical fields possibly taking on more domestic responsibility and requiring more work flexibility to do that.”
Regarding perceptions, she added, cardiology tends to show resident cardiologists who are working in inpatient services with “ballooning and unpredictable hours,” rather than those who are working in more time-controlled clinics. Therefore, “their prime exposure to physicians is not truly representative of the career.” The study was published online in JAMA Cardiology.
‘Lack of diversity’
The updated surveys were sent by various means to close to 30,000 residents, and were completed by 840 (mean age, 29; 50% male; 55% White). Cardiology was a favored subspecialty choice among men, with 46.5% reporting they were considering it vs. 29.7% of women. Women were more likely to report never having considered cardiology as a career choice (37.6%) compared with men (22.3%).
The survey incorporated a 5-point Likert scale of 1 (not important) to 5 (extremely important) for some of the questions.
The most important professional development preferences for respondents were positive role models (4.56), stimulating career (3.81), family friendly (3.78), patient focus (3.70), stable work hours (3.66), female or race friendly (3.33), professional challenges (3.21), and financial benefits (3.20).
The cardiology perception statements with the highest agreement were:
- Interferes with family life during training (3.93).
- Having met positive role models or having positive views of cardiovascular disease as a topic (3.85).
- Reasonable compensation (3.69).
- Adverse job conditions (3.16).
- Field lacks diversity (2.90).
Compared with the 2010 survey, the 2020 findings indicated increased importance on work-life balance components for both male and female residents, with a greater change among males.
In addition, 2020 respondents were more likely than their predecessors to report negative perceptions of cardiology, such as too much overnight or weekend call, challenging to have children during fellowship, and lack of diversity.
“The culture of the subspecialty of cardiology has not improved to become significantly more diverse or inclusive, whereas other specialties and subspecialties have, and residents interact with cardiologists frequently and can see that,” Dr. York noted.
“As women now make up greater than 50% of medical students,” she said, “it is reasonable to focus on women in medical school and residency to bring them into the field of cardiology. But as racial and ethnic minority groups are also massively underrepresented in medical school, recruitment into medicine needs to start much earlier, in high school and college.
“Creating and supporting rotations that embed residents in the outpatient cardiology setting and exposure to more longitudinal experiences will provide a more realistic picture of the career,” she concluded.
ACC ‘at the forefront’
“Work-life balance looks different for each and every individual, but there are some themes that we need to think about,” Lisa Rose-Jones, MD, chair of the American College of Cardiology’s Program Directors and Graduate Medical Educators Section, said in her comments on the study. “The ACC is really at the forefront of this. They are putting together different work groups to focus on ‘how can we have some innovations?’ ”
The ACC is seeking mentors as part of its workforce diversity efforts among African American/Black, Hispanic/LatinX and Women’s IM cardiology programs, she noted. Furthermore, on Oct. 13, the organization released its 2022 health policy statement on career flexibility in cardiology, which calls for more leeway for cardiologists to deal with common life events without jeopardizing their careers.
Dr. Rose-Jones, director of the training program in cardiovascular disease at the University of North Carolina at Chapel Hill, said that because both male and female residents placed a high value on work-life balance, “we’ve got to think about how we can have flexibility in our work hours. That is critically important. Health systems need to be able to accommodate working families that may need to alter traditional 9 to 5 work hours to meet the demands of being a successful cardiologist and also being a parent.”
In addition, she said, “We need to have very clear policies at every institution on gender-related and parent-related discrimination. Data show that many female trainees are still being questioned on their family planning. That is absolutely not appropriate. It is none of our business. While we continue to do that, we continue to create stigma in our field.”
Like Dr. York, she noted generational differences in the doctors who are coming up now. “They’ve seen burnout firsthand and want to have a well-balanced life that includes medicine, but also life outside of the hospital,” Dr. Rose-Jones said. “So, those of us in cardiology really need to look deep inside and make changes. We need to be thoughtful about how we can be innovative.”
No commercial funding or conflicts of interest were declared.
A version of this article first appeared on Medscape.com.
Both male and female internal medicine (IM) residents prioritized work-life balance, such as stable working hours and family friendliness, when considering career choices, and cardiology was perceived to fall short in this area, an updated survey revealed.
Originally conducted in 2010, the survey aimed to understand IM residents’ professional development preferences and perceptions of cardiology as a specialty. That survey demonstrated a discordance between what residents valued in making a career choice and their perceptions of a career in cardiology.
The discordance remained in 2020, with residents even more likely than their predecessors to report negative perceptions of cardiology.
Compared with residents surveyed in 2010, respondents in 2020 placed higher value on all aspects of work-life balance and of having role models who demonstrated a successful balance. The value change was particularly notable for men.
“While our survey does not elucidate why this is, speculation could be made that this value on work-life balance is generational and prominent in the youngest generations entering all professional fields, not just medicine,” lead author Meghan York, MD, of Beth Israel Deaconess Medical Center, Harvard Medical School, Boston, told this news organization.
“There is also an interesting trend that dual-career couples are on the rise in the U.S.,” she said. “This may reflect that trend, [with] men in medical fields possibly taking on more domestic responsibility and requiring more work flexibility to do that.”
Regarding perceptions, she added, cardiology tends to show resident cardiologists who are working in inpatient services with “ballooning and unpredictable hours,” rather than those who are working in more time-controlled clinics. Therefore, “their prime exposure to physicians is not truly representative of the career.” The study was published online in JAMA Cardiology.
‘Lack of diversity’
The updated surveys were sent by various means to close to 30,000 residents, and were completed by 840 (mean age, 29; 50% male; 55% White). Cardiology was a favored subspecialty choice among men, with 46.5% reporting they were considering it vs. 29.7% of women. Women were more likely to report never having considered cardiology as a career choice (37.6%) compared with men (22.3%).
The survey incorporated a 5-point Likert scale of 1 (not important) to 5 (extremely important) for some of the questions.
The most important professional development preferences for respondents were positive role models (4.56), stimulating career (3.81), family friendly (3.78), patient focus (3.70), stable work hours (3.66), female or race friendly (3.33), professional challenges (3.21), and financial benefits (3.20).
The cardiology perception statements with the highest agreement were:
- Interferes with family life during training (3.93).
- Having met positive role models or having positive views of cardiovascular disease as a topic (3.85).
- Reasonable compensation (3.69).
- Adverse job conditions (3.16).
- Field lacks diversity (2.90).
Compared with the 2010 survey, the 2020 findings indicated increased importance on work-life balance components for both male and female residents, with a greater change among males.
In addition, 2020 respondents were more likely than their predecessors to report negative perceptions of cardiology, such as too much overnight or weekend call, challenging to have children during fellowship, and lack of diversity.
“The culture of the subspecialty of cardiology has not improved to become significantly more diverse or inclusive, whereas other specialties and subspecialties have, and residents interact with cardiologists frequently and can see that,” Dr. York noted.
“As women now make up greater than 50% of medical students,” she said, “it is reasonable to focus on women in medical school and residency to bring them into the field of cardiology. But as racial and ethnic minority groups are also massively underrepresented in medical school, recruitment into medicine needs to start much earlier, in high school and college.
“Creating and supporting rotations that embed residents in the outpatient cardiology setting and exposure to more longitudinal experiences will provide a more realistic picture of the career,” she concluded.
ACC ‘at the forefront’
“Work-life balance looks different for each and every individual, but there are some themes that we need to think about,” Lisa Rose-Jones, MD, chair of the American College of Cardiology’s Program Directors and Graduate Medical Educators Section, said in her comments on the study. “The ACC is really at the forefront of this. They are putting together different work groups to focus on ‘how can we have some innovations?’ ”
The ACC is seeking mentors as part of its workforce diversity efforts among African American/Black, Hispanic/LatinX and Women’s IM cardiology programs, she noted. Furthermore, on Oct. 13, the organization released its 2022 health policy statement on career flexibility in cardiology, which calls for more leeway for cardiologists to deal with common life events without jeopardizing their careers.
Dr. Rose-Jones, director of the training program in cardiovascular disease at the University of North Carolina at Chapel Hill, said that because both male and female residents placed a high value on work-life balance, “we’ve got to think about how we can have flexibility in our work hours. That is critically important. Health systems need to be able to accommodate working families that may need to alter traditional 9 to 5 work hours to meet the demands of being a successful cardiologist and also being a parent.”
In addition, she said, “We need to have very clear policies at every institution on gender-related and parent-related discrimination. Data show that many female trainees are still being questioned on their family planning. That is absolutely not appropriate. It is none of our business. While we continue to do that, we continue to create stigma in our field.”
Like Dr. York, she noted generational differences in the doctors who are coming up now. “They’ve seen burnout firsthand and want to have a well-balanced life that includes medicine, but also life outside of the hospital,” Dr. Rose-Jones said. “So, those of us in cardiology really need to look deep inside and make changes. We need to be thoughtful about how we can be innovative.”
No commercial funding or conflicts of interest were declared.
A version of this article first appeared on Medscape.com.
Both male and female internal medicine (IM) residents prioritized work-life balance, such as stable working hours and family friendliness, when considering career choices, and cardiology was perceived to fall short in this area, an updated survey revealed.
Originally conducted in 2010, the survey aimed to understand IM residents’ professional development preferences and perceptions of cardiology as a specialty. That survey demonstrated a discordance between what residents valued in making a career choice and their perceptions of a career in cardiology.
The discordance remained in 2020, with residents even more likely than their predecessors to report negative perceptions of cardiology.
Compared with residents surveyed in 2010, respondents in 2020 placed higher value on all aspects of work-life balance and of having role models who demonstrated a successful balance. The value change was particularly notable for men.
“While our survey does not elucidate why this is, speculation could be made that this value on work-life balance is generational and prominent in the youngest generations entering all professional fields, not just medicine,” lead author Meghan York, MD, of Beth Israel Deaconess Medical Center, Harvard Medical School, Boston, told this news organization.
“There is also an interesting trend that dual-career couples are on the rise in the U.S.,” she said. “This may reflect that trend, [with] men in medical fields possibly taking on more domestic responsibility and requiring more work flexibility to do that.”
Regarding perceptions, she added, cardiology tends to show resident cardiologists who are working in inpatient services with “ballooning and unpredictable hours,” rather than those who are working in more time-controlled clinics. Therefore, “their prime exposure to physicians is not truly representative of the career.” The study was published online in JAMA Cardiology.
‘Lack of diversity’
The updated surveys were sent by various means to close to 30,000 residents, and were completed by 840 (mean age, 29; 50% male; 55% White). Cardiology was a favored subspecialty choice among men, with 46.5% reporting they were considering it vs. 29.7% of women. Women were more likely to report never having considered cardiology as a career choice (37.6%) compared with men (22.3%).
The survey incorporated a 5-point Likert scale of 1 (not important) to 5 (extremely important) for some of the questions.
The most important professional development preferences for respondents were positive role models (4.56), stimulating career (3.81), family friendly (3.78), patient focus (3.70), stable work hours (3.66), female or race friendly (3.33), professional challenges (3.21), and financial benefits (3.20).
The cardiology perception statements with the highest agreement were:
- Interferes with family life during training (3.93).
- Having met positive role models or having positive views of cardiovascular disease as a topic (3.85).
- Reasonable compensation (3.69).
- Adverse job conditions (3.16).
- Field lacks diversity (2.90).
Compared with the 2010 survey, the 2020 findings indicated increased importance on work-life balance components for both male and female residents, with a greater change among males.
In addition, 2020 respondents were more likely than their predecessors to report negative perceptions of cardiology, such as too much overnight or weekend call, challenging to have children during fellowship, and lack of diversity.
“The culture of the subspecialty of cardiology has not improved to become significantly more diverse or inclusive, whereas other specialties and subspecialties have, and residents interact with cardiologists frequently and can see that,” Dr. York noted.
“As women now make up greater than 50% of medical students,” she said, “it is reasonable to focus on women in medical school and residency to bring them into the field of cardiology. But as racial and ethnic minority groups are also massively underrepresented in medical school, recruitment into medicine needs to start much earlier, in high school and college.
“Creating and supporting rotations that embed residents in the outpatient cardiology setting and exposure to more longitudinal experiences will provide a more realistic picture of the career,” she concluded.
ACC ‘at the forefront’
“Work-life balance looks different for each and every individual, but there are some themes that we need to think about,” Lisa Rose-Jones, MD, chair of the American College of Cardiology’s Program Directors and Graduate Medical Educators Section, said in her comments on the study. “The ACC is really at the forefront of this. They are putting together different work groups to focus on ‘how can we have some innovations?’ ”
The ACC is seeking mentors as part of its workforce diversity efforts among African American/Black, Hispanic/LatinX and Women’s IM cardiology programs, she noted. Furthermore, on Oct. 13, the organization released its 2022 health policy statement on career flexibility in cardiology, which calls for more leeway for cardiologists to deal with common life events without jeopardizing their careers.
Dr. Rose-Jones, director of the training program in cardiovascular disease at the University of North Carolina at Chapel Hill, said that because both male and female residents placed a high value on work-life balance, “we’ve got to think about how we can have flexibility in our work hours. That is critically important. Health systems need to be able to accommodate working families that may need to alter traditional 9 to 5 work hours to meet the demands of being a successful cardiologist and also being a parent.”
In addition, she said, “We need to have very clear policies at every institution on gender-related and parent-related discrimination. Data show that many female trainees are still being questioned on their family planning. That is absolutely not appropriate. It is none of our business. While we continue to do that, we continue to create stigma in our field.”
Like Dr. York, she noted generational differences in the doctors who are coming up now. “They’ve seen burnout firsthand and want to have a well-balanced life that includes medicine, but also life outside of the hospital,” Dr. Rose-Jones said. “So, those of us in cardiology really need to look deep inside and make changes. We need to be thoughtful about how we can be innovative.”
No commercial funding or conflicts of interest were declared.
A version of this article first appeared on Medscape.com.
FROM JAMA CARDIOLOGY
Rapid point-of-care test could help avoid inappropriate antibiotic prescribing
The fingerstick test, FebriDx, works by detecting myxovirus resistance protein A, which the body generates in response to viral infections, and C-reactive protein (CRP), which is associated with systemic bacterial or viral infection.
In a study of 520 adults and children with symptoms of acute respiratory illness who were treated in outpatient settings, the test correctly classified bacterial infections 93.2% of the time (95% confidence interval [CI], 84.9-97.0). The negative predictive value (NPV), or probability that a person with a negative test result was truly free of a bacterial infection, was 98.7% (95% CI, 96.9-99.4).
The findings of the study, which was sponsored by the test’s manufacturer, were published in JAMA Network Open).
The ability to rule out a bacterial cause “may provide clinicians with reassurance to withhold antibiotics when supported by the clinical assessment,” the researchers wrote.
They added that the ability to identify infections that may benefit from antibiotics and confidently rule out those that will not “is essential to optimizing clinical management and addressing global antimicrobial resistance.”
FDA concerned about false negative viral infection results
FebriDx has been cleared for sale in the United Kingdom, Europe, Canada, United Arab Emirates, Brazil, and Australia, according to the manufacturer, Australia-based Lumos Diagnostics.
However, the product is not available in the United States, where the Food and Drug Administration denied marketing clearance in July. In a news release, Lumos said the FDA determined that FebriDx did not demonstrate “substantial equivalence” to a predicate device and expressed concern that false negative viral infection results could lead to missed cases of COVID-19.
In the newly published study, FebriDx identified individuals with viral infections 70.3% of the time (95% CI, 64.8-75.2). The probability that a person who tested negative for a viral infection was truly negative was 66.7% (95%CI, 60.8-72.1).
The study included patients with respiratory symptoms and recent fever who were enrolled from October 2019 to April 2021 at nine emergency departments, six urgent care clinics, and five primary care clinics in the United States. All patients were tested with FebriDx and underwent separate laboratory testing to determine a final diagnosis.
In addition, researchers recruited a control group of 120 individuals without symptoms.
Among 496 symptomatic individuals who had a final diagnosis, 73 (14.7%) were classified as having a response associated with a bacterial infection, 296 (59.7%) as having a viral-associated response, and 127 (25.6%) as negative.
FebriDx correctly ruled out a bacterial infection 88.4% of the time (95% CI, 85.0-91.1). The probability that a patient with a positive result for bacterial infection actually had a bacterial infection was 58.1% (95%CI, 49.1-66.7).
The findings bolster those of a previous study on the same test. This research included 220 patients who reported having a fever within the prior 3 days or had a measurable fever at the time of enrollment. In that study, the test correctly identified bacterial infections 85% of the time and correctly ruled out bacterial infection 93% of the time, with a NPV of 97%.
Too early to say test will be useful in practice
The idea of a test to guide the prescribing of antibiotics isn’t new, according to an expert who was not involved in FebriDx research.
Noah Ivers, MD, PhD, a family physician and associate professor at the University of Toronto who studies strategies to optimize primary care delivery, said, “many such point-of-care tests have been tried” to detect biomarkers such as CRP or procalcitonin, which is associated with bacterial infections.
Such tests have looked good in initial studies, he said, but when trialed in urgent care clinics, primary care clinics, or emergency departments, “they tend run into implementation challenges or simply lack of effects, or both.
“So, while I am happy at the news of this result, it’s too early to say with any certainty that it will prove useful in practice,” he added.
Meanwhile, Dr. Ivers said it’s “crucial that people understand that most illnesses are likely to be viral” and therefore not helped by antibiotics. When antibiotics are needed for outpatients, he said, “5 days is usually ample.”
The study was funded by Lumos Diagnostics. Among the 15 study authors, 6 had conflicts of interest disclosures, reporting ties to Inflammatix, Medical College of Wisconsin, Siemens, Technomics Research, and Lumos Diagnostics. Dr. Ivers reported no relevant financial interests.
The fingerstick test, FebriDx, works by detecting myxovirus resistance protein A, which the body generates in response to viral infections, and C-reactive protein (CRP), which is associated with systemic bacterial or viral infection.
In a study of 520 adults and children with symptoms of acute respiratory illness who were treated in outpatient settings, the test correctly classified bacterial infections 93.2% of the time (95% confidence interval [CI], 84.9-97.0). The negative predictive value (NPV), or probability that a person with a negative test result was truly free of a bacterial infection, was 98.7% (95% CI, 96.9-99.4).
The findings of the study, which was sponsored by the test’s manufacturer, were published in JAMA Network Open).
The ability to rule out a bacterial cause “may provide clinicians with reassurance to withhold antibiotics when supported by the clinical assessment,” the researchers wrote.
They added that the ability to identify infections that may benefit from antibiotics and confidently rule out those that will not “is essential to optimizing clinical management and addressing global antimicrobial resistance.”
FDA concerned about false negative viral infection results
FebriDx has been cleared for sale in the United Kingdom, Europe, Canada, United Arab Emirates, Brazil, and Australia, according to the manufacturer, Australia-based Lumos Diagnostics.
However, the product is not available in the United States, where the Food and Drug Administration denied marketing clearance in July. In a news release, Lumos said the FDA determined that FebriDx did not demonstrate “substantial equivalence” to a predicate device and expressed concern that false negative viral infection results could lead to missed cases of COVID-19.
In the newly published study, FebriDx identified individuals with viral infections 70.3% of the time (95% CI, 64.8-75.2). The probability that a person who tested negative for a viral infection was truly negative was 66.7% (95%CI, 60.8-72.1).
The study included patients with respiratory symptoms and recent fever who were enrolled from October 2019 to April 2021 at nine emergency departments, six urgent care clinics, and five primary care clinics in the United States. All patients were tested with FebriDx and underwent separate laboratory testing to determine a final diagnosis.
In addition, researchers recruited a control group of 120 individuals without symptoms.
Among 496 symptomatic individuals who had a final diagnosis, 73 (14.7%) were classified as having a response associated with a bacterial infection, 296 (59.7%) as having a viral-associated response, and 127 (25.6%) as negative.
FebriDx correctly ruled out a bacterial infection 88.4% of the time (95% CI, 85.0-91.1). The probability that a patient with a positive result for bacterial infection actually had a bacterial infection was 58.1% (95%CI, 49.1-66.7).
The findings bolster those of a previous study on the same test. This research included 220 patients who reported having a fever within the prior 3 days or had a measurable fever at the time of enrollment. In that study, the test correctly identified bacterial infections 85% of the time and correctly ruled out bacterial infection 93% of the time, with a NPV of 97%.
Too early to say test will be useful in practice
The idea of a test to guide the prescribing of antibiotics isn’t new, according to an expert who was not involved in FebriDx research.
Noah Ivers, MD, PhD, a family physician and associate professor at the University of Toronto who studies strategies to optimize primary care delivery, said, “many such point-of-care tests have been tried” to detect biomarkers such as CRP or procalcitonin, which is associated with bacterial infections.
Such tests have looked good in initial studies, he said, but when trialed in urgent care clinics, primary care clinics, or emergency departments, “they tend run into implementation challenges or simply lack of effects, or both.
“So, while I am happy at the news of this result, it’s too early to say with any certainty that it will prove useful in practice,” he added.
Meanwhile, Dr. Ivers said it’s “crucial that people understand that most illnesses are likely to be viral” and therefore not helped by antibiotics. When antibiotics are needed for outpatients, he said, “5 days is usually ample.”
The study was funded by Lumos Diagnostics. Among the 15 study authors, 6 had conflicts of interest disclosures, reporting ties to Inflammatix, Medical College of Wisconsin, Siemens, Technomics Research, and Lumos Diagnostics. Dr. Ivers reported no relevant financial interests.
The fingerstick test, FebriDx, works by detecting myxovirus resistance protein A, which the body generates in response to viral infections, and C-reactive protein (CRP), which is associated with systemic bacterial or viral infection.
In a study of 520 adults and children with symptoms of acute respiratory illness who were treated in outpatient settings, the test correctly classified bacterial infections 93.2% of the time (95% confidence interval [CI], 84.9-97.0). The negative predictive value (NPV), or probability that a person with a negative test result was truly free of a bacterial infection, was 98.7% (95% CI, 96.9-99.4).
The findings of the study, which was sponsored by the test’s manufacturer, were published in JAMA Network Open).
The ability to rule out a bacterial cause “may provide clinicians with reassurance to withhold antibiotics when supported by the clinical assessment,” the researchers wrote.
They added that the ability to identify infections that may benefit from antibiotics and confidently rule out those that will not “is essential to optimizing clinical management and addressing global antimicrobial resistance.”
FDA concerned about false negative viral infection results
FebriDx has been cleared for sale in the United Kingdom, Europe, Canada, United Arab Emirates, Brazil, and Australia, according to the manufacturer, Australia-based Lumos Diagnostics.
However, the product is not available in the United States, where the Food and Drug Administration denied marketing clearance in July. In a news release, Lumos said the FDA determined that FebriDx did not demonstrate “substantial equivalence” to a predicate device and expressed concern that false negative viral infection results could lead to missed cases of COVID-19.
In the newly published study, FebriDx identified individuals with viral infections 70.3% of the time (95% CI, 64.8-75.2). The probability that a person who tested negative for a viral infection was truly negative was 66.7% (95%CI, 60.8-72.1).
The study included patients with respiratory symptoms and recent fever who were enrolled from October 2019 to April 2021 at nine emergency departments, six urgent care clinics, and five primary care clinics in the United States. All patients were tested with FebriDx and underwent separate laboratory testing to determine a final diagnosis.
In addition, researchers recruited a control group of 120 individuals without symptoms.
Among 496 symptomatic individuals who had a final diagnosis, 73 (14.7%) were classified as having a response associated with a bacterial infection, 296 (59.7%) as having a viral-associated response, and 127 (25.6%) as negative.
FebriDx correctly ruled out a bacterial infection 88.4% of the time (95% CI, 85.0-91.1). The probability that a patient with a positive result for bacterial infection actually had a bacterial infection was 58.1% (95%CI, 49.1-66.7).
The findings bolster those of a previous study on the same test. This research included 220 patients who reported having a fever within the prior 3 days or had a measurable fever at the time of enrollment. In that study, the test correctly identified bacterial infections 85% of the time and correctly ruled out bacterial infection 93% of the time, with a NPV of 97%.
Too early to say test will be useful in practice
The idea of a test to guide the prescribing of antibiotics isn’t new, according to an expert who was not involved in FebriDx research.
Noah Ivers, MD, PhD, a family physician and associate professor at the University of Toronto who studies strategies to optimize primary care delivery, said, “many such point-of-care tests have been tried” to detect biomarkers such as CRP or procalcitonin, which is associated with bacterial infections.
Such tests have looked good in initial studies, he said, but when trialed in urgent care clinics, primary care clinics, or emergency departments, “they tend run into implementation challenges or simply lack of effects, or both.
“So, while I am happy at the news of this result, it’s too early to say with any certainty that it will prove useful in practice,” he added.
Meanwhile, Dr. Ivers said it’s “crucial that people understand that most illnesses are likely to be viral” and therefore not helped by antibiotics. When antibiotics are needed for outpatients, he said, “5 days is usually ample.”
The study was funded by Lumos Diagnostics. Among the 15 study authors, 6 had conflicts of interest disclosures, reporting ties to Inflammatix, Medical College of Wisconsin, Siemens, Technomics Research, and Lumos Diagnostics. Dr. Ivers reported no relevant financial interests.
FROM JAMA NETWORK OPEN
Insulin rationing common, ‘surprising’ even among privately insured
Insulin rationing due to cost in the United States is common even among people with diabetes who have private health insurance, new data show.
The findings from the 2021 National Health Interview Survey (NHIS) suggest that about one in six people with insulin-treated diabetes in the United States practice insulin rationing – skipping doses, taking less insulin than needed, or delaying the purchase of insulin – because of the price.
Not surprisingly, those without insurance had the highest rationing rate, at nearly a third. However, those with private insurance also had higher rates, at nearly one in five, than those of the overall diabetes population. And those with public insurance – Medicare and Medicaid – had lower rates.
The finding regarding privately insured individuals was “somewhat surprising,” lead author Adam Gaffney, MD, told this news organization. But he noted that the finding likely reflects issues such as copays and deductibles, along with other barriers patients experience within the private health insurance system.
The authors pointed out that the $35 copay cap on insulin included in the Inflation Reduction Act of 2022 might improve insulin access for Medicare beneficiaries but a similar cap for privately insured people was removed from the bill. Moreover, copay caps don’t help people who are uninsured.
And, although some states have also passed insulin copay caps that apply to privately insured people, “even a monthly cost of $35 can be a lot of money for people with low incomes. That isn’t negligible. It’s important to keep that in mind,” said Dr. Gaffney, a pulmonary and critical care physician at Harvard Medical School, Boston, and Cambridge (Mass.) Health Alliance.
“Insulin rationing is frequently harmful and sometimes deadly. In the ICU, I have cared for patients who have life-threatening complications of diabetes because they couldn’t afford this life-saving drug. Universal access to insulin, without cost barriers, is urgently needed,” Dr. Gaffney said in a Public Citizen statement.
Senior author Steffie Woolhandler, MD, agrees. “Drug companies have ramped up prices on insulin year after year, even for products that remain completely unchanged,” she noted.
“Drug firms are making vast profits at the expense of the health, and even the lives, of patients,” noted Dr. Woolhandler, a distinguished professor at Hunter College, City University of New York, a lecturer in medicine at Harvard, and a research associate at Public Citizen.
Uninsured, privately insured, and younger people more likely to ration
Dr. Gaffney and colleagues’ findings were published online in Annals of Internal Medicine.
The study is the first to examine insulin rationing across the United States among people with all diabetes types treated with insulin using the nationally representative NHIS data.
The results are consistent with those of previous studies, which have found similar rates of insulin rationing at a single U.S. institution and internationally among just those with type 1 diabetes, Dr. Gaffney noted.
In 2021, questions about insulin rationing were added to the NHIS for the first time.
The sample included 982 insulin users with diabetes, representing about 1.4 million U.S. adults with type 1 diabetes, 5.8 million with type 2 diabetes, and 0.4 million with other/unknown types.
Overall, 16.5% of participants – 1.3 million nationwide – reported skipping or reducing insulin doses or delaying the purchase of it in the past year. Delaying purchase was the most common type of rationing, reported by 14.2%, while taking less than needed was the most common practice among those with type 1 diabetes (16.5%).
Age made a difference, with 11.2% of adults aged 65 or older versus 20.4% of younger people reporting rationing. And by income level, even among those at the top level examined – 400% or higher of the federal poverty line – 10.8% reported rationing.
“The high-income group is not necessarily rich. Many would be considered middle-income,” Dr. Gaffney pointed out.
By race, 23.2% of Black participants reported rationing compared with 16.0% of White and Hispanic individuals.
People without insurance had the highest rationing rate (29.2%), followed by those with private insurance (18.8%), other coverage (16.1%), Medicare (13.5%), and Medicaid (11.6%).
‘It’s a complicated system’
Dr. Gaffney noted that even when the patient has private insurance, it’s challenging for the clinician to know in advance whether there are formulary restrictions on what type of insulin can be prescribed or what the patient’s copay or deductible will be.
“Often the prescription gets written without clear knowledge of coverage beforehand ... Coverage differs from patient to patient, from insurance to insurance. It’s a complicated system.”
He added, though, that some electronic health records (EHRs) incorporate this information. “Currently, some EHRs give real-time feedback. I see no reason why, for all the money we plug into these EHRs, there couldn’t be real-time feedback for every patient so you know what the copay is and whether it’s covered at the time you’re prescribing it. To me that’s a very straightforward technological fix that we could achieve. We have the information, but it’s hard to act on it.”
But beyond the EHR, “there are also problems when the patient’s insurance changes or their network changes, and what insulin is covered changes. And they don’t necessarily get that new prescription in time. And suddenly they have a gap. Gaps can be dangerous.”
What’s more, Dr. Gaffney noted: “The study raises concerning questions about what happens when the public health emergency ends and millions of people with Medicaid lose their coverage. Where are they going to get insulin? That’s another population we have to be worried about.”
All of this puts clinicians in a difficult spot, he said.
“They want the best for their patients but they’re working in a system that’s not letting them focus on practicing medicine and instead is forcing them to think about these economic issues that are in large part out of their control.”
Dr. Gaffney is a member of Physicians for a National Health Program, which advocates for a single-payer health system in the United States.
A version of this article first appeared on Medscape.com.
Insulin rationing due to cost in the United States is common even among people with diabetes who have private health insurance, new data show.
The findings from the 2021 National Health Interview Survey (NHIS) suggest that about one in six people with insulin-treated diabetes in the United States practice insulin rationing – skipping doses, taking less insulin than needed, or delaying the purchase of insulin – because of the price.
Not surprisingly, those without insurance had the highest rationing rate, at nearly a third. However, those with private insurance also had higher rates, at nearly one in five, than those of the overall diabetes population. And those with public insurance – Medicare and Medicaid – had lower rates.
The finding regarding privately insured individuals was “somewhat surprising,” lead author Adam Gaffney, MD, told this news organization. But he noted that the finding likely reflects issues such as copays and deductibles, along with other barriers patients experience within the private health insurance system.
The authors pointed out that the $35 copay cap on insulin included in the Inflation Reduction Act of 2022 might improve insulin access for Medicare beneficiaries but a similar cap for privately insured people was removed from the bill. Moreover, copay caps don’t help people who are uninsured.
And, although some states have also passed insulin copay caps that apply to privately insured people, “even a monthly cost of $35 can be a lot of money for people with low incomes. That isn’t negligible. It’s important to keep that in mind,” said Dr. Gaffney, a pulmonary and critical care physician at Harvard Medical School, Boston, and Cambridge (Mass.) Health Alliance.
“Insulin rationing is frequently harmful and sometimes deadly. In the ICU, I have cared for patients who have life-threatening complications of diabetes because they couldn’t afford this life-saving drug. Universal access to insulin, without cost barriers, is urgently needed,” Dr. Gaffney said in a Public Citizen statement.
Senior author Steffie Woolhandler, MD, agrees. “Drug companies have ramped up prices on insulin year after year, even for products that remain completely unchanged,” she noted.
“Drug firms are making vast profits at the expense of the health, and even the lives, of patients,” noted Dr. Woolhandler, a distinguished professor at Hunter College, City University of New York, a lecturer in medicine at Harvard, and a research associate at Public Citizen.
Uninsured, privately insured, and younger people more likely to ration
Dr. Gaffney and colleagues’ findings were published online in Annals of Internal Medicine.
The study is the first to examine insulin rationing across the United States among people with all diabetes types treated with insulin using the nationally representative NHIS data.
The results are consistent with those of previous studies, which have found similar rates of insulin rationing at a single U.S. institution and internationally among just those with type 1 diabetes, Dr. Gaffney noted.
In 2021, questions about insulin rationing were added to the NHIS for the first time.
The sample included 982 insulin users with diabetes, representing about 1.4 million U.S. adults with type 1 diabetes, 5.8 million with type 2 diabetes, and 0.4 million with other/unknown types.
Overall, 16.5% of participants – 1.3 million nationwide – reported skipping or reducing insulin doses or delaying the purchase of it in the past year. Delaying purchase was the most common type of rationing, reported by 14.2%, while taking less than needed was the most common practice among those with type 1 diabetes (16.5%).
Age made a difference, with 11.2% of adults aged 65 or older versus 20.4% of younger people reporting rationing. And by income level, even among those at the top level examined – 400% or higher of the federal poverty line – 10.8% reported rationing.
“The high-income group is not necessarily rich. Many would be considered middle-income,” Dr. Gaffney pointed out.
By race, 23.2% of Black participants reported rationing compared with 16.0% of White and Hispanic individuals.
People without insurance had the highest rationing rate (29.2%), followed by those with private insurance (18.8%), other coverage (16.1%), Medicare (13.5%), and Medicaid (11.6%).
‘It’s a complicated system’
Dr. Gaffney noted that even when the patient has private insurance, it’s challenging for the clinician to know in advance whether there are formulary restrictions on what type of insulin can be prescribed or what the patient’s copay or deductible will be.
“Often the prescription gets written without clear knowledge of coverage beforehand ... Coverage differs from patient to patient, from insurance to insurance. It’s a complicated system.”
He added, though, that some electronic health records (EHRs) incorporate this information. “Currently, some EHRs give real-time feedback. I see no reason why, for all the money we plug into these EHRs, there couldn’t be real-time feedback for every patient so you know what the copay is and whether it’s covered at the time you’re prescribing it. To me that’s a very straightforward technological fix that we could achieve. We have the information, but it’s hard to act on it.”
But beyond the EHR, “there are also problems when the patient’s insurance changes or their network changes, and what insulin is covered changes. And they don’t necessarily get that new prescription in time. And suddenly they have a gap. Gaps can be dangerous.”
What’s more, Dr. Gaffney noted: “The study raises concerning questions about what happens when the public health emergency ends and millions of people with Medicaid lose their coverage. Where are they going to get insulin? That’s another population we have to be worried about.”
All of this puts clinicians in a difficult spot, he said.
“They want the best for their patients but they’re working in a system that’s not letting them focus on practicing medicine and instead is forcing them to think about these economic issues that are in large part out of their control.”
Dr. Gaffney is a member of Physicians for a National Health Program, which advocates for a single-payer health system in the United States.
A version of this article first appeared on Medscape.com.
Insulin rationing due to cost in the United States is common even among people with diabetes who have private health insurance, new data show.
The findings from the 2021 National Health Interview Survey (NHIS) suggest that about one in six people with insulin-treated diabetes in the United States practice insulin rationing – skipping doses, taking less insulin than needed, or delaying the purchase of insulin – because of the price.
Not surprisingly, those without insurance had the highest rationing rate, at nearly a third. However, those with private insurance also had higher rates, at nearly one in five, than those of the overall diabetes population. And those with public insurance – Medicare and Medicaid – had lower rates.
The finding regarding privately insured individuals was “somewhat surprising,” lead author Adam Gaffney, MD, told this news organization. But he noted that the finding likely reflects issues such as copays and deductibles, along with other barriers patients experience within the private health insurance system.
The authors pointed out that the $35 copay cap on insulin included in the Inflation Reduction Act of 2022 might improve insulin access for Medicare beneficiaries but a similar cap for privately insured people was removed from the bill. Moreover, copay caps don’t help people who are uninsured.
And, although some states have also passed insulin copay caps that apply to privately insured people, “even a monthly cost of $35 can be a lot of money for people with low incomes. That isn’t negligible. It’s important to keep that in mind,” said Dr. Gaffney, a pulmonary and critical care physician at Harvard Medical School, Boston, and Cambridge (Mass.) Health Alliance.
“Insulin rationing is frequently harmful and sometimes deadly. In the ICU, I have cared for patients who have life-threatening complications of diabetes because they couldn’t afford this life-saving drug. Universal access to insulin, without cost barriers, is urgently needed,” Dr. Gaffney said in a Public Citizen statement.
Senior author Steffie Woolhandler, MD, agrees. “Drug companies have ramped up prices on insulin year after year, even for products that remain completely unchanged,” she noted.
“Drug firms are making vast profits at the expense of the health, and even the lives, of patients,” noted Dr. Woolhandler, a distinguished professor at Hunter College, City University of New York, a lecturer in medicine at Harvard, and a research associate at Public Citizen.
Uninsured, privately insured, and younger people more likely to ration
Dr. Gaffney and colleagues’ findings were published online in Annals of Internal Medicine.
The study is the first to examine insulin rationing across the United States among people with all diabetes types treated with insulin using the nationally representative NHIS data.
The results are consistent with those of previous studies, which have found similar rates of insulin rationing at a single U.S. institution and internationally among just those with type 1 diabetes, Dr. Gaffney noted.
In 2021, questions about insulin rationing were added to the NHIS for the first time.
The sample included 982 insulin users with diabetes, representing about 1.4 million U.S. adults with type 1 diabetes, 5.8 million with type 2 diabetes, and 0.4 million with other/unknown types.
Overall, 16.5% of participants – 1.3 million nationwide – reported skipping or reducing insulin doses or delaying the purchase of it in the past year. Delaying purchase was the most common type of rationing, reported by 14.2%, while taking less than needed was the most common practice among those with type 1 diabetes (16.5%).
Age made a difference, with 11.2% of adults aged 65 or older versus 20.4% of younger people reporting rationing. And by income level, even among those at the top level examined – 400% or higher of the federal poverty line – 10.8% reported rationing.
“The high-income group is not necessarily rich. Many would be considered middle-income,” Dr. Gaffney pointed out.
By race, 23.2% of Black participants reported rationing compared with 16.0% of White and Hispanic individuals.
People without insurance had the highest rationing rate (29.2%), followed by those with private insurance (18.8%), other coverage (16.1%), Medicare (13.5%), and Medicaid (11.6%).
‘It’s a complicated system’
Dr. Gaffney noted that even when the patient has private insurance, it’s challenging for the clinician to know in advance whether there are formulary restrictions on what type of insulin can be prescribed or what the patient’s copay or deductible will be.
“Often the prescription gets written without clear knowledge of coverage beforehand ... Coverage differs from patient to patient, from insurance to insurance. It’s a complicated system.”
He added, though, that some electronic health records (EHRs) incorporate this information. “Currently, some EHRs give real-time feedback. I see no reason why, for all the money we plug into these EHRs, there couldn’t be real-time feedback for every patient so you know what the copay is and whether it’s covered at the time you’re prescribing it. To me that’s a very straightforward technological fix that we could achieve. We have the information, but it’s hard to act on it.”
But beyond the EHR, “there are also problems when the patient’s insurance changes or their network changes, and what insulin is covered changes. And they don’t necessarily get that new prescription in time. And suddenly they have a gap. Gaps can be dangerous.”
What’s more, Dr. Gaffney noted: “The study raises concerning questions about what happens when the public health emergency ends and millions of people with Medicaid lose their coverage. Where are they going to get insulin? That’s another population we have to be worried about.”
All of this puts clinicians in a difficult spot, he said.
“They want the best for their patients but they’re working in a system that’s not letting them focus on practicing medicine and instead is forcing them to think about these economic issues that are in large part out of their control.”
Dr. Gaffney is a member of Physicians for a National Health Program, which advocates for a single-payer health system in the United States.
A version of this article first appeared on Medscape.com.
FROM ANNALS OF INTERNAL MEDICINE
The ‘root cause’ visit
“How did we miss out on that?” “What?” my physician friend replied as we stood in line at the coffee cart. “Root cause. I mean, we invented this idea and now all these naturopaths and functional medicine quacks are gettin’ rich off it.” “Take it easy,” he says. “Just order a coffee.”
It’s hard not to be indignant. I had a morning clinic with three patients insisting I find the “root cause” of their problem. Now, if one had flagellate dermatitis after eating Asian mushroom soup, I’d have said “Root cause? Shiitake mushrooms!” and walked out like Costanza in Seinfeld, “All right, that’s it for me! Be good everybody!”
Alas no. They had perioral dermatitis, alopecia areata, eczema – no satisfying “roots” for walk-off answers.
There is a universal desire to find the proximal cause for problems. Patients often want to know it so that we address the root of their trouble and not just cut off the branches. This is deeply gratifying for those who want not only to know why, but also to have agency in how to control their disease. For example, if they believe the root cause of perioral dermatitis was excess yeast, then eating a “candida diet’’ should do the trick! Food sensitivities, hormones, and heavy metals round out the top suspects that root cause patients want to talk about.
Of course, patients have been asking about this for a long time, but lately, the root cause visit seems to be on trend. Check out any hip primary care start-up such as One Medical or any hot direct-to-consumer virtual offering such as ParsleyHealth and you will see root-cause everywhere. Our patients are expecting us to address it, or it seems they will find someone cooler who will.
Yet, it wasn’t the slick marketing team at ParsleyHeath who invented the “root cause doctor visit.” We did. It’s an idea that started with our Greek physician ancestors. Breaking from the diviners and priests, we were the first “naturalists” positing that there was a natural, not a divine cause for illness. The cardinal concept in the Hippocratic Corpus was that health was an equilibrium and illness an imbalance. They didn’t have dehydroepiandrosterone tests or mercury levels, but did have bodily fluids. Yellow bile, black bile, blood, and phlegm, were the root of all root causes. A physician simply had to identify which was in excess or deficient and fix that to cure the disease. Interestingly, the word “diagnosis” appears only once in the Corpus. The word “Diagignoskein” appears occasionally but this describes studying thoroughly, not naming a diagnosis as we understand it.
Advances in chemistry in the 17th century meant physicians could add new theories, and new root causes. Now alkaline or other chemical elixirs were added to cure at the source. Since there was no verifiable evidence to prove causes, theories were adopted to provide some rational direction to treatment. In the 18th century, physicians such as Dr. Benjamin Rush, one of the original faculty at the University of Pennsylvania school of medicine, taught that spasms of the arteries were the root cause of illnesses. “Heroic” treatments such as extreme bloodletting were the cure. (Note, those patients who survived us kept coming back to us for more).
Scientific knowledge and diagnostic technologies led to more and more complex and abstruse causes. Yet, as we became more precise and effective, our explanations became less satisfying to our patients. I can diagnose and readily treat perioral dermatitis, yet I’m hard pressed to give an answer to its root cause. “Root cause? Yes. Just apply this pimecrolimus cream for a couple of weeks and it’ll be better! All right, that’s it for me! Be good everybody!”
You’ll have to do better, George.
Dr. Benabio is director of Healthcare Transformation and chief of dermatology at Kaiser Permanente San Diego. The opinions expressed in this column are his own and do not represent those of Kaiser Permanente. Dr. Benabio is @Dermdoc on Twitter. Write to him at [email protected]
“How did we miss out on that?” “What?” my physician friend replied as we stood in line at the coffee cart. “Root cause. I mean, we invented this idea and now all these naturopaths and functional medicine quacks are gettin’ rich off it.” “Take it easy,” he says. “Just order a coffee.”
It’s hard not to be indignant. I had a morning clinic with three patients insisting I find the “root cause” of their problem. Now, if one had flagellate dermatitis after eating Asian mushroom soup, I’d have said “Root cause? Shiitake mushrooms!” and walked out like Costanza in Seinfeld, “All right, that’s it for me! Be good everybody!”
Alas no. They had perioral dermatitis, alopecia areata, eczema – no satisfying “roots” for walk-off answers.
There is a universal desire to find the proximal cause for problems. Patients often want to know it so that we address the root of their trouble and not just cut off the branches. This is deeply gratifying for those who want not only to know why, but also to have agency in how to control their disease. For example, if they believe the root cause of perioral dermatitis was excess yeast, then eating a “candida diet’’ should do the trick! Food sensitivities, hormones, and heavy metals round out the top suspects that root cause patients want to talk about.
Of course, patients have been asking about this for a long time, but lately, the root cause visit seems to be on trend. Check out any hip primary care start-up such as One Medical or any hot direct-to-consumer virtual offering such as ParsleyHealth and you will see root-cause everywhere. Our patients are expecting us to address it, or it seems they will find someone cooler who will.
Yet, it wasn’t the slick marketing team at ParsleyHeath who invented the “root cause doctor visit.” We did. It’s an idea that started with our Greek physician ancestors. Breaking from the diviners and priests, we were the first “naturalists” positing that there was a natural, not a divine cause for illness. The cardinal concept in the Hippocratic Corpus was that health was an equilibrium and illness an imbalance. They didn’t have dehydroepiandrosterone tests or mercury levels, but did have bodily fluids. Yellow bile, black bile, blood, and phlegm, were the root of all root causes. A physician simply had to identify which was in excess or deficient and fix that to cure the disease. Interestingly, the word “diagnosis” appears only once in the Corpus. The word “Diagignoskein” appears occasionally but this describes studying thoroughly, not naming a diagnosis as we understand it.
Advances in chemistry in the 17th century meant physicians could add new theories, and new root causes. Now alkaline or other chemical elixirs were added to cure at the source. Since there was no verifiable evidence to prove causes, theories were adopted to provide some rational direction to treatment. In the 18th century, physicians such as Dr. Benjamin Rush, one of the original faculty at the University of Pennsylvania school of medicine, taught that spasms of the arteries were the root cause of illnesses. “Heroic” treatments such as extreme bloodletting were the cure. (Note, those patients who survived us kept coming back to us for more).
Scientific knowledge and diagnostic technologies led to more and more complex and abstruse causes. Yet, as we became more precise and effective, our explanations became less satisfying to our patients. I can diagnose and readily treat perioral dermatitis, yet I’m hard pressed to give an answer to its root cause. “Root cause? Yes. Just apply this pimecrolimus cream for a couple of weeks and it’ll be better! All right, that’s it for me! Be good everybody!”
You’ll have to do better, George.
Dr. Benabio is director of Healthcare Transformation and chief of dermatology at Kaiser Permanente San Diego. The opinions expressed in this column are his own and do not represent those of Kaiser Permanente. Dr. Benabio is @Dermdoc on Twitter. Write to him at [email protected]
“How did we miss out on that?” “What?” my physician friend replied as we stood in line at the coffee cart. “Root cause. I mean, we invented this idea and now all these naturopaths and functional medicine quacks are gettin’ rich off it.” “Take it easy,” he says. “Just order a coffee.”
It’s hard not to be indignant. I had a morning clinic with three patients insisting I find the “root cause” of their problem. Now, if one had flagellate dermatitis after eating Asian mushroom soup, I’d have said “Root cause? Shiitake mushrooms!” and walked out like Costanza in Seinfeld, “All right, that’s it for me! Be good everybody!”
Alas no. They had perioral dermatitis, alopecia areata, eczema – no satisfying “roots” for walk-off answers.
There is a universal desire to find the proximal cause for problems. Patients often want to know it so that we address the root of their trouble and not just cut off the branches. This is deeply gratifying for those who want not only to know why, but also to have agency in how to control their disease. For example, if they believe the root cause of perioral dermatitis was excess yeast, then eating a “candida diet’’ should do the trick! Food sensitivities, hormones, and heavy metals round out the top suspects that root cause patients want to talk about.
Of course, patients have been asking about this for a long time, but lately, the root cause visit seems to be on trend. Check out any hip primary care start-up such as One Medical or any hot direct-to-consumer virtual offering such as ParsleyHealth and you will see root-cause everywhere. Our patients are expecting us to address it, or it seems they will find someone cooler who will.
Yet, it wasn’t the slick marketing team at ParsleyHeath who invented the “root cause doctor visit.” We did. It’s an idea that started with our Greek physician ancestors. Breaking from the diviners and priests, we were the first “naturalists” positing that there was a natural, not a divine cause for illness. The cardinal concept in the Hippocratic Corpus was that health was an equilibrium and illness an imbalance. They didn’t have dehydroepiandrosterone tests or mercury levels, but did have bodily fluids. Yellow bile, black bile, blood, and phlegm, were the root of all root causes. A physician simply had to identify which was in excess or deficient and fix that to cure the disease. Interestingly, the word “diagnosis” appears only once in the Corpus. The word “Diagignoskein” appears occasionally but this describes studying thoroughly, not naming a diagnosis as we understand it.
Advances in chemistry in the 17th century meant physicians could add new theories, and new root causes. Now alkaline or other chemical elixirs were added to cure at the source. Since there was no verifiable evidence to prove causes, theories were adopted to provide some rational direction to treatment. In the 18th century, physicians such as Dr. Benjamin Rush, one of the original faculty at the University of Pennsylvania school of medicine, taught that spasms of the arteries were the root cause of illnesses. “Heroic” treatments such as extreme bloodletting were the cure. (Note, those patients who survived us kept coming back to us for more).
Scientific knowledge and diagnostic technologies led to more and more complex and abstruse causes. Yet, as we became more precise and effective, our explanations became less satisfying to our patients. I can diagnose and readily treat perioral dermatitis, yet I’m hard pressed to give an answer to its root cause. “Root cause? Yes. Just apply this pimecrolimus cream for a couple of weeks and it’ll be better! All right, that’s it for me! Be good everybody!”
You’ll have to do better, George.
Dr. Benabio is director of Healthcare Transformation and chief of dermatology at Kaiser Permanente San Diego. The opinions expressed in this column are his own and do not represent those of Kaiser Permanente. Dr. Benabio is @Dermdoc on Twitter. Write to him at [email protected]
Are doctors savers or spenders?
In a poll that ran from August 30 to Sept. 21, conducted by Medscape, physicians were asked if they lived within their means. They were asked whether they pay their bills on time, save at least 20% of their monthly income toward retirement, pay down student loan debt, and contribute to their kids’ college savings or a rainy-day emergency fund.
Medscape polled 468 U.S. physicians and 159 living outside of the United States. Eighty-nine percent of U.S. respondents report living within their means, while only 11% said they don’t.
Medscape’s Physician Wealth & Debt Report 2022 similarly reported that of 13,000 physicians in more than 29 specialties, 94% said they live at or below their means.
For example, over half of physicians have a net worth above $1 million. In contrast, according to Credit Suisse’s Global Wealth Report, less than 7% of the general population has a seven-figure net worth.
So just how do physicians stack up financially?
Habits of physician super savers
Physicians who consider themselves savers likely have money habits that correlate. They buy things on sale, are DIYers for home projects and maintenance, and wait to buy luxury or large expenses when the timing is right, an item is on sale, or they’ve saved for it.
For example, when it comes to life’s luxuries like buying a new car or dining out, overall, physicians seem to be more frugal, as 43% of those who buy cars said they only buy a new car every 10 years; 30% said they buy a new vehicle every 6-7 years, and 22% said every 4-5 years.
When asked about weekly dine-out or delivery habits, 82% of those polled who said they dine out, or order takeout, do so a nominal 1-2 times per week. That’s on par with the Centers for Disease Control, which reports that 3 in 5 Americans eat out once weekly. Another 14% of polled physicians said they dine out 3-5 nights per week. Only 4% revealed they eat out or grab to-go food more than 5 nights a week.
When hiring for essential home maintenance, like house cleaning and pool or lawn service, almost a third of physicians we polled who require such maintenance employ a service for these tasks, and 23% hire out often while 21% hire out only sometimes. However, 14% say they rarely hire out for home maintenance, and 11% never do.
Since physicians are typically tight on time, they tend to favor outsourcing things like housecleaning, lawn service, landscaping, maintenance, and even cooking. So, the fact that a quarter of physicians polled rarely or never hire out for household help is somewhat surprising.
Most physicians also prioritize saving. When asked how important it is to save money consistently, 93% think it’s either extremely or very important, while only 6% think it’s somewhat important.
Barriers to wealth
When asked what barriers prevent them from saving at least 20% of their monthly income, physician respondents who said they live within their means and encountered barriers reported that family necessities (35%), student loan debt (19%), and mortgage sizes (18%) were the top reasons. The average doctor earns five times as much as the average American, according to the Global Wealth Report.
“What prevents me from saving is holding too much debt, responsibilities at home, bills, being unprepared for what is coming, and making excuses to spend even when it’s not necessary,” says Sean Ormond, MD, a dual board-certified physician in Anesthesiology and Pain Management in Phoenix.
When physician respondents who said they didn’t live within their means were asked about the barriers preventing them from saving at least 20% of their monthly income, they cited the cost of family necessities (49%), the size of their mortgage (47%), credit card debt (30%), student loan debt (21%), other loans (15%), and car lease/loan (13%).
“My most significant financial splurge is vacation, since I always choose the best, and the best comes at an extra cost,” says Dr. Ormond.
What’s your financial grade?
Finally, physicians were asked who they considered better at saving money, themselves or their spouse/domestic partner. Forty-four percent think they are the better saver, whereas 41% said that both they and their partner were equally good at saving. Thirteen percent credited their partner with better saving habits, and 2% said neither themselves nor their partner were good at saving money.
More than half (63%) of physicians polled pay off their credit card balance monthly, but 18% carry a $1,000-$5,000 balance, 10% have $5,000-$10,000 in credit card debt, and 6% hold more than $10,000 of credit card debt.
“I would grade myself with a B, because however much I love having the best, I still have a budget, and I always ensure that I follow it to the dot,” says Dr. Ormond.
A version of this article first appeared on Medscape.com.
In a poll that ran from August 30 to Sept. 21, conducted by Medscape, physicians were asked if they lived within their means. They were asked whether they pay their bills on time, save at least 20% of their monthly income toward retirement, pay down student loan debt, and contribute to their kids’ college savings or a rainy-day emergency fund.
Medscape polled 468 U.S. physicians and 159 living outside of the United States. Eighty-nine percent of U.S. respondents report living within their means, while only 11% said they don’t.
Medscape’s Physician Wealth & Debt Report 2022 similarly reported that of 13,000 physicians in more than 29 specialties, 94% said they live at or below their means.
For example, over half of physicians have a net worth above $1 million. In contrast, according to Credit Suisse’s Global Wealth Report, less than 7% of the general population has a seven-figure net worth.
So just how do physicians stack up financially?
Habits of physician super savers
Physicians who consider themselves savers likely have money habits that correlate. They buy things on sale, are DIYers for home projects and maintenance, and wait to buy luxury or large expenses when the timing is right, an item is on sale, or they’ve saved for it.
For example, when it comes to life’s luxuries like buying a new car or dining out, overall, physicians seem to be more frugal, as 43% of those who buy cars said they only buy a new car every 10 years; 30% said they buy a new vehicle every 6-7 years, and 22% said every 4-5 years.
When asked about weekly dine-out or delivery habits, 82% of those polled who said they dine out, or order takeout, do so a nominal 1-2 times per week. That’s on par with the Centers for Disease Control, which reports that 3 in 5 Americans eat out once weekly. Another 14% of polled physicians said they dine out 3-5 nights per week. Only 4% revealed they eat out or grab to-go food more than 5 nights a week.
When hiring for essential home maintenance, like house cleaning and pool or lawn service, almost a third of physicians we polled who require such maintenance employ a service for these tasks, and 23% hire out often while 21% hire out only sometimes. However, 14% say they rarely hire out for home maintenance, and 11% never do.
Since physicians are typically tight on time, they tend to favor outsourcing things like housecleaning, lawn service, landscaping, maintenance, and even cooking. So, the fact that a quarter of physicians polled rarely or never hire out for household help is somewhat surprising.
Most physicians also prioritize saving. When asked how important it is to save money consistently, 93% think it’s either extremely or very important, while only 6% think it’s somewhat important.
Barriers to wealth
When asked what barriers prevent them from saving at least 20% of their monthly income, physician respondents who said they live within their means and encountered barriers reported that family necessities (35%), student loan debt (19%), and mortgage sizes (18%) were the top reasons. The average doctor earns five times as much as the average American, according to the Global Wealth Report.
“What prevents me from saving is holding too much debt, responsibilities at home, bills, being unprepared for what is coming, and making excuses to spend even when it’s not necessary,” says Sean Ormond, MD, a dual board-certified physician in Anesthesiology and Pain Management in Phoenix.
When physician respondents who said they didn’t live within their means were asked about the barriers preventing them from saving at least 20% of their monthly income, they cited the cost of family necessities (49%), the size of their mortgage (47%), credit card debt (30%), student loan debt (21%), other loans (15%), and car lease/loan (13%).
“My most significant financial splurge is vacation, since I always choose the best, and the best comes at an extra cost,” says Dr. Ormond.
What’s your financial grade?
Finally, physicians were asked who they considered better at saving money, themselves or their spouse/domestic partner. Forty-four percent think they are the better saver, whereas 41% said that both they and their partner were equally good at saving. Thirteen percent credited their partner with better saving habits, and 2% said neither themselves nor their partner were good at saving money.
More than half (63%) of physicians polled pay off their credit card balance monthly, but 18% carry a $1,000-$5,000 balance, 10% have $5,000-$10,000 in credit card debt, and 6% hold more than $10,000 of credit card debt.
“I would grade myself with a B, because however much I love having the best, I still have a budget, and I always ensure that I follow it to the dot,” says Dr. Ormond.
A version of this article first appeared on Medscape.com.
In a poll that ran from August 30 to Sept. 21, conducted by Medscape, physicians were asked if they lived within their means. They were asked whether they pay their bills on time, save at least 20% of their monthly income toward retirement, pay down student loan debt, and contribute to their kids’ college savings or a rainy-day emergency fund.
Medscape polled 468 U.S. physicians and 159 living outside of the United States. Eighty-nine percent of U.S. respondents report living within their means, while only 11% said they don’t.
Medscape’s Physician Wealth & Debt Report 2022 similarly reported that of 13,000 physicians in more than 29 specialties, 94% said they live at or below their means.
For example, over half of physicians have a net worth above $1 million. In contrast, according to Credit Suisse’s Global Wealth Report, less than 7% of the general population has a seven-figure net worth.
So just how do physicians stack up financially?
Habits of physician super savers
Physicians who consider themselves savers likely have money habits that correlate. They buy things on sale, are DIYers for home projects and maintenance, and wait to buy luxury or large expenses when the timing is right, an item is on sale, or they’ve saved for it.
For example, when it comes to life’s luxuries like buying a new car or dining out, overall, physicians seem to be more frugal, as 43% of those who buy cars said they only buy a new car every 10 years; 30% said they buy a new vehicle every 6-7 years, and 22% said every 4-5 years.
When asked about weekly dine-out or delivery habits, 82% of those polled who said they dine out, or order takeout, do so a nominal 1-2 times per week. That’s on par with the Centers for Disease Control, which reports that 3 in 5 Americans eat out once weekly. Another 14% of polled physicians said they dine out 3-5 nights per week. Only 4% revealed they eat out or grab to-go food more than 5 nights a week.
When hiring for essential home maintenance, like house cleaning and pool or lawn service, almost a third of physicians we polled who require such maintenance employ a service for these tasks, and 23% hire out often while 21% hire out only sometimes. However, 14% say they rarely hire out for home maintenance, and 11% never do.
Since physicians are typically tight on time, they tend to favor outsourcing things like housecleaning, lawn service, landscaping, maintenance, and even cooking. So, the fact that a quarter of physicians polled rarely or never hire out for household help is somewhat surprising.
Most physicians also prioritize saving. When asked how important it is to save money consistently, 93% think it’s either extremely or very important, while only 6% think it’s somewhat important.
Barriers to wealth
When asked what barriers prevent them from saving at least 20% of their monthly income, physician respondents who said they live within their means and encountered barriers reported that family necessities (35%), student loan debt (19%), and mortgage sizes (18%) were the top reasons. The average doctor earns five times as much as the average American, according to the Global Wealth Report.
“What prevents me from saving is holding too much debt, responsibilities at home, bills, being unprepared for what is coming, and making excuses to spend even when it’s not necessary,” says Sean Ormond, MD, a dual board-certified physician in Anesthesiology and Pain Management in Phoenix.
When physician respondents who said they didn’t live within their means were asked about the barriers preventing them from saving at least 20% of their monthly income, they cited the cost of family necessities (49%), the size of their mortgage (47%), credit card debt (30%), student loan debt (21%), other loans (15%), and car lease/loan (13%).
“My most significant financial splurge is vacation, since I always choose the best, and the best comes at an extra cost,” says Dr. Ormond.
What’s your financial grade?
Finally, physicians were asked who they considered better at saving money, themselves or their spouse/domestic partner. Forty-four percent think they are the better saver, whereas 41% said that both they and their partner were equally good at saving. Thirteen percent credited their partner with better saving habits, and 2% said neither themselves nor their partner were good at saving money.
More than half (63%) of physicians polled pay off their credit card balance monthly, but 18% carry a $1,000-$5,000 balance, 10% have $5,000-$10,000 in credit card debt, and 6% hold more than $10,000 of credit card debt.
“I would grade myself with a B, because however much I love having the best, I still have a budget, and I always ensure that I follow it to the dot,” says Dr. Ormond.
A version of this article first appeared on Medscape.com.