Ob.Gyn. News

Physicians wearing white coats were rated as significantly more experienced and professional than peers wearing casual attire. Regardless of their attire, however, female physicians were more likely to be judged as appearing less professional and were more likely to be misidentified as medical technicians, physician assistants, or nurses, found research published in JAMA Network Open.

“A white coat with scrubs attire was most preferred for surgeons (mean preference index, 1.3), whereas a white coat with business attire was preferred for family physicians and dermatologists (mean preference indexes, 1.6 and 1.2, respectively; P < .001),” Helen Xun, MD, Johns Hopkins University, Baltimore, and colleagues wrote. “A male model wearing business inner wear with a white coat, fleece jacket, or softshell jacket was perceived as significantly more professional than a female model wearing the same attire (mean professionalism score: male, 65.8; female, 56.2; mean difference in professionalism score: white coat, 12.06; fleece, 7.89; softshell, 8.82; P < .001). ... A male model wearing hospital scrubs or fashion scrubs alone was also perceived as more professional than a female model in the same attire.”

While casual attire, such as fleece or softshell jackets emblazoned with the names of the institution and wearer, has become more popular attire for physicians in recent years, the researchers noted theirs is the first published research to identify associations between gender, attire, and how people distinguish between various health care roles. The study authors launched their web-based survey from May to June 2020 and asked people aged 18 years and older to rate a series of photographs of deidentified models wearing health care attire. Inner wear choices were business attire versus scrubs with and without outer wear options of a long white coat, gray fleece jacket, or black softshell jackets. Survey respondents ranked the images on a 6-point Likert scale with 1 being the least experienced, professional, and friendly and 6 being the most experienced, professional, and friendly. Survey respondents also viewed individual images of male or female models and were asked to rate their professionalism on a scale of 0-100 – with 100 as the “most professional” as well as to identify their profession as either physician, surgeon, nurse, medical technician, or physician assistant.

The study team included 487 (93.3%) of 522 completed surveys in their analyses. Respondents’ mean age was 36.2 years; 260 (53.4%) were female; 372 (76.4%) were White; 33 (6.8%) were Black or African American. Younger respondents and those living in the Western United States who had more exposure to physician casual attire appeared more accepting of it, the authors wrote.

“I remember attending my white-coat ceremony as a medical student, and the symbolism of it all representing me entering the profession. It felt very emotional and heavy and I felt very proud to be there. I also remember taking a ‘selfie’ in my long white coat as a doctor for the first time before my first shift as a resident. But, I’ve also been wearing that same white coat, and a large badge with a ‘DOCTOR’ label on it, and been mistaken by a patient or parent for something other than the physician,” Alexandra M. Sims, a pediatrician and health equity researcher in Cincinnati, said in an interview. “So, I’d really hope that the take-home here is not simply that we must wear our white coats to be considered more professional. I think we have to unpack and dismantle how we’ve even built this notion of ‘professionalism’ in the first place. Women, people of color, and other marginalized groups were certainly not a part of the defining, but we must be a part of the reimagining of an equitable health care profession in this new era.”

As sartorial trends usher in more casual attire, clinicians should redouble efforts to build rapport and enhance communication with patients, such as clarifying team members’ roles when introducing themselves. Dr. Xun and coauthors noted that addressing gender bias is important for all clinicians – not just women – and point to the need for institutional and organizational support for disciplines where gender bias is “especially prevalent,” like surgery. “This responsibility should not be undertaken only by the individuals that experience the biases, which may result in additional cumulative career disadvantages. The promotion of equality and diversity begins with recognition, characterization, and evidence-supported interventions and is a community operation,” Dr. Xun and colleagues concluded.

“I do not equate attire to professionalism or experience, nor is it connected to my satisfaction with the physician. For myself and my daughter, it is the experience of care that ultimately influences our perceptions regarding the professionalism of the physician,” Hala H. Durrah, MTA, parent to a chronically ill child with special health care needs and a Patient and Family Engagement Consultant, said in an interview. “My respect for a physician will ultimately be determined by how my daughter and I were treated, not just from a clinical perspective, but how we felt during those interactions.”

Physicians wearing white coats were rated as significantly more experienced and professional than peers wearing casual attire. Regardless of their attire, however, female physicians were more likely to be judged as appearing less professional and were more likely to be misidentified as medical technicians, physician assistants, or nurses, found research published in JAMA Network Open.

“A white coat with scrubs attire was most preferred for surgeons (mean preference index, 1.3), whereas a white coat with business attire was preferred for family physicians and dermatologists (mean preference indexes, 1.6 and 1.2, respectively; P < .001),” Helen Xun, MD, Johns Hopkins University, Baltimore, and colleagues wrote. “A male model wearing business inner wear with a white coat, fleece jacket, or softshell jacket was perceived as significantly more professional than a female model wearing the same attire (mean professionalism score: male, 65.8; female, 56.2; mean difference in professionalism score: white coat, 12.06; fleece, 7.89; softshell, 8.82; P < .001). ... A male model wearing hospital scrubs or fashion scrubs alone was also perceived as more professional than a female model in the same attire.”

While casual attire, such as fleece or softshell jackets emblazoned with the names of the institution and wearer, has become more popular attire for physicians in recent years, the researchers noted theirs is the first published research to identify associations between gender, attire, and how people distinguish between various health care roles. The study authors launched their web-based survey from May to June 2020 and asked people aged 18 years and older to rate a series of photographs of deidentified models wearing health care attire. Inner wear choices were business attire versus scrubs with and without outer wear options of a long white coat, gray fleece jacket, or black softshell jackets. Survey respondents ranked the images on a 6-point Likert scale with 1 being the least experienced, professional, and friendly and 6 being the most experienced, professional, and friendly. Survey respondents also viewed individual images of male or female models and were asked to rate their professionalism on a scale of 0-100 – with 100 as the “most professional” as well as to identify their profession as either physician, surgeon, nurse, medical technician, or physician assistant.

The study team included 487 (93.3%) of 522 completed surveys in their analyses. Respondents’ mean age was 36.2 years; 260 (53.4%) were female; 372 (76.4%) were White; 33 (6.8%) were Black or African American. Younger respondents and those living in the Western United States who had more exposure to physician casual attire appeared more accepting of it, the authors wrote.

“I remember attending my white-coat ceremony as a medical student, and the symbolism of it all representing me entering the profession. It felt very emotional and heavy and I felt very proud to be there. I also remember taking a ‘selfie’ in my long white coat as a doctor for the first time before my first shift as a resident. But, I’ve also been wearing that same white coat, and a large badge with a ‘DOCTOR’ label on it, and been mistaken by a patient or parent for something other than the physician,” Alexandra M. Sims, a pediatrician and health equity researcher in Cincinnati, said in an interview. “So, I’d really hope that the take-home here is not simply that we must wear our white coats to be considered more professional. I think we have to unpack and dismantle how we’ve even built this notion of ‘professionalism’ in the first place. Women, people of color, and other marginalized groups were certainly not a part of the defining, but we must be a part of the reimagining of an equitable health care profession in this new era.”

As sartorial trends usher in more casual attire, clinicians should redouble efforts to build rapport and enhance communication with patients, such as clarifying team members’ roles when introducing themselves. Dr. Xun and coauthors noted that addressing gender bias is important for all clinicians – not just women – and point to the need for institutional and organizational support for disciplines where gender bias is “especially prevalent,” like surgery. “This responsibility should not be undertaken only by the individuals that experience the biases, which may result in additional cumulative career disadvantages. The promotion of equality and diversity begins with recognition, characterization, and evidence-supported interventions and is a community operation,” Dr. Xun and colleagues concluded.

“I do not equate attire to professionalism or experience, nor is it connected to my satisfaction with the physician. For myself and my daughter, it is the experience of care that ultimately influences our perceptions regarding the professionalism of the physician,” Hala H. Durrah, MTA, parent to a chronically ill child with special health care needs and a Patient and Family Engagement Consultant, said in an interview. “My respect for a physician will ultimately be determined by how my daughter and I were treated, not just from a clinical perspective, but how we felt during those interactions.”

Physicians wearing white coats were rated as significantly more experienced and professional than peers wearing casual attire. Regardless of their attire, however, female physicians were more likely to be judged as appearing less professional and were more likely to be misidentified as medical technicians, physician assistants, or nurses, found research published in JAMA Network Open.

“A white coat with scrubs attire was most preferred for surgeons (mean preference index, 1.3), whereas a white coat with business attire was preferred for family physicians and dermatologists (mean preference indexes, 1.6 and 1.2, respectively; P < .001),” Helen Xun, MD, Johns Hopkins University, Baltimore, and colleagues wrote. “A male model wearing business inner wear with a white coat, fleece jacket, or softshell jacket was perceived as significantly more professional than a female model wearing the same attire (mean professionalism score: male, 65.8; female, 56.2; mean difference in professionalism score: white coat, 12.06; fleece, 7.89; softshell, 8.82; P < .001). ... A male model wearing hospital scrubs or fashion scrubs alone was also perceived as more professional than a female model in the same attire.”

While casual attire, such as fleece or softshell jackets emblazoned with the names of the institution and wearer, has become more popular attire for physicians in recent years, the researchers noted theirs is the first published research to identify associations between gender, attire, and how people distinguish between various health care roles. The study authors launched their web-based survey from May to June 2020 and asked people aged 18 years and older to rate a series of photographs of deidentified models wearing health care attire. Inner wear choices were business attire versus scrubs with and without outer wear options of a long white coat, gray fleece jacket, or black softshell jackets. Survey respondents ranked the images on a 6-point Likert scale with 1 being the least experienced, professional, and friendly and 6 being the most experienced, professional, and friendly. Survey respondents also viewed individual images of male or female models and were asked to rate their professionalism on a scale of 0-100 – with 100 as the “most professional” as well as to identify their profession as either physician, surgeon, nurse, medical technician, or physician assistant.

The study team included 487 (93.3%) of 522 completed surveys in their analyses. Respondents’ mean age was 36.2 years; 260 (53.4%) were female; 372 (76.4%) were White; 33 (6.8%) were Black or African American. Younger respondents and those living in the Western United States who had more exposure to physician casual attire appeared more accepting of it, the authors wrote.

“I remember attending my white-coat ceremony as a medical student, and the symbolism of it all representing me entering the profession. It felt very emotional and heavy and I felt very proud to be there. I also remember taking a ‘selfie’ in my long white coat as a doctor for the first time before my first shift as a resident. But, I’ve also been wearing that same white coat, and a large badge with a ‘DOCTOR’ label on it, and been mistaken by a patient or parent for something other than the physician,” Alexandra M. Sims, a pediatrician and health equity researcher in Cincinnati, said in an interview. “So, I’d really hope that the take-home here is not simply that we must wear our white coats to be considered more professional. I think we have to unpack and dismantle how we’ve even built this notion of ‘professionalism’ in the first place. Women, people of color, and other marginalized groups were certainly not a part of the defining, but we must be a part of the reimagining of an equitable health care profession in this new era.”

As sartorial trends usher in more casual attire, clinicians should redouble efforts to build rapport and enhance communication with patients, such as clarifying team members’ roles when introducing themselves. Dr. Xun and coauthors noted that addressing gender bias is important for all clinicians – not just women – and point to the need for institutional and organizational support for disciplines where gender bias is “especially prevalent,” like surgery. “This responsibility should not be undertaken only by the individuals that experience the biases, which may result in additional cumulative career disadvantages. The promotion of equality and diversity begins with recognition, characterization, and evidence-supported interventions and is a community operation,” Dr. Xun and colleagues concluded.

“I do not equate attire to professionalism or experience, nor is it connected to my satisfaction with the physician. For myself and my daughter, it is the experience of care that ultimately influences our perceptions regarding the professionalism of the physician,” Hala H. Durrah, MTA, parent to a chronically ill child with special health care needs and a Patient and Family Engagement Consultant, said in an interview. “My respect for a physician will ultimately be determined by how my daughter and I were treated, not just from a clinical perspective, but how we felt during those interactions.”

Wrong-site surgery

Florida regulators have imposed a fine and other measures on a Tampa doctor who made a crucial error prior to his patient’s testicular surgery, as a story in the Miami Herald, among other news sites, reports.

On Sept. 10, 2019, a patient referred to in state documents as “C.F.” showed up for a procedure – a varicocelectomy – that would remove the enlarged veins in his left testicle. His doctor that day was Raul Fernandez-Crespo, MD, a urologist who had been licensed to practice in Florida since April of the same year. Dr. Fernandez-Crespo completed his urology residency at the University of Puerto Rico in 2019.

Following a conversation with C.F., Dr. Fernandez-Crespo designated what he believed was the proper surgical site – his patient’s right testicle.

He then proceeded to operate, but at some point during the procedure – news accounts don’t make clear when or how he became aware of his error – he realized C.F. had actually consented to a left-testicle varicocelectomy. With his patient still sedated, Dr. Fernandez-Crespo also completed the second procedure.

His mistake came to the attention of the Department of Health, which filed an administrative complaint against the surgeon. On June 17, 2021, the department’s medical licensing body, the Florida Board of Medicine, handed down its final order about the case.

In addition to imposing a $2,500 fine on Dr. Fernandez-Crespo and issuing “a letter of concern” – a public document that can be used as evidence in any relevant future disciplinary action against him – regulators said the surgeon must reimburse $2,045.56 to the department for its case-related administrative costs; take a 5-hour CME course in risk management or attend 8 hours of board disciplinary hearings; and, finally, give a 1-hour lecture on wrong-site surgeries at a board-approved medical facility.

Before this, Dr. Fernandez-Crespo had no previous disciplinary history with the Florida Board of Medicine.
 

Huge judgment after fertility procedure goes wrong

A Connecticut couple whose fertility and prenatal care at a state university health center proved disastrous will receive millions of dollars in damages, according to a report in the Hartford Courant.

In 2014, Jean-Marie Monroe-Lynch and her husband, Aaron Lynch, went to UConn Health, in Farmington, for treatment of Jean-Marie’s infertility. Her care was overseen by the Center for Advanced Reproductive Services (CARS), a private company then under contract with UConn Health. (The contract, which ended in 2014, obligated UConn to provide CARS providers with medical malpractice coverage.)

There, Jean-Marie was inseminated with sperm from a donor who turned out to be a carrier for cytomegalovirus (CMV), the herpes virus that can cause severe birth defects, or fetal death, when contracted by a pregnant woman. The insemination resulted in a twin pregnancy, a boy and a girl. The girl, Shay, died in utero after several of her organs became infected with CMV; the boy, Joshua, was born with severe mental and physical disabilities.

In their suit, Ms. Monroe-Lynch and her husband alleged that they were never cautioned about the risks associated with using a sperm donor whose blood had tested positive for CMV antibodies. Their suit further alleged that, at the 20-week ultrasound, UConn’s prenatal team failed to detect evidence of congenital CMV infection and again failed, at the 22-week ultrasound, to properly recognize and respond to abnormal findings.

“They totally dropped the ball,” said the couple’s attorney. “If you’re a pregnant woman and contract the virus for the first time, the results can be devastating.” 

CARS disputes this conclusion, arguing that the plaintiffs failed to prove as a “matter of scientific fact” that Ms. Monroe-Lynch was infected with CMV as the result of her intrauterine insemination.

But Superior Court Judge Mark H. Taylor disagreed. In his 107-page ruling, he said that the court “agrees with the vast majority of superior courts, concluding that a physician providing obstetric care owes a direct duty to a mother to prevent harm to her child during gestation and delivery.”

Jean-Marie Monroe-Lynch and Aaron Lynch received a $37.6 million award, consisting of $24.1 million in economic damages and $13.5 million in noneconomic damages.

Their surviving child, Joshua, will reportedly require a lifetime of medical and other care. In the meantime, UConn Health vows to appeal the Superior Court’s decision.
 

COVID patient’s relative demands justice for fatal outcome

An Indiana man whose grandfather recently died after suffering a stroke is calling on state lawmakers to rethink legislation passed earlier this year to protect health care providers during the COVID-19 pandemic, according to a story reported by CBS4Indy.

Late last year, Daniel Enlow’s 83-year-old grandfather, Edward Rigney, was checked into Eskenazi Hospital, in Indianapolis. Mr. Rigney suffered from COPD and had also been diagnosed with COVID-19.

At some point during his hospitalization, medical staff attempted to place what seems to have been an arterial line in order to monitor his condition. During the procedure, or at some point shortly thereafter, an “iatrogenic air embolus” was released into his veins and caused a stroke, according to medical records and Mr. Rigney’s death certificate.

“I started asking for medical records because I wanted to know what was happening leading up to it in black and white in front of me,” said Mr. Enlow, who wished to present his evidence to a medical review panel, as required by Indiana law. The first step in this process would have been to consult with a medical malpractice attorney, but several declined to take his case.

Why? Because a pair of bills passed by Indiana legislators in early 2021 make COVID-19–related suits – even tangentially related ones – potentially difficult to take to court.

The bills raised the bar to file a medical malpractice claim in COVID-19 cases and to allow only those that involve “gross negligence or willful or wanton misconduct.”

“In the vast majority of cases, it’s impossible to prove that,” said Fred Schultz, immediate past president of the Indiana Trial Lawyers Association, who lobbied against the legislation.

The bills were never designed to offer “blanket freedom,” said GOP State Senator Aaron Freeman, sponsor of one of the bills. “If something is being used in a way that it is a complete bar to certain claims, then maybe we need to go back and look at it and open that up a little bit and make it less restrictive. I’m certainly open to having those conversations.”

Meanwhile, Mr. Enlow has vowed to keep pushing in the name of his late grandfather. The hospital’s parent company, Eskenazi Health, has declined to comment.

A version of this article first appeared on Medscape.com.

Wrong-site surgery

Florida regulators have imposed a fine and other measures on a Tampa doctor who made a crucial error prior to his patient’s testicular surgery, as a story in the Miami Herald, among other news sites, reports.

On Sept. 10, 2019, a patient referred to in state documents as “C.F.” showed up for a procedure – a varicocelectomy – that would remove the enlarged veins in his left testicle. His doctor that day was Raul Fernandez-Crespo, MD, a urologist who had been licensed to practice in Florida since April of the same year. Dr. Fernandez-Crespo completed his urology residency at the University of Puerto Rico in 2019.

Following a conversation with C.F., Dr. Fernandez-Crespo designated what he believed was the proper surgical site – his patient’s right testicle.

He then proceeded to operate, but at some point during the procedure – news accounts don’t make clear when or how he became aware of his error – he realized C.F. had actually consented to a left-testicle varicocelectomy. With his patient still sedated, Dr. Fernandez-Crespo also completed the second procedure.

His mistake came to the attention of the Department of Health, which filed an administrative complaint against the surgeon. On June 17, 2021, the department’s medical licensing body, the Florida Board of Medicine, handed down its final order about the case.

In addition to imposing a $2,500 fine on Dr. Fernandez-Crespo and issuing “a letter of concern” – a public document that can be used as evidence in any relevant future disciplinary action against him – regulators said the surgeon must reimburse $2,045.56 to the department for its case-related administrative costs; take a 5-hour CME course in risk management or attend 8 hours of board disciplinary hearings; and, finally, give a 1-hour lecture on wrong-site surgeries at a board-approved medical facility.

Before this, Dr. Fernandez-Crespo had no previous disciplinary history with the Florida Board of Medicine.
 

Huge judgment after fertility procedure goes wrong

A Connecticut couple whose fertility and prenatal care at a state university health center proved disastrous will receive millions of dollars in damages, according to a report in the Hartford Courant.

In 2014, Jean-Marie Monroe-Lynch and her husband, Aaron Lynch, went to UConn Health, in Farmington, for treatment of Jean-Marie’s infertility. Her care was overseen by the Center for Advanced Reproductive Services (CARS), a private company then under contract with UConn Health. (The contract, which ended in 2014, obligated UConn to provide CARS providers with medical malpractice coverage.)

There, Jean-Marie was inseminated with sperm from a donor who turned out to be a carrier for cytomegalovirus (CMV), the herpes virus that can cause severe birth defects, or fetal death, when contracted by a pregnant woman. The insemination resulted in a twin pregnancy, a boy and a girl. The girl, Shay, died in utero after several of her organs became infected with CMV; the boy, Joshua, was born with severe mental and physical disabilities.

In their suit, Ms. Monroe-Lynch and her husband alleged that they were never cautioned about the risks associated with using a sperm donor whose blood had tested positive for CMV antibodies. Their suit further alleged that, at the 20-week ultrasound, UConn’s prenatal team failed to detect evidence of congenital CMV infection and again failed, at the 22-week ultrasound, to properly recognize and respond to abnormal findings.

“They totally dropped the ball,” said the couple’s attorney. “If you’re a pregnant woman and contract the virus for the first time, the results can be devastating.” 

CARS disputes this conclusion, arguing that the plaintiffs failed to prove as a “matter of scientific fact” that Ms. Monroe-Lynch was infected with CMV as the result of her intrauterine insemination.

But Superior Court Judge Mark H. Taylor disagreed. In his 107-page ruling, he said that the court “agrees with the vast majority of superior courts, concluding that a physician providing obstetric care owes a direct duty to a mother to prevent harm to her child during gestation and delivery.”

Jean-Marie Monroe-Lynch and Aaron Lynch received a $37.6 million award, consisting of $24.1 million in economic damages and $13.5 million in noneconomic damages.

Their surviving child, Joshua, will reportedly require a lifetime of medical and other care. In the meantime, UConn Health vows to appeal the Superior Court’s decision.
 

COVID patient’s relative demands justice for fatal outcome

An Indiana man whose grandfather recently died after suffering a stroke is calling on state lawmakers to rethink legislation passed earlier this year to protect health care providers during the COVID-19 pandemic, according to a story reported by CBS4Indy.

Late last year, Daniel Enlow’s 83-year-old grandfather, Edward Rigney, was checked into Eskenazi Hospital, in Indianapolis. Mr. Rigney suffered from COPD and had also been diagnosed with COVID-19.

At some point during his hospitalization, medical staff attempted to place what seems to have been an arterial line in order to monitor his condition. During the procedure, or at some point shortly thereafter, an “iatrogenic air embolus” was released into his veins and caused a stroke, according to medical records and Mr. Rigney’s death certificate.

“I started asking for medical records because I wanted to know what was happening leading up to it in black and white in front of me,” said Mr. Enlow, who wished to present his evidence to a medical review panel, as required by Indiana law. The first step in this process would have been to consult with a medical malpractice attorney, but several declined to take his case.

Why? Because a pair of bills passed by Indiana legislators in early 2021 make COVID-19–related suits – even tangentially related ones – potentially difficult to take to court.

The bills raised the bar to file a medical malpractice claim in COVID-19 cases and to allow only those that involve “gross negligence or willful or wanton misconduct.”

“In the vast majority of cases, it’s impossible to prove that,” said Fred Schultz, immediate past president of the Indiana Trial Lawyers Association, who lobbied against the legislation.

The bills were never designed to offer “blanket freedom,” said GOP State Senator Aaron Freeman, sponsor of one of the bills. “If something is being used in a way that it is a complete bar to certain claims, then maybe we need to go back and look at it and open that up a little bit and make it less restrictive. I’m certainly open to having those conversations.”

Meanwhile, Mr. Enlow has vowed to keep pushing in the name of his late grandfather. The hospital’s parent company, Eskenazi Health, has declined to comment.

A version of this article first appeared on Medscape.com.

Wrong-site surgery

Florida regulators have imposed a fine and other measures on a Tampa doctor who made a crucial error prior to his patient’s testicular surgery, as a story in the Miami Herald, among other news sites, reports.

On Sept. 10, 2019, a patient referred to in state documents as “C.F.” showed up for a procedure – a varicocelectomy – that would remove the enlarged veins in his left testicle. His doctor that day was Raul Fernandez-Crespo, MD, a urologist who had been licensed to practice in Florida since April of the same year. Dr. Fernandez-Crespo completed his urology residency at the University of Puerto Rico in 2019.

Following a conversation with C.F., Dr. Fernandez-Crespo designated what he believed was the proper surgical site – his patient’s right testicle.

He then proceeded to operate, but at some point during the procedure – news accounts don’t make clear when or how he became aware of his error – he realized C.F. had actually consented to a left-testicle varicocelectomy. With his patient still sedated, Dr. Fernandez-Crespo also completed the second procedure.

His mistake came to the attention of the Department of Health, which filed an administrative complaint against the surgeon. On June 17, 2021, the department’s medical licensing body, the Florida Board of Medicine, handed down its final order about the case.

In addition to imposing a $2,500 fine on Dr. Fernandez-Crespo and issuing “a letter of concern” – a public document that can be used as evidence in any relevant future disciplinary action against him – regulators said the surgeon must reimburse $2,045.56 to the department for its case-related administrative costs; take a 5-hour CME course in risk management or attend 8 hours of board disciplinary hearings; and, finally, give a 1-hour lecture on wrong-site surgeries at a board-approved medical facility.

Before this, Dr. Fernandez-Crespo had no previous disciplinary history with the Florida Board of Medicine.
 

Huge judgment after fertility procedure goes wrong

A Connecticut couple whose fertility and prenatal care at a state university health center proved disastrous will receive millions of dollars in damages, according to a report in the Hartford Courant.

In 2014, Jean-Marie Monroe-Lynch and her husband, Aaron Lynch, went to UConn Health, in Farmington, for treatment of Jean-Marie’s infertility. Her care was overseen by the Center for Advanced Reproductive Services (CARS), a private company then under contract with UConn Health. (The contract, which ended in 2014, obligated UConn to provide CARS providers with medical malpractice coverage.)

There, Jean-Marie was inseminated with sperm from a donor who turned out to be a carrier for cytomegalovirus (CMV), the herpes virus that can cause severe birth defects, or fetal death, when contracted by a pregnant woman. The insemination resulted in a twin pregnancy, a boy and a girl. The girl, Shay, died in utero after several of her organs became infected with CMV; the boy, Joshua, was born with severe mental and physical disabilities.

In their suit, Ms. Monroe-Lynch and her husband alleged that they were never cautioned about the risks associated with using a sperm donor whose blood had tested positive for CMV antibodies. Their suit further alleged that, at the 20-week ultrasound, UConn’s prenatal team failed to detect evidence of congenital CMV infection and again failed, at the 22-week ultrasound, to properly recognize and respond to abnormal findings.

“They totally dropped the ball,” said the couple’s attorney. “If you’re a pregnant woman and contract the virus for the first time, the results can be devastating.” 

CARS disputes this conclusion, arguing that the plaintiffs failed to prove as a “matter of scientific fact” that Ms. Monroe-Lynch was infected with CMV as the result of her intrauterine insemination.

But Superior Court Judge Mark H. Taylor disagreed. In his 107-page ruling, he said that the court “agrees with the vast majority of superior courts, concluding that a physician providing obstetric care owes a direct duty to a mother to prevent harm to her child during gestation and delivery.”

Jean-Marie Monroe-Lynch and Aaron Lynch received a $37.6 million award, consisting of $24.1 million in economic damages and $13.5 million in noneconomic damages.

Their surviving child, Joshua, will reportedly require a lifetime of medical and other care. In the meantime, UConn Health vows to appeal the Superior Court’s decision.
 

COVID patient’s relative demands justice for fatal outcome

An Indiana man whose grandfather recently died after suffering a stroke is calling on state lawmakers to rethink legislation passed earlier this year to protect health care providers during the COVID-19 pandemic, according to a story reported by CBS4Indy.

Late last year, Daniel Enlow’s 83-year-old grandfather, Edward Rigney, was checked into Eskenazi Hospital, in Indianapolis. Mr. Rigney suffered from COPD and had also been diagnosed with COVID-19.

At some point during his hospitalization, medical staff attempted to place what seems to have been an arterial line in order to monitor his condition. During the procedure, or at some point shortly thereafter, an “iatrogenic air embolus” was released into his veins and caused a stroke, according to medical records and Mr. Rigney’s death certificate.

“I started asking for medical records because I wanted to know what was happening leading up to it in black and white in front of me,” said Mr. Enlow, who wished to present his evidence to a medical review panel, as required by Indiana law. The first step in this process would have been to consult with a medical malpractice attorney, but several declined to take his case.

Why? Because a pair of bills passed by Indiana legislators in early 2021 make COVID-19–related suits – even tangentially related ones – potentially difficult to take to court.

The bills raised the bar to file a medical malpractice claim in COVID-19 cases and to allow only those that involve “gross negligence or willful or wanton misconduct.”

“In the vast majority of cases, it’s impossible to prove that,” said Fred Schultz, immediate past president of the Indiana Trial Lawyers Association, who lobbied against the legislation.

The bills were never designed to offer “blanket freedom,” said GOP State Senator Aaron Freeman, sponsor of one of the bills. “If something is being used in a way that it is a complete bar to certain claims, then maybe we need to go back and look at it and open that up a little bit and make it less restrictive. I’m certainly open to having those conversations.”

Meanwhile, Mr. Enlow has vowed to keep pushing in the name of his late grandfather. The hospital’s parent company, Eskenazi Health, has declined to comment.

A version of this article first appeared on Medscape.com.

Nearly half of female surgeons (42%) who were recently surveyed have had a miscarriage or stillbirth – twice the rate of women aged 30-40 years in the general population – according to an article published online July 28 in JAMA Surgery.

The authors, led by Erika L. Rangel, MD, division of general and gastrointestinal surgery, department of surgery, Brigham and Women’s Hospital, Boston, found that after the losses, the women took little or no time off.

Of 692 surgeons surveyed, 347 female surgeons had experienced a pregnancy loss. Of those, 244 had had a miscarriage at less than 10 weeks’ gestation, 92 had had a miscarriage between 10 and 20 weeks’ gestation, and 11 had had a stillbirth (loss at 20 weeks or later).
 

Most took no time off after miscarriage

After a miscarriage, 225 of 336 women (75%) took no time off work, and after a stillbirth, 5 of 11 (45%) took off 1 week or less, the authors found.

The study addressed an issue that people have talked about anecdotally or on social media, Dr. Rangel told this news organization.

“This was finally an opportunity to do a study of enough magnitude to show that there is a very quantifiable difference in complication rate, use of IVF [in vitro fertilization], and the age at which we have children. These are not just anecdotal stories,” she said.

For the study, a self-administered questionnaire was distributed electronically. Answers were collected from November 2020 to January 2021 through multiple U.S. surgical societies and social media among attending and resident surgeons with children. The control group for the study comprised 158 male surgeons who answered questions regarding their partners’ pregnancies.

Female surgeons had fewer children compared with male surgeons and their female partners (mean [SD],1.8 [0.8], versus 2.3 [1.1]; P < .001) and were more likely to delay having children because of surgical training (450 of 692 [65.0%] versus 69 of 158 [43.7%]; P < .001).

In addition, Dr. Rangel and colleagues found that 57% of female surgeons worked more than 60 hours a week during pregnancy and that 37% took more than six overnight calls.

The data show that female surgeons who operated 12 or more hours per week during the last trimester of pregnancy were at higher risk compared with those who operated fewer hours (odds ratio, 1.57; 95% confidence interval, 1.08-2.26).

“Pregnant surgeons should not be operating more than 12 hours a week when they are in the third trimester,” Dr. Rangel said.

“That is a modifiable risk factor,” she told this news organization. “It’s a very brief period of support – a couple of months of support for a woman who may do 25-30 more years of serving the public with surgical skills.”

She said that training programs should be organized so as to have colleagues cover operating room (OR) shifts to reduce the operating hours for pregnant colleagues. In addition, advanced practice health care professionals should be paid to take up the paperwork and perform non-OR care to reduce the stigma associated with pregnant trainees overburdening other surgical trainees.
 

‘It’s too big an ask’

Obstetrician-gynecologist Maryam Siddiqui, MD, said in an interview that she was particularly struck by the number of female surgeons who experience involuntary childlessness.

“That’s a big ask for people who want childbearing to be a part of the fulfillment of their life. It’s too big,” said Dr. Siddiqui, a gynecologic surgeon at UChicago Medicine.

She said the amount of detail in the article and the large number of participants were persuasive factors that can support establishing a more humane system than one in which one person at a time has to ask for change.

Pointing to the finding that three-fourths of the women in the study who had had miscarriages didn’t take time off, she said, “That’s not really humane. But they’re afraid to ask or they don’t want to reveal they’re trying [to get pregnant]. Why should you be afraid of building your family?”

The authors also found other adverse outcomes. Female surgeons were more likely to have musculoskeletal disorders compared with female nonsurgeon partners (36.9% versus 18.4%; P < .001), and they were more likely to undergo nonelective cesarean delivery (25.5% versus 15.3%; P = .01) and to experience postpartum depression (11.1% versus 5.7%; P = .04).

Dr. Siddiqui said the conditions that surgeons encounter on their return to work after childbirth are “a perfect storm” for postpartum depression among women who are not accustomed to being reliant on others.

Women often feel coerced into returning to work before they are physically or emotionally ready, then toggle back and forth from night shift to day shift, losing sleep, she said. “We can do better.”

One of the solutions, she said, is to provide better work coverage for the surgeon while she is pregnant and when she returns to work. That includes properly compensating the person covering for the surgeon by giving that person extra pay or additional time off.

“You have to value both people,” she said. “If both people are valued, there’s still collegiality.”

She acknowledged that that kind of compensation may be more readily available at large academic centers.

At UChicago, she said, they are creative with scheduling in training. For women at the height of pregnancy, rotations are less intensive, and trauma rotations are avoided.

Dr. Siddiqui said one of the most important aspects of the article is the authors’ list of two dozen ways, both big and small, to improve conditions.

Adopting such changes will become increasingly important for hiring and retaining female surgeons. “You want to work someplace where you’re respected as a whole person,” she said.

Sarah Blair, MD, a surgical oncologist at University of California, San Diego, stated that the number of miscarriages in particular provides disturbing proof of a problem women in surgery frequently discuss.

For nearly a decade, she led a women-in-surgery committee at UCSD in which they discussed such issues regarding pregnancy and medicine.

She said she hopes these data can help push for change in flexibility in residency so that women can graduate on time and have the families they want.

“There’s a movement away from time-based training to competency-based training, so maybe that will help women,” she said.
 

‘We have to figure this out’

“We will have to figure this out, because more than half of the people in medical school are women, and there are a lot more women in surgery than when I trained more than 20 years ago. It’s not a problem that’s going away,” she said.

One sign of improvement happened recently, Dr. Rangel said.

As previously reported, according to the American Board of Medical Specialties, as of July 1, 2021, residents and fellows are allowed a minimum 6 weeks away for medical leave or caregiving once during training, without having to use vacation time or sick leave and without having to extend their training.

“That’s huge,” she said. “But we still have a long way to go, because the residency programs still don’t have to have policy that abides that. It merely says you can take 6 weeks off and take your boards. It doesn’t say that the residency program has to allow you to take 6 weeks off.”

The authors noted that the United States and Papua New Guinea are the only countries in the world without federally mandated paid parental leave.

“Most U.S. female surgeons rely on their employer for this benefit, but only half of top-ranked medical schools offer paid leave, and 33%-65% of U.S. surgical training programs lack clear maternity leave policies,” she said.

Funding for the study was provided by the department of surgery at Brigham and Women’s Hospital. The study authors, Dr. Blair, and Dr. Siddiqui have disclosed no relevant financial relationships.

A version of this article first appeared on Medscape.com.

Nearly half of female surgeons (42%) who were recently surveyed have had a miscarriage or stillbirth – twice the rate of women aged 30-40 years in the general population – according to an article published online July 28 in JAMA Surgery.

The authors, led by Erika L. Rangel, MD, division of general and gastrointestinal surgery, department of surgery, Brigham and Women’s Hospital, Boston, found that after the losses, the women took little or no time off.

Of 692 surgeons surveyed, 347 female surgeons had experienced a pregnancy loss. Of those, 244 had had a miscarriage at less than 10 weeks’ gestation, 92 had had a miscarriage between 10 and 20 weeks’ gestation, and 11 had had a stillbirth (loss at 20 weeks or later).
 

Most took no time off after miscarriage

After a miscarriage, 225 of 336 women (75%) took no time off work, and after a stillbirth, 5 of 11 (45%) took off 1 week or less, the authors found.

The study addressed an issue that people have talked about anecdotally or on social media, Dr. Rangel told this news organization.

“This was finally an opportunity to do a study of enough magnitude to show that there is a very quantifiable difference in complication rate, use of IVF [in vitro fertilization], and the age at which we have children. These are not just anecdotal stories,” she said.

For the study, a self-administered questionnaire was distributed electronically. Answers were collected from November 2020 to January 2021 through multiple U.S. surgical societies and social media among attending and resident surgeons with children. The control group for the study comprised 158 male surgeons who answered questions regarding their partners’ pregnancies.

Female surgeons had fewer children compared with male surgeons and their female partners (mean [SD],1.8 [0.8], versus 2.3 [1.1]; P < .001) and were more likely to delay having children because of surgical training (450 of 692 [65.0%] versus 69 of 158 [43.7%]; P < .001).

In addition, Dr. Rangel and colleagues found that 57% of female surgeons worked more than 60 hours a week during pregnancy and that 37% took more than six overnight calls.

The data show that female surgeons who operated 12 or more hours per week during the last trimester of pregnancy were at higher risk compared with those who operated fewer hours (odds ratio, 1.57; 95% confidence interval, 1.08-2.26).

“Pregnant surgeons should not be operating more than 12 hours a week when they are in the third trimester,” Dr. Rangel said.

“That is a modifiable risk factor,” she told this news organization. “It’s a very brief period of support – a couple of months of support for a woman who may do 25-30 more years of serving the public with surgical skills.”

She said that training programs should be organized so as to have colleagues cover operating room (OR) shifts to reduce the operating hours for pregnant colleagues. In addition, advanced practice health care professionals should be paid to take up the paperwork and perform non-OR care to reduce the stigma associated with pregnant trainees overburdening other surgical trainees.
 

‘It’s too big an ask’

Obstetrician-gynecologist Maryam Siddiqui, MD, said in an interview that she was particularly struck by the number of female surgeons who experience involuntary childlessness.

“That’s a big ask for people who want childbearing to be a part of the fulfillment of their life. It’s too big,” said Dr. Siddiqui, a gynecologic surgeon at UChicago Medicine.

She said the amount of detail in the article and the large number of participants were persuasive factors that can support establishing a more humane system than one in which one person at a time has to ask for change.

Pointing to the finding that three-fourths of the women in the study who had had miscarriages didn’t take time off, she said, “That’s not really humane. But they’re afraid to ask or they don’t want to reveal they’re trying [to get pregnant]. Why should you be afraid of building your family?”

The authors also found other adverse outcomes. Female surgeons were more likely to have musculoskeletal disorders compared with female nonsurgeon partners (36.9% versus 18.4%; P < .001), and they were more likely to undergo nonelective cesarean delivery (25.5% versus 15.3%; P = .01) and to experience postpartum depression (11.1% versus 5.7%; P = .04).

Dr. Siddiqui said the conditions that surgeons encounter on their return to work after childbirth are “a perfect storm” for postpartum depression among women who are not accustomed to being reliant on others.

Women often feel coerced into returning to work before they are physically or emotionally ready, then toggle back and forth from night shift to day shift, losing sleep, she said. “We can do better.”

One of the solutions, she said, is to provide better work coverage for the surgeon while she is pregnant and when she returns to work. That includes properly compensating the person covering for the surgeon by giving that person extra pay or additional time off.

“You have to value both people,” she said. “If both people are valued, there’s still collegiality.”

She acknowledged that that kind of compensation may be more readily available at large academic centers.

At UChicago, she said, they are creative with scheduling in training. For women at the height of pregnancy, rotations are less intensive, and trauma rotations are avoided.

Dr. Siddiqui said one of the most important aspects of the article is the authors’ list of two dozen ways, both big and small, to improve conditions.

Adopting such changes will become increasingly important for hiring and retaining female surgeons. “You want to work someplace where you’re respected as a whole person,” she said.

Sarah Blair, MD, a surgical oncologist at University of California, San Diego, stated that the number of miscarriages in particular provides disturbing proof of a problem women in surgery frequently discuss.

For nearly a decade, she led a women-in-surgery committee at UCSD in which they discussed such issues regarding pregnancy and medicine.

She said she hopes these data can help push for change in flexibility in residency so that women can graduate on time and have the families they want.

“There’s a movement away from time-based training to competency-based training, so maybe that will help women,” she said.
 

‘We have to figure this out’

“We will have to figure this out, because more than half of the people in medical school are women, and there are a lot more women in surgery than when I trained more than 20 years ago. It’s not a problem that’s going away,” she said.

One sign of improvement happened recently, Dr. Rangel said.

As previously reported, according to the American Board of Medical Specialties, as of July 1, 2021, residents and fellows are allowed a minimum 6 weeks away for medical leave or caregiving once during training, without having to use vacation time or sick leave and without having to extend their training.

“That’s huge,” she said. “But we still have a long way to go, because the residency programs still don’t have to have policy that abides that. It merely says you can take 6 weeks off and take your boards. It doesn’t say that the residency program has to allow you to take 6 weeks off.”

The authors noted that the United States and Papua New Guinea are the only countries in the world without federally mandated paid parental leave.

“Most U.S. female surgeons rely on their employer for this benefit, but only half of top-ranked medical schools offer paid leave, and 33%-65% of U.S. surgical training programs lack clear maternity leave policies,” she said.

Funding for the study was provided by the department of surgery at Brigham and Women’s Hospital. The study authors, Dr. Blair, and Dr. Siddiqui have disclosed no relevant financial relationships.

A version of this article first appeared on Medscape.com.

Nearly half of female surgeons (42%) who were recently surveyed have had a miscarriage or stillbirth – twice the rate of women aged 30-40 years in the general population – according to an article published online July 28 in JAMA Surgery.

The authors, led by Erika L. Rangel, MD, division of general and gastrointestinal surgery, department of surgery, Brigham and Women’s Hospital, Boston, found that after the losses, the women took little or no time off.

Of 692 surgeons surveyed, 347 female surgeons had experienced a pregnancy loss. Of those, 244 had had a miscarriage at less than 10 weeks’ gestation, 92 had had a miscarriage between 10 and 20 weeks’ gestation, and 11 had had a stillbirth (loss at 20 weeks or later).
 

Most took no time off after miscarriage

After a miscarriage, 225 of 336 women (75%) took no time off work, and after a stillbirth, 5 of 11 (45%) took off 1 week or less, the authors found.

The study addressed an issue that people have talked about anecdotally or on social media, Dr. Rangel told this news organization.

“This was finally an opportunity to do a study of enough magnitude to show that there is a very quantifiable difference in complication rate, use of IVF [in vitro fertilization], and the age at which we have children. These are not just anecdotal stories,” she said.

For the study, a self-administered questionnaire was distributed electronically. Answers were collected from November 2020 to January 2021 through multiple U.S. surgical societies and social media among attending and resident surgeons with children. The control group for the study comprised 158 male surgeons who answered questions regarding their partners’ pregnancies.

Female surgeons had fewer children compared with male surgeons and their female partners (mean [SD],1.8 [0.8], versus 2.3 [1.1]; P < .001) and were more likely to delay having children because of surgical training (450 of 692 [65.0%] versus 69 of 158 [43.7%]; P < .001).

In addition, Dr. Rangel and colleagues found that 57% of female surgeons worked more than 60 hours a week during pregnancy and that 37% took more than six overnight calls.

The data show that female surgeons who operated 12 or more hours per week during the last trimester of pregnancy were at higher risk compared with those who operated fewer hours (odds ratio, 1.57; 95% confidence interval, 1.08-2.26).

“Pregnant surgeons should not be operating more than 12 hours a week when they are in the third trimester,” Dr. Rangel said.

“That is a modifiable risk factor,” she told this news organization. “It’s a very brief period of support – a couple of months of support for a woman who may do 25-30 more years of serving the public with surgical skills.”

She said that training programs should be organized so as to have colleagues cover operating room (OR) shifts to reduce the operating hours for pregnant colleagues. In addition, advanced practice health care professionals should be paid to take up the paperwork and perform non-OR care to reduce the stigma associated with pregnant trainees overburdening other surgical trainees.
 

‘It’s too big an ask’

Obstetrician-gynecologist Maryam Siddiqui, MD, said in an interview that she was particularly struck by the number of female surgeons who experience involuntary childlessness.

“That’s a big ask for people who want childbearing to be a part of the fulfillment of their life. It’s too big,” said Dr. Siddiqui, a gynecologic surgeon at UChicago Medicine.

She said the amount of detail in the article and the large number of participants were persuasive factors that can support establishing a more humane system than one in which one person at a time has to ask for change.

Pointing to the finding that three-fourths of the women in the study who had had miscarriages didn’t take time off, she said, “That’s not really humane. But they’re afraid to ask or they don’t want to reveal they’re trying [to get pregnant]. Why should you be afraid of building your family?”

The authors also found other adverse outcomes. Female surgeons were more likely to have musculoskeletal disorders compared with female nonsurgeon partners (36.9% versus 18.4%; P < .001), and they were more likely to undergo nonelective cesarean delivery (25.5% versus 15.3%; P = .01) and to experience postpartum depression (11.1% versus 5.7%; P = .04).

Dr. Siddiqui said the conditions that surgeons encounter on their return to work after childbirth are “a perfect storm” for postpartum depression among women who are not accustomed to being reliant on others.

Women often feel coerced into returning to work before they are physically or emotionally ready, then toggle back and forth from night shift to day shift, losing sleep, she said. “We can do better.”

One of the solutions, she said, is to provide better work coverage for the surgeon while she is pregnant and when she returns to work. That includes properly compensating the person covering for the surgeon by giving that person extra pay or additional time off.

“You have to value both people,” she said. “If both people are valued, there’s still collegiality.”

She acknowledged that that kind of compensation may be more readily available at large academic centers.

At UChicago, she said, they are creative with scheduling in training. For women at the height of pregnancy, rotations are less intensive, and trauma rotations are avoided.

Dr. Siddiqui said one of the most important aspects of the article is the authors’ list of two dozen ways, both big and small, to improve conditions.

Adopting such changes will become increasingly important for hiring and retaining female surgeons. “You want to work someplace where you’re respected as a whole person,” she said.

Sarah Blair, MD, a surgical oncologist at University of California, San Diego, stated that the number of miscarriages in particular provides disturbing proof of a problem women in surgery frequently discuss.

For nearly a decade, she led a women-in-surgery committee at UCSD in which they discussed such issues regarding pregnancy and medicine.

She said she hopes these data can help push for change in flexibility in residency so that women can graduate on time and have the families they want.

“There’s a movement away from time-based training to competency-based training, so maybe that will help women,” she said.
 

‘We have to figure this out’

“We will have to figure this out, because more than half of the people in medical school are women, and there are a lot more women in surgery than when I trained more than 20 years ago. It’s not a problem that’s going away,” she said.

One sign of improvement happened recently, Dr. Rangel said.

As previously reported, according to the American Board of Medical Specialties, as of July 1, 2021, residents and fellows are allowed a minimum 6 weeks away for medical leave or caregiving once during training, without having to use vacation time or sick leave and without having to extend their training.

“That’s huge,” she said. “But we still have a long way to go, because the residency programs still don’t have to have policy that abides that. It merely says you can take 6 weeks off and take your boards. It doesn’t say that the residency program has to allow you to take 6 weeks off.”

The authors noted that the United States and Papua New Guinea are the only countries in the world without federally mandated paid parental leave.

“Most U.S. female surgeons rely on their employer for this benefit, but only half of top-ranked medical schools offer paid leave, and 33%-65% of U.S. surgical training programs lack clear maternity leave policies,” she said.

Funding for the study was provided by the department of surgery at Brigham and Women’s Hospital. The study authors, Dr. Blair, and Dr. Siddiqui have disclosed no relevant financial relationships.

A version of this article first appeared on Medscape.com.

Since the U.S. Food and Drug Administration established its accelerated drug approval pathway 28 years ago, more than 2 in 5 drugs granted fast-track approval have not been confirmed clinically effective as required, an in-depth investigation published in The BMJ has determined.

“Despite the pathway’s good intentions to accelerate ‘the availability of drugs that treat serious diseases,’ experts are concerned that it is now being exploited – to the detriment of patients, who may be prescribed a drug that offers little benefit and possible harm, and to taxpayers,” writes Elisabeth Mahase, clinical reporter at The BMJ, who carried out the analysis.

The FDA’s accelerated approval pathway is intended to provide earlier access to drugs for serious diseases when there is lingering uncertainty at the time of approval regarding the drug’s ultimate clinical benefit.
 

Required studies rarely completed

As part of this fast-track pathway, drug manufacturers must conduct postapproval, phase 4 confirmatory trials to verify the anticipated clinical benefit. If these trials indicate no benefit, FDA approval can be withdrawn.

However, the analysis of FDA data shows once they are approved drugs are rarely taken off the market.

The BMJ investigation that analyzed data up to the end of 2020 shows that 112 of the 253 (44%) medications granted accelerated approval have not been confirmed to be effective.

In addition, 24 (21%) of these questionable drugs have been on the market for more than 5 years and some have been on the market for more than 20 years – often with a hefty price tag.

Furthermore, only 16 drugs approved through the accelerated approval process have ever been withdrawn, and most were shown to be ineffective, but in some cases the confirmatory trials were never done, Ms. Mahase reports.

For example, the COX-2 inhibitor celecoxib (Celebrex), which was granted accelerated approval in 1999 for the treatment of familial adenomatous polyposis, was on the market for 12 years before the FDA finally asked Pfizer to voluntarily withdraw it for this indication because efficacy trials were never completed.

As part of The BMJ’s investigation, Ms. Mahase asked manufacturers of the 24 drugs that have remained on the market for more than 5 years whether they had conducted the required phase 4 confirmatory trials. Six of the drugs had been withdrawn, approved, or postponed.

Of the remaining 18 drugs, the manufacturers provided the relevant trial information for only six. Only four drugmakers had started to recruit patients; two said they were still in discussion with the FDA over the final trial design.

“These products routinely have side effects, but the benefit information is a lot less certain. That’s what we’re concerned about – that we may have drugs on the market that don’t have any benefits, but certainly predictably have harms associated with them,” Huseyin Naci, PhD, MHS, with the London School of Economics, comments in the report.
 

Call for reform

As reported by this news organization, a 2015 report by the General Accountability Office (GAO) concluded that the FDA does not do an effective job of tracking the clinical efficacy or the safety of drugs with expedited approval after they hit the market.

In April of this year, the Institute for Clinical and Economic Review (ICER) cited a lack of “credible threats” to withdraw approval if companies don’t do confirmatory trials – meaning drugmakers have little incentive to do the trials.

“There are some instances where the companies really do seem to be taking advantage of the accelerated approval pathway and are using it in a way that makes it harder to get at the truth about whether these products really are safe and effective,” Rachel Sachs, JD, MPH, Washington University, St. Louis, said in The BMJ article.

In addition, the authors of a recent viewpoint article in JAMA Internal Medicine assert the recent approval of the controversial anti-amyloid drug aducanumab (Aduhelm, Biogen) shows that the accelerated approval pathway needs to be reformed.

Despite the concerns, Ms. Mahase said all experts who spoke to The BMJ believe the accelerated approval pathway is still useful and can be beneficial to patients, although some changes are needed.

One effective reform might be to have confirmatory trials designed, and even started, as part of accelerated approval.

“One important piece of the puzzle is for the FDA itself to be tougher on these companies, to hold them to the bargain that they have agreed to, and to take action when the company has not met their obligations,” Ms. Sachs told the journal.

An FDA spokesperson told the BMJ that the agency is “committed to working with sponsors to ensure that confirmatory studies are completed in a timely manner.”

“We expect sponsors to commit all resources needed to move trials forward as effectively as possible, with the aim of completing trials as soon as is feasible, while assuring the quality of the data and the robustness of the results,” the agency said.

A version of this article first appeared on Medscape.com.

Since the U.S. Food and Drug Administration established its accelerated drug approval pathway 28 years ago, more than 2 in 5 drugs granted fast-track approval have not been confirmed clinically effective as required, an in-depth investigation published in The BMJ has determined.

“Despite the pathway’s good intentions to accelerate ‘the availability of drugs that treat serious diseases,’ experts are concerned that it is now being exploited – to the detriment of patients, who may be prescribed a drug that offers little benefit and possible harm, and to taxpayers,” writes Elisabeth Mahase, clinical reporter at The BMJ, who carried out the analysis.

The FDA’s accelerated approval pathway is intended to provide earlier access to drugs for serious diseases when there is lingering uncertainty at the time of approval regarding the drug’s ultimate clinical benefit.
 

Required studies rarely completed

As part of this fast-track pathway, drug manufacturers must conduct postapproval, phase 4 confirmatory trials to verify the anticipated clinical benefit. If these trials indicate no benefit, FDA approval can be withdrawn.

However, the analysis of FDA data shows once they are approved drugs are rarely taken off the market.

The BMJ investigation that analyzed data up to the end of 2020 shows that 112 of the 253 (44%) medications granted accelerated approval have not been confirmed to be effective.

In addition, 24 (21%) of these questionable drugs have been on the market for more than 5 years and some have been on the market for more than 20 years – often with a hefty price tag.

Furthermore, only 16 drugs approved through the accelerated approval process have ever been withdrawn, and most were shown to be ineffective, but in some cases the confirmatory trials were never done, Ms. Mahase reports.

For example, the COX-2 inhibitor celecoxib (Celebrex), which was granted accelerated approval in 1999 for the treatment of familial adenomatous polyposis, was on the market for 12 years before the FDA finally asked Pfizer to voluntarily withdraw it for this indication because efficacy trials were never completed.

As part of The BMJ’s investigation, Ms. Mahase asked manufacturers of the 24 drugs that have remained on the market for more than 5 years whether they had conducted the required phase 4 confirmatory trials. Six of the drugs had been withdrawn, approved, or postponed.

Of the remaining 18 drugs, the manufacturers provided the relevant trial information for only six. Only four drugmakers had started to recruit patients; two said they were still in discussion with the FDA over the final trial design.

“These products routinely have side effects, but the benefit information is a lot less certain. That’s what we’re concerned about – that we may have drugs on the market that don’t have any benefits, but certainly predictably have harms associated with them,” Huseyin Naci, PhD, MHS, with the London School of Economics, comments in the report.
 

Call for reform

As reported by this news organization, a 2015 report by the General Accountability Office (GAO) concluded that the FDA does not do an effective job of tracking the clinical efficacy or the safety of drugs with expedited approval after they hit the market.

In April of this year, the Institute for Clinical and Economic Review (ICER) cited a lack of “credible threats” to withdraw approval if companies don’t do confirmatory trials – meaning drugmakers have little incentive to do the trials.

“There are some instances where the companies really do seem to be taking advantage of the accelerated approval pathway and are using it in a way that makes it harder to get at the truth about whether these products really are safe and effective,” Rachel Sachs, JD, MPH, Washington University, St. Louis, said in The BMJ article.

In addition, the authors of a recent viewpoint article in JAMA Internal Medicine assert the recent approval of the controversial anti-amyloid drug aducanumab (Aduhelm, Biogen) shows that the accelerated approval pathway needs to be reformed.

Despite the concerns, Ms. Mahase said all experts who spoke to The BMJ believe the accelerated approval pathway is still useful and can be beneficial to patients, although some changes are needed.

One effective reform might be to have confirmatory trials designed, and even started, as part of accelerated approval.

“One important piece of the puzzle is for the FDA itself to be tougher on these companies, to hold them to the bargain that they have agreed to, and to take action when the company has not met their obligations,” Ms. Sachs told the journal.

An FDA spokesperson told the BMJ that the agency is “committed to working with sponsors to ensure that confirmatory studies are completed in a timely manner.”

“We expect sponsors to commit all resources needed to move trials forward as effectively as possible, with the aim of completing trials as soon as is feasible, while assuring the quality of the data and the robustness of the results,” the agency said.

A version of this article first appeared on Medscape.com.

Since the U.S. Food and Drug Administration established its accelerated drug approval pathway 28 years ago, more than 2 in 5 drugs granted fast-track approval have not been confirmed clinically effective as required, an in-depth investigation published in The BMJ has determined.

“Despite the pathway’s good intentions to accelerate ‘the availability of drugs that treat serious diseases,’ experts are concerned that it is now being exploited – to the detriment of patients, who may be prescribed a drug that offers little benefit and possible harm, and to taxpayers,” writes Elisabeth Mahase, clinical reporter at The BMJ, who carried out the analysis.

The FDA’s accelerated approval pathway is intended to provide earlier access to drugs for serious diseases when there is lingering uncertainty at the time of approval regarding the drug’s ultimate clinical benefit.
 

Required studies rarely completed

As part of this fast-track pathway, drug manufacturers must conduct postapproval, phase 4 confirmatory trials to verify the anticipated clinical benefit. If these trials indicate no benefit, FDA approval can be withdrawn.

However, the analysis of FDA data shows once they are approved drugs are rarely taken off the market.

The BMJ investigation that analyzed data up to the end of 2020 shows that 112 of the 253 (44%) medications granted accelerated approval have not been confirmed to be effective.

In addition, 24 (21%) of these questionable drugs have been on the market for more than 5 years and some have been on the market for more than 20 years – often with a hefty price tag.

Furthermore, only 16 drugs approved through the accelerated approval process have ever been withdrawn, and most were shown to be ineffective, but in some cases the confirmatory trials were never done, Ms. Mahase reports.

For example, the COX-2 inhibitor celecoxib (Celebrex), which was granted accelerated approval in 1999 for the treatment of familial adenomatous polyposis, was on the market for 12 years before the FDA finally asked Pfizer to voluntarily withdraw it for this indication because efficacy trials were never completed.

As part of The BMJ’s investigation, Ms. Mahase asked manufacturers of the 24 drugs that have remained on the market for more than 5 years whether they had conducted the required phase 4 confirmatory trials. Six of the drugs had been withdrawn, approved, or postponed.

Of the remaining 18 drugs, the manufacturers provided the relevant trial information for only six. Only four drugmakers had started to recruit patients; two said they were still in discussion with the FDA over the final trial design.

“These products routinely have side effects, but the benefit information is a lot less certain. That’s what we’re concerned about – that we may have drugs on the market that don’t have any benefits, but certainly predictably have harms associated with them,” Huseyin Naci, PhD, MHS, with the London School of Economics, comments in the report.
 

Call for reform

As reported by this news organization, a 2015 report by the General Accountability Office (GAO) concluded that the FDA does not do an effective job of tracking the clinical efficacy or the safety of drugs with expedited approval after they hit the market.

In April of this year, the Institute for Clinical and Economic Review (ICER) cited a lack of “credible threats” to withdraw approval if companies don’t do confirmatory trials – meaning drugmakers have little incentive to do the trials.

“There are some instances where the companies really do seem to be taking advantage of the accelerated approval pathway and are using it in a way that makes it harder to get at the truth about whether these products really are safe and effective,” Rachel Sachs, JD, MPH, Washington University, St. Louis, said in The BMJ article.

In addition, the authors of a recent viewpoint article in JAMA Internal Medicine assert the recent approval of the controversial anti-amyloid drug aducanumab (Aduhelm, Biogen) shows that the accelerated approval pathway needs to be reformed.

Despite the concerns, Ms. Mahase said all experts who spoke to The BMJ believe the accelerated approval pathway is still useful and can be beneficial to patients, although some changes are needed.

One effective reform might be to have confirmatory trials designed, and even started, as part of accelerated approval.

“One important piece of the puzzle is for the FDA itself to be tougher on these companies, to hold them to the bargain that they have agreed to, and to take action when the company has not met their obligations,” Ms. Sachs told the journal.

An FDA spokesperson told the BMJ that the agency is “committed to working with sponsors to ensure that confirmatory studies are completed in a timely manner.”

“We expect sponsors to commit all resources needed to move trials forward as effectively as possible, with the aim of completing trials as soon as is feasible, while assuring the quality of the data and the robustness of the results,” the agency said.

A version of this article first appeared on Medscape.com.

The Centers for Disease Control and Prevention Director Rochelle Walensky, MD, MPH, made a dire prediction during a media briefing this week that, if we weren’t already living within the reality of the COVID-19 pandemic, would sound more like a pitch for a movie about a dystopian future.

“For the amount of virus circulating in this country right now largely among unvaccinated people, the largest concern that we in public health and science are worried about is that the virus … [becomes] a very transmissible virus that has the potential to evade our vaccines in terms of how it protects us from severe disease and death,” Dr. Walensky told reporters on July 27. 

A new, more elusive variant could be “just a few mutations away,” she said.

“That’s a very prescient comment,” Lewis Nelson, MD, professor and clinical chair of emergency medicine and chief of the division of medical toxicology at Rutgers New Jersey Medical School in Newark, told this news organization.

“We’ve gone through a few mutations already that have been named, and each one of them gets a little more transmissible,” he said. “That’s normal, natural selection and what you would expect to happen as viruses mutate from one strain to another.”

“What we’ve mostly seen this virus do is evolve to become more infectious,” said Stuart Ray, MD, when also asked to comment. “That is the remarkable feature of Delta – that it is so infectious.”

He said that the SARS-CoV-2 has evolved largely as expected, at least so far. “The potential for this virus to mutate has been something that has been a concern from early on.”

“The viral evolution is a bit like a ticking clock. The more we allow infections to occur, the more likely changes will occur. When we have lots of people infected, we give more chances to the virus to diversify and then adapt to selective pressures,” said Dr. Ray, vice-chair of medicine for data integrity and analytics and professor in the division of infectious diseases at Johns Hopkins School of Medicine in Baltimore.

“The problem is if the virus changes in such a way that the spike protein – which the antibodies from the vaccine are directed against – are no longer effective at binding and destroying the virus, and the virus escapes immune surveillance,” Dr. Nelson said.

If this occurs, he added, “we will have an ineffective vaccine, essentially. And we’ll be back to where we were last March with a brand-new disease.”
 

Technology to the rescue?

The flexibility of mRNA vaccines is one potential solution. These vaccines could be more easily and quickly adapted to respond to a new, more vaccine-elusive variant.

“That’s absolutely reassuring,” Dr. Nelson said. For example, if a mutation changes the spike protein and vaccines no longer recognize it, a manufacturer could identify the new protein and incorporate that in a new mRNA vaccine.

“The problem is that some people are not taking the current vaccine,” he added. “I’m not sure what is going to make them take the next vaccine.”
 

Nothing appears certain

When asked how likely a new strain of SARS-CoV-2 could emerge that gets around vaccine protection, Dr. Nelson said, “I think [what] we’ve learned so far there is no way to predict anything” about this pandemic.

“The best way to prevent the virus from mutating is to prevent hosts, people, from getting sick with it,” he said. “That’s why it’s so important people should get immunized and wear masks.”

Both Dr. Nelson and Dr. Ray pointed out that it is in the best interest of the virus to evolve to be more transmissible and spread to more people. In contrast, a virus that causes people to get so sick that they isolate or die, thus halting transmission, works against viruses surviving evolutionarily.

Some viruses also mutate to become milder over time, but that has not been the case with SARS-CoV-2, Dr. Ray said.
 

Mutations not the only concern

Viruses have another mechanism that produces new strains, and it works even more quickly than mutations. Recombination, as it’s known, can occur when a person is infected with two different strains of the same virus. If the two versions enter the same cell, the viruses can swap genetic material and produce a third, altogether different strain.

Recombination has already been seen with influenza strains, where H and N genetic segments are swapped to yield H1N1, H1N2, and H3N2 versions of the flu, for example.

“In the early days of SARS-CoV-2 there was so little diversity that recombination did not matter,” Dr. Ray said. However, there are now distinct lineages of the virus circulating globally. If two of these lineages swap segments “this would make a very new viral sequence in one step without having to mutate to gain those differences.”

“The more diverse the strains that are circulating, the bigger a possibility this is,” Dr. Ray said.
 

Protected, for now

Dr. Walensky’s sober warning came at the same time the CDC released new guidance calling for the wearing of masks indoors in schools and in any location in the country where COVID-19 cases surpass 50 people per 100,000, also known as substantial or high transmission areas.

On a positive note, Dr. Walensky said: “Right now, fortunately, we are not there. The vaccines operate really well in protecting us from severe disease and death.”

A version of this article first appeared on Medscape.com.

The Centers for Disease Control and Prevention Director Rochelle Walensky, MD, MPH, made a dire prediction during a media briefing this week that, if we weren’t already living within the reality of the COVID-19 pandemic, would sound more like a pitch for a movie about a dystopian future.

“For the amount of virus circulating in this country right now largely among unvaccinated people, the largest concern that we in public health and science are worried about is that the virus … [becomes] a very transmissible virus that has the potential to evade our vaccines in terms of how it protects us from severe disease and death,” Dr. Walensky told reporters on July 27. 

A new, more elusive variant could be “just a few mutations away,” she said.

“That’s a very prescient comment,” Lewis Nelson, MD, professor and clinical chair of emergency medicine and chief of the division of medical toxicology at Rutgers New Jersey Medical School in Newark, told this news organization.

“We’ve gone through a few mutations already that have been named, and each one of them gets a little more transmissible,” he said. “That’s normal, natural selection and what you would expect to happen as viruses mutate from one strain to another.”

“What we’ve mostly seen this virus do is evolve to become more infectious,” said Stuart Ray, MD, when also asked to comment. “That is the remarkable feature of Delta – that it is so infectious.”

He said that the SARS-CoV-2 has evolved largely as expected, at least so far. “The potential for this virus to mutate has been something that has been a concern from early on.”

“The viral evolution is a bit like a ticking clock. The more we allow infections to occur, the more likely changes will occur. When we have lots of people infected, we give more chances to the virus to diversify and then adapt to selective pressures,” said Dr. Ray, vice-chair of medicine for data integrity and analytics and professor in the division of infectious diseases at Johns Hopkins School of Medicine in Baltimore.

“The problem is if the virus changes in such a way that the spike protein – which the antibodies from the vaccine are directed against – are no longer effective at binding and destroying the virus, and the virus escapes immune surveillance,” Dr. Nelson said.

If this occurs, he added, “we will have an ineffective vaccine, essentially. And we’ll be back to where we were last March with a brand-new disease.”
 

Technology to the rescue?

The flexibility of mRNA vaccines is one potential solution. These vaccines could be more easily and quickly adapted to respond to a new, more vaccine-elusive variant.

“That’s absolutely reassuring,” Dr. Nelson said. For example, if a mutation changes the spike protein and vaccines no longer recognize it, a manufacturer could identify the new protein and incorporate that in a new mRNA vaccine.

“The problem is that some people are not taking the current vaccine,” he added. “I’m not sure what is going to make them take the next vaccine.”
 

Nothing appears certain

When asked how likely a new strain of SARS-CoV-2 could emerge that gets around vaccine protection, Dr. Nelson said, “I think [what] we’ve learned so far there is no way to predict anything” about this pandemic.

“The best way to prevent the virus from mutating is to prevent hosts, people, from getting sick with it,” he said. “That’s why it’s so important people should get immunized and wear masks.”

Both Dr. Nelson and Dr. Ray pointed out that it is in the best interest of the virus to evolve to be more transmissible and spread to more people. In contrast, a virus that causes people to get so sick that they isolate or die, thus halting transmission, works against viruses surviving evolutionarily.

Some viruses also mutate to become milder over time, but that has not been the case with SARS-CoV-2, Dr. Ray said.
 

Mutations not the only concern

Viruses have another mechanism that produces new strains, and it works even more quickly than mutations. Recombination, as it’s known, can occur when a person is infected with two different strains of the same virus. If the two versions enter the same cell, the viruses can swap genetic material and produce a third, altogether different strain.

Recombination has already been seen with influenza strains, where H and N genetic segments are swapped to yield H1N1, H1N2, and H3N2 versions of the flu, for example.

“In the early days of SARS-CoV-2 there was so little diversity that recombination did not matter,” Dr. Ray said. However, there are now distinct lineages of the virus circulating globally. If two of these lineages swap segments “this would make a very new viral sequence in one step without having to mutate to gain those differences.”

“The more diverse the strains that are circulating, the bigger a possibility this is,” Dr. Ray said.
 

Protected, for now

Dr. Walensky’s sober warning came at the same time the CDC released new guidance calling for the wearing of masks indoors in schools and in any location in the country where COVID-19 cases surpass 50 people per 100,000, also known as substantial or high transmission areas.

On a positive note, Dr. Walensky said: “Right now, fortunately, we are not there. The vaccines operate really well in protecting us from severe disease and death.”

A version of this article first appeared on Medscape.com.

The Centers for Disease Control and Prevention Director Rochelle Walensky, MD, MPH, made a dire prediction during a media briefing this week that, if we weren’t already living within the reality of the COVID-19 pandemic, would sound more like a pitch for a movie about a dystopian future.

“For the amount of virus circulating in this country right now largely among unvaccinated people, the largest concern that we in public health and science are worried about is that the virus … [becomes] a very transmissible virus that has the potential to evade our vaccines in terms of how it protects us from severe disease and death,” Dr. Walensky told reporters on July 27. 

A new, more elusive variant could be “just a few mutations away,” she said.

“That’s a very prescient comment,” Lewis Nelson, MD, professor and clinical chair of emergency medicine and chief of the division of medical toxicology at Rutgers New Jersey Medical School in Newark, told this news organization.

“We’ve gone through a few mutations already that have been named, and each one of them gets a little more transmissible,” he said. “That’s normal, natural selection and what you would expect to happen as viruses mutate from one strain to another.”

“What we’ve mostly seen this virus do is evolve to become more infectious,” said Stuart Ray, MD, when also asked to comment. “That is the remarkable feature of Delta – that it is so infectious.”

He said that the SARS-CoV-2 has evolved largely as expected, at least so far. “The potential for this virus to mutate has been something that has been a concern from early on.”

“The viral evolution is a bit like a ticking clock. The more we allow infections to occur, the more likely changes will occur. When we have lots of people infected, we give more chances to the virus to diversify and then adapt to selective pressures,” said Dr. Ray, vice-chair of medicine for data integrity and analytics and professor in the division of infectious diseases at Johns Hopkins School of Medicine in Baltimore.

“The problem is if the virus changes in such a way that the spike protein – which the antibodies from the vaccine are directed against – are no longer effective at binding and destroying the virus, and the virus escapes immune surveillance,” Dr. Nelson said.

If this occurs, he added, “we will have an ineffective vaccine, essentially. And we’ll be back to where we were last March with a brand-new disease.”
 

Technology to the rescue?

The flexibility of mRNA vaccines is one potential solution. These vaccines could be more easily and quickly adapted to respond to a new, more vaccine-elusive variant.

“That’s absolutely reassuring,” Dr. Nelson said. For example, if a mutation changes the spike protein and vaccines no longer recognize it, a manufacturer could identify the new protein and incorporate that in a new mRNA vaccine.

“The problem is that some people are not taking the current vaccine,” he added. “I’m not sure what is going to make them take the next vaccine.”
 

Nothing appears certain

When asked how likely a new strain of SARS-CoV-2 could emerge that gets around vaccine protection, Dr. Nelson said, “I think [what] we’ve learned so far there is no way to predict anything” about this pandemic.

“The best way to prevent the virus from mutating is to prevent hosts, people, from getting sick with it,” he said. “That’s why it’s so important people should get immunized and wear masks.”

Both Dr. Nelson and Dr. Ray pointed out that it is in the best interest of the virus to evolve to be more transmissible and spread to more people. In contrast, a virus that causes people to get so sick that they isolate or die, thus halting transmission, works against viruses surviving evolutionarily.

Some viruses also mutate to become milder over time, but that has not been the case with SARS-CoV-2, Dr. Ray said.
 

Mutations not the only concern

Viruses have another mechanism that produces new strains, and it works even more quickly than mutations. Recombination, as it’s known, can occur when a person is infected with two different strains of the same virus. If the two versions enter the same cell, the viruses can swap genetic material and produce a third, altogether different strain.

Recombination has already been seen with influenza strains, where H and N genetic segments are swapped to yield H1N1, H1N2, and H3N2 versions of the flu, for example.

“In the early days of SARS-CoV-2 there was so little diversity that recombination did not matter,” Dr. Ray said. However, there are now distinct lineages of the virus circulating globally. If two of these lineages swap segments “this would make a very new viral sequence in one step without having to mutate to gain those differences.”

“The more diverse the strains that are circulating, the bigger a possibility this is,” Dr. Ray said.
 

Protected, for now

Dr. Walensky’s sober warning came at the same time the CDC released new guidance calling for the wearing of masks indoors in schools and in any location in the country where COVID-19 cases surpass 50 people per 100,000, also known as substantial or high transmission areas.

On a positive note, Dr. Walensky said: “Right now, fortunately, we are not there. The vaccines operate really well in protecting us from severe disease and death.”

A version of this article first appeared on Medscape.com.

About one-third of U.S. adults struggled with medical debt during the pandemic, according to data from a Commonwealth Fund survey released July 16.

Despite the passage of four major relief bills in 2020 and 2021 and federal efforts to offset pandemic- and job-related coverage loss, many people continued to face financial challenges, especially those with a low income and those who are Black or Latino.

The survey, which included responses from 5,450 adults, revealed that 10% of adults aged 19-64 were uninsured during the first half of 2021, a rate lower than what was recorded in 2020 and 2019 in both federal and private surveys. However, uninsured rates were highest among those with low income, those younger than 50 years old, and Black and Latino adults.

For most adults who lost employee health insurance, the coverage gap was relatively brief, with 54% saying their coverage gap lasted 3-4 months. Only 16% of adults said coverage gaps lasted a year or longer.

“The good news is that this survey is suggesting that the coverage losses during the pandemic may have been offset by federal efforts to help people get and maintain health insurance coverage,” lead author Sara Collins, PhD, Commonwealth Fund vice president for health care coverage, access, and tracking, said in an interview.

“The bad news is that a third of Americans continue to struggle with medical bills and medical debt, even among those who have health insurance coverage,” Dr. Collins added.

Indeed, the survey found that about one-third of insured adults reported a medical bill problem or that they were paying off medical debt, as did approximately half of those who were uninsured. Medical debt caused 35% of respondents to use up most or all of their savings to pay it off.

Meanwhile, 27% of adults said medical bills left them unable to pay for necessities such as food, heat, or rent. What surprised Dr. Collins was that 43% of adults said they received a lower credit rating as a result of their medical debt, and 35% said they had taken on more credit card debt to pay off these bills.

“The fact that it’s bleeding over into people’s financial security in terms of their credit scores, I think is something that really needs to be looked at by policymakers,” Dr. Collins said.

When analyzed by race/ethnicity, the researchers found that 55% of Black adults and 44% of Latino/Hispanic adults reported medical bills and debt problems, compared with 32% of White adults. In addition, 47% of those living below the poverty line also reported problems with medical bills.

According to the survey, 45% of respondents were directly affected by the pandemic in at least one of three ways – testing positive or getting sick from COVID-19, losing income, or losing employer coverage – with Black and Latinx adults and those with lower incomes at greater risk.

George Abraham, MD, president of the American College of Physicians, said the Commonwealth Fund’s findings were not surprising because it has always been known that underrepresented populations struggle for access to care because of socioeconomic factors. He said these populations were more vulnerable in terms of more severe infections and disease burden during the pandemic.

“[This study] validates what primary care physicians have been saying all along in regard to our patients’ access to care and their ability to cover health care costs,” said Dr. Abraham, who was not involved with the study. “This will hopefully be an eye-opener and wake-up call that reiterates that we still do not have equitable access to care and vulnerable populations are disproportionately affected.”

He believes that, although people are insured, many of them may contend with medical debt when they fall ill because they can’t afford the premiums.

“Even though they may have been registered for health coverage, they may not have active coverage at the time of illness simply because they weren’t able to make their last premium payments because they’ve been down, because they lost their job, or whatever else,” Dr. Abraham explained. “On paper, they appear to have health care coverage. But in reality, clearly, that coverage does not match their needs or it’s not affordable.”

For Dr. Abraham, the study emphasizes the need to continue support for health care reform, including pricing it so that insurance is available for those with fewer socioeconomic resources.

Yalda Jabbarpour, MD, medical director of the Robert Graham Center for Policy Studies, Washington, said high-deductible health plans need to be “reined in” because they can lead to greater debt, particularly among vulnerable populations.

“Hopefully this will encourage policymakers to look more closely at the problem of medical debt as a contributing factor to financial instability,” Dr. Jabbarpour said. “Federal relief is important, so is expanding access to comprehensive, affordable health care coverage.”

Dr. Collins said there should also be a way to raise awareness of the health care marketplace and coverage options so that people have an easier time getting insured.

A version of this article first appeared on Medscape.com.

About one-third of U.S. adults struggled with medical debt during the pandemic, according to data from a Commonwealth Fund survey released July 16.

Despite the passage of four major relief bills in 2020 and 2021 and federal efforts to offset pandemic- and job-related coverage loss, many people continued to face financial challenges, especially those with a low income and those who are Black or Latino.

The survey, which included responses from 5,450 adults, revealed that 10% of adults aged 19-64 were uninsured during the first half of 2021, a rate lower than what was recorded in 2020 and 2019 in both federal and private surveys. However, uninsured rates were highest among those with low income, those younger than 50 years old, and Black and Latino adults.

For most adults who lost employee health insurance, the coverage gap was relatively brief, with 54% saying their coverage gap lasted 3-4 months. Only 16% of adults said coverage gaps lasted a year or longer.

“The good news is that this survey is suggesting that the coverage losses during the pandemic may have been offset by federal efforts to help people get and maintain health insurance coverage,” lead author Sara Collins, PhD, Commonwealth Fund vice president for health care coverage, access, and tracking, said in an interview.

“The bad news is that a third of Americans continue to struggle with medical bills and medical debt, even among those who have health insurance coverage,” Dr. Collins added.

Indeed, the survey found that about one-third of insured adults reported a medical bill problem or that they were paying off medical debt, as did approximately half of those who were uninsured. Medical debt caused 35% of respondents to use up most or all of their savings to pay it off.

Meanwhile, 27% of adults said medical bills left them unable to pay for necessities such as food, heat, or rent. What surprised Dr. Collins was that 43% of adults said they received a lower credit rating as a result of their medical debt, and 35% said they had taken on more credit card debt to pay off these bills.

“The fact that it’s bleeding over into people’s financial security in terms of their credit scores, I think is something that really needs to be looked at by policymakers,” Dr. Collins said.

When analyzed by race/ethnicity, the researchers found that 55% of Black adults and 44% of Latino/Hispanic adults reported medical bills and debt problems, compared with 32% of White adults. In addition, 47% of those living below the poverty line also reported problems with medical bills.

According to the survey, 45% of respondents were directly affected by the pandemic in at least one of three ways – testing positive or getting sick from COVID-19, losing income, or losing employer coverage – with Black and Latinx adults and those with lower incomes at greater risk.

George Abraham, MD, president of the American College of Physicians, said the Commonwealth Fund’s findings were not surprising because it has always been known that underrepresented populations struggle for access to care because of socioeconomic factors. He said these populations were more vulnerable in terms of more severe infections and disease burden during the pandemic.

“[This study] validates what primary care physicians have been saying all along in regard to our patients’ access to care and their ability to cover health care costs,” said Dr. Abraham, who was not involved with the study. “This will hopefully be an eye-opener and wake-up call that reiterates that we still do not have equitable access to care and vulnerable populations are disproportionately affected.”

He believes that, although people are insured, many of them may contend with medical debt when they fall ill because they can’t afford the premiums.

“Even though they may have been registered for health coverage, they may not have active coverage at the time of illness simply because they weren’t able to make their last premium payments because they’ve been down, because they lost their job, or whatever else,” Dr. Abraham explained. “On paper, they appear to have health care coverage. But in reality, clearly, that coverage does not match their needs or it’s not affordable.”

For Dr. Abraham, the study emphasizes the need to continue support for health care reform, including pricing it so that insurance is available for those with fewer socioeconomic resources.

Yalda Jabbarpour, MD, medical director of the Robert Graham Center for Policy Studies, Washington, said high-deductible health plans need to be “reined in” because they can lead to greater debt, particularly among vulnerable populations.

“Hopefully this will encourage policymakers to look more closely at the problem of medical debt as a contributing factor to financial instability,” Dr. Jabbarpour said. “Federal relief is important, so is expanding access to comprehensive, affordable health care coverage.”

Dr. Collins said there should also be a way to raise awareness of the health care marketplace and coverage options so that people have an easier time getting insured.

A version of this article first appeared on Medscape.com.

About one-third of U.S. adults struggled with medical debt during the pandemic, according to data from a Commonwealth Fund survey released July 16.

Despite the passage of four major relief bills in 2020 and 2021 and federal efforts to offset pandemic- and job-related coverage loss, many people continued to face financial challenges, especially those with a low income and those who are Black or Latino.

The survey, which included responses from 5,450 adults, revealed that 10% of adults aged 19-64 were uninsured during the first half of 2021, a rate lower than what was recorded in 2020 and 2019 in both federal and private surveys. However, uninsured rates were highest among those with low income, those younger than 50 years old, and Black and Latino adults.

For most adults who lost employee health insurance, the coverage gap was relatively brief, with 54% saying their coverage gap lasted 3-4 months. Only 16% of adults said coverage gaps lasted a year or longer.

“The good news is that this survey is suggesting that the coverage losses during the pandemic may have been offset by federal efforts to help people get and maintain health insurance coverage,” lead author Sara Collins, PhD, Commonwealth Fund vice president for health care coverage, access, and tracking, said in an interview.

“The bad news is that a third of Americans continue to struggle with medical bills and medical debt, even among those who have health insurance coverage,” Dr. Collins added.

Indeed, the survey found that about one-third of insured adults reported a medical bill problem or that they were paying off medical debt, as did approximately half of those who were uninsured. Medical debt caused 35% of respondents to use up most or all of their savings to pay it off.

Meanwhile, 27% of adults said medical bills left them unable to pay for necessities such as food, heat, or rent. What surprised Dr. Collins was that 43% of adults said they received a lower credit rating as a result of their medical debt, and 35% said they had taken on more credit card debt to pay off these bills.

“The fact that it’s bleeding over into people’s financial security in terms of their credit scores, I think is something that really needs to be looked at by policymakers,” Dr. Collins said.

When analyzed by race/ethnicity, the researchers found that 55% of Black adults and 44% of Latino/Hispanic adults reported medical bills and debt problems, compared with 32% of White adults. In addition, 47% of those living below the poverty line also reported problems with medical bills.

According to the survey, 45% of respondents were directly affected by the pandemic in at least one of three ways – testing positive or getting sick from COVID-19, losing income, or losing employer coverage – with Black and Latinx adults and those with lower incomes at greater risk.

George Abraham, MD, president of the American College of Physicians, said the Commonwealth Fund’s findings were not surprising because it has always been known that underrepresented populations struggle for access to care because of socioeconomic factors. He said these populations were more vulnerable in terms of more severe infections and disease burden during the pandemic.

“[This study] validates what primary care physicians have been saying all along in regard to our patients’ access to care and their ability to cover health care costs,” said Dr. Abraham, who was not involved with the study. “This will hopefully be an eye-opener and wake-up call that reiterates that we still do not have equitable access to care and vulnerable populations are disproportionately affected.”

He believes that, although people are insured, many of them may contend with medical debt when they fall ill because they can’t afford the premiums.

“Even though they may have been registered for health coverage, they may not have active coverage at the time of illness simply because they weren’t able to make their last premium payments because they’ve been down, because they lost their job, or whatever else,” Dr. Abraham explained. “On paper, they appear to have health care coverage. But in reality, clearly, that coverage does not match their needs or it’s not affordable.”

For Dr. Abraham, the study emphasizes the need to continue support for health care reform, including pricing it so that insurance is available for those with fewer socioeconomic resources.

Yalda Jabbarpour, MD, medical director of the Robert Graham Center for Policy Studies, Washington, said high-deductible health plans need to be “reined in” because they can lead to greater debt, particularly among vulnerable populations.

“Hopefully this will encourage policymakers to look more closely at the problem of medical debt as a contributing factor to financial instability,” Dr. Jabbarpour said. “Federal relief is important, so is expanding access to comprehensive, affordable health care coverage.”

Dr. Collins said there should also be a way to raise awareness of the health care marketplace and coverage options so that people have an easier time getting insured.

A version of this article first appeared on Medscape.com.

The Centers for Disease Control and Prevention is expected to announce this week that new data show people vaccinated against COVID-19 who become infected with the Delta variant can spread it and infect others, The New York Times reported late on July 29.

The revelation is one reason the agency reversed course this week and said fully vaccinated people should go back to wearing masks in many cases.

The new findings also are a reversal from what scientists had believed to be true about other variants of the virus, the Times said. The bottom line is that the CDC data show people with so-called breakthrough cases of the Delta variant may be just as contagious as unvaccinated people, even if they do not show symptoms.

ABC News reported earlier on July 29 that the CDC’s updated mask guidance followed an outbreak in Cape Cod, where crowds gathered for the Fourth of July.

As of July 29, 882 people were tied to the outbreak centered in Provincetown, Mass. Of those who live in Massachusetts, 74% were unvaccinated. ABC said the majority were showing symptoms of COVID-19.

The Centers for Disease Control and Prevention is expected to announce this week that new data show people vaccinated against COVID-19 who become infected with the Delta variant can spread it and infect others, The New York Times reported late on July 29.

The revelation is one reason the agency reversed course this week and said fully vaccinated people should go back to wearing masks in many cases.

The new findings also are a reversal from what scientists had believed to be true about other variants of the virus, the Times said. The bottom line is that the CDC data show people with so-called breakthrough cases of the Delta variant may be just as contagious as unvaccinated people, even if they do not show symptoms.

ABC News reported earlier on July 29 that the CDC’s updated mask guidance followed an outbreak in Cape Cod, where crowds gathered for the Fourth of July.

As of July 29, 882 people were tied to the outbreak centered in Provincetown, Mass. Of those who live in Massachusetts, 74% were unvaccinated. ABC said the majority were showing symptoms of COVID-19.

The Centers for Disease Control and Prevention is expected to announce this week that new data show people vaccinated against COVID-19 who become infected with the Delta variant can spread it and infect others, The New York Times reported late on July 29.

The revelation is one reason the agency reversed course this week and said fully vaccinated people should go back to wearing masks in many cases.

The new findings also are a reversal from what scientists had believed to be true about other variants of the virus, the Times said. The bottom line is that the CDC data show people with so-called breakthrough cases of the Delta variant may be just as contagious as unvaccinated people, even if they do not show symptoms.

ABC News reported earlier on July 29 that the CDC’s updated mask guidance followed an outbreak in Cape Cod, where crowds gathered for the Fourth of July.

As of July 29, 882 people were tied to the outbreak centered in Provincetown, Mass. Of those who live in Massachusetts, 74% were unvaccinated. ABC said the majority were showing symptoms of COVID-19.

Adult women with acne describe significant impacts on their lived experience of acne, including concerns about appearance, mental and emotional health consequences, and disruption to their personal and professional lives, results from a qualitative study demonstrated.

“Nearly 50% of women experience acne in their 20s, and 35% experience acne in their 30s,” the study’s corresponding author, John S. Barbieri, MD, MBA, formerly of the department of dermatology at the University of Pennsylvania, Philadelphia, told this news organization. “While several qualitative studies have examined acne in adolescence, the lived experience of adult female acne has not been explored in detail and prior studies have included relatively few patients. As a result, we conducted a series of semistructured interviews among adult women with acne to examine the lived experience of adult acne and its treatment.”

For the study, published online July 28, 2021, in JAMA Dermatology, Dr. Barbieri and colleagues conducted voluntary, confidential phone interviews with 50 women aged between 18 and 40 years with moderate to severe acne who were recruited from the University of Pennsylvania Health System and from a private dermatology clinic in Cincinnati. They used free listing and open-ended, semistructured interviews to elicit opinions from the women on how acne affected their lives; their experience with acne treatments, dermatologists, and health care systems; as well as their views on treatment success.

The mean age of the participants was 28 years and 48% were white (10% were Black, 8% were Asian, 4% were more than one race, and the rest abstained from answering this question; 10% said they were Hispanic).

More than three-quarters (78%) reported prior treatment with topical retinoids, followed by spironolactone (70%), topical antibiotics (43%), combined oral contraceptives (43%), and isotretinoin (41%). During the free-listing part of interviews, where the women reported the first words that came to their mind when asked about success of treatment and adverse effects, the most important terms expressed related to treatment success were clear skin, no scarring, and no acne. The most important terms related to treatment adverse effects were dryness, redness, and burning.

In the semistructured interview portion of the study, the main themes expressed were acne-related concerns about appearance, including feeling less confident at work; mental and emotional health, including feelings of depression, anxiety, depression, and low self-worth during acne breakouts; and everyday life impact, including the notion that acne affected how other people perceived them. The other main themes included successful treatment, with clear skin and having a manageable number of lesions being desirable outcomes; and interactions with health care, including varied experiences with dermatologists. The researchers observed that most participants did not think oral antibiotics were appropriate treatments for their acne, specifically because of limited long-term effectiveness.

“Many patients described frustration with finding a dermatologist with whom they were comfortable and with identifying effective treatments for their acne,” the authors wrote. “In contrast, those who thought their dermatologist listened to their concerns and individualized their treatment plan reported higher levels of satisfaction.”

In an interview, Dr. Barbieri, who is now with the department of dermatology at Brigham and Women’s Hospital, Boston, said that he was surprised by how many patients expressed interest in nonantibiotic treatments for acne, “given that oral antibiotics are by far the most commonly prescribed systemic treatment for acne.”

Moreover, he added, “although I have experienced many patients being hesitant about isotretinoin, I was surprised by how strong patients’ concerns were about isotretinoin side effects. Unfortunately, there are many misconceptions about isotretinoin that limit use of this treatment that can be highly effective and safe for the appropriate patient.”

In an accompanying editorial, dermatologists Diane M. Thiboutot, MD and Andrea L. Zaenglein, MD, with Penn State University, Hershey, and Alison M. Layton, MB, ChB, with the Harrogate Foundation Trust, Harrogate, North Yorkshire, England, wrote that the findings from the study “resonate with those recently reported in several international studies that examine the impacts of acne, how patients assess treatment success, and what is important to measure from a patient and health care professional perspective in a clinical trial for acne.”

A large systematic review on the impact of acne on patients, conducted by the Acne Core Outcomes Research Network (ACORN), found that “appearance-related concerns and negative psychosocial effects were found to be a major impact of acne,” they noted. “Surprisingly, only 22 of the 473 studies identified in this review included qualitative data gathered from patient interviews. It is encouraging to see the concordance between the concerns voiced by the participants in the current study and those identified from the literature review, wherein a variety of methods were used to assess acne impacts.”

For his part, Dr. Barbieri said that the study findings “justify the importance of having a discussion with patients about their unique lived experience of acne and individualizing treatment to their specific needs. Patient reported outcome measures could be a useful adjunctive tool to capture these impacts on quality of life.”

This study was funded by grant from the National Institute of Arthritis and Musculoskeletal and Skin Diseases. Dr. Barbieri disclosed that he received partial salary support through a Pfizer Fellowship in Dermatology Patient Oriented Research grant to the Trustees of the University of Pennsylvania. Dr. Thiboutot reported receiving consultant fees from Galderma and Novartis outside the submitted work. Dr. Layton reported receiving unrestricted educational presentation, advisory board, and consultancy fees from Galderma Honoraria; unrestricted educational presentation and advisory board honoraria from Leo; advisory board honoraria from Novartis and Mylan; consultancy honoraria from Procter and Gamble and Meda; grants from Galderma; and consultancy and advisory board honoraria from Origimm outside the submitted work.

dbrunk@mdedge.com

Adult women with acne describe significant impacts on their lived experience of acne, including concerns about appearance, mental and emotional health consequences, and disruption to their personal and professional lives, results from a qualitative study demonstrated.

“Nearly 50% of women experience acne in their 20s, and 35% experience acne in their 30s,” the study’s corresponding author, John S. Barbieri, MD, MBA, formerly of the department of dermatology at the University of Pennsylvania, Philadelphia, told this news organization. “While several qualitative studies have examined acne in adolescence, the lived experience of adult female acne has not been explored in detail and prior studies have included relatively few patients. As a result, we conducted a series of semistructured interviews among adult women with acne to examine the lived experience of adult acne and its treatment.”

For the study, published online July 28, 2021, in JAMA Dermatology, Dr. Barbieri and colleagues conducted voluntary, confidential phone interviews with 50 women aged between 18 and 40 years with moderate to severe acne who were recruited from the University of Pennsylvania Health System and from a private dermatology clinic in Cincinnati. They used free listing and open-ended, semistructured interviews to elicit opinions from the women on how acne affected their lives; their experience with acne treatments, dermatologists, and health care systems; as well as their views on treatment success.

The mean age of the participants was 28 years and 48% were white (10% were Black, 8% were Asian, 4% were more than one race, and the rest abstained from answering this question; 10% said they were Hispanic).

More than three-quarters (78%) reported prior treatment with topical retinoids, followed by spironolactone (70%), topical antibiotics (43%), combined oral contraceptives (43%), and isotretinoin (41%). During the free-listing part of interviews, where the women reported the first words that came to their mind when asked about success of treatment and adverse effects, the most important terms expressed related to treatment success were clear skin, no scarring, and no acne. The most important terms related to treatment adverse effects were dryness, redness, and burning.

In the semistructured interview portion of the study, the main themes expressed were acne-related concerns about appearance, including feeling less confident at work; mental and emotional health, including feelings of depression, anxiety, depression, and low self-worth during acne breakouts; and everyday life impact, including the notion that acne affected how other people perceived them. The other main themes included successful treatment, with clear skin and having a manageable number of lesions being desirable outcomes; and interactions with health care, including varied experiences with dermatologists. The researchers observed that most participants did not think oral antibiotics were appropriate treatments for their acne, specifically because of limited long-term effectiveness.

“Many patients described frustration with finding a dermatologist with whom they were comfortable and with identifying effective treatments for their acne,” the authors wrote. “In contrast, those who thought their dermatologist listened to their concerns and individualized their treatment plan reported higher levels of satisfaction.”

In an interview, Dr. Barbieri, who is now with the department of dermatology at Brigham and Women’s Hospital, Boston, said that he was surprised by how many patients expressed interest in nonantibiotic treatments for acne, “given that oral antibiotics are by far the most commonly prescribed systemic treatment for acne.”

Moreover, he added, “although I have experienced many patients being hesitant about isotretinoin, I was surprised by how strong patients’ concerns were about isotretinoin side effects. Unfortunately, there are many misconceptions about isotretinoin that limit use of this treatment that can be highly effective and safe for the appropriate patient.”

In an accompanying editorial, dermatologists Diane M. Thiboutot, MD and Andrea L. Zaenglein, MD, with Penn State University, Hershey, and Alison M. Layton, MB, ChB, with the Harrogate Foundation Trust, Harrogate, North Yorkshire, England, wrote that the findings from the study “resonate with those recently reported in several international studies that examine the impacts of acne, how patients assess treatment success, and what is important to measure from a patient and health care professional perspective in a clinical trial for acne.”

A large systematic review on the impact of acne on patients, conducted by the Acne Core Outcomes Research Network (ACORN), found that “appearance-related concerns and negative psychosocial effects were found to be a major impact of acne,” they noted. “Surprisingly, only 22 of the 473 studies identified in this review included qualitative data gathered from patient interviews. It is encouraging to see the concordance between the concerns voiced by the participants in the current study and those identified from the literature review, wherein a variety of methods were used to assess acne impacts.”

For his part, Dr. Barbieri said that the study findings “justify the importance of having a discussion with patients about their unique lived experience of acne and individualizing treatment to their specific needs. Patient reported outcome measures could be a useful adjunctive tool to capture these impacts on quality of life.”

This study was funded by grant from the National Institute of Arthritis and Musculoskeletal and Skin Diseases. Dr. Barbieri disclosed that he received partial salary support through a Pfizer Fellowship in Dermatology Patient Oriented Research grant to the Trustees of the University of Pennsylvania. Dr. Thiboutot reported receiving consultant fees from Galderma and Novartis outside the submitted work. Dr. Layton reported receiving unrestricted educational presentation, advisory board, and consultancy fees from Galderma Honoraria; unrestricted educational presentation and advisory board honoraria from Leo; advisory board honoraria from Novartis and Mylan; consultancy honoraria from Procter and Gamble and Meda; grants from Galderma; and consultancy and advisory board honoraria from Origimm outside the submitted work.

dbrunk@mdedge.com

Adult women with acne describe significant impacts on their lived experience of acne, including concerns about appearance, mental and emotional health consequences, and disruption to their personal and professional lives, results from a qualitative study demonstrated.

“Nearly 50% of women experience acne in their 20s, and 35% experience acne in their 30s,” the study’s corresponding author, John S. Barbieri, MD, MBA, formerly of the department of dermatology at the University of Pennsylvania, Philadelphia, told this news organization. “While several qualitative studies have examined acne in adolescence, the lived experience of adult female acne has not been explored in detail and prior studies have included relatively few patients. As a result, we conducted a series of semistructured interviews among adult women with acne to examine the lived experience of adult acne and its treatment.”

For the study, published online July 28, 2021, in JAMA Dermatology, Dr. Barbieri and colleagues conducted voluntary, confidential phone interviews with 50 women aged between 18 and 40 years with moderate to severe acne who were recruited from the University of Pennsylvania Health System and from a private dermatology clinic in Cincinnati. They used free listing and open-ended, semistructured interviews to elicit opinions from the women on how acne affected their lives; their experience with acne treatments, dermatologists, and health care systems; as well as their views on treatment success.

The mean age of the participants was 28 years and 48% were white (10% were Black, 8% were Asian, 4% were more than one race, and the rest abstained from answering this question; 10% said they were Hispanic).

More than three-quarters (78%) reported prior treatment with topical retinoids, followed by spironolactone (70%), topical antibiotics (43%), combined oral contraceptives (43%), and isotretinoin (41%). During the free-listing part of interviews, where the women reported the first words that came to their mind when asked about success of treatment and adverse effects, the most important terms expressed related to treatment success were clear skin, no scarring, and no acne. The most important terms related to treatment adverse effects were dryness, redness, and burning.

In the semistructured interview portion of the study, the main themes expressed were acne-related concerns about appearance, including feeling less confident at work; mental and emotional health, including feelings of depression, anxiety, depression, and low self-worth during acne breakouts; and everyday life impact, including the notion that acne affected how other people perceived them. The other main themes included successful treatment, with clear skin and having a manageable number of lesions being desirable outcomes; and interactions with health care, including varied experiences with dermatologists. The researchers observed that most participants did not think oral antibiotics were appropriate treatments for their acne, specifically because of limited long-term effectiveness.

“Many patients described frustration with finding a dermatologist with whom they were comfortable and with identifying effective treatments for their acne,” the authors wrote. “In contrast, those who thought their dermatologist listened to their concerns and individualized their treatment plan reported higher levels of satisfaction.”

In an interview, Dr. Barbieri, who is now with the department of dermatology at Brigham and Women’s Hospital, Boston, said that he was surprised by how many patients expressed interest in nonantibiotic treatments for acne, “given that oral antibiotics are by far the most commonly prescribed systemic treatment for acne.”

Moreover, he added, “although I have experienced many patients being hesitant about isotretinoin, I was surprised by how strong patients’ concerns were about isotretinoin side effects. Unfortunately, there are many misconceptions about isotretinoin that limit use of this treatment that can be highly effective and safe for the appropriate patient.”

In an accompanying editorial, dermatologists Diane M. Thiboutot, MD and Andrea L. Zaenglein, MD, with Penn State University, Hershey, and Alison M. Layton, MB, ChB, with the Harrogate Foundation Trust, Harrogate, North Yorkshire, England, wrote that the findings from the study “resonate with those recently reported in several international studies that examine the impacts of acne, how patients assess treatment success, and what is important to measure from a patient and health care professional perspective in a clinical trial for acne.”

A large systematic review on the impact of acne on patients, conducted by the Acne Core Outcomes Research Network (ACORN), found that “appearance-related concerns and negative psychosocial effects were found to be a major impact of acne,” they noted. “Surprisingly, only 22 of the 473 studies identified in this review included qualitative data gathered from patient interviews. It is encouraging to see the concordance between the concerns voiced by the participants in the current study and those identified from the literature review, wherein a variety of methods were used to assess acne impacts.”

For his part, Dr. Barbieri said that the study findings “justify the importance of having a discussion with patients about their unique lived experience of acne and individualizing treatment to their specific needs. Patient reported outcome measures could be a useful adjunctive tool to capture these impacts on quality of life.”

This study was funded by grant from the National Institute of Arthritis and Musculoskeletal and Skin Diseases. Dr. Barbieri disclosed that he received partial salary support through a Pfizer Fellowship in Dermatology Patient Oriented Research grant to the Trustees of the University of Pennsylvania. Dr. Thiboutot reported receiving consultant fees from Galderma and Novartis outside the submitted work. Dr. Layton reported receiving unrestricted educational presentation, advisory board, and consultancy fees from Galderma Honoraria; unrestricted educational presentation and advisory board honoraria from Leo; advisory board honoraria from Novartis and Mylan; consultancy honoraria from Procter and Gamble and Meda; grants from Galderma; and consultancy and advisory board honoraria from Origimm outside the submitted work.

dbrunk@mdedge.com

Administering hyperimmune globulin to pregnant women who tested positive for cytomegalovirus did not reduce CMV infections or deaths among their fetuses or newborns, according to a randomized controlled trial published online July 28 in the New England Journal of Medicine.

Up to 40,000 infants a year have congenital CMV infections, which can lead to stillbirth, neonatal death, deafness, and cognitive and motor delay. An estimated 35%-40% of fetuses of women with a primary CMV infection will develop an infection, write Brenna Hughes, MD, an associate professor of ob/gyn and chief of the division of maternal fetal medicine at Duke University, Durham, N.C., and colleagues.

Previous trials and observational studies have shown mixed results with hyperimmune globulin for the prevention of congenital CMV infection.

“It was surprising to us that none of the outcomes in this trial were in the direction of potential benefit,” Dr. Hughes told this news organization. “However, this is why it is important to do large trials in a diverse population.”

The study cohort comprised 206,082 pregnant women who were screened for CMV infection before 23 weeks’ gestation. Of those women, 712 (0.35%) tested positive for CMV. The researchers enrolled 399 women who had tested positive and randomly assigned them to receive either a monthly infusion of CMV hyperimmune globulin (100 mg/kg) or placebo until delivery. The researchers used a composite of CMV infection or, if no testing occurred, fetal/neonatal death as the primary endpoint.

The trial was stopped early for futility when data from 394 participants revealed that 22.7% of offspring in the hyperimmune globulin group and 19.4% of those in the placebo group had had a CMV infection or had died (relative risk = 1.17; P = .42).

When individual endpoints were examined, trends were detected in favor of the placebo, but they did not reach statistical significance. The incidence of death was higher in the hyperimmune globulin group (4.9%) than in the placebo group (2.6%). The rate of preterm birth was also higher in the intervention group (12.2%) than in the group that received placebo (8.3%). The incidence of birth weight below the fifth percentile was 10.3% in the intervention group and 5.4% in the placebo group.

One woman who received hyperimmune globulin experienced a severe allergic reaction to the first infusion. Additionally, more women in the hyperimmune globulin group experienced headaches and shaking chills during infusions than did those who received placebo. There were no differences in maternal outcomes between the groups. There were no thromboembolic or ischemic events in either group.

“These findings suggest CMV hyperimmune globulin should not be used for the prevention of congenital CMV in pregnant patients with primary CMV during pregnancy,” Dr. Hughes said in an interview.

“A CMV vaccine is likely to be the most effective public health measure that we can offer, and that should be at the forefront of research investments,” she said. “But some of the other medications that work against CMV should be tested on a large scale as well,” she said. For example, a small trial in Israel showed that high-dose valacyclovir in early pregnancy decreased congenital CMV, and thus the drug merits study in a larger trial, she said.

Other experts agree that developing a vaccine should be the priority.

“The ultimate goal for preventing the brain damage and birth defects caused by congenital CMV infection is a vaccine that is as effective as the rubella vaccine has been for eliminating congenital rubella syndrome and that can be given well before pregnancy,” said Sallie Permar, MD, PhD, chair of pediatrics at Weill Cornell Medicine and pediatrician-in-chief at New York–Presbyterian/Weill Cornell Medical Center and the New York–Presbyterian Komansky Children’s Hospital in New York.

“While trials of vaccines are ongoing, there is a need to have a therapeutic option, especially for the high-risk setting of a mother acquiring the virus for the first time during pregnancy,” Dr. Permar said in an interview.

Dr. Permar was not involved in this study but is involved in follow-up studies of this cohort and is conducting research on CMV maternal vaccines. She noted the need for safe, effective antiviral treatments and for research into newer immunoglobulin products, such as monoclonal antibodies.

Both Dr. Permar and Dr. Hughes highlighted the challenge of raising awareness about the danger of CMV infections during pregnancy.

“Pregnant women, and especially those who have or work with young children, who are frequently carriers of the infection, should be informed of this risk,” Dr. Permar said. She hopes universal testing of newborns will be implemented and that it enables people to recognize the frequency and burden of these infections. She remains optimistic about a vaccine.

“After 60 years of research into a CMV vaccine, I believe we are currently in a ‘golden age’ of CMV vaccine development,” she said. She noted that Moderna is about to launch a phase 3 mRNA vaccine trial for CMV. “Moreover, immune correlates of protection against CMV have been identified from previous partially effective vaccines, and animal models have improved for preclinical studies. Therefore, I believe we will have an effective and safe vaccine against this most common congenital infection in the coming years.”

The research was funded by the Eunice Kennedy Shriver National Institute of Child Health and Human Development and the National Center for Advancing Translational Sciences. Dr. Hughes has served on Merck’s scientific advisory board. Various coauthors have received personal fees from Medela and nonfinancial support from Hologic; personal fees from Moderna and VBI vaccines, and grants from Novavax. Dr. Permar consults for Pfizer, Moderna, Merck, Sanofi, and Dynavax on their CMV vaccine programs, and she has a sponsored research program with Merck and Moderna on CMV vaccines.

A version of this article first appeared on Medscape.com.

Administering hyperimmune globulin to pregnant women who tested positive for cytomegalovirus did not reduce CMV infections or deaths among their fetuses or newborns, according to a randomized controlled trial published online July 28 in the New England Journal of Medicine.

Up to 40,000 infants a year have congenital CMV infections, which can lead to stillbirth, neonatal death, deafness, and cognitive and motor delay. An estimated 35%-40% of fetuses of women with a primary CMV infection will develop an infection, write Brenna Hughes, MD, an associate professor of ob/gyn and chief of the division of maternal fetal medicine at Duke University, Durham, N.C., and colleagues.

Previous trials and observational studies have shown mixed results with hyperimmune globulin for the prevention of congenital CMV infection.

“It was surprising to us that none of the outcomes in this trial were in the direction of potential benefit,” Dr. Hughes told this news organization. “However, this is why it is important to do large trials in a diverse population.”

The study cohort comprised 206,082 pregnant women who were screened for CMV infection before 23 weeks’ gestation. Of those women, 712 (0.35%) tested positive for CMV. The researchers enrolled 399 women who had tested positive and randomly assigned them to receive either a monthly infusion of CMV hyperimmune globulin (100 mg/kg) or placebo until delivery. The researchers used a composite of CMV infection or, if no testing occurred, fetal/neonatal death as the primary endpoint.

The trial was stopped early for futility when data from 394 participants revealed that 22.7% of offspring in the hyperimmune globulin group and 19.4% of those in the placebo group had had a CMV infection or had died (relative risk = 1.17; P = .42).

When individual endpoints were examined, trends were detected in favor of the placebo, but they did not reach statistical significance. The incidence of death was higher in the hyperimmune globulin group (4.9%) than in the placebo group (2.6%). The rate of preterm birth was also higher in the intervention group (12.2%) than in the group that received placebo (8.3%). The incidence of birth weight below the fifth percentile was 10.3% in the intervention group and 5.4% in the placebo group.

One woman who received hyperimmune globulin experienced a severe allergic reaction to the first infusion. Additionally, more women in the hyperimmune globulin group experienced headaches and shaking chills during infusions than did those who received placebo. There were no differences in maternal outcomes between the groups. There were no thromboembolic or ischemic events in either group.

“These findings suggest CMV hyperimmune globulin should not be used for the prevention of congenital CMV in pregnant patients with primary CMV during pregnancy,” Dr. Hughes said in an interview.

“A CMV vaccine is likely to be the most effective public health measure that we can offer, and that should be at the forefront of research investments,” she said. “But some of the other medications that work against CMV should be tested on a large scale as well,” she said. For example, a small trial in Israel showed that high-dose valacyclovir in early pregnancy decreased congenital CMV, and thus the drug merits study in a larger trial, she said.

Other experts agree that developing a vaccine should be the priority.

“The ultimate goal for preventing the brain damage and birth defects caused by congenital CMV infection is a vaccine that is as effective as the rubella vaccine has been for eliminating congenital rubella syndrome and that can be given well before pregnancy,” said Sallie Permar, MD, PhD, chair of pediatrics at Weill Cornell Medicine and pediatrician-in-chief at New York–Presbyterian/Weill Cornell Medical Center and the New York–Presbyterian Komansky Children’s Hospital in New York.

“While trials of vaccines are ongoing, there is a need to have a therapeutic option, especially for the high-risk setting of a mother acquiring the virus for the first time during pregnancy,” Dr. Permar said in an interview.

Dr. Permar was not involved in this study but is involved in follow-up studies of this cohort and is conducting research on CMV maternal vaccines. She noted the need for safe, effective antiviral treatments and for research into newer immunoglobulin products, such as monoclonal antibodies.

Both Dr. Permar and Dr. Hughes highlighted the challenge of raising awareness about the danger of CMV infections during pregnancy.

“Pregnant women, and especially those who have or work with young children, who are frequently carriers of the infection, should be informed of this risk,” Dr. Permar said. She hopes universal testing of newborns will be implemented and that it enables people to recognize the frequency and burden of these infections. She remains optimistic about a vaccine.

“After 60 years of research into a CMV vaccine, I believe we are currently in a ‘golden age’ of CMV vaccine development,” she said. She noted that Moderna is about to launch a phase 3 mRNA vaccine trial for CMV. “Moreover, immune correlates of protection against CMV have been identified from previous partially effective vaccines, and animal models have improved for preclinical studies. Therefore, I believe we will have an effective and safe vaccine against this most common congenital infection in the coming years.”

The research was funded by the Eunice Kennedy Shriver National Institute of Child Health and Human Development and the National Center for Advancing Translational Sciences. Dr. Hughes has served on Merck’s scientific advisory board. Various coauthors have received personal fees from Medela and nonfinancial support from Hologic; personal fees from Moderna and VBI vaccines, and grants from Novavax. Dr. Permar consults for Pfizer, Moderna, Merck, Sanofi, and Dynavax on their CMV vaccine programs, and she has a sponsored research program with Merck and Moderna on CMV vaccines.

A version of this article first appeared on Medscape.com.

Administering hyperimmune globulin to pregnant women who tested positive for cytomegalovirus did not reduce CMV infections or deaths among their fetuses or newborns, according to a randomized controlled trial published online July 28 in the New England Journal of Medicine.

Up to 40,000 infants a year have congenital CMV infections, which can lead to stillbirth, neonatal death, deafness, and cognitive and motor delay. An estimated 35%-40% of fetuses of women with a primary CMV infection will develop an infection, write Brenna Hughes, MD, an associate professor of ob/gyn and chief of the division of maternal fetal medicine at Duke University, Durham, N.C., and colleagues.

Previous trials and observational studies have shown mixed results with hyperimmune globulin for the prevention of congenital CMV infection.

“It was surprising to us that none of the outcomes in this trial were in the direction of potential benefit,” Dr. Hughes told this news organization. “However, this is why it is important to do large trials in a diverse population.”

The study cohort comprised 206,082 pregnant women who were screened for CMV infection before 23 weeks’ gestation. Of those women, 712 (0.35%) tested positive for CMV. The researchers enrolled 399 women who had tested positive and randomly assigned them to receive either a monthly infusion of CMV hyperimmune globulin (100 mg/kg) or placebo until delivery. The researchers used a composite of CMV infection or, if no testing occurred, fetal/neonatal death as the primary endpoint.

The trial was stopped early for futility when data from 394 participants revealed that 22.7% of offspring in the hyperimmune globulin group and 19.4% of those in the placebo group had had a CMV infection or had died (relative risk = 1.17; P = .42).

When individual endpoints were examined, trends were detected in favor of the placebo, but they did not reach statistical significance. The incidence of death was higher in the hyperimmune globulin group (4.9%) than in the placebo group (2.6%). The rate of preterm birth was also higher in the intervention group (12.2%) than in the group that received placebo (8.3%). The incidence of birth weight below the fifth percentile was 10.3% in the intervention group and 5.4% in the placebo group.

One woman who received hyperimmune globulin experienced a severe allergic reaction to the first infusion. Additionally, more women in the hyperimmune globulin group experienced headaches and shaking chills during infusions than did those who received placebo. There were no differences in maternal outcomes between the groups. There were no thromboembolic or ischemic events in either group.

“These findings suggest CMV hyperimmune globulin should not be used for the prevention of congenital CMV in pregnant patients with primary CMV during pregnancy,” Dr. Hughes said in an interview.

“A CMV vaccine is likely to be the most effective public health measure that we can offer, and that should be at the forefront of research investments,” she said. “But some of the other medications that work against CMV should be tested on a large scale as well,” she said. For example, a small trial in Israel showed that high-dose valacyclovir in early pregnancy decreased congenital CMV, and thus the drug merits study in a larger trial, she said.

Other experts agree that developing a vaccine should be the priority.

“The ultimate goal for preventing the brain damage and birth defects caused by congenital CMV infection is a vaccine that is as effective as the rubella vaccine has been for eliminating congenital rubella syndrome and that can be given well before pregnancy,” said Sallie Permar, MD, PhD, chair of pediatrics at Weill Cornell Medicine and pediatrician-in-chief at New York–Presbyterian/Weill Cornell Medical Center and the New York–Presbyterian Komansky Children’s Hospital in New York.

“While trials of vaccines are ongoing, there is a need to have a therapeutic option, especially for the high-risk setting of a mother acquiring the virus for the first time during pregnancy,” Dr. Permar said in an interview.

Dr. Permar was not involved in this study but is involved in follow-up studies of this cohort and is conducting research on CMV maternal vaccines. She noted the need for safe, effective antiviral treatments and for research into newer immunoglobulin products, such as monoclonal antibodies.

Both Dr. Permar and Dr. Hughes highlighted the challenge of raising awareness about the danger of CMV infections during pregnancy.

“Pregnant women, and especially those who have or work with young children, who are frequently carriers of the infection, should be informed of this risk,” Dr. Permar said. She hopes universal testing of newborns will be implemented and that it enables people to recognize the frequency and burden of these infections. She remains optimistic about a vaccine.

“After 60 years of research into a CMV vaccine, I believe we are currently in a ‘golden age’ of CMV vaccine development,” she said. She noted that Moderna is about to launch a phase 3 mRNA vaccine trial for CMV. “Moreover, immune correlates of protection against CMV have been identified from previous partially effective vaccines, and animal models have improved for preclinical studies. Therefore, I believe we will have an effective and safe vaccine against this most common congenital infection in the coming years.”

The research was funded by the Eunice Kennedy Shriver National Institute of Child Health and Human Development and the National Center for Advancing Translational Sciences. Dr. Hughes has served on Merck’s scientific advisory board. Various coauthors have received personal fees from Medela and nonfinancial support from Hologic; personal fees from Moderna and VBI vaccines, and grants from Novavax. Dr. Permar consults for Pfizer, Moderna, Merck, Sanofi, and Dynavax on their CMV vaccine programs, and she has a sponsored research program with Merck and Moderna on CMV vaccines.

A version of this article first appeared on Medscape.com.