Alicia Ault

Illinois has a new law designed to boost the mental health care workforce at a time when it has been devastated by the COVID-19 pandemic, say state leaders.

Governor J.B. Pritzker (D) signed the legislation, which took effect on June 10.

The law seeks to attract psychologists, social workers, and counselors who have left the workforce within the past 5 years by temporarily ending relicensing requirements, including the need for continuing education credit completion, passing new exams, and fee payments. It also eases the process for those practicing in other states to become licensed in Illinois.

State legislators said there is currently a crushing need for mental health providers, estimating that there are only 14 behavioral health care professionals for every 10,000 Illinois residents. The preamble to the law noted that there will be 8,353 unfilled mental health care jobs in Illinois by 2026.

“We need a mental health care workforce that is robust enough to get people help when they need it – not after months on a waiting list,” Governor Pritzker said in news release. “This legislation invests in mental health infrastructure – and that infrastructure is people,” he added.
 

Grant pathway

“Being told you have to wait weeks – or months – for care is extremely discouraging,” State Senator Laura Fine (D), a lead sponsor of the legislation, noted in the release.

“We need to support people struggling with mental and behavioral health issues, as well as address difficulties our mental health providers are facing trying to see as many patients as possible,” said Senator Fine.

Marvin Lindsey, CEO of the Community Behavioral Healthcare Association, added that the law would “accelerate the process for out-of-state professionals to obtain their Illinois licensure and [increase] the pipeline and diversity of the behavioral health workforce by implementing a funding mechanism that supports new or existing licensure training of interns.”

The law sets up a grant pathway for community mental health centers, which often serve as training sites. The grants would provide funds to establish or enhance training and supervision of interns and behavioral health providers-in-training seeking to become licensed clinical social workers, licensed clinical professional counselors, or licensed marriage and family therapists.

The money for those grants still has to be appropriated.

The law will also allow patient visits at Specialized Mental Health Rehabilitation Facilities conducted by either a psychiatrist or an advanced practice registered mental health or psychiatric nurse.

Finally, it would establish tax credits for employers who hire individuals in recovery from a substance use disorder or a behavioral disorder. Beginning in January 2023, employers will be eligible for up to $2,000 in credits per employee hired.

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

Illinois has a new law designed to boost the mental health care workforce at a time when it has been devastated by the COVID-19 pandemic, say state leaders.

Governor J.B. Pritzker (D) signed the legislation, which took effect on June 10.

The law seeks to attract psychologists, social workers, and counselors who have left the workforce within the past 5 years by temporarily ending relicensing requirements, including the need for continuing education credit completion, passing new exams, and fee payments. It also eases the process for those practicing in other states to become licensed in Illinois.

State legislators said there is currently a crushing need for mental health providers, estimating that there are only 14 behavioral health care professionals for every 10,000 Illinois residents. The preamble to the law noted that there will be 8,353 unfilled mental health care jobs in Illinois by 2026.

“We need a mental health care workforce that is robust enough to get people help when they need it – not after months on a waiting list,” Governor Pritzker said in news release. “This legislation invests in mental health infrastructure – and that infrastructure is people,” he added.
 

Grant pathway

“Being told you have to wait weeks – or months – for care is extremely discouraging,” State Senator Laura Fine (D), a lead sponsor of the legislation, noted in the release.

“We need to support people struggling with mental and behavioral health issues, as well as address difficulties our mental health providers are facing trying to see as many patients as possible,” said Senator Fine.

Marvin Lindsey, CEO of the Community Behavioral Healthcare Association, added that the law would “accelerate the process for out-of-state professionals to obtain their Illinois licensure and [increase] the pipeline and diversity of the behavioral health workforce by implementing a funding mechanism that supports new or existing licensure training of interns.”

The law sets up a grant pathway for community mental health centers, which often serve as training sites. The grants would provide funds to establish or enhance training and supervision of interns and behavioral health providers-in-training seeking to become licensed clinical social workers, licensed clinical professional counselors, or licensed marriage and family therapists.

The money for those grants still has to be appropriated.

The law will also allow patient visits at Specialized Mental Health Rehabilitation Facilities conducted by either a psychiatrist or an advanced practice registered mental health or psychiatric nurse.

Finally, it would establish tax credits for employers who hire individuals in recovery from a substance use disorder or a behavioral disorder. Beginning in January 2023, employers will be eligible for up to $2,000 in credits per employee hired.

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

Illinois has a new law designed to boost the mental health care workforce at a time when it has been devastated by the COVID-19 pandemic, say state leaders.

Governor J.B. Pritzker (D) signed the legislation, which took effect on June 10.

The law seeks to attract psychologists, social workers, and counselors who have left the workforce within the past 5 years by temporarily ending relicensing requirements, including the need for continuing education credit completion, passing new exams, and fee payments. It also eases the process for those practicing in other states to become licensed in Illinois.

State legislators said there is currently a crushing need for mental health providers, estimating that there are only 14 behavioral health care professionals for every 10,000 Illinois residents. The preamble to the law noted that there will be 8,353 unfilled mental health care jobs in Illinois by 2026.

“We need a mental health care workforce that is robust enough to get people help when they need it – not after months on a waiting list,” Governor Pritzker said in news release. “This legislation invests in mental health infrastructure – and that infrastructure is people,” he added.
 

Grant pathway

“Being told you have to wait weeks – or months – for care is extremely discouraging,” State Senator Laura Fine (D), a lead sponsor of the legislation, noted in the release.

“We need to support people struggling with mental and behavioral health issues, as well as address difficulties our mental health providers are facing trying to see as many patients as possible,” said Senator Fine.

Marvin Lindsey, CEO of the Community Behavioral Healthcare Association, added that the law would “accelerate the process for out-of-state professionals to obtain their Illinois licensure and [increase] the pipeline and diversity of the behavioral health workforce by implementing a funding mechanism that supports new or existing licensure training of interns.”

The law sets up a grant pathway for community mental health centers, which often serve as training sites. The grants would provide funds to establish or enhance training and supervision of interns and behavioral health providers-in-training seeking to become licensed clinical social workers, licensed clinical professional counselors, or licensed marriage and family therapists.

The money for those grants still has to be appropriated.

The law will also allow patient visits at Specialized Mental Health Rehabilitation Facilities conducted by either a psychiatrist or an advanced practice registered mental health or psychiatric nurse.

Finally, it would establish tax credits for employers who hire individuals in recovery from a substance use disorder or a behavioral disorder. Beginning in January 2023, employers will be eligible for up to $2,000 in credits per employee hired.

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

Two new studies point to an ever-increasing number of young people in the United States who identify as transgender and nonbinary, with the figures doubling among 18- to 24-year-olds in one institute’s research – from 0.66% of the population in 2016 to 1.3% (398,900) in 2022.

In addition, 1.4% (300,100) of 13- to 17-year-olds identify as trans or nonbinary, according to the report from that group, the Williams Institute at the University of California, Los Angeles, School of Law.

Williams, which conducts independent research on sexual orientation and gender identity law and public policy, did not contain data on 13- to 17-year-olds in its 2016 study, so the growth in that group over the past 5+ years is not as well documented.

Overall, some 1.6 million Americans older than age 13 now identify as transgender, reported the Williams researchers.

And in a new Pew Research Center survey, 2% of adults aged 18-29 identify as transgender and 3% identify as nonbinary, a far greater number than in other age cohorts.

These reports are likely underestimates. The Human Rights Campaign estimates that some 2 million Americans of all ages identify as transgender.

The Pew survey is weighted to be representative but still has limitations, said the organization. The Williams analysis, based on responses to two CDC surveys – the Behavioral Risk Factor Surveillance System (BRFSS) and Youth Risk Behavior Survey (YRBS) – is incomplete, say researchers, because not every state collects data on gender identity.
 

Transgender identities more predominant among youth

The Williams researchers report that 18.3% of those who identified as trans were 13- to 17-year-olds; that age group makes up 7.6% of the United States population 13 and older.

And despite not having firm figures from earlier reports, they comment: “Youth ages 13-17 comprise a larger share of the transgender-identified population than we previously estimated, currently comprising about 18% of the transgender-identified population in the United State, up from 10% previously.”  

About one-quarter of those who identified as trans in the new 2022 report were aged 18-24; that age cohort accounts for 11% of Americans.

The number of older Americans who identify as trans are more proportionate to their representation in the population, according to Williams. Overall, about half of those who said they were trans were aged 25-64; that group accounts for 62% of the overall American population. Some 10% of trans-identified individuals were over age 65. About 20% of Americans are 65 or older, said the researchers.

The Pew research – based on the responses of 10,188 individuals surveyed in May – also found growing numbers of young people who identify as trans. “The share of U.S. adults who are transgender is particularly high among adults younger than 25,” reported Pew in a blog post.

In the 18- to 25-year-old group, 3.1% identified as a trans man or a trans woman, compared with just 0.5% of those ages 25-29.  

That compares to 0.3% of those aged 30-49 and 0.2% of those older than 50.
 

Racial and state-by-state variation

Similar percentages of youth aged 13-17 of all races and ethnicities in the Williams study report they are transgender, ranging from 1% of those who are Asian, to 1.3% of White youth, 1.4% of Black youth, 1.8% of American Indian or Alaska Native, and 1.8% of Latinx youth. The institute reported that 1.5% of biracial and multiracial youth identified as transgender.

The researchers said, however, that “transgender-identified youth and adults appear more likely to report being Latinx and less likely to report being White, as compared to the United States population.”

Transgender individuals live in every state, with the greatest percentage of both youth and adults in the Northeast and West, and lesser percentages in the Midwest and South, reported the Williams Institute.

Williams estimates as many as 3% of 13- to 17-year-olds in New York identify as trans, while just 0.6% of that age group in Wyoming is transgender. A total of 2%-2.5% of those aged 13-17 are transgender in Hawaii, New Mexico, Maryland, and Washington, D.C.

Among the states with higher percentages of trans-identifying 18- to 24-year-olds: Arizona (1.9%), Arkansas (3.6%), Colorado (2%), Delaware (2.4%), Illinois (1.9%), Maryland (1.9%), North Carolina (2.5%), Oklahoma (2.5%), Massachusetts (2.3%), Rhode Island (2.1%), and Washington (2%).

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

Two new studies point to an ever-increasing number of young people in the United States who identify as transgender and nonbinary, with the figures doubling among 18- to 24-year-olds in one institute’s research – from 0.66% of the population in 2016 to 1.3% (398,900) in 2022.

In addition, 1.4% (300,100) of 13- to 17-year-olds identify as trans or nonbinary, according to the report from that group, the Williams Institute at the University of California, Los Angeles, School of Law.

Williams, which conducts independent research on sexual orientation and gender identity law and public policy, did not contain data on 13- to 17-year-olds in its 2016 study, so the growth in that group over the past 5+ years is not as well documented.

Overall, some 1.6 million Americans older than age 13 now identify as transgender, reported the Williams researchers.

And in a new Pew Research Center survey, 2% of adults aged 18-29 identify as transgender and 3% identify as nonbinary, a far greater number than in other age cohorts.

These reports are likely underestimates. The Human Rights Campaign estimates that some 2 million Americans of all ages identify as transgender.

The Pew survey is weighted to be representative but still has limitations, said the organization. The Williams analysis, based on responses to two CDC surveys – the Behavioral Risk Factor Surveillance System (BRFSS) and Youth Risk Behavior Survey (YRBS) – is incomplete, say researchers, because not every state collects data on gender identity.
 

Transgender identities more predominant among youth

The Williams researchers report that 18.3% of those who identified as trans were 13- to 17-year-olds; that age group makes up 7.6% of the United States population 13 and older.

And despite not having firm figures from earlier reports, they comment: “Youth ages 13-17 comprise a larger share of the transgender-identified population than we previously estimated, currently comprising about 18% of the transgender-identified population in the United State, up from 10% previously.”  

About one-quarter of those who identified as trans in the new 2022 report were aged 18-24; that age cohort accounts for 11% of Americans.

The number of older Americans who identify as trans are more proportionate to their representation in the population, according to Williams. Overall, about half of those who said they were trans were aged 25-64; that group accounts for 62% of the overall American population. Some 10% of trans-identified individuals were over age 65. About 20% of Americans are 65 or older, said the researchers.

The Pew research – based on the responses of 10,188 individuals surveyed in May – also found growing numbers of young people who identify as trans. “The share of U.S. adults who are transgender is particularly high among adults younger than 25,” reported Pew in a blog post.

In the 18- to 25-year-old group, 3.1% identified as a trans man or a trans woman, compared with just 0.5% of those ages 25-29.  

That compares to 0.3% of those aged 30-49 and 0.2% of those older than 50.
 

Racial and state-by-state variation

Similar percentages of youth aged 13-17 of all races and ethnicities in the Williams study report they are transgender, ranging from 1% of those who are Asian, to 1.3% of White youth, 1.4% of Black youth, 1.8% of American Indian or Alaska Native, and 1.8% of Latinx youth. The institute reported that 1.5% of biracial and multiracial youth identified as transgender.

The researchers said, however, that “transgender-identified youth and adults appear more likely to report being Latinx and less likely to report being White, as compared to the United States population.”

Transgender individuals live in every state, with the greatest percentage of both youth and adults in the Northeast and West, and lesser percentages in the Midwest and South, reported the Williams Institute.

Williams estimates as many as 3% of 13- to 17-year-olds in New York identify as trans, while just 0.6% of that age group in Wyoming is transgender. A total of 2%-2.5% of those aged 13-17 are transgender in Hawaii, New Mexico, Maryland, and Washington, D.C.

Among the states with higher percentages of trans-identifying 18- to 24-year-olds: Arizona (1.9%), Arkansas (3.6%), Colorado (2%), Delaware (2.4%), Illinois (1.9%), Maryland (1.9%), North Carolina (2.5%), Oklahoma (2.5%), Massachusetts (2.3%), Rhode Island (2.1%), and Washington (2%).

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

Two new studies point to an ever-increasing number of young people in the United States who identify as transgender and nonbinary, with the figures doubling among 18- to 24-year-olds in one institute’s research – from 0.66% of the population in 2016 to 1.3% (398,900) in 2022.

In addition, 1.4% (300,100) of 13- to 17-year-olds identify as trans or nonbinary, according to the report from that group, the Williams Institute at the University of California, Los Angeles, School of Law.

Williams, which conducts independent research on sexual orientation and gender identity law and public policy, did not contain data on 13- to 17-year-olds in its 2016 study, so the growth in that group over the past 5+ years is not as well documented.

Overall, some 1.6 million Americans older than age 13 now identify as transgender, reported the Williams researchers.

And in a new Pew Research Center survey, 2% of adults aged 18-29 identify as transgender and 3% identify as nonbinary, a far greater number than in other age cohorts.

These reports are likely underestimates. The Human Rights Campaign estimates that some 2 million Americans of all ages identify as transgender.

The Pew survey is weighted to be representative but still has limitations, said the organization. The Williams analysis, based on responses to two CDC surveys – the Behavioral Risk Factor Surveillance System (BRFSS) and Youth Risk Behavior Survey (YRBS) – is incomplete, say researchers, because not every state collects data on gender identity.
 

Transgender identities more predominant among youth

The Williams researchers report that 18.3% of those who identified as trans were 13- to 17-year-olds; that age group makes up 7.6% of the United States population 13 and older.

And despite not having firm figures from earlier reports, they comment: “Youth ages 13-17 comprise a larger share of the transgender-identified population than we previously estimated, currently comprising about 18% of the transgender-identified population in the United State, up from 10% previously.”  

About one-quarter of those who identified as trans in the new 2022 report were aged 18-24; that age cohort accounts for 11% of Americans.

The number of older Americans who identify as trans are more proportionate to their representation in the population, according to Williams. Overall, about half of those who said they were trans were aged 25-64; that group accounts for 62% of the overall American population. Some 10% of trans-identified individuals were over age 65. About 20% of Americans are 65 or older, said the researchers.

The Pew research – based on the responses of 10,188 individuals surveyed in May – also found growing numbers of young people who identify as trans. “The share of U.S. adults who are transgender is particularly high among adults younger than 25,” reported Pew in a blog post.

In the 18- to 25-year-old group, 3.1% identified as a trans man or a trans woman, compared with just 0.5% of those ages 25-29.  

That compares to 0.3% of those aged 30-49 and 0.2% of those older than 50.
 

Racial and state-by-state variation

Similar percentages of youth aged 13-17 of all races and ethnicities in the Williams study report they are transgender, ranging from 1% of those who are Asian, to 1.3% of White youth, 1.4% of Black youth, 1.8% of American Indian or Alaska Native, and 1.8% of Latinx youth. The institute reported that 1.5% of biracial and multiracial youth identified as transgender.

The researchers said, however, that “transgender-identified youth and adults appear more likely to report being Latinx and less likely to report being White, as compared to the United States population.”

Transgender individuals live in every state, with the greatest percentage of both youth and adults in the Northeast and West, and lesser percentages in the Midwest and South, reported the Williams Institute.

Williams estimates as many as 3% of 13- to 17-year-olds in New York identify as trans, while just 0.6% of that age group in Wyoming is transgender. A total of 2%-2.5% of those aged 13-17 are transgender in Hawaii, New Mexico, Maryland, and Washington, D.C.

Among the states with higher percentages of trans-identifying 18- to 24-year-olds: Arizona (1.9%), Arkansas (3.6%), Colorado (2%), Delaware (2.4%), Illinois (1.9%), Maryland (1.9%), North Carolina (2.5%), Oklahoma (2.5%), Massachusetts (2.3%), Rhode Island (2.1%), and Washington (2%).

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

The next generation of COVID-19 vaccines should be able to fight off a new strain and be given each year, a panel of experts that advises the Food and Drug Administration said April 6.

But members of the panel also acknowledged that it will be an uphill battle to reach that goal, especially given how quickly the virus continues to change.

The members of the Vaccines and Related Biological Products Advisory Committee said they want to find the balance that makes sure Americans are protected against severe illness and death but doesn’t wear them out with constant recommendations for boosters.

“We don’t feel comfortable with multiple boosters every 8 weeks,” said committee chairman Arnold Monto, MD, professor emeritus of public health at the University of Michigan, Ann Arbor. “We’d love to see an annual vaccination similar to influenza but realize that the evolution of the virus will dictate how we respond in terms of additional vaccine doses.”

The virus itself will dictate vaccination plans, he said.

The government must also keep its focus on convincing Americans who haven’t been vaccinated to join the club, said committee member Henry H. Bernstein, DO, given that “it seems quite obvious that those who are vaccinated do better than those who aren’t vaccinated.”

The government should clearly communicate to the public the goals of vaccination, he said.

“I would suggest that our overall aim is to prevent severe disease, hospitalization, and death more than just infection prevention,” said Dr. Bernstein, professor of pediatrics at Hofstra University, Hempstead, N.Y.

The FDA called the meeting of its advisers to discuss overall booster and vaccine strategy, even though it already authorized a fourth dose of the Pfizer and Moderna vaccines for certain immune compromised adults and for everyone over age 50.

Early in the all-day meeting, temporary committee member James Hildreth, MD, the president of Meharry Medical College, Nashville, Tenn., asked why that authorization was given without the panel’s input. Peter Marks, MD, the director of FDA’s Center for Biologics Evaluation and Research, said the decision was based on data from the United Kingdom and Israel that suggested immunity from a third shot was already waning.

Dr. Marks later said the fourth dose was “authorized as a stopgap measure until we could get something else in place,” because the aim was to protect older Americans who had died at a higher rate than younger individuals.

“I think we’re very much on board that we simply can’t be boosting people as frequently as we are,” said Dr. Marks.
 

Not enough information to make broader plan

The meeting was meant to be a larger conversation about how to keep pace with the evolving virus and to set up a vaccine selection and development process to better and more quickly respond to changes, such as new variants.

But committee members said they felt stymied by a lack of information. They wanted more data from vaccine manufacturers’ clinical trials. And they noted that so far, there’s no objective, reliable lab-based measurement of COVID-19 vaccine effectiveness – known as a correlate of immunity. Instead, public health officials have looked at rates of hospitalizations and deaths to measure whether the vaccine is still offering protection.

“The question is, what is insufficient protection?” asked H. Cody Meissner, MD, director of pediatric infectious disease at Tufts Medical Center in Boston. “At what point will we say the vaccine isn’t working well enough?”

Centers for Disease Control and Prevention officials presented data showing that a third shot has been more effective than a two-shot regimen in preventing serious disease and death, and that the three shots were significantly more protective than being unvaccinated.

In February, as the Omicron variant continued to rage, unvaccinated Americans aged 5 years and older had an almost three times higher risk of testing positive, and nine times higher risk of dying, compared with those who were considered fully vaccinated, said Heather Scobie, PhD, MPH, a member of the CDC’s COVID-19 Emergency Response team.

But only 98 million Americans – about half of those aged 12 years or older – have received a third dose, Dr. Scobie said.

It’s also still not clear how much more protection a fourth shot adds, or how long it will last. The committee heard data on a just-published study of a fourth dose of the Pfizer vaccine given to some 600,000 Israelis during the Omicron wave from January to March. The rate of severe COVID-19 was 3.5 times lower in the group that received a fourth dose, compared with those who had gotten only three shots, and protection lasted for at least 12 weeks.

Still, study authors said, any protection against infection itself was “short lived.”


 

More like flu vaccine?

The advisers discussed the possibility of making COVID-19 vaccine development similar to the process for the flu vaccine but acknowledged many difficulties.

The flu predictably hits during the winter in each hemisphere and a global surveillance network helps the World Health Organization decide on the vaccine strains each year. Then each nation’s regulatory and public health officials choose the strains for their shot and vaccine makers begin what is typically a 6-month-long manufacturing process.

COVID outbreaks have happened during all seasons and new variants haven’t always hit every country in a similar fashion. The COVID virus has mutated at five times the speed of the flu virus – producing a new dominant strain in a year, compared with the 3-5 years it takes for the flu virus to do so, said Trevor Bedford, PhD, a professor in the vaccine and infectious disease division at the Fred Hutchinson Cancer Research Center in Seattle.

Global COVID surveillance is patchy and the WHO has not yet created a program to help select strains for a COVID-19 vaccine but is working on a process. Currently, vaccine makers seem to be driving vaccine strain selection, said panelist Paul Offit, MD, professor of paediatrics at Children’s Hospital of Philadelphia. “I feel like to some extent the companies dictate the conversation. It shouldn’t come from them. It should come from us.”

“The important thing is that the public understands how complex this is,” said temporary committee member Oveta A. Fuller, PhD, associate professor of microbiology and immunology at the University of Michigan. “We didn’t get to understand influenza in 2 years. It’s taken years to get an imperfect but useful process to deal with flu.”

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

The next generation of COVID-19 vaccines should be able to fight off a new strain and be given each year, a panel of experts that advises the Food and Drug Administration said April 6.

But members of the panel also acknowledged that it will be an uphill battle to reach that goal, especially given how quickly the virus continues to change.

The members of the Vaccines and Related Biological Products Advisory Committee said they want to find the balance that makes sure Americans are protected against severe illness and death but doesn’t wear them out with constant recommendations for boosters.

“We don’t feel comfortable with multiple boosters every 8 weeks,” said committee chairman Arnold Monto, MD, professor emeritus of public health at the University of Michigan, Ann Arbor. “We’d love to see an annual vaccination similar to influenza but realize that the evolution of the virus will dictate how we respond in terms of additional vaccine doses.”

The virus itself will dictate vaccination plans, he said.

The government must also keep its focus on convincing Americans who haven’t been vaccinated to join the club, said committee member Henry H. Bernstein, DO, given that “it seems quite obvious that those who are vaccinated do better than those who aren’t vaccinated.”

The government should clearly communicate to the public the goals of vaccination, he said.

“I would suggest that our overall aim is to prevent severe disease, hospitalization, and death more than just infection prevention,” said Dr. Bernstein, professor of pediatrics at Hofstra University, Hempstead, N.Y.

The FDA called the meeting of its advisers to discuss overall booster and vaccine strategy, even though it already authorized a fourth dose of the Pfizer and Moderna vaccines for certain immune compromised adults and for everyone over age 50.

Early in the all-day meeting, temporary committee member James Hildreth, MD, the president of Meharry Medical College, Nashville, Tenn., asked why that authorization was given without the panel’s input. Peter Marks, MD, the director of FDA’s Center for Biologics Evaluation and Research, said the decision was based on data from the United Kingdom and Israel that suggested immunity from a third shot was already waning.

Dr. Marks later said the fourth dose was “authorized as a stopgap measure until we could get something else in place,” because the aim was to protect older Americans who had died at a higher rate than younger individuals.

“I think we’re very much on board that we simply can’t be boosting people as frequently as we are,” said Dr. Marks.
 

Not enough information to make broader plan

The meeting was meant to be a larger conversation about how to keep pace with the evolving virus and to set up a vaccine selection and development process to better and more quickly respond to changes, such as new variants.

But committee members said they felt stymied by a lack of information. They wanted more data from vaccine manufacturers’ clinical trials. And they noted that so far, there’s no objective, reliable lab-based measurement of COVID-19 vaccine effectiveness – known as a correlate of immunity. Instead, public health officials have looked at rates of hospitalizations and deaths to measure whether the vaccine is still offering protection.

“The question is, what is insufficient protection?” asked H. Cody Meissner, MD, director of pediatric infectious disease at Tufts Medical Center in Boston. “At what point will we say the vaccine isn’t working well enough?”

Centers for Disease Control and Prevention officials presented data showing that a third shot has been more effective than a two-shot regimen in preventing serious disease and death, and that the three shots were significantly more protective than being unvaccinated.

In February, as the Omicron variant continued to rage, unvaccinated Americans aged 5 years and older had an almost three times higher risk of testing positive, and nine times higher risk of dying, compared with those who were considered fully vaccinated, said Heather Scobie, PhD, MPH, a member of the CDC’s COVID-19 Emergency Response team.

But only 98 million Americans – about half of those aged 12 years or older – have received a third dose, Dr. Scobie said.

It’s also still not clear how much more protection a fourth shot adds, or how long it will last. The committee heard data on a just-published study of a fourth dose of the Pfizer vaccine given to some 600,000 Israelis during the Omicron wave from January to March. The rate of severe COVID-19 was 3.5 times lower in the group that received a fourth dose, compared with those who had gotten only three shots, and protection lasted for at least 12 weeks.

Still, study authors said, any protection against infection itself was “short lived.”


 

More like flu vaccine?

The advisers discussed the possibility of making COVID-19 vaccine development similar to the process for the flu vaccine but acknowledged many difficulties.

The flu predictably hits during the winter in each hemisphere and a global surveillance network helps the World Health Organization decide on the vaccine strains each year. Then each nation’s regulatory and public health officials choose the strains for their shot and vaccine makers begin what is typically a 6-month-long manufacturing process.

COVID outbreaks have happened during all seasons and new variants haven’t always hit every country in a similar fashion. The COVID virus has mutated at five times the speed of the flu virus – producing a new dominant strain in a year, compared with the 3-5 years it takes for the flu virus to do so, said Trevor Bedford, PhD, a professor in the vaccine and infectious disease division at the Fred Hutchinson Cancer Research Center in Seattle.

Global COVID surveillance is patchy and the WHO has not yet created a program to help select strains for a COVID-19 vaccine but is working on a process. Currently, vaccine makers seem to be driving vaccine strain selection, said panelist Paul Offit, MD, professor of paediatrics at Children’s Hospital of Philadelphia. “I feel like to some extent the companies dictate the conversation. It shouldn’t come from them. It should come from us.”

“The important thing is that the public understands how complex this is,” said temporary committee member Oveta A. Fuller, PhD, associate professor of microbiology and immunology at the University of Michigan. “We didn’t get to understand influenza in 2 years. It’s taken years to get an imperfect but useful process to deal with flu.”

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

The next generation of COVID-19 vaccines should be able to fight off a new strain and be given each year, a panel of experts that advises the Food and Drug Administration said April 6.

But members of the panel also acknowledged that it will be an uphill battle to reach that goal, especially given how quickly the virus continues to change.

The members of the Vaccines and Related Biological Products Advisory Committee said they want to find the balance that makes sure Americans are protected against severe illness and death but doesn’t wear them out with constant recommendations for boosters.

“We don’t feel comfortable with multiple boosters every 8 weeks,” said committee chairman Arnold Monto, MD, professor emeritus of public health at the University of Michigan, Ann Arbor. “We’d love to see an annual vaccination similar to influenza but realize that the evolution of the virus will dictate how we respond in terms of additional vaccine doses.”

The virus itself will dictate vaccination plans, he said.

The government must also keep its focus on convincing Americans who haven’t been vaccinated to join the club, said committee member Henry H. Bernstein, DO, given that “it seems quite obvious that those who are vaccinated do better than those who aren’t vaccinated.”

The government should clearly communicate to the public the goals of vaccination, he said.

“I would suggest that our overall aim is to prevent severe disease, hospitalization, and death more than just infection prevention,” said Dr. Bernstein, professor of pediatrics at Hofstra University, Hempstead, N.Y.

The FDA called the meeting of its advisers to discuss overall booster and vaccine strategy, even though it already authorized a fourth dose of the Pfizer and Moderna vaccines for certain immune compromised adults and for everyone over age 50.

Early in the all-day meeting, temporary committee member James Hildreth, MD, the president of Meharry Medical College, Nashville, Tenn., asked why that authorization was given without the panel’s input. Peter Marks, MD, the director of FDA’s Center for Biologics Evaluation and Research, said the decision was based on data from the United Kingdom and Israel that suggested immunity from a third shot was already waning.

Dr. Marks later said the fourth dose was “authorized as a stopgap measure until we could get something else in place,” because the aim was to protect older Americans who had died at a higher rate than younger individuals.

“I think we’re very much on board that we simply can’t be boosting people as frequently as we are,” said Dr. Marks.
 

Not enough information to make broader plan

The meeting was meant to be a larger conversation about how to keep pace with the evolving virus and to set up a vaccine selection and development process to better and more quickly respond to changes, such as new variants.

But committee members said they felt stymied by a lack of information. They wanted more data from vaccine manufacturers’ clinical trials. And they noted that so far, there’s no objective, reliable lab-based measurement of COVID-19 vaccine effectiveness – known as a correlate of immunity. Instead, public health officials have looked at rates of hospitalizations and deaths to measure whether the vaccine is still offering protection.

“The question is, what is insufficient protection?” asked H. Cody Meissner, MD, director of pediatric infectious disease at Tufts Medical Center in Boston. “At what point will we say the vaccine isn’t working well enough?”

Centers for Disease Control and Prevention officials presented data showing that a third shot has been more effective than a two-shot regimen in preventing serious disease and death, and that the three shots were significantly more protective than being unvaccinated.

In February, as the Omicron variant continued to rage, unvaccinated Americans aged 5 years and older had an almost three times higher risk of testing positive, and nine times higher risk of dying, compared with those who were considered fully vaccinated, said Heather Scobie, PhD, MPH, a member of the CDC’s COVID-19 Emergency Response team.

But only 98 million Americans – about half of those aged 12 years or older – have received a third dose, Dr. Scobie said.

It’s also still not clear how much more protection a fourth shot adds, or how long it will last. The committee heard data on a just-published study of a fourth dose of the Pfizer vaccine given to some 600,000 Israelis during the Omicron wave from January to March. The rate of severe COVID-19 was 3.5 times lower in the group that received a fourth dose, compared with those who had gotten only three shots, and protection lasted for at least 12 weeks.

Still, study authors said, any protection against infection itself was “short lived.”


 

More like flu vaccine?

The advisers discussed the possibility of making COVID-19 vaccine development similar to the process for the flu vaccine but acknowledged many difficulties.

The flu predictably hits during the winter in each hemisphere and a global surveillance network helps the World Health Organization decide on the vaccine strains each year. Then each nation’s regulatory and public health officials choose the strains for their shot and vaccine makers begin what is typically a 6-month-long manufacturing process.

COVID outbreaks have happened during all seasons and new variants haven’t always hit every country in a similar fashion. The COVID virus has mutated at five times the speed of the flu virus – producing a new dominant strain in a year, compared with the 3-5 years it takes for the flu virus to do so, said Trevor Bedford, PhD, a professor in the vaccine and infectious disease division at the Fred Hutchinson Cancer Research Center in Seattle.

Global COVID surveillance is patchy and the WHO has not yet created a program to help select strains for a COVID-19 vaccine but is working on a process. Currently, vaccine makers seem to be driving vaccine strain selection, said panelist Paul Offit, MD, professor of paediatrics at Children’s Hospital of Philadelphia. “I feel like to some extent the companies dictate the conversation. It shouldn’t come from them. It should come from us.”

“The important thing is that the public understands how complex this is,” said temporary committee member Oveta A. Fuller, PhD, associate professor of microbiology and immunology at the University of Michigan. “We didn’t get to understand influenza in 2 years. It’s taken years to get an imperfect but useful process to deal with flu.”

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

The Osteopathic Medical Board of California has revoked a psychiatrist’s license because it found that he sexually assaulted two patients after giving them ketamine and that he had an affair with the sister of another patient.

In its decision, the board stated that the psychiatrist, Cuyler Burns Goodwin, DO, committed gross negligence, violated ethical standards, departed from the standard of care, and was guilty of sexual misconduct.

“Even if one were to believe respondent’s denial of sexual assaults on Patient B and Patient C, his overall course of conduct in committing multiple other ethical violations and violations of the Medical Practice Act in connection with Patient A’s Sister, Patient B, and Patient C; his attitude toward and lack of insight into his offenses; and his lack of candor at hearing demonstrate that revocation of respondent’s license is required for protection of the public,” the board wrote in its March 8 order.

The board seeks to recover almost $65,000 in costs for the investigation, including for legal fees and expert testimony. The psychiatrist is not currently facing any criminal charges.
 

Family-run business

Dr. Goodwin received his medical license in 2013 and opened Sequoia Mind Health, a practice in Santa Rosa, Calif., soon after completing his residency at the University of California San Francisco, according to the board.

The allegations leading to the revocation of his license occurred at the Sequoia Mind Health practice, a family-run business that employed Dr. Goodwin’s mother as the office manager, his wife as the sole registered nurse, and his sister who worked reception for a time. Dr. Goodwin closed the practice in October 2019.

Until 2020, he worked as an emergency services psychiatrist for Sonoma County Behavioral Health. Other positions included stints at John George Psychiatric Pavilion in San Leandro, at Mendocino County Jail from 2018 to 2021, and at Lake County Jail from 2020 to 2021.

Since closing his practice, he also worked as a psychiatrist for Redwood Quality Management Company in Ukiah, Calif.

The board notified Dr. Goodwin in November 2020 that it was opening an investigation into his conduct.
 

Affair with patient’s sister

Patient A came to Dr. Goodwin in 2017 as an uninsured, homebound, 24-year-old with schizophrenia. He had not received previous mental health treatment and was entirely dependent on his family because of the severity of his symptoms.

Dr. Goodwin agreed to make home visits to provide medication management and psychotherapy and was paid in cash by the patient’s sister, who was a point of contact for the family.

The sister and Dr. Goodwin developed a friendship and, after commiserating about their troubled marriages, began a sexual relationship in 2018 and decided they would divorce their spouses and marry each other.

However, in November 2018, the sister became pregnant and, at her request, Dr. Goodwin prescribed misoprostol to induce an abortion. The affair and the abortion were later discovered by the sister’s family, who agreed to not file a complaint with the medical board in exchange for Dr. Goodwin’s agreeing to cease communications with the sister.

Nevertheless, the two continued the affair and in February 2019 the patient’s father and mother each separately complained to the medical board. The sister also sent a letter to the board urging against disciplinary action – but later acknowledged that the letter was prepared by Dr. Goodwin.

The family removed Patient A from Dr. Goodwin’s care in 2019. The sister’s relationship with Patient A and her family was damaged; she subsequently divorced her husband and moved out of state. She later told the board she regretted the relationship and knew it was wrong.

When Dr. Goodwin was initially interviewed in 2019 by the medical board, he refused to discuss the relationship or the misoprostol prescription. Then, at a later hearing, he said he did not see anything wrong with the relationship and did not believe it affected the care of Patient A.

The medical board’s expert witness said Dr. Goodwin’s behavior “showed he either had no knowledge of ethical boundaries or chose to ignore them, showing poor judgment and ‘cluelessness’ about the potential adverse effects of having a sexual relationship with Sister, which had the significant potential to compromise Patient A’s treatment.”
 

Sexual assault

Patient B came to Dr. Goodwin in 2017 to help taper her anxiety and depression medications. She informed him she had experienced multiple sexual assaults. He helped her taper off the drugs within a month and then hired her to work part-time at the practice’s reception desk.

After her symptoms worsened again after a traumatic event, Dr. Goodwin recommended the use of ketamine. Patient B received five ketamine treatments in a month with only Dr. Goodwin present in the room.

During one of those treatments he asked her questions about her sex life.  Another night in the office he asked her to have a glass of wine with him and then allegedly sexually assaulted her.

Patient B soon quit the job via text, telling him his behavior was inappropriate. She told Dr. Goodwin she would not say anything about the assault but asked for a letter of recommendation for another job. Dr. Goodwin texted back that she was “100% right,” and he would give her a great recommendation, which he later did.

A year later, in 2019, Pamela Albro, PhD, a psychologist who provided therapy at Sequoia Mind Health, contacted Patient B to ask why she quit.

When Patient B told her about the assault, the therapist asked to share her name with Patient C, who had a similar experience. Patient B agreed and then submitted a police report and a complaint to the medical board in March 2019.

Dr. Goodwin denied Patient B’s allegations and “offered evasive and non-credible testimony” about Patient B’s text messages, the board said.
 

Another patient-employee

Patient C attended Dr. Goodwin’s clinic in May 2017 after a suicide attempt that required hospitalization. She told Dr. Goodwin she had experienced sexual trauma and assault in the past. Dr. Goodwin referred Patient C to Dr. Albro for therapy, managed her medications himself, and hired her to work at the clinic’s reception desk, even though she was still a patient.

Patient C worked 32 hours a week and took on other duties that included assisting in the administration of transcranial magnetic stimulation to clinic patients.

In late 2017, Dr. Goodwin recommended ketamine for Patient C and she received seven treatments from December 2017 through April 2019. There were no records of vital signs monitoring during the treatments, and Dr. Goodwin’s wife was present for only two sessions.

During the first treatment, where Patient C said she was feeling “out of it,” Dr. Goodwin allegedly sexually assaulted her.

Because of the ketamine, she told the medical board she was unable to speak or yell but said, “I screamed in my head.” After Dr. Goodwin left the room, she said she felt afraid, ashamed, and wanted to go home. Dr. Goodwin walked her to the lobby where her husband was waiting.

The patient did not tell her husband about the assault because she said she felt ashamed, and said she did not report Dr. Goodwin because it was not safe.
 

Disciplinary hearing

Patient C continued to work for Dr. Goodwin, calling it a confusing time in her life. She later learned about the affair with Patient A’s sister and about Patient B’s experience and resigned from the clinic in July 2019.

She still did not discuss the assault until early 2021 when the board contacted her again. She confided to her primary care physician, who noted that her PTSD symptoms had worsened.

Dr. Goodwin said in the disciplinary hearing that hiring Patient B and Patient C was “boundary crossing,” but he denied allegations of asking inappropriate questions or of sexual assault. The board, however, characterized the testimony of Patient B and Patient C as credible.

All of Dr. Goodwin’s other employers said at his disciplinary hearing that they believed he was a good psychiatrist and that they had never seen any unprofessional behavior.

The revocation of Dr. Goodwin’s license will be effective as of April 7. Dr. Goodwin’s attorney, Marvin H. Firestone, MD, JD, told this news organization he had “no comment” on the medical board’s decision or about his client.

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

The Osteopathic Medical Board of California has revoked a psychiatrist’s license because it found that he sexually assaulted two patients after giving them ketamine and that he had an affair with the sister of another patient.

In its decision, the board stated that the psychiatrist, Cuyler Burns Goodwin, DO, committed gross negligence, violated ethical standards, departed from the standard of care, and was guilty of sexual misconduct.

“Even if one were to believe respondent’s denial of sexual assaults on Patient B and Patient C, his overall course of conduct in committing multiple other ethical violations and violations of the Medical Practice Act in connection with Patient A’s Sister, Patient B, and Patient C; his attitude toward and lack of insight into his offenses; and his lack of candor at hearing demonstrate that revocation of respondent’s license is required for protection of the public,” the board wrote in its March 8 order.

The board seeks to recover almost $65,000 in costs for the investigation, including for legal fees and expert testimony. The psychiatrist is not currently facing any criminal charges.
 

Family-run business

Dr. Goodwin received his medical license in 2013 and opened Sequoia Mind Health, a practice in Santa Rosa, Calif., soon after completing his residency at the University of California San Francisco, according to the board.

The allegations leading to the revocation of his license occurred at the Sequoia Mind Health practice, a family-run business that employed Dr. Goodwin’s mother as the office manager, his wife as the sole registered nurse, and his sister who worked reception for a time. Dr. Goodwin closed the practice in October 2019.

Until 2020, he worked as an emergency services psychiatrist for Sonoma County Behavioral Health. Other positions included stints at John George Psychiatric Pavilion in San Leandro, at Mendocino County Jail from 2018 to 2021, and at Lake County Jail from 2020 to 2021.

Since closing his practice, he also worked as a psychiatrist for Redwood Quality Management Company in Ukiah, Calif.

The board notified Dr. Goodwin in November 2020 that it was opening an investigation into his conduct.
 

Affair with patient’s sister

Patient A came to Dr. Goodwin in 2017 as an uninsured, homebound, 24-year-old with schizophrenia. He had not received previous mental health treatment and was entirely dependent on his family because of the severity of his symptoms.

Dr. Goodwin agreed to make home visits to provide medication management and psychotherapy and was paid in cash by the patient’s sister, who was a point of contact for the family.

The sister and Dr. Goodwin developed a friendship and, after commiserating about their troubled marriages, began a sexual relationship in 2018 and decided they would divorce their spouses and marry each other.

However, in November 2018, the sister became pregnant and, at her request, Dr. Goodwin prescribed misoprostol to induce an abortion. The affair and the abortion were later discovered by the sister’s family, who agreed to not file a complaint with the medical board in exchange for Dr. Goodwin’s agreeing to cease communications with the sister.

Nevertheless, the two continued the affair and in February 2019 the patient’s father and mother each separately complained to the medical board. The sister also sent a letter to the board urging against disciplinary action – but later acknowledged that the letter was prepared by Dr. Goodwin.

The family removed Patient A from Dr. Goodwin’s care in 2019. The sister’s relationship with Patient A and her family was damaged; she subsequently divorced her husband and moved out of state. She later told the board she regretted the relationship and knew it was wrong.

When Dr. Goodwin was initially interviewed in 2019 by the medical board, he refused to discuss the relationship or the misoprostol prescription. Then, at a later hearing, he said he did not see anything wrong with the relationship and did not believe it affected the care of Patient A.

The medical board’s expert witness said Dr. Goodwin’s behavior “showed he either had no knowledge of ethical boundaries or chose to ignore them, showing poor judgment and ‘cluelessness’ about the potential adverse effects of having a sexual relationship with Sister, which had the significant potential to compromise Patient A’s treatment.”
 

Sexual assault

Patient B came to Dr. Goodwin in 2017 to help taper her anxiety and depression medications. She informed him she had experienced multiple sexual assaults. He helped her taper off the drugs within a month and then hired her to work part-time at the practice’s reception desk.

After her symptoms worsened again after a traumatic event, Dr. Goodwin recommended the use of ketamine. Patient B received five ketamine treatments in a month with only Dr. Goodwin present in the room.

During one of those treatments he asked her questions about her sex life.  Another night in the office he asked her to have a glass of wine with him and then allegedly sexually assaulted her.

Patient B soon quit the job via text, telling him his behavior was inappropriate. She told Dr. Goodwin she would not say anything about the assault but asked for a letter of recommendation for another job. Dr. Goodwin texted back that she was “100% right,” and he would give her a great recommendation, which he later did.

A year later, in 2019, Pamela Albro, PhD, a psychologist who provided therapy at Sequoia Mind Health, contacted Patient B to ask why she quit.

When Patient B told her about the assault, the therapist asked to share her name with Patient C, who had a similar experience. Patient B agreed and then submitted a police report and a complaint to the medical board in March 2019.

Dr. Goodwin denied Patient B’s allegations and “offered evasive and non-credible testimony” about Patient B’s text messages, the board said.
 

Another patient-employee

Patient C attended Dr. Goodwin’s clinic in May 2017 after a suicide attempt that required hospitalization. She told Dr. Goodwin she had experienced sexual trauma and assault in the past. Dr. Goodwin referred Patient C to Dr. Albro for therapy, managed her medications himself, and hired her to work at the clinic’s reception desk, even though she was still a patient.

Patient C worked 32 hours a week and took on other duties that included assisting in the administration of transcranial magnetic stimulation to clinic patients.

In late 2017, Dr. Goodwin recommended ketamine for Patient C and she received seven treatments from December 2017 through April 2019. There were no records of vital signs monitoring during the treatments, and Dr. Goodwin’s wife was present for only two sessions.

During the first treatment, where Patient C said she was feeling “out of it,” Dr. Goodwin allegedly sexually assaulted her.

Because of the ketamine, she told the medical board she was unable to speak or yell but said, “I screamed in my head.” After Dr. Goodwin left the room, she said she felt afraid, ashamed, and wanted to go home. Dr. Goodwin walked her to the lobby where her husband was waiting.

The patient did not tell her husband about the assault because she said she felt ashamed, and said she did not report Dr. Goodwin because it was not safe.
 

Disciplinary hearing

Patient C continued to work for Dr. Goodwin, calling it a confusing time in her life. She later learned about the affair with Patient A’s sister and about Patient B’s experience and resigned from the clinic in July 2019.

She still did not discuss the assault until early 2021 when the board contacted her again. She confided to her primary care physician, who noted that her PTSD symptoms had worsened.

Dr. Goodwin said in the disciplinary hearing that hiring Patient B and Patient C was “boundary crossing,” but he denied allegations of asking inappropriate questions or of sexual assault. The board, however, characterized the testimony of Patient B and Patient C as credible.

All of Dr. Goodwin’s other employers said at his disciplinary hearing that they believed he was a good psychiatrist and that they had never seen any unprofessional behavior.

The revocation of Dr. Goodwin’s license will be effective as of April 7. Dr. Goodwin’s attorney, Marvin H. Firestone, MD, JD, told this news organization he had “no comment” on the medical board’s decision or about his client.

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

The Osteopathic Medical Board of California has revoked a psychiatrist’s license because it found that he sexually assaulted two patients after giving them ketamine and that he had an affair with the sister of another patient.

In its decision, the board stated that the psychiatrist, Cuyler Burns Goodwin, DO, committed gross negligence, violated ethical standards, departed from the standard of care, and was guilty of sexual misconduct.

“Even if one were to believe respondent’s denial of sexual assaults on Patient B and Patient C, his overall course of conduct in committing multiple other ethical violations and violations of the Medical Practice Act in connection with Patient A’s Sister, Patient B, and Patient C; his attitude toward and lack of insight into his offenses; and his lack of candor at hearing demonstrate that revocation of respondent’s license is required for protection of the public,” the board wrote in its March 8 order.

The board seeks to recover almost $65,000 in costs for the investigation, including for legal fees and expert testimony. The psychiatrist is not currently facing any criminal charges.
 

Family-run business

Dr. Goodwin received his medical license in 2013 and opened Sequoia Mind Health, a practice in Santa Rosa, Calif., soon after completing his residency at the University of California San Francisco, according to the board.

The allegations leading to the revocation of his license occurred at the Sequoia Mind Health practice, a family-run business that employed Dr. Goodwin’s mother as the office manager, his wife as the sole registered nurse, and his sister who worked reception for a time. Dr. Goodwin closed the practice in October 2019.

Until 2020, he worked as an emergency services psychiatrist for Sonoma County Behavioral Health. Other positions included stints at John George Psychiatric Pavilion in San Leandro, at Mendocino County Jail from 2018 to 2021, and at Lake County Jail from 2020 to 2021.

Since closing his practice, he also worked as a psychiatrist for Redwood Quality Management Company in Ukiah, Calif.

The board notified Dr. Goodwin in November 2020 that it was opening an investigation into his conduct.
 

Affair with patient’s sister

Patient A came to Dr. Goodwin in 2017 as an uninsured, homebound, 24-year-old with schizophrenia. He had not received previous mental health treatment and was entirely dependent on his family because of the severity of his symptoms.

Dr. Goodwin agreed to make home visits to provide medication management and psychotherapy and was paid in cash by the patient’s sister, who was a point of contact for the family.

The sister and Dr. Goodwin developed a friendship and, after commiserating about their troubled marriages, began a sexual relationship in 2018 and decided they would divorce their spouses and marry each other.

However, in November 2018, the sister became pregnant and, at her request, Dr. Goodwin prescribed misoprostol to induce an abortion. The affair and the abortion were later discovered by the sister’s family, who agreed to not file a complaint with the medical board in exchange for Dr. Goodwin’s agreeing to cease communications with the sister.

Nevertheless, the two continued the affair and in February 2019 the patient’s father and mother each separately complained to the medical board. The sister also sent a letter to the board urging against disciplinary action – but later acknowledged that the letter was prepared by Dr. Goodwin.

The family removed Patient A from Dr. Goodwin’s care in 2019. The sister’s relationship with Patient A and her family was damaged; she subsequently divorced her husband and moved out of state. She later told the board she regretted the relationship and knew it was wrong.

When Dr. Goodwin was initially interviewed in 2019 by the medical board, he refused to discuss the relationship or the misoprostol prescription. Then, at a later hearing, he said he did not see anything wrong with the relationship and did not believe it affected the care of Patient A.

The medical board’s expert witness said Dr. Goodwin’s behavior “showed he either had no knowledge of ethical boundaries or chose to ignore them, showing poor judgment and ‘cluelessness’ about the potential adverse effects of having a sexual relationship with Sister, which had the significant potential to compromise Patient A’s treatment.”
 

Sexual assault

Patient B came to Dr. Goodwin in 2017 to help taper her anxiety and depression medications. She informed him she had experienced multiple sexual assaults. He helped her taper off the drugs within a month and then hired her to work part-time at the practice’s reception desk.

After her symptoms worsened again after a traumatic event, Dr. Goodwin recommended the use of ketamine. Patient B received five ketamine treatments in a month with only Dr. Goodwin present in the room.

During one of those treatments he asked her questions about her sex life.  Another night in the office he asked her to have a glass of wine with him and then allegedly sexually assaulted her.

Patient B soon quit the job via text, telling him his behavior was inappropriate. She told Dr. Goodwin she would not say anything about the assault but asked for a letter of recommendation for another job. Dr. Goodwin texted back that she was “100% right,” and he would give her a great recommendation, which he later did.

A year later, in 2019, Pamela Albro, PhD, a psychologist who provided therapy at Sequoia Mind Health, contacted Patient B to ask why she quit.

When Patient B told her about the assault, the therapist asked to share her name with Patient C, who had a similar experience. Patient B agreed and then submitted a police report and a complaint to the medical board in March 2019.

Dr. Goodwin denied Patient B’s allegations and “offered evasive and non-credible testimony” about Patient B’s text messages, the board said.
 

Another patient-employee

Patient C attended Dr. Goodwin’s clinic in May 2017 after a suicide attempt that required hospitalization. She told Dr. Goodwin she had experienced sexual trauma and assault in the past. Dr. Goodwin referred Patient C to Dr. Albro for therapy, managed her medications himself, and hired her to work at the clinic’s reception desk, even though she was still a patient.

Patient C worked 32 hours a week and took on other duties that included assisting in the administration of transcranial magnetic stimulation to clinic patients.

In late 2017, Dr. Goodwin recommended ketamine for Patient C and she received seven treatments from December 2017 through April 2019. There were no records of vital signs monitoring during the treatments, and Dr. Goodwin’s wife was present for only two sessions.

During the first treatment, where Patient C said she was feeling “out of it,” Dr. Goodwin allegedly sexually assaulted her.

Because of the ketamine, she told the medical board she was unable to speak or yell but said, “I screamed in my head.” After Dr. Goodwin left the room, she said she felt afraid, ashamed, and wanted to go home. Dr. Goodwin walked her to the lobby where her husband was waiting.

The patient did not tell her husband about the assault because she said she felt ashamed, and said she did not report Dr. Goodwin because it was not safe.
 

Disciplinary hearing

Patient C continued to work for Dr. Goodwin, calling it a confusing time in her life. She later learned about the affair with Patient A’s sister and about Patient B’s experience and resigned from the clinic in July 2019.

She still did not discuss the assault until early 2021 when the board contacted her again. She confided to her primary care physician, who noted that her PTSD symptoms had worsened.

Dr. Goodwin said in the disciplinary hearing that hiring Patient B and Patient C was “boundary crossing,” but he denied allegations of asking inappropriate questions or of sexual assault. The board, however, characterized the testimony of Patient B and Patient C as credible.

All of Dr. Goodwin’s other employers said at his disciplinary hearing that they believed he was a good psychiatrist and that they had never seen any unprofessional behavior.

The revocation of Dr. Goodwin’s license will be effective as of April 7. Dr. Goodwin’s attorney, Marvin H. Firestone, MD, JD, told this news organization he had “no comment” on the medical board’s decision or about his client.

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

The Food and Drug Administration today authorized Americans over the age of 50 to receive a second COVID-19 booster shot, even though many top infectious disease experts questioned the need before the agency’s decision.

The FDA granted emergency use authorization for both Pfizer and Moderna to offer the second booster – and fourth shot overall – for adults over 50 as well as those over 18 with compromised immune systems.

The Centers for Control and Prevention must still sign off before those doses start reaching American arms. That approval could come at any time.

“The general consensus, certainly the CDC’s consensus, is that the current vaccines are still really quite effective against Omicron and this new BA.2 variant in keeping people out of the hospital, and preventing the development of severe disease,” William Schaffner, MD, an infectious disease specialist at Vanderbilt University in Nashville said prior to the FDA’s announcement March 29.

Of the 217.4 million Americans who are “fully vaccinated,” i.e., received two doses of either Pfizer or Moderna’s vaccines or one dose of the Johnson & Johnson vaccine, only 45% have also received a booster shot, according to the CDC.

“Given that, there’s no need at the moment for the general population to get a fourth inoculation,” Dr. Schaffner says. “Our current focus ought to be on making sure that as many people as possible get that [first] booster who are eligible.”

Monica Gandhi, MD, an infectious disease specialist at the University of California, San Francisco, agreed that another booster for everyone was unnecessary. The only people who would need a fourth shot (or third, if they had the Johnson & Johnson vaccine initially) are those over age 65 or 70 years, Dr. Gandhi says.

“Older people need those antibodies up high because they’re more susceptible to severe breakthroughs,” she said, also before the latest development.
 

To boost or not to boost

Daniel Kuritzkes, MD, chief of infectious diseases at Brigham & Women’s Hospital in Boston, said the timing of a booster and who should be eligible depends on what the nation is trying to achieve with its vaccination strategy.

“Is the goal to prevent any symptomatic infection with COVID-19, is the goal to prevent the spread of COVID-19, or is the goal to prevent severe disease that requires hospitalization?” asked Dr. Kuritzkes.

The current vaccine — with a booster — has prevented severe disease, he said.

An Israeli study showed, for instance, that a third Pfizer dose was 93% effective against hospitalization, 92% effective against severe illness, and 81% effective against death.

A just-published study in the New England Journal of Medicine found that a booster of the Pfizer vaccine was 95% effective against COVID-19 infection and that it did not raise any new safety issues.

A small Israeli study, also published in NEJM, of a fourth Pfizer dose given to health care workers found that it prevented symptomatic infection and illness, but that it was much less effective than previous doses — maybe 65% effective against symptomatic illness, the authors write.

Giving Americans another booster now — which has been shown to lose some effectiveness after about 4 months — means it might not offer protection this fall and winter, when there could be a seasonal surge of the virus, Dr. Kuritzkes says.

And, even if people receive boosters every few months, they are still likely to get a mild respiratory virus infection, he said.

“I’m pretty convinced that we cannot boost ourselves out of this pandemic,” said Dr. Kuritzkes. “We need to first of all ensure there’s global immunization so that all the people who have not been vaccinated at all get vaccinated. That’s far more important than boosting people a fourth time.”
 

Booster confusion

The April 6 FDA meeting of the agency’s Vaccines and Related Biological Products Advisory Committee comes as the two major COVID vaccine makers — Pfizer and Moderna — have applied for emergency use authorization for an additional booster.

Pfizer had asked for authorization for a fourth shot in patients over age 65 years, while Moderna wanted a booster to be available to all Americans over 18. The FDA instead granted authorization to both companies for those over 50 and anyone 18 or older who is immunocompromised.

What this means for the committee’s April 6 meeting is not clear. The original agenda says the committee will consider the evidence on safety and effectiveness of the additional vaccine doses and discuss how to set up a process — similar to that used for the influenza vaccine — to be able to determine the makeup of COVID vaccines as new variants emerge. That could lay the groundwork for an annual COVID shot, if needed.

The FDA advisers will not make recommendations nor vote on whether — and which — Americans should get a COVID booster. That is the job of the CDC’s Advisory Committee on Immunization Practices (ACIP).

The last time a booster was considered, CDC Director Rochelle Walensky, MD, overrode the committee and recommended that all Americans — not just older individuals — get an additional COVID shot, which became the first booster.

That past action worries Dr. Gandhi, who calls it confusing, and says it may have contributed to the fact that less than half of Americans have since chosen to get a booster.

Dr. Schaffner says he expects the FDA to authorize emergency use for fourth doses of the Pfizer and Moderna vaccines, but he doesn’t think the CDC committee will recommend routine use. As was seen before, however, the CDC director does not have to follow the committee’s advice.

The members of ACIP “might be more conservative or narrower in scope in terms of recommending who needs to be boosted and when boosting is appropriate,” Dr. Kuritzkes says.

Dr. Gandhi says she’s concerned the FDA’s deliberations could be swayed by Moderna and Pfizer’s influence and that “pharmaceutical companies are going to have more of a say than they should in the scientific process.”

There are similar worries for Dr. Schaffner. He says he’s “a bit grumpy” that the vaccine makers have been using press releases to argue for boosters.

“Press releases are no way to make vaccine recommendations,” Dr. Schaffner said, adding that he “would advise [vaccine makers] to sit down and be quiet and let the FDA and CDC advisory committee do their thing.”

Moderna Chief Medical Officer Paul Burton, MD, however, told WebMD last week that the signs point to why a fourth shot may be needed.

“We see waning of effectiveness, antibody levels come down, and certainly effectiveness against Omicron comes down in 3 to 6 months,” Burton said. “The natural history, from what we’re seeing around the world, is that BA.2 is definitely here, it’s highly transmissible, and I think we are going to get an additional wave of BA.2 here in the United States.”

Another wave is coming, he said, and “I think there will be waning of effectiveness. We need to be prepared for that, so that’s why we need the fourth dose.”
 

Supply issues?

Meanwhile, the United Kingdom has begun offering boosters to anyone over 75, and Sweden’s health authority has recommended a fourth shot to people over age 80.

That puts pressure on the United States — at least on its politicians and policymakers — to, in a sense, keep up, said the infectious disease specialists.

Indeed, the White House has been keeping fourth shots in the news, warning that it is running out of money to ensure that all Americans would have access to one, if recommended.

On March 23, outgoing White House COVID-19 Response Coordinator Jeff Zients said the federal government had enough vaccine for the immunocompromised to get a fourth dose “and, if authorized in the coming weeks, enough supply for fourth doses for our most vulnerable, including seniors.”

But he warned that without congressional approval of a COVID-19 funding package, “We can’t procure the necessary vaccine supply to support fourth shots for all Americans.”

Mr. Zients also noted that other countries, including Japan, Vietnam, and the Philippines had already secured future booster doses and added, “We should be securing additional supply right now.”

Dr. Schaffner says that while it would be nice to “have a booster on the shelf,” the United States needs to put more effort into creating a globally-coordinated process for ensuring that vaccines match circulating strains and that they are manufactured on a timely basis.

He says he and others “have been reminding the public that the COVID pandemic may indeed be diminishing and moving into the endemic, but that doesn’t mean COVID is over or finished or disappeared.”

Dr. Schaffner says that it may be that “perhaps we’d need a periodic reminder to our immune system to remain protected. In other words, we might have to get boosted perhaps annually like we do with influenza.”

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

The Food and Drug Administration today authorized Americans over the age of 50 to receive a second COVID-19 booster shot, even though many top infectious disease experts questioned the need before the agency’s decision.

The FDA granted emergency use authorization for both Pfizer and Moderna to offer the second booster – and fourth shot overall – for adults over 50 as well as those over 18 with compromised immune systems.

The Centers for Control and Prevention must still sign off before those doses start reaching American arms. That approval could come at any time.

“The general consensus, certainly the CDC’s consensus, is that the current vaccines are still really quite effective against Omicron and this new BA.2 variant in keeping people out of the hospital, and preventing the development of severe disease,” William Schaffner, MD, an infectious disease specialist at Vanderbilt University in Nashville said prior to the FDA’s announcement March 29.

Of the 217.4 million Americans who are “fully vaccinated,” i.e., received two doses of either Pfizer or Moderna’s vaccines or one dose of the Johnson & Johnson vaccine, only 45% have also received a booster shot, according to the CDC.

“Given that, there’s no need at the moment for the general population to get a fourth inoculation,” Dr. Schaffner says. “Our current focus ought to be on making sure that as many people as possible get that [first] booster who are eligible.”

Monica Gandhi, MD, an infectious disease specialist at the University of California, San Francisco, agreed that another booster for everyone was unnecessary. The only people who would need a fourth shot (or third, if they had the Johnson & Johnson vaccine initially) are those over age 65 or 70 years, Dr. Gandhi says.

“Older people need those antibodies up high because they’re more susceptible to severe breakthroughs,” she said, also before the latest development.
 

To boost or not to boost

Daniel Kuritzkes, MD, chief of infectious diseases at Brigham & Women’s Hospital in Boston, said the timing of a booster and who should be eligible depends on what the nation is trying to achieve with its vaccination strategy.

“Is the goal to prevent any symptomatic infection with COVID-19, is the goal to prevent the spread of COVID-19, or is the goal to prevent severe disease that requires hospitalization?” asked Dr. Kuritzkes.

The current vaccine — with a booster — has prevented severe disease, he said.

An Israeli study showed, for instance, that a third Pfizer dose was 93% effective against hospitalization, 92% effective against severe illness, and 81% effective against death.

A just-published study in the New England Journal of Medicine found that a booster of the Pfizer vaccine was 95% effective against COVID-19 infection and that it did not raise any new safety issues.

A small Israeli study, also published in NEJM, of a fourth Pfizer dose given to health care workers found that it prevented symptomatic infection and illness, but that it was much less effective than previous doses — maybe 65% effective against symptomatic illness, the authors write.

Giving Americans another booster now — which has been shown to lose some effectiveness after about 4 months — means it might not offer protection this fall and winter, when there could be a seasonal surge of the virus, Dr. Kuritzkes says.

And, even if people receive boosters every few months, they are still likely to get a mild respiratory virus infection, he said.

“I’m pretty convinced that we cannot boost ourselves out of this pandemic,” said Dr. Kuritzkes. “We need to first of all ensure there’s global immunization so that all the people who have not been vaccinated at all get vaccinated. That’s far more important than boosting people a fourth time.”
 

Booster confusion

The April 6 FDA meeting of the agency’s Vaccines and Related Biological Products Advisory Committee comes as the two major COVID vaccine makers — Pfizer and Moderna — have applied for emergency use authorization for an additional booster.

Pfizer had asked for authorization for a fourth shot in patients over age 65 years, while Moderna wanted a booster to be available to all Americans over 18. The FDA instead granted authorization to both companies for those over 50 and anyone 18 or older who is immunocompromised.

What this means for the committee’s April 6 meeting is not clear. The original agenda says the committee will consider the evidence on safety and effectiveness of the additional vaccine doses and discuss how to set up a process — similar to that used for the influenza vaccine — to be able to determine the makeup of COVID vaccines as new variants emerge. That could lay the groundwork for an annual COVID shot, if needed.

The FDA advisers will not make recommendations nor vote on whether — and which — Americans should get a COVID booster. That is the job of the CDC’s Advisory Committee on Immunization Practices (ACIP).

The last time a booster was considered, CDC Director Rochelle Walensky, MD, overrode the committee and recommended that all Americans — not just older individuals — get an additional COVID shot, which became the first booster.

That past action worries Dr. Gandhi, who calls it confusing, and says it may have contributed to the fact that less than half of Americans have since chosen to get a booster.

Dr. Schaffner says he expects the FDA to authorize emergency use for fourth doses of the Pfizer and Moderna vaccines, but he doesn’t think the CDC committee will recommend routine use. As was seen before, however, the CDC director does not have to follow the committee’s advice.

The members of ACIP “might be more conservative or narrower in scope in terms of recommending who needs to be boosted and when boosting is appropriate,” Dr. Kuritzkes says.

Dr. Gandhi says she’s concerned the FDA’s deliberations could be swayed by Moderna and Pfizer’s influence and that “pharmaceutical companies are going to have more of a say than they should in the scientific process.”

There are similar worries for Dr. Schaffner. He says he’s “a bit grumpy” that the vaccine makers have been using press releases to argue for boosters.

“Press releases are no way to make vaccine recommendations,” Dr. Schaffner said, adding that he “would advise [vaccine makers] to sit down and be quiet and let the FDA and CDC advisory committee do their thing.”

Moderna Chief Medical Officer Paul Burton, MD, however, told WebMD last week that the signs point to why a fourth shot may be needed.

“We see waning of effectiveness, antibody levels come down, and certainly effectiveness against Omicron comes down in 3 to 6 months,” Burton said. “The natural history, from what we’re seeing around the world, is that BA.2 is definitely here, it’s highly transmissible, and I think we are going to get an additional wave of BA.2 here in the United States.”

Another wave is coming, he said, and “I think there will be waning of effectiveness. We need to be prepared for that, so that’s why we need the fourth dose.”
 

Supply issues?

Meanwhile, the United Kingdom has begun offering boosters to anyone over 75, and Sweden’s health authority has recommended a fourth shot to people over age 80.

That puts pressure on the United States — at least on its politicians and policymakers — to, in a sense, keep up, said the infectious disease specialists.

Indeed, the White House has been keeping fourth shots in the news, warning that it is running out of money to ensure that all Americans would have access to one, if recommended.

On March 23, outgoing White House COVID-19 Response Coordinator Jeff Zients said the federal government had enough vaccine for the immunocompromised to get a fourth dose “and, if authorized in the coming weeks, enough supply for fourth doses for our most vulnerable, including seniors.”

But he warned that without congressional approval of a COVID-19 funding package, “We can’t procure the necessary vaccine supply to support fourth shots for all Americans.”

Mr. Zients also noted that other countries, including Japan, Vietnam, and the Philippines had already secured future booster doses and added, “We should be securing additional supply right now.”

Dr. Schaffner says that while it would be nice to “have a booster on the shelf,” the United States needs to put more effort into creating a globally-coordinated process for ensuring that vaccines match circulating strains and that they are manufactured on a timely basis.

He says he and others “have been reminding the public that the COVID pandemic may indeed be diminishing and moving into the endemic, but that doesn’t mean COVID is over or finished or disappeared.”

Dr. Schaffner says that it may be that “perhaps we’d need a periodic reminder to our immune system to remain protected. In other words, we might have to get boosted perhaps annually like we do with influenza.”

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

The Food and Drug Administration today authorized Americans over the age of 50 to receive a second COVID-19 booster shot, even though many top infectious disease experts questioned the need before the agency’s decision.

The FDA granted emergency use authorization for both Pfizer and Moderna to offer the second booster – and fourth shot overall – for adults over 50 as well as those over 18 with compromised immune systems.

The Centers for Control and Prevention must still sign off before those doses start reaching American arms. That approval could come at any time.

“The general consensus, certainly the CDC’s consensus, is that the current vaccines are still really quite effective against Omicron and this new BA.2 variant in keeping people out of the hospital, and preventing the development of severe disease,” William Schaffner, MD, an infectious disease specialist at Vanderbilt University in Nashville said prior to the FDA’s announcement March 29.

Of the 217.4 million Americans who are “fully vaccinated,” i.e., received two doses of either Pfizer or Moderna’s vaccines or one dose of the Johnson & Johnson vaccine, only 45% have also received a booster shot, according to the CDC.

“Given that, there’s no need at the moment for the general population to get a fourth inoculation,” Dr. Schaffner says. “Our current focus ought to be on making sure that as many people as possible get that [first] booster who are eligible.”

Monica Gandhi, MD, an infectious disease specialist at the University of California, San Francisco, agreed that another booster for everyone was unnecessary. The only people who would need a fourth shot (or third, if they had the Johnson & Johnson vaccine initially) are those over age 65 or 70 years, Dr. Gandhi says.

“Older people need those antibodies up high because they’re more susceptible to severe breakthroughs,” she said, also before the latest development.
 

To boost or not to boost

Daniel Kuritzkes, MD, chief of infectious diseases at Brigham & Women’s Hospital in Boston, said the timing of a booster and who should be eligible depends on what the nation is trying to achieve with its vaccination strategy.

“Is the goal to prevent any symptomatic infection with COVID-19, is the goal to prevent the spread of COVID-19, or is the goal to prevent severe disease that requires hospitalization?” asked Dr. Kuritzkes.

The current vaccine — with a booster — has prevented severe disease, he said.

An Israeli study showed, for instance, that a third Pfizer dose was 93% effective against hospitalization, 92% effective against severe illness, and 81% effective against death.

A just-published study in the New England Journal of Medicine found that a booster of the Pfizer vaccine was 95% effective against COVID-19 infection and that it did not raise any new safety issues.

A small Israeli study, also published in NEJM, of a fourth Pfizer dose given to health care workers found that it prevented symptomatic infection and illness, but that it was much less effective than previous doses — maybe 65% effective against symptomatic illness, the authors write.

Giving Americans another booster now — which has been shown to lose some effectiveness after about 4 months — means it might not offer protection this fall and winter, when there could be a seasonal surge of the virus, Dr. Kuritzkes says.

And, even if people receive boosters every few months, they are still likely to get a mild respiratory virus infection, he said.

“I’m pretty convinced that we cannot boost ourselves out of this pandemic,” said Dr. Kuritzkes. “We need to first of all ensure there’s global immunization so that all the people who have not been vaccinated at all get vaccinated. That’s far more important than boosting people a fourth time.”
 

Booster confusion

The April 6 FDA meeting of the agency’s Vaccines and Related Biological Products Advisory Committee comes as the two major COVID vaccine makers — Pfizer and Moderna — have applied for emergency use authorization for an additional booster.

Pfizer had asked for authorization for a fourth shot in patients over age 65 years, while Moderna wanted a booster to be available to all Americans over 18. The FDA instead granted authorization to both companies for those over 50 and anyone 18 or older who is immunocompromised.

What this means for the committee’s April 6 meeting is not clear. The original agenda says the committee will consider the evidence on safety and effectiveness of the additional vaccine doses and discuss how to set up a process — similar to that used for the influenza vaccine — to be able to determine the makeup of COVID vaccines as new variants emerge. That could lay the groundwork for an annual COVID shot, if needed.

The FDA advisers will not make recommendations nor vote on whether — and which — Americans should get a COVID booster. That is the job of the CDC’s Advisory Committee on Immunization Practices (ACIP).

The last time a booster was considered, CDC Director Rochelle Walensky, MD, overrode the committee and recommended that all Americans — not just older individuals — get an additional COVID shot, which became the first booster.

That past action worries Dr. Gandhi, who calls it confusing, and says it may have contributed to the fact that less than half of Americans have since chosen to get a booster.

Dr. Schaffner says he expects the FDA to authorize emergency use for fourth doses of the Pfizer and Moderna vaccines, but he doesn’t think the CDC committee will recommend routine use. As was seen before, however, the CDC director does not have to follow the committee’s advice.

The members of ACIP “might be more conservative or narrower in scope in terms of recommending who needs to be boosted and when boosting is appropriate,” Dr. Kuritzkes says.

Dr. Gandhi says she’s concerned the FDA’s deliberations could be swayed by Moderna and Pfizer’s influence and that “pharmaceutical companies are going to have more of a say than they should in the scientific process.”

There are similar worries for Dr. Schaffner. He says he’s “a bit grumpy” that the vaccine makers have been using press releases to argue for boosters.

“Press releases are no way to make vaccine recommendations,” Dr. Schaffner said, adding that he “would advise [vaccine makers] to sit down and be quiet and let the FDA and CDC advisory committee do their thing.”

Moderna Chief Medical Officer Paul Burton, MD, however, told WebMD last week that the signs point to why a fourth shot may be needed.

“We see waning of effectiveness, antibody levels come down, and certainly effectiveness against Omicron comes down in 3 to 6 months,” Burton said. “The natural history, from what we’re seeing around the world, is that BA.2 is definitely here, it’s highly transmissible, and I think we are going to get an additional wave of BA.2 here in the United States.”

Another wave is coming, he said, and “I think there will be waning of effectiveness. We need to be prepared for that, so that’s why we need the fourth dose.”
 

Supply issues?

Meanwhile, the United Kingdom has begun offering boosters to anyone over 75, and Sweden’s health authority has recommended a fourth shot to people over age 80.

That puts pressure on the United States — at least on its politicians and policymakers — to, in a sense, keep up, said the infectious disease specialists.

Indeed, the White House has been keeping fourth shots in the news, warning that it is running out of money to ensure that all Americans would have access to one, if recommended.

On March 23, outgoing White House COVID-19 Response Coordinator Jeff Zients said the federal government had enough vaccine for the immunocompromised to get a fourth dose “and, if authorized in the coming weeks, enough supply for fourth doses for our most vulnerable, including seniors.”

But he warned that without congressional approval of a COVID-19 funding package, “We can’t procure the necessary vaccine supply to support fourth shots for all Americans.”

Mr. Zients also noted that other countries, including Japan, Vietnam, and the Philippines had already secured future booster doses and added, “We should be securing additional supply right now.”

Dr. Schaffner says that while it would be nice to “have a booster on the shelf,” the United States needs to put more effort into creating a globally-coordinated process for ensuring that vaccines match circulating strains and that they are manufactured on a timely basis.

He says he and others “have been reminding the public that the COVID pandemic may indeed be diminishing and moving into the endemic, but that doesn’t mean COVID is over or finished or disappeared.”

Dr. Schaffner says that it may be that “perhaps we’d need a periodic reminder to our immune system to remain protected. In other words, we might have to get boosted perhaps annually like we do with influenza.”

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

In a unique Zoom conference, a number of detransitioners enumerated the ways they said the medical establishment initially failed them when they transitioned to the opposite gender, and again, when they decided to go back to their natal gender.

The forum was convened on what was dubbed #DetransitionAwarenessDay by Genspect, a parent-based organization that seeks to put the brakes on medical transitions for children and adolescents. The group has doubts about the gender-affirming care model supported by the World Professional Association for Transgender Health, the American Medical Association, the American Academy of Pediatrics, and other medical groups.

“Affirmative” medical care is defined as treatment with puberty blockers and cross-sex hormones for those with gender dysphoria to transition to the opposite sex and is often followed by gender reassignment surgery. However, there is growing concern among many doctors and other health care professionals as to whether this is, in fact, the best way to proceed for those under aged 18, in particular, with several countries pulling back on medical treatment and instead emphasizing psychotherapy first.

The purpose of the second annual Genspect meeting was to shed light on the experiences of individuals who have detransitioned – those that identified as transgender and transitioned, but then decided to end their medical transition. People logged on from all over the United States, Canada, New Zealand, Australia, the United Kingdom, Germany, Spain, Chile, and Brazil, among other countries.

“This is a minority within a minority,” said Genspect advisor Stella O’Malley, adding that the first meeting in 2021 was held because “too many people were dismissing the stories of the detransitioners.” Ms. O’Malley is a psychotherapist, a clinical advisor to the Society for Evidence-Based Gender Medicine, and a founding member of the International Association of Therapists for Desisters and Detransitioners.

“It’s become blindingly obvious over the last year that ... ‘detrans’ is a huge part of the trans phenomenon,” said Ms. O’Malley, adding that detransitioners have been “undermined and dismissed.”

Laura Edwards-Leeper, PhD (@DrLauraEL), a prominent gender therapist who has recently expressed concern regarding adequate gatekeeping when treating youth with gender dysphoria, agreed.

She tweeted: “You simply can’t call yourself a legit gender provider if you don’t believe that detransitioners exist. As part of the informed consent process for transitioning, it is unethical to not discuss this possibility with young people.” Dr. Edwards-Leeper is professor emeritus at Pacific University in Hillsboro, Ore.

Speakers in the forum largely offered experiences, not data. They pointed out that there has been little to no study of detransition, but all testified that it was less rare than it has been portrayed by the transgender community.
 

Struggles with going back

“There are so many reasons why people detransition,” said Sinead Watson, aged 30, a Genspect advisor who transitioned from female to male, starting in 2015, and who decided to detransition in 2019. Citing a study by Lisa Littman, MD, MPH, published in 2021, Ms. Watson said the most common reasons for detransitioning were realizing that gender dysphoria was caused by other issues; internal homophobia; and the unbearable nature of transphobia.

Ms. Watson said the hardest part of detransitioning was admitting to herself that her transition had been a mistake. “It’s embarrassing and you feel ashamed and guilty,” she said, adding that it may mean losing friends who now regard you as a “bigot, while you’re also dealing with transition regret.”

“It’s a living hell, especially when none of your therapists or counselors will listen to you,” she said. “Detransitioning isn’t fun.”

Carol (@sourpatches2077) said she knew for a year that her transition had been a mistake.

“The biggest part was I couldn’t tell my family,” said Carol, who identifies as a lesbian. “I put them through so much. It seems ridiculous to go: ‘Oops, I made this huge [expletive] mistake,’ ” she said, describing the moment she did tell them as “devastating.”

Grace (@hormonehangover) said she remembers finally hitting a moment of “undeniability” some years after transitioning. “I accept it, I’ve ruined my life, this is wrong,” she remembers thinking. “It was devastating, but I couldn’t deny it anymore.” 

Don’t trust therapists

People experiencing feelings of unease “need a therapist who will listen to them,” said Ms. Watson. When she first detransitioned, her therapists treated her badly. “They just didn’t want to speak about detransition,” she said, adding that “it was like a kick in the stomach.”

Ms. Watson said she’d like to see more training about detransition, but also on “preventative techniques,” adding that many people transition who should not. “I don’t want more detransitioners – I want less.

“In order for that to happen, we need to treat people with gender dysphoria properly,” said Ms. Watson, adding that the affirmative model is “disgusting, and that’s what needs to change.”

“I would tell somebody to not go to a therapist,” said Carol. Identifying as a butch lesbian, she felt like her therapists had pushed her into transitioning to male. “The No. 1 thing not understood by the mental health professionals is that the vast majority of homosexuals were gender-nonconforming children.” She added that this is especially true of butch lesbians.

Therapists – and doctors – also need to acknowledge both the trauma of transition and detransition, she said.

Kaiser, where she had transitioned, offered her breast reconstruction. Carol said it felt demeaning. “Like you’re Mr. Potatohead: ‘Here, we can just ... put on some new parts and you’re good to go.’ ”

“Doctors are concretizing transient obsessions,” said Helena Kerschner (@lacroicsz), quoting a chatroom user.

Ms. Kerschner gave a presentation on “fandom”: becoming obsessed with a movie, book, TV show, musician, or celebrity, spending every waking hour chatting online or writing fan fiction, or attempting to interact with the celebrity online. It’s a fantasy-dominated world and “the vast majority” of participants are teenage girls who are “identifying as trans,” in part, because they are fed a community-reinforced message that it’s better to be a boy.  

Therapists and physicians who help them transition “are harming them for life based on something they would have grown out of or overcome without the permanent damage,” Ms. Kerschner added.

 

Doctors ‘gaslighting’ people into believing that transition is the answer

A pervasive theme during the webinar was that many people are being misdiagnosed with gender dysphoria, which may not be resolved by medical transition.

Allie, a 22-year-old who stopped taking testosterone after 1½ years, said she initially started the transition to male when she gave up trying to figure out why she could not identify with, or befriend, women, and after a childhood and adolescence spent mostly in the company of boys and being more interested in traditionally male activities.

She endured sexual abuse as a teenager and her parents divorced while she was in high school. Allie also had multiple suicide attempts and many incidents of self-harm. When she decided to transition, at age 18, she went to a private clinic and received cross-sex hormones within a few months of her first and only 30-minute consultation. “There was no explorative therapy,” she said, adding that she was never given a formal diagnosis of gender dysphoria.

For the first year, she said she was “over the freaking moon” because she felt like it was the answer. But things started to unravel while she attended university, and she attempted suicide attempt at age 20. A social worker at the school identified her symptoms – which had been the same since childhood – as autism. She then decided to cease her transition.

Another detransitioner, Laura Becker, said it took 5 years after her transition to recognize that she had undiagnosed PTSD from emotional and psychiatric abuse. Despite a history of substance abuse, self-harm, suicidal ideation, and other mental health issues, she was given testosterone and had a double mastectomy at age 20. She became fixated on gay men, which devolved into a methamphetamine- and crack-fueled relationship with a man she met on the gay dating platform Grindr.

“No one around me knew any better or knew how to help, including the medical professionals who performed the mastectomy and who casually signed off and administered my medical transition,” she said.

Once she was aware of her PTSD she started to detransition, which itself was traumatic, said Laura.

Limpida, aged 24, said he felt pushed into transitioning after seeking help at a Planned Parenthood clinic. He identified as trans at age 15 and spent years attempting to be a woman socially, but every step made him feel more miserable, he said. When he went to the clinic at age 21 to get estrogen, he said he felt like the staff was dismissive of his mental health concerns – including that he was suicidal, had substance abuse, and was severely depressed. He was told he was the “perfect candidate” for transitioning.

A year later, he said he felt worse. The nurse suggested he seek out surgery. After Limpida researched what was involved, he decided to detransition. He has since received an autism diagnosis.

Robin, also aged 24, said the idea of surgery had helped push him into detransitioning, which began in 2020 after 4 years of estrogen. He said he had always been gender nonconforming and knew he was gay at an early age. He believes that gender-nonconforming people are “gaslighted” into thinking that transitioning is the answer.
 

Lack of evidence-based, informed consent

Michelle Alleva, who stopped identifying as transgender in 2020 but had ceased testosterone 4 years earlier because of side effects, cited what she called a lack of evidence base for the effectiveness and safety of medical transitions.

“You need to have a really, really good evidence base in place if you’re going straight to an invasive treatment that is going to cause permanent changes to your body,” she said.

Access to medical transition used to involve more “gatekeeping” through mental health evaluations and other interventions, she said, but there has been a shift from treating what was considered a psychiatric issue to essentially affirming an identity.

“This shift was activist driven, not evidence based,” she emphasized.

Most studies showing satisfaction with transition only involve a few years of follow-up, she said. She added that the longest follow-up study of transition, published in 2011 and spanning 30 years, showed that the suicide rate 10-15 years post surgery was 20 times higher than the general population.

Studies of regret were primarily conducted before the rapid increase in the number of trans-identifying individuals, she said, which makes it hard to draw conclusions about pediatric transition. Getting estimates on this population is difficult because so many who detransition do not tell their clinicians, and many studies have short follow-up times or a high loss to follow-up.

Ms. Alleva also took issue with the notion that physicians were offering true informed consent, noting that it’s not possible to know if someone is psychologically sound if they haven’t had a thorough mental health evaluation and that there are so many unknowns with medical transition, including that many of the therapies are not approved for the uses being employed.

With regret on the rise, “we need professionals that are prepared for detransitioners,” said Ms. Alleva. “Some of us have lost trust in health care professionals as a result of our experience.”

“It’s a huge feeling of institutional betrayal,” said Grace.

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

In a unique Zoom conference, a number of detransitioners enumerated the ways they said the medical establishment initially failed them when they transitioned to the opposite gender, and again, when they decided to go back to their natal gender.

The forum was convened on what was dubbed #DetransitionAwarenessDay by Genspect, a parent-based organization that seeks to put the brakes on medical transitions for children and adolescents. The group has doubts about the gender-affirming care model supported by the World Professional Association for Transgender Health, the American Medical Association, the American Academy of Pediatrics, and other medical groups.

“Affirmative” medical care is defined as treatment with puberty blockers and cross-sex hormones for those with gender dysphoria to transition to the opposite sex and is often followed by gender reassignment surgery. However, there is growing concern among many doctors and other health care professionals as to whether this is, in fact, the best way to proceed for those under aged 18, in particular, with several countries pulling back on medical treatment and instead emphasizing psychotherapy first.

The purpose of the second annual Genspect meeting was to shed light on the experiences of individuals who have detransitioned – those that identified as transgender and transitioned, but then decided to end their medical transition. People logged on from all over the United States, Canada, New Zealand, Australia, the United Kingdom, Germany, Spain, Chile, and Brazil, among other countries.

“This is a minority within a minority,” said Genspect advisor Stella O’Malley, adding that the first meeting in 2021 was held because “too many people were dismissing the stories of the detransitioners.” Ms. O’Malley is a psychotherapist, a clinical advisor to the Society for Evidence-Based Gender Medicine, and a founding member of the International Association of Therapists for Desisters and Detransitioners.

“It’s become blindingly obvious over the last year that ... ‘detrans’ is a huge part of the trans phenomenon,” said Ms. O’Malley, adding that detransitioners have been “undermined and dismissed.”

Laura Edwards-Leeper, PhD (@DrLauraEL), a prominent gender therapist who has recently expressed concern regarding adequate gatekeeping when treating youth with gender dysphoria, agreed.

She tweeted: “You simply can’t call yourself a legit gender provider if you don’t believe that detransitioners exist. As part of the informed consent process for transitioning, it is unethical to not discuss this possibility with young people.” Dr. Edwards-Leeper is professor emeritus at Pacific University in Hillsboro, Ore.

Speakers in the forum largely offered experiences, not data. They pointed out that there has been little to no study of detransition, but all testified that it was less rare than it has been portrayed by the transgender community.
 

Struggles with going back

“There are so many reasons why people detransition,” said Sinead Watson, aged 30, a Genspect advisor who transitioned from female to male, starting in 2015, and who decided to detransition in 2019. Citing a study by Lisa Littman, MD, MPH, published in 2021, Ms. Watson said the most common reasons for detransitioning were realizing that gender dysphoria was caused by other issues; internal homophobia; and the unbearable nature of transphobia.

Ms. Watson said the hardest part of detransitioning was admitting to herself that her transition had been a mistake. “It’s embarrassing and you feel ashamed and guilty,” she said, adding that it may mean losing friends who now regard you as a “bigot, while you’re also dealing with transition regret.”

“It’s a living hell, especially when none of your therapists or counselors will listen to you,” she said. “Detransitioning isn’t fun.”

Carol (@sourpatches2077) said she knew for a year that her transition had been a mistake.

“The biggest part was I couldn’t tell my family,” said Carol, who identifies as a lesbian. “I put them through so much. It seems ridiculous to go: ‘Oops, I made this huge [expletive] mistake,’ ” she said, describing the moment she did tell them as “devastating.”

Grace (@hormonehangover) said she remembers finally hitting a moment of “undeniability” some years after transitioning. “I accept it, I’ve ruined my life, this is wrong,” she remembers thinking. “It was devastating, but I couldn’t deny it anymore.” 

Don’t trust therapists

People experiencing feelings of unease “need a therapist who will listen to them,” said Ms. Watson. When she first detransitioned, her therapists treated her badly. “They just didn’t want to speak about detransition,” she said, adding that “it was like a kick in the stomach.”

Ms. Watson said she’d like to see more training about detransition, but also on “preventative techniques,” adding that many people transition who should not. “I don’t want more detransitioners – I want less.

“In order for that to happen, we need to treat people with gender dysphoria properly,” said Ms. Watson, adding that the affirmative model is “disgusting, and that’s what needs to change.”

“I would tell somebody to not go to a therapist,” said Carol. Identifying as a butch lesbian, she felt like her therapists had pushed her into transitioning to male. “The No. 1 thing not understood by the mental health professionals is that the vast majority of homosexuals were gender-nonconforming children.” She added that this is especially true of butch lesbians.

Therapists – and doctors – also need to acknowledge both the trauma of transition and detransition, she said.

Kaiser, where she had transitioned, offered her breast reconstruction. Carol said it felt demeaning. “Like you’re Mr. Potatohead: ‘Here, we can just ... put on some new parts and you’re good to go.’ ”

“Doctors are concretizing transient obsessions,” said Helena Kerschner (@lacroicsz), quoting a chatroom user.

Ms. Kerschner gave a presentation on “fandom”: becoming obsessed with a movie, book, TV show, musician, or celebrity, spending every waking hour chatting online or writing fan fiction, or attempting to interact with the celebrity online. It’s a fantasy-dominated world and “the vast majority” of participants are teenage girls who are “identifying as trans,” in part, because they are fed a community-reinforced message that it’s better to be a boy.  

Therapists and physicians who help them transition “are harming them for life based on something they would have grown out of or overcome without the permanent damage,” Ms. Kerschner added.

 

Doctors ‘gaslighting’ people into believing that transition is the answer

A pervasive theme during the webinar was that many people are being misdiagnosed with gender dysphoria, which may not be resolved by medical transition.

Allie, a 22-year-old who stopped taking testosterone after 1½ years, said she initially started the transition to male when she gave up trying to figure out why she could not identify with, or befriend, women, and after a childhood and adolescence spent mostly in the company of boys and being more interested in traditionally male activities.

She endured sexual abuse as a teenager and her parents divorced while she was in high school. Allie also had multiple suicide attempts and many incidents of self-harm. When she decided to transition, at age 18, she went to a private clinic and received cross-sex hormones within a few months of her first and only 30-minute consultation. “There was no explorative therapy,” she said, adding that she was never given a formal diagnosis of gender dysphoria.

For the first year, she said she was “over the freaking moon” because she felt like it was the answer. But things started to unravel while she attended university, and she attempted suicide attempt at age 20. A social worker at the school identified her symptoms – which had been the same since childhood – as autism. She then decided to cease her transition.

Another detransitioner, Laura Becker, said it took 5 years after her transition to recognize that she had undiagnosed PTSD from emotional and psychiatric abuse. Despite a history of substance abuse, self-harm, suicidal ideation, and other mental health issues, she was given testosterone and had a double mastectomy at age 20. She became fixated on gay men, which devolved into a methamphetamine- and crack-fueled relationship with a man she met on the gay dating platform Grindr.

“No one around me knew any better or knew how to help, including the medical professionals who performed the mastectomy and who casually signed off and administered my medical transition,” she said.

Once she was aware of her PTSD she started to detransition, which itself was traumatic, said Laura.

Limpida, aged 24, said he felt pushed into transitioning after seeking help at a Planned Parenthood clinic. He identified as trans at age 15 and spent years attempting to be a woman socially, but every step made him feel more miserable, he said. When he went to the clinic at age 21 to get estrogen, he said he felt like the staff was dismissive of his mental health concerns – including that he was suicidal, had substance abuse, and was severely depressed. He was told he was the “perfect candidate” for transitioning.

A year later, he said he felt worse. The nurse suggested he seek out surgery. After Limpida researched what was involved, he decided to detransition. He has since received an autism diagnosis.

Robin, also aged 24, said the idea of surgery had helped push him into detransitioning, which began in 2020 after 4 years of estrogen. He said he had always been gender nonconforming and knew he was gay at an early age. He believes that gender-nonconforming people are “gaslighted” into thinking that transitioning is the answer.
 

Lack of evidence-based, informed consent

Michelle Alleva, who stopped identifying as transgender in 2020 but had ceased testosterone 4 years earlier because of side effects, cited what she called a lack of evidence base for the effectiveness and safety of medical transitions.

“You need to have a really, really good evidence base in place if you’re going straight to an invasive treatment that is going to cause permanent changes to your body,” she said.

Access to medical transition used to involve more “gatekeeping” through mental health evaluations and other interventions, she said, but there has been a shift from treating what was considered a psychiatric issue to essentially affirming an identity.

“This shift was activist driven, not evidence based,” she emphasized.

Most studies showing satisfaction with transition only involve a few years of follow-up, she said. She added that the longest follow-up study of transition, published in 2011 and spanning 30 years, showed that the suicide rate 10-15 years post surgery was 20 times higher than the general population.

Studies of regret were primarily conducted before the rapid increase in the number of trans-identifying individuals, she said, which makes it hard to draw conclusions about pediatric transition. Getting estimates on this population is difficult because so many who detransition do not tell their clinicians, and many studies have short follow-up times or a high loss to follow-up.

Ms. Alleva also took issue with the notion that physicians were offering true informed consent, noting that it’s not possible to know if someone is psychologically sound if they haven’t had a thorough mental health evaluation and that there are so many unknowns with medical transition, including that many of the therapies are not approved for the uses being employed.

With regret on the rise, “we need professionals that are prepared for detransitioners,” said Ms. Alleva. “Some of us have lost trust in health care professionals as a result of our experience.”

“It’s a huge feeling of institutional betrayal,” said Grace.

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

In a unique Zoom conference, a number of detransitioners enumerated the ways they said the medical establishment initially failed them when they transitioned to the opposite gender, and again, when they decided to go back to their natal gender.

The forum was convened on what was dubbed #DetransitionAwarenessDay by Genspect, a parent-based organization that seeks to put the brakes on medical transitions for children and adolescents. The group has doubts about the gender-affirming care model supported by the World Professional Association for Transgender Health, the American Medical Association, the American Academy of Pediatrics, and other medical groups.

“Affirmative” medical care is defined as treatment with puberty blockers and cross-sex hormones for those with gender dysphoria to transition to the opposite sex and is often followed by gender reassignment surgery. However, there is growing concern among many doctors and other health care professionals as to whether this is, in fact, the best way to proceed for those under aged 18, in particular, with several countries pulling back on medical treatment and instead emphasizing psychotherapy first.

The purpose of the second annual Genspect meeting was to shed light on the experiences of individuals who have detransitioned – those that identified as transgender and transitioned, but then decided to end their medical transition. People logged on from all over the United States, Canada, New Zealand, Australia, the United Kingdom, Germany, Spain, Chile, and Brazil, among other countries.

“This is a minority within a minority,” said Genspect advisor Stella O’Malley, adding that the first meeting in 2021 was held because “too many people were dismissing the stories of the detransitioners.” Ms. O’Malley is a psychotherapist, a clinical advisor to the Society for Evidence-Based Gender Medicine, and a founding member of the International Association of Therapists for Desisters and Detransitioners.

“It’s become blindingly obvious over the last year that ... ‘detrans’ is a huge part of the trans phenomenon,” said Ms. O’Malley, adding that detransitioners have been “undermined and dismissed.”

Laura Edwards-Leeper, PhD (@DrLauraEL), a prominent gender therapist who has recently expressed concern regarding adequate gatekeeping when treating youth with gender dysphoria, agreed.

She tweeted: “You simply can’t call yourself a legit gender provider if you don’t believe that detransitioners exist. As part of the informed consent process for transitioning, it is unethical to not discuss this possibility with young people.” Dr. Edwards-Leeper is professor emeritus at Pacific University in Hillsboro, Ore.

Speakers in the forum largely offered experiences, not data. They pointed out that there has been little to no study of detransition, but all testified that it was less rare than it has been portrayed by the transgender community.
 

Struggles with going back

“There are so many reasons why people detransition,” said Sinead Watson, aged 30, a Genspect advisor who transitioned from female to male, starting in 2015, and who decided to detransition in 2019. Citing a study by Lisa Littman, MD, MPH, published in 2021, Ms. Watson said the most common reasons for detransitioning were realizing that gender dysphoria was caused by other issues; internal homophobia; and the unbearable nature of transphobia.

Ms. Watson said the hardest part of detransitioning was admitting to herself that her transition had been a mistake. “It’s embarrassing and you feel ashamed and guilty,” she said, adding that it may mean losing friends who now regard you as a “bigot, while you’re also dealing with transition regret.”

“It’s a living hell, especially when none of your therapists or counselors will listen to you,” she said. “Detransitioning isn’t fun.”

Carol (@sourpatches2077) said she knew for a year that her transition had been a mistake.

“The biggest part was I couldn’t tell my family,” said Carol, who identifies as a lesbian. “I put them through so much. It seems ridiculous to go: ‘Oops, I made this huge [expletive] mistake,’ ” she said, describing the moment she did tell them as “devastating.”

Grace (@hormonehangover) said she remembers finally hitting a moment of “undeniability” some years after transitioning. “I accept it, I’ve ruined my life, this is wrong,” she remembers thinking. “It was devastating, but I couldn’t deny it anymore.” 

Don’t trust therapists

People experiencing feelings of unease “need a therapist who will listen to them,” said Ms. Watson. When she first detransitioned, her therapists treated her badly. “They just didn’t want to speak about detransition,” she said, adding that “it was like a kick in the stomach.”

Ms. Watson said she’d like to see more training about detransition, but also on “preventative techniques,” adding that many people transition who should not. “I don’t want more detransitioners – I want less.

“In order for that to happen, we need to treat people with gender dysphoria properly,” said Ms. Watson, adding that the affirmative model is “disgusting, and that’s what needs to change.”

“I would tell somebody to not go to a therapist,” said Carol. Identifying as a butch lesbian, she felt like her therapists had pushed her into transitioning to male. “The No. 1 thing not understood by the mental health professionals is that the vast majority of homosexuals were gender-nonconforming children.” She added that this is especially true of butch lesbians.

Therapists – and doctors – also need to acknowledge both the trauma of transition and detransition, she said.

Kaiser, where she had transitioned, offered her breast reconstruction. Carol said it felt demeaning. “Like you’re Mr. Potatohead: ‘Here, we can just ... put on some new parts and you’re good to go.’ ”

“Doctors are concretizing transient obsessions,” said Helena Kerschner (@lacroicsz), quoting a chatroom user.

Ms. Kerschner gave a presentation on “fandom”: becoming obsessed with a movie, book, TV show, musician, or celebrity, spending every waking hour chatting online or writing fan fiction, or attempting to interact with the celebrity online. It’s a fantasy-dominated world and “the vast majority” of participants are teenage girls who are “identifying as trans,” in part, because they are fed a community-reinforced message that it’s better to be a boy.  

Therapists and physicians who help them transition “are harming them for life based on something they would have grown out of or overcome without the permanent damage,” Ms. Kerschner added.

 

Doctors ‘gaslighting’ people into believing that transition is the answer

A pervasive theme during the webinar was that many people are being misdiagnosed with gender dysphoria, which may not be resolved by medical transition.

Allie, a 22-year-old who stopped taking testosterone after 1½ years, said she initially started the transition to male when she gave up trying to figure out why she could not identify with, or befriend, women, and after a childhood and adolescence spent mostly in the company of boys and being more interested in traditionally male activities.

She endured sexual abuse as a teenager and her parents divorced while she was in high school. Allie also had multiple suicide attempts and many incidents of self-harm. When she decided to transition, at age 18, she went to a private clinic and received cross-sex hormones within a few months of her first and only 30-minute consultation. “There was no explorative therapy,” she said, adding that she was never given a formal diagnosis of gender dysphoria.

For the first year, she said she was “over the freaking moon” because she felt like it was the answer. But things started to unravel while she attended university, and she attempted suicide attempt at age 20. A social worker at the school identified her symptoms – which had been the same since childhood – as autism. She then decided to cease her transition.

Another detransitioner, Laura Becker, said it took 5 years after her transition to recognize that she had undiagnosed PTSD from emotional and psychiatric abuse. Despite a history of substance abuse, self-harm, suicidal ideation, and other mental health issues, she was given testosterone and had a double mastectomy at age 20. She became fixated on gay men, which devolved into a methamphetamine- and crack-fueled relationship with a man she met on the gay dating platform Grindr.

“No one around me knew any better or knew how to help, including the medical professionals who performed the mastectomy and who casually signed off and administered my medical transition,” she said.

Once she was aware of her PTSD she started to detransition, which itself was traumatic, said Laura.

Limpida, aged 24, said he felt pushed into transitioning after seeking help at a Planned Parenthood clinic. He identified as trans at age 15 and spent years attempting to be a woman socially, but every step made him feel more miserable, he said. When he went to the clinic at age 21 to get estrogen, he said he felt like the staff was dismissive of his mental health concerns – including that he was suicidal, had substance abuse, and was severely depressed. He was told he was the “perfect candidate” for transitioning.

A year later, he said he felt worse. The nurse suggested he seek out surgery. After Limpida researched what was involved, he decided to detransition. He has since received an autism diagnosis.

Robin, also aged 24, said the idea of surgery had helped push him into detransitioning, which began in 2020 after 4 years of estrogen. He said he had always been gender nonconforming and knew he was gay at an early age. He believes that gender-nonconforming people are “gaslighted” into thinking that transitioning is the answer.
 

Lack of evidence-based, informed consent

Michelle Alleva, who stopped identifying as transgender in 2020 but had ceased testosterone 4 years earlier because of side effects, cited what she called a lack of evidence base for the effectiveness and safety of medical transitions.

“You need to have a really, really good evidence base in place if you’re going straight to an invasive treatment that is going to cause permanent changes to your body,” she said.

Access to medical transition used to involve more “gatekeeping” through mental health evaluations and other interventions, she said, but there has been a shift from treating what was considered a psychiatric issue to essentially affirming an identity.

“This shift was activist driven, not evidence based,” she emphasized.

Most studies showing satisfaction with transition only involve a few years of follow-up, she said. She added that the longest follow-up study of transition, published in 2011 and spanning 30 years, showed that the suicide rate 10-15 years post surgery was 20 times higher than the general population.

Studies of regret were primarily conducted before the rapid increase in the number of trans-identifying individuals, she said, which makes it hard to draw conclusions about pediatric transition. Getting estimates on this population is difficult because so many who detransition do not tell their clinicians, and many studies have short follow-up times or a high loss to follow-up.

Ms. Alleva also took issue with the notion that physicians were offering true informed consent, noting that it’s not possible to know if someone is psychologically sound if they haven’t had a thorough mental health evaluation and that there are so many unknowns with medical transition, including that many of the therapies are not approved for the uses being employed.

With regret on the rise, “we need professionals that are prepared for detransitioners,” said Ms. Alleva. “Some of us have lost trust in health care professionals as a result of our experience.”

“It’s a huge feeling of institutional betrayal,” said Grace.

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

A former pain medicine physician received a sentence of 20 years in prison for selling opioids and writing prescriptions for patients who were abusing or diverting the medications.

Patrick Titus, 58, operated Lighthouse Internal Medicine in Milford, Delaware, from 2005-2014.

Federal prosecutors said Mr. Titus unlawfully distributed or dispensed opioids including fentanyl, morphine, methadone, OxyContin, and oxycodone outside the scope of practice and often prescribed them in combination with each other or in other dangerous combinations. Mr. Titus distributed over 1 million pills, said the government.

In a 2018 indictment, the government said that Mr. Titus would, “at the first and nearly every follow-up visit” prescribe opioids in high dosages, often without conducting an exam or reviewing any urine test results. He would also write prescriptions for opioids without getting patients’s prior medical records or reviewing test results and rarely referred patients to alternative pain treatments such as physical therapy, psychotherapy, or massage.

According to the indictment, he ignored “red flags,” including that patients would come from long distances, sometimes from out of state, and would pay cash, despite having Medicaid coverage.

“Today’s sentencing makes clear that medical professionals who recklessly prescribe opioids and endanger the safety and health of patients will be held accountable,” said Anne Milgram, a Drug Enforcement Administration administrator.

“This sentence is a reminder that the Department of Justice will hold accountable those doctors who are illegitimately prescribing opioids and fueling the country’s opioid crisis,” said Assistant Attorney General Kenneth A. Polite Jr., of the Justice Department’s Criminal Division, in the same statement. “Doctors who commit these unlawful acts exploit their roles as stewards of their patients’s care for their own profit,” he added.

The sentence follows Mr. Titus’s 2-week jury trial in 2021, when he was convicted of 13 counts of unlawful distribution and dispensing of controlled substances and one count of maintaining his practice primarily as a location to sell drugs. Mr. Titus faced a maximum of 20 years per count.

At the time of his conviction, Mr. Titus’s attorney said he planned to appeal, according to Delaware Online.

Delaware suspended Mr. Titus’s registration to prescribe controlled substances for 1 year in 2011. At the time, the state said it had determined that his continued prescribing “poses [an] imminent danger to the public health or safety.”

The state found that from January to November 2011, Mr. Titus issued 3,941 prescriptions for almost 750,000 pills for 17 different controlled substances, all sent to a single pharmacy.

The state also alleged that he wrote prescriptions for controlled substances to patients with felony convictions for drug trafficking and to at least one patient who his staff told him was selling the opioid that Mr. Titus had prescribed. It later determined that Mr. Titus continued prescribing even after it had suspended his DEA registration.

According to a 2014 consent agreement, the state subsequently ordered another 1-year suspension of his DEA registration, to be followed by a 3-year probation period.

Meanwhile, the same year, the state Board of Medical Licensure put Mr. Titus’s medical license on probation for 2 years and ordered him to complete 15 continuing medical education credits in medical recordkeeping, ethics, how to detect diversion and abuse, and in some other areas, and to pay a $7,500 fine.

In 2016, the medical board revoked Mr. Titus’s license, after finding that he continued to prescribe pain medications to patients he did not screen or monitor and for a multitude of other infractions.

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

A former pain medicine physician received a sentence of 20 years in prison for selling opioids and writing prescriptions for patients who were abusing or diverting the medications.

Patrick Titus, 58, operated Lighthouse Internal Medicine in Milford, Delaware, from 2005-2014.

Federal prosecutors said Mr. Titus unlawfully distributed or dispensed opioids including fentanyl, morphine, methadone, OxyContin, and oxycodone outside the scope of practice and often prescribed them in combination with each other or in other dangerous combinations. Mr. Titus distributed over 1 million pills, said the government.

In a 2018 indictment, the government said that Mr. Titus would, “at the first and nearly every follow-up visit” prescribe opioids in high dosages, often without conducting an exam or reviewing any urine test results. He would also write prescriptions for opioids without getting patients’s prior medical records or reviewing test results and rarely referred patients to alternative pain treatments such as physical therapy, psychotherapy, or massage.

According to the indictment, he ignored “red flags,” including that patients would come from long distances, sometimes from out of state, and would pay cash, despite having Medicaid coverage.

“Today’s sentencing makes clear that medical professionals who recklessly prescribe opioids and endanger the safety and health of patients will be held accountable,” said Anne Milgram, a Drug Enforcement Administration administrator.

“This sentence is a reminder that the Department of Justice will hold accountable those doctors who are illegitimately prescribing opioids and fueling the country’s opioid crisis,” said Assistant Attorney General Kenneth A. Polite Jr., of the Justice Department’s Criminal Division, in the same statement. “Doctors who commit these unlawful acts exploit their roles as stewards of their patients’s care for their own profit,” he added.

The sentence follows Mr. Titus’s 2-week jury trial in 2021, when he was convicted of 13 counts of unlawful distribution and dispensing of controlled substances and one count of maintaining his practice primarily as a location to sell drugs. Mr. Titus faced a maximum of 20 years per count.

At the time of his conviction, Mr. Titus’s attorney said he planned to appeal, according to Delaware Online.

Delaware suspended Mr. Titus’s registration to prescribe controlled substances for 1 year in 2011. At the time, the state said it had determined that his continued prescribing “poses [an] imminent danger to the public health or safety.”

The state found that from January to November 2011, Mr. Titus issued 3,941 prescriptions for almost 750,000 pills for 17 different controlled substances, all sent to a single pharmacy.

The state also alleged that he wrote prescriptions for controlled substances to patients with felony convictions for drug trafficking and to at least one patient who his staff told him was selling the opioid that Mr. Titus had prescribed. It later determined that Mr. Titus continued prescribing even after it had suspended his DEA registration.

According to a 2014 consent agreement, the state subsequently ordered another 1-year suspension of his DEA registration, to be followed by a 3-year probation period.

Meanwhile, the same year, the state Board of Medical Licensure put Mr. Titus’s medical license on probation for 2 years and ordered him to complete 15 continuing medical education credits in medical recordkeeping, ethics, how to detect diversion and abuse, and in some other areas, and to pay a $7,500 fine.

In 2016, the medical board revoked Mr. Titus’s license, after finding that he continued to prescribe pain medications to patients he did not screen or monitor and for a multitude of other infractions.

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

A former pain medicine physician received a sentence of 20 years in prison for selling opioids and writing prescriptions for patients who were abusing or diverting the medications.

Patrick Titus, 58, operated Lighthouse Internal Medicine in Milford, Delaware, from 2005-2014.

Federal prosecutors said Mr. Titus unlawfully distributed or dispensed opioids including fentanyl, morphine, methadone, OxyContin, and oxycodone outside the scope of practice and often prescribed them in combination with each other or in other dangerous combinations. Mr. Titus distributed over 1 million pills, said the government.

In a 2018 indictment, the government said that Mr. Titus would, “at the first and nearly every follow-up visit” prescribe opioids in high dosages, often without conducting an exam or reviewing any urine test results. He would also write prescriptions for opioids without getting patients’s prior medical records or reviewing test results and rarely referred patients to alternative pain treatments such as physical therapy, psychotherapy, or massage.

According to the indictment, he ignored “red flags,” including that patients would come from long distances, sometimes from out of state, and would pay cash, despite having Medicaid coverage.

“Today’s sentencing makes clear that medical professionals who recklessly prescribe opioids and endanger the safety and health of patients will be held accountable,” said Anne Milgram, a Drug Enforcement Administration administrator.

“This sentence is a reminder that the Department of Justice will hold accountable those doctors who are illegitimately prescribing opioids and fueling the country’s opioid crisis,” said Assistant Attorney General Kenneth A. Polite Jr., of the Justice Department’s Criminal Division, in the same statement. “Doctors who commit these unlawful acts exploit their roles as stewards of their patients’s care for their own profit,” he added.

The sentence follows Mr. Titus’s 2-week jury trial in 2021, when he was convicted of 13 counts of unlawful distribution and dispensing of controlled substances and one count of maintaining his practice primarily as a location to sell drugs. Mr. Titus faced a maximum of 20 years per count.

At the time of his conviction, Mr. Titus’s attorney said he planned to appeal, according to Delaware Online.

Delaware suspended Mr. Titus’s registration to prescribe controlled substances for 1 year in 2011. At the time, the state said it had determined that his continued prescribing “poses [an] imminent danger to the public health or safety.”

The state found that from January to November 2011, Mr. Titus issued 3,941 prescriptions for almost 750,000 pills for 17 different controlled substances, all sent to a single pharmacy.

The state also alleged that he wrote prescriptions for controlled substances to patients with felony convictions for drug trafficking and to at least one patient who his staff told him was selling the opioid that Mr. Titus had prescribed. It later determined that Mr. Titus continued prescribing even after it had suspended his DEA registration.

According to a 2014 consent agreement, the state subsequently ordered another 1-year suspension of his DEA registration, to be followed by a 3-year probation period.

Meanwhile, the same year, the state Board of Medical Licensure put Mr. Titus’s medical license on probation for 2 years and ordered him to complete 15 continuing medical education credits in medical recordkeeping, ethics, how to detect diversion and abuse, and in some other areas, and to pay a $7,500 fine.

In 2016, the medical board revoked Mr. Titus’s license, after finding that he continued to prescribe pain medications to patients he did not screen or monitor and for a multitude of other infractions.

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

TikTok users seeking deep tans are employing a questionable method: spraying self-tanning products up their noses, and then laying out in the sun or in a tanning bed.

Although nasal spray tanning is being described as a new “viral” trend, it seems to have gotten its start as early as the spring of 2021. The tanning method appears to be especially popular in the United Kingdom, where self-tanning product brands have TikTok videos promoting nasal sprays.

The rising concerns of this and other viral TikTok trends has now prompted a bipartisan group of seven state attorneys general to launch an investigation.

“As children and teens already grapple with issues of anxiety, social pressure, and depression, we cannot allow social media to further harm their physical health and mental wellbeing,” Massachusetts Attorney General Maura Healey, a Democrat, said in a statement. “State attorneys general have an imperative to protect young people and seek more information about how companies like TikTok are influencing their daily lives.”

Ms. Healey, along with colleagues from California, Florida, Kentucky, Nebraska, New Jersey, Tennessee, and Vermont, will whether Chinese-based TikTok violates state consumer protection laws.

The trend of people shooting spray tan up their nose is just the latest in a long line of so-called TikTok challenges that have caused controversy, and often, injury.

In a February TikTok, put out by the British company So Tanned (@_sotanned), a young woman appears with text stating that she uses nasal spray “morning and night” and then adds self-tanning oral drops a half hour before getting into a tanning bed.

But, dermatologist Lily Talakoub, MD, of McLean, Va., posted a TikTok with the bold warning “DO NOT USE NASAL TANNING SPRAY!” In the video, the white coat–clad Dr. Talakoub is in the foreground of the TikTok made by @Sashawoodx.

“Don’t try this at home,” said Dr. Talakoub.

“Don’t try this even if you think it can make you tanner. It can cause nausea, vomiting, very bad side effects,” she said, adding “this can be very dangerous to your health.”

It’s also worth mentioning that self-tanning products are not approved by the Food and Drug Administration for inhalation.

Still, another U.K. company, 2btanned, posted a TikTok showing a user spraying the product up his nose and, in the comments, @2btanned suggested that the spray should be used at least a week or two before sun exposure “in order to get full effects.”

@Sashawoodx tells her viewers: “Don’t walk ... RUN for these products,” as she shows herself in several different outfits, squirting 2btanned spray up her nose. As of March 2, the TikTok video had been viewed over 212,000 times.

TikTokker @giannaarose, who has 125,000 followers, said in a video that she uses two to three sprays up the nose before stepping into the tanning bed. A commenter said, “this is scary but where do I buy it”.

The main ingredient in self-tanning products is dihydroxyacetone, or DHA. DHA, which is FDA-approved for use on skin, causes a chemical reaction when heat is applied, and a pigment is deposited on the skin.

Adam Friedman, MD, professor and chair of dermatology at George Washington University, Washington, said, given that self-tanning products were never meant to be inhaled and that nasal sprays of any kind must be approved by the FDA, a company promoting the products is engaged in a dangerous game.

“People could go to jail over this,” said Dr. Friedman. What’s more, the products are unlikely to produce a tan.

“Because of the way self-tanners work, it would make no sense,” said Dr. Friedman.

“It’s purely a camouflage,” he said, adding that it does not produce melanin. Self-tanners were never intended to be inhaled, “so who knows what those ingredients would do to a different anatomical site like the inner passages of the nose.”

At a minimum, spraying into the nose could at cause irritation. But it could also potentially lead to acute or long-term damage, he said.

Some other spray ingredients, such as tyrosine and tyrosinase, are involved in producing melanin, but they only act within skin cells. If sprayed into the nose, the ingredients might produce melanin inside the nose, but not on the skin.

“This is not going to work,” said Dr. Friedman. “If anything, it could be dangerous.”

He added that there’s no such thing as a safe tan, and that self-tanning products offer no protection from dangerous ultraviolet rays. The nasal sprays are “quick fixes” that are not going to work.

“At the end of the day, just don’t inhale,” Dr. Friedman said.

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

TikTok users seeking deep tans are employing a questionable method: spraying self-tanning products up their noses, and then laying out in the sun or in a tanning bed.

Although nasal spray tanning is being described as a new “viral” trend, it seems to have gotten its start as early as the spring of 2021. The tanning method appears to be especially popular in the United Kingdom, where self-tanning product brands have TikTok videos promoting nasal sprays.

The rising concerns of this and other viral TikTok trends has now prompted a bipartisan group of seven state attorneys general to launch an investigation.

“As children and teens already grapple with issues of anxiety, social pressure, and depression, we cannot allow social media to further harm their physical health and mental wellbeing,” Massachusetts Attorney General Maura Healey, a Democrat, said in a statement. “State attorneys general have an imperative to protect young people and seek more information about how companies like TikTok are influencing their daily lives.”

Ms. Healey, along with colleagues from California, Florida, Kentucky, Nebraska, New Jersey, Tennessee, and Vermont, will whether Chinese-based TikTok violates state consumer protection laws.

The trend of people shooting spray tan up their nose is just the latest in a long line of so-called TikTok challenges that have caused controversy, and often, injury.

In a February TikTok, put out by the British company So Tanned (@_sotanned), a young woman appears with text stating that she uses nasal spray “morning and night” and then adds self-tanning oral drops a half hour before getting into a tanning bed.

But, dermatologist Lily Talakoub, MD, of McLean, Va., posted a TikTok with the bold warning “DO NOT USE NASAL TANNING SPRAY!” In the video, the white coat–clad Dr. Talakoub is in the foreground of the TikTok made by @Sashawoodx.

“Don’t try this at home,” said Dr. Talakoub.

“Don’t try this even if you think it can make you tanner. It can cause nausea, vomiting, very bad side effects,” she said, adding “this can be very dangerous to your health.”

It’s also worth mentioning that self-tanning products are not approved by the Food and Drug Administration for inhalation.

Still, another U.K. company, 2btanned, posted a TikTok showing a user spraying the product up his nose and, in the comments, @2btanned suggested that the spray should be used at least a week or two before sun exposure “in order to get full effects.”

@Sashawoodx tells her viewers: “Don’t walk ... RUN for these products,” as she shows herself in several different outfits, squirting 2btanned spray up her nose. As of March 2, the TikTok video had been viewed over 212,000 times.

TikTokker @giannaarose, who has 125,000 followers, said in a video that she uses two to three sprays up the nose before stepping into the tanning bed. A commenter said, “this is scary but where do I buy it”.

The main ingredient in self-tanning products is dihydroxyacetone, or DHA. DHA, which is FDA-approved for use on skin, causes a chemical reaction when heat is applied, and a pigment is deposited on the skin.

Adam Friedman, MD, professor and chair of dermatology at George Washington University, Washington, said, given that self-tanning products were never meant to be inhaled and that nasal sprays of any kind must be approved by the FDA, a company promoting the products is engaged in a dangerous game.

“People could go to jail over this,” said Dr. Friedman. What’s more, the products are unlikely to produce a tan.

“Because of the way self-tanners work, it would make no sense,” said Dr. Friedman.

“It’s purely a camouflage,” he said, adding that it does not produce melanin. Self-tanners were never intended to be inhaled, “so who knows what those ingredients would do to a different anatomical site like the inner passages of the nose.”

At a minimum, spraying into the nose could at cause irritation. But it could also potentially lead to acute or long-term damage, he said.

Some other spray ingredients, such as tyrosine and tyrosinase, are involved in producing melanin, but they only act within skin cells. If sprayed into the nose, the ingredients might produce melanin inside the nose, but not on the skin.

“This is not going to work,” said Dr. Friedman. “If anything, it could be dangerous.”

He added that there’s no such thing as a safe tan, and that self-tanning products offer no protection from dangerous ultraviolet rays. The nasal sprays are “quick fixes” that are not going to work.

“At the end of the day, just don’t inhale,” Dr. Friedman said.

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

TikTok users seeking deep tans are employing a questionable method: spraying self-tanning products up their noses, and then laying out in the sun or in a tanning bed.

Although nasal spray tanning is being described as a new “viral” trend, it seems to have gotten its start as early as the spring of 2021. The tanning method appears to be especially popular in the United Kingdom, where self-tanning product brands have TikTok videos promoting nasal sprays.

The rising concerns of this and other viral TikTok trends has now prompted a bipartisan group of seven state attorneys general to launch an investigation.

“As children and teens already grapple with issues of anxiety, social pressure, and depression, we cannot allow social media to further harm their physical health and mental wellbeing,” Massachusetts Attorney General Maura Healey, a Democrat, said in a statement. “State attorneys general have an imperative to protect young people and seek more information about how companies like TikTok are influencing their daily lives.”

Ms. Healey, along with colleagues from California, Florida, Kentucky, Nebraska, New Jersey, Tennessee, and Vermont, will whether Chinese-based TikTok violates state consumer protection laws.

The trend of people shooting spray tan up their nose is just the latest in a long line of so-called TikTok challenges that have caused controversy, and often, injury.

In a February TikTok, put out by the British company So Tanned (@_sotanned), a young woman appears with text stating that she uses nasal spray “morning and night” and then adds self-tanning oral drops a half hour before getting into a tanning bed.

But, dermatologist Lily Talakoub, MD, of McLean, Va., posted a TikTok with the bold warning “DO NOT USE NASAL TANNING SPRAY!” In the video, the white coat–clad Dr. Talakoub is in the foreground of the TikTok made by @Sashawoodx.

“Don’t try this at home,” said Dr. Talakoub.

“Don’t try this even if you think it can make you tanner. It can cause nausea, vomiting, very bad side effects,” she said, adding “this can be very dangerous to your health.”

It’s also worth mentioning that self-tanning products are not approved by the Food and Drug Administration for inhalation.

Still, another U.K. company, 2btanned, posted a TikTok showing a user spraying the product up his nose and, in the comments, @2btanned suggested that the spray should be used at least a week or two before sun exposure “in order to get full effects.”

@Sashawoodx tells her viewers: “Don’t walk ... RUN for these products,” as she shows herself in several different outfits, squirting 2btanned spray up her nose. As of March 2, the TikTok video had been viewed over 212,000 times.

TikTokker @giannaarose, who has 125,000 followers, said in a video that she uses two to three sprays up the nose before stepping into the tanning bed. A commenter said, “this is scary but where do I buy it”.

The main ingredient in self-tanning products is dihydroxyacetone, or DHA. DHA, which is FDA-approved for use on skin, causes a chemical reaction when heat is applied, and a pigment is deposited on the skin.

Adam Friedman, MD, professor and chair of dermatology at George Washington University, Washington, said, given that self-tanning products were never meant to be inhaled and that nasal sprays of any kind must be approved by the FDA, a company promoting the products is engaged in a dangerous game.

“People could go to jail over this,” said Dr. Friedman. What’s more, the products are unlikely to produce a tan.

“Because of the way self-tanners work, it would make no sense,” said Dr. Friedman.

“It’s purely a camouflage,” he said, adding that it does not produce melanin. Self-tanners were never intended to be inhaled, “so who knows what those ingredients would do to a different anatomical site like the inner passages of the nose.”

At a minimum, spraying into the nose could at cause irritation. But it could also potentially lead to acute or long-term damage, he said.

Some other spray ingredients, such as tyrosine and tyrosinase, are involved in producing melanin, but they only act within skin cells. If sprayed into the nose, the ingredients might produce melanin inside the nose, but not on the skin.

“This is not going to work,” said Dr. Friedman. “If anything, it could be dangerous.”

He added that there’s no such thing as a safe tan, and that self-tanning products offer no protection from dangerous ultraviolet rays. The nasal sprays are “quick fixes” that are not going to work.

“At the end of the day, just don’t inhale,” Dr. Friedman said.

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

Ahead of its official release on March 18, the new Diagnostic and Statistical Manual of Mental Disorders, which is in the form of a textbook, is already drawing some criticism.

The American Psychiatric Association’s DSM-5-TR (Text Revision) which is not a full revision, only includes one new condition, prolonged grief disorder.

It also includes symptom codes for suicidal behavior and nonsuicidal self-injury, clarifying modifications to criteria sets for more than 70 disorders, including autism spectrum disorder; changes in terminology for gender dysphoria; and a comprehensive review of the impact of racism and discrimination on the diagnosis and manifestations of mental disorders.

The Text Revision is a compilation of iterative changes that have been made online on a rolling basis since the DSM-5 was first published in 2013.

“The goal of the Text Revision was to allow a thorough revision of the text, not the criteria,” Paul Appelbaum, MD, chair of the APA’s DSM steering committee, told this news organization.

For the Text Revision, some 200 experts across a variety of APA working groups recommended changes to the text based on a comprehensive literature review, said Appelbaum, who is the Elizabeth K. Dollard Professor of Psychiatry, Medicine and Law, and director of the division of law, ethics and psychiatry at Columbia University, New York.

However, there’s not a lot that’s new, in part, because there have been few therapeutic advances.
 

Money maker?

Allen Frances, MD, chair of the DSM-4 task force and professor and chair emeritus of psychiatry at Duke University, Durham, N.C., said the APA is publishing the Text Revision “just to make money. They’re very anxious to do anything that will increase sales and having a revision forces some people, especially in institutions, to buy the book, even though it may not have anything substantive to add to the original.”

Dr. Frances told this news organization that when the APA published the first DSM in the late 1970s, “it became an instantaneous best-seller, to everyone’s surprise.”

The APA would not comment on how many of the $170 (list price) volumes it sells or how much those sales contribute to its budget.

Dr. Appelbaum acknowledged, “at any point in time, the canonical version is the online version.” However, it’s clear from DSM-5 sales “that many people still value having a hard copy of the DSM available to them.”  
 

Prolonged grief: Timely or overkill?

Persistent complex bereavement disorder (PCBD) was listed as a “condition for further study” in DSM-5. After a 2019 workshop aimed at getting consensus for diagnosis criteria, the APA board approved the new prolonged grief disorder in October 2020, and the APA assembly approved the new disorder in November 2020. 

Given the 950,000 deaths from COVID-19 over the past 2 years, inclusion of prolonged grief disorder in the DSM-5 may arrive at just the right time.

The diagnostic criteria for PCBD include:

• The development of a persistent grief response (longer than a year for adults and 6 months for children and adolescents) characterized by one or both of the following symptoms, which have been present most days to a clinically significant degree, and have occurred nearly every day for at least the last month: intense yearning/longing for the deceased person; preoccupation with thoughts or memories of the deceased person.
• Since the death, at least three symptoms present most days to a clinically significant degree, and occurring nearly every day for at least the last month, including identity disruption, marked sense of disbelief about the death, avoidance of reminders that the person is dead, intense emotional pain related to the death, difficulty reintegrating into one’s relationships and activities after the death, emotional numbness, feeling that life is meaningless as a result of the death, and intense loneliness as a result of the death.
• The disturbance causes clinically significant distress or impairment in social, occupational, or other important areas of functioning.
• The duration and severity of the bereavement reaction clearly exceed expected social, cultural, or religious norms for the individual’s culture and context.
• The symptoms are not better explained by another mental disorder, such as major depressive disorder (MDD) or PTSD, and are not attributable to the physiological effects of a substance or another medical condition.

Dr. Frances said he believes creating a new diagnosis pathologizes grief. In DSM-3 and DSM-4, an exception was made under the diagnosis of MDD for individuals who had recently lost a loved one. “We wanted to have at least an opportunity for people to grieve without being stigmatized, mislabeled, and overtreated with medication.”

DSM-5 removed the bereavement exclusion. After 2 weeks, people who are grieving and have particular symptoms could receive a diagnosis of MDD, said Dr. Frances. He believes the exclusion should have been broadened to cover anyone experiencing a major loss – such as a job loss or divorce. If someone is having prolonged symptoms that interfere with functioning, they should get an MDD diagnosis.

The new disorder “doesn’t solve anything, it just adds to the confusion and stigmatization, and it’s part of a kind of creeping medical imperialization of everyday life, where everything has to have a mental disorder label,” Dr. Frances said.

However, Dr. Appelbaum countered that “the criteria for prolonged grief disorder are constructed in such a way as to make every effort to exclude people who are going through a normal grieving process.”

“Part of the purpose of the data analyses was to ensure the criteria that were adopted would, in fact, effectively distinguish between what anybody goes through, say when someone close to you dies, and this unusual prolonged grieving process without end that affects a much smaller number of people but which really can be crippling for them,” he added.

The Text Revision adds new symptom codes for suicidal behavior and nonsuicidal self-injury, which appear in the chapter, “Other Conditions That May Be a Focus of Clinical Attention,” said Dr. Appelbaum.

“Both suicidal behavior and nonsuicidal self-injury seem pretty persuasively to fall into that category – something a clinician would want to know about, pay attention to, and factor into treatment planning, although they are behaviors that cross many diagnostic categories,” he added.

Codes also provide a systematic way of ascertaining the incidence and prevalence of such behaviors, said Dr. Appelbaum.
 

Changes to gender terminology

The Text Revision also tweaks some terminology with respect to transgender individuals. The term “desired gender” is now “experienced gender”, the term “cross-sex medical procedure” is now “gender-affirming medical procedure”, and the terms “natal male/natal female” are now “individual assigned male/female at birth”.

Dr. Frances said that the existence of gender dysphoria as a diagnosis has been a matter of controversy ever since it was first included.

“The transgender community has had mixed feelings on whether there should be anything at all in the manual,” he said. On one hand is the argument that gender dysphoria should be removed because it’s not really a psychiatric issue.

“We seriously considered eliminating it altogether in DSM-4,” said Dr. Frances.

However, an argument in favor of keeping it was that if the diagnosis was removed, it would mean that people could not receive treatment. “There’s no right argument for this dilemma,” he said.

Dr. Frances, who has been a frequent critic of DSM-5, said he believes the manual continues to miss opportunities to tighten criteria for many diagnoses, including ADHD and autism spectrum disorder.

“There’s a consistent pattern of taking behaviors and symptoms of behaviors that are on the border with normality and expanding the definition of mental disorder and reducing the realm of normality,” he said.

That has consequences, Dr. Frances added. “When someone gets a diagnosis that they need to get, it’s the beginning of a much better future. When someone gets a diagnosis that’s a mislabel that they don’t need, it has all harms and no benefits. It’s stigmatizing, leads to too much treatment, the wrong treatment, and it’s much more harmful than helpful.”

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

Ahead of its official release on March 18, the new Diagnostic and Statistical Manual of Mental Disorders, which is in the form of a textbook, is already drawing some criticism.

The American Psychiatric Association’s DSM-5-TR (Text Revision) which is not a full revision, only includes one new condition, prolonged grief disorder.

It also includes symptom codes for suicidal behavior and nonsuicidal self-injury, clarifying modifications to criteria sets for more than 70 disorders, including autism spectrum disorder; changes in terminology for gender dysphoria; and a comprehensive review of the impact of racism and discrimination on the diagnosis and manifestations of mental disorders.

The Text Revision is a compilation of iterative changes that have been made online on a rolling basis since the DSM-5 was first published in 2013.

“The goal of the Text Revision was to allow a thorough revision of the text, not the criteria,” Paul Appelbaum, MD, chair of the APA’s DSM steering committee, told this news organization.

For the Text Revision, some 200 experts across a variety of APA working groups recommended changes to the text based on a comprehensive literature review, said Appelbaum, who is the Elizabeth K. Dollard Professor of Psychiatry, Medicine and Law, and director of the division of law, ethics and psychiatry at Columbia University, New York.

However, there’s not a lot that’s new, in part, because there have been few therapeutic advances.
 

Money maker?

Allen Frances, MD, chair of the DSM-4 task force and professor and chair emeritus of psychiatry at Duke University, Durham, N.C., said the APA is publishing the Text Revision “just to make money. They’re very anxious to do anything that will increase sales and having a revision forces some people, especially in institutions, to buy the book, even though it may not have anything substantive to add to the original.”

Dr. Frances told this news organization that when the APA published the first DSM in the late 1970s, “it became an instantaneous best-seller, to everyone’s surprise.”

The APA would not comment on how many of the $170 (list price) volumes it sells or how much those sales contribute to its budget.

Dr. Appelbaum acknowledged, “at any point in time, the canonical version is the online version.” However, it’s clear from DSM-5 sales “that many people still value having a hard copy of the DSM available to them.”  
 

Prolonged grief: Timely or overkill?

Persistent complex bereavement disorder (PCBD) was listed as a “condition for further study” in DSM-5. After a 2019 workshop aimed at getting consensus for diagnosis criteria, the APA board approved the new prolonged grief disorder in October 2020, and the APA assembly approved the new disorder in November 2020. 

Given the 950,000 deaths from COVID-19 over the past 2 years, inclusion of prolonged grief disorder in the DSM-5 may arrive at just the right time.

The diagnostic criteria for PCBD include:

• The development of a persistent grief response (longer than a year for adults and 6 months for children and adolescents) characterized by one or both of the following symptoms, which have been present most days to a clinically significant degree, and have occurred nearly every day for at least the last month: intense yearning/longing for the deceased person; preoccupation with thoughts or memories of the deceased person.
• Since the death, at least three symptoms present most days to a clinically significant degree, and occurring nearly every day for at least the last month, including identity disruption, marked sense of disbelief about the death, avoidance of reminders that the person is dead, intense emotional pain related to the death, difficulty reintegrating into one’s relationships and activities after the death, emotional numbness, feeling that life is meaningless as a result of the death, and intense loneliness as a result of the death.
• The disturbance causes clinically significant distress or impairment in social, occupational, or other important areas of functioning.
• The duration and severity of the bereavement reaction clearly exceed expected social, cultural, or religious norms for the individual’s culture and context.
• The symptoms are not better explained by another mental disorder, such as major depressive disorder (MDD) or PTSD, and are not attributable to the physiological effects of a substance or another medical condition.

Dr. Frances said he believes creating a new diagnosis pathologizes grief. In DSM-3 and DSM-4, an exception was made under the diagnosis of MDD for individuals who had recently lost a loved one. “We wanted to have at least an opportunity for people to grieve without being stigmatized, mislabeled, and overtreated with medication.”

DSM-5 removed the bereavement exclusion. After 2 weeks, people who are grieving and have particular symptoms could receive a diagnosis of MDD, said Dr. Frances. He believes the exclusion should have been broadened to cover anyone experiencing a major loss – such as a job loss or divorce. If someone is having prolonged symptoms that interfere with functioning, they should get an MDD diagnosis.

The new disorder “doesn’t solve anything, it just adds to the confusion and stigmatization, and it’s part of a kind of creeping medical imperialization of everyday life, where everything has to have a mental disorder label,” Dr. Frances said.

However, Dr. Appelbaum countered that “the criteria for prolonged grief disorder are constructed in such a way as to make every effort to exclude people who are going through a normal grieving process.”

“Part of the purpose of the data analyses was to ensure the criteria that were adopted would, in fact, effectively distinguish between what anybody goes through, say when someone close to you dies, and this unusual prolonged grieving process without end that affects a much smaller number of people but which really can be crippling for them,” he added.

The Text Revision adds new symptom codes for suicidal behavior and nonsuicidal self-injury, which appear in the chapter, “Other Conditions That May Be a Focus of Clinical Attention,” said Dr. Appelbaum.

“Both suicidal behavior and nonsuicidal self-injury seem pretty persuasively to fall into that category – something a clinician would want to know about, pay attention to, and factor into treatment planning, although they are behaviors that cross many diagnostic categories,” he added.

Codes also provide a systematic way of ascertaining the incidence and prevalence of such behaviors, said Dr. Appelbaum.
 

Changes to gender terminology

The Text Revision also tweaks some terminology with respect to transgender individuals. The term “desired gender” is now “experienced gender”, the term “cross-sex medical procedure” is now “gender-affirming medical procedure”, and the terms “natal male/natal female” are now “individual assigned male/female at birth”.

Dr. Frances said that the existence of gender dysphoria as a diagnosis has been a matter of controversy ever since it was first included.

“The transgender community has had mixed feelings on whether there should be anything at all in the manual,” he said. On one hand is the argument that gender dysphoria should be removed because it’s not really a psychiatric issue.

“We seriously considered eliminating it altogether in DSM-4,” said Dr. Frances.

However, an argument in favor of keeping it was that if the diagnosis was removed, it would mean that people could not receive treatment. “There’s no right argument for this dilemma,” he said.

Dr. Frances, who has been a frequent critic of DSM-5, said he believes the manual continues to miss opportunities to tighten criteria for many diagnoses, including ADHD and autism spectrum disorder.

“There’s a consistent pattern of taking behaviors and symptoms of behaviors that are on the border with normality and expanding the definition of mental disorder and reducing the realm of normality,” he said.

That has consequences, Dr. Frances added. “When someone gets a diagnosis that they need to get, it’s the beginning of a much better future. When someone gets a diagnosis that’s a mislabel that they don’t need, it has all harms and no benefits. It’s stigmatizing, leads to too much treatment, the wrong treatment, and it’s much more harmful than helpful.”

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

Ahead of its official release on March 18, the new Diagnostic and Statistical Manual of Mental Disorders, which is in the form of a textbook, is already drawing some criticism.

The American Psychiatric Association’s DSM-5-TR (Text Revision) which is not a full revision, only includes one new condition, prolonged grief disorder.

It also includes symptom codes for suicidal behavior and nonsuicidal self-injury, clarifying modifications to criteria sets for more than 70 disorders, including autism spectrum disorder; changes in terminology for gender dysphoria; and a comprehensive review of the impact of racism and discrimination on the diagnosis and manifestations of mental disorders.

The Text Revision is a compilation of iterative changes that have been made online on a rolling basis since the DSM-5 was first published in 2013.

“The goal of the Text Revision was to allow a thorough revision of the text, not the criteria,” Paul Appelbaum, MD, chair of the APA’s DSM steering committee, told this news organization.

For the Text Revision, some 200 experts across a variety of APA working groups recommended changes to the text based on a comprehensive literature review, said Appelbaum, who is the Elizabeth K. Dollard Professor of Psychiatry, Medicine and Law, and director of the division of law, ethics and psychiatry at Columbia University, New York.

However, there’s not a lot that’s new, in part, because there have been few therapeutic advances.
 

Money maker?

Allen Frances, MD, chair of the DSM-4 task force and professor and chair emeritus of psychiatry at Duke University, Durham, N.C., said the APA is publishing the Text Revision “just to make money. They’re very anxious to do anything that will increase sales and having a revision forces some people, especially in institutions, to buy the book, even though it may not have anything substantive to add to the original.”

Dr. Frances told this news organization that when the APA published the first DSM in the late 1970s, “it became an instantaneous best-seller, to everyone’s surprise.”

The APA would not comment on how many of the $170 (list price) volumes it sells or how much those sales contribute to its budget.

Dr. Appelbaum acknowledged, “at any point in time, the canonical version is the online version.” However, it’s clear from DSM-5 sales “that many people still value having a hard copy of the DSM available to them.”  
 

Prolonged grief: Timely or overkill?

Persistent complex bereavement disorder (PCBD) was listed as a “condition for further study” in DSM-5. After a 2019 workshop aimed at getting consensus for diagnosis criteria, the APA board approved the new prolonged grief disorder in October 2020, and the APA assembly approved the new disorder in November 2020. 

Given the 950,000 deaths from COVID-19 over the past 2 years, inclusion of prolonged grief disorder in the DSM-5 may arrive at just the right time.

The diagnostic criteria for PCBD include:

• The development of a persistent grief response (longer than a year for adults and 6 months for children and adolescents) characterized by one or both of the following symptoms, which have been present most days to a clinically significant degree, and have occurred nearly every day for at least the last month: intense yearning/longing for the deceased person; preoccupation with thoughts or memories of the deceased person.
• Since the death, at least three symptoms present most days to a clinically significant degree, and occurring nearly every day for at least the last month, including identity disruption, marked sense of disbelief about the death, avoidance of reminders that the person is dead, intense emotional pain related to the death, difficulty reintegrating into one’s relationships and activities after the death, emotional numbness, feeling that life is meaningless as a result of the death, and intense loneliness as a result of the death.
• The disturbance causes clinically significant distress or impairment in social, occupational, or other important areas of functioning.
• The duration and severity of the bereavement reaction clearly exceed expected social, cultural, or religious norms for the individual’s culture and context.
• The symptoms are not better explained by another mental disorder, such as major depressive disorder (MDD) or PTSD, and are not attributable to the physiological effects of a substance or another medical condition.

Dr. Frances said he believes creating a new diagnosis pathologizes grief. In DSM-3 and DSM-4, an exception was made under the diagnosis of MDD for individuals who had recently lost a loved one. “We wanted to have at least an opportunity for people to grieve without being stigmatized, mislabeled, and overtreated with medication.”

DSM-5 removed the bereavement exclusion. After 2 weeks, people who are grieving and have particular symptoms could receive a diagnosis of MDD, said Dr. Frances. He believes the exclusion should have been broadened to cover anyone experiencing a major loss – such as a job loss or divorce. If someone is having prolonged symptoms that interfere with functioning, they should get an MDD diagnosis.

The new disorder “doesn’t solve anything, it just adds to the confusion and stigmatization, and it’s part of a kind of creeping medical imperialization of everyday life, where everything has to have a mental disorder label,” Dr. Frances said.

However, Dr. Appelbaum countered that “the criteria for prolonged grief disorder are constructed in such a way as to make every effort to exclude people who are going through a normal grieving process.”

“Part of the purpose of the data analyses was to ensure the criteria that were adopted would, in fact, effectively distinguish between what anybody goes through, say when someone close to you dies, and this unusual prolonged grieving process without end that affects a much smaller number of people but which really can be crippling for them,” he added.

The Text Revision adds new symptom codes for suicidal behavior and nonsuicidal self-injury, which appear in the chapter, “Other Conditions That May Be a Focus of Clinical Attention,” said Dr. Appelbaum.

“Both suicidal behavior and nonsuicidal self-injury seem pretty persuasively to fall into that category – something a clinician would want to know about, pay attention to, and factor into treatment planning, although they are behaviors that cross many diagnostic categories,” he added.

Codes also provide a systematic way of ascertaining the incidence and prevalence of such behaviors, said Dr. Appelbaum.
 

Changes to gender terminology

The Text Revision also tweaks some terminology with respect to transgender individuals. The term “desired gender” is now “experienced gender”, the term “cross-sex medical procedure” is now “gender-affirming medical procedure”, and the terms “natal male/natal female” are now “individual assigned male/female at birth”.

Dr. Frances said that the existence of gender dysphoria as a diagnosis has been a matter of controversy ever since it was first included.

“The transgender community has had mixed feelings on whether there should be anything at all in the manual,” he said. On one hand is the argument that gender dysphoria should be removed because it’s not really a psychiatric issue.

“We seriously considered eliminating it altogether in DSM-4,” said Dr. Frances.

However, an argument in favor of keeping it was that if the diagnosis was removed, it would mean that people could not receive treatment. “There’s no right argument for this dilemma,” he said.

Dr. Frances, who has been a frequent critic of DSM-5, said he believes the manual continues to miss opportunities to tighten criteria for many diagnoses, including ADHD and autism spectrum disorder.

“There’s a consistent pattern of taking behaviors and symptoms of behaviors that are on the border with normality and expanding the definition of mental disorder and reducing the realm of normality,” he said.

That has consequences, Dr. Frances added. “When someone gets a diagnosis that they need to get, it’s the beginning of a much better future. When someone gets a diagnosis that’s a mislabel that they don’t need, it has all harms and no benefits. It’s stigmatizing, leads to too much treatment, the wrong treatment, and it’s much more harmful than helpful.”

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

In April 2021, Express Scripts stopped covering low-volume bowel preparations in its National Preferred Formulary, a move that had the potential to affect many of the 75 million Americans covered by that pharmacy benefit manager’s programs, according to the American Society for Gastrointestinal Endoscopy (ASGE).

For gastroenterologists and their patients, it was an action that added insult to injury. The COVID-19 pandemic had already led to shortages of various preps, causing many thousands of Americans to forego colonoscopies. One study estimated that there was a 95% decline in weekly colorectal cancer screenings in the first half of 2020.

Just as screenings were returning to prepandemic levels, the Express Scripts coverage change threatened to create a new barrier for those already hesitant, especially since the prep is what patients most loathe about colonoscopy, said the gastroenterologists interviewed for this story.

Almost a year later, not much has changed. Bowel prep shortages persist, and some insurers and pharmacy benefit management (PBM) companies are restricting coverage of certain prescription preps or instituting higher copays.

Gastroenterologists are having to delay procedures and patients are canceling appointments; some never return.

“I and many of my colleagues are very concerned that we are going to see an increase in advanced colon polyps and colon cancer,” said Jennifer A. Christie, MD, professor of medicine in the digestive diseases division at Emory University School of Medicine, Atlanta, and vice president of the ASGE.

Obstacles to getting the right prep “not only [delay] the care, but the negative outcomes could be horrible,” agreed Tauseef Ali, MD, clinical assistant professor at the University of Oklahoma and a member of the American College of Gastroenterology’s board of governors.

For the majority of patients, a wait might not be an issue, said Christian Stevoff, MD, assistant professor of medicine at Northwestern University Feinberg School of Medicine, Chicago. But a delayed diagnosis would be significant for those with larger polyps or cancer in the colon, he said.

“It’s a major problem for those people that it does affect,” Dr. Stevoff told this news organization.

He noted that his practice had to delay around 3,000 procedures in 2020, and while they have since caught up, approximately 25% of cases are being delayed right now for a variety of reasons. Most of those are in patients deemed to be low risk, though, he said.
 

PBMs: ‘a parasitic infection to our health care system’

Shortages of preps have been a persistent headache, but restrictions such as those instituted by Express Scripts have become a bigger problem, said some gastroenterologists.

Express Scripts did have several exceptions to its prohibition on coverage of low-volume preps. First, it could be approved if the patient had failed with a polyethylene glycol (PEG)–based prep like GoLYTELY. It could also be approved if the patient had tried MoviPrep and failed, if MoviPrep was unavailable, or if the patient has phenylketonuria or glucose-6-phosphate dehydrogenase deficiency.

Cigna-owned Express Scripts is one of three PBMs – along with CVS Caremark and OptumRX (owned by UnitedHealth Group) – that control 85% of prescription drug benefits in the United States, according to a 2019 investigation of the industry by the New York State Senate.

Express Scripts did not return requests for comment on its bowel prep coverage, and CVS Caremark declined to participate. A spokesperson for OptumRX told this news organization that the PBM provides bowel preps at “$0 cost-share” but only for health plan sponsors that are subject to Affordable Care Act regulations that require providing colonoscopies under such a payment structure. The company did not provide further information.

For some gastroenterologists, the anger toward PBMs is palpable. Dr. Ali calls PBMs “a parasitic infection to our health care system.”

“Keeping track of these bowel prep coverages has become a nightmare,” he said, noting that every payer seems to have its own preferred prep. “We have a dedicated nurse whose only job is to keep tabs on this, and she’s unable to because it’s just getting out of control.”

Some preps are contraindicated for patients, Dr. Ali said. Yet even in those cases, it’s difficult to get the alternatives covered. It often comes down to a joint effort by a pharmacist, the patient, and Dr. Ali’s office staff to get coverage for a medically necessary prep.

If it’s an emergency, Dr. Ali said, “either our patients bite the bullet and pay the price, or we have to come up with alternative solutions that may not lead to an optimal bowel preparation. It defeats the whole purpose of having a good bowel preparation and giving them a good outcome.”

He added that “there are a lot of patients who cancel their colonoscopies out of frustration,” because the bowel prep is not available or too expensive and that some patients choose to simply not reschedule.

Dr. Christie’s experience is similar. Sometimes patients must be rescheduled because “we could not get the prep in a timely fashion for them to be ready for their procedure.” Bringing back patients can be hard: They are busy, or they can’t get a ride, or time off work, or coverage for caregiving, she said. Ultimately, “some patients do decide to either defer or decline screening.”

The hassles also have the potential to exacerbate existing health disparities, she added.

Dr. Stevoff, the gastroenterologist at Northwestern, said cancellations are a concern, but to his knowledge, none of his patients have quit in frustration.

He said that because “most of the [preps] are equivalent to each other,” he often gives preference to what’s available.

He does tell patients that they may have a higher copay. For some that may be fine for what is only a once every 5- or 10-year payment. For others who cannot afford the cost, it may mean spending time trying to convince the insurer to pay for a prep that is not normally covered, he said.
 

A step backwards

Dr. Stevoff understands why payers might have preferred preps.

“As long as the outcomes are equivalent, I don’t think they’re going to be willing to pay for a prep that’s three or four times more expensive for a night of inconvenience for the patient,” he said.

David Johnson, MD, professor of medicine and chief of gastroenterology at Eastern Virginia Medical School, Norfolk, said he’s mystified by moves to limit bowel preps.

“Having to do an end-run to figure out what preps we can get for a patient is a step backwards,” he said.

Douglas Rex, MD, distinguished professor emeritus of medicine at Indiana University School of Medicine, Indianapolis, said it was dangerous to limit options.

“Trying to save relatively small amounts of money by restricting access to specific preps is seriously wrong-headed and a mistake,” he said. “If you keep the big picture in mind, we’re trying to keep people from getting colon cancer.”

Dr. Johnson also noted that a poor-quality prep might lead to a poor-quality exam, which is associated with not only reduced adenoma detection rates but also a shortened interval for a repeat exam, which just adds costs to the system.

“The whole impact of colon cancer screening is to discover polyps and remove them to prevent cancer,” Dr. Johnson said.
 

No rhyme or reason to ongoing shortages

Pandemic-related supply chain headaches have trickled down to bowel preps, which then lead to occasional delays in procedures.

“We have definitely seen shortages throughout most of the pandemic,” Dr. Rex said. At various times, he added, low-volume or high-volume prescription preps have not been available in all pharmacies or not available in certain pharmacies.

The spotty supplies have created a hassle and added costs because his office staff spends time making calls to find an available prep, he said.

Dr. Christie described similar issues at her practice, where the shortages have been “a significant challenge and issue.”

As of late January, some polyethylene glycol 3,350-based preps were still in short supply or had been discontinued, according to the American Society of Health-System Pharmacists (ASHP). Two companies – Teva and Lupin – did not provide a reason for the lack of product. However, ASHP said the companies anticipated being able to provide supplies in February.

Many PEG-based prescription products have been on back order for some time, said Dr. Johnson, who tries to avoid the higher-volume PEG-based preps in favor of low-volume preps that are more tolerable to patients.

The lack of information about a reason for the shortages has led to speculation.

At the beginning of the COVID-19 pandemic, GoLYTELY, one of the more commonly used PEG-based preps, was not available at all, Dr. Ali said. It was his understanding that PEG was being used as an ingredient in COVID vaccines, which helped explain the shortage, at least initially.

Dr. Stevoff also heard this explanation but said he had come to believe it was an “urban myth,” and added that he “never got confirmation from any of the companies” that they couldn’t get PEG because it was being used for vaccines. He noted that shortages of some PEG-based preps have continued even though vaccine production has stabilized.
 

Over-the-counter alternatives can be ‘hit or miss’

With the price for all bowel preps – and co-pays – increasing in the last 2 years, some practices are directing patients on how to mix up their own using over-the-counter (OTC) ingredients, which is likely to be less expensive.

The out-of-pocket cost for a four-liter, high-volume PEG-based prep might be $35-$50, according to GoodRx. Alternatives such as Suprep (sodium/potassium/magnesium) run $110-$120, according to the website, and a sodium phosphate-based prep, such as OsmoPrep, runs close to $300.

The OTC prep uses MiraLAX (PEG-based but without additional electrolytes mixed in) and bisacodyl (Dulcolax). Johns Hopkins University, Cleveland Clinic, and Memorial Sloan Kettering, among many other institutions, have advised patients to use the OTC do-it-yourself preps. It is a split prep, using 238 grams of MiraLAX mixed with 64 ounces of water or a sports drink (for example, Gatorade). The day before the procedure, patients take 2 bisacodyl (5 mg) tablets, followed by four 8-ounce glasses of a MiraLAX/water mixture. The same regimen is followed the day of the procedure.

There are mixed results on how adequately the regimen cleans the colon. A 2014 meta-analysis found that the MiraLAX-based prep was inferior in terms of bowel cleansing to PEG-based formulations premixed with electrolyte solutions (PEG-ELS). There was no statistically significant difference in polyp detection between the two. In a 2011 analysis, researchers concluded that GoLYTELY was superior to MiraLAX in colon prep and adenoma detection.

The 2014 U.S. Multi-Society Task Force on Colorectal Cancer Guidelines reported that the MiraLAX-based prep had less effective bowel preparation than 4-liter PEG-ELS solutions in at least one study but that it appeared to be more tolerable for patients and associated with few adverse events. More study of its safety is “warranted and desirable,” write the authors.

Even before the pandemic, Dr. Rex said his practice used the MiraLAX-based prep because it was less expensive, and “anecdotally it tends to be very well tolerated.”

However, he noted that the regimen is not approved by the Food and Drug Administration.

“A lot of people don’t like to use non–FDA approved preps because they’re afraid of some liability if there is a complication,” Dr. Rex said.

Dr. Ali added that he has advised patients to use the OTC preps, but the results can be “hit or miss.”

Some patients can easily comply with the instructions and will have good results, but others may not have the education or understanding or may have underlying medical conditions that lessen the OTC formulation’s effectiveness in getting a good cleanout, said Dr. Ali.

Dr. Stevoff has occasionally used the OTC prep but agrees that not all patients will be able to follow the directions.

“The more complicated a process is, the more likely it is that somebody will make a mistake,” he said.

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

In April 2021, Express Scripts stopped covering low-volume bowel preparations in its National Preferred Formulary, a move that had the potential to affect many of the 75 million Americans covered by that pharmacy benefit manager’s programs, according to the American Society for Gastrointestinal Endoscopy (ASGE).

For gastroenterologists and their patients, it was an action that added insult to injury. The COVID-19 pandemic had already led to shortages of various preps, causing many thousands of Americans to forego colonoscopies. One study estimated that there was a 95% decline in weekly colorectal cancer screenings in the first half of 2020.

Just as screenings were returning to prepandemic levels, the Express Scripts coverage change threatened to create a new barrier for those already hesitant, especially since the prep is what patients most loathe about colonoscopy, said the gastroenterologists interviewed for this story.

Almost a year later, not much has changed. Bowel prep shortages persist, and some insurers and pharmacy benefit management (PBM) companies are restricting coverage of certain prescription preps or instituting higher copays.

Gastroenterologists are having to delay procedures and patients are canceling appointments; some never return.

“I and many of my colleagues are very concerned that we are going to see an increase in advanced colon polyps and colon cancer,” said Jennifer A. Christie, MD, professor of medicine in the digestive diseases division at Emory University School of Medicine, Atlanta, and vice president of the ASGE.

Obstacles to getting the right prep “not only [delay] the care, but the negative outcomes could be horrible,” agreed Tauseef Ali, MD, clinical assistant professor at the University of Oklahoma and a member of the American College of Gastroenterology’s board of governors.

For the majority of patients, a wait might not be an issue, said Christian Stevoff, MD, assistant professor of medicine at Northwestern University Feinberg School of Medicine, Chicago. But a delayed diagnosis would be significant for those with larger polyps or cancer in the colon, he said.

“It’s a major problem for those people that it does affect,” Dr. Stevoff told this news organization.

He noted that his practice had to delay around 3,000 procedures in 2020, and while they have since caught up, approximately 25% of cases are being delayed right now for a variety of reasons. Most of those are in patients deemed to be low risk, though, he said.
 

PBMs: ‘a parasitic infection to our health care system’

Shortages of preps have been a persistent headache, but restrictions such as those instituted by Express Scripts have become a bigger problem, said some gastroenterologists.

Express Scripts did have several exceptions to its prohibition on coverage of low-volume preps. First, it could be approved if the patient had failed with a polyethylene glycol (PEG)–based prep like GoLYTELY. It could also be approved if the patient had tried MoviPrep and failed, if MoviPrep was unavailable, or if the patient has phenylketonuria or glucose-6-phosphate dehydrogenase deficiency.

Cigna-owned Express Scripts is one of three PBMs – along with CVS Caremark and OptumRX (owned by UnitedHealth Group) – that control 85% of prescription drug benefits in the United States, according to a 2019 investigation of the industry by the New York State Senate.

Express Scripts did not return requests for comment on its bowel prep coverage, and CVS Caremark declined to participate. A spokesperson for OptumRX told this news organization that the PBM provides bowel preps at “$0 cost-share” but only for health plan sponsors that are subject to Affordable Care Act regulations that require providing colonoscopies under such a payment structure. The company did not provide further information.

For some gastroenterologists, the anger toward PBMs is palpable. Dr. Ali calls PBMs “a parasitic infection to our health care system.”

“Keeping track of these bowel prep coverages has become a nightmare,” he said, noting that every payer seems to have its own preferred prep. “We have a dedicated nurse whose only job is to keep tabs on this, and she’s unable to because it’s just getting out of control.”

Some preps are contraindicated for patients, Dr. Ali said. Yet even in those cases, it’s difficult to get the alternatives covered. It often comes down to a joint effort by a pharmacist, the patient, and Dr. Ali’s office staff to get coverage for a medically necessary prep.

If it’s an emergency, Dr. Ali said, “either our patients bite the bullet and pay the price, or we have to come up with alternative solutions that may not lead to an optimal bowel preparation. It defeats the whole purpose of having a good bowel preparation and giving them a good outcome.”

He added that “there are a lot of patients who cancel their colonoscopies out of frustration,” because the bowel prep is not available or too expensive and that some patients choose to simply not reschedule.

Dr. Christie’s experience is similar. Sometimes patients must be rescheduled because “we could not get the prep in a timely fashion for them to be ready for their procedure.” Bringing back patients can be hard: They are busy, or they can’t get a ride, or time off work, or coverage for caregiving, she said. Ultimately, “some patients do decide to either defer or decline screening.”

The hassles also have the potential to exacerbate existing health disparities, she added.

Dr. Stevoff, the gastroenterologist at Northwestern, said cancellations are a concern, but to his knowledge, none of his patients have quit in frustration.

He said that because “most of the [preps] are equivalent to each other,” he often gives preference to what’s available.

He does tell patients that they may have a higher copay. For some that may be fine for what is only a once every 5- or 10-year payment. For others who cannot afford the cost, it may mean spending time trying to convince the insurer to pay for a prep that is not normally covered, he said.
 

A step backwards

Dr. Stevoff understands why payers might have preferred preps.

“As long as the outcomes are equivalent, I don’t think they’re going to be willing to pay for a prep that’s three or four times more expensive for a night of inconvenience for the patient,” he said.

David Johnson, MD, professor of medicine and chief of gastroenterology at Eastern Virginia Medical School, Norfolk, said he’s mystified by moves to limit bowel preps.

“Having to do an end-run to figure out what preps we can get for a patient is a step backwards,” he said.

Douglas Rex, MD, distinguished professor emeritus of medicine at Indiana University School of Medicine, Indianapolis, said it was dangerous to limit options.

“Trying to save relatively small amounts of money by restricting access to specific preps is seriously wrong-headed and a mistake,” he said. “If you keep the big picture in mind, we’re trying to keep people from getting colon cancer.”

Dr. Johnson also noted that a poor-quality prep might lead to a poor-quality exam, which is associated with not only reduced adenoma detection rates but also a shortened interval for a repeat exam, which just adds costs to the system.

“The whole impact of colon cancer screening is to discover polyps and remove them to prevent cancer,” Dr. Johnson said.
 

No rhyme or reason to ongoing shortages

Pandemic-related supply chain headaches have trickled down to bowel preps, which then lead to occasional delays in procedures.

“We have definitely seen shortages throughout most of the pandemic,” Dr. Rex said. At various times, he added, low-volume or high-volume prescription preps have not been available in all pharmacies or not available in certain pharmacies.

The spotty supplies have created a hassle and added costs because his office staff spends time making calls to find an available prep, he said.

Dr. Christie described similar issues at her practice, where the shortages have been “a significant challenge and issue.”

As of late January, some polyethylene glycol 3,350-based preps were still in short supply or had been discontinued, according to the American Society of Health-System Pharmacists (ASHP). Two companies – Teva and Lupin – did not provide a reason for the lack of product. However, ASHP said the companies anticipated being able to provide supplies in February.

Many PEG-based prescription products have been on back order for some time, said Dr. Johnson, who tries to avoid the higher-volume PEG-based preps in favor of low-volume preps that are more tolerable to patients.

The lack of information about a reason for the shortages has led to speculation.

At the beginning of the COVID-19 pandemic, GoLYTELY, one of the more commonly used PEG-based preps, was not available at all, Dr. Ali said. It was his understanding that PEG was being used as an ingredient in COVID vaccines, which helped explain the shortage, at least initially.

Dr. Stevoff also heard this explanation but said he had come to believe it was an “urban myth,” and added that he “never got confirmation from any of the companies” that they couldn’t get PEG because it was being used for vaccines. He noted that shortages of some PEG-based preps have continued even though vaccine production has stabilized.
 

Over-the-counter alternatives can be ‘hit or miss’

With the price for all bowel preps – and co-pays – increasing in the last 2 years, some practices are directing patients on how to mix up their own using over-the-counter (OTC) ingredients, which is likely to be less expensive.

The out-of-pocket cost for a four-liter, high-volume PEG-based prep might be $35-$50, according to GoodRx. Alternatives such as Suprep (sodium/potassium/magnesium) run $110-$120, according to the website, and a sodium phosphate-based prep, such as OsmoPrep, runs close to $300.

The OTC prep uses MiraLAX (PEG-based but without additional electrolytes mixed in) and bisacodyl (Dulcolax). Johns Hopkins University, Cleveland Clinic, and Memorial Sloan Kettering, among many other institutions, have advised patients to use the OTC do-it-yourself preps. It is a split prep, using 238 grams of MiraLAX mixed with 64 ounces of water or a sports drink (for example, Gatorade). The day before the procedure, patients take 2 bisacodyl (5 mg) tablets, followed by four 8-ounce glasses of a MiraLAX/water mixture. The same regimen is followed the day of the procedure.

There are mixed results on how adequately the regimen cleans the colon. A 2014 meta-analysis found that the MiraLAX-based prep was inferior in terms of bowel cleansing to PEG-based formulations premixed with electrolyte solutions (PEG-ELS). There was no statistically significant difference in polyp detection between the two. In a 2011 analysis, researchers concluded that GoLYTELY was superior to MiraLAX in colon prep and adenoma detection.

The 2014 U.S. Multi-Society Task Force on Colorectal Cancer Guidelines reported that the MiraLAX-based prep had less effective bowel preparation than 4-liter PEG-ELS solutions in at least one study but that it appeared to be more tolerable for patients and associated with few adverse events. More study of its safety is “warranted and desirable,” write the authors.

Even before the pandemic, Dr. Rex said his practice used the MiraLAX-based prep because it was less expensive, and “anecdotally it tends to be very well tolerated.”

However, he noted that the regimen is not approved by the Food and Drug Administration.

“A lot of people don’t like to use non–FDA approved preps because they’re afraid of some liability if there is a complication,” Dr. Rex said.

Dr. Ali added that he has advised patients to use the OTC preps, but the results can be “hit or miss.”

Some patients can easily comply with the instructions and will have good results, but others may not have the education or understanding or may have underlying medical conditions that lessen the OTC formulation’s effectiveness in getting a good cleanout, said Dr. Ali.

Dr. Stevoff has occasionally used the OTC prep but agrees that not all patients will be able to follow the directions.

“The more complicated a process is, the more likely it is that somebody will make a mistake,” he said.

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

In April 2021, Express Scripts stopped covering low-volume bowel preparations in its National Preferred Formulary, a move that had the potential to affect many of the 75 million Americans covered by that pharmacy benefit manager’s programs, according to the American Society for Gastrointestinal Endoscopy (ASGE).

For gastroenterologists and their patients, it was an action that added insult to injury. The COVID-19 pandemic had already led to shortages of various preps, causing many thousands of Americans to forego colonoscopies. One study estimated that there was a 95% decline in weekly colorectal cancer screenings in the first half of 2020.

Just as screenings were returning to prepandemic levels, the Express Scripts coverage change threatened to create a new barrier for those already hesitant, especially since the prep is what patients most loathe about colonoscopy, said the gastroenterologists interviewed for this story.

Almost a year later, not much has changed. Bowel prep shortages persist, and some insurers and pharmacy benefit management (PBM) companies are restricting coverage of certain prescription preps or instituting higher copays.

Gastroenterologists are having to delay procedures and patients are canceling appointments; some never return.

“I and many of my colleagues are very concerned that we are going to see an increase in advanced colon polyps and colon cancer,” said Jennifer A. Christie, MD, professor of medicine in the digestive diseases division at Emory University School of Medicine, Atlanta, and vice president of the ASGE.

Obstacles to getting the right prep “not only [delay] the care, but the negative outcomes could be horrible,” agreed Tauseef Ali, MD, clinical assistant professor at the University of Oklahoma and a member of the American College of Gastroenterology’s board of governors.

For the majority of patients, a wait might not be an issue, said Christian Stevoff, MD, assistant professor of medicine at Northwestern University Feinberg School of Medicine, Chicago. But a delayed diagnosis would be significant for those with larger polyps or cancer in the colon, he said.

“It’s a major problem for those people that it does affect,” Dr. Stevoff told this news organization.

He noted that his practice had to delay around 3,000 procedures in 2020, and while they have since caught up, approximately 25% of cases are being delayed right now for a variety of reasons. Most of those are in patients deemed to be low risk, though, he said.
 

PBMs: ‘a parasitic infection to our health care system’

Shortages of preps have been a persistent headache, but restrictions such as those instituted by Express Scripts have become a bigger problem, said some gastroenterologists.

Express Scripts did have several exceptions to its prohibition on coverage of low-volume preps. First, it could be approved if the patient had failed with a polyethylene glycol (PEG)–based prep like GoLYTELY. It could also be approved if the patient had tried MoviPrep and failed, if MoviPrep was unavailable, or if the patient has phenylketonuria or glucose-6-phosphate dehydrogenase deficiency.

Cigna-owned Express Scripts is one of three PBMs – along with CVS Caremark and OptumRX (owned by UnitedHealth Group) – that control 85% of prescription drug benefits in the United States, according to a 2019 investigation of the industry by the New York State Senate.

Express Scripts did not return requests for comment on its bowel prep coverage, and CVS Caremark declined to participate. A spokesperson for OptumRX told this news organization that the PBM provides bowel preps at “$0 cost-share” but only for health plan sponsors that are subject to Affordable Care Act regulations that require providing colonoscopies under such a payment structure. The company did not provide further information.

For some gastroenterologists, the anger toward PBMs is palpable. Dr. Ali calls PBMs “a parasitic infection to our health care system.”

“Keeping track of these bowel prep coverages has become a nightmare,” he said, noting that every payer seems to have its own preferred prep. “We have a dedicated nurse whose only job is to keep tabs on this, and she’s unable to because it’s just getting out of control.”

Some preps are contraindicated for patients, Dr. Ali said. Yet even in those cases, it’s difficult to get the alternatives covered. It often comes down to a joint effort by a pharmacist, the patient, and Dr. Ali’s office staff to get coverage for a medically necessary prep.

If it’s an emergency, Dr. Ali said, “either our patients bite the bullet and pay the price, or we have to come up with alternative solutions that may not lead to an optimal bowel preparation. It defeats the whole purpose of having a good bowel preparation and giving them a good outcome.”

He added that “there are a lot of patients who cancel their colonoscopies out of frustration,” because the bowel prep is not available or too expensive and that some patients choose to simply not reschedule.

Dr. Christie’s experience is similar. Sometimes patients must be rescheduled because “we could not get the prep in a timely fashion for them to be ready for their procedure.” Bringing back patients can be hard: They are busy, or they can’t get a ride, or time off work, or coverage for caregiving, she said. Ultimately, “some patients do decide to either defer or decline screening.”

The hassles also have the potential to exacerbate existing health disparities, she added.

Dr. Stevoff, the gastroenterologist at Northwestern, said cancellations are a concern, but to his knowledge, none of his patients have quit in frustration.

He said that because “most of the [preps] are equivalent to each other,” he often gives preference to what’s available.

He does tell patients that they may have a higher copay. For some that may be fine for what is only a once every 5- or 10-year payment. For others who cannot afford the cost, it may mean spending time trying to convince the insurer to pay for a prep that is not normally covered, he said.
 

A step backwards

Dr. Stevoff understands why payers might have preferred preps.

“As long as the outcomes are equivalent, I don’t think they’re going to be willing to pay for a prep that’s three or four times more expensive for a night of inconvenience for the patient,” he said.

David Johnson, MD, professor of medicine and chief of gastroenterology at Eastern Virginia Medical School, Norfolk, said he’s mystified by moves to limit bowel preps.

“Having to do an end-run to figure out what preps we can get for a patient is a step backwards,” he said.

Douglas Rex, MD, distinguished professor emeritus of medicine at Indiana University School of Medicine, Indianapolis, said it was dangerous to limit options.

“Trying to save relatively small amounts of money by restricting access to specific preps is seriously wrong-headed and a mistake,” he said. “If you keep the big picture in mind, we’re trying to keep people from getting colon cancer.”

Dr. Johnson also noted that a poor-quality prep might lead to a poor-quality exam, which is associated with not only reduced adenoma detection rates but also a shortened interval for a repeat exam, which just adds costs to the system.

“The whole impact of colon cancer screening is to discover polyps and remove them to prevent cancer,” Dr. Johnson said.
 

No rhyme or reason to ongoing shortages

Pandemic-related supply chain headaches have trickled down to bowel preps, which then lead to occasional delays in procedures.

“We have definitely seen shortages throughout most of the pandemic,” Dr. Rex said. At various times, he added, low-volume or high-volume prescription preps have not been available in all pharmacies or not available in certain pharmacies.

The spotty supplies have created a hassle and added costs because his office staff spends time making calls to find an available prep, he said.

Dr. Christie described similar issues at her practice, where the shortages have been “a significant challenge and issue.”

As of late January, some polyethylene glycol 3,350-based preps were still in short supply or had been discontinued, according to the American Society of Health-System Pharmacists (ASHP). Two companies – Teva and Lupin – did not provide a reason for the lack of product. However, ASHP said the companies anticipated being able to provide supplies in February.

Many PEG-based prescription products have been on back order for some time, said Dr. Johnson, who tries to avoid the higher-volume PEG-based preps in favor of low-volume preps that are more tolerable to patients.

The lack of information about a reason for the shortages has led to speculation.

At the beginning of the COVID-19 pandemic, GoLYTELY, one of the more commonly used PEG-based preps, was not available at all, Dr. Ali said. It was his understanding that PEG was being used as an ingredient in COVID vaccines, which helped explain the shortage, at least initially.

Dr. Stevoff also heard this explanation but said he had come to believe it was an “urban myth,” and added that he “never got confirmation from any of the companies” that they couldn’t get PEG because it was being used for vaccines. He noted that shortages of some PEG-based preps have continued even though vaccine production has stabilized.
 

Over-the-counter alternatives can be ‘hit or miss’

With the price for all bowel preps – and co-pays – increasing in the last 2 years, some practices are directing patients on how to mix up their own using over-the-counter (OTC) ingredients, which is likely to be less expensive.

The out-of-pocket cost for a four-liter, high-volume PEG-based prep might be $35-$50, according to GoodRx. Alternatives such as Suprep (sodium/potassium/magnesium) run $110-$120, according to the website, and a sodium phosphate-based prep, such as OsmoPrep, runs close to $300.

The OTC prep uses MiraLAX (PEG-based but without additional electrolytes mixed in) and bisacodyl (Dulcolax). Johns Hopkins University, Cleveland Clinic, and Memorial Sloan Kettering, among many other institutions, have advised patients to use the OTC do-it-yourself preps. It is a split prep, using 238 grams of MiraLAX mixed with 64 ounces of water or a sports drink (for example, Gatorade). The day before the procedure, patients take 2 bisacodyl (5 mg) tablets, followed by four 8-ounce glasses of a MiraLAX/water mixture. The same regimen is followed the day of the procedure.

There are mixed results on how adequately the regimen cleans the colon. A 2014 meta-analysis found that the MiraLAX-based prep was inferior in terms of bowel cleansing to PEG-based formulations premixed with electrolyte solutions (PEG-ELS). There was no statistically significant difference in polyp detection between the two. In a 2011 analysis, researchers concluded that GoLYTELY was superior to MiraLAX in colon prep and adenoma detection.

The 2014 U.S. Multi-Society Task Force on Colorectal Cancer Guidelines reported that the MiraLAX-based prep had less effective bowel preparation than 4-liter PEG-ELS solutions in at least one study but that it appeared to be more tolerable for patients and associated with few adverse events. More study of its safety is “warranted and desirable,” write the authors.

Even before the pandemic, Dr. Rex said his practice used the MiraLAX-based prep because it was less expensive, and “anecdotally it tends to be very well tolerated.”

However, he noted that the regimen is not approved by the Food and Drug Administration.

“A lot of people don’t like to use non–FDA approved preps because they’re afraid of some liability if there is a complication,” Dr. Rex said.

Dr. Ali added that he has advised patients to use the OTC preps, but the results can be “hit or miss.”

Some patients can easily comply with the instructions and will have good results, but others may not have the education or understanding or may have underlying medical conditions that lessen the OTC formulation’s effectiveness in getting a good cleanout, said Dr. Ali.

Dr. Stevoff has occasionally used the OTC prep but agrees that not all patients will be able to follow the directions.

“The more complicated a process is, the more likely it is that somebody will make a mistake,” he said.

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