High-deductible health plans detrimental for those with diabetes

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Individuals with diabetes who are forced to switch to high-deductible health plans have more episodes of severe hypo- and hyperglycemia compared with those on conventional insurance plans, according to a new study.

Previous studies have shown that people with diabetes who are enrolled in high-deductible health plans (HDHPs) have an increased financial burden, lower medication adherence, and more low-severity emergency department visits, and they delay care for cardiovascular conditions.  

Dr. Rozalina G. McCoy

But no study has looked at the plans’ impact on acute diabetes complications and glycemic control, wrote the authors in JAMA Network Open.

They found evidence that the high-dollar plans were associated with increased odds of severe hypoglycemic and hyperglycemic events, and that the risk increased with each successive year of enrollment. Low-income individuals, Blacks, and Hispanics were disproportionately more impacted, noted senior author Rozalina G. McCoy, MD, Mayo Clinic, Rochester, Minn., and colleagues.

Overall, “enrollees may be rationing or forgoing necessary care, which is detrimental to their health and ultimately increases the morbidity, mortality, and costs associated with diabetes,” they concluded.

systematic review of eight studies published in Endocrine Practice in 2021 backs up this latest finding. That analysis reported enrollees in HDHPs often forgo routine care and monitoring, and that they have lower medication adherence, leading to an increase in total health care expenditures for emergency department visits, hospitalizations, and preventable complications.
 

Increased frequency of hypoglycemia is detrimental

The new study published in JAMA Network Open was based on data for adults enrolled in private insurance programs from 2010 to 2018. Researchers analyzed medical and pharmacy claims data contained in a large health insurance claims database, comparing adults with diabetes who had been in an HDHP for at least 1 year (and after a year of being in a conventional plan), with those who were in a conventional plan.

They identified 42,326 individuals who had been switched from a conventional plan to an HDHP. Of those, 7,375 (17.4%) were Black, 5,740 (13.6%) were Hispanic, 26,572 (62.8%) were non-Hispanic White, and 6,880 (16.3%) had a household income below $40,000 a year.

Baseline characteristics of the 202,729 people in conventional plans were similar to those in the HDHP group. 

The median deductible for individuals in the HDHP group was $1,500 and for families it was $3,000, compared with $350 and $800, respectively, for those in conventional plans.

The odds of having any severe hypoglycemic event were significantly higher in the HDHP group (odds ratio [OR], 1.11; P < .001). Each year of HDHP enrollment increased the odds of a hypoglycemia-related ED or hospital visit by 2% (OR, 1.02; P = .04).  

Aware that only a small number of severe hypoglycemic events, as well as an unknown number of such events, result in an emergency department visit or hospitalization, and that “the decision to seek ED or hospital care may be influenced by health plan assignment,” the authors also looked at office visits where severe, or any, hypoglycemia or hyperglycemia was coded or documented.

The proportion of HDHP enrollees where hypoglycemia was coded was 14% higher than for conventional plan enrollees (OR, 1.14; P < .001), with each year of the high-dollar plan enrollment increasing these odds by 6% (OR, 1.06; P < .001).

The tally of hypoglycemic events is an underestimate because HDHP enrollees might forgo ambulatory care for cost-related reasons, wrote the authors. Hypoglycemia might also be treated at home. But that is not necessarily a positive, they noted.

“The increased frequency of severe hypoglycemia – no matter where managed and discussed – is a sign of detrimental effects of HDHP enrollment for people living with diabetes.”

They found that individuals of racial and ethnic minorities were less likely than were White patients to have an increase in hypoglycemia-related office visits, which suggests that those patients were deferring care, wrote Dr. McCoy and colleagues.

Switching to an HDHP was associated with a significant increase in the odds of having at least one hyperglycemia-related ED or hospital visit per year (OR, 1.25; P < .001). Each successive year in the plan increased these odds by 5% (OR, 1.05; P = .02). However, the authors found no increase in hyperglycemia-related office visits.

“Because severe dysglycemic events may be prevented with optimal glycemic management, the increase in the frequency of their occurrence suggests important gaps in access to and implementation of diabetes therapy,” wrote the authors.

They noted that people with diabetes already face high out-of-pocket expenses. A high-deductible plan might make care even less affordable, they wrote.

“Individuals may be forced to ration medications, glucose-monitoring supplies, diabetes self-management education, food, and other essential cares to the detriment of their health,” they noted.

The authors added that because the study was observational, they could not delve into the root causes of the glycemic events or whether, for instance, any HDHP enrollees also had health savings accounts (HSAs) that might help defray costs.

They suggested that employers offer a wide variety of health plans, or if they are offering only a high-deductible plan that they be more transparent about potential costs. “Previous studies have shown that enrollees are not fully aware of the details within their health plans and may be focusing on reducing the cost of monthly premiums – not overall care – when choosing health plans.”

The authors said employers should find ways to fund HSAs for people with low incomes – those who appear to be most vulnerable to the effects of HDHPs. 

study published in JAMA Internal Medicine in 2017 found that low-income and HSA-eligible individuals with diabetes switched to an HDHP had major increases in emergency department visits for preventable acute diabetes complications.

The study was funded by a grant from the National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), the Mayo Clinic K2R Research Award, and the Mayo Clinic Robert D. and Patricia E. Kern Center for the Science of Health Care Delivery. Dr. McCoy has reported receiving grants from the NIDDK, AARP, and the Patient-Centered Outcomes Research Institute, and personal fees from Emmi for the development of patient education materials about diabetes outside the submitted work.

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

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Individuals with diabetes who are forced to switch to high-deductible health plans have more episodes of severe hypo- and hyperglycemia compared with those on conventional insurance plans, according to a new study.

Previous studies have shown that people with diabetes who are enrolled in high-deductible health plans (HDHPs) have an increased financial burden, lower medication adherence, and more low-severity emergency department visits, and they delay care for cardiovascular conditions.  

Dr. Rozalina G. McCoy

But no study has looked at the plans’ impact on acute diabetes complications and glycemic control, wrote the authors in JAMA Network Open.

They found evidence that the high-dollar plans were associated with increased odds of severe hypoglycemic and hyperglycemic events, and that the risk increased with each successive year of enrollment. Low-income individuals, Blacks, and Hispanics were disproportionately more impacted, noted senior author Rozalina G. McCoy, MD, Mayo Clinic, Rochester, Minn., and colleagues.

Overall, “enrollees may be rationing or forgoing necessary care, which is detrimental to their health and ultimately increases the morbidity, mortality, and costs associated with diabetes,” they concluded.

systematic review of eight studies published in Endocrine Practice in 2021 backs up this latest finding. That analysis reported enrollees in HDHPs often forgo routine care and monitoring, and that they have lower medication adherence, leading to an increase in total health care expenditures for emergency department visits, hospitalizations, and preventable complications.
 

Increased frequency of hypoglycemia is detrimental

The new study published in JAMA Network Open was based on data for adults enrolled in private insurance programs from 2010 to 2018. Researchers analyzed medical and pharmacy claims data contained in a large health insurance claims database, comparing adults with diabetes who had been in an HDHP for at least 1 year (and after a year of being in a conventional plan), with those who were in a conventional plan.

They identified 42,326 individuals who had been switched from a conventional plan to an HDHP. Of those, 7,375 (17.4%) were Black, 5,740 (13.6%) were Hispanic, 26,572 (62.8%) were non-Hispanic White, and 6,880 (16.3%) had a household income below $40,000 a year.

Baseline characteristics of the 202,729 people in conventional plans were similar to those in the HDHP group. 

The median deductible for individuals in the HDHP group was $1,500 and for families it was $3,000, compared with $350 and $800, respectively, for those in conventional plans.

The odds of having any severe hypoglycemic event were significantly higher in the HDHP group (odds ratio [OR], 1.11; P < .001). Each year of HDHP enrollment increased the odds of a hypoglycemia-related ED or hospital visit by 2% (OR, 1.02; P = .04).  

Aware that only a small number of severe hypoglycemic events, as well as an unknown number of such events, result in an emergency department visit or hospitalization, and that “the decision to seek ED or hospital care may be influenced by health plan assignment,” the authors also looked at office visits where severe, or any, hypoglycemia or hyperglycemia was coded or documented.

The proportion of HDHP enrollees where hypoglycemia was coded was 14% higher than for conventional plan enrollees (OR, 1.14; P < .001), with each year of the high-dollar plan enrollment increasing these odds by 6% (OR, 1.06; P < .001).

The tally of hypoglycemic events is an underestimate because HDHP enrollees might forgo ambulatory care for cost-related reasons, wrote the authors. Hypoglycemia might also be treated at home. But that is not necessarily a positive, they noted.

“The increased frequency of severe hypoglycemia – no matter where managed and discussed – is a sign of detrimental effects of HDHP enrollment for people living with diabetes.”

They found that individuals of racial and ethnic minorities were less likely than were White patients to have an increase in hypoglycemia-related office visits, which suggests that those patients were deferring care, wrote Dr. McCoy and colleagues.

Switching to an HDHP was associated with a significant increase in the odds of having at least one hyperglycemia-related ED or hospital visit per year (OR, 1.25; P < .001). Each successive year in the plan increased these odds by 5% (OR, 1.05; P = .02). However, the authors found no increase in hyperglycemia-related office visits.

“Because severe dysglycemic events may be prevented with optimal glycemic management, the increase in the frequency of their occurrence suggests important gaps in access to and implementation of diabetes therapy,” wrote the authors.

They noted that people with diabetes already face high out-of-pocket expenses. A high-deductible plan might make care even less affordable, they wrote.

“Individuals may be forced to ration medications, glucose-monitoring supplies, diabetes self-management education, food, and other essential cares to the detriment of their health,” they noted.

The authors added that because the study was observational, they could not delve into the root causes of the glycemic events or whether, for instance, any HDHP enrollees also had health savings accounts (HSAs) that might help defray costs.

They suggested that employers offer a wide variety of health plans, or if they are offering only a high-deductible plan that they be more transparent about potential costs. “Previous studies have shown that enrollees are not fully aware of the details within their health plans and may be focusing on reducing the cost of monthly premiums – not overall care – when choosing health plans.”

The authors said employers should find ways to fund HSAs for people with low incomes – those who appear to be most vulnerable to the effects of HDHPs. 

study published in JAMA Internal Medicine in 2017 found that low-income and HSA-eligible individuals with diabetes switched to an HDHP had major increases in emergency department visits for preventable acute diabetes complications.

The study was funded by a grant from the National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), the Mayo Clinic K2R Research Award, and the Mayo Clinic Robert D. and Patricia E. Kern Center for the Science of Health Care Delivery. Dr. McCoy has reported receiving grants from the NIDDK, AARP, and the Patient-Centered Outcomes Research Institute, and personal fees from Emmi for the development of patient education materials about diabetes outside the submitted work.

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

Individuals with diabetes who are forced to switch to high-deductible health plans have more episodes of severe hypo- and hyperglycemia compared with those on conventional insurance plans, according to a new study.

Previous studies have shown that people with diabetes who are enrolled in high-deductible health plans (HDHPs) have an increased financial burden, lower medication adherence, and more low-severity emergency department visits, and they delay care for cardiovascular conditions.  

Dr. Rozalina G. McCoy

But no study has looked at the plans’ impact on acute diabetes complications and glycemic control, wrote the authors in JAMA Network Open.

They found evidence that the high-dollar plans were associated with increased odds of severe hypoglycemic and hyperglycemic events, and that the risk increased with each successive year of enrollment. Low-income individuals, Blacks, and Hispanics were disproportionately more impacted, noted senior author Rozalina G. McCoy, MD, Mayo Clinic, Rochester, Minn., and colleagues.

Overall, “enrollees may be rationing or forgoing necessary care, which is detrimental to their health and ultimately increases the morbidity, mortality, and costs associated with diabetes,” they concluded.

systematic review of eight studies published in Endocrine Practice in 2021 backs up this latest finding. That analysis reported enrollees in HDHPs often forgo routine care and monitoring, and that they have lower medication adherence, leading to an increase in total health care expenditures for emergency department visits, hospitalizations, and preventable complications.
 

Increased frequency of hypoglycemia is detrimental

The new study published in JAMA Network Open was based on data for adults enrolled in private insurance programs from 2010 to 2018. Researchers analyzed medical and pharmacy claims data contained in a large health insurance claims database, comparing adults with diabetes who had been in an HDHP for at least 1 year (and after a year of being in a conventional plan), with those who were in a conventional plan.

They identified 42,326 individuals who had been switched from a conventional plan to an HDHP. Of those, 7,375 (17.4%) were Black, 5,740 (13.6%) were Hispanic, 26,572 (62.8%) were non-Hispanic White, and 6,880 (16.3%) had a household income below $40,000 a year.

Baseline characteristics of the 202,729 people in conventional plans were similar to those in the HDHP group. 

The median deductible for individuals in the HDHP group was $1,500 and for families it was $3,000, compared with $350 and $800, respectively, for those in conventional plans.

The odds of having any severe hypoglycemic event were significantly higher in the HDHP group (odds ratio [OR], 1.11; P < .001). Each year of HDHP enrollment increased the odds of a hypoglycemia-related ED or hospital visit by 2% (OR, 1.02; P = .04).  

Aware that only a small number of severe hypoglycemic events, as well as an unknown number of such events, result in an emergency department visit or hospitalization, and that “the decision to seek ED or hospital care may be influenced by health plan assignment,” the authors also looked at office visits where severe, or any, hypoglycemia or hyperglycemia was coded or documented.

The proportion of HDHP enrollees where hypoglycemia was coded was 14% higher than for conventional plan enrollees (OR, 1.14; P < .001), with each year of the high-dollar plan enrollment increasing these odds by 6% (OR, 1.06; P < .001).

The tally of hypoglycemic events is an underestimate because HDHP enrollees might forgo ambulatory care for cost-related reasons, wrote the authors. Hypoglycemia might also be treated at home. But that is not necessarily a positive, they noted.

“The increased frequency of severe hypoglycemia – no matter where managed and discussed – is a sign of detrimental effects of HDHP enrollment for people living with diabetes.”

They found that individuals of racial and ethnic minorities were less likely than were White patients to have an increase in hypoglycemia-related office visits, which suggests that those patients were deferring care, wrote Dr. McCoy and colleagues.

Switching to an HDHP was associated with a significant increase in the odds of having at least one hyperglycemia-related ED or hospital visit per year (OR, 1.25; P < .001). Each successive year in the plan increased these odds by 5% (OR, 1.05; P = .02). However, the authors found no increase in hyperglycemia-related office visits.

“Because severe dysglycemic events may be prevented with optimal glycemic management, the increase in the frequency of their occurrence suggests important gaps in access to and implementation of diabetes therapy,” wrote the authors.

They noted that people with diabetes already face high out-of-pocket expenses. A high-deductible plan might make care even less affordable, they wrote.

“Individuals may be forced to ration medications, glucose-monitoring supplies, diabetes self-management education, food, and other essential cares to the detriment of their health,” they noted.

The authors added that because the study was observational, they could not delve into the root causes of the glycemic events or whether, for instance, any HDHP enrollees also had health savings accounts (HSAs) that might help defray costs.

They suggested that employers offer a wide variety of health plans, or if they are offering only a high-deductible plan that they be more transparent about potential costs. “Previous studies have shown that enrollees are not fully aware of the details within their health plans and may be focusing on reducing the cost of monthly premiums – not overall care – when choosing health plans.”

The authors said employers should find ways to fund HSAs for people with low incomes – those who appear to be most vulnerable to the effects of HDHPs. 

study published in JAMA Internal Medicine in 2017 found that low-income and HSA-eligible individuals with diabetes switched to an HDHP had major increases in emergency department visits for preventable acute diabetes complications.

The study was funded by a grant from the National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), the Mayo Clinic K2R Research Award, and the Mayo Clinic Robert D. and Patricia E. Kern Center for the Science of Health Care Delivery. Dr. McCoy has reported receiving grants from the NIDDK, AARP, and the Patient-Centered Outcomes Research Institute, and personal fees from Emmi for the development of patient education materials about diabetes outside the submitted work.

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

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Physician sues AMA for defamation over 2022 election controversy

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If Willarda Edwards, MD, MBA, had won her 2022 campaign for president-elect of the American Medical Association (AMA), she would have been the second Black woman to head the group.

The AMA, however, accused her of vote trading. Now, the Baltimore internist and AMA trustee has sued the organization for defamation and conspiracy.

The lawsuit sheds light on the power dynamics of a politically potent organization that has more than 271,000 members and holds assets of $1.2 billion. The AMA president is one of the most visible figures in American medicine.

“The AMA impugned Dr. Edwards with these false charges, which destroyed her candidacy and irreparably damaged her reputation,” according to the complaint, which was filed Nov. 9, 2022, in Baltimore County Circuit Court. The case was later moved to federal court.

The AMA “previously rejected our attempt to resolve this matter without litigation,” Dr. Edwards’ attorney, Timothy Maloney, told this news organization. An AMA spokesman said the organization had no comment on Dr. Edwards’ suit.

Dr. Edwards is a past president of the National Medical Association, MedChi, the Baltimore City Medical Society, the Monumental City Medical Society, and the Sickle Cell Disease Association of America. She joined the AMA in 1994 and has served as a trustee since 2016.

As chair of the AMA Task Force on Health Equity, “she helped lead the way in consensus building and driving action that in 2019 resulted in the AMA House of Delegates establishing the AMA Center on Health Equity,” according to her AMA bio page.
 

‘Quid pro quo’ alleged

In June 2022, Dr. Edwards was one of three individuals running to be AMA president-elect.

According to Dr. Edwards’ complaint, she was “incorrectly advised by colleagues” that Virginia urologist William Reha, MD, had decided not to seek the AMA vice-speakership in 2023. This was important because both Dr. Edwards and Dr. Reha were in the Southeastern delegation. It could be in Dr. Edwards’ favor if Dr. Reha was not running, as it would mean one less leadership candidate from the same region.

Dr. Edwards called Dr. Reha on June 6 to discuss the matter. When they talked, Dr. Reha allegedly recorded the call without Dr. Edwards’ knowledge or permission – a felony in Maryland – and also steered her toward discussions about how his decision could benefit her campaign, according to the complaint.

The suit alleges that Dr. Reha’s questions were “clearly calculated to draw some statements by Dr. Edwards that he could use later to thwart her candidacy and to benefit her opponent.”

On June 10, at the AMA’s House of Delegates meeting in Chicago, Dr. Edwards was taken aside and questioned by members of the AMA’s Election Campaign Committee, according to the complaint. They accused her of “vote trading” but did not provide any evidence or a copy of a complaint they said had been filed against her, the suit said.

Dr. Edwards was given no opportunity to produce her own evidence or rebut the accusations, the suit alleges.

Just before the delegates started formal business on June 13, House Speaker Bruce Scott, MD, read a statement to the assembly saying that a complaint of a possible campaign violation had been filed against Dr. Edwards.

Dr. Scott told the delegates that “committee members interviewed the complainant and multiple other individuals said to have knowledge of the circumstances. In addition to conducting multiple interviews, the committee reviewed evidence that was deemed credible and corroborated that a campaign violation did in fact occur,” according to the complaint.

The supposed violation: A “quid pro quo” in which an unnamed delegation would support Dr. Edwards’ current candidacy, and the Southeastern delegation would support a future candidate from that other unnamed delegation.

Dr. Edwards was given a short opportunity to speak, in which she denied any violations.

According to a news report, Dr. Edwards said, “I’ve been in the House of Delegates for 30 years, and you know me as a process person – a person who truly believes in the process and trying to follow the complexities of our election campaign.”

The lawsuit alleges that “this defamatory conduct was repeated the next day to more than 600 delegates just minutes prior to the casting of votes, when Dr Scott repeated these allegations.”

Dr. Edwards lost the election.
 

 

 

AMA: Nothing more to add

The suit alleges that neither the Election Campaign Committee nor the AMA itself has made any accusers or complaints available to Dr. Edwards and that it has not provided any audio or written evidence of her alleged violation.

In July, the AMA’s Southeastern delegation told its membership, “We continue to maintain that Willarda was ‘set up’ ... The whole affair lacked any reasonable semblance of due process.”

The delegation has filed a counter claim against the AMA seeking “to address this lack of due process as well as the reputational harm” to the delegation.

The AMA said that it has nothing it can produce. “The Speaker of the House presented a verbal report to the attending delegates,” said a spokesman. “The Speaker’s report remains the only remarks from an AMA officer, and no additional remarks can be expected at this time.”

He added that there “is no official transcript of the Speaker’s report.”

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

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If Willarda Edwards, MD, MBA, had won her 2022 campaign for president-elect of the American Medical Association (AMA), she would have been the second Black woman to head the group.

The AMA, however, accused her of vote trading. Now, the Baltimore internist and AMA trustee has sued the organization for defamation and conspiracy.

The lawsuit sheds light on the power dynamics of a politically potent organization that has more than 271,000 members and holds assets of $1.2 billion. The AMA president is one of the most visible figures in American medicine.

“The AMA impugned Dr. Edwards with these false charges, which destroyed her candidacy and irreparably damaged her reputation,” according to the complaint, which was filed Nov. 9, 2022, in Baltimore County Circuit Court. The case was later moved to federal court.

The AMA “previously rejected our attempt to resolve this matter without litigation,” Dr. Edwards’ attorney, Timothy Maloney, told this news organization. An AMA spokesman said the organization had no comment on Dr. Edwards’ suit.

Dr. Edwards is a past president of the National Medical Association, MedChi, the Baltimore City Medical Society, the Monumental City Medical Society, and the Sickle Cell Disease Association of America. She joined the AMA in 1994 and has served as a trustee since 2016.

As chair of the AMA Task Force on Health Equity, “she helped lead the way in consensus building and driving action that in 2019 resulted in the AMA House of Delegates establishing the AMA Center on Health Equity,” according to her AMA bio page.
 

‘Quid pro quo’ alleged

In June 2022, Dr. Edwards was one of three individuals running to be AMA president-elect.

According to Dr. Edwards’ complaint, she was “incorrectly advised by colleagues” that Virginia urologist William Reha, MD, had decided not to seek the AMA vice-speakership in 2023. This was important because both Dr. Edwards and Dr. Reha were in the Southeastern delegation. It could be in Dr. Edwards’ favor if Dr. Reha was not running, as it would mean one less leadership candidate from the same region.

Dr. Edwards called Dr. Reha on June 6 to discuss the matter. When they talked, Dr. Reha allegedly recorded the call without Dr. Edwards’ knowledge or permission – a felony in Maryland – and also steered her toward discussions about how his decision could benefit her campaign, according to the complaint.

The suit alleges that Dr. Reha’s questions were “clearly calculated to draw some statements by Dr. Edwards that he could use later to thwart her candidacy and to benefit her opponent.”

On June 10, at the AMA’s House of Delegates meeting in Chicago, Dr. Edwards was taken aside and questioned by members of the AMA’s Election Campaign Committee, according to the complaint. They accused her of “vote trading” but did not provide any evidence or a copy of a complaint they said had been filed against her, the suit said.

Dr. Edwards was given no opportunity to produce her own evidence or rebut the accusations, the suit alleges.

Just before the delegates started formal business on June 13, House Speaker Bruce Scott, MD, read a statement to the assembly saying that a complaint of a possible campaign violation had been filed against Dr. Edwards.

Dr. Scott told the delegates that “committee members interviewed the complainant and multiple other individuals said to have knowledge of the circumstances. In addition to conducting multiple interviews, the committee reviewed evidence that was deemed credible and corroborated that a campaign violation did in fact occur,” according to the complaint.

The supposed violation: A “quid pro quo” in which an unnamed delegation would support Dr. Edwards’ current candidacy, and the Southeastern delegation would support a future candidate from that other unnamed delegation.

Dr. Edwards was given a short opportunity to speak, in which she denied any violations.

According to a news report, Dr. Edwards said, “I’ve been in the House of Delegates for 30 years, and you know me as a process person – a person who truly believes in the process and trying to follow the complexities of our election campaign.”

The lawsuit alleges that “this defamatory conduct was repeated the next day to more than 600 delegates just minutes prior to the casting of votes, when Dr Scott repeated these allegations.”

Dr. Edwards lost the election.
 

 

 

AMA: Nothing more to add

The suit alleges that neither the Election Campaign Committee nor the AMA itself has made any accusers or complaints available to Dr. Edwards and that it has not provided any audio or written evidence of her alleged violation.

In July, the AMA’s Southeastern delegation told its membership, “We continue to maintain that Willarda was ‘set up’ ... The whole affair lacked any reasonable semblance of due process.”

The delegation has filed a counter claim against the AMA seeking “to address this lack of due process as well as the reputational harm” to the delegation.

The AMA said that it has nothing it can produce. “The Speaker of the House presented a verbal report to the attending delegates,” said a spokesman. “The Speaker’s report remains the only remarks from an AMA officer, and no additional remarks can be expected at this time.”

He added that there “is no official transcript of the Speaker’s report.”

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

If Willarda Edwards, MD, MBA, had won her 2022 campaign for president-elect of the American Medical Association (AMA), she would have been the second Black woman to head the group.

The AMA, however, accused her of vote trading. Now, the Baltimore internist and AMA trustee has sued the organization for defamation and conspiracy.

The lawsuit sheds light on the power dynamics of a politically potent organization that has more than 271,000 members and holds assets of $1.2 billion. The AMA president is one of the most visible figures in American medicine.

“The AMA impugned Dr. Edwards with these false charges, which destroyed her candidacy and irreparably damaged her reputation,” according to the complaint, which was filed Nov. 9, 2022, in Baltimore County Circuit Court. The case was later moved to federal court.

The AMA “previously rejected our attempt to resolve this matter without litigation,” Dr. Edwards’ attorney, Timothy Maloney, told this news organization. An AMA spokesman said the organization had no comment on Dr. Edwards’ suit.

Dr. Edwards is a past president of the National Medical Association, MedChi, the Baltimore City Medical Society, the Monumental City Medical Society, and the Sickle Cell Disease Association of America. She joined the AMA in 1994 and has served as a trustee since 2016.

As chair of the AMA Task Force on Health Equity, “she helped lead the way in consensus building and driving action that in 2019 resulted in the AMA House of Delegates establishing the AMA Center on Health Equity,” according to her AMA bio page.
 

‘Quid pro quo’ alleged

In June 2022, Dr. Edwards was one of three individuals running to be AMA president-elect.

According to Dr. Edwards’ complaint, she was “incorrectly advised by colleagues” that Virginia urologist William Reha, MD, had decided not to seek the AMA vice-speakership in 2023. This was important because both Dr. Edwards and Dr. Reha were in the Southeastern delegation. It could be in Dr. Edwards’ favor if Dr. Reha was not running, as it would mean one less leadership candidate from the same region.

Dr. Edwards called Dr. Reha on June 6 to discuss the matter. When they talked, Dr. Reha allegedly recorded the call without Dr. Edwards’ knowledge or permission – a felony in Maryland – and also steered her toward discussions about how his decision could benefit her campaign, according to the complaint.

The suit alleges that Dr. Reha’s questions were “clearly calculated to draw some statements by Dr. Edwards that he could use later to thwart her candidacy and to benefit her opponent.”

On June 10, at the AMA’s House of Delegates meeting in Chicago, Dr. Edwards was taken aside and questioned by members of the AMA’s Election Campaign Committee, according to the complaint. They accused her of “vote trading” but did not provide any evidence or a copy of a complaint they said had been filed against her, the suit said.

Dr. Edwards was given no opportunity to produce her own evidence or rebut the accusations, the suit alleges.

Just before the delegates started formal business on June 13, House Speaker Bruce Scott, MD, read a statement to the assembly saying that a complaint of a possible campaign violation had been filed against Dr. Edwards.

Dr. Scott told the delegates that “committee members interviewed the complainant and multiple other individuals said to have knowledge of the circumstances. In addition to conducting multiple interviews, the committee reviewed evidence that was deemed credible and corroborated that a campaign violation did in fact occur,” according to the complaint.

The supposed violation: A “quid pro quo” in which an unnamed delegation would support Dr. Edwards’ current candidacy, and the Southeastern delegation would support a future candidate from that other unnamed delegation.

Dr. Edwards was given a short opportunity to speak, in which she denied any violations.

According to a news report, Dr. Edwards said, “I’ve been in the House of Delegates for 30 years, and you know me as a process person – a person who truly believes in the process and trying to follow the complexities of our election campaign.”

The lawsuit alleges that “this defamatory conduct was repeated the next day to more than 600 delegates just minutes prior to the casting of votes, when Dr Scott repeated these allegations.”

Dr. Edwards lost the election.
 

 

 

AMA: Nothing more to add

The suit alleges that neither the Election Campaign Committee nor the AMA itself has made any accusers or complaints available to Dr. Edwards and that it has not provided any audio or written evidence of her alleged violation.

In July, the AMA’s Southeastern delegation told its membership, “We continue to maintain that Willarda was ‘set up’ ... The whole affair lacked any reasonable semblance of due process.”

The delegation has filed a counter claim against the AMA seeking “to address this lack of due process as well as the reputational harm” to the delegation.

The AMA said that it has nothing it can produce. “The Speaker of the House presented a verbal report to the attending delegates,” said a spokesman. “The Speaker’s report remains the only remarks from an AMA officer, and no additional remarks can be expected at this time.”

He added that there “is no official transcript of the Speaker’s report.”

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

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‘Slugging’: A TikTok skin trend that has some merit

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They’ve been around for a while and show no signs of going away: videos on TikTok of people, often teens, slathering their face with petroleum jelly and claiming that it’s transformed their skin, cured their acne, or given them an amazing “glow up.”

Towfiqu Barbhuiya / EyeEm / Getty Images
Petroleum jelly

TikTok videos mentioning petrolatum increased by 46% and Instagram videos by 93% from 2021 to 2022, reported Gabriel Santos Malave, BA, of the Icahn School of Medicine at Mount Sinai, New York, and William D. James, MD, professor of dermatology, University of Pennsylvania, Philadelphia, in a review of petroleum jelly’s uses recently published in Cutis.

The authors said that Vaseline maker Unilever reports that mentions of the product increased by 327% on social media in 2022, primarily because of “slugging,” which involves smearing petroleum jelly on the face after application of a moisturizer.

In a typical demonstration, a dermatologist in the United Kingdom showed how she incorporates slugging into her routine in a TikTok video that’s had more than 1 million views.

Unlike many TikTok trends, slugging may not be entirely bad, say dermatologists.

“I think it’s a great way to keep your skin protected and moisturized, especially in those dry, cold winter months,” said dermatologist Mamina Turegano, MD, in a video posted in February 2022. That TikTok video has had more than 6 million views.

Dr. Turegano, who is in private practice in the New Orleans suburb of Metairie, La., told this news organization that she decided to post about slugging after she’d noticed that the topic was trending. Also, she had tried the technique herself when she was a resident in Washington more than a decade ago.

At the time, Dr. Turegano said that she was aware that “putting petroleum jelly on your face was not a normal thing.” But, given its history of being used in dermatology, she gave it a try and found that it worked well for her dry skin, she said.

Dr. Turegano is one among many dermatologists who have joined TikTok to dispel myths, educate, and inform. It’s important for them to be there “to engage and empower the public to become a better consumer of information out there and take ownership of their skin health,” said Jean McGee, MD, PhD, a dermatologist at Beth Israel Deaconess Medical Center, Boston, and assistant professor of dermatology at Harvard Medical School, also in Boston.

Dr. McGee and colleagues studied TikTok content on slugging and found that by far, videos that were created by health care providers were more educational. Dermatologists who posted were more likely to discuss the risks and benefits, whereas so-called “influencers” rarely posted on the risks, according to the study, published in Clinics in Dermatology.

Slugging is generally safe and effective for those who have a compromised skin barrier or “for those who have sensitive skin and can’t tolerate other products but need some form of moisturization,” said Dr. Turegano.

“Its oil-based nature allows it to seal water in the skin by creating a hydrophobic barrier that decreases transepidermal water loss (TEWL),” write Mr. Malave and Dr. James in Cutis. They note that petrolatum reduces TEWL by 98%, compared with only 20% to 30% for other oil-based moisturizers.

Dermatologists have often recommended a “seal and trap” regimen for dry skin or eczema. It involves a short, lukewarm shower, followed by immediately moisturizing with a petrolatum-based ointment, said Dr. McGee.

This could be safe for the face, but “other variables need to be considered,” including use of other topical medications and other skin care practices, she added.

The concept of double-layering a moisturizer and an occlusive agent can be beneficial but more typically for the hands and feet, where the skin can be severely dry and cracked, said Adam Friedman, MD, professor and chair of dermatology, George Washington University, Washington. “I would not recommend that on the face,” Dr. Friedman told this news organization.

He and other dermatologists warned about the potential for slugging – given petroleum jelly’s occlusive nature – to enhance the action of any topical steroid, retinol, or exfoliating agent.

Muneeb Shah, MD, who practices in Mooresville, N.C., is one of the most popular dermatologists on TikTok, with more than 17 million followers. He also warned in a February 2022 video about potential downsides. “Be careful after using retinol or exfoliating acids because it may actually irritate your skin more,” he says in the video.

“Slugging is awesome for some people but not for others, and not for every night,” said Whitney Bowe, MD, on a TikTok video she posted in July. She recommended it for eczema or really dry skin. Dr. Bowe, who practices with Advanced Dermatology in New York, advised those with acne-prone skin to “skip this trend.”

On a web page aimed at the general public, the American Academy of Dermatology similarly cautioned, “Avoid putting petroleum jelly on your face if you are acne-prone, as this may cause breakouts in some people.”
 

 

 

Acne cure or pore clogger?

And yet, plenty of TikTok users claim that it has improved their acne.

One such user posted a before and after video purporting to show that slugging had almost completely eliminated her acne and prior scarring. Not surprisingly, it has been viewed some 9 million times and got 1.5 million “likes.”

Dr. Friedman notes that it’s theoretically possible – but not likely – that acne could improve by slugging, given that acne basically is a disease of barrier disruption. “The idea here is you have disrupted skin barrier throughout the face regardless of whether you have a pimple in that spot or not, so you need to repair it,” he said. “That’s where I think slugging is somewhat on the right track, because by putting an occlusive agent on the skin, you are restoring the barrier element,” he said.

However, applying a thick, greasy ointment on the face could block pores and cause a backup of sebum and dead skin cells, and it could trap bacteria, he said. “Skin barrier protection and repair is central to acne management, but you need to do it in a safe way,” he said. He noted that that means applying an oil-free moisturizer to damp skin.

Dr. Turegano said she has seen slugging improve acne, but it’s hard to say which people with acne-prone skin would be the best candidates. Those who have used harsh products to treat acne and subsequently experienced worsening acne could potentially benefit, she said.

Even so, she said, “I’d be very cautious in anyone with acne.”

Dr. Friedman, Dr. McGee, and Dr. Turegano reported no relevant financial relationships.

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

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They’ve been around for a while and show no signs of going away: videos on TikTok of people, often teens, slathering their face with petroleum jelly and claiming that it’s transformed their skin, cured their acne, or given them an amazing “glow up.”

Towfiqu Barbhuiya / EyeEm / Getty Images
Petroleum jelly

TikTok videos mentioning petrolatum increased by 46% and Instagram videos by 93% from 2021 to 2022, reported Gabriel Santos Malave, BA, of the Icahn School of Medicine at Mount Sinai, New York, and William D. James, MD, professor of dermatology, University of Pennsylvania, Philadelphia, in a review of petroleum jelly’s uses recently published in Cutis.

The authors said that Vaseline maker Unilever reports that mentions of the product increased by 327% on social media in 2022, primarily because of “slugging,” which involves smearing petroleum jelly on the face after application of a moisturizer.

In a typical demonstration, a dermatologist in the United Kingdom showed how she incorporates slugging into her routine in a TikTok video that’s had more than 1 million views.

Unlike many TikTok trends, slugging may not be entirely bad, say dermatologists.

“I think it’s a great way to keep your skin protected and moisturized, especially in those dry, cold winter months,” said dermatologist Mamina Turegano, MD, in a video posted in February 2022. That TikTok video has had more than 6 million views.

Dr. Turegano, who is in private practice in the New Orleans suburb of Metairie, La., told this news organization that she decided to post about slugging after she’d noticed that the topic was trending. Also, she had tried the technique herself when she was a resident in Washington more than a decade ago.

At the time, Dr. Turegano said that she was aware that “putting petroleum jelly on your face was not a normal thing.” But, given its history of being used in dermatology, she gave it a try and found that it worked well for her dry skin, she said.

Dr. Turegano is one among many dermatologists who have joined TikTok to dispel myths, educate, and inform. It’s important for them to be there “to engage and empower the public to become a better consumer of information out there and take ownership of their skin health,” said Jean McGee, MD, PhD, a dermatologist at Beth Israel Deaconess Medical Center, Boston, and assistant professor of dermatology at Harvard Medical School, also in Boston.

Dr. McGee and colleagues studied TikTok content on slugging and found that by far, videos that were created by health care providers were more educational. Dermatologists who posted were more likely to discuss the risks and benefits, whereas so-called “influencers” rarely posted on the risks, according to the study, published in Clinics in Dermatology.

Slugging is generally safe and effective for those who have a compromised skin barrier or “for those who have sensitive skin and can’t tolerate other products but need some form of moisturization,” said Dr. Turegano.

“Its oil-based nature allows it to seal water in the skin by creating a hydrophobic barrier that decreases transepidermal water loss (TEWL),” write Mr. Malave and Dr. James in Cutis. They note that petrolatum reduces TEWL by 98%, compared with only 20% to 30% for other oil-based moisturizers.

Dermatologists have often recommended a “seal and trap” regimen for dry skin or eczema. It involves a short, lukewarm shower, followed by immediately moisturizing with a petrolatum-based ointment, said Dr. McGee.

This could be safe for the face, but “other variables need to be considered,” including use of other topical medications and other skin care practices, she added.

The concept of double-layering a moisturizer and an occlusive agent can be beneficial but more typically for the hands and feet, where the skin can be severely dry and cracked, said Adam Friedman, MD, professor and chair of dermatology, George Washington University, Washington. “I would not recommend that on the face,” Dr. Friedman told this news organization.

He and other dermatologists warned about the potential for slugging – given petroleum jelly’s occlusive nature – to enhance the action of any topical steroid, retinol, or exfoliating agent.

Muneeb Shah, MD, who practices in Mooresville, N.C., is one of the most popular dermatologists on TikTok, with more than 17 million followers. He also warned in a February 2022 video about potential downsides. “Be careful after using retinol or exfoliating acids because it may actually irritate your skin more,” he says in the video.

“Slugging is awesome for some people but not for others, and not for every night,” said Whitney Bowe, MD, on a TikTok video she posted in July. She recommended it for eczema or really dry skin. Dr. Bowe, who practices with Advanced Dermatology in New York, advised those with acne-prone skin to “skip this trend.”

On a web page aimed at the general public, the American Academy of Dermatology similarly cautioned, “Avoid putting petroleum jelly on your face if you are acne-prone, as this may cause breakouts in some people.”
 

 

 

Acne cure or pore clogger?

And yet, plenty of TikTok users claim that it has improved their acne.

One such user posted a before and after video purporting to show that slugging had almost completely eliminated her acne and prior scarring. Not surprisingly, it has been viewed some 9 million times and got 1.5 million “likes.”

Dr. Friedman notes that it’s theoretically possible – but not likely – that acne could improve by slugging, given that acne basically is a disease of barrier disruption. “The idea here is you have disrupted skin barrier throughout the face regardless of whether you have a pimple in that spot or not, so you need to repair it,” he said. “That’s where I think slugging is somewhat on the right track, because by putting an occlusive agent on the skin, you are restoring the barrier element,” he said.

However, applying a thick, greasy ointment on the face could block pores and cause a backup of sebum and dead skin cells, and it could trap bacteria, he said. “Skin barrier protection and repair is central to acne management, but you need to do it in a safe way,” he said. He noted that that means applying an oil-free moisturizer to damp skin.

Dr. Turegano said she has seen slugging improve acne, but it’s hard to say which people with acne-prone skin would be the best candidates. Those who have used harsh products to treat acne and subsequently experienced worsening acne could potentially benefit, she said.

Even so, she said, “I’d be very cautious in anyone with acne.”

Dr. Friedman, Dr. McGee, and Dr. Turegano reported no relevant financial relationships.

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

They’ve been around for a while and show no signs of going away: videos on TikTok of people, often teens, slathering their face with petroleum jelly and claiming that it’s transformed their skin, cured their acne, or given them an amazing “glow up.”

Towfiqu Barbhuiya / EyeEm / Getty Images
Petroleum jelly

TikTok videos mentioning petrolatum increased by 46% and Instagram videos by 93% from 2021 to 2022, reported Gabriel Santos Malave, BA, of the Icahn School of Medicine at Mount Sinai, New York, and William D. James, MD, professor of dermatology, University of Pennsylvania, Philadelphia, in a review of petroleum jelly’s uses recently published in Cutis.

The authors said that Vaseline maker Unilever reports that mentions of the product increased by 327% on social media in 2022, primarily because of “slugging,” which involves smearing petroleum jelly on the face after application of a moisturizer.

In a typical demonstration, a dermatologist in the United Kingdom showed how she incorporates slugging into her routine in a TikTok video that’s had more than 1 million views.

Unlike many TikTok trends, slugging may not be entirely bad, say dermatologists.

“I think it’s a great way to keep your skin protected and moisturized, especially in those dry, cold winter months,” said dermatologist Mamina Turegano, MD, in a video posted in February 2022. That TikTok video has had more than 6 million views.

Dr. Turegano, who is in private practice in the New Orleans suburb of Metairie, La., told this news organization that she decided to post about slugging after she’d noticed that the topic was trending. Also, she had tried the technique herself when she was a resident in Washington more than a decade ago.

At the time, Dr. Turegano said that she was aware that “putting petroleum jelly on your face was not a normal thing.” But, given its history of being used in dermatology, she gave it a try and found that it worked well for her dry skin, she said.

Dr. Turegano is one among many dermatologists who have joined TikTok to dispel myths, educate, and inform. It’s important for them to be there “to engage and empower the public to become a better consumer of information out there and take ownership of their skin health,” said Jean McGee, MD, PhD, a dermatologist at Beth Israel Deaconess Medical Center, Boston, and assistant professor of dermatology at Harvard Medical School, also in Boston.

Dr. McGee and colleagues studied TikTok content on slugging and found that by far, videos that were created by health care providers were more educational. Dermatologists who posted were more likely to discuss the risks and benefits, whereas so-called “influencers” rarely posted on the risks, according to the study, published in Clinics in Dermatology.

Slugging is generally safe and effective for those who have a compromised skin barrier or “for those who have sensitive skin and can’t tolerate other products but need some form of moisturization,” said Dr. Turegano.

“Its oil-based nature allows it to seal water in the skin by creating a hydrophobic barrier that decreases transepidermal water loss (TEWL),” write Mr. Malave and Dr. James in Cutis. They note that petrolatum reduces TEWL by 98%, compared with only 20% to 30% for other oil-based moisturizers.

Dermatologists have often recommended a “seal and trap” regimen for dry skin or eczema. It involves a short, lukewarm shower, followed by immediately moisturizing with a petrolatum-based ointment, said Dr. McGee.

This could be safe for the face, but “other variables need to be considered,” including use of other topical medications and other skin care practices, she added.

The concept of double-layering a moisturizer and an occlusive agent can be beneficial but more typically for the hands and feet, where the skin can be severely dry and cracked, said Adam Friedman, MD, professor and chair of dermatology, George Washington University, Washington. “I would not recommend that on the face,” Dr. Friedman told this news organization.

He and other dermatologists warned about the potential for slugging – given petroleum jelly’s occlusive nature – to enhance the action of any topical steroid, retinol, or exfoliating agent.

Muneeb Shah, MD, who practices in Mooresville, N.C., is one of the most popular dermatologists on TikTok, with more than 17 million followers. He also warned in a February 2022 video about potential downsides. “Be careful after using retinol or exfoliating acids because it may actually irritate your skin more,” he says in the video.

“Slugging is awesome for some people but not for others, and not for every night,” said Whitney Bowe, MD, on a TikTok video she posted in July. She recommended it for eczema or really dry skin. Dr. Bowe, who practices with Advanced Dermatology in New York, advised those with acne-prone skin to “skip this trend.”

On a web page aimed at the general public, the American Academy of Dermatology similarly cautioned, “Avoid putting petroleum jelly on your face if you are acne-prone, as this may cause breakouts in some people.”
 

 

 

Acne cure or pore clogger?

And yet, plenty of TikTok users claim that it has improved their acne.

One such user posted a before and after video purporting to show that slugging had almost completely eliminated her acne and prior scarring. Not surprisingly, it has been viewed some 9 million times and got 1.5 million “likes.”

Dr. Friedman notes that it’s theoretically possible – but not likely – that acne could improve by slugging, given that acne basically is a disease of barrier disruption. “The idea here is you have disrupted skin barrier throughout the face regardless of whether you have a pimple in that spot or not, so you need to repair it,” he said. “That’s where I think slugging is somewhat on the right track, because by putting an occlusive agent on the skin, you are restoring the barrier element,” he said.

However, applying a thick, greasy ointment on the face could block pores and cause a backup of sebum and dead skin cells, and it could trap bacteria, he said. “Skin barrier protection and repair is central to acne management, but you need to do it in a safe way,” he said. He noted that that means applying an oil-free moisturizer to damp skin.

Dr. Turegano said she has seen slugging improve acne, but it’s hard to say which people with acne-prone skin would be the best candidates. Those who have used harsh products to treat acne and subsequently experienced worsening acne could potentially benefit, she said.

Even so, she said, “I’d be very cautious in anyone with acne.”

Dr. Friedman, Dr. McGee, and Dr. Turegano reported no relevant financial relationships.

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

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Review gives weight to supplements for hair loss

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A systematic review of nutritional supplements for hair loss finds that a wide range of the products have potential but that the studies could not provide definitive evidence of safety and effectiveness because of small sample sizes, heterogeneity of hair loss types in study subjects, or other limitations.

The review, published online in JAMA Dermatology, notes that “Twelve of the 20 nutritional interventions had high-quality studies suggesting objectively evaluated effectiveness.”

It is “ground breaking,” in part because of its breadth and depth, said Eva Simmons-O’Brien, MD, a dermatologist in Towson, Md., who often recommends supplements for her patients with hair loss. “It basically kind of vindicates what some of us have been doing for a number of years in terms of treating hair loss,” she told this news organization. “It should hopefully make it more commonplace for dermatologists to consider using nutritional supplements as an adjuvant to treating hair loss,” added Dr. Simmons-O’Brien.

The review “is very helpful,” agreed Lynne J. Goldberg, MD, professor of dermatology and pathology and laboratory medicine at Boston University. Dr. Goldberg noted that many patients are already taking supplements and want to know whether they are safe and effective. The review “points out what the problems are; it talks about what the individual ingredients are and what they do, what the problems are; and it concluded that some people may find these helpful. Which is exactly what I tell my patients,” said Dr. Goldberg, who is also director of the Hair Clinic at Boston Medical Center.

Dr. Arash Mostaghimi

“For patients who are highly motivated and eager to try this, we’re hoping that this systematic review serves as a foundation to have a conversation,” study coauthor Arash Mostaghimi, MD, MPA, MPH, of the department of dermatology at Harvard Medical School, told this news organization. “When there’s medical uncertainty and the question is how much risk is one willing to take, the most important thing to do is to present the data and engage in shared decision-making with the patient,” noted Dr. Mostaghimi, who is also director of the inpatient dermatology consult service at Brigham and Women’s Hospital, Boston.
 

Surprising effectiveness

Going into the study, “we felt it would be likely that majority of nutritional supplements would either not be effective or not studied,” he said.

Dr. Mostaghimi and his coauthors conducted the study because so many patients take nutritional supplements to address hair loss, he said. An initial literature survey yielded more than 6,300 citations, but after screening and reviews, the authors included 30 articles for evaluation.

The review begins with a look at studies of saw palmetto (Serenoa repens), a botanical compound thought to inhibit the enzyme 5-alpha reductase (5AR), which converts testosterone to dihydroxytestosterone (DHT). DHT is a mediator of androgenic alopecia (AGA). The studies suggest that the compound might stabilize hair loss, “although its effect is likely less than that of finasteride,” write the authors. They also note that side effects associated with finasteride, such as sexual dysfunction, were also observed with saw palmetto “but to a lesser extent.”



For AGA, pumpkin seed oil may also be effective and a “potential alternative” to finasteride for AGA, and Forti5, a nutritional supplement that includes botanical 5AR inhibitors and other ingredients, had favorable effects in one study, the authors write. But neither has been compared to finasteride, and the Forti5 study lacked a control group.

The review also examines the micronutrients vitamin Dzinc, B vitamins, and antioxidants. Low levels of vitamin D have been associated with alopecia areata (AA), AGA, and telogen effluvium (TE) in some studies, and zinc deficiencies have been associated with TE, hair breakage, and thinning, according to the review. A single-arm vitamin D study showed improved results at 6 months for women with TE, but there was no control group and TE is self-resolving, the authors add. Studies in patients with normal zinc levels at baseline who had AA or hair loss showed significant hair regrowth and increased hair thickness and density, but the trials were a mishmash of controls and no controls and relied on self-perceived hair-loss data.

Larger more rigorous studies should be done to evaluate zinc’s effectiveness with AA, the authors comment.

Dr. Eva Simmons-O'Brien

Many patients take vitamin B7 (biotin) for hair loss. It has not been studied on its own but was an ingredient in some supplements in the review. Dr. Simmons-O’Brien said that biotin won’t result in new hair growth but that it can help strengthen the new hairs that grow as a result of other therapies. Both she and the study authors note that the Food and Drug Administration has warned against biotin supplementation because it can interfere with troponin and other test results.

The review also finds that immunomodulators –such as Chinese herbal extracts from paeony and glycyrrhizin – were effective in severe AA. Growth hormone modulators targeting deficiencies in insulin growth factor 1 or growth hormone are also promising. Studies of the modulators capsaicin and isoflavones – used topically – spurred hair growth, the authors write.

Products containing marine protein supplements, including Viviscal and Nourkrin, appeared effective in increasing hair counts in men and women, but the studies were funded by the manufacturer and were not well controlled. Side effects with Viviscal included bloating, according to the review.

The multi-ingredient supplements Nutrafol, Omni-Three, Apple Nutraceutical, and Lambdapil were also included in the review. Only Omni-Three showed no effectiveness, but studies of the other supplements had various limitations, including lack of controls and small sample sizes.
 

 

 

Complicated problem, multiple solutions

Given the many reasons for hair loss, multiple solutions are needed, the dermatologists note.

Dr. Mostaghimi said that he’s still a bit skeptical that supplements work as consistently as described or as well as described, given that he and his coauthors were unable to find any negative studies. In talking with patients who are taking supplements, he said that his first aim is to make sure they are safe. At least the supplements in the review have been studied for safety, he added.

He will encourage replacement of vitamin D or zinc or other vitamins or minerals if patients are deficient but said that he does not “actively encourage supplementation.”

Dr. Simmons-O’Brien said that, when evaluating patients with hair loss, she orders lab tests to determine whether the patient has anemia or a thyroid issue or deficiencies in vitamins or minerals or other nutritional deficiencies, asks about diet and styling practices, and takes a scalp biopsy. It is not uncommon to recommend supplementation on the basis of those findings, she added.

Dr. Lynne Goldberg

“As a hair-loss specialist, my job is to treat the patient at their level, in their framework, in their comfort zone,” said Dr. Goldberg. Some patients don’t want to take medications for hair loss, so she might recommend supplements in those cases but tells patients that they aren’t well studied.

She added that it can be hard to tell whether a supplement is working, particularly if it has multiple ingredients.

Dr. Mostaghimi reported consulting fees from Pfizer, Concert, Lilly, Hims and Hers, Equillium, AbbVie, Digital Diagnostics, and Bioniz and grants from Pfizer, all outside the submitted work. In addition, Dr. Mostaghimi disclosed that he is an associate editor of JAMA Dermatology but was not involved in any of the decisions regarding the review of the manuscript or its acceptance. No other disclosures were reported by the other study authors. Dr. Goldberg reported no disclosures. Dr. Simmons-O›Brien is a medical consultant for Isdin, but not for hair products.

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

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A systematic review of nutritional supplements for hair loss finds that a wide range of the products have potential but that the studies could not provide definitive evidence of safety and effectiveness because of small sample sizes, heterogeneity of hair loss types in study subjects, or other limitations.

The review, published online in JAMA Dermatology, notes that “Twelve of the 20 nutritional interventions had high-quality studies suggesting objectively evaluated effectiveness.”

It is “ground breaking,” in part because of its breadth and depth, said Eva Simmons-O’Brien, MD, a dermatologist in Towson, Md., who often recommends supplements for her patients with hair loss. “It basically kind of vindicates what some of us have been doing for a number of years in terms of treating hair loss,” she told this news organization. “It should hopefully make it more commonplace for dermatologists to consider using nutritional supplements as an adjuvant to treating hair loss,” added Dr. Simmons-O’Brien.

The review “is very helpful,” agreed Lynne J. Goldberg, MD, professor of dermatology and pathology and laboratory medicine at Boston University. Dr. Goldberg noted that many patients are already taking supplements and want to know whether they are safe and effective. The review “points out what the problems are; it talks about what the individual ingredients are and what they do, what the problems are; and it concluded that some people may find these helpful. Which is exactly what I tell my patients,” said Dr. Goldberg, who is also director of the Hair Clinic at Boston Medical Center.

Dr. Arash Mostaghimi

“For patients who are highly motivated and eager to try this, we’re hoping that this systematic review serves as a foundation to have a conversation,” study coauthor Arash Mostaghimi, MD, MPA, MPH, of the department of dermatology at Harvard Medical School, told this news organization. “When there’s medical uncertainty and the question is how much risk is one willing to take, the most important thing to do is to present the data and engage in shared decision-making with the patient,” noted Dr. Mostaghimi, who is also director of the inpatient dermatology consult service at Brigham and Women’s Hospital, Boston.
 

Surprising effectiveness

Going into the study, “we felt it would be likely that majority of nutritional supplements would either not be effective or not studied,” he said.

Dr. Mostaghimi and his coauthors conducted the study because so many patients take nutritional supplements to address hair loss, he said. An initial literature survey yielded more than 6,300 citations, but after screening and reviews, the authors included 30 articles for evaluation.

The review begins with a look at studies of saw palmetto (Serenoa repens), a botanical compound thought to inhibit the enzyme 5-alpha reductase (5AR), which converts testosterone to dihydroxytestosterone (DHT). DHT is a mediator of androgenic alopecia (AGA). The studies suggest that the compound might stabilize hair loss, “although its effect is likely less than that of finasteride,” write the authors. They also note that side effects associated with finasteride, such as sexual dysfunction, were also observed with saw palmetto “but to a lesser extent.”



For AGA, pumpkin seed oil may also be effective and a “potential alternative” to finasteride for AGA, and Forti5, a nutritional supplement that includes botanical 5AR inhibitors and other ingredients, had favorable effects in one study, the authors write. But neither has been compared to finasteride, and the Forti5 study lacked a control group.

The review also examines the micronutrients vitamin Dzinc, B vitamins, and antioxidants. Low levels of vitamin D have been associated with alopecia areata (AA), AGA, and telogen effluvium (TE) in some studies, and zinc deficiencies have been associated with TE, hair breakage, and thinning, according to the review. A single-arm vitamin D study showed improved results at 6 months for women with TE, but there was no control group and TE is self-resolving, the authors add. Studies in patients with normal zinc levels at baseline who had AA or hair loss showed significant hair regrowth and increased hair thickness and density, but the trials were a mishmash of controls and no controls and relied on self-perceived hair-loss data.

Larger more rigorous studies should be done to evaluate zinc’s effectiveness with AA, the authors comment.

Dr. Eva Simmons-O'Brien

Many patients take vitamin B7 (biotin) for hair loss. It has not been studied on its own but was an ingredient in some supplements in the review. Dr. Simmons-O’Brien said that biotin won’t result in new hair growth but that it can help strengthen the new hairs that grow as a result of other therapies. Both she and the study authors note that the Food and Drug Administration has warned against biotin supplementation because it can interfere with troponin and other test results.

The review also finds that immunomodulators –such as Chinese herbal extracts from paeony and glycyrrhizin – were effective in severe AA. Growth hormone modulators targeting deficiencies in insulin growth factor 1 or growth hormone are also promising. Studies of the modulators capsaicin and isoflavones – used topically – spurred hair growth, the authors write.

Products containing marine protein supplements, including Viviscal and Nourkrin, appeared effective in increasing hair counts in men and women, but the studies were funded by the manufacturer and were not well controlled. Side effects with Viviscal included bloating, according to the review.

The multi-ingredient supplements Nutrafol, Omni-Three, Apple Nutraceutical, and Lambdapil were also included in the review. Only Omni-Three showed no effectiveness, but studies of the other supplements had various limitations, including lack of controls and small sample sizes.
 

 

 

Complicated problem, multiple solutions

Given the many reasons for hair loss, multiple solutions are needed, the dermatologists note.

Dr. Mostaghimi said that he’s still a bit skeptical that supplements work as consistently as described or as well as described, given that he and his coauthors were unable to find any negative studies. In talking with patients who are taking supplements, he said that his first aim is to make sure they are safe. At least the supplements in the review have been studied for safety, he added.

He will encourage replacement of vitamin D or zinc or other vitamins or minerals if patients are deficient but said that he does not “actively encourage supplementation.”

Dr. Simmons-O’Brien said that, when evaluating patients with hair loss, she orders lab tests to determine whether the patient has anemia or a thyroid issue or deficiencies in vitamins or minerals or other nutritional deficiencies, asks about diet and styling practices, and takes a scalp biopsy. It is not uncommon to recommend supplementation on the basis of those findings, she added.

Dr. Lynne Goldberg

“As a hair-loss specialist, my job is to treat the patient at their level, in their framework, in their comfort zone,” said Dr. Goldberg. Some patients don’t want to take medications for hair loss, so she might recommend supplements in those cases but tells patients that they aren’t well studied.

She added that it can be hard to tell whether a supplement is working, particularly if it has multiple ingredients.

Dr. Mostaghimi reported consulting fees from Pfizer, Concert, Lilly, Hims and Hers, Equillium, AbbVie, Digital Diagnostics, and Bioniz and grants from Pfizer, all outside the submitted work. In addition, Dr. Mostaghimi disclosed that he is an associate editor of JAMA Dermatology but was not involved in any of the decisions regarding the review of the manuscript or its acceptance. No other disclosures were reported by the other study authors. Dr. Goldberg reported no disclosures. Dr. Simmons-O›Brien is a medical consultant for Isdin, but not for hair products.

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

A systematic review of nutritional supplements for hair loss finds that a wide range of the products have potential but that the studies could not provide definitive evidence of safety and effectiveness because of small sample sizes, heterogeneity of hair loss types in study subjects, or other limitations.

The review, published online in JAMA Dermatology, notes that “Twelve of the 20 nutritional interventions had high-quality studies suggesting objectively evaluated effectiveness.”

It is “ground breaking,” in part because of its breadth and depth, said Eva Simmons-O’Brien, MD, a dermatologist in Towson, Md., who often recommends supplements for her patients with hair loss. “It basically kind of vindicates what some of us have been doing for a number of years in terms of treating hair loss,” she told this news organization. “It should hopefully make it more commonplace for dermatologists to consider using nutritional supplements as an adjuvant to treating hair loss,” added Dr. Simmons-O’Brien.

The review “is very helpful,” agreed Lynne J. Goldberg, MD, professor of dermatology and pathology and laboratory medicine at Boston University. Dr. Goldberg noted that many patients are already taking supplements and want to know whether they are safe and effective. The review “points out what the problems are; it talks about what the individual ingredients are and what they do, what the problems are; and it concluded that some people may find these helpful. Which is exactly what I tell my patients,” said Dr. Goldberg, who is also director of the Hair Clinic at Boston Medical Center.

Dr. Arash Mostaghimi

“For patients who are highly motivated and eager to try this, we’re hoping that this systematic review serves as a foundation to have a conversation,” study coauthor Arash Mostaghimi, MD, MPA, MPH, of the department of dermatology at Harvard Medical School, told this news organization. “When there’s medical uncertainty and the question is how much risk is one willing to take, the most important thing to do is to present the data and engage in shared decision-making with the patient,” noted Dr. Mostaghimi, who is also director of the inpatient dermatology consult service at Brigham and Women’s Hospital, Boston.
 

Surprising effectiveness

Going into the study, “we felt it would be likely that majority of nutritional supplements would either not be effective or not studied,” he said.

Dr. Mostaghimi and his coauthors conducted the study because so many patients take nutritional supplements to address hair loss, he said. An initial literature survey yielded more than 6,300 citations, but after screening and reviews, the authors included 30 articles for evaluation.

The review begins with a look at studies of saw palmetto (Serenoa repens), a botanical compound thought to inhibit the enzyme 5-alpha reductase (5AR), which converts testosterone to dihydroxytestosterone (DHT). DHT is a mediator of androgenic alopecia (AGA). The studies suggest that the compound might stabilize hair loss, “although its effect is likely less than that of finasteride,” write the authors. They also note that side effects associated with finasteride, such as sexual dysfunction, were also observed with saw palmetto “but to a lesser extent.”



For AGA, pumpkin seed oil may also be effective and a “potential alternative” to finasteride for AGA, and Forti5, a nutritional supplement that includes botanical 5AR inhibitors and other ingredients, had favorable effects in one study, the authors write. But neither has been compared to finasteride, and the Forti5 study lacked a control group.

The review also examines the micronutrients vitamin Dzinc, B vitamins, and antioxidants. Low levels of vitamin D have been associated with alopecia areata (AA), AGA, and telogen effluvium (TE) in some studies, and zinc deficiencies have been associated with TE, hair breakage, and thinning, according to the review. A single-arm vitamin D study showed improved results at 6 months for women with TE, but there was no control group and TE is self-resolving, the authors add. Studies in patients with normal zinc levels at baseline who had AA or hair loss showed significant hair regrowth and increased hair thickness and density, but the trials were a mishmash of controls and no controls and relied on self-perceived hair-loss data.

Larger more rigorous studies should be done to evaluate zinc’s effectiveness with AA, the authors comment.

Dr. Eva Simmons-O'Brien

Many patients take vitamin B7 (biotin) for hair loss. It has not been studied on its own but was an ingredient in some supplements in the review. Dr. Simmons-O’Brien said that biotin won’t result in new hair growth but that it can help strengthen the new hairs that grow as a result of other therapies. Both she and the study authors note that the Food and Drug Administration has warned against biotin supplementation because it can interfere with troponin and other test results.

The review also finds that immunomodulators –such as Chinese herbal extracts from paeony and glycyrrhizin – were effective in severe AA. Growth hormone modulators targeting deficiencies in insulin growth factor 1 or growth hormone are also promising. Studies of the modulators capsaicin and isoflavones – used topically – spurred hair growth, the authors write.

Products containing marine protein supplements, including Viviscal and Nourkrin, appeared effective in increasing hair counts in men and women, but the studies were funded by the manufacturer and were not well controlled. Side effects with Viviscal included bloating, according to the review.

The multi-ingredient supplements Nutrafol, Omni-Three, Apple Nutraceutical, and Lambdapil were also included in the review. Only Omni-Three showed no effectiveness, but studies of the other supplements had various limitations, including lack of controls and small sample sizes.
 

 

 

Complicated problem, multiple solutions

Given the many reasons for hair loss, multiple solutions are needed, the dermatologists note.

Dr. Mostaghimi said that he’s still a bit skeptical that supplements work as consistently as described or as well as described, given that he and his coauthors were unable to find any negative studies. In talking with patients who are taking supplements, he said that his first aim is to make sure they are safe. At least the supplements in the review have been studied for safety, he added.

He will encourage replacement of vitamin D or zinc or other vitamins or minerals if patients are deficient but said that he does not “actively encourage supplementation.”

Dr. Simmons-O’Brien said that, when evaluating patients with hair loss, she orders lab tests to determine whether the patient has anemia or a thyroid issue or deficiencies in vitamins or minerals or other nutritional deficiencies, asks about diet and styling practices, and takes a scalp biopsy. It is not uncommon to recommend supplementation on the basis of those findings, she added.

Dr. Lynne Goldberg

“As a hair-loss specialist, my job is to treat the patient at their level, in their framework, in their comfort zone,” said Dr. Goldberg. Some patients don’t want to take medications for hair loss, so she might recommend supplements in those cases but tells patients that they aren’t well studied.

She added that it can be hard to tell whether a supplement is working, particularly if it has multiple ingredients.

Dr. Mostaghimi reported consulting fees from Pfizer, Concert, Lilly, Hims and Hers, Equillium, AbbVie, Digital Diagnostics, and Bioniz and grants from Pfizer, all outside the submitted work. In addition, Dr. Mostaghimi disclosed that he is an associate editor of JAMA Dermatology but was not involved in any of the decisions regarding the review of the manuscript or its acceptance. No other disclosures were reported by the other study authors. Dr. Goldberg reported no disclosures. Dr. Simmons-O›Brien is a medical consultant for Isdin, but not for hair products.

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

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Dermatologists embrace low-dose oral minoxidil as hair loss adjunctive therapy

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It’s not a new drug – it’s been available in topical form for hair loss since 1988 and was approved as an antihypertensive in 1979 – but a low-dose oral form of minoxidil is gaining new currency – and a growing public profile – as an adjunctive therapy for hair loss.

The number of scholarly publications examining its use for hair loss has grown dramatically in the last 2 years: There were 2 in 2019, and that jumped to 17 in 2020 and 20 in 2021, with another 16 published so far this year, according to a PubMed search. An August article in The New York Times touting it as a potential cheap magic bullet is likely to drum up even more interest, said dermatologists.

The low-dose formulation is especially exciting for women, as there have been few great oral options for them, clinicians said.

Female hair loss “is devastating,” said Lily Talakoub, MD, adding that topical minoxidil (Rogaine), topical serums, and supplements “really do not provide the considerable growth that women really want to see.” Oral minoxidil is not approved by the U.S. Food and Drug Administration for hair loss, but “it has been shown in studies to cause the hairs to grow,” and has become a “lifeline” for women, said Dr. Talakoub, a dermatologist who is in private practice in McLean, Va.

“For many years we haven’t had anything new to tell patients medically,” said Lynne J. Goldberg, MD, professor of dermatology and pathology at Boston University School of Medicine. “Now, all of the sudden there’s a cheap, widely available efficacious medicine. That’s huge for female-pattern hair loss,” said Dr. Goldberg, who is also the director of the Boston Medical Center’s Hair Clinic.

“I’ve been using oral minoxidil for about 4 years with great success,” said dermatologist Eva Simmons-O’Brien, MD, who is in private practice in Towson, Md. She has used it primarily in women, mainly because she sees more women than men for hair loss.

Dr. Simmons-O’Brien said the excitement about low-dose oral minoxidil follows an increasing recognition in the medical and scientific community that hair loss is more than just a cosmetic issue.
 

Mechanism not fully understood

When minoxidil was first brought to market as an antihypertensive, clinicians noted hair growth in “balding patients,” which led to the development of the topical form. Even though it has been used for hair growth for decades, its mechanism of action is not fully understood. It is known that minoxidil is a vasodilator; it may also increase DNA synthesis and enhance cell proliferation, according to a review published in 2019.

“The positive effect of minoxidil on hair growth is mainly due to its metabolite, minoxidil sulfate, and the enzyme responsible for this conversion is sulfotransferase, which is located in hair follicles and varies in production among individuals,” write the authors, all affiliated with Mahidol University in Bangkok, Thailand.

Writing in the American Academy of Dermatology’s Dermatology World Insights and Inquiries, Warren R. Heymann, MD, observed that “even after decades of use,” how minoxidil improves alopecia is still not completely understood. He noted that a 2020 review found that minoxidil’s vasodilatory effects “are propagated by upregulation of vascular endothelial growth factor (VEGF), increasing cutaneous blood flow with resultant increase in oxygen and growth factor delivery to the hair follicle.” The medication prolongs the anagen phase and shortens the telogen phase, added Dr. Heymann, head of dermatology at Rowan University, Camden, N.J.

As an antihypertensive, minoxidil is given at 5-40 mg daily. Those doses have produced serious side effects such as sodium and fluid retention, ischemic heart disease, pericardial effusion, and pulmonary hypertension, according to the Thai researchers.

Those side effects have appeared to be rare with low-dose oral minoxidil. However, in JAAD Case Reports, South African researchers reported a case in which low-dose oral minoxidil may have led to cardiac side effects. A healthy 40-year-old woman, who after 3 weeks of treatment with 5% topical minoxidil, tacrolimus ointment 0.1%, clobetasol propionate ointment, 100 mg of doxycycline twice daily, and 0.25 mg of oral minoxidil daily, was hospitalized with full-body edema. An ultrasound showed fluid collections in the pericardium, pleural space, and abdomen. She also had a pleural effusion. The patient was given 40 mg of intravenous furosemide daily for 4 days, and the edema resolved.

“Having excluded other causes of pericardial effusion and anasarca in the previously healthy, young woman, we concluded that LDOM [low-dose oral minoxidil] was responsible for her clinical presentation,” write the authors.

review of 17 studies published on-line in 2020 in the Journal of the American Academy of Dermatology found low-dose minoxidil to be safe and effective. Androgenetic alopecia was the most commonly studied, with doses of 0.25-1.25 mg proving to be effective and safe. It was also safe and effective for female-pattern hair loss, traction alopecia, chronic telogen effluvium, lichen planopilaris, alopecia areata, and permanent chemotherapy-induced alopecia.

The most common adverse effect was hypertrichosis. Other adverse events included postural hypotension and dizziness, lower-limb edema, and mild blood pressure changes.

In another multicenter, 1,404-patient safety study published in 2021 in JAAD, the authors found that hypertrichosis was the most frequent adverse event, reported by 15% of patients. Systemic adverse events included lightheadedness (1.7% of patients), fluid retention (1.3%), tachycardia (0.9%), headache (0.4%), periorbital edema (0.3%), and insomnia (0.2%). Only 29 patients (1.2%) withdrew because of these side effects.

“It definitely helps, and it’s relatively safe,” said Adam Friedman, MD, professor and chair of dermatology at George Washington University in Washington. “But I wouldn’t want to call it a game-changer,” he said, adding that it works best when used in combination with other therapies. He often uses it with a 5-alpha reductase inhibitor – finasteride (Propecia) or dutasteride (Avodart) – “rather than as a monotherapy,” said Dr. Friedman.
 

 

 

From Australia to around the globe

The first publication on low-dose oral minoxidil for hair loss was in December 2017. The pilot study in female-pattern hair loss was published in the International Journal of Dermatology by Rodney Sinclair, MBBS, MD, a Melbourne, Australia–based dermatologist.

Amy McMichael, MD, professor of dermatology at Wake Forest University, Winston-Salem, N.C., said she first heard Dr. Sinclair present his findings at an alopecia research meeting in Japan shortly before his initial publication.

“After that, I think all of us said, ‘Huh, this is interesting, and let’s try it, because we’re always looking for something more to help our patients,’” Dr. McMichael said, adding that she’s been prescribing low-dose minoxidil to her patients for 5 years.

She and colleagues at Wake Forest, along with Jerry Cooley, MD, a dermatologist in private practice in Charlotte, published a retrospective case series in March, looking at 105 adult patients – 80 women (ages 24-80) and 25 men (ages 19-63) – who were treated for androgenetic alopecia and/or telogen effluvium with oral minoxidil (dose range of 0.625–2.5 mg) once daily for a year, matched to 105 case controls.

Efficacy was based on the clinician’s assessment of clinical response and clinical photographic evaluation using a 3-point scale (worsening, stabilization, and improvement). Half of those treated demonstrated clinical improvement and 43% demonstrated stabilization. There was a significant difference (P < .001) in clinical response between those who received minoxidil and the controls.

Ideal patients?

Given its ease of use and low cost – $4-$12 for a 30-day supply of 2.5 mg tablets, according to GoodRX – low-dose minoxidil is a good fit for many patients, said dermatologists.

The best candidate is “a woman who’s perimenopausal or menopausal who’s got what we would say is moderate to severe loss of hair that’s kind of just starting,” said Dr. Simmons-O’Brien. The medication is not likely to grow hair where there is scarring already, however, she said.

“I tend to use it in people who either don’t want to do the topical minoxidil or have used it and have a lot of potential side effects from it,” like itching and irritation, said Dr. McMichael. She said oral minoxidil can also be helpful as an adjunct in patients with alopecia areata and that it can be used after anti-inflammatory treatments in central centrifugal cicatricial alopecia.

Dr. Goldberg said low-dose minoxidil would not be her first choice for female-pattern hair loss but that it’s “a great alternative” for people who can’t tolerate the topical form. Most of the women she has prescribed it to “have been pretty happy,” she added.

“I would be a little cautious in patients on a number of other medications,” Dr. Goldberg said, noting minoxidil’s potential systemic side effects.

Clinicians said they generally consult with a patient’s internist when they are starting them on oral minoxidil. “I always want to touch base with the primary care physician first,” said Dr. Friedman.

“If they’re on oral antihypertensive medications already, then I would ask them to talk to either their primary care physician or their cardiologist to make sure it’s okay to give this low dose,” said Dr. McMichael.

At the low doses, minoxidil rarely has any blood pressure–lowering effects, dermatologists said.

Women are usually started on 1.25 mg, while men can start at a higher, 2.5-mg dose, said clinicians.

Dr. Goldberg and Dr. Simmons-O’Brien said that recent additional warnings for finasteride about sexual side effects and the potential for suicide have changed the way they approach its use in young men, and that it has highlighted the potential for oral minoxidil as an alternative.

Oral minoxidil is rarely used as a monotherapy. “It takes a village” to address hair loss, said Dr. Simmons-O’Brien, noting that she likes to evaluate nutrition, vitamin D levels, and whether a patient is anemic or has thyroid disease when determining a course of action.

Dermatologists said they use oral minoxidil in combination with spironolactone, topical minoxidil, finasteride, or dutasteride. If patients are already on antihypertensives or at risk for excessive blood pressure–lowering effects of a combination that includes spironolactone, the dermatologists said again they will consult with a patient’s primary care physician first.

For women, the main limiting factor with oral minoxidil may be unwanted hair growth, usually on the face. Most of the clinicians interviewed for this story said they did not use spironolactone to counteract that hypertrichosis.

Dr. McMichael said she cautions African American women or women of African descent – who tend to have more body hair at baseline – that they should be aware of the potential for excess hair growth associated with low-dose minoxidil. She and other dermatologists interviewed for this story said they urge patients who are bothered by the excess hair to shave or wax or use other nonpharmacologic approaches.

The excess hair growth is less bothersome for men, they said.
 

 

 

Not a magic wand

Despite the increased profile and interest, oral minoxidil is not a cure-all, clinicians said.

“It’s important for patients to realize that hair loss can be complicated and there is no one magic wand,” said Dr. Simmons-O’Brien. Clinicians typically “are using several things to help encourage these follicular units to not miniaturize and disappear and create scars,” she said.

Dr. Friedman said he finds that patients have a hard time hearing that to continue to maintain growth, they have to take a medication for the rest of their life. “If you stop, you will have to start again,” he said. 

Oral minoxidil, when used in combination with other therapies, will improve hair growth, said Dr. Goldberg. But it will not take someone back a decade, she said. “I try to temper expectations – promise a little and achieve more,” Dr. Goldberg said.

The study was independently supported. Dr. Smith and Dr. Jones report no relevant financial relationships. Dr. Simmons-O’Brien reports that she has received speaking fees from Isdin. Dr. McMichael disclosed relationships with Eli Lilly, Pfizer, Nutrafol, Revian, and UCB Pharma. Dr. Friedman, Dr. Goldberg, and Dr. Talakoub reported no disclosures.

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

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It’s not a new drug – it’s been available in topical form for hair loss since 1988 and was approved as an antihypertensive in 1979 – but a low-dose oral form of minoxidil is gaining new currency – and a growing public profile – as an adjunctive therapy for hair loss.

The number of scholarly publications examining its use for hair loss has grown dramatically in the last 2 years: There were 2 in 2019, and that jumped to 17 in 2020 and 20 in 2021, with another 16 published so far this year, according to a PubMed search. An August article in The New York Times touting it as a potential cheap magic bullet is likely to drum up even more interest, said dermatologists.

The low-dose formulation is especially exciting for women, as there have been few great oral options for them, clinicians said.

Female hair loss “is devastating,” said Lily Talakoub, MD, adding that topical minoxidil (Rogaine), topical serums, and supplements “really do not provide the considerable growth that women really want to see.” Oral minoxidil is not approved by the U.S. Food and Drug Administration for hair loss, but “it has been shown in studies to cause the hairs to grow,” and has become a “lifeline” for women, said Dr. Talakoub, a dermatologist who is in private practice in McLean, Va.

“For many years we haven’t had anything new to tell patients medically,” said Lynne J. Goldberg, MD, professor of dermatology and pathology at Boston University School of Medicine. “Now, all of the sudden there’s a cheap, widely available efficacious medicine. That’s huge for female-pattern hair loss,” said Dr. Goldberg, who is also the director of the Boston Medical Center’s Hair Clinic.

“I’ve been using oral minoxidil for about 4 years with great success,” said dermatologist Eva Simmons-O’Brien, MD, who is in private practice in Towson, Md. She has used it primarily in women, mainly because she sees more women than men for hair loss.

Dr. Simmons-O’Brien said the excitement about low-dose oral minoxidil follows an increasing recognition in the medical and scientific community that hair loss is more than just a cosmetic issue.
 

Mechanism not fully understood

When minoxidil was first brought to market as an antihypertensive, clinicians noted hair growth in “balding patients,” which led to the development of the topical form. Even though it has been used for hair growth for decades, its mechanism of action is not fully understood. It is known that minoxidil is a vasodilator; it may also increase DNA synthesis and enhance cell proliferation, according to a review published in 2019.

“The positive effect of minoxidil on hair growth is mainly due to its metabolite, minoxidil sulfate, and the enzyme responsible for this conversion is sulfotransferase, which is located in hair follicles and varies in production among individuals,” write the authors, all affiliated with Mahidol University in Bangkok, Thailand.

Writing in the American Academy of Dermatology’s Dermatology World Insights and Inquiries, Warren R. Heymann, MD, observed that “even after decades of use,” how minoxidil improves alopecia is still not completely understood. He noted that a 2020 review found that minoxidil’s vasodilatory effects “are propagated by upregulation of vascular endothelial growth factor (VEGF), increasing cutaneous blood flow with resultant increase in oxygen and growth factor delivery to the hair follicle.” The medication prolongs the anagen phase and shortens the telogen phase, added Dr. Heymann, head of dermatology at Rowan University, Camden, N.J.

As an antihypertensive, minoxidil is given at 5-40 mg daily. Those doses have produced serious side effects such as sodium and fluid retention, ischemic heart disease, pericardial effusion, and pulmonary hypertension, according to the Thai researchers.

Those side effects have appeared to be rare with low-dose oral minoxidil. However, in JAAD Case Reports, South African researchers reported a case in which low-dose oral minoxidil may have led to cardiac side effects. A healthy 40-year-old woman, who after 3 weeks of treatment with 5% topical minoxidil, tacrolimus ointment 0.1%, clobetasol propionate ointment, 100 mg of doxycycline twice daily, and 0.25 mg of oral minoxidil daily, was hospitalized with full-body edema. An ultrasound showed fluid collections in the pericardium, pleural space, and abdomen. She also had a pleural effusion. The patient was given 40 mg of intravenous furosemide daily for 4 days, and the edema resolved.

“Having excluded other causes of pericardial effusion and anasarca in the previously healthy, young woman, we concluded that LDOM [low-dose oral minoxidil] was responsible for her clinical presentation,” write the authors.

review of 17 studies published on-line in 2020 in the Journal of the American Academy of Dermatology found low-dose minoxidil to be safe and effective. Androgenetic alopecia was the most commonly studied, with doses of 0.25-1.25 mg proving to be effective and safe. It was also safe and effective for female-pattern hair loss, traction alopecia, chronic telogen effluvium, lichen planopilaris, alopecia areata, and permanent chemotherapy-induced alopecia.

The most common adverse effect was hypertrichosis. Other adverse events included postural hypotension and dizziness, lower-limb edema, and mild blood pressure changes.

In another multicenter, 1,404-patient safety study published in 2021 in JAAD, the authors found that hypertrichosis was the most frequent adverse event, reported by 15% of patients. Systemic adverse events included lightheadedness (1.7% of patients), fluid retention (1.3%), tachycardia (0.9%), headache (0.4%), periorbital edema (0.3%), and insomnia (0.2%). Only 29 patients (1.2%) withdrew because of these side effects.

“It definitely helps, and it’s relatively safe,” said Adam Friedman, MD, professor and chair of dermatology at George Washington University in Washington. “But I wouldn’t want to call it a game-changer,” he said, adding that it works best when used in combination with other therapies. He often uses it with a 5-alpha reductase inhibitor – finasteride (Propecia) or dutasteride (Avodart) – “rather than as a monotherapy,” said Dr. Friedman.
 

 

 

From Australia to around the globe

The first publication on low-dose oral minoxidil for hair loss was in December 2017. The pilot study in female-pattern hair loss was published in the International Journal of Dermatology by Rodney Sinclair, MBBS, MD, a Melbourne, Australia–based dermatologist.

Amy McMichael, MD, professor of dermatology at Wake Forest University, Winston-Salem, N.C., said she first heard Dr. Sinclair present his findings at an alopecia research meeting in Japan shortly before his initial publication.

“After that, I think all of us said, ‘Huh, this is interesting, and let’s try it, because we’re always looking for something more to help our patients,’” Dr. McMichael said, adding that she’s been prescribing low-dose minoxidil to her patients for 5 years.

She and colleagues at Wake Forest, along with Jerry Cooley, MD, a dermatologist in private practice in Charlotte, published a retrospective case series in March, looking at 105 adult patients – 80 women (ages 24-80) and 25 men (ages 19-63) – who were treated for androgenetic alopecia and/or telogen effluvium with oral minoxidil (dose range of 0.625–2.5 mg) once daily for a year, matched to 105 case controls.

Efficacy was based on the clinician’s assessment of clinical response and clinical photographic evaluation using a 3-point scale (worsening, stabilization, and improvement). Half of those treated demonstrated clinical improvement and 43% demonstrated stabilization. There was a significant difference (P < .001) in clinical response between those who received minoxidil and the controls.

Ideal patients?

Given its ease of use and low cost – $4-$12 for a 30-day supply of 2.5 mg tablets, according to GoodRX – low-dose minoxidil is a good fit for many patients, said dermatologists.

The best candidate is “a woman who’s perimenopausal or menopausal who’s got what we would say is moderate to severe loss of hair that’s kind of just starting,” said Dr. Simmons-O’Brien. The medication is not likely to grow hair where there is scarring already, however, she said.

“I tend to use it in people who either don’t want to do the topical minoxidil or have used it and have a lot of potential side effects from it,” like itching and irritation, said Dr. McMichael. She said oral minoxidil can also be helpful as an adjunct in patients with alopecia areata and that it can be used after anti-inflammatory treatments in central centrifugal cicatricial alopecia.

Dr. Goldberg said low-dose minoxidil would not be her first choice for female-pattern hair loss but that it’s “a great alternative” for people who can’t tolerate the topical form. Most of the women she has prescribed it to “have been pretty happy,” she added.

“I would be a little cautious in patients on a number of other medications,” Dr. Goldberg said, noting minoxidil’s potential systemic side effects.

Clinicians said they generally consult with a patient’s internist when they are starting them on oral minoxidil. “I always want to touch base with the primary care physician first,” said Dr. Friedman.

“If they’re on oral antihypertensive medications already, then I would ask them to talk to either their primary care physician or their cardiologist to make sure it’s okay to give this low dose,” said Dr. McMichael.

At the low doses, minoxidil rarely has any blood pressure–lowering effects, dermatologists said.

Women are usually started on 1.25 mg, while men can start at a higher, 2.5-mg dose, said clinicians.

Dr. Goldberg and Dr. Simmons-O’Brien said that recent additional warnings for finasteride about sexual side effects and the potential for suicide have changed the way they approach its use in young men, and that it has highlighted the potential for oral minoxidil as an alternative.

Oral minoxidil is rarely used as a monotherapy. “It takes a village” to address hair loss, said Dr. Simmons-O’Brien, noting that she likes to evaluate nutrition, vitamin D levels, and whether a patient is anemic or has thyroid disease when determining a course of action.

Dermatologists said they use oral minoxidil in combination with spironolactone, topical minoxidil, finasteride, or dutasteride. If patients are already on antihypertensives or at risk for excessive blood pressure–lowering effects of a combination that includes spironolactone, the dermatologists said again they will consult with a patient’s primary care physician first.

For women, the main limiting factor with oral minoxidil may be unwanted hair growth, usually on the face. Most of the clinicians interviewed for this story said they did not use spironolactone to counteract that hypertrichosis.

Dr. McMichael said she cautions African American women or women of African descent – who tend to have more body hair at baseline – that they should be aware of the potential for excess hair growth associated with low-dose minoxidil. She and other dermatologists interviewed for this story said they urge patients who are bothered by the excess hair to shave or wax or use other nonpharmacologic approaches.

The excess hair growth is less bothersome for men, they said.
 

 

 

Not a magic wand

Despite the increased profile and interest, oral minoxidil is not a cure-all, clinicians said.

“It’s important for patients to realize that hair loss can be complicated and there is no one magic wand,” said Dr. Simmons-O’Brien. Clinicians typically “are using several things to help encourage these follicular units to not miniaturize and disappear and create scars,” she said.

Dr. Friedman said he finds that patients have a hard time hearing that to continue to maintain growth, they have to take a medication for the rest of their life. “If you stop, you will have to start again,” he said. 

Oral minoxidil, when used in combination with other therapies, will improve hair growth, said Dr. Goldberg. But it will not take someone back a decade, she said. “I try to temper expectations – promise a little and achieve more,” Dr. Goldberg said.

The study was independently supported. Dr. Smith and Dr. Jones report no relevant financial relationships. Dr. Simmons-O’Brien reports that she has received speaking fees from Isdin. Dr. McMichael disclosed relationships with Eli Lilly, Pfizer, Nutrafol, Revian, and UCB Pharma. Dr. Friedman, Dr. Goldberg, and Dr. Talakoub reported no disclosures.

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

It’s not a new drug – it’s been available in topical form for hair loss since 1988 and was approved as an antihypertensive in 1979 – but a low-dose oral form of minoxidil is gaining new currency – and a growing public profile – as an adjunctive therapy for hair loss.

The number of scholarly publications examining its use for hair loss has grown dramatically in the last 2 years: There were 2 in 2019, and that jumped to 17 in 2020 and 20 in 2021, with another 16 published so far this year, according to a PubMed search. An August article in The New York Times touting it as a potential cheap magic bullet is likely to drum up even more interest, said dermatologists.

The low-dose formulation is especially exciting for women, as there have been few great oral options for them, clinicians said.

Female hair loss “is devastating,” said Lily Talakoub, MD, adding that topical minoxidil (Rogaine), topical serums, and supplements “really do not provide the considerable growth that women really want to see.” Oral minoxidil is not approved by the U.S. Food and Drug Administration for hair loss, but “it has been shown in studies to cause the hairs to grow,” and has become a “lifeline” for women, said Dr. Talakoub, a dermatologist who is in private practice in McLean, Va.

“For many years we haven’t had anything new to tell patients medically,” said Lynne J. Goldberg, MD, professor of dermatology and pathology at Boston University School of Medicine. “Now, all of the sudden there’s a cheap, widely available efficacious medicine. That’s huge for female-pattern hair loss,” said Dr. Goldberg, who is also the director of the Boston Medical Center’s Hair Clinic.

“I’ve been using oral minoxidil for about 4 years with great success,” said dermatologist Eva Simmons-O’Brien, MD, who is in private practice in Towson, Md. She has used it primarily in women, mainly because she sees more women than men for hair loss.

Dr. Simmons-O’Brien said the excitement about low-dose oral minoxidil follows an increasing recognition in the medical and scientific community that hair loss is more than just a cosmetic issue.
 

Mechanism not fully understood

When minoxidil was first brought to market as an antihypertensive, clinicians noted hair growth in “balding patients,” which led to the development of the topical form. Even though it has been used for hair growth for decades, its mechanism of action is not fully understood. It is known that minoxidil is a vasodilator; it may also increase DNA synthesis and enhance cell proliferation, according to a review published in 2019.

“The positive effect of minoxidil on hair growth is mainly due to its metabolite, minoxidil sulfate, and the enzyme responsible for this conversion is sulfotransferase, which is located in hair follicles and varies in production among individuals,” write the authors, all affiliated with Mahidol University in Bangkok, Thailand.

Writing in the American Academy of Dermatology’s Dermatology World Insights and Inquiries, Warren R. Heymann, MD, observed that “even after decades of use,” how minoxidil improves alopecia is still not completely understood. He noted that a 2020 review found that minoxidil’s vasodilatory effects “are propagated by upregulation of vascular endothelial growth factor (VEGF), increasing cutaneous blood flow with resultant increase in oxygen and growth factor delivery to the hair follicle.” The medication prolongs the anagen phase and shortens the telogen phase, added Dr. Heymann, head of dermatology at Rowan University, Camden, N.J.

As an antihypertensive, minoxidil is given at 5-40 mg daily. Those doses have produced serious side effects such as sodium and fluid retention, ischemic heart disease, pericardial effusion, and pulmonary hypertension, according to the Thai researchers.

Those side effects have appeared to be rare with low-dose oral minoxidil. However, in JAAD Case Reports, South African researchers reported a case in which low-dose oral minoxidil may have led to cardiac side effects. A healthy 40-year-old woman, who after 3 weeks of treatment with 5% topical minoxidil, tacrolimus ointment 0.1%, clobetasol propionate ointment, 100 mg of doxycycline twice daily, and 0.25 mg of oral minoxidil daily, was hospitalized with full-body edema. An ultrasound showed fluid collections in the pericardium, pleural space, and abdomen. She also had a pleural effusion. The patient was given 40 mg of intravenous furosemide daily for 4 days, and the edema resolved.

“Having excluded other causes of pericardial effusion and anasarca in the previously healthy, young woman, we concluded that LDOM [low-dose oral minoxidil] was responsible for her clinical presentation,” write the authors.

review of 17 studies published on-line in 2020 in the Journal of the American Academy of Dermatology found low-dose minoxidil to be safe and effective. Androgenetic alopecia was the most commonly studied, with doses of 0.25-1.25 mg proving to be effective and safe. It was also safe and effective for female-pattern hair loss, traction alopecia, chronic telogen effluvium, lichen planopilaris, alopecia areata, and permanent chemotherapy-induced alopecia.

The most common adverse effect was hypertrichosis. Other adverse events included postural hypotension and dizziness, lower-limb edema, and mild blood pressure changes.

In another multicenter, 1,404-patient safety study published in 2021 in JAAD, the authors found that hypertrichosis was the most frequent adverse event, reported by 15% of patients. Systemic adverse events included lightheadedness (1.7% of patients), fluid retention (1.3%), tachycardia (0.9%), headache (0.4%), periorbital edema (0.3%), and insomnia (0.2%). Only 29 patients (1.2%) withdrew because of these side effects.

“It definitely helps, and it’s relatively safe,” said Adam Friedman, MD, professor and chair of dermatology at George Washington University in Washington. “But I wouldn’t want to call it a game-changer,” he said, adding that it works best when used in combination with other therapies. He often uses it with a 5-alpha reductase inhibitor – finasteride (Propecia) or dutasteride (Avodart) – “rather than as a monotherapy,” said Dr. Friedman.
 

 

 

From Australia to around the globe

The first publication on low-dose oral minoxidil for hair loss was in December 2017. The pilot study in female-pattern hair loss was published in the International Journal of Dermatology by Rodney Sinclair, MBBS, MD, a Melbourne, Australia–based dermatologist.

Amy McMichael, MD, professor of dermatology at Wake Forest University, Winston-Salem, N.C., said she first heard Dr. Sinclair present his findings at an alopecia research meeting in Japan shortly before his initial publication.

“After that, I think all of us said, ‘Huh, this is interesting, and let’s try it, because we’re always looking for something more to help our patients,’” Dr. McMichael said, adding that she’s been prescribing low-dose minoxidil to her patients for 5 years.

She and colleagues at Wake Forest, along with Jerry Cooley, MD, a dermatologist in private practice in Charlotte, published a retrospective case series in March, looking at 105 adult patients – 80 women (ages 24-80) and 25 men (ages 19-63) – who were treated for androgenetic alopecia and/or telogen effluvium with oral minoxidil (dose range of 0.625–2.5 mg) once daily for a year, matched to 105 case controls.

Efficacy was based on the clinician’s assessment of clinical response and clinical photographic evaluation using a 3-point scale (worsening, stabilization, and improvement). Half of those treated demonstrated clinical improvement and 43% demonstrated stabilization. There was a significant difference (P < .001) in clinical response between those who received minoxidil and the controls.

Ideal patients?

Given its ease of use and low cost – $4-$12 for a 30-day supply of 2.5 mg tablets, according to GoodRX – low-dose minoxidil is a good fit for many patients, said dermatologists.

The best candidate is “a woman who’s perimenopausal or menopausal who’s got what we would say is moderate to severe loss of hair that’s kind of just starting,” said Dr. Simmons-O’Brien. The medication is not likely to grow hair where there is scarring already, however, she said.

“I tend to use it in people who either don’t want to do the topical minoxidil or have used it and have a lot of potential side effects from it,” like itching and irritation, said Dr. McMichael. She said oral minoxidil can also be helpful as an adjunct in patients with alopecia areata and that it can be used after anti-inflammatory treatments in central centrifugal cicatricial alopecia.

Dr. Goldberg said low-dose minoxidil would not be her first choice for female-pattern hair loss but that it’s “a great alternative” for people who can’t tolerate the topical form. Most of the women she has prescribed it to “have been pretty happy,” she added.

“I would be a little cautious in patients on a number of other medications,” Dr. Goldberg said, noting minoxidil’s potential systemic side effects.

Clinicians said they generally consult with a patient’s internist when they are starting them on oral minoxidil. “I always want to touch base with the primary care physician first,” said Dr. Friedman.

“If they’re on oral antihypertensive medications already, then I would ask them to talk to either their primary care physician or their cardiologist to make sure it’s okay to give this low dose,” said Dr. McMichael.

At the low doses, minoxidil rarely has any blood pressure–lowering effects, dermatologists said.

Women are usually started on 1.25 mg, while men can start at a higher, 2.5-mg dose, said clinicians.

Dr. Goldberg and Dr. Simmons-O’Brien said that recent additional warnings for finasteride about sexual side effects and the potential for suicide have changed the way they approach its use in young men, and that it has highlighted the potential for oral minoxidil as an alternative.

Oral minoxidil is rarely used as a monotherapy. “It takes a village” to address hair loss, said Dr. Simmons-O’Brien, noting that she likes to evaluate nutrition, vitamin D levels, and whether a patient is anemic or has thyroid disease when determining a course of action.

Dermatologists said they use oral minoxidil in combination with spironolactone, topical minoxidil, finasteride, or dutasteride. If patients are already on antihypertensives or at risk for excessive blood pressure–lowering effects of a combination that includes spironolactone, the dermatologists said again they will consult with a patient’s primary care physician first.

For women, the main limiting factor with oral minoxidil may be unwanted hair growth, usually on the face. Most of the clinicians interviewed for this story said they did not use spironolactone to counteract that hypertrichosis.

Dr. McMichael said she cautions African American women or women of African descent – who tend to have more body hair at baseline – that they should be aware of the potential for excess hair growth associated with low-dose minoxidil. She and other dermatologists interviewed for this story said they urge patients who are bothered by the excess hair to shave or wax or use other nonpharmacologic approaches.

The excess hair growth is less bothersome for men, they said.
 

 

 

Not a magic wand

Despite the increased profile and interest, oral minoxidil is not a cure-all, clinicians said.

“It’s important for patients to realize that hair loss can be complicated and there is no one magic wand,” said Dr. Simmons-O’Brien. Clinicians typically “are using several things to help encourage these follicular units to not miniaturize and disappear and create scars,” she said.

Dr. Friedman said he finds that patients have a hard time hearing that to continue to maintain growth, they have to take a medication for the rest of their life. “If you stop, you will have to start again,” he said. 

Oral minoxidil, when used in combination with other therapies, will improve hair growth, said Dr. Goldberg. But it will not take someone back a decade, she said. “I try to temper expectations – promise a little and achieve more,” Dr. Goldberg said.

The study was independently supported. Dr. Smith and Dr. Jones report no relevant financial relationships. Dr. Simmons-O’Brien reports that she has received speaking fees from Isdin. Dr. McMichael disclosed relationships with Eli Lilly, Pfizer, Nutrafol, Revian, and UCB Pharma. Dr. Friedman, Dr. Goldberg, and Dr. Talakoub reported no disclosures.

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

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Psychiatrist sentenced to 11 years for sledgehammer attack against another psychiatrist

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A New York psychiatrist who has been suspended from practicing pending an investigation by state licensing authorities has been sentenced to 11 years in state prison for her role in the attempted murder of her child’s father, who is also a psychiatrist.

Pamela Buchbinder pled guilty to first-degree burglary and assault on September 7, almost exactly 10 years after the November 2012 attack on Michael Weiss, MD. Weiss was beaten with a sledgehammer and stabbed multiple times but survived the attack.

The September plea deal was announced by the Manhattan district attorney, who said that Ms. Buchbinder acknowledged she had enlisted the help of her then-19-year-old cousin Jacob Nolan to kill Dr. Weiss. Ms. Buchbinder was in a custody battle with Dr. Weiss over their then-5-year-old child.

At the Oct. 11 sentencing, Ms. Buchbinder and her defense attorney attempted to withdraw that plea. NBC4 New York reported that Buchbinder claimed she was not in her right mind on the day of the plea because she had received a “contact high” from others in her holding cell who were using synthetic marijuana and that she had not taken her prescribed medications that day.

The judge did not entertain the request and proceeded with the sentencing.

Ms. Buchbinder has been held at Rikers Island prison, in East Elmhurst, N.Y., since she was arrested in 2017, so has already served 5 years of her 11-year sentence. She must also serve 5 years of postrelease probation.
 

Insurance policy beneficiary

Ms. Buchbinder’s cousin was convicted of second-degree attempted murder in 2016 and was sentenced to 9.5 years in prison.

In a 2017 interview with CBS News, Mr. Nolan, who said he was “bipolar,” claimed Ms. Buchbinder had manipulated him into trying to kill her child’s father by telling him “horror stories” about Weiss. Soon after the interview, Ms. Buchbinder was arrested.

In 2022, the New York Post reported that Ms. Buchbinder had been named a beneficiary of Dr. Weiss’ $1.5 million life insurance policy several days before the attack.

Prosecutors had surveillance footage of Ms. Buchbinder with Nolan at a Manhattan hardware store purchasing the sledgehammer. According to the CBS report, at the time of her arrest, she also was apparently preparing to flee.

She was denied bail and has been held at Rikers Island since her arrest.

Ms. Buchbinder was licensed to practice in New York in 1999. In April 2018, the New York State Board for Professional Medical Conduct issued an interim order that precluded her from practicing medicine in New York.

The interim order will be in effect until the board completes its investigation. As of press time, the board had not updated its files.

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

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A New York psychiatrist who has been suspended from practicing pending an investigation by state licensing authorities has been sentenced to 11 years in state prison for her role in the attempted murder of her child’s father, who is also a psychiatrist.

Pamela Buchbinder pled guilty to first-degree burglary and assault on September 7, almost exactly 10 years after the November 2012 attack on Michael Weiss, MD. Weiss was beaten with a sledgehammer and stabbed multiple times but survived the attack.

The September plea deal was announced by the Manhattan district attorney, who said that Ms. Buchbinder acknowledged she had enlisted the help of her then-19-year-old cousin Jacob Nolan to kill Dr. Weiss. Ms. Buchbinder was in a custody battle with Dr. Weiss over their then-5-year-old child.

At the Oct. 11 sentencing, Ms. Buchbinder and her defense attorney attempted to withdraw that plea. NBC4 New York reported that Buchbinder claimed she was not in her right mind on the day of the plea because she had received a “contact high” from others in her holding cell who were using synthetic marijuana and that she had not taken her prescribed medications that day.

The judge did not entertain the request and proceeded with the sentencing.

Ms. Buchbinder has been held at Rikers Island prison, in East Elmhurst, N.Y., since she was arrested in 2017, so has already served 5 years of her 11-year sentence. She must also serve 5 years of postrelease probation.
 

Insurance policy beneficiary

Ms. Buchbinder’s cousin was convicted of second-degree attempted murder in 2016 and was sentenced to 9.5 years in prison.

In a 2017 interview with CBS News, Mr. Nolan, who said he was “bipolar,” claimed Ms. Buchbinder had manipulated him into trying to kill her child’s father by telling him “horror stories” about Weiss. Soon after the interview, Ms. Buchbinder was arrested.

In 2022, the New York Post reported that Ms. Buchbinder had been named a beneficiary of Dr. Weiss’ $1.5 million life insurance policy several days before the attack.

Prosecutors had surveillance footage of Ms. Buchbinder with Nolan at a Manhattan hardware store purchasing the sledgehammer. According to the CBS report, at the time of her arrest, she also was apparently preparing to flee.

She was denied bail and has been held at Rikers Island since her arrest.

Ms. Buchbinder was licensed to practice in New York in 1999. In April 2018, the New York State Board for Professional Medical Conduct issued an interim order that precluded her from practicing medicine in New York.

The interim order will be in effect until the board completes its investigation. As of press time, the board had not updated its files.

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

 

A New York psychiatrist who has been suspended from practicing pending an investigation by state licensing authorities has been sentenced to 11 years in state prison for her role in the attempted murder of her child’s father, who is also a psychiatrist.

Pamela Buchbinder pled guilty to first-degree burglary and assault on September 7, almost exactly 10 years after the November 2012 attack on Michael Weiss, MD. Weiss was beaten with a sledgehammer and stabbed multiple times but survived the attack.

The September plea deal was announced by the Manhattan district attorney, who said that Ms. Buchbinder acknowledged she had enlisted the help of her then-19-year-old cousin Jacob Nolan to kill Dr. Weiss. Ms. Buchbinder was in a custody battle with Dr. Weiss over their then-5-year-old child.

At the Oct. 11 sentencing, Ms. Buchbinder and her defense attorney attempted to withdraw that plea. NBC4 New York reported that Buchbinder claimed she was not in her right mind on the day of the plea because she had received a “contact high” from others in her holding cell who were using synthetic marijuana and that she had not taken her prescribed medications that day.

The judge did not entertain the request and proceeded with the sentencing.

Ms. Buchbinder has been held at Rikers Island prison, in East Elmhurst, N.Y., since she was arrested in 2017, so has already served 5 years of her 11-year sentence. She must also serve 5 years of postrelease probation.
 

Insurance policy beneficiary

Ms. Buchbinder’s cousin was convicted of second-degree attempted murder in 2016 and was sentenced to 9.5 years in prison.

In a 2017 interview with CBS News, Mr. Nolan, who said he was “bipolar,” claimed Ms. Buchbinder had manipulated him into trying to kill her child’s father by telling him “horror stories” about Weiss. Soon after the interview, Ms. Buchbinder was arrested.

In 2022, the New York Post reported that Ms. Buchbinder had been named a beneficiary of Dr. Weiss’ $1.5 million life insurance policy several days before the attack.

Prosecutors had surveillance footage of Ms. Buchbinder with Nolan at a Manhattan hardware store purchasing the sledgehammer. According to the CBS report, at the time of her arrest, she also was apparently preparing to flee.

She was denied bail and has been held at Rikers Island since her arrest.

Ms. Buchbinder was licensed to practice in New York in 1999. In April 2018, the New York State Board for Professional Medical Conduct issued an interim order that precluded her from practicing medicine in New York.

The interim order will be in effect until the board completes its investigation. As of press time, the board had not updated its files.

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

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Pediatricians at odds over gender-affirming care for trans kids

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Some members of the American Academy of Pediatrics say its association leadership is blocking discussion about a resolution asking for a “rigorous systematic review” of gender-affirming care guidelines.

At issue is 2018 guidance that states children can undergo hormonal therapy after they are deemed appropriate candidates following a thorough mental health evaluation.

Critics say minors under age 18 may be getting “fast-tracked” to hormonal treatment too quickly or inappropriately and can end up regretting the decision and facing medical conditions like sterility.

Five AAP members, which has a total membership of around 67,000 pediatricians in the United States and Canada, this year penned Resolution 27, calling for a possible update of the guidelines following consultation with stakeholders that include mental health and medical clinicians, parents, and patients “with diverse views and experiences.”

Those members and others in written comments on a members-only website accuse the AAP of deliberately silencing debate on the issue and changing resolution rules. Any AAP member can submit a resolution for consideration by the group’s leadership at its annual policy meeting.

This year, the AAP sent an email to members stating it would not allow comments on resolutions that had not been “sponsored” by one of the group’s 66 chapters or 88 internal committees, councils, or sections.

That’s why comments were not allowed on Resolution 27, said Mark Del Monte, the AAP’s CEO. A second attempt to get sponsorship during the annual leadership forum, held earlier this month in Chicago, also failed, he noted. Mr. Del Monte told this news organization that changes to the resolution process are made every year and that no rule changes were directly associated with Resolution 27.

But one of the resolution’s authors said there was sponsorship when members first drafted the suggestion. Julia Mason, MD, a board member for the Society for Evidence-based Gender Medicine and a pediatrician in private practice in Gresham, Ore., says an AAP chapter president agreed to second Resolution 27 but backed off after attending a different AAP meeting. Dr. Mason did not name the member.

On Aug. 10, AAP President Moira Szilagyi, MD, PhD, wrote in a blog on the AAP website – after the AAP leadership meeting in Chicago – that the lack of sponsorship “meant no one was willing to support their proposal.”

The AAP Leadership Council’s 154 voting entities approved 48 resolutions at the meeting, all of which will be referred to the AAP Board of Directors for potential, but not definite, action as the Board only takes resolutions under advisement, Mr. Del Monte notes.

In an email allowing members to comment on a resolution (number 28) regarding education support for caring for transgender patients, 23 chose to support Resolution 27 instead.

“I am wholeheartedly in support of Resolution 27, which interestingly has been removed from the list of resolutions for member comment,” one comment read. “I can no longer trust the AAP to provide medical evidence-based education with regard to care for transgender individuals.” 

“We don’t need a formal resolution to look at the evidence around the care of transgender young people. Evaluating the evidence behind our recommendations, which the unsponsored resolution called for, is a routine part of the Academy’s policy-writing process,” wrote Dr. Szilagyi in her blog.

Mr. Del Monte says that “the 2018 policy is under review now.”

So far, “the evidence that we have seen reinforces our policy that gender-affirming care is the correct approach,” Mr. Del Monte stresses. “It is supported by every mainstream medical society in the world and is the standard of care,” he maintains.

Among those societies is the World Professional Association for Transgender Health, which in the draft of its latest Standards of Care (SOC8) – the first new guidance on the issue for 10 years – reportedly lowers the age for “top surgery” to 15 years.

The final SOC8 will most likely be published to coincide with WPATH’s annual meeting in September in Montreal.

Opponents plan to protest outside the AAP’s annual meeting, in Anaheim in October, Dr. Mason says.

“I’m concerned that kids with a transient gender identity are being funneled into medicalization that does not serve them,” Dr. Mason says. “I am worried that the trans identity is valued over the possibility of desistance,” she adds, admitting that her goal is to have fewer children transition gender.

Last summer, AAP found itself in hot water on the same topic when it barred SEGM from having a booth at the AAP annual meeting in 2021, as reported by this news organization.

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

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Some members of the American Academy of Pediatrics say its association leadership is blocking discussion about a resolution asking for a “rigorous systematic review” of gender-affirming care guidelines.

At issue is 2018 guidance that states children can undergo hormonal therapy after they are deemed appropriate candidates following a thorough mental health evaluation.

Critics say minors under age 18 may be getting “fast-tracked” to hormonal treatment too quickly or inappropriately and can end up regretting the decision and facing medical conditions like sterility.

Five AAP members, which has a total membership of around 67,000 pediatricians in the United States and Canada, this year penned Resolution 27, calling for a possible update of the guidelines following consultation with stakeholders that include mental health and medical clinicians, parents, and patients “with diverse views and experiences.”

Those members and others in written comments on a members-only website accuse the AAP of deliberately silencing debate on the issue and changing resolution rules. Any AAP member can submit a resolution for consideration by the group’s leadership at its annual policy meeting.

This year, the AAP sent an email to members stating it would not allow comments on resolutions that had not been “sponsored” by one of the group’s 66 chapters or 88 internal committees, councils, or sections.

That’s why comments were not allowed on Resolution 27, said Mark Del Monte, the AAP’s CEO. A second attempt to get sponsorship during the annual leadership forum, held earlier this month in Chicago, also failed, he noted. Mr. Del Monte told this news organization that changes to the resolution process are made every year and that no rule changes were directly associated with Resolution 27.

But one of the resolution’s authors said there was sponsorship when members first drafted the suggestion. Julia Mason, MD, a board member for the Society for Evidence-based Gender Medicine and a pediatrician in private practice in Gresham, Ore., says an AAP chapter president agreed to second Resolution 27 but backed off after attending a different AAP meeting. Dr. Mason did not name the member.

On Aug. 10, AAP President Moira Szilagyi, MD, PhD, wrote in a blog on the AAP website – after the AAP leadership meeting in Chicago – that the lack of sponsorship “meant no one was willing to support their proposal.”

The AAP Leadership Council’s 154 voting entities approved 48 resolutions at the meeting, all of which will be referred to the AAP Board of Directors for potential, but not definite, action as the Board only takes resolutions under advisement, Mr. Del Monte notes.

In an email allowing members to comment on a resolution (number 28) regarding education support for caring for transgender patients, 23 chose to support Resolution 27 instead.

“I am wholeheartedly in support of Resolution 27, which interestingly has been removed from the list of resolutions for member comment,” one comment read. “I can no longer trust the AAP to provide medical evidence-based education with regard to care for transgender individuals.” 

“We don’t need a formal resolution to look at the evidence around the care of transgender young people. Evaluating the evidence behind our recommendations, which the unsponsored resolution called for, is a routine part of the Academy’s policy-writing process,” wrote Dr. Szilagyi in her blog.

Mr. Del Monte says that “the 2018 policy is under review now.”

So far, “the evidence that we have seen reinforces our policy that gender-affirming care is the correct approach,” Mr. Del Monte stresses. “It is supported by every mainstream medical society in the world and is the standard of care,” he maintains.

Among those societies is the World Professional Association for Transgender Health, which in the draft of its latest Standards of Care (SOC8) – the first new guidance on the issue for 10 years – reportedly lowers the age for “top surgery” to 15 years.

The final SOC8 will most likely be published to coincide with WPATH’s annual meeting in September in Montreal.

Opponents plan to protest outside the AAP’s annual meeting, in Anaheim in October, Dr. Mason says.

“I’m concerned that kids with a transient gender identity are being funneled into medicalization that does not serve them,” Dr. Mason says. “I am worried that the trans identity is valued over the possibility of desistance,” she adds, admitting that her goal is to have fewer children transition gender.

Last summer, AAP found itself in hot water on the same topic when it barred SEGM from having a booth at the AAP annual meeting in 2021, as reported by this news organization.

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

 

Some members of the American Academy of Pediatrics say its association leadership is blocking discussion about a resolution asking for a “rigorous systematic review” of gender-affirming care guidelines.

At issue is 2018 guidance that states children can undergo hormonal therapy after they are deemed appropriate candidates following a thorough mental health evaluation.

Critics say minors under age 18 may be getting “fast-tracked” to hormonal treatment too quickly or inappropriately and can end up regretting the decision and facing medical conditions like sterility.

Five AAP members, which has a total membership of around 67,000 pediatricians in the United States and Canada, this year penned Resolution 27, calling for a possible update of the guidelines following consultation with stakeholders that include mental health and medical clinicians, parents, and patients “with diverse views and experiences.”

Those members and others in written comments on a members-only website accuse the AAP of deliberately silencing debate on the issue and changing resolution rules. Any AAP member can submit a resolution for consideration by the group’s leadership at its annual policy meeting.

This year, the AAP sent an email to members stating it would not allow comments on resolutions that had not been “sponsored” by one of the group’s 66 chapters or 88 internal committees, councils, or sections.

That’s why comments were not allowed on Resolution 27, said Mark Del Monte, the AAP’s CEO. A second attempt to get sponsorship during the annual leadership forum, held earlier this month in Chicago, also failed, he noted. Mr. Del Monte told this news organization that changes to the resolution process are made every year and that no rule changes were directly associated with Resolution 27.

But one of the resolution’s authors said there was sponsorship when members first drafted the suggestion. Julia Mason, MD, a board member for the Society for Evidence-based Gender Medicine and a pediatrician in private practice in Gresham, Ore., says an AAP chapter president agreed to second Resolution 27 but backed off after attending a different AAP meeting. Dr. Mason did not name the member.

On Aug. 10, AAP President Moira Szilagyi, MD, PhD, wrote in a blog on the AAP website – after the AAP leadership meeting in Chicago – that the lack of sponsorship “meant no one was willing to support their proposal.”

The AAP Leadership Council’s 154 voting entities approved 48 resolutions at the meeting, all of which will be referred to the AAP Board of Directors for potential, but not definite, action as the Board only takes resolutions under advisement, Mr. Del Monte notes.

In an email allowing members to comment on a resolution (number 28) regarding education support for caring for transgender patients, 23 chose to support Resolution 27 instead.

“I am wholeheartedly in support of Resolution 27, which interestingly has been removed from the list of resolutions for member comment,” one comment read. “I can no longer trust the AAP to provide medical evidence-based education with regard to care for transgender individuals.” 

“We don’t need a formal resolution to look at the evidence around the care of transgender young people. Evaluating the evidence behind our recommendations, which the unsponsored resolution called for, is a routine part of the Academy’s policy-writing process,” wrote Dr. Szilagyi in her blog.

Mr. Del Monte says that “the 2018 policy is under review now.”

So far, “the evidence that we have seen reinforces our policy that gender-affirming care is the correct approach,” Mr. Del Monte stresses. “It is supported by every mainstream medical society in the world and is the standard of care,” he maintains.

Among those societies is the World Professional Association for Transgender Health, which in the draft of its latest Standards of Care (SOC8) – the first new guidance on the issue for 10 years – reportedly lowers the age for “top surgery” to 15 years.

The final SOC8 will most likely be published to coincide with WPATH’s annual meeting in September in Montreal.

Opponents plan to protest outside the AAP’s annual meeting, in Anaheim in October, Dr. Mason says.

“I’m concerned that kids with a transient gender identity are being funneled into medicalization that does not serve them,” Dr. Mason says. “I am worried that the trans identity is valued over the possibility of desistance,” she adds, admitting that her goal is to have fewer children transition gender.

Last summer, AAP found itself in hot water on the same topic when it barred SEGM from having a booth at the AAP annual meeting in 2021, as reported by this news organization.

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

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Diagnosing children with long COVID can be tricky: Experts

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When Spencer Siedlecki got COVID-19 in March 2021, he was sick for weeks with extreme fatigue, fevers, a sore throat, bad headaches, nausea, and eventually, pneumonia.

That was scary enough for the then-13-year-old and his parents, who live in Ohio. More than a year later, Spencer still had many of the symptoms and, more alarming, the once-healthy teen had postural orthostatic tachycardia syndrome, a condition that has caused dizziness, a racing heart when he stands, and fainting. Spencer missed most of the last few months of eighth grade because of long COVID.

“He gets sick very easily,” said his mother, Melissa Siedlecki, who works in technology sales. “The common cold that he would shake off in a few days takes weeks for him to feel better.”

The transformation from regular teen life to someone with a chronic illness “sucked,” said Spencer, who will turn 15 in August. “I felt like I was never going to get better.” Fortunately, after some therapy at a specialized clinic, Spencer is back to playing baseball and golf.

Spencer’s journey to better health was difficult; his regular pediatrician told the family at first that there were no treatments to help him – a reaction that is not uncommon. “I still get a lot of parents who heard of me through the grapevine,” said Amy Edwards, MD, director of the pediatric COVID clinic at University Hospitals Rainbow Babies & Children’s and an assistant professor of pediatrics at Case Western Reserve University, both in Cleveland. “The pediatricians either are unsure of what is wrong, or worse, tell children ‘there is nothing wrong with you. Stop faking it.’ ” Dr. Edwards treated Spencer after his mother found the clinic through an internet search.

Alexandra Yonts, MD, a pediatric infectious diseases doctor and director of the post-COVID program clinic at Children’s National Medical Center in Washington, has seen this too. They’ve had “a lot of kids coming in and saying we’ve been passed around from doctor to doctor, and some of them don’t even believe long COVID exists,” she said.

But those who do get attention tend to be White and affluent, something Dr. Yonts said “doesn’t jibe with the epidemiologic data of who COVID has affected the most.” Black, Latino, and American Indian and Alaska Native children are more likely to be infected with COVID than White children, and have higher rates of hospitalization and death than White children.

It’s not clear whether these children have a particular risk factor, or if they are just the ones who have the resources to get to the clinics. But Dr. Yonts and Dr. Edwards believe many children are not getting the help they need. High-performing kids are coming in “because they are the ones whose symptoms are most obvious,” said Dr. Edwards. “I think there are kids out there who are getting missed because they’re already struggling because of socioeconomic reasons.”

Spencer is one of 14 million children who have tested positive for SARS-CoV-2 since the start of the pandemic. Many pediatricians are still grappling with how to address cases like Spencer’s. The American Academy of Pediatrics has issued only brief guidance on long COVID in children, in part because there have been so few studies to use as a basis for guidance.

The federal government is aiming to change that with a newly launched National Research Action Plan on Long COVID that includes speeding up research on how the condition affects children and youths, including their ability to learn and thrive.

A CDC study found children with COVID were significantly more likely to have smell and taste disturbances, circulatory system problems, fatigue and malaise, and pain. Those who had been infected had higher rates of acute blockage of a lung artery, myocarditis and weakening of the heart, kidney failure, and type 1 diabetes.
 

Difficult to diagnose

Even with increased media attention and more published studies on pediatric long COVID, it’s still hard for a busy primary care doctor “to sort through what could just be a cold or what could be a series of colds and trying to look at the bigger picture of what’s been going on in a 1- to 3-month period with a kid,” Dr. Yonts said.

Most children with potential or definite long COVID are still being seen by individual pediatricians, not in a specialized clinic with easy access to an army of specialists. It’s not clear how many of those pediatric clinics exist. Survivor Corps, an advocacy group for people with long COVID, has posted a map of locations providing care, but few are specialized or focus on pediatric long COVID.

Long COVID is different from multisystem inflammatory syndrome in children (MIS-C), which occurs within a month or so of infection, triggers high fevers and severe symptoms in the gut, and often results in hospitalization. MIS-C “is not subtle,” said Dr. Edwards.

The long COVID clinic doctors said most of their patients were not very sick at first. “Anecdotally, of the 83 kids that we’ve seen, most have had mild, very mild, or even asymptomatic infections initially,” and then went on to have long COVID, said Dr. Yonts.

“We see it even in children who have very mild disease or even are asymptomatic,” agreed Allison Eckard, MD, director of pediatric infectious diseases at the Medical University of South Carolina, Charleston.
 

Fatigue, mood problems

Dr. Yonts said 90% of her patients have fatigue, and many also have severe symptoms in their gut. Those and other long COVID symptoms will be looked at more closely in a 3-year study the Children’s National Medical Center is doing along with the National Institute of Allergy and Infectious Diseases.

There are no treatments for long COVID itself.

“Management is probably more the correct term for what we do in our clinic at this point,” said Dr. Yonts. That means dealing with fatigue and managing headache and digestive symptoms with medications or coping strategies. Guidelines from the American Academy of Physical Medicine and Rehabilitation help inform how to help kids safely resume exercise.

At the Children’s National Medical Center clinic, children will typically meet with a team of specialists including infectious diseases doctors on the same day, said Dr. Yonts. Psychologists help children with coping skills. Dr. Yonts is careful not to imply that long COVID is a psychological illness. Parents “will just shut down, because for so long, they’ve been told this is all a mental thing.”

In about a third of children, symptoms get better on their own, and most kids get better over time. But many still struggle. “We don’t talk about cure, because we don’t know what cure looks like,” said Dr. Edwards.
 

Vaccination may be best protection

Vaccination seems to help reduce the risk of long COVID, perhaps by as much as half. But parents have been slow to vaccinate children, especially the very young. The AAP reported that, as of Aug. 3, just 5% of children under age 5, 37% of those ages 5-11, and 69% of 12- to 17-year-olds have received at least one dose of a COVID-19 vaccine.

“We have tried to really push vaccine as one of the ways to help prevent some of these long COVID syndromes,” said Dr. Eckard. But that advice is not always welcome. Dr. Eckard told the story of a mother who refused to have her autistic son vaccinated, even as she tearfully pleaded for help with his long COVID symptoms, which had also worsened his autism. The woman told Dr. Eckard: “Nothing you can say will convince me to get him vaccinated.” She thought a vaccine could make his symptoms even worse.

The best prevention is to avoid being infected in the first place.

“The more times you get COVID, the more you increase your risk of getting long COVID,” said Dr. Yonts. “The more times you roll the dice, eventually your number could come up.

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

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When Spencer Siedlecki got COVID-19 in March 2021, he was sick for weeks with extreme fatigue, fevers, a sore throat, bad headaches, nausea, and eventually, pneumonia.

That was scary enough for the then-13-year-old and his parents, who live in Ohio. More than a year later, Spencer still had many of the symptoms and, more alarming, the once-healthy teen had postural orthostatic tachycardia syndrome, a condition that has caused dizziness, a racing heart when he stands, and fainting. Spencer missed most of the last few months of eighth grade because of long COVID.

“He gets sick very easily,” said his mother, Melissa Siedlecki, who works in technology sales. “The common cold that he would shake off in a few days takes weeks for him to feel better.”

The transformation from regular teen life to someone with a chronic illness “sucked,” said Spencer, who will turn 15 in August. “I felt like I was never going to get better.” Fortunately, after some therapy at a specialized clinic, Spencer is back to playing baseball and golf.

Spencer’s journey to better health was difficult; his regular pediatrician told the family at first that there were no treatments to help him – a reaction that is not uncommon. “I still get a lot of parents who heard of me through the grapevine,” said Amy Edwards, MD, director of the pediatric COVID clinic at University Hospitals Rainbow Babies & Children’s and an assistant professor of pediatrics at Case Western Reserve University, both in Cleveland. “The pediatricians either are unsure of what is wrong, or worse, tell children ‘there is nothing wrong with you. Stop faking it.’ ” Dr. Edwards treated Spencer after his mother found the clinic through an internet search.

Alexandra Yonts, MD, a pediatric infectious diseases doctor and director of the post-COVID program clinic at Children’s National Medical Center in Washington, has seen this too. They’ve had “a lot of kids coming in and saying we’ve been passed around from doctor to doctor, and some of them don’t even believe long COVID exists,” she said.

But those who do get attention tend to be White and affluent, something Dr. Yonts said “doesn’t jibe with the epidemiologic data of who COVID has affected the most.” Black, Latino, and American Indian and Alaska Native children are more likely to be infected with COVID than White children, and have higher rates of hospitalization and death than White children.

It’s not clear whether these children have a particular risk factor, or if they are just the ones who have the resources to get to the clinics. But Dr. Yonts and Dr. Edwards believe many children are not getting the help they need. High-performing kids are coming in “because they are the ones whose symptoms are most obvious,” said Dr. Edwards. “I think there are kids out there who are getting missed because they’re already struggling because of socioeconomic reasons.”

Spencer is one of 14 million children who have tested positive for SARS-CoV-2 since the start of the pandemic. Many pediatricians are still grappling with how to address cases like Spencer’s. The American Academy of Pediatrics has issued only brief guidance on long COVID in children, in part because there have been so few studies to use as a basis for guidance.

The federal government is aiming to change that with a newly launched National Research Action Plan on Long COVID that includes speeding up research on how the condition affects children and youths, including their ability to learn and thrive.

A CDC study found children with COVID were significantly more likely to have smell and taste disturbances, circulatory system problems, fatigue and malaise, and pain. Those who had been infected had higher rates of acute blockage of a lung artery, myocarditis and weakening of the heart, kidney failure, and type 1 diabetes.
 

Difficult to diagnose

Even with increased media attention and more published studies on pediatric long COVID, it’s still hard for a busy primary care doctor “to sort through what could just be a cold or what could be a series of colds and trying to look at the bigger picture of what’s been going on in a 1- to 3-month period with a kid,” Dr. Yonts said.

Most children with potential or definite long COVID are still being seen by individual pediatricians, not in a specialized clinic with easy access to an army of specialists. It’s not clear how many of those pediatric clinics exist. Survivor Corps, an advocacy group for people with long COVID, has posted a map of locations providing care, but few are specialized or focus on pediatric long COVID.

Long COVID is different from multisystem inflammatory syndrome in children (MIS-C), which occurs within a month or so of infection, triggers high fevers and severe symptoms in the gut, and often results in hospitalization. MIS-C “is not subtle,” said Dr. Edwards.

The long COVID clinic doctors said most of their patients were not very sick at first. “Anecdotally, of the 83 kids that we’ve seen, most have had mild, very mild, or even asymptomatic infections initially,” and then went on to have long COVID, said Dr. Yonts.

“We see it even in children who have very mild disease or even are asymptomatic,” agreed Allison Eckard, MD, director of pediatric infectious diseases at the Medical University of South Carolina, Charleston.
 

Fatigue, mood problems

Dr. Yonts said 90% of her patients have fatigue, and many also have severe symptoms in their gut. Those and other long COVID symptoms will be looked at more closely in a 3-year study the Children’s National Medical Center is doing along with the National Institute of Allergy and Infectious Diseases.

There are no treatments for long COVID itself.

“Management is probably more the correct term for what we do in our clinic at this point,” said Dr. Yonts. That means dealing with fatigue and managing headache and digestive symptoms with medications or coping strategies. Guidelines from the American Academy of Physical Medicine and Rehabilitation help inform how to help kids safely resume exercise.

At the Children’s National Medical Center clinic, children will typically meet with a team of specialists including infectious diseases doctors on the same day, said Dr. Yonts. Psychologists help children with coping skills. Dr. Yonts is careful not to imply that long COVID is a psychological illness. Parents “will just shut down, because for so long, they’ve been told this is all a mental thing.”

In about a third of children, symptoms get better on their own, and most kids get better over time. But many still struggle. “We don’t talk about cure, because we don’t know what cure looks like,” said Dr. Edwards.
 

Vaccination may be best protection

Vaccination seems to help reduce the risk of long COVID, perhaps by as much as half. But parents have been slow to vaccinate children, especially the very young. The AAP reported that, as of Aug. 3, just 5% of children under age 5, 37% of those ages 5-11, and 69% of 12- to 17-year-olds have received at least one dose of a COVID-19 vaccine.

“We have tried to really push vaccine as one of the ways to help prevent some of these long COVID syndromes,” said Dr. Eckard. But that advice is not always welcome. Dr. Eckard told the story of a mother who refused to have her autistic son vaccinated, even as she tearfully pleaded for help with his long COVID symptoms, which had also worsened his autism. The woman told Dr. Eckard: “Nothing you can say will convince me to get him vaccinated.” She thought a vaccine could make his symptoms even worse.

The best prevention is to avoid being infected in the first place.

“The more times you get COVID, the more you increase your risk of getting long COVID,” said Dr. Yonts. “The more times you roll the dice, eventually your number could come up.

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

 

When Spencer Siedlecki got COVID-19 in March 2021, he was sick for weeks with extreme fatigue, fevers, a sore throat, bad headaches, nausea, and eventually, pneumonia.

That was scary enough for the then-13-year-old and his parents, who live in Ohio. More than a year later, Spencer still had many of the symptoms and, more alarming, the once-healthy teen had postural orthostatic tachycardia syndrome, a condition that has caused dizziness, a racing heart when he stands, and fainting. Spencer missed most of the last few months of eighth grade because of long COVID.

“He gets sick very easily,” said his mother, Melissa Siedlecki, who works in technology sales. “The common cold that he would shake off in a few days takes weeks for him to feel better.”

The transformation from regular teen life to someone with a chronic illness “sucked,” said Spencer, who will turn 15 in August. “I felt like I was never going to get better.” Fortunately, after some therapy at a specialized clinic, Spencer is back to playing baseball and golf.

Spencer’s journey to better health was difficult; his regular pediatrician told the family at first that there were no treatments to help him – a reaction that is not uncommon. “I still get a lot of parents who heard of me through the grapevine,” said Amy Edwards, MD, director of the pediatric COVID clinic at University Hospitals Rainbow Babies & Children’s and an assistant professor of pediatrics at Case Western Reserve University, both in Cleveland. “The pediatricians either are unsure of what is wrong, or worse, tell children ‘there is nothing wrong with you. Stop faking it.’ ” Dr. Edwards treated Spencer after his mother found the clinic through an internet search.

Alexandra Yonts, MD, a pediatric infectious diseases doctor and director of the post-COVID program clinic at Children’s National Medical Center in Washington, has seen this too. They’ve had “a lot of kids coming in and saying we’ve been passed around from doctor to doctor, and some of them don’t even believe long COVID exists,” she said.

But those who do get attention tend to be White and affluent, something Dr. Yonts said “doesn’t jibe with the epidemiologic data of who COVID has affected the most.” Black, Latino, and American Indian and Alaska Native children are more likely to be infected with COVID than White children, and have higher rates of hospitalization and death than White children.

It’s not clear whether these children have a particular risk factor, or if they are just the ones who have the resources to get to the clinics. But Dr. Yonts and Dr. Edwards believe many children are not getting the help they need. High-performing kids are coming in “because they are the ones whose symptoms are most obvious,” said Dr. Edwards. “I think there are kids out there who are getting missed because they’re already struggling because of socioeconomic reasons.”

Spencer is one of 14 million children who have tested positive for SARS-CoV-2 since the start of the pandemic. Many pediatricians are still grappling with how to address cases like Spencer’s. The American Academy of Pediatrics has issued only brief guidance on long COVID in children, in part because there have been so few studies to use as a basis for guidance.

The federal government is aiming to change that with a newly launched National Research Action Plan on Long COVID that includes speeding up research on how the condition affects children and youths, including their ability to learn and thrive.

A CDC study found children with COVID were significantly more likely to have smell and taste disturbances, circulatory system problems, fatigue and malaise, and pain. Those who had been infected had higher rates of acute blockage of a lung artery, myocarditis and weakening of the heart, kidney failure, and type 1 diabetes.
 

Difficult to diagnose

Even with increased media attention and more published studies on pediatric long COVID, it’s still hard for a busy primary care doctor “to sort through what could just be a cold or what could be a series of colds and trying to look at the bigger picture of what’s been going on in a 1- to 3-month period with a kid,” Dr. Yonts said.

Most children with potential or definite long COVID are still being seen by individual pediatricians, not in a specialized clinic with easy access to an army of specialists. It’s not clear how many of those pediatric clinics exist. Survivor Corps, an advocacy group for people with long COVID, has posted a map of locations providing care, but few are specialized or focus on pediatric long COVID.

Long COVID is different from multisystem inflammatory syndrome in children (MIS-C), which occurs within a month or so of infection, triggers high fevers and severe symptoms in the gut, and often results in hospitalization. MIS-C “is not subtle,” said Dr. Edwards.

The long COVID clinic doctors said most of their patients were not very sick at first. “Anecdotally, of the 83 kids that we’ve seen, most have had mild, very mild, or even asymptomatic infections initially,” and then went on to have long COVID, said Dr. Yonts.

“We see it even in children who have very mild disease or even are asymptomatic,” agreed Allison Eckard, MD, director of pediatric infectious diseases at the Medical University of South Carolina, Charleston.
 

Fatigue, mood problems

Dr. Yonts said 90% of her patients have fatigue, and many also have severe symptoms in their gut. Those and other long COVID symptoms will be looked at more closely in a 3-year study the Children’s National Medical Center is doing along with the National Institute of Allergy and Infectious Diseases.

There are no treatments for long COVID itself.

“Management is probably more the correct term for what we do in our clinic at this point,” said Dr. Yonts. That means dealing with fatigue and managing headache and digestive symptoms with medications or coping strategies. Guidelines from the American Academy of Physical Medicine and Rehabilitation help inform how to help kids safely resume exercise.

At the Children’s National Medical Center clinic, children will typically meet with a team of specialists including infectious diseases doctors on the same day, said Dr. Yonts. Psychologists help children with coping skills. Dr. Yonts is careful not to imply that long COVID is a psychological illness. Parents “will just shut down, because for so long, they’ve been told this is all a mental thing.”

In about a third of children, symptoms get better on their own, and most kids get better over time. But many still struggle. “We don’t talk about cure, because we don’t know what cure looks like,” said Dr. Edwards.
 

Vaccination may be best protection

Vaccination seems to help reduce the risk of long COVID, perhaps by as much as half. But parents have been slow to vaccinate children, especially the very young. The AAP reported that, as of Aug. 3, just 5% of children under age 5, 37% of those ages 5-11, and 69% of 12- to 17-year-olds have received at least one dose of a COVID-19 vaccine.

“We have tried to really push vaccine as one of the ways to help prevent some of these long COVID syndromes,” said Dr. Eckard. But that advice is not always welcome. Dr. Eckard told the story of a mother who refused to have her autistic son vaccinated, even as she tearfully pleaded for help with his long COVID symptoms, which had also worsened his autism. The woman told Dr. Eckard: “Nothing you can say will convince me to get him vaccinated.” She thought a vaccine could make his symptoms even worse.

The best prevention is to avoid being infected in the first place.

“The more times you get COVID, the more you increase your risk of getting long COVID,” said Dr. Yonts. “The more times you roll the dice, eventually your number could come up.

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

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Dermatologist arrested for allegedly poisoning radiologist husband

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It is a story that has quickly gone viral around the world: A Mission Viejo, Calif.-based dermatologist has been arrested for allegedly poisoning her husband.

Yue Yu, MD, aged 45, was booked into the Orange County Jail on Aug. 4, after Irvine Police had been called to her residence that day by her husband, Jack Chen, MD, 53, a radiologist. Dr. Chen provided the police with video evidence that he said showed Dr. Yu pouring a drain-opening chemical into his hot lemonade drink.

“The victim sustained significant internal injuries but is expected to recover,” the Irvine police department said in a statement.

Dr. Yu was released after paying a $30,000 bond and has not been formally charged, according to the New York Post.

In a statement to the court on Aug. 5, Dr. Chen said he and the couple’s two children had long suffered verbal abuse from his wife and her mother, according to the Post. Multiple news organizations reported that Dr. Chen filed for divorce and also for a restraining order against Dr. Yu on that day.

After feeling ill for months – and being diagnosed with ulcers and esophageal inflammation – Dr. Chen reportedly set up video cameras in the couple’s house. He said he caught Dr. Yu on camera pouring something into his drink on several occasions in July.

According to NBC News, Dr. Yu’s attorney, David E. Wohl, said that Dr. Yu “vehemently and unequivocally denies ever attempting to poison her husband or anyone else.”

Dr. Yu received her medical degree from Washington University in St. Louis in 2006 and has no disciplinary actions against her, according to the Medical Board of California. She was head of dermatology at Mission Heritage Medical Group, but her name and information have been scrubbed from that group’s website. Mission Heritage is affiliated with Providence Mission Hospital. A spokesperson for the hospital told NBC News that it is cooperating with the police investigation and that no patients are in danger.

The dermatologist is due to report back to court in November, NBC News said.

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

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It is a story that has quickly gone viral around the world: A Mission Viejo, Calif.-based dermatologist has been arrested for allegedly poisoning her husband.

Yue Yu, MD, aged 45, was booked into the Orange County Jail on Aug. 4, after Irvine Police had been called to her residence that day by her husband, Jack Chen, MD, 53, a radiologist. Dr. Chen provided the police with video evidence that he said showed Dr. Yu pouring a drain-opening chemical into his hot lemonade drink.

“The victim sustained significant internal injuries but is expected to recover,” the Irvine police department said in a statement.

Dr. Yu was released after paying a $30,000 bond and has not been formally charged, according to the New York Post.

In a statement to the court on Aug. 5, Dr. Chen said he and the couple’s two children had long suffered verbal abuse from his wife and her mother, according to the Post. Multiple news organizations reported that Dr. Chen filed for divorce and also for a restraining order against Dr. Yu on that day.

After feeling ill for months – and being diagnosed with ulcers and esophageal inflammation – Dr. Chen reportedly set up video cameras in the couple’s house. He said he caught Dr. Yu on camera pouring something into his drink on several occasions in July.

According to NBC News, Dr. Yu’s attorney, David E. Wohl, said that Dr. Yu “vehemently and unequivocally denies ever attempting to poison her husband or anyone else.”

Dr. Yu received her medical degree from Washington University in St. Louis in 2006 and has no disciplinary actions against her, according to the Medical Board of California. She was head of dermatology at Mission Heritage Medical Group, but her name and information have been scrubbed from that group’s website. Mission Heritage is affiliated with Providence Mission Hospital. A spokesperson for the hospital told NBC News that it is cooperating with the police investigation and that no patients are in danger.

The dermatologist is due to report back to court in November, NBC News said.

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

It is a story that has quickly gone viral around the world: A Mission Viejo, Calif.-based dermatologist has been arrested for allegedly poisoning her husband.

Yue Yu, MD, aged 45, was booked into the Orange County Jail on Aug. 4, after Irvine Police had been called to her residence that day by her husband, Jack Chen, MD, 53, a radiologist. Dr. Chen provided the police with video evidence that he said showed Dr. Yu pouring a drain-opening chemical into his hot lemonade drink.

“The victim sustained significant internal injuries but is expected to recover,” the Irvine police department said in a statement.

Dr. Yu was released after paying a $30,000 bond and has not been formally charged, according to the New York Post.

In a statement to the court on Aug. 5, Dr. Chen said he and the couple’s two children had long suffered verbal abuse from his wife and her mother, according to the Post. Multiple news organizations reported that Dr. Chen filed for divorce and also for a restraining order against Dr. Yu on that day.

After feeling ill for months – and being diagnosed with ulcers and esophageal inflammation – Dr. Chen reportedly set up video cameras in the couple’s house. He said he caught Dr. Yu on camera pouring something into his drink on several occasions in July.

According to NBC News, Dr. Yu’s attorney, David E. Wohl, said that Dr. Yu “vehemently and unequivocally denies ever attempting to poison her husband or anyone else.”

Dr. Yu received her medical degree from Washington University in St. Louis in 2006 and has no disciplinary actions against her, according to the Medical Board of California. She was head of dermatology at Mission Heritage Medical Group, but her name and information have been scrubbed from that group’s website. Mission Heritage is affiliated with Providence Mission Hospital. A spokesperson for the hospital told NBC News that it is cooperating with the police investigation and that no patients are in danger.

The dermatologist is due to report back to court in November, NBC News said.

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

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University to train ‘trip facilitators’ for psychedelic therapy

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In September 2022, the University of California, Berkeley, will start training its first class of “trip facilitators,” who will learn how to guide individuals through therapeutic psychedelic experiences aimed at addressing a variety of mental health problems.

The UC Berkeley Center for the Science of Psychedelics (BCSP) training program aims to create a cadre of facilitators who will be ready to help if, and when, substances such as psilocybin, MDMA, and LSD are approved in the United States, Tina Trujillo, PhD, an associate professor at UC Berkeley’s School of Education, told reporters at a press briefing.

Hallucinogenic drugs are on the Drug Enforcement Administration’s (DEA) Schedule I list because they are considered to have no currently accepted medical use and high abuse potential. But there has been an explosion of research into psychedelics – combined with therapy – as treatment for severe depression, posttraumatic stress disorder, substance-use disorder, and other mental health conditions. Some 100 clinical trials are underway.

“The estimates are that we’re going to need 100,000 trained psychedelic facilitators once psilocybin and MDMA are approved by the [U.S. Food and Drug Administration] FDA, which is expected to happen within the next 5 years or so,” said Michael Pollan, co-founder of the BCSP. He is author of “How to Change Your Mind,” a 2018 book about psychedelics, which has been adapted into a four-part docuseries currently streaming on Netflix.

Courtesy Alia Malley
Michael Pollan

 

Nine-month program

The first 24 trainees – a mix of physicians, nurses, psychotherapists, and social workers – will undergo 9 months of education and preparation in “the technical, the cultural, the mystical, and the ethical dimensions of psychedelic facilitation,” said Dr. Trujillo.

The BCSP’s Certificate Program in Psychedelic Facilitation will have “an emphasis on both western science and spiritual care traditions,” she said.

Trainees will receive 150 instructional hours and a 25-hour practicum and will take part in a final 5-day retreat. The program will initially focus only on psilocybin, in part because the BCSP is involved in several FDA-approved trials testing the drug.

In one study – which aims to enroll participants in the fall – researchers will use functional MRI to examine the neural correlates of the psychedelic experience in individuals receiving low-dose psilocybin.

Eligible trainees will have an opportunity to participate in the Berkeley psilocybin trials and “increase their first-hand knowledge,” Dr. Trujillo said.

At the conclusion of the training, students will receive a certificate, “not a license or sanction to go off and practice,” she said. She noted that eventually, when facilitation is legal, certificate holders will be able to practice in clinical research settings or in health care settings.
 

Growing acceptance in psychiatry

Mr. Pollan said there has been a radical change in acceptance of psychedelics as potential therapies.

“The shift from destroyer of young minds in the ‘60s to effective medicine in the 2020s is as sudden as it is confusing for many people,” he said. He noted that the Berkeley center hopes to provide evidence-based information for journalists, the public, and clinicians.

He said that after his book was released, he expected pushback from “mainstream psychiatry.” Instead, he was invited to give grand rounds talks. Psychiatrists are “very open to the potential of psychedelics,” Mr. Pollan said.

“The reason for that, quite frankly, is because they are desperate,” he said. “The tools of conventional psychiatry to deal with things like depression and anxiety and addiction are not very good, and some of them are failing,” he said.

Mr. Pollan cited some other indicators of acceptance. In Oregon, beginning in 2023, psilocybin will be available to anyone older than 21 years but only for use in licensed facilities with licensed facilitators, and the substance must be produced by a licensed manufacturer.

In November, Colorado will ask voters whether they want to follow the Oregon model and legalize psilocybin. If approved, another Colorado ballot initiative would decriminalize possession.

Mr. Pollan noted that Cory Booker, the Democratic Senator from New Jersey, and Rand Paul, a conservative Republican Senator from Kentucky, have found a common cause, introducing legislation to let select terminally ill patients have access to psychedelics and other Schedule I drugs.

Some 400 companies are conducting research on psychedelics. Researchers must have a license from the DEA to obtain and study the substances, Andrea Gomez, assistant professor of neurobiology at UC Berkeley, told reporters.

She said growing interest in the potential of these drugs might lead more researchers to “jump through the hoops” to get the licenses. The floodgates would truly open if the National Institutes of Health started funding studies, she said.

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

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In September 2022, the University of California, Berkeley, will start training its first class of “trip facilitators,” who will learn how to guide individuals through therapeutic psychedelic experiences aimed at addressing a variety of mental health problems.

The UC Berkeley Center for the Science of Psychedelics (BCSP) training program aims to create a cadre of facilitators who will be ready to help if, and when, substances such as psilocybin, MDMA, and LSD are approved in the United States, Tina Trujillo, PhD, an associate professor at UC Berkeley’s School of Education, told reporters at a press briefing.

Hallucinogenic drugs are on the Drug Enforcement Administration’s (DEA) Schedule I list because they are considered to have no currently accepted medical use and high abuse potential. But there has been an explosion of research into psychedelics – combined with therapy – as treatment for severe depression, posttraumatic stress disorder, substance-use disorder, and other mental health conditions. Some 100 clinical trials are underway.

“The estimates are that we’re going to need 100,000 trained psychedelic facilitators once psilocybin and MDMA are approved by the [U.S. Food and Drug Administration] FDA, which is expected to happen within the next 5 years or so,” said Michael Pollan, co-founder of the BCSP. He is author of “How to Change Your Mind,” a 2018 book about psychedelics, which has been adapted into a four-part docuseries currently streaming on Netflix.

Courtesy Alia Malley
Michael Pollan

 

Nine-month program

The first 24 trainees – a mix of physicians, nurses, psychotherapists, and social workers – will undergo 9 months of education and preparation in “the technical, the cultural, the mystical, and the ethical dimensions of psychedelic facilitation,” said Dr. Trujillo.

The BCSP’s Certificate Program in Psychedelic Facilitation will have “an emphasis on both western science and spiritual care traditions,” she said.

Trainees will receive 150 instructional hours and a 25-hour practicum and will take part in a final 5-day retreat. The program will initially focus only on psilocybin, in part because the BCSP is involved in several FDA-approved trials testing the drug.

In one study – which aims to enroll participants in the fall – researchers will use functional MRI to examine the neural correlates of the psychedelic experience in individuals receiving low-dose psilocybin.

Eligible trainees will have an opportunity to participate in the Berkeley psilocybin trials and “increase their first-hand knowledge,” Dr. Trujillo said.

At the conclusion of the training, students will receive a certificate, “not a license or sanction to go off and practice,” she said. She noted that eventually, when facilitation is legal, certificate holders will be able to practice in clinical research settings or in health care settings.
 

Growing acceptance in psychiatry

Mr. Pollan said there has been a radical change in acceptance of psychedelics as potential therapies.

“The shift from destroyer of young minds in the ‘60s to effective medicine in the 2020s is as sudden as it is confusing for many people,” he said. He noted that the Berkeley center hopes to provide evidence-based information for journalists, the public, and clinicians.

He said that after his book was released, he expected pushback from “mainstream psychiatry.” Instead, he was invited to give grand rounds talks. Psychiatrists are “very open to the potential of psychedelics,” Mr. Pollan said.

“The reason for that, quite frankly, is because they are desperate,” he said. “The tools of conventional psychiatry to deal with things like depression and anxiety and addiction are not very good, and some of them are failing,” he said.

Mr. Pollan cited some other indicators of acceptance. In Oregon, beginning in 2023, psilocybin will be available to anyone older than 21 years but only for use in licensed facilities with licensed facilitators, and the substance must be produced by a licensed manufacturer.

In November, Colorado will ask voters whether they want to follow the Oregon model and legalize psilocybin. If approved, another Colorado ballot initiative would decriminalize possession.

Mr. Pollan noted that Cory Booker, the Democratic Senator from New Jersey, and Rand Paul, a conservative Republican Senator from Kentucky, have found a common cause, introducing legislation to let select terminally ill patients have access to psychedelics and other Schedule I drugs.

Some 400 companies are conducting research on psychedelics. Researchers must have a license from the DEA to obtain and study the substances, Andrea Gomez, assistant professor of neurobiology at UC Berkeley, told reporters.

She said growing interest in the potential of these drugs might lead more researchers to “jump through the hoops” to get the licenses. The floodgates would truly open if the National Institutes of Health started funding studies, she said.

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

In September 2022, the University of California, Berkeley, will start training its first class of “trip facilitators,” who will learn how to guide individuals through therapeutic psychedelic experiences aimed at addressing a variety of mental health problems.

The UC Berkeley Center for the Science of Psychedelics (BCSP) training program aims to create a cadre of facilitators who will be ready to help if, and when, substances such as psilocybin, MDMA, and LSD are approved in the United States, Tina Trujillo, PhD, an associate professor at UC Berkeley’s School of Education, told reporters at a press briefing.

Hallucinogenic drugs are on the Drug Enforcement Administration’s (DEA) Schedule I list because they are considered to have no currently accepted medical use and high abuse potential. But there has been an explosion of research into psychedelics – combined with therapy – as treatment for severe depression, posttraumatic stress disorder, substance-use disorder, and other mental health conditions. Some 100 clinical trials are underway.

“The estimates are that we’re going to need 100,000 trained psychedelic facilitators once psilocybin and MDMA are approved by the [U.S. Food and Drug Administration] FDA, which is expected to happen within the next 5 years or so,” said Michael Pollan, co-founder of the BCSP. He is author of “How to Change Your Mind,” a 2018 book about psychedelics, which has been adapted into a four-part docuseries currently streaming on Netflix.

Courtesy Alia Malley
Michael Pollan

 

Nine-month program

The first 24 trainees – a mix of physicians, nurses, psychotherapists, and social workers – will undergo 9 months of education and preparation in “the technical, the cultural, the mystical, and the ethical dimensions of psychedelic facilitation,” said Dr. Trujillo.

The BCSP’s Certificate Program in Psychedelic Facilitation will have “an emphasis on both western science and spiritual care traditions,” she said.

Trainees will receive 150 instructional hours and a 25-hour practicum and will take part in a final 5-day retreat. The program will initially focus only on psilocybin, in part because the BCSP is involved in several FDA-approved trials testing the drug.

In one study – which aims to enroll participants in the fall – researchers will use functional MRI to examine the neural correlates of the psychedelic experience in individuals receiving low-dose psilocybin.

Eligible trainees will have an opportunity to participate in the Berkeley psilocybin trials and “increase their first-hand knowledge,” Dr. Trujillo said.

At the conclusion of the training, students will receive a certificate, “not a license or sanction to go off and practice,” she said. She noted that eventually, when facilitation is legal, certificate holders will be able to practice in clinical research settings or in health care settings.
 

Growing acceptance in psychiatry

Mr. Pollan said there has been a radical change in acceptance of psychedelics as potential therapies.

“The shift from destroyer of young minds in the ‘60s to effective medicine in the 2020s is as sudden as it is confusing for many people,” he said. He noted that the Berkeley center hopes to provide evidence-based information for journalists, the public, and clinicians.

He said that after his book was released, he expected pushback from “mainstream psychiatry.” Instead, he was invited to give grand rounds talks. Psychiatrists are “very open to the potential of psychedelics,” Mr. Pollan said.

“The reason for that, quite frankly, is because they are desperate,” he said. “The tools of conventional psychiatry to deal with things like depression and anxiety and addiction are not very good, and some of them are failing,” he said.

Mr. Pollan cited some other indicators of acceptance. In Oregon, beginning in 2023, psilocybin will be available to anyone older than 21 years but only for use in licensed facilities with licensed facilitators, and the substance must be produced by a licensed manufacturer.

In November, Colorado will ask voters whether they want to follow the Oregon model and legalize psilocybin. If approved, another Colorado ballot initiative would decriminalize possession.

Mr. Pollan noted that Cory Booker, the Democratic Senator from New Jersey, and Rand Paul, a conservative Republican Senator from Kentucky, have found a common cause, introducing legislation to let select terminally ill patients have access to psychedelics and other Schedule I drugs.

Some 400 companies are conducting research on psychedelics. Researchers must have a license from the DEA to obtain and study the substances, Andrea Gomez, assistant professor of neurobiology at UC Berkeley, told reporters.

She said growing interest in the potential of these drugs might lead more researchers to “jump through the hoops” to get the licenses. The floodgates would truly open if the National Institutes of Health started funding studies, she said.

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

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