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FDA approves OTC naloxone, but will cost be a barrier?
Greater access to the drug should mean more lives saved. However, it’s unclear how much the nasal spray will cost and whether pharmacies will stock the product openly on shelves.
Currently, major pharmacy chains such as CVS and Walgreens make naloxone available without prescription, but consumers have to ask a pharmacist to dispense the drug.
“The major question is what is it going to cost,” Brian Hurley, MD, MBA, president-elect of the American Society of Addiction Medicine, said in an interview. “In order for people to access it they have to be able to afford it.”
“We won’t accomplish much if people can’t afford to buy Narcan,” said Chuck Ingoglia, president and CEO of the National Council for Mental Wellbeing, in a statement. Still, he applauded the FDA.
“No single approach will end overdose deaths but making Narcan easy to obtain and widely available likely will save countless lives annually,” he said.
“The timeline for availability and price of this OTC product is determined by the manufacturer,” the FDA said in a statement.
Commissioner Robert M. Califf, MD, called for the drug’s manufacturer to “make accessibility to the product a priority by making it available as soon as possible and at an affordable price.”
Emergent BioSolutions did not comment on cost. It said in a statement that the spray “will be available on U.S. shelves and at online retailers by the late summer,” after it has adapted Narcan for direct-to-consumer use, including more consumer-oriented packaging.
Naloxone’s cost varies, depending on geographic location and whether it is generic. According to GoodRX, a box containing two doses of generic naloxone costs $31-$100, depending on location and coupon availability.
A two-dose box of Narcan costs $135-$140. Emergent reported a 14% decline in naloxone sales in 2022 – to $373.7 million – blaming it in part on the introduction of generic formulations.
Dr. Hurley said he expects those who purchase Narcan at a drug store will primarily already be shopping there. It may or may not be those who most often experience overdose, such as people leaving incarceration or experiencing homelessness.
Having Narcan available over-the-counter “is an important supplement but it doesn’t replace the existing array of naloxone distribution programs,” Dr. Hurley said.
The FDA has encouraged naloxone manufacturers to seek OTC approval for the medication since at least 2019, when it designed a model label for a theoretical OTC product.
In November, the agency said it had determined that some naloxone products had the potential to be safe and effective for OTC use and again urged drugmakers to seek such an approval.
Emergent BioSolutions was the first to pursue OTC approval, but another manufacturer – the nonprofit Harm Reduction Therapeutics – is awaiting approval of its application to sell its spray directly to consumers.
Scott Gottlieb, MD, who was the FDA commissioner from 2017 to 2019, said in a tweet that more work needed to be done.
“This regulatory move should be followed by a strong push by elected officials to support wider deployment of Narcan, getting more doses into the hands of at risk households and frontline workers,” he tweeted.
Mr. Ingoglia said that “Narcan represents a second chance. By giving people a second chance, we also give them an opportunity to enter treatment if they so choose. You can’t recover if you’re dead, and we shouldn’t turn our backs on those who may choose a pathway to recovery that includes treatment.”
A version of this article first appeared on Medscape.com.
Greater access to the drug should mean more lives saved. However, it’s unclear how much the nasal spray will cost and whether pharmacies will stock the product openly on shelves.
Currently, major pharmacy chains such as CVS and Walgreens make naloxone available without prescription, but consumers have to ask a pharmacist to dispense the drug.
“The major question is what is it going to cost,” Brian Hurley, MD, MBA, president-elect of the American Society of Addiction Medicine, said in an interview. “In order for people to access it they have to be able to afford it.”
“We won’t accomplish much if people can’t afford to buy Narcan,” said Chuck Ingoglia, president and CEO of the National Council for Mental Wellbeing, in a statement. Still, he applauded the FDA.
“No single approach will end overdose deaths but making Narcan easy to obtain and widely available likely will save countless lives annually,” he said.
“The timeline for availability and price of this OTC product is determined by the manufacturer,” the FDA said in a statement.
Commissioner Robert M. Califf, MD, called for the drug’s manufacturer to “make accessibility to the product a priority by making it available as soon as possible and at an affordable price.”
Emergent BioSolutions did not comment on cost. It said in a statement that the spray “will be available on U.S. shelves and at online retailers by the late summer,” after it has adapted Narcan for direct-to-consumer use, including more consumer-oriented packaging.
Naloxone’s cost varies, depending on geographic location and whether it is generic. According to GoodRX, a box containing two doses of generic naloxone costs $31-$100, depending on location and coupon availability.
A two-dose box of Narcan costs $135-$140. Emergent reported a 14% decline in naloxone sales in 2022 – to $373.7 million – blaming it in part on the introduction of generic formulations.
Dr. Hurley said he expects those who purchase Narcan at a drug store will primarily already be shopping there. It may or may not be those who most often experience overdose, such as people leaving incarceration or experiencing homelessness.
Having Narcan available over-the-counter “is an important supplement but it doesn’t replace the existing array of naloxone distribution programs,” Dr. Hurley said.
The FDA has encouraged naloxone manufacturers to seek OTC approval for the medication since at least 2019, when it designed a model label for a theoretical OTC product.
In November, the agency said it had determined that some naloxone products had the potential to be safe and effective for OTC use and again urged drugmakers to seek such an approval.
Emergent BioSolutions was the first to pursue OTC approval, but another manufacturer – the nonprofit Harm Reduction Therapeutics – is awaiting approval of its application to sell its spray directly to consumers.
Scott Gottlieb, MD, who was the FDA commissioner from 2017 to 2019, said in a tweet that more work needed to be done.
“This regulatory move should be followed by a strong push by elected officials to support wider deployment of Narcan, getting more doses into the hands of at risk households and frontline workers,” he tweeted.
Mr. Ingoglia said that “Narcan represents a second chance. By giving people a second chance, we also give them an opportunity to enter treatment if they so choose. You can’t recover if you’re dead, and we shouldn’t turn our backs on those who may choose a pathway to recovery that includes treatment.”
A version of this article first appeared on Medscape.com.
Greater access to the drug should mean more lives saved. However, it’s unclear how much the nasal spray will cost and whether pharmacies will stock the product openly on shelves.
Currently, major pharmacy chains such as CVS and Walgreens make naloxone available without prescription, but consumers have to ask a pharmacist to dispense the drug.
“The major question is what is it going to cost,” Brian Hurley, MD, MBA, president-elect of the American Society of Addiction Medicine, said in an interview. “In order for people to access it they have to be able to afford it.”
“We won’t accomplish much if people can’t afford to buy Narcan,” said Chuck Ingoglia, president and CEO of the National Council for Mental Wellbeing, in a statement. Still, he applauded the FDA.
“No single approach will end overdose deaths but making Narcan easy to obtain and widely available likely will save countless lives annually,” he said.
“The timeline for availability and price of this OTC product is determined by the manufacturer,” the FDA said in a statement.
Commissioner Robert M. Califf, MD, called for the drug’s manufacturer to “make accessibility to the product a priority by making it available as soon as possible and at an affordable price.”
Emergent BioSolutions did not comment on cost. It said in a statement that the spray “will be available on U.S. shelves and at online retailers by the late summer,” after it has adapted Narcan for direct-to-consumer use, including more consumer-oriented packaging.
Naloxone’s cost varies, depending on geographic location and whether it is generic. According to GoodRX, a box containing two doses of generic naloxone costs $31-$100, depending on location and coupon availability.
A two-dose box of Narcan costs $135-$140. Emergent reported a 14% decline in naloxone sales in 2022 – to $373.7 million – blaming it in part on the introduction of generic formulations.
Dr. Hurley said he expects those who purchase Narcan at a drug store will primarily already be shopping there. It may or may not be those who most often experience overdose, such as people leaving incarceration or experiencing homelessness.
Having Narcan available over-the-counter “is an important supplement but it doesn’t replace the existing array of naloxone distribution programs,” Dr. Hurley said.
The FDA has encouraged naloxone manufacturers to seek OTC approval for the medication since at least 2019, when it designed a model label for a theoretical OTC product.
In November, the agency said it had determined that some naloxone products had the potential to be safe and effective for OTC use and again urged drugmakers to seek such an approval.
Emergent BioSolutions was the first to pursue OTC approval, but another manufacturer – the nonprofit Harm Reduction Therapeutics – is awaiting approval of its application to sell its spray directly to consumers.
Scott Gottlieb, MD, who was the FDA commissioner from 2017 to 2019, said in a tweet that more work needed to be done.
“This regulatory move should be followed by a strong push by elected officials to support wider deployment of Narcan, getting more doses into the hands of at risk households and frontline workers,” he tweeted.
Mr. Ingoglia said that “Narcan represents a second chance. By giving people a second chance, we also give them an opportunity to enter treatment if they so choose. You can’t recover if you’re dead, and we shouldn’t turn our backs on those who may choose a pathway to recovery that includes treatment.”
A version of this article first appeared on Medscape.com.
FDA moves to stop the spread of illicit ‘tranq’ in the U.S.
The agency issued an import alert, which gives it the power to detain raw ingredients or bulk finished product if the shipments are suspected to be in violation of the law. Xylazine was first approved by the FDA in 1972 as a sedative and analgesic for use only in animals.
It is increasingly being detected and is usually mixed with fentanyl, cocaine, methamphetamine, and other illicit drugs. A January 2023 study by Nashville-based testing company Aegis Sciences found xylazine in 413 of about 60,000 urine samples and in 25 of 39 states that submitted tests. The vast majority of xylazine-positive samples also tested positive for fentanyl.
The FDA said it would continue to ensure the availability of xylazine for veterinary use, and the American Veterinary Medicine Association said in a statement that it “supports such efforts to combat illicit drug use.”
FDA Commissioner Robert M. Califf, MD, said in a statement that the agency “remains concerned about the increasing prevalence of xylazine mixed with illicit drugs, and this action is one part of broader efforts the agency is undertaking to address this issue.”
In November, the agency warned health care providers that because xylazine is not an opioid, the overdose reversal agent naloxone would not be effective. Xylazine acts as a central alpha-2-adrenergic receptor agonist in the brainstem, causing a rapid decrease in the release of norepinephrine and dopamine in the central nervous system. Its use can lead to central nervous system and respiratory depression, said the FDA.
Clinicians have scrambled to treat severe necrotic skin ulcerations that develop at injection sites.
Xylazine is relatively cheap and easy to access, said the Drug Enforcement Administration and Department of Justice in a November joint report. The drug is “readily available for purchase on other Internet sites in liquid and powder form, often with no association to the veterinary profession nor requirements to prove legitimate need,” said the Justice Department. A buyer can purchase xylazine powder online from Chinese suppliers for $6-$20 per kilogram, according to the report.
In 2021, xylazine-positive overdoses were highest in the South, which experienced a 1,127% increase from 2020, the Justice Department reported. The same year, there were 1,281 overdoses involving the substance in the Northeast and 351 in the Midwest.
There were just 34 overdoses involving xylazine in the West in 2021, but its use appears to be growing. The San Francisco Department of Public Health said it had detected low levels of xylazine in four people who died of overdoses in December and January.
“Identifying xylazine in San Francisco is concerning,” said the department in a statement, adding that it had not yet seen evidence of skin wounds in injection drug users in the city.
In late February, the Los Angeles County Department of Public Health issued a warning to first responders and health care professionals that xylazine had been detected in the area’s illicit drug supply.
The department said it will “work closely with other partners to understand the extent of the possible xylazine contamination in the illicit drug supply to increase awareness and education to the public.”
The FDA commissioner said the agency will coordinate with public health officials to more closely track xylazine.
“We will continue to use all tools at our disposal and partner with the Drug Enforcement Administration and other federal, state, local agencies, and stakeholders as appropriate to stem these illicit activities and protect public health,” said Dr. Califf.
A version of this article first appeared on Medscape.com.
The agency issued an import alert, which gives it the power to detain raw ingredients or bulk finished product if the shipments are suspected to be in violation of the law. Xylazine was first approved by the FDA in 1972 as a sedative and analgesic for use only in animals.
It is increasingly being detected and is usually mixed with fentanyl, cocaine, methamphetamine, and other illicit drugs. A January 2023 study by Nashville-based testing company Aegis Sciences found xylazine in 413 of about 60,000 urine samples and in 25 of 39 states that submitted tests. The vast majority of xylazine-positive samples also tested positive for fentanyl.
The FDA said it would continue to ensure the availability of xylazine for veterinary use, and the American Veterinary Medicine Association said in a statement that it “supports such efforts to combat illicit drug use.”
FDA Commissioner Robert M. Califf, MD, said in a statement that the agency “remains concerned about the increasing prevalence of xylazine mixed with illicit drugs, and this action is one part of broader efforts the agency is undertaking to address this issue.”
In November, the agency warned health care providers that because xylazine is not an opioid, the overdose reversal agent naloxone would not be effective. Xylazine acts as a central alpha-2-adrenergic receptor agonist in the brainstem, causing a rapid decrease in the release of norepinephrine and dopamine in the central nervous system. Its use can lead to central nervous system and respiratory depression, said the FDA.
Clinicians have scrambled to treat severe necrotic skin ulcerations that develop at injection sites.
Xylazine is relatively cheap and easy to access, said the Drug Enforcement Administration and Department of Justice in a November joint report. The drug is “readily available for purchase on other Internet sites in liquid and powder form, often with no association to the veterinary profession nor requirements to prove legitimate need,” said the Justice Department. A buyer can purchase xylazine powder online from Chinese suppliers for $6-$20 per kilogram, according to the report.
In 2021, xylazine-positive overdoses were highest in the South, which experienced a 1,127% increase from 2020, the Justice Department reported. The same year, there were 1,281 overdoses involving the substance in the Northeast and 351 in the Midwest.
There were just 34 overdoses involving xylazine in the West in 2021, but its use appears to be growing. The San Francisco Department of Public Health said it had detected low levels of xylazine in four people who died of overdoses in December and January.
“Identifying xylazine in San Francisco is concerning,” said the department in a statement, adding that it had not yet seen evidence of skin wounds in injection drug users in the city.
In late February, the Los Angeles County Department of Public Health issued a warning to first responders and health care professionals that xylazine had been detected in the area’s illicit drug supply.
The department said it will “work closely with other partners to understand the extent of the possible xylazine contamination in the illicit drug supply to increase awareness and education to the public.”
The FDA commissioner said the agency will coordinate with public health officials to more closely track xylazine.
“We will continue to use all tools at our disposal and partner with the Drug Enforcement Administration and other federal, state, local agencies, and stakeholders as appropriate to stem these illicit activities and protect public health,” said Dr. Califf.
A version of this article first appeared on Medscape.com.
The agency issued an import alert, which gives it the power to detain raw ingredients or bulk finished product if the shipments are suspected to be in violation of the law. Xylazine was first approved by the FDA in 1972 as a sedative and analgesic for use only in animals.
It is increasingly being detected and is usually mixed with fentanyl, cocaine, methamphetamine, and other illicit drugs. A January 2023 study by Nashville-based testing company Aegis Sciences found xylazine in 413 of about 60,000 urine samples and in 25 of 39 states that submitted tests. The vast majority of xylazine-positive samples also tested positive for fentanyl.
The FDA said it would continue to ensure the availability of xylazine for veterinary use, and the American Veterinary Medicine Association said in a statement that it “supports such efforts to combat illicit drug use.”
FDA Commissioner Robert M. Califf, MD, said in a statement that the agency “remains concerned about the increasing prevalence of xylazine mixed with illicit drugs, and this action is one part of broader efforts the agency is undertaking to address this issue.”
In November, the agency warned health care providers that because xylazine is not an opioid, the overdose reversal agent naloxone would not be effective. Xylazine acts as a central alpha-2-adrenergic receptor agonist in the brainstem, causing a rapid decrease in the release of norepinephrine and dopamine in the central nervous system. Its use can lead to central nervous system and respiratory depression, said the FDA.
Clinicians have scrambled to treat severe necrotic skin ulcerations that develop at injection sites.
Xylazine is relatively cheap and easy to access, said the Drug Enforcement Administration and Department of Justice in a November joint report. The drug is “readily available for purchase on other Internet sites in liquid and powder form, often with no association to the veterinary profession nor requirements to prove legitimate need,” said the Justice Department. A buyer can purchase xylazine powder online from Chinese suppliers for $6-$20 per kilogram, according to the report.
In 2021, xylazine-positive overdoses were highest in the South, which experienced a 1,127% increase from 2020, the Justice Department reported. The same year, there were 1,281 overdoses involving the substance in the Northeast and 351 in the Midwest.
There were just 34 overdoses involving xylazine in the West in 2021, but its use appears to be growing. The San Francisco Department of Public Health said it had detected low levels of xylazine in four people who died of overdoses in December and January.
“Identifying xylazine in San Francisco is concerning,” said the department in a statement, adding that it had not yet seen evidence of skin wounds in injection drug users in the city.
In late February, the Los Angeles County Department of Public Health issued a warning to first responders and health care professionals that xylazine had been detected in the area’s illicit drug supply.
The department said it will “work closely with other partners to understand the extent of the possible xylazine contamination in the illicit drug supply to increase awareness and education to the public.”
The FDA commissioner said the agency will coordinate with public health officials to more closely track xylazine.
“We will continue to use all tools at our disposal and partner with the Drug Enforcement Administration and other federal, state, local agencies, and stakeholders as appropriate to stem these illicit activities and protect public health,” said Dr. Califf.
A version of this article first appeared on Medscape.com.
DEA proposals on telehealth for controlled substances draw fire
The proposed rules – one for Schedule III-V substances, and the other for buprenorphine – are due to go into effect on May 11, when the COVID-19 public health emergency (PHE), and temporary flexibilities, end.
Essentially, both proposals would allow providers to prescribe a 30-day supply of a controlled substance or buprenorphine, but then require a face-to-face meeting for patients to receive additional prescriptions.
The DEA says that the rules are aimed at preventing abuse and diversion of the substances, but clinicians claim they are creating unnecessary hurdles that will probably lead to some patients dropping out of treatment.
“We were happy to see that there is ongoing flexibility to be able to initiate buprenorphine through telehealth, but we were disappointed to see that the DEA set an arbitrary time frame, in this case, a 30-day time frame after which the patient would have to be seen in person before ongoing care with buprenorphine for opioid use disorder could be provided,” Brian Hurley, MD, MBA, the president-elect of the American Society of Addiction Medicine told this news organization.
Dr. Hurley agreed that it is best practice to see patients in person for ongoing care, but he noted they have many reasons why they might not be able to make it into an office every month.
“What this rule would do if instituted as written is prevent me from continuing care for patients unless I can get them in in person,” he said. “And while I’d make every effort as a clinician, it’s not always feasible to do so.”
The addiction specialist noted that only about 20% of Americans with opioid use disorder have access to medications for the disorder. “I would posit that untreated opioid use disorder is a bigger threat to public safety currently than the risk of diversion,” he said.
The DEA is also proposing to allow state laws to supersede its regulations, which concerns Dr. Hurley and other clinicians because some states are more restrictive. “Our position is that state laws that restrict access to medications for opioid use disorder through telehealth means are inconsistent with our policy recommendation. I certainly hope that the DEA hears our concerns and amends the proposal,” said Dr. Hurley.
A potential ‘telehealth cliff’
Shabana Khan, MD, chair of the American Psychiatric Association’s telepsychiatry committee, said that “because of potential overlap with state rules that may be more stringent than these new regulations, APA is concerned that the proposed rules will create a telehealth cliff for those in most need of critical psychiatric and opioid use disorder treatment, particularly in communities where this specialty care is limited or nonexistent.”
Dr. Khan noted that “clarification is necessary on how patients who started treatment during the PHE can continue treatment with a prescribing provider, if at all, through an in-person evaluation with a DEA-registered provider referral.”
Telehealth companies were also disappointed in the DEA proposals.
“The continuity of care for countless Americans will be severed, potentially leaving these patients to fall through the cracks of our health care system without access to needed medications,” said Kyle Zebley, the American Telemedicine Association’s senior vice president of public policy, in a statement.
“Requiring every patient who has initiated treatment via telemedicine during the pandemic to now visit a provider in person clearly falls on the side of being overly restrictive,” Mr. Zebley added.
The DEA is proposing to allow patients who have been receiving telehealth over the past 3 years to continue to do so for 180 days after the PHE ends.
But the American Telemedicine Association and others said that they still want to see a change in the proposal as written. “Our hope is that the DEA works with us to avoid unnecessary and inappropriate restrictions on the prescription of essential medications for these vulnerable and underserved populations,” Mr. Zebley said in the statement.
DEA Administrator Anne Milgram said in a statement that the agency believes that “the telemedicine regulations would continue to expand access to buprenorphine for patients with opioid use disorder,” and that the DEA “is committed to the expansion of telemedicine with guardrails that prevent the online overprescribing of controlled medications that can cause harm.”
Rahul Gupta, MD, director of the White House Office of National Drug Control Policy, said in a statement that “This proposed rule builds on President Biden’s historic move to eliminate the X-waiver that prevented many prescribers from treating patients with buprenorphine.” He added, “Thanks to these changes, millions of Americans will be able to access the lifesaving care they need.”
The DEA estimated that there were 15.7 million prescriptions for buprenorphine in 2021 and that about 67,000 were for initial prescriptions.
Ketamine confusion
The rule on controlled substances has also caused some consternation, especially given that it does not differentiate between racemic ketamine and esketamine, said Lisa Marie Harding, MD, vice president of the board of the American Society of Ketamine Physicians, Psychotherapists & Practitioners.
Esketamine (Spravato) is approved by the Food and Drug Administration and, under a Risk Evaluation and Mitigation Strategy, can only be administered in FDA-monitored treatment facilities. Racemic ketamine is being prescribed – often for home use – with almost no regulatory oversight.
Dr. Harding, who is an approved Spravato provider and also administers intravenous ketamine in her practice, does not believe that ketamine should be used at home without supervision.
“I had a patient who had a very powerful dissociative experience in my office earlier this week,” Dr. Harding said in an interview. One of her staff asked what would happen if the patient had experienced that at home. “We don’t know. Nor do we want this to happen,” said Dr. Harding.
However, the DEA proposal would continue to allow for home use, at least initially. “If it’s open to interpretation, those people that prescribe ketamine for home use can use that leeway to then continue to do it,” she said. “That is not safe.”
Dr. Harding approves of the proposed DEA requirement for face-to-face visits. “It’s good patient care,” she said. But she wants the administration to adjust the rules to make it harder to offer home ketamine therapy.
“Lots of people are using racemic ketamine off-label for treating depression with success but doing it in treatment settings that are appropriate,” said Dr. Harding.
Dr. Hurley and Dr. Harding report no relevant financial relationships.
A version of this article first appeared on Medscape.com.
The proposed rules – one for Schedule III-V substances, and the other for buprenorphine – are due to go into effect on May 11, when the COVID-19 public health emergency (PHE), and temporary flexibilities, end.
Essentially, both proposals would allow providers to prescribe a 30-day supply of a controlled substance or buprenorphine, but then require a face-to-face meeting for patients to receive additional prescriptions.
The DEA says that the rules are aimed at preventing abuse and diversion of the substances, but clinicians claim they are creating unnecessary hurdles that will probably lead to some patients dropping out of treatment.
“We were happy to see that there is ongoing flexibility to be able to initiate buprenorphine through telehealth, but we were disappointed to see that the DEA set an arbitrary time frame, in this case, a 30-day time frame after which the patient would have to be seen in person before ongoing care with buprenorphine for opioid use disorder could be provided,” Brian Hurley, MD, MBA, the president-elect of the American Society of Addiction Medicine told this news organization.
Dr. Hurley agreed that it is best practice to see patients in person for ongoing care, but he noted they have many reasons why they might not be able to make it into an office every month.
“What this rule would do if instituted as written is prevent me from continuing care for patients unless I can get them in in person,” he said. “And while I’d make every effort as a clinician, it’s not always feasible to do so.”
The addiction specialist noted that only about 20% of Americans with opioid use disorder have access to medications for the disorder. “I would posit that untreated opioid use disorder is a bigger threat to public safety currently than the risk of diversion,” he said.
The DEA is also proposing to allow state laws to supersede its regulations, which concerns Dr. Hurley and other clinicians because some states are more restrictive. “Our position is that state laws that restrict access to medications for opioid use disorder through telehealth means are inconsistent with our policy recommendation. I certainly hope that the DEA hears our concerns and amends the proposal,” said Dr. Hurley.
A potential ‘telehealth cliff’
Shabana Khan, MD, chair of the American Psychiatric Association’s telepsychiatry committee, said that “because of potential overlap with state rules that may be more stringent than these new regulations, APA is concerned that the proposed rules will create a telehealth cliff for those in most need of critical psychiatric and opioid use disorder treatment, particularly in communities where this specialty care is limited or nonexistent.”
Dr. Khan noted that “clarification is necessary on how patients who started treatment during the PHE can continue treatment with a prescribing provider, if at all, through an in-person evaluation with a DEA-registered provider referral.”
Telehealth companies were also disappointed in the DEA proposals.
“The continuity of care for countless Americans will be severed, potentially leaving these patients to fall through the cracks of our health care system without access to needed medications,” said Kyle Zebley, the American Telemedicine Association’s senior vice president of public policy, in a statement.
“Requiring every patient who has initiated treatment via telemedicine during the pandemic to now visit a provider in person clearly falls on the side of being overly restrictive,” Mr. Zebley added.
The DEA is proposing to allow patients who have been receiving telehealth over the past 3 years to continue to do so for 180 days after the PHE ends.
But the American Telemedicine Association and others said that they still want to see a change in the proposal as written. “Our hope is that the DEA works with us to avoid unnecessary and inappropriate restrictions on the prescription of essential medications for these vulnerable and underserved populations,” Mr. Zebley said in the statement.
DEA Administrator Anne Milgram said in a statement that the agency believes that “the telemedicine regulations would continue to expand access to buprenorphine for patients with opioid use disorder,” and that the DEA “is committed to the expansion of telemedicine with guardrails that prevent the online overprescribing of controlled medications that can cause harm.”
Rahul Gupta, MD, director of the White House Office of National Drug Control Policy, said in a statement that “This proposed rule builds on President Biden’s historic move to eliminate the X-waiver that prevented many prescribers from treating patients with buprenorphine.” He added, “Thanks to these changes, millions of Americans will be able to access the lifesaving care they need.”
The DEA estimated that there were 15.7 million prescriptions for buprenorphine in 2021 and that about 67,000 were for initial prescriptions.
Ketamine confusion
The rule on controlled substances has also caused some consternation, especially given that it does not differentiate between racemic ketamine and esketamine, said Lisa Marie Harding, MD, vice president of the board of the American Society of Ketamine Physicians, Psychotherapists & Practitioners.
Esketamine (Spravato) is approved by the Food and Drug Administration and, under a Risk Evaluation and Mitigation Strategy, can only be administered in FDA-monitored treatment facilities. Racemic ketamine is being prescribed – often for home use – with almost no regulatory oversight.
Dr. Harding, who is an approved Spravato provider and also administers intravenous ketamine in her practice, does not believe that ketamine should be used at home without supervision.
“I had a patient who had a very powerful dissociative experience in my office earlier this week,” Dr. Harding said in an interview. One of her staff asked what would happen if the patient had experienced that at home. “We don’t know. Nor do we want this to happen,” said Dr. Harding.
However, the DEA proposal would continue to allow for home use, at least initially. “If it’s open to interpretation, those people that prescribe ketamine for home use can use that leeway to then continue to do it,” she said. “That is not safe.”
Dr. Harding approves of the proposed DEA requirement for face-to-face visits. “It’s good patient care,” she said. But she wants the administration to adjust the rules to make it harder to offer home ketamine therapy.
“Lots of people are using racemic ketamine off-label for treating depression with success but doing it in treatment settings that are appropriate,” said Dr. Harding.
Dr. Hurley and Dr. Harding report no relevant financial relationships.
A version of this article first appeared on Medscape.com.
The proposed rules – one for Schedule III-V substances, and the other for buprenorphine – are due to go into effect on May 11, when the COVID-19 public health emergency (PHE), and temporary flexibilities, end.
Essentially, both proposals would allow providers to prescribe a 30-day supply of a controlled substance or buprenorphine, but then require a face-to-face meeting for patients to receive additional prescriptions.
The DEA says that the rules are aimed at preventing abuse and diversion of the substances, but clinicians claim they are creating unnecessary hurdles that will probably lead to some patients dropping out of treatment.
“We were happy to see that there is ongoing flexibility to be able to initiate buprenorphine through telehealth, but we were disappointed to see that the DEA set an arbitrary time frame, in this case, a 30-day time frame after which the patient would have to be seen in person before ongoing care with buprenorphine for opioid use disorder could be provided,” Brian Hurley, MD, MBA, the president-elect of the American Society of Addiction Medicine told this news organization.
Dr. Hurley agreed that it is best practice to see patients in person for ongoing care, but he noted they have many reasons why they might not be able to make it into an office every month.
“What this rule would do if instituted as written is prevent me from continuing care for patients unless I can get them in in person,” he said. “And while I’d make every effort as a clinician, it’s not always feasible to do so.”
The addiction specialist noted that only about 20% of Americans with opioid use disorder have access to medications for the disorder. “I would posit that untreated opioid use disorder is a bigger threat to public safety currently than the risk of diversion,” he said.
The DEA is also proposing to allow state laws to supersede its regulations, which concerns Dr. Hurley and other clinicians because some states are more restrictive. “Our position is that state laws that restrict access to medications for opioid use disorder through telehealth means are inconsistent with our policy recommendation. I certainly hope that the DEA hears our concerns and amends the proposal,” said Dr. Hurley.
A potential ‘telehealth cliff’
Shabana Khan, MD, chair of the American Psychiatric Association’s telepsychiatry committee, said that “because of potential overlap with state rules that may be more stringent than these new regulations, APA is concerned that the proposed rules will create a telehealth cliff for those in most need of critical psychiatric and opioid use disorder treatment, particularly in communities where this specialty care is limited or nonexistent.”
Dr. Khan noted that “clarification is necessary on how patients who started treatment during the PHE can continue treatment with a prescribing provider, if at all, through an in-person evaluation with a DEA-registered provider referral.”
Telehealth companies were also disappointed in the DEA proposals.
“The continuity of care for countless Americans will be severed, potentially leaving these patients to fall through the cracks of our health care system without access to needed medications,” said Kyle Zebley, the American Telemedicine Association’s senior vice president of public policy, in a statement.
“Requiring every patient who has initiated treatment via telemedicine during the pandemic to now visit a provider in person clearly falls on the side of being overly restrictive,” Mr. Zebley added.
The DEA is proposing to allow patients who have been receiving telehealth over the past 3 years to continue to do so for 180 days after the PHE ends.
But the American Telemedicine Association and others said that they still want to see a change in the proposal as written. “Our hope is that the DEA works with us to avoid unnecessary and inappropriate restrictions on the prescription of essential medications for these vulnerable and underserved populations,” Mr. Zebley said in the statement.
DEA Administrator Anne Milgram said in a statement that the agency believes that “the telemedicine regulations would continue to expand access to buprenorphine for patients with opioid use disorder,” and that the DEA “is committed to the expansion of telemedicine with guardrails that prevent the online overprescribing of controlled medications that can cause harm.”
Rahul Gupta, MD, director of the White House Office of National Drug Control Policy, said in a statement that “This proposed rule builds on President Biden’s historic move to eliminate the X-waiver that prevented many prescribers from treating patients with buprenorphine.” He added, “Thanks to these changes, millions of Americans will be able to access the lifesaving care they need.”
The DEA estimated that there were 15.7 million prescriptions for buprenorphine in 2021 and that about 67,000 were for initial prescriptions.
Ketamine confusion
The rule on controlled substances has also caused some consternation, especially given that it does not differentiate between racemic ketamine and esketamine, said Lisa Marie Harding, MD, vice president of the board of the American Society of Ketamine Physicians, Psychotherapists & Practitioners.
Esketamine (Spravato) is approved by the Food and Drug Administration and, under a Risk Evaluation and Mitigation Strategy, can only be administered in FDA-monitored treatment facilities. Racemic ketamine is being prescribed – often for home use – with almost no regulatory oversight.
Dr. Harding, who is an approved Spravato provider and also administers intravenous ketamine in her practice, does not believe that ketamine should be used at home without supervision.
“I had a patient who had a very powerful dissociative experience in my office earlier this week,” Dr. Harding said in an interview. One of her staff asked what would happen if the patient had experienced that at home. “We don’t know. Nor do we want this to happen,” said Dr. Harding.
However, the DEA proposal would continue to allow for home use, at least initially. “If it’s open to interpretation, those people that prescribe ketamine for home use can use that leeway to then continue to do it,” she said. “That is not safe.”
Dr. Harding approves of the proposed DEA requirement for face-to-face visits. “It’s good patient care,” she said. But she wants the administration to adjust the rules to make it harder to offer home ketamine therapy.
“Lots of people are using racemic ketamine off-label for treating depression with success but doing it in treatment settings that are appropriate,” said Dr. Harding.
Dr. Hurley and Dr. Harding report no relevant financial relationships.
A version of this article first appeared on Medscape.com.
Physician pleads guilty to 52 counts in opioid scheme
Jeffrey B. Sutton, DO, a neuromuscular medicine specialist, pled guilty on January 30 in federal court to 31 counts of illegally prescribing opioids and other controlled substances, 1 count of illegally distributing controlled substances, and 20 counts of health care fraud.
Prosecutors said Dr. Sutton admitted that he ignored warnings from prescription drug management organizations, insurers, and state authorities that he was prescribing excessively high dosages of opioids.
Dr. Sutton also admitted to ignoring patient requests to lower dosages and that he also ignored signs that patients were selling prescribed medications or otherwise engaging in illicit activity, including violations of a “pain management agreement” that he required them to sign.
The fraud counts pertained to Dr. Sutton billing Medicare, Medicaid, and other insurers for medically unnecessary visits that he required of patients so that he could prescribe inappropriate or unnecessary opioids.
In the charging document shared with this news organization, prosecutors said Dr. Sutton had sex with at least three patients, including during office visits and outside of the office. Occasionally, the physician would give opioids or other controlled substances – often benzodiazepines – to these patients, without a prescription or valid medical need.
Dr. Sutton escalated the dosage for one of those patients, even as the subjective pain score did not improve and when the patient’s urine tests showed the presence of THC and buprenorphine, but not any of the prescribed medications.
Another patient came to Dr. Sutton in 2007 with a warning that she had a history of “narcotic-seeking” behavior and diagnoses of depression, anxiety, paranoid schizophrenia, and obsessive-compulsive disorder.
The patient was hospitalized in 2018 for complications from benzodiazepine use (prescribed by Dr. Sutton). She weighed 80 pounds at the time. Dr. Sutton continued to prescribe benzodiazepines and extreme doses of opioids – in excess of 2,000 morphine equivalent dose – “despite recognizing and documenting repeated instances of noncompliance with treatment for psychiatric conditions, and despite the known contraindications of long-term opioid use for patients with these mental illnesses,” according to the charging document.
Dr. Sutton continued to prescribe opioids despite two hospitalizations for overdoses, more than 20 failed urine drug screens that showed presence of illicit drugs such as cocaine, and documented excessive use of alprazolam (Xanax) and methadone.
The physician surrendered his Drug Enforcement Administration Certificate of Registration of Controlled Substances Privileges in February 2022 “as an indication of your good faith in desiring to remedy any incorrect or unlawful practices on your part,” according to a letter to Dr. Sutton from the State Medical Board of Ohio. In that September 2022 letter, the Board notified Dr. Sutton of its intention to possibly suspend or revoke his license.
Dr. Sutton did not request a hearing, and the Board permanently revoked his medical license on January 16.
The court will sentence Dr. Sutton on May 23, according to a report by WFMJ.
A version of this article originally appeared on Medscape.com.
Jeffrey B. Sutton, DO, a neuromuscular medicine specialist, pled guilty on January 30 in federal court to 31 counts of illegally prescribing opioids and other controlled substances, 1 count of illegally distributing controlled substances, and 20 counts of health care fraud.
Prosecutors said Dr. Sutton admitted that he ignored warnings from prescription drug management organizations, insurers, and state authorities that he was prescribing excessively high dosages of opioids.
Dr. Sutton also admitted to ignoring patient requests to lower dosages and that he also ignored signs that patients were selling prescribed medications or otherwise engaging in illicit activity, including violations of a “pain management agreement” that he required them to sign.
The fraud counts pertained to Dr. Sutton billing Medicare, Medicaid, and other insurers for medically unnecessary visits that he required of patients so that he could prescribe inappropriate or unnecessary opioids.
In the charging document shared with this news organization, prosecutors said Dr. Sutton had sex with at least three patients, including during office visits and outside of the office. Occasionally, the physician would give opioids or other controlled substances – often benzodiazepines – to these patients, without a prescription or valid medical need.
Dr. Sutton escalated the dosage for one of those patients, even as the subjective pain score did not improve and when the patient’s urine tests showed the presence of THC and buprenorphine, but not any of the prescribed medications.
Another patient came to Dr. Sutton in 2007 with a warning that she had a history of “narcotic-seeking” behavior and diagnoses of depression, anxiety, paranoid schizophrenia, and obsessive-compulsive disorder.
The patient was hospitalized in 2018 for complications from benzodiazepine use (prescribed by Dr. Sutton). She weighed 80 pounds at the time. Dr. Sutton continued to prescribe benzodiazepines and extreme doses of opioids – in excess of 2,000 morphine equivalent dose – “despite recognizing and documenting repeated instances of noncompliance with treatment for psychiatric conditions, and despite the known contraindications of long-term opioid use for patients with these mental illnesses,” according to the charging document.
Dr. Sutton continued to prescribe opioids despite two hospitalizations for overdoses, more than 20 failed urine drug screens that showed presence of illicit drugs such as cocaine, and documented excessive use of alprazolam (Xanax) and methadone.
The physician surrendered his Drug Enforcement Administration Certificate of Registration of Controlled Substances Privileges in February 2022 “as an indication of your good faith in desiring to remedy any incorrect or unlawful practices on your part,” according to a letter to Dr. Sutton from the State Medical Board of Ohio. In that September 2022 letter, the Board notified Dr. Sutton of its intention to possibly suspend or revoke his license.
Dr. Sutton did not request a hearing, and the Board permanently revoked his medical license on January 16.
The court will sentence Dr. Sutton on May 23, according to a report by WFMJ.
A version of this article originally appeared on Medscape.com.
Jeffrey B. Sutton, DO, a neuromuscular medicine specialist, pled guilty on January 30 in federal court to 31 counts of illegally prescribing opioids and other controlled substances, 1 count of illegally distributing controlled substances, and 20 counts of health care fraud.
Prosecutors said Dr. Sutton admitted that he ignored warnings from prescription drug management organizations, insurers, and state authorities that he was prescribing excessively high dosages of opioids.
Dr. Sutton also admitted to ignoring patient requests to lower dosages and that he also ignored signs that patients were selling prescribed medications or otherwise engaging in illicit activity, including violations of a “pain management agreement” that he required them to sign.
The fraud counts pertained to Dr. Sutton billing Medicare, Medicaid, and other insurers for medically unnecessary visits that he required of patients so that he could prescribe inappropriate or unnecessary opioids.
In the charging document shared with this news organization, prosecutors said Dr. Sutton had sex with at least three patients, including during office visits and outside of the office. Occasionally, the physician would give opioids or other controlled substances – often benzodiazepines – to these patients, without a prescription or valid medical need.
Dr. Sutton escalated the dosage for one of those patients, even as the subjective pain score did not improve and when the patient’s urine tests showed the presence of THC and buprenorphine, but not any of the prescribed medications.
Another patient came to Dr. Sutton in 2007 with a warning that she had a history of “narcotic-seeking” behavior and diagnoses of depression, anxiety, paranoid schizophrenia, and obsessive-compulsive disorder.
The patient was hospitalized in 2018 for complications from benzodiazepine use (prescribed by Dr. Sutton). She weighed 80 pounds at the time. Dr. Sutton continued to prescribe benzodiazepines and extreme doses of opioids – in excess of 2,000 morphine equivalent dose – “despite recognizing and documenting repeated instances of noncompliance with treatment for psychiatric conditions, and despite the known contraindications of long-term opioid use for patients with these mental illnesses,” according to the charging document.
Dr. Sutton continued to prescribe opioids despite two hospitalizations for overdoses, more than 20 failed urine drug screens that showed presence of illicit drugs such as cocaine, and documented excessive use of alprazolam (Xanax) and methadone.
The physician surrendered his Drug Enforcement Administration Certificate of Registration of Controlled Substances Privileges in February 2022 “as an indication of your good faith in desiring to remedy any incorrect or unlawful practices on your part,” according to a letter to Dr. Sutton from the State Medical Board of Ohio. In that September 2022 letter, the Board notified Dr. Sutton of its intention to possibly suspend or revoke his license.
Dr. Sutton did not request a hearing, and the Board permanently revoked his medical license on January 16.
The court will sentence Dr. Sutton on May 23, according to a report by WFMJ.
A version of this article originally appeared on Medscape.com.
Feds charge 25 nursing school execs, staff in fake diploma scheme
The U.S. Department of Justice recently announced charges against 25 owners, operators, and employees of three Florida nursing schools in a fraud scheme in which they sold as many as 7,600 fake nursing degrees.
The purchasers in the diploma scheme paid $10,000 to $15,000 for degrees and transcripts and some 2,800 of the buyers passed the national nursing licensing exam to become registered nurses (RNs) and licensed practice nurses/vocational nurses (LPN/VNs) around the country, according to The New York Times.
Many of the degree recipients went on to work at hospitals, nursing homes, and Veterans Affairs medical centers, according to the U.S. Attorney’s Office for the Southern District of Florida.
Several national nursing organizations cooperated with the investigation, and the Delaware Division of Professional Regulation already annulled 26 licenses, according to the Delaware Nurses Association. Fake licenses were issued in five states, according to federal reports.
“We are deeply unsettled by this egregious act,” DNA President Stephanie McClellan, MSN, RN, CMSRN, said in the group’s press statement. “We want all Delaware nurses to be aware of this active issue and to speak up if there is a concern regarding capacity to practice safely by a colleague/peer,” she said.
The Oregon State Board of Nursing is also investigating at least a dozen nurses who may have paid for their degrees, according to a Portland CBS affiliate.
The National Council of State Boards of Nursing said in a statement that it had helped authorities identify and monitor the individuals who allegedly provided the false degrees.
Nursing community reacts
News of the fraud scheme spread through the nursing community, including social media. “The recent report on falsified nursing school degrees is both heartbreaking and serves as an eye-opener,” tweeted Usha Menon, PhD, RN, FAAN, dean and health professor of the University of South Florida Health College of Nursing. “There was enough of a need that prompted these bad actors to develop a scheme that could’ve endangered dozens of lives.”
Jennifer Mensik Kennedy, PhD, MBA, RN, the new president of the American Nurses Association, also weighed in. “The accusation that personnel at once-accredited nursing schools allegedly participated in this scheme is simply deplorable. These unlawful and unethical acts disparage the reputation of actual nurses everywhere who have rightfully earned [their titles] through their education, hard work, dedication, and time.”
The false degrees and transcripts were issued by three once-accredited and now-shuttered nursing schools in South Florida: Palm Beach School of Nursing, Sacred Heart International Institute, and Sienna College.
The alleged co-conspirators reportedly made $114 million from the scheme, which dates back to 2016, according to several news reports. Each defendant faces up to 20 years in prison.
Most LPN programs charge $10,000 to $15,000 to complete a program, Robert Rosseter, a spokesperson for the American Association of Colleges of Nursing (AACN), told this news organization.
None were AACN members, and none were accredited by the Commission on Collegiate Nursing Education, which is AACN’s autonomous accrediting agency, Mr. Rosseter said. AACN membership is voluntary and is open to schools offering baccalaureate or higher degrees, he explained.
“What is disturbing about this investigation is that there are over 7,600 people around the country with fraudulent nursing credentials who are potentially in critical health care roles treating patients,” Chad Yarbrough, acting special agent in charge for the FBI in Miami, said in the federal justice department release.
‘Operation Nightingale’ based on tip
The federal action, dubbed “Operation Nightingale” after the nursing pioneer Florence Nightingale, began in 2019. It was based on a tip related to a case in Maryland, according to Nurse.org.
That case ensnared Palm Beach School of Nursing owner Johanah Napoleon, who reportedly was selling fake degrees for $6,000 to $18,000 each to two individuals in Maryland and Virginia. Ms. Napoleon was charged in 2021 and eventually pled guilty. The Florida Board of Nursing shut down the Palm Beach school in 2017 owing to its students’ low passing rate on the national licensing exam.
Two participants in the bigger scheme who had also worked with Ms. Napoleon – Geralda Adrien and Woosvelt Predestin – were indicted in 2021. Ms. Adrien owned private education companies for people who at aspired to be nurses, and Mr. Predestin was an employee. They were sentenced to 27 months in prison last year and helped the federal officials build the larger case.
The 25 individuals who were charged Jan. 25 operated in Delaware, New York, New Jersey, Texas, and Florida.
Schemes lured immigrants
In the scheme involving Siena College, some of the individuals acted as recruiters to direct nurses who were looking for employment to the school, where they allegedly would then pay for an RN or LPN/VN degree. The recipients of the false documents then used them to obtain jobs, including at a hospital in Georgia and a Veterans Affairs medical center in Maryland, according to one indictment. The president of Siena and her co-conspirators sold more than 2,000 fake diplomas, according to charging documents.
At the Palm Beach College of Nursing, individuals at various nursing prep and education programs allegedly helped others obtain fake degrees and transcripts, which were then used to pass RN and LPN/VN licensing exams in states that included Massachusetts, New Jersey, New York, and Ohio, according to the indictment.
Some individuals then secured employment with a nursing home in Ohio, a home health agency for pediatric patients in Massachusetts, and skilled nursing facilities in New York and New Jersey.
Prosecutors allege that the president of Sacred Heart International Institute and two other co-conspirators sold 588 fake diplomas.
The FBI said that some of the aspiring nurses who were talked into buying the degrees were LPNs who wanted to become RNs and that most of those lured into the scheme were from South Florida’s Haitian American immigrant community, Nurse.org reported.
A version of this article first appeared on Medscape.com.
The U.S. Department of Justice recently announced charges against 25 owners, operators, and employees of three Florida nursing schools in a fraud scheme in which they sold as many as 7,600 fake nursing degrees.
The purchasers in the diploma scheme paid $10,000 to $15,000 for degrees and transcripts and some 2,800 of the buyers passed the national nursing licensing exam to become registered nurses (RNs) and licensed practice nurses/vocational nurses (LPN/VNs) around the country, according to The New York Times.
Many of the degree recipients went on to work at hospitals, nursing homes, and Veterans Affairs medical centers, according to the U.S. Attorney’s Office for the Southern District of Florida.
Several national nursing organizations cooperated with the investigation, and the Delaware Division of Professional Regulation already annulled 26 licenses, according to the Delaware Nurses Association. Fake licenses were issued in five states, according to federal reports.
“We are deeply unsettled by this egregious act,” DNA President Stephanie McClellan, MSN, RN, CMSRN, said in the group’s press statement. “We want all Delaware nurses to be aware of this active issue and to speak up if there is a concern regarding capacity to practice safely by a colleague/peer,” she said.
The Oregon State Board of Nursing is also investigating at least a dozen nurses who may have paid for their degrees, according to a Portland CBS affiliate.
The National Council of State Boards of Nursing said in a statement that it had helped authorities identify and monitor the individuals who allegedly provided the false degrees.
Nursing community reacts
News of the fraud scheme spread through the nursing community, including social media. “The recent report on falsified nursing school degrees is both heartbreaking and serves as an eye-opener,” tweeted Usha Menon, PhD, RN, FAAN, dean and health professor of the University of South Florida Health College of Nursing. “There was enough of a need that prompted these bad actors to develop a scheme that could’ve endangered dozens of lives.”
Jennifer Mensik Kennedy, PhD, MBA, RN, the new president of the American Nurses Association, also weighed in. “The accusation that personnel at once-accredited nursing schools allegedly participated in this scheme is simply deplorable. These unlawful and unethical acts disparage the reputation of actual nurses everywhere who have rightfully earned [their titles] through their education, hard work, dedication, and time.”
The false degrees and transcripts were issued by three once-accredited and now-shuttered nursing schools in South Florida: Palm Beach School of Nursing, Sacred Heart International Institute, and Sienna College.
The alleged co-conspirators reportedly made $114 million from the scheme, which dates back to 2016, according to several news reports. Each defendant faces up to 20 years in prison.
Most LPN programs charge $10,000 to $15,000 to complete a program, Robert Rosseter, a spokesperson for the American Association of Colleges of Nursing (AACN), told this news organization.
None were AACN members, and none were accredited by the Commission on Collegiate Nursing Education, which is AACN’s autonomous accrediting agency, Mr. Rosseter said. AACN membership is voluntary and is open to schools offering baccalaureate or higher degrees, he explained.
“What is disturbing about this investigation is that there are over 7,600 people around the country with fraudulent nursing credentials who are potentially in critical health care roles treating patients,” Chad Yarbrough, acting special agent in charge for the FBI in Miami, said in the federal justice department release.
‘Operation Nightingale’ based on tip
The federal action, dubbed “Operation Nightingale” after the nursing pioneer Florence Nightingale, began in 2019. It was based on a tip related to a case in Maryland, according to Nurse.org.
That case ensnared Palm Beach School of Nursing owner Johanah Napoleon, who reportedly was selling fake degrees for $6,000 to $18,000 each to two individuals in Maryland and Virginia. Ms. Napoleon was charged in 2021 and eventually pled guilty. The Florida Board of Nursing shut down the Palm Beach school in 2017 owing to its students’ low passing rate on the national licensing exam.
Two participants in the bigger scheme who had also worked with Ms. Napoleon – Geralda Adrien and Woosvelt Predestin – were indicted in 2021. Ms. Adrien owned private education companies for people who at aspired to be nurses, and Mr. Predestin was an employee. They were sentenced to 27 months in prison last year and helped the federal officials build the larger case.
The 25 individuals who were charged Jan. 25 operated in Delaware, New York, New Jersey, Texas, and Florida.
Schemes lured immigrants
In the scheme involving Siena College, some of the individuals acted as recruiters to direct nurses who were looking for employment to the school, where they allegedly would then pay for an RN or LPN/VN degree. The recipients of the false documents then used them to obtain jobs, including at a hospital in Georgia and a Veterans Affairs medical center in Maryland, according to one indictment. The president of Siena and her co-conspirators sold more than 2,000 fake diplomas, according to charging documents.
At the Palm Beach College of Nursing, individuals at various nursing prep and education programs allegedly helped others obtain fake degrees and transcripts, which were then used to pass RN and LPN/VN licensing exams in states that included Massachusetts, New Jersey, New York, and Ohio, according to the indictment.
Some individuals then secured employment with a nursing home in Ohio, a home health agency for pediatric patients in Massachusetts, and skilled nursing facilities in New York and New Jersey.
Prosecutors allege that the president of Sacred Heart International Institute and two other co-conspirators sold 588 fake diplomas.
The FBI said that some of the aspiring nurses who were talked into buying the degrees were LPNs who wanted to become RNs and that most of those lured into the scheme were from South Florida’s Haitian American immigrant community, Nurse.org reported.
A version of this article first appeared on Medscape.com.
The U.S. Department of Justice recently announced charges against 25 owners, operators, and employees of three Florida nursing schools in a fraud scheme in which they sold as many as 7,600 fake nursing degrees.
The purchasers in the diploma scheme paid $10,000 to $15,000 for degrees and transcripts and some 2,800 of the buyers passed the national nursing licensing exam to become registered nurses (RNs) and licensed practice nurses/vocational nurses (LPN/VNs) around the country, according to The New York Times.
Many of the degree recipients went on to work at hospitals, nursing homes, and Veterans Affairs medical centers, according to the U.S. Attorney’s Office for the Southern District of Florida.
Several national nursing organizations cooperated with the investigation, and the Delaware Division of Professional Regulation already annulled 26 licenses, according to the Delaware Nurses Association. Fake licenses were issued in five states, according to federal reports.
“We are deeply unsettled by this egregious act,” DNA President Stephanie McClellan, MSN, RN, CMSRN, said in the group’s press statement. “We want all Delaware nurses to be aware of this active issue and to speak up if there is a concern regarding capacity to practice safely by a colleague/peer,” she said.
The Oregon State Board of Nursing is also investigating at least a dozen nurses who may have paid for their degrees, according to a Portland CBS affiliate.
The National Council of State Boards of Nursing said in a statement that it had helped authorities identify and monitor the individuals who allegedly provided the false degrees.
Nursing community reacts
News of the fraud scheme spread through the nursing community, including social media. “The recent report on falsified nursing school degrees is both heartbreaking and serves as an eye-opener,” tweeted Usha Menon, PhD, RN, FAAN, dean and health professor of the University of South Florida Health College of Nursing. “There was enough of a need that prompted these bad actors to develop a scheme that could’ve endangered dozens of lives.”
Jennifer Mensik Kennedy, PhD, MBA, RN, the new president of the American Nurses Association, also weighed in. “The accusation that personnel at once-accredited nursing schools allegedly participated in this scheme is simply deplorable. These unlawful and unethical acts disparage the reputation of actual nurses everywhere who have rightfully earned [their titles] through their education, hard work, dedication, and time.”
The false degrees and transcripts were issued by three once-accredited and now-shuttered nursing schools in South Florida: Palm Beach School of Nursing, Sacred Heart International Institute, and Sienna College.
The alleged co-conspirators reportedly made $114 million from the scheme, which dates back to 2016, according to several news reports. Each defendant faces up to 20 years in prison.
Most LPN programs charge $10,000 to $15,000 to complete a program, Robert Rosseter, a spokesperson for the American Association of Colleges of Nursing (AACN), told this news organization.
None were AACN members, and none were accredited by the Commission on Collegiate Nursing Education, which is AACN’s autonomous accrediting agency, Mr. Rosseter said. AACN membership is voluntary and is open to schools offering baccalaureate or higher degrees, he explained.
“What is disturbing about this investigation is that there are over 7,600 people around the country with fraudulent nursing credentials who are potentially in critical health care roles treating patients,” Chad Yarbrough, acting special agent in charge for the FBI in Miami, said in the federal justice department release.
‘Operation Nightingale’ based on tip
The federal action, dubbed “Operation Nightingale” after the nursing pioneer Florence Nightingale, began in 2019. It was based on a tip related to a case in Maryland, according to Nurse.org.
That case ensnared Palm Beach School of Nursing owner Johanah Napoleon, who reportedly was selling fake degrees for $6,000 to $18,000 each to two individuals in Maryland and Virginia. Ms. Napoleon was charged in 2021 and eventually pled guilty. The Florida Board of Nursing shut down the Palm Beach school in 2017 owing to its students’ low passing rate on the national licensing exam.
Two participants in the bigger scheme who had also worked with Ms. Napoleon – Geralda Adrien and Woosvelt Predestin – were indicted in 2021. Ms. Adrien owned private education companies for people who at aspired to be nurses, and Mr. Predestin was an employee. They were sentenced to 27 months in prison last year and helped the federal officials build the larger case.
The 25 individuals who were charged Jan. 25 operated in Delaware, New York, New Jersey, Texas, and Florida.
Schemes lured immigrants
In the scheme involving Siena College, some of the individuals acted as recruiters to direct nurses who were looking for employment to the school, where they allegedly would then pay for an RN or LPN/VN degree. The recipients of the false documents then used them to obtain jobs, including at a hospital in Georgia and a Veterans Affairs medical center in Maryland, according to one indictment. The president of Siena and her co-conspirators sold more than 2,000 fake diplomas, according to charging documents.
At the Palm Beach College of Nursing, individuals at various nursing prep and education programs allegedly helped others obtain fake degrees and transcripts, which were then used to pass RN and LPN/VN licensing exams in states that included Massachusetts, New Jersey, New York, and Ohio, according to the indictment.
Some individuals then secured employment with a nursing home in Ohio, a home health agency for pediatric patients in Massachusetts, and skilled nursing facilities in New York and New Jersey.
Prosecutors allege that the president of Sacred Heart International Institute and two other co-conspirators sold 588 fake diplomas.
The FBI said that some of the aspiring nurses who were talked into buying the degrees were LPNs who wanted to become RNs and that most of those lured into the scheme were from South Florida’s Haitian American immigrant community, Nurse.org reported.
A version of this article first appeared on Medscape.com.
Concern grows over ‘medical assistance in dying for mental illness’ law
Canada already has the largest number of deaths by MAID of any nation, with 10,064 in 2021, a 32% increase from 2020. With the addition of serious mental illness (SMI) as an eligible category, the country is on track to have the most liberal assisted-death policy in the world.
Concerns about the additional number of patients who could become eligible for MAID, and a lack of evidence-backed standards from disability rights groups, mental health advocates, First Nations leaders, psychiatrists, and other mental health providers, seems to have led the Canadian government to give the proposed law some sober second thought.
“Listening to experts and Canadians, we believe this date needs to be temporarily delayed,” said David Lametti, Canada’s minister of Justice and attorney general of Canada; Jean-Yves Duclos, minister of Health; and Carolyn Bennett, minister of Mental Health and Addictions, in a Dec. 15, 2022, joint statement.
Canada’s Parliament – which approved the expansion – will now have to vote on whether to okay a pause on the legislation.
However, the Canadian Psychiatric Association has not been calling for a delay in the proposed legislation. In a November 2021 statement, the CPA said it “does not take a position on the legality or morality of MAID,” but added that to deny MAID to people with mental illness was discriminatory, and that, as it was the law, it must be followed.
“CPA has not taken a position about MAID,” the association’s president Gary Chaimowitz, MBChB, told this news organization. “We know this is coming and our organization is trying to get its members ready for what will be most likely the ability of people with mental conditions to be able to request MAID,” said Dr. Chaimowitz, who is also head of forensic psychiatry at St. Joseph’s Healthcare and a professor of psychiatry at McMaster University, both in Hamilton, Ont.
Dr. Chaimowitz acknowledges that “a majority of psychiatrists do not want to be involved in anything to do with MAID.”
“The idea, certainly in psychiatry, is to get people well and we’ve been taught that people dying from a major mental disorder is something that we’re trained to prevent,” he added.
A ‘clinical option’
Assisted medical death is especially fraught in psychiatry, said Rebecca Brendel, MD, president of the American Psychiatric Association. She noted a 25-year life expectancy gap between people with SMI and those who do not have such conditions.
“As a profession we have very serious obligations to advance treatment so that a person with serious mental illness can live [a] full, productive, and healthy [life],” Dr. Brendel, associate director of the Center for Bioethics at Harvard Medical School in Boston, said in an interview.
Under the Canadian proposal, psychiatrists would be allowed to suggest MAID as a “clinical option.”
Harold Braswell, PhD, a fellow with The Hastings Center, a bioethics research institute, calls that problematic.
“It’s not neutral to suggest to someone that it would be theoretically reasonable to end their lives,” Dr. Braswell, associate professor at the Albert Gnaegi Center for Health Care Ethics at Saint Louis University, told this news organization.
It also creates a double standard in the treatment of suicidal ideation, in which suicide prevention is absolute for some, but encouraging it as a possibility for others, he added.
“To have that come from an authority figure is something that’s very harsh and, in my opinion, very potentially destructive,” especially for vulnerable groups, like First Nations people, who already have elevated rates of suicide, said Dr. Braswell.
Fierce debate
Since 2016, Canada has allowed MAID for medical conditions and diseases that will not improve and in cases where the evidence shows that medical providers can accurately predict the condition will not improve.
However, in 2019, a Quebec court ruled that the law unconstitutionally barred euthanasia in people who were not terminally ill. In March 2021, Canada’s criminal code was amended to allow MAID for people whose natural death was not “reasonably foreseeable,” but it excluded SMI for a period of 2 years, ending in March 2023.
The 2-year stay was intended to allow for study and to give mental health providers and MAID assessors time to develop standards.
The federal government charged a 12-member expert panel with determining how to safely allow MAID for SMI. In its final report released in May 2022 it recommended that standards be developed.
The panel acknowledged that for many conditions it may be impossible to make predictions about whether an individual might improve. However, it did not mention SMI.
In those cases, when MAID is requested, “establishing incurability and irreversibility on the basis of the evolution and response to past interventions is necessary,” the panel noted, adding that these are the criteria used by psychiatrists assessing euthanasia requests in the Netherlands and Belgium.
But the notion that mental illness can be irremediable has been fiercely debated.
Soon after the expert report was released, the Center for Addiction and Mental Health in Toronto noted on its website that there are currently “no agreed upon standards for psychiatrists or other health care practitioners to use to determine if a person’s mental illness is ‘grievous and irremediable’ for the purposes of MAID.”
Dr. Chaimowitz acknowledged that “there’s no agreed-upon definition of incurability” in mental illness. Some psychiatrists “will argue that there’s always another treatment that can be attempted,” he said, adding that there has been a lack of consensus on irremediability among CPA members.
Protecting vulnerable populations
Matt Wynia, MD, MPH, FACP, director of the Center for Bioethics and Humanities at the University of Colorado at Denver, Aurora, said the question of irremediability is crucial. “Most people with mental illness do get better, especially if they’re in treatment,” Dr. Wynia said.
For MAID assessors it may be difficult to know when someone has tried all possible treatments, especially given the wide array of options, including psychedelics, said Dr. Wynia.
Dr. Braswell said there is not enough evidence that mental illness is incurable. With SMI, “there’s a lot more potential for the causes of the individual’s suffering to be ameliorated. By offering MAID, you’re going to kill people who might have been able to get out of this through other nonlethal means.”
Currently, MAID is provided for an irremediable medical condition, “in other words, a condition that will not improve and that we can predict will not improve,” said Karandeep S. Gaind, MD, chief of psychiatry at Toronto’s Humber River Hospital and physician chair of the hospital’s MAID team.
“If that’s the premise, then I think we cannot provide MAID for sole mental illness,” Dr. Gaind said. “Because we can’t honestly make those predictions” with mental illness, he added.
Dr. Gaind does not support MAID for mental illness and believes that it will put the vulnerable – including those living in poverty – at particular risk.
With the proposed expansion, MAID is “now becoming something which is being sought as a way to escape a painful life rather than to avoid a painful death,” said Dr. Gaind, who is also a past president of the CPA.
One member of the federal government’s expert panel – Ellen Cohen, who had a psychiatric condition – wrote in The Globe and Mail that she quit early on when it became apparent that the panel was not seriously considering her own experiences or the possibility that poverty and lack of access to care or social supports could strongly influence a request for MAID.
Social determinants of suffering
People with mental illness often are without homes, have substance use disorders, have been stigmatized and discriminated against, and have poor social supports, said Dr. Wynia. “You worry that it’s all of those things that are making them want to end their lives,” he said.
The Daily Mail ran a story in December 2022 about a 65-year-old Canadian who said he’d applied for MAID solely because of fears that his disability benefits for various chronic health conditions were being cut off and that he didn’t want to live in poverty.
A 51-year-old Ontario woman with multiple chemical sensitivities was granted MAID after she said she could not find housing that could keep her safe, according to an August report by CTV News.
Tarek Rajji, MD, chief of the Adult Neurodevelopment and Geriatric Psychiatry Division at CAMH, said social determinants of health need to be considered in standards created to guide MAID for mental illness.
“We’re very mindful of the fact that the suffering, that is, the grievousness that the person is living with, in the context of mental illness, many times is due to the social determinants of their illness and the social determinants of their suffering,” Dr. Rajji said.
Many are also concerned that it will be difficult to separate out suicidality from sheer hopelessness.
The CPA has advised a group that’s working on developing guidelines for MAID in SMI and is also developing a curriculum for mental health providers, Dr. Chaimowitz said. As part of that, there will be a process to ensure that someone who is actively suicidal is not granted MAID.
“I do not believe that it’s contemplated that MAID is going to accelerate or facilitate suicidal ideation,” he said. Someone who is suicidal will be referred to treatment, said Dr. Chaimowitz.
“People with depression often feel hopeless,” and may refuse treatments that have worked in the past, countered Dr. Gaind. Some of his patients “are absolutely convinced that nothing will help,” he said.
Troublesome cases
The expert panel said in its final report that “it is not possible to provide fixed rules for how many attempts at interventions, how many types of interventions, and over how much time,” are necessary to establish “irreversibility” of mental illness.
Dr. Chaimowitz said MAID will not be offered to anyone “refusing treatment for their condition without any good reason.” They will be “unlikely to meet criteria for incurable,” as they will have needed to avail themselves of the array of treatments available, he said.
That would be similar to rules in Belgium and the Netherlands, which allow euthanasia for psychiatric conditions.
An estimated 100-300 psychiatric patients receive euthanasia each year in those countries, according to a 2021 commentary in Psychiatric Times (Jun 7;38[6]) by Mark S. Komrad, MD, a Towson, Maryland-based psychiatrist.
There are still troublesome cases.
As previously reported by this news organization, many in Belgium were distressed recently at the news that a 23-year-old woman who had survived a terrorist attack, Shanti De Corte, requested and was granted euthanasia.
As the deadline for implementation of MAID grew closer, calls for delay grew louder, especially given the lack of concrete standards for providers.
During the waning months of 2022, Dr. Gaind – who said he was suspended from CPA for “unprofessional interactions” and allegedly misrepresenting CPA’s processes and governance matters – announced the launch of a new organization, the Society of Canadian Psychiatry, in November calling for a delay in MAID of at least 1 year so that evidence-based safeguards could be implemented. The petition has been signed by more than 200 psychiatrists, along with several dozen physicians, MAID assessors, and individuals with mental illness and family members.
The Association of Chairs of Psychiatry in Canada, the Canadian Association for Suicide Prevention, the Council of Canadians with Disabilities, a group of indigenous leaders, and the Ontario Association for ACT and FACT, psychiatrists who provide care to individuals with severe mental illness, among other groups, joined the call for a delay.
In its December announcement, the Canadian federal ministers said a factor in seeking a delay was that standards guiding clinicians would not be delivered until at least February – too close to when applications would be opened.
Upon hearing about the federal government’s intentions, the chair of the expert panel, Mona Gupta, MD, told The Canadian Press that she did not think it was necessary to put off implementation because necessary safeguards were already in place.
Dr. Chaimowitz awaits the standards but is optimistic that for mental illness, “the process will be tightly controlled, closely monitored, and open to scrutiny,” he said.
Dr. Braswell is not convinced. The concern is that adding people with mental illness is “going to overload the capacity of the government to monitor this practice,” he said.
Is the United States next?
Although Canada and the United States share a border, it’s unlikely that U.S. states will allow aid in dying for nonterminal illness, much less for psychiatric conditions any time soon, said Dr. Braswell and others.
Ten states – California, Colorado, Hawaii, Maine, Montana, New Jersey, New Mexico, Oregon, Vermont, and Washington – have laws allowing assistance in dying, but for terminal illness only.
In 2016, the APA adopted the American Medical Association policy on medical euthanasia, stating, “that a psychiatrist should not prescribe or administer any intervention to a nonterminally ill person for the purpose of causing death.”
Dr. Brendel said the field is acutely aware that people with mental illness do suffer, but that more work needs to be done – and is being done – on “distinguishing wishes to hasten death or end one’s life from these historical or traditional notions that any premature death is a suicide.”
There is also increasing discussion within the medical community, not just psychiatry, about a physician’s duty to relieve suffering, said Dr. Wynia. “There’s debate basically about whether we stand for preserving life essentially at all costs and never being involved in the taking of life, or whether we stand for reduction of suffering and being the advocate for the patients that we serve,” he said.
“Those are both legitimate,” said Dr. Wynia, adding, “there are good reasons to want both of those to be true.”
“I suspect that 20 years from now we will still be having conversations about how physicians, how psychiatrists ought to participate in preserving life and in shepherding death,” said Dr. Brendel.
But to Dr. Gaind, the debate is not just esoteric, it’s a soon-to-be reality in Canada. “When we’re providing death to people who aren’t dying, to me that’s like providing what amounts to a wrongful death,” he said.
A version of this article originally appeared on Medscape.com.
Canada already has the largest number of deaths by MAID of any nation, with 10,064 in 2021, a 32% increase from 2020. With the addition of serious mental illness (SMI) as an eligible category, the country is on track to have the most liberal assisted-death policy in the world.
Concerns about the additional number of patients who could become eligible for MAID, and a lack of evidence-backed standards from disability rights groups, mental health advocates, First Nations leaders, psychiatrists, and other mental health providers, seems to have led the Canadian government to give the proposed law some sober second thought.
“Listening to experts and Canadians, we believe this date needs to be temporarily delayed,” said David Lametti, Canada’s minister of Justice and attorney general of Canada; Jean-Yves Duclos, minister of Health; and Carolyn Bennett, minister of Mental Health and Addictions, in a Dec. 15, 2022, joint statement.
Canada’s Parliament – which approved the expansion – will now have to vote on whether to okay a pause on the legislation.
However, the Canadian Psychiatric Association has not been calling for a delay in the proposed legislation. In a November 2021 statement, the CPA said it “does not take a position on the legality or morality of MAID,” but added that to deny MAID to people with mental illness was discriminatory, and that, as it was the law, it must be followed.
“CPA has not taken a position about MAID,” the association’s president Gary Chaimowitz, MBChB, told this news organization. “We know this is coming and our organization is trying to get its members ready for what will be most likely the ability of people with mental conditions to be able to request MAID,” said Dr. Chaimowitz, who is also head of forensic psychiatry at St. Joseph’s Healthcare and a professor of psychiatry at McMaster University, both in Hamilton, Ont.
Dr. Chaimowitz acknowledges that “a majority of psychiatrists do not want to be involved in anything to do with MAID.”
“The idea, certainly in psychiatry, is to get people well and we’ve been taught that people dying from a major mental disorder is something that we’re trained to prevent,” he added.
A ‘clinical option’
Assisted medical death is especially fraught in psychiatry, said Rebecca Brendel, MD, president of the American Psychiatric Association. She noted a 25-year life expectancy gap between people with SMI and those who do not have such conditions.
“As a profession we have very serious obligations to advance treatment so that a person with serious mental illness can live [a] full, productive, and healthy [life],” Dr. Brendel, associate director of the Center for Bioethics at Harvard Medical School in Boston, said in an interview.
Under the Canadian proposal, psychiatrists would be allowed to suggest MAID as a “clinical option.”
Harold Braswell, PhD, a fellow with The Hastings Center, a bioethics research institute, calls that problematic.
“It’s not neutral to suggest to someone that it would be theoretically reasonable to end their lives,” Dr. Braswell, associate professor at the Albert Gnaegi Center for Health Care Ethics at Saint Louis University, told this news organization.
It also creates a double standard in the treatment of suicidal ideation, in which suicide prevention is absolute for some, but encouraging it as a possibility for others, he added.
“To have that come from an authority figure is something that’s very harsh and, in my opinion, very potentially destructive,” especially for vulnerable groups, like First Nations people, who already have elevated rates of suicide, said Dr. Braswell.
Fierce debate
Since 2016, Canada has allowed MAID for medical conditions and diseases that will not improve and in cases where the evidence shows that medical providers can accurately predict the condition will not improve.
However, in 2019, a Quebec court ruled that the law unconstitutionally barred euthanasia in people who were not terminally ill. In March 2021, Canada’s criminal code was amended to allow MAID for people whose natural death was not “reasonably foreseeable,” but it excluded SMI for a period of 2 years, ending in March 2023.
The 2-year stay was intended to allow for study and to give mental health providers and MAID assessors time to develop standards.
The federal government charged a 12-member expert panel with determining how to safely allow MAID for SMI. In its final report released in May 2022 it recommended that standards be developed.
The panel acknowledged that for many conditions it may be impossible to make predictions about whether an individual might improve. However, it did not mention SMI.
In those cases, when MAID is requested, “establishing incurability and irreversibility on the basis of the evolution and response to past interventions is necessary,” the panel noted, adding that these are the criteria used by psychiatrists assessing euthanasia requests in the Netherlands and Belgium.
But the notion that mental illness can be irremediable has been fiercely debated.
Soon after the expert report was released, the Center for Addiction and Mental Health in Toronto noted on its website that there are currently “no agreed upon standards for psychiatrists or other health care practitioners to use to determine if a person’s mental illness is ‘grievous and irremediable’ for the purposes of MAID.”
Dr. Chaimowitz acknowledged that “there’s no agreed-upon definition of incurability” in mental illness. Some psychiatrists “will argue that there’s always another treatment that can be attempted,” he said, adding that there has been a lack of consensus on irremediability among CPA members.
Protecting vulnerable populations
Matt Wynia, MD, MPH, FACP, director of the Center for Bioethics and Humanities at the University of Colorado at Denver, Aurora, said the question of irremediability is crucial. “Most people with mental illness do get better, especially if they’re in treatment,” Dr. Wynia said.
For MAID assessors it may be difficult to know when someone has tried all possible treatments, especially given the wide array of options, including psychedelics, said Dr. Wynia.
Dr. Braswell said there is not enough evidence that mental illness is incurable. With SMI, “there’s a lot more potential for the causes of the individual’s suffering to be ameliorated. By offering MAID, you’re going to kill people who might have been able to get out of this through other nonlethal means.”
Currently, MAID is provided for an irremediable medical condition, “in other words, a condition that will not improve and that we can predict will not improve,” said Karandeep S. Gaind, MD, chief of psychiatry at Toronto’s Humber River Hospital and physician chair of the hospital’s MAID team.
“If that’s the premise, then I think we cannot provide MAID for sole mental illness,” Dr. Gaind said. “Because we can’t honestly make those predictions” with mental illness, he added.
Dr. Gaind does not support MAID for mental illness and believes that it will put the vulnerable – including those living in poverty – at particular risk.
With the proposed expansion, MAID is “now becoming something which is being sought as a way to escape a painful life rather than to avoid a painful death,” said Dr. Gaind, who is also a past president of the CPA.
One member of the federal government’s expert panel – Ellen Cohen, who had a psychiatric condition – wrote in The Globe and Mail that she quit early on when it became apparent that the panel was not seriously considering her own experiences or the possibility that poverty and lack of access to care or social supports could strongly influence a request for MAID.
Social determinants of suffering
People with mental illness often are without homes, have substance use disorders, have been stigmatized and discriminated against, and have poor social supports, said Dr. Wynia. “You worry that it’s all of those things that are making them want to end their lives,” he said.
The Daily Mail ran a story in December 2022 about a 65-year-old Canadian who said he’d applied for MAID solely because of fears that his disability benefits for various chronic health conditions were being cut off and that he didn’t want to live in poverty.
A 51-year-old Ontario woman with multiple chemical sensitivities was granted MAID after she said she could not find housing that could keep her safe, according to an August report by CTV News.
Tarek Rajji, MD, chief of the Adult Neurodevelopment and Geriatric Psychiatry Division at CAMH, said social determinants of health need to be considered in standards created to guide MAID for mental illness.
“We’re very mindful of the fact that the suffering, that is, the grievousness that the person is living with, in the context of mental illness, many times is due to the social determinants of their illness and the social determinants of their suffering,” Dr. Rajji said.
Many are also concerned that it will be difficult to separate out suicidality from sheer hopelessness.
The CPA has advised a group that’s working on developing guidelines for MAID in SMI and is also developing a curriculum for mental health providers, Dr. Chaimowitz said. As part of that, there will be a process to ensure that someone who is actively suicidal is not granted MAID.
“I do not believe that it’s contemplated that MAID is going to accelerate or facilitate suicidal ideation,” he said. Someone who is suicidal will be referred to treatment, said Dr. Chaimowitz.
“People with depression often feel hopeless,” and may refuse treatments that have worked in the past, countered Dr. Gaind. Some of his patients “are absolutely convinced that nothing will help,” he said.
Troublesome cases
The expert panel said in its final report that “it is not possible to provide fixed rules for how many attempts at interventions, how many types of interventions, and over how much time,” are necessary to establish “irreversibility” of mental illness.
Dr. Chaimowitz said MAID will not be offered to anyone “refusing treatment for their condition without any good reason.” They will be “unlikely to meet criteria for incurable,” as they will have needed to avail themselves of the array of treatments available, he said.
That would be similar to rules in Belgium and the Netherlands, which allow euthanasia for psychiatric conditions.
An estimated 100-300 psychiatric patients receive euthanasia each year in those countries, according to a 2021 commentary in Psychiatric Times (Jun 7;38[6]) by Mark S. Komrad, MD, a Towson, Maryland-based psychiatrist.
There are still troublesome cases.
As previously reported by this news organization, many in Belgium were distressed recently at the news that a 23-year-old woman who had survived a terrorist attack, Shanti De Corte, requested and was granted euthanasia.
As the deadline for implementation of MAID grew closer, calls for delay grew louder, especially given the lack of concrete standards for providers.
During the waning months of 2022, Dr. Gaind – who said he was suspended from CPA for “unprofessional interactions” and allegedly misrepresenting CPA’s processes and governance matters – announced the launch of a new organization, the Society of Canadian Psychiatry, in November calling for a delay in MAID of at least 1 year so that evidence-based safeguards could be implemented. The petition has been signed by more than 200 psychiatrists, along with several dozen physicians, MAID assessors, and individuals with mental illness and family members.
The Association of Chairs of Psychiatry in Canada, the Canadian Association for Suicide Prevention, the Council of Canadians with Disabilities, a group of indigenous leaders, and the Ontario Association for ACT and FACT, psychiatrists who provide care to individuals with severe mental illness, among other groups, joined the call for a delay.
In its December announcement, the Canadian federal ministers said a factor in seeking a delay was that standards guiding clinicians would not be delivered until at least February – too close to when applications would be opened.
Upon hearing about the federal government’s intentions, the chair of the expert panel, Mona Gupta, MD, told The Canadian Press that she did not think it was necessary to put off implementation because necessary safeguards were already in place.
Dr. Chaimowitz awaits the standards but is optimistic that for mental illness, “the process will be tightly controlled, closely monitored, and open to scrutiny,” he said.
Dr. Braswell is not convinced. The concern is that adding people with mental illness is “going to overload the capacity of the government to monitor this practice,” he said.
Is the United States next?
Although Canada and the United States share a border, it’s unlikely that U.S. states will allow aid in dying for nonterminal illness, much less for psychiatric conditions any time soon, said Dr. Braswell and others.
Ten states – California, Colorado, Hawaii, Maine, Montana, New Jersey, New Mexico, Oregon, Vermont, and Washington – have laws allowing assistance in dying, but for terminal illness only.
In 2016, the APA adopted the American Medical Association policy on medical euthanasia, stating, “that a psychiatrist should not prescribe or administer any intervention to a nonterminally ill person for the purpose of causing death.”
Dr. Brendel said the field is acutely aware that people with mental illness do suffer, but that more work needs to be done – and is being done – on “distinguishing wishes to hasten death or end one’s life from these historical or traditional notions that any premature death is a suicide.”
There is also increasing discussion within the medical community, not just psychiatry, about a physician’s duty to relieve suffering, said Dr. Wynia. “There’s debate basically about whether we stand for preserving life essentially at all costs and never being involved in the taking of life, or whether we stand for reduction of suffering and being the advocate for the patients that we serve,” he said.
“Those are both legitimate,” said Dr. Wynia, adding, “there are good reasons to want both of those to be true.”
“I suspect that 20 years from now we will still be having conversations about how physicians, how psychiatrists ought to participate in preserving life and in shepherding death,” said Dr. Brendel.
But to Dr. Gaind, the debate is not just esoteric, it’s a soon-to-be reality in Canada. “When we’re providing death to people who aren’t dying, to me that’s like providing what amounts to a wrongful death,” he said.
A version of this article originally appeared on Medscape.com.
Canada already has the largest number of deaths by MAID of any nation, with 10,064 in 2021, a 32% increase from 2020. With the addition of serious mental illness (SMI) as an eligible category, the country is on track to have the most liberal assisted-death policy in the world.
Concerns about the additional number of patients who could become eligible for MAID, and a lack of evidence-backed standards from disability rights groups, mental health advocates, First Nations leaders, psychiatrists, and other mental health providers, seems to have led the Canadian government to give the proposed law some sober second thought.
“Listening to experts and Canadians, we believe this date needs to be temporarily delayed,” said David Lametti, Canada’s minister of Justice and attorney general of Canada; Jean-Yves Duclos, minister of Health; and Carolyn Bennett, minister of Mental Health and Addictions, in a Dec. 15, 2022, joint statement.
Canada’s Parliament – which approved the expansion – will now have to vote on whether to okay a pause on the legislation.
However, the Canadian Psychiatric Association has not been calling for a delay in the proposed legislation. In a November 2021 statement, the CPA said it “does not take a position on the legality or morality of MAID,” but added that to deny MAID to people with mental illness was discriminatory, and that, as it was the law, it must be followed.
“CPA has not taken a position about MAID,” the association’s president Gary Chaimowitz, MBChB, told this news organization. “We know this is coming and our organization is trying to get its members ready for what will be most likely the ability of people with mental conditions to be able to request MAID,” said Dr. Chaimowitz, who is also head of forensic psychiatry at St. Joseph’s Healthcare and a professor of psychiatry at McMaster University, both in Hamilton, Ont.
Dr. Chaimowitz acknowledges that “a majority of psychiatrists do not want to be involved in anything to do with MAID.”
“The idea, certainly in psychiatry, is to get people well and we’ve been taught that people dying from a major mental disorder is something that we’re trained to prevent,” he added.
A ‘clinical option’
Assisted medical death is especially fraught in psychiatry, said Rebecca Brendel, MD, president of the American Psychiatric Association. She noted a 25-year life expectancy gap between people with SMI and those who do not have such conditions.
“As a profession we have very serious obligations to advance treatment so that a person with serious mental illness can live [a] full, productive, and healthy [life],” Dr. Brendel, associate director of the Center for Bioethics at Harvard Medical School in Boston, said in an interview.
Under the Canadian proposal, psychiatrists would be allowed to suggest MAID as a “clinical option.”
Harold Braswell, PhD, a fellow with The Hastings Center, a bioethics research institute, calls that problematic.
“It’s not neutral to suggest to someone that it would be theoretically reasonable to end their lives,” Dr. Braswell, associate professor at the Albert Gnaegi Center for Health Care Ethics at Saint Louis University, told this news organization.
It also creates a double standard in the treatment of suicidal ideation, in which suicide prevention is absolute for some, but encouraging it as a possibility for others, he added.
“To have that come from an authority figure is something that’s very harsh and, in my opinion, very potentially destructive,” especially for vulnerable groups, like First Nations people, who already have elevated rates of suicide, said Dr. Braswell.
Fierce debate
Since 2016, Canada has allowed MAID for medical conditions and diseases that will not improve and in cases where the evidence shows that medical providers can accurately predict the condition will not improve.
However, in 2019, a Quebec court ruled that the law unconstitutionally barred euthanasia in people who were not terminally ill. In March 2021, Canada’s criminal code was amended to allow MAID for people whose natural death was not “reasonably foreseeable,” but it excluded SMI for a period of 2 years, ending in March 2023.
The 2-year stay was intended to allow for study and to give mental health providers and MAID assessors time to develop standards.
The federal government charged a 12-member expert panel with determining how to safely allow MAID for SMI. In its final report released in May 2022 it recommended that standards be developed.
The panel acknowledged that for many conditions it may be impossible to make predictions about whether an individual might improve. However, it did not mention SMI.
In those cases, when MAID is requested, “establishing incurability and irreversibility on the basis of the evolution and response to past interventions is necessary,” the panel noted, adding that these are the criteria used by psychiatrists assessing euthanasia requests in the Netherlands and Belgium.
But the notion that mental illness can be irremediable has been fiercely debated.
Soon after the expert report was released, the Center for Addiction and Mental Health in Toronto noted on its website that there are currently “no agreed upon standards for psychiatrists or other health care practitioners to use to determine if a person’s mental illness is ‘grievous and irremediable’ for the purposes of MAID.”
Dr. Chaimowitz acknowledged that “there’s no agreed-upon definition of incurability” in mental illness. Some psychiatrists “will argue that there’s always another treatment that can be attempted,” he said, adding that there has been a lack of consensus on irremediability among CPA members.
Protecting vulnerable populations
Matt Wynia, MD, MPH, FACP, director of the Center for Bioethics and Humanities at the University of Colorado at Denver, Aurora, said the question of irremediability is crucial. “Most people with mental illness do get better, especially if they’re in treatment,” Dr. Wynia said.
For MAID assessors it may be difficult to know when someone has tried all possible treatments, especially given the wide array of options, including psychedelics, said Dr. Wynia.
Dr. Braswell said there is not enough evidence that mental illness is incurable. With SMI, “there’s a lot more potential for the causes of the individual’s suffering to be ameliorated. By offering MAID, you’re going to kill people who might have been able to get out of this through other nonlethal means.”
Currently, MAID is provided for an irremediable medical condition, “in other words, a condition that will not improve and that we can predict will not improve,” said Karandeep S. Gaind, MD, chief of psychiatry at Toronto’s Humber River Hospital and physician chair of the hospital’s MAID team.
“If that’s the premise, then I think we cannot provide MAID for sole mental illness,” Dr. Gaind said. “Because we can’t honestly make those predictions” with mental illness, he added.
Dr. Gaind does not support MAID for mental illness and believes that it will put the vulnerable – including those living in poverty – at particular risk.
With the proposed expansion, MAID is “now becoming something which is being sought as a way to escape a painful life rather than to avoid a painful death,” said Dr. Gaind, who is also a past president of the CPA.
One member of the federal government’s expert panel – Ellen Cohen, who had a psychiatric condition – wrote in The Globe and Mail that she quit early on when it became apparent that the panel was not seriously considering her own experiences or the possibility that poverty and lack of access to care or social supports could strongly influence a request for MAID.
Social determinants of suffering
People with mental illness often are without homes, have substance use disorders, have been stigmatized and discriminated against, and have poor social supports, said Dr. Wynia. “You worry that it’s all of those things that are making them want to end their lives,” he said.
The Daily Mail ran a story in December 2022 about a 65-year-old Canadian who said he’d applied for MAID solely because of fears that his disability benefits for various chronic health conditions were being cut off and that he didn’t want to live in poverty.
A 51-year-old Ontario woman with multiple chemical sensitivities was granted MAID after she said she could not find housing that could keep her safe, according to an August report by CTV News.
Tarek Rajji, MD, chief of the Adult Neurodevelopment and Geriatric Psychiatry Division at CAMH, said social determinants of health need to be considered in standards created to guide MAID for mental illness.
“We’re very mindful of the fact that the suffering, that is, the grievousness that the person is living with, in the context of mental illness, many times is due to the social determinants of their illness and the social determinants of their suffering,” Dr. Rajji said.
Many are also concerned that it will be difficult to separate out suicidality from sheer hopelessness.
The CPA has advised a group that’s working on developing guidelines for MAID in SMI and is also developing a curriculum for mental health providers, Dr. Chaimowitz said. As part of that, there will be a process to ensure that someone who is actively suicidal is not granted MAID.
“I do not believe that it’s contemplated that MAID is going to accelerate or facilitate suicidal ideation,” he said. Someone who is suicidal will be referred to treatment, said Dr. Chaimowitz.
“People with depression often feel hopeless,” and may refuse treatments that have worked in the past, countered Dr. Gaind. Some of his patients “are absolutely convinced that nothing will help,” he said.
Troublesome cases
The expert panel said in its final report that “it is not possible to provide fixed rules for how many attempts at interventions, how many types of interventions, and over how much time,” are necessary to establish “irreversibility” of mental illness.
Dr. Chaimowitz said MAID will not be offered to anyone “refusing treatment for their condition without any good reason.” They will be “unlikely to meet criteria for incurable,” as they will have needed to avail themselves of the array of treatments available, he said.
That would be similar to rules in Belgium and the Netherlands, which allow euthanasia for psychiatric conditions.
An estimated 100-300 psychiatric patients receive euthanasia each year in those countries, according to a 2021 commentary in Psychiatric Times (Jun 7;38[6]) by Mark S. Komrad, MD, a Towson, Maryland-based psychiatrist.
There are still troublesome cases.
As previously reported by this news organization, many in Belgium were distressed recently at the news that a 23-year-old woman who had survived a terrorist attack, Shanti De Corte, requested and was granted euthanasia.
As the deadline for implementation of MAID grew closer, calls for delay grew louder, especially given the lack of concrete standards for providers.
During the waning months of 2022, Dr. Gaind – who said he was suspended from CPA for “unprofessional interactions” and allegedly misrepresenting CPA’s processes and governance matters – announced the launch of a new organization, the Society of Canadian Psychiatry, in November calling for a delay in MAID of at least 1 year so that evidence-based safeguards could be implemented. The petition has been signed by more than 200 psychiatrists, along with several dozen physicians, MAID assessors, and individuals with mental illness and family members.
The Association of Chairs of Psychiatry in Canada, the Canadian Association for Suicide Prevention, the Council of Canadians with Disabilities, a group of indigenous leaders, and the Ontario Association for ACT and FACT, psychiatrists who provide care to individuals with severe mental illness, among other groups, joined the call for a delay.
In its December announcement, the Canadian federal ministers said a factor in seeking a delay was that standards guiding clinicians would not be delivered until at least February – too close to when applications would be opened.
Upon hearing about the federal government’s intentions, the chair of the expert panel, Mona Gupta, MD, told The Canadian Press that she did not think it was necessary to put off implementation because necessary safeguards were already in place.
Dr. Chaimowitz awaits the standards but is optimistic that for mental illness, “the process will be tightly controlled, closely monitored, and open to scrutiny,” he said.
Dr. Braswell is not convinced. The concern is that adding people with mental illness is “going to overload the capacity of the government to monitor this practice,” he said.
Is the United States next?
Although Canada and the United States share a border, it’s unlikely that U.S. states will allow aid in dying for nonterminal illness, much less for psychiatric conditions any time soon, said Dr. Braswell and others.
Ten states – California, Colorado, Hawaii, Maine, Montana, New Jersey, New Mexico, Oregon, Vermont, and Washington – have laws allowing assistance in dying, but for terminal illness only.
In 2016, the APA adopted the American Medical Association policy on medical euthanasia, stating, “that a psychiatrist should not prescribe or administer any intervention to a nonterminally ill person for the purpose of causing death.”
Dr. Brendel said the field is acutely aware that people with mental illness do suffer, but that more work needs to be done – and is being done – on “distinguishing wishes to hasten death or end one’s life from these historical or traditional notions that any premature death is a suicide.”
There is also increasing discussion within the medical community, not just psychiatry, about a physician’s duty to relieve suffering, said Dr. Wynia. “There’s debate basically about whether we stand for preserving life essentially at all costs and never being involved in the taking of life, or whether we stand for reduction of suffering and being the advocate for the patients that we serve,” he said.
“Those are both legitimate,” said Dr. Wynia, adding, “there are good reasons to want both of those to be true.”
“I suspect that 20 years from now we will still be having conversations about how physicians, how psychiatrists ought to participate in preserving life and in shepherding death,” said Dr. Brendel.
But to Dr. Gaind, the debate is not just esoteric, it’s a soon-to-be reality in Canada. “When we’re providing death to people who aren’t dying, to me that’s like providing what amounts to a wrongful death,” he said.
A version of this article originally appeared on Medscape.com.
High-deductible health plans detrimental for those with diabetes
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. 
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.
A 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.
A 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.
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.
A 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.
A 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.
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.
A 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.
A 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.
Physician sues AMA for defamation over 2022 election controversy
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 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 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 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.
‘Slugging’: A TikTok skin trend that has some merit
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.”
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 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.”
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 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.”
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 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.
Review gives weight to supplements for hair loss
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.
“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 D, zinc, 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.
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.
“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.
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.
“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 D, zinc, 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.
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.
“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.
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.
“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 D, zinc, 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.
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.
“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.