Dermatology News

Congress averted bigger reductions in Medicare’s future payments for clinicians in its massive, year-end spending bill, but physicians will still see a 2% cut in a key payment variable in 2023.

The bill also authorizes new policies regarding accelerated drug approvals and substance use disorder treatment.

The House voted 225-201 to clear a wide-ranging legislative package, known as an omnibus, for President Joe Biden’s signature. The Senate voted 68-29 to approve the measure.

Clinicians had been facing as much as 8.5% in cuts to certain factors that set their Medicare payment. The American Medical Association credited an advocacy campaign it joined with more than 150 organizations with fending off the much-feared reimbursement cuts. The 2% trim for 2023 will decline to 1.25% for 2024.

These reductions will hit as many clinicians face the toll on rising costs for running their practices, as Congress has not included inflation-based payment adjustments in Medicare’s physician payment rule, the AMA said.

“Congress must immediately begin the work of long-overdue Medicare physician payment reform that will lead to the program stability that beneficiaries and physicians need,” AMA President Jack Resneck, MD, said in a statement.

While the omnibus bill blocks 6.5% of Medicare payment cuts originally slated to take effect in 2023, it still puts “untenable strain” on primary care clinicians, said Tochi Iroku-Malize, MD, MPH, president of the American Academy of Family Physicians, in a statement.

“However, we’re pleased to see several provisions that will improve access to care, including bolstering mental health services, extending telehealth, and expanding Medicaid and CHIP coverage,” Dr. Iroku-Malize added.
 

New health care policies in omnibus

Lawmakers adopted many health care policy changes in the omnibus package, which contained 12 overdue spending bills for fiscal year 2023. (Much of the federal government has been funded through stop-gap measures since this budget year began on Oct. 1.) The final measure runs to more than 4,100 pages in PDF form.

House Energy and Commerce Chairman Frank Pallone Jr. (D-NJ) said the health care provisions will:

• Expand patient access to opioid addiction treatment by making it easier for clinicians to dispense buprenorphine for opioid use disorder maintenance or detoxification treatment
• Require health care providers to complete a training requirement on identifying and treating patients with substance use disorders
• Guarantee 12 months of continuous Medicaid coverage for 40 million children
• Provide 2 years of additional Children’s Health Insurance Program (CHIP) funding
• Permanently extend the option for states to offer 12 months of Medicaid coverage to new mothers
• Continue Medicare’s expanded access to telehealth by extending COVID-19 telehealth flexibilities through Dec. 31, 2024.

FDA’s accelerated approval

The omnibus also will shorten the period of uncertainty patients and clinicians face with medicines cleared under the accelerated approval pathway.

The Food and Drug Administration uses accelerated approvals to give conditional clearances to medicines for fatal and serious conditions based on limited evidence signaling a potential benefit. Companies are expected to continue research needed to prove whether promising signals, such as stemming tumor growth, benefits patients.

Concerns have mounted when companies delay confirmatory trials or try to maintain accelerated approvals for drugs that fail those trials.

Mr. Pallone said the omnibus contains provisions that:

• Require the FDA to specify conditions for required post-approval studies
• Authorize the FDA to require post-approval studies to be underway at the time of approval or within a specified time period following approval.
• Clarify and streamline current FDA authority to withdraw approvals when sponsors fail to conduct studies with due diligence.

Reshma Ramachandran, MD, MPP, MHS, who serves as the chair of the Doctors for America’s FDA Task Force, told this news organization that she was pleased to see these provisions pass. She had been disappointed they were not included earlier this year in the latest Prescription Drug User Fee Act reauthorization.

The provisions in the omnibus make “clear what steps the FDA can take to remove an unproven drug off the market should manufacturers fail to complete these studies or demonstrate meaningful clinical benefit,” Dr. Ramachandran wrote in an email.

Dr. Ramachandran said she hopes lawmakers build on these steps in the future. She suggested Congress add a mandate to require drug labels to clearly state when the FDA is still waiting for evidence needed to confirm benefits of medicines cleared by accelerated approval.

“Nevertheless, Congress in including and, hopefully, passing these reforms has made it clear that drug companies need to provide meaningful evidence that their accelerated approval drugs work in patients and FDA can take action to protect patients should this not occur,” Dr. Ramachandran wrote.

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

Congress averted bigger reductions in Medicare’s future payments for clinicians in its massive, year-end spending bill, but physicians will still see a 2% cut in a key payment variable in 2023.

The bill also authorizes new policies regarding accelerated drug approvals and substance use disorder treatment.

The House voted 225-201 to clear a wide-ranging legislative package, known as an omnibus, for President Joe Biden’s signature. The Senate voted 68-29 to approve the measure.

Clinicians had been facing as much as 8.5% in cuts to certain factors that set their Medicare payment. The American Medical Association credited an advocacy campaign it joined with more than 150 organizations with fending off the much-feared reimbursement cuts. The 2% trim for 2023 will decline to 1.25% for 2024.

These reductions will hit as many clinicians face the toll on rising costs for running their practices, as Congress has not included inflation-based payment adjustments in Medicare’s physician payment rule, the AMA said.

“Congress must immediately begin the work of long-overdue Medicare physician payment reform that will lead to the program stability that beneficiaries and physicians need,” AMA President Jack Resneck, MD, said in a statement.

While the omnibus bill blocks 6.5% of Medicare payment cuts originally slated to take effect in 2023, it still puts “untenable strain” on primary care clinicians, said Tochi Iroku-Malize, MD, MPH, president of the American Academy of Family Physicians, in a statement.

“However, we’re pleased to see several provisions that will improve access to care, including bolstering mental health services, extending telehealth, and expanding Medicaid and CHIP coverage,” Dr. Iroku-Malize added.
 

New health care policies in omnibus

Lawmakers adopted many health care policy changes in the omnibus package, which contained 12 overdue spending bills for fiscal year 2023. (Much of the federal government has been funded through stop-gap measures since this budget year began on Oct. 1.) The final measure runs to more than 4,100 pages in PDF form.

House Energy and Commerce Chairman Frank Pallone Jr. (D-NJ) said the health care provisions will:

• Expand patient access to opioid addiction treatment by making it easier for clinicians to dispense buprenorphine for opioid use disorder maintenance or detoxification treatment
• Require health care providers to complete a training requirement on identifying and treating patients with substance use disorders
• Guarantee 12 months of continuous Medicaid coverage for 40 million children
• Provide 2 years of additional Children’s Health Insurance Program (CHIP) funding
• Permanently extend the option for states to offer 12 months of Medicaid coverage to new mothers
• Continue Medicare’s expanded access to telehealth by extending COVID-19 telehealth flexibilities through Dec. 31, 2024.

FDA’s accelerated approval

The omnibus also will shorten the period of uncertainty patients and clinicians face with medicines cleared under the accelerated approval pathway.

The Food and Drug Administration uses accelerated approvals to give conditional clearances to medicines for fatal and serious conditions based on limited evidence signaling a potential benefit. Companies are expected to continue research needed to prove whether promising signals, such as stemming tumor growth, benefits patients.

Concerns have mounted when companies delay confirmatory trials or try to maintain accelerated approvals for drugs that fail those trials.

Mr. Pallone said the omnibus contains provisions that:

• Require the FDA to specify conditions for required post-approval studies
• Authorize the FDA to require post-approval studies to be underway at the time of approval or within a specified time period following approval.
• Clarify and streamline current FDA authority to withdraw approvals when sponsors fail to conduct studies with due diligence.

Reshma Ramachandran, MD, MPP, MHS, who serves as the chair of the Doctors for America’s FDA Task Force, told this news organization that she was pleased to see these provisions pass. She had been disappointed they were not included earlier this year in the latest Prescription Drug User Fee Act reauthorization.

The provisions in the omnibus make “clear what steps the FDA can take to remove an unproven drug off the market should manufacturers fail to complete these studies or demonstrate meaningful clinical benefit,” Dr. Ramachandran wrote in an email.

Dr. Ramachandran said she hopes lawmakers build on these steps in the future. She suggested Congress add a mandate to require drug labels to clearly state when the FDA is still waiting for evidence needed to confirm benefits of medicines cleared by accelerated approval.

“Nevertheless, Congress in including and, hopefully, passing these reforms has made it clear that drug companies need to provide meaningful evidence that their accelerated approval drugs work in patients and FDA can take action to protect patients should this not occur,” Dr. Ramachandran wrote.

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

Congress averted bigger reductions in Medicare’s future payments for clinicians in its massive, year-end spending bill, but physicians will still see a 2% cut in a key payment variable in 2023.

The bill also authorizes new policies regarding accelerated drug approvals and substance use disorder treatment.

The House voted 225-201 to clear a wide-ranging legislative package, known as an omnibus, for President Joe Biden’s signature. The Senate voted 68-29 to approve the measure.

Clinicians had been facing as much as 8.5% in cuts to certain factors that set their Medicare payment. The American Medical Association credited an advocacy campaign it joined with more than 150 organizations with fending off the much-feared reimbursement cuts. The 2% trim for 2023 will decline to 1.25% for 2024.

These reductions will hit as many clinicians face the toll on rising costs for running their practices, as Congress has not included inflation-based payment adjustments in Medicare’s physician payment rule, the AMA said.

“Congress must immediately begin the work of long-overdue Medicare physician payment reform that will lead to the program stability that beneficiaries and physicians need,” AMA President Jack Resneck, MD, said in a statement.

While the omnibus bill blocks 6.5% of Medicare payment cuts originally slated to take effect in 2023, it still puts “untenable strain” on primary care clinicians, said Tochi Iroku-Malize, MD, MPH, president of the American Academy of Family Physicians, in a statement.

“However, we’re pleased to see several provisions that will improve access to care, including bolstering mental health services, extending telehealth, and expanding Medicaid and CHIP coverage,” Dr. Iroku-Malize added.
 

New health care policies in omnibus

Lawmakers adopted many health care policy changes in the omnibus package, which contained 12 overdue spending bills for fiscal year 2023. (Much of the federal government has been funded through stop-gap measures since this budget year began on Oct. 1.) The final measure runs to more than 4,100 pages in PDF form.

House Energy and Commerce Chairman Frank Pallone Jr. (D-NJ) said the health care provisions will:

• Expand patient access to opioid addiction treatment by making it easier for clinicians to dispense buprenorphine for opioid use disorder maintenance or detoxification treatment
• Require health care providers to complete a training requirement on identifying and treating patients with substance use disorders
• Guarantee 12 months of continuous Medicaid coverage for 40 million children
• Provide 2 years of additional Children’s Health Insurance Program (CHIP) funding
• Permanently extend the option for states to offer 12 months of Medicaid coverage to new mothers
• Continue Medicare’s expanded access to telehealth by extending COVID-19 telehealth flexibilities through Dec. 31, 2024.

FDA’s accelerated approval

The omnibus also will shorten the period of uncertainty patients and clinicians face with medicines cleared under the accelerated approval pathway.

The Food and Drug Administration uses accelerated approvals to give conditional clearances to medicines for fatal and serious conditions based on limited evidence signaling a potential benefit. Companies are expected to continue research needed to prove whether promising signals, such as stemming tumor growth, benefits patients.

Concerns have mounted when companies delay confirmatory trials or try to maintain accelerated approvals for drugs that fail those trials.

Mr. Pallone said the omnibus contains provisions that:

• Require the FDA to specify conditions for required post-approval studies
• Authorize the FDA to require post-approval studies to be underway at the time of approval or within a specified time period following approval.
• Clarify and streamline current FDA authority to withdraw approvals when sponsors fail to conduct studies with due diligence.

Reshma Ramachandran, MD, MPP, MHS, who serves as the chair of the Doctors for America’s FDA Task Force, told this news organization that she was pleased to see these provisions pass. She had been disappointed they were not included earlier this year in the latest Prescription Drug User Fee Act reauthorization.

The provisions in the omnibus make “clear what steps the FDA can take to remove an unproven drug off the market should manufacturers fail to complete these studies or demonstrate meaningful clinical benefit,” Dr. Ramachandran wrote in an email.

Dr. Ramachandran said she hopes lawmakers build on these steps in the future. She suggested Congress add a mandate to require drug labels to clearly state when the FDA is still waiting for evidence needed to confirm benefits of medicines cleared by accelerated approval.

“Nevertheless, Congress in including and, hopefully, passing these reforms has made it clear that drug companies need to provide meaningful evidence that their accelerated approval drugs work in patients and FDA can take action to protect patients should this not occur,” Dr. Ramachandran wrote.

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

Clinicians in the United States are reporting more cases of invasive group A streptococcal infection (iGAS) in children, according to an alert from the Centers for Disease Control and Prevention. These infections are rare but can be deadly, and they can affect adults as well as children.

Health care providers should consider this bacterial infection as a possible cause of severe illness in children and adults, including those with recent or co-occurring viral respiratory infections, the agency advised in a Dec. 22 alert.

In some cases, iGAS manifests as persistent or worsening symptoms after a patient with a known viral infection initially starts to show signs of improvement, according to the agency.

In November, the CDC was notified about a possible increase in cases of pediatric iGAS at a hospital in Colorado. Since then, two surveillance systems – the Infectious Diseases Society of America’s Emerging Infections Network and the CDC’s Active Bacterial Core Surveillance System – have detected potential increases in pediatric iGAS cases in other states.

The uptick has coincided with “increased circulation of respiratory syncytial virus (RSV), influenza viruses, SARS-CoV-2, and other respiratory viruses,” the advisory stated. “While the overall number of cases has remained relatively low and iGAS infections remain rare in children, [the] CDC is investigating these reports.”
 

Not just strep throat

Group A Streptococcus bacteria can cause strep throat and infections in skin and soft tissue. The pathogens also can lead to uncommon but severe diseases, such as sepsis, streptococcal toxic shock syndrome, and necrotizing fasciitis, according to the CDC. The severe illnesses “are associated with high mortality rates and require immediate treatment, including appropriate antibiotic therapy,” the agency said.

Groups at higher risk for iGAS include people aged 65 years or older, American Indian and Alaska Native populations, residents of long-term care facilities, those with wounds or skin disease, people who inject drugs, and people experiencing homelessness.

People with medical conditions such as diabetes, cancer, immunosuppression, and chronic kidney, heart, or respiratory disease also are at increased risk.

Invasive strep A infections initially decreased during the COVID-19 pandemic amid measures to reduce the spread of disease, such as masking and social distancing. But since September, monthly cases have exceeded those in 2020 and 2021. “It is too early to determine whether this rise is beyond what would be expected for pre-COVID” seasonal patterns, the CDC said.
 

Recommendations

Because iGAS can occur after the flu or chickenpox, health care providers should offer influenza and varicella vaccinations to all eligible people who are not up to date with their vaccines.

In addition, clinicians should educate patients about symptoms of iGAS that require urgent medical attention, including necrotizing fasciitis, cellulitis, and toxic shock syndrome.

They also should obtain cultures for suspected cases of iGAS as clinically indicated, follow guidelines for the diagnosis and treatment of strep throat, and be aware of alternative ways to treat strep throat in children amid a shortage of amoxicillin suspension.

Researchers have reported more cases of iGAS in the United Kingdom this year, as well. According to the UK Health Security Agency, 74 deaths, including 16 children, in England have been attributed to iGAS since September.

“We know that this is concerning for parents, but I want to stress that while we are seeing an increase in cases in children, this remains very uncommon,” UKHSA Deputy Director Colin Brown said in a news release. “There are lots of winter bugs circulating that can make your child feel unwell that mostly aren’t cause for alarm. However, make sure you talk to a health professional if your child is getting worse after a bout of scarlet fever, a sore throat, or respiratory infection.”

A fever that doesn’t resolve, dehydration, extreme tiredness, and difficulty breathing are signs to watch out for, Dr. Brown said.

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

Clinicians in the United States are reporting more cases of invasive group A streptococcal infection (iGAS) in children, according to an alert from the Centers for Disease Control and Prevention. These infections are rare but can be deadly, and they can affect adults as well as children.

Health care providers should consider this bacterial infection as a possible cause of severe illness in children and adults, including those with recent or co-occurring viral respiratory infections, the agency advised in a Dec. 22 alert.

In some cases, iGAS manifests as persistent or worsening symptoms after a patient with a known viral infection initially starts to show signs of improvement, according to the agency.

In November, the CDC was notified about a possible increase in cases of pediatric iGAS at a hospital in Colorado. Since then, two surveillance systems – the Infectious Diseases Society of America’s Emerging Infections Network and the CDC’s Active Bacterial Core Surveillance System – have detected potential increases in pediatric iGAS cases in other states.

The uptick has coincided with “increased circulation of respiratory syncytial virus (RSV), influenza viruses, SARS-CoV-2, and other respiratory viruses,” the advisory stated. “While the overall number of cases has remained relatively low and iGAS infections remain rare in children, [the] CDC is investigating these reports.”
 

Not just strep throat

Group A Streptococcus bacteria can cause strep throat and infections in skin and soft tissue. The pathogens also can lead to uncommon but severe diseases, such as sepsis, streptococcal toxic shock syndrome, and necrotizing fasciitis, according to the CDC. The severe illnesses “are associated with high mortality rates and require immediate treatment, including appropriate antibiotic therapy,” the agency said.

Groups at higher risk for iGAS include people aged 65 years or older, American Indian and Alaska Native populations, residents of long-term care facilities, those with wounds or skin disease, people who inject drugs, and people experiencing homelessness.

People with medical conditions such as diabetes, cancer, immunosuppression, and chronic kidney, heart, or respiratory disease also are at increased risk.

Invasive strep A infections initially decreased during the COVID-19 pandemic amid measures to reduce the spread of disease, such as masking and social distancing. But since September, monthly cases have exceeded those in 2020 and 2021. “It is too early to determine whether this rise is beyond what would be expected for pre-COVID” seasonal patterns, the CDC said.
 

Recommendations

Because iGAS can occur after the flu or chickenpox, health care providers should offer influenza and varicella vaccinations to all eligible people who are not up to date with their vaccines.

In addition, clinicians should educate patients about symptoms of iGAS that require urgent medical attention, including necrotizing fasciitis, cellulitis, and toxic shock syndrome.

They also should obtain cultures for suspected cases of iGAS as clinically indicated, follow guidelines for the diagnosis and treatment of strep throat, and be aware of alternative ways to treat strep throat in children amid a shortage of amoxicillin suspension.

Researchers have reported more cases of iGAS in the United Kingdom this year, as well. According to the UK Health Security Agency, 74 deaths, including 16 children, in England have been attributed to iGAS since September.

“We know that this is concerning for parents, but I want to stress that while we are seeing an increase in cases in children, this remains very uncommon,” UKHSA Deputy Director Colin Brown said in a news release. “There are lots of winter bugs circulating that can make your child feel unwell that mostly aren’t cause for alarm. However, make sure you talk to a health professional if your child is getting worse after a bout of scarlet fever, a sore throat, or respiratory infection.”

A fever that doesn’t resolve, dehydration, extreme tiredness, and difficulty breathing are signs to watch out for, Dr. Brown said.

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

Clinicians in the United States are reporting more cases of invasive group A streptococcal infection (iGAS) in children, according to an alert from the Centers for Disease Control and Prevention. These infections are rare but can be deadly, and they can affect adults as well as children.

Health care providers should consider this bacterial infection as a possible cause of severe illness in children and adults, including those with recent or co-occurring viral respiratory infections, the agency advised in a Dec. 22 alert.

In some cases, iGAS manifests as persistent or worsening symptoms after a patient with a known viral infection initially starts to show signs of improvement, according to the agency.

In November, the CDC was notified about a possible increase in cases of pediatric iGAS at a hospital in Colorado. Since then, two surveillance systems – the Infectious Diseases Society of America’s Emerging Infections Network and the CDC’s Active Bacterial Core Surveillance System – have detected potential increases in pediatric iGAS cases in other states.

The uptick has coincided with “increased circulation of respiratory syncytial virus (RSV), influenza viruses, SARS-CoV-2, and other respiratory viruses,” the advisory stated. “While the overall number of cases has remained relatively low and iGAS infections remain rare in children, [the] CDC is investigating these reports.”
 

Not just strep throat

Group A Streptococcus bacteria can cause strep throat and infections in skin and soft tissue. The pathogens also can lead to uncommon but severe diseases, such as sepsis, streptococcal toxic shock syndrome, and necrotizing fasciitis, according to the CDC. The severe illnesses “are associated with high mortality rates and require immediate treatment, including appropriate antibiotic therapy,” the agency said.

Groups at higher risk for iGAS include people aged 65 years or older, American Indian and Alaska Native populations, residents of long-term care facilities, those with wounds or skin disease, people who inject drugs, and people experiencing homelessness.

People with medical conditions such as diabetes, cancer, immunosuppression, and chronic kidney, heart, or respiratory disease also are at increased risk.

Invasive strep A infections initially decreased during the COVID-19 pandemic amid measures to reduce the spread of disease, such as masking and social distancing. But since September, monthly cases have exceeded those in 2020 and 2021. “It is too early to determine whether this rise is beyond what would be expected for pre-COVID” seasonal patterns, the CDC said.
 

Recommendations

Because iGAS can occur after the flu or chickenpox, health care providers should offer influenza and varicella vaccinations to all eligible people who are not up to date with their vaccines.

In addition, clinicians should educate patients about symptoms of iGAS that require urgent medical attention, including necrotizing fasciitis, cellulitis, and toxic shock syndrome.

They also should obtain cultures for suspected cases of iGAS as clinically indicated, follow guidelines for the diagnosis and treatment of strep throat, and be aware of alternative ways to treat strep throat in children amid a shortage of amoxicillin suspension.

Researchers have reported more cases of iGAS in the United Kingdom this year, as well. According to the UK Health Security Agency, 74 deaths, including 16 children, in England have been attributed to iGAS since September.

“We know that this is concerning for parents, but I want to stress that while we are seeing an increase in cases in children, this remains very uncommon,” UKHSA Deputy Director Colin Brown said in a news release. “There are lots of winter bugs circulating that can make your child feel unwell that mostly aren’t cause for alarm. However, make sure you talk to a health professional if your child is getting worse after a bout of scarlet fever, a sore throat, or respiratory infection.”

A fever that doesn’t resolve, dehydration, extreme tiredness, and difficulty breathing are signs to watch out for, Dr. Brown said.

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

An updated Cochrane Review on infant skincare interventions for preventing atopic dermatitis (AD) and food allergy has reaffirmed previous study findings indicating a lack of benefit, and strengthened the suggestion of harm associated with early use of emollients.

The document, published in November 2022, updates a February 2021 version, said Robert Boyle, MD, PhD, senior author of the Cochrane Review and a pediatric allergist at Imperial College London. “The differences were slight,” he told this news organization. “Mainly, we had a little more data about food allergy outcomes, which slightly strengthened the concern about a possible increase in food allergy with emollients; and we had some new genetic information, which allowed us to add some further interaction analyses and confirm that chromosome 11 intergenic variant rs2212434 doesn’t seem to impact the effect – or lack of effect – of emollient on eczema development.”

The updated Cochrane Review concludes that, “based on low‐ to moderate-certainty evidence, skin care interventions such as emollients during the first year of life in healthy infants are probably not effective for preventing eczema; may increase risk of food allergy; and probably increase risk of skin infection.”

The latest publication should strengthen clinicians’ confidence in not recommending emollient use for preventing AD in at-risk infants – however, that message is being diluted by a stream of contradictory conclusions from poor-quality systematic reviews, say Dr. Boyle and two coauthors. “It’s a systematic problem of people churning out endless systematic reviews without much rigor,” explained the lead author Maeve Kelleher, MD, from Children’s Health Ireland, Crumlin. There have been “misleading systematic reviews published, often in high-ranking journals,” agreed Dr. Boyle.

“I have been an advocate of systematic reviews for the last 20 years, but they have gone completely out of control,” added Hywel Williams, MD, PhD, another of the Cochrane Review coauthors, who is professor of dermato-epidemiology and codirector of the Centre of Evidence Based Dermatology, at Nottingham (England) University Hospitals NHS Trust. In an editorial, published last year, Dr. Williams even posed the question: “Are Dermatology Systematic Reviews Spinning Out of Control?” in which he blamed “the misrepresentation of study results” – which he calls “the sin of spin” – for degrading the quality of science in dermatology.

“The field has become a ‘sausage machine’ industry that undermines the value of systematic reviews in providing a summary of the best evidence to inform patient care,” he wrote. “Fewer systematic reviews are needed in dermatology,” but “better ones” are needed, he continued, calling for all systematic reviews to be registered prospectively, and reported according to PRISMA (Preferred Reporting Items for Systematic Reviews and Meta-Analyses) guidelines.

Earlier this year, in a letter to the editor, Dr. Kelleher, Dr. Boyle, Dr. Williams, and several others outlined their concerns after a systemic review and meta-analysis was published, “which came to very different conclusions” than their Cochrane Review.

“It is quite common to see non-Cochrane reviews published in leading specialty journals, which interpret data in a more positive light than Cochrane reviews, which have assessed a similar dataset/topic,” Dr. Boyle said in the interview.

Such concerns also apply to the publication of another systematic review that was recently published. “Overall, early application of emollients is an effective strategy for preventing AD development in high-risk infants,” reported senior author Xiaojing Kang, MD, PhD, from People’s Hospital of Xinjiang Uygur Autonomous Region, Urumchi, China, and coauthors, who could not be reached for comment. In their discussion, the authors cite several criticisms of the Cochrane Review: that it included two meeting abstracts and two “ineligible” studies; did not do subgroup analysis of high-risk infants; did not look at different types of emollients; and did not examine the risk of food sensitization.

“A Cochrane Review can be quite a large and complex document to negotiate for those who are not very familiar with Cochrane’s methodology,” said Dr. Boyle. He dismissed the criticism, saying “we did do subgroup analysis of high risk infants, we did look at different types of emollient, and we did look at food sensitization and food allergy risk. We only included eligible studies. … Certainly we would include abstracts of trials, which are not reported in any other form, in order to capture as complete a picture.”

Ultimately, Dr. Boyle said, the discrepancy in conclusions between such systematic reviews and the Cochrane Review relates to quality of methodology. “Our Cochrane review was an individual participant data (IPD) meta-analysis, meaning that authors of the main trials in this area shared their original datasets with us,” he said in the interview. “This is the ‘gold standard’ in systematic reviews, and allowed us to check data/ query inconsistencies and to apply a single-analysis methodology across all studies. It also allowed us to undertake some analyses, which are just not possible in aggregate data analysis based on published work without IPD.”

The most recently published systematic review had no registered protocol, “so, there is no transparency about the methods used,” he noted. “It is free and simple to register a protocol – multiple websites such as PROSPERO, open science framework, and zenodo allow this,” he said “In the journal I edit, we use availability of a registered protocol as a marker of quality. We find that systematic reviews with no registered protocol are almost universally poor quality.”

Dr. Williams is a founding member and coordinating editor of the Cochrane Skin Group 1998 to 2017. Dr. Boyle was paid by Cochrane for senior editor work, until recently, and had no other relevant disclosures. Dr. Kelleher had no relevant disclosures.

An updated Cochrane Review on infant skincare interventions for preventing atopic dermatitis (AD) and food allergy has reaffirmed previous study findings indicating a lack of benefit, and strengthened the suggestion of harm associated with early use of emollients.

The document, published in November 2022, updates a February 2021 version, said Robert Boyle, MD, PhD, senior author of the Cochrane Review and a pediatric allergist at Imperial College London. “The differences were slight,” he told this news organization. “Mainly, we had a little more data about food allergy outcomes, which slightly strengthened the concern about a possible increase in food allergy with emollients; and we had some new genetic information, which allowed us to add some further interaction analyses and confirm that chromosome 11 intergenic variant rs2212434 doesn’t seem to impact the effect – or lack of effect – of emollient on eczema development.”

The updated Cochrane Review concludes that, “based on low‐ to moderate-certainty evidence, skin care interventions such as emollients during the first year of life in healthy infants are probably not effective for preventing eczema; may increase risk of food allergy; and probably increase risk of skin infection.”

The latest publication should strengthen clinicians’ confidence in not recommending emollient use for preventing AD in at-risk infants – however, that message is being diluted by a stream of contradictory conclusions from poor-quality systematic reviews, say Dr. Boyle and two coauthors. “It’s a systematic problem of people churning out endless systematic reviews without much rigor,” explained the lead author Maeve Kelleher, MD, from Children’s Health Ireland, Crumlin. There have been “misleading systematic reviews published, often in high-ranking journals,” agreed Dr. Boyle.

“I have been an advocate of systematic reviews for the last 20 years, but they have gone completely out of control,” added Hywel Williams, MD, PhD, another of the Cochrane Review coauthors, who is professor of dermato-epidemiology and codirector of the Centre of Evidence Based Dermatology, at Nottingham (England) University Hospitals NHS Trust. In an editorial, published last year, Dr. Williams even posed the question: “Are Dermatology Systematic Reviews Spinning Out of Control?” in which he blamed “the misrepresentation of study results” – which he calls “the sin of spin” – for degrading the quality of science in dermatology.

“The field has become a ‘sausage machine’ industry that undermines the value of systematic reviews in providing a summary of the best evidence to inform patient care,” he wrote. “Fewer systematic reviews are needed in dermatology,” but “better ones” are needed, he continued, calling for all systematic reviews to be registered prospectively, and reported according to PRISMA (Preferred Reporting Items for Systematic Reviews and Meta-Analyses) guidelines.

Earlier this year, in a letter to the editor, Dr. Kelleher, Dr. Boyle, Dr. Williams, and several others outlined their concerns after a systemic review and meta-analysis was published, “which came to very different conclusions” than their Cochrane Review.

“It is quite common to see non-Cochrane reviews published in leading specialty journals, which interpret data in a more positive light than Cochrane reviews, which have assessed a similar dataset/topic,” Dr. Boyle said in the interview.

Such concerns also apply to the publication of another systematic review that was recently published. “Overall, early application of emollients is an effective strategy for preventing AD development in high-risk infants,” reported senior author Xiaojing Kang, MD, PhD, from People’s Hospital of Xinjiang Uygur Autonomous Region, Urumchi, China, and coauthors, who could not be reached for comment. In their discussion, the authors cite several criticisms of the Cochrane Review: that it included two meeting abstracts and two “ineligible” studies; did not do subgroup analysis of high-risk infants; did not look at different types of emollients; and did not examine the risk of food sensitization.

“A Cochrane Review can be quite a large and complex document to negotiate for those who are not very familiar with Cochrane’s methodology,” said Dr. Boyle. He dismissed the criticism, saying “we did do subgroup analysis of high risk infants, we did look at different types of emollient, and we did look at food sensitization and food allergy risk. We only included eligible studies. … Certainly we would include abstracts of trials, which are not reported in any other form, in order to capture as complete a picture.”

Ultimately, Dr. Boyle said, the discrepancy in conclusions between such systematic reviews and the Cochrane Review relates to quality of methodology. “Our Cochrane review was an individual participant data (IPD) meta-analysis, meaning that authors of the main trials in this area shared their original datasets with us,” he said in the interview. “This is the ‘gold standard’ in systematic reviews, and allowed us to check data/ query inconsistencies and to apply a single-analysis methodology across all studies. It also allowed us to undertake some analyses, which are just not possible in aggregate data analysis based on published work without IPD.”

The most recently published systematic review had no registered protocol, “so, there is no transparency about the methods used,” he noted. “It is free and simple to register a protocol – multiple websites such as PROSPERO, open science framework, and zenodo allow this,” he said “In the journal I edit, we use availability of a registered protocol as a marker of quality. We find that systematic reviews with no registered protocol are almost universally poor quality.”

Dr. Williams is a founding member and coordinating editor of the Cochrane Skin Group 1998 to 2017. Dr. Boyle was paid by Cochrane for senior editor work, until recently, and had no other relevant disclosures. Dr. Kelleher had no relevant disclosures.

An updated Cochrane Review on infant skincare interventions for preventing atopic dermatitis (AD) and food allergy has reaffirmed previous study findings indicating a lack of benefit, and strengthened the suggestion of harm associated with early use of emollients.

The document, published in November 2022, updates a February 2021 version, said Robert Boyle, MD, PhD, senior author of the Cochrane Review and a pediatric allergist at Imperial College London. “The differences were slight,” he told this news organization. “Mainly, we had a little more data about food allergy outcomes, which slightly strengthened the concern about a possible increase in food allergy with emollients; and we had some new genetic information, which allowed us to add some further interaction analyses and confirm that chromosome 11 intergenic variant rs2212434 doesn’t seem to impact the effect – or lack of effect – of emollient on eczema development.”

The updated Cochrane Review concludes that, “based on low‐ to moderate-certainty evidence, skin care interventions such as emollients during the first year of life in healthy infants are probably not effective for preventing eczema; may increase risk of food allergy; and probably increase risk of skin infection.”

The latest publication should strengthen clinicians’ confidence in not recommending emollient use for preventing AD in at-risk infants – however, that message is being diluted by a stream of contradictory conclusions from poor-quality systematic reviews, say Dr. Boyle and two coauthors. “It’s a systematic problem of people churning out endless systematic reviews without much rigor,” explained the lead author Maeve Kelleher, MD, from Children’s Health Ireland, Crumlin. There have been “misleading systematic reviews published, often in high-ranking journals,” agreed Dr. Boyle.

“I have been an advocate of systematic reviews for the last 20 years, but they have gone completely out of control,” added Hywel Williams, MD, PhD, another of the Cochrane Review coauthors, who is professor of dermato-epidemiology and codirector of the Centre of Evidence Based Dermatology, at Nottingham (England) University Hospitals NHS Trust. In an editorial, published last year, Dr. Williams even posed the question: “Are Dermatology Systematic Reviews Spinning Out of Control?” in which he blamed “the misrepresentation of study results” – which he calls “the sin of spin” – for degrading the quality of science in dermatology.

“The field has become a ‘sausage machine’ industry that undermines the value of systematic reviews in providing a summary of the best evidence to inform patient care,” he wrote. “Fewer systematic reviews are needed in dermatology,” but “better ones” are needed, he continued, calling for all systematic reviews to be registered prospectively, and reported according to PRISMA (Preferred Reporting Items for Systematic Reviews and Meta-Analyses) guidelines.

Earlier this year, in a letter to the editor, Dr. Kelleher, Dr. Boyle, Dr. Williams, and several others outlined their concerns after a systemic review and meta-analysis was published, “which came to very different conclusions” than their Cochrane Review.

“It is quite common to see non-Cochrane reviews published in leading specialty journals, which interpret data in a more positive light than Cochrane reviews, which have assessed a similar dataset/topic,” Dr. Boyle said in the interview.

Such concerns also apply to the publication of another systematic review that was recently published. “Overall, early application of emollients is an effective strategy for preventing AD development in high-risk infants,” reported senior author Xiaojing Kang, MD, PhD, from People’s Hospital of Xinjiang Uygur Autonomous Region, Urumchi, China, and coauthors, who could not be reached for comment. In their discussion, the authors cite several criticisms of the Cochrane Review: that it included two meeting abstracts and two “ineligible” studies; did not do subgroup analysis of high-risk infants; did not look at different types of emollients; and did not examine the risk of food sensitization.

“A Cochrane Review can be quite a large and complex document to negotiate for those who are not very familiar with Cochrane’s methodology,” said Dr. Boyle. He dismissed the criticism, saying “we did do subgroup analysis of high risk infants, we did look at different types of emollient, and we did look at food sensitization and food allergy risk. We only included eligible studies. … Certainly we would include abstracts of trials, which are not reported in any other form, in order to capture as complete a picture.”

Ultimately, Dr. Boyle said, the discrepancy in conclusions between such systematic reviews and the Cochrane Review relates to quality of methodology. “Our Cochrane review was an individual participant data (IPD) meta-analysis, meaning that authors of the main trials in this area shared their original datasets with us,” he said in the interview. “This is the ‘gold standard’ in systematic reviews, and allowed us to check data/ query inconsistencies and to apply a single-analysis methodology across all studies. It also allowed us to undertake some analyses, which are just not possible in aggregate data analysis based on published work without IPD.”

The most recently published systematic review had no registered protocol, “so, there is no transparency about the methods used,” he noted. “It is free and simple to register a protocol – multiple websites such as PROSPERO, open science framework, and zenodo allow this,” he said “In the journal I edit, we use availability of a registered protocol as a marker of quality. We find that systematic reviews with no registered protocol are almost universally poor quality.”

Dr. Williams is a founding member and coordinating editor of the Cochrane Skin Group 1998 to 2017. Dr. Boyle was paid by Cochrane for senior editor work, until recently, and had no other relevant disclosures. Dr. Kelleher had no relevant disclosures.

Problematic alcohol use by physicians appears to be increasing, new research shows. However, good data on exactly how common this is and on salient risk factors are lacking.
 

In a systematic literature review, investigators found the prevalence of self-reported problematic alcohol use varied widely, but could affect up to one third of physicians.

However, all studies were survey-based and self-reported, and definitions of problematic alcohol use were mixed, with inconsistent reporting on differences across sex, age, physician specialty, and career stage.

“Key epidemiologic information of the prevalence of problematic alcohol use in physicians and associated risk factors are unknown, hampering the ability to identify high-risk individuals for targeted interventions,” Manish Sood, MD, University of Ottawa, and colleagues wrote.

The findings were published online in JAMA Network Open.
 

Serious concern

The researchers noted that physicians are at a higher risk for burnout and mental health conditions, including depression and anxiety, than the general population, which could contribute to problematic drinking.

Problematic drinking among physicians poses a “serious concern” to their health and ability to provide care, the investigators wrote. Understanding the extent and characteristics of the issue is important to guide interventions.

To better characterize problematic drinking among physicians, the investigators reviewed 31 studies from 2006 to 2020 involving 51,680 residents, fellows, or staff physicians in 17 countries.

In the studies, problematic alcohol use was measured by a validated tool: the Alcohol Use Disorders Identification Test, AUDIT Version C (AUDIT-C), or the Cut down, Annoyed, Guilty, and Eye-opener (CAGE) questionnaire.

“Problematic alcohol use” included hazardous, potentially hazardous, risky, at-risk, harmful, problematic, or heavy drinking or alcohol use, as well as alcohol misuse, alcohol dependence, and alcohol use more than low-risk guidelines and alcohol use disorder.

Results showed problematic alcohol use “varied widely” regardless of measurement method used. The rate was 0%-34% with AUDIT, 9%-35% with AUDIT-C, and 4%-22% with CAGE.

The data also showed an increase in reported problematic alcohol use over time, rising from 16.3% between 2006 and 2010 to 26.8% between 2017 and 2020.
 

True prevalence unknown

“It remains unknown whether this increase is indeed accurate or whether it is due to increased transparency by physicians in self-reporting problematic alcohol use because of a changing culture of medicine,” the investigators wrote.

The data suggest that problematic alcohol use is more common in male than female physicians; but no firm conclusions can be drawn from the data on how problematic alcohol use varies based on physician age, sex, specialty, and career stage, the researchers noted.

True prevalence of problematic alcohol use among physicians remains unknown – and identifying this type of behavior is difficult, they pointed out.

They added that physicians with problematic use may be “high functioning,” making identifying potential impairment a challenge. Also, societal stigma and fear of reprisal from professional colleges for reporting or seeking care for problematic alcohol use may encourage physicians with alcohol problems to keep their problems hidden.

The researchers noted that future population-based studies with longitudinal designs or using health administrative data could help identify the prevalence of and salient risk factors for problematic alcohol use in physicians.

The study was supported by the Canadian Medical Association. The authors reported no relevant disclosures.

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

Problematic alcohol use by physicians appears to be increasing, new research shows. However, good data on exactly how common this is and on salient risk factors are lacking.
 

In a systematic literature review, investigators found the prevalence of self-reported problematic alcohol use varied widely, but could affect up to one third of physicians.

However, all studies were survey-based and self-reported, and definitions of problematic alcohol use were mixed, with inconsistent reporting on differences across sex, age, physician specialty, and career stage.

“Key epidemiologic information of the prevalence of problematic alcohol use in physicians and associated risk factors are unknown, hampering the ability to identify high-risk individuals for targeted interventions,” Manish Sood, MD, University of Ottawa, and colleagues wrote.

The findings were published online in JAMA Network Open.
 

Serious concern

The researchers noted that physicians are at a higher risk for burnout and mental health conditions, including depression and anxiety, than the general population, which could contribute to problematic drinking.

Problematic drinking among physicians poses a “serious concern” to their health and ability to provide care, the investigators wrote. Understanding the extent and characteristics of the issue is important to guide interventions.

To better characterize problematic drinking among physicians, the investigators reviewed 31 studies from 2006 to 2020 involving 51,680 residents, fellows, or staff physicians in 17 countries.

In the studies, problematic alcohol use was measured by a validated tool: the Alcohol Use Disorders Identification Test, AUDIT Version C (AUDIT-C), or the Cut down, Annoyed, Guilty, and Eye-opener (CAGE) questionnaire.

“Problematic alcohol use” included hazardous, potentially hazardous, risky, at-risk, harmful, problematic, or heavy drinking or alcohol use, as well as alcohol misuse, alcohol dependence, and alcohol use more than low-risk guidelines and alcohol use disorder.

Results showed problematic alcohol use “varied widely” regardless of measurement method used. The rate was 0%-34% with AUDIT, 9%-35% with AUDIT-C, and 4%-22% with CAGE.

The data also showed an increase in reported problematic alcohol use over time, rising from 16.3% between 2006 and 2010 to 26.8% between 2017 and 2020.
 

True prevalence unknown

“It remains unknown whether this increase is indeed accurate or whether it is due to increased transparency by physicians in self-reporting problematic alcohol use because of a changing culture of medicine,” the investigators wrote.

The data suggest that problematic alcohol use is more common in male than female physicians; but no firm conclusions can be drawn from the data on how problematic alcohol use varies based on physician age, sex, specialty, and career stage, the researchers noted.

True prevalence of problematic alcohol use among physicians remains unknown – and identifying this type of behavior is difficult, they pointed out.

They added that physicians with problematic use may be “high functioning,” making identifying potential impairment a challenge. Also, societal stigma and fear of reprisal from professional colleges for reporting or seeking care for problematic alcohol use may encourage physicians with alcohol problems to keep their problems hidden.

The researchers noted that future population-based studies with longitudinal designs or using health administrative data could help identify the prevalence of and salient risk factors for problematic alcohol use in physicians.

The study was supported by the Canadian Medical Association. The authors reported no relevant disclosures.

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

Problematic alcohol use by physicians appears to be increasing, new research shows. However, good data on exactly how common this is and on salient risk factors are lacking.
 

In a systematic literature review, investigators found the prevalence of self-reported problematic alcohol use varied widely, but could affect up to one third of physicians.

However, all studies were survey-based and self-reported, and definitions of problematic alcohol use were mixed, with inconsistent reporting on differences across sex, age, physician specialty, and career stage.

“Key epidemiologic information of the prevalence of problematic alcohol use in physicians and associated risk factors are unknown, hampering the ability to identify high-risk individuals for targeted interventions,” Manish Sood, MD, University of Ottawa, and colleagues wrote.

The findings were published online in JAMA Network Open.
 

Serious concern

The researchers noted that physicians are at a higher risk for burnout and mental health conditions, including depression and anxiety, than the general population, which could contribute to problematic drinking.

Problematic drinking among physicians poses a “serious concern” to their health and ability to provide care, the investigators wrote. Understanding the extent and characteristics of the issue is important to guide interventions.

To better characterize problematic drinking among physicians, the investigators reviewed 31 studies from 2006 to 2020 involving 51,680 residents, fellows, or staff physicians in 17 countries.

In the studies, problematic alcohol use was measured by a validated tool: the Alcohol Use Disorders Identification Test, AUDIT Version C (AUDIT-C), or the Cut down, Annoyed, Guilty, and Eye-opener (CAGE) questionnaire.

“Problematic alcohol use” included hazardous, potentially hazardous, risky, at-risk, harmful, problematic, or heavy drinking or alcohol use, as well as alcohol misuse, alcohol dependence, and alcohol use more than low-risk guidelines and alcohol use disorder.

Results showed problematic alcohol use “varied widely” regardless of measurement method used. The rate was 0%-34% with AUDIT, 9%-35% with AUDIT-C, and 4%-22% with CAGE.

The data also showed an increase in reported problematic alcohol use over time, rising from 16.3% between 2006 and 2010 to 26.8% between 2017 and 2020.
 

True prevalence unknown

“It remains unknown whether this increase is indeed accurate or whether it is due to increased transparency by physicians in self-reporting problematic alcohol use because of a changing culture of medicine,” the investigators wrote.

The data suggest that problematic alcohol use is more common in male than female physicians; but no firm conclusions can be drawn from the data on how problematic alcohol use varies based on physician age, sex, specialty, and career stage, the researchers noted.

True prevalence of problematic alcohol use among physicians remains unknown – and identifying this type of behavior is difficult, they pointed out.

They added that physicians with problematic use may be “high functioning,” making identifying potential impairment a challenge. Also, societal stigma and fear of reprisal from professional colleges for reporting or seeking care for problematic alcohol use may encourage physicians with alcohol problems to keep their problems hidden.

The researchers noted that future population-based studies with longitudinal designs or using health administrative data could help identify the prevalence of and salient risk factors for problematic alcohol use in physicians.

The study was supported by the Canadian Medical Association. The authors reported no relevant disclosures.

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

Emergencies happen anywhere, anytime, and sometimes physicians find themselves in situations where they are the only ones who can help. Is There a Doctor in the House? is a new series telling these stories.
 

I live on the Maumee River in Ohio, about 50 yards from the water. I had an early quit time and came home to meet my wife for lunch. Afterward, I went up to my barn across the main road to tinker around. It was a nice day out, so my wife had opened some windows. Suddenly, she heard screaming from the river. It did not sound like fun.

She ran down to the river’s edge and saw a dad and three boys struggling in the water. She phoned me screaming: “They’re drowning! They’re drowning!” I jumped in my truck and drove up our driveway through the yard right down to the river.

My wife was on the phone with 911 at that point, and I could see them about 75-100 yards out. The dad had two of the boys clinging around his neck. They were going under the water and coming up and going under again. The other boy was just floating nearby, face down, motionless.

I threw my shoes and scrubs off and started to walk towards the water. My wife screamed at me, “You’re not going in there!” I said, “I’m not going to stand here and watch this. It’s not going to happen.”

I’m not a kid anymore, but I was a high school swimmer, and to this day I work out all the time. I felt like I had to try something. So, I went in the water despite my wife yelling and I swam towards them.

What happens when you get in that deep water is that you panic. You can’t hear anyone because of the rapids, and your instinct is to swim back towards where you went in, which is against the current. Unless you’re a very strong swimmer, you’re just wasting your time, swimming in place.

But these guys weren’t trying to go anywhere. Dad was just trying to stay up and keep the boys alive. He was in about 10 feet of water. What they didn’t see or just didn’t know: About 20 yards upstream from that deep water is a little island.

When I got to them, I yelled at the dad to move towards the island, “Go backwards! Go back!” I flipped the boy over who wasn’t moving. He was the oldest of the three, around 10 or 11 years old. When I turned him over, he was blue and wasn’t breathing. I put my fingers on his neck and didn’t feel a pulse.

So, I’m treading water, holding him. I put an arm behind his back and started doing chest compressions on him. I probably did a dozen to 15 compressions – nothing. I thought, I’ve got to get some air in this kid. So, I gave him two deep breaths and then started doing compressions again. I know ACLS and CPR training would say we don’t do that anymore. But I couldn’t just sit there and give up. Shortly after that, he coughed out a large amount of water and started breathing.

The dad and the other two boys had made it to the island. So, I started moving towards it with the boy. It was a few minutes before he regained consciousness. Of course, he was unaware of what had happened. He started to scream, because here’s this strange man holding him. But he was breathing. That’s all I cared about.

When we got to the island, I saw that my neighbor downstream had launched his canoe. He’s a retired gentleman who lives next to me, a very physically fit man. He started rolling as hard as he could towards us, against the stream. I kind of gave him a thumbs up, like, “we’re safe now. We’re standing.” We loaded the kids and the dad in the canoe and made it back against the stream to the parking lot where they went in.

All this took probably 10 or 15 minutes, and by then the paramedics were there. Life Flight had been dispatched up by my barn where there’s room to land. So, they drove up there in the ambulance. The boy I revived was flown to the hospital. The others went in the ambulance.

I know all the ED docs, so I talked to somebody later who, with permission from the family, said they were all doing fine. They were getting x-rays on the boy’s lungs. And then I heard the dad and two boys were released that night. The other boy I worked on was observed overnight and discharged the following morning.

Four or 5 days later, I heard from their pediatrician, who also had permission to share. He sent me a very nice note through Epic that he had seen the boys. Besides some mental trauma, they were all healthy and doing fine.

The family lives in the area and the kids go to school 5 miles from my house. So, the following weekend they came over. It was Father’s Day, which was kind of cool. They brought me some flowers and candy and a card the boys had drawn to thank me.

I learned that the dad had brought the boys to the fishing site. They were horsing around in knee deep water. One of the boys walked off a little way and didn’t realize there was a drop off. He went in, and of course the dad went after him, and the other two followed.

I said to the parents: “Look, things like this happen for a reason. People like your son are saved and go on in this world because they’ve got special things to do. I can’t wait to see what kind of man he becomes.”

Two or 3 months later, it was football season, and I got at a message from the dad saying their son was playing football on Saturday at the school. He wondered if I could drop by. So, I kind of snuck over and watched, but I didn’t go say hi. There’s trauma there, and I didn’t want them to have to relive that.

I’m very fortunate that I exercise every day and I know how to do CPR and swim. And thank God the boy was floating when I got to him, or I never would’ve found him. The Maumee River is known as the “muddy Maumee.” You can’t see anything under the water.

Depending on the time of year, the river can be almost dry or overflowing into the parking lot with the current rushing hard. If it had been like that, I wouldn’t have considered going in. And they wouldn’t they have been there in the first place. They’d have been a mile downstream.

I took a risk. I could have gone out there and had the dad and two other kids jump on top of me. Then we all would have been in trouble. But like I told my wife, I couldn’t stand there and watch it. I’m just not that person.

I think it was also about being a dad myself and having grandkids now. Doctor or no doctor, I felt like I was in reasonably good shape and I had to go in there to help. This dad was trying his butt off, but three little kids is too many. You can’t do that by yourself. They were not going to make it.

I go to the hospital and I save lives as part of my job, and I don’t even come home and talk about it. But this is a whole different thing. Being able to save someone’s life when put in this situation is very gratifying. It’s a tremendous feeling. There’s a reason that young man is here today, and I’ll be watching for great things from him.

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

Daniel Cassavar, MD, is a cardiologist with ProMedica in Perrysburg, Ohio.

Emergencies happen anywhere, anytime, and sometimes physicians find themselves in situations where they are the only ones who can help. Is There a Doctor in the House? is a new series telling these stories.
 

I live on the Maumee River in Ohio, about 50 yards from the water. I had an early quit time and came home to meet my wife for lunch. Afterward, I went up to my barn across the main road to tinker around. It was a nice day out, so my wife had opened some windows. Suddenly, she heard screaming from the river. It did not sound like fun.

She ran down to the river’s edge and saw a dad and three boys struggling in the water. She phoned me screaming: “They’re drowning! They’re drowning!” I jumped in my truck and drove up our driveway through the yard right down to the river.

My wife was on the phone with 911 at that point, and I could see them about 75-100 yards out. The dad had two of the boys clinging around his neck. They were going under the water and coming up and going under again. The other boy was just floating nearby, face down, motionless.

I threw my shoes and scrubs off and started to walk towards the water. My wife screamed at me, “You’re not going in there!” I said, “I’m not going to stand here and watch this. It’s not going to happen.”

I’m not a kid anymore, but I was a high school swimmer, and to this day I work out all the time. I felt like I had to try something. So, I went in the water despite my wife yelling and I swam towards them.

What happens when you get in that deep water is that you panic. You can’t hear anyone because of the rapids, and your instinct is to swim back towards where you went in, which is against the current. Unless you’re a very strong swimmer, you’re just wasting your time, swimming in place.

But these guys weren’t trying to go anywhere. Dad was just trying to stay up and keep the boys alive. He was in about 10 feet of water. What they didn’t see or just didn’t know: About 20 yards upstream from that deep water is a little island.

When I got to them, I yelled at the dad to move towards the island, “Go backwards! Go back!” I flipped the boy over who wasn’t moving. He was the oldest of the three, around 10 or 11 years old. When I turned him over, he was blue and wasn’t breathing. I put my fingers on his neck and didn’t feel a pulse.

So, I’m treading water, holding him. I put an arm behind his back and started doing chest compressions on him. I probably did a dozen to 15 compressions – nothing. I thought, I’ve got to get some air in this kid. So, I gave him two deep breaths and then started doing compressions again. I know ACLS and CPR training would say we don’t do that anymore. But I couldn’t just sit there and give up. Shortly after that, he coughed out a large amount of water and started breathing.

The dad and the other two boys had made it to the island. So, I started moving towards it with the boy. It was a few minutes before he regained consciousness. Of course, he was unaware of what had happened. He started to scream, because here’s this strange man holding him. But he was breathing. That’s all I cared about.

When we got to the island, I saw that my neighbor downstream had launched his canoe. He’s a retired gentleman who lives next to me, a very physically fit man. He started rolling as hard as he could towards us, against the stream. I kind of gave him a thumbs up, like, “we’re safe now. We’re standing.” We loaded the kids and the dad in the canoe and made it back against the stream to the parking lot where they went in.

All this took probably 10 or 15 minutes, and by then the paramedics were there. Life Flight had been dispatched up by my barn where there’s room to land. So, they drove up there in the ambulance. The boy I revived was flown to the hospital. The others went in the ambulance.

I know all the ED docs, so I talked to somebody later who, with permission from the family, said they were all doing fine. They were getting x-rays on the boy’s lungs. And then I heard the dad and two boys were released that night. The other boy I worked on was observed overnight and discharged the following morning.

Four or 5 days later, I heard from their pediatrician, who also had permission to share. He sent me a very nice note through Epic that he had seen the boys. Besides some mental trauma, they were all healthy and doing fine.

The family lives in the area and the kids go to school 5 miles from my house. So, the following weekend they came over. It was Father’s Day, which was kind of cool. They brought me some flowers and candy and a card the boys had drawn to thank me.

I learned that the dad had brought the boys to the fishing site. They were horsing around in knee deep water. One of the boys walked off a little way and didn’t realize there was a drop off. He went in, and of course the dad went after him, and the other two followed.

I said to the parents: “Look, things like this happen for a reason. People like your son are saved and go on in this world because they’ve got special things to do. I can’t wait to see what kind of man he becomes.”

Two or 3 months later, it was football season, and I got at a message from the dad saying their son was playing football on Saturday at the school. He wondered if I could drop by. So, I kind of snuck over and watched, but I didn’t go say hi. There’s trauma there, and I didn’t want them to have to relive that.

I’m very fortunate that I exercise every day and I know how to do CPR and swim. And thank God the boy was floating when I got to him, or I never would’ve found him. The Maumee River is known as the “muddy Maumee.” You can’t see anything under the water.

Depending on the time of year, the river can be almost dry or overflowing into the parking lot with the current rushing hard. If it had been like that, I wouldn’t have considered going in. And they wouldn’t they have been there in the first place. They’d have been a mile downstream.

I took a risk. I could have gone out there and had the dad and two other kids jump on top of me. Then we all would have been in trouble. But like I told my wife, I couldn’t stand there and watch it. I’m just not that person.

I think it was also about being a dad myself and having grandkids now. Doctor or no doctor, I felt like I was in reasonably good shape and I had to go in there to help. This dad was trying his butt off, but three little kids is too many. You can’t do that by yourself. They were not going to make it.

I go to the hospital and I save lives as part of my job, and I don’t even come home and talk about it. But this is a whole different thing. Being able to save someone’s life when put in this situation is very gratifying. It’s a tremendous feeling. There’s a reason that young man is here today, and I’ll be watching for great things from him.

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

Daniel Cassavar, MD, is a cardiologist with ProMedica in Perrysburg, Ohio.

Emergencies happen anywhere, anytime, and sometimes physicians find themselves in situations where they are the only ones who can help. Is There a Doctor in the House? is a new series telling these stories.
 

I live on the Maumee River in Ohio, about 50 yards from the water. I had an early quit time and came home to meet my wife for lunch. Afterward, I went up to my barn across the main road to tinker around. It was a nice day out, so my wife had opened some windows. Suddenly, she heard screaming from the river. It did not sound like fun.

She ran down to the river’s edge and saw a dad and three boys struggling in the water. She phoned me screaming: “They’re drowning! They’re drowning!” I jumped in my truck and drove up our driveway through the yard right down to the river.

My wife was on the phone with 911 at that point, and I could see them about 75-100 yards out. The dad had two of the boys clinging around his neck. They were going under the water and coming up and going under again. The other boy was just floating nearby, face down, motionless.

I threw my shoes and scrubs off and started to walk towards the water. My wife screamed at me, “You’re not going in there!” I said, “I’m not going to stand here and watch this. It’s not going to happen.”

I’m not a kid anymore, but I was a high school swimmer, and to this day I work out all the time. I felt like I had to try something. So, I went in the water despite my wife yelling and I swam towards them.

What happens when you get in that deep water is that you panic. You can’t hear anyone because of the rapids, and your instinct is to swim back towards where you went in, which is against the current. Unless you’re a very strong swimmer, you’re just wasting your time, swimming in place.

But these guys weren’t trying to go anywhere. Dad was just trying to stay up and keep the boys alive. He was in about 10 feet of water. What they didn’t see or just didn’t know: About 20 yards upstream from that deep water is a little island.

When I got to them, I yelled at the dad to move towards the island, “Go backwards! Go back!” I flipped the boy over who wasn’t moving. He was the oldest of the three, around 10 or 11 years old. When I turned him over, he was blue and wasn’t breathing. I put my fingers on his neck and didn’t feel a pulse.

So, I’m treading water, holding him. I put an arm behind his back and started doing chest compressions on him. I probably did a dozen to 15 compressions – nothing. I thought, I’ve got to get some air in this kid. So, I gave him two deep breaths and then started doing compressions again. I know ACLS and CPR training would say we don’t do that anymore. But I couldn’t just sit there and give up. Shortly after that, he coughed out a large amount of water and started breathing.

The dad and the other two boys had made it to the island. So, I started moving towards it with the boy. It was a few minutes before he regained consciousness. Of course, he was unaware of what had happened. He started to scream, because here’s this strange man holding him. But he was breathing. That’s all I cared about.

When we got to the island, I saw that my neighbor downstream had launched his canoe. He’s a retired gentleman who lives next to me, a very physically fit man. He started rolling as hard as he could towards us, against the stream. I kind of gave him a thumbs up, like, “we’re safe now. We’re standing.” We loaded the kids and the dad in the canoe and made it back against the stream to the parking lot where they went in.

All this took probably 10 or 15 minutes, and by then the paramedics were there. Life Flight had been dispatched up by my barn where there’s room to land. So, they drove up there in the ambulance. The boy I revived was flown to the hospital. The others went in the ambulance.

I know all the ED docs, so I talked to somebody later who, with permission from the family, said they were all doing fine. They were getting x-rays on the boy’s lungs. And then I heard the dad and two boys were released that night. The other boy I worked on was observed overnight and discharged the following morning.

Four or 5 days later, I heard from their pediatrician, who also had permission to share. He sent me a very nice note through Epic that he had seen the boys. Besides some mental trauma, they were all healthy and doing fine.

The family lives in the area and the kids go to school 5 miles from my house. So, the following weekend they came over. It was Father’s Day, which was kind of cool. They brought me some flowers and candy and a card the boys had drawn to thank me.

I learned that the dad had brought the boys to the fishing site. They were horsing around in knee deep water. One of the boys walked off a little way and didn’t realize there was a drop off. He went in, and of course the dad went after him, and the other two followed.

I said to the parents: “Look, things like this happen for a reason. People like your son are saved and go on in this world because they’ve got special things to do. I can’t wait to see what kind of man he becomes.”

Two or 3 months later, it was football season, and I got at a message from the dad saying their son was playing football on Saturday at the school. He wondered if I could drop by. So, I kind of snuck over and watched, but I didn’t go say hi. There’s trauma there, and I didn’t want them to have to relive that.

I’m very fortunate that I exercise every day and I know how to do CPR and swim. And thank God the boy was floating when I got to him, or I never would’ve found him. The Maumee River is known as the “muddy Maumee.” You can’t see anything under the water.

Depending on the time of year, the river can be almost dry or overflowing into the parking lot with the current rushing hard. If it had been like that, I wouldn’t have considered going in. And they wouldn’t they have been there in the first place. They’d have been a mile downstream.

I took a risk. I could have gone out there and had the dad and two other kids jump on top of me. Then we all would have been in trouble. But like I told my wife, I couldn’t stand there and watch it. I’m just not that person.

I think it was also about being a dad myself and having grandkids now. Doctor or no doctor, I felt like I was in reasonably good shape and I had to go in there to help. This dad was trying his butt off, but three little kids is too many. You can’t do that by yourself. They were not going to make it.

I go to the hospital and I save lives as part of my job, and I don’t even come home and talk about it. But this is a whole different thing. Being able to save someone’s life when put in this situation is very gratifying. It’s a tremendous feeling. There’s a reason that young man is here today, and I’ll be watching for great things from him.

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

Daniel Cassavar, MD, is a cardiologist with ProMedica in Perrysburg, Ohio.

A new study provides more evidence that endocarditis associated with drug use is a significant and growing health concern, and further demonstrates that this risk has been exacerbated by the COVID-19 pandemic.

The rate of infective endocarditis among individuals in the United States with opioid or cocaine use disorder increased in the 11-year period 2011 to 2022, with the steepest increase logged during the COVID-19 pandemic (2021-2022), according to the study.

A diagnosis of COVID-19 more than doubled the risk for a new diagnosis of endocarditis in patients with either cocaine (hazard ratio, 2.24) or opioid use disorder (HR, 2.23).

“Our data suggests that, in addition to the major social disruption from the pandemic, including disrupted access to health care, COVID-19 infection itself is a significant risk factor for new diagnosis of endocarditis in drug using populations,” authors Nora Volkow, MD, director of the National Institute on Drug Abuse, and colleagues wrote.

“Drug-using populations, particularly those who use cocaine or opioids, have some of the highest risk for endocarditis, and here we show that having a COVID-19 diagnoses further increases this risk,” they added.

The study was published online in Molecular Psychiatry.

The researchers analyzed electronic health record data collected from January 2011 to August 2022 for more than 109 million people across the United States, including more than 736,000 with an opioid use disorder and more than 379,000 with a cocaine use disorder.

In 2011, there were 4 cases of endocarditis per day for every 1 million people with opioid use disorder. By 2022, the rate had increased to 30 cases per day per 1 million people with opioid use disorder.

For people with cocaine use disorder, cases of endocarditis increased from 5 per 1 million in 2011 to 23 per 1 million in 2022.

Among individuals with cocaine or opioid use disorder, the risk of being hospitalized within 180 days following a diagnosis of endocarditis was higher in those with than without COVID-19 (67.5% vs. 58.7%; HR, 1.21). 

The risk of dying within 180 days following new diagnosis of endocarditis was also higher in those with than without COVID-19 (9.2% vs. 8%; HR, 1.16).

The study also showed that Black and Hispanic individuals had a lower risk for COVID-19-associated endocarditis than non-Hispanic White individuals, which is consistent with a higher prevalence of injection drug use in non-Hispanic White populations, compared with Black or Hispanic populations, the researchers pointed out.

Dr. Volkow and colleagues said their findings highlight the need to screen drug users for endocarditis and link them to infectious disease and addiction treatment if they contract COVID-19.

“People with substance use disorder already face major impediments to proper health care due to lack of access and stigma,” Dr. Volkow said in a news release. 

“Proven techniques like syringe service programs, which help people avoid infection from reused or shared injection equipment, can help prevent this often fatal and costly condition,” Dr. Volkow added.

The authors said it will also be important to determine exactly how SARS-CoV-2 viral infection exacerbates the risk for endocarditis in drug users.

Support for the study was provided by the National Institute on Aging, National Institute on Alcohol Abuse and Alcoholism, the Clinical and Translational Science Collaborative of Cleveland, and the National Cancer Institute Case Comprehensive Cancer Center. The authors reported no relevant financial relationships.

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

A new study provides more evidence that endocarditis associated with drug use is a significant and growing health concern, and further demonstrates that this risk has been exacerbated by the COVID-19 pandemic.

The rate of infective endocarditis among individuals in the United States with opioid or cocaine use disorder increased in the 11-year period 2011 to 2022, with the steepest increase logged during the COVID-19 pandemic (2021-2022), according to the study.

A diagnosis of COVID-19 more than doubled the risk for a new diagnosis of endocarditis in patients with either cocaine (hazard ratio, 2.24) or opioid use disorder (HR, 2.23).

“Our data suggests that, in addition to the major social disruption from the pandemic, including disrupted access to health care, COVID-19 infection itself is a significant risk factor for new diagnosis of endocarditis in drug using populations,” authors Nora Volkow, MD, director of the National Institute on Drug Abuse, and colleagues wrote.

“Drug-using populations, particularly those who use cocaine or opioids, have some of the highest risk for endocarditis, and here we show that having a COVID-19 diagnoses further increases this risk,” they added.

The study was published online in Molecular Psychiatry.

The researchers analyzed electronic health record data collected from January 2011 to August 2022 for more than 109 million people across the United States, including more than 736,000 with an opioid use disorder and more than 379,000 with a cocaine use disorder.

In 2011, there were 4 cases of endocarditis per day for every 1 million people with opioid use disorder. By 2022, the rate had increased to 30 cases per day per 1 million people with opioid use disorder.

For people with cocaine use disorder, cases of endocarditis increased from 5 per 1 million in 2011 to 23 per 1 million in 2022.

Among individuals with cocaine or opioid use disorder, the risk of being hospitalized within 180 days following a diagnosis of endocarditis was higher in those with than without COVID-19 (67.5% vs. 58.7%; HR, 1.21). 

The risk of dying within 180 days following new diagnosis of endocarditis was also higher in those with than without COVID-19 (9.2% vs. 8%; HR, 1.16).

The study also showed that Black and Hispanic individuals had a lower risk for COVID-19-associated endocarditis than non-Hispanic White individuals, which is consistent with a higher prevalence of injection drug use in non-Hispanic White populations, compared with Black or Hispanic populations, the researchers pointed out.

Dr. Volkow and colleagues said their findings highlight the need to screen drug users for endocarditis and link them to infectious disease and addiction treatment if they contract COVID-19.

“People with substance use disorder already face major impediments to proper health care due to lack of access and stigma,” Dr. Volkow said in a news release. 

“Proven techniques like syringe service programs, which help people avoid infection from reused or shared injection equipment, can help prevent this often fatal and costly condition,” Dr. Volkow added.

The authors said it will also be important to determine exactly how SARS-CoV-2 viral infection exacerbates the risk for endocarditis in drug users.

Support for the study was provided by the National Institute on Aging, National Institute on Alcohol Abuse and Alcoholism, the Clinical and Translational Science Collaborative of Cleveland, and the National Cancer Institute Case Comprehensive Cancer Center. The authors reported no relevant financial relationships.

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

A new study provides more evidence that endocarditis associated with drug use is a significant and growing health concern, and further demonstrates that this risk has been exacerbated by the COVID-19 pandemic.

The rate of infective endocarditis among individuals in the United States with opioid or cocaine use disorder increased in the 11-year period 2011 to 2022, with the steepest increase logged during the COVID-19 pandemic (2021-2022), according to the study.

A diagnosis of COVID-19 more than doubled the risk for a new diagnosis of endocarditis in patients with either cocaine (hazard ratio, 2.24) or opioid use disorder (HR, 2.23).

“Our data suggests that, in addition to the major social disruption from the pandemic, including disrupted access to health care, COVID-19 infection itself is a significant risk factor for new diagnosis of endocarditis in drug using populations,” authors Nora Volkow, MD, director of the National Institute on Drug Abuse, and colleagues wrote.

“Drug-using populations, particularly those who use cocaine or opioids, have some of the highest risk for endocarditis, and here we show that having a COVID-19 diagnoses further increases this risk,” they added.

The study was published online in Molecular Psychiatry.

The researchers analyzed electronic health record data collected from January 2011 to August 2022 for more than 109 million people across the United States, including more than 736,000 with an opioid use disorder and more than 379,000 with a cocaine use disorder.

In 2011, there were 4 cases of endocarditis per day for every 1 million people with opioid use disorder. By 2022, the rate had increased to 30 cases per day per 1 million people with opioid use disorder.

For people with cocaine use disorder, cases of endocarditis increased from 5 per 1 million in 2011 to 23 per 1 million in 2022.

Among individuals with cocaine or opioid use disorder, the risk of being hospitalized within 180 days following a diagnosis of endocarditis was higher in those with than without COVID-19 (67.5% vs. 58.7%; HR, 1.21). 

The risk of dying within 180 days following new diagnosis of endocarditis was also higher in those with than without COVID-19 (9.2% vs. 8%; HR, 1.16).

The study also showed that Black and Hispanic individuals had a lower risk for COVID-19-associated endocarditis than non-Hispanic White individuals, which is consistent with a higher prevalence of injection drug use in non-Hispanic White populations, compared with Black or Hispanic populations, the researchers pointed out.

Dr. Volkow and colleagues said their findings highlight the need to screen drug users for endocarditis and link them to infectious disease and addiction treatment if they contract COVID-19.

“People with substance use disorder already face major impediments to proper health care due to lack of access and stigma,” Dr. Volkow said in a news release. 

“Proven techniques like syringe service programs, which help people avoid infection from reused or shared injection equipment, can help prevent this often fatal and costly condition,” Dr. Volkow added.

The authors said it will also be important to determine exactly how SARS-CoV-2 viral infection exacerbates the risk for endocarditis in drug users.

Support for the study was provided by the National Institute on Aging, National Institute on Alcohol Abuse and Alcoholism, the Clinical and Translational Science Collaborative of Cleveland, and the National Cancer Institute Case Comprehensive Cancer Center. The authors reported no relevant financial relationships.

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

A new drug application for a first-in-class photodynamic (PDT) therapy for treating early-stage cutaneous T-cell lymphoma (CTCL) has been submitted to the Food and Drug Administration based on phase 3 findings published in JAMA Dermatology.

The treatment employs an ointment formulation of synthetic hypericin (HyBryte), a photosensitizer, that is preferentially absorbed into malignant cells and activated with visible light – rather than ultraviolet light – approximately 24 hours later. Investigators saw significant clinical responses in both patch and plaque type lesions and across races during the 24-week placebo-controlled, double-blinded, phase 3, randomized clinical trial.

“Traditional phototherapy, ultraviolet B phototherapy, has a limited depth of penetration, so patients with thicker plaque lesions don’t respond as well ... and UVB phototherapy typically is less effective in penetrating pigmented skin,” Ellen J. Kim, MD, lead author of the FLASH phase 3 trial, said in an interview.

Visible light in the yellow-red spectrum (500-650 nm) “penetrates deeper into the skin” and is nonmutagenic in vitro, so “theoretically it should have a much more favorable long-term safety profile,” said Dr. Kim, a dermatologist at the University of Pennsylvania, Philadelphia.

Currently, she said, the risk of secondary malignancies inherent with UV PDT, including melanoma, is a deterrent for some patients, especially “patients with really fair skin and a history of skin cancer.”

Hypericin PDT also seems well suited for use with an at-home light unit. “In our field, it’s not about which therapy is [universally] better or best, but a matter of what works best for each patient at that moment in time, depending on the side-effect profile and other issues such as access,” Dr. Kim said. “It will be great to have another option for an incurable disease that requires chronic management.”

Mycosis fungoides (MF)/CTCL is considered an orphan disease, and the treatment has received orphan drug and fast track designations from the FDA, and orphan designation from the European Medicines Agency, according to a press release from its developer, Soligenix. The company is anticipating potential approval in the second half of 2023 and is targeting early 2024 for a U.S. launch, the statement said.

Phase 3 results

The pivotal trial involved 169 patients at 39 academic and community-based U.S. medical centers and consisted of several 6-week cycles of twice-weekly treatment punctuated by 2-week breaks. In cycle 1, patients were randomized 2:1 to receive hypericin or placebo treatment of three index lesions. Cycle 2 involved the crossover of placebo patients to active treatment of index lesions, and cycle 3 (optional) involved open-label treatment of all desired lesions (index and nonindex).

The trial defined the primary endpoint in phase 1 as 50% or greater improvement in the modified Composite Assessment of Index Lesion Severity score – a tool that’s endorsed by U.S. and international MF/CTCL specialty group consensus guidelines. For cycles 2 and 3, open-label response rates were secondary endpoints. Responses were assessed after 2-week rest periods to allow for treatment-induced skin reactions to subside.

After one cycle of treatment, topical hypericin PDT was more effective than placebo (an index lesion response rate of 16% vs. 4%; P =.04). The index lesion response rate with treatment increased to 40% after two cycles and 49% after three cycles. All were statistically significant changes.

Response rates were similar in patch and plaque-type lesions and regardless of age, sex, race, stage IA versus IB, time since diagnosis, and number of prior therapies. Adverse events were primarily mild application-site skin reactions. No serious drug-related adverse events occurred, Dr. Kim said, and “we had a low drop-out rate overall.”
 

Into the real world

The 24-week phase 3 trial duration is short, considering that “typically, phototherapy takes between 4 to 24 months [to achieve] full responses in CTCL,” Dr. Kim said in the interview.

So with real-world application, she said, “we’ll want to see where the overall response peaks with longer treatment, what the effects are of continuous treatment without any built-in breaks, and whether we will indeed see less skin cancer development in patients who are at higher risk of developing skin cancers from light treatment.”

Such questions will be explored as part of a new 4-year, 50-patient, open-label, multicenter study with the primary aim of investigating home-based hypericin PDT therapy in a supervised setting, said Dr. Kim, principal investigator of this study. Patients who are doing well after 6 weeks of twice-weekly therapy will be given at-home light units to continue therapy and achieve 1 year of treatment with no breaks. They will be monitored with video-based telemedicine.

“Long term, having a home unit should really improve patient access and compliance and hopefully effectiveness,” Dr. Kim said. Based on the phase 3 experience, “we think that continuous treatment will be well tolerated and that we may see greater responses.”

On Dec. 19, Soligenix announced that enrollment had begun in a phase 2a study of synthetic hypericin for treating patients with mild to moderate psoriasis.

Dr. Kim reported to JAMA Dermatology grants from Innate Pharma and Galderma; consulting/advisory fees from Almirall, Galderma, and Helsinn; and honoraria from Ology and UptoDate.

A new drug application for a first-in-class photodynamic (PDT) therapy for treating early-stage cutaneous T-cell lymphoma (CTCL) has been submitted to the Food and Drug Administration based on phase 3 findings published in JAMA Dermatology.

The treatment employs an ointment formulation of synthetic hypericin (HyBryte), a photosensitizer, that is preferentially absorbed into malignant cells and activated with visible light – rather than ultraviolet light – approximately 24 hours later. Investigators saw significant clinical responses in both patch and plaque type lesions and across races during the 24-week placebo-controlled, double-blinded, phase 3, randomized clinical trial.

“Traditional phototherapy, ultraviolet B phototherapy, has a limited depth of penetration, so patients with thicker plaque lesions don’t respond as well ... and UVB phototherapy typically is less effective in penetrating pigmented skin,” Ellen J. Kim, MD, lead author of the FLASH phase 3 trial, said in an interview.

Visible light in the yellow-red spectrum (500-650 nm) “penetrates deeper into the skin” and is nonmutagenic in vitro, so “theoretically it should have a much more favorable long-term safety profile,” said Dr. Kim, a dermatologist at the University of Pennsylvania, Philadelphia.

Currently, she said, the risk of secondary malignancies inherent with UV PDT, including melanoma, is a deterrent for some patients, especially “patients with really fair skin and a history of skin cancer.”

Hypericin PDT also seems well suited for use with an at-home light unit. “In our field, it’s not about which therapy is [universally] better or best, but a matter of what works best for each patient at that moment in time, depending on the side-effect profile and other issues such as access,” Dr. Kim said. “It will be great to have another option for an incurable disease that requires chronic management.”

Mycosis fungoides (MF)/CTCL is considered an orphan disease, and the treatment has received orphan drug and fast track designations from the FDA, and orphan designation from the European Medicines Agency, according to a press release from its developer, Soligenix. The company is anticipating potential approval in the second half of 2023 and is targeting early 2024 for a U.S. launch, the statement said.

Phase 3 results

The pivotal trial involved 169 patients at 39 academic and community-based U.S. medical centers and consisted of several 6-week cycles of twice-weekly treatment punctuated by 2-week breaks. In cycle 1, patients were randomized 2:1 to receive hypericin or placebo treatment of three index lesions. Cycle 2 involved the crossover of placebo patients to active treatment of index lesions, and cycle 3 (optional) involved open-label treatment of all desired lesions (index and nonindex).

The trial defined the primary endpoint in phase 1 as 50% or greater improvement in the modified Composite Assessment of Index Lesion Severity score – a tool that’s endorsed by U.S. and international MF/CTCL specialty group consensus guidelines. For cycles 2 and 3, open-label response rates were secondary endpoints. Responses were assessed after 2-week rest periods to allow for treatment-induced skin reactions to subside.

After one cycle of treatment, topical hypericin PDT was more effective than placebo (an index lesion response rate of 16% vs. 4%; P =.04). The index lesion response rate with treatment increased to 40% after two cycles and 49% after three cycles. All were statistically significant changes.

Response rates were similar in patch and plaque-type lesions and regardless of age, sex, race, stage IA versus IB, time since diagnosis, and number of prior therapies. Adverse events were primarily mild application-site skin reactions. No serious drug-related adverse events occurred, Dr. Kim said, and “we had a low drop-out rate overall.”
 

Into the real world

The 24-week phase 3 trial duration is short, considering that “typically, phototherapy takes between 4 to 24 months [to achieve] full responses in CTCL,” Dr. Kim said in the interview.

So with real-world application, she said, “we’ll want to see where the overall response peaks with longer treatment, what the effects are of continuous treatment without any built-in breaks, and whether we will indeed see less skin cancer development in patients who are at higher risk of developing skin cancers from light treatment.”

Such questions will be explored as part of a new 4-year, 50-patient, open-label, multicenter study with the primary aim of investigating home-based hypericin PDT therapy in a supervised setting, said Dr. Kim, principal investigator of this study. Patients who are doing well after 6 weeks of twice-weekly therapy will be given at-home light units to continue therapy and achieve 1 year of treatment with no breaks. They will be monitored with video-based telemedicine.

“Long term, having a home unit should really improve patient access and compliance and hopefully effectiveness,” Dr. Kim said. Based on the phase 3 experience, “we think that continuous treatment will be well tolerated and that we may see greater responses.”

On Dec. 19, Soligenix announced that enrollment had begun in a phase 2a study of synthetic hypericin for treating patients with mild to moderate psoriasis.

Dr. Kim reported to JAMA Dermatology grants from Innate Pharma and Galderma; consulting/advisory fees from Almirall, Galderma, and Helsinn; and honoraria from Ology and UptoDate.

A new drug application for a first-in-class photodynamic (PDT) therapy for treating early-stage cutaneous T-cell lymphoma (CTCL) has been submitted to the Food and Drug Administration based on phase 3 findings published in JAMA Dermatology.

The treatment employs an ointment formulation of synthetic hypericin (HyBryte), a photosensitizer, that is preferentially absorbed into malignant cells and activated with visible light – rather than ultraviolet light – approximately 24 hours later. Investigators saw significant clinical responses in both patch and plaque type lesions and across races during the 24-week placebo-controlled, double-blinded, phase 3, randomized clinical trial.

“Traditional phototherapy, ultraviolet B phototherapy, has a limited depth of penetration, so patients with thicker plaque lesions don’t respond as well ... and UVB phototherapy typically is less effective in penetrating pigmented skin,” Ellen J. Kim, MD, lead author of the FLASH phase 3 trial, said in an interview.

Visible light in the yellow-red spectrum (500-650 nm) “penetrates deeper into the skin” and is nonmutagenic in vitro, so “theoretically it should have a much more favorable long-term safety profile,” said Dr. Kim, a dermatologist at the University of Pennsylvania, Philadelphia.

Currently, she said, the risk of secondary malignancies inherent with UV PDT, including melanoma, is a deterrent for some patients, especially “patients with really fair skin and a history of skin cancer.”

Hypericin PDT also seems well suited for use with an at-home light unit. “In our field, it’s not about which therapy is [universally] better or best, but a matter of what works best for each patient at that moment in time, depending on the side-effect profile and other issues such as access,” Dr. Kim said. “It will be great to have another option for an incurable disease that requires chronic management.”

Mycosis fungoides (MF)/CTCL is considered an orphan disease, and the treatment has received orphan drug and fast track designations from the FDA, and orphan designation from the European Medicines Agency, according to a press release from its developer, Soligenix. The company is anticipating potential approval in the second half of 2023 and is targeting early 2024 for a U.S. launch, the statement said.

Phase 3 results

The pivotal trial involved 169 patients at 39 academic and community-based U.S. medical centers and consisted of several 6-week cycles of twice-weekly treatment punctuated by 2-week breaks. In cycle 1, patients were randomized 2:1 to receive hypericin or placebo treatment of three index lesions. Cycle 2 involved the crossover of placebo patients to active treatment of index lesions, and cycle 3 (optional) involved open-label treatment of all desired lesions (index and nonindex).

The trial defined the primary endpoint in phase 1 as 50% or greater improvement in the modified Composite Assessment of Index Lesion Severity score – a tool that’s endorsed by U.S. and international MF/CTCL specialty group consensus guidelines. For cycles 2 and 3, open-label response rates were secondary endpoints. Responses were assessed after 2-week rest periods to allow for treatment-induced skin reactions to subside.

After one cycle of treatment, topical hypericin PDT was more effective than placebo (an index lesion response rate of 16% vs. 4%; P =.04). The index lesion response rate with treatment increased to 40% after two cycles and 49% after three cycles. All were statistically significant changes.

Response rates were similar in patch and plaque-type lesions and regardless of age, sex, race, stage IA versus IB, time since diagnosis, and number of prior therapies. Adverse events were primarily mild application-site skin reactions. No serious drug-related adverse events occurred, Dr. Kim said, and “we had a low drop-out rate overall.”
 

Into the real world

The 24-week phase 3 trial duration is short, considering that “typically, phototherapy takes between 4 to 24 months [to achieve] full responses in CTCL,” Dr. Kim said in the interview.

So with real-world application, she said, “we’ll want to see where the overall response peaks with longer treatment, what the effects are of continuous treatment without any built-in breaks, and whether we will indeed see less skin cancer development in patients who are at higher risk of developing skin cancers from light treatment.”

Such questions will be explored as part of a new 4-year, 50-patient, open-label, multicenter study with the primary aim of investigating home-based hypericin PDT therapy in a supervised setting, said Dr. Kim, principal investigator of this study. Patients who are doing well after 6 weeks of twice-weekly therapy will be given at-home light units to continue therapy and achieve 1 year of treatment with no breaks. They will be monitored with video-based telemedicine.

“Long term, having a home unit should really improve patient access and compliance and hopefully effectiveness,” Dr. Kim said. Based on the phase 3 experience, “we think that continuous treatment will be well tolerated and that we may see greater responses.”

On Dec. 19, Soligenix announced that enrollment had begun in a phase 2a study of synthetic hypericin for treating patients with mild to moderate psoriasis.

Dr. Kim reported to JAMA Dermatology grants from Innate Pharma and Galderma; consulting/advisory fees from Almirall, Galderma, and Helsinn; and honoraria from Ology and UptoDate.

Three cups of tea, two biscuit packs, and a Christmas study from the BMJ

Warning: The following content may contain excessive Britishness. Continue at your own risk.

It’s no secret that the world economy is in an … interesting spot right now. Belt tightening is occurring around the world despite the holiday season, and hospitals across the pond in Great Britain are no exception.

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It was a simple sign that prompted the study, published in the Christmas edition of the BMJ: “Please do not take excessive quantities of these refreshments.” And if we all know one thing, you do not get between Brits and their tea and biscuits. So the researchers behind the study drafted a survey and sent it around to nearly 2,000 British health care workers and asked what they considered to be excessive consumption of work-provided hot drinks and biscuits.

In the hot drinks department (tea and coffee, though we appreciate the two people who voiced a preference for free hot whiskey, if it was available) the survey participants decreed that 3.32 drinks was the maximum before consumption became excessive. That’s pretty close to the actual number of hot drinks respondents drank daily (3.04), so it’s pretty fair to say that British health care workers do a good job of self-limiting.

It’s much the same story with biscuits: Health care workers reported that consuming 2.25 packets of free biscuits would be excessive. Notably, doctors would take more than nondoctors (2.35 vs. 2.14 – typical doctor behavior), and those who had been in their role for less than 2 years would consume nearly 3 packets a day before calling it quits.

The study did not include an official cost analysis, but calculations conducted on a biscuit wrapper (that’s not a joke, by the way) estimated that the combined cost for providing every National Health Service employee with three free drinks and two free biscuit packages a day would be about 160 million pounds a year. Now, that’s a lot of money for tea and biscuits, but, they added, it’s a meager 0.1% of the NHS annual budget. They also noted that most employees consider free hot drinks a more valuable workplace perk than free support for mental health.

In conclusion, the authors wrote, “As a target for cost-saving initiatives, limiting free refreshment consumption is really scraping the biscuit barrel (although some limits on hot whiskey availability may be necessary), and implementing, or continuing, perks that improve staff morale seems justifiable. … Healthcare employers should allow biscuits and hot drinks to be freely available to staff, and they should leave these grateful recipients to judge for themselves what constitutes reasonable consumption.”

Now there’s a Christmas sentiment we can all get behind.
 

We come not to bury sugar, but to improve it

When we think about sugar, healthy isn’t the first thing that comes to mind. Research also shows that artificial sweeteners, as well as processed foods in general, are bad for your body and brain. People, however, love the stuff. That’s why one of the leading brands in processed foods, Kraft Heinz, partnered with the Wyss Institute for Biologically Inspired Engineering at Harvard to find a way to reduce consumers’ sugar consumption.

Vassiliy Vassilenko/thinkstockphotos.com

The question that Kraft Heinz presented to Wyss was this: How could it reduce the fructose in its products without losing the functionality of regular sugar.

The Wyss team’s approach seems pretty simple: Use a naturally occurring enzyme to convert sugar to fiber. The trick was to add the enzymes into the food so they could convert the sugar to fiber after being consumed. The enzymes also needed to be able to be added to existing food products without changing their existing recipes, Kraft Heinz insisted.

How does it work? The crafted enzyme is encapsulated to remain dormant in the food until exposed to an increased pH level, as is found in the GI tract between the stomach and the intestine. It reduces the amount of sugar absorbed in the bloodstream and creates a healthy prebiotic fiber, the institute explained.

This opens a whole new window for consumers. People with diabetes can enjoy their favorite cookies from time to time, while parents can feel less guilty about their children bathing their chicken nuggets in unholy amounts of ketchup.
 

New genes, or not new genes? That is the question

… and the police report that no capybaras were harmed in the incident. What a relief. Now Action News 8 brings you Carol Espinosa’s exclusive interview with legendary scientist and zombie, Charles Darwin.

Carol: Thanks, Daryl. Tell us, Prof. Darwin, what have you been up to lately?

Gio_tto/Thinkstock

Three cups of tea, two biscuit packs, and a Christmas study from the BMJ

Warning: The following content may contain excessive Britishness. Continue at your own risk.

It’s no secret that the world economy is in an … interesting spot right now. Belt tightening is occurring around the world despite the holiday season, and hospitals across the pond in Great Britain are no exception.

PxHere

It was a simple sign that prompted the study, published in the Christmas edition of the BMJ: “Please do not take excessive quantities of these refreshments.” And if we all know one thing, you do not get between Brits and their tea and biscuits. So the researchers behind the study drafted a survey and sent it around to nearly 2,000 British health care workers and asked what they considered to be excessive consumption of work-provided hot drinks and biscuits.

In the hot drinks department (tea and coffee, though we appreciate the two people who voiced a preference for free hot whiskey, if it was available) the survey participants decreed that 3.32 drinks was the maximum before consumption became excessive. That’s pretty close to the actual number of hot drinks respondents drank daily (3.04), so it’s pretty fair to say that British health care workers do a good job of self-limiting.

It’s much the same story with biscuits: Health care workers reported that consuming 2.25 packets of free biscuits would be excessive. Notably, doctors would take more than nondoctors (2.35 vs. 2.14 – typical doctor behavior), and those who had been in their role for less than 2 years would consume nearly 3 packets a day before calling it quits.

The study did not include an official cost analysis, but calculations conducted on a biscuit wrapper (that’s not a joke, by the way) estimated that the combined cost for providing every National Health Service employee with three free drinks and two free biscuit packages a day would be about 160 million pounds a year. Now, that’s a lot of money for tea and biscuits, but, they added, it’s a meager 0.1% of the NHS annual budget. They also noted that most employees consider free hot drinks a more valuable workplace perk than free support for mental health.

In conclusion, the authors wrote, “As a target for cost-saving initiatives, limiting free refreshment consumption is really scraping the biscuit barrel (although some limits on hot whiskey availability may be necessary), and implementing, or continuing, perks that improve staff morale seems justifiable. … Healthcare employers should allow biscuits and hot drinks to be freely available to staff, and they should leave these grateful recipients to judge for themselves what constitutes reasonable consumption.”

Now there’s a Christmas sentiment we can all get behind.
 

We come not to bury sugar, but to improve it

When we think about sugar, healthy isn’t the first thing that comes to mind. Research also shows that artificial sweeteners, as well as processed foods in general, are bad for your body and brain. People, however, love the stuff. That’s why one of the leading brands in processed foods, Kraft Heinz, partnered with the Wyss Institute for Biologically Inspired Engineering at Harvard to find a way to reduce consumers’ sugar consumption.

Vassiliy Vassilenko/thinkstockphotos.com

The question that Kraft Heinz presented to Wyss was this: How could it reduce the fructose in its products without losing the functionality of regular sugar.

The Wyss team’s approach seems pretty simple: Use a naturally occurring enzyme to convert sugar to fiber. The trick was to add the enzymes into the food so they could convert the sugar to fiber after being consumed. The enzymes also needed to be able to be added to existing food products without changing their existing recipes, Kraft Heinz insisted.

How does it work? The crafted enzyme is encapsulated to remain dormant in the food until exposed to an increased pH level, as is found in the GI tract between the stomach and the intestine. It reduces the amount of sugar absorbed in the bloodstream and creates a healthy prebiotic fiber, the institute explained.

This opens a whole new window for consumers. People with diabetes can enjoy their favorite cookies from time to time, while parents can feel less guilty about their children bathing their chicken nuggets in unholy amounts of ketchup.
 

New genes, or not new genes? That is the question

… and the police report that no capybaras were harmed in the incident. What a relief. Now Action News 8 brings you Carol Espinosa’s exclusive interview with legendary scientist and zombie, Charles Darwin.

Carol: Thanks, Daryl. Tell us, Prof. Darwin, what have you been up to lately?

Gio_tto/Thinkstock

Three cups of tea, two biscuit packs, and a Christmas study from the BMJ

Warning: The following content may contain excessive Britishness. Continue at your own risk.

It’s no secret that the world economy is in an … interesting spot right now. Belt tightening is occurring around the world despite the holiday season, and hospitals across the pond in Great Britain are no exception.

PxHere

It was a simple sign that prompted the study, published in the Christmas edition of the BMJ: “Please do not take excessive quantities of these refreshments.” And if we all know one thing, you do not get between Brits and their tea and biscuits. So the researchers behind the study drafted a survey and sent it around to nearly 2,000 British health care workers and asked what they considered to be excessive consumption of work-provided hot drinks and biscuits.

In the hot drinks department (tea and coffee, though we appreciate the two people who voiced a preference for free hot whiskey, if it was available) the survey participants decreed that 3.32 drinks was the maximum before consumption became excessive. That’s pretty close to the actual number of hot drinks respondents drank daily (3.04), so it’s pretty fair to say that British health care workers do a good job of self-limiting.

It’s much the same story with biscuits: Health care workers reported that consuming 2.25 packets of free biscuits would be excessive. Notably, doctors would take more than nondoctors (2.35 vs. 2.14 – typical doctor behavior), and those who had been in their role for less than 2 years would consume nearly 3 packets a day before calling it quits.

The study did not include an official cost analysis, but calculations conducted on a biscuit wrapper (that’s not a joke, by the way) estimated that the combined cost for providing every National Health Service employee with three free drinks and two free biscuit packages a day would be about 160 million pounds a year. Now, that’s a lot of money for tea and biscuits, but, they added, it’s a meager 0.1% of the NHS annual budget. They also noted that most employees consider free hot drinks a more valuable workplace perk than free support for mental health.

In conclusion, the authors wrote, “As a target for cost-saving initiatives, limiting free refreshment consumption is really scraping the biscuit barrel (although some limits on hot whiskey availability may be necessary), and implementing, or continuing, perks that improve staff morale seems justifiable. … Healthcare employers should allow biscuits and hot drinks to be freely available to staff, and they should leave these grateful recipients to judge for themselves what constitutes reasonable consumption.”

Now there’s a Christmas sentiment we can all get behind.
 

We come not to bury sugar, but to improve it

When we think about sugar, healthy isn’t the first thing that comes to mind. Research also shows that artificial sweeteners, as well as processed foods in general, are bad for your body and brain. People, however, love the stuff. That’s why one of the leading brands in processed foods, Kraft Heinz, partnered with the Wyss Institute for Biologically Inspired Engineering at Harvard to find a way to reduce consumers’ sugar consumption.

Vassiliy Vassilenko/thinkstockphotos.com

The question that Kraft Heinz presented to Wyss was this: How could it reduce the fructose in its products without losing the functionality of regular sugar.

The Wyss team’s approach seems pretty simple: Use a naturally occurring enzyme to convert sugar to fiber. The trick was to add the enzymes into the food so they could convert the sugar to fiber after being consumed. The enzymes also needed to be able to be added to existing food products without changing their existing recipes, Kraft Heinz insisted.

How does it work? The crafted enzyme is encapsulated to remain dormant in the food until exposed to an increased pH level, as is found in the GI tract between the stomach and the intestine. It reduces the amount of sugar absorbed in the bloodstream and creates a healthy prebiotic fiber, the institute explained.

This opens a whole new window for consumers. People with diabetes can enjoy their favorite cookies from time to time, while parents can feel less guilty about their children bathing their chicken nuggets in unholy amounts of ketchup.
 

New genes, or not new genes? That is the question

… and the police report that no capybaras were harmed in the incident. What a relief. Now Action News 8 brings you Carol Espinosa’s exclusive interview with legendary scientist and zombie, Charles Darwin.

Carol: Thanks, Daryl. Tell us, Prof. Darwin, what have you been up to lately?

Gio_tto/Thinkstock

SAN DIEGO – When Omar A. Ibrahimi, MD, PhD, opened his own cosmetic dermatology practice in Stamford, Conn., in 2012, he sensed that he had his work cut out for him.

“I was a fellowship-trained Mohs surgeon who wanted to do aesthetics,” Dr. Ibrahimi, medical director of the Connecticut Skin Institute, recalled during the annual Masters of Aesthetics Symposium. “I was in a geographic area that was new to me. I didn’t know any referring doctors, but I started to network and tried to grow my practice.”

Someone once told him that the “three As” of being a medical specialist are “Available, Affable, and Ability,” so he applied that principle as he began to cultivate relationships with physicians in his geographic area. “I told my referring doctors, ‘If you’re kind enough to send me Mohs cases, I’ll help you out if there’s something you don’t like doing, whether it’s a nail biopsy or treating male genital warts,’” he said. “You want to make it easy for doctors to refer to you, but you also want to make their lives easier.”

Dr. Ibrahimi, who is also on the board of directors for the American Society for Dermatologic Surgery and the American Society for Laser Medicine and Surgery, offered nine other recommendations for building and growing a cosmetic dermatology practice. They include:

Know yourself. Do what you love to do, not what you feel like you should do. “Whatever you’re doing in your practice, it should be something that you’re passionate about and excited about,” he said. “I do a mix of Mohs surgery and procedural aesthetic dermatology. Most of my practice is shaped toward energy-based devices and laser procedures. Pick the things that you enjoy doing and try to deliver good results.”

Know your patients. When dermatologists who plan to open their own practice ask Dr. Ibrahimi what kind of laser they should buy, he typically responds by asking them to consider what procedures their patients are asking for. “Depending on where you are geographically and the economic profile of the community in which you practice, it can be a different answer,” Dr. Ibrahimi said. “If you practice in the Northeast and do a lot of medical dermatology, it might mean getting a vascular laser to treat rosacea. If you’re in Southern California, treating pigment might be a bigger concern than treating rosacea.” The annual ASDS Survey on Dermatologic Procedures provides a snapshot of trends and can be useful for decision-making, he said.

Know your practice. “Make sure you are capable of entering the aesthetics field,” he advised. “You cannot have a practice that runs like the DMV, with people waiting 30 to 40 minutes to be seen.” Proper training of staff is also key and representatives from device and injectable companies can provide advice and support. As for marketing, some dermatologists hire a public relations agency, but Dr. Ibrahimi finds that the best source of his referrals is word of mouth. “If I do a good job taking care of patients, they will send their friends and family over to me, but social media is also important,” he said. Taking quality before-and-after photos, and obtaining consent from patients to use them online in educational posts is a good approach, he noted.

Know your market. When Dr. Ibrahimi first opened his practice, offering laser hair removal was not a priority because so many other dermatologists and medical spas in his area were already providing it. With time, though, he added laser hair removal to his menu of treatment offerings because “I knew that if my patients weren’t getting that service from me, they would be getting it from somewhere else,” he said. “Initially it wasn’t important for me, but as my practice matured, I wanted to make sure that I was comprehensive.”

Start cautiously. Think safety first. “I tell people that starting a cosmetic practice is like baseball: don’t try to hit home runs,” Dr. Ibrahimi said. “Just aim for base hits and keep your patients happy. Make sure you deliver safe, good results.” This means knowing everything possible about the devices used in the office, because if the use of a laser is delegated to a staff member and a problem arises, “you have to know everything about how that device works so that you can troubleshoot,” he said. “A lot of problems that arise are from lack of intimacy with your device.”

Seek knowledge. Attend courses in cosmetic dermatology and read literature from journals like Dermatologic Surgery and Lasers in Surgery and Medicine, he advised. “People will see the success, but they won’t know how much hard work it takes to get there,” he said. “You have to develop your reputation to develop the kind of practice that you want.”

Understand the business of aesthetics. Most energy devices carry a steep price tag, and leasing or financing devices come with a monthly payment, he said. “Make sure that what you’re bringing in on that device is going to be sufficient to cover the monthly payment. With something like tissue microcoring, you don’t have to use that five times a day to cover that lease payment. But if you have a vascular laser, you probably need to be treating more than a couple patients per day to make that lease payment. If you can recover the amount the device costs in about a year, that’s going to be a good investment. Many devices come with consumables, so you have to remember that.”

Don’t be afraid to be unique/change directions. Becoming an early adopter of new technologies and procedures can make someone stand out. “Other providers feel more comfortable waiting to allow more data to come out about a new technology before they make a purchase,” he said. “But if you’re established and have a busy practice, that’s an opportunity that can draw people in.”

Have patience and realistic expectations. It’s smart to offer a variety of services, he said, such as medical or surgical dermatology in addition to cosmetic dermatology. “That’s going to help you through any kind of economic downturn,” he said. “Success depends on a lot of factors going right. Make sure you set short- and long-term goals.”

Dr. Ibrahimi disclosed that he is a member of the Advisory Board for Accure Acne, AbbVie, Cutera, Lutronic, Blueberry Therapeutics, Cytrellis, and Quthero. He also holds stock in many device and pharmaceutical companies.

SAN DIEGO – When Omar A. Ibrahimi, MD, PhD, opened his own cosmetic dermatology practice in Stamford, Conn., in 2012, he sensed that he had his work cut out for him.

“I was a fellowship-trained Mohs surgeon who wanted to do aesthetics,” Dr. Ibrahimi, medical director of the Connecticut Skin Institute, recalled during the annual Masters of Aesthetics Symposium. “I was in a geographic area that was new to me. I didn’t know any referring doctors, but I started to network and tried to grow my practice.”

Someone once told him that the “three As” of being a medical specialist are “Available, Affable, and Ability,” so he applied that principle as he began to cultivate relationships with physicians in his geographic area. “I told my referring doctors, ‘If you’re kind enough to send me Mohs cases, I’ll help you out if there’s something you don’t like doing, whether it’s a nail biopsy or treating male genital warts,’” he said. “You want to make it easy for doctors to refer to you, but you also want to make their lives easier.”

Dr. Ibrahimi, who is also on the board of directors for the American Society for Dermatologic Surgery and the American Society for Laser Medicine and Surgery, offered nine other recommendations for building and growing a cosmetic dermatology practice. They include:

Know yourself. Do what you love to do, not what you feel like you should do. “Whatever you’re doing in your practice, it should be something that you’re passionate about and excited about,” he said. “I do a mix of Mohs surgery and procedural aesthetic dermatology. Most of my practice is shaped toward energy-based devices and laser procedures. Pick the things that you enjoy doing and try to deliver good results.”

Know your patients. When dermatologists who plan to open their own practice ask Dr. Ibrahimi what kind of laser they should buy, he typically responds by asking them to consider what procedures their patients are asking for. “Depending on where you are geographically and the economic profile of the community in which you practice, it can be a different answer,” Dr. Ibrahimi said. “If you practice in the Northeast and do a lot of medical dermatology, it might mean getting a vascular laser to treat rosacea. If you’re in Southern California, treating pigment might be a bigger concern than treating rosacea.” The annual ASDS Survey on Dermatologic Procedures provides a snapshot of trends and can be useful for decision-making, he said.

Know your practice. “Make sure you are capable of entering the aesthetics field,” he advised. “You cannot have a practice that runs like the DMV, with people waiting 30 to 40 minutes to be seen.” Proper training of staff is also key and representatives from device and injectable companies can provide advice and support. As for marketing, some dermatologists hire a public relations agency, but Dr. Ibrahimi finds that the best source of his referrals is word of mouth. “If I do a good job taking care of patients, they will send their friends and family over to me, but social media is also important,” he said. Taking quality before-and-after photos, and obtaining consent from patients to use them online in educational posts is a good approach, he noted.

Know your market. When Dr. Ibrahimi first opened his practice, offering laser hair removal was not a priority because so many other dermatologists and medical spas in his area were already providing it. With time, though, he added laser hair removal to his menu of treatment offerings because “I knew that if my patients weren’t getting that service from me, they would be getting it from somewhere else,” he said. “Initially it wasn’t important for me, but as my practice matured, I wanted to make sure that I was comprehensive.”

Start cautiously. Think safety first. “I tell people that starting a cosmetic practice is like baseball: don’t try to hit home runs,” Dr. Ibrahimi said. “Just aim for base hits and keep your patients happy. Make sure you deliver safe, good results.” This means knowing everything possible about the devices used in the office, because if the use of a laser is delegated to a staff member and a problem arises, “you have to know everything about how that device works so that you can troubleshoot,” he said. “A lot of problems that arise are from lack of intimacy with your device.”

Seek knowledge. Attend courses in cosmetic dermatology and read literature from journals like Dermatologic Surgery and Lasers in Surgery and Medicine, he advised. “People will see the success, but they won’t know how much hard work it takes to get there,” he said. “You have to develop your reputation to develop the kind of practice that you want.”

Understand the business of aesthetics. Most energy devices carry a steep price tag, and leasing or financing devices come with a monthly payment, he said. “Make sure that what you’re bringing in on that device is going to be sufficient to cover the monthly payment. With something like tissue microcoring, you don’t have to use that five times a day to cover that lease payment. But if you have a vascular laser, you probably need to be treating more than a couple patients per day to make that lease payment. If you can recover the amount the device costs in about a year, that’s going to be a good investment. Many devices come with consumables, so you have to remember that.”

Don’t be afraid to be unique/change directions. Becoming an early adopter of new technologies and procedures can make someone stand out. “Other providers feel more comfortable waiting to allow more data to come out about a new technology before they make a purchase,” he said. “But if you’re established and have a busy practice, that’s an opportunity that can draw people in.”

Have patience and realistic expectations. It’s smart to offer a variety of services, he said, such as medical or surgical dermatology in addition to cosmetic dermatology. “That’s going to help you through any kind of economic downturn,” he said. “Success depends on a lot of factors going right. Make sure you set short- and long-term goals.”

Dr. Ibrahimi disclosed that he is a member of the Advisory Board for Accure Acne, AbbVie, Cutera, Lutronic, Blueberry Therapeutics, Cytrellis, and Quthero. He also holds stock in many device and pharmaceutical companies.

SAN DIEGO – When Omar A. Ibrahimi, MD, PhD, opened his own cosmetic dermatology practice in Stamford, Conn., in 2012, he sensed that he had his work cut out for him.

“I was a fellowship-trained Mohs surgeon who wanted to do aesthetics,” Dr. Ibrahimi, medical director of the Connecticut Skin Institute, recalled during the annual Masters of Aesthetics Symposium. “I was in a geographic area that was new to me. I didn’t know any referring doctors, but I started to network and tried to grow my practice.”

Someone once told him that the “three As” of being a medical specialist are “Available, Affable, and Ability,” so he applied that principle as he began to cultivate relationships with physicians in his geographic area. “I told my referring doctors, ‘If you’re kind enough to send me Mohs cases, I’ll help you out if there’s something you don’t like doing, whether it’s a nail biopsy or treating male genital warts,’” he said. “You want to make it easy for doctors to refer to you, but you also want to make their lives easier.”

Dr. Ibrahimi, who is also on the board of directors for the American Society for Dermatologic Surgery and the American Society for Laser Medicine and Surgery, offered nine other recommendations for building and growing a cosmetic dermatology practice. They include:

Know yourself. Do what you love to do, not what you feel like you should do. “Whatever you’re doing in your practice, it should be something that you’re passionate about and excited about,” he said. “I do a mix of Mohs surgery and procedural aesthetic dermatology. Most of my practice is shaped toward energy-based devices and laser procedures. Pick the things that you enjoy doing and try to deliver good results.”

Know your patients. When dermatologists who plan to open their own practice ask Dr. Ibrahimi what kind of laser they should buy, he typically responds by asking them to consider what procedures their patients are asking for. “Depending on where you are geographically and the economic profile of the community in which you practice, it can be a different answer,” Dr. Ibrahimi said. “If you practice in the Northeast and do a lot of medical dermatology, it might mean getting a vascular laser to treat rosacea. If you’re in Southern California, treating pigment might be a bigger concern than treating rosacea.” The annual ASDS Survey on Dermatologic Procedures provides a snapshot of trends and can be useful for decision-making, he said.

Know your practice. “Make sure you are capable of entering the aesthetics field,” he advised. “You cannot have a practice that runs like the DMV, with people waiting 30 to 40 minutes to be seen.” Proper training of staff is also key and representatives from device and injectable companies can provide advice and support. As for marketing, some dermatologists hire a public relations agency, but Dr. Ibrahimi finds that the best source of his referrals is word of mouth. “If I do a good job taking care of patients, they will send their friends and family over to me, but social media is also important,” he said. Taking quality before-and-after photos, and obtaining consent from patients to use them online in educational posts is a good approach, he noted.

Know your market. When Dr. Ibrahimi first opened his practice, offering laser hair removal was not a priority because so many other dermatologists and medical spas in his area were already providing it. With time, though, he added laser hair removal to his menu of treatment offerings because “I knew that if my patients weren’t getting that service from me, they would be getting it from somewhere else,” he said. “Initially it wasn’t important for me, but as my practice matured, I wanted to make sure that I was comprehensive.”

Start cautiously. Think safety first. “I tell people that starting a cosmetic practice is like baseball: don’t try to hit home runs,” Dr. Ibrahimi said. “Just aim for base hits and keep your patients happy. Make sure you deliver safe, good results.” This means knowing everything possible about the devices used in the office, because if the use of a laser is delegated to a staff member and a problem arises, “you have to know everything about how that device works so that you can troubleshoot,” he said. “A lot of problems that arise are from lack of intimacy with your device.”

Seek knowledge. Attend courses in cosmetic dermatology and read literature from journals like Dermatologic Surgery and Lasers in Surgery and Medicine, he advised. “People will see the success, but they won’t know how much hard work it takes to get there,” he said. “You have to develop your reputation to develop the kind of practice that you want.”

Understand the business of aesthetics. Most energy devices carry a steep price tag, and leasing or financing devices come with a monthly payment, he said. “Make sure that what you’re bringing in on that device is going to be sufficient to cover the monthly payment. With something like tissue microcoring, you don’t have to use that five times a day to cover that lease payment. But if you have a vascular laser, you probably need to be treating more than a couple patients per day to make that lease payment. If you can recover the amount the device costs in about a year, that’s going to be a good investment. Many devices come with consumables, so you have to remember that.”

Don’t be afraid to be unique/change directions. Becoming an early adopter of new technologies and procedures can make someone stand out. “Other providers feel more comfortable waiting to allow more data to come out about a new technology before they make a purchase,” he said. “But if you’re established and have a busy practice, that’s an opportunity that can draw people in.”

Have patience and realistic expectations. It’s smart to offer a variety of services, he said, such as medical or surgical dermatology in addition to cosmetic dermatology. “That’s going to help you through any kind of economic downturn,” he said. “Success depends on a lot of factors going right. Make sure you set short- and long-term goals.”

Dr. Ibrahimi disclosed that he is a member of the Advisory Board for Accure Acne, AbbVie, Cutera, Lutronic, Blueberry Therapeutics, Cytrellis, and Quthero. He also holds stock in many device and pharmaceutical companies.

SAN DIEGO – Proper patient selection and setting realistic expectations are the keys to enhancing results with fractional radiofrequency (RF) microneedling devices, according to Catherine M. DiGiorgio, MD.

Most core fractional RF microneedling indications – acne scars, rhytides, skin tightening – require multiple treatments, Dr. DiGiorgio, a laser and cosmetic dermatologist who practices in Boston, said at the annual Masters of Aesthetics Symposium. “That’s an important expectation to set for your patients,” she said. “You also want to select depth and density parameters based on pathophysiology of the condition being treated, and combination treatments always provide the best results. So, whether you’re treating someone for acne scars or rhytides, you want to treat them for their erythema or their dermatoheliosis. The same goes for skin tightening procedures.”

Many nonpolar and bipolar devices are available for use, most of which feature adjustable depths and energies. Tips can be insulated or noninsulated. Generally, the insulated tips are safer for darker skin types because the energy is not delivered to the epidermis. However, the Sylfirm X device from Benev has a noninsulated tip but is safe for all skin types because the energy is delivered from the tip of a conically shaped needle and moves proximally but never reaches the epidermis, said Dr. DiGiorgio. Continuous wave mode is used for tightening and wrinkles while pulsed mode is used for pigment and vascular lesions.

Treatment with most fractional RF microneedling devices is painful so topical anesthesia is required. Dr. DiGiorgio typically uses topical 23% lidocaine and 7% tetracaine. The downtime varies depending on which device is being used. For anesthesia prior to aggressive fractional microneedle RF treatments such as with the Profound RF for skin tightening, Dr. DiGiorgio typically uses a Mesoram needle with a cocktail of 30 ccs of 2% lidocaine with epinephrine, 15 ccs of bicarbonate, and 5 ccs of saline. “More aggressive RF procedures can result in bruising for 7 to 8 days,” she said. “It can be covered with makeup. Wearing masks during the COVID-19 pandemic have also helped patients cover the bruising.”

In her clinical experience, the ideal patient for skin tightening with fractional RF microneedling has mild to moderate skin laxity that does not require surgical intervention. “Nonsurgical treatments provide nonsurgical results,” she said. “If a patient comes in holding their skin back and there is a lot of laxity, this is not going to be the right treatment for that person.”

Dr. DiGiorgio offers fractional RF microneedling in the context of a full-face rejuvenation. She begins by addressing volume loss and dynamic rhytides with injectables prior to skin tightening devices such as fractional RF microneedling or ultrasound-based tightening devices such as Sofwave or Ulthera (also referred to as Ultherapy). “You can add an ablative fractional to target deeper rhytides or pigment-targeting laser to address their dermatoheliosis, which will enhance their results,” she said. “Finally, you can follow up with a thread lift two weeks after the microneedle RF to achieve greater skin tightening. If the thread lift is performed before the microneedle RF, you want to wait about 2 months because the microneedle RF can damage the thread.”

Despite the limited efficacy for tissue tightening with fractional RF microneedling, “it’s a good alternative to lasers, especially for darker skin types,” she said. “Combination treatments will always enhance your results.”

Dr. DiGiorgio disclosed that she is a member of the advisory board for Quthero. She is also a consultant for Revelle and has received equipment from Acclaro.

SAN DIEGO – Proper patient selection and setting realistic expectations are the keys to enhancing results with fractional radiofrequency (RF) microneedling devices, according to Catherine M. DiGiorgio, MD.

Most core fractional RF microneedling indications – acne scars, rhytides, skin tightening – require multiple treatments, Dr. DiGiorgio, a laser and cosmetic dermatologist who practices in Boston, said at the annual Masters of Aesthetics Symposium. “That’s an important expectation to set for your patients,” she said. “You also want to select depth and density parameters based on pathophysiology of the condition being treated, and combination treatments always provide the best results. So, whether you’re treating someone for acne scars or rhytides, you want to treat them for their erythema or their dermatoheliosis. The same goes for skin tightening procedures.”

Many nonpolar and bipolar devices are available for use, most of which feature adjustable depths and energies. Tips can be insulated or noninsulated. Generally, the insulated tips are safer for darker skin types because the energy is not delivered to the epidermis. However, the Sylfirm X device from Benev has a noninsulated tip but is safe for all skin types because the energy is delivered from the tip of a conically shaped needle and moves proximally but never reaches the epidermis, said Dr. DiGiorgio. Continuous wave mode is used for tightening and wrinkles while pulsed mode is used for pigment and vascular lesions.

Treatment with most fractional RF microneedling devices is painful so topical anesthesia is required. Dr. DiGiorgio typically uses topical 23% lidocaine and 7% tetracaine. The downtime varies depending on which device is being used. For anesthesia prior to aggressive fractional microneedle RF treatments such as with the Profound RF for skin tightening, Dr. DiGiorgio typically uses a Mesoram needle with a cocktail of 30 ccs of 2% lidocaine with epinephrine, 15 ccs of bicarbonate, and 5 ccs of saline. “More aggressive RF procedures can result in bruising for 7 to 8 days,” she said. “It can be covered with makeup. Wearing masks during the COVID-19 pandemic have also helped patients cover the bruising.”

In her clinical experience, the ideal patient for skin tightening with fractional RF microneedling has mild to moderate skin laxity that does not require surgical intervention. “Nonsurgical treatments provide nonsurgical results,” she said. “If a patient comes in holding their skin back and there is a lot of laxity, this is not going to be the right treatment for that person.”

Dr. DiGiorgio offers fractional RF microneedling in the context of a full-face rejuvenation. She begins by addressing volume loss and dynamic rhytides with injectables prior to skin tightening devices such as fractional RF microneedling or ultrasound-based tightening devices such as Sofwave or Ulthera (also referred to as Ultherapy). “You can add an ablative fractional to target deeper rhytides or pigment-targeting laser to address their dermatoheliosis, which will enhance their results,” she said. “Finally, you can follow up with a thread lift two weeks after the microneedle RF to achieve greater skin tightening. If the thread lift is performed before the microneedle RF, you want to wait about 2 months because the microneedle RF can damage the thread.”

Despite the limited efficacy for tissue tightening with fractional RF microneedling, “it’s a good alternative to lasers, especially for darker skin types,” she said. “Combination treatments will always enhance your results.”

Dr. DiGiorgio disclosed that she is a member of the advisory board for Quthero. She is also a consultant for Revelle and has received equipment from Acclaro.

SAN DIEGO – Proper patient selection and setting realistic expectations are the keys to enhancing results with fractional radiofrequency (RF) microneedling devices, according to Catherine M. DiGiorgio, MD.

Most core fractional RF microneedling indications – acne scars, rhytides, skin tightening – require multiple treatments, Dr. DiGiorgio, a laser and cosmetic dermatologist who practices in Boston, said at the annual Masters of Aesthetics Symposium. “That’s an important expectation to set for your patients,” she said. “You also want to select depth and density parameters based on pathophysiology of the condition being treated, and combination treatments always provide the best results. So, whether you’re treating someone for acne scars or rhytides, you want to treat them for their erythema or their dermatoheliosis. The same goes for skin tightening procedures.”

Many nonpolar and bipolar devices are available for use, most of which feature adjustable depths and energies. Tips can be insulated or noninsulated. Generally, the insulated tips are safer for darker skin types because the energy is not delivered to the epidermis. However, the Sylfirm X device from Benev has a noninsulated tip but is safe for all skin types because the energy is delivered from the tip of a conically shaped needle and moves proximally but never reaches the epidermis, said Dr. DiGiorgio. Continuous wave mode is used for tightening and wrinkles while pulsed mode is used for pigment and vascular lesions.

Treatment with most fractional RF microneedling devices is painful so topical anesthesia is required. Dr. DiGiorgio typically uses topical 23% lidocaine and 7% tetracaine. The downtime varies depending on which device is being used. For anesthesia prior to aggressive fractional microneedle RF treatments such as with the Profound RF for skin tightening, Dr. DiGiorgio typically uses a Mesoram needle with a cocktail of 30 ccs of 2% lidocaine with epinephrine, 15 ccs of bicarbonate, and 5 ccs of saline. “More aggressive RF procedures can result in bruising for 7 to 8 days,” she said. “It can be covered with makeup. Wearing masks during the COVID-19 pandemic have also helped patients cover the bruising.”

In her clinical experience, the ideal patient for skin tightening with fractional RF microneedling has mild to moderate skin laxity that does not require surgical intervention. “Nonsurgical treatments provide nonsurgical results,” she said. “If a patient comes in holding their skin back and there is a lot of laxity, this is not going to be the right treatment for that person.”

Dr. DiGiorgio offers fractional RF microneedling in the context of a full-face rejuvenation. She begins by addressing volume loss and dynamic rhytides with injectables prior to skin tightening devices such as fractional RF microneedling or ultrasound-based tightening devices such as Sofwave or Ulthera (also referred to as Ultherapy). “You can add an ablative fractional to target deeper rhytides or pigment-targeting laser to address their dermatoheliosis, which will enhance their results,” she said. “Finally, you can follow up with a thread lift two weeks after the microneedle RF to achieve greater skin tightening. If the thread lift is performed before the microneedle RF, you want to wait about 2 months because the microneedle RF can damage the thread.”

Despite the limited efficacy for tissue tightening with fractional RF microneedling, “it’s a good alternative to lasers, especially for darker skin types,” she said. “Combination treatments will always enhance your results.”

Dr. DiGiorgio disclosed that she is a member of the advisory board for Quthero. She is also a consultant for Revelle and has received equipment from Acclaro.