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Evaluations of novel approaches to treating NF-1 tumors are underway

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In the clinical experience of R. Rox Anderson, MD, currently available treatment options for benign tumors caused by neurofibromatosis type 1 (NF-1) are not acceptable.

“Simply removing the tumors with surgery is not the answer,” Dr. Anderson, a dermatologist who is the director of the Wellman Center for Photomedicine at Massachusetts General Hospital, Boston, said during a virtual course on laser and aesthetic skin therapy. “We need a way to inhibit the cutaneous neurofibromatosis early in life and prevent disfigurement that occurs when kids become adults.

“Kids with NF-1 are born looking normal,” he said. “They have café au lait macules and Lisch nodules in their eye, but they’re normal-looking kids. By early adulthood, many will grow hundreds of tumors that are disfiguring.”

In patients with NF-1, surgical excision works for cutaneous tumors but is expensive and not widely available, and is usually not covered by health insurance. “Plus, you have these adults who have already been through a lot of trauma, with the disfigurement in their lives, who have to be put under general anesthesia to remove a large number of tumors,” Dr. Anderson said at the meeting, which was named What’s the Truth and was sponsored by Harvard Medical School, Massachusetts General Hospital, and the Wellman Center for Photomedicine. Cryotherapy is a minimally invasive way to treat cutaneous neurofibroma tumors, “but this destroys the overlying skin, so you get unwanted destruction,” he said. “I like the idea of selecting heating, but we don’t know yet by what method.”



Dr. Anderson and his colleagues just launched a comparative clinical trial that will test four different approaches to treating tumors in adults with cutaneous NF: deoxycholate injection, an insulated radiofrequency needle, a 980-nm diode laser, and a 860-nm Alexandrite laser. They plan to perform one or more treatment methods per patient in a single treatment session, then follow up at least 6 months later. Baseline and untreated cutaneous NF lesions will serve as controls. The researchers plan to conduct three-dimensional imaging, clinical assessments, and evaluate pain and other subjective measures.

Use of deoxycholate in a pilot trial was well tolerated and induced tumor regression in adults with cutaneous NF, he said.

Dr. Anderson noted that other researchers are studying the potential role of topical or local mitogen-activated protein kinase (MEK) inhibitors for these tumors. “Systemic MEK inhibitors are effective for plexiform neuromas, but cause significant cutaneous side effects,” he said. A “soft” MEK inhibitor, NFX-179 is rapidly metabolized such that high drug levels are achieved in skin without systemic drug levels. However, Dr. Anderson said that it remains unclear if this approach will prevent cutaneous NF tumors from forming, arrest their growth, or induce their regression.

Dr. Anderson reported having received research funding and/or consulting fees from numerous device and pharmaceutical companies.

Neurofibromatosis type 1 (NF1) is a common genodermatosis, associated with the development of neurofibromas derived from nerves, soft tissue, and skin. Cutaneous NFs often develop in later childhood onward and may be deforming, associated with pruritus, pain, and significant effect on quality of life. Dr. Anderson is a world leader in laser treatment, having developed the theories behind laser development for medical usage, as well as the laser technology used for vascular birthmarks and hair removal, laser and cooling techniques targeting fat, and “fractionating” laser energy, which has revolutionized scar management. We look forward to his group’s insights into better management of NF1 lesions!

Dr. Eichenfield is chief of pediatric and adolescent dermatology at Rady Children's Hospital-San Diego. He is vice chair of the department of dermatology and professor of dermatology and pediatrics at the University of California, San Diego. He disclosed that he has served as an investigator and/or consultant to AbbVie, Lilly, Pfizer, Regeneron, Sanofi-Genzyme, and Verrica.

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

This article was updated 6/18/22.

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In the clinical experience of R. Rox Anderson, MD, currently available treatment options for benign tumors caused by neurofibromatosis type 1 (NF-1) are not acceptable.

“Simply removing the tumors with surgery is not the answer,” Dr. Anderson, a dermatologist who is the director of the Wellman Center for Photomedicine at Massachusetts General Hospital, Boston, said during a virtual course on laser and aesthetic skin therapy. “We need a way to inhibit the cutaneous neurofibromatosis early in life and prevent disfigurement that occurs when kids become adults.

“Kids with NF-1 are born looking normal,” he said. “They have café au lait macules and Lisch nodules in their eye, but they’re normal-looking kids. By early adulthood, many will grow hundreds of tumors that are disfiguring.”

In patients with NF-1, surgical excision works for cutaneous tumors but is expensive and not widely available, and is usually not covered by health insurance. “Plus, you have these adults who have already been through a lot of trauma, with the disfigurement in their lives, who have to be put under general anesthesia to remove a large number of tumors,” Dr. Anderson said at the meeting, which was named What’s the Truth and was sponsored by Harvard Medical School, Massachusetts General Hospital, and the Wellman Center for Photomedicine. Cryotherapy is a minimally invasive way to treat cutaneous neurofibroma tumors, “but this destroys the overlying skin, so you get unwanted destruction,” he said. “I like the idea of selecting heating, but we don’t know yet by what method.”



Dr. Anderson and his colleagues just launched a comparative clinical trial that will test four different approaches to treating tumors in adults with cutaneous NF: deoxycholate injection, an insulated radiofrequency needle, a 980-nm diode laser, and a 860-nm Alexandrite laser. They plan to perform one or more treatment methods per patient in a single treatment session, then follow up at least 6 months later. Baseline and untreated cutaneous NF lesions will serve as controls. The researchers plan to conduct three-dimensional imaging, clinical assessments, and evaluate pain and other subjective measures.

Use of deoxycholate in a pilot trial was well tolerated and induced tumor regression in adults with cutaneous NF, he said.

Dr. Anderson noted that other researchers are studying the potential role of topical or local mitogen-activated protein kinase (MEK) inhibitors for these tumors. “Systemic MEK inhibitors are effective for plexiform neuromas, but cause significant cutaneous side effects,” he said. A “soft” MEK inhibitor, NFX-179 is rapidly metabolized such that high drug levels are achieved in skin without systemic drug levels. However, Dr. Anderson said that it remains unclear if this approach will prevent cutaneous NF tumors from forming, arrest their growth, or induce their regression.

Dr. Anderson reported having received research funding and/or consulting fees from numerous device and pharmaceutical companies.

Neurofibromatosis type 1 (NF1) is a common genodermatosis, associated with the development of neurofibromas derived from nerves, soft tissue, and skin. Cutaneous NFs often develop in later childhood onward and may be deforming, associated with pruritus, pain, and significant effect on quality of life. Dr. Anderson is a world leader in laser treatment, having developed the theories behind laser development for medical usage, as well as the laser technology used for vascular birthmarks and hair removal, laser and cooling techniques targeting fat, and “fractionating” laser energy, which has revolutionized scar management. We look forward to his group’s insights into better management of NF1 lesions!

Dr. Eichenfield is chief of pediatric and adolescent dermatology at Rady Children's Hospital-San Diego. He is vice chair of the department of dermatology and professor of dermatology and pediatrics at the University of California, San Diego. He disclosed that he has served as an investigator and/or consultant to AbbVie, Lilly, Pfizer, Regeneron, Sanofi-Genzyme, and Verrica.

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

This article was updated 6/18/22.

In the clinical experience of R. Rox Anderson, MD, currently available treatment options for benign tumors caused by neurofibromatosis type 1 (NF-1) are not acceptable.

“Simply removing the tumors with surgery is not the answer,” Dr. Anderson, a dermatologist who is the director of the Wellman Center for Photomedicine at Massachusetts General Hospital, Boston, said during a virtual course on laser and aesthetic skin therapy. “We need a way to inhibit the cutaneous neurofibromatosis early in life and prevent disfigurement that occurs when kids become adults.

“Kids with NF-1 are born looking normal,” he said. “They have café au lait macules and Lisch nodules in their eye, but they’re normal-looking kids. By early adulthood, many will grow hundreds of tumors that are disfiguring.”

In patients with NF-1, surgical excision works for cutaneous tumors but is expensive and not widely available, and is usually not covered by health insurance. “Plus, you have these adults who have already been through a lot of trauma, with the disfigurement in their lives, who have to be put under general anesthesia to remove a large number of tumors,” Dr. Anderson said at the meeting, which was named What’s the Truth and was sponsored by Harvard Medical School, Massachusetts General Hospital, and the Wellman Center for Photomedicine. Cryotherapy is a minimally invasive way to treat cutaneous neurofibroma tumors, “but this destroys the overlying skin, so you get unwanted destruction,” he said. “I like the idea of selecting heating, but we don’t know yet by what method.”



Dr. Anderson and his colleagues just launched a comparative clinical trial that will test four different approaches to treating tumors in adults with cutaneous NF: deoxycholate injection, an insulated radiofrequency needle, a 980-nm diode laser, and a 860-nm Alexandrite laser. They plan to perform one or more treatment methods per patient in a single treatment session, then follow up at least 6 months later. Baseline and untreated cutaneous NF lesions will serve as controls. The researchers plan to conduct three-dimensional imaging, clinical assessments, and evaluate pain and other subjective measures.

Use of deoxycholate in a pilot trial was well tolerated and induced tumor regression in adults with cutaneous NF, he said.

Dr. Anderson noted that other researchers are studying the potential role of topical or local mitogen-activated protein kinase (MEK) inhibitors for these tumors. “Systemic MEK inhibitors are effective for plexiform neuromas, but cause significant cutaneous side effects,” he said. A “soft” MEK inhibitor, NFX-179 is rapidly metabolized such that high drug levels are achieved in skin without systemic drug levels. However, Dr. Anderson said that it remains unclear if this approach will prevent cutaneous NF tumors from forming, arrest their growth, or induce their regression.

Dr. Anderson reported having received research funding and/or consulting fees from numerous device and pharmaceutical companies.

Neurofibromatosis type 1 (NF1) is a common genodermatosis, associated with the development of neurofibromas derived from nerves, soft tissue, and skin. Cutaneous NFs often develop in later childhood onward and may be deforming, associated with pruritus, pain, and significant effect on quality of life. Dr. Anderson is a world leader in laser treatment, having developed the theories behind laser development for medical usage, as well as the laser technology used for vascular birthmarks and hair removal, laser and cooling techniques targeting fat, and “fractionating” laser energy, which has revolutionized scar management. We look forward to his group’s insights into better management of NF1 lesions!

Dr. Eichenfield is chief of pediatric and adolescent dermatology at Rady Children's Hospital-San Diego. He is vice chair of the department of dermatology and professor of dermatology and pediatrics at the University of California, San Diego. He disclosed that he has served as an investigator and/or consultant to AbbVie, Lilly, Pfizer, Regeneron, Sanofi-Genzyme, and Verrica.

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

This article was updated 6/18/22.

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FROM A LASER & AESTHETIC SKIN THERAPY COURSE

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Sunscreen, other sun-protective habits not linked with poorer bone health, fractures

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Using sunscreen and following other sun-protective behaviors such as wearing long sleeves or staying in the shade do not decrease bone mineral density overall or increase the risk of osteoporotic fracture, according to a new study that included more than 3,000 men and women.

Aja Koska/Getty Images

“We have objective data for the first time, and in a large-scale representative population of the U.S. adults, to indicate sun protection is not associated with negative bone-related outcomes,” said study lead author Mohsen Afarideh, MD, MPH, a postdoctoral research fellow at the autoimmune skin diseases unit at the University of Pennsylvania, Philadelphia.

The study, published online in JAMA Dermatology, goes a step further than previous research by others that has found sunscreen use does not compromise vitamin D synthesis and has little effect on circulating 25-hydroxyvitamin D levels.

In the new study, researchers looked at three sun-protective behaviors – sunscreen use, staying in the shade, wearing long sleeves – and their effects on bone mineral density and the risk of fractures.

While the effects of sun-protective habits on blood levels of vitamin D and BMD scores are important, ‘’what we are more interested to know is if the sun-protective behaviors actually cause or increase the risk of fracture,” Dr. Afarideh said in an interview. “The answer to that is a firm ‘No.’ These data are very reassuring and will help clinicians to keep recommending sun protection to the public.”

Study details

Dr. Afarideh and his colleagues from the Mayo Clinic in Rochester, Minn., looked at data from the National Health and Nutrition Examination Survey (NHANES) from 2017 to 2018, obtaining final information on 3,403 men and women, ages 20-59, who completed a dermatology questionnaire The men and women reported on the three sun-protective habits, and noted whether they followed these practices always or most of the time, sometimes, or never or rarely.

The frequency of the three behaviors was not widespread. Frequent staying in the shade was reported by 31.6% of the sample, wearing long sleeves by 11.8%, and sunscreen use by 26.1%.

The researchers also had data on the participants’ bone mineral density (BMD) scores along with dietary information such as milk consumption, vitamin D supplement use, taking steroid drugs, and exercise activity.

“Moderate sunscreen use was linked with a slightly lower lumbar BMD score,” Dr. Afarideh said, which was “the only significant association that could be interpreted as concerning.” And this was more likely to be seen in older respondents, he said.

However, otherwise they found the practice of the three behaviors was not associated with lower total or site-specific BMD z scores, nor was it linked with an increased risk of osteoporotic fractures. (The BMD z score compares an individual’s bone density to the average bone density of someone their same age and gender.)

The focus on fracture risk is the more important outcome, Dr. Afarideh said. And they found no increased risk overall of osteoporotic fractures in those who practiced sun-protective behaviors.

Moderate to frequent staying in the shade was actually linked with a reduced prevalence of spine fractures in the multivariate model (odds ratio, 0.19; 95% confidence interval, 0.04-0.86, P = .02). The researchers say that may be attributable to these respondents also being careful in other areas of life, such as avoiding falls and not participating in high-risk activities that would increase the chance of fractures. “However, this is just an assumption,” Dr. Afarideh said.

 

 



Expert perspectives

Other dermatologists not involved in the new research said the study results provide some “real-world” information that’s valuable for clinicians to share with patients.

“I think this is an important study on multiple levels,” said Henry W. Lim, MD, a former president of the American Academy of Dermatology who is a member of the department of dermatology and senior vice president of academic affairs at Henry Ford Health System, Detroit. “It is a well-done study, involving a large number. It is a real-life situation, asking people their photo protective behaviors and then looking at their bone mineral density.” The bottom line, he said: “Bone health is not affected by photo protection habits in real life.”

The findings are important but not surprising, said Antony R. Young, PhD, emeritus professor of experimental photobiology at St. John’s Institute of Dermatology, King’s College, London, who has researched sunscreens and vitamin D status. “My study showed that correct sunscreen use, albeit with a relatively low SPF of 15, did prevent sunburn in a high UVR [ultraviolet radiation] environment but did allow very good vitamin D synthesis. I think this is because the necessary dose of UVB is very low.”



Michele Green, MD, a New York dermatologist and clinical staff member at Lenox Hill Hospital there, said she often hears concerns about bone health from patients. “Every week, patients ask, ‘Why would I wear sunblock? Don’t I need sun for bone health? Don’t I need it for vitamin D?’’’

Now, she said, ‘’Dermatologists can point to the study and say ‘Don’t worry.’ It clarifies that using sunscreen won’t cause you to have osteoporosis.’’

Dr. Afarideh, who was a postdoctoral research fellow at the Mayo Clinic, and his coauthors, Megha M. Tollefson, MD, and Julio C. Sartori-Valinotti, of the Mayo Clinic, and Dr. Green had no disclosures. Dr. Lim and Dr. Young consult for the sunscreen industry.

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Using sunscreen and following other sun-protective behaviors such as wearing long sleeves or staying in the shade do not decrease bone mineral density overall or increase the risk of osteoporotic fracture, according to a new study that included more than 3,000 men and women.

Aja Koska/Getty Images

“We have objective data for the first time, and in a large-scale representative population of the U.S. adults, to indicate sun protection is not associated with negative bone-related outcomes,” said study lead author Mohsen Afarideh, MD, MPH, a postdoctoral research fellow at the autoimmune skin diseases unit at the University of Pennsylvania, Philadelphia.

The study, published online in JAMA Dermatology, goes a step further than previous research by others that has found sunscreen use does not compromise vitamin D synthesis and has little effect on circulating 25-hydroxyvitamin D levels.

In the new study, researchers looked at three sun-protective behaviors – sunscreen use, staying in the shade, wearing long sleeves – and their effects on bone mineral density and the risk of fractures.

While the effects of sun-protective habits on blood levels of vitamin D and BMD scores are important, ‘’what we are more interested to know is if the sun-protective behaviors actually cause or increase the risk of fracture,” Dr. Afarideh said in an interview. “The answer to that is a firm ‘No.’ These data are very reassuring and will help clinicians to keep recommending sun protection to the public.”

Study details

Dr. Afarideh and his colleagues from the Mayo Clinic in Rochester, Minn., looked at data from the National Health and Nutrition Examination Survey (NHANES) from 2017 to 2018, obtaining final information on 3,403 men and women, ages 20-59, who completed a dermatology questionnaire The men and women reported on the three sun-protective habits, and noted whether they followed these practices always or most of the time, sometimes, or never or rarely.

The frequency of the three behaviors was not widespread. Frequent staying in the shade was reported by 31.6% of the sample, wearing long sleeves by 11.8%, and sunscreen use by 26.1%.

The researchers also had data on the participants’ bone mineral density (BMD) scores along with dietary information such as milk consumption, vitamin D supplement use, taking steroid drugs, and exercise activity.

“Moderate sunscreen use was linked with a slightly lower lumbar BMD score,” Dr. Afarideh said, which was “the only significant association that could be interpreted as concerning.” And this was more likely to be seen in older respondents, he said.

However, otherwise they found the practice of the three behaviors was not associated with lower total or site-specific BMD z scores, nor was it linked with an increased risk of osteoporotic fractures. (The BMD z score compares an individual’s bone density to the average bone density of someone their same age and gender.)

The focus on fracture risk is the more important outcome, Dr. Afarideh said. And they found no increased risk overall of osteoporotic fractures in those who practiced sun-protective behaviors.

Moderate to frequent staying in the shade was actually linked with a reduced prevalence of spine fractures in the multivariate model (odds ratio, 0.19; 95% confidence interval, 0.04-0.86, P = .02). The researchers say that may be attributable to these respondents also being careful in other areas of life, such as avoiding falls and not participating in high-risk activities that would increase the chance of fractures. “However, this is just an assumption,” Dr. Afarideh said.

 

 



Expert perspectives

Other dermatologists not involved in the new research said the study results provide some “real-world” information that’s valuable for clinicians to share with patients.

“I think this is an important study on multiple levels,” said Henry W. Lim, MD, a former president of the American Academy of Dermatology who is a member of the department of dermatology and senior vice president of academic affairs at Henry Ford Health System, Detroit. “It is a well-done study, involving a large number. It is a real-life situation, asking people their photo protective behaviors and then looking at their bone mineral density.” The bottom line, he said: “Bone health is not affected by photo protection habits in real life.”

The findings are important but not surprising, said Antony R. Young, PhD, emeritus professor of experimental photobiology at St. John’s Institute of Dermatology, King’s College, London, who has researched sunscreens and vitamin D status. “My study showed that correct sunscreen use, albeit with a relatively low SPF of 15, did prevent sunburn in a high UVR [ultraviolet radiation] environment but did allow very good vitamin D synthesis. I think this is because the necessary dose of UVB is very low.”



Michele Green, MD, a New York dermatologist and clinical staff member at Lenox Hill Hospital there, said she often hears concerns about bone health from patients. “Every week, patients ask, ‘Why would I wear sunblock? Don’t I need sun for bone health? Don’t I need it for vitamin D?’’’

Now, she said, ‘’Dermatologists can point to the study and say ‘Don’t worry.’ It clarifies that using sunscreen won’t cause you to have osteoporosis.’’

Dr. Afarideh, who was a postdoctoral research fellow at the Mayo Clinic, and his coauthors, Megha M. Tollefson, MD, and Julio C. Sartori-Valinotti, of the Mayo Clinic, and Dr. Green had no disclosures. Dr. Lim and Dr. Young consult for the sunscreen industry.

Using sunscreen and following other sun-protective behaviors such as wearing long sleeves or staying in the shade do not decrease bone mineral density overall or increase the risk of osteoporotic fracture, according to a new study that included more than 3,000 men and women.

Aja Koska/Getty Images

“We have objective data for the first time, and in a large-scale representative population of the U.S. adults, to indicate sun protection is not associated with negative bone-related outcomes,” said study lead author Mohsen Afarideh, MD, MPH, a postdoctoral research fellow at the autoimmune skin diseases unit at the University of Pennsylvania, Philadelphia.

The study, published online in JAMA Dermatology, goes a step further than previous research by others that has found sunscreen use does not compromise vitamin D synthesis and has little effect on circulating 25-hydroxyvitamin D levels.

In the new study, researchers looked at three sun-protective behaviors – sunscreen use, staying in the shade, wearing long sleeves – and their effects on bone mineral density and the risk of fractures.

While the effects of sun-protective habits on blood levels of vitamin D and BMD scores are important, ‘’what we are more interested to know is if the sun-protective behaviors actually cause or increase the risk of fracture,” Dr. Afarideh said in an interview. “The answer to that is a firm ‘No.’ These data are very reassuring and will help clinicians to keep recommending sun protection to the public.”

Study details

Dr. Afarideh and his colleagues from the Mayo Clinic in Rochester, Minn., looked at data from the National Health and Nutrition Examination Survey (NHANES) from 2017 to 2018, obtaining final information on 3,403 men and women, ages 20-59, who completed a dermatology questionnaire The men and women reported on the three sun-protective habits, and noted whether they followed these practices always or most of the time, sometimes, or never or rarely.

The frequency of the three behaviors was not widespread. Frequent staying in the shade was reported by 31.6% of the sample, wearing long sleeves by 11.8%, and sunscreen use by 26.1%.

The researchers also had data on the participants’ bone mineral density (BMD) scores along with dietary information such as milk consumption, vitamin D supplement use, taking steroid drugs, and exercise activity.

“Moderate sunscreen use was linked with a slightly lower lumbar BMD score,” Dr. Afarideh said, which was “the only significant association that could be interpreted as concerning.” And this was more likely to be seen in older respondents, he said.

However, otherwise they found the practice of the three behaviors was not associated with lower total or site-specific BMD z scores, nor was it linked with an increased risk of osteoporotic fractures. (The BMD z score compares an individual’s bone density to the average bone density of someone their same age and gender.)

The focus on fracture risk is the more important outcome, Dr. Afarideh said. And they found no increased risk overall of osteoporotic fractures in those who practiced sun-protective behaviors.

Moderate to frequent staying in the shade was actually linked with a reduced prevalence of spine fractures in the multivariate model (odds ratio, 0.19; 95% confidence interval, 0.04-0.86, P = .02). The researchers say that may be attributable to these respondents also being careful in other areas of life, such as avoiding falls and not participating in high-risk activities that would increase the chance of fractures. “However, this is just an assumption,” Dr. Afarideh said.

 

 



Expert perspectives

Other dermatologists not involved in the new research said the study results provide some “real-world” information that’s valuable for clinicians to share with patients.

“I think this is an important study on multiple levels,” said Henry W. Lim, MD, a former president of the American Academy of Dermatology who is a member of the department of dermatology and senior vice president of academic affairs at Henry Ford Health System, Detroit. “It is a well-done study, involving a large number. It is a real-life situation, asking people their photo protective behaviors and then looking at their bone mineral density.” The bottom line, he said: “Bone health is not affected by photo protection habits in real life.”

The findings are important but not surprising, said Antony R. Young, PhD, emeritus professor of experimental photobiology at St. John’s Institute of Dermatology, King’s College, London, who has researched sunscreens and vitamin D status. “My study showed that correct sunscreen use, albeit with a relatively low SPF of 15, did prevent sunburn in a high UVR [ultraviolet radiation] environment but did allow very good vitamin D synthesis. I think this is because the necessary dose of UVB is very low.”



Michele Green, MD, a New York dermatologist and clinical staff member at Lenox Hill Hospital there, said she often hears concerns about bone health from patients. “Every week, patients ask, ‘Why would I wear sunblock? Don’t I need sun for bone health? Don’t I need it for vitamin D?’’’

Now, she said, ‘’Dermatologists can point to the study and say ‘Don’t worry.’ It clarifies that using sunscreen won’t cause you to have osteoporosis.’’

Dr. Afarideh, who was a postdoctoral research fellow at the Mayo Clinic, and his coauthors, Megha M. Tollefson, MD, and Julio C. Sartori-Valinotti, of the Mayo Clinic, and Dr. Green had no disclosures. Dr. Lim and Dr. Young consult for the sunscreen industry.

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FDA issues stronger safety requirements for breast implants

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The Food and Drug Administration on Oct. 27 announced stronger safety requirements for breast implants, restricting sales of implants only to providers and health facilities that review potential risks of the devices with patients before surgery, via a “Patient Decision Checklist.” The agency also placed a boxed warning – the strongest warning that the FDA requires – on all legally marketed breast implants.

“Protecting patients’ health when they are treated with a medical device is our most important priority,” Binita Ashar, MD, director of the Office of Surgical and Infection Control Devices in the FDA’s Center for Devices and Radiological Health, said in a press release. “In recent years, the FDA has sought more ways to increase patients’ access to clear and understandable information about the benefits and risks of breast implants. By strengthening the safety requirements for manufacturers, the FDA is working to close information gaps for anyone who may be considering breast implant surgery.”

This announcement comes 10 years after the FDA issued a comprehensive safety update on silicone gel–filled implants, which reported a possible association between these devices and anaplastic large cell lymphoma (ALCL). The studies reviewed in the 2011 document also noted that a “significant percentage of women who receive silicone gel–filled breast implants experience complications and adverse outcomes,” the most common being repeat operation, implant removal, rupture, or capsular contracture (scar tissue tightening around the implant).

Breast augmentation has been one of the top five cosmetic procedures in the United States since 2006, according to the American Society for Plastic Surgery, with more than 400,000 people getting breast implants in 2019. Nearly 300,000 were for cosmetic reasons, and more than 100,000 were for breast reconstruction after mastectomies.

In 2019, the FDA proposed adding a boxed warning for breast implants, stating that the devices do not last an entire lifetime; that over time the risk for complications increases; and that breast implants have been associated with ALCL, and also may be associated with systemic symptoms such as fatigue, joint pain, and brain fog. The Oct. 27 FDA action now requires that manufacturers update breast implant packaging to include that information in a boxed warning, as well as the following:

  • A patient-decision checklist
  • Updated silicone gel–filled breast implant rupture screening recommendations
  • A device description including materials used in the device
  • Patient device ID cards

The updated label changes must be present on manufacturers’ websites in 30 days, the FDA said.

The new requirements have received largely positive reactions from both physicians and patient organizations. In an emailed statement to this news organization, Lynn Jeffers, MD, MBA, the immediate past president of the American Society of Plastic Surgeons, said that “ASPS has always supported patients being fully informed about their choices and the risks, benefits, and alternatives of the options available. “We look forward to our continued collaboration with the FDA on the safety of implants and other devices.”

Maria Gmitro, president and cofounder of the Breast Implant Safety Alliance, an all-volunteer nonprofit based in Charleston, S.C., said that some of the language in the patient checklist could be stronger, especially when referring to breast implant–associated ALCL.

To inform patients of risks more clearly, “it’s the words like ‘associated with’ that we feel need to be stronger” she said in an interview. She also noted that women who already have breast implants may not be aware of these potential complications, which these new FDA requirements do not address.

But overall, the nonprofit was “thrilled” with the announcement, Ms. Gmitro said. “Placing restrictions on breast implants is a really big step, and we applaud the FDA’s efforts. This is information that every patient considering breast implants should know, and we’ve been advocating for better informed consent.”

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

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The Food and Drug Administration on Oct. 27 announced stronger safety requirements for breast implants, restricting sales of implants only to providers and health facilities that review potential risks of the devices with patients before surgery, via a “Patient Decision Checklist.” The agency also placed a boxed warning – the strongest warning that the FDA requires – on all legally marketed breast implants.

“Protecting patients’ health when they are treated with a medical device is our most important priority,” Binita Ashar, MD, director of the Office of Surgical and Infection Control Devices in the FDA’s Center for Devices and Radiological Health, said in a press release. “In recent years, the FDA has sought more ways to increase patients’ access to clear and understandable information about the benefits and risks of breast implants. By strengthening the safety requirements for manufacturers, the FDA is working to close information gaps for anyone who may be considering breast implant surgery.”

This announcement comes 10 years after the FDA issued a comprehensive safety update on silicone gel–filled implants, which reported a possible association between these devices and anaplastic large cell lymphoma (ALCL). The studies reviewed in the 2011 document also noted that a “significant percentage of women who receive silicone gel–filled breast implants experience complications and adverse outcomes,” the most common being repeat operation, implant removal, rupture, or capsular contracture (scar tissue tightening around the implant).

Breast augmentation has been one of the top five cosmetic procedures in the United States since 2006, according to the American Society for Plastic Surgery, with more than 400,000 people getting breast implants in 2019. Nearly 300,000 were for cosmetic reasons, and more than 100,000 were for breast reconstruction after mastectomies.

In 2019, the FDA proposed adding a boxed warning for breast implants, stating that the devices do not last an entire lifetime; that over time the risk for complications increases; and that breast implants have been associated with ALCL, and also may be associated with systemic symptoms such as fatigue, joint pain, and brain fog. The Oct. 27 FDA action now requires that manufacturers update breast implant packaging to include that information in a boxed warning, as well as the following:

  • A patient-decision checklist
  • Updated silicone gel–filled breast implant rupture screening recommendations
  • A device description including materials used in the device
  • Patient device ID cards

The updated label changes must be present on manufacturers’ websites in 30 days, the FDA said.

The new requirements have received largely positive reactions from both physicians and patient organizations. In an emailed statement to this news organization, Lynn Jeffers, MD, MBA, the immediate past president of the American Society of Plastic Surgeons, said that “ASPS has always supported patients being fully informed about their choices and the risks, benefits, and alternatives of the options available. “We look forward to our continued collaboration with the FDA on the safety of implants and other devices.”

Maria Gmitro, president and cofounder of the Breast Implant Safety Alliance, an all-volunteer nonprofit based in Charleston, S.C., said that some of the language in the patient checklist could be stronger, especially when referring to breast implant–associated ALCL.

To inform patients of risks more clearly, “it’s the words like ‘associated with’ that we feel need to be stronger” she said in an interview. She also noted that women who already have breast implants may not be aware of these potential complications, which these new FDA requirements do not address.

But overall, the nonprofit was “thrilled” with the announcement, Ms. Gmitro said. “Placing restrictions on breast implants is a really big step, and we applaud the FDA’s efforts. This is information that every patient considering breast implants should know, and we’ve been advocating for better informed consent.”

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

The Food and Drug Administration on Oct. 27 announced stronger safety requirements for breast implants, restricting sales of implants only to providers and health facilities that review potential risks of the devices with patients before surgery, via a “Patient Decision Checklist.” The agency also placed a boxed warning – the strongest warning that the FDA requires – on all legally marketed breast implants.

“Protecting patients’ health when they are treated with a medical device is our most important priority,” Binita Ashar, MD, director of the Office of Surgical and Infection Control Devices in the FDA’s Center for Devices and Radiological Health, said in a press release. “In recent years, the FDA has sought more ways to increase patients’ access to clear and understandable information about the benefits and risks of breast implants. By strengthening the safety requirements for manufacturers, the FDA is working to close information gaps for anyone who may be considering breast implant surgery.”

This announcement comes 10 years after the FDA issued a comprehensive safety update on silicone gel–filled implants, which reported a possible association between these devices and anaplastic large cell lymphoma (ALCL). The studies reviewed in the 2011 document also noted that a “significant percentage of women who receive silicone gel–filled breast implants experience complications and adverse outcomes,” the most common being repeat operation, implant removal, rupture, or capsular contracture (scar tissue tightening around the implant).

Breast augmentation has been one of the top five cosmetic procedures in the United States since 2006, according to the American Society for Plastic Surgery, with more than 400,000 people getting breast implants in 2019. Nearly 300,000 were for cosmetic reasons, and more than 100,000 were for breast reconstruction after mastectomies.

In 2019, the FDA proposed adding a boxed warning for breast implants, stating that the devices do not last an entire lifetime; that over time the risk for complications increases; and that breast implants have been associated with ALCL, and also may be associated with systemic symptoms such as fatigue, joint pain, and brain fog. The Oct. 27 FDA action now requires that manufacturers update breast implant packaging to include that information in a boxed warning, as well as the following:

  • A patient-decision checklist
  • Updated silicone gel–filled breast implant rupture screening recommendations
  • A device description including materials used in the device
  • Patient device ID cards

The updated label changes must be present on manufacturers’ websites in 30 days, the FDA said.

The new requirements have received largely positive reactions from both physicians and patient organizations. In an emailed statement to this news organization, Lynn Jeffers, MD, MBA, the immediate past president of the American Society of Plastic Surgeons, said that “ASPS has always supported patients being fully informed about their choices and the risks, benefits, and alternatives of the options available. “We look forward to our continued collaboration with the FDA on the safety of implants and other devices.”

Maria Gmitro, president and cofounder of the Breast Implant Safety Alliance, an all-volunteer nonprofit based in Charleston, S.C., said that some of the language in the patient checklist could be stronger, especially when referring to breast implant–associated ALCL.

To inform patients of risks more clearly, “it’s the words like ‘associated with’ that we feel need to be stronger” she said in an interview. She also noted that women who already have breast implants may not be aware of these potential complications, which these new FDA requirements do not address.

But overall, the nonprofit was “thrilled” with the announcement, Ms. Gmitro said. “Placing restrictions on breast implants is a really big step, and we applaud the FDA’s efforts. This is information that every patient considering breast implants should know, and we’ve been advocating for better informed consent.”

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

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Higher odds for preterm, C-section births seen in women with PsA

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Disease-modifying antirheumatic drugs (DMARDs) such as biologics may carry an increased risk for preterm birth or cesarean delivery for pregnant women with psoriatic arthritis (PsA), according to a recent study published in Arthritis & Rheumatology.

zoranm/Getty Images

The risk was particularly high for women with PsA who received biologic disease-modifying antirheumatic drugs (bDMARDs), according to Katarina Remaeus, PhD, of the Karolinska Institute in Stockholm and colleagues.

“The results may indicate that a more severe or active PsA disease that requires antirheumatic treatment during pregnancy, especially bDMARDs, is associated with increased risks of adverse pregnancy outcomes compared to non-PsA pregnancies,” Dr. Remaeus and colleagues write in their study. “The risk of preterm birth in PsA pregnancies is further influenced by parity with the most increased risks observed in first pregnancies.”

In a nationwide, register-based cohort study, the researchers evaluated 921 pregnancies of women with PsA between 2007 and 2017, comparing them to the pregnancies of 9,210 women without PsA over the same time frame. The pregnancies for women with PsA were further categorized based on whether the women had not received antirheumatic treatment in the year prior to and/or during pregnancy (495 pregnancies) or had received antirheumatic treatment at any point in the year before and/or during pregnancy (426 pregnancies).



Of the women in the PsA group who were treated in the year prior to pregnancy (170 women), 39.4% received monotherapy with a conventional synthetic DMARD (csDMARD) such as an antimalarial, methotrexate, or sulfasalazine; 24.1% received oral corticosteroids, and 15.9% received a tumor necrosis factor inhibitor (TNFi), whereas about 20% of women received two or more antirheumatic drugs.

In the group of women treated during pregnancy (256 women), 153 did not receive bDMARDs; of these, 41.8% had monotherapy with either a csDMARD or corticosteroids, whereas the group treated with bDMARDs received TNFi monotherapy (43.7%) or TNFi with corticosteroids (35.9%), TNFi with csDMARD (9.7%), or TNFi with csDMARD plus corticosteroids (9.7%).

A majority of women in both groups (70.1%) were between ages 30 and 34 years (37.1%) or older than age 35 years (33%) and had delivered more than one child (63.2%). Women in the PsA group were more likely to be born in a Nordic country (91.8% vs. 82.8%), to have a body mass index between 30.0 and 60.0 kg/m2 (19.9% vs. 12.6%), to be a smoker (9.2% vs. 5.3%), to have hypertension (1.4% vs. 0.8%) or diabetes (1.3% vs. 0.5%) prior to pregnancy, and to have a higher level of education (>12 years; 50.1% vs. 43.3%), compared with women in the non-PsA group.



The results showed women in the PsA group were more likely to experience preterm birth (adjusted odds ratio, 1.69; 95% confidence interval, 1.27-2.24) and undergo an elective (aOR, 1.77; 95% CI, 1.43-2.20) or emergency C-section (aOR, 1.42; 95% CI, 1.10-1.84). The group at highest risk for preterm birth with regard to parity was women with PsA having their first child (aOR, 3.95; 95% CI, 1.43-10.95).

Women who received antirheumatic treatment were at greater risk for experiencing preterm birth (aOR, 2.30; 95% CI, 1.49-3.56), and this risk was even higher for treatment with bDMARDs, compared with women without PsA (aOR, 4.49; 95% CI, 2.60-7.79). Use of bDMARDs also was associated with higher risks for spontaneous preterm birth (aOR, 4.73; 95% CI, 2.53-8.87), preterm birth between 32 and 36 weeks’ gestation (aOR, 5.06; 95% CI, 2.91-8.79), elective C-section (aOR, 2.72; 95% CI, 1.61-4.59), emergency C-section (aOR, 2.06; 95% CI, 1.04-4.07), and preeclampsia (aOR, 2.88, 95% CI, 1.35-6.17).

The researchers note that women with PsA should be evaluated for preterm birth particularly if they are having their first child, and “from a clinical point of view, all women with PsA, regardless of antirheumatic treatment, should be counseled about pregnancy outcomes and receive individualized monitoring during pregnancy.”

 

 

Are adverse outcomes linked to disease activity or treatment?

Patients in the study had a higher risk of adverse outcomes when they had a PsA diagnosis, and when they received antirheumatic treatment – but were the adverse outcomes associated with a patient’s high disease activity or need for antirheumatic treatment?

“Our interpretation is that a PsA disease that requires continued antirheumatic treatment during pregnancy is more severe than PsA that does not require treatment,” Dr. Remaeus and colleagues write. “Thus, the increased risk of adverse outcomes in pregnancies with maternal antirheumatic treatment is probably attributed to disease severity rather than an effect of the medication itself.”

Dr. Anja Strangfeld

Anja Strangfeld, MD, PhD, of the German Rheumatism Research Centre in Berlin, told this news organization that the results of the study are important because it is one of the first to report differences in risk in pregnancy outcomes for women with and without PsA.

“The information is relevant to guide rheumatologists in advising patients with PsA when planning the first or subsequent pregnancies,” she said. “The results are reassuring in reporting that the elevated risk for PsA patients for adverse pregnancy outcomes is low in patients not in need of antirheumatic medication, presumably in low-disease activity.”

However, the study is still unclear on whether the association with adverse pregnancy outcomes in patients is the result of higher disease activity or the need for antirheumatic treatment, she explained.

“It was only hypothesized that those patients under bDMARD treatment are/were in high disease activity. There [is] no information on disease activity in the data sources, which limits the results,” she said. “The investigation still does not solve the important question – if adverse pregnancy outcomes are rather related to high disease activity or the medication to treat this situation.”

There was no specific funding for this study. The study authors and Dr. Strangfeld have disclosed no relevant financial relationships.

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

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Disease-modifying antirheumatic drugs (DMARDs) such as biologics may carry an increased risk for preterm birth or cesarean delivery for pregnant women with psoriatic arthritis (PsA), according to a recent study published in Arthritis & Rheumatology.

zoranm/Getty Images

The risk was particularly high for women with PsA who received biologic disease-modifying antirheumatic drugs (bDMARDs), according to Katarina Remaeus, PhD, of the Karolinska Institute in Stockholm and colleagues.

“The results may indicate that a more severe or active PsA disease that requires antirheumatic treatment during pregnancy, especially bDMARDs, is associated with increased risks of adverse pregnancy outcomes compared to non-PsA pregnancies,” Dr. Remaeus and colleagues write in their study. “The risk of preterm birth in PsA pregnancies is further influenced by parity with the most increased risks observed in first pregnancies.”

In a nationwide, register-based cohort study, the researchers evaluated 921 pregnancies of women with PsA between 2007 and 2017, comparing them to the pregnancies of 9,210 women without PsA over the same time frame. The pregnancies for women with PsA were further categorized based on whether the women had not received antirheumatic treatment in the year prior to and/or during pregnancy (495 pregnancies) or had received antirheumatic treatment at any point in the year before and/or during pregnancy (426 pregnancies).



Of the women in the PsA group who were treated in the year prior to pregnancy (170 women), 39.4% received monotherapy with a conventional synthetic DMARD (csDMARD) such as an antimalarial, methotrexate, or sulfasalazine; 24.1% received oral corticosteroids, and 15.9% received a tumor necrosis factor inhibitor (TNFi), whereas about 20% of women received two or more antirheumatic drugs.

In the group of women treated during pregnancy (256 women), 153 did not receive bDMARDs; of these, 41.8% had monotherapy with either a csDMARD or corticosteroids, whereas the group treated with bDMARDs received TNFi monotherapy (43.7%) or TNFi with corticosteroids (35.9%), TNFi with csDMARD (9.7%), or TNFi with csDMARD plus corticosteroids (9.7%).

A majority of women in both groups (70.1%) were between ages 30 and 34 years (37.1%) or older than age 35 years (33%) and had delivered more than one child (63.2%). Women in the PsA group were more likely to be born in a Nordic country (91.8% vs. 82.8%), to have a body mass index between 30.0 and 60.0 kg/m2 (19.9% vs. 12.6%), to be a smoker (9.2% vs. 5.3%), to have hypertension (1.4% vs. 0.8%) or diabetes (1.3% vs. 0.5%) prior to pregnancy, and to have a higher level of education (>12 years; 50.1% vs. 43.3%), compared with women in the non-PsA group.



The results showed women in the PsA group were more likely to experience preterm birth (adjusted odds ratio, 1.69; 95% confidence interval, 1.27-2.24) and undergo an elective (aOR, 1.77; 95% CI, 1.43-2.20) or emergency C-section (aOR, 1.42; 95% CI, 1.10-1.84). The group at highest risk for preterm birth with regard to parity was women with PsA having their first child (aOR, 3.95; 95% CI, 1.43-10.95).

Women who received antirheumatic treatment were at greater risk for experiencing preterm birth (aOR, 2.30; 95% CI, 1.49-3.56), and this risk was even higher for treatment with bDMARDs, compared with women without PsA (aOR, 4.49; 95% CI, 2.60-7.79). Use of bDMARDs also was associated with higher risks for spontaneous preterm birth (aOR, 4.73; 95% CI, 2.53-8.87), preterm birth between 32 and 36 weeks’ gestation (aOR, 5.06; 95% CI, 2.91-8.79), elective C-section (aOR, 2.72; 95% CI, 1.61-4.59), emergency C-section (aOR, 2.06; 95% CI, 1.04-4.07), and preeclampsia (aOR, 2.88, 95% CI, 1.35-6.17).

The researchers note that women with PsA should be evaluated for preterm birth particularly if they are having their first child, and “from a clinical point of view, all women with PsA, regardless of antirheumatic treatment, should be counseled about pregnancy outcomes and receive individualized monitoring during pregnancy.”

 

 

Are adverse outcomes linked to disease activity or treatment?

Patients in the study had a higher risk of adverse outcomes when they had a PsA diagnosis, and when they received antirheumatic treatment – but were the adverse outcomes associated with a patient’s high disease activity or need for antirheumatic treatment?

“Our interpretation is that a PsA disease that requires continued antirheumatic treatment during pregnancy is more severe than PsA that does not require treatment,” Dr. Remaeus and colleagues write. “Thus, the increased risk of adverse outcomes in pregnancies with maternal antirheumatic treatment is probably attributed to disease severity rather than an effect of the medication itself.”

Dr. Anja Strangfeld

Anja Strangfeld, MD, PhD, of the German Rheumatism Research Centre in Berlin, told this news organization that the results of the study are important because it is one of the first to report differences in risk in pregnancy outcomes for women with and without PsA.

“The information is relevant to guide rheumatologists in advising patients with PsA when planning the first or subsequent pregnancies,” she said. “The results are reassuring in reporting that the elevated risk for PsA patients for adverse pregnancy outcomes is low in patients not in need of antirheumatic medication, presumably in low-disease activity.”

However, the study is still unclear on whether the association with adverse pregnancy outcomes in patients is the result of higher disease activity or the need for antirheumatic treatment, she explained.

“It was only hypothesized that those patients under bDMARD treatment are/were in high disease activity. There [is] no information on disease activity in the data sources, which limits the results,” she said. “The investigation still does not solve the important question – if adverse pregnancy outcomes are rather related to high disease activity or the medication to treat this situation.”

There was no specific funding for this study. The study authors and Dr. Strangfeld have disclosed no relevant financial relationships.

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

 

Disease-modifying antirheumatic drugs (DMARDs) such as biologics may carry an increased risk for preterm birth or cesarean delivery for pregnant women with psoriatic arthritis (PsA), according to a recent study published in Arthritis & Rheumatology.

zoranm/Getty Images

The risk was particularly high for women with PsA who received biologic disease-modifying antirheumatic drugs (bDMARDs), according to Katarina Remaeus, PhD, of the Karolinska Institute in Stockholm and colleagues.

“The results may indicate that a more severe or active PsA disease that requires antirheumatic treatment during pregnancy, especially bDMARDs, is associated with increased risks of adverse pregnancy outcomes compared to non-PsA pregnancies,” Dr. Remaeus and colleagues write in their study. “The risk of preterm birth in PsA pregnancies is further influenced by parity with the most increased risks observed in first pregnancies.”

In a nationwide, register-based cohort study, the researchers evaluated 921 pregnancies of women with PsA between 2007 and 2017, comparing them to the pregnancies of 9,210 women without PsA over the same time frame. The pregnancies for women with PsA were further categorized based on whether the women had not received antirheumatic treatment in the year prior to and/or during pregnancy (495 pregnancies) or had received antirheumatic treatment at any point in the year before and/or during pregnancy (426 pregnancies).



Of the women in the PsA group who were treated in the year prior to pregnancy (170 women), 39.4% received monotherapy with a conventional synthetic DMARD (csDMARD) such as an antimalarial, methotrexate, or sulfasalazine; 24.1% received oral corticosteroids, and 15.9% received a tumor necrosis factor inhibitor (TNFi), whereas about 20% of women received two or more antirheumatic drugs.

In the group of women treated during pregnancy (256 women), 153 did not receive bDMARDs; of these, 41.8% had monotherapy with either a csDMARD or corticosteroids, whereas the group treated with bDMARDs received TNFi monotherapy (43.7%) or TNFi with corticosteroids (35.9%), TNFi with csDMARD (9.7%), or TNFi with csDMARD plus corticosteroids (9.7%).

A majority of women in both groups (70.1%) were between ages 30 and 34 years (37.1%) or older than age 35 years (33%) and had delivered more than one child (63.2%). Women in the PsA group were more likely to be born in a Nordic country (91.8% vs. 82.8%), to have a body mass index between 30.0 and 60.0 kg/m2 (19.9% vs. 12.6%), to be a smoker (9.2% vs. 5.3%), to have hypertension (1.4% vs. 0.8%) or diabetes (1.3% vs. 0.5%) prior to pregnancy, and to have a higher level of education (>12 years; 50.1% vs. 43.3%), compared with women in the non-PsA group.



The results showed women in the PsA group were more likely to experience preterm birth (adjusted odds ratio, 1.69; 95% confidence interval, 1.27-2.24) and undergo an elective (aOR, 1.77; 95% CI, 1.43-2.20) or emergency C-section (aOR, 1.42; 95% CI, 1.10-1.84). The group at highest risk for preterm birth with regard to parity was women with PsA having their first child (aOR, 3.95; 95% CI, 1.43-10.95).

Women who received antirheumatic treatment were at greater risk for experiencing preterm birth (aOR, 2.30; 95% CI, 1.49-3.56), and this risk was even higher for treatment with bDMARDs, compared with women without PsA (aOR, 4.49; 95% CI, 2.60-7.79). Use of bDMARDs also was associated with higher risks for spontaneous preterm birth (aOR, 4.73; 95% CI, 2.53-8.87), preterm birth between 32 and 36 weeks’ gestation (aOR, 5.06; 95% CI, 2.91-8.79), elective C-section (aOR, 2.72; 95% CI, 1.61-4.59), emergency C-section (aOR, 2.06; 95% CI, 1.04-4.07), and preeclampsia (aOR, 2.88, 95% CI, 1.35-6.17).

The researchers note that women with PsA should be evaluated for preterm birth particularly if they are having their first child, and “from a clinical point of view, all women with PsA, regardless of antirheumatic treatment, should be counseled about pregnancy outcomes and receive individualized monitoring during pregnancy.”

 

 

Are adverse outcomes linked to disease activity or treatment?

Patients in the study had a higher risk of adverse outcomes when they had a PsA diagnosis, and when they received antirheumatic treatment – but were the adverse outcomes associated with a patient’s high disease activity or need for antirheumatic treatment?

“Our interpretation is that a PsA disease that requires continued antirheumatic treatment during pregnancy is more severe than PsA that does not require treatment,” Dr. Remaeus and colleagues write. “Thus, the increased risk of adverse outcomes in pregnancies with maternal antirheumatic treatment is probably attributed to disease severity rather than an effect of the medication itself.”

Dr. Anja Strangfeld

Anja Strangfeld, MD, PhD, of the German Rheumatism Research Centre in Berlin, told this news organization that the results of the study are important because it is one of the first to report differences in risk in pregnancy outcomes for women with and without PsA.

“The information is relevant to guide rheumatologists in advising patients with PsA when planning the first or subsequent pregnancies,” she said. “The results are reassuring in reporting that the elevated risk for PsA patients for adverse pregnancy outcomes is low in patients not in need of antirheumatic medication, presumably in low-disease activity.”

However, the study is still unclear on whether the association with adverse pregnancy outcomes in patients is the result of higher disease activity or the need for antirheumatic treatment, she explained.

“It was only hypothesized that those patients under bDMARD treatment are/were in high disease activity. There [is] no information on disease activity in the data sources, which limits the results,” she said. “The investigation still does not solve the important question – if adverse pregnancy outcomes are rather related to high disease activity or the medication to treat this situation.”

There was no specific funding for this study. The study authors and Dr. Strangfeld have disclosed no relevant financial relationships.

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

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Some diuretics tied to increased skin cancer risk

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Researchers writing in the British Journal of Dermatology confirm the long-term use of hydrochlorothiazide is associated with a dose-dependent, twofold increased risk of squamous cell carcinoma, compared with calcium channel blocker use.

The findings were originally reported in two Danish case-control studies in which physicians reported a fourfold increased risk of squamous cell carcinoma, and a moderate increased risk of basal cell carcinoma and cutaneous malignant melanoma in patients who used hydrochlorothiazide long-term.

And, while the new study did not find an increased risk of basal cell carcinoma and cutaneous malignant melanoma among long-term users of hydrochlorothiazide, they suggest that bendroflumethiazide “may be a safer alternative for patients at increased risk of skin cancer.” The long-term use of indapamide was associated with a moderately increased risk of cutaneous malignant melanoma but did not alter the risk of either squamous cell or basal cell carcinoma

“Our results suggest that bendroflumethiazide may be a safer alternative to hydrochlorothiazide and indapamide, especially for patients at increased risk of skin cancer, but future studies are needed to rule out a causal association between bendroflumethiazide and cutaneous malignant melanoma,” wrote authors who were led by Christoph R. Meier, PhD, a professor in pharmacy with University Hospital Basel (Switzerland) and a contributor to the Boston Collaborative Drug Surveillance Program.

This study adds to existing evidence that there is a dose-dependent increased risk of squamous cell carcinoma in users of high cumulative doses of hydrochlorothiazide, compared with non–hydrochlorothiazide users.

The study, an observational cohort study, was published earlier this year. It is based on data from the U.K.-based Clinical Practice Research Datalink. It included 271,154 new users of thiazides and thiazidelike diuretics, the majority at 87.6% having been prescribed bendroflumethiazide, 5.8% indapamide, and 3.6% hydrochlorothiazide. Outcomes were compared to those observed in 275,263 users of calcium channel blockers.

“The three primary outcomes of interest were a first-time diagnosis of cutaneous malignant melanoma, basal cell carcinoma, or squamous cell carcinoma,” the authors wrote.

Incidence rates and incidence rate ratios were estimated for both short-term and long-term users of thiazidelike diuretics and calcium channel blockers, while a propensity score (PS) analysis was done in order to control for 23 baseline covariates. The mean follow-up after PS weighting was 3.9 years for indapamide users and 5.5 years for hydrochlorothiazide users. Overall, the incidence rate ratios of squamous cell carcinoma were not markedly increased for either short-term or long-term users of thiazidelike diuretics, the authors reported.

In contrast, the incidence rate ratios of squamous cell carcinoma for hydrochlorothiazide users were increased by 29% for short-term users at an IRR of 1.29 while they were increased by almost twofold for long-term hydrochlorothiazide users at an IRR of 1.95.

Long-term use of hydrochlorothiazide was again associated with a 64% increased risk of basal cell carcinoma, compared with users of a renin-angiotensin inhibitor at a weighted IRR of 1.64.

In contrast, weighted incident rate ratios for basal cell carcinoma for both short-term and long-term thiazide users were not significantly different and results were similar for patients who took hydrochlorothiazide, indapamide, or bendroflumethiazide.

Weighted overall incident rate ratios for cutaneous malignant melanoma were not significantly different for either short-term or long-term users of thiazidelike diuretics, compared with calcium channel blocker users.

However, there was a 43% increased risk of cutaneous malignant melanoma among long-term indapamide users at a weighted IRR of 1.43, compared with calcium channel blocker users, the authors reported.

“Given the biological plausibility and the severe clinical implications of cutaneous malignant melanoma, this finding should be considered carefully,” they cautioned.

Limitations to the study include the fact that the database analyzed does not have information on sun exposure, skin characteristics, or socioeconomic status which may affect the amount of sun exposure participants received.

The authors had no conflicts of interest to declare.

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Researchers writing in the British Journal of Dermatology confirm the long-term use of hydrochlorothiazide is associated with a dose-dependent, twofold increased risk of squamous cell carcinoma, compared with calcium channel blocker use.

The findings were originally reported in two Danish case-control studies in which physicians reported a fourfold increased risk of squamous cell carcinoma, and a moderate increased risk of basal cell carcinoma and cutaneous malignant melanoma in patients who used hydrochlorothiazide long-term.

And, while the new study did not find an increased risk of basal cell carcinoma and cutaneous malignant melanoma among long-term users of hydrochlorothiazide, they suggest that bendroflumethiazide “may be a safer alternative for patients at increased risk of skin cancer.” The long-term use of indapamide was associated with a moderately increased risk of cutaneous malignant melanoma but did not alter the risk of either squamous cell or basal cell carcinoma

“Our results suggest that bendroflumethiazide may be a safer alternative to hydrochlorothiazide and indapamide, especially for patients at increased risk of skin cancer, but future studies are needed to rule out a causal association between bendroflumethiazide and cutaneous malignant melanoma,” wrote authors who were led by Christoph R. Meier, PhD, a professor in pharmacy with University Hospital Basel (Switzerland) and a contributor to the Boston Collaborative Drug Surveillance Program.

This study adds to existing evidence that there is a dose-dependent increased risk of squamous cell carcinoma in users of high cumulative doses of hydrochlorothiazide, compared with non–hydrochlorothiazide users.

The study, an observational cohort study, was published earlier this year. It is based on data from the U.K.-based Clinical Practice Research Datalink. It included 271,154 new users of thiazides and thiazidelike diuretics, the majority at 87.6% having been prescribed bendroflumethiazide, 5.8% indapamide, and 3.6% hydrochlorothiazide. Outcomes were compared to those observed in 275,263 users of calcium channel blockers.

“The three primary outcomes of interest were a first-time diagnosis of cutaneous malignant melanoma, basal cell carcinoma, or squamous cell carcinoma,” the authors wrote.

Incidence rates and incidence rate ratios were estimated for both short-term and long-term users of thiazidelike diuretics and calcium channel blockers, while a propensity score (PS) analysis was done in order to control for 23 baseline covariates. The mean follow-up after PS weighting was 3.9 years for indapamide users and 5.5 years for hydrochlorothiazide users. Overall, the incidence rate ratios of squamous cell carcinoma were not markedly increased for either short-term or long-term users of thiazidelike diuretics, the authors reported.

In contrast, the incidence rate ratios of squamous cell carcinoma for hydrochlorothiazide users were increased by 29% for short-term users at an IRR of 1.29 while they were increased by almost twofold for long-term hydrochlorothiazide users at an IRR of 1.95.

Long-term use of hydrochlorothiazide was again associated with a 64% increased risk of basal cell carcinoma, compared with users of a renin-angiotensin inhibitor at a weighted IRR of 1.64.

In contrast, weighted incident rate ratios for basal cell carcinoma for both short-term and long-term thiazide users were not significantly different and results were similar for patients who took hydrochlorothiazide, indapamide, or bendroflumethiazide.

Weighted overall incident rate ratios for cutaneous malignant melanoma were not significantly different for either short-term or long-term users of thiazidelike diuretics, compared with calcium channel blocker users.

However, there was a 43% increased risk of cutaneous malignant melanoma among long-term indapamide users at a weighted IRR of 1.43, compared with calcium channel blocker users, the authors reported.

“Given the biological plausibility and the severe clinical implications of cutaneous malignant melanoma, this finding should be considered carefully,” they cautioned.

Limitations to the study include the fact that the database analyzed does not have information on sun exposure, skin characteristics, or socioeconomic status which may affect the amount of sun exposure participants received.

The authors had no conflicts of interest to declare.

Researchers writing in the British Journal of Dermatology confirm the long-term use of hydrochlorothiazide is associated with a dose-dependent, twofold increased risk of squamous cell carcinoma, compared with calcium channel blocker use.

The findings were originally reported in two Danish case-control studies in which physicians reported a fourfold increased risk of squamous cell carcinoma, and a moderate increased risk of basal cell carcinoma and cutaneous malignant melanoma in patients who used hydrochlorothiazide long-term.

And, while the new study did not find an increased risk of basal cell carcinoma and cutaneous malignant melanoma among long-term users of hydrochlorothiazide, they suggest that bendroflumethiazide “may be a safer alternative for patients at increased risk of skin cancer.” The long-term use of indapamide was associated with a moderately increased risk of cutaneous malignant melanoma but did not alter the risk of either squamous cell or basal cell carcinoma

“Our results suggest that bendroflumethiazide may be a safer alternative to hydrochlorothiazide and indapamide, especially for patients at increased risk of skin cancer, but future studies are needed to rule out a causal association between bendroflumethiazide and cutaneous malignant melanoma,” wrote authors who were led by Christoph R. Meier, PhD, a professor in pharmacy with University Hospital Basel (Switzerland) and a contributor to the Boston Collaborative Drug Surveillance Program.

This study adds to existing evidence that there is a dose-dependent increased risk of squamous cell carcinoma in users of high cumulative doses of hydrochlorothiazide, compared with non–hydrochlorothiazide users.

The study, an observational cohort study, was published earlier this year. It is based on data from the U.K.-based Clinical Practice Research Datalink. It included 271,154 new users of thiazides and thiazidelike diuretics, the majority at 87.6% having been prescribed bendroflumethiazide, 5.8% indapamide, and 3.6% hydrochlorothiazide. Outcomes were compared to those observed in 275,263 users of calcium channel blockers.

“The three primary outcomes of interest were a first-time diagnosis of cutaneous malignant melanoma, basal cell carcinoma, or squamous cell carcinoma,” the authors wrote.

Incidence rates and incidence rate ratios were estimated for both short-term and long-term users of thiazidelike diuretics and calcium channel blockers, while a propensity score (PS) analysis was done in order to control for 23 baseline covariates. The mean follow-up after PS weighting was 3.9 years for indapamide users and 5.5 years for hydrochlorothiazide users. Overall, the incidence rate ratios of squamous cell carcinoma were not markedly increased for either short-term or long-term users of thiazidelike diuretics, the authors reported.

In contrast, the incidence rate ratios of squamous cell carcinoma for hydrochlorothiazide users were increased by 29% for short-term users at an IRR of 1.29 while they were increased by almost twofold for long-term hydrochlorothiazide users at an IRR of 1.95.

Long-term use of hydrochlorothiazide was again associated with a 64% increased risk of basal cell carcinoma, compared with users of a renin-angiotensin inhibitor at a weighted IRR of 1.64.

In contrast, weighted incident rate ratios for basal cell carcinoma for both short-term and long-term thiazide users were not significantly different and results were similar for patients who took hydrochlorothiazide, indapamide, or bendroflumethiazide.

Weighted overall incident rate ratios for cutaneous malignant melanoma were not significantly different for either short-term or long-term users of thiazidelike diuretics, compared with calcium channel blocker users.

However, there was a 43% increased risk of cutaneous malignant melanoma among long-term indapamide users at a weighted IRR of 1.43, compared with calcium channel blocker users, the authors reported.

“Given the biological plausibility and the severe clinical implications of cutaneous malignant melanoma, this finding should be considered carefully,” they cautioned.

Limitations to the study include the fact that the database analyzed does not have information on sun exposure, skin characteristics, or socioeconomic status which may affect the amount of sun exposure participants received.

The authors had no conflicts of interest to declare.

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Uncertainty looms large in treatment options for high-risk cutaneous SCC

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Checkpoint inhibitor use as adjuvant therapy for patients with high-risk cutaneous squamous cell carcinoma (cSCC) may eventually overtake the use of cytotoxic chemotherapeutic agents, say the authors of a clinical review recently published in the journal Head and Neck.

The review, led by Jason G. Newman, MD, director of head and neck surgery at Penn Medicine, Philadelphia, includes evidence-based research findings from the last 10 years which describe the possible roles for adjuvant radiation, chemotherapy, immunotherapy, and/or targeted therapy in the management of high-risk cSCC.

Dr. Newman and colleagues wrote that more data – and high-quality data – are needed for physicians to determine with more confidence which adjuvant therapies would be best for specific patients with high-risk cSCC. But without that data, uncertainty in treatment decisions will persist.

“The requirements for and efficacy of adjuvant therapies in cutaneous squamous cell carcinoma are unclear, and the gap in evidence for practice decisions regarding adjuvant therapy in patients with high-risk cSCC has been apparent for more than a decade,” they wrote.

While surgical excision with clear margins of the primary cSCC lesion remains the standard of care, certain high-risk factors necessitate adjuvant therapy, the authors wrote. However, since the evidence consists of small retrospective studies with conflicting results, it is unclear which patients might benefit from adjuvant therapy. This review included recent and current trials in cutaneous SCC and the role of immune checkpoint inhibitors.

According to the review, adjuvant radiation therapy is usually considered with high-risk features, such as perineural invasion, lymph node metastasis and extracapsular/extranodal extension, if the patient is otherwise at high risk for metastasis or recurrence, or if further surgery is not possible.

The National Comprehensive Cancer Network, the American College of Radiology, and the American Society for Radiation Oncology do not recommend adjuvant radiation therapy for most patients with cSCC. However, adjuvant radiation therapy with or without systemic therapy may be considered in locally advanced disease, when further surgery is not an option, or if there is regional lymph node metastasis, but multidisciplinary consultation is recommended.

Regarding checkpoint inhibitors, the NCCN, ACR, and ASTRO do not recommend the use of systemic therapy for local disease amenable to surgery. Potential use of a checkpoint inhibitor with radiation therapy in a clinical trial is recommended for residual disease in locally advanced cSCC as palliative care when other options are not available. While the use of cemiplimab or pembrolizumab are preferred in regional recurrence when curative surgery and radiation therapy are not an option, a targeted therapy can be considered if this is not feasible.

“Given the current activity of checkpoint inhibition in this disease, enthusiasm for the addition of cytotoxic chemotherapeutic agents in the adjuvant setting may be on the decline,” the authors wrote. “Multidisciplinary approaches will most likely continue to be recommended in complicated cases, including those involving immunosuppression.”

The authors said that further study is needed on prognostic testing, such as gene expression profile testing or sentinel lymph node biopsy, as such testing early in disease could identify patients who would likely benefit from adjuvant therapy. They added that the need to identify patients at early stages of disease who are at high risk for metastasis continues to remain critical.

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Checkpoint inhibitor use as adjuvant therapy for patients with high-risk cutaneous squamous cell carcinoma (cSCC) may eventually overtake the use of cytotoxic chemotherapeutic agents, say the authors of a clinical review recently published in the journal Head and Neck.

The review, led by Jason G. Newman, MD, director of head and neck surgery at Penn Medicine, Philadelphia, includes evidence-based research findings from the last 10 years which describe the possible roles for adjuvant radiation, chemotherapy, immunotherapy, and/or targeted therapy in the management of high-risk cSCC.

Dr. Newman and colleagues wrote that more data – and high-quality data – are needed for physicians to determine with more confidence which adjuvant therapies would be best for specific patients with high-risk cSCC. But without that data, uncertainty in treatment decisions will persist.

“The requirements for and efficacy of adjuvant therapies in cutaneous squamous cell carcinoma are unclear, and the gap in evidence for practice decisions regarding adjuvant therapy in patients with high-risk cSCC has been apparent for more than a decade,” they wrote.

While surgical excision with clear margins of the primary cSCC lesion remains the standard of care, certain high-risk factors necessitate adjuvant therapy, the authors wrote. However, since the evidence consists of small retrospective studies with conflicting results, it is unclear which patients might benefit from adjuvant therapy. This review included recent and current trials in cutaneous SCC and the role of immune checkpoint inhibitors.

According to the review, adjuvant radiation therapy is usually considered with high-risk features, such as perineural invasion, lymph node metastasis and extracapsular/extranodal extension, if the patient is otherwise at high risk for metastasis or recurrence, or if further surgery is not possible.

The National Comprehensive Cancer Network, the American College of Radiology, and the American Society for Radiation Oncology do not recommend adjuvant radiation therapy for most patients with cSCC. However, adjuvant radiation therapy with or without systemic therapy may be considered in locally advanced disease, when further surgery is not an option, or if there is regional lymph node metastasis, but multidisciplinary consultation is recommended.

Regarding checkpoint inhibitors, the NCCN, ACR, and ASTRO do not recommend the use of systemic therapy for local disease amenable to surgery. Potential use of a checkpoint inhibitor with radiation therapy in a clinical trial is recommended for residual disease in locally advanced cSCC as palliative care when other options are not available. While the use of cemiplimab or pembrolizumab are preferred in regional recurrence when curative surgery and radiation therapy are not an option, a targeted therapy can be considered if this is not feasible.

“Given the current activity of checkpoint inhibition in this disease, enthusiasm for the addition of cytotoxic chemotherapeutic agents in the adjuvant setting may be on the decline,” the authors wrote. “Multidisciplinary approaches will most likely continue to be recommended in complicated cases, including those involving immunosuppression.”

The authors said that further study is needed on prognostic testing, such as gene expression profile testing or sentinel lymph node biopsy, as such testing early in disease could identify patients who would likely benefit from adjuvant therapy. They added that the need to identify patients at early stages of disease who are at high risk for metastasis continues to remain critical.

 

Checkpoint inhibitor use as adjuvant therapy for patients with high-risk cutaneous squamous cell carcinoma (cSCC) may eventually overtake the use of cytotoxic chemotherapeutic agents, say the authors of a clinical review recently published in the journal Head and Neck.

The review, led by Jason G. Newman, MD, director of head and neck surgery at Penn Medicine, Philadelphia, includes evidence-based research findings from the last 10 years which describe the possible roles for adjuvant radiation, chemotherapy, immunotherapy, and/or targeted therapy in the management of high-risk cSCC.

Dr. Newman and colleagues wrote that more data – and high-quality data – are needed for physicians to determine with more confidence which adjuvant therapies would be best for specific patients with high-risk cSCC. But without that data, uncertainty in treatment decisions will persist.

“The requirements for and efficacy of adjuvant therapies in cutaneous squamous cell carcinoma are unclear, and the gap in evidence for practice decisions regarding adjuvant therapy in patients with high-risk cSCC has been apparent for more than a decade,” they wrote.

While surgical excision with clear margins of the primary cSCC lesion remains the standard of care, certain high-risk factors necessitate adjuvant therapy, the authors wrote. However, since the evidence consists of small retrospective studies with conflicting results, it is unclear which patients might benefit from adjuvant therapy. This review included recent and current trials in cutaneous SCC and the role of immune checkpoint inhibitors.

According to the review, adjuvant radiation therapy is usually considered with high-risk features, such as perineural invasion, lymph node metastasis and extracapsular/extranodal extension, if the patient is otherwise at high risk for metastasis or recurrence, or if further surgery is not possible.

The National Comprehensive Cancer Network, the American College of Radiology, and the American Society for Radiation Oncology do not recommend adjuvant radiation therapy for most patients with cSCC. However, adjuvant radiation therapy with or without systemic therapy may be considered in locally advanced disease, when further surgery is not an option, or if there is regional lymph node metastasis, but multidisciplinary consultation is recommended.

Regarding checkpoint inhibitors, the NCCN, ACR, and ASTRO do not recommend the use of systemic therapy for local disease amenable to surgery. Potential use of a checkpoint inhibitor with radiation therapy in a clinical trial is recommended for residual disease in locally advanced cSCC as palliative care when other options are not available. While the use of cemiplimab or pembrolizumab are preferred in regional recurrence when curative surgery and radiation therapy are not an option, a targeted therapy can be considered if this is not feasible.

“Given the current activity of checkpoint inhibition in this disease, enthusiasm for the addition of cytotoxic chemotherapeutic agents in the adjuvant setting may be on the decline,” the authors wrote. “Multidisciplinary approaches will most likely continue to be recommended in complicated cases, including those involving immunosuppression.”

The authors said that further study is needed on prognostic testing, such as gene expression profile testing or sentinel lymph node biopsy, as such testing early in disease could identify patients who would likely benefit from adjuvant therapy. They added that the need to identify patients at early stages of disease who are at high risk for metastasis continues to remain critical.

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One of the keys to success on social media? Entertain and educate the public

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Social media isn’t everyone’s cup of tea, but for those who want to become a significant influencer on Instagram, YouTube, TikTok, or other platforms, “you have to enjoy it,” Sandra Lee, MD, said during a virtual course on laser and aesthetic skin therapy.

Dr. Sandra Lee

“I admit that I’m somewhat obsessed with it. I kind of blame it on my work as a dermatologist, that I’m trying to grow my social media as well. It’s interesting to me, fascinating, and I want to understand it more. I think that’s the mindset you need to approach it with.”

Perhaps no other public figure in dermatology has enjoyed success in social media more than Dr. Lee, a board-certified dermatologist who practices in Upland, Calif. In the fall of 2014, she started using Instagram to provide followers a glimpse into her life as a dermatologist, everything from Mohs surgery and Botox to keloid removals and ear lobe repair surgeries. From this she formed her alter ego, “Dr. Pimple Popper,” and became a YouTube sensation, building 7.1 million subscribers over the course of a few years, amounting to 4.5 billion lifetime views. She also grew 12 million followers on TikTok, 4.4 million followers on Instagram, 3 million on Facebook, and more than 139,000 on Twitter. About 80% of her followers are women who range between 18 and 40 years of age.



During the meeting she offered five social media marketing tips for busy clinicians:

You have to ‘play’ to ‘win.’ Active participation in social media is required to develop followers. “You cannot delegate this content,” Dr. Lee said. “You can hire people to help you or leave the task to a social media-savvy medical assistant in your office, but the content should be your responsibility ultimately, because you are the physician,” she added. Not everyone chooses to participate in social media, but it’s also something not to shy away from out of intimidation. “There is some talent associated with it, but it takes a lot of persistence as well,” she said.

Patients come first. Protect them at all costs. Dr. Lee rarely posts the faces of patients she cares for unless they grant consent in advance. “I try to show the work that I do and the beauty of dermatology,” she said during the meeting, which was named “Laser & Aesthetic Skin Therapy: What’s the Truth?” and was sponsored by Harvard Medical School, Massachusetts General Hospital, and the Wellman Center for Photomedicine. She added that taking part in social media can help you improve communication skills by engaging with followers who like, share, or respond to the material posted. “When you look back at your posts objectively, you learn about yourself and how you relate to your patients,” she said. “It helps to hone my bedside manner and my skills as a dermatologist.”

Show that you are human. Many dermatologists and other “skin influencers” have established their presence on the Internet and may be direct competitors for patients, but that doesn’t mean you can’t establish your own identity. One way to stand out is by posting content related to your authentic self, such as a photo or video that shows you engaged in a hobby, dining at a favorite restaurant, or visiting a beloved vacation spot. “Your followers don’t want a robot, someone who thinks they’re amazing and can do everything,” said Dr. Lee, who stars in her own TV reality show on TLC. “Show that you have a funny side. You want them to fall in love with you and see a little bit of your world, whatever it might be. Charm the socks off of them.”

Entertain first, educate a close second. The main way you’re going to get people to follow and watch you is to provide some entertainment, “not at the expense of a patient or your practice, though,” she said. “Then you’re going to educate people. We dermatologists have something to teach the world because we are experts on skin, hair, and nails. You want to impart this knowledge in a way that captivates people.” It’s like the sense of accomplishment that comes from learning something new after reading a book or watching a movie, she explained. “You feel good about it, and you can take that knowledge with you somewhere else. I love it when kids come up to me and tell me they know what a lipoma is, what a cyst is, and what psoriasis is because they’ve seen my show, or because they follow me on social media. It’s wonderful because I can see that I’ve educated them.”

Be kind and don’t activate the trolls. Dr. Lee allows positivity and kindness to rule the day on her social media content. “This is what I try to relay to followers, but I also do not engage with the negativity,” she said. “Every now and then, there will be someone who tries to insult what you do or who insults you personally. If you engage with them, it almost invites them to do it more. It almost gives them the ability to fight with you. Try to stay above that; just put out goodness and kindness.”

Several years ago, YouTube and Instagram temporarily shut down Dr. Lee’s accounts because she posted graphic images of skin lesions and procedures – a practice that wasn’t so commonplace at the time. “Don’t just post a graphic image just to be graphic,” she advised. “Make sure it has an educational message associated with it. That will help to validate your content. Posting a warning sign that some images may be graphic could help, too.”

Dr. Lee reported having no relevant financial disclosures.

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Social media isn’t everyone’s cup of tea, but for those who want to become a significant influencer on Instagram, YouTube, TikTok, or other platforms, “you have to enjoy it,” Sandra Lee, MD, said during a virtual course on laser and aesthetic skin therapy.

Dr. Sandra Lee

“I admit that I’m somewhat obsessed with it. I kind of blame it on my work as a dermatologist, that I’m trying to grow my social media as well. It’s interesting to me, fascinating, and I want to understand it more. I think that’s the mindset you need to approach it with.”

Perhaps no other public figure in dermatology has enjoyed success in social media more than Dr. Lee, a board-certified dermatologist who practices in Upland, Calif. In the fall of 2014, she started using Instagram to provide followers a glimpse into her life as a dermatologist, everything from Mohs surgery and Botox to keloid removals and ear lobe repair surgeries. From this she formed her alter ego, “Dr. Pimple Popper,” and became a YouTube sensation, building 7.1 million subscribers over the course of a few years, amounting to 4.5 billion lifetime views. She also grew 12 million followers on TikTok, 4.4 million followers on Instagram, 3 million on Facebook, and more than 139,000 on Twitter. About 80% of her followers are women who range between 18 and 40 years of age.



During the meeting she offered five social media marketing tips for busy clinicians:

You have to ‘play’ to ‘win.’ Active participation in social media is required to develop followers. “You cannot delegate this content,” Dr. Lee said. “You can hire people to help you or leave the task to a social media-savvy medical assistant in your office, but the content should be your responsibility ultimately, because you are the physician,” she added. Not everyone chooses to participate in social media, but it’s also something not to shy away from out of intimidation. “There is some talent associated with it, but it takes a lot of persistence as well,” she said.

Patients come first. Protect them at all costs. Dr. Lee rarely posts the faces of patients she cares for unless they grant consent in advance. “I try to show the work that I do and the beauty of dermatology,” she said during the meeting, which was named “Laser & Aesthetic Skin Therapy: What’s the Truth?” and was sponsored by Harvard Medical School, Massachusetts General Hospital, and the Wellman Center for Photomedicine. She added that taking part in social media can help you improve communication skills by engaging with followers who like, share, or respond to the material posted. “When you look back at your posts objectively, you learn about yourself and how you relate to your patients,” she said. “It helps to hone my bedside manner and my skills as a dermatologist.”

Show that you are human. Many dermatologists and other “skin influencers” have established their presence on the Internet and may be direct competitors for patients, but that doesn’t mean you can’t establish your own identity. One way to stand out is by posting content related to your authentic self, such as a photo or video that shows you engaged in a hobby, dining at a favorite restaurant, or visiting a beloved vacation spot. “Your followers don’t want a robot, someone who thinks they’re amazing and can do everything,” said Dr. Lee, who stars in her own TV reality show on TLC. “Show that you have a funny side. You want them to fall in love with you and see a little bit of your world, whatever it might be. Charm the socks off of them.”

Entertain first, educate a close second. The main way you’re going to get people to follow and watch you is to provide some entertainment, “not at the expense of a patient or your practice, though,” she said. “Then you’re going to educate people. We dermatologists have something to teach the world because we are experts on skin, hair, and nails. You want to impart this knowledge in a way that captivates people.” It’s like the sense of accomplishment that comes from learning something new after reading a book or watching a movie, she explained. “You feel good about it, and you can take that knowledge with you somewhere else. I love it when kids come up to me and tell me they know what a lipoma is, what a cyst is, and what psoriasis is because they’ve seen my show, or because they follow me on social media. It’s wonderful because I can see that I’ve educated them.”

Be kind and don’t activate the trolls. Dr. Lee allows positivity and kindness to rule the day on her social media content. “This is what I try to relay to followers, but I also do not engage with the negativity,” she said. “Every now and then, there will be someone who tries to insult what you do or who insults you personally. If you engage with them, it almost invites them to do it more. It almost gives them the ability to fight with you. Try to stay above that; just put out goodness and kindness.”

Several years ago, YouTube and Instagram temporarily shut down Dr. Lee’s accounts because she posted graphic images of skin lesions and procedures – a practice that wasn’t so commonplace at the time. “Don’t just post a graphic image just to be graphic,” she advised. “Make sure it has an educational message associated with it. That will help to validate your content. Posting a warning sign that some images may be graphic could help, too.”

Dr. Lee reported having no relevant financial disclosures.

 

Social media isn’t everyone’s cup of tea, but for those who want to become a significant influencer on Instagram, YouTube, TikTok, or other platforms, “you have to enjoy it,” Sandra Lee, MD, said during a virtual course on laser and aesthetic skin therapy.

Dr. Sandra Lee

“I admit that I’m somewhat obsessed with it. I kind of blame it on my work as a dermatologist, that I’m trying to grow my social media as well. It’s interesting to me, fascinating, and I want to understand it more. I think that’s the mindset you need to approach it with.”

Perhaps no other public figure in dermatology has enjoyed success in social media more than Dr. Lee, a board-certified dermatologist who practices in Upland, Calif. In the fall of 2014, she started using Instagram to provide followers a glimpse into her life as a dermatologist, everything from Mohs surgery and Botox to keloid removals and ear lobe repair surgeries. From this she formed her alter ego, “Dr. Pimple Popper,” and became a YouTube sensation, building 7.1 million subscribers over the course of a few years, amounting to 4.5 billion lifetime views. She also grew 12 million followers on TikTok, 4.4 million followers on Instagram, 3 million on Facebook, and more than 139,000 on Twitter. About 80% of her followers are women who range between 18 and 40 years of age.



During the meeting she offered five social media marketing tips for busy clinicians:

You have to ‘play’ to ‘win.’ Active participation in social media is required to develop followers. “You cannot delegate this content,” Dr. Lee said. “You can hire people to help you or leave the task to a social media-savvy medical assistant in your office, but the content should be your responsibility ultimately, because you are the physician,” she added. Not everyone chooses to participate in social media, but it’s also something not to shy away from out of intimidation. “There is some talent associated with it, but it takes a lot of persistence as well,” she said.

Patients come first. Protect them at all costs. Dr. Lee rarely posts the faces of patients she cares for unless they grant consent in advance. “I try to show the work that I do and the beauty of dermatology,” she said during the meeting, which was named “Laser & Aesthetic Skin Therapy: What’s the Truth?” and was sponsored by Harvard Medical School, Massachusetts General Hospital, and the Wellman Center for Photomedicine. She added that taking part in social media can help you improve communication skills by engaging with followers who like, share, or respond to the material posted. “When you look back at your posts objectively, you learn about yourself and how you relate to your patients,” she said. “It helps to hone my bedside manner and my skills as a dermatologist.”

Show that you are human. Many dermatologists and other “skin influencers” have established their presence on the Internet and may be direct competitors for patients, but that doesn’t mean you can’t establish your own identity. One way to stand out is by posting content related to your authentic self, such as a photo or video that shows you engaged in a hobby, dining at a favorite restaurant, or visiting a beloved vacation spot. “Your followers don’t want a robot, someone who thinks they’re amazing and can do everything,” said Dr. Lee, who stars in her own TV reality show on TLC. “Show that you have a funny side. You want them to fall in love with you and see a little bit of your world, whatever it might be. Charm the socks off of them.”

Entertain first, educate a close second. The main way you’re going to get people to follow and watch you is to provide some entertainment, “not at the expense of a patient or your practice, though,” she said. “Then you’re going to educate people. We dermatologists have something to teach the world because we are experts on skin, hair, and nails. You want to impart this knowledge in a way that captivates people.” It’s like the sense of accomplishment that comes from learning something new after reading a book or watching a movie, she explained. “You feel good about it, and you can take that knowledge with you somewhere else. I love it when kids come up to me and tell me they know what a lipoma is, what a cyst is, and what psoriasis is because they’ve seen my show, or because they follow me on social media. It’s wonderful because I can see that I’ve educated them.”

Be kind and don’t activate the trolls. Dr. Lee allows positivity and kindness to rule the day on her social media content. “This is what I try to relay to followers, but I also do not engage with the negativity,” she said. “Every now and then, there will be someone who tries to insult what you do or who insults you personally. If you engage with them, it almost invites them to do it more. It almost gives them the ability to fight with you. Try to stay above that; just put out goodness and kindness.”

Several years ago, YouTube and Instagram temporarily shut down Dr. Lee’s accounts because she posted graphic images of skin lesions and procedures – a practice that wasn’t so commonplace at the time. “Don’t just post a graphic image just to be graphic,” she advised. “Make sure it has an educational message associated with it. That will help to validate your content. Posting a warning sign that some images may be graphic could help, too.”

Dr. Lee reported having no relevant financial disclosures.

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FROM A LASER & AESTHETIC SKIN THERAPY COURSE

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Accused: Doc increases patient’s penis size with improper fillers; more

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New Jersey officials have suspended the license of a physician whose aesthetic medicine practice allegedly poses a “clear and imminent danger” to the public, as reported in NJ.com.

The physician, Muhammad A. Mirza, MD, is a board-certified internal medicine doctor and owner of Mirza Aesthetics, which has its main New Jersey office in Cedar Grove, a township in Essex County. The practice also leases space in New York, Pennsylvania, and Connecticut, where at press time Dr. Mirza was still licensed to practice medicine.

The acting New Jersey attorney general said that Dr. Mirza had deviated from the accepted standards of medical care in at least four key areas: he practiced in ways that put his patients in bodily danger; he lacked the formal training in and an adequate knowledge of aesthetic medicine; he practiced in office settings that inspectors found to be subpar; and he failed to safely store medical supplies or maintain proper medical records.

In one instance singled out by the attorney general’s office, Dr. Mirza used an injectable dermal filler to enhance a patient’s penis. As a result of that nonsurgical procedure, the patient needed to be rushed to a nearby hospital, where he underwent two emergency surgical interventions. Contacted by the emergency department doctor, Dr. Mirza allegedly failed to disclose the name of the filler he used, thereby complicating the patient’s recovery, according to the board complaint.

Dr. Mirza’s other alleged breaches of professional conduct include the following:

  • Failure to wear a mask or surgical gloves during procedures
  • Failure to keep electronic medical records of any kind
  • Improper, off-label use of an injectable dermal filler in proximity to patients’ eyes
  • Improper, off-label use of an injectable dermal filler for breast enhancement
  • Use of a certain injectable dermal filler without first testing for skin allergies

In addition, site inspections of Dr. Mirza’s offices turned up substandard conditions. On April 23, 2021, in response to numerous patient complaints, the Enforcement Bureau of the Division of Consumer Affairs inspected Dr. Mirza’s Summit, N.J. office, one of several in the state.

Among other things, the inspection uncovered the following:

  • The medical office was one large room. A curtain separated the reception area and the examination/treatment area, which consisted of only chairs and a fold-away table.
  • “Duffle bags” were used to store injectable fillers. No medical storage refrigerators were observed.
  • COVID-19 protocols were not followed. Inspectors could identify no barrier between receptionist and patients, no posted mask mandate, no social distancing policy, and no COVID-19 screening measures.

In addition to temporarily suspending Dr. Mirza’s license, the medical board has prohibited him from treating New Jersey patients in any of the out-of-state locations where he’s licensed to practice medicine.

Prosecutors have urged other patients who believe they’ve been injured by Mirza Aesthetics to file a complaint with the State Division of Consumer Affairs.

Dr. Mirza has agreed to the temporary suspension of his medical license, pending a hearing before an administrative law judge. In addition to facing civil penalties for each of the counts against him, he could be held responsible for paying investigative costs, attorney fees, trial costs, and other costs.
 

 

 

Doctor’s failure to diagnose results in mega award

In what is believed to be a record verdict in a wrongful death suit in Volusia County, Fla., a jury awarded $6.46 million to the family of a woman who died from an undiagnosed heart infection after being transferred from a local hospital, according to a report in The Daytona Beach News-Journal, among other news outlets.

In March 2016, Laura Staib went to what was then Florida Hospital DeLand — now AdventHealth DeLand — complaining of a variety of symptoms. There, she was examined by a doctor who was a member of a nearby cardiology group. His diagnosis: congestive heart failure, pneumonia, and sepsis. Transferred to a long-term care facility, Ms. Staib died 4 days later.

In their complaint against the cardiologist and his cardiology group, family members alleged that the doctor failed to identify Ms. Staib’s main problem: viral myocarditis.

“This was primarily a heart failure problem and a heart infection that was probably causing some problems in the lungs,” said the attorney representing the family. “A virus was attacking her heart, and they missed it,” he said. Claims against the hospital and other doctors were eventually resolved and dismissed.

The jury’s verdict will be appealed, said the attorney representing the cardiologist.

He argues that his client “did not cause that woman’s death. She died of an overwhelming lung infection...acute respiratory distress syndrome, caused by an overwhelming pneumonia that got worse after she was transferred to a facility where [my client] doesn’t practice.”

The bulk of the award will be in compensation for family members’ future pain and suffering and for other noneconomic damages.
 

Botched outpatient procedure leaves woman disfigured

In early September, a patient was allegedly administered the wrong drug during an outpatient procedure on her hand. She sued the Austin, Tex., hospital and surgical center where that procedure was performed, according to a story in Law/Street.

On January 9, 2020, Jessica Arguello went to HCA Healthcare’s South Austin Surgery Center to undergo a right-hand first metacarpophalangeal arthrodesis (fusion) and neuroma excision. In her suit against the hospital, Ms. Arguello claims that while her surgeon was preparing to close the incision after having irrigated the site, he called for a syringe containing an anesthetic. He was instead handed a syringe that contained formalin, the chemical used to preserve specimens for later review.

The mistake, Ms. Arguello claims, caused her to suffer massive chemical burns and necrosis of her flesh, which required four additional surgeries. In the end, she says, her right hand is disfigured and has limited mobility.

She adds that her injuries were preventable. Standard surgical procedure typically forbids chemicals such as formalin to be included among items on the prep tray. In addition to other compensation, she seeks damages for past and future medical expenses and past and future pain and suffering.

At press time, the defendants had not responded to Ms. Arguello’s complaint.

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

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New Jersey officials have suspended the license of a physician whose aesthetic medicine practice allegedly poses a “clear and imminent danger” to the public, as reported in NJ.com.

The physician, Muhammad A. Mirza, MD, is a board-certified internal medicine doctor and owner of Mirza Aesthetics, which has its main New Jersey office in Cedar Grove, a township in Essex County. The practice also leases space in New York, Pennsylvania, and Connecticut, where at press time Dr. Mirza was still licensed to practice medicine.

The acting New Jersey attorney general said that Dr. Mirza had deviated from the accepted standards of medical care in at least four key areas: he practiced in ways that put his patients in bodily danger; he lacked the formal training in and an adequate knowledge of aesthetic medicine; he practiced in office settings that inspectors found to be subpar; and he failed to safely store medical supplies or maintain proper medical records.

In one instance singled out by the attorney general’s office, Dr. Mirza used an injectable dermal filler to enhance a patient’s penis. As a result of that nonsurgical procedure, the patient needed to be rushed to a nearby hospital, where he underwent two emergency surgical interventions. Contacted by the emergency department doctor, Dr. Mirza allegedly failed to disclose the name of the filler he used, thereby complicating the patient’s recovery, according to the board complaint.

Dr. Mirza’s other alleged breaches of professional conduct include the following:

  • Failure to wear a mask or surgical gloves during procedures
  • Failure to keep electronic medical records of any kind
  • Improper, off-label use of an injectable dermal filler in proximity to patients’ eyes
  • Improper, off-label use of an injectable dermal filler for breast enhancement
  • Use of a certain injectable dermal filler without first testing for skin allergies

In addition, site inspections of Dr. Mirza’s offices turned up substandard conditions. On April 23, 2021, in response to numerous patient complaints, the Enforcement Bureau of the Division of Consumer Affairs inspected Dr. Mirza’s Summit, N.J. office, one of several in the state.

Among other things, the inspection uncovered the following:

  • The medical office was one large room. A curtain separated the reception area and the examination/treatment area, which consisted of only chairs and a fold-away table.
  • “Duffle bags” were used to store injectable fillers. No medical storage refrigerators were observed.
  • COVID-19 protocols were not followed. Inspectors could identify no barrier between receptionist and patients, no posted mask mandate, no social distancing policy, and no COVID-19 screening measures.

In addition to temporarily suspending Dr. Mirza’s license, the medical board has prohibited him from treating New Jersey patients in any of the out-of-state locations where he’s licensed to practice medicine.

Prosecutors have urged other patients who believe they’ve been injured by Mirza Aesthetics to file a complaint with the State Division of Consumer Affairs.

Dr. Mirza has agreed to the temporary suspension of his medical license, pending a hearing before an administrative law judge. In addition to facing civil penalties for each of the counts against him, he could be held responsible for paying investigative costs, attorney fees, trial costs, and other costs.
 

 

 

Doctor’s failure to diagnose results in mega award

In what is believed to be a record verdict in a wrongful death suit in Volusia County, Fla., a jury awarded $6.46 million to the family of a woman who died from an undiagnosed heart infection after being transferred from a local hospital, according to a report in The Daytona Beach News-Journal, among other news outlets.

In March 2016, Laura Staib went to what was then Florida Hospital DeLand — now AdventHealth DeLand — complaining of a variety of symptoms. There, she was examined by a doctor who was a member of a nearby cardiology group. His diagnosis: congestive heart failure, pneumonia, and sepsis. Transferred to a long-term care facility, Ms. Staib died 4 days later.

In their complaint against the cardiologist and his cardiology group, family members alleged that the doctor failed to identify Ms. Staib’s main problem: viral myocarditis.

“This was primarily a heart failure problem and a heart infection that was probably causing some problems in the lungs,” said the attorney representing the family. “A virus was attacking her heart, and they missed it,” he said. Claims against the hospital and other doctors were eventually resolved and dismissed.

The jury’s verdict will be appealed, said the attorney representing the cardiologist.

He argues that his client “did not cause that woman’s death. She died of an overwhelming lung infection...acute respiratory distress syndrome, caused by an overwhelming pneumonia that got worse after she was transferred to a facility where [my client] doesn’t practice.”

The bulk of the award will be in compensation for family members’ future pain and suffering and for other noneconomic damages.
 

Botched outpatient procedure leaves woman disfigured

In early September, a patient was allegedly administered the wrong drug during an outpatient procedure on her hand. She sued the Austin, Tex., hospital and surgical center where that procedure was performed, according to a story in Law/Street.

On January 9, 2020, Jessica Arguello went to HCA Healthcare’s South Austin Surgery Center to undergo a right-hand first metacarpophalangeal arthrodesis (fusion) and neuroma excision. In her suit against the hospital, Ms. Arguello claims that while her surgeon was preparing to close the incision after having irrigated the site, he called for a syringe containing an anesthetic. He was instead handed a syringe that contained formalin, the chemical used to preserve specimens for later review.

The mistake, Ms. Arguello claims, caused her to suffer massive chemical burns and necrosis of her flesh, which required four additional surgeries. In the end, she says, her right hand is disfigured and has limited mobility.

She adds that her injuries were preventable. Standard surgical procedure typically forbids chemicals such as formalin to be included among items on the prep tray. In addition to other compensation, she seeks damages for past and future medical expenses and past and future pain and suffering.

At press time, the defendants had not responded to Ms. Arguello’s complaint.

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

New Jersey officials have suspended the license of a physician whose aesthetic medicine practice allegedly poses a “clear and imminent danger” to the public, as reported in NJ.com.

The physician, Muhammad A. Mirza, MD, is a board-certified internal medicine doctor and owner of Mirza Aesthetics, which has its main New Jersey office in Cedar Grove, a township in Essex County. The practice also leases space in New York, Pennsylvania, and Connecticut, where at press time Dr. Mirza was still licensed to practice medicine.

The acting New Jersey attorney general said that Dr. Mirza had deviated from the accepted standards of medical care in at least four key areas: he practiced in ways that put his patients in bodily danger; he lacked the formal training in and an adequate knowledge of aesthetic medicine; he practiced in office settings that inspectors found to be subpar; and he failed to safely store medical supplies or maintain proper medical records.

In one instance singled out by the attorney general’s office, Dr. Mirza used an injectable dermal filler to enhance a patient’s penis. As a result of that nonsurgical procedure, the patient needed to be rushed to a nearby hospital, where he underwent two emergency surgical interventions. Contacted by the emergency department doctor, Dr. Mirza allegedly failed to disclose the name of the filler he used, thereby complicating the patient’s recovery, according to the board complaint.

Dr. Mirza’s other alleged breaches of professional conduct include the following:

  • Failure to wear a mask or surgical gloves during procedures
  • Failure to keep electronic medical records of any kind
  • Improper, off-label use of an injectable dermal filler in proximity to patients’ eyes
  • Improper, off-label use of an injectable dermal filler for breast enhancement
  • Use of a certain injectable dermal filler without first testing for skin allergies

In addition, site inspections of Dr. Mirza’s offices turned up substandard conditions. On April 23, 2021, in response to numerous patient complaints, the Enforcement Bureau of the Division of Consumer Affairs inspected Dr. Mirza’s Summit, N.J. office, one of several in the state.

Among other things, the inspection uncovered the following:

  • The medical office was one large room. A curtain separated the reception area and the examination/treatment area, which consisted of only chairs and a fold-away table.
  • “Duffle bags” were used to store injectable fillers. No medical storage refrigerators were observed.
  • COVID-19 protocols were not followed. Inspectors could identify no barrier between receptionist and patients, no posted mask mandate, no social distancing policy, and no COVID-19 screening measures.

In addition to temporarily suspending Dr. Mirza’s license, the medical board has prohibited him from treating New Jersey patients in any of the out-of-state locations where he’s licensed to practice medicine.

Prosecutors have urged other patients who believe they’ve been injured by Mirza Aesthetics to file a complaint with the State Division of Consumer Affairs.

Dr. Mirza has agreed to the temporary suspension of his medical license, pending a hearing before an administrative law judge. In addition to facing civil penalties for each of the counts against him, he could be held responsible for paying investigative costs, attorney fees, trial costs, and other costs.
 

 

 

Doctor’s failure to diagnose results in mega award

In what is believed to be a record verdict in a wrongful death suit in Volusia County, Fla., a jury awarded $6.46 million to the family of a woman who died from an undiagnosed heart infection after being transferred from a local hospital, according to a report in The Daytona Beach News-Journal, among other news outlets.

In March 2016, Laura Staib went to what was then Florida Hospital DeLand — now AdventHealth DeLand — complaining of a variety of symptoms. There, she was examined by a doctor who was a member of a nearby cardiology group. His diagnosis: congestive heart failure, pneumonia, and sepsis. Transferred to a long-term care facility, Ms. Staib died 4 days later.

In their complaint against the cardiologist and his cardiology group, family members alleged that the doctor failed to identify Ms. Staib’s main problem: viral myocarditis.

“This was primarily a heart failure problem and a heart infection that was probably causing some problems in the lungs,” said the attorney representing the family. “A virus was attacking her heart, and they missed it,” he said. Claims against the hospital and other doctors were eventually resolved and dismissed.

The jury’s verdict will be appealed, said the attorney representing the cardiologist.

He argues that his client “did not cause that woman’s death. She died of an overwhelming lung infection...acute respiratory distress syndrome, caused by an overwhelming pneumonia that got worse after she was transferred to a facility where [my client] doesn’t practice.”

The bulk of the award will be in compensation for family members’ future pain and suffering and for other noneconomic damages.
 

Botched outpatient procedure leaves woman disfigured

In early September, a patient was allegedly administered the wrong drug during an outpatient procedure on her hand. She sued the Austin, Tex., hospital and surgical center where that procedure was performed, according to a story in Law/Street.

On January 9, 2020, Jessica Arguello went to HCA Healthcare’s South Austin Surgery Center to undergo a right-hand first metacarpophalangeal arthrodesis (fusion) and neuroma excision. In her suit against the hospital, Ms. Arguello claims that while her surgeon was preparing to close the incision after having irrigated the site, he called for a syringe containing an anesthetic. He was instead handed a syringe that contained formalin, the chemical used to preserve specimens for later review.

The mistake, Ms. Arguello claims, caused her to suffer massive chemical burns and necrosis of her flesh, which required four additional surgeries. In the end, she says, her right hand is disfigured and has limited mobility.

She adds that her injuries were preventable. Standard surgical procedure typically forbids chemicals such as formalin to be included among items on the prep tray. In addition to other compensation, she seeks damages for past and future medical expenses and past and future pain and suffering.

At press time, the defendants had not responded to Ms. Arguello’s complaint.

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

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Immunocompromised people face highest risk of cutaneous SCC metastasis

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Head and neck cutaneous squamous cell carcinoma (SCC) has an excellent prognosis but around 5% of patients develop nodal metastasis. In cutaneous SCC, metastasis is associated with a 50% decrease in 5-year survival. However, no study has thoroughly evaluated the prognostic factors associated with metastasis until now.

In the Journal of Otolaryngology – Head & Neck Surgery, researchers wrote that immunocompromised individuals, such as solid organ transplant patients, make up 73.3% of all patients with cutaneous SCC who are at risk of metastasis and decreased overall survival.

Led by Alex M. Mlynarek, MD, a specialist in head and neck oncology and microvascular reconstruction at McGill University, Montreal, the finding is based on a systematic literature review of 40 studies involving 8,535 patients.

“The prognostic factors for head and neck cutaneous squamous cell carcinoma that were most consistently reported as significant in the literature are a state of immunosuppression, tumor depth, margins involved, number of lymph nodes affected by carcinoma, parotideal disease, and age,” Dr. Mlynarek and colleagues wrote.

Cutaneous SCC is the second most common nonmelanoma skin cancer with an increase of 263% between 2000 and 2010, shows research from the Mayo Clinic Rochester Epidemiology Project.

Patients in this study with tumors that are 6 mm or greater, or whose tumor invaded fat tissue, were found to have a poor prognosis followed by patients with perineural and lymphovascular invasion and in particular, patients with a poorer grade of cellular differentiation. The number of lymph nodes was significant at 70%, with more than two nodes involved linked to a worse the prognosis, followed by 66.7% for margins involved with carcinoma and 50% for tumor depth.

“The majority of patients with cutaneous SCC undergoes electrodesiccation and curettage, cryosurgery, or Mohs surgery, and have an excellent prognosis,” the authors wrote. “However, there is a subset of patients in which these therapies are unsuccessful and where cutaneous SCC appears to be far more aggressive, often resulting in metastasis and recurrence.”

Age was shown to be a significant factor in 53.3% of the studies, but the extent of its effect on prognosis was questionable.

Sentinel lymph node biopsy is commonly used to stage melanoma and has been used in oral SCC.

“A patient post biopsy with either two major criteria or one major and two minor criteria should be considered as a candidate for sentinel lymph node biopsy,” the authors wrote, adding that the findings were consistent with those for cutaneous SCC generally, not specified to the head and neck.

Limitations of the systematic review include potential selection bias as the majority of the studies were based in Australia and most studies were not specified to cutaneous SCC of the head and neck region.

“Given the low rate of metastasis from head and neck cutaneous SCC lesions, it can be challenging to identify the patients who are at high risk of having metastatic disease,” the authors wrote. “We believe this review could help identify patients that would require a closer follow-up and those that could possibly profit from a sentinel lymph node biopsy.”

No disclosures were disclosed for the authors.

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Head and neck cutaneous squamous cell carcinoma (SCC) has an excellent prognosis but around 5% of patients develop nodal metastasis. In cutaneous SCC, metastasis is associated with a 50% decrease in 5-year survival. However, no study has thoroughly evaluated the prognostic factors associated with metastasis until now.

In the Journal of Otolaryngology – Head & Neck Surgery, researchers wrote that immunocompromised individuals, such as solid organ transplant patients, make up 73.3% of all patients with cutaneous SCC who are at risk of metastasis and decreased overall survival.

Led by Alex M. Mlynarek, MD, a specialist in head and neck oncology and microvascular reconstruction at McGill University, Montreal, the finding is based on a systematic literature review of 40 studies involving 8,535 patients.

“The prognostic factors for head and neck cutaneous squamous cell carcinoma that were most consistently reported as significant in the literature are a state of immunosuppression, tumor depth, margins involved, number of lymph nodes affected by carcinoma, parotideal disease, and age,” Dr. Mlynarek and colleagues wrote.

Cutaneous SCC is the second most common nonmelanoma skin cancer with an increase of 263% between 2000 and 2010, shows research from the Mayo Clinic Rochester Epidemiology Project.

Patients in this study with tumors that are 6 mm or greater, or whose tumor invaded fat tissue, were found to have a poor prognosis followed by patients with perineural and lymphovascular invasion and in particular, patients with a poorer grade of cellular differentiation. The number of lymph nodes was significant at 70%, with more than two nodes involved linked to a worse the prognosis, followed by 66.7% for margins involved with carcinoma and 50% for tumor depth.

“The majority of patients with cutaneous SCC undergoes electrodesiccation and curettage, cryosurgery, or Mohs surgery, and have an excellent prognosis,” the authors wrote. “However, there is a subset of patients in which these therapies are unsuccessful and where cutaneous SCC appears to be far more aggressive, often resulting in metastasis and recurrence.”

Age was shown to be a significant factor in 53.3% of the studies, but the extent of its effect on prognosis was questionable.

Sentinel lymph node biopsy is commonly used to stage melanoma and has been used in oral SCC.

“A patient post biopsy with either two major criteria or one major and two minor criteria should be considered as a candidate for sentinel lymph node biopsy,” the authors wrote, adding that the findings were consistent with those for cutaneous SCC generally, not specified to the head and neck.

Limitations of the systematic review include potential selection bias as the majority of the studies were based in Australia and most studies were not specified to cutaneous SCC of the head and neck region.

“Given the low rate of metastasis from head and neck cutaneous SCC lesions, it can be challenging to identify the patients who are at high risk of having metastatic disease,” the authors wrote. “We believe this review could help identify patients that would require a closer follow-up and those that could possibly profit from a sentinel lymph node biopsy.”

No disclosures were disclosed for the authors.

Head and neck cutaneous squamous cell carcinoma (SCC) has an excellent prognosis but around 5% of patients develop nodal metastasis. In cutaneous SCC, metastasis is associated with a 50% decrease in 5-year survival. However, no study has thoroughly evaluated the prognostic factors associated with metastasis until now.

In the Journal of Otolaryngology – Head & Neck Surgery, researchers wrote that immunocompromised individuals, such as solid organ transplant patients, make up 73.3% of all patients with cutaneous SCC who are at risk of metastasis and decreased overall survival.

Led by Alex M. Mlynarek, MD, a specialist in head and neck oncology and microvascular reconstruction at McGill University, Montreal, the finding is based on a systematic literature review of 40 studies involving 8,535 patients.

“The prognostic factors for head and neck cutaneous squamous cell carcinoma that were most consistently reported as significant in the literature are a state of immunosuppression, tumor depth, margins involved, number of lymph nodes affected by carcinoma, parotideal disease, and age,” Dr. Mlynarek and colleagues wrote.

Cutaneous SCC is the second most common nonmelanoma skin cancer with an increase of 263% between 2000 and 2010, shows research from the Mayo Clinic Rochester Epidemiology Project.

Patients in this study with tumors that are 6 mm or greater, or whose tumor invaded fat tissue, were found to have a poor prognosis followed by patients with perineural and lymphovascular invasion and in particular, patients with a poorer grade of cellular differentiation. The number of lymph nodes was significant at 70%, with more than two nodes involved linked to a worse the prognosis, followed by 66.7% for margins involved with carcinoma and 50% for tumor depth.

“The majority of patients with cutaneous SCC undergoes electrodesiccation and curettage, cryosurgery, or Mohs surgery, and have an excellent prognosis,” the authors wrote. “However, there is a subset of patients in which these therapies are unsuccessful and where cutaneous SCC appears to be far more aggressive, often resulting in metastasis and recurrence.”

Age was shown to be a significant factor in 53.3% of the studies, but the extent of its effect on prognosis was questionable.

Sentinel lymph node biopsy is commonly used to stage melanoma and has been used in oral SCC.

“A patient post biopsy with either two major criteria or one major and two minor criteria should be considered as a candidate for sentinel lymph node biopsy,” the authors wrote, adding that the findings were consistent with those for cutaneous SCC generally, not specified to the head and neck.

Limitations of the systematic review include potential selection bias as the majority of the studies were based in Australia and most studies were not specified to cutaneous SCC of the head and neck region.

“Given the low rate of metastasis from head and neck cutaneous SCC lesions, it can be challenging to identify the patients who are at high risk of having metastatic disease,” the authors wrote. “We believe this review could help identify patients that would require a closer follow-up and those that could possibly profit from a sentinel lymph node biopsy.”

No disclosures were disclosed for the authors.

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FROM THE JOURNAL OF OTOLARYNGOLOGY – HEAD AND NECK SURGERY

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The devil in the (masking) details

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The Devil’s own face covering?

It’s been over a year and a half since the COVID-19 emergency was declared in the United States, and we’ve been starting to wonder what our good friend SARS-CoV-2 has left to give. The collective cynic/optimist in us figures that the insanity can’t last forever, right?

Tatyana Kolchugina/Getty

Maybe not forever, but …

A group of parents is suing the Central Bucks (Pa.) School District over school mask mandates, suggesting that the district has no legal authority to enforce such measures. Most of their arguments, Philadelphia Magazine says, are pretty standard stuff: Masks are causing depression, anxiety, and discomfort in their children; masks are a violation of their constitutional rights; and “masks are being used as a control mechanism over the population.”

There are some unusual claims, though. One of the parents, Shannon Harris, said that “wearing masks interferes with their religious duty to spread the word of God and forces them to participate in a satanic ritual,” according to the Philadelphia Inquirer.

Philadelphia Magazine decided to check on that “satanic ritual” claim by asking an expert, in this case a spokesperson for the Church of Satan. The Reverend Raul Antony said that “simply ‘wearing a mask’ is not a Satanic ritual, and anyone that genuinely thinks otherwise is a blithering idiot,” adding that the group’s rituals were available on its website.

COVID, you never let us down.
 

You’re the (hurricane) wind beneath my wings

Marriage isn’t easy. From finances to everyday stressors like work and children, maintaining a solid relationship is tough. Then a natural disaster shows up on top of everything else, and marriages actually improve, researchers found.

pxfuel

In a study published by Psychological Science, researchers surveyed 231 newlywed couples about the satisfaction of their marriage before and after Hurricane Harvey in 2017. They found after the hurricane couples had a “significant boost” in the satisfaction of their relationship.

One would think something like this would create what researchers call a “stress spillover,” creating a decrease in relationship satisfaction. Destruction to your home or even displacement after a natural disaster seems pretty stressful. But, “a natural disaster can really put things in perspective. People realize how important their partner is to them when they are jolted out of the day-to-day stress of life,” said Hannah Williamson, PhD, the lead author of the study.

And although everyone saw an increase, the biggest jumps in relationship satisfaction belonged to the people who were most unhappy before the hurricane. Unfortunately, the researchers also found that the effects were only temporary and the dissatisfaction came back within a year.

Dr. Williamson thinks there may be something to these findings that can be beneficial from a therapy standpoint where “couples can shift their perspective in a similar way without having to go through a natural disaster.”

Let’s hope she’s right, because the alternative is to seek out a rampaging hurricane every time your relationship is on the rocks, and that just seems impractical after the second or third year.
 

 

 

Not-so-essential oils

Many people use essential oils as a way to unwind and relax. Stressed? Can’t sleep? There’s probably an essential oil for that. However, it seems like these days a lot of things we love and/or think are good for us have a side that’s not so.

pxfuel

According to the Centers for Disease Control and Prevention, a woman from Georgia died from a rare bacteria called Burkholderia pseudomallei. There have been three previous infections in Kansas, Minnesota, and Texas throughout 2021; two of the four infections were in children. Melioidosis, the disease caused by B. pseudomallei, is usually found in southeast Asia and isn’t obvious or easy to diagnose, especially in places like decidedly untropical Minnesota.

The Georgia case was the real break in this medical mystery, as the infection was traced back to a Walmart product called “Better Homes and Gardens Essential Oil Infused Aromatherapy Room Spray with Gemstones” (a very pithy name). The bacteria were in the lavender and chamomile scent. The CDC is investigating all other product scents, and Walmart has recalled all lots of the product.

If you’ve got that particular essential oil, it’s probably for the best that you stop using it. Don’t worry, we’re sure there’s plenty of other essential oil–infused aromatherapy room sprays with gemstones out there for your scent-based needs.
 

Welcome to the Ministry of Sleep-Deprived Walks

Walking is simple, right? You put one foot in front of the other, and soon you’re walking out the door. Little kids can do it. Even zombies can walk, and they don’t even have brains.

riskms/Getty

Research from MIT and the University of São Paulo has shown that walking is a little trickier than we might think. One researcher in particular noticed that student volunteers tended to perform worse toward the end of semesters, as project deadlines and multiple exams crashed over their heads and they were deprived of solid sleep schedules.

In a study published in Scientific Reports, our intrepid walking researchers had a collection of students monitor their sleep patterns for 2 weeks; on average, the students got 6 hours per night, though some were able to compensate on weekends. On the final day of a 14-day period, some students pulled all-nighters while the rest were allowed to sleep as usual. Then all students performed a walking test involving keeping time with a metronome.

To absolutely no one’s surprise, the students who performed all-nighters before being tested walked the worst, but between the other students, the ones who compensated for sleep deprivation on weekends did better than those who got 6 hours every night, despite getting a similar amount of sleep overall. This effect persisted even when the compensating students performed their walking tests late in the week, just before they got their weekend beauty sleep.

The moral of the story? Sleep is good, and you should get more of it. But if you can’t, sleep in on weekends. Science has given you permission. All those suburban dads looking to get their teenagers up at 8 in the morning must be sweating right now.

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The Devil’s own face covering?

It’s been over a year and a half since the COVID-19 emergency was declared in the United States, and we’ve been starting to wonder what our good friend SARS-CoV-2 has left to give. The collective cynic/optimist in us figures that the insanity can’t last forever, right?

Tatyana Kolchugina/Getty

Maybe not forever, but …

A group of parents is suing the Central Bucks (Pa.) School District over school mask mandates, suggesting that the district has no legal authority to enforce such measures. Most of their arguments, Philadelphia Magazine says, are pretty standard stuff: Masks are causing depression, anxiety, and discomfort in their children; masks are a violation of their constitutional rights; and “masks are being used as a control mechanism over the population.”

There are some unusual claims, though. One of the parents, Shannon Harris, said that “wearing masks interferes with their religious duty to spread the word of God and forces them to participate in a satanic ritual,” according to the Philadelphia Inquirer.

Philadelphia Magazine decided to check on that “satanic ritual” claim by asking an expert, in this case a spokesperson for the Church of Satan. The Reverend Raul Antony said that “simply ‘wearing a mask’ is not a Satanic ritual, and anyone that genuinely thinks otherwise is a blithering idiot,” adding that the group’s rituals were available on its website.

COVID, you never let us down.
 

You’re the (hurricane) wind beneath my wings

Marriage isn’t easy. From finances to everyday stressors like work and children, maintaining a solid relationship is tough. Then a natural disaster shows up on top of everything else, and marriages actually improve, researchers found.

pxfuel

In a study published by Psychological Science, researchers surveyed 231 newlywed couples about the satisfaction of their marriage before and after Hurricane Harvey in 2017. They found after the hurricane couples had a “significant boost” in the satisfaction of their relationship.

One would think something like this would create what researchers call a “stress spillover,” creating a decrease in relationship satisfaction. Destruction to your home or even displacement after a natural disaster seems pretty stressful. But, “a natural disaster can really put things in perspective. People realize how important their partner is to them when they are jolted out of the day-to-day stress of life,” said Hannah Williamson, PhD, the lead author of the study.

And although everyone saw an increase, the biggest jumps in relationship satisfaction belonged to the people who were most unhappy before the hurricane. Unfortunately, the researchers also found that the effects were only temporary and the dissatisfaction came back within a year.

Dr. Williamson thinks there may be something to these findings that can be beneficial from a therapy standpoint where “couples can shift their perspective in a similar way without having to go through a natural disaster.”

Let’s hope she’s right, because the alternative is to seek out a rampaging hurricane every time your relationship is on the rocks, and that just seems impractical after the second or third year.
 

 

 

Not-so-essential oils

Many people use essential oils as a way to unwind and relax. Stressed? Can’t sleep? There’s probably an essential oil for that. However, it seems like these days a lot of things we love and/or think are good for us have a side that’s not so.

pxfuel

According to the Centers for Disease Control and Prevention, a woman from Georgia died from a rare bacteria called Burkholderia pseudomallei. There have been three previous infections in Kansas, Minnesota, and Texas throughout 2021; two of the four infections were in children. Melioidosis, the disease caused by B. pseudomallei, is usually found in southeast Asia and isn’t obvious or easy to diagnose, especially in places like decidedly untropical Minnesota.

The Georgia case was the real break in this medical mystery, as the infection was traced back to a Walmart product called “Better Homes and Gardens Essential Oil Infused Aromatherapy Room Spray with Gemstones” (a very pithy name). The bacteria were in the lavender and chamomile scent. The CDC is investigating all other product scents, and Walmart has recalled all lots of the product.

If you’ve got that particular essential oil, it’s probably for the best that you stop using it. Don’t worry, we’re sure there’s plenty of other essential oil–infused aromatherapy room sprays with gemstones out there for your scent-based needs.
 

Welcome to the Ministry of Sleep-Deprived Walks

Walking is simple, right? You put one foot in front of the other, and soon you’re walking out the door. Little kids can do it. Even zombies can walk, and they don’t even have brains.

riskms/Getty

Research from MIT and the University of São Paulo has shown that walking is a little trickier than we might think. One researcher in particular noticed that student volunteers tended to perform worse toward the end of semesters, as project deadlines and multiple exams crashed over their heads and they were deprived of solid sleep schedules.

In a study published in Scientific Reports, our intrepid walking researchers had a collection of students monitor their sleep patterns for 2 weeks; on average, the students got 6 hours per night, though some were able to compensate on weekends. On the final day of a 14-day period, some students pulled all-nighters while the rest were allowed to sleep as usual. Then all students performed a walking test involving keeping time with a metronome.

To absolutely no one’s surprise, the students who performed all-nighters before being tested walked the worst, but between the other students, the ones who compensated for sleep deprivation on weekends did better than those who got 6 hours every night, despite getting a similar amount of sleep overall. This effect persisted even when the compensating students performed their walking tests late in the week, just before they got their weekend beauty sleep.

The moral of the story? Sleep is good, and you should get more of it. But if you can’t, sleep in on weekends. Science has given you permission. All those suburban dads looking to get their teenagers up at 8 in the morning must be sweating right now.

 

The Devil’s own face covering?

It’s been over a year and a half since the COVID-19 emergency was declared in the United States, and we’ve been starting to wonder what our good friend SARS-CoV-2 has left to give. The collective cynic/optimist in us figures that the insanity can’t last forever, right?

Tatyana Kolchugina/Getty

Maybe not forever, but …

A group of parents is suing the Central Bucks (Pa.) School District over school mask mandates, suggesting that the district has no legal authority to enforce such measures. Most of their arguments, Philadelphia Magazine says, are pretty standard stuff: Masks are causing depression, anxiety, and discomfort in their children; masks are a violation of their constitutional rights; and “masks are being used as a control mechanism over the population.”

There are some unusual claims, though. One of the parents, Shannon Harris, said that “wearing masks interferes with their religious duty to spread the word of God and forces them to participate in a satanic ritual,” according to the Philadelphia Inquirer.

Philadelphia Magazine decided to check on that “satanic ritual” claim by asking an expert, in this case a spokesperson for the Church of Satan. The Reverend Raul Antony said that “simply ‘wearing a mask’ is not a Satanic ritual, and anyone that genuinely thinks otherwise is a blithering idiot,” adding that the group’s rituals were available on its website.

COVID, you never let us down.
 

You’re the (hurricane) wind beneath my wings

Marriage isn’t easy. From finances to everyday stressors like work and children, maintaining a solid relationship is tough. Then a natural disaster shows up on top of everything else, and marriages actually improve, researchers found.

pxfuel

In a study published by Psychological Science, researchers surveyed 231 newlywed couples about the satisfaction of their marriage before and after Hurricane Harvey in 2017. They found after the hurricane couples had a “significant boost” in the satisfaction of their relationship.

One would think something like this would create what researchers call a “stress spillover,” creating a decrease in relationship satisfaction. Destruction to your home or even displacement after a natural disaster seems pretty stressful. But, “a natural disaster can really put things in perspective. People realize how important their partner is to them when they are jolted out of the day-to-day stress of life,” said Hannah Williamson, PhD, the lead author of the study.

And although everyone saw an increase, the biggest jumps in relationship satisfaction belonged to the people who were most unhappy before the hurricane. Unfortunately, the researchers also found that the effects were only temporary and the dissatisfaction came back within a year.

Dr. Williamson thinks there may be something to these findings that can be beneficial from a therapy standpoint where “couples can shift their perspective in a similar way without having to go through a natural disaster.”

Let’s hope she’s right, because the alternative is to seek out a rampaging hurricane every time your relationship is on the rocks, and that just seems impractical after the second or third year.
 

 

 

Not-so-essential oils

Many people use essential oils as a way to unwind and relax. Stressed? Can’t sleep? There’s probably an essential oil for that. However, it seems like these days a lot of things we love and/or think are good for us have a side that’s not so.

pxfuel

According to the Centers for Disease Control and Prevention, a woman from Georgia died from a rare bacteria called Burkholderia pseudomallei. There have been three previous infections in Kansas, Minnesota, and Texas throughout 2021; two of the four infections were in children. Melioidosis, the disease caused by B. pseudomallei, is usually found in southeast Asia and isn’t obvious or easy to diagnose, especially in places like decidedly untropical Minnesota.

The Georgia case was the real break in this medical mystery, as the infection was traced back to a Walmart product called “Better Homes and Gardens Essential Oil Infused Aromatherapy Room Spray with Gemstones” (a very pithy name). The bacteria were in the lavender and chamomile scent. The CDC is investigating all other product scents, and Walmart has recalled all lots of the product.

If you’ve got that particular essential oil, it’s probably for the best that you stop using it. Don’t worry, we’re sure there’s plenty of other essential oil–infused aromatherapy room sprays with gemstones out there for your scent-based needs.
 

Welcome to the Ministry of Sleep-Deprived Walks

Walking is simple, right? You put one foot in front of the other, and soon you’re walking out the door. Little kids can do it. Even zombies can walk, and they don’t even have brains.

riskms/Getty

Research from MIT and the University of São Paulo has shown that walking is a little trickier than we might think. One researcher in particular noticed that student volunteers tended to perform worse toward the end of semesters, as project deadlines and multiple exams crashed over their heads and they were deprived of solid sleep schedules.

In a study published in Scientific Reports, our intrepid walking researchers had a collection of students monitor their sleep patterns for 2 weeks; on average, the students got 6 hours per night, though some were able to compensate on weekends. On the final day of a 14-day period, some students pulled all-nighters while the rest were allowed to sleep as usual. Then all students performed a walking test involving keeping time with a metronome.

To absolutely no one’s surprise, the students who performed all-nighters before being tested walked the worst, but between the other students, the ones who compensated for sleep deprivation on weekends did better than those who got 6 hours every night, despite getting a similar amount of sleep overall. This effect persisted even when the compensating students performed their walking tests late in the week, just before they got their weekend beauty sleep.

The moral of the story? Sleep is good, and you should get more of it. But if you can’t, sleep in on weekends. Science has given you permission. All those suburban dads looking to get their teenagers up at 8 in the morning must be sweating right now.

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