Have you ever had a really good idea about how to improve the delivery of mental health services? An idea that would help people, but that would require passion, innovation, and hard work to implement, and one that immediately is beset with a list of reasons why it can not be implemented?

Mona Masood, DO, had an idea. The Pennsylvania psychiatrist was asked to help moderate a Facebook group started by one of her infectious disease colleagues last winter – a private Facebook group for physicians working with COVID-19 patients.

“The group was getting posts from frontline workers about how depressed and hopeless they were feeling.” Dr. Masood said. “People were posting about how they were having escape fantasies and how they regretted becoming physicians. It became clear that there was a need for more support.”

She could pinpoint the day – March 22, 2020 – when she came up with the idea to start a peer-to-peer physician support hotline: psychiatrist volunteers would take calls from physicians who needed someone to talk to – the psychiatrist would provide a sympathetic ear and have a list of resources, but this would be support, not treatment. There would be no prescriptions, no treatment relationship, no reporting to licensing boards or employers. The calls would be anonymous.

She posted her idea on the Facebook group, and the response was immediate. “There were a lot of emails – 200 psychiatrists responded saying: “Sign me up.” A Zoom meeting was set up, and the process was set in motion.

Dr. Masood used a Google document for weekly sign-ups so the volunteer psychiatrists could choose times. “We had to pay for an upgraded Google suite package for that many users. Getting this up and running was like the saying about building a plane as you fly it,” Dr. Masood said. “It forced so much so quickly because there was this acknowledgment that the need was there.”

Initially, the support line launched with a telehealth platform, but there was a problem. “Many doctors don’t want to be seen; they worry about being recognized.” Dr. Masood researched hotline phone services and was able to get one for a reduced fee. The volunteers have an App on their smartphones that enables them to log in at the start of their shifts and log out at the end. In addition to the logistics of coordinating the volunteers – now numbering over 700 – the group found a health care law firm that provided pro bono services to review the policies and procedures.

Now that the support line is running, Dr. Masood is able to set up the day’s volunteers for the support line connection in a few minutes each morning, but the beginning was not easy. Her private practice transitioned to telemedicine, and her two children were home with one in virtual school. “At first, it was like another full-time job.” She still remains available for trouble-shooting during the day. It’s a project she has taken on with passion.

The support line began as a response to watching colleagues struggle with COVID. Since it launched, there have been approximately 2,000 calls. Calls typically last for 20 to 90 minutes, and no one has called with a suicidal crisis. It is now open to doctors and medical students looking for support for any reason. “Physicians call with all kinds of issues. In the first 3 months, it was COVID, but then they called with other concerns – there were doctors who called with election anxiety, really anything that affects the general public also affects us.”

The group has also offered Saturday didactic sessions for volunteers and weekly debriefing sessions. Dr. Masood has been approached by Vibrant Emotional Health, the administrator of the National Suicide Prevention Lifeline, about resources to help with funding – until now, this endeavor has had no financing – and she is hopeful that their financial support will allow the support line to sustain itself and grow. Future directions include advocating for systemic change in how physician mental health and wellness issues are addressed.

The Physician Support Line was one psychiatrist’s vision for how to address a problem. Like so many things related to this pandemic, it happened quickly and with surprising efficiency. Implementing this service, however, was not easy – it required hard work, innovative thinking, and passion. Those looking for someone to listen can call 1-888-409-0141 and psychiatrists who wish to volunteer can sign up at physiciansupportline.com/volunteer-info.

Dr. Miller is coauthor of “Committed: The Battle Over Involuntary Psychiatric Care” (Johns Hopkins University Press, 2018). She has a private practice and is assistant professor of psychiatry and behavioral sciences at Johns Hopkins University, both in Baltimore.

Have you ever had a really good idea about how to improve the delivery of mental health services? An idea that would help people, but that would require passion, innovation, and hard work to implement, and one that immediately is beset with a list of reasons why it can not be implemented?

Mona Masood, DO, had an idea. The Pennsylvania psychiatrist was asked to help moderate a Facebook group started by one of her infectious disease colleagues last winter – a private Facebook group for physicians working with COVID-19 patients.

“The group was getting posts from frontline workers about how depressed and hopeless they were feeling.” Dr. Masood said. “People were posting about how they were having escape fantasies and how they regretted becoming physicians. It became clear that there was a need for more support.”

She could pinpoint the day – March 22, 2020 – when she came up with the idea to start a peer-to-peer physician support hotline: psychiatrist volunteers would take calls from physicians who needed someone to talk to – the psychiatrist would provide a sympathetic ear and have a list of resources, but this would be support, not treatment. There would be no prescriptions, no treatment relationship, no reporting to licensing boards or employers. The calls would be anonymous.

She posted her idea on the Facebook group, and the response was immediate. “There were a lot of emails – 200 psychiatrists responded saying: “Sign me up.” A Zoom meeting was set up, and the process was set in motion.

Dr. Masood used a Google document for weekly sign-ups so the volunteer psychiatrists could choose times. “We had to pay for an upgraded Google suite package for that many users. Getting this up and running was like the saying about building a plane as you fly it,” Dr. Masood said. “It forced so much so quickly because there was this acknowledgment that the need was there.”

Initially, the support line launched with a telehealth platform, but there was a problem. “Many doctors don’t want to be seen; they worry about being recognized.” Dr. Masood researched hotline phone services and was able to get one for a reduced fee. The volunteers have an App on their smartphones that enables them to log in at the start of their shifts and log out at the end. In addition to the logistics of coordinating the volunteers – now numbering over 700 – the group found a health care law firm that provided pro bono services to review the policies and procedures.

Now that the support line is running, Dr. Masood is able to set up the day’s volunteers for the support line connection in a few minutes each morning, but the beginning was not easy. Her private practice transitioned to telemedicine, and her two children were home with one in virtual school. “At first, it was like another full-time job.” She still remains available for trouble-shooting during the day. It’s a project she has taken on with passion.

The support line began as a response to watching colleagues struggle with COVID. Since it launched, there have been approximately 2,000 calls. Calls typically last for 20 to 90 minutes, and no one has called with a suicidal crisis. It is now open to doctors and medical students looking for support for any reason. “Physicians call with all kinds of issues. In the first 3 months, it was COVID, but then they called with other concerns – there were doctors who called with election anxiety, really anything that affects the general public also affects us.”

The group has also offered Saturday didactic sessions for volunteers and weekly debriefing sessions. Dr. Masood has been approached by Vibrant Emotional Health, the administrator of the National Suicide Prevention Lifeline, about resources to help with funding – until now, this endeavor has had no financing – and she is hopeful that their financial support will allow the support line to sustain itself and grow. Future directions include advocating for systemic change in how physician mental health and wellness issues are addressed.

The Physician Support Line was one psychiatrist’s vision for how to address a problem. Like so many things related to this pandemic, it happened quickly and with surprising efficiency. Implementing this service, however, was not easy – it required hard work, innovative thinking, and passion. Those looking for someone to listen can call 1-888-409-0141 and psychiatrists who wish to volunteer can sign up at physiciansupportline.com/volunteer-info.

Dr. Miller is coauthor of “Committed: The Battle Over Involuntary Psychiatric Care” (Johns Hopkins University Press, 2018). She has a private practice and is assistant professor of psychiatry and behavioral sciences at Johns Hopkins University, both in Baltimore.

Have you ever had a really good idea about how to improve the delivery of mental health services? An idea that would help people, but that would require passion, innovation, and hard work to implement, and one that immediately is beset with a list of reasons why it can not be implemented?

Mona Masood, DO, had an idea. The Pennsylvania psychiatrist was asked to help moderate a Facebook group started by one of her infectious disease colleagues last winter – a private Facebook group for physicians working with COVID-19 patients.

“The group was getting posts from frontline workers about how depressed and hopeless they were feeling.” Dr. Masood said. “People were posting about how they were having escape fantasies and how they regretted becoming physicians. It became clear that there was a need for more support.”

She could pinpoint the day – March 22, 2020 – when she came up with the idea to start a peer-to-peer physician support hotline: psychiatrist volunteers would take calls from physicians who needed someone to talk to – the psychiatrist would provide a sympathetic ear and have a list of resources, but this would be support, not treatment. There would be no prescriptions, no treatment relationship, no reporting to licensing boards or employers. The calls would be anonymous.

She posted her idea on the Facebook group, and the response was immediate. “There were a lot of emails – 200 psychiatrists responded saying: “Sign me up.” A Zoom meeting was set up, and the process was set in motion.

Dr. Masood used a Google document for weekly sign-ups so the volunteer psychiatrists could choose times. “We had to pay for an upgraded Google suite package for that many users. Getting this up and running was like the saying about building a plane as you fly it,” Dr. Masood said. “It forced so much so quickly because there was this acknowledgment that the need was there.”

Initially, the support line launched with a telehealth platform, but there was a problem. “Many doctors don’t want to be seen; they worry about being recognized.” Dr. Masood researched hotline phone services and was able to get one for a reduced fee. The volunteers have an App on their smartphones that enables them to log in at the start of their shifts and log out at the end. In addition to the logistics of coordinating the volunteers – now numbering over 700 – the group found a health care law firm that provided pro bono services to review the policies and procedures.

Now that the support line is running, Dr. Masood is able to set up the day’s volunteers for the support line connection in a few minutes each morning, but the beginning was not easy. Her private practice transitioned to telemedicine, and her two children were home with one in virtual school. “At first, it was like another full-time job.” She still remains available for trouble-shooting during the day. It’s a project she has taken on with passion.

The support line began as a response to watching colleagues struggle with COVID. Since it launched, there have been approximately 2,000 calls. Calls typically last for 20 to 90 minutes, and no one has called with a suicidal crisis. It is now open to doctors and medical students looking for support for any reason. “Physicians call with all kinds of issues. In the first 3 months, it was COVID, but then they called with other concerns – there were doctors who called with election anxiety, really anything that affects the general public also affects us.”

The group has also offered Saturday didactic sessions for volunteers and weekly debriefing sessions. Dr. Masood has been approached by Vibrant Emotional Health, the administrator of the National Suicide Prevention Lifeline, about resources to help with funding – until now, this endeavor has had no financing – and she is hopeful that their financial support will allow the support line to sustain itself and grow. Future directions include advocating for systemic change in how physician mental health and wellness issues are addressed.

The Physician Support Line was one psychiatrist’s vision for how to address a problem. Like so many things related to this pandemic, it happened quickly and with surprising efficiency. Implementing this service, however, was not easy – it required hard work, innovative thinking, and passion. Those looking for someone to listen can call 1-888-409-0141 and psychiatrists who wish to volunteer can sign up at physiciansupportline.com/volunteer-info.

Dr. Miller is coauthor of “Committed: The Battle Over Involuntary Psychiatric Care” (Johns Hopkins University Press, 2018). She has a private practice and is assistant professor of psychiatry and behavioral sciences at Johns Hopkins University, both in Baltimore.

The Journal of Family Practice rightfully places a high priority on evidence-based practice by including “strength of evidence” qualifiers to help physicians analyze scientific studies and emphasizing campaigns that encourage good stewardship of medical resources. The editorial “When patients don’t get the care they should” (J Fam Pract. 2020;69:427) struck on an often-neglected aspect of evidence-based practice: the increase in care provided by nonphysician practitioners.

Henry Silver, MD, created the first pediatric nurse practitioner (NP) training program at the University of Colorado in 1965. That same year, Eugene Stead, MD, created the first physician assistant (PA) program at Duke University. The goal of both professions was simple: to create physician extenders to reach medically needy patients in underserved areas. But over the past 20 years, NPs and PAs have increasingly sought—and legislatively gained—independent practice, the right to treat patients without physician supervision.

Studies show that nonphysician practitioners order more labs and radiographic tests and prescribe more medications— including antibiotics—than physicians.

Here’s where evidence-based practice comes in. Despite claims by NP advocates that “50 years of evidence” shows safe and effective practice, the truth is that there is no scientific evidence that nonphysicians can practice safely and effectively without physician supervision. The best meta-analysis of nurse practitioner care, a Cochrane review, found only 18 studies of adequate quality to analyze.¹ Of these, only 3 were performed in the United States, and every single study in the Cochrane review involved nurses working under physician supervision or following physician-­created protocols. Yes, even supposedly independent NPs in Mary Mundinger’s famous 2000 study were practicing under a collaborating physician, as required by New York statute at the time. In addition, NPs in the study were assigned a physician mentor and received an additional 9 months of training with medical residents.

Regarding the emphasis for physicians to “choose wisely,” research raises concerns about an overuse of health care resources by nonphysician practitioners.Studies show that nonphysician practitioners order more labs² and radiographic tests³ than physicians; prescribe more medications, including opioids,⁴ antipsychotics,⁴ and antibiotics⁵ than physicians; place lower-quality referrals than physicians⁶; and perform significantly more biopsies than physicians to diagnose malignant neoplasms in patients < 65 years.⁷ 

As the rate of nonphysician practitioners increases (significantly outpacing the growth of physicians), we must be cognizant of the rising risks to our patients in the absence of appropriate physician oversight.⁸ This issue is so concerning to me that I co-authored a book on the subject.⁸ I encourage all physicians to educate themselves on this topic and make practice decisions with the evidence in mind.

The Journal of Family Practice rightfully places a high priority on evidence-based practice by including “strength of evidence” qualifiers to help physicians analyze scientific studies and emphasizing campaigns that encourage good stewardship of medical resources. The editorial “When patients don’t get the care they should” (J Fam Pract. 2020;69:427) struck on an often-neglected aspect of evidence-based practice: the increase in care provided by nonphysician practitioners.

Henry Silver, MD, created the first pediatric nurse practitioner (NP) training program at the University of Colorado in 1965. That same year, Eugene Stead, MD, created the first physician assistant (PA) program at Duke University. The goal of both professions was simple: to create physician extenders to reach medically needy patients in underserved areas. But over the past 20 years, NPs and PAs have increasingly sought—and legislatively gained—independent practice, the right to treat patients without physician supervision.

Studies show that nonphysician practitioners order more labs and radiographic tests and prescribe more medications— including antibiotics—than physicians.

Here’s where evidence-based practice comes in. Despite claims by NP advocates that “50 years of evidence” shows safe and effective practice, the truth is that there is no scientific evidence that nonphysicians can practice safely and effectively without physician supervision. The best meta-analysis of nurse practitioner care, a Cochrane review, found only 18 studies of adequate quality to analyze.¹ Of these, only 3 were performed in the United States, and every single study in the Cochrane review involved nurses working under physician supervision or following physician-­created protocols. Yes, even supposedly independent NPs in Mary Mundinger’s famous 2000 study were practicing under a collaborating physician, as required by New York statute at the time. In addition, NPs in the study were assigned a physician mentor and received an additional 9 months of training with medical residents.

Regarding the emphasis for physicians to “choose wisely,” research raises concerns about an overuse of health care resources by nonphysician practitioners.Studies show that nonphysician practitioners order more labs² and radiographic tests³ than physicians; prescribe more medications, including opioids,⁴ antipsychotics,⁴ and antibiotics⁵ than physicians; place lower-quality referrals than physicians⁶; and perform significantly more biopsies than physicians to diagnose malignant neoplasms in patients < 65 years.⁷ 

As the rate of nonphysician practitioners increases (significantly outpacing the growth of physicians), we must be cognizant of the rising risks to our patients in the absence of appropriate physician oversight.⁸ This issue is so concerning to me that I co-authored a book on the subject.⁸ I encourage all physicians to educate themselves on this topic and make practice decisions with the evidence in mind.

The Journal of Family Practice rightfully places a high priority on evidence-based practice by including “strength of evidence” qualifiers to help physicians analyze scientific studies and emphasizing campaigns that encourage good stewardship of medical resources. The editorial “When patients don’t get the care they should” (J Fam Pract. 2020;69:427) struck on an often-neglected aspect of evidence-based practice: the increase in care provided by nonphysician practitioners.

Henry Silver, MD, created the first pediatric nurse practitioner (NP) training program at the University of Colorado in 1965. That same year, Eugene Stead, MD, created the first physician assistant (PA) program at Duke University. The goal of both professions was simple: to create physician extenders to reach medically needy patients in underserved areas. But over the past 20 years, NPs and PAs have increasingly sought—and legislatively gained—independent practice, the right to treat patients without physician supervision.

Studies show that nonphysician practitioners order more labs and radiographic tests and prescribe more medications— including antibiotics—than physicians.

Here’s where evidence-based practice comes in. Despite claims by NP advocates that “50 years of evidence” shows safe and effective practice, the truth is that there is no scientific evidence that nonphysicians can practice safely and effectively without physician supervision. The best meta-analysis of nurse practitioner care, a Cochrane review, found only 18 studies of adequate quality to analyze.¹ Of these, only 3 were performed in the United States, and every single study in the Cochrane review involved nurses working under physician supervision or following physician-­created protocols. Yes, even supposedly independent NPs in Mary Mundinger’s famous 2000 study were practicing under a collaborating physician, as required by New York statute at the time. In addition, NPs in the study were assigned a physician mentor and received an additional 9 months of training with medical residents.

Regarding the emphasis for physicians to “choose wisely,” research raises concerns about an overuse of health care resources by nonphysician practitioners.Studies show that nonphysician practitioners order more labs² and radiographic tests³ than physicians; prescribe more medications, including opioids,⁴ antipsychotics,⁴ and antibiotics⁵ than physicians; place lower-quality referrals than physicians⁶; and perform significantly more biopsies than physicians to diagnose malignant neoplasms in patients < 65 years.⁷ 

As the rate of nonphysician practitioners increases (significantly outpacing the growth of physicians), we must be cognizant of the rising risks to our patients in the absence of appropriate physician oversight.⁸ This issue is so concerning to me that I co-authored a book on the subject.⁸ I encourage all physicians to educate themselves on this topic and make practice decisions with the evidence in mind.

A new technique in which near-infrared hyperspectral imaging (NIR-HSI) is combined with machine learning could be useful for detecting cancers deep within tissue, suggests a research team from Japan.

An example of such a cancer is gastrointestinal stromal tumor (GIST). These tumors are often located in the submucosal layer and are covered by mucosal tissue, making diagnosis by conventional endoscopy difficult.

In a study to assess the new technique, the researchers examined 12 GIST lesions that were surgically resected. Seven of these lesions were totally covered by a mucosal layer (thickness, 0.4-2.5 mm); three lesions were partially covered.

Using NIR-HSI with machine learning, the researchers found that GIST lesions appeared green and that normal tissue appeared yellow. Calculation of classified pixels showed that the technique detected the GISTs with a specificity of 73%, a sensitivity of 91.3%, and an accuracy of 86.1%.

The findings were published in Nature’s Scientific Reports.

“There are many situations where we need to be able to detect cancers deep in the tissue that are not visible during surgery or diagnosis,” said lead author Toshihiro Takamatsu, PhD, assistant professor, Tokyo University of Science. “Near-infrared hyperspectral imaging has a strong potential to detect deep lesions,” he said.

In this study, the imaging was performed ex vivo.

“The data presented in the paper were not obtained endoscopically but utilized surgical specimens to demonstrate proof of concept. Additional data would be required to demonstrate its feasibility with endoscopy,” noted Margaret von Mehren, MD, chief, division of sarcoma medical oncology, Fox Chase Cancer Center, Philadelphia, who was approached for comment.

Dr. Takamatsu said his team is currently developing prototypes of laparoscopes and endoscopes for NIR-HSI.

“This technology is being developed to be added onto endoscopy, and as such I think may well be feasible,” Dr. von Mehren commented.
 

Currently diagnosed by endoscopy and biopsy

GISTs are found predominantly in the stomach (60%) and the small intestine (30%). Although some are detected after the occurrence of symptoms such as pain, gastrointestinal bleeding, and bowel obstruction, most cases are asymptomatic.

The authors note that endoscopic examination is the primary tool for detecting GISTs. Lesions usually first appear as submucosal tumors. Direct observation cannot differentially diagnose these tumors, and biopsies may have a low diagnostic yield, because the lesions are often deep and not easily accessible.

Endoscopic ultrasound-guided fine-needle aspiration can be used for taking samples for biopsy, but it can be technically demanding, and making a definitive diagnosis of GIST requires time-consuming immunohistochemical procedures, the authors write. A high-throughput, simple diagnostic technique for identifying GISTs located under the mucosa is needed. They report on the potential of NIR-HSI for diagnosing submucosal tumors that present deep within organs.
 

Study details

For the study, the team worked on GIST lesions that had been surgically resected from 12 patients. The median size of the tumors was 41 mm (range, 24-80 mm).

The researchers imaged each specimen with an NIR hyperspectral camera from the aspect of the mucosal surface.

The site of the GIST was defined by a pathologist who used the NIR image to prepare training data for normal regions and regions with GISTs. A machine learning algorithm–support vector machine was then used to predict normal and GIST regions.

The results were displayed using color-coded regions. The team says the results from this small study show that the technique has “great potential” in the diagnosis of GISTs as well as other tumors that are located deep within tissue.

“I think the potential benefit of such a diagnostic tool is with small lesions when trying to differentiate benign findings, such as leiomyomas,” Dr. von Mehren commented.

She pointed out that this study comes from Japan, where endoscopy is routinely used for surveillance of gastric cancer. Thus, many cases of GIST may be diagnosed before symptoms occur and when lesions are small. Such a practice is less common in other parts of the world, she told this news organization.

Overall, she sees this technique as having the most utility in cases involving small lesions, inasmuch as larger lesions are easily assessed through biopsy with endoscopic ultrasound, and pathologic assessment is not a lengthy procedure. “In addition, as we now appreciate that GISTs with different molecular drivers require different therapeutic approaches, I continue to see a role for tissue biopsies in the diagnostic workup of GISTs,” she said.

“Current approaches using endoscopic ultrasound have defined criteria for lesions more likely to be GISTs rather than benign lesions,” she added. “I would want to see a comparison of near-infrared hyperspectral imaging data compared to endoscopic ultrasound to see if this provides additional benefit to our current approaches.”

The study was partially funded by the National Cancer Center Research and Development Fund. The authors and Dr. von Mehren have disclosed no relevant financial relationships.

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

A new technique in which near-infrared hyperspectral imaging (NIR-HSI) is combined with machine learning could be useful for detecting cancers deep within tissue, suggests a research team from Japan.

An example of such a cancer is gastrointestinal stromal tumor (GIST). These tumors are often located in the submucosal layer and are covered by mucosal tissue, making diagnosis by conventional endoscopy difficult.

In a study to assess the new technique, the researchers examined 12 GIST lesions that were surgically resected. Seven of these lesions were totally covered by a mucosal layer (thickness, 0.4-2.5 mm); three lesions were partially covered.

Using NIR-HSI with machine learning, the researchers found that GIST lesions appeared green and that normal tissue appeared yellow. Calculation of classified pixels showed that the technique detected the GISTs with a specificity of 73%, a sensitivity of 91.3%, and an accuracy of 86.1%.

The findings were published in Nature’s Scientific Reports.

“There are many situations where we need to be able to detect cancers deep in the tissue that are not visible during surgery or diagnosis,” said lead author Toshihiro Takamatsu, PhD, assistant professor, Tokyo University of Science. “Near-infrared hyperspectral imaging has a strong potential to detect deep lesions,” he said.

In this study, the imaging was performed ex vivo.

“The data presented in the paper were not obtained endoscopically but utilized surgical specimens to demonstrate proof of concept. Additional data would be required to demonstrate its feasibility with endoscopy,” noted Margaret von Mehren, MD, chief, division of sarcoma medical oncology, Fox Chase Cancer Center, Philadelphia, who was approached for comment.

Dr. Takamatsu said his team is currently developing prototypes of laparoscopes and endoscopes for NIR-HSI.

“This technology is being developed to be added onto endoscopy, and as such I think may well be feasible,” Dr. von Mehren commented.
 

Currently diagnosed by endoscopy and biopsy

GISTs are found predominantly in the stomach (60%) and the small intestine (30%). Although some are detected after the occurrence of symptoms such as pain, gastrointestinal bleeding, and bowel obstruction, most cases are asymptomatic.

The authors note that endoscopic examination is the primary tool for detecting GISTs. Lesions usually first appear as submucosal tumors. Direct observation cannot differentially diagnose these tumors, and biopsies may have a low diagnostic yield, because the lesions are often deep and not easily accessible.

Endoscopic ultrasound-guided fine-needle aspiration can be used for taking samples for biopsy, but it can be technically demanding, and making a definitive diagnosis of GIST requires time-consuming immunohistochemical procedures, the authors write. A high-throughput, simple diagnostic technique for identifying GISTs located under the mucosa is needed. They report on the potential of NIR-HSI for diagnosing submucosal tumors that present deep within organs.
 

Study details

For the study, the team worked on GIST lesions that had been surgically resected from 12 patients. The median size of the tumors was 41 mm (range, 24-80 mm).

The researchers imaged each specimen with an NIR hyperspectral camera from the aspect of the mucosal surface.

The site of the GIST was defined by a pathologist who used the NIR image to prepare training data for normal regions and regions with GISTs. A machine learning algorithm–support vector machine was then used to predict normal and GIST regions.

The results were displayed using color-coded regions. The team says the results from this small study show that the technique has “great potential” in the diagnosis of GISTs as well as other tumors that are located deep within tissue.

“I think the potential benefit of such a diagnostic tool is with small lesions when trying to differentiate benign findings, such as leiomyomas,” Dr. von Mehren commented.

She pointed out that this study comes from Japan, where endoscopy is routinely used for surveillance of gastric cancer. Thus, many cases of GIST may be diagnosed before symptoms occur and when lesions are small. Such a practice is less common in other parts of the world, she told this news organization.

Overall, she sees this technique as having the most utility in cases involving small lesions, inasmuch as larger lesions are easily assessed through biopsy with endoscopic ultrasound, and pathologic assessment is not a lengthy procedure. “In addition, as we now appreciate that GISTs with different molecular drivers require different therapeutic approaches, I continue to see a role for tissue biopsies in the diagnostic workup of GISTs,” she said.

“Current approaches using endoscopic ultrasound have defined criteria for lesions more likely to be GISTs rather than benign lesions,” she added. “I would want to see a comparison of near-infrared hyperspectral imaging data compared to endoscopic ultrasound to see if this provides additional benefit to our current approaches.”

The study was partially funded by the National Cancer Center Research and Development Fund. The authors and Dr. von Mehren have disclosed no relevant financial relationships.

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

A new technique in which near-infrared hyperspectral imaging (NIR-HSI) is combined with machine learning could be useful for detecting cancers deep within tissue, suggests a research team from Japan.

An example of such a cancer is gastrointestinal stromal tumor (GIST). These tumors are often located in the submucosal layer and are covered by mucosal tissue, making diagnosis by conventional endoscopy difficult.

In a study to assess the new technique, the researchers examined 12 GIST lesions that were surgically resected. Seven of these lesions were totally covered by a mucosal layer (thickness, 0.4-2.5 mm); three lesions were partially covered.

Using NIR-HSI with machine learning, the researchers found that GIST lesions appeared green and that normal tissue appeared yellow. Calculation of classified pixels showed that the technique detected the GISTs with a specificity of 73%, a sensitivity of 91.3%, and an accuracy of 86.1%.

The findings were published in Nature’s Scientific Reports.

“There are many situations where we need to be able to detect cancers deep in the tissue that are not visible during surgery or diagnosis,” said lead author Toshihiro Takamatsu, PhD, assistant professor, Tokyo University of Science. “Near-infrared hyperspectral imaging has a strong potential to detect deep lesions,” he said.

In this study, the imaging was performed ex vivo.

“The data presented in the paper were not obtained endoscopically but utilized surgical specimens to demonstrate proof of concept. Additional data would be required to demonstrate its feasibility with endoscopy,” noted Margaret von Mehren, MD, chief, division of sarcoma medical oncology, Fox Chase Cancer Center, Philadelphia, who was approached for comment.

Dr. Takamatsu said his team is currently developing prototypes of laparoscopes and endoscopes for NIR-HSI.

“This technology is being developed to be added onto endoscopy, and as such I think may well be feasible,” Dr. von Mehren commented.
 

Currently diagnosed by endoscopy and biopsy

GISTs are found predominantly in the stomach (60%) and the small intestine (30%). Although some are detected after the occurrence of symptoms such as pain, gastrointestinal bleeding, and bowel obstruction, most cases are asymptomatic.

The authors note that endoscopic examination is the primary tool for detecting GISTs. Lesions usually first appear as submucosal tumors. Direct observation cannot differentially diagnose these tumors, and biopsies may have a low diagnostic yield, because the lesions are often deep and not easily accessible.

Endoscopic ultrasound-guided fine-needle aspiration can be used for taking samples for biopsy, but it can be technically demanding, and making a definitive diagnosis of GIST requires time-consuming immunohistochemical procedures, the authors write. A high-throughput, simple diagnostic technique for identifying GISTs located under the mucosa is needed. They report on the potential of NIR-HSI for diagnosing submucosal tumors that present deep within organs.
 

Study details

For the study, the team worked on GIST lesions that had been surgically resected from 12 patients. The median size of the tumors was 41 mm (range, 24-80 mm).

The researchers imaged each specimen with an NIR hyperspectral camera from the aspect of the mucosal surface.

The site of the GIST was defined by a pathologist who used the NIR image to prepare training data for normal regions and regions with GISTs. A machine learning algorithm–support vector machine was then used to predict normal and GIST regions.

The results were displayed using color-coded regions. The team says the results from this small study show that the technique has “great potential” in the diagnosis of GISTs as well as other tumors that are located deep within tissue.

“I think the potential benefit of such a diagnostic tool is with small lesions when trying to differentiate benign findings, such as leiomyomas,” Dr. von Mehren commented.

She pointed out that this study comes from Japan, where endoscopy is routinely used for surveillance of gastric cancer. Thus, many cases of GIST may be diagnosed before symptoms occur and when lesions are small. Such a practice is less common in other parts of the world, she told this news organization.

Overall, she sees this technique as having the most utility in cases involving small lesions, inasmuch as larger lesions are easily assessed through biopsy with endoscopic ultrasound, and pathologic assessment is not a lengthy procedure. “In addition, as we now appreciate that GISTs with different molecular drivers require different therapeutic approaches, I continue to see a role for tissue biopsies in the diagnostic workup of GISTs,” she said.

“Current approaches using endoscopic ultrasound have defined criteria for lesions more likely to be GISTs rather than benign lesions,” she added. “I would want to see a comparison of near-infrared hyperspectral imaging data compared to endoscopic ultrasound to see if this provides additional benefit to our current approaches.”

The study was partially funded by the National Cancer Center Research and Development Fund. The authors and Dr. von Mehren have disclosed no relevant financial relationships.

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

Surgeons have a new tool for use in benign hysterectomies with the Food & Drug Administration’s authorization for marketing of the Hominis Surgical System, a robotic-assisted surgical device. The marketing authorization was granted to Memic Innovative Surgery.

The FDA reviewed the device through the De Novo classification review process, a regulatory pathway for low- to moderate-risk devices of a new type.

The robotically assisted surgical device (RASD) is designed to facilitate transvaginal hysterectomy procedures and salpingo-oophorectomy procedures in patients without cancer.

RASDs are not robots and require human control, but they allow a surgeon to use computer technology to control and move surgical instruments inserted through incisions or orifices. “RASD technology facilitates performing minimally invasive surgery and complex tasks in confined areas inside the body,” according to an FDA press release announcing the authorization.

“The FDA continues to support advancements in safe and effective medical devices that can improve patient experiences when undergoing surgical procedures,” Binita Ashar, MD, of the Office of Surgical and Infection Control Devices in the FDA’s Center for Devices and Radiological Health, said in the press release. The device represents another minimally invasive option for noncancerous conditions requiring gynecologic surgery.

The FDA also is establishing controls to ensure safety and effectiveness for RASDs, including labeling and performance testing requirements. “When met, the special controls, along with general controls, provide reasonable assurance of safety and effectiveness for devices of this type,” according to the press release.

The Hominis Surgical System involves the use of minimally invasive surgical instruments inserted through the vagina. A video camera is inserted laparoscopically through an abdominal incision; the camera allows the surgeon to visualize the instruments inside the patient.

“The FDA will require the manufacturer to develop and provide a comprehensive training program for surgeons and operating room staff to complete before operation of the device,” according to the press release.

The FDA reviewed data from a clinical study of 30 patients aged 37-79 years who underwent transvaginal total hysterectomy with salpingo-oophorectomy or salpingectomy for benign conditions.

Observed adverse events included minor blood loss, urinary tract infection and delayed healing of the closure made at the top of the vagina (vaginal cuff) that is done as part of a hysterectomy, according to the FDA. However, all 30 procedures were completed with no need for conversion to an open or other procedure.

Surgeons have a new tool for use in benign hysterectomies with the Food & Drug Administration’s authorization for marketing of the Hominis Surgical System, a robotic-assisted surgical device. The marketing authorization was granted to Memic Innovative Surgery.

The FDA reviewed the device through the De Novo classification review process, a regulatory pathway for low- to moderate-risk devices of a new type.

The robotically assisted surgical device (RASD) is designed to facilitate transvaginal hysterectomy procedures and salpingo-oophorectomy procedures in patients without cancer.

RASDs are not robots and require human control, but they allow a surgeon to use computer technology to control and move surgical instruments inserted through incisions or orifices. “RASD technology facilitates performing minimally invasive surgery and complex tasks in confined areas inside the body,” according to an FDA press release announcing the authorization.

“The FDA continues to support advancements in safe and effective medical devices that can improve patient experiences when undergoing surgical procedures,” Binita Ashar, MD, of the Office of Surgical and Infection Control Devices in the FDA’s Center for Devices and Radiological Health, said in the press release. The device represents another minimally invasive option for noncancerous conditions requiring gynecologic surgery.

The FDA also is establishing controls to ensure safety and effectiveness for RASDs, including labeling and performance testing requirements. “When met, the special controls, along with general controls, provide reasonable assurance of safety and effectiveness for devices of this type,” according to the press release.

The Hominis Surgical System involves the use of minimally invasive surgical instruments inserted through the vagina. A video camera is inserted laparoscopically through an abdominal incision; the camera allows the surgeon to visualize the instruments inside the patient.

“The FDA will require the manufacturer to develop and provide a comprehensive training program for surgeons and operating room staff to complete before operation of the device,” according to the press release.

The FDA reviewed data from a clinical study of 30 patients aged 37-79 years who underwent transvaginal total hysterectomy with salpingo-oophorectomy or salpingectomy for benign conditions.

Observed adverse events included minor blood loss, urinary tract infection and delayed healing of the closure made at the top of the vagina (vaginal cuff) that is done as part of a hysterectomy, according to the FDA. However, all 30 procedures were completed with no need for conversion to an open or other procedure.

Surgeons have a new tool for use in benign hysterectomies with the Food & Drug Administration’s authorization for marketing of the Hominis Surgical System, a robotic-assisted surgical device. The marketing authorization was granted to Memic Innovative Surgery.

The FDA reviewed the device through the De Novo classification review process, a regulatory pathway for low- to moderate-risk devices of a new type.

The robotically assisted surgical device (RASD) is designed to facilitate transvaginal hysterectomy procedures and salpingo-oophorectomy procedures in patients without cancer.

RASDs are not robots and require human control, but they allow a surgeon to use computer technology to control and move surgical instruments inserted through incisions or orifices. “RASD technology facilitates performing minimally invasive surgery and complex tasks in confined areas inside the body,” according to an FDA press release announcing the authorization.

“The FDA continues to support advancements in safe and effective medical devices that can improve patient experiences when undergoing surgical procedures,” Binita Ashar, MD, of the Office of Surgical and Infection Control Devices in the FDA’s Center for Devices and Radiological Health, said in the press release. The device represents another minimally invasive option for noncancerous conditions requiring gynecologic surgery.

The FDA also is establishing controls to ensure safety and effectiveness for RASDs, including labeling and performance testing requirements. “When met, the special controls, along with general controls, provide reasonable assurance of safety and effectiveness for devices of this type,” according to the press release.

The Hominis Surgical System involves the use of minimally invasive surgical instruments inserted through the vagina. A video camera is inserted laparoscopically through an abdominal incision; the camera allows the surgeon to visualize the instruments inside the patient.

“The FDA will require the manufacturer to develop and provide a comprehensive training program for surgeons and operating room staff to complete before operation of the device,” according to the press release.

The FDA reviewed data from a clinical study of 30 patients aged 37-79 years who underwent transvaginal total hysterectomy with salpingo-oophorectomy or salpingectomy for benign conditions.

Observed adverse events included minor blood loss, urinary tract infection and delayed healing of the closure made at the top of the vagina (vaginal cuff) that is done as part of a hysterectomy, according to the FDA. However, all 30 procedures were completed with no need for conversion to an open or other procedure.

Late one night in early February, Jen Gunter, MD, was scrolling online when she discovered a new “feminine hygiene” product being marketed for teen girls. The new vanilla clementine scented wipes and cleansers with confetti-colored packaging and a cute name (OMV!) irked Dr. Gunter because they are designed for girls to use to “freshen” their vaginal area.

Dr. Gunter, a San Francisco-based gynecologist and author of “The Vagina Bible,” has built a reputation as a fierce advocate for women’s health and debunker of pseudoscience. She has called out jade eggs and “detox pearls” and various other items that promise to improve the vagina but that she and other doctors warn could actually be harmful. And, in her view, this product is no different.

She fired off a tweet that became the first volley in a vociferous social media countercampaign: “Hey @vagisil going to call you out here for this predatory line of products aimed at teen girls. Why do you think teen vulvas need special cleaning? To be prepped for men? Because they are dirty. Anxiously awaiting your answer as are all my followers.”

Vagisil responded on Instagram that “we want to clarify any confusion or the underlying belief that OMV! was developed because there is something wrong with teens or that vulvas/vaginas are inherently dirty. That is not the case. All-Day Fresh Wash is an all-over body wash, that is safe, gentle, and pH-balanced for sensitive vulvar area skin.”

Dr. Gunter’s Feb. 4 tweet attracted more than 8,300 likes, 1,300 retweets and hundreds of comments, but that was just the beginning. Dr. Gunter has continued to tweet about the OMV! product line – and has inspired dozens of other gynecologists to join in.
 

‘Your vagina is fine’

Dr. Gunter and other gynecologists have long delivered the message that water alone is sufficient to cleanse the vulvar area and that the vagina itself is self-cleaning. Research into the vaginal microbiome reveals the role of lactobacilli in preventing urogenital diseases. “Disturbances in your vagina microbiome are hard to undo,” says Jocelyn Fitzgerald, MD, a urogynecologist and pelvic reconstructive surgeon at Magee-Womens Hospital at the University of Pittsburgh Medical Center.

To underscore that message, Dr. Fitzgerald recently tweeted in support of Dr. Gunter’s Twitter thread: “Honestly, the @vagisil marketing campaign is a brilliant one because using their products while your vagina is perfectly fine will destroy your microbiome, give you real Bacterial Vaginosis, and prompt you to buy more Vagisil. DON’T FALL FOR IT GIRLS YOUR VAGINA IS FINE.”

In an emailed response to this news organization, a Vagisil spokesperson said, “We follow industry best practices for testing and OMV! products are rigorously assessed for safety and quality. In addition, we work with respected, independent clinical labs that follow strict testing protocols, using board-certified gynecologists and dermatologists to test our products before launch.”

However, beyond the potential for irritation or misuse, the gynecologists zeroed in on the underlying message that girls would feel more confident if they used the wipes and cleanser. For example, the company suggested that teens could use the wipes to get rid of “period funk.”

“There is no such thing as period funk!” gynecologist Danielle Jones, MD, exclaimed in a video on YouTube, where she has a channel called Mama Doctor Jones – with 700,000 subscribers. “All you need is ordinary hygiene. Period funk is not a thing! And if you feel like something is going on because there’s an odor that is abnormal, you need to talk to your doctor.”

Adult women often use wipes and special cleansers in the vaginal area. An online survey of 1,435 Canadian women, published in BMC Women’s Health in 2018, found 42% had used vaginal wipes, 12% had used vaginal washes or cleansers – and 4% had used them internally.

When it launched OMV! in July, Vagisil said it had engaged 2,500 teens and their mothers in creating the product, which it said was “designed to meet the cleansing and care needs of a new generation of young women.”

That extension of a product most commonly used by adult women to teenagers – who often feel self-conscious about their bodies – is exactly what bothers Dr. Gunter. “BTW I am sorry I am subjecting you all to my @vagisil outrage, but preying on teens and amplifying patriarchal shame of normal bodily functions to sell an irritating product is not acceptable. I’m not stopping until they take that OMV! product line down everywhere,” she said in a Feb. 8 tweet that attracted more than 7,900 likes.
 

No ‘glow up’ needed

Dr. Gunter’s tweets tapped into collective anger over the shaming of women’s bodies. The OMV! marketing suggested that teens could get a “glow up” with the products.

“Your vulva doesn’t need a ‘glow up.’ It’s fine like it is. And if it’s not, talk to your doctor,” Dr. Jones said in her Feb. 8 video, which has had almost 350,000 views, with 28,000 likes and only 149 dislikes.

“They’re very clearly pathologizing normal physiology,” Dr. Jones says. “They’re creating language that makes people feel as though their normal bodily functions have to be somehow fixed or changed.”

Dr. Gunter says she specifically wanted to prevent Vagisil from leveraging social media to influence teen girls. With her stream of tweets and support from colleagues around the country, she has sparked a prolonged online conversation.

“I am encouraged by the strong response on social media from both other enraged ob.gyns. and health care professionals as well the response from a lot of women and men,” Dr. Gunter said in an interview. “We have effectively blocked [Vagisil] from using social media.”

In its response to this news organization, Vagisil noted, “We are a brand run by women with daughters of our own.” While defending the products, Vagisil acknowledged the criticisms: “We are always listening to our consumers and our expert partners so that we continuously evolve. We appreciate the perspective that our language choice surrounding periods may perpetuate an old idea and have already begun to make changes to address this.”

Dr. Gunter says she plans to stay on topic. “Given the number of people outraged, I suspect if they venture out on social media again the reaction will be swift,” she said. “Hopefully we have made OMV! toxic for influencers as well.”

In fact, she’s ready to take on “the entire predatory feminine hygiene market. I’m sick of their false claims about balancing pH and not-so-subtle suggestions that vaginas and vulvas and menstruation stink. These products cause psychological harm as well as physical harm from their irritants,” she said.

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

Late one night in early February, Jen Gunter, MD, was scrolling online when she discovered a new “feminine hygiene” product being marketed for teen girls. The new vanilla clementine scented wipes and cleansers with confetti-colored packaging and a cute name (OMV!) irked Dr. Gunter because they are designed for girls to use to “freshen” their vaginal area.

Dr. Gunter, a San Francisco-based gynecologist and author of “The Vagina Bible,” has built a reputation as a fierce advocate for women’s health and debunker of pseudoscience. She has called out jade eggs and “detox pearls” and various other items that promise to improve the vagina but that she and other doctors warn could actually be harmful. And, in her view, this product is no different.

She fired off a tweet that became the first volley in a vociferous social media countercampaign: “Hey @vagisil going to call you out here for this predatory line of products aimed at teen girls. Why do you think teen vulvas need special cleaning? To be prepped for men? Because they are dirty. Anxiously awaiting your answer as are all my followers.”

Vagisil responded on Instagram that “we want to clarify any confusion or the underlying belief that OMV! was developed because there is something wrong with teens or that vulvas/vaginas are inherently dirty. That is not the case. All-Day Fresh Wash is an all-over body wash, that is safe, gentle, and pH-balanced for sensitive vulvar area skin.”

Dr. Gunter’s Feb. 4 tweet attracted more than 8,300 likes, 1,300 retweets and hundreds of comments, but that was just the beginning. Dr. Gunter has continued to tweet about the OMV! product line – and has inspired dozens of other gynecologists to join in.
 

‘Your vagina is fine’

Dr. Gunter and other gynecologists have long delivered the message that water alone is sufficient to cleanse the vulvar area and that the vagina itself is self-cleaning. Research into the vaginal microbiome reveals the role of lactobacilli in preventing urogenital diseases. “Disturbances in your vagina microbiome are hard to undo,” says Jocelyn Fitzgerald, MD, a urogynecologist and pelvic reconstructive surgeon at Magee-Womens Hospital at the University of Pittsburgh Medical Center.

To underscore that message, Dr. Fitzgerald recently tweeted in support of Dr. Gunter’s Twitter thread: “Honestly, the @vagisil marketing campaign is a brilliant one because using their products while your vagina is perfectly fine will destroy your microbiome, give you real Bacterial Vaginosis, and prompt you to buy more Vagisil. DON’T FALL FOR IT GIRLS YOUR VAGINA IS FINE.”

In an emailed response to this news organization, a Vagisil spokesperson said, “We follow industry best practices for testing and OMV! products are rigorously assessed for safety and quality. In addition, we work with respected, independent clinical labs that follow strict testing protocols, using board-certified gynecologists and dermatologists to test our products before launch.”

However, beyond the potential for irritation or misuse, the gynecologists zeroed in on the underlying message that girls would feel more confident if they used the wipes and cleanser. For example, the company suggested that teens could use the wipes to get rid of “period funk.”

“There is no such thing as period funk!” gynecologist Danielle Jones, MD, exclaimed in a video on YouTube, where she has a channel called Mama Doctor Jones – with 700,000 subscribers. “All you need is ordinary hygiene. Period funk is not a thing! And if you feel like something is going on because there’s an odor that is abnormal, you need to talk to your doctor.”

Adult women often use wipes and special cleansers in the vaginal area. An online survey of 1,435 Canadian women, published in BMC Women’s Health in 2018, found 42% had used vaginal wipes, 12% had used vaginal washes or cleansers – and 4% had used them internally.

When it launched OMV! in July, Vagisil said it had engaged 2,500 teens and their mothers in creating the product, which it said was “designed to meet the cleansing and care needs of a new generation of young women.”

That extension of a product most commonly used by adult women to teenagers – who often feel self-conscious about their bodies – is exactly what bothers Dr. Gunter. “BTW I am sorry I am subjecting you all to my @vagisil outrage, but preying on teens and amplifying patriarchal shame of normal bodily functions to sell an irritating product is not acceptable. I’m not stopping until they take that OMV! product line down everywhere,” she said in a Feb. 8 tweet that attracted more than 7,900 likes.
 

No ‘glow up’ needed

Dr. Gunter’s tweets tapped into collective anger over the shaming of women’s bodies. The OMV! marketing suggested that teens could get a “glow up” with the products.

“Your vulva doesn’t need a ‘glow up.’ It’s fine like it is. And if it’s not, talk to your doctor,” Dr. Jones said in her Feb. 8 video, which has had almost 350,000 views, with 28,000 likes and only 149 dislikes.

“They’re very clearly pathologizing normal physiology,” Dr. Jones says. “They’re creating language that makes people feel as though their normal bodily functions have to be somehow fixed or changed.”

Dr. Gunter says she specifically wanted to prevent Vagisil from leveraging social media to influence teen girls. With her stream of tweets and support from colleagues around the country, she has sparked a prolonged online conversation.

“I am encouraged by the strong response on social media from both other enraged ob.gyns. and health care professionals as well the response from a lot of women and men,” Dr. Gunter said in an interview. “We have effectively blocked [Vagisil] from using social media.”

In its response to this news organization, Vagisil noted, “We are a brand run by women with daughters of our own.” While defending the products, Vagisil acknowledged the criticisms: “We are always listening to our consumers and our expert partners so that we continuously evolve. We appreciate the perspective that our language choice surrounding periods may perpetuate an old idea and have already begun to make changes to address this.”

Dr. Gunter says she plans to stay on topic. “Given the number of people outraged, I suspect if they venture out on social media again the reaction will be swift,” she said. “Hopefully we have made OMV! toxic for influencers as well.”

In fact, she’s ready to take on “the entire predatory feminine hygiene market. I’m sick of their false claims about balancing pH and not-so-subtle suggestions that vaginas and vulvas and menstruation stink. These products cause psychological harm as well as physical harm from their irritants,” she said.

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

Late one night in early February, Jen Gunter, MD, was scrolling online when she discovered a new “feminine hygiene” product being marketed for teen girls. The new vanilla clementine scented wipes and cleansers with confetti-colored packaging and a cute name (OMV!) irked Dr. Gunter because they are designed for girls to use to “freshen” their vaginal area.

Dr. Gunter, a San Francisco-based gynecologist and author of “The Vagina Bible,” has built a reputation as a fierce advocate for women’s health and debunker of pseudoscience. She has called out jade eggs and “detox pearls” and various other items that promise to improve the vagina but that she and other doctors warn could actually be harmful. And, in her view, this product is no different.

She fired off a tweet that became the first volley in a vociferous social media countercampaign: “Hey @vagisil going to call you out here for this predatory line of products aimed at teen girls. Why do you think teen vulvas need special cleaning? To be prepped for men? Because they are dirty. Anxiously awaiting your answer as are all my followers.”

Vagisil responded on Instagram that “we want to clarify any confusion or the underlying belief that OMV! was developed because there is something wrong with teens or that vulvas/vaginas are inherently dirty. That is not the case. All-Day Fresh Wash is an all-over body wash, that is safe, gentle, and pH-balanced for sensitive vulvar area skin.”

Dr. Gunter’s Feb. 4 tweet attracted more than 8,300 likes, 1,300 retweets and hundreds of comments, but that was just the beginning. Dr. Gunter has continued to tweet about the OMV! product line – and has inspired dozens of other gynecologists to join in.
 

‘Your vagina is fine’

Dr. Gunter and other gynecologists have long delivered the message that water alone is sufficient to cleanse the vulvar area and that the vagina itself is self-cleaning. Research into the vaginal microbiome reveals the role of lactobacilli in preventing urogenital diseases. “Disturbances in your vagina microbiome are hard to undo,” says Jocelyn Fitzgerald, MD, a urogynecologist and pelvic reconstructive surgeon at Magee-Womens Hospital at the University of Pittsburgh Medical Center.

To underscore that message, Dr. Fitzgerald recently tweeted in support of Dr. Gunter’s Twitter thread: “Honestly, the @vagisil marketing campaign is a brilliant one because using their products while your vagina is perfectly fine will destroy your microbiome, give you real Bacterial Vaginosis, and prompt you to buy more Vagisil. DON’T FALL FOR IT GIRLS YOUR VAGINA IS FINE.”

In an emailed response to this news organization, a Vagisil spokesperson said, “We follow industry best practices for testing and OMV! products are rigorously assessed for safety and quality. In addition, we work with respected, independent clinical labs that follow strict testing protocols, using board-certified gynecologists and dermatologists to test our products before launch.”

However, beyond the potential for irritation or misuse, the gynecologists zeroed in on the underlying message that girls would feel more confident if they used the wipes and cleanser. For example, the company suggested that teens could use the wipes to get rid of “period funk.”

“There is no such thing as period funk!” gynecologist Danielle Jones, MD, exclaimed in a video on YouTube, where she has a channel called Mama Doctor Jones – with 700,000 subscribers. “All you need is ordinary hygiene. Period funk is not a thing! And if you feel like something is going on because there’s an odor that is abnormal, you need to talk to your doctor.”

Adult women often use wipes and special cleansers in the vaginal area. An online survey of 1,435 Canadian women, published in BMC Women’s Health in 2018, found 42% had used vaginal wipes, 12% had used vaginal washes or cleansers – and 4% had used them internally.

When it launched OMV! in July, Vagisil said it had engaged 2,500 teens and their mothers in creating the product, which it said was “designed to meet the cleansing and care needs of a new generation of young women.”

That extension of a product most commonly used by adult women to teenagers – who often feel self-conscious about their bodies – is exactly what bothers Dr. Gunter. “BTW I am sorry I am subjecting you all to my @vagisil outrage, but preying on teens and amplifying patriarchal shame of normal bodily functions to sell an irritating product is not acceptable. I’m not stopping until they take that OMV! product line down everywhere,” she said in a Feb. 8 tweet that attracted more than 7,900 likes.
 

No ‘glow up’ needed

Dr. Gunter’s tweets tapped into collective anger over the shaming of women’s bodies. The OMV! marketing suggested that teens could get a “glow up” with the products.

“Your vulva doesn’t need a ‘glow up.’ It’s fine like it is. And if it’s not, talk to your doctor,” Dr. Jones said in her Feb. 8 video, which has had almost 350,000 views, with 28,000 likes and only 149 dislikes.

“They’re very clearly pathologizing normal physiology,” Dr. Jones says. “They’re creating language that makes people feel as though their normal bodily functions have to be somehow fixed or changed.”

Dr. Gunter says she specifically wanted to prevent Vagisil from leveraging social media to influence teen girls. With her stream of tweets and support from colleagues around the country, she has sparked a prolonged online conversation.

“I am encouraged by the strong response on social media from both other enraged ob.gyns. and health care professionals as well the response from a lot of women and men,” Dr. Gunter said in an interview. “We have effectively blocked [Vagisil] from using social media.”

In its response to this news organization, Vagisil noted, “We are a brand run by women with daughters of our own.” While defending the products, Vagisil acknowledged the criticisms: “We are always listening to our consumers and our expert partners so that we continuously evolve. We appreciate the perspective that our language choice surrounding periods may perpetuate an old idea and have already begun to make changes to address this.”

Dr. Gunter says she plans to stay on topic. “Given the number of people outraged, I suspect if they venture out on social media again the reaction will be swift,” she said. “Hopefully we have made OMV! toxic for influencers as well.”

In fact, she’s ready to take on “the entire predatory feminine hygiene market. I’m sick of their false claims about balancing pH and not-so-subtle suggestions that vaginas and vulvas and menstruation stink. These products cause psychological harm as well as physical harm from their irritants,” she said.

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

A 49-year-old woman with a history of end-stage renal disease, uncontrolled type 2 diabetes, and congestive heart failure visited the hospital for an acute heart failure exacerbation secondary to missed dialysis appointments. On admission, her provider noted that she had tender, pruritic lesions on the extensor surface of her arms. She said they had appeared 2 to 3 months after she started dialysis. She had attempted to control the pain and pruritus with over-the-counter topical hydrocortisone and oral diphenhydramine but nothing provided relief. She was recommended for follow-up at the hospital for further examination and biopsy of one of her lesions.

At this follow-up visit, the patient noted that the lesions had spread to her left knee. Multiple firm discrete papules and nodules, with central hyperkeratotic plugs, were noted along the extensor surfaces of her forearms, left extensor knee, and around her ankles (FIGURES 1A and 1B). Some of the lesions were tender. Examination of the rest of her skin was normal. A punch biopsy was obtained.

WHAT IS YOUR DIAGNOSIS?
HOW WOULD YOU TREAT THIS PATIENT?

Diagnosis: Kyrle disease

The patient’s end-stage renal disease and type 2 diabetes—along with findings from the physical examination—led us to suspect Kyrle disease. The punch biopsy, as well as the characteristic keratotic plugs (FIGURE 2) within epidermal invagination that was bordered by hyperkeratotic epidermis, confirmed the diagnosis.

The acquired form of Kyrle disease is associated with diabetes and renal failure, but there is a lack of data on its pathogenesis.

Kyrle disease (also known as hyperkeratosis follicularis et follicularis in cutem penetrans) is a rare skin condition. It is 1 of 4 skin conditions that are classified as perforating skin disorders; the other 3 are elastosis perforans serpiginosa, reactive perforating collagenosis, and perforating folliculitis (TABLE^1,2).³ Perforating skin disorders share the common characteristic of transepidermal elimination of material from the upper dermis.⁴ These disorders are typically classified based on the nature of the eliminated material and the type of epidermal disruption.⁵

There are 2 forms of Kyrle disease: an inherited form often seen in childhood that is not associated with systemic disease and an acquired form that occurs in adulthood, most commonly among women ages 35 to 70 years who have systemic disease.^3,4,6 The acquired form of Kyrle disease is associated with diabetes and renal failure, but there is a lack of data on its pathogenesis.^7,8

Characteristic findings include discrete pruritic, dry papules and nodules with central keratotic plugs that are occasionally tender. These can manifest over the extensor surface of the extremities, trunk, face, and scalp.^4,7,9 Lesions most commonly manifest on the extensor surfaces of the lower extremities.

Other conditions that feature pruritic lesions

In addition to the other perforating skin disorders described in the TABLE,^1,2 the differential for Kyrle disease includes the following:

Prurigo nodularis (PN) is a skin disorder in which the manifestation of extremely pruritic nodules leads to vigorous scratching and secondary infections. These lesions typically have a grouped and symmetrically distributed appearance. They often appear on extensor surfaces of upper and lower extremities.¹⁰ PN has no known etiology, but like Kyrle disease, is associated with renal failure. Biopsy can help to distinguish PN from Kyrle disease.

Continue to: Hypertrophic lichen planus

Hypertrophic lichen planus is a pruritic skin disorder characterized by the “6 Ps”: planar, purple, polygonal, pruritic, papules, and plaques. These lesions can mimic the early stages of Kyrle disease.¹¹ However, in the later stages of Kyrle disease, discrete papules with hyperkeratotic plugs develop, whereas large plaques will be seen with lichen planus.

Keratosis pilaris (KP) is an extremely common, yet benign, disorder in which hair follicles become keratinized.¹² KP can feature rough papules that are often described as “goosebumps” or having a sandpaper–like appearance. These papules often affect the upper arms. KP usually manifests in adolescents or young adults and tends to improve with age.¹² The lesions are typically smaller than those seen in Kyrle disease and are asymptomatic. In addition, KP is not associated with systemic disease.

Target symptoms and any underlying conditions

In patients who have an acquired form of the disease, symptoms may improve by treating the underlying condition. For instance, better control of type 2 diabetes may improve symptoms. In patients with end-stage renal disease, a renal transplant can bring complete resolution.¹³

For patients whose Kyrle disease is inherited or whose underlying condition is not easily treated, there are a number of treatment options to consider. First-line treatment includes topical keratolytics (salicylic acid and urea), topical retinoids, and ultraviolet light therapy.^5,7 Systemic retinoids, topical steroids, cryotherapy, electrosurgery, CO₂ laser surgery, and surgical excision have also been used with some success.^7,14 Oral histamines and emollients also may help to relieve the pruritus. Lesions often recur upon discontinuation of therapy.

Our patient was referred to Dermatology for ultraviolet light therapy. She was also treated with topical 12% ammonium lactate twice daily. Within a few months, she reported improvement of her symptoms.

A 49-year-old woman with a history of end-stage renal disease, uncontrolled type 2 diabetes, and congestive heart failure visited the hospital for an acute heart failure exacerbation secondary to missed dialysis appointments. On admission, her provider noted that she had tender, pruritic lesions on the extensor surface of her arms. She said they had appeared 2 to 3 months after she started dialysis. She had attempted to control the pain and pruritus with over-the-counter topical hydrocortisone and oral diphenhydramine but nothing provided relief. She was recommended for follow-up at the hospital for further examination and biopsy of one of her lesions.

At this follow-up visit, the patient noted that the lesions had spread to her left knee. Multiple firm discrete papules and nodules, with central hyperkeratotic plugs, were noted along the extensor surfaces of her forearms, left extensor knee, and around her ankles (FIGURES 1A and 1B). Some of the lesions were tender. Examination of the rest of her skin was normal. A punch biopsy was obtained.

WHAT IS YOUR DIAGNOSIS?
HOW WOULD YOU TREAT THIS PATIENT?

Diagnosis: Kyrle disease

The patient’s end-stage renal disease and type 2 diabetes—along with findings from the physical examination—led us to suspect Kyrle disease. The punch biopsy, as well as the characteristic keratotic plugs (FIGURE 2) within epidermal invagination that was bordered by hyperkeratotic epidermis, confirmed the diagnosis.

The acquired form of Kyrle disease is associated with diabetes and renal failure, but there is a lack of data on its pathogenesis.

Kyrle disease (also known as hyperkeratosis follicularis et follicularis in cutem penetrans) is a rare skin condition. It is 1 of 4 skin conditions that are classified as perforating skin disorders; the other 3 are elastosis perforans serpiginosa, reactive perforating collagenosis, and perforating folliculitis (TABLE^1,2).³ Perforating skin disorders share the common characteristic of transepidermal elimination of material from the upper dermis.⁴ These disorders are typically classified based on the nature of the eliminated material and the type of epidermal disruption.⁵

There are 2 forms of Kyrle disease: an inherited form often seen in childhood that is not associated with systemic disease and an acquired form that occurs in adulthood, most commonly among women ages 35 to 70 years who have systemic disease.^3,4,6 The acquired form of Kyrle disease is associated with diabetes and renal failure, but there is a lack of data on its pathogenesis.^7,8

Characteristic findings include discrete pruritic, dry papules and nodules with central keratotic plugs that are occasionally tender. These can manifest over the extensor surface of the extremities, trunk, face, and scalp.^4,7,9 Lesions most commonly manifest on the extensor surfaces of the lower extremities.

Other conditions that feature pruritic lesions

In addition to the other perforating skin disorders described in the TABLE,^1,2 the differential for Kyrle disease includes the following:

Prurigo nodularis (PN) is a skin disorder in which the manifestation of extremely pruritic nodules leads to vigorous scratching and secondary infections. These lesions typically have a grouped and symmetrically distributed appearance. They often appear on extensor surfaces of upper and lower extremities.¹⁰ PN has no known etiology, but like Kyrle disease, is associated with renal failure. Biopsy can help to distinguish PN from Kyrle disease.

Continue to: Hypertrophic lichen planus

Hypertrophic lichen planus is a pruritic skin disorder characterized by the “6 Ps”: planar, purple, polygonal, pruritic, papules, and plaques. These lesions can mimic the early stages of Kyrle disease.¹¹ However, in the later stages of Kyrle disease, discrete papules with hyperkeratotic plugs develop, whereas large plaques will be seen with lichen planus.

Keratosis pilaris (KP) is an extremely common, yet benign, disorder in which hair follicles become keratinized.¹² KP can feature rough papules that are often described as “goosebumps” or having a sandpaper–like appearance. These papules often affect the upper arms. KP usually manifests in adolescents or young adults and tends to improve with age.¹² The lesions are typically smaller than those seen in Kyrle disease and are asymptomatic. In addition, KP is not associated with systemic disease.

Target symptoms and any underlying conditions

In patients who have an acquired form of the disease, symptoms may improve by treating the underlying condition. For instance, better control of type 2 diabetes may improve symptoms. In patients with end-stage renal disease, a renal transplant can bring complete resolution.¹³

For patients whose Kyrle disease is inherited or whose underlying condition is not easily treated, there are a number of treatment options to consider. First-line treatment includes topical keratolytics (salicylic acid and urea), topical retinoids, and ultraviolet light therapy.^5,7 Systemic retinoids, topical steroids, cryotherapy, electrosurgery, CO₂ laser surgery, and surgical excision have also been used with some success.^7,14 Oral histamines and emollients also may help to relieve the pruritus. Lesions often recur upon discontinuation of therapy.

Our patient was referred to Dermatology for ultraviolet light therapy. She was also treated with topical 12% ammonium lactate twice daily. Within a few months, she reported improvement of her symptoms.

A 49-year-old woman with a history of end-stage renal disease, uncontrolled type 2 diabetes, and congestive heart failure visited the hospital for an acute heart failure exacerbation secondary to missed dialysis appointments. On admission, her provider noted that she had tender, pruritic lesions on the extensor surface of her arms. She said they had appeared 2 to 3 months after she started dialysis. She had attempted to control the pain and pruritus with over-the-counter topical hydrocortisone and oral diphenhydramine but nothing provided relief. She was recommended for follow-up at the hospital for further examination and biopsy of one of her lesions.

At this follow-up visit, the patient noted that the lesions had spread to her left knee. Multiple firm discrete papules and nodules, with central hyperkeratotic plugs, were noted along the extensor surfaces of her forearms, left extensor knee, and around her ankles (FIGURES 1A and 1B). Some of the lesions were tender. Examination of the rest of her skin was normal. A punch biopsy was obtained.

WHAT IS YOUR DIAGNOSIS?
HOW WOULD YOU TREAT THIS PATIENT?

Diagnosis: Kyrle disease

The patient’s end-stage renal disease and type 2 diabetes—along with findings from the physical examination—led us to suspect Kyrle disease. The punch biopsy, as well as the characteristic keratotic plugs (FIGURE 2) within epidermal invagination that was bordered by hyperkeratotic epidermis, confirmed the diagnosis.

The acquired form of Kyrle disease is associated with diabetes and renal failure, but there is a lack of data on its pathogenesis.

Kyrle disease (also known as hyperkeratosis follicularis et follicularis in cutem penetrans) is a rare skin condition. It is 1 of 4 skin conditions that are classified as perforating skin disorders; the other 3 are elastosis perforans serpiginosa, reactive perforating collagenosis, and perforating folliculitis (TABLE^1,2).³ Perforating skin disorders share the common characteristic of transepidermal elimination of material from the upper dermis.⁴ These disorders are typically classified based on the nature of the eliminated material and the type of epidermal disruption.⁵

There are 2 forms of Kyrle disease: an inherited form often seen in childhood that is not associated with systemic disease and an acquired form that occurs in adulthood, most commonly among women ages 35 to 70 years who have systemic disease.^3,4,6 The acquired form of Kyrle disease is associated with diabetes and renal failure, but there is a lack of data on its pathogenesis.^7,8

Characteristic findings include discrete pruritic, dry papules and nodules with central keratotic plugs that are occasionally tender. These can manifest over the extensor surface of the extremities, trunk, face, and scalp.^4,7,9 Lesions most commonly manifest on the extensor surfaces of the lower extremities.

Other conditions that feature pruritic lesions

In addition to the other perforating skin disorders described in the TABLE,^1,2 the differential for Kyrle disease includes the following:

Prurigo nodularis (PN) is a skin disorder in which the manifestation of extremely pruritic nodules leads to vigorous scratching and secondary infections. These lesions typically have a grouped and symmetrically distributed appearance. They often appear on extensor surfaces of upper and lower extremities.¹⁰ PN has no known etiology, but like Kyrle disease, is associated with renal failure. Biopsy can help to distinguish PN from Kyrle disease.

Continue to: Hypertrophic lichen planus

Hypertrophic lichen planus is a pruritic skin disorder characterized by the “6 Ps”: planar, purple, polygonal, pruritic, papules, and plaques. These lesions can mimic the early stages of Kyrle disease.¹¹ However, in the later stages of Kyrle disease, discrete papules with hyperkeratotic plugs develop, whereas large plaques will be seen with lichen planus.

Keratosis pilaris (KP) is an extremely common, yet benign, disorder in which hair follicles become keratinized.¹² KP can feature rough papules that are often described as “goosebumps” or having a sandpaper–like appearance. These papules often affect the upper arms. KP usually manifests in adolescents or young adults and tends to improve with age.¹² The lesions are typically smaller than those seen in Kyrle disease and are asymptomatic. In addition, KP is not associated with systemic disease.

Target symptoms and any underlying conditions

In patients who have an acquired form of the disease, symptoms may improve by treating the underlying condition. For instance, better control of type 2 diabetes may improve symptoms. In patients with end-stage renal disease, a renal transplant can bring complete resolution.¹³

For patients whose Kyrle disease is inherited or whose underlying condition is not easily treated, there are a number of treatment options to consider. First-line treatment includes topical keratolytics (salicylic acid and urea), topical retinoids, and ultraviolet light therapy.^5,7 Systemic retinoids, topical steroids, cryotherapy, electrosurgery, CO₂ laser surgery, and surgical excision have also been used with some success.^7,14 Oral histamines and emollients also may help to relieve the pruritus. Lesions often recur upon discontinuation of therapy.

Our patient was referred to Dermatology for ultraviolet light therapy. She was also treated with topical 12% ammonium lactate twice daily. Within a few months, she reported improvement of her symptoms.

Patients with multiple myeloma that has continued to progress despite many lines of therapy have shown deep and durable responses to a new chimeric antigen receptor (CAR) T-cell therapy, idecabtagene vicleucel (ide-cel, under development by Bristol-Myers Squibb and Bluebird Bio).

An expert not involved in the trial described the results as “phenomenal.”

Krina Patel, MD, an associate professor in the department of lymphoma/myeloma at the University of Texas MD Anderson Cancer Center, Houston, said that “the response rate of 73% in a patient population with a median of six lines of therapy, and with one-third of those patients achieving a deep response of complete response or better, is phenomenal.”

“We are very excited as a myeloma community for this study of idecabtagene vicleucel for relapsed/refractory patients,” Dr. Patel said.

The new data on ide-cell, from a trial in 128 patients, were published Feb. 25 in the New England Journal of Medicine.

Lead investigator of the study Nikhil Munshi, MD, of Dana-Farber Cancer Institute, Boston, said: “The results of this trial represent a true turning point in the treatment of this disease. In my 30 years of treating myeloma, I have not seen any other therapy as effective in this group of patients.”

Both experts highlighted the poor prognosis for this population of relapsed/refractory patients. Recent decades have seen a flurry of new agents for myeloma, and there are now three main classes of agents: immunomodulatory agents, proteasome inhibitors, and anti-CD38 antibodies. Nevertheless, in some patients, the disease continues to progress. For patients who have failed all three classes of drugs, the median progression-free survival is about 3-4 months, with a median overall survival of 8-9 months.
 

Product is awaiting approval

Ide-cel is currently awaiting FDA approval, with a decision date slated for March 27.

Several CAR T-cell products are already marketed for use in certain leukemias and lymphomas, and there is another for use in multiple myeloma, ciltacabtagene autoleucel (cilta-cel, under development by Janssen), that is awaiting approval in Europe.
 

Strong and sustained responses

The trial involved 128 patients treated with ide-cel infusions. At the time of data cutoff for this report (Jan. 14, 2020), 62 patients remained in the primary study. Of the 128 treated patients, the median age was 61 years and the median time since diagnosis was 6 years. About half (51%) had a high tumor burden (≥50% bone marrow plasma cells), 39% had extramedullary disease, 16% had stage III disease, and 35% had a high-risk cytogenetic abnormality, defined as del(17p), t(4;14), or t(14;16).

Patients in the cohort had received a median of six previous antimyeloma regimens (range, 3-16), and most of the patients (120, 94%) had undergone autologous hematopoietic stem cell transplants. In addition, the majority of patients (84%) had disease that was triple refractory (to an immunomodulatory agent, a proteasome inhibitor, and an anti-CD38 antibody), 60% had disease that was penta exposed (to bortezomib, carfilzomib, lenalidomide, pomalidomide, and daratumumab), and 26% had disease that was penta refractory.

At a median follow-up of 13.3 months, 94 of 128 patients (73%) showed a response to therapy (P < .001), with 42 (33%) showing a complete or stringent complete response, and 67 patients (52%) showing a “very good partial response or better.”

Overall median progression-free survival was 8.8 months at the 450×106 dose but more than double that (20.2 months) for patients who achieved a complete or stringent complete response. Estimated median overall survival was 19.4 months, with an overall survival of 78% at 12 months. The authors noted that overall survival data are not yet mature.

After experiencing disease progression, 28 patients were retreated with ide-cel, with 6 patients showing a second response. The durations of response ranged from 1.9 to 6.8 months.

All patients in the cohort experienced adverse events, primarily grade 3 or 4 events that occurred in 127 patients (99%). The most common events reported were hematologic toxicities, including neutropenia in 114 patients (89%), anemia in 77 (60%), and thrombocytopenia in 67 (52%), and were at least partially related to the lymphodepleting chemotherapy administered before ide-cel infusion, the authors note. Cytokine-release syndrome occurred in 107 patients (84%), primarily grade 1 or 2.

“Results of the KarMMa study support substantial antitumor activity for ide-cel across a target dose range of 150×106 to 450×106 CAR+ T cells,” the authors conclude. “The 450×106 dose appeared to be somewhat more effective than the other doses.”
 

New option?

“What this study further highlights is that higher cell dose tends to increase cell expansion, which correlates to improved response and duration of response,” said Dr. Patel.

Importantly, multiple vulnerable subgroups experienced impressive outcomes, such as those who are older or with high risk or extramedullary disease, she noted.

“My patients who have undergone this therapy, albeit on other clinical trials, all say that their quality of life during this time of remission is priceless,” Dr. Patel added. “The is the first therapy in the relapsed/refractory setting that allows patients to have a significant chemo-free period. We need to find more ways to do this for our patients.”

The study was supported by Bluebird Bio and Bristol-Myers Squibb. Dr. Patel has served on the advisory board for Janssen and Bristol-Myers Squibb. She also reports a speaking engagement with Oncopeptides. Dr. Munshi acts as a consultant for several pharmaceutical companies, and many coauthors also have relationships with industry, as listed in the original article.

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

Patients with multiple myeloma that has continued to progress despite many lines of therapy have shown deep and durable responses to a new chimeric antigen receptor (CAR) T-cell therapy, idecabtagene vicleucel (ide-cel, under development by Bristol-Myers Squibb and Bluebird Bio).

An expert not involved in the trial described the results as “phenomenal.”

Krina Patel, MD, an associate professor in the department of lymphoma/myeloma at the University of Texas MD Anderson Cancer Center, Houston, said that “the response rate of 73% in a patient population with a median of six lines of therapy, and with one-third of those patients achieving a deep response of complete response or better, is phenomenal.”

“We are very excited as a myeloma community for this study of idecabtagene vicleucel for relapsed/refractory patients,” Dr. Patel said.

The new data on ide-cell, from a trial in 128 patients, were published Feb. 25 in the New England Journal of Medicine.

Lead investigator of the study Nikhil Munshi, MD, of Dana-Farber Cancer Institute, Boston, said: “The results of this trial represent a true turning point in the treatment of this disease. In my 30 years of treating myeloma, I have not seen any other therapy as effective in this group of patients.”

Both experts highlighted the poor prognosis for this population of relapsed/refractory patients. Recent decades have seen a flurry of new agents for myeloma, and there are now three main classes of agents: immunomodulatory agents, proteasome inhibitors, and anti-CD38 antibodies. Nevertheless, in some patients, the disease continues to progress. For patients who have failed all three classes of drugs, the median progression-free survival is about 3-4 months, with a median overall survival of 8-9 months.
 

Product is awaiting approval

Ide-cel is currently awaiting FDA approval, with a decision date slated for March 27.

Several CAR T-cell products are already marketed for use in certain leukemias and lymphomas, and there is another for use in multiple myeloma, ciltacabtagene autoleucel (cilta-cel, under development by Janssen), that is awaiting approval in Europe.
 

Strong and sustained responses

The trial involved 128 patients treated with ide-cel infusions. At the time of data cutoff for this report (Jan. 14, 2020), 62 patients remained in the primary study. Of the 128 treated patients, the median age was 61 years and the median time since diagnosis was 6 years. About half (51%) had a high tumor burden (≥50% bone marrow plasma cells), 39% had extramedullary disease, 16% had stage III disease, and 35% had a high-risk cytogenetic abnormality, defined as del(17p), t(4;14), or t(14;16).

Patients in the cohort had received a median of six previous antimyeloma regimens (range, 3-16), and most of the patients (120, 94%) had undergone autologous hematopoietic stem cell transplants. In addition, the majority of patients (84%) had disease that was triple refractory (to an immunomodulatory agent, a proteasome inhibitor, and an anti-CD38 antibody), 60% had disease that was penta exposed (to bortezomib, carfilzomib, lenalidomide, pomalidomide, and daratumumab), and 26% had disease that was penta refractory.

At a median follow-up of 13.3 months, 94 of 128 patients (73%) showed a response to therapy (P < .001), with 42 (33%) showing a complete or stringent complete response, and 67 patients (52%) showing a “very good partial response or better.”

Overall median progression-free survival was 8.8 months at the 450×106 dose but more than double that (20.2 months) for patients who achieved a complete or stringent complete response. Estimated median overall survival was 19.4 months, with an overall survival of 78% at 12 months. The authors noted that overall survival data are not yet mature.

After experiencing disease progression, 28 patients were retreated with ide-cel, with 6 patients showing a second response. The durations of response ranged from 1.9 to 6.8 months.

All patients in the cohort experienced adverse events, primarily grade 3 or 4 events that occurred in 127 patients (99%). The most common events reported were hematologic toxicities, including neutropenia in 114 patients (89%), anemia in 77 (60%), and thrombocytopenia in 67 (52%), and were at least partially related to the lymphodepleting chemotherapy administered before ide-cel infusion, the authors note. Cytokine-release syndrome occurred in 107 patients (84%), primarily grade 1 or 2.

“Results of the KarMMa study support substantial antitumor activity for ide-cel across a target dose range of 150×106 to 450×106 CAR+ T cells,” the authors conclude. “The 450×106 dose appeared to be somewhat more effective than the other doses.”
 

New option?

“What this study further highlights is that higher cell dose tends to increase cell expansion, which correlates to improved response and duration of response,” said Dr. Patel.

Importantly, multiple vulnerable subgroups experienced impressive outcomes, such as those who are older or with high risk or extramedullary disease, she noted.

“My patients who have undergone this therapy, albeit on other clinical trials, all say that their quality of life during this time of remission is priceless,” Dr. Patel added. “The is the first therapy in the relapsed/refractory setting that allows patients to have a significant chemo-free period. We need to find more ways to do this for our patients.”

The study was supported by Bluebird Bio and Bristol-Myers Squibb. Dr. Patel has served on the advisory board for Janssen and Bristol-Myers Squibb. She also reports a speaking engagement with Oncopeptides. Dr. Munshi acts as a consultant for several pharmaceutical companies, and many coauthors also have relationships with industry, as listed in the original article.

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

Patients with multiple myeloma that has continued to progress despite many lines of therapy have shown deep and durable responses to a new chimeric antigen receptor (CAR) T-cell therapy, idecabtagene vicleucel (ide-cel, under development by Bristol-Myers Squibb and Bluebird Bio).

An expert not involved in the trial described the results as “phenomenal.”

Krina Patel, MD, an associate professor in the department of lymphoma/myeloma at the University of Texas MD Anderson Cancer Center, Houston, said that “the response rate of 73% in a patient population with a median of six lines of therapy, and with one-third of those patients achieving a deep response of complete response or better, is phenomenal.”

“We are very excited as a myeloma community for this study of idecabtagene vicleucel for relapsed/refractory patients,” Dr. Patel said.

The new data on ide-cell, from a trial in 128 patients, were published Feb. 25 in the New England Journal of Medicine.

Lead investigator of the study Nikhil Munshi, MD, of Dana-Farber Cancer Institute, Boston, said: “The results of this trial represent a true turning point in the treatment of this disease. In my 30 years of treating myeloma, I have not seen any other therapy as effective in this group of patients.”

Both experts highlighted the poor prognosis for this population of relapsed/refractory patients. Recent decades have seen a flurry of new agents for myeloma, and there are now three main classes of agents: immunomodulatory agents, proteasome inhibitors, and anti-CD38 antibodies. Nevertheless, in some patients, the disease continues to progress. For patients who have failed all three classes of drugs, the median progression-free survival is about 3-4 months, with a median overall survival of 8-9 months.
 

Product is awaiting approval

Ide-cel is currently awaiting FDA approval, with a decision date slated for March 27.

Several CAR T-cell products are already marketed for use in certain leukemias and lymphomas, and there is another for use in multiple myeloma, ciltacabtagene autoleucel (cilta-cel, under development by Janssen), that is awaiting approval in Europe.
 

Strong and sustained responses

The trial involved 128 patients treated with ide-cel infusions. At the time of data cutoff for this report (Jan. 14, 2020), 62 patients remained in the primary study. Of the 128 treated patients, the median age was 61 years and the median time since diagnosis was 6 years. About half (51%) had a high tumor burden (≥50% bone marrow plasma cells), 39% had extramedullary disease, 16% had stage III disease, and 35% had a high-risk cytogenetic abnormality, defined as del(17p), t(4;14), or t(14;16).

Patients in the cohort had received a median of six previous antimyeloma regimens (range, 3-16), and most of the patients (120, 94%) had undergone autologous hematopoietic stem cell transplants. In addition, the majority of patients (84%) had disease that was triple refractory (to an immunomodulatory agent, a proteasome inhibitor, and an anti-CD38 antibody), 60% had disease that was penta exposed (to bortezomib, carfilzomib, lenalidomide, pomalidomide, and daratumumab), and 26% had disease that was penta refractory.

At a median follow-up of 13.3 months, 94 of 128 patients (73%) showed a response to therapy (P < .001), with 42 (33%) showing a complete or stringent complete response, and 67 patients (52%) showing a “very good partial response or better.”

Overall median progression-free survival was 8.8 months at the 450×106 dose but more than double that (20.2 months) for patients who achieved a complete or stringent complete response. Estimated median overall survival was 19.4 months, with an overall survival of 78% at 12 months. The authors noted that overall survival data are not yet mature.

After experiencing disease progression, 28 patients were retreated with ide-cel, with 6 patients showing a second response. The durations of response ranged from 1.9 to 6.8 months.

All patients in the cohort experienced adverse events, primarily grade 3 or 4 events that occurred in 127 patients (99%). The most common events reported were hematologic toxicities, including neutropenia in 114 patients (89%), anemia in 77 (60%), and thrombocytopenia in 67 (52%), and were at least partially related to the lymphodepleting chemotherapy administered before ide-cel infusion, the authors note. Cytokine-release syndrome occurred in 107 patients (84%), primarily grade 1 or 2.

“Results of the KarMMa study support substantial antitumor activity for ide-cel across a target dose range of 150×106 to 450×106 CAR+ T cells,” the authors conclude. “The 450×106 dose appeared to be somewhat more effective than the other doses.”
 

New option?

“What this study further highlights is that higher cell dose tends to increase cell expansion, which correlates to improved response and duration of response,” said Dr. Patel.

Importantly, multiple vulnerable subgroups experienced impressive outcomes, such as those who are older or with high risk or extramedullary disease, she noted.

“My patients who have undergone this therapy, albeit on other clinical trials, all say that their quality of life during this time of remission is priceless,” Dr. Patel added. “The is the first therapy in the relapsed/refractory setting that allows patients to have a significant chemo-free period. We need to find more ways to do this for our patients.”

The study was supported by Bluebird Bio and Bristol-Myers Squibb. Dr. Patel has served on the advisory board for Janssen and Bristol-Myers Squibb. She also reports a speaking engagement with Oncopeptides. Dr. Munshi acts as a consultant for several pharmaceutical companies, and many coauthors also have relationships with industry, as listed in the original article.

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

Merck & Co. is withdrawing the U.S. indication for pembrolizumab (Keytruda) for metastatic small cell lung cancer (SCLC) in patients with disease progression on or after platinum-based chemotherapy and at least one other prior line of therapy, according to a company statement.

The move does not affect any of the drug’s other indications. The immunotherapy is used in the treatment of many different types of cancer.

The SCLC indication had been granted an accelerated approval by the Food and Drug Administration in 2019 based on tumor response rate and durability of response data from patient cohorts in two trials. However, the anti-PD-1 therapy failed to demonstrate statistically significant improved overall survival in a confirmatory trial, which is mandated after an accelerated approval.

The FDA is conducting “an industry-wide evaluation of indications based on accelerated approvals that have not yet met their postmarketing requirements,” said Merck.

In February of 2021, an indication for durvalumab (Imfinzi) was withdrawn by AstraZeneca in concert with the FDA after the drug failed to improve overall survival in unresectable metastatic bladder cancer in a confirmatory trial, as reported by Medscape Medical News.

“We will continue to rigorously evaluate the benefits of [pembrolizumab] in small cell lung cancer and other types of cancer, in pursuit of Merck’s mission to save and improve lives,” Roy Baynes, MD, chief medical officer, Merck Research Laboratories, said in the company statement

Dr. Baynes also championed the value of accelerated approvals.

“The accelerated pathways created by the FDA have been integral to the remarkable progress in oncology care over the past 5 years and have helped many cancer patients with advanced disease, including small cell lung cancer, access new treatments,” he said.

However, in the past, the FDA has been criticized for approving new cancer drugs based on surrogate markers such as response rates because, in many cases, subsequent studies often show that the drug fails to improve overall survival.

For example, a 2015 study found that 36 (67%) of 54 cancer drug approvals from 2008 to 2012 were made on the basis of surrogate markers – either tumor response rate or progression-free survival. Over a median follow-up period of 4.4 years, only 5 of those 36 drugs were shown in randomized studies to improve overall survival, as reported by Medscape Medical News.

The FDA says that it instituted the accelerated approval program to “allow for earlier approval of drugs that treat serious conditions, and that fill an unmet medical need based on a surrogate endpoint.” The program was started in 1992, in the midst of the HIV/AIDS epidemic.

In 2020, the nonprofit Friends of Cancer Research issued a white paper calling for reform in the accelerated approval process, which included a proposal to add risk assessment to surrogate endpoints that would factor in variables such as toxicity.

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

Merck & Co. is withdrawing the U.S. indication for pembrolizumab (Keytruda) for metastatic small cell lung cancer (SCLC) in patients with disease progression on or after platinum-based chemotherapy and at least one other prior line of therapy, according to a company statement.

The move does not affect any of the drug’s other indications. The immunotherapy is used in the treatment of many different types of cancer.

The SCLC indication had been granted an accelerated approval by the Food and Drug Administration in 2019 based on tumor response rate and durability of response data from patient cohorts in two trials. However, the anti-PD-1 therapy failed to demonstrate statistically significant improved overall survival in a confirmatory trial, which is mandated after an accelerated approval.

The FDA is conducting “an industry-wide evaluation of indications based on accelerated approvals that have not yet met their postmarketing requirements,” said Merck.

In February of 2021, an indication for durvalumab (Imfinzi) was withdrawn by AstraZeneca in concert with the FDA after the drug failed to improve overall survival in unresectable metastatic bladder cancer in a confirmatory trial, as reported by Medscape Medical News.

“We will continue to rigorously evaluate the benefits of [pembrolizumab] in small cell lung cancer and other types of cancer, in pursuit of Merck’s mission to save and improve lives,” Roy Baynes, MD, chief medical officer, Merck Research Laboratories, said in the company statement

Dr. Baynes also championed the value of accelerated approvals.

“The accelerated pathways created by the FDA have been integral to the remarkable progress in oncology care over the past 5 years and have helped many cancer patients with advanced disease, including small cell lung cancer, access new treatments,” he said.

However, in the past, the FDA has been criticized for approving new cancer drugs based on surrogate markers such as response rates because, in many cases, subsequent studies often show that the drug fails to improve overall survival.

For example, a 2015 study found that 36 (67%) of 54 cancer drug approvals from 2008 to 2012 were made on the basis of surrogate markers – either tumor response rate or progression-free survival. Over a median follow-up period of 4.4 years, only 5 of those 36 drugs were shown in randomized studies to improve overall survival, as reported by Medscape Medical News.

The FDA says that it instituted the accelerated approval program to “allow for earlier approval of drugs that treat serious conditions, and that fill an unmet medical need based on a surrogate endpoint.” The program was started in 1992, in the midst of the HIV/AIDS epidemic.

In 2020, the nonprofit Friends of Cancer Research issued a white paper calling for reform in the accelerated approval process, which included a proposal to add risk assessment to surrogate endpoints that would factor in variables such as toxicity.

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

Merck & Co. is withdrawing the U.S. indication for pembrolizumab (Keytruda) for metastatic small cell lung cancer (SCLC) in patients with disease progression on or after platinum-based chemotherapy and at least one other prior line of therapy, according to a company statement.

The move does not affect any of the drug’s other indications. The immunotherapy is used in the treatment of many different types of cancer.

The SCLC indication had been granted an accelerated approval by the Food and Drug Administration in 2019 based on tumor response rate and durability of response data from patient cohorts in two trials. However, the anti-PD-1 therapy failed to demonstrate statistically significant improved overall survival in a confirmatory trial, which is mandated after an accelerated approval.

The FDA is conducting “an industry-wide evaluation of indications based on accelerated approvals that have not yet met their postmarketing requirements,” said Merck.

In February of 2021, an indication for durvalumab (Imfinzi) was withdrawn by AstraZeneca in concert with the FDA after the drug failed to improve overall survival in unresectable metastatic bladder cancer in a confirmatory trial, as reported by Medscape Medical News.

“We will continue to rigorously evaluate the benefits of [pembrolizumab] in small cell lung cancer and other types of cancer, in pursuit of Merck’s mission to save and improve lives,” Roy Baynes, MD, chief medical officer, Merck Research Laboratories, said in the company statement

Dr. Baynes also championed the value of accelerated approvals.

“The accelerated pathways created by the FDA have been integral to the remarkable progress in oncology care over the past 5 years and have helped many cancer patients with advanced disease, including small cell lung cancer, access new treatments,” he said.

However, in the past, the FDA has been criticized for approving new cancer drugs based on surrogate markers such as response rates because, in many cases, subsequent studies often show that the drug fails to improve overall survival.

For example, a 2015 study found that 36 (67%) of 54 cancer drug approvals from 2008 to 2012 were made on the basis of surrogate markers – either tumor response rate or progression-free survival. Over a median follow-up period of 4.4 years, only 5 of those 36 drugs were shown in randomized studies to improve overall survival, as reported by Medscape Medical News.

The FDA says that it instituted the accelerated approval program to “allow for earlier approval of drugs that treat serious conditions, and that fill an unmet medical need based on a surrogate endpoint.” The program was started in 1992, in the midst of the HIV/AIDS epidemic.

In 2020, the nonprofit Friends of Cancer Research issued a white paper calling for reform in the accelerated approval process, which included a proposal to add risk assessment to surrogate endpoints that would factor in variables such as toxicity.

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

THE CASE

A 14-year-old girl with no significant medical history presented to the office accompanied by her mother for a routine well-adolescent visit. She attended school online due to a history of severe bullying and, when interviewed alone, admitted to a lack of a social life as a result. On questioning, she denied tobacco, alcohol, or illicit drug use. Her gender identity was female. Her sexual orientation was toward both males and females, but she was not sexually active. She denied exposure to physical or emotional violence at home and said she did not feel depressed or think about suicide.

Physical examination revealed multiple erythematous linear scars surrounding the areola of both breasts. When questioned about these lesions, she admitted to cutting herself on the breasts during the past several months but again denied suicidal intent. She believed that her behavior was a normal coping mechanism. 

The physical exam was otherwise normal. Lab results, including thyroid-stimulating hormone and complete blood count, were within normal limits.

THE DIAGNOSIS

The physical exam findings and the patient’s self report pointed to a diagnosis of nonsuicidal self-injurious (NSSI) behavior involving cutting.

DISCUSSION

The NSSI behavior displayed by this patient is a common biopsychosocial disorder observed in adolescents. Self-injury is defined as the deliberate injuring of body tissues without suicidal intent.¹ Self-injurious behavior typically begins when patients are 13 to 16 years of age, and cutting is the most common form. Most acts occur on the arms, legs, wrists, and stomach.² Studies have shown that the prevalence of this behavior is on the rise among adolescents, from about 7% in 2014 to between 14% and 24% in 2015.³

Risk for suicide. Although a feature of NSSI is the lack of suicidal intent, this type of high-risk behavior is associated with past, present, and future suicide attempts. It is important for physicians to identify NSSI in an adolescent, as it is linked to a 7-fold increased risk for a suicide attempt.³

Screening for NSSI. Less than one-fifth of adolescents who injure themselves come to the attention of health care providers.⁴ We propose that primary care physicians add NSSI to the list of risky behaviors—including drug abuse, sexual activity, and depression—for which they screen during well-child visits.

Continue to: Identifying risk factors

Identifying risk factors. The case patient experienced bullying and reported a nonheterosexual orientation, both of which have been demonstrated as strong risk factors for NSSI.⁵ Female gender has also been identified as a risk factor for NSSI.³

In adolescent psychiatric samples, prevalence rates of NSSI were found to be as high as 60% for 1 incident of NSSI and around 50% for repetitive NSSI.⁶ NSSI coincides with other psychiatric comorbidities, including eating disorders, mood disorders (depression), anxiety disorders, posttraumatic stress disorder, and borderline personality disorder.³ In a study of 93 subjects, each of whom was a self-reported abuse survivor with a history of self-injury, 96% were in therapy for diagnoses that included posttraumatic stress disorder (73%), dissociative disorder (40%), borderline personality disorder (37%), and multiple personality disorder (29%).⁷

Some patients may self-harm to generate feeling when emotionally empty or to avert suicidal intent.

The experience of adverse childhood events also increases risk for NSSI. This includes parental neglect, abuse, or deprivation.⁶ Insecure paternal attachment and parental neglect are significant predictors for women, while childhood separation is a primary predictor for men.⁸ Indirect childhood maltreatment, such as witnessing domestic violence or increased parental critique, is also associated with NSSI.⁸ NSSI is also more prevalent among young people who identify with a subculture such as gothic or emo.⁶

Why they do it and how to help

In multiple studies aimed at identifying reasons for self-injury, converging evidence suggests that nearly all patients act with the intent of alleviating negative affect.⁹ Patients self-harm to regulate distress, anxiety, and frustration that they perceive to be intolerable.⁹ They may self-harm to generate feeling when emotionally empty or to avert suicidal intent.⁹ For others, self-harm is a way to communicate their distress.

How to proceed. After a physician identifies NSSI, the patient should be assessed for suicidality and medical severity of the injury.³ Factors associated with higher likelihood of suicidality in patients with NSSI include multiple self-injurious methods and locations, early age of onset, longer history of NSSI, recent worsening of the injuries, simultaneous substance use, and the perception that the patient is addicted to self-injury.¹⁰

Continue to: It is also important...

It is also important to ask the patient whether she or he has told anyone about the behavior. Participation in NSSI communities may reinforce it.³

Treatment found to be effective for NSSI involves dialectical behavioral therapy, cognitive behavioral therapy, and mentalization-based therapy.¹¹

Our patient was admitted to the hospital several weeks after her well visit because she expressed suicidal ideation. After being discharged, she was referred to outpatient Psychiatry with a treatment plan that included cognitive behavioral therapy.

THE TAKEAWAY

While our patient may have concealed her self-injurious experience because of stigma and concern about others’ reactions, there were several risk factors for NSSI in her history that prompted further investigation with a skin exam.

If a patient presents with 1 or more risk factors, an initial assessment for possible NSSI should be performed with detailed history-taking and a skin exam. Once NSSI is identified, the initial response and tone of questioning toward the patient need to convey a sense of genuine curiosity about the patient’s experience. From there, the physician can avail the patient to the proper treatment modalities.

NSSI patients can be resistant to sharing and participating in support groups. However, a referred counselor can follow up with a stepwise approach to slowly gain the trust of the individual, find the root cause, and get the patient to a point where she or he is ready to start the necessary treatment.

THE CASE

A 14-year-old girl with no significant medical history presented to the office accompanied by her mother for a routine well-adolescent visit. She attended school online due to a history of severe bullying and, when interviewed alone, admitted to a lack of a social life as a result. On questioning, she denied tobacco, alcohol, or illicit drug use. Her gender identity was female. Her sexual orientation was toward both males and females, but she was not sexually active. She denied exposure to physical or emotional violence at home and said she did not feel depressed or think about suicide.

Physical examination revealed multiple erythematous linear scars surrounding the areola of both breasts. When questioned about these lesions, she admitted to cutting herself on the breasts during the past several months but again denied suicidal intent. She believed that her behavior was a normal coping mechanism. 

The physical exam was otherwise normal. Lab results, including thyroid-stimulating hormone and complete blood count, were within normal limits.

THE DIAGNOSIS

The physical exam findings and the patient’s self report pointed to a diagnosis of nonsuicidal self-injurious (NSSI) behavior involving cutting.

DISCUSSION

The NSSI behavior displayed by this patient is a common biopsychosocial disorder observed in adolescents. Self-injury is defined as the deliberate injuring of body tissues without suicidal intent.¹ Self-injurious behavior typically begins when patients are 13 to 16 years of age, and cutting is the most common form. Most acts occur on the arms, legs, wrists, and stomach.² Studies have shown that the prevalence of this behavior is on the rise among adolescents, from about 7% in 2014 to between 14% and 24% in 2015.³

Risk for suicide. Although a feature of NSSI is the lack of suicidal intent, this type of high-risk behavior is associated with past, present, and future suicide attempts. It is important for physicians to identify NSSI in an adolescent, as it is linked to a 7-fold increased risk for a suicide attempt.³

Screening for NSSI. Less than one-fifth of adolescents who injure themselves come to the attention of health care providers.⁴ We propose that primary care physicians add NSSI to the list of risky behaviors—including drug abuse, sexual activity, and depression—for which they screen during well-child visits.

Continue to: Identifying risk factors

Identifying risk factors. The case patient experienced bullying and reported a nonheterosexual orientation, both of which have been demonstrated as strong risk factors for NSSI.⁵ Female gender has also been identified as a risk factor for NSSI.³

In adolescent psychiatric samples, prevalence rates of NSSI were found to be as high as 60% for 1 incident of NSSI and around 50% for repetitive NSSI.⁶ NSSI coincides with other psychiatric comorbidities, including eating disorders, mood disorders (depression), anxiety disorders, posttraumatic stress disorder, and borderline personality disorder.³ In a study of 93 subjects, each of whom was a self-reported abuse survivor with a history of self-injury, 96% were in therapy for diagnoses that included posttraumatic stress disorder (73%), dissociative disorder (40%), borderline personality disorder (37%), and multiple personality disorder (29%).⁷

Some patients may self-harm to generate feeling when emotionally empty or to avert suicidal intent.

The experience of adverse childhood events also increases risk for NSSI. This includes parental neglect, abuse, or deprivation.⁶ Insecure paternal attachment and parental neglect are significant predictors for women, while childhood separation is a primary predictor for men.⁸ Indirect childhood maltreatment, such as witnessing domestic violence or increased parental critique, is also associated with NSSI.⁸ NSSI is also more prevalent among young people who identify with a subculture such as gothic or emo.⁶

Why they do it and how to help

In multiple studies aimed at identifying reasons for self-injury, converging evidence suggests that nearly all patients act with the intent of alleviating negative affect.⁹ Patients self-harm to regulate distress, anxiety, and frustration that they perceive to be intolerable.⁹ They may self-harm to generate feeling when emotionally empty or to avert suicidal intent.⁹ For others, self-harm is a way to communicate their distress.

How to proceed. After a physician identifies NSSI, the patient should be assessed for suicidality and medical severity of the injury.³ Factors associated with higher likelihood of suicidality in patients with NSSI include multiple self-injurious methods and locations, early age of onset, longer history of NSSI, recent worsening of the injuries, simultaneous substance use, and the perception that the patient is addicted to self-injury.¹⁰

Continue to: It is also important...

It is also important to ask the patient whether she or he has told anyone about the behavior. Participation in NSSI communities may reinforce it.³

Treatment found to be effective for NSSI involves dialectical behavioral therapy, cognitive behavioral therapy, and mentalization-based therapy.¹¹

Our patient was admitted to the hospital several weeks after her well visit because she expressed suicidal ideation. After being discharged, she was referred to outpatient Psychiatry with a treatment plan that included cognitive behavioral therapy.

THE TAKEAWAY

While our patient may have concealed her self-injurious experience because of stigma and concern about others’ reactions, there were several risk factors for NSSI in her history that prompted further investigation with a skin exam.

If a patient presents with 1 or more risk factors, an initial assessment for possible NSSI should be performed with detailed history-taking and a skin exam. Once NSSI is identified, the initial response and tone of questioning toward the patient need to convey a sense of genuine curiosity about the patient’s experience. From there, the physician can avail the patient to the proper treatment modalities.

NSSI patients can be resistant to sharing and participating in support groups. However, a referred counselor can follow up with a stepwise approach to slowly gain the trust of the individual, find the root cause, and get the patient to a point where she or he is ready to start the necessary treatment.

THE CASE

A 14-year-old girl with no significant medical history presented to the office accompanied by her mother for a routine well-adolescent visit. She attended school online due to a history of severe bullying and, when interviewed alone, admitted to a lack of a social life as a result. On questioning, she denied tobacco, alcohol, or illicit drug use. Her gender identity was female. Her sexual orientation was toward both males and females, but she was not sexually active. She denied exposure to physical or emotional violence at home and said she did not feel depressed or think about suicide.

Physical examination revealed multiple erythematous linear scars surrounding the areola of both breasts. When questioned about these lesions, she admitted to cutting herself on the breasts during the past several months but again denied suicidal intent. She believed that her behavior was a normal coping mechanism. 

The physical exam was otherwise normal. Lab results, including thyroid-stimulating hormone and complete blood count, were within normal limits.

THE DIAGNOSIS

The physical exam findings and the patient’s self report pointed to a diagnosis of nonsuicidal self-injurious (NSSI) behavior involving cutting.

DISCUSSION

The NSSI behavior displayed by this patient is a common biopsychosocial disorder observed in adolescents. Self-injury is defined as the deliberate injuring of body tissues without suicidal intent.¹ Self-injurious behavior typically begins when patients are 13 to 16 years of age, and cutting is the most common form. Most acts occur on the arms, legs, wrists, and stomach.² Studies have shown that the prevalence of this behavior is on the rise among adolescents, from about 7% in 2014 to between 14% and 24% in 2015.³

Risk for suicide. Although a feature of NSSI is the lack of suicidal intent, this type of high-risk behavior is associated with past, present, and future suicide attempts. It is important for physicians to identify NSSI in an adolescent, as it is linked to a 7-fold increased risk for a suicide attempt.³

Screening for NSSI. Less than one-fifth of adolescents who injure themselves come to the attention of health care providers.⁴ We propose that primary care physicians add NSSI to the list of risky behaviors—including drug abuse, sexual activity, and depression—for which they screen during well-child visits.

Continue to: Identifying risk factors

Identifying risk factors. The case patient experienced bullying and reported a nonheterosexual orientation, both of which have been demonstrated as strong risk factors for NSSI.⁵ Female gender has also been identified as a risk factor for NSSI.³

In adolescent psychiatric samples, prevalence rates of NSSI were found to be as high as 60% for 1 incident of NSSI and around 50% for repetitive NSSI.⁶ NSSI coincides with other psychiatric comorbidities, including eating disorders, mood disorders (depression), anxiety disorders, posttraumatic stress disorder, and borderline personality disorder.³ In a study of 93 subjects, each of whom was a self-reported abuse survivor with a history of self-injury, 96% were in therapy for diagnoses that included posttraumatic stress disorder (73%), dissociative disorder (40%), borderline personality disorder (37%), and multiple personality disorder (29%).⁷

Some patients may self-harm to generate feeling when emotionally empty or to avert suicidal intent.

The experience of adverse childhood events also increases risk for NSSI. This includes parental neglect, abuse, or deprivation.⁶ Insecure paternal attachment and parental neglect are significant predictors for women, while childhood separation is a primary predictor for men.⁸ Indirect childhood maltreatment, such as witnessing domestic violence or increased parental critique, is also associated with NSSI.⁸ NSSI is also more prevalent among young people who identify with a subculture such as gothic or emo.⁶

Why they do it and how to help

In multiple studies aimed at identifying reasons for self-injury, converging evidence suggests that nearly all patients act with the intent of alleviating negative affect.⁹ Patients self-harm to regulate distress, anxiety, and frustration that they perceive to be intolerable.⁹ They may self-harm to generate feeling when emotionally empty or to avert suicidal intent.⁹ For others, self-harm is a way to communicate their distress.

How to proceed. After a physician identifies NSSI, the patient should be assessed for suicidality and medical severity of the injury.³ Factors associated with higher likelihood of suicidality in patients with NSSI include multiple self-injurious methods and locations, early age of onset, longer history of NSSI, recent worsening of the injuries, simultaneous substance use, and the perception that the patient is addicted to self-injury.¹⁰

Continue to: It is also important...

It is also important to ask the patient whether she or he has told anyone about the behavior. Participation in NSSI communities may reinforce it.³

Treatment found to be effective for NSSI involves dialectical behavioral therapy, cognitive behavioral therapy, and mentalization-based therapy.¹¹

Our patient was admitted to the hospital several weeks after her well visit because she expressed suicidal ideation. After being discharged, she was referred to outpatient Psychiatry with a treatment plan that included cognitive behavioral therapy.

THE TAKEAWAY

While our patient may have concealed her self-injurious experience because of stigma and concern about others’ reactions, there were several risk factors for NSSI in her history that prompted further investigation with a skin exam.

If a patient presents with 1 or more risk factors, an initial assessment for possible NSSI should be performed with detailed history-taking and a skin exam. Once NSSI is identified, the initial response and tone of questioning toward the patient need to convey a sense of genuine curiosity about the patient’s experience. From there, the physician can avail the patient to the proper treatment modalities.

NSSI patients can be resistant to sharing and participating in support groups. However, a referred counselor can follow up with a stepwise approach to slowly gain the trust of the individual, find the root cause, and get the patient to a point where she or he is ready to start the necessary treatment.

The year 2020 was challenging for public health agencies and especially for the Centers for Disease Control and Prevention (CDC) and its Advisory Committee on Immunization Practices (ACIP). In a normal year, the ACIP meets in person 3 times for a total of 6 days of deliberations. In 2020, there were 10 meetings (all but 1 using Zoom) covering 14 days. Much of the time was dedicated to the COVID-19 pandemic, the vaccines being developed to prevent COVID-19, and the prioritization of those who should receive the vaccines first.

The ACIP also made recommendations for the use of influenza vaccines in the 2020-2021 season, approved the adult and pediatric immunization schedules for 2021, and approved the use of 2 new vaccines, one to protect against meningococcal meningitis and the other to prevent Ebola virus disease. The influenza recommendations were covered in the October 2020 Practice Alert,¹ and the immunization schedules can be found on the CDC website at www.cdc.gov/vaccines/schedules/hcp/index.html.

COVID-19 vaccines

Two COVID-19 vaccines have been approved for use in the United States. The first was the Pfizer-BioNTech COVID-19 vaccine, approved by the Food and Drug Administration (FDA) on December 11 and recommended for use by the ACIP on December 12.² The second vaccine, from Moderna, was approved by the FDA on December 18 and recommended by the ACIP on December 19.³ Both were approved by the FDA under an Emergency Use Authorization (EUA) and were approved by the ACIP for use while the EUA is in effect. Both vaccines must eventually undergo regular approval by the FDA and will be reconsidered by the ACIP regarding use in non–public health emergency conditions. A description of the EUA process and measures taken to assure efficacy and safety, before and after approval, were discussed in the September 2020 audiocast.

Both COVID-19 vaccines consist of nucleoside-modified mRNA encapsulated with lipid nanoparticles, which encode for a spike glycoprotein of SARS-CoV-2, the virus that causes COVID-19. Both vaccines require 2 doses (separated by 3 weeks for the Pfizer vaccine and 4 weeks for the Moderna vaccine) and are approved for use only in adults and older adolescents (ages ≥ 16 years for the Pfizer vaccine and ≥ 18 years for the Moderna vaccine) (TABLE 1^2-5).

In anticipation of vaccine shortages immediately after approval for use and a high demand for the vaccine, the ACIP developed a list of high-priority groups who should receive the vaccine in ranked order.⁶ States are encouraged, but not required, to follow this priority list (TABLE 2⁶).

Caveats with usage. Both COVID-19 vaccines are very reactogenic, causing local and systemic adverse effects that patients should be warned about (TABLE 3^7,8). These reactions are usually mild to moderate and last 24 hours or less. Acetaminophen can alleviate these symptoms but should not be used to prevent them. In addition, both vaccines have stringent cold-storage requirements; once the vaccines are thawed, they must be used within a defined time-period.

Neither vaccine is listed as preferred. And they are not interchangeable; both recommended doses should be completed with the same vaccine. More details about the use of these vaccines were discussed in the January 2021 audiocast (www.mdedge.com/familymedicine/article/234239/coronavirus-updates/covid-19-vaccines-rollout-risks-and-reason-still) and can be located on the CDC website (www.cdc.gov/vaccines/covid-19/info-by-product/pfizer/reactogenicity.html; www.cdc.gov/vaccines/covid-19/info-by-product/moderna/reactogenicity.html).

Continue to: Much remains unknown...

Much remains unknown regarding the use of these COVID-19 vaccines:

• What is their duration of protection, and will booster doses be needed?
• Will they protect against asymptomatic infection and carrier states, and thereby prevent transmission?
• Can they be co-administered with other vaccines?
• Will they be efficacious and safe to use during pregnancy and breastfeeding?

These issues will need to be addressed before they are recommended for non–public health emergency use.

Quadrivalent meningococcal conjugate vaccine (MenACWY)

In June 2020, the ACIP added a third quadrivalent meningococcal conjugate vaccine to its recommended list of vaccines that are FDA-approved for meningococcal disease (TABLE 4⁹). The new vaccine fills a void left by the meningococcal polysaccharide vaccine (MPSV4), which is no longer marketed in the United States. MPSV4 was previously the only meningococcal vaccine approved for individuals 55 years and older.

MenQuadfi, approved for those ≥ 2 years including those > 55, will likely be approved for individuals ≥ 6 months and replace Menactra.

The new vaccine, MenACWY-TT (MenQuadfi), is approved for those ages 2 years and older, including those > 55 years. It is anticipated that MenQuadfi will, in the near future, be licensed and approved for individuals 6 months and older and will replace MenACWY-D (Menactra). (Both are manufactured by Sanofi Pasteur.)

Groups for whom a MenACWY vaccine is recommended are listed in TABLE 5.⁹ A full description of current, updated recommendations for the prevention of meningococcal disease is also available.⁹

Continue to: Ebola virus (EBOV) vaccine

A vaccine to prevent Ebola virus disease (EVD) is available by special request in the United States. Recombinant vesicular stomatitis virus-based Ebola virus vaccine, abbreviated as rVSVΔG-ZEBOV-GP (brand name, ERVBO) is manufactured by Merck and received approval by the FDA on December 19, 2019, for use in those ages 18 years and older. It is a live, attenuated vaccine.

The ACIP has recommended pre-­exposure vaccination with rVSVΔG-­ZEBOV-GP for adults 18 years or older who are at risk of exposure to EBOV while responding to an outbreak of EVD; while working as health care personnel at a federally designated Ebola Treatment Center; or while working at biosafety-level 4 facilities.¹⁰ The vaccine is protective against just 1 of 4 EBOV species, Zaire ebolavirus, which has been the cause of most reported EVD outbreaks, including the 2 largest EVD outbreaks in history that occurred in West Africa and the Republic of Congo.

It is estimated that EBOV outbreaks have infected more than 31,000 people and resulted in more than 12,000 deaths worldwide.¹¹ Only 11 people infected with EBOV have been treated in the United States, all related to the 2014-2016 large outbreaks in West Africa. Nine of these cases were imported and only 1 resulted in transmission, to 2 people.¹⁰ The mammalian species that are suspected as intermediate hosts for EBOV are not present in the United States, which prevents EBOV from becoming endemic here.

The rVSVΔG-ZEBOV-GP vaccine was tested in a large trial in Africa during the 2014 outbreak. Its effectiveness was 100% (95% confidence interval, 63.5%-100%). The most common adverse effects were injection site pain, swelling, and redness. Mild-to-­moderate systemic symptoms can occur within the first 2 days following vaccination, and include headache (37%), fever (34%), muscle pain (33%), fatigue (19%), joint pain (18%), nausea (8%), arthritis (5%), rash (4%), and sweating (3%).¹⁰ Data are not available to assess the safety of the vaccine during pregnancy; vaccinating pregnant women should probably be avoided unless the risk of exposure to EBOV is high.

Since the vaccine contains a live virus that causes stomatitis in animals, it is possible that the virus could be transmitted to humans and other animals through close contact. Accordingly, the CDC has published some precautions including, but not limited to, not donating blood and, for 6 weeks after vaccination, avoiding contact with those who are immunosuppressed.¹⁰ The vaccine is not commercially available in the United States and must be obtained from the CDC. Information on requesting the vaccine is available at www.cdc.gov/vhf/ebola/clinicians/vaccine/.

The year 2020 was challenging for public health agencies and especially for the Centers for Disease Control and Prevention (CDC) and its Advisory Committee on Immunization Practices (ACIP). In a normal year, the ACIP meets in person 3 times for a total of 6 days of deliberations. In 2020, there were 10 meetings (all but 1 using Zoom) covering 14 days. Much of the time was dedicated to the COVID-19 pandemic, the vaccines being developed to prevent COVID-19, and the prioritization of those who should receive the vaccines first.

The ACIP also made recommendations for the use of influenza vaccines in the 2020-2021 season, approved the adult and pediatric immunization schedules for 2021, and approved the use of 2 new vaccines, one to protect against meningococcal meningitis and the other to prevent Ebola virus disease. The influenza recommendations were covered in the October 2020 Practice Alert,¹ and the immunization schedules can be found on the CDC website at www.cdc.gov/vaccines/schedules/hcp/index.html.

COVID-19 vaccines

Two COVID-19 vaccines have been approved for use in the United States. The first was the Pfizer-BioNTech COVID-19 vaccine, approved by the Food and Drug Administration (FDA) on December 11 and recommended for use by the ACIP on December 12.² The second vaccine, from Moderna, was approved by the FDA on December 18 and recommended by the ACIP on December 19.³ Both were approved by the FDA under an Emergency Use Authorization (EUA) and were approved by the ACIP for use while the EUA is in effect. Both vaccines must eventually undergo regular approval by the FDA and will be reconsidered by the ACIP regarding use in non–public health emergency conditions. A description of the EUA process and measures taken to assure efficacy and safety, before and after approval, were discussed in the September 2020 audiocast.

Both COVID-19 vaccines consist of nucleoside-modified mRNA encapsulated with lipid nanoparticles, which encode for a spike glycoprotein of SARS-CoV-2, the virus that causes COVID-19. Both vaccines require 2 doses (separated by 3 weeks for the Pfizer vaccine and 4 weeks for the Moderna vaccine) and are approved for use only in adults and older adolescents (ages ≥ 16 years for the Pfizer vaccine and ≥ 18 years for the Moderna vaccine) (TABLE 1^2-5).

In anticipation of vaccine shortages immediately after approval for use and a high demand for the vaccine, the ACIP developed a list of high-priority groups who should receive the vaccine in ranked order.⁶ States are encouraged, but not required, to follow this priority list (TABLE 2⁶).

Caveats with usage. Both COVID-19 vaccines are very reactogenic, causing local and systemic adverse effects that patients should be warned about (TABLE 3^7,8). These reactions are usually mild to moderate and last 24 hours or less. Acetaminophen can alleviate these symptoms but should not be used to prevent them. In addition, both vaccines have stringent cold-storage requirements; once the vaccines are thawed, they must be used within a defined time-period.

Neither vaccine is listed as preferred. And they are not interchangeable; both recommended doses should be completed with the same vaccine. More details about the use of these vaccines were discussed in the January 2021 audiocast (www.mdedge.com/familymedicine/article/234239/coronavirus-updates/covid-19-vaccines-rollout-risks-and-reason-still) and can be located on the CDC website (www.cdc.gov/vaccines/covid-19/info-by-product/pfizer/reactogenicity.html; www.cdc.gov/vaccines/covid-19/info-by-product/moderna/reactogenicity.html).

Continue to: Much remains unknown...

Much remains unknown regarding the use of these COVID-19 vaccines:

• What is their duration of protection, and will booster doses be needed?
• Will they protect against asymptomatic infection and carrier states, and thereby prevent transmission?
• Can they be co-administered with other vaccines?
• Will they be efficacious and safe to use during pregnancy and breastfeeding?

These issues will need to be addressed before they are recommended for non–public health emergency use.

Quadrivalent meningococcal conjugate vaccine (MenACWY)

In June 2020, the ACIP added a third quadrivalent meningococcal conjugate vaccine to its recommended list of vaccines that are FDA-approved for meningococcal disease (TABLE 4⁹). The new vaccine fills a void left by the meningococcal polysaccharide vaccine (MPSV4), which is no longer marketed in the United States. MPSV4 was previously the only meningococcal vaccine approved for individuals 55 years and older.

MenQuadfi, approved for those ≥ 2 years including those > 55, will likely be approved for individuals ≥ 6 months and replace Menactra.

The new vaccine, MenACWY-TT (MenQuadfi), is approved for those ages 2 years and older, including those > 55 years. It is anticipated that MenQuadfi will, in the near future, be licensed and approved for individuals 6 months and older and will replace MenACWY-D (Menactra). (Both are manufactured by Sanofi Pasteur.)

Groups for whom a MenACWY vaccine is recommended are listed in TABLE 5.⁹ A full description of current, updated recommendations for the prevention of meningococcal disease is also available.⁹

Continue to: Ebola virus (EBOV) vaccine

A vaccine to prevent Ebola virus disease (EVD) is available by special request in the United States. Recombinant vesicular stomatitis virus-based Ebola virus vaccine, abbreviated as rVSVΔG-ZEBOV-GP (brand name, ERVBO) is manufactured by Merck and received approval by the FDA on December 19, 2019, for use in those ages 18 years and older. It is a live, attenuated vaccine.

The ACIP has recommended pre-­exposure vaccination with rVSVΔG-­ZEBOV-GP for adults 18 years or older who are at risk of exposure to EBOV while responding to an outbreak of EVD; while working as health care personnel at a federally designated Ebola Treatment Center; or while working at biosafety-level 4 facilities.¹⁰ The vaccine is protective against just 1 of 4 EBOV species, Zaire ebolavirus, which has been the cause of most reported EVD outbreaks, including the 2 largest EVD outbreaks in history that occurred in West Africa and the Republic of Congo.

It is estimated that EBOV outbreaks have infected more than 31,000 people and resulted in more than 12,000 deaths worldwide.¹¹ Only 11 people infected with EBOV have been treated in the United States, all related to the 2014-2016 large outbreaks in West Africa. Nine of these cases were imported and only 1 resulted in transmission, to 2 people.¹⁰ The mammalian species that are suspected as intermediate hosts for EBOV are not present in the United States, which prevents EBOV from becoming endemic here.

The rVSVΔG-ZEBOV-GP vaccine was tested in a large trial in Africa during the 2014 outbreak. Its effectiveness was 100% (95% confidence interval, 63.5%-100%). The most common adverse effects were injection site pain, swelling, and redness. Mild-to-­moderate systemic symptoms can occur within the first 2 days following vaccination, and include headache (37%), fever (34%), muscle pain (33%), fatigue (19%), joint pain (18%), nausea (8%), arthritis (5%), rash (4%), and sweating (3%).¹⁰ Data are not available to assess the safety of the vaccine during pregnancy; vaccinating pregnant women should probably be avoided unless the risk of exposure to EBOV is high.

Since the vaccine contains a live virus that causes stomatitis in animals, it is possible that the virus could be transmitted to humans and other animals through close contact. Accordingly, the CDC has published some precautions including, but not limited to, not donating blood and, for 6 weeks after vaccination, avoiding contact with those who are immunosuppressed.¹⁰ The vaccine is not commercially available in the United States and must be obtained from the CDC. Information on requesting the vaccine is available at www.cdc.gov/vhf/ebola/clinicians/vaccine/.

The year 2020 was challenging for public health agencies and especially for the Centers for Disease Control and Prevention (CDC) and its Advisory Committee on Immunization Practices (ACIP). In a normal year, the ACIP meets in person 3 times for a total of 6 days of deliberations. In 2020, there were 10 meetings (all but 1 using Zoom) covering 14 days. Much of the time was dedicated to the COVID-19 pandemic, the vaccines being developed to prevent COVID-19, and the prioritization of those who should receive the vaccines first.

The ACIP also made recommendations for the use of influenza vaccines in the 2020-2021 season, approved the adult and pediatric immunization schedules for 2021, and approved the use of 2 new vaccines, one to protect against meningococcal meningitis and the other to prevent Ebola virus disease. The influenza recommendations were covered in the October 2020 Practice Alert,¹ and the immunization schedules can be found on the CDC website at www.cdc.gov/vaccines/schedules/hcp/index.html.

COVID-19 vaccines

Two COVID-19 vaccines have been approved for use in the United States. The first was the Pfizer-BioNTech COVID-19 vaccine, approved by the Food and Drug Administration (FDA) on December 11 and recommended for use by the ACIP on December 12.² The second vaccine, from Moderna, was approved by the FDA on December 18 and recommended by the ACIP on December 19.³ Both were approved by the FDA under an Emergency Use Authorization (EUA) and were approved by the ACIP for use while the EUA is in effect. Both vaccines must eventually undergo regular approval by the FDA and will be reconsidered by the ACIP regarding use in non–public health emergency conditions. A description of the EUA process and measures taken to assure efficacy and safety, before and after approval, were discussed in the September 2020 audiocast.

Both COVID-19 vaccines consist of nucleoside-modified mRNA encapsulated with lipid nanoparticles, which encode for a spike glycoprotein of SARS-CoV-2, the virus that causes COVID-19. Both vaccines require 2 doses (separated by 3 weeks for the Pfizer vaccine and 4 weeks for the Moderna vaccine) and are approved for use only in adults and older adolescents (ages ≥ 16 years for the Pfizer vaccine and ≥ 18 years for the Moderna vaccine) (TABLE 1^2-5).

In anticipation of vaccine shortages immediately after approval for use and a high demand for the vaccine, the ACIP developed a list of high-priority groups who should receive the vaccine in ranked order.⁶ States are encouraged, but not required, to follow this priority list (TABLE 2⁶).

Caveats with usage. Both COVID-19 vaccines are very reactogenic, causing local and systemic adverse effects that patients should be warned about (TABLE 3^7,8). These reactions are usually mild to moderate and last 24 hours or less. Acetaminophen can alleviate these symptoms but should not be used to prevent them. In addition, both vaccines have stringent cold-storage requirements; once the vaccines are thawed, they must be used within a defined time-period.

Neither vaccine is listed as preferred. And they are not interchangeable; both recommended doses should be completed with the same vaccine. More details about the use of these vaccines were discussed in the January 2021 audiocast (www.mdedge.com/familymedicine/article/234239/coronavirus-updates/covid-19-vaccines-rollout-risks-and-reason-still) and can be located on the CDC website (www.cdc.gov/vaccines/covid-19/info-by-product/pfizer/reactogenicity.html; www.cdc.gov/vaccines/covid-19/info-by-product/moderna/reactogenicity.html).

Continue to: Much remains unknown...

Much remains unknown regarding the use of these COVID-19 vaccines:

• What is their duration of protection, and will booster doses be needed?
• Will they protect against asymptomatic infection and carrier states, and thereby prevent transmission?
• Can they be co-administered with other vaccines?
• Will they be efficacious and safe to use during pregnancy and breastfeeding?

These issues will need to be addressed before they are recommended for non–public health emergency use.

Quadrivalent meningococcal conjugate vaccine (MenACWY)

In June 2020, the ACIP added a third quadrivalent meningococcal conjugate vaccine to its recommended list of vaccines that are FDA-approved for meningococcal disease (TABLE 4⁹). The new vaccine fills a void left by the meningococcal polysaccharide vaccine (MPSV4), which is no longer marketed in the United States. MPSV4 was previously the only meningococcal vaccine approved for individuals 55 years and older.

MenQuadfi, approved for those ≥ 2 years including those > 55, will likely be approved for individuals ≥ 6 months and replace Menactra.

The new vaccine, MenACWY-TT (MenQuadfi), is approved for those ages 2 years and older, including those > 55 years. It is anticipated that MenQuadfi will, in the near future, be licensed and approved for individuals 6 months and older and will replace MenACWY-D (Menactra). (Both are manufactured by Sanofi Pasteur.)

Groups for whom a MenACWY vaccine is recommended are listed in TABLE 5.⁹ A full description of current, updated recommendations for the prevention of meningococcal disease is also available.⁹

Continue to: Ebola virus (EBOV) vaccine

A vaccine to prevent Ebola virus disease (EVD) is available by special request in the United States. Recombinant vesicular stomatitis virus-based Ebola virus vaccine, abbreviated as rVSVΔG-ZEBOV-GP (brand name, ERVBO) is manufactured by Merck and received approval by the FDA on December 19, 2019, for use in those ages 18 years and older. It is a live, attenuated vaccine.

The ACIP has recommended pre-­exposure vaccination with rVSVΔG-­ZEBOV-GP for adults 18 years or older who are at risk of exposure to EBOV while responding to an outbreak of EVD; while working as health care personnel at a federally designated Ebola Treatment Center; or while working at biosafety-level 4 facilities.¹⁰ The vaccine is protective against just 1 of 4 EBOV species, Zaire ebolavirus, which has been the cause of most reported EVD outbreaks, including the 2 largest EVD outbreaks in history that occurred in West Africa and the Republic of Congo.

It is estimated that EBOV outbreaks have infected more than 31,000 people and resulted in more than 12,000 deaths worldwide.¹¹ Only 11 people infected with EBOV have been treated in the United States, all related to the 2014-2016 large outbreaks in West Africa. Nine of these cases were imported and only 1 resulted in transmission, to 2 people.¹⁰ The mammalian species that are suspected as intermediate hosts for EBOV are not present in the United States, which prevents EBOV from becoming endemic here.

The rVSVΔG-ZEBOV-GP vaccine was tested in a large trial in Africa during the 2014 outbreak. Its effectiveness was 100% (95% confidence interval, 63.5%-100%). The most common adverse effects were injection site pain, swelling, and redness. Mild-to-­moderate systemic symptoms can occur within the first 2 days following vaccination, and include headache (37%), fever (34%), muscle pain (33%), fatigue (19%), joint pain (18%), nausea (8%), arthritis (5%), rash (4%), and sweating (3%).¹⁰ Data are not available to assess the safety of the vaccine during pregnancy; vaccinating pregnant women should probably be avoided unless the risk of exposure to EBOV is high.

Since the vaccine contains a live virus that causes stomatitis in animals, it is possible that the virus could be transmitted to humans and other animals through close contact. Accordingly, the CDC has published some precautions including, but not limited to, not donating blood and, for 6 weeks after vaccination, avoiding contact with those who are immunosuppressed.¹⁰ The vaccine is not commercially available in the United States and must be obtained from the CDC. Information on requesting the vaccine is available at www.cdc.gov/vhf/ebola/clinicians/vaccine/.