User login
CDC director cites rise in hospitalizations in urging teen vaccinations
“I am deeply concerned by the numbers of hospitalized adolescents and saddened to see the number of adolescents who required treatment in intensive care units or mechanical ventilation,” CDC Director Rochelle Walensky, MD, said in a statement.
While urging teenagers to wear masks and take precautions around others, she asked “parents, relatives, and close friends to join me and talk with teens about the importance of these prevention strategies and to encourage them to get vaccinated.”
Dr. Walensky referred to the CDC’s Morbidity and Mortality Weekly Report that showed adolescent hospitalizations peaked at 2.1 per 100,000 in early January 2021, then dropped to 0.6 per 100,000 in mid-March.
Alarmingly, hospitalizations rose to 1.3 per 100,000 in April, and a number of teens required serious interventions.
“Among hospitalized adolescents, nearly one-third required intensive care unit admission, and 5% required invasive mechanical ventilation,” the report said. No deaths occurred.
The study looked at 376 adolescents aged 12-17 who were hospitalized and tested positive for coronavirus. Of that group, 204 were hospitalized for COVID-19 and the other 172 were hospitalized for reasons not directly related to COVID-19.
Of the 204 hospitalized for COVID-19, 70.6% had an underlying medical condition such as obesity or chronic lung disease.
The study noted that children and teenagers have lower hospitalization rates and generally show less severe symptoms than do older people.
Possible causes for the rise in adolescent COVID-19 hospitalizations include the arrival of variants, the growing number of children returning to in-person education, and the changes in mask-wearing and other safety precautions, the study said.
The American Academy of Pediatrics said that as of May 27, 4 million children have tested positive for COVID-19 since the pandemic began, with about 34,500 new child cases reported for the week ending May 27.
The AAP said children have represented 14.1% of total cases since the pandemic began, but for the week ending May 27, children represented 24.3% of new reported weekly COVID-19 cases.
On May 10, the FDA granted emergency use authorization for the Pfizer coronavirus vaccine to be given to children aged 12-15 years. Previously, the FDA had authorized the Pfizer vaccine for people aged 16 years and up, whereas the Moderna and Johnson & Johnson vaccines are authorized for people aged 18 years and up.
“Vaccination is our way out of this pandemic,” Dr. Walensky said in her statement. “I continue to see promising signs in CDC data that we are nearing the end of this pandemic in this country; however, we all have to do our part and get vaccinated to cross the finish line.”
A version of this article was first published on WebMD.com.
“I am deeply concerned by the numbers of hospitalized adolescents and saddened to see the number of adolescents who required treatment in intensive care units or mechanical ventilation,” CDC Director Rochelle Walensky, MD, said in a statement.
While urging teenagers to wear masks and take precautions around others, she asked “parents, relatives, and close friends to join me and talk with teens about the importance of these prevention strategies and to encourage them to get vaccinated.”
Dr. Walensky referred to the CDC’s Morbidity and Mortality Weekly Report that showed adolescent hospitalizations peaked at 2.1 per 100,000 in early January 2021, then dropped to 0.6 per 100,000 in mid-March.
Alarmingly, hospitalizations rose to 1.3 per 100,000 in April, and a number of teens required serious interventions.
“Among hospitalized adolescents, nearly one-third required intensive care unit admission, and 5% required invasive mechanical ventilation,” the report said. No deaths occurred.
The study looked at 376 adolescents aged 12-17 who were hospitalized and tested positive for coronavirus. Of that group, 204 were hospitalized for COVID-19 and the other 172 were hospitalized for reasons not directly related to COVID-19.
Of the 204 hospitalized for COVID-19, 70.6% had an underlying medical condition such as obesity or chronic lung disease.
The study noted that children and teenagers have lower hospitalization rates and generally show less severe symptoms than do older people.
Possible causes for the rise in adolescent COVID-19 hospitalizations include the arrival of variants, the growing number of children returning to in-person education, and the changes in mask-wearing and other safety precautions, the study said.
The American Academy of Pediatrics said that as of May 27, 4 million children have tested positive for COVID-19 since the pandemic began, with about 34,500 new child cases reported for the week ending May 27.
The AAP said children have represented 14.1% of total cases since the pandemic began, but for the week ending May 27, children represented 24.3% of new reported weekly COVID-19 cases.
On May 10, the FDA granted emergency use authorization for the Pfizer coronavirus vaccine to be given to children aged 12-15 years. Previously, the FDA had authorized the Pfizer vaccine for people aged 16 years and up, whereas the Moderna and Johnson & Johnson vaccines are authorized for people aged 18 years and up.
“Vaccination is our way out of this pandemic,” Dr. Walensky said in her statement. “I continue to see promising signs in CDC data that we are nearing the end of this pandemic in this country; however, we all have to do our part and get vaccinated to cross the finish line.”
A version of this article was first published on WebMD.com.
“I am deeply concerned by the numbers of hospitalized adolescents and saddened to see the number of adolescents who required treatment in intensive care units or mechanical ventilation,” CDC Director Rochelle Walensky, MD, said in a statement.
While urging teenagers to wear masks and take precautions around others, she asked “parents, relatives, and close friends to join me and talk with teens about the importance of these prevention strategies and to encourage them to get vaccinated.”
Dr. Walensky referred to the CDC’s Morbidity and Mortality Weekly Report that showed adolescent hospitalizations peaked at 2.1 per 100,000 in early January 2021, then dropped to 0.6 per 100,000 in mid-March.
Alarmingly, hospitalizations rose to 1.3 per 100,000 in April, and a number of teens required serious interventions.
“Among hospitalized adolescents, nearly one-third required intensive care unit admission, and 5% required invasive mechanical ventilation,” the report said. No deaths occurred.
The study looked at 376 adolescents aged 12-17 who were hospitalized and tested positive for coronavirus. Of that group, 204 were hospitalized for COVID-19 and the other 172 were hospitalized for reasons not directly related to COVID-19.
Of the 204 hospitalized for COVID-19, 70.6% had an underlying medical condition such as obesity or chronic lung disease.
The study noted that children and teenagers have lower hospitalization rates and generally show less severe symptoms than do older people.
Possible causes for the rise in adolescent COVID-19 hospitalizations include the arrival of variants, the growing number of children returning to in-person education, and the changes in mask-wearing and other safety precautions, the study said.
The American Academy of Pediatrics said that as of May 27, 4 million children have tested positive for COVID-19 since the pandemic began, with about 34,500 new child cases reported for the week ending May 27.
The AAP said children have represented 14.1% of total cases since the pandemic began, but for the week ending May 27, children represented 24.3% of new reported weekly COVID-19 cases.
On May 10, the FDA granted emergency use authorization for the Pfizer coronavirus vaccine to be given to children aged 12-15 years. Previously, the FDA had authorized the Pfizer vaccine for people aged 16 years and up, whereas the Moderna and Johnson & Johnson vaccines are authorized for people aged 18 years and up.
“Vaccination is our way out of this pandemic,” Dr. Walensky said in her statement. “I continue to see promising signs in CDC data that we are nearing the end of this pandemic in this country; however, we all have to do our part and get vaccinated to cross the finish line.”
A version of this article was first published on WebMD.com.
Improving racial and gender equity in pediatric HM programs
Converge 2021 session
Racial and Gender Equity in Your PHM Program
Presenters
Jorge Ganem, MD, FAAP, and Vanessa N. Durand, DO, FAAP
Session summary
Dr. Ganem, associate professor of pediatrics at the University of Texas at Austin and director of pediatric hospital medicine at Dell Children’s Medical Center, and Dr. Durand, assistant professor of pediatrics at Drexel University and pediatric hospitalist at St. Christopher’s Hospital for Children, Philadelphia, presented an engaging session regarding gender equity in the workplace during SHM Converge 2021.
Dr. Ganem and Dr. Durand first presented data to illustrate the gender equity problem. They touched on the mental burden underrepresented minorities face professionally. Dr. Ganem and Dr. Durand discussed cognitive biases, defined allyship, sponsorship, and mentorship and shared how to distinguish between the three. They concluded their session with concrete ways to narrow gaps in equity in hospital medicine programs.
The highlights of this session included evidence-based “best-practices” that pediatric hospital medicine divisions can adopt. One important theme was regarding metrics. Dr. Ganem and Dr. Durand shared how important it is to evaluate divisions for pay and diversity gaps. Armed with these data, programs can be more effective in developing solutions. Some solutions provided by the presenters included “blind” interviews where traditional “cognitive metrics” (i.e., board scores) are not shared with interviewers to minimize anchoring and confirmation biases. Instead, interviewers should focus on the experiences and attributes of the job that the applicant can hopefully embody. This could be accomplished using a holistic review tool from the Association of American Medical Colleges.
One of the most powerful ideas shared in this session was a quote from a Harvard student shown in a video regarding bias and racism where he said, “Nothing in all the world is more dangerous than sincere ignorance and conscious stupidity.” Changes will only happen if we make them happen.
Key takeaways
- Racial and gender equity are problems that are undeniable, even in pediatrics.
- Be wary of conscious biases and the mental burden placed unfairly on underrepresented minorities in your institution.
- Becoming an amplifier, a sponsor, or a champion are ways to make a small individual difference.
- Measure your program’s data and commit to making change using evidence-based actions and assessments aimed at decreasing bias and increasing equity.
References
Association of American Medical Colleges. Holistic Review. 2021. www.aamc.org/services/member-capacity-building/holistic-review.
Dr. Singh is a board-certified pediatric hospitalist at Stanford University and Lucile Packard Children’s Hospital Stanford, both in Palo Alto, Calif. He is a native Texan living in the San Francisco Bay area with his wife and two young boys. His nonclinical passions include bedside communication and inpatient health care information technology.
Converge 2021 session
Racial and Gender Equity in Your PHM Program
Presenters
Jorge Ganem, MD, FAAP, and Vanessa N. Durand, DO, FAAP
Session summary
Dr. Ganem, associate professor of pediatrics at the University of Texas at Austin and director of pediatric hospital medicine at Dell Children’s Medical Center, and Dr. Durand, assistant professor of pediatrics at Drexel University and pediatric hospitalist at St. Christopher’s Hospital for Children, Philadelphia, presented an engaging session regarding gender equity in the workplace during SHM Converge 2021.
Dr. Ganem and Dr. Durand first presented data to illustrate the gender equity problem. They touched on the mental burden underrepresented minorities face professionally. Dr. Ganem and Dr. Durand discussed cognitive biases, defined allyship, sponsorship, and mentorship and shared how to distinguish between the three. They concluded their session with concrete ways to narrow gaps in equity in hospital medicine programs.
The highlights of this session included evidence-based “best-practices” that pediatric hospital medicine divisions can adopt. One important theme was regarding metrics. Dr. Ganem and Dr. Durand shared how important it is to evaluate divisions for pay and diversity gaps. Armed with these data, programs can be more effective in developing solutions. Some solutions provided by the presenters included “blind” interviews where traditional “cognitive metrics” (i.e., board scores) are not shared with interviewers to minimize anchoring and confirmation biases. Instead, interviewers should focus on the experiences and attributes of the job that the applicant can hopefully embody. This could be accomplished using a holistic review tool from the Association of American Medical Colleges.
One of the most powerful ideas shared in this session was a quote from a Harvard student shown in a video regarding bias and racism where he said, “Nothing in all the world is more dangerous than sincere ignorance and conscious stupidity.” Changes will only happen if we make them happen.
Key takeaways
- Racial and gender equity are problems that are undeniable, even in pediatrics.
- Be wary of conscious biases and the mental burden placed unfairly on underrepresented minorities in your institution.
- Becoming an amplifier, a sponsor, or a champion are ways to make a small individual difference.
- Measure your program’s data and commit to making change using evidence-based actions and assessments aimed at decreasing bias and increasing equity.
References
Association of American Medical Colleges. Holistic Review. 2021. www.aamc.org/services/member-capacity-building/holistic-review.
Dr. Singh is a board-certified pediatric hospitalist at Stanford University and Lucile Packard Children’s Hospital Stanford, both in Palo Alto, Calif. He is a native Texan living in the San Francisco Bay area with his wife and two young boys. His nonclinical passions include bedside communication and inpatient health care information technology.
Converge 2021 session
Racial and Gender Equity in Your PHM Program
Presenters
Jorge Ganem, MD, FAAP, and Vanessa N. Durand, DO, FAAP
Session summary
Dr. Ganem, associate professor of pediatrics at the University of Texas at Austin and director of pediatric hospital medicine at Dell Children’s Medical Center, and Dr. Durand, assistant professor of pediatrics at Drexel University and pediatric hospitalist at St. Christopher’s Hospital for Children, Philadelphia, presented an engaging session regarding gender equity in the workplace during SHM Converge 2021.
Dr. Ganem and Dr. Durand first presented data to illustrate the gender equity problem. They touched on the mental burden underrepresented minorities face professionally. Dr. Ganem and Dr. Durand discussed cognitive biases, defined allyship, sponsorship, and mentorship and shared how to distinguish between the three. They concluded their session with concrete ways to narrow gaps in equity in hospital medicine programs.
The highlights of this session included evidence-based “best-practices” that pediatric hospital medicine divisions can adopt. One important theme was regarding metrics. Dr. Ganem and Dr. Durand shared how important it is to evaluate divisions for pay and diversity gaps. Armed with these data, programs can be more effective in developing solutions. Some solutions provided by the presenters included “blind” interviews where traditional “cognitive metrics” (i.e., board scores) are not shared with interviewers to minimize anchoring and confirmation biases. Instead, interviewers should focus on the experiences and attributes of the job that the applicant can hopefully embody. This could be accomplished using a holistic review tool from the Association of American Medical Colleges.
One of the most powerful ideas shared in this session was a quote from a Harvard student shown in a video regarding bias and racism where he said, “Nothing in all the world is more dangerous than sincere ignorance and conscious stupidity.” Changes will only happen if we make them happen.
Key takeaways
- Racial and gender equity are problems that are undeniable, even in pediatrics.
- Be wary of conscious biases and the mental burden placed unfairly on underrepresented minorities in your institution.
- Becoming an amplifier, a sponsor, or a champion are ways to make a small individual difference.
- Measure your program’s data and commit to making change using evidence-based actions and assessments aimed at decreasing bias and increasing equity.
References
Association of American Medical Colleges. Holistic Review. 2021. www.aamc.org/services/member-capacity-building/holistic-review.
Dr. Singh is a board-certified pediatric hospitalist at Stanford University and Lucile Packard Children’s Hospital Stanford, both in Palo Alto, Calif. He is a native Texan living in the San Francisco Bay area with his wife and two young boys. His nonclinical passions include bedside communication and inpatient health care information technology.
FROM SHM CONVERGE 2021
A primer on COVID-19 in hospitalized children
Converge 2021 session
COVID-19 in Children
Presenter
Philip Zachariah, MD, MPH
Session summary
Children have been less severely affected by COVID-19 than adults (hospitalization rates around 5%). However, once hospitalized, ICU admission rates in children have been similar to adults, around 30%. Mortality has been 1%-2%. Risk factors for more severe acute SARS CoV-2 infections include age extremes, minorities, obesity, medical complexity, immunocompromised pediatric patients, and asthma.
Multisystem-inflammatory-syndrome-in-children (MIS-C) continues to present among persistently febrile children with multisystem findings and the history of acute COVID-19 infection in prior 3-6 weeks. There seems to be a link between the immunological defects in type I and II interferon production, as autoantibodies to type I interferon may predispose to severe disease. Dr. Zachariah of Columbia University Medical Center in New York, discussed the recent study exploring intravenous immunoglobulin (IVIG) alone versus IVIG and steroids as treatment options for MIS-C. So far, the failure rates in IVIG-alone group were higher (51%) versus IVIG and steroids (9%).
Besides MIS-C, many neurological manifestations of COVID-19 have been seen among children including GBS, seizures, encephalitis, cranial neuropathies, and demyelination cases. Diabetic ketoacidosis (DKA), secondary hemophagocytic lymphohistiocytosis (HLH), and pseudo-appendicitis have all been described in the literature, however, larger case control studied are needed.
In children, clinical vascular thrombotic events (VTEs) are rare. Anticoagulant thromboprophylaxis is suggested for hospitalized patients with COVID-19–related illness, whose D-dimer is >5 times upper limit of normal values and who have one or more non–COVID-19 related clinical risk factors for hospital acquired VTEs.
Key takeaways
- Once hospitalized, the ICU admission rates for children have been similar to those in adults, ~30%.
- MIS-C is showing lower failure rates if treated with IVIG and steroids, and most reliable laboratory findings should be elevated C-reactive protein, lymphopenia, and elevated brain natriuretic peptide.
- In hospitalized children with COVID-19, clinical VTEs are rare.
Dr. Giordano is an associate professor of pediatrics at Columbia University Medical Center in New York. She is a pediatric hospitalist with expertise in pediatric surgical comanagement
Converge 2021 session
COVID-19 in Children
Presenter
Philip Zachariah, MD, MPH
Session summary
Children have been less severely affected by COVID-19 than adults (hospitalization rates around 5%). However, once hospitalized, ICU admission rates in children have been similar to adults, around 30%. Mortality has been 1%-2%. Risk factors for more severe acute SARS CoV-2 infections include age extremes, minorities, obesity, medical complexity, immunocompromised pediatric patients, and asthma.
Multisystem-inflammatory-syndrome-in-children (MIS-C) continues to present among persistently febrile children with multisystem findings and the history of acute COVID-19 infection in prior 3-6 weeks. There seems to be a link between the immunological defects in type I and II interferon production, as autoantibodies to type I interferon may predispose to severe disease. Dr. Zachariah of Columbia University Medical Center in New York, discussed the recent study exploring intravenous immunoglobulin (IVIG) alone versus IVIG and steroids as treatment options for MIS-C. So far, the failure rates in IVIG-alone group were higher (51%) versus IVIG and steroids (9%).
Besides MIS-C, many neurological manifestations of COVID-19 have been seen among children including GBS, seizures, encephalitis, cranial neuropathies, and demyelination cases. Diabetic ketoacidosis (DKA), secondary hemophagocytic lymphohistiocytosis (HLH), and pseudo-appendicitis have all been described in the literature, however, larger case control studied are needed.
In children, clinical vascular thrombotic events (VTEs) are rare. Anticoagulant thromboprophylaxis is suggested for hospitalized patients with COVID-19–related illness, whose D-dimer is >5 times upper limit of normal values and who have one or more non–COVID-19 related clinical risk factors for hospital acquired VTEs.
Key takeaways
- Once hospitalized, the ICU admission rates for children have been similar to those in adults, ~30%.
- MIS-C is showing lower failure rates if treated with IVIG and steroids, and most reliable laboratory findings should be elevated C-reactive protein, lymphopenia, and elevated brain natriuretic peptide.
- In hospitalized children with COVID-19, clinical VTEs are rare.
Dr. Giordano is an associate professor of pediatrics at Columbia University Medical Center in New York. She is a pediatric hospitalist with expertise in pediatric surgical comanagement
Converge 2021 session
COVID-19 in Children
Presenter
Philip Zachariah, MD, MPH
Session summary
Children have been less severely affected by COVID-19 than adults (hospitalization rates around 5%). However, once hospitalized, ICU admission rates in children have been similar to adults, around 30%. Mortality has been 1%-2%. Risk factors for more severe acute SARS CoV-2 infections include age extremes, minorities, obesity, medical complexity, immunocompromised pediatric patients, and asthma.
Multisystem-inflammatory-syndrome-in-children (MIS-C) continues to present among persistently febrile children with multisystem findings and the history of acute COVID-19 infection in prior 3-6 weeks. There seems to be a link between the immunological defects in type I and II interferon production, as autoantibodies to type I interferon may predispose to severe disease. Dr. Zachariah of Columbia University Medical Center in New York, discussed the recent study exploring intravenous immunoglobulin (IVIG) alone versus IVIG and steroids as treatment options for MIS-C. So far, the failure rates in IVIG-alone group were higher (51%) versus IVIG and steroids (9%).
Besides MIS-C, many neurological manifestations of COVID-19 have been seen among children including GBS, seizures, encephalitis, cranial neuropathies, and demyelination cases. Diabetic ketoacidosis (DKA), secondary hemophagocytic lymphohistiocytosis (HLH), and pseudo-appendicitis have all been described in the literature, however, larger case control studied are needed.
In children, clinical vascular thrombotic events (VTEs) are rare. Anticoagulant thromboprophylaxis is suggested for hospitalized patients with COVID-19–related illness, whose D-dimer is >5 times upper limit of normal values and who have one or more non–COVID-19 related clinical risk factors for hospital acquired VTEs.
Key takeaways
- Once hospitalized, the ICU admission rates for children have been similar to those in adults, ~30%.
- MIS-C is showing lower failure rates if treated with IVIG and steroids, and most reliable laboratory findings should be elevated C-reactive protein, lymphopenia, and elevated brain natriuretic peptide.
- In hospitalized children with COVID-19, clinical VTEs are rare.
Dr. Giordano is an associate professor of pediatrics at Columbia University Medical Center in New York. She is a pediatric hospitalist with expertise in pediatric surgical comanagement
FROM SHM CONVERGE 2021
EULAR, ACR present preliminary recommendations for rare genetic autoinflammatory diseases
As researchers learn more about the genetic etiology of immunopathology, they have been able to more clearly understand rare but debilitating autoinflammatory conditions in ways that have improved identification and management of these diseases. At this year’s European Congress of Rheumatology, two researchers outlined new recommendations from the European Alliance of Associations for Rheumatology (EULAR) and the American College of Rheumatology (ACR) for the management of two groups of such autoinflammatory diseases: interleukin-1-mediated and Type-I interferonopathies, and suspected macrophage activation syndrome and hemophagocytic lymphohistiocytosis.
These are the first recommendations from EULAR for these diseases, according to Loreto Carmona, MD, PhD, chair of the EULAR scientific program committee and scientific director of the Institute for Musculoskeletal Health in Madrid.
“They are rare diseases and there is a great need to standardize diagnosis and care for the safety and outcome of the patients,” Dr. Carmona said in an interview. “These diseases need deep expertise and so the experts are trying, they are still preliminary, to add clarity to their management.” Dr. Carmona was not involved with the development of the guidelines and moderated the session during which they were presented.
“The rapidly emerging knowledge of the genetic causes of novel systemic autoinflammatory diseases, which present typically in early childhood with severe and chronic systemic and organ-specific inflammation, linked the disease pathogenesis to the pathologic production of major proinflammatory cytokines,” presenter Raphaela Goldbach-Mansky, MD, a senior investigator and chief of the translational autoinflammatory disease studies unit of the U.S. National Institute of Allergy and Infectious Diseases, told congress attendees. This greater understanding led to the “targeted and anticytokine treatments that have changed patients’ lives,” she said.
The guidelines relied on the products of three working groups for each disease type. After meeting to come up with clinical questions, the groups each conducted systematic literature reviews through EMBASE, PubMed, and the Cochrane Library for publications dated from 1970 to August 2020 that excluded non-English-language studies, case reports, and animal model or basic science studies. They then met again to develop final consensus statements.
The interferonopathy and interleukin (IL)-1-mediated systemic autoinflammatory diseases (SAIDs) working groups met throughout 2020, and the hemophagocytic lymphohistiocytosis (HLH)/ macrophage activation syndrome (MAS) working group met in March and April of 2021.
“One needs a lot of experience with these diseases to even think about them,” Dr. Carmona said. “We haven’t been presented yet with all the details of the recommendations, but we hope they are clear because they are much needed.”
She noted that these preliminary recommendations are based on the best available evidence to date along with expertise from multidisciplinary panels.
“We need to be acquainted with these recommendations, as the majority of us, either if we are pediatric or adult rheumatologists, will face some problem with these diseases at some point,” Dr. Carmona said.
IL-1-mediated SAIDs
Recommendations for IL-1-mediated SAIDs focused on mevalonate kinase deficiency (MKD), tumor necrosis factor receptor-associated periodic syndrome (TRAPS), cryopyrinopathies (CAPS), and deficiency of the IL-1 receptor antagonist (DIRA). Presentation of these conditions involves chronic or intermittent flares of systemic and organ inflammation that can cause progressive organ damage, morbidity, and increased mortality if not treated. Diagnosis requires a multidisciplinary team whose evaluation should include disease-related complications and long-term care plans.
Diagnostic workup should include genetic testing using next-generation sequencing as this “facilitates initiation of targeted treatments, genetic counseling, and informs prognosis” for patients with CAPS, TRAPS, MKD, and DIRA, Erkan Demirkaya, MD, a scientist at the Children’s Health Research Institute and professor of pediatric rheumatology at the University of Western Ontario in London, Canada, told attendees. Evaluation should also include clinical workup that focuses on the extent of inflammatory organ involvement, and screening for disease- and treatment-related comorbidities.
“The goal of therapy is to control clinical signs and symptoms and normalize laboratory biomarkers of systemic inflammation,” Dr. Demirkaya said. Long-term monitoring goals should focus on the following:
- “Adequate treatment adjusted to the needs of the growing child and prevention of systemic and organ-specific inflammatory manifestations;
- Fostering of self-management skills and medical decision-making;
- Initiating a transition program to adult specialist care in adolescent patients.”
Type-1 interferonopathies
The recommendations for this disease group focused on chronic atypical neutrophilic dermatosis with lipodystrophy and elevated temperatures (CANDLE)/proteasome-associated autoinflammatory syndromes (PRAAS), STING-associated vasculopathy with onset in infancy (SAVI), and Aicardi-Goutières syndrome (AGS).
These patients similarly present with chronic and organ-specific inflammation that leads to progressive organ damage, morbidity, and higher mortality risk when not managed. Each of these diseases requires a confirmed genetic diagnosis so that treatments can be targeted and the patient receives appropriate genetic counseling, screening for complications, and information on prognosis, Dr. Goldbach-Mansky said.
Treatment goals for type-1 interferonopathies are to “reduce systematic and organ inflammation to prevent or limit the development of progression of organ injury or damage and to improve quality of life,” Dr. Goldbach-Mansky told attendees.
Each patient requires a multidisciplinary care provider team that conducts long-term monitoring of disease activity, damage to specific organs, and any treatment-related complications.
Management of HLH/MAS
Early recognition and management of HLH and MAS can be challenging because systemic hyperinflammation exists along an immunopathologic continuum with typically nonspecific clinical and laboratory findings, Dr. Goldbach-Mansky said, but holistic, longitudinal consideration of these findings “are recognizable and warrant prompt diagnostic evaluation.” Even if the patient does not meet all specific diagnostic criteria for HLH/MAS, it may be necessary to begin therapies, she said.
One important point to consider is that “systemic hyperinflammation can be associated with hyperferritinemia and can progress to life-threatening HLH/MAS,” Dr. Goldbach-Mansky said. Further, although “systemic hyperinflammation and HLH/MAS can occur in nearly any inflammatory state,” certain common triggers and predisposing conditions can indicate the need to consider these conditions and begin appropriate treatment if needed. Part of effective management of systemic hyperinflammation and HLH/MAS is determining any modifiable factors contributing to the disease and mitigating or treating those.
HLH/MAS requires urgent intervention based on the patient’s degree of inflammation and extent of organ dysfunction, the recommendations state. Treatment goals include preventing or limiting immunopathology, preserving the integrity of the diagnostic workup, and minimizing therapy-related toxicity.
Dr. Carmona, Dr. Goldbach-Mansky, and Dr. Demirkaya have reported no relevant financial relationships.
A version of this article first appeared on Medscape.com.
As researchers learn more about the genetic etiology of immunopathology, they have been able to more clearly understand rare but debilitating autoinflammatory conditions in ways that have improved identification and management of these diseases. At this year’s European Congress of Rheumatology, two researchers outlined new recommendations from the European Alliance of Associations for Rheumatology (EULAR) and the American College of Rheumatology (ACR) for the management of two groups of such autoinflammatory diseases: interleukin-1-mediated and Type-I interferonopathies, and suspected macrophage activation syndrome and hemophagocytic lymphohistiocytosis.
These are the first recommendations from EULAR for these diseases, according to Loreto Carmona, MD, PhD, chair of the EULAR scientific program committee and scientific director of the Institute for Musculoskeletal Health in Madrid.
“They are rare diseases and there is a great need to standardize diagnosis and care for the safety and outcome of the patients,” Dr. Carmona said in an interview. “These diseases need deep expertise and so the experts are trying, they are still preliminary, to add clarity to their management.” Dr. Carmona was not involved with the development of the guidelines and moderated the session during which they were presented.
“The rapidly emerging knowledge of the genetic causes of novel systemic autoinflammatory diseases, which present typically in early childhood with severe and chronic systemic and organ-specific inflammation, linked the disease pathogenesis to the pathologic production of major proinflammatory cytokines,” presenter Raphaela Goldbach-Mansky, MD, a senior investigator and chief of the translational autoinflammatory disease studies unit of the U.S. National Institute of Allergy and Infectious Diseases, told congress attendees. This greater understanding led to the “targeted and anticytokine treatments that have changed patients’ lives,” she said.
The guidelines relied on the products of three working groups for each disease type. After meeting to come up with clinical questions, the groups each conducted systematic literature reviews through EMBASE, PubMed, and the Cochrane Library for publications dated from 1970 to August 2020 that excluded non-English-language studies, case reports, and animal model or basic science studies. They then met again to develop final consensus statements.
The interferonopathy and interleukin (IL)-1-mediated systemic autoinflammatory diseases (SAIDs) working groups met throughout 2020, and the hemophagocytic lymphohistiocytosis (HLH)/ macrophage activation syndrome (MAS) working group met in March and April of 2021.
“One needs a lot of experience with these diseases to even think about them,” Dr. Carmona said. “We haven’t been presented yet with all the details of the recommendations, but we hope they are clear because they are much needed.”
She noted that these preliminary recommendations are based on the best available evidence to date along with expertise from multidisciplinary panels.
“We need to be acquainted with these recommendations, as the majority of us, either if we are pediatric or adult rheumatologists, will face some problem with these diseases at some point,” Dr. Carmona said.
IL-1-mediated SAIDs
Recommendations for IL-1-mediated SAIDs focused on mevalonate kinase deficiency (MKD), tumor necrosis factor receptor-associated periodic syndrome (TRAPS), cryopyrinopathies (CAPS), and deficiency of the IL-1 receptor antagonist (DIRA). Presentation of these conditions involves chronic or intermittent flares of systemic and organ inflammation that can cause progressive organ damage, morbidity, and increased mortality if not treated. Diagnosis requires a multidisciplinary team whose evaluation should include disease-related complications and long-term care plans.
Diagnostic workup should include genetic testing using next-generation sequencing as this “facilitates initiation of targeted treatments, genetic counseling, and informs prognosis” for patients with CAPS, TRAPS, MKD, and DIRA, Erkan Demirkaya, MD, a scientist at the Children’s Health Research Institute and professor of pediatric rheumatology at the University of Western Ontario in London, Canada, told attendees. Evaluation should also include clinical workup that focuses on the extent of inflammatory organ involvement, and screening for disease- and treatment-related comorbidities.
“The goal of therapy is to control clinical signs and symptoms and normalize laboratory biomarkers of systemic inflammation,” Dr. Demirkaya said. Long-term monitoring goals should focus on the following:
- “Adequate treatment adjusted to the needs of the growing child and prevention of systemic and organ-specific inflammatory manifestations;
- Fostering of self-management skills and medical decision-making;
- Initiating a transition program to adult specialist care in adolescent patients.”
Type-1 interferonopathies
The recommendations for this disease group focused on chronic atypical neutrophilic dermatosis with lipodystrophy and elevated temperatures (CANDLE)/proteasome-associated autoinflammatory syndromes (PRAAS), STING-associated vasculopathy with onset in infancy (SAVI), and Aicardi-Goutières syndrome (AGS).
These patients similarly present with chronic and organ-specific inflammation that leads to progressive organ damage, morbidity, and higher mortality risk when not managed. Each of these diseases requires a confirmed genetic diagnosis so that treatments can be targeted and the patient receives appropriate genetic counseling, screening for complications, and information on prognosis, Dr. Goldbach-Mansky said.
Treatment goals for type-1 interferonopathies are to “reduce systematic and organ inflammation to prevent or limit the development of progression of organ injury or damage and to improve quality of life,” Dr. Goldbach-Mansky told attendees.
Each patient requires a multidisciplinary care provider team that conducts long-term monitoring of disease activity, damage to specific organs, and any treatment-related complications.
Management of HLH/MAS
Early recognition and management of HLH and MAS can be challenging because systemic hyperinflammation exists along an immunopathologic continuum with typically nonspecific clinical and laboratory findings, Dr. Goldbach-Mansky said, but holistic, longitudinal consideration of these findings “are recognizable and warrant prompt diagnostic evaluation.” Even if the patient does not meet all specific diagnostic criteria for HLH/MAS, it may be necessary to begin therapies, she said.
One important point to consider is that “systemic hyperinflammation can be associated with hyperferritinemia and can progress to life-threatening HLH/MAS,” Dr. Goldbach-Mansky said. Further, although “systemic hyperinflammation and HLH/MAS can occur in nearly any inflammatory state,” certain common triggers and predisposing conditions can indicate the need to consider these conditions and begin appropriate treatment if needed. Part of effective management of systemic hyperinflammation and HLH/MAS is determining any modifiable factors contributing to the disease and mitigating or treating those.
HLH/MAS requires urgent intervention based on the patient’s degree of inflammation and extent of organ dysfunction, the recommendations state. Treatment goals include preventing or limiting immunopathology, preserving the integrity of the diagnostic workup, and minimizing therapy-related toxicity.
Dr. Carmona, Dr. Goldbach-Mansky, and Dr. Demirkaya have reported no relevant financial relationships.
A version of this article first appeared on Medscape.com.
As researchers learn more about the genetic etiology of immunopathology, they have been able to more clearly understand rare but debilitating autoinflammatory conditions in ways that have improved identification and management of these diseases. At this year’s European Congress of Rheumatology, two researchers outlined new recommendations from the European Alliance of Associations for Rheumatology (EULAR) and the American College of Rheumatology (ACR) for the management of two groups of such autoinflammatory diseases: interleukin-1-mediated and Type-I interferonopathies, and suspected macrophage activation syndrome and hemophagocytic lymphohistiocytosis.
These are the first recommendations from EULAR for these diseases, according to Loreto Carmona, MD, PhD, chair of the EULAR scientific program committee and scientific director of the Institute for Musculoskeletal Health in Madrid.
“They are rare diseases and there is a great need to standardize diagnosis and care for the safety and outcome of the patients,” Dr. Carmona said in an interview. “These diseases need deep expertise and so the experts are trying, they are still preliminary, to add clarity to their management.” Dr. Carmona was not involved with the development of the guidelines and moderated the session during which they were presented.
“The rapidly emerging knowledge of the genetic causes of novel systemic autoinflammatory diseases, which present typically in early childhood with severe and chronic systemic and organ-specific inflammation, linked the disease pathogenesis to the pathologic production of major proinflammatory cytokines,” presenter Raphaela Goldbach-Mansky, MD, a senior investigator and chief of the translational autoinflammatory disease studies unit of the U.S. National Institute of Allergy and Infectious Diseases, told congress attendees. This greater understanding led to the “targeted and anticytokine treatments that have changed patients’ lives,” she said.
The guidelines relied on the products of three working groups for each disease type. After meeting to come up with clinical questions, the groups each conducted systematic literature reviews through EMBASE, PubMed, and the Cochrane Library for publications dated from 1970 to August 2020 that excluded non-English-language studies, case reports, and animal model or basic science studies. They then met again to develop final consensus statements.
The interferonopathy and interleukin (IL)-1-mediated systemic autoinflammatory diseases (SAIDs) working groups met throughout 2020, and the hemophagocytic lymphohistiocytosis (HLH)/ macrophage activation syndrome (MAS) working group met in March and April of 2021.
“One needs a lot of experience with these diseases to even think about them,” Dr. Carmona said. “We haven’t been presented yet with all the details of the recommendations, but we hope they are clear because they are much needed.”
She noted that these preliminary recommendations are based on the best available evidence to date along with expertise from multidisciplinary panels.
“We need to be acquainted with these recommendations, as the majority of us, either if we are pediatric or adult rheumatologists, will face some problem with these diseases at some point,” Dr. Carmona said.
IL-1-mediated SAIDs
Recommendations for IL-1-mediated SAIDs focused on mevalonate kinase deficiency (MKD), tumor necrosis factor receptor-associated periodic syndrome (TRAPS), cryopyrinopathies (CAPS), and deficiency of the IL-1 receptor antagonist (DIRA). Presentation of these conditions involves chronic or intermittent flares of systemic and organ inflammation that can cause progressive organ damage, morbidity, and increased mortality if not treated. Diagnosis requires a multidisciplinary team whose evaluation should include disease-related complications and long-term care plans.
Diagnostic workup should include genetic testing using next-generation sequencing as this “facilitates initiation of targeted treatments, genetic counseling, and informs prognosis” for patients with CAPS, TRAPS, MKD, and DIRA, Erkan Demirkaya, MD, a scientist at the Children’s Health Research Institute and professor of pediatric rheumatology at the University of Western Ontario in London, Canada, told attendees. Evaluation should also include clinical workup that focuses on the extent of inflammatory organ involvement, and screening for disease- and treatment-related comorbidities.
“The goal of therapy is to control clinical signs and symptoms and normalize laboratory biomarkers of systemic inflammation,” Dr. Demirkaya said. Long-term monitoring goals should focus on the following:
- “Adequate treatment adjusted to the needs of the growing child and prevention of systemic and organ-specific inflammatory manifestations;
- Fostering of self-management skills and medical decision-making;
- Initiating a transition program to adult specialist care in adolescent patients.”
Type-1 interferonopathies
The recommendations for this disease group focused on chronic atypical neutrophilic dermatosis with lipodystrophy and elevated temperatures (CANDLE)/proteasome-associated autoinflammatory syndromes (PRAAS), STING-associated vasculopathy with onset in infancy (SAVI), and Aicardi-Goutières syndrome (AGS).
These patients similarly present with chronic and organ-specific inflammation that leads to progressive organ damage, morbidity, and higher mortality risk when not managed. Each of these diseases requires a confirmed genetic diagnosis so that treatments can be targeted and the patient receives appropriate genetic counseling, screening for complications, and information on prognosis, Dr. Goldbach-Mansky said.
Treatment goals for type-1 interferonopathies are to “reduce systematic and organ inflammation to prevent or limit the development of progression of organ injury or damage and to improve quality of life,” Dr. Goldbach-Mansky told attendees.
Each patient requires a multidisciplinary care provider team that conducts long-term monitoring of disease activity, damage to specific organs, and any treatment-related complications.
Management of HLH/MAS
Early recognition and management of HLH and MAS can be challenging because systemic hyperinflammation exists along an immunopathologic continuum with typically nonspecific clinical and laboratory findings, Dr. Goldbach-Mansky said, but holistic, longitudinal consideration of these findings “are recognizable and warrant prompt diagnostic evaluation.” Even if the patient does not meet all specific diagnostic criteria for HLH/MAS, it may be necessary to begin therapies, she said.
One important point to consider is that “systemic hyperinflammation can be associated with hyperferritinemia and can progress to life-threatening HLH/MAS,” Dr. Goldbach-Mansky said. Further, although “systemic hyperinflammation and HLH/MAS can occur in nearly any inflammatory state,” certain common triggers and predisposing conditions can indicate the need to consider these conditions and begin appropriate treatment if needed. Part of effective management of systemic hyperinflammation and HLH/MAS is determining any modifiable factors contributing to the disease and mitigating or treating those.
HLH/MAS requires urgent intervention based on the patient’s degree of inflammation and extent of organ dysfunction, the recommendations state. Treatment goals include preventing or limiting immunopathology, preserving the integrity of the diagnostic workup, and minimizing therapy-related toxicity.
Dr. Carmona, Dr. Goldbach-Mansky, and Dr. Demirkaya have reported no relevant financial relationships.
A version of this article first appeared on Medscape.com.
FROM THE EULAR 2021 CONGRESS
Child suicides drive Colorado hospital to declare state of emergency
On May 25, Jena Hausmann, CEO of Children’s Hospital Colorado, Aurora, declared a state of emergency in youth mental health in response to an astronomical increase in pediatric mental health cases, including suicide, which has overwhelmed the institution.
From April 2019 to April 2021, the demand for pediatric behavioral health treatment at the hospital system increased by 90%. In Colorado, suicide is now the number one cause of death among youth and occurs in children as young as 10 years of age.
“Now we are seeing our pediatric emergency departments and our inpatient units overrun with kids attempting suicide and suffering from other forms of major mental health illness,” Dr. Hausmann said in a press release.
“We had to draw attention to what we’re seeing in our hospital and our community on an everyday basis – an unprecedented number of suicidal children who need acute treatment for behavioral health problems – and when I say ‘unprecedented,’ I’m serious – I’ve been in pediatrics for two decades and have never seen anything like this before,” David Brumbaugh, MD, a pediatric gastroenterologist and chief medical officer for Children’s Colorado, told this news organization.
Christine Crawford, MD, associate medical director of the National Alliance on Mental Illness, stated in an interview that she “commends the CEO of the hospital for making this announcement, because it is outrageous to see what is happening with more and more children with significant psychiatric symptoms who are not getting adequate care.”
Jenna Glover, PhD, child psychologist and director of psychology training at Children’s Hospital, said that during the past decade, there has been a steady increase in depression, anxiety, and suicide among youth in Colorado. Suicide, she added, is now the number one cause of death in youth, “so we were already in a state of crisis.” She added that COVID-19 was “the straw that broke the camel’s back.”
“In January to April of this year, behavioral health ED visits to Children’s Hospital were 72% higher than they were 2 years ago at this time,” she said. “Colorado Springs had a 145% increase for ED behavioral health visits during the first 4 months of 2021, compared to the first 4 months of 2020.”
COVID’s impact
Other problems that have been “skyrocketing” in youth are self-harm, substance use, and eating disorders. Younger children are experiencing an increase in behavioral problems, including developmental regression, such as tantrums, and problems with sleeping, toileting, and eating, Dr. Glover noted.
The youth mental health crisis has mushroomed, although social distancing requirements are now beginning to ease and we are in the “home stretch of the pandemic,” Dr. Brumbaugh said.
One possible reason “is that we took kids out of their normal routines, social circles, friendships, etc., for 12 months, and that was the limit of their physiological or mental resistance, and they got to the end of their rope,” he speculated.
Dr. Glover said, “Kids are burned out, and although they’re asking to return to their life, they don’t feel they have the resources. They feel so behind; they don’t know how to catch up.”
Dr. Brumbaugh said that there are not enough child psychiatrists to provide outpatient services or enough inpatient beds for children in crisis.
“This is an unacceptable situation. We would never allow a child with leukemia or appendicitis to go several weeks without treatment,” he said.
Community donors have come forward, enabling an anticipated 50% increase in Children’s Hospital’s mental health outpatient, inpatient, and day services by March 2022.
“On a hospital level, we are continuing to do things to expand access to care, like opening units that provide different levels of care for patients with psychiatric problems, as well as expanding into areas that are more rural,” Dr. Glover said.
However, the “blueprint is not in action yet, and a lot of money still needs to be allocated. A workforce has to be created, because there are not enough clinicians to fill these roles,” she added.
Chronic underfunding
Dr. Brumbaugh said Colorado has always had a “relatively underfunded behavioral health system for kids.” A 2021 report by
However, Dr. Glover noted that Colorado is “not exceptional.” The increased vulnerability to youth mental illness and suicide is characteristic of other mountain states, which have larger rural areas, less access to care, and increased access to guns, she said.
Mass shootings may have amped up stress levels. “For some kids, this is happening in their schools or towns, and they feel traumatized and unsafe,” Dr. Glover added.
Dr. Crawford, who is an assistant professor of psychiatry at Boston University, also pointed out that the mental health crisis in youth is not unique to Colorado.
“Throughout the country, we’ve seen these colliding pandemics – inadequate mental health resources for children and COVID-19, which exacerbated the existing mental health crisis,” she said.
“The pandemic led to an increase in telehealth services, making individual and group psychotherapy available to kids in areas that never had access to these before, which is a ‘silver lining’ of the pandemic,” Dr. Glover said.
Dr. Crawford is “encouraged that we are having more conversations about pediatric mental health, because the pandemic amplified what was already going on and made it impossible to ignore.”
Screening is essential
Screening for mental health problems should be at the top of the mind of pediatricians and other clinicians who work with children, Dr. Glover said.
“Pediatricians are in the best place to catch potentially suicidal kids, because they are more likely to see these kids than therapists,” she noted.
She suggested using a rapid screen for depression, such as the Patient Health Questionnaire-9 (PHQ-9) modified for adolescents. Parents can also fill out a PHQ-9 for younger children and even for themselves.
“Depression, anxiety, and suicidality affect the whole family, so screening for these conditions in adults will benefit the children too,” she said. Teachers should also “be aware of what depression and anxiety symptoms look like in kids, because sometimes they can manifest more as irritability,” Dr. Glover added.
Policymakers and insurers need to prioritize pediatric mental health when determining allocation of health care, said Dr. Crawford.
“Financial incentives should be provided for hospitals to want to reserve beds for psychiatric patients, and in the outpatient setting, we also need to look at the payment structure of psychiatric visits,” she added.
Many psychiatrists do not want to accept insurance because of the increased bureaucracy and low reimbursement rates of insurance companies, and families cannot afford to pay out of pocket, “so we really need to look at the insurance issue at a policy level,” Dr. Crawford said.
Dr. Brumbaugh, Dr. Glover, and Dr. Crawford have disclosed no relevant financial relationships.
A version of this article first appeared on Medscape.com.
On May 25, Jena Hausmann, CEO of Children’s Hospital Colorado, Aurora, declared a state of emergency in youth mental health in response to an astronomical increase in pediatric mental health cases, including suicide, which has overwhelmed the institution.
From April 2019 to April 2021, the demand for pediatric behavioral health treatment at the hospital system increased by 90%. In Colorado, suicide is now the number one cause of death among youth and occurs in children as young as 10 years of age.
“Now we are seeing our pediatric emergency departments and our inpatient units overrun with kids attempting suicide and suffering from other forms of major mental health illness,” Dr. Hausmann said in a press release.
“We had to draw attention to what we’re seeing in our hospital and our community on an everyday basis – an unprecedented number of suicidal children who need acute treatment for behavioral health problems – and when I say ‘unprecedented,’ I’m serious – I’ve been in pediatrics for two decades and have never seen anything like this before,” David Brumbaugh, MD, a pediatric gastroenterologist and chief medical officer for Children’s Colorado, told this news organization.
Christine Crawford, MD, associate medical director of the National Alliance on Mental Illness, stated in an interview that she “commends the CEO of the hospital for making this announcement, because it is outrageous to see what is happening with more and more children with significant psychiatric symptoms who are not getting adequate care.”
Jenna Glover, PhD, child psychologist and director of psychology training at Children’s Hospital, said that during the past decade, there has been a steady increase in depression, anxiety, and suicide among youth in Colorado. Suicide, she added, is now the number one cause of death in youth, “so we were already in a state of crisis.” She added that COVID-19 was “the straw that broke the camel’s back.”
“In January to April of this year, behavioral health ED visits to Children’s Hospital were 72% higher than they were 2 years ago at this time,” she said. “Colorado Springs had a 145% increase for ED behavioral health visits during the first 4 months of 2021, compared to the first 4 months of 2020.”
COVID’s impact
Other problems that have been “skyrocketing” in youth are self-harm, substance use, and eating disorders. Younger children are experiencing an increase in behavioral problems, including developmental regression, such as tantrums, and problems with sleeping, toileting, and eating, Dr. Glover noted.
The youth mental health crisis has mushroomed, although social distancing requirements are now beginning to ease and we are in the “home stretch of the pandemic,” Dr. Brumbaugh said.
One possible reason “is that we took kids out of their normal routines, social circles, friendships, etc., for 12 months, and that was the limit of their physiological or mental resistance, and they got to the end of their rope,” he speculated.
Dr. Glover said, “Kids are burned out, and although they’re asking to return to their life, they don’t feel they have the resources. They feel so behind; they don’t know how to catch up.”
Dr. Brumbaugh said that there are not enough child psychiatrists to provide outpatient services or enough inpatient beds for children in crisis.
“This is an unacceptable situation. We would never allow a child with leukemia or appendicitis to go several weeks without treatment,” he said.
Community donors have come forward, enabling an anticipated 50% increase in Children’s Hospital’s mental health outpatient, inpatient, and day services by March 2022.
“On a hospital level, we are continuing to do things to expand access to care, like opening units that provide different levels of care for patients with psychiatric problems, as well as expanding into areas that are more rural,” Dr. Glover said.
However, the “blueprint is not in action yet, and a lot of money still needs to be allocated. A workforce has to be created, because there are not enough clinicians to fill these roles,” she added.
Chronic underfunding
Dr. Brumbaugh said Colorado has always had a “relatively underfunded behavioral health system for kids.” A 2021 report by
However, Dr. Glover noted that Colorado is “not exceptional.” The increased vulnerability to youth mental illness and suicide is characteristic of other mountain states, which have larger rural areas, less access to care, and increased access to guns, she said.
Mass shootings may have amped up stress levels. “For some kids, this is happening in their schools or towns, and they feel traumatized and unsafe,” Dr. Glover added.
Dr. Crawford, who is an assistant professor of psychiatry at Boston University, also pointed out that the mental health crisis in youth is not unique to Colorado.
“Throughout the country, we’ve seen these colliding pandemics – inadequate mental health resources for children and COVID-19, which exacerbated the existing mental health crisis,” she said.
“The pandemic led to an increase in telehealth services, making individual and group psychotherapy available to kids in areas that never had access to these before, which is a ‘silver lining’ of the pandemic,” Dr. Glover said.
Dr. Crawford is “encouraged that we are having more conversations about pediatric mental health, because the pandemic amplified what was already going on and made it impossible to ignore.”
Screening is essential
Screening for mental health problems should be at the top of the mind of pediatricians and other clinicians who work with children, Dr. Glover said.
“Pediatricians are in the best place to catch potentially suicidal kids, because they are more likely to see these kids than therapists,” she noted.
She suggested using a rapid screen for depression, such as the Patient Health Questionnaire-9 (PHQ-9) modified for adolescents. Parents can also fill out a PHQ-9 for younger children and even for themselves.
“Depression, anxiety, and suicidality affect the whole family, so screening for these conditions in adults will benefit the children too,” she said. Teachers should also “be aware of what depression and anxiety symptoms look like in kids, because sometimes they can manifest more as irritability,” Dr. Glover added.
Policymakers and insurers need to prioritize pediatric mental health when determining allocation of health care, said Dr. Crawford.
“Financial incentives should be provided for hospitals to want to reserve beds for psychiatric patients, and in the outpatient setting, we also need to look at the payment structure of psychiatric visits,” she added.
Many psychiatrists do not want to accept insurance because of the increased bureaucracy and low reimbursement rates of insurance companies, and families cannot afford to pay out of pocket, “so we really need to look at the insurance issue at a policy level,” Dr. Crawford said.
Dr. Brumbaugh, Dr. Glover, and Dr. Crawford have disclosed no relevant financial relationships.
A version of this article first appeared on Medscape.com.
On May 25, Jena Hausmann, CEO of Children’s Hospital Colorado, Aurora, declared a state of emergency in youth mental health in response to an astronomical increase in pediatric mental health cases, including suicide, which has overwhelmed the institution.
From April 2019 to April 2021, the demand for pediatric behavioral health treatment at the hospital system increased by 90%. In Colorado, suicide is now the number one cause of death among youth and occurs in children as young as 10 years of age.
“Now we are seeing our pediatric emergency departments and our inpatient units overrun with kids attempting suicide and suffering from other forms of major mental health illness,” Dr. Hausmann said in a press release.
“We had to draw attention to what we’re seeing in our hospital and our community on an everyday basis – an unprecedented number of suicidal children who need acute treatment for behavioral health problems – and when I say ‘unprecedented,’ I’m serious – I’ve been in pediatrics for two decades and have never seen anything like this before,” David Brumbaugh, MD, a pediatric gastroenterologist and chief medical officer for Children’s Colorado, told this news organization.
Christine Crawford, MD, associate medical director of the National Alliance on Mental Illness, stated in an interview that she “commends the CEO of the hospital for making this announcement, because it is outrageous to see what is happening with more and more children with significant psychiatric symptoms who are not getting adequate care.”
Jenna Glover, PhD, child psychologist and director of psychology training at Children’s Hospital, said that during the past decade, there has been a steady increase in depression, anxiety, and suicide among youth in Colorado. Suicide, she added, is now the number one cause of death in youth, “so we were already in a state of crisis.” She added that COVID-19 was “the straw that broke the camel’s back.”
“In January to April of this year, behavioral health ED visits to Children’s Hospital were 72% higher than they were 2 years ago at this time,” she said. “Colorado Springs had a 145% increase for ED behavioral health visits during the first 4 months of 2021, compared to the first 4 months of 2020.”
COVID’s impact
Other problems that have been “skyrocketing” in youth are self-harm, substance use, and eating disorders. Younger children are experiencing an increase in behavioral problems, including developmental regression, such as tantrums, and problems with sleeping, toileting, and eating, Dr. Glover noted.
The youth mental health crisis has mushroomed, although social distancing requirements are now beginning to ease and we are in the “home stretch of the pandemic,” Dr. Brumbaugh said.
One possible reason “is that we took kids out of their normal routines, social circles, friendships, etc., for 12 months, and that was the limit of their physiological or mental resistance, and they got to the end of their rope,” he speculated.
Dr. Glover said, “Kids are burned out, and although they’re asking to return to their life, they don’t feel they have the resources. They feel so behind; they don’t know how to catch up.”
Dr. Brumbaugh said that there are not enough child psychiatrists to provide outpatient services or enough inpatient beds for children in crisis.
“This is an unacceptable situation. We would never allow a child with leukemia or appendicitis to go several weeks without treatment,” he said.
Community donors have come forward, enabling an anticipated 50% increase in Children’s Hospital’s mental health outpatient, inpatient, and day services by March 2022.
“On a hospital level, we are continuing to do things to expand access to care, like opening units that provide different levels of care for patients with psychiatric problems, as well as expanding into areas that are more rural,” Dr. Glover said.
However, the “blueprint is not in action yet, and a lot of money still needs to be allocated. A workforce has to be created, because there are not enough clinicians to fill these roles,” she added.
Chronic underfunding
Dr. Brumbaugh said Colorado has always had a “relatively underfunded behavioral health system for kids.” A 2021 report by
However, Dr. Glover noted that Colorado is “not exceptional.” The increased vulnerability to youth mental illness and suicide is characteristic of other mountain states, which have larger rural areas, less access to care, and increased access to guns, she said.
Mass shootings may have amped up stress levels. “For some kids, this is happening in their schools or towns, and they feel traumatized and unsafe,” Dr. Glover added.
Dr. Crawford, who is an assistant professor of psychiatry at Boston University, also pointed out that the mental health crisis in youth is not unique to Colorado.
“Throughout the country, we’ve seen these colliding pandemics – inadequate mental health resources for children and COVID-19, which exacerbated the existing mental health crisis,” she said.
“The pandemic led to an increase in telehealth services, making individual and group psychotherapy available to kids in areas that never had access to these before, which is a ‘silver lining’ of the pandemic,” Dr. Glover said.
Dr. Crawford is “encouraged that we are having more conversations about pediatric mental health, because the pandemic amplified what was already going on and made it impossible to ignore.”
Screening is essential
Screening for mental health problems should be at the top of the mind of pediatricians and other clinicians who work with children, Dr. Glover said.
“Pediatricians are in the best place to catch potentially suicidal kids, because they are more likely to see these kids than therapists,” she noted.
She suggested using a rapid screen for depression, such as the Patient Health Questionnaire-9 (PHQ-9) modified for adolescents. Parents can also fill out a PHQ-9 for younger children and even for themselves.
“Depression, anxiety, and suicidality affect the whole family, so screening for these conditions in adults will benefit the children too,” she said. Teachers should also “be aware of what depression and anxiety symptoms look like in kids, because sometimes they can manifest more as irritability,” Dr. Glover added.
Policymakers and insurers need to prioritize pediatric mental health when determining allocation of health care, said Dr. Crawford.
“Financial incentives should be provided for hospitals to want to reserve beds for psychiatric patients, and in the outpatient setting, we also need to look at the payment structure of psychiatric visits,” she added.
Many psychiatrists do not want to accept insurance because of the increased bureaucracy and low reimbursement rates of insurance companies, and families cannot afford to pay out of pocket, “so we really need to look at the insurance issue at a policy level,” Dr. Crawford said.
Dr. Brumbaugh, Dr. Glover, and Dr. Crawford have disclosed no relevant financial relationships.
A version of this article first appeared on Medscape.com.
Mortality trends in childhood after infant bacterial meningitis
Among infants younger than 1 year of age, bacterial meningitis is associated with worse long-term mortality, even after recovery from the initial infection. Heightened mortality risk stretched out to 10 years, and was highest in the wake of infection from Streptococcus agalactiae, according to a retrospective analysis of children in the Netherlands.
“The adjusted hazard rates were high for the whole group of bacterial meningitis, especially within the first year after onset. (Staphylococcus agalactiae) meningitis has the highest mortality risk within one year of disease onset,” Linde Snoek said during her presentation of the study (abstract 913) at the annual meeting of the European Society for Paediatric Infectious Diseases, held virtually this year. Ms. Snoek is a PhD student at Amsterdam University Medical Center.
Over longer time periods, the mortality associations were different. “The adjusted hazard rates were highest for pneumococcal meningitis compared to the other pathogens. And this was the case for 1 year, 5 years, and 10 years after disease onset,” said Ms. Snoek.
The study appears to be the first to look at extended mortality following bacterial meningitis in this age group, according to Marie Rohr, MD, who comoderated the session where the research was presented.
“In a quick review of the literature I did not find any [equivalent] study concerning short- and long-term mortality after bacterial meningitis in under 1 year of age,” said Dr. Rohr, a fellow in pediatric infectious diseases at University Hospitals of Geneva. But the message to physicians is clear. “Children with history of bacterial meningitis have a higher long-term mortality than children without a history of bacterial meningitis,” said Dr. Rohr.
The study did have a key limitation: For matched controls, it relied on anonymous data from the Municipal Personal Records Database in Statistics Netherlands. “Important information like cause of death is lacking,” said Dr. Rohr.
Bacterial meningitis is associated with significant mortality and morbidity. Pathogens behind the infections vary with age group and geographic location, as well as immunization status.
To examine long-term mortality after bacterial meningitis, the researchers collected 1,646 records from an exposed cohort, with a date range of 1995 to 2018, from the Netherlands Reference Laboratory for Bacterial Meningitis. Included patients had a positive culture diagnosis of bacterial meningitis during the first year of life. Each exposed subject was compared to 10 controls matched by birth month, birth year, and sex, who had no exposure to bacterial meningitis.
Staphylococcus pneumoniae accounted for the most cases, at 32.0% (median age of onset, 180 days), followed by Neisseria meningitidis at 29.0% (median age of onset, 203 days). Other pathogens included S. agalactiae (19.7%, 10 days), Escherichia coli (8.8%, 13 days), and Haemophilus influenzae (5.4%, 231 days).
The mortality risk within 1 year of disease onset was higher for all pathogens (6.2% vs. 0.2% unexposed). The highest mortality risk was seen for S. agalactiae (8.7%), followed by E. coli (6.4%), N. meningitidis (4.9%), and H. influenzae (3.4%).
Hazard ratios (HR) for mortality were also higher, particularly in the first year after disease onset. For all pathogens, mortality rates were higher within 1 year (HR, 39.2), 5 years (HR, 28.7), and 10 years (HR, 24.1). The consistently highest mortality rates were associated with S. pneumoniae over 1-year, 5-year, and 10-year follow-up (HR, 42.8; HR, 45.6; HR, 40.6, respectively). Within 1 year, the highest mortality rate was associated with N. meningitidis (HR, 58.4).
Ms. Snoek and Dr. Rohr have no relevant financial disclosures.
Among infants younger than 1 year of age, bacterial meningitis is associated with worse long-term mortality, even after recovery from the initial infection. Heightened mortality risk stretched out to 10 years, and was highest in the wake of infection from Streptococcus agalactiae, according to a retrospective analysis of children in the Netherlands.
“The adjusted hazard rates were high for the whole group of bacterial meningitis, especially within the first year after onset. (Staphylococcus agalactiae) meningitis has the highest mortality risk within one year of disease onset,” Linde Snoek said during her presentation of the study (abstract 913) at the annual meeting of the European Society for Paediatric Infectious Diseases, held virtually this year. Ms. Snoek is a PhD student at Amsterdam University Medical Center.
Over longer time periods, the mortality associations were different. “The adjusted hazard rates were highest for pneumococcal meningitis compared to the other pathogens. And this was the case for 1 year, 5 years, and 10 years after disease onset,” said Ms. Snoek.
The study appears to be the first to look at extended mortality following bacterial meningitis in this age group, according to Marie Rohr, MD, who comoderated the session where the research was presented.
“In a quick review of the literature I did not find any [equivalent] study concerning short- and long-term mortality after bacterial meningitis in under 1 year of age,” said Dr. Rohr, a fellow in pediatric infectious diseases at University Hospitals of Geneva. But the message to physicians is clear. “Children with history of bacterial meningitis have a higher long-term mortality than children without a history of bacterial meningitis,” said Dr. Rohr.
The study did have a key limitation: For matched controls, it relied on anonymous data from the Municipal Personal Records Database in Statistics Netherlands. “Important information like cause of death is lacking,” said Dr. Rohr.
Bacterial meningitis is associated with significant mortality and morbidity. Pathogens behind the infections vary with age group and geographic location, as well as immunization status.
To examine long-term mortality after bacterial meningitis, the researchers collected 1,646 records from an exposed cohort, with a date range of 1995 to 2018, from the Netherlands Reference Laboratory for Bacterial Meningitis. Included patients had a positive culture diagnosis of bacterial meningitis during the first year of life. Each exposed subject was compared to 10 controls matched by birth month, birth year, and sex, who had no exposure to bacterial meningitis.
Staphylococcus pneumoniae accounted for the most cases, at 32.0% (median age of onset, 180 days), followed by Neisseria meningitidis at 29.0% (median age of onset, 203 days). Other pathogens included S. agalactiae (19.7%, 10 days), Escherichia coli (8.8%, 13 days), and Haemophilus influenzae (5.4%, 231 days).
The mortality risk within 1 year of disease onset was higher for all pathogens (6.2% vs. 0.2% unexposed). The highest mortality risk was seen for S. agalactiae (8.7%), followed by E. coli (6.4%), N. meningitidis (4.9%), and H. influenzae (3.4%).
Hazard ratios (HR) for mortality were also higher, particularly in the first year after disease onset. For all pathogens, mortality rates were higher within 1 year (HR, 39.2), 5 years (HR, 28.7), and 10 years (HR, 24.1). The consistently highest mortality rates were associated with S. pneumoniae over 1-year, 5-year, and 10-year follow-up (HR, 42.8; HR, 45.6; HR, 40.6, respectively). Within 1 year, the highest mortality rate was associated with N. meningitidis (HR, 58.4).
Ms. Snoek and Dr. Rohr have no relevant financial disclosures.
Among infants younger than 1 year of age, bacterial meningitis is associated with worse long-term mortality, even after recovery from the initial infection. Heightened mortality risk stretched out to 10 years, and was highest in the wake of infection from Streptococcus agalactiae, according to a retrospective analysis of children in the Netherlands.
“The adjusted hazard rates were high for the whole group of bacterial meningitis, especially within the first year after onset. (Staphylococcus agalactiae) meningitis has the highest mortality risk within one year of disease onset,” Linde Snoek said during her presentation of the study (abstract 913) at the annual meeting of the European Society for Paediatric Infectious Diseases, held virtually this year. Ms. Snoek is a PhD student at Amsterdam University Medical Center.
Over longer time periods, the mortality associations were different. “The adjusted hazard rates were highest for pneumococcal meningitis compared to the other pathogens. And this was the case for 1 year, 5 years, and 10 years after disease onset,” said Ms. Snoek.
The study appears to be the first to look at extended mortality following bacterial meningitis in this age group, according to Marie Rohr, MD, who comoderated the session where the research was presented.
“In a quick review of the literature I did not find any [equivalent] study concerning short- and long-term mortality after bacterial meningitis in under 1 year of age,” said Dr. Rohr, a fellow in pediatric infectious diseases at University Hospitals of Geneva. But the message to physicians is clear. “Children with history of bacterial meningitis have a higher long-term mortality than children without a history of bacterial meningitis,” said Dr. Rohr.
The study did have a key limitation: For matched controls, it relied on anonymous data from the Municipal Personal Records Database in Statistics Netherlands. “Important information like cause of death is lacking,” said Dr. Rohr.
Bacterial meningitis is associated with significant mortality and morbidity. Pathogens behind the infections vary with age group and geographic location, as well as immunization status.
To examine long-term mortality after bacterial meningitis, the researchers collected 1,646 records from an exposed cohort, with a date range of 1995 to 2018, from the Netherlands Reference Laboratory for Bacterial Meningitis. Included patients had a positive culture diagnosis of bacterial meningitis during the first year of life. Each exposed subject was compared to 10 controls matched by birth month, birth year, and sex, who had no exposure to bacterial meningitis.
Staphylococcus pneumoniae accounted for the most cases, at 32.0% (median age of onset, 180 days), followed by Neisseria meningitidis at 29.0% (median age of onset, 203 days). Other pathogens included S. agalactiae (19.7%, 10 days), Escherichia coli (8.8%, 13 days), and Haemophilus influenzae (5.4%, 231 days).
The mortality risk within 1 year of disease onset was higher for all pathogens (6.2% vs. 0.2% unexposed). The highest mortality risk was seen for S. agalactiae (8.7%), followed by E. coli (6.4%), N. meningitidis (4.9%), and H. influenzae (3.4%).
Hazard ratios (HR) for mortality were also higher, particularly in the first year after disease onset. For all pathogens, mortality rates were higher within 1 year (HR, 39.2), 5 years (HR, 28.7), and 10 years (HR, 24.1). The consistently highest mortality rates were associated with S. pneumoniae over 1-year, 5-year, and 10-year follow-up (HR, 42.8; HR, 45.6; HR, 40.6, respectively). Within 1 year, the highest mortality rate was associated with N. meningitidis (HR, 58.4).
Ms. Snoek and Dr. Rohr have no relevant financial disclosures.
FROM ESPID 2021
FDA approves secukinumab in psoriasis patients age six and older
The
who are candidates for systemic therapy or phototherapy. The expanded indication marks the first time the drug has been available for a pediatric population in the United States.Children with plaque psoriasis are often undertreated because of fear of side effects of therapies, according to Kelly M. Cordoro, MD, professor of dermatology and pediatrics at the University of California, San Francisco. “Now, more and more medicines are being tested for safety and efficacy in children, and we no longer have to rely on adult studies to inform treatment choices for children,” Dr. Cordoro told this news organization.
The FDA approval of secukinumab for children aged 6 and older with moderate to severe psoriasis “is a welcome addition to the therapeutic toolbox for pediatric psoriasis,” she said. “We’ve entered an era where severe pediatric psoriasis has become a condition that can be adequately controlled with minimal risk and with the convenience of intermittent injections. This has changed the playing field for these children and their families completely. Given the potential short- and long-term negative impact of chronic inflammation on the body of a growing child, we now have approved treatments that can safely offset the risks of undertreated severe psoriasis on the functional and psychological health of the child.”
The approved pediatric dosing for secukinumab is 75 mg or 150 mg depending on the child’s weight at the time of dosing, and it is administered by subcutaneous injection every 4 weeks after an initial loading regimen. According to a press release from Novartis, the FDA approval came on the heels of two phase 3 studies that evaluated the use of secukinumab in children aged 6 to younger than 18 years with plaque psoriasis. The first was a 52-week, randomized, double-blind, placebo- and active-controlled study which included 162 children 6 years of age and older with severe plaque psoriasis. The doses evaluated were 75 mg for children who weighed less than 50 kg and 150 mg for those 50 kg or greater.
At week 12, the Psoriasis Area Severity Index (PASI)-75 response was 55% among children in the 75-mg dosing group vs. 10% in the placebo group and 86% in the 150-mg dosing group vs. 19% in the placebo group.
Meanwhile, the Investigator’s Global Assessment modified 2011 (IGA) “clear” response was achieved in 32% of children in the 75-mg dosing group vs. 5% in the placebo group and in 81% of children in the 150-mg dosing group vs. 5% in the placebo group. An IGA “almost clear” skin response was achieved in 81% of children in the 75-mg dosing group vs. 5% in the placebo group.
The second phase 3 study was a randomized open-label, 208-week trial of 84 subjects 6 years of age and older with moderate to severe plaque psoriasis. According to the Novartis press release, the safety profile reported in both trials was consistent with the safety profile reported in adult plaque psoriasis trials and no new safety signals were observed. The updated prescribing information for secukinumab can be found here.
“When considering treatment with a systemic agent such as a biologic, it is important to consider objective measures of severity, such as extent of disease and involvement of joints but also subjective indicators of severity such as impact beyond the skin on psychological well-being,” Dr. Cordoro said in the interview. “Kids with psoriasis in visible locations may socially isolate themselves due to embarrassment or bullying. Therefore, the impact of moderate to severe psoriasis not only on overall health but on self-esteem and identity formation can be significant, and therefore adequately treating children of all ages to prevent the downstream negative consequences of childhood psoriasis is critical.”
Dr. Cordoro reported having no financial disclosures.
The
who are candidates for systemic therapy or phototherapy. The expanded indication marks the first time the drug has been available for a pediatric population in the United States.Children with plaque psoriasis are often undertreated because of fear of side effects of therapies, according to Kelly M. Cordoro, MD, professor of dermatology and pediatrics at the University of California, San Francisco. “Now, more and more medicines are being tested for safety and efficacy in children, and we no longer have to rely on adult studies to inform treatment choices for children,” Dr. Cordoro told this news organization.
The FDA approval of secukinumab for children aged 6 and older with moderate to severe psoriasis “is a welcome addition to the therapeutic toolbox for pediatric psoriasis,” she said. “We’ve entered an era where severe pediatric psoriasis has become a condition that can be adequately controlled with minimal risk and with the convenience of intermittent injections. This has changed the playing field for these children and their families completely. Given the potential short- and long-term negative impact of chronic inflammation on the body of a growing child, we now have approved treatments that can safely offset the risks of undertreated severe psoriasis on the functional and psychological health of the child.”
The approved pediatric dosing for secukinumab is 75 mg or 150 mg depending on the child’s weight at the time of dosing, and it is administered by subcutaneous injection every 4 weeks after an initial loading regimen. According to a press release from Novartis, the FDA approval came on the heels of two phase 3 studies that evaluated the use of secukinumab in children aged 6 to younger than 18 years with plaque psoriasis. The first was a 52-week, randomized, double-blind, placebo- and active-controlled study which included 162 children 6 years of age and older with severe plaque psoriasis. The doses evaluated were 75 mg for children who weighed less than 50 kg and 150 mg for those 50 kg or greater.
At week 12, the Psoriasis Area Severity Index (PASI)-75 response was 55% among children in the 75-mg dosing group vs. 10% in the placebo group and 86% in the 150-mg dosing group vs. 19% in the placebo group.
Meanwhile, the Investigator’s Global Assessment modified 2011 (IGA) “clear” response was achieved in 32% of children in the 75-mg dosing group vs. 5% in the placebo group and in 81% of children in the 150-mg dosing group vs. 5% in the placebo group. An IGA “almost clear” skin response was achieved in 81% of children in the 75-mg dosing group vs. 5% in the placebo group.
The second phase 3 study was a randomized open-label, 208-week trial of 84 subjects 6 years of age and older with moderate to severe plaque psoriasis. According to the Novartis press release, the safety profile reported in both trials was consistent with the safety profile reported in adult plaque psoriasis trials and no new safety signals were observed. The updated prescribing information for secukinumab can be found here.
“When considering treatment with a systemic agent such as a biologic, it is important to consider objective measures of severity, such as extent of disease and involvement of joints but also subjective indicators of severity such as impact beyond the skin on psychological well-being,” Dr. Cordoro said in the interview. “Kids with psoriasis in visible locations may socially isolate themselves due to embarrassment or bullying. Therefore, the impact of moderate to severe psoriasis not only on overall health but on self-esteem and identity formation can be significant, and therefore adequately treating children of all ages to prevent the downstream negative consequences of childhood psoriasis is critical.”
Dr. Cordoro reported having no financial disclosures.
The
who are candidates for systemic therapy or phototherapy. The expanded indication marks the first time the drug has been available for a pediatric population in the United States.Children with plaque psoriasis are often undertreated because of fear of side effects of therapies, according to Kelly M. Cordoro, MD, professor of dermatology and pediatrics at the University of California, San Francisco. “Now, more and more medicines are being tested for safety and efficacy in children, and we no longer have to rely on adult studies to inform treatment choices for children,” Dr. Cordoro told this news organization.
The FDA approval of secukinumab for children aged 6 and older with moderate to severe psoriasis “is a welcome addition to the therapeutic toolbox for pediatric psoriasis,” she said. “We’ve entered an era where severe pediatric psoriasis has become a condition that can be adequately controlled with minimal risk and with the convenience of intermittent injections. This has changed the playing field for these children and their families completely. Given the potential short- and long-term negative impact of chronic inflammation on the body of a growing child, we now have approved treatments that can safely offset the risks of undertreated severe psoriasis on the functional and psychological health of the child.”
The approved pediatric dosing for secukinumab is 75 mg or 150 mg depending on the child’s weight at the time of dosing, and it is administered by subcutaneous injection every 4 weeks after an initial loading regimen. According to a press release from Novartis, the FDA approval came on the heels of two phase 3 studies that evaluated the use of secukinumab in children aged 6 to younger than 18 years with plaque psoriasis. The first was a 52-week, randomized, double-blind, placebo- and active-controlled study which included 162 children 6 years of age and older with severe plaque psoriasis. The doses evaluated were 75 mg for children who weighed less than 50 kg and 150 mg for those 50 kg or greater.
At week 12, the Psoriasis Area Severity Index (PASI)-75 response was 55% among children in the 75-mg dosing group vs. 10% in the placebo group and 86% in the 150-mg dosing group vs. 19% in the placebo group.
Meanwhile, the Investigator’s Global Assessment modified 2011 (IGA) “clear” response was achieved in 32% of children in the 75-mg dosing group vs. 5% in the placebo group and in 81% of children in the 150-mg dosing group vs. 5% in the placebo group. An IGA “almost clear” skin response was achieved in 81% of children in the 75-mg dosing group vs. 5% in the placebo group.
The second phase 3 study was a randomized open-label, 208-week trial of 84 subjects 6 years of age and older with moderate to severe plaque psoriasis. According to the Novartis press release, the safety profile reported in both trials was consistent with the safety profile reported in adult plaque psoriasis trials and no new safety signals were observed. The updated prescribing information for secukinumab can be found here.
“When considering treatment with a systemic agent such as a biologic, it is important to consider objective measures of severity, such as extent of disease and involvement of joints but also subjective indicators of severity such as impact beyond the skin on psychological well-being,” Dr. Cordoro said in the interview. “Kids with psoriasis in visible locations may socially isolate themselves due to embarrassment or bullying. Therefore, the impact of moderate to severe psoriasis not only on overall health but on self-esteem and identity formation can be significant, and therefore adequately treating children of all ages to prevent the downstream negative consequences of childhood psoriasis is critical.”
Dr. Cordoro reported having no financial disclosures.
Phacomatosis Pigmentokeratotica Associated With Raynaud Phenomenon, Segmental Nevi, Hyperhidrosis, and Scoliosis
To the Editor:
Phacomatosis pigmentokeratotica (PPK) is a rare epidermal nevus syndrome complicated by multiple extracutaneous anomalies, including skeletal defects and neurologic anomalies. Less common associations include lateral curvature of the spine and hyperhidrosis. We present a patient with PPK and unilateral Raynaud phenomenon in addition to a segmental distribution of melanocytic nevi, hyperhidrosis, and scoliosis.
A 9-year-old girl was born with a yellow-orange alopecic plaque on the right side of the scalp (Figure 1). There also were 2 large, irregularly pigmented patches localized on the right side of the upper back and buttock. Over 3 years, numerous papular nevi developed within these pigmented patches and were diagnosed as speckled lentiginous nevi (Figure 2). In addition, numerous nevi of various sizes affected the right face, right shoulder, right arm (Figure 3), and right neck and were clearly demarcated along the midline. Several nevi also were noted within the nevus sebaceous on the right scalp. These skin lesions expanded progressively with age. At 6 years of age, she was diagnosed with hyperhidrosis of the right half of the body, which was most pronounced on the face. Raynaud phenomenon restricted to the right hand also was noted (Figure 4). Upon cold exposure, the digits become pale white, cold, and numb; then blue; and finally red. She lacked other features of connective tissue disease, and autoantibody testing was negative. She also was noted to have an abnormal lateral curvature of the spine (scoliosis). Auditory, ocular, and neurologic examinations were normal. Cranial and cerebral magnetic resonance imaging showed no central nervous system abnormalities. Her family history was negative for nevus spilus, nevus sebaceous, and neurofibromatosis. The clinical findings in our patient led to the diagnosis of PPK.
Phacomatosis pigmentokeratotica is a distinctive epidermal nevus syndrome characterized by the coexistence of a speckled lentiginous nevus, also known as a nevus spilus, and a nevus sebaceous1; PPK frequently is complicated by skeletal, ophthalmic, or neurologic abnormalities.2 Most cases reported are sporadic, and a postzygotic mosaic HRas proto-oncogene, GTPase, HRAS, mutation has been demonstrated in some patients and may contribute to the phenotype of PPK.3,4
Other anomalies have included ichthyosislike diffuse hyperkeratosis, laxity of the hands, pelvic hypoplasia, glaucoma, psychomotor retardation, and hypophosphatemic rickets. These patients also should be monitored for the development of malignant neoplasms within the nevus sebaceous.5 Segmental hyperhidrosis may be seen in association with the nevus spilus component.2
Raynaud phenomenon involving only the right hand was a unique finding in our patient. In 3 years of follow-up, our patient developed no evidence of connective tissue disease or other systemic illness. We speculate that Raynaud phenomenon of the right hand along with hyperhidrosis of the right side of the body could be a result of dysfunction of the autonomic nervous system. We propose that Raynaud phenomenon represents an unusual manifestation of PPK and may broaden the spectrum of extracutaneous anomalies associated with the disease. The finding of segmental nevi outside of the confines of the nevus spilus was another unusual manifestation of mosaicism.
- Happle R, Hoffmann R, Restano L, et al. Phacomatosis pigmentokeratotica: a melanocytic-epidermal twin nevus syndrome. Am J Med Genet. 1996;65:363-365.
- Happle R. The group of epidermal nevus syndromes part I. well defined phenotypes. J Am Acad Dermatol. 2010;63:1-22, 23-24.
- Groesser L, Herschberger E, Sagrera A, et al. Phacomatosis pigmentokeratotica is caused by a postzygotic HRAS mutation in a multipotent progenitor cell. J Invest Dermatol. 2013;133:1998-2003.
- Martin RJ, Arefi M, Splitt M, et al. Phacomatosis pigmentokeratotica and precocious puberty associated with HRAS mutation. Br J Dermatol. 2018;178:289-291.
- Chu GY, Wu CY. Phacomatosis pigmentokeratotica: a follow-up report with fatal outcome. Acta Derm Venereol. 2014;94:467-468.
To the Editor:
Phacomatosis pigmentokeratotica (PPK) is a rare epidermal nevus syndrome complicated by multiple extracutaneous anomalies, including skeletal defects and neurologic anomalies. Less common associations include lateral curvature of the spine and hyperhidrosis. We present a patient with PPK and unilateral Raynaud phenomenon in addition to a segmental distribution of melanocytic nevi, hyperhidrosis, and scoliosis.
A 9-year-old girl was born with a yellow-orange alopecic plaque on the right side of the scalp (Figure 1). There also were 2 large, irregularly pigmented patches localized on the right side of the upper back and buttock. Over 3 years, numerous papular nevi developed within these pigmented patches and were diagnosed as speckled lentiginous nevi (Figure 2). In addition, numerous nevi of various sizes affected the right face, right shoulder, right arm (Figure 3), and right neck and were clearly demarcated along the midline. Several nevi also were noted within the nevus sebaceous on the right scalp. These skin lesions expanded progressively with age. At 6 years of age, she was diagnosed with hyperhidrosis of the right half of the body, which was most pronounced on the face. Raynaud phenomenon restricted to the right hand also was noted (Figure 4). Upon cold exposure, the digits become pale white, cold, and numb; then blue; and finally red. She lacked other features of connective tissue disease, and autoantibody testing was negative. She also was noted to have an abnormal lateral curvature of the spine (scoliosis). Auditory, ocular, and neurologic examinations were normal. Cranial and cerebral magnetic resonance imaging showed no central nervous system abnormalities. Her family history was negative for nevus spilus, nevus sebaceous, and neurofibromatosis. The clinical findings in our patient led to the diagnosis of PPK.
Phacomatosis pigmentokeratotica is a distinctive epidermal nevus syndrome characterized by the coexistence of a speckled lentiginous nevus, also known as a nevus spilus, and a nevus sebaceous1; PPK frequently is complicated by skeletal, ophthalmic, or neurologic abnormalities.2 Most cases reported are sporadic, and a postzygotic mosaic HRas proto-oncogene, GTPase, HRAS, mutation has been demonstrated in some patients and may contribute to the phenotype of PPK.3,4
Other anomalies have included ichthyosislike diffuse hyperkeratosis, laxity of the hands, pelvic hypoplasia, glaucoma, psychomotor retardation, and hypophosphatemic rickets. These patients also should be monitored for the development of malignant neoplasms within the nevus sebaceous.5 Segmental hyperhidrosis may be seen in association with the nevus spilus component.2
Raynaud phenomenon involving only the right hand was a unique finding in our patient. In 3 years of follow-up, our patient developed no evidence of connective tissue disease or other systemic illness. We speculate that Raynaud phenomenon of the right hand along with hyperhidrosis of the right side of the body could be a result of dysfunction of the autonomic nervous system. We propose that Raynaud phenomenon represents an unusual manifestation of PPK and may broaden the spectrum of extracutaneous anomalies associated with the disease. The finding of segmental nevi outside of the confines of the nevus spilus was another unusual manifestation of mosaicism.
To the Editor:
Phacomatosis pigmentokeratotica (PPK) is a rare epidermal nevus syndrome complicated by multiple extracutaneous anomalies, including skeletal defects and neurologic anomalies. Less common associations include lateral curvature of the spine and hyperhidrosis. We present a patient with PPK and unilateral Raynaud phenomenon in addition to a segmental distribution of melanocytic nevi, hyperhidrosis, and scoliosis.
A 9-year-old girl was born with a yellow-orange alopecic plaque on the right side of the scalp (Figure 1). There also were 2 large, irregularly pigmented patches localized on the right side of the upper back and buttock. Over 3 years, numerous papular nevi developed within these pigmented patches and were diagnosed as speckled lentiginous nevi (Figure 2). In addition, numerous nevi of various sizes affected the right face, right shoulder, right arm (Figure 3), and right neck and were clearly demarcated along the midline. Several nevi also were noted within the nevus sebaceous on the right scalp. These skin lesions expanded progressively with age. At 6 years of age, she was diagnosed with hyperhidrosis of the right half of the body, which was most pronounced on the face. Raynaud phenomenon restricted to the right hand also was noted (Figure 4). Upon cold exposure, the digits become pale white, cold, and numb; then blue; and finally red. She lacked other features of connective tissue disease, and autoantibody testing was negative. She also was noted to have an abnormal lateral curvature of the spine (scoliosis). Auditory, ocular, and neurologic examinations were normal. Cranial and cerebral magnetic resonance imaging showed no central nervous system abnormalities. Her family history was negative for nevus spilus, nevus sebaceous, and neurofibromatosis. The clinical findings in our patient led to the diagnosis of PPK.
Phacomatosis pigmentokeratotica is a distinctive epidermal nevus syndrome characterized by the coexistence of a speckled lentiginous nevus, also known as a nevus spilus, and a nevus sebaceous1; PPK frequently is complicated by skeletal, ophthalmic, or neurologic abnormalities.2 Most cases reported are sporadic, and a postzygotic mosaic HRas proto-oncogene, GTPase, HRAS, mutation has been demonstrated in some patients and may contribute to the phenotype of PPK.3,4
Other anomalies have included ichthyosislike diffuse hyperkeratosis, laxity of the hands, pelvic hypoplasia, glaucoma, psychomotor retardation, and hypophosphatemic rickets. These patients also should be monitored for the development of malignant neoplasms within the nevus sebaceous.5 Segmental hyperhidrosis may be seen in association with the nevus spilus component.2
Raynaud phenomenon involving only the right hand was a unique finding in our patient. In 3 years of follow-up, our patient developed no evidence of connective tissue disease or other systemic illness. We speculate that Raynaud phenomenon of the right hand along with hyperhidrosis of the right side of the body could be a result of dysfunction of the autonomic nervous system. We propose that Raynaud phenomenon represents an unusual manifestation of PPK and may broaden the spectrum of extracutaneous anomalies associated with the disease. The finding of segmental nevi outside of the confines of the nevus spilus was another unusual manifestation of mosaicism.
- Happle R, Hoffmann R, Restano L, et al. Phacomatosis pigmentokeratotica: a melanocytic-epidermal twin nevus syndrome. Am J Med Genet. 1996;65:363-365.
- Happle R. The group of epidermal nevus syndromes part I. well defined phenotypes. J Am Acad Dermatol. 2010;63:1-22, 23-24.
- Groesser L, Herschberger E, Sagrera A, et al. Phacomatosis pigmentokeratotica is caused by a postzygotic HRAS mutation in a multipotent progenitor cell. J Invest Dermatol. 2013;133:1998-2003.
- Martin RJ, Arefi M, Splitt M, et al. Phacomatosis pigmentokeratotica and precocious puberty associated with HRAS mutation. Br J Dermatol. 2018;178:289-291.
- Chu GY, Wu CY. Phacomatosis pigmentokeratotica: a follow-up report with fatal outcome. Acta Derm Venereol. 2014;94:467-468.
- Happle R, Hoffmann R, Restano L, et al. Phacomatosis pigmentokeratotica: a melanocytic-epidermal twin nevus syndrome. Am J Med Genet. 1996;65:363-365.
- Happle R. The group of epidermal nevus syndromes part I. well defined phenotypes. J Am Acad Dermatol. 2010;63:1-22, 23-24.
- Groesser L, Herschberger E, Sagrera A, et al. Phacomatosis pigmentokeratotica is caused by a postzygotic HRAS mutation in a multipotent progenitor cell. J Invest Dermatol. 2013;133:1998-2003.
- Martin RJ, Arefi M, Splitt M, et al. Phacomatosis pigmentokeratotica and precocious puberty associated with HRAS mutation. Br J Dermatol. 2018;178:289-291.
- Chu GY, Wu CY. Phacomatosis pigmentokeratotica: a follow-up report with fatal outcome. Acta Derm Venereol. 2014;94:467-468.
Practice Points
- Phacomatosis pigmentokeratotica (PPK) is characterized by the coexistence of speckled lentiginous nevus and nevus sebaceous.
- Raynaud phenomenon may be an unreported association with PPK.
FDA approves diagnostic device for autism spectrum disorder
The Food and Drug Administration has approved marketing for a device that will help diagnose autism spectrum disorder (ASD) in children between the ages of 18 months and 5 years old who exhibit potential symptoms.
Cognoa ASD Diagnosis Aid is a machine learning–based software program that receives information from parents or caregivers, video analysts, and health care providers to assist physicians in evaluating whether a child is at risk of having autism.
Autism is a developmental disorder that can cause social, communication, and behavioral challenges, according to the Centers for Disease Control and Prevention. The disorder affects about 1 in 54 children. The disorder is difficult to diagnose because there isn’t a medical test to diagnose the it. Instead, physicians have to look at a child’s developmental history and behavior to make a diagnosis.
Many children are not diagnosed with ASD until later in childhood, which in some cases delays treatment and early intervention. ASD may be detected as early as 18 months, but the average age of diagnosis for ASD is 4.3 years, according to the FDA.
“[ASD] can delay a child’s physical, cognitive, and social development, including motor skill development, learning, communication, and interacting with others. The earlier ASD can be diagnosed, the more quickly intervention strategies and appropriate therapies can begin,” Jeff Shuren, MD, JD, director of the FDA’s Center for Devices and Radiological Health, said in a statement. “Today’s marketing authorization provides a new tool for helping diagnose children with ASD.”
The safety and efficacy of the Cognoa ASD Diagnosis Aid was assessed in a study of 425 patients between the ages of 18 months and 5 years old. For the study, researchers compared the diagnostic assessments made by the device to those made by a panel of clinical experts who used the current standard ASD diagnostic process. The device diagnosed 32% of the children with either a “Positive for ASD” or a “Negative for ASD” result. Researchers found that the device matched the panel’s conclusions for 81% of the patients who received a positive diagnosis. For those who received a negative diagnosis, the device matched the panel’s conclusions for 98% of the patients. In addition, the device made an accurate ASD determination in 98.4% of patients with the condition and in 78.9% of patients without the condition.
Cognoa ASD Diagnosis Aid has three main components. One component includes a mobile app for caregivers to answer questions about the child’s behavioral problems and to upload videos of the child. The next component is a video analysis portal for specialists to view and analyze uploaded videos of patients. Another component is a portal for health care providers that allows them to enter answers to preloaded questions about behavior problems, track the information provided by parents, and review a report of the results.
After the machine learning–based device processes the information provided by parents and health care providers, it reports either a positive or a negative diagnosis. If there is insufficient information to make either a positive or a negative diagnosis, the ASD Diagnostic AID will report that no result can be generated.
Some of the risks associated with this device include misdiagnosis and delayed diagnosis of ASD because of a false-positive or false-negative result, or when no result is generated. Researchers said a false-positive result occurred in 15 out of 303 study subjects without ASD and a false-negative result occurred in 1 out of 122 study subjects with ASD.
The FDA emphasized that the device is indicated to aid physicians in the process of diagnosing ASD in children. This means it shouldn’t be treated as a standalone diagnostic device, but as an adjunct to the diagnostic process.
The Food and Drug Administration has approved marketing for a device that will help diagnose autism spectrum disorder (ASD) in children between the ages of 18 months and 5 years old who exhibit potential symptoms.
Cognoa ASD Diagnosis Aid is a machine learning–based software program that receives information from parents or caregivers, video analysts, and health care providers to assist physicians in evaluating whether a child is at risk of having autism.
Autism is a developmental disorder that can cause social, communication, and behavioral challenges, according to the Centers for Disease Control and Prevention. The disorder affects about 1 in 54 children. The disorder is difficult to diagnose because there isn’t a medical test to diagnose the it. Instead, physicians have to look at a child’s developmental history and behavior to make a diagnosis.
Many children are not diagnosed with ASD until later in childhood, which in some cases delays treatment and early intervention. ASD may be detected as early as 18 months, but the average age of diagnosis for ASD is 4.3 years, according to the FDA.
“[ASD] can delay a child’s physical, cognitive, and social development, including motor skill development, learning, communication, and interacting with others. The earlier ASD can be diagnosed, the more quickly intervention strategies and appropriate therapies can begin,” Jeff Shuren, MD, JD, director of the FDA’s Center for Devices and Radiological Health, said in a statement. “Today’s marketing authorization provides a new tool for helping diagnose children with ASD.”
The safety and efficacy of the Cognoa ASD Diagnosis Aid was assessed in a study of 425 patients between the ages of 18 months and 5 years old. For the study, researchers compared the diagnostic assessments made by the device to those made by a panel of clinical experts who used the current standard ASD diagnostic process. The device diagnosed 32% of the children with either a “Positive for ASD” or a “Negative for ASD” result. Researchers found that the device matched the panel’s conclusions for 81% of the patients who received a positive diagnosis. For those who received a negative diagnosis, the device matched the panel’s conclusions for 98% of the patients. In addition, the device made an accurate ASD determination in 98.4% of patients with the condition and in 78.9% of patients without the condition.
Cognoa ASD Diagnosis Aid has three main components. One component includes a mobile app for caregivers to answer questions about the child’s behavioral problems and to upload videos of the child. The next component is a video analysis portal for specialists to view and analyze uploaded videos of patients. Another component is a portal for health care providers that allows them to enter answers to preloaded questions about behavior problems, track the information provided by parents, and review a report of the results.
After the machine learning–based device processes the information provided by parents and health care providers, it reports either a positive or a negative diagnosis. If there is insufficient information to make either a positive or a negative diagnosis, the ASD Diagnostic AID will report that no result can be generated.
Some of the risks associated with this device include misdiagnosis and delayed diagnosis of ASD because of a false-positive or false-negative result, or when no result is generated. Researchers said a false-positive result occurred in 15 out of 303 study subjects without ASD and a false-negative result occurred in 1 out of 122 study subjects with ASD.
The FDA emphasized that the device is indicated to aid physicians in the process of diagnosing ASD in children. This means it shouldn’t be treated as a standalone diagnostic device, but as an adjunct to the diagnostic process.
The Food and Drug Administration has approved marketing for a device that will help diagnose autism spectrum disorder (ASD) in children between the ages of 18 months and 5 years old who exhibit potential symptoms.
Cognoa ASD Diagnosis Aid is a machine learning–based software program that receives information from parents or caregivers, video analysts, and health care providers to assist physicians in evaluating whether a child is at risk of having autism.
Autism is a developmental disorder that can cause social, communication, and behavioral challenges, according to the Centers for Disease Control and Prevention. The disorder affects about 1 in 54 children. The disorder is difficult to diagnose because there isn’t a medical test to diagnose the it. Instead, physicians have to look at a child’s developmental history and behavior to make a diagnosis.
Many children are not diagnosed with ASD until later in childhood, which in some cases delays treatment and early intervention. ASD may be detected as early as 18 months, but the average age of diagnosis for ASD is 4.3 years, according to the FDA.
“[ASD] can delay a child’s physical, cognitive, and social development, including motor skill development, learning, communication, and interacting with others. The earlier ASD can be diagnosed, the more quickly intervention strategies and appropriate therapies can begin,” Jeff Shuren, MD, JD, director of the FDA’s Center for Devices and Radiological Health, said in a statement. “Today’s marketing authorization provides a new tool for helping diagnose children with ASD.”
The safety and efficacy of the Cognoa ASD Diagnosis Aid was assessed in a study of 425 patients between the ages of 18 months and 5 years old. For the study, researchers compared the diagnostic assessments made by the device to those made by a panel of clinical experts who used the current standard ASD diagnostic process. The device diagnosed 32% of the children with either a “Positive for ASD” or a “Negative for ASD” result. Researchers found that the device matched the panel’s conclusions for 81% of the patients who received a positive diagnosis. For those who received a negative diagnosis, the device matched the panel’s conclusions for 98% of the patients. In addition, the device made an accurate ASD determination in 98.4% of patients with the condition and in 78.9% of patients without the condition.
Cognoa ASD Diagnosis Aid has three main components. One component includes a mobile app for caregivers to answer questions about the child’s behavioral problems and to upload videos of the child. The next component is a video analysis portal for specialists to view and analyze uploaded videos of patients. Another component is a portal for health care providers that allows them to enter answers to preloaded questions about behavior problems, track the information provided by parents, and review a report of the results.
After the machine learning–based device processes the information provided by parents and health care providers, it reports either a positive or a negative diagnosis. If there is insufficient information to make either a positive or a negative diagnosis, the ASD Diagnostic AID will report that no result can be generated.
Some of the risks associated with this device include misdiagnosis and delayed diagnosis of ASD because of a false-positive or false-negative result, or when no result is generated. Researchers said a false-positive result occurred in 15 out of 303 study subjects without ASD and a false-negative result occurred in 1 out of 122 study subjects with ASD.
The FDA emphasized that the device is indicated to aid physicians in the process of diagnosing ASD in children. This means it shouldn’t be treated as a standalone diagnostic device, but as an adjunct to the diagnostic process.
Benzene found in some sunscreen products, online pharmacy says
Valisure, an online pharmacy known for testing every batch of medication it sells, announced that it has
The company tested 294 batches from 69 companies and found benzene in 27% – many in major national brands like Neutrogena and Banana Boat. Some batches contained as much as three times the emergency FDA limit of 2 parts per million.
Long-term exposure to benzene is known to cause cancer in humans.
“This is especially concerning with sunscreen because multiple FDA studies have shown that sunscreen ingredients absorb through the skin and end up in the blood at high levels,” said David Light, CEO of Valisure.
The FDA is seeking more information about the potential risks from common sunscreen ingredients.
“There is not a safe level of benzene that can exist in sunscreen products,” Christopher Bunick, MD, PhD, associate professor of dermatology at Yale University, New Haven, Conn., said in Valisure’s FDA petition. “The total mass of sunscreen required to cover and protect the human body, in single daily application or repeated applications daily, means that even benzene at 0.1 ppm in a sunscreen could expose people to excessively high nanogram amounts of benzene.”
Valisure’s testing previously led to FDA recalls of heartburn medications and hand sanitizers.
Examining sunscreen’s environmental impact
Chemicals in sunscreen may be harmful to other forms of life, too. For years, scientists have been examining whether certain chemicals in sunscreen could be causing damage to marine life, in particular the world’s coral reefs. Specific ingredients, including oxybenzone, benzophenone-1, benzophenone-8, OD-PABA, 4-methylbenzylidene camphor, 3-benzylidene camphor, nano-titanium dioxide, nano-zinc oxide, octinoxate, and octocrylene, have been identified as potential risks.
Earlier this year, the National Academies of Sciences, Engineering, and Medicine created a committee to review the existing science about the potential environmental hazards. Over the next 2 years, they’ll also consider the public health implications if people stopped using sunscreen.
Valisure’s announcement included this message: “It is important to note that not all sunscreen products contain benzene and that uncontaminated products are available, should continue to be used, and are important for protecting against potentially harmful solar radiation.”
Using sunscreen with SPF 15 every day can lower risk of squamous cell carcinoma by around 40% and melanoma by 50%. The American Academy of Dermatology recommends a broad-spectrum, water-resistant sunscreen with an SPF of 30 or higher.
A version of this article first appeared on WebMD.com.
Valisure, an online pharmacy known for testing every batch of medication it sells, announced that it has
The company tested 294 batches from 69 companies and found benzene in 27% – many in major national brands like Neutrogena and Banana Boat. Some batches contained as much as three times the emergency FDA limit of 2 parts per million.
Long-term exposure to benzene is known to cause cancer in humans.
“This is especially concerning with sunscreen because multiple FDA studies have shown that sunscreen ingredients absorb through the skin and end up in the blood at high levels,” said David Light, CEO of Valisure.
The FDA is seeking more information about the potential risks from common sunscreen ingredients.
“There is not a safe level of benzene that can exist in sunscreen products,” Christopher Bunick, MD, PhD, associate professor of dermatology at Yale University, New Haven, Conn., said in Valisure’s FDA petition. “The total mass of sunscreen required to cover and protect the human body, in single daily application or repeated applications daily, means that even benzene at 0.1 ppm in a sunscreen could expose people to excessively high nanogram amounts of benzene.”
Valisure’s testing previously led to FDA recalls of heartburn medications and hand sanitizers.
Examining sunscreen’s environmental impact
Chemicals in sunscreen may be harmful to other forms of life, too. For years, scientists have been examining whether certain chemicals in sunscreen could be causing damage to marine life, in particular the world’s coral reefs. Specific ingredients, including oxybenzone, benzophenone-1, benzophenone-8, OD-PABA, 4-methylbenzylidene camphor, 3-benzylidene camphor, nano-titanium dioxide, nano-zinc oxide, octinoxate, and octocrylene, have been identified as potential risks.
Earlier this year, the National Academies of Sciences, Engineering, and Medicine created a committee to review the existing science about the potential environmental hazards. Over the next 2 years, they’ll also consider the public health implications if people stopped using sunscreen.
Valisure’s announcement included this message: “It is important to note that not all sunscreen products contain benzene and that uncontaminated products are available, should continue to be used, and are important for protecting against potentially harmful solar radiation.”
Using sunscreen with SPF 15 every day can lower risk of squamous cell carcinoma by around 40% and melanoma by 50%. The American Academy of Dermatology recommends a broad-spectrum, water-resistant sunscreen with an SPF of 30 or higher.
A version of this article first appeared on WebMD.com.
Valisure, an online pharmacy known for testing every batch of medication it sells, announced that it has
The company tested 294 batches from 69 companies and found benzene in 27% – many in major national brands like Neutrogena and Banana Boat. Some batches contained as much as three times the emergency FDA limit of 2 parts per million.
Long-term exposure to benzene is known to cause cancer in humans.
“This is especially concerning with sunscreen because multiple FDA studies have shown that sunscreen ingredients absorb through the skin and end up in the blood at high levels,” said David Light, CEO of Valisure.
The FDA is seeking more information about the potential risks from common sunscreen ingredients.
“There is not a safe level of benzene that can exist in sunscreen products,” Christopher Bunick, MD, PhD, associate professor of dermatology at Yale University, New Haven, Conn., said in Valisure’s FDA petition. “The total mass of sunscreen required to cover and protect the human body, in single daily application or repeated applications daily, means that even benzene at 0.1 ppm in a sunscreen could expose people to excessively high nanogram amounts of benzene.”
Valisure’s testing previously led to FDA recalls of heartburn medications and hand sanitizers.
Examining sunscreen’s environmental impact
Chemicals in sunscreen may be harmful to other forms of life, too. For years, scientists have been examining whether certain chemicals in sunscreen could be causing damage to marine life, in particular the world’s coral reefs. Specific ingredients, including oxybenzone, benzophenone-1, benzophenone-8, OD-PABA, 4-methylbenzylidene camphor, 3-benzylidene camphor, nano-titanium dioxide, nano-zinc oxide, octinoxate, and octocrylene, have been identified as potential risks.
Earlier this year, the National Academies of Sciences, Engineering, and Medicine created a committee to review the existing science about the potential environmental hazards. Over the next 2 years, they’ll also consider the public health implications if people stopped using sunscreen.
Valisure’s announcement included this message: “It is important to note that not all sunscreen products contain benzene and that uncontaminated products are available, should continue to be used, and are important for protecting against potentially harmful solar radiation.”
Using sunscreen with SPF 15 every day can lower risk of squamous cell carcinoma by around 40% and melanoma by 50%. The American Academy of Dermatology recommends a broad-spectrum, water-resistant sunscreen with an SPF of 30 or higher.
A version of this article first appeared on WebMD.com.