User login
Get familiar with evidence on these supplements
NEW ORLEANS – With more than 10% of children receiving complementary or alternative medicine (CAM), you should be familiar with what does and doesn’t work when it comes to using supplements for various medical issues, said Cora Breuner, MD, a professor of pediatrics at the University of Washington, Seattle, and attending physician at Seattle Children’s Hospital.
Dr. Breuner presented an overview of more than a dozen popular supplements with their uses and evidence at the American Academy of Pediatrics annual meeting. Most of the evidence comes from studies in adults, not children, and the evidence overall is sometimes scant, but it can guide physicians in discussing options with parents interested in CAM.
Butterbur
This root primarily is used to treat migraines via anti-inflammatory effects. The ideal dose is 50-75 mg daily in 2-3 divided doses for children aged 8-9 years and 100-150 mg daily in 2-3 divided doses for those aged 10 and older (Headache. 2005 Mar;45:196-203; Eur J Pain. 2008;12:301-13; Neurology. 2012 Apr 24;78[17]:1346-53).
Adverse effects are mostly gastrointestinal, such as diarrhea and stomach upset, and dermal/allergic reactions, such as itchy eyes, asthma, and itching.
Caffeine
Caffeine is the most popular drug of choice for reducing drowsiness and increasing alertness and has the strongest evidence base, including for improving sports and work performance (J Strength Cond Res. 2010 Jan;24[1]:257-65). Regular caffeine use can lead to dependence, however, and it can cause anxiety, nervousness, irritability, insomnia, peptic ulcers, palpitations, gastroesophageal reflux disease (GERD), and tremors. Withdrawal can involve headaches, irritability, and anxiety.
Cannabidiol
Marijuana has more than 80 cannabinoids, and a nonpsychoactive one, cannabidiol, makes up about 40% of cannabis extracts, Dr. Breuner said. It’s been used as an anticonvulsant and to combat anxiety, psychosis, nausea and rheumatoid arthritis pain. In a study using a rat model for arthritis, inflammation and pain-related behaviors decreased in rats that received cannabidiol (Eur J Pain. 2016 Jul;20[6]:936-48).
A human dose would be about 160-300 mg daily, but side effects can include dry mouth, hypotension, lightheadedness, psychomotor slowing, sedation, and sleepiness.
Coenzyme Q10
This antioxidant is fat-soluble and has a chemical structure similar to vitamin K. It has been used in people with autism, chronic fatigue syndrome, fatigue from chemotherapy, Lyme disease, and muscular dystrophy, but the evidence focuses on fibromyalgia. One study of patients with fibromyalgia found that a 300-mg daily dose for 40 days reduced pain by 52%-56%, fatigue by 47%, morning tiredness by 56%, and tender points by 44%, compared with baseline (Antioxid Redox Signal. 2013;19[12]:1356-61.)
In another, 200 mg of coenzyme Q10 with 200 mg ginkgo daily for 3 months resulted in improvement of quality of life measures, including physical fitness levels, emotional feelings, social activities, overall health, and pain (J Int Med Res. 2002;30:195-9).
Potential adverse effects of coenzyme Q10 include nausea, vomiting, diarrhea, appetite suppression, and heartburn, albeit typically in less than 1% of patients.
Echinacea
Echinacea actually is approved in Germany for supportive therapy in treating upper respiratory tract infections, urogenital infections, and wound healing, Dr. Breuner said. Hypothesized mechanisms of action include stimulation of the alternate complement pathway, immune-modulating effects, activating nonspecific T cells, inhibiting viral replication, and enhancing phagocytosis.
However, in clinical studies, echinacea did not reduce the duration or severity of upper respiratory tract infections or the occurrence or severity of infection, compared with placebo (JAMA. 2003 Dec 3;290[21]:2824-30; N Engl J Med. 2005 Jul 28;353[4]:341-8); this was tested in children aged 2-11 years in the first study, and the mean age of the subjects in the second study was 21 years. A 2014 Cochrane review found no overall benefits for treating common colds but noted the possibility of “a weak benefit from some echinacea products” based on individual trials with consistently positive, yet nonsignificant, trends, albeit with “questionable clinical relevance” (Cochrane Database Syst Rev. 2014 Feb 20;[2]:CD000530).
People with autoimmune conditions or who are immunocompromised should not use echinacea.
Magnesium
Magnesium also is used to treat migraines with a dose of 300-500 mg daily, although also it can be consumed in food, such as soy beans, black beans, tofu, seeds, nuts, whole grains, and shellfish (Expert Rev Neurother. 2009 Mar;9[3]:369-79; Neurology. 2012 Apr 24;78[17]:1346-53).
Side effects can include diarrhea and interactions with bisphosphonates, antibiotics] and diuretics. Taking proton pump inhibitors also may reduce magnesium levels.
Melatonin
Melatonin, a synthetic version of the hormone produced in humans to signal the onset of nighttime, has been studied extensively for jet lag, insomnia, shift-work disorder, circadian rhythm disorders, and withdrawal from benzodiazepine and nicotine.
Research shows that melatonin can improve sleep onset, duration, and quality. Some research has shown increased total sleep time (PLoS One. 2013 May 17;8(5):e63773).
Some evidence suggests it has endocrine-disrupting adverse effects, such as inhibiting ovulation and impairing glucose utilization.
N-acetyl cysteine (NAC)
Although it’s primarily an antidote for acetaminophen and carbon monoxide poisoning, NAC has been used for a wide range of conditions, including reducing lipoprotein levels with hyperlipidemia and reducing risk of cardiovascular events in people with end-stage renal disease and other conditions. It also has been used in people with bipolar disorder, schizophrenia, PTSD, substance disorders, and Tourette syndrome.
“Some clinical research shows that taking NAC 900 mg daily for 4 weeks, followed by 900 mg twice daily for 4 weeks and then 900 mg three times daily for 4 weeks improves symptoms of irritability in children with autism,” Dr. Breuner said. Other research showed reduced irritability in children with autism when they took 1,200 mg of NAC daily with risperidone, compared with risperidone alone. One study also has found “that NAC adds to the effect of citalopram in improving resistance/control to compulsions in OCD children and adolescents” (Iran J Psychiatry. 2017 Apr;12[2]:134-141).
Side effects can include diarrhea, nausea, and heartburn.
Omega-3 fatty acids: DHA and EHA
Docosahexanoic acid (DHA) and eicosapentanoic acid (EHA) have been used to treat ADHD, depression, heart disease, and also to lower the risk of macular degeneration.
A systematic review of 25 randomized controlled trials of more than 3,600 subjects found that “omega-3 supplementation generally correlated with improvements in blood biomarkers” (Nutrients. 2018 Aug 15;10[8]. pii: E1094). A small study in children with Tourette syndrome found that omega-3 fatty acids did not reduce tic scores, but “may be beneficial in reduction of tic-related impairment” for some children and teens (Pediatrics. 2012 Jun;129[6]:e1493-500).
Possible adverse effects include fishy taste, belching, nosebleeds, nausea, loose stools, and – at higher doses – decreased blood coagulation.
St. John’s wort
This herb has long been used to treat depression and appears to work by inhibiting serotonin reuptake, monoamine oxidase (MAO), 5-hydroxytryptamine (5-HT), dopamine, noradrenaline, gamma aminobutyric acid (GABA), and glutamate. A 2005 Cochrane review found St. John’s wort to work better than placebo with similar effectiveness as standard antidepressants for mild to moderate depression, but its benefit for major depression is questionable (Cochrane Database Syst Rev. 2005 Apr 18;[2]:CD000448).
An ideal dose is 300 mg daily, but physicians should be aware of the herb’s potential for certain drug interactions. It may increase metabolism of warfarin, cyclosporin, HIV protease inhibitors, theophylline, digoxin, and oral contraceptives (Expert Opin Drug Metab Toxicol. 2012 Jun;8[6]:691-708). Other potential side effects include decreased platelet aggregation, serotonin syndrome, and photosensitivity.
Turmeric (curcumin)
Turmeric is an anti-inflammatory agent used for a wide range of complaints, but research primarily has focused on its use for pain. No studies exist in children, but a handful of studies have found reduction in joint pain and rheumatoid arthritis symptoms in adults with 500-mg doses twice daily (Phytother Res. 2012 Nov;26[11]:1719-25; J Med Food. 2017 Oct;20[10]:1022-30). One of these studies focused on a specific product, Instaflex, that contained turmeric among multiple other active ingredients (Nutr J. 2013 Nov 25;12[1]:154).
Potential adverse effects of turmeric/curcumin include constipation, dyspepsia, diarrhea, dissension, reflux, nausea, vomiting, itching, and hives.
Zinc
Like echinacea, zinc is commonly used to treat the common cold. A 2013 Cochrane review of randomized, controlled trials found that taking zinc “within 24 hours of onset of symptoms reduces the duration of common cold symptoms in healthy people, but some caution is needed due to the heterogeneity of the data” (Cochrane Database Syst Rev. 2013 Jun 18;[6]:CD001364). The dose is 75 mg a day, and potential adverse effects include bad taste, nausea, and anosmia.
Dr. Breuner said she had no relevant financial disclosures.
NEW ORLEANS – With more than 10% of children receiving complementary or alternative medicine (CAM), you should be familiar with what does and doesn’t work when it comes to using supplements for various medical issues, said Cora Breuner, MD, a professor of pediatrics at the University of Washington, Seattle, and attending physician at Seattle Children’s Hospital.
Dr. Breuner presented an overview of more than a dozen popular supplements with their uses and evidence at the American Academy of Pediatrics annual meeting. Most of the evidence comes from studies in adults, not children, and the evidence overall is sometimes scant, but it can guide physicians in discussing options with parents interested in CAM.
Butterbur
This root primarily is used to treat migraines via anti-inflammatory effects. The ideal dose is 50-75 mg daily in 2-3 divided doses for children aged 8-9 years and 100-150 mg daily in 2-3 divided doses for those aged 10 and older (Headache. 2005 Mar;45:196-203; Eur J Pain. 2008;12:301-13; Neurology. 2012 Apr 24;78[17]:1346-53).
Adverse effects are mostly gastrointestinal, such as diarrhea and stomach upset, and dermal/allergic reactions, such as itchy eyes, asthma, and itching.
Caffeine
Caffeine is the most popular drug of choice for reducing drowsiness and increasing alertness and has the strongest evidence base, including for improving sports and work performance (J Strength Cond Res. 2010 Jan;24[1]:257-65). Regular caffeine use can lead to dependence, however, and it can cause anxiety, nervousness, irritability, insomnia, peptic ulcers, palpitations, gastroesophageal reflux disease (GERD), and tremors. Withdrawal can involve headaches, irritability, and anxiety.
Cannabidiol
Marijuana has more than 80 cannabinoids, and a nonpsychoactive one, cannabidiol, makes up about 40% of cannabis extracts, Dr. Breuner said. It’s been used as an anticonvulsant and to combat anxiety, psychosis, nausea and rheumatoid arthritis pain. In a study using a rat model for arthritis, inflammation and pain-related behaviors decreased in rats that received cannabidiol (Eur J Pain. 2016 Jul;20[6]:936-48).
A human dose would be about 160-300 mg daily, but side effects can include dry mouth, hypotension, lightheadedness, psychomotor slowing, sedation, and sleepiness.
Coenzyme Q10
This antioxidant is fat-soluble and has a chemical structure similar to vitamin K. It has been used in people with autism, chronic fatigue syndrome, fatigue from chemotherapy, Lyme disease, and muscular dystrophy, but the evidence focuses on fibromyalgia. One study of patients with fibromyalgia found that a 300-mg daily dose for 40 days reduced pain by 52%-56%, fatigue by 47%, morning tiredness by 56%, and tender points by 44%, compared with baseline (Antioxid Redox Signal. 2013;19[12]:1356-61.)
In another, 200 mg of coenzyme Q10 with 200 mg ginkgo daily for 3 months resulted in improvement of quality of life measures, including physical fitness levels, emotional feelings, social activities, overall health, and pain (J Int Med Res. 2002;30:195-9).
Potential adverse effects of coenzyme Q10 include nausea, vomiting, diarrhea, appetite suppression, and heartburn, albeit typically in less than 1% of patients.
Echinacea
Echinacea actually is approved in Germany for supportive therapy in treating upper respiratory tract infections, urogenital infections, and wound healing, Dr. Breuner said. Hypothesized mechanisms of action include stimulation of the alternate complement pathway, immune-modulating effects, activating nonspecific T cells, inhibiting viral replication, and enhancing phagocytosis.
However, in clinical studies, echinacea did not reduce the duration or severity of upper respiratory tract infections or the occurrence or severity of infection, compared with placebo (JAMA. 2003 Dec 3;290[21]:2824-30; N Engl J Med. 2005 Jul 28;353[4]:341-8); this was tested in children aged 2-11 years in the first study, and the mean age of the subjects in the second study was 21 years. A 2014 Cochrane review found no overall benefits for treating common colds but noted the possibility of “a weak benefit from some echinacea products” based on individual trials with consistently positive, yet nonsignificant, trends, albeit with “questionable clinical relevance” (Cochrane Database Syst Rev. 2014 Feb 20;[2]:CD000530).
People with autoimmune conditions or who are immunocompromised should not use echinacea.
Magnesium
Magnesium also is used to treat migraines with a dose of 300-500 mg daily, although also it can be consumed in food, such as soy beans, black beans, tofu, seeds, nuts, whole grains, and shellfish (Expert Rev Neurother. 2009 Mar;9[3]:369-79; Neurology. 2012 Apr 24;78[17]:1346-53).
Side effects can include diarrhea and interactions with bisphosphonates, antibiotics] and diuretics. Taking proton pump inhibitors also may reduce magnesium levels.
Melatonin
Melatonin, a synthetic version of the hormone produced in humans to signal the onset of nighttime, has been studied extensively for jet lag, insomnia, shift-work disorder, circadian rhythm disorders, and withdrawal from benzodiazepine and nicotine.
Research shows that melatonin can improve sleep onset, duration, and quality. Some research has shown increased total sleep time (PLoS One. 2013 May 17;8(5):e63773).
Some evidence suggests it has endocrine-disrupting adverse effects, such as inhibiting ovulation and impairing glucose utilization.
N-acetyl cysteine (NAC)
Although it’s primarily an antidote for acetaminophen and carbon monoxide poisoning, NAC has been used for a wide range of conditions, including reducing lipoprotein levels with hyperlipidemia and reducing risk of cardiovascular events in people with end-stage renal disease and other conditions. It also has been used in people with bipolar disorder, schizophrenia, PTSD, substance disorders, and Tourette syndrome.
“Some clinical research shows that taking NAC 900 mg daily for 4 weeks, followed by 900 mg twice daily for 4 weeks and then 900 mg three times daily for 4 weeks improves symptoms of irritability in children with autism,” Dr. Breuner said. Other research showed reduced irritability in children with autism when they took 1,200 mg of NAC daily with risperidone, compared with risperidone alone. One study also has found “that NAC adds to the effect of citalopram in improving resistance/control to compulsions in OCD children and adolescents” (Iran J Psychiatry. 2017 Apr;12[2]:134-141).
Side effects can include diarrhea, nausea, and heartburn.
Omega-3 fatty acids: DHA and EHA
Docosahexanoic acid (DHA) and eicosapentanoic acid (EHA) have been used to treat ADHD, depression, heart disease, and also to lower the risk of macular degeneration.
A systematic review of 25 randomized controlled trials of more than 3,600 subjects found that “omega-3 supplementation generally correlated with improvements in blood biomarkers” (Nutrients. 2018 Aug 15;10[8]. pii: E1094). A small study in children with Tourette syndrome found that omega-3 fatty acids did not reduce tic scores, but “may be beneficial in reduction of tic-related impairment” for some children and teens (Pediatrics. 2012 Jun;129[6]:e1493-500).
Possible adverse effects include fishy taste, belching, nosebleeds, nausea, loose stools, and – at higher doses – decreased blood coagulation.
St. John’s wort
This herb has long been used to treat depression and appears to work by inhibiting serotonin reuptake, monoamine oxidase (MAO), 5-hydroxytryptamine (5-HT), dopamine, noradrenaline, gamma aminobutyric acid (GABA), and glutamate. A 2005 Cochrane review found St. John’s wort to work better than placebo with similar effectiveness as standard antidepressants for mild to moderate depression, but its benefit for major depression is questionable (Cochrane Database Syst Rev. 2005 Apr 18;[2]:CD000448).
An ideal dose is 300 mg daily, but physicians should be aware of the herb’s potential for certain drug interactions. It may increase metabolism of warfarin, cyclosporin, HIV protease inhibitors, theophylline, digoxin, and oral contraceptives (Expert Opin Drug Metab Toxicol. 2012 Jun;8[6]:691-708). Other potential side effects include decreased platelet aggregation, serotonin syndrome, and photosensitivity.
Turmeric (curcumin)
Turmeric is an anti-inflammatory agent used for a wide range of complaints, but research primarily has focused on its use for pain. No studies exist in children, but a handful of studies have found reduction in joint pain and rheumatoid arthritis symptoms in adults with 500-mg doses twice daily (Phytother Res. 2012 Nov;26[11]:1719-25; J Med Food. 2017 Oct;20[10]:1022-30). One of these studies focused on a specific product, Instaflex, that contained turmeric among multiple other active ingredients (Nutr J. 2013 Nov 25;12[1]:154).
Potential adverse effects of turmeric/curcumin include constipation, dyspepsia, diarrhea, dissension, reflux, nausea, vomiting, itching, and hives.
Zinc
Like echinacea, zinc is commonly used to treat the common cold. A 2013 Cochrane review of randomized, controlled trials found that taking zinc “within 24 hours of onset of symptoms reduces the duration of common cold symptoms in healthy people, but some caution is needed due to the heterogeneity of the data” (Cochrane Database Syst Rev. 2013 Jun 18;[6]:CD001364). The dose is 75 mg a day, and potential adverse effects include bad taste, nausea, and anosmia.
Dr. Breuner said she had no relevant financial disclosures.
NEW ORLEANS – With more than 10% of children receiving complementary or alternative medicine (CAM), you should be familiar with what does and doesn’t work when it comes to using supplements for various medical issues, said Cora Breuner, MD, a professor of pediatrics at the University of Washington, Seattle, and attending physician at Seattle Children’s Hospital.
Dr. Breuner presented an overview of more than a dozen popular supplements with their uses and evidence at the American Academy of Pediatrics annual meeting. Most of the evidence comes from studies in adults, not children, and the evidence overall is sometimes scant, but it can guide physicians in discussing options with parents interested in CAM.
Butterbur
This root primarily is used to treat migraines via anti-inflammatory effects. The ideal dose is 50-75 mg daily in 2-3 divided doses for children aged 8-9 years and 100-150 mg daily in 2-3 divided doses for those aged 10 and older (Headache. 2005 Mar;45:196-203; Eur J Pain. 2008;12:301-13; Neurology. 2012 Apr 24;78[17]:1346-53).
Adverse effects are mostly gastrointestinal, such as diarrhea and stomach upset, and dermal/allergic reactions, such as itchy eyes, asthma, and itching.
Caffeine
Caffeine is the most popular drug of choice for reducing drowsiness and increasing alertness and has the strongest evidence base, including for improving sports and work performance (J Strength Cond Res. 2010 Jan;24[1]:257-65). Regular caffeine use can lead to dependence, however, and it can cause anxiety, nervousness, irritability, insomnia, peptic ulcers, palpitations, gastroesophageal reflux disease (GERD), and tremors. Withdrawal can involve headaches, irritability, and anxiety.
Cannabidiol
Marijuana has more than 80 cannabinoids, and a nonpsychoactive one, cannabidiol, makes up about 40% of cannabis extracts, Dr. Breuner said. It’s been used as an anticonvulsant and to combat anxiety, psychosis, nausea and rheumatoid arthritis pain. In a study using a rat model for arthritis, inflammation and pain-related behaviors decreased in rats that received cannabidiol (Eur J Pain. 2016 Jul;20[6]:936-48).
A human dose would be about 160-300 mg daily, but side effects can include dry mouth, hypotension, lightheadedness, psychomotor slowing, sedation, and sleepiness.
Coenzyme Q10
This antioxidant is fat-soluble and has a chemical structure similar to vitamin K. It has been used in people with autism, chronic fatigue syndrome, fatigue from chemotherapy, Lyme disease, and muscular dystrophy, but the evidence focuses on fibromyalgia. One study of patients with fibromyalgia found that a 300-mg daily dose for 40 days reduced pain by 52%-56%, fatigue by 47%, morning tiredness by 56%, and tender points by 44%, compared with baseline (Antioxid Redox Signal. 2013;19[12]:1356-61.)
In another, 200 mg of coenzyme Q10 with 200 mg ginkgo daily for 3 months resulted in improvement of quality of life measures, including physical fitness levels, emotional feelings, social activities, overall health, and pain (J Int Med Res. 2002;30:195-9).
Potential adverse effects of coenzyme Q10 include nausea, vomiting, diarrhea, appetite suppression, and heartburn, albeit typically in less than 1% of patients.
Echinacea
Echinacea actually is approved in Germany for supportive therapy in treating upper respiratory tract infections, urogenital infections, and wound healing, Dr. Breuner said. Hypothesized mechanisms of action include stimulation of the alternate complement pathway, immune-modulating effects, activating nonspecific T cells, inhibiting viral replication, and enhancing phagocytosis.
However, in clinical studies, echinacea did not reduce the duration or severity of upper respiratory tract infections or the occurrence or severity of infection, compared with placebo (JAMA. 2003 Dec 3;290[21]:2824-30; N Engl J Med. 2005 Jul 28;353[4]:341-8); this was tested in children aged 2-11 years in the first study, and the mean age of the subjects in the second study was 21 years. A 2014 Cochrane review found no overall benefits for treating common colds but noted the possibility of “a weak benefit from some echinacea products” based on individual trials with consistently positive, yet nonsignificant, trends, albeit with “questionable clinical relevance” (Cochrane Database Syst Rev. 2014 Feb 20;[2]:CD000530).
People with autoimmune conditions or who are immunocompromised should not use echinacea.
Magnesium
Magnesium also is used to treat migraines with a dose of 300-500 mg daily, although also it can be consumed in food, such as soy beans, black beans, tofu, seeds, nuts, whole grains, and shellfish (Expert Rev Neurother. 2009 Mar;9[3]:369-79; Neurology. 2012 Apr 24;78[17]:1346-53).
Side effects can include diarrhea and interactions with bisphosphonates, antibiotics] and diuretics. Taking proton pump inhibitors also may reduce magnesium levels.
Melatonin
Melatonin, a synthetic version of the hormone produced in humans to signal the onset of nighttime, has been studied extensively for jet lag, insomnia, shift-work disorder, circadian rhythm disorders, and withdrawal from benzodiazepine and nicotine.
Research shows that melatonin can improve sleep onset, duration, and quality. Some research has shown increased total sleep time (PLoS One. 2013 May 17;8(5):e63773).
Some evidence suggests it has endocrine-disrupting adverse effects, such as inhibiting ovulation and impairing glucose utilization.
N-acetyl cysteine (NAC)
Although it’s primarily an antidote for acetaminophen and carbon monoxide poisoning, NAC has been used for a wide range of conditions, including reducing lipoprotein levels with hyperlipidemia and reducing risk of cardiovascular events in people with end-stage renal disease and other conditions. It also has been used in people with bipolar disorder, schizophrenia, PTSD, substance disorders, and Tourette syndrome.
“Some clinical research shows that taking NAC 900 mg daily for 4 weeks, followed by 900 mg twice daily for 4 weeks and then 900 mg three times daily for 4 weeks improves symptoms of irritability in children with autism,” Dr. Breuner said. Other research showed reduced irritability in children with autism when they took 1,200 mg of NAC daily with risperidone, compared with risperidone alone. One study also has found “that NAC adds to the effect of citalopram in improving resistance/control to compulsions in OCD children and adolescents” (Iran J Psychiatry. 2017 Apr;12[2]:134-141).
Side effects can include diarrhea, nausea, and heartburn.
Omega-3 fatty acids: DHA and EHA
Docosahexanoic acid (DHA) and eicosapentanoic acid (EHA) have been used to treat ADHD, depression, heart disease, and also to lower the risk of macular degeneration.
A systematic review of 25 randomized controlled trials of more than 3,600 subjects found that “omega-3 supplementation generally correlated with improvements in blood biomarkers” (Nutrients. 2018 Aug 15;10[8]. pii: E1094). A small study in children with Tourette syndrome found that omega-3 fatty acids did not reduce tic scores, but “may be beneficial in reduction of tic-related impairment” for some children and teens (Pediatrics. 2012 Jun;129[6]:e1493-500).
Possible adverse effects include fishy taste, belching, nosebleeds, nausea, loose stools, and – at higher doses – decreased blood coagulation.
St. John’s wort
This herb has long been used to treat depression and appears to work by inhibiting serotonin reuptake, monoamine oxidase (MAO), 5-hydroxytryptamine (5-HT), dopamine, noradrenaline, gamma aminobutyric acid (GABA), and glutamate. A 2005 Cochrane review found St. John’s wort to work better than placebo with similar effectiveness as standard antidepressants for mild to moderate depression, but its benefit for major depression is questionable (Cochrane Database Syst Rev. 2005 Apr 18;[2]:CD000448).
An ideal dose is 300 mg daily, but physicians should be aware of the herb’s potential for certain drug interactions. It may increase metabolism of warfarin, cyclosporin, HIV protease inhibitors, theophylline, digoxin, and oral contraceptives (Expert Opin Drug Metab Toxicol. 2012 Jun;8[6]:691-708). Other potential side effects include decreased platelet aggregation, serotonin syndrome, and photosensitivity.
Turmeric (curcumin)
Turmeric is an anti-inflammatory agent used for a wide range of complaints, but research primarily has focused on its use for pain. No studies exist in children, but a handful of studies have found reduction in joint pain and rheumatoid arthritis symptoms in adults with 500-mg doses twice daily (Phytother Res. 2012 Nov;26[11]:1719-25; J Med Food. 2017 Oct;20[10]:1022-30). One of these studies focused on a specific product, Instaflex, that contained turmeric among multiple other active ingredients (Nutr J. 2013 Nov 25;12[1]:154).
Potential adverse effects of turmeric/curcumin include constipation, dyspepsia, diarrhea, dissension, reflux, nausea, vomiting, itching, and hives.
Zinc
Like echinacea, zinc is commonly used to treat the common cold. A 2013 Cochrane review of randomized, controlled trials found that taking zinc “within 24 hours of onset of symptoms reduces the duration of common cold symptoms in healthy people, but some caution is needed due to the heterogeneity of the data” (Cochrane Database Syst Rev. 2013 Jun 18;[6]:CD001364). The dose is 75 mg a day, and potential adverse effects include bad taste, nausea, and anosmia.
Dr. Breuner said she had no relevant financial disclosures.
EXPERT ANALYSIS FROM AAP 19
For pediatric use of supplements, rely on resources, evidence
NEW ORLEANS – More than 1 in 10 children (12%) have received complementary or alternative medicine (CAM), according to the 2012 National Health Interview Survey. It’s therefore vital that you are familiar with the options and evidence on these treatments, according to Cora Breuner, MD, a professor of pediatrics at the University of Washington, Seattle, and attending physician at Seattle Children’s Hospital.
“Use of CAM by a parent was strongly associated with the child’s use of CAM,” Dr. Breuner told attendees at the annual meeting of the American Academy of Pediatrics. Parents of children using CAM were more likely to have a college education and to use prescription medication, the National Health Interview Survey found, and teens were more frequent users of CAM than infants.
The most common conditions treated in children with CAM were back and neck pain, colds, anxiety, stress, ADHD, insomnia, and general musculoskeletal conditions or complaints. Fish oil, melatonin, probiotics, and chiropractic and osteopathic manipulation were used more frequently than any other CAM treatments, but Dr. Breuner’s presentation focused specifically on supplements, including vitamins and herbs.
of how lax the law is when it comes to the safety and effectiveness of vitamins, minerals, herbs, and other dietary supplements.
“Products can go on the market with no testing of efficacy, and companies do not have to prove that their products are safe – only offer reasonable assurance of safety,” Dr. Breuner explained. “Supplements do not have to be manufactured to any standards, and FDA [Food and Drug Administration] approval is not needed for package or marketing claims,” although the reputable manufacturers favor standards.
She cited a 2011 study of popular supplement products on the market that found 75% of them did not include key safety messages (BMC Med. 2011 Aug 9;9:94). The study focused on St. John’s wort, ginkgo, ginseng, garlic, and echinacea products, and it’s likely other products lack such safety information as well. Yet researchers have identified a wide range of potential adverse effects from herbal medicines (Clin Med [Lond]. 2013 Feb;13[1]:7-12).
Physicians and consumers can rely on a handful of voluntary standards and online databases to guide therapeutic decisions and learn more about the evidence on specific products. The U.S. Pharmacopeia Dietary Supplement Verification Program is a seal consumers can look for on supplement products that indicates the product meets stricter standards than what the FDA allows.
Other resources include ConsumerLab.com, the Natural Medicines Research Collaboration, and the Pubmed Dietary Supplement Subset database from the National Institute of Medicine. The latter contains more than 676,000 unique scientific citations on published studies about vitamins, minerals, and botanicals, Dr. Breuner said.
Dr. Breuner presented an overview of more than a dozen popular supplements that included their uses and the evidence related to their use. Although not exhaustive, her list included the most common supplements for which some research has been done: butterbur, caffeine, cannabidiol, coenzyme Q10, echinacea, magnesium, melatonin, N-acetylcysteine, omega 3 fatty acids, St. John’s wort, turmeric (curcumin), and zinc.
The findings from these studies, however, vary greatly, and the studies themselves are often small and limited to adults. Shared decision making is key in working with families interested in using CAM, and families should be aware that supplements can have side effects just as FDA-approved drugs do.
Dr. Breuner reported that she had no relevant financial disclosures.
NEW ORLEANS – More than 1 in 10 children (12%) have received complementary or alternative medicine (CAM), according to the 2012 National Health Interview Survey. It’s therefore vital that you are familiar with the options and evidence on these treatments, according to Cora Breuner, MD, a professor of pediatrics at the University of Washington, Seattle, and attending physician at Seattle Children’s Hospital.
“Use of CAM by a parent was strongly associated with the child’s use of CAM,” Dr. Breuner told attendees at the annual meeting of the American Academy of Pediatrics. Parents of children using CAM were more likely to have a college education and to use prescription medication, the National Health Interview Survey found, and teens were more frequent users of CAM than infants.
The most common conditions treated in children with CAM were back and neck pain, colds, anxiety, stress, ADHD, insomnia, and general musculoskeletal conditions or complaints. Fish oil, melatonin, probiotics, and chiropractic and osteopathic manipulation were used more frequently than any other CAM treatments, but Dr. Breuner’s presentation focused specifically on supplements, including vitamins and herbs.
of how lax the law is when it comes to the safety and effectiveness of vitamins, minerals, herbs, and other dietary supplements.
“Products can go on the market with no testing of efficacy, and companies do not have to prove that their products are safe – only offer reasonable assurance of safety,” Dr. Breuner explained. “Supplements do not have to be manufactured to any standards, and FDA [Food and Drug Administration] approval is not needed for package or marketing claims,” although the reputable manufacturers favor standards.
She cited a 2011 study of popular supplement products on the market that found 75% of them did not include key safety messages (BMC Med. 2011 Aug 9;9:94). The study focused on St. John’s wort, ginkgo, ginseng, garlic, and echinacea products, and it’s likely other products lack such safety information as well. Yet researchers have identified a wide range of potential adverse effects from herbal medicines (Clin Med [Lond]. 2013 Feb;13[1]:7-12).
Physicians and consumers can rely on a handful of voluntary standards and online databases to guide therapeutic decisions and learn more about the evidence on specific products. The U.S. Pharmacopeia Dietary Supplement Verification Program is a seal consumers can look for on supplement products that indicates the product meets stricter standards than what the FDA allows.
Other resources include ConsumerLab.com, the Natural Medicines Research Collaboration, and the Pubmed Dietary Supplement Subset database from the National Institute of Medicine. The latter contains more than 676,000 unique scientific citations on published studies about vitamins, minerals, and botanicals, Dr. Breuner said.
Dr. Breuner presented an overview of more than a dozen popular supplements that included their uses and the evidence related to their use. Although not exhaustive, her list included the most common supplements for which some research has been done: butterbur, caffeine, cannabidiol, coenzyme Q10, echinacea, magnesium, melatonin, N-acetylcysteine, omega 3 fatty acids, St. John’s wort, turmeric (curcumin), and zinc.
The findings from these studies, however, vary greatly, and the studies themselves are often small and limited to adults. Shared decision making is key in working with families interested in using CAM, and families should be aware that supplements can have side effects just as FDA-approved drugs do.
Dr. Breuner reported that she had no relevant financial disclosures.
NEW ORLEANS – More than 1 in 10 children (12%) have received complementary or alternative medicine (CAM), according to the 2012 National Health Interview Survey. It’s therefore vital that you are familiar with the options and evidence on these treatments, according to Cora Breuner, MD, a professor of pediatrics at the University of Washington, Seattle, and attending physician at Seattle Children’s Hospital.
“Use of CAM by a parent was strongly associated with the child’s use of CAM,” Dr. Breuner told attendees at the annual meeting of the American Academy of Pediatrics. Parents of children using CAM were more likely to have a college education and to use prescription medication, the National Health Interview Survey found, and teens were more frequent users of CAM than infants.
The most common conditions treated in children with CAM were back and neck pain, colds, anxiety, stress, ADHD, insomnia, and general musculoskeletal conditions or complaints. Fish oil, melatonin, probiotics, and chiropractic and osteopathic manipulation were used more frequently than any other CAM treatments, but Dr. Breuner’s presentation focused specifically on supplements, including vitamins and herbs.
of how lax the law is when it comes to the safety and effectiveness of vitamins, minerals, herbs, and other dietary supplements.
“Products can go on the market with no testing of efficacy, and companies do not have to prove that their products are safe – only offer reasonable assurance of safety,” Dr. Breuner explained. “Supplements do not have to be manufactured to any standards, and FDA [Food and Drug Administration] approval is not needed for package or marketing claims,” although the reputable manufacturers favor standards.
She cited a 2011 study of popular supplement products on the market that found 75% of them did not include key safety messages (BMC Med. 2011 Aug 9;9:94). The study focused on St. John’s wort, ginkgo, ginseng, garlic, and echinacea products, and it’s likely other products lack such safety information as well. Yet researchers have identified a wide range of potential adverse effects from herbal medicines (Clin Med [Lond]. 2013 Feb;13[1]:7-12).
Physicians and consumers can rely on a handful of voluntary standards and online databases to guide therapeutic decisions and learn more about the evidence on specific products. The U.S. Pharmacopeia Dietary Supplement Verification Program is a seal consumers can look for on supplement products that indicates the product meets stricter standards than what the FDA allows.
Other resources include ConsumerLab.com, the Natural Medicines Research Collaboration, and the Pubmed Dietary Supplement Subset database from the National Institute of Medicine. The latter contains more than 676,000 unique scientific citations on published studies about vitamins, minerals, and botanicals, Dr. Breuner said.
Dr. Breuner presented an overview of more than a dozen popular supplements that included their uses and the evidence related to their use. Although not exhaustive, her list included the most common supplements for which some research has been done: butterbur, caffeine, cannabidiol, coenzyme Q10, echinacea, magnesium, melatonin, N-acetylcysteine, omega 3 fatty acids, St. John’s wort, turmeric (curcumin), and zinc.
The findings from these studies, however, vary greatly, and the studies themselves are often small and limited to adults. Shared decision making is key in working with families interested in using CAM, and families should be aware that supplements can have side effects just as FDA-approved drugs do.
Dr. Breuner reported that she had no relevant financial disclosures.
EXPERT ANALYSIS FROM AAP 19
2019 Novel Coronavirus: Frequently asked questions for clinicians
The 2019 Novel Coronavirus (2019-nCoV) outbreak has unfolded so rapidly that many clinicians are scrambling to stay on top of it. Here are the answers to some frequently asked questions about how to prepare your clinic to respond to this outbreak.
Keep in mind that the outbreak is moving rapidly. Though scientific and epidemiologic knowledge has increased at unprecedented speed, there is much we don’t know, and some of what we think we know will change. Follow the links for the most up-to-date information.
What should our clinic do first?
Plan ahead with the following:
- Develop a plan for office staff to take travel histories from anyone with a respiratory illness and provide training for those who need it. Travel history at present should include asking about travel to China in the past 14 days, specifically Wuhan city or Hubei province.
- Review up-to-date infection control practices with all office staff and provide training for those who need it.
- Take an inventory of supplies of personal protective equipment (PPE), such as gowns, gloves, masks, eye protection, and N95 respirators or powered air-purifying respirators (PAPRs), and order items that are missing or low in stock.
- Fit-test users of N95 masks for maximal effectiveness.
- Plan where a potential patient would be isolated while obtaining expert advice.
- Know whom to contact at the state or local health department if you have a patient with the appropriate travel history.
The Centers for Disease Control and Prevention has prepared a toolkit to help frontline health care professionals prepare for this virus. Providers need to stay up to date on the latest recommendations, as the situation is changing rapidly.
When should I suspect 2019-nCoV illness, and what should I do?
Take the following steps to assess the concern and respond:
- If a patient with respiratory illness has traveled to China in the past 14 days, immediately put a mask on the patient and move the individual to a private room. Use a negative-pressure room if available.
- Put on appropriate PPE (including gloves, gown, eye protection, and mask) for contact, droplet, and airborne precautions. CDC recommends an N95 respirator mask if available, although we don’t know yet if there is true airborne spread.
- Obtain an accurate travel history, including dates and cities. (Tip: Get the correct spelling, as the English spelling of cities in China can cause confusion.)
- If the patient meets the current CDC definition of “person under investigation” or PUI, or if you need guidance on how to proceed, notify infection control (if you are in a facility that has it) and call your state or local health department immediately.
- Contact public health authorities who can help decide whether the patient should be admitted to airborne isolation or monitored at home with appropriate precautions.
What is the definition of a PUI?
The current definition of a PUI is a person who has fever and symptoms of a respiratory infection (cough, shortness of breath) AND who has EITHER been in Wuhan city or Hubei province in the past 14 days OR had close contact with a person either under investigation for 2019-nCoV infection or with confirmed infection. The definition of a PUI will change over time, so check this link.
How can I test for 2019-nCoV?
As of Jan. 30, 2020, testing is by polymerase chain reaction (PCR) and is available in the United States only through the CDC in Atlanta. Testing should soon be available in state health department laboratories. If public health authorities decide that your patient should be tested, they will instruct you on which samples to obtain.
The full sequence of 2019-nCoV has been shared, so some reference laboratories may develop and validate tests, ideally with assistance from CDC. If testing becomes available, make certain that it is a reputable lab that has carefully validated the test.
Should I test for other viruses?
Because the symptoms of 2019-nCoV infection overlap with those of influenza and other respiratory viruses, PCR testing for other viruses should be considered if it will change management (i.e., change the decision to provide influenza antivirals). Use appropriate PPE while collecting specimens, including eye protection. If 2019-nCoV is a consideration, you may want to send the specimen to a hospital lab for testing, where the sample will be processed under a biosafety hood, rather than doing point-of-care testing in the office.
How dangerous is 2019-nCoV?
The current estimated mortality rate is 2%-3%. That is probably an overestimate, as those with severe disease and those who die are more likely to be tested and reported early in an epidemic.
Our current knowledge is based on preliminary reports from hospitalized patients and will probably change. From the speed of spread and a single family cluster, it seems likely that there are milder cases and perhaps asymptomatic infection.
What else do I need to know about coronaviruses?
Coronaviruses are a large and diverse group of viruses, many of which are animal viruses. Before the discovery of the 2019-nCoV, six coronaviruses were known to infect humans. Four of these (HKU1, NL63, OC43, and 229E) predominantly caused mild to moderate upper respiratory illness, and they are thought to be responsible for 10%-30% of colds. They occasionally cause viral pneumonia and can be detected by some commercial multiplex panels.
Two other coronaviruses have caused outbreaks of severe respiratory illness in people: SARS, which emerged in Southern China in 2002, and MERS in the Middle East, in 2012. Unlike SARS, sporadic cases of MERS continue to occur.
The current outbreak is caused by 2019-nCoV, a previously unknown beta coronavirus. It is most closely related (~96%) to a bat virus and shares about 80% sequence homology with SARS CoV.
Andrew T. Pavia, MD, is the George and Esther Gross Presidential Professor and chief of the division of pediatric infectious disease in the department of pediatrics at the University of Utah, Salt Lake City. He is also director of hospital epidemiology and associate director of antimicrobial stewardship at Primary Children’s Hospital, Salt Lake City. Dr. Pavia has disclosed that he has served as a consultant for Genentech, Merck, and Seqirus and that he has served as associate editor for The Sanford Guide.
This article first appeared on Medscape.com.
The 2019 Novel Coronavirus (2019-nCoV) outbreak has unfolded so rapidly that many clinicians are scrambling to stay on top of it. Here are the answers to some frequently asked questions about how to prepare your clinic to respond to this outbreak.
Keep in mind that the outbreak is moving rapidly. Though scientific and epidemiologic knowledge has increased at unprecedented speed, there is much we don’t know, and some of what we think we know will change. Follow the links for the most up-to-date information.
What should our clinic do first?
Plan ahead with the following:
- Develop a plan for office staff to take travel histories from anyone with a respiratory illness and provide training for those who need it. Travel history at present should include asking about travel to China in the past 14 days, specifically Wuhan city or Hubei province.
- Review up-to-date infection control practices with all office staff and provide training for those who need it.
- Take an inventory of supplies of personal protective equipment (PPE), such as gowns, gloves, masks, eye protection, and N95 respirators or powered air-purifying respirators (PAPRs), and order items that are missing or low in stock.
- Fit-test users of N95 masks for maximal effectiveness.
- Plan where a potential patient would be isolated while obtaining expert advice.
- Know whom to contact at the state or local health department if you have a patient with the appropriate travel history.
The Centers for Disease Control and Prevention has prepared a toolkit to help frontline health care professionals prepare for this virus. Providers need to stay up to date on the latest recommendations, as the situation is changing rapidly.
When should I suspect 2019-nCoV illness, and what should I do?
Take the following steps to assess the concern and respond:
- If a patient with respiratory illness has traveled to China in the past 14 days, immediately put a mask on the patient and move the individual to a private room. Use a negative-pressure room if available.
- Put on appropriate PPE (including gloves, gown, eye protection, and mask) for contact, droplet, and airborne precautions. CDC recommends an N95 respirator mask if available, although we don’t know yet if there is true airborne spread.
- Obtain an accurate travel history, including dates and cities. (Tip: Get the correct spelling, as the English spelling of cities in China can cause confusion.)
- If the patient meets the current CDC definition of “person under investigation” or PUI, or if you need guidance on how to proceed, notify infection control (if you are in a facility that has it) and call your state or local health department immediately.
- Contact public health authorities who can help decide whether the patient should be admitted to airborne isolation or monitored at home with appropriate precautions.
What is the definition of a PUI?
The current definition of a PUI is a person who has fever and symptoms of a respiratory infection (cough, shortness of breath) AND who has EITHER been in Wuhan city or Hubei province in the past 14 days OR had close contact with a person either under investigation for 2019-nCoV infection or with confirmed infection. The definition of a PUI will change over time, so check this link.
How can I test for 2019-nCoV?
As of Jan. 30, 2020, testing is by polymerase chain reaction (PCR) and is available in the United States only through the CDC in Atlanta. Testing should soon be available in state health department laboratories. If public health authorities decide that your patient should be tested, they will instruct you on which samples to obtain.
The full sequence of 2019-nCoV has been shared, so some reference laboratories may develop and validate tests, ideally with assistance from CDC. If testing becomes available, make certain that it is a reputable lab that has carefully validated the test.
Should I test for other viruses?
Because the symptoms of 2019-nCoV infection overlap with those of influenza and other respiratory viruses, PCR testing for other viruses should be considered if it will change management (i.e., change the decision to provide influenza antivirals). Use appropriate PPE while collecting specimens, including eye protection. If 2019-nCoV is a consideration, you may want to send the specimen to a hospital lab for testing, where the sample will be processed under a biosafety hood, rather than doing point-of-care testing in the office.
How dangerous is 2019-nCoV?
The current estimated mortality rate is 2%-3%. That is probably an overestimate, as those with severe disease and those who die are more likely to be tested and reported early in an epidemic.
Our current knowledge is based on preliminary reports from hospitalized patients and will probably change. From the speed of spread and a single family cluster, it seems likely that there are milder cases and perhaps asymptomatic infection.
What else do I need to know about coronaviruses?
Coronaviruses are a large and diverse group of viruses, many of which are animal viruses. Before the discovery of the 2019-nCoV, six coronaviruses were known to infect humans. Four of these (HKU1, NL63, OC43, and 229E) predominantly caused mild to moderate upper respiratory illness, and they are thought to be responsible for 10%-30% of colds. They occasionally cause viral pneumonia and can be detected by some commercial multiplex panels.
Two other coronaviruses have caused outbreaks of severe respiratory illness in people: SARS, which emerged in Southern China in 2002, and MERS in the Middle East, in 2012. Unlike SARS, sporadic cases of MERS continue to occur.
The current outbreak is caused by 2019-nCoV, a previously unknown beta coronavirus. It is most closely related (~96%) to a bat virus and shares about 80% sequence homology with SARS CoV.
Andrew T. Pavia, MD, is the George and Esther Gross Presidential Professor and chief of the division of pediatric infectious disease in the department of pediatrics at the University of Utah, Salt Lake City. He is also director of hospital epidemiology and associate director of antimicrobial stewardship at Primary Children’s Hospital, Salt Lake City. Dr. Pavia has disclosed that he has served as a consultant for Genentech, Merck, and Seqirus and that he has served as associate editor for The Sanford Guide.
This article first appeared on Medscape.com.
The 2019 Novel Coronavirus (2019-nCoV) outbreak has unfolded so rapidly that many clinicians are scrambling to stay on top of it. Here are the answers to some frequently asked questions about how to prepare your clinic to respond to this outbreak.
Keep in mind that the outbreak is moving rapidly. Though scientific and epidemiologic knowledge has increased at unprecedented speed, there is much we don’t know, and some of what we think we know will change. Follow the links for the most up-to-date information.
What should our clinic do first?
Plan ahead with the following:
- Develop a plan for office staff to take travel histories from anyone with a respiratory illness and provide training for those who need it. Travel history at present should include asking about travel to China in the past 14 days, specifically Wuhan city or Hubei province.
- Review up-to-date infection control practices with all office staff and provide training for those who need it.
- Take an inventory of supplies of personal protective equipment (PPE), such as gowns, gloves, masks, eye protection, and N95 respirators or powered air-purifying respirators (PAPRs), and order items that are missing or low in stock.
- Fit-test users of N95 masks for maximal effectiveness.
- Plan where a potential patient would be isolated while obtaining expert advice.
- Know whom to contact at the state or local health department if you have a patient with the appropriate travel history.
The Centers for Disease Control and Prevention has prepared a toolkit to help frontline health care professionals prepare for this virus. Providers need to stay up to date on the latest recommendations, as the situation is changing rapidly.
When should I suspect 2019-nCoV illness, and what should I do?
Take the following steps to assess the concern and respond:
- If a patient with respiratory illness has traveled to China in the past 14 days, immediately put a mask on the patient and move the individual to a private room. Use a negative-pressure room if available.
- Put on appropriate PPE (including gloves, gown, eye protection, and mask) for contact, droplet, and airborne precautions. CDC recommends an N95 respirator mask if available, although we don’t know yet if there is true airborne spread.
- Obtain an accurate travel history, including dates and cities. (Tip: Get the correct spelling, as the English spelling of cities in China can cause confusion.)
- If the patient meets the current CDC definition of “person under investigation” or PUI, or if you need guidance on how to proceed, notify infection control (if you are in a facility that has it) and call your state or local health department immediately.
- Contact public health authorities who can help decide whether the patient should be admitted to airborne isolation or monitored at home with appropriate precautions.
What is the definition of a PUI?
The current definition of a PUI is a person who has fever and symptoms of a respiratory infection (cough, shortness of breath) AND who has EITHER been in Wuhan city or Hubei province in the past 14 days OR had close contact with a person either under investigation for 2019-nCoV infection or with confirmed infection. The definition of a PUI will change over time, so check this link.
How can I test for 2019-nCoV?
As of Jan. 30, 2020, testing is by polymerase chain reaction (PCR) and is available in the United States only through the CDC in Atlanta. Testing should soon be available in state health department laboratories. If public health authorities decide that your patient should be tested, they will instruct you on which samples to obtain.
The full sequence of 2019-nCoV has been shared, so some reference laboratories may develop and validate tests, ideally with assistance from CDC. If testing becomes available, make certain that it is a reputable lab that has carefully validated the test.
Should I test for other viruses?
Because the symptoms of 2019-nCoV infection overlap with those of influenza and other respiratory viruses, PCR testing for other viruses should be considered if it will change management (i.e., change the decision to provide influenza antivirals). Use appropriate PPE while collecting specimens, including eye protection. If 2019-nCoV is a consideration, you may want to send the specimen to a hospital lab for testing, where the sample will be processed under a biosafety hood, rather than doing point-of-care testing in the office.
How dangerous is 2019-nCoV?
The current estimated mortality rate is 2%-3%. That is probably an overestimate, as those with severe disease and those who die are more likely to be tested and reported early in an epidemic.
Our current knowledge is based on preliminary reports from hospitalized patients and will probably change. From the speed of spread and a single family cluster, it seems likely that there are milder cases and perhaps asymptomatic infection.
What else do I need to know about coronaviruses?
Coronaviruses are a large and diverse group of viruses, many of which are animal viruses. Before the discovery of the 2019-nCoV, six coronaviruses were known to infect humans. Four of these (HKU1, NL63, OC43, and 229E) predominantly caused mild to moderate upper respiratory illness, and they are thought to be responsible for 10%-30% of colds. They occasionally cause viral pneumonia and can be detected by some commercial multiplex panels.
Two other coronaviruses have caused outbreaks of severe respiratory illness in people: SARS, which emerged in Southern China in 2002, and MERS in the Middle East, in 2012. Unlike SARS, sporadic cases of MERS continue to occur.
The current outbreak is caused by 2019-nCoV, a previously unknown beta coronavirus. It is most closely related (~96%) to a bat virus and shares about 80% sequence homology with SARS CoV.
Andrew T. Pavia, MD, is the George and Esther Gross Presidential Professor and chief of the division of pediatric infectious disease in the department of pediatrics at the University of Utah, Salt Lake City. He is also director of hospital epidemiology and associate director of antimicrobial stewardship at Primary Children’s Hospital, Salt Lake City. Dr. Pavia has disclosed that he has served as a consultant for Genentech, Merck, and Seqirus and that he has served as associate editor for The Sanford Guide.
This article first appeared on Medscape.com.
Smoking ban in cars: 72% relative drop in percentage of kids’ smoke exposure
England’s ban on smoking in cars carrying children led to a 72% relative reduction in the percentage of children self-reporting exposure to tobacco smoke in cars.
“Given children’s known vulnerability to secondhand smoke, reductions in exposure will probably result in improved health,” wrote Anthony A. Laverty, PhD, of Imperial College London and coauthors. Their findings were published in Thorax.
To determine the impact of a 2015 ban on smoking in cars carrying children in England and a 2016 ban in Scotland, the researchers analyzed survey data from 2012, 2014, and 2016 for each of the two countries. In England, children aged 13-15 years were asked, “In the past year, how often were you in a car with somebody smoking?” In Scotland, they were asked, “Are you regularly exposed to other people’s tobacco smoke in any of these places?” with cars/vehicles being one of the options.
Overall, 15,318 responses were received in England and 822 were received in Scotland. In England, self-reported regular exposure to smoke in cars was 6% in 2012, 6% in 2014 and 2% in 2016. In Scotland, it was 3% in 2012, 2% in 2014 and 1% in 2016. From 2014-2016 in England, implementation of the smoke-free policy was associated with a 4% absolute reduction – or a 72% relative reduction – in the percentage of children self-reporting exposure.
The authors acknowledged their study’s limitations, including exposure being based on self-reporting alone and the analyses using only three data points. “Future analyses with more data are recommended,” they wrote, “and may provide discrepant results.”
The study was funded by the National Institute for Health Research School for Public Health Research. One author was funded by the Medical Research Council on a clinician scientist fellowship. The others reported no potential conflicts of interest.
SOURCE: Laverty AA et al. Thorax. 2020 Jan 27. doi: 10.1136/thoraxjnl-2019-213998.
England’s ban on smoking in cars carrying children led to a 72% relative reduction in the percentage of children self-reporting exposure to tobacco smoke in cars.
“Given children’s known vulnerability to secondhand smoke, reductions in exposure will probably result in improved health,” wrote Anthony A. Laverty, PhD, of Imperial College London and coauthors. Their findings were published in Thorax.
To determine the impact of a 2015 ban on smoking in cars carrying children in England and a 2016 ban in Scotland, the researchers analyzed survey data from 2012, 2014, and 2016 for each of the two countries. In England, children aged 13-15 years were asked, “In the past year, how often were you in a car with somebody smoking?” In Scotland, they were asked, “Are you regularly exposed to other people’s tobacco smoke in any of these places?” with cars/vehicles being one of the options.
Overall, 15,318 responses were received in England and 822 were received in Scotland. In England, self-reported regular exposure to smoke in cars was 6% in 2012, 6% in 2014 and 2% in 2016. In Scotland, it was 3% in 2012, 2% in 2014 and 1% in 2016. From 2014-2016 in England, implementation of the smoke-free policy was associated with a 4% absolute reduction – or a 72% relative reduction – in the percentage of children self-reporting exposure.
The authors acknowledged their study’s limitations, including exposure being based on self-reporting alone and the analyses using only three data points. “Future analyses with more data are recommended,” they wrote, “and may provide discrepant results.”
The study was funded by the National Institute for Health Research School for Public Health Research. One author was funded by the Medical Research Council on a clinician scientist fellowship. The others reported no potential conflicts of interest.
SOURCE: Laverty AA et al. Thorax. 2020 Jan 27. doi: 10.1136/thoraxjnl-2019-213998.
England’s ban on smoking in cars carrying children led to a 72% relative reduction in the percentage of children self-reporting exposure to tobacco smoke in cars.
“Given children’s known vulnerability to secondhand smoke, reductions in exposure will probably result in improved health,” wrote Anthony A. Laverty, PhD, of Imperial College London and coauthors. Their findings were published in Thorax.
To determine the impact of a 2015 ban on smoking in cars carrying children in England and a 2016 ban in Scotland, the researchers analyzed survey data from 2012, 2014, and 2016 for each of the two countries. In England, children aged 13-15 years were asked, “In the past year, how often were you in a car with somebody smoking?” In Scotland, they were asked, “Are you regularly exposed to other people’s tobacco smoke in any of these places?” with cars/vehicles being one of the options.
Overall, 15,318 responses were received in England and 822 were received in Scotland. In England, self-reported regular exposure to smoke in cars was 6% in 2012, 6% in 2014 and 2% in 2016. In Scotland, it was 3% in 2012, 2% in 2014 and 1% in 2016. From 2014-2016 in England, implementation of the smoke-free policy was associated with a 4% absolute reduction – or a 72% relative reduction – in the percentage of children self-reporting exposure.
The authors acknowledged their study’s limitations, including exposure being based on self-reporting alone and the analyses using only three data points. “Future analyses with more data are recommended,” they wrote, “and may provide discrepant results.”
The study was funded by the National Institute for Health Research School for Public Health Research. One author was funded by the Medical Research Council on a clinician scientist fellowship. The others reported no potential conflicts of interest.
SOURCE: Laverty AA et al. Thorax. 2020 Jan 27. doi: 10.1136/thoraxjnl-2019-213998.
FROM THORAX
In rheumatology, biosimilars are flatlining. Why?
Although biosimilar versions of tumor necrosis factor inhibitors (TNFis) have been available to U.S. rheumatologists and their patients for over 3 years, uptake has thus far been slow.
In an analysis of data from a large commercial payer, the two available biosimilars for infliximab (Remicade) accounted for less than 1% of TNFi prescribing since the first biosimilar to infliximab was approved in 2016.
The study, published in Arthritis & Rheumatology, involved a total of 1.1 million TNFi prescriptions or infusions received by 95,906 patients from 2016 to 2019. Investigators found that uptake of biosimilar infliximab was essentially flat, standing at 0.1% of prescribing in the second quarter of 2017, and topping out at 0.9% in the first quarter of 2019. For branded infliximab, prescribing was also stable, but accounted for about 20% of overall biologic dispensing in each quarter of the period studied.
There are currently two biosimilar medications to the originator infliximab, which is one of five originator biologics available to treat rheumatic diseases in the United States: infliximab-dyyb (Inflectra) and infliximab-abda (Renflexis). The former was approved in 2016 and the latter in 2017, said study author Seoyoung C. Kim, MD, ScD, of the division of pharmacoepidemiology and pharmacoeconomics, Brigham and Women’s Hospital, Boston, and her coauthors.
“Our paper reports a disappointingly low uptake of biosimilar infliximab since the first quarter of 2017 using claims data from a large private health plan. The main and maybe the only reason to consider using a biosimilar is cost saving,” said Dr. Kim in an interview. “Our results suggest that current modest cost savings from infliximab biosimilars in the U.S. are not sufficient to promote their widespread use.”
In the payer database study conducted by Dr. Kim and colleagues, the insurer paid similar mean amounts per patient per quarter for originator and biosimilar infliximab in mid-2017 ($8,322 versus $8,656). By the end of 2018, a gap appeared, with the insurer paying a mean quarterly per-patient sum of $8,111 for biosimilar infliximab compared with $9,535 for the branded biologic.
“The lack of market penetration and very modest price reductions for biosimilars have left policymakers, payers, physicians, and the public frustrated, particularly because sales in Europe continue to rapidly expand and robust cost-savings have materialized,” wrote Jinoos Yazdany, MD, MPH, in an editorial accompanying the study.
Dr. Yazdany, professor and chief of the division of rheumatology at the University of California, San Francisco, noted that increased spending on biologics in the United States – which increased by 50% from 2014 to 2018 – has been driven by rising prices as well as increased uptake of biologic therapies.
At least in part, Europe has been able to reap cost savings where the United States hasn’t because fundamental differences in health care reimbursement can ease sweeping biosimilar adoption, Dr. Yazdany noted. “Countries like Denmark and Sweden, using the negotiating and purchasing power of their single-payer systems have instituted a winner-takes-all bidding system,” with Denmark seeing cost savings of up to two-thirds when bidding was combined with mandatory switching, she said.
The continued market dominance of originator infliximab means that savings from biosimilars have thus far amounted to about $91 million, far short of the $1 billion that the Congressional Budget Office had projected for this date, Dr. Yazdany said.
One problem in the adoption of biosimilars by U.S. rheumatologists may have been uneven marketing and pricing across different types of practice, Colin C. Edgerton, MD, a rheumatologist at Low Country Rheumatology in South Carolina and chair of the American College of Rheumatology’s Committee on Rheumatologic Care, said in an interview.
“Rheumatologists have generally developed comfort with biosimilars, although this is not universal. The core message, that all biologics vary and that this is OK, is getting out. In general, rheumatologists also understand the problem with high drug prices and the threat to patient access,” Dr. Edgerton said. But “the early marketing and pricing focus for biosimilars seemed to be on hospitals and facilities, and this did not work effectively for community rheumatologists, where the majority of care is delivered. We have been pleased to see a manufacturer pivot toward community rheumatology where additional efforts need to be made to bend the curve on biosimilar adoption. It is critical for practices with experience using biosimilars to educate peers, and this is where networks of practicing rheumatologists are important.”
In Dr. Yazdany’s editorial, she cited four structural factors impeding biosimilar uptake and downstream savings.
First, she cites ongoing actions by pharmaceutical companies, which create a “patent thicket” that has the effect of fencing off originator biologics from biosimilars long beyond the original 12-year exclusivity period. Supporting the notion that “patent thickets” are a common strategy, Dr. Yazdany noted that almost half of the patent applications that AbbVie has filed for adalimumab (Humira) have come in after the original exclusivity period expired in 2014. Humira’s price has risen 18% yearly during this period.
The complicated role played by pharmacy benefit managers (PBMs) is another factor in slow adoption, said Dr. Yazdany: When manufacturers offer rebates to PBMs, the price of the originator biologic may be less than its biosimilar. Further, manufacturers may sign multiyear rebate agreements just before a biosimilar launch; PBMs are also sometimes threatened with the withdrawal of rebates if they offer biosimilars, she noted.
Third, prescriber inertia may also be at play, Dr. Yazdany noted, not least because patients often see little difference in out-of-pocket costs when they make the switch to a biosimilar – PBM rebates are not necessarily passed on to patients. Payers may not reimburse a biosimilar, or formularies can be built without them, influencing prescribing, and there’s usually no reimbursement incentive for biosimilar prescribing in the nonpublic sector, she said. To the contrary, infusing a drug with a higher price often means higher reimbursement for the administering clinician, since commercial insurance reimbursement is often calculated as a percent of the charge for the drug.
Further contributing to inertia is the extra time required for patient education and writing a new set of orders – all work that can’t be captured for extra reimbursement. Dr. Edgerton said that rheumatologists can talk with patients about the “nocebo effect” relating to biosimilars. “This is a phenomenon in which patients are thought to experience worsening symptoms associated with negative beliefs about biosimilars. There has been a study in Arthritis Care & Research addressing this concern. The authors found that positive framing of biosimilars led to more participants being willing to switch than negative framing. This suggests that clinicians have an important role in informing patients about biosimilars, and addressing hesitancy.”
Finally, Dr. Yazdany pointed out that for a pharmaceutical company pursuing biosimilar approval, the regulatory pathway itself can provide its own set of complications and confusion. Biosimilars are not exact molecular replicas of the originator biologic, and these differences can change efficacy and immunogenicity, and also affect stability. Hence, a company wishing to market a biosimilar has to show the Food and Drug Administration that safety and efficacy aren’t affected by a switch to biosimilar from an originator biologic. Extrapolation from one indication to another can be made – with scientific justification.
Rheumatologists are mindful of the potential differences between biosimilars and the originator biologic, as evinced in a recent position statement from the American College of Rheumatology. The position statement advises that “extrapolation should be pursued with caution,” and asks for clear labeling when biosimilars have been designated “interchangeable” with their biosimilar. Interchangeability can clear the way for pharmacy substitution of a prescribed biologic, though Dr. Yazdany noted that 40 states have passed legislation requiring prescriber notification.
The FDA is currently using postmarketing pharmacovigilance to monitor biosimilar performance in the real world, and a recent systematic review “should provide some reassurance,” wrote Dr. Yazdany, citing the study, which looked at 14,000 patients who had a total of 14 disease indications for biosimilar use. The 90-article review largely found no differences in safety, efficacy, or immunogenicity between originators and their biosimilars. Dr. Yazdany recommended greater openness to incorporating the European experience in the FDA’s ongoing reassessment.
A further way forward can come through tackling the patent thicket with the proposed bipartisan Biologic Patent Transparency Act, which would require publication of biologic patents in a one-stop publicly searchable database. Going further with legislation to address anticompetitive activity by pharmaceutical companies could shorten the runway to biosimilar launching considerably, she noted.
The complicated landscape of PBMs and rebates affects many sectors of health care, and new policy efforts are needed here as well, she said. Reimbursement strategies – and much-needed continuing medical education – can both ease prescriber unfamiliarity with biosimilars and provide incentives for their use, she concluded.
Dr. Kim concurred that change is needed before the United States is likely to reap significant economic benefit from biosimilars. “The uptake of biosimilars and their impact on overall health care cost needs to be reevaluated when we have more biosimilars available in the next 3-4 years. However, for now, it appears that substantial savings achieved in some European countries – for example, Denmark – may not be possible without systemic reform of the U.S. pharmaceutical market,” she said.
Dr. Yazdany is supported by the Alice Betts Endowed Chair in Arthritis Research, the Russel/Engleman Research Center at the University of California, San Francisco, and the National Institutes of Health. She has received independent research grants from Pfizer and Genentech and research consulting fees from Eli Lilly and AstraZeneca.
Dr. Kim’s study was supported by the division of pharmacoepidemiology and pharmacoeconomics, department of medicine, Brigham and Women’s Hospital, and Arnold Ventures. Dr. Kim has received research grants to Brigham and Women’s Hospital from Pfizer, AbbVie, Bristol-Myers Squibb, and Roche.
SOURCES: Kim SC et al. Arthritis Rheumatol. 2020 Jan 13. doi: 10.1002/art.41201; Yazdany J. Arthritis Rheumatol. 2020 Jan 10. doi: 10.1002/art.41203.
Although biosimilar versions of tumor necrosis factor inhibitors (TNFis) have been available to U.S. rheumatologists and their patients for over 3 years, uptake has thus far been slow.
In an analysis of data from a large commercial payer, the two available biosimilars for infliximab (Remicade) accounted for less than 1% of TNFi prescribing since the first biosimilar to infliximab was approved in 2016.
The study, published in Arthritis & Rheumatology, involved a total of 1.1 million TNFi prescriptions or infusions received by 95,906 patients from 2016 to 2019. Investigators found that uptake of biosimilar infliximab was essentially flat, standing at 0.1% of prescribing in the second quarter of 2017, and topping out at 0.9% in the first quarter of 2019. For branded infliximab, prescribing was also stable, but accounted for about 20% of overall biologic dispensing in each quarter of the period studied.
There are currently two biosimilar medications to the originator infliximab, which is one of five originator biologics available to treat rheumatic diseases in the United States: infliximab-dyyb (Inflectra) and infliximab-abda (Renflexis). The former was approved in 2016 and the latter in 2017, said study author Seoyoung C. Kim, MD, ScD, of the division of pharmacoepidemiology and pharmacoeconomics, Brigham and Women’s Hospital, Boston, and her coauthors.
“Our paper reports a disappointingly low uptake of biosimilar infliximab since the first quarter of 2017 using claims data from a large private health plan. The main and maybe the only reason to consider using a biosimilar is cost saving,” said Dr. Kim in an interview. “Our results suggest that current modest cost savings from infliximab biosimilars in the U.S. are not sufficient to promote their widespread use.”
In the payer database study conducted by Dr. Kim and colleagues, the insurer paid similar mean amounts per patient per quarter for originator and biosimilar infliximab in mid-2017 ($8,322 versus $8,656). By the end of 2018, a gap appeared, with the insurer paying a mean quarterly per-patient sum of $8,111 for biosimilar infliximab compared with $9,535 for the branded biologic.
“The lack of market penetration and very modest price reductions for biosimilars have left policymakers, payers, physicians, and the public frustrated, particularly because sales in Europe continue to rapidly expand and robust cost-savings have materialized,” wrote Jinoos Yazdany, MD, MPH, in an editorial accompanying the study.
Dr. Yazdany, professor and chief of the division of rheumatology at the University of California, San Francisco, noted that increased spending on biologics in the United States – which increased by 50% from 2014 to 2018 – has been driven by rising prices as well as increased uptake of biologic therapies.
At least in part, Europe has been able to reap cost savings where the United States hasn’t because fundamental differences in health care reimbursement can ease sweeping biosimilar adoption, Dr. Yazdany noted. “Countries like Denmark and Sweden, using the negotiating and purchasing power of their single-payer systems have instituted a winner-takes-all bidding system,” with Denmark seeing cost savings of up to two-thirds when bidding was combined with mandatory switching, she said.
The continued market dominance of originator infliximab means that savings from biosimilars have thus far amounted to about $91 million, far short of the $1 billion that the Congressional Budget Office had projected for this date, Dr. Yazdany said.
One problem in the adoption of biosimilars by U.S. rheumatologists may have been uneven marketing and pricing across different types of practice, Colin C. Edgerton, MD, a rheumatologist at Low Country Rheumatology in South Carolina and chair of the American College of Rheumatology’s Committee on Rheumatologic Care, said in an interview.
“Rheumatologists have generally developed comfort with biosimilars, although this is not universal. The core message, that all biologics vary and that this is OK, is getting out. In general, rheumatologists also understand the problem with high drug prices and the threat to patient access,” Dr. Edgerton said. But “the early marketing and pricing focus for biosimilars seemed to be on hospitals and facilities, and this did not work effectively for community rheumatologists, where the majority of care is delivered. We have been pleased to see a manufacturer pivot toward community rheumatology where additional efforts need to be made to bend the curve on biosimilar adoption. It is critical for practices with experience using biosimilars to educate peers, and this is where networks of practicing rheumatologists are important.”
In Dr. Yazdany’s editorial, she cited four structural factors impeding biosimilar uptake and downstream savings.
First, she cites ongoing actions by pharmaceutical companies, which create a “patent thicket” that has the effect of fencing off originator biologics from biosimilars long beyond the original 12-year exclusivity period. Supporting the notion that “patent thickets” are a common strategy, Dr. Yazdany noted that almost half of the patent applications that AbbVie has filed for adalimumab (Humira) have come in after the original exclusivity period expired in 2014. Humira’s price has risen 18% yearly during this period.
The complicated role played by pharmacy benefit managers (PBMs) is another factor in slow adoption, said Dr. Yazdany: When manufacturers offer rebates to PBMs, the price of the originator biologic may be less than its biosimilar. Further, manufacturers may sign multiyear rebate agreements just before a biosimilar launch; PBMs are also sometimes threatened with the withdrawal of rebates if they offer biosimilars, she noted.
Third, prescriber inertia may also be at play, Dr. Yazdany noted, not least because patients often see little difference in out-of-pocket costs when they make the switch to a biosimilar – PBM rebates are not necessarily passed on to patients. Payers may not reimburse a biosimilar, or formularies can be built without them, influencing prescribing, and there’s usually no reimbursement incentive for biosimilar prescribing in the nonpublic sector, she said. To the contrary, infusing a drug with a higher price often means higher reimbursement for the administering clinician, since commercial insurance reimbursement is often calculated as a percent of the charge for the drug.
Further contributing to inertia is the extra time required for patient education and writing a new set of orders – all work that can’t be captured for extra reimbursement. Dr. Edgerton said that rheumatologists can talk with patients about the “nocebo effect” relating to biosimilars. “This is a phenomenon in which patients are thought to experience worsening symptoms associated with negative beliefs about biosimilars. There has been a study in Arthritis Care & Research addressing this concern. The authors found that positive framing of biosimilars led to more participants being willing to switch than negative framing. This suggests that clinicians have an important role in informing patients about biosimilars, and addressing hesitancy.”
Finally, Dr. Yazdany pointed out that for a pharmaceutical company pursuing biosimilar approval, the regulatory pathway itself can provide its own set of complications and confusion. Biosimilars are not exact molecular replicas of the originator biologic, and these differences can change efficacy and immunogenicity, and also affect stability. Hence, a company wishing to market a biosimilar has to show the Food and Drug Administration that safety and efficacy aren’t affected by a switch to biosimilar from an originator biologic. Extrapolation from one indication to another can be made – with scientific justification.
Rheumatologists are mindful of the potential differences between biosimilars and the originator biologic, as evinced in a recent position statement from the American College of Rheumatology. The position statement advises that “extrapolation should be pursued with caution,” and asks for clear labeling when biosimilars have been designated “interchangeable” with their biosimilar. Interchangeability can clear the way for pharmacy substitution of a prescribed biologic, though Dr. Yazdany noted that 40 states have passed legislation requiring prescriber notification.
The FDA is currently using postmarketing pharmacovigilance to monitor biosimilar performance in the real world, and a recent systematic review “should provide some reassurance,” wrote Dr. Yazdany, citing the study, which looked at 14,000 patients who had a total of 14 disease indications for biosimilar use. The 90-article review largely found no differences in safety, efficacy, or immunogenicity between originators and their biosimilars. Dr. Yazdany recommended greater openness to incorporating the European experience in the FDA’s ongoing reassessment.
A further way forward can come through tackling the patent thicket with the proposed bipartisan Biologic Patent Transparency Act, which would require publication of biologic patents in a one-stop publicly searchable database. Going further with legislation to address anticompetitive activity by pharmaceutical companies could shorten the runway to biosimilar launching considerably, she noted.
The complicated landscape of PBMs and rebates affects many sectors of health care, and new policy efforts are needed here as well, she said. Reimbursement strategies – and much-needed continuing medical education – can both ease prescriber unfamiliarity with biosimilars and provide incentives for their use, she concluded.
Dr. Kim concurred that change is needed before the United States is likely to reap significant economic benefit from biosimilars. “The uptake of biosimilars and their impact on overall health care cost needs to be reevaluated when we have more biosimilars available in the next 3-4 years. However, for now, it appears that substantial savings achieved in some European countries – for example, Denmark – may not be possible without systemic reform of the U.S. pharmaceutical market,” she said.
Dr. Yazdany is supported by the Alice Betts Endowed Chair in Arthritis Research, the Russel/Engleman Research Center at the University of California, San Francisco, and the National Institutes of Health. She has received independent research grants from Pfizer and Genentech and research consulting fees from Eli Lilly and AstraZeneca.
Dr. Kim’s study was supported by the division of pharmacoepidemiology and pharmacoeconomics, department of medicine, Brigham and Women’s Hospital, and Arnold Ventures. Dr. Kim has received research grants to Brigham and Women’s Hospital from Pfizer, AbbVie, Bristol-Myers Squibb, and Roche.
SOURCES: Kim SC et al. Arthritis Rheumatol. 2020 Jan 13. doi: 10.1002/art.41201; Yazdany J. Arthritis Rheumatol. 2020 Jan 10. doi: 10.1002/art.41203.
Although biosimilar versions of tumor necrosis factor inhibitors (TNFis) have been available to U.S. rheumatologists and their patients for over 3 years, uptake has thus far been slow.
In an analysis of data from a large commercial payer, the two available biosimilars for infliximab (Remicade) accounted for less than 1% of TNFi prescribing since the first biosimilar to infliximab was approved in 2016.
The study, published in Arthritis & Rheumatology, involved a total of 1.1 million TNFi prescriptions or infusions received by 95,906 patients from 2016 to 2019. Investigators found that uptake of biosimilar infliximab was essentially flat, standing at 0.1% of prescribing in the second quarter of 2017, and topping out at 0.9% in the first quarter of 2019. For branded infliximab, prescribing was also stable, but accounted for about 20% of overall biologic dispensing in each quarter of the period studied.
There are currently two biosimilar medications to the originator infliximab, which is one of five originator biologics available to treat rheumatic diseases in the United States: infliximab-dyyb (Inflectra) and infliximab-abda (Renflexis). The former was approved in 2016 and the latter in 2017, said study author Seoyoung C. Kim, MD, ScD, of the division of pharmacoepidemiology and pharmacoeconomics, Brigham and Women’s Hospital, Boston, and her coauthors.
“Our paper reports a disappointingly low uptake of biosimilar infliximab since the first quarter of 2017 using claims data from a large private health plan. The main and maybe the only reason to consider using a biosimilar is cost saving,” said Dr. Kim in an interview. “Our results suggest that current modest cost savings from infliximab biosimilars in the U.S. are not sufficient to promote their widespread use.”
In the payer database study conducted by Dr. Kim and colleagues, the insurer paid similar mean amounts per patient per quarter for originator and biosimilar infliximab in mid-2017 ($8,322 versus $8,656). By the end of 2018, a gap appeared, with the insurer paying a mean quarterly per-patient sum of $8,111 for biosimilar infliximab compared with $9,535 for the branded biologic.
“The lack of market penetration and very modest price reductions for biosimilars have left policymakers, payers, physicians, and the public frustrated, particularly because sales in Europe continue to rapidly expand and robust cost-savings have materialized,” wrote Jinoos Yazdany, MD, MPH, in an editorial accompanying the study.
Dr. Yazdany, professor and chief of the division of rheumatology at the University of California, San Francisco, noted that increased spending on biologics in the United States – which increased by 50% from 2014 to 2018 – has been driven by rising prices as well as increased uptake of biologic therapies.
At least in part, Europe has been able to reap cost savings where the United States hasn’t because fundamental differences in health care reimbursement can ease sweeping biosimilar adoption, Dr. Yazdany noted. “Countries like Denmark and Sweden, using the negotiating and purchasing power of their single-payer systems have instituted a winner-takes-all bidding system,” with Denmark seeing cost savings of up to two-thirds when bidding was combined with mandatory switching, she said.
The continued market dominance of originator infliximab means that savings from biosimilars have thus far amounted to about $91 million, far short of the $1 billion that the Congressional Budget Office had projected for this date, Dr. Yazdany said.
One problem in the adoption of biosimilars by U.S. rheumatologists may have been uneven marketing and pricing across different types of practice, Colin C. Edgerton, MD, a rheumatologist at Low Country Rheumatology in South Carolina and chair of the American College of Rheumatology’s Committee on Rheumatologic Care, said in an interview.
“Rheumatologists have generally developed comfort with biosimilars, although this is not universal. The core message, that all biologics vary and that this is OK, is getting out. In general, rheumatologists also understand the problem with high drug prices and the threat to patient access,” Dr. Edgerton said. But “the early marketing and pricing focus for biosimilars seemed to be on hospitals and facilities, and this did not work effectively for community rheumatologists, where the majority of care is delivered. We have been pleased to see a manufacturer pivot toward community rheumatology where additional efforts need to be made to bend the curve on biosimilar adoption. It is critical for practices with experience using biosimilars to educate peers, and this is where networks of practicing rheumatologists are important.”
In Dr. Yazdany’s editorial, she cited four structural factors impeding biosimilar uptake and downstream savings.
First, she cites ongoing actions by pharmaceutical companies, which create a “patent thicket” that has the effect of fencing off originator biologics from biosimilars long beyond the original 12-year exclusivity period. Supporting the notion that “patent thickets” are a common strategy, Dr. Yazdany noted that almost half of the patent applications that AbbVie has filed for adalimumab (Humira) have come in after the original exclusivity period expired in 2014. Humira’s price has risen 18% yearly during this period.
The complicated role played by pharmacy benefit managers (PBMs) is another factor in slow adoption, said Dr. Yazdany: When manufacturers offer rebates to PBMs, the price of the originator biologic may be less than its biosimilar. Further, manufacturers may sign multiyear rebate agreements just before a biosimilar launch; PBMs are also sometimes threatened with the withdrawal of rebates if they offer biosimilars, she noted.
Third, prescriber inertia may also be at play, Dr. Yazdany noted, not least because patients often see little difference in out-of-pocket costs when they make the switch to a biosimilar – PBM rebates are not necessarily passed on to patients. Payers may not reimburse a biosimilar, or formularies can be built without them, influencing prescribing, and there’s usually no reimbursement incentive for biosimilar prescribing in the nonpublic sector, she said. To the contrary, infusing a drug with a higher price often means higher reimbursement for the administering clinician, since commercial insurance reimbursement is often calculated as a percent of the charge for the drug.
Further contributing to inertia is the extra time required for patient education and writing a new set of orders – all work that can’t be captured for extra reimbursement. Dr. Edgerton said that rheumatologists can talk with patients about the “nocebo effect” relating to biosimilars. “This is a phenomenon in which patients are thought to experience worsening symptoms associated with negative beliefs about biosimilars. There has been a study in Arthritis Care & Research addressing this concern. The authors found that positive framing of biosimilars led to more participants being willing to switch than negative framing. This suggests that clinicians have an important role in informing patients about biosimilars, and addressing hesitancy.”
Finally, Dr. Yazdany pointed out that for a pharmaceutical company pursuing biosimilar approval, the regulatory pathway itself can provide its own set of complications and confusion. Biosimilars are not exact molecular replicas of the originator biologic, and these differences can change efficacy and immunogenicity, and also affect stability. Hence, a company wishing to market a biosimilar has to show the Food and Drug Administration that safety and efficacy aren’t affected by a switch to biosimilar from an originator biologic. Extrapolation from one indication to another can be made – with scientific justification.
Rheumatologists are mindful of the potential differences between biosimilars and the originator biologic, as evinced in a recent position statement from the American College of Rheumatology. The position statement advises that “extrapolation should be pursued with caution,” and asks for clear labeling when biosimilars have been designated “interchangeable” with their biosimilar. Interchangeability can clear the way for pharmacy substitution of a prescribed biologic, though Dr. Yazdany noted that 40 states have passed legislation requiring prescriber notification.
The FDA is currently using postmarketing pharmacovigilance to monitor biosimilar performance in the real world, and a recent systematic review “should provide some reassurance,” wrote Dr. Yazdany, citing the study, which looked at 14,000 patients who had a total of 14 disease indications for biosimilar use. The 90-article review largely found no differences in safety, efficacy, or immunogenicity between originators and their biosimilars. Dr. Yazdany recommended greater openness to incorporating the European experience in the FDA’s ongoing reassessment.
A further way forward can come through tackling the patent thicket with the proposed bipartisan Biologic Patent Transparency Act, which would require publication of biologic patents in a one-stop publicly searchable database. Going further with legislation to address anticompetitive activity by pharmaceutical companies could shorten the runway to biosimilar launching considerably, she noted.
The complicated landscape of PBMs and rebates affects many sectors of health care, and new policy efforts are needed here as well, she said. Reimbursement strategies – and much-needed continuing medical education – can both ease prescriber unfamiliarity with biosimilars and provide incentives for their use, she concluded.
Dr. Kim concurred that change is needed before the United States is likely to reap significant economic benefit from biosimilars. “The uptake of biosimilars and their impact on overall health care cost needs to be reevaluated when we have more biosimilars available in the next 3-4 years. However, for now, it appears that substantial savings achieved in some European countries – for example, Denmark – may not be possible without systemic reform of the U.S. pharmaceutical market,” she said.
Dr. Yazdany is supported by the Alice Betts Endowed Chair in Arthritis Research, the Russel/Engleman Research Center at the University of California, San Francisco, and the National Institutes of Health. She has received independent research grants from Pfizer and Genentech and research consulting fees from Eli Lilly and AstraZeneca.
Dr. Kim’s study was supported by the division of pharmacoepidemiology and pharmacoeconomics, department of medicine, Brigham and Women’s Hospital, and Arnold Ventures. Dr. Kim has received research grants to Brigham and Women’s Hospital from Pfizer, AbbVie, Bristol-Myers Squibb, and Roche.
SOURCES: Kim SC et al. Arthritis Rheumatol. 2020 Jan 13. doi: 10.1002/art.41201; Yazdany J. Arthritis Rheumatol. 2020 Jan 10. doi: 10.1002/art.41203.
FROM ARTHRITIS & RHEUMATOLOGY
FDA approves fidaxomicin for treatment of C. difficile–associated diarrhea
The Food and Drug Administration has approved fidaxomicin (Dificid) for the treatment of Clostridioides difficile–associated diarrhea in children aged 6 months and older.
Approval was based on results from SUNSHINE, a phase 3, multicenter, investigator-blind, randomized, parallel-group study in 142 pediatric patients aged between 6 months and 18 years with confirmed C. difficile infection who received either fidaxomicin or vancomycin for 10 days. Clinical response 2 days after the conclusion of treatment was similar in both groups (77.6% for fidaxomicin vs. 70.5% for vancomycin), and fidaxomicin had a superior sustained response 30 days after the conclusion of treatment (68.4% vs. 50.0%).
The safety of fidaxomicin was assessed in a pair of clinical trials involving 136 patients; the most common adverse events were pyrexia, abdominal pain, vomiting, diarrhea, constipation, increased aminotransferases, and rash. Four patients discontinued fidaxomicin treatment because of adverse events, and four patients died during the trials, though all deaths were in patients aged younger than 2 years and seemed to be related to other comorbidities.
“C. difficile is an important cause of health care– and community-associated diarrheal illness in children, and sustained cure is difficult to achieve in some patients. The fidaxomicin pediatric trial was the first randomized, controlled trial of C. difficile infection treatment in children,” Larry K. Kociolek, MD, associate medical director of infection prevention and control at Ann & Robert H. Lurie Children’s Hospital of Chicago, said in the press release from Merck, manufacturer of fidaxomicin.
*This story was updated on 1/27/2020.
The Food and Drug Administration has approved fidaxomicin (Dificid) for the treatment of Clostridioides difficile–associated diarrhea in children aged 6 months and older.
Approval was based on results from SUNSHINE, a phase 3, multicenter, investigator-blind, randomized, parallel-group study in 142 pediatric patients aged between 6 months and 18 years with confirmed C. difficile infection who received either fidaxomicin or vancomycin for 10 days. Clinical response 2 days after the conclusion of treatment was similar in both groups (77.6% for fidaxomicin vs. 70.5% for vancomycin), and fidaxomicin had a superior sustained response 30 days after the conclusion of treatment (68.4% vs. 50.0%).
The safety of fidaxomicin was assessed in a pair of clinical trials involving 136 patients; the most common adverse events were pyrexia, abdominal pain, vomiting, diarrhea, constipation, increased aminotransferases, and rash. Four patients discontinued fidaxomicin treatment because of adverse events, and four patients died during the trials, though all deaths were in patients aged younger than 2 years and seemed to be related to other comorbidities.
“C. difficile is an important cause of health care– and community-associated diarrheal illness in children, and sustained cure is difficult to achieve in some patients. The fidaxomicin pediatric trial was the first randomized, controlled trial of C. difficile infection treatment in children,” Larry K. Kociolek, MD, associate medical director of infection prevention and control at Ann & Robert H. Lurie Children’s Hospital of Chicago, said in the press release from Merck, manufacturer of fidaxomicin.
*This story was updated on 1/27/2020.
The Food and Drug Administration has approved fidaxomicin (Dificid) for the treatment of Clostridioides difficile–associated diarrhea in children aged 6 months and older.
Approval was based on results from SUNSHINE, a phase 3, multicenter, investigator-blind, randomized, parallel-group study in 142 pediatric patients aged between 6 months and 18 years with confirmed C. difficile infection who received either fidaxomicin or vancomycin for 10 days. Clinical response 2 days after the conclusion of treatment was similar in both groups (77.6% for fidaxomicin vs. 70.5% for vancomycin), and fidaxomicin had a superior sustained response 30 days after the conclusion of treatment (68.4% vs. 50.0%).
The safety of fidaxomicin was assessed in a pair of clinical trials involving 136 patients; the most common adverse events were pyrexia, abdominal pain, vomiting, diarrhea, constipation, increased aminotransferases, and rash. Four patients discontinued fidaxomicin treatment because of adverse events, and four patients died during the trials, though all deaths were in patients aged younger than 2 years and seemed to be related to other comorbidities.
“C. difficile is an important cause of health care– and community-associated diarrheal illness in children, and sustained cure is difficult to achieve in some patients. The fidaxomicin pediatric trial was the first randomized, controlled trial of C. difficile infection treatment in children,” Larry K. Kociolek, MD, associate medical director of infection prevention and control at Ann & Robert H. Lurie Children’s Hospital of Chicago, said in the press release from Merck, manufacturer of fidaxomicin.
*This story was updated on 1/27/2020.
Zika virus: Birth defects rose fourfold in U.S. hardest-hit areas
according to the Centers for Disease Control and Prevention.
That spike in the prevalence of brain abnormalities and/or microcephaly or eye abnormalities without brain abnormalities came during January through March 2017, about 6 months after the Zika outbreak’s reported peak in the jurisdictions with widespread local transmission, Puerto Rico and the U.S. Virgin Islands, wrote Ashley N. Smoots, MPH, of the CDC’s National Center on Birth Defects and Developmental Disabilities and associates in the Morbidity and Mortality Weekly Report.
In those two territories, the prevalence of birth defects potentially related to Zika virus infection was 5.6 per 1,000 live births during January through March 2017, compared with 1.3 per 1,000 in January through March 2016, they reported.
In the southern areas of Florida and Texas, where there was limited local Zika transmission, the highest prevalence of birth defects, 2.7 per 1,000, occurred during October through December 2016, and was only slightly greater than the baseline rate of 2.2 per 1,000 in January through March 2016, the investigators reported.
Among the other 19 jurisdictions (including Illinois, Louisiana, New Jersey, South Carolina, and Virginia) involved in the analysis, the rate of Zika virus–related birth defects never reached any higher than the 1.7 per 1,000 recorded at the start of the study period in January through March 2016, they said.
“Population-based birth defects surveillance is critical for identifying infants and fetuses with birth defects potentially related to Zika virus regardless of whether Zika virus testing was conducted, especially given the high prevalence of asymptomatic disease. These data can be used to inform follow-up care and services as well as strengthen surveillance,” the investigators wrote.
SOURCE: Smoots AN et al. MMWR. 2020 Jan 24;69(3):67-71.
according to the Centers for Disease Control and Prevention.
That spike in the prevalence of brain abnormalities and/or microcephaly or eye abnormalities without brain abnormalities came during January through March 2017, about 6 months after the Zika outbreak’s reported peak in the jurisdictions with widespread local transmission, Puerto Rico and the U.S. Virgin Islands, wrote Ashley N. Smoots, MPH, of the CDC’s National Center on Birth Defects and Developmental Disabilities and associates in the Morbidity and Mortality Weekly Report.
In those two territories, the prevalence of birth defects potentially related to Zika virus infection was 5.6 per 1,000 live births during January through March 2017, compared with 1.3 per 1,000 in January through March 2016, they reported.
In the southern areas of Florida and Texas, where there was limited local Zika transmission, the highest prevalence of birth defects, 2.7 per 1,000, occurred during October through December 2016, and was only slightly greater than the baseline rate of 2.2 per 1,000 in January through March 2016, the investigators reported.
Among the other 19 jurisdictions (including Illinois, Louisiana, New Jersey, South Carolina, and Virginia) involved in the analysis, the rate of Zika virus–related birth defects never reached any higher than the 1.7 per 1,000 recorded at the start of the study period in January through March 2016, they said.
“Population-based birth defects surveillance is critical for identifying infants and fetuses with birth defects potentially related to Zika virus regardless of whether Zika virus testing was conducted, especially given the high prevalence of asymptomatic disease. These data can be used to inform follow-up care and services as well as strengthen surveillance,” the investigators wrote.
SOURCE: Smoots AN et al. MMWR. 2020 Jan 24;69(3):67-71.
according to the Centers for Disease Control and Prevention.
That spike in the prevalence of brain abnormalities and/or microcephaly or eye abnormalities without brain abnormalities came during January through March 2017, about 6 months after the Zika outbreak’s reported peak in the jurisdictions with widespread local transmission, Puerto Rico and the U.S. Virgin Islands, wrote Ashley N. Smoots, MPH, of the CDC’s National Center on Birth Defects and Developmental Disabilities and associates in the Morbidity and Mortality Weekly Report.
In those two territories, the prevalence of birth defects potentially related to Zika virus infection was 5.6 per 1,000 live births during January through March 2017, compared with 1.3 per 1,000 in January through March 2016, they reported.
In the southern areas of Florida and Texas, where there was limited local Zika transmission, the highest prevalence of birth defects, 2.7 per 1,000, occurred during October through December 2016, and was only slightly greater than the baseline rate of 2.2 per 1,000 in January through March 2016, the investigators reported.
Among the other 19 jurisdictions (including Illinois, Louisiana, New Jersey, South Carolina, and Virginia) involved in the analysis, the rate of Zika virus–related birth defects never reached any higher than the 1.7 per 1,000 recorded at the start of the study period in January through March 2016, they said.
“Population-based birth defects surveillance is critical for identifying infants and fetuses with birth defects potentially related to Zika virus regardless of whether Zika virus testing was conducted, especially given the high prevalence of asymptomatic disease. These data can be used to inform follow-up care and services as well as strengthen surveillance,” the investigators wrote.
SOURCE: Smoots AN et al. MMWR. 2020 Jan 24;69(3):67-71.
FROM MMWR
Core behaviors enhance communication about neonatal death
Clinicians can improve communications with parents during neonatal end-of-life situations by adopting key behaviors such as sitting down to talk to parents and using the infant’s name, according to data from a simulation study.
“Empirical evidence regarding communication with parents during and after a child’s critical instability or death is scarce,” wrote Marie-Hélène Lizotte, MD, of Centre Hospitalier Universitaire Sainte-Justine, Montréal, and colleagues. Noting that realistic simulation has been shown to help clinicians improve their communication skills, the investigators recruited clinicians to participate in a simulated unsuccessful neonatal resuscitation to identify behaviors associated with optimal parent communication.
Behaviors associated with high scores for clinicians deemed “good communicators” included introducing themselves to parents, using the infant’s name (if known), sitting down to speak to parents, not leaving the infant alone on the bed after death, and allowing time for silence, the researchers reported in Pediatrics.
The investigators presented the video simulations to evaluators, including clinicians and bereaved parents. In the simulation, a term infant was born after an emergency cesarean delivery for fetal distress and died after an unsuccessful attempt at resuscitation. A manikin infant was programmed to remain pulseless, and two actors played the roles of the parents in the video.
Evaluators scored the videos for overall performance and for communication with the parent actors during and after the resuscitation.
Overall, parent evaluators and parent actors agreed with clinicians on what actions exemplified optimal communication in about 81% of evaluations. Discrepancies were mainly related to the language participants used related to death, as some parent evaluators said they had trouble understanding certain sentences or found them insensitive, such as “her heart never came back” and “allowing natural death.”
A total of 31 participants were recruited for the simulation, including 15 pediatric residents, 5 neonatal fellows, 3 neonatologists, 3 neonatal nurse practitioners, and 5 transport and resuscitation team providers. Videos of the simulations were examined by 21 evaluators, including bereaved parents, the parent actors, a neonatologist, a maternal-fetal medicine specialist, a psychologist, and a respiratory therapist. There were 651 evaluations.
The study findings were limited by several factors including the use of a single center, use of videos for evaluations, and the use of a single infant-resuscitation scenario, the researchers noted. The results were strengthened, however, by the large number of evaluations, and they support the core behaviors as “a skeleton on which to build additional skills with practice and training” with attention to cultural differences in their application, such as recognizing that infants are not named until after birth in some cultures, they said.
The existing literature on strategies for providing empathy and support to parents facing the death of a child is limited, but this simulation study provides a design model to help address this issue, Chris Feudtner, MD, of the Children’s Hospital of Philadelphia wrote in an accompanying editorial. “Overall, this study, in terms of design and methodologic rigor, is a great advance toward answering our key question: how to best support parents in such circumstances,” he said.
Dr. Feudtner said that he would divide the clinician behaviors into two groups. The first, “Calm kind politeness,” includes acknowledging the parents, introducing themselves, using the infant’s name, and remaining calm. The second set of behaviors, which he called “Skillful situational leadership,” includes preparing parents for the resuscitation activities and providing verbal milestones that prepared them for the fatal outcome.
“Picking up on a metaphor offered by the authors of the study, training and repetitive drills on these specific behaviors cannot be emphasized enough because they are not only the skeleton of excellent communication; they are likely also the muscles, the heart, and even the soul,” he concluded.
The study was supported by a grant from the Fonds de Recherche en Santé du Québec and the Medical Education Grant from Centre Hospitalier Universitaire Sainte-Justine. The researchers and Dr. Feudtner reported no financial conflicts.
SOURCE: Lizotte M-H et al. Pediatrics. 2020 Jan 27. doi: 10.1542/peds.2019-1925; Feudtner C. Pediatrics. 2020 Jan 27. doi: 10.1542/peds.2019-3116.
Clinicians can improve communications with parents during neonatal end-of-life situations by adopting key behaviors such as sitting down to talk to parents and using the infant’s name, according to data from a simulation study.
“Empirical evidence regarding communication with parents during and after a child’s critical instability or death is scarce,” wrote Marie-Hélène Lizotte, MD, of Centre Hospitalier Universitaire Sainte-Justine, Montréal, and colleagues. Noting that realistic simulation has been shown to help clinicians improve their communication skills, the investigators recruited clinicians to participate in a simulated unsuccessful neonatal resuscitation to identify behaviors associated with optimal parent communication.
Behaviors associated with high scores for clinicians deemed “good communicators” included introducing themselves to parents, using the infant’s name (if known), sitting down to speak to parents, not leaving the infant alone on the bed after death, and allowing time for silence, the researchers reported in Pediatrics.
The investigators presented the video simulations to evaluators, including clinicians and bereaved parents. In the simulation, a term infant was born after an emergency cesarean delivery for fetal distress and died after an unsuccessful attempt at resuscitation. A manikin infant was programmed to remain pulseless, and two actors played the roles of the parents in the video.
Evaluators scored the videos for overall performance and for communication with the parent actors during and after the resuscitation.
Overall, parent evaluators and parent actors agreed with clinicians on what actions exemplified optimal communication in about 81% of evaluations. Discrepancies were mainly related to the language participants used related to death, as some parent evaluators said they had trouble understanding certain sentences or found them insensitive, such as “her heart never came back” and “allowing natural death.”
A total of 31 participants were recruited for the simulation, including 15 pediatric residents, 5 neonatal fellows, 3 neonatologists, 3 neonatal nurse practitioners, and 5 transport and resuscitation team providers. Videos of the simulations were examined by 21 evaluators, including bereaved parents, the parent actors, a neonatologist, a maternal-fetal medicine specialist, a psychologist, and a respiratory therapist. There were 651 evaluations.
The study findings were limited by several factors including the use of a single center, use of videos for evaluations, and the use of a single infant-resuscitation scenario, the researchers noted. The results were strengthened, however, by the large number of evaluations, and they support the core behaviors as “a skeleton on which to build additional skills with practice and training” with attention to cultural differences in their application, such as recognizing that infants are not named until after birth in some cultures, they said.
The existing literature on strategies for providing empathy and support to parents facing the death of a child is limited, but this simulation study provides a design model to help address this issue, Chris Feudtner, MD, of the Children’s Hospital of Philadelphia wrote in an accompanying editorial. “Overall, this study, in terms of design and methodologic rigor, is a great advance toward answering our key question: how to best support parents in such circumstances,” he said.
Dr. Feudtner said that he would divide the clinician behaviors into two groups. The first, “Calm kind politeness,” includes acknowledging the parents, introducing themselves, using the infant’s name, and remaining calm. The second set of behaviors, which he called “Skillful situational leadership,” includes preparing parents for the resuscitation activities and providing verbal milestones that prepared them for the fatal outcome.
“Picking up on a metaphor offered by the authors of the study, training and repetitive drills on these specific behaviors cannot be emphasized enough because they are not only the skeleton of excellent communication; they are likely also the muscles, the heart, and even the soul,” he concluded.
The study was supported by a grant from the Fonds de Recherche en Santé du Québec and the Medical Education Grant from Centre Hospitalier Universitaire Sainte-Justine. The researchers and Dr. Feudtner reported no financial conflicts.
SOURCE: Lizotte M-H et al. Pediatrics. 2020 Jan 27. doi: 10.1542/peds.2019-1925; Feudtner C. Pediatrics. 2020 Jan 27. doi: 10.1542/peds.2019-3116.
Clinicians can improve communications with parents during neonatal end-of-life situations by adopting key behaviors such as sitting down to talk to parents and using the infant’s name, according to data from a simulation study.
“Empirical evidence regarding communication with parents during and after a child’s critical instability or death is scarce,” wrote Marie-Hélène Lizotte, MD, of Centre Hospitalier Universitaire Sainte-Justine, Montréal, and colleagues. Noting that realistic simulation has been shown to help clinicians improve their communication skills, the investigators recruited clinicians to participate in a simulated unsuccessful neonatal resuscitation to identify behaviors associated with optimal parent communication.
Behaviors associated with high scores for clinicians deemed “good communicators” included introducing themselves to parents, using the infant’s name (if known), sitting down to speak to parents, not leaving the infant alone on the bed after death, and allowing time for silence, the researchers reported in Pediatrics.
The investigators presented the video simulations to evaluators, including clinicians and bereaved parents. In the simulation, a term infant was born after an emergency cesarean delivery for fetal distress and died after an unsuccessful attempt at resuscitation. A manikin infant was programmed to remain pulseless, and two actors played the roles of the parents in the video.
Evaluators scored the videos for overall performance and for communication with the parent actors during and after the resuscitation.
Overall, parent evaluators and parent actors agreed with clinicians on what actions exemplified optimal communication in about 81% of evaluations. Discrepancies were mainly related to the language participants used related to death, as some parent evaluators said they had trouble understanding certain sentences or found them insensitive, such as “her heart never came back” and “allowing natural death.”
A total of 31 participants were recruited for the simulation, including 15 pediatric residents, 5 neonatal fellows, 3 neonatologists, 3 neonatal nurse practitioners, and 5 transport and resuscitation team providers. Videos of the simulations were examined by 21 evaluators, including bereaved parents, the parent actors, a neonatologist, a maternal-fetal medicine specialist, a psychologist, and a respiratory therapist. There were 651 evaluations.
The study findings were limited by several factors including the use of a single center, use of videos for evaluations, and the use of a single infant-resuscitation scenario, the researchers noted. The results were strengthened, however, by the large number of evaluations, and they support the core behaviors as “a skeleton on which to build additional skills with practice and training” with attention to cultural differences in their application, such as recognizing that infants are not named until after birth in some cultures, they said.
The existing literature on strategies for providing empathy and support to parents facing the death of a child is limited, but this simulation study provides a design model to help address this issue, Chris Feudtner, MD, of the Children’s Hospital of Philadelphia wrote in an accompanying editorial. “Overall, this study, in terms of design and methodologic rigor, is a great advance toward answering our key question: how to best support parents in such circumstances,” he said.
Dr. Feudtner said that he would divide the clinician behaviors into two groups. The first, “Calm kind politeness,” includes acknowledging the parents, introducing themselves, using the infant’s name, and remaining calm. The second set of behaviors, which he called “Skillful situational leadership,” includes preparing parents for the resuscitation activities and providing verbal milestones that prepared them for the fatal outcome.
“Picking up on a metaphor offered by the authors of the study, training and repetitive drills on these specific behaviors cannot be emphasized enough because they are not only the skeleton of excellent communication; they are likely also the muscles, the heart, and even the soul,” he concluded.
The study was supported by a grant from the Fonds de Recherche en Santé du Québec and the Medical Education Grant from Centre Hospitalier Universitaire Sainte-Justine. The researchers and Dr. Feudtner reported no financial conflicts.
SOURCE: Lizotte M-H et al. Pediatrics. 2020 Jan 27. doi: 10.1542/peds.2019-1925; Feudtner C. Pediatrics. 2020 Jan 27. doi: 10.1542/peds.2019-3116.
FROM PEDIATRICS
Key clinical point: Clinicians who took steps such as sitting down and using the infant’s name were seen by parents as good communicators.
Major finding: Evaluators of a simulation agreed 81% of the time on defining optimal communication.
Study details: The data come from a simulation study of 31 participants and 21 evaluators and a total of 651 evaluations.
Disclosures: The study was supported in part by the Fonds de Recherche en Santé du Québec and the Medical Education Grant from Centre Hospitalier Universitaire Sainte-Justine. The researchers and editorialist said they had no financial conflicts.
Source: Lizotte M-H et al. Pediatrics. 2020 Jan 27. doi: 10.1542/peds.2019-1925; Feudtner C. Pediatrics. 2020 Jan 27. doi: 10.1542/peds.2019-3116.
Bariatric surgery lacks impact on teens’ long-term mental health
Young people treated with bariatric surgery for severe obesity did not experience better mental health in the 5 years following their procedures, Swedish researchers said, and indeed fared worse than their nontreated peers on certain measures.
The results of this study do not necessarily argue “that metabolic and bariatric surgery during adolescence causes mental health problems,” the investigators wrote in the Lancet Child and Adolescent Health, but “it is reasonable to conclude that metabolic and bariatric surgery does not result in a substantial alleviation of mental health problems in adolescents with severe obesity,” and that “long-term mental health support should be required in programs providing adolescent metabolic and bariatric surgery.”
Kajsa Järvholm, PhD, of Skåne University Hospital, in Malmö, Sweden, and colleagues reported results from a prospective nonrandomized study that recruited 81 adolescents in Sweden aged 13-18 years (mean age, 16.5) who had a body mass index of 40 or higher, or BMI of 35 with obesity-related comorbidities and who underwent Roux-en-Y gastric bypass for weight loss. Subjects were matched by age, sex, and BMI to 80 controls (mean age, 15.8 years) who were assigned to conventional nonsurgical treatment. All patients were assessed at 1, 2, and 5 years.
Although mental health treatment, including use of psychiatric drugs, did not differ between the groups at baseline, during the follow-up period the subjects who underwent surgery saw 15% more impatient and outpatient mental health treatment, compared with controls, a significant difference. About a quarter of patients in the surgically treated group required specialized mental health treatment for the first time after their surgeries.
Though the surgical group lost much more weight – mean BMI was 32.3 at 5 years, compared with 41.7 for controls – none of the mental health changes from baseline were significantly associated with percentage change of BMI at 5 years.
The findings from the study are consistent with results from studies in adults in which bariatric surgery improves many health outcomes but does not alter the need for mental health treatment. Although 5 years is a longer follow-up than in previous studies in young patients – a key strength of the study – Dr. Järvholm and colleagues acknowledged some weaknesses, including a nonrandomized design, lack of a comparison group of nonobese youths for mental health measures, a small sample size, and a surgical procedure that is now out of favor in adolescents.
The study was funded by Swedish government and health foundations. Dr. Järvholm disclosed pharmaceutical industry funding not related to the study, and three coauthors also disclosed industry relationships.
SOURCE: Järvholm K et al. Lancet Child Adolesc Health. 2020. doi: 10.1016/s2352-4642(20)30024-9.
Young people treated with bariatric surgery for severe obesity did not experience better mental health in the 5 years following their procedures, Swedish researchers said, and indeed fared worse than their nontreated peers on certain measures.
The results of this study do not necessarily argue “that metabolic and bariatric surgery during adolescence causes mental health problems,” the investigators wrote in the Lancet Child and Adolescent Health, but “it is reasonable to conclude that metabolic and bariatric surgery does not result in a substantial alleviation of mental health problems in adolescents with severe obesity,” and that “long-term mental health support should be required in programs providing adolescent metabolic and bariatric surgery.”
Kajsa Järvholm, PhD, of Skåne University Hospital, in Malmö, Sweden, and colleagues reported results from a prospective nonrandomized study that recruited 81 adolescents in Sweden aged 13-18 years (mean age, 16.5) who had a body mass index of 40 or higher, or BMI of 35 with obesity-related comorbidities and who underwent Roux-en-Y gastric bypass for weight loss. Subjects were matched by age, sex, and BMI to 80 controls (mean age, 15.8 years) who were assigned to conventional nonsurgical treatment. All patients were assessed at 1, 2, and 5 years.
Although mental health treatment, including use of psychiatric drugs, did not differ between the groups at baseline, during the follow-up period the subjects who underwent surgery saw 15% more impatient and outpatient mental health treatment, compared with controls, a significant difference. About a quarter of patients in the surgically treated group required specialized mental health treatment for the first time after their surgeries.
Though the surgical group lost much more weight – mean BMI was 32.3 at 5 years, compared with 41.7 for controls – none of the mental health changes from baseline were significantly associated with percentage change of BMI at 5 years.
The findings from the study are consistent with results from studies in adults in which bariatric surgery improves many health outcomes but does not alter the need for mental health treatment. Although 5 years is a longer follow-up than in previous studies in young patients – a key strength of the study – Dr. Järvholm and colleagues acknowledged some weaknesses, including a nonrandomized design, lack of a comparison group of nonobese youths for mental health measures, a small sample size, and a surgical procedure that is now out of favor in adolescents.
The study was funded by Swedish government and health foundations. Dr. Järvholm disclosed pharmaceutical industry funding not related to the study, and three coauthors also disclosed industry relationships.
SOURCE: Järvholm K et al. Lancet Child Adolesc Health. 2020. doi: 10.1016/s2352-4642(20)30024-9.
Young people treated with bariatric surgery for severe obesity did not experience better mental health in the 5 years following their procedures, Swedish researchers said, and indeed fared worse than their nontreated peers on certain measures.
The results of this study do not necessarily argue “that metabolic and bariatric surgery during adolescence causes mental health problems,” the investigators wrote in the Lancet Child and Adolescent Health, but “it is reasonable to conclude that metabolic and bariatric surgery does not result in a substantial alleviation of mental health problems in adolescents with severe obesity,” and that “long-term mental health support should be required in programs providing adolescent metabolic and bariatric surgery.”
Kajsa Järvholm, PhD, of Skåne University Hospital, in Malmö, Sweden, and colleagues reported results from a prospective nonrandomized study that recruited 81 adolescents in Sweden aged 13-18 years (mean age, 16.5) who had a body mass index of 40 or higher, or BMI of 35 with obesity-related comorbidities and who underwent Roux-en-Y gastric bypass for weight loss. Subjects were matched by age, sex, and BMI to 80 controls (mean age, 15.8 years) who were assigned to conventional nonsurgical treatment. All patients were assessed at 1, 2, and 5 years.
Although mental health treatment, including use of psychiatric drugs, did not differ between the groups at baseline, during the follow-up period the subjects who underwent surgery saw 15% more impatient and outpatient mental health treatment, compared with controls, a significant difference. About a quarter of patients in the surgically treated group required specialized mental health treatment for the first time after their surgeries.
Though the surgical group lost much more weight – mean BMI was 32.3 at 5 years, compared with 41.7 for controls – none of the mental health changes from baseline were significantly associated with percentage change of BMI at 5 years.
The findings from the study are consistent with results from studies in adults in which bariatric surgery improves many health outcomes but does not alter the need for mental health treatment. Although 5 years is a longer follow-up than in previous studies in young patients – a key strength of the study – Dr. Järvholm and colleagues acknowledged some weaknesses, including a nonrandomized design, lack of a comparison group of nonobese youths for mental health measures, a small sample size, and a surgical procedure that is now out of favor in adolescents.
The study was funded by Swedish government and health foundations. Dr. Järvholm disclosed pharmaceutical industry funding not related to the study, and three coauthors also disclosed industry relationships.
SOURCE: Järvholm K et al. Lancet Child Adolesc Health. 2020. doi: 10.1016/s2352-4642(20)30024-9.
FROM THE LANCET CHILD & ADOLESCENT HEALTH
Key clinical point: Bariatric surgery was not associated with improvement in obese adolescents’ long-term mental health, despite significant weight loss.
Major finding: During 5 years of follow up, surgically treated patients experienced 15% more mental health care usage than controls.
Study details: A prospective, nonrandomized study involving 161 adolescents with a BMI of 40 or greater (or 35 with comorbidities).
Disclosures: The Swedish government and Swedish health research foundations sponsored the study.
Source: Järvholm K et al. Lancet Child Adolesc Health. 2020. doi: 10.1016/s2352-4642(20)30024-9.
Pubertal suppression reduces risk of later suicidal ideation in transgender people
Transgender adults who, as adolescents, desired and received pubertal suppression had reduced odds of suicidal ideation, compared with those who wanted but didn’t receive pubertal suppression during their teen years.
Raw frequency of lifetime suicidal ideation was 90% in transgender adults who wanted, but did not receive, pubertal suppression in adolescence, compared with 75% in those who did receive pubertal suppression in adolescence, according to a new analysis of a nationwide survey of transgender people reported in Pediatrics. After controlling for demographic variables, the lifetime adjusted odds ratio for suicidal ideation was 0.3 for those receiving pubertal suppression, compared with those who wanted but didn’t receive pubertal suppression.
The study was the first to examine this association, and findings were drawn from the 2015 U.S. Transgender Survey, the largest known dataset of transgender adults, wrote the study’s lead author Jack Turban, MD, and coinvestigators.
“Suicidality is of particular concern for this population because the estimated lifetime prevalence of suicide attempts among transgender people is as high as 40%,” noted Dr. Turban, a psychiatry resident at Harvard Medical School and Massachusetts General Hospital, Boston, and McLean Hospital, Belmont, Mass., and coauthors. Anxiety, depression, and suicidality all are more common among transgender youth, who make up almost 2% of the nation’s adolescent population, they said.
Among transgender youth, the researchers explained, a spectrum exists: “Some have minimal body dysphoria and do not desire pubertal suppression, whereas others report significant dysphoria around the physical changes related to puberty.” Accordingly, they said, “We examined only those youth who desired pubertal suppression,” because this is the population of youth about whom clinicians need to make treatment decisions.
For individuals who might experience distress from the irreversible bodily changes of endogenous puberty, suppression via gonadotropin releasing hormone analogues (GnRHas) “allows these adolescents more time to decide if they wish to either induce exogenous gender-congruent puberty or allow endogenous puberty to progress,” wrote Dr. Turban and his collaborators.
The U.S. Transgender Survey dataset includes response from over 27,000 transgender adults with nationwide representation. However, this study included only participants who were younger than 17 years in 1998, when GnRHas for pubertal suppression became available. Filtering this group further to just those respondents between the ages of 18 and 36 years whose survey responses indicated they had ever wanted pubertal suppression yielded 3,494 individuals. Of these individuals, just 2.5% (89 participants) had ever received pubertal suppression.
“Results from this study suggest that the majority of transgender adults in the United States who have wanted pubertal suppression did not receive it,” noted the authors. Even among the youngest respondents – who received care during puberty most recently – just 5% of the 18-year-olds in 2015 desiring pubertal suppression actually received the treatment.
Among other associations, individuals who were younger, those with feminine gender identity, those with male sex assigned at birth, and those reporting heterosexual sexual orientation were more likely to have received pubertal suppression.
Receiving GnRHas also was more likely for individuals with higher household income and more family support of their gender identity. Without insurance, studies have indicated that the annual cost of GnRHA treatment can be $4,000-$25,000. Another study noted that at the Boston Children’s Hospital Gender Management Service before 2012, fewer than 20% of patients were able to get insurance coverage for pubertal suppression, according to Dr. Turban and colleagues.
The study looked at suicidality over the past year and lifetime suicidality, as well as severe psychological distress and binge drinking over the past month. Investigators also asked about lifetime history of illicit drug use, hypothesizing that those who received pubertal suppression would have “superior mental health outcomes” when compared to those who desired – but didn’t receive – pubertal suppression, wrote Dr. Turban and coauthors.
Suicidality within the past 12 months and severe psychological distress were both significantly more common among those who did not receive pubertal suppression, but these associations lost significance after multivariable analysis. There was no difference in odds of suicide attempts, although the study may have been underpowered to detect some of these associations, said the investigators.
After statistical analysis to control for demographic variables, pubertal suppression still was associated with decreased odds of having suicidal ideation over the lifespan.
Dr. Turban and colleagues acknowledged that reverse causation may have been in play, because adolescents with better mental health might have been considered better candidates for GnRHa therapy. But the study’s large sample size and wide geographic reach are strengths, they said, concluding that overall, the findings lend support to existing recommendations from the Endocrine Society and the World Professional Association for Transgender Health that pubertal suppression therapy be available to those adolescents who desire it.
Investigators were supported by the U.S. Health Resources and Services Administration, the Patient-Centered Outcomes Research Institute, and the American Academy of Child & Adolescent Psychiatry. The authors reported that they had no financial conflicts of interest.
SOURCE: Turban JL et al. Pediatrics. 2020;145(2):e20191725.
Access to good medical care for transgender adolescents remains very limited. When it is available, puberty blockers are an excellent, conservative option for trans adolescents entering puberty so that they have time to consider longer-term treatment options with their providers and families. As demonstrated by the data in this study, good attention to transgender children can substantially improve their mental health.
The biggest barrier to health care for trans adolescents is access to knowledgeable providers – even more than affordability, which is improving with better coverage by payers. As noted in the study by Turban et al., the lack of access to care remains a huge problem.
It is not surprising that, when we neglect health care, we get bad outcomes. In that sense, the study by Turban et al. is quite intuitive. The few adolescents with access to the appropriate health care had better immediate outcomes. Still, as a scientist I take nothing for granted, and a study confirming what seems logical is important confirmation.
Joshua D. Safer, MD, who is the executive director of the Center for Transgender Medicine and Surgery at Mount Sinai Health System, and professor of medicine at Icahn School of Medicine at Mount Sinai, both in New York, was asked to comment on the article by Turban et al. He said he had no relevant financial disclosures.
Access to good medical care for transgender adolescents remains very limited. When it is available, puberty blockers are an excellent, conservative option for trans adolescents entering puberty so that they have time to consider longer-term treatment options with their providers and families. As demonstrated by the data in this study, good attention to transgender children can substantially improve their mental health.
The biggest barrier to health care for trans adolescents is access to knowledgeable providers – even more than affordability, which is improving with better coverage by payers. As noted in the study by Turban et al., the lack of access to care remains a huge problem.
It is not surprising that, when we neglect health care, we get bad outcomes. In that sense, the study by Turban et al. is quite intuitive. The few adolescents with access to the appropriate health care had better immediate outcomes. Still, as a scientist I take nothing for granted, and a study confirming what seems logical is important confirmation.
Joshua D. Safer, MD, who is the executive director of the Center for Transgender Medicine and Surgery at Mount Sinai Health System, and professor of medicine at Icahn School of Medicine at Mount Sinai, both in New York, was asked to comment on the article by Turban et al. He said he had no relevant financial disclosures.
Access to good medical care for transgender adolescents remains very limited. When it is available, puberty blockers are an excellent, conservative option for trans adolescents entering puberty so that they have time to consider longer-term treatment options with their providers and families. As demonstrated by the data in this study, good attention to transgender children can substantially improve their mental health.
The biggest barrier to health care for trans adolescents is access to knowledgeable providers – even more than affordability, which is improving with better coverage by payers. As noted in the study by Turban et al., the lack of access to care remains a huge problem.
It is not surprising that, when we neglect health care, we get bad outcomes. In that sense, the study by Turban et al. is quite intuitive. The few adolescents with access to the appropriate health care had better immediate outcomes. Still, as a scientist I take nothing for granted, and a study confirming what seems logical is important confirmation.
Joshua D. Safer, MD, who is the executive director of the Center for Transgender Medicine and Surgery at Mount Sinai Health System, and professor of medicine at Icahn School of Medicine at Mount Sinai, both in New York, was asked to comment on the article by Turban et al. He said he had no relevant financial disclosures.
Transgender adults who, as adolescents, desired and received pubertal suppression had reduced odds of suicidal ideation, compared with those who wanted but didn’t receive pubertal suppression during their teen years.
Raw frequency of lifetime suicidal ideation was 90% in transgender adults who wanted, but did not receive, pubertal suppression in adolescence, compared with 75% in those who did receive pubertal suppression in adolescence, according to a new analysis of a nationwide survey of transgender people reported in Pediatrics. After controlling for demographic variables, the lifetime adjusted odds ratio for suicidal ideation was 0.3 for those receiving pubertal suppression, compared with those who wanted but didn’t receive pubertal suppression.
The study was the first to examine this association, and findings were drawn from the 2015 U.S. Transgender Survey, the largest known dataset of transgender adults, wrote the study’s lead author Jack Turban, MD, and coinvestigators.
“Suicidality is of particular concern for this population because the estimated lifetime prevalence of suicide attempts among transgender people is as high as 40%,” noted Dr. Turban, a psychiatry resident at Harvard Medical School and Massachusetts General Hospital, Boston, and McLean Hospital, Belmont, Mass., and coauthors. Anxiety, depression, and suicidality all are more common among transgender youth, who make up almost 2% of the nation’s adolescent population, they said.
Among transgender youth, the researchers explained, a spectrum exists: “Some have minimal body dysphoria and do not desire pubertal suppression, whereas others report significant dysphoria around the physical changes related to puberty.” Accordingly, they said, “We examined only those youth who desired pubertal suppression,” because this is the population of youth about whom clinicians need to make treatment decisions.
For individuals who might experience distress from the irreversible bodily changes of endogenous puberty, suppression via gonadotropin releasing hormone analogues (GnRHas) “allows these adolescents more time to decide if they wish to either induce exogenous gender-congruent puberty or allow endogenous puberty to progress,” wrote Dr. Turban and his collaborators.
The U.S. Transgender Survey dataset includes response from over 27,000 transgender adults with nationwide representation. However, this study included only participants who were younger than 17 years in 1998, when GnRHas for pubertal suppression became available. Filtering this group further to just those respondents between the ages of 18 and 36 years whose survey responses indicated they had ever wanted pubertal suppression yielded 3,494 individuals. Of these individuals, just 2.5% (89 participants) had ever received pubertal suppression.
“Results from this study suggest that the majority of transgender adults in the United States who have wanted pubertal suppression did not receive it,” noted the authors. Even among the youngest respondents – who received care during puberty most recently – just 5% of the 18-year-olds in 2015 desiring pubertal suppression actually received the treatment.
Among other associations, individuals who were younger, those with feminine gender identity, those with male sex assigned at birth, and those reporting heterosexual sexual orientation were more likely to have received pubertal suppression.
Receiving GnRHas also was more likely for individuals with higher household income and more family support of their gender identity. Without insurance, studies have indicated that the annual cost of GnRHA treatment can be $4,000-$25,000. Another study noted that at the Boston Children’s Hospital Gender Management Service before 2012, fewer than 20% of patients were able to get insurance coverage for pubertal suppression, according to Dr. Turban and colleagues.
The study looked at suicidality over the past year and lifetime suicidality, as well as severe psychological distress and binge drinking over the past month. Investigators also asked about lifetime history of illicit drug use, hypothesizing that those who received pubertal suppression would have “superior mental health outcomes” when compared to those who desired – but didn’t receive – pubertal suppression, wrote Dr. Turban and coauthors.
Suicidality within the past 12 months and severe psychological distress were both significantly more common among those who did not receive pubertal suppression, but these associations lost significance after multivariable analysis. There was no difference in odds of suicide attempts, although the study may have been underpowered to detect some of these associations, said the investigators.
After statistical analysis to control for demographic variables, pubertal suppression still was associated with decreased odds of having suicidal ideation over the lifespan.
Dr. Turban and colleagues acknowledged that reverse causation may have been in play, because adolescents with better mental health might have been considered better candidates for GnRHa therapy. But the study’s large sample size and wide geographic reach are strengths, they said, concluding that overall, the findings lend support to existing recommendations from the Endocrine Society and the World Professional Association for Transgender Health that pubertal suppression therapy be available to those adolescents who desire it.
Investigators were supported by the U.S. Health Resources and Services Administration, the Patient-Centered Outcomes Research Institute, and the American Academy of Child & Adolescent Psychiatry. The authors reported that they had no financial conflicts of interest.
SOURCE: Turban JL et al. Pediatrics. 2020;145(2):e20191725.
Transgender adults who, as adolescents, desired and received pubertal suppression had reduced odds of suicidal ideation, compared with those who wanted but didn’t receive pubertal suppression during their teen years.
Raw frequency of lifetime suicidal ideation was 90% in transgender adults who wanted, but did not receive, pubertal suppression in adolescence, compared with 75% in those who did receive pubertal suppression in adolescence, according to a new analysis of a nationwide survey of transgender people reported in Pediatrics. After controlling for demographic variables, the lifetime adjusted odds ratio for suicidal ideation was 0.3 for those receiving pubertal suppression, compared with those who wanted but didn’t receive pubertal suppression.
The study was the first to examine this association, and findings were drawn from the 2015 U.S. Transgender Survey, the largest known dataset of transgender adults, wrote the study’s lead author Jack Turban, MD, and coinvestigators.
“Suicidality is of particular concern for this population because the estimated lifetime prevalence of suicide attempts among transgender people is as high as 40%,” noted Dr. Turban, a psychiatry resident at Harvard Medical School and Massachusetts General Hospital, Boston, and McLean Hospital, Belmont, Mass., and coauthors. Anxiety, depression, and suicidality all are more common among transgender youth, who make up almost 2% of the nation’s adolescent population, they said.
Among transgender youth, the researchers explained, a spectrum exists: “Some have minimal body dysphoria and do not desire pubertal suppression, whereas others report significant dysphoria around the physical changes related to puberty.” Accordingly, they said, “We examined only those youth who desired pubertal suppression,” because this is the population of youth about whom clinicians need to make treatment decisions.
For individuals who might experience distress from the irreversible bodily changes of endogenous puberty, suppression via gonadotropin releasing hormone analogues (GnRHas) “allows these adolescents more time to decide if they wish to either induce exogenous gender-congruent puberty or allow endogenous puberty to progress,” wrote Dr. Turban and his collaborators.
The U.S. Transgender Survey dataset includes response from over 27,000 transgender adults with nationwide representation. However, this study included only participants who were younger than 17 years in 1998, when GnRHas for pubertal suppression became available. Filtering this group further to just those respondents between the ages of 18 and 36 years whose survey responses indicated they had ever wanted pubertal suppression yielded 3,494 individuals. Of these individuals, just 2.5% (89 participants) had ever received pubertal suppression.
“Results from this study suggest that the majority of transgender adults in the United States who have wanted pubertal suppression did not receive it,” noted the authors. Even among the youngest respondents – who received care during puberty most recently – just 5% of the 18-year-olds in 2015 desiring pubertal suppression actually received the treatment.
Among other associations, individuals who were younger, those with feminine gender identity, those with male sex assigned at birth, and those reporting heterosexual sexual orientation were more likely to have received pubertal suppression.
Receiving GnRHas also was more likely for individuals with higher household income and more family support of their gender identity. Without insurance, studies have indicated that the annual cost of GnRHA treatment can be $4,000-$25,000. Another study noted that at the Boston Children’s Hospital Gender Management Service before 2012, fewer than 20% of patients were able to get insurance coverage for pubertal suppression, according to Dr. Turban and colleagues.
The study looked at suicidality over the past year and lifetime suicidality, as well as severe psychological distress and binge drinking over the past month. Investigators also asked about lifetime history of illicit drug use, hypothesizing that those who received pubertal suppression would have “superior mental health outcomes” when compared to those who desired – but didn’t receive – pubertal suppression, wrote Dr. Turban and coauthors.
Suicidality within the past 12 months and severe psychological distress were both significantly more common among those who did not receive pubertal suppression, but these associations lost significance after multivariable analysis. There was no difference in odds of suicide attempts, although the study may have been underpowered to detect some of these associations, said the investigators.
After statistical analysis to control for demographic variables, pubertal suppression still was associated with decreased odds of having suicidal ideation over the lifespan.
Dr. Turban and colleagues acknowledged that reverse causation may have been in play, because adolescents with better mental health might have been considered better candidates for GnRHa therapy. But the study’s large sample size and wide geographic reach are strengths, they said, concluding that overall, the findings lend support to existing recommendations from the Endocrine Society and the World Professional Association for Transgender Health that pubertal suppression therapy be available to those adolescents who desire it.
Investigators were supported by the U.S. Health Resources and Services Administration, the Patient-Centered Outcomes Research Institute, and the American Academy of Child & Adolescent Psychiatry. The authors reported that they had no financial conflicts of interest.
SOURCE: Turban JL et al. Pediatrics. 2020;145(2):e20191725.
FROM PEDIATRICS