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Neurology Reviews covers innovative and emerging news in neurology and neuroscience every month, with a focus on practical approaches to treating Parkinson's disease, epilepsy, headache, stroke, multiple sclerosis, Alzheimer's disease, and other neurologic disorders.
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Progressive multifocal leukoencephalopathy
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Lumbar epidural steroid jab lowers bone formation in older women
Among postmenopausal women who received an epidural steroid injection (ESI) in the lumbar spine to treat back and leg pain arising from a compressed nerve in the spine, levels of bone formation biomarkers were decreased. The decrease in levels persisted more than 12 weeks, results from a new study show.
In addition, serum cortisol levels decreased by 50% at week 1 after the ESI, indicating systemic absorption of the steroid.
“The extent and duration of these effects suggest that patients who receive multiple [ESIs in the lumbar spine] may be at particular risk for harmful skeletal consequences,” Shannon Clare reported in an oral presentation at the annual meeting of the American Society for Bone and Mineral Research.
Further studies are needed of the relationship between these short-term changes in bone turnover and bone loss and the risk for fracture among the burgeoning population treated with ESIs, added Ms. Clare, of the Hospital for Special Surgery, New York.
The researchers examined changes in serum levels of bone formation and resorption markers and other analytes in 24 women who received a lumbar ESI for radicular back pain and in 8 other women from the hospital population who served as control persons.
Among the women who received ESI, 1 week after the injection, serum levels of two bone formation biomarkers – total procollagen type 1 N-terminal peptide (P1NP) and osteocalcin – were about 27% lower than at baseline. The suppression persisted beyond 12 weeks.
Serum levels of the bone resorption biomarker C-terminal telopeptide of type I collagen (CTX) did not differ significantly after ESI.
“Our results are notable because we found that the duration of suppression of bone formation extended beyond 12 weeks, a far longer duration than seen previously with intra-articular injections” of glucocorticoids, said Ms. Clare and senior author Emily M. Stein, MD, director of research for the Metabolic Bone Service and an endocrinologist at the Hospital for Special Surgery and is associate professor of medicine at Weill Cornell Medicine, both in New York.
The findings suggest that patients should not receive multiple doses within a 12-week period, they told this news organization in a joint email response.
Women are not typically screened for osteopenia or osteoporosis before ESI. However, “our results suggest that physicians should consider screening women for osteoporosis who receive ESI, particularly those who are treated with multiple doses,” said Ms. Clare and Dr. Stein. “Steroid exposure should be minimized as much as possible by having patients space injections as far as they can tolerate.”
Systemic absorption, negative impact on bone turnover markers
“The hypothesis that [ESIs] interfere with the vertebral osseous microenvironment and increase the risk of vertebral fractures has been supported with evidence in the literature,” Mohamad Bydon, MD, professor of neurosurgery, orthopedic surgery, and health services research at the Mayo Clinic, Rochester, Minn., said in an interview.
Prior studies have demonstrated a decrease in bone mineral density (BMD) and an increase in vertebral fractures following ESI, added Dr. Bydon, senior author of a 2018 review of the effect of ESI on BMD and vertebral fracture risk that was published in Pain Medicine. He was not involved with the current study.
“The article by Clare et al. provides evidence on the systemic absorption of glucocorticoids by demonstrating a drop in serum cortisol following ESI,” he noted. “The measurement of bone metabolism biomarkers offers molecular confirmation of clinical and radiological observations of previous studies” showing that ESI affects the vertebrae.
More than 9 million ESIs each year
Each year, more than 9 million ESIs are administered to patients in the United States to relieve radicular back and leg pain that may be caused by a herniated disc or spinal stenosis (a gradual narrowing of the open spaces in the spinal column, which is common in older adults), the researchers explained.
Some patients experience sufficient pain relief with ESIs. Others may not be eligible for surgery and may receive multiple ESIs annually for many years because they provide pain relief.
It is well established that oral and intravenous glucocorticoids profoundly suppress bone formation and transiently increase bone resorption, causing substantial bone loss and increased fracture risk within 3 months of administration, Ms. Clare explained in the session.
Long-term use of high-dose inhaled glucocorticoids has been associated with bone loss and fractures. However, the effect of ESIs on bone has been less well studied.
The researchers hypothesized that ESIs are systemically absorbed and cause suppression of bone formation without a compensatory decrease in bone resorption.
They enrolled 24 patients who had undergone lumbar ESIs and 8 control patients. The mean age of the patients in the two groups was 63 years and 68 years, respectively. Most patients were White (88% and 100%, respectively). The mean body mass index was 27 kg/m2 and 28 kg/m2, respectively. On average, the patients had entered menopause 12 and 16 years earlier, respectively.
In the group that received steroid injections, almost two-thirds (15 patients, 63%) received triamcinolone. The rest received dexamethasone (six patients, 25%) or betamethasone (three patients, 12%) at doses that were equivalent to 80 mg triamcinolone.
The patients’ baseline serum levels of 25-hydroxy vitamin D, parathyroid hormone, cortisol, P1NP, osteocalcin, and CTX were within the reference ranges and were similar in the two groups.
The researchers also determined serum levels of cortisol (to assess suppression of endogenous glucocorticoids), osteocalcin, P1NP, and CTX in the patients and control persons at 1, 4, 12, 26, and 52 weeks after patients had received the ESI.
The researchers acknowledged that the small sample is a study limitation. In addition, the first serum samples were taken 1 week after the injection, and so any earlier changes in analyte levels were not captured. The patients also received different types of steroids, although the doses were similar when converted to triamcinolone equivalents.
The study was supported by a Spine Service grant from the Hospital for Special Surgery. The authors disclosed no relevant financial relationships.
A version of this article first appeared on Medscape.com.
Among postmenopausal women who received an epidural steroid injection (ESI) in the lumbar spine to treat back and leg pain arising from a compressed nerve in the spine, levels of bone formation biomarkers were decreased. The decrease in levels persisted more than 12 weeks, results from a new study show.
In addition, serum cortisol levels decreased by 50% at week 1 after the ESI, indicating systemic absorption of the steroid.
“The extent and duration of these effects suggest that patients who receive multiple [ESIs in the lumbar spine] may be at particular risk for harmful skeletal consequences,” Shannon Clare reported in an oral presentation at the annual meeting of the American Society for Bone and Mineral Research.
Further studies are needed of the relationship between these short-term changes in bone turnover and bone loss and the risk for fracture among the burgeoning population treated with ESIs, added Ms. Clare, of the Hospital for Special Surgery, New York.
The researchers examined changes in serum levels of bone formation and resorption markers and other analytes in 24 women who received a lumbar ESI for radicular back pain and in 8 other women from the hospital population who served as control persons.
Among the women who received ESI, 1 week after the injection, serum levels of two bone formation biomarkers – total procollagen type 1 N-terminal peptide (P1NP) and osteocalcin – were about 27% lower than at baseline. The suppression persisted beyond 12 weeks.
Serum levels of the bone resorption biomarker C-terminal telopeptide of type I collagen (CTX) did not differ significantly after ESI.
“Our results are notable because we found that the duration of suppression of bone formation extended beyond 12 weeks, a far longer duration than seen previously with intra-articular injections” of glucocorticoids, said Ms. Clare and senior author Emily M. Stein, MD, director of research for the Metabolic Bone Service and an endocrinologist at the Hospital for Special Surgery and is associate professor of medicine at Weill Cornell Medicine, both in New York.
The findings suggest that patients should not receive multiple doses within a 12-week period, they told this news organization in a joint email response.
Women are not typically screened for osteopenia or osteoporosis before ESI. However, “our results suggest that physicians should consider screening women for osteoporosis who receive ESI, particularly those who are treated with multiple doses,” said Ms. Clare and Dr. Stein. “Steroid exposure should be minimized as much as possible by having patients space injections as far as they can tolerate.”
Systemic absorption, negative impact on bone turnover markers
“The hypothesis that [ESIs] interfere with the vertebral osseous microenvironment and increase the risk of vertebral fractures has been supported with evidence in the literature,” Mohamad Bydon, MD, professor of neurosurgery, orthopedic surgery, and health services research at the Mayo Clinic, Rochester, Minn., said in an interview.
Prior studies have demonstrated a decrease in bone mineral density (BMD) and an increase in vertebral fractures following ESI, added Dr. Bydon, senior author of a 2018 review of the effect of ESI on BMD and vertebral fracture risk that was published in Pain Medicine. He was not involved with the current study.
“The article by Clare et al. provides evidence on the systemic absorption of glucocorticoids by demonstrating a drop in serum cortisol following ESI,” he noted. “The measurement of bone metabolism biomarkers offers molecular confirmation of clinical and radiological observations of previous studies” showing that ESI affects the vertebrae.
More than 9 million ESIs each year
Each year, more than 9 million ESIs are administered to patients in the United States to relieve radicular back and leg pain that may be caused by a herniated disc or spinal stenosis (a gradual narrowing of the open spaces in the spinal column, which is common in older adults), the researchers explained.
Some patients experience sufficient pain relief with ESIs. Others may not be eligible for surgery and may receive multiple ESIs annually for many years because they provide pain relief.
It is well established that oral and intravenous glucocorticoids profoundly suppress bone formation and transiently increase bone resorption, causing substantial bone loss and increased fracture risk within 3 months of administration, Ms. Clare explained in the session.
Long-term use of high-dose inhaled glucocorticoids has been associated with bone loss and fractures. However, the effect of ESIs on bone has been less well studied.
The researchers hypothesized that ESIs are systemically absorbed and cause suppression of bone formation without a compensatory decrease in bone resorption.
They enrolled 24 patients who had undergone lumbar ESIs and 8 control patients. The mean age of the patients in the two groups was 63 years and 68 years, respectively. Most patients were White (88% and 100%, respectively). The mean body mass index was 27 kg/m2 and 28 kg/m2, respectively. On average, the patients had entered menopause 12 and 16 years earlier, respectively.
In the group that received steroid injections, almost two-thirds (15 patients, 63%) received triamcinolone. The rest received dexamethasone (six patients, 25%) or betamethasone (three patients, 12%) at doses that were equivalent to 80 mg triamcinolone.
The patients’ baseline serum levels of 25-hydroxy vitamin D, parathyroid hormone, cortisol, P1NP, osteocalcin, and CTX were within the reference ranges and were similar in the two groups.
The researchers also determined serum levels of cortisol (to assess suppression of endogenous glucocorticoids), osteocalcin, P1NP, and CTX in the patients and control persons at 1, 4, 12, 26, and 52 weeks after patients had received the ESI.
The researchers acknowledged that the small sample is a study limitation. In addition, the first serum samples were taken 1 week after the injection, and so any earlier changes in analyte levels were not captured. The patients also received different types of steroids, although the doses were similar when converted to triamcinolone equivalents.
The study was supported by a Spine Service grant from the Hospital for Special Surgery. The authors disclosed no relevant financial relationships.
A version of this article first appeared on Medscape.com.
Among postmenopausal women who received an epidural steroid injection (ESI) in the lumbar spine to treat back and leg pain arising from a compressed nerve in the spine, levels of bone formation biomarkers were decreased. The decrease in levels persisted more than 12 weeks, results from a new study show.
In addition, serum cortisol levels decreased by 50% at week 1 after the ESI, indicating systemic absorption of the steroid.
“The extent and duration of these effects suggest that patients who receive multiple [ESIs in the lumbar spine] may be at particular risk for harmful skeletal consequences,” Shannon Clare reported in an oral presentation at the annual meeting of the American Society for Bone and Mineral Research.
Further studies are needed of the relationship between these short-term changes in bone turnover and bone loss and the risk for fracture among the burgeoning population treated with ESIs, added Ms. Clare, of the Hospital for Special Surgery, New York.
The researchers examined changes in serum levels of bone formation and resorption markers and other analytes in 24 women who received a lumbar ESI for radicular back pain and in 8 other women from the hospital population who served as control persons.
Among the women who received ESI, 1 week after the injection, serum levels of two bone formation biomarkers – total procollagen type 1 N-terminal peptide (P1NP) and osteocalcin – were about 27% lower than at baseline. The suppression persisted beyond 12 weeks.
Serum levels of the bone resorption biomarker C-terminal telopeptide of type I collagen (CTX) did not differ significantly after ESI.
“Our results are notable because we found that the duration of suppression of bone formation extended beyond 12 weeks, a far longer duration than seen previously with intra-articular injections” of glucocorticoids, said Ms. Clare and senior author Emily M. Stein, MD, director of research for the Metabolic Bone Service and an endocrinologist at the Hospital for Special Surgery and is associate professor of medicine at Weill Cornell Medicine, both in New York.
The findings suggest that patients should not receive multiple doses within a 12-week period, they told this news organization in a joint email response.
Women are not typically screened for osteopenia or osteoporosis before ESI. However, “our results suggest that physicians should consider screening women for osteoporosis who receive ESI, particularly those who are treated with multiple doses,” said Ms. Clare and Dr. Stein. “Steroid exposure should be minimized as much as possible by having patients space injections as far as they can tolerate.”
Systemic absorption, negative impact on bone turnover markers
“The hypothesis that [ESIs] interfere with the vertebral osseous microenvironment and increase the risk of vertebral fractures has been supported with evidence in the literature,” Mohamad Bydon, MD, professor of neurosurgery, orthopedic surgery, and health services research at the Mayo Clinic, Rochester, Minn., said in an interview.
Prior studies have demonstrated a decrease in bone mineral density (BMD) and an increase in vertebral fractures following ESI, added Dr. Bydon, senior author of a 2018 review of the effect of ESI on BMD and vertebral fracture risk that was published in Pain Medicine. He was not involved with the current study.
“The article by Clare et al. provides evidence on the systemic absorption of glucocorticoids by demonstrating a drop in serum cortisol following ESI,” he noted. “The measurement of bone metabolism biomarkers offers molecular confirmation of clinical and radiological observations of previous studies” showing that ESI affects the vertebrae.
More than 9 million ESIs each year
Each year, more than 9 million ESIs are administered to patients in the United States to relieve radicular back and leg pain that may be caused by a herniated disc or spinal stenosis (a gradual narrowing of the open spaces in the spinal column, which is common in older adults), the researchers explained.
Some patients experience sufficient pain relief with ESIs. Others may not be eligible for surgery and may receive multiple ESIs annually for many years because they provide pain relief.
It is well established that oral and intravenous glucocorticoids profoundly suppress bone formation and transiently increase bone resorption, causing substantial bone loss and increased fracture risk within 3 months of administration, Ms. Clare explained in the session.
Long-term use of high-dose inhaled glucocorticoids has been associated with bone loss and fractures. However, the effect of ESIs on bone has been less well studied.
The researchers hypothesized that ESIs are systemically absorbed and cause suppression of bone formation without a compensatory decrease in bone resorption.
They enrolled 24 patients who had undergone lumbar ESIs and 8 control patients. The mean age of the patients in the two groups was 63 years and 68 years, respectively. Most patients were White (88% and 100%, respectively). The mean body mass index was 27 kg/m2 and 28 kg/m2, respectively. On average, the patients had entered menopause 12 and 16 years earlier, respectively.
In the group that received steroid injections, almost two-thirds (15 patients, 63%) received triamcinolone. The rest received dexamethasone (six patients, 25%) or betamethasone (three patients, 12%) at doses that were equivalent to 80 mg triamcinolone.
The patients’ baseline serum levels of 25-hydroxy vitamin D, parathyroid hormone, cortisol, P1NP, osteocalcin, and CTX were within the reference ranges and were similar in the two groups.
The researchers also determined serum levels of cortisol (to assess suppression of endogenous glucocorticoids), osteocalcin, P1NP, and CTX in the patients and control persons at 1, 4, 12, 26, and 52 weeks after patients had received the ESI.
The researchers acknowledged that the small sample is a study limitation. In addition, the first serum samples were taken 1 week after the injection, and so any earlier changes in analyte levels were not captured. The patients also received different types of steroids, although the doses were similar when converted to triamcinolone equivalents.
The study was supported by a Spine Service grant from the Hospital for Special Surgery. The authors disclosed no relevant financial relationships.
A version of this article first appeared on Medscape.com.
Therapeutic homework adherence improves tics in Tourette’s disorder
Homework adherence between behavior therapy sessions is a significant predictor of therapeutic improvement in patients with Tourette’s disorder (TD), a study of 119 youth and adults suggests.
The assigning of “homework” to be completed between sessions – often used in cognitive-behavioral therapy – has been shown to reinforce learning but has not been well studied in TD.
“Understanding the relationship between homework adherence and therapeutic improvement from behavior therapy for TD may offer new insights for enhancing tic severity reductions achieved during this evidence-based treatment,” wrote Joey Ka-Yee Essoe, PhD, of the department of psychiatry and behavioral sciences at Johns Hopkins University, Baltimore, and colleagues.
To conduct the study, published in Behaviour Research and Therapy, the researchers recruited 70 youth and 49 adults with TD, ranging in age from 9 to 67 years, who underwent treatment at a single center. The average age was 21 years, and 80 participants were male. Treatment response was based on the Clinical Global Impressions of Improvement scale (CGI-I). Participants were assessed at baseline for tic severity and received eight sessions over 10 weeks. During those sessions, they were taught to perform a competing response to inhibit the expression of a tic when the tic or urge was detected.
Participants received homework at each weekly therapy session; most consisted of three to four practice sessions of about 30 minutes per week. Therapists reviewed the homework at the following session and adapted as needed to improve tic reduction skills.
After eight sessions of behavior therapy, overall greater homework adherence significantly predicted reduced tic severity and therapeutic improvement. However, early homework adherence predicted therapeutic improvement in youth, while late homework adherence predicted it in adults.
Overall,
However, homework adherence dipped midway through treatment in youth and showed a linear decline in adults, the researchers noted.
Among youth, baseline predictors of early homework adherence included lower levels of hyperactivity/impulsivity and caregiver strain. Among adults, baseline predictors of early homework adherence included lower anger scores, less social disability, and greater work disability.
The study findings were limited by several factors, including the absence of complete data on baseline predictors of homework adherence, reliance on a single measure of tic severity and improvement, and reliance on therapists’ reports of homework adherence, the researchers noted.
Future research should include objective measures of homework adherence, such as time-stamped videos, and different strategies may be needed for youth vs. adults, they added.
“Strategies that optimize homework adherence may enhance the efficacy of behavioral therapy, lead to greater tic severity reductions, and higher treatment response rates,” Dr. Essoe and colleagues wrote.
The study was supported by the Tourette Association of America, the National Institute of Mental Health, the American Academy of Neurology, and the American Psychological Foundation.
Homework adherence between behavior therapy sessions is a significant predictor of therapeutic improvement in patients with Tourette’s disorder (TD), a study of 119 youth and adults suggests.
The assigning of “homework” to be completed between sessions – often used in cognitive-behavioral therapy – has been shown to reinforce learning but has not been well studied in TD.
“Understanding the relationship between homework adherence and therapeutic improvement from behavior therapy for TD may offer new insights for enhancing tic severity reductions achieved during this evidence-based treatment,” wrote Joey Ka-Yee Essoe, PhD, of the department of psychiatry and behavioral sciences at Johns Hopkins University, Baltimore, and colleagues.
To conduct the study, published in Behaviour Research and Therapy, the researchers recruited 70 youth and 49 adults with TD, ranging in age from 9 to 67 years, who underwent treatment at a single center. The average age was 21 years, and 80 participants were male. Treatment response was based on the Clinical Global Impressions of Improvement scale (CGI-I). Participants were assessed at baseline for tic severity and received eight sessions over 10 weeks. During those sessions, they were taught to perform a competing response to inhibit the expression of a tic when the tic or urge was detected.
Participants received homework at each weekly therapy session; most consisted of three to four practice sessions of about 30 minutes per week. Therapists reviewed the homework at the following session and adapted as needed to improve tic reduction skills.
After eight sessions of behavior therapy, overall greater homework adherence significantly predicted reduced tic severity and therapeutic improvement. However, early homework adherence predicted therapeutic improvement in youth, while late homework adherence predicted it in adults.
Overall,
However, homework adherence dipped midway through treatment in youth and showed a linear decline in adults, the researchers noted.
Among youth, baseline predictors of early homework adherence included lower levels of hyperactivity/impulsivity and caregiver strain. Among adults, baseline predictors of early homework adherence included lower anger scores, less social disability, and greater work disability.
The study findings were limited by several factors, including the absence of complete data on baseline predictors of homework adherence, reliance on a single measure of tic severity and improvement, and reliance on therapists’ reports of homework adherence, the researchers noted.
Future research should include objective measures of homework adherence, such as time-stamped videos, and different strategies may be needed for youth vs. adults, they added.
“Strategies that optimize homework adherence may enhance the efficacy of behavioral therapy, lead to greater tic severity reductions, and higher treatment response rates,” Dr. Essoe and colleagues wrote.
The study was supported by the Tourette Association of America, the National Institute of Mental Health, the American Academy of Neurology, and the American Psychological Foundation.
Homework adherence between behavior therapy sessions is a significant predictor of therapeutic improvement in patients with Tourette’s disorder (TD), a study of 119 youth and adults suggests.
The assigning of “homework” to be completed between sessions – often used in cognitive-behavioral therapy – has been shown to reinforce learning but has not been well studied in TD.
“Understanding the relationship between homework adherence and therapeutic improvement from behavior therapy for TD may offer new insights for enhancing tic severity reductions achieved during this evidence-based treatment,” wrote Joey Ka-Yee Essoe, PhD, of the department of psychiatry and behavioral sciences at Johns Hopkins University, Baltimore, and colleagues.
To conduct the study, published in Behaviour Research and Therapy, the researchers recruited 70 youth and 49 adults with TD, ranging in age from 9 to 67 years, who underwent treatment at a single center. The average age was 21 years, and 80 participants were male. Treatment response was based on the Clinical Global Impressions of Improvement scale (CGI-I). Participants were assessed at baseline for tic severity and received eight sessions over 10 weeks. During those sessions, they were taught to perform a competing response to inhibit the expression of a tic when the tic or urge was detected.
Participants received homework at each weekly therapy session; most consisted of three to four practice sessions of about 30 minutes per week. Therapists reviewed the homework at the following session and adapted as needed to improve tic reduction skills.
After eight sessions of behavior therapy, overall greater homework adherence significantly predicted reduced tic severity and therapeutic improvement. However, early homework adherence predicted therapeutic improvement in youth, while late homework adherence predicted it in adults.
Overall,
However, homework adherence dipped midway through treatment in youth and showed a linear decline in adults, the researchers noted.
Among youth, baseline predictors of early homework adherence included lower levels of hyperactivity/impulsivity and caregiver strain. Among adults, baseline predictors of early homework adherence included lower anger scores, less social disability, and greater work disability.
The study findings were limited by several factors, including the absence of complete data on baseline predictors of homework adherence, reliance on a single measure of tic severity and improvement, and reliance on therapists’ reports of homework adherence, the researchers noted.
Future research should include objective measures of homework adherence, such as time-stamped videos, and different strategies may be needed for youth vs. adults, they added.
“Strategies that optimize homework adherence may enhance the efficacy of behavioral therapy, lead to greater tic severity reductions, and higher treatment response rates,” Dr. Essoe and colleagues wrote.
The study was supported by the Tourette Association of America, the National Institute of Mental Health, the American Academy of Neurology, and the American Psychological Foundation.
FROM BEHAVIOUR RESEARCH & THERAPY
Melatonin improves sleep in MS
according to a new pilot study.
The study included only 30 patients, but the findings suggest that melatonin could potentially help patients with MS who have sleep issues, according to Wan-Yu Hsu, PhD, who presented the study at the annual meeting of the European Committee for Treatment and Research in Multiple Sclerosis (ECTRIMS).
There is no optimal management of sleep issues for these patients, and objective studies of sleep in patients with MS are scarce, said Dr. Hsu, who is an associate specialist in the department of neurology at the University of California, San Francisco. She worked with Riley Bove, MD, who is an associate professor of neurology at UCSF Weill Institute for Neurosciences.
“Melatonin use was associated with improvement in sleep quality and sleep disturbance in MS patients, although there was no significant change in other outcomes, like daytime sleepiness, mood, and walking ability” Dr. Hsu said in an interview.
Melatonin is inexpensive and readily available over the counter, but it’s too soon to begin recommending it to MS patients experiencing sleep problems, according to Dr. Hsu. “It’s a good start that we’re seeing some effects here with this relatively small group of people. Larger studies are needed to unravel the complex relationship between MS and sleep disturbances, as well as develop successful interventions. But for now, since melatonin is an over-the-counter, low-cost supplement, many patients are trying it already.”
Melatonin regulates the sleep-wake cycle, and previous research has shown a decrease in melatonin serum levels as a result of corticosteroid administration. Other work has suggested that the decline of melatonin secretion in MS may reflect progressive failure of the pineal gland in the pathogenesis of MS. “The cause of sleep problems can be lesions and neural damage to brain structures involved in sleep, or symptoms that indirectly disrupt sleep,” she said.
Indeed, sleep issues in MS are common and wide-ranging, according to Mark Gudesblatt, MD, who was asked to comment on the study. His group previously reported that 65% of people with MS who reported fatigue had undiagnosed obstructive sleep apnea. He also pointed out that disruption of the neural network also disrupts sleep. “That is not only sleep-disordered breathing, that’s sleep onset, REM latency, and sleep efficiency,” said Dr. Gudesblatt, who is medical director of the Comprehensive MS Care Center at South Shore Neurologic Associates in Patchogue, N.Y.
Dr. Gudesblatt cautioned that melatonin, as a dietary supplement, is unregulated. The potency listed on the package may not be accurate and also may not be the correct dose for the patient. “It’s fraught with problems, but ultimately it’s relatively safe,” said Dr. Gudesblatt.
The study was a double-blind, placebo-controlled, crossover study. Participants had a Pittsburgh Sleep Quality Index (PSQI) score of 5 or more, or an Insomnia Severity Index (ISI) score higher than 14 at baseline. Other baseline assessments included patient-reported outcomes for sleep disturbances, sleep quality, daytime sleepiness, fatigue, walking ability, and mood. Half of the participants received melatonin for the first 2 weeks and then switched to placebo. The other half started with placebo and moved over to melatonin at the beginning of week 3.
Participants in the trial started out at 0.5 mg melatonin and were stepped up to 3.0 mg after 3 days if they didn't feel it was working, both when taking melatonin and when taking placebo. Of the 30 patients, 24 stepped up to 3.0 mg when they were receiving melatonin.*
During the second and fourth weeks, participants wore an actigraph watch to measure their physical and sleep activities, and then repeated the patient-reported outcome measures at the end of weeks 2 and 4. Melatonin improved average sleep time (6.96 vs. 6.67 hours; P = .03) as measured by the actigraph watch. Sleep efficiency was also nominally improved (84.7% vs. 83.2%), though the result was not statistically significant (P = .07). Other trends toward statistical significance included improvements in ISI (–3.5 vs. –2.4; P = .07), change in PSQI component 1 (–0.03 vs. 0.0; P = .07), and change in the NeuroQoL-Fatigue score (–4.7 vs. –2.4; P = .06).
Dr. Hsu hopes to conduct larger studies to examine how the disease-modifying therapies might affect the results of the study.
The study was funded by the National Multiple Sclerosis Society. Dr. Hsu and Dr. Gudesblatt have no relevant financial disclosures.
*This article was updated on Oct. 15.
according to a new pilot study.
The study included only 30 patients, but the findings suggest that melatonin could potentially help patients with MS who have sleep issues, according to Wan-Yu Hsu, PhD, who presented the study at the annual meeting of the European Committee for Treatment and Research in Multiple Sclerosis (ECTRIMS).
There is no optimal management of sleep issues for these patients, and objective studies of sleep in patients with MS are scarce, said Dr. Hsu, who is an associate specialist in the department of neurology at the University of California, San Francisco. She worked with Riley Bove, MD, who is an associate professor of neurology at UCSF Weill Institute for Neurosciences.
“Melatonin use was associated with improvement in sleep quality and sleep disturbance in MS patients, although there was no significant change in other outcomes, like daytime sleepiness, mood, and walking ability” Dr. Hsu said in an interview.
Melatonin is inexpensive and readily available over the counter, but it’s too soon to begin recommending it to MS patients experiencing sleep problems, according to Dr. Hsu. “It’s a good start that we’re seeing some effects here with this relatively small group of people. Larger studies are needed to unravel the complex relationship between MS and sleep disturbances, as well as develop successful interventions. But for now, since melatonin is an over-the-counter, low-cost supplement, many patients are trying it already.”
Melatonin regulates the sleep-wake cycle, and previous research has shown a decrease in melatonin serum levels as a result of corticosteroid administration. Other work has suggested that the decline of melatonin secretion in MS may reflect progressive failure of the pineal gland in the pathogenesis of MS. “The cause of sleep problems can be lesions and neural damage to brain structures involved in sleep, or symptoms that indirectly disrupt sleep,” she said.
Indeed, sleep issues in MS are common and wide-ranging, according to Mark Gudesblatt, MD, who was asked to comment on the study. His group previously reported that 65% of people with MS who reported fatigue had undiagnosed obstructive sleep apnea. He also pointed out that disruption of the neural network also disrupts sleep. “That is not only sleep-disordered breathing, that’s sleep onset, REM latency, and sleep efficiency,” said Dr. Gudesblatt, who is medical director of the Comprehensive MS Care Center at South Shore Neurologic Associates in Patchogue, N.Y.
Dr. Gudesblatt cautioned that melatonin, as a dietary supplement, is unregulated. The potency listed on the package may not be accurate and also may not be the correct dose for the patient. “It’s fraught with problems, but ultimately it’s relatively safe,” said Dr. Gudesblatt.
The study was a double-blind, placebo-controlled, crossover study. Participants had a Pittsburgh Sleep Quality Index (PSQI) score of 5 or more, or an Insomnia Severity Index (ISI) score higher than 14 at baseline. Other baseline assessments included patient-reported outcomes for sleep disturbances, sleep quality, daytime sleepiness, fatigue, walking ability, and mood. Half of the participants received melatonin for the first 2 weeks and then switched to placebo. The other half started with placebo and moved over to melatonin at the beginning of week 3.
Participants in the trial started out at 0.5 mg melatonin and were stepped up to 3.0 mg after 3 days if they didn't feel it was working, both when taking melatonin and when taking placebo. Of the 30 patients, 24 stepped up to 3.0 mg when they were receiving melatonin.*
During the second and fourth weeks, participants wore an actigraph watch to measure their physical and sleep activities, and then repeated the patient-reported outcome measures at the end of weeks 2 and 4. Melatonin improved average sleep time (6.96 vs. 6.67 hours; P = .03) as measured by the actigraph watch. Sleep efficiency was also nominally improved (84.7% vs. 83.2%), though the result was not statistically significant (P = .07). Other trends toward statistical significance included improvements in ISI (–3.5 vs. –2.4; P = .07), change in PSQI component 1 (–0.03 vs. 0.0; P = .07), and change in the NeuroQoL-Fatigue score (–4.7 vs. –2.4; P = .06).
Dr. Hsu hopes to conduct larger studies to examine how the disease-modifying therapies might affect the results of the study.
The study was funded by the National Multiple Sclerosis Society. Dr. Hsu and Dr. Gudesblatt have no relevant financial disclosures.
*This article was updated on Oct. 15.
according to a new pilot study.
The study included only 30 patients, but the findings suggest that melatonin could potentially help patients with MS who have sleep issues, according to Wan-Yu Hsu, PhD, who presented the study at the annual meeting of the European Committee for Treatment and Research in Multiple Sclerosis (ECTRIMS).
There is no optimal management of sleep issues for these patients, and objective studies of sleep in patients with MS are scarce, said Dr. Hsu, who is an associate specialist in the department of neurology at the University of California, San Francisco. She worked with Riley Bove, MD, who is an associate professor of neurology at UCSF Weill Institute for Neurosciences.
“Melatonin use was associated with improvement in sleep quality and sleep disturbance in MS patients, although there was no significant change in other outcomes, like daytime sleepiness, mood, and walking ability” Dr. Hsu said in an interview.
Melatonin is inexpensive and readily available over the counter, but it’s too soon to begin recommending it to MS patients experiencing sleep problems, according to Dr. Hsu. “It’s a good start that we’re seeing some effects here with this relatively small group of people. Larger studies are needed to unravel the complex relationship between MS and sleep disturbances, as well as develop successful interventions. But for now, since melatonin is an over-the-counter, low-cost supplement, many patients are trying it already.”
Melatonin regulates the sleep-wake cycle, and previous research has shown a decrease in melatonin serum levels as a result of corticosteroid administration. Other work has suggested that the decline of melatonin secretion in MS may reflect progressive failure of the pineal gland in the pathogenesis of MS. “The cause of sleep problems can be lesions and neural damage to brain structures involved in sleep, or symptoms that indirectly disrupt sleep,” she said.
Indeed, sleep issues in MS are common and wide-ranging, according to Mark Gudesblatt, MD, who was asked to comment on the study. His group previously reported that 65% of people with MS who reported fatigue had undiagnosed obstructive sleep apnea. He also pointed out that disruption of the neural network also disrupts sleep. “That is not only sleep-disordered breathing, that’s sleep onset, REM latency, and sleep efficiency,” said Dr. Gudesblatt, who is medical director of the Comprehensive MS Care Center at South Shore Neurologic Associates in Patchogue, N.Y.
Dr. Gudesblatt cautioned that melatonin, as a dietary supplement, is unregulated. The potency listed on the package may not be accurate and also may not be the correct dose for the patient. “It’s fraught with problems, but ultimately it’s relatively safe,” said Dr. Gudesblatt.
The study was a double-blind, placebo-controlled, crossover study. Participants had a Pittsburgh Sleep Quality Index (PSQI) score of 5 or more, or an Insomnia Severity Index (ISI) score higher than 14 at baseline. Other baseline assessments included patient-reported outcomes for sleep disturbances, sleep quality, daytime sleepiness, fatigue, walking ability, and mood. Half of the participants received melatonin for the first 2 weeks and then switched to placebo. The other half started with placebo and moved over to melatonin at the beginning of week 3.
Participants in the trial started out at 0.5 mg melatonin and were stepped up to 3.0 mg after 3 days if they didn't feel it was working, both when taking melatonin and when taking placebo. Of the 30 patients, 24 stepped up to 3.0 mg when they were receiving melatonin.*
During the second and fourth weeks, participants wore an actigraph watch to measure their physical and sleep activities, and then repeated the patient-reported outcome measures at the end of weeks 2 and 4. Melatonin improved average sleep time (6.96 vs. 6.67 hours; P = .03) as measured by the actigraph watch. Sleep efficiency was also nominally improved (84.7% vs. 83.2%), though the result was not statistically significant (P = .07). Other trends toward statistical significance included improvements in ISI (–3.5 vs. –2.4; P = .07), change in PSQI component 1 (–0.03 vs. 0.0; P = .07), and change in the NeuroQoL-Fatigue score (–4.7 vs. –2.4; P = .06).
Dr. Hsu hopes to conduct larger studies to examine how the disease-modifying therapies might affect the results of the study.
The study was funded by the National Multiple Sclerosis Society. Dr. Hsu and Dr. Gudesblatt have no relevant financial disclosures.
*This article was updated on Oct. 15.
FROM ECTRIMS 2021
Pandemic survey: Forty-six percent of pediatric headache patients got worse
, a newly released survey finds. But some actually found the pandemic era to be less stressful since they were tightly wound and could more easily control their home environments, a researcher said.
“We need to be very mindful of the connections between school and home environments – and social situations – and how they impact headache frequency,” said Marc DiSabella, DO, a pediatric neurologist at Children’s National Hospital/George Washington University, Washington. He is coauthor of a poster presented at the 50th annual meeting of the Child Neurology Society.
Dr. DiSabella and colleagues launched the survey to understand what headache patients were experiencing during the pandemic. They expected that “things were going to go really terrible in terms of headaches – or things would go great, and then things would crash when we had to reintegrate into society,” he said in an interview.
The team surveyed 113 pediatric patients who were evaluated at the hospital’s headache clinic between summer 2020 and winter 2021. Most of the patients were female (60%) and were aged 12-17 years (63%). Twenty-one percent were younger than 12 and 16% were older than 17. Chronic migraine (37%) was the most common diagnosis, followed by migraine with aura (22%), migraine without aura (19%), and new daily persistent headache (15%).
Nearly half (46%) of patients said their headaches had worsened during the pandemic. Many also reported more anxiety (55%), worsened mood (48%) and more stress (55%).
Dr. DiSabella said it’s especially notable that nearly two-thirds of those surveyed reported they were exercising less during the pandemic. Research has suggested that exercise and proper diet/sleep are crucial to improving headaches in kids, he said, and the survey findings suggest that exercise may be especially important. “Engaging in physical activity changes their pain threshold,” he said.
The researchers also reported that 60% of those surveyed said they looked at screens more than 6 hours per day. According to Dr. DiSabella, high screen use may not be worrisome from a headache perspective. “We have another study in publication that shows there’s not a clear association between frequency of screen use and headache intensity,” he said.
The survey doesn’t examine what has happened in recent weeks as schools have reopened. Anecdotally, Dr. DiSabella said some patients with migraine are feeling the stress of returning to normal routines. “They tend to be type A perfectionists and do well when they’re in control of their environment,” he said. “Now they’ve lost the control they had at home and are being put back into a stressful environment.”
Pandemic effects mixed
Commenting on the study, child neurologist Andrew D. Hershey, MD, PhD, of Cincinnati Children’s Hospital Medical Center, questioned the finding that many children suffered from more headaches during the pandemic. In his experience, “headaches were overall better when [children] were doing virtual learning,” he said in an interview. “We had fewer admissions, ED visits declined, and patients were maintaining better healthy habits. Some did express anxiety about not seeing friends, but were accommodating by doing this remotely.”
He added: “Since their return, kids are back to the same sleep deprivation issue since schools start too early, and they have more difficulty treating headaches acutely since they have to go to the nurse’s office [to do so]. They self-report a higher degree of stress and anxiety.”
On the other hand, Jack Gladstein, MD, a child neurologist at the University of Maryland, Baltimore, said in an interview that most of his patients suffered more headaches during the pandemic, although a small number with social anxiety thrived because they got to stay at home.
He agreed with Dr. DiSabella about the value of exercise. “At every visit we remind our youngsters with migraine to eat breakfast, exercise, get regular sleep, and drink fluids,” he said.
No study funding was reported. The study authors, Dr. Hershey, and Dr. Gladstein reported no disclosures.
, a newly released survey finds. But some actually found the pandemic era to be less stressful since they were tightly wound and could more easily control their home environments, a researcher said.
“We need to be very mindful of the connections between school and home environments – and social situations – and how they impact headache frequency,” said Marc DiSabella, DO, a pediatric neurologist at Children’s National Hospital/George Washington University, Washington. He is coauthor of a poster presented at the 50th annual meeting of the Child Neurology Society.
Dr. DiSabella and colleagues launched the survey to understand what headache patients were experiencing during the pandemic. They expected that “things were going to go really terrible in terms of headaches – or things would go great, and then things would crash when we had to reintegrate into society,” he said in an interview.
The team surveyed 113 pediatric patients who were evaluated at the hospital’s headache clinic between summer 2020 and winter 2021. Most of the patients were female (60%) and were aged 12-17 years (63%). Twenty-one percent were younger than 12 and 16% were older than 17. Chronic migraine (37%) was the most common diagnosis, followed by migraine with aura (22%), migraine without aura (19%), and new daily persistent headache (15%).
Nearly half (46%) of patients said their headaches had worsened during the pandemic. Many also reported more anxiety (55%), worsened mood (48%) and more stress (55%).
Dr. DiSabella said it’s especially notable that nearly two-thirds of those surveyed reported they were exercising less during the pandemic. Research has suggested that exercise and proper diet/sleep are crucial to improving headaches in kids, he said, and the survey findings suggest that exercise may be especially important. “Engaging in physical activity changes their pain threshold,” he said.
The researchers also reported that 60% of those surveyed said they looked at screens more than 6 hours per day. According to Dr. DiSabella, high screen use may not be worrisome from a headache perspective. “We have another study in publication that shows there’s not a clear association between frequency of screen use and headache intensity,” he said.
The survey doesn’t examine what has happened in recent weeks as schools have reopened. Anecdotally, Dr. DiSabella said some patients with migraine are feeling the stress of returning to normal routines. “They tend to be type A perfectionists and do well when they’re in control of their environment,” he said. “Now they’ve lost the control they had at home and are being put back into a stressful environment.”
Pandemic effects mixed
Commenting on the study, child neurologist Andrew D. Hershey, MD, PhD, of Cincinnati Children’s Hospital Medical Center, questioned the finding that many children suffered from more headaches during the pandemic. In his experience, “headaches were overall better when [children] were doing virtual learning,” he said in an interview. “We had fewer admissions, ED visits declined, and patients were maintaining better healthy habits. Some did express anxiety about not seeing friends, but were accommodating by doing this remotely.”
He added: “Since their return, kids are back to the same sleep deprivation issue since schools start too early, and they have more difficulty treating headaches acutely since they have to go to the nurse’s office [to do so]. They self-report a higher degree of stress and anxiety.”
On the other hand, Jack Gladstein, MD, a child neurologist at the University of Maryland, Baltimore, said in an interview that most of his patients suffered more headaches during the pandemic, although a small number with social anxiety thrived because they got to stay at home.
He agreed with Dr. DiSabella about the value of exercise. “At every visit we remind our youngsters with migraine to eat breakfast, exercise, get regular sleep, and drink fluids,” he said.
No study funding was reported. The study authors, Dr. Hershey, and Dr. Gladstein reported no disclosures.
, a newly released survey finds. But some actually found the pandemic era to be less stressful since they were tightly wound and could more easily control their home environments, a researcher said.
“We need to be very mindful of the connections between school and home environments – and social situations – and how they impact headache frequency,” said Marc DiSabella, DO, a pediatric neurologist at Children’s National Hospital/George Washington University, Washington. He is coauthor of a poster presented at the 50th annual meeting of the Child Neurology Society.
Dr. DiSabella and colleagues launched the survey to understand what headache patients were experiencing during the pandemic. They expected that “things were going to go really terrible in terms of headaches – or things would go great, and then things would crash when we had to reintegrate into society,” he said in an interview.
The team surveyed 113 pediatric patients who were evaluated at the hospital’s headache clinic between summer 2020 and winter 2021. Most of the patients were female (60%) and were aged 12-17 years (63%). Twenty-one percent were younger than 12 and 16% were older than 17. Chronic migraine (37%) was the most common diagnosis, followed by migraine with aura (22%), migraine without aura (19%), and new daily persistent headache (15%).
Nearly half (46%) of patients said their headaches had worsened during the pandemic. Many also reported more anxiety (55%), worsened mood (48%) and more stress (55%).
Dr. DiSabella said it’s especially notable that nearly two-thirds of those surveyed reported they were exercising less during the pandemic. Research has suggested that exercise and proper diet/sleep are crucial to improving headaches in kids, he said, and the survey findings suggest that exercise may be especially important. “Engaging in physical activity changes their pain threshold,” he said.
The researchers also reported that 60% of those surveyed said they looked at screens more than 6 hours per day. According to Dr. DiSabella, high screen use may not be worrisome from a headache perspective. “We have another study in publication that shows there’s not a clear association between frequency of screen use and headache intensity,” he said.
The survey doesn’t examine what has happened in recent weeks as schools have reopened. Anecdotally, Dr. DiSabella said some patients with migraine are feeling the stress of returning to normal routines. “They tend to be type A perfectionists and do well when they’re in control of their environment,” he said. “Now they’ve lost the control they had at home and are being put back into a stressful environment.”
Pandemic effects mixed
Commenting on the study, child neurologist Andrew D. Hershey, MD, PhD, of Cincinnati Children’s Hospital Medical Center, questioned the finding that many children suffered from more headaches during the pandemic. In his experience, “headaches were overall better when [children] were doing virtual learning,” he said in an interview. “We had fewer admissions, ED visits declined, and patients were maintaining better healthy habits. Some did express anxiety about not seeing friends, but were accommodating by doing this remotely.”
He added: “Since their return, kids are back to the same sleep deprivation issue since schools start too early, and they have more difficulty treating headaches acutely since they have to go to the nurse’s office [to do so]. They self-report a higher degree of stress and anxiety.”
On the other hand, Jack Gladstein, MD, a child neurologist at the University of Maryland, Baltimore, said in an interview that most of his patients suffered more headaches during the pandemic, although a small number with social anxiety thrived because they got to stay at home.
He agreed with Dr. DiSabella about the value of exercise. “At every visit we remind our youngsters with migraine to eat breakfast, exercise, get regular sleep, and drink fluids,” he said.
No study funding was reported. The study authors, Dr. Hershey, and Dr. Gladstein reported no disclosures.
FROM CNS 2021
FDA advisors vote to recommend Moderna boosters
A panel of experts that advises the Food and Drug Administration on vaccine decisions voted unanimously Oct. 14 to approve booster doses of Moderna’s COVID-19 vaccine.
The 19 members of the FDA’s Vaccines and Related Biological Products Advisory Committee voted to authorize a 50-milligram dose -- half the dose used in the primary series of shots -- to boost immunity against COVID-19 at least 6 months after the second dose. Those who might need a booster are the same groups who’ve gotten a green light for third Pfizer doses. They include people:
- Over age 65
- Ages 18 to 64 who are at higher risk for severe COVID
- Who are at higher risk of catching COVID because they live in group settings like nursing homes or prisons, or because they are frequently exposed at work, as health care workers are
The agency is not bound by the committee’s vote but usually follows its recommendations.
Some members of the committee said they weren’t satisfied with the data Moderna submitted to support its application but, for practical reasons, said it wouldn’t be fair to take booster doses off the table for Moderna recipients when Pfizer’s boosters were already available.
“The data are not perfect, but these are extraordinary times and we have to work with data that are not perfect,” said Eric Rubin, MD, editor-in-chief of TheNew England Journal of Medicine and a temporary voting member on the committee.
Patrick Moore, MD, a professor at the University of Pittsburgh Cancer Institute who is also a temporary voting member, said he voted to approve the Moderna boosters based “more on a gut feeling than on truly serious data.”
“I’ve got some real issues with this vote,” he said.
“We need to see good solid data, and it needs to be explained well,” Dr. Moore said, challenging companies making future applications to do better.
Next, the FDA will have to formally sign off on the emergency use authorization, which it is expected to do. Then, the Centers for Disease Control and Prevention’s Advisory Committee on Immunization Practices will meet to make formal recommendations on use of the Moderna boosters. That group is scheduled to meet Oct. 21 to take up questions of exactly how these boosters should be used.
Peter Marks, MD, head of the FDA’s Center for Biologics Evaluation and Research, cautioned that the CDC is more constrained in making recommendations under an emergency use authorization than it would be if the boosters had gotten full approval. So it will likely align its vote with the conditions of the emergency use authorization from the FDA.
After the advisory committee votes, the director of the CDC has to approve its recommendation.
Overall, data show that two doses of the Moderna vaccine remains highly effective at preventing hospitalization and death. But over time, levels of the body’s first line of defense against a virus -- its neutralizing antibodies -- fall somewhat. This drop seems to correspond with an increased risk for breakthrough cases of COVID-19.
Data presented by Moderna Oct. 14 showed the risk of breakthrough infections increased by 36% in study participants who received the vaccine in their clinical trials, compared to people in the same study who received a placebo first, and got the vaccine later, when the trial was unblended. Their protection was more recent, and they had fewer breakthrough infections.
In considering booster doses, the FDA has asked drugmakers to do studies that look at the immune responses of small groups of study participants and compare them to the immune responses seen in study participants after their first two vaccine doses.
To be considered effective, boosters have to clear two bars. The first looks at the concentration of antibodies generated in the blood of boosted study volunteers. The second looks at how many boosted study participants saw a four-fold increase in their blood antibody levels a month after the booster minus the number of people who saw the same increase after their original two doses.
Moderna presented data that its boosters met the first criteria, but failed to meet the second, perhaps because so many people in the study had good responses after their first two doses of the vaccines.
The FDA’s advisory committee will reconvene Oct. 15 to hear evidence supporting the emergency use authorization of a booster dose of the Johnson & Johnson vaccine.
This article was updated Oct. 15 and first appeared on WebMD.com.
A panel of experts that advises the Food and Drug Administration on vaccine decisions voted unanimously Oct. 14 to approve booster doses of Moderna’s COVID-19 vaccine.
The 19 members of the FDA’s Vaccines and Related Biological Products Advisory Committee voted to authorize a 50-milligram dose -- half the dose used in the primary series of shots -- to boost immunity against COVID-19 at least 6 months after the second dose. Those who might need a booster are the same groups who’ve gotten a green light for third Pfizer doses. They include people:
- Over age 65
- Ages 18 to 64 who are at higher risk for severe COVID
- Who are at higher risk of catching COVID because they live in group settings like nursing homes or prisons, or because they are frequently exposed at work, as health care workers are
The agency is not bound by the committee’s vote but usually follows its recommendations.
Some members of the committee said they weren’t satisfied with the data Moderna submitted to support its application but, for practical reasons, said it wouldn’t be fair to take booster doses off the table for Moderna recipients when Pfizer’s boosters were already available.
“The data are not perfect, but these are extraordinary times and we have to work with data that are not perfect,” said Eric Rubin, MD, editor-in-chief of TheNew England Journal of Medicine and a temporary voting member on the committee.
Patrick Moore, MD, a professor at the University of Pittsburgh Cancer Institute who is also a temporary voting member, said he voted to approve the Moderna boosters based “more on a gut feeling than on truly serious data.”
“I’ve got some real issues with this vote,” he said.
“We need to see good solid data, and it needs to be explained well,” Dr. Moore said, challenging companies making future applications to do better.
Next, the FDA will have to formally sign off on the emergency use authorization, which it is expected to do. Then, the Centers for Disease Control and Prevention’s Advisory Committee on Immunization Practices will meet to make formal recommendations on use of the Moderna boosters. That group is scheduled to meet Oct. 21 to take up questions of exactly how these boosters should be used.
Peter Marks, MD, head of the FDA’s Center for Biologics Evaluation and Research, cautioned that the CDC is more constrained in making recommendations under an emergency use authorization than it would be if the boosters had gotten full approval. So it will likely align its vote with the conditions of the emergency use authorization from the FDA.
After the advisory committee votes, the director of the CDC has to approve its recommendation.
Overall, data show that two doses of the Moderna vaccine remains highly effective at preventing hospitalization and death. But over time, levels of the body’s first line of defense against a virus -- its neutralizing antibodies -- fall somewhat. This drop seems to correspond with an increased risk for breakthrough cases of COVID-19.
Data presented by Moderna Oct. 14 showed the risk of breakthrough infections increased by 36% in study participants who received the vaccine in their clinical trials, compared to people in the same study who received a placebo first, and got the vaccine later, when the trial was unblended. Their protection was more recent, and they had fewer breakthrough infections.
In considering booster doses, the FDA has asked drugmakers to do studies that look at the immune responses of small groups of study participants and compare them to the immune responses seen in study participants after their first two vaccine doses.
To be considered effective, boosters have to clear two bars. The first looks at the concentration of antibodies generated in the blood of boosted study volunteers. The second looks at how many boosted study participants saw a four-fold increase in their blood antibody levels a month after the booster minus the number of people who saw the same increase after their original two doses.
Moderna presented data that its boosters met the first criteria, but failed to meet the second, perhaps because so many people in the study had good responses after their first two doses of the vaccines.
The FDA’s advisory committee will reconvene Oct. 15 to hear evidence supporting the emergency use authorization of a booster dose of the Johnson & Johnson vaccine.
This article was updated Oct. 15 and first appeared on WebMD.com.
A panel of experts that advises the Food and Drug Administration on vaccine decisions voted unanimously Oct. 14 to approve booster doses of Moderna’s COVID-19 vaccine.
The 19 members of the FDA’s Vaccines and Related Biological Products Advisory Committee voted to authorize a 50-milligram dose -- half the dose used in the primary series of shots -- to boost immunity against COVID-19 at least 6 months after the second dose. Those who might need a booster are the same groups who’ve gotten a green light for third Pfizer doses. They include people:
- Over age 65
- Ages 18 to 64 who are at higher risk for severe COVID
- Who are at higher risk of catching COVID because they live in group settings like nursing homes or prisons, or because they are frequently exposed at work, as health care workers are
The agency is not bound by the committee’s vote but usually follows its recommendations.
Some members of the committee said they weren’t satisfied with the data Moderna submitted to support its application but, for practical reasons, said it wouldn’t be fair to take booster doses off the table for Moderna recipients when Pfizer’s boosters were already available.
“The data are not perfect, but these are extraordinary times and we have to work with data that are not perfect,” said Eric Rubin, MD, editor-in-chief of TheNew England Journal of Medicine and a temporary voting member on the committee.
Patrick Moore, MD, a professor at the University of Pittsburgh Cancer Institute who is also a temporary voting member, said he voted to approve the Moderna boosters based “more on a gut feeling than on truly serious data.”
“I’ve got some real issues with this vote,” he said.
“We need to see good solid data, and it needs to be explained well,” Dr. Moore said, challenging companies making future applications to do better.
Next, the FDA will have to formally sign off on the emergency use authorization, which it is expected to do. Then, the Centers for Disease Control and Prevention’s Advisory Committee on Immunization Practices will meet to make formal recommendations on use of the Moderna boosters. That group is scheduled to meet Oct. 21 to take up questions of exactly how these boosters should be used.
Peter Marks, MD, head of the FDA’s Center for Biologics Evaluation and Research, cautioned that the CDC is more constrained in making recommendations under an emergency use authorization than it would be if the boosters had gotten full approval. So it will likely align its vote with the conditions of the emergency use authorization from the FDA.
After the advisory committee votes, the director of the CDC has to approve its recommendation.
Overall, data show that two doses of the Moderna vaccine remains highly effective at preventing hospitalization and death. But over time, levels of the body’s first line of defense against a virus -- its neutralizing antibodies -- fall somewhat. This drop seems to correspond with an increased risk for breakthrough cases of COVID-19.
Data presented by Moderna Oct. 14 showed the risk of breakthrough infections increased by 36% in study participants who received the vaccine in their clinical trials, compared to people in the same study who received a placebo first, and got the vaccine later, when the trial was unblended. Their protection was more recent, and they had fewer breakthrough infections.
In considering booster doses, the FDA has asked drugmakers to do studies that look at the immune responses of small groups of study participants and compare them to the immune responses seen in study participants after their first two vaccine doses.
To be considered effective, boosters have to clear two bars. The first looks at the concentration of antibodies generated in the blood of boosted study volunteers. The second looks at how many boosted study participants saw a four-fold increase in their blood antibody levels a month after the booster minus the number of people who saw the same increase after their original two doses.
Moderna presented data that its boosters met the first criteria, but failed to meet the second, perhaps because so many people in the study had good responses after their first two doses of the vaccines.
The FDA’s advisory committee will reconvene Oct. 15 to hear evidence supporting the emergency use authorization of a booster dose of the Johnson & Johnson vaccine.
This article was updated Oct. 15 and first appeared on WebMD.com.
AAN blasts ‘runaway’ costs for neurologic and other prescription drugs
This situation is also taking a toll on neurologists’ mental health, who already have the second-highest burnout rate across medical specialties, the statement adds.
The statement was published online Oct. 5, 2021, in Neurology.
Dramatic price increases
Drafted by the Ethics, Law, and Humanities Committee – a joint committee that includes the AAN, the American Neurological Association, and the Child Neurology Society – the statement was prompted by a 2018 report from the AAN Neurology Drug Pricing Task Force to address challenges associated with high drug costs.
It highlights ethical concerns from high drug costs, policy proposals that might temper the problem, and how clinicians can adjust to the current reality of pharmaceutical pricing and better advocate for changes to the healthcare system.
“Runaway drug costs continue to be a pressing problem with recent dramatic price increases not only for specialty drugs, but also generic ones,” said lead author Amy Tsou, MD, MSc, codirector of the ECRI Evidence-Based Practice Center at the Center for Evidence and Guidelines in Plymouth Meeting, Pa.
She noted that one in four Americans has difficulty paying for medication, and many report going without a medication because of cost.
“Ensuring a fair system for drug pricing and coverage rules that balance the goods of individual patients with the needs of broader populations when resources are limited remains more important than ever,” Dr. Tsou said.
Out-of-pocket costs for neurologic medications have risen dramatically over the past decade, with the fastest rise reported among drugs for multiple sclerosis. Results from a study published in 2019 showed that, between 2004 and 2016, patients’ out-of-pocket expenses skyrocketed from $15 a month to $309 a month.
The steep increases have forced some neurology patients to ration their medication or stop taking it altogether, which is one of the ethical concerns cited in the AAN statement.
Patient self-rationing
Commenting on the statement, Ilana Katz Sand, MD, associate director of the Dickinson Center for Multiple Sclerosis at Mount Sinai Medical Center, New York, noted that clinicians are already acutely aware of the effect high drug costs have on their patients’ medical decisions. However, statements such as the current one bring much-needed outside attention to the problem.
“I’ve definitely had more and more people struggling with deductibles and copays, even among people who are insured,” said Dr. Katz Sand, who was not involved with the AAN paper.
She has a number of patients who have rationed their medication or stopped taking it altogether when their copays increased or they lost access to a copay assistance program because their insurance company chose to cover a still-expensive generic drug with no assistance program over a slightly costlier brand-name medication that comes with patient discounts.
Too often, patients don’t tell her they’re not taking their medication as prescribed. At a recent appointment, Dr. Katz Sand learned about a patient’s drug rationing only after a routine MRI showed new brain lesions that regular treatment might have prevented.
Another patient, new to her clinic, questioned the treatment plan Dr. Katz Sand recommended because they could not cover the copay. This sort of self-rationing happens in patients with and without insurance, she added.
“It’s a terrible thing and it’s happening to all patients,” Dr. Katz Sand said, adding that “the old credo of ‘yeah, the drug prices are high, but they are covered by insurance’ is not a sustainable argument anymore.”
What neurologists can do
Some sort of rationing is an unavoidable outcome of steep treatment costs, the authors noted. But what does that mean in clinical practice?
Neurologists should be aware of the costs involved in ordering diagnostic tests, treatment, or medication – and shouldn’t feel compelled to order treatments or tests that they feel are medically inappropriate just because a patient requests them, the authors wrote.
The statement also encourages clinicians to include financial realities in the shared decision-making process with patients.
However, Dr. Katz Sand said that is not always possible. Drug prices aren’t fixed, with different insurance plans offering different pricing, deductibles, and copays. “It’s hard for us to attempt to incorporate discussions about price in our discussions with patients when we can’t even predict what their out-of-pocket cost is going to be,” she said.
“Every single prescription we write requires prior authorization, and that’s directly related to the fact that the cost of these drugs is so high,” she added.
As do many other clinicians, Dr. Katz Sand spends hours each week on preauthorization forms and haggling with insurance companies on behalf of her patients. To get needed medication at a cost they can afford sometimes takes creative problem solving and almost always takes a lot of time. “It all adds to the administrative burden, patients’ stress, and our stress,” she said.
Physician-advocates needed
The AAN paper identifies a number of policy reforms to address drug pricing at a national level, including giving Medicare officials the power to negotiate drug prices, allowing the safe importation of drugs from other countries, and speeding the Food and Drug Administration approval process for generic drugs.
There is also a need to address systemic problems that, the authors noted, help create and perpetuate health care disparities. Lawmakers at the state and federal level are considering a number of these policy ideas and others that could address the kinds of issues Dr. Katz Sand described. However, the chances of their success are slim at best, said Bruce H. Cohen, MD, chair of the AAN advocacy committee and director of the NeuroDevelopmental Science Center at Akron (Ohio) Children’s Hospital.
“On a federal level, we’re watching in real time how the entrenched divisions, even within parties, are resulting in continued stalemate,” said Dr. Cohen, who is not one of the statement authors.
Those ideas need advocates and the AAN paper suggests neurologists should be among the ones championing these changes, he added.
“One of the most effective strategies is to bring attention to the impact high drug costs have on neurology patients and medical practices,” Dr. Cohen said. “It’s so important to make sure policy makers know the significant impact of high drug costs in neurology and within the context of finite resources.”
One way to do that is to share statements such as the current one with members of Congress working on policy reform, Dr. Cohen said. Another is through programs such as the academy’s annual Neurology on the Hill conference.
A third strategy is to encourage individuals such as Dr. Katz Sand to speak out when and where they can, he added.
While she agrees with the idea, finding time for advocacy work amid patient care, administrative work, and research is challenging. Dr. Katz Sand would like to see groups like the AAN work with health care institutions to implement policies that allocate time and resources to train clinicians in advocacy – and then support their efforts on that front.
“I’m really glad they wrote this and think they did a good job of crystallizing the issues,” Dr. Katz Sand said. “It’s good to put it out there as a document that could help serve as the basis for the requests we make collectively. I just hope that people listen.”
The paper received no funding. The authors disclosed no relevant financial relationships.
A version of this article first appeared on Medscape.com.
This situation is also taking a toll on neurologists’ mental health, who already have the second-highest burnout rate across medical specialties, the statement adds.
The statement was published online Oct. 5, 2021, in Neurology.
Dramatic price increases
Drafted by the Ethics, Law, and Humanities Committee – a joint committee that includes the AAN, the American Neurological Association, and the Child Neurology Society – the statement was prompted by a 2018 report from the AAN Neurology Drug Pricing Task Force to address challenges associated with high drug costs.
It highlights ethical concerns from high drug costs, policy proposals that might temper the problem, and how clinicians can adjust to the current reality of pharmaceutical pricing and better advocate for changes to the healthcare system.
“Runaway drug costs continue to be a pressing problem with recent dramatic price increases not only for specialty drugs, but also generic ones,” said lead author Amy Tsou, MD, MSc, codirector of the ECRI Evidence-Based Practice Center at the Center for Evidence and Guidelines in Plymouth Meeting, Pa.
She noted that one in four Americans has difficulty paying for medication, and many report going without a medication because of cost.
“Ensuring a fair system for drug pricing and coverage rules that balance the goods of individual patients with the needs of broader populations when resources are limited remains more important than ever,” Dr. Tsou said.
Out-of-pocket costs for neurologic medications have risen dramatically over the past decade, with the fastest rise reported among drugs for multiple sclerosis. Results from a study published in 2019 showed that, between 2004 and 2016, patients’ out-of-pocket expenses skyrocketed from $15 a month to $309 a month.
The steep increases have forced some neurology patients to ration their medication or stop taking it altogether, which is one of the ethical concerns cited in the AAN statement.
Patient self-rationing
Commenting on the statement, Ilana Katz Sand, MD, associate director of the Dickinson Center for Multiple Sclerosis at Mount Sinai Medical Center, New York, noted that clinicians are already acutely aware of the effect high drug costs have on their patients’ medical decisions. However, statements such as the current one bring much-needed outside attention to the problem.
“I’ve definitely had more and more people struggling with deductibles and copays, even among people who are insured,” said Dr. Katz Sand, who was not involved with the AAN paper.
She has a number of patients who have rationed their medication or stopped taking it altogether when their copays increased or they lost access to a copay assistance program because their insurance company chose to cover a still-expensive generic drug with no assistance program over a slightly costlier brand-name medication that comes with patient discounts.
Too often, patients don’t tell her they’re not taking their medication as prescribed. At a recent appointment, Dr. Katz Sand learned about a patient’s drug rationing only after a routine MRI showed new brain lesions that regular treatment might have prevented.
Another patient, new to her clinic, questioned the treatment plan Dr. Katz Sand recommended because they could not cover the copay. This sort of self-rationing happens in patients with and without insurance, she added.
“It’s a terrible thing and it’s happening to all patients,” Dr. Katz Sand said, adding that “the old credo of ‘yeah, the drug prices are high, but they are covered by insurance’ is not a sustainable argument anymore.”
What neurologists can do
Some sort of rationing is an unavoidable outcome of steep treatment costs, the authors noted. But what does that mean in clinical practice?
Neurologists should be aware of the costs involved in ordering diagnostic tests, treatment, or medication – and shouldn’t feel compelled to order treatments or tests that they feel are medically inappropriate just because a patient requests them, the authors wrote.
The statement also encourages clinicians to include financial realities in the shared decision-making process with patients.
However, Dr. Katz Sand said that is not always possible. Drug prices aren’t fixed, with different insurance plans offering different pricing, deductibles, and copays. “It’s hard for us to attempt to incorporate discussions about price in our discussions with patients when we can’t even predict what their out-of-pocket cost is going to be,” she said.
“Every single prescription we write requires prior authorization, and that’s directly related to the fact that the cost of these drugs is so high,” she added.
As do many other clinicians, Dr. Katz Sand spends hours each week on preauthorization forms and haggling with insurance companies on behalf of her patients. To get needed medication at a cost they can afford sometimes takes creative problem solving and almost always takes a lot of time. “It all adds to the administrative burden, patients’ stress, and our stress,” she said.
Physician-advocates needed
The AAN paper identifies a number of policy reforms to address drug pricing at a national level, including giving Medicare officials the power to negotiate drug prices, allowing the safe importation of drugs from other countries, and speeding the Food and Drug Administration approval process for generic drugs.
There is also a need to address systemic problems that, the authors noted, help create and perpetuate health care disparities. Lawmakers at the state and federal level are considering a number of these policy ideas and others that could address the kinds of issues Dr. Katz Sand described. However, the chances of their success are slim at best, said Bruce H. Cohen, MD, chair of the AAN advocacy committee and director of the NeuroDevelopmental Science Center at Akron (Ohio) Children’s Hospital.
“On a federal level, we’re watching in real time how the entrenched divisions, even within parties, are resulting in continued stalemate,” said Dr. Cohen, who is not one of the statement authors.
Those ideas need advocates and the AAN paper suggests neurologists should be among the ones championing these changes, he added.
“One of the most effective strategies is to bring attention to the impact high drug costs have on neurology patients and medical practices,” Dr. Cohen said. “It’s so important to make sure policy makers know the significant impact of high drug costs in neurology and within the context of finite resources.”
One way to do that is to share statements such as the current one with members of Congress working on policy reform, Dr. Cohen said. Another is through programs such as the academy’s annual Neurology on the Hill conference.
A third strategy is to encourage individuals such as Dr. Katz Sand to speak out when and where they can, he added.
While she agrees with the idea, finding time for advocacy work amid patient care, administrative work, and research is challenging. Dr. Katz Sand would like to see groups like the AAN work with health care institutions to implement policies that allocate time and resources to train clinicians in advocacy – and then support their efforts on that front.
“I’m really glad they wrote this and think they did a good job of crystallizing the issues,” Dr. Katz Sand said. “It’s good to put it out there as a document that could help serve as the basis for the requests we make collectively. I just hope that people listen.”
The paper received no funding. The authors disclosed no relevant financial relationships.
A version of this article first appeared on Medscape.com.
This situation is also taking a toll on neurologists’ mental health, who already have the second-highest burnout rate across medical specialties, the statement adds.
The statement was published online Oct. 5, 2021, in Neurology.
Dramatic price increases
Drafted by the Ethics, Law, and Humanities Committee – a joint committee that includes the AAN, the American Neurological Association, and the Child Neurology Society – the statement was prompted by a 2018 report from the AAN Neurology Drug Pricing Task Force to address challenges associated with high drug costs.
It highlights ethical concerns from high drug costs, policy proposals that might temper the problem, and how clinicians can adjust to the current reality of pharmaceutical pricing and better advocate for changes to the healthcare system.
“Runaway drug costs continue to be a pressing problem with recent dramatic price increases not only for specialty drugs, but also generic ones,” said lead author Amy Tsou, MD, MSc, codirector of the ECRI Evidence-Based Practice Center at the Center for Evidence and Guidelines in Plymouth Meeting, Pa.
She noted that one in four Americans has difficulty paying for medication, and many report going without a medication because of cost.
“Ensuring a fair system for drug pricing and coverage rules that balance the goods of individual patients with the needs of broader populations when resources are limited remains more important than ever,” Dr. Tsou said.
Out-of-pocket costs for neurologic medications have risen dramatically over the past decade, with the fastest rise reported among drugs for multiple sclerosis. Results from a study published in 2019 showed that, between 2004 and 2016, patients’ out-of-pocket expenses skyrocketed from $15 a month to $309 a month.
The steep increases have forced some neurology patients to ration their medication or stop taking it altogether, which is one of the ethical concerns cited in the AAN statement.
Patient self-rationing
Commenting on the statement, Ilana Katz Sand, MD, associate director of the Dickinson Center for Multiple Sclerosis at Mount Sinai Medical Center, New York, noted that clinicians are already acutely aware of the effect high drug costs have on their patients’ medical decisions. However, statements such as the current one bring much-needed outside attention to the problem.
“I’ve definitely had more and more people struggling with deductibles and copays, even among people who are insured,” said Dr. Katz Sand, who was not involved with the AAN paper.
She has a number of patients who have rationed their medication or stopped taking it altogether when their copays increased or they lost access to a copay assistance program because their insurance company chose to cover a still-expensive generic drug with no assistance program over a slightly costlier brand-name medication that comes with patient discounts.
Too often, patients don’t tell her they’re not taking their medication as prescribed. At a recent appointment, Dr. Katz Sand learned about a patient’s drug rationing only after a routine MRI showed new brain lesions that regular treatment might have prevented.
Another patient, new to her clinic, questioned the treatment plan Dr. Katz Sand recommended because they could not cover the copay. This sort of self-rationing happens in patients with and without insurance, she added.
“It’s a terrible thing and it’s happening to all patients,” Dr. Katz Sand said, adding that “the old credo of ‘yeah, the drug prices are high, but they are covered by insurance’ is not a sustainable argument anymore.”
What neurologists can do
Some sort of rationing is an unavoidable outcome of steep treatment costs, the authors noted. But what does that mean in clinical practice?
Neurologists should be aware of the costs involved in ordering diagnostic tests, treatment, or medication – and shouldn’t feel compelled to order treatments or tests that they feel are medically inappropriate just because a patient requests them, the authors wrote.
The statement also encourages clinicians to include financial realities in the shared decision-making process with patients.
However, Dr. Katz Sand said that is not always possible. Drug prices aren’t fixed, with different insurance plans offering different pricing, deductibles, and copays. “It’s hard for us to attempt to incorporate discussions about price in our discussions with patients when we can’t even predict what their out-of-pocket cost is going to be,” she said.
“Every single prescription we write requires prior authorization, and that’s directly related to the fact that the cost of these drugs is so high,” she added.
As do many other clinicians, Dr. Katz Sand spends hours each week on preauthorization forms and haggling with insurance companies on behalf of her patients. To get needed medication at a cost they can afford sometimes takes creative problem solving and almost always takes a lot of time. “It all adds to the administrative burden, patients’ stress, and our stress,” she said.
Physician-advocates needed
The AAN paper identifies a number of policy reforms to address drug pricing at a national level, including giving Medicare officials the power to negotiate drug prices, allowing the safe importation of drugs from other countries, and speeding the Food and Drug Administration approval process for generic drugs.
There is also a need to address systemic problems that, the authors noted, help create and perpetuate health care disparities. Lawmakers at the state and federal level are considering a number of these policy ideas and others that could address the kinds of issues Dr. Katz Sand described. However, the chances of their success are slim at best, said Bruce H. Cohen, MD, chair of the AAN advocacy committee and director of the NeuroDevelopmental Science Center at Akron (Ohio) Children’s Hospital.
“On a federal level, we’re watching in real time how the entrenched divisions, even within parties, are resulting in continued stalemate,” said Dr. Cohen, who is not one of the statement authors.
Those ideas need advocates and the AAN paper suggests neurologists should be among the ones championing these changes, he added.
“One of the most effective strategies is to bring attention to the impact high drug costs have on neurology patients and medical practices,” Dr. Cohen said. “It’s so important to make sure policy makers know the significant impact of high drug costs in neurology and within the context of finite resources.”
One way to do that is to share statements such as the current one with members of Congress working on policy reform, Dr. Cohen said. Another is through programs such as the academy’s annual Neurology on the Hill conference.
A third strategy is to encourage individuals such as Dr. Katz Sand to speak out when and where they can, he added.
While she agrees with the idea, finding time for advocacy work amid patient care, administrative work, and research is challenging. Dr. Katz Sand would like to see groups like the AAN work with health care institutions to implement policies that allocate time and resources to train clinicians in advocacy – and then support their efforts on that front.
“I’m really glad they wrote this and think they did a good job of crystallizing the issues,” Dr. Katz Sand said. “It’s good to put it out there as a document that could help serve as the basis for the requests we make collectively. I just hope that people listen.”
The paper received no funding. The authors disclosed no relevant financial relationships.
A version of this article first appeared on Medscape.com.
COVID-19 vaccination in MS: Lower response on certain medications
The results also show a reduced response to COVID vaccination in some patients on fingolimod.
The data come from a new series of vaccinated patients with MS from Madrid, which was presented at the annual meeting of the European Committee for Treatment and Research in Multiple Sclerosis (ECTRIMS).
Presenting the data, Celia Oreja-Guevara, MD, Hospital Clínico San Carlos, Madrid, concluded that “currently approved COVID-19 vaccines appear safe in MS patients and are effective in most patients. However, vaccine strategy in patients treated with anti-CD20 and S1P inhibitors [such as fingolimod] need further study.”
“We showed that patients on ocrelizumab or rituximab had a very low or no antibody response to COVID vaccination,” she added. “However, some previous studies have shown some T-cell response to vaccination in these patients, and we are looking at that now.”
Assessing postvaccination antibody response
For the current study, the researchers analyzed the antibody response to COVID-19 vaccination at week 3, week 6, and month 3 after the first dose in 165 patients with MS and 200 healthy controls.
Of the patients with MS, 120 received both doses of mRNA vaccine and 42 received the AstraZeneca vaccine. The mean age of the MS patients was 45 years and 46 years in the healthy controls.
Adverse events were similar in the two groups, and no increase in relapse activity was seen in the patients with MS.
Mean antibody titers were slightly lower in the patients with MS versus the healthy controls. At 3 weeks, mean titers were 7,910 AU/mL in the patients with MS and 9,397 in the healthy controls. At 6 weeks, mean levels were 16,347 AU/mL in the patients with MS and 18,120 in the healthy controls.
Patients with MS treated with interferon-beta, glatiramer acetate, teriflunomide, dimethyl fumarate, cladribine, and natalizumab who received mRNA vaccines developed a similar postvaccination humoral response as the healthy controls at each of 3, 6, and 12 weeks after the first dose.
Patients with MS receiving the AstraZeneca vaccine mounted a lower humoral response than those receiving the mRNA vaccine, but this same effect was also seen in the healthy controls.
However, patients on the anti-CD20 drugs ocrelizumab or rituximab showed a lower humoral response to COVID vaccination. Only 3 of 20 patients who had been treated with ocrelizumab developed antibodies, but these patients had longer washout periods (at least 6 months) between receiving ocrelizumab and the COVID vaccine. All six patients treated with rituximab had no antibody response to the COVID vaccination.
Dr. Oreja-Guevara suggested that ocrelizumab-treated patients may have a worse outcome after COVID-19 infection. “In the first wave of infection in Madrid, we recorded five patients on ocrelizumab with COVID-19, four of whom were hospitalized,” she noted.
“In patients on ocrelizumab we need to try and have a long interval between giving this drug and giving the COVID vaccine. The longer the washout period, the more antibodies are seen,” she said.
She noted that two patients in the study received the COVID vaccine 1 year after ocrelizumab administration and had a normal humoral response, similar to the healthy controls.
The new anti-CD20 drug, ofatumumab, did not seem to affect the COVID vaccine antibody response as much as ocrelizumab or rituximab. In the current study, four of five patients treated with ofatumumab had an antibody response.
Dr. Oreja-Guevara suggested that this was probably because the depletion of B cells is not so strong with ofatumumab. “This drug is dosed every 4 weeks and it doesn’t deplete all the B cells and they are replaced quite quickly.”
Fingolimod is another MS drug that seems to affect the antibody response to COVID-19 vaccination.
Dr. Oreja-Guevara described the response to COVID vaccination in patients on fingolimod as “very variable.” Of 16 patients treated with fingolimod, 4 failed to develop a humoral response, 7 had a low antibody response, and 5 had a similar response to that seen in the healthy controls (three of these patients had also had a previous COVID-19 infection). The response to vaccination in fingolimod-treated patients did not appear to be related to lymphopenia.
Cellular response also impaired with fingolimod
These data are consistent with those from another cohort from Israel reported previously.
In that study, which was published earlier in 2021, a team led by Anat Achiron, MD, Sheba Medical Center, Tel Aviv, analyzed humoral immunity in 125 patients with MS 1 month after the second dose of the Pfizer COVID vaccine. A group of healthy people similarly vaccinated served as control.
Results showed that protective humoral immunity occurred in 97.9% of the control group after vaccination, compared with 100% in untreated patients and 100% in patients treated with cladribine but in just 22.7% of those treated with ocrelizumab and only 3.8% of those taking fingolimod.
For ocrelizumab-treated patients, the failure to mount appropriate IgG immune response was regardless of the absolute lymphocyte counts that were in the normal range or to the time interval from the last ocrelizumab treatment dose that ranged from 3.1 to 8.9 months, “suggesting the need to postpone the next dosing to enable an effective postvaccination humoral response,” the authors said.
They noted that the majority of the fingolimod-treated patients in the study had a low lymphocyte count (<1,000 cells/mm3), which may be the cause for failing to mount an immune response. But even in the small group of fingolimod-treated MS patients with an absolute lymphocyte count above 1,000 cells/mm3, no humoral response was detected.
At the ECTRIMS meeting, Dr. Achiron presented further results from this study on memory B-cell and T-cell responses to the COVID vaccine in these patients.
The results showed that COVID-specific B- and T-cell responses were only present in about half of healthy subjects, untreated patients with MS, and those treated with cladribine.
While the B-cell response was almost completely impaired in the ocrelizumab-treated patients, the T-cell response was present to the same extent as in the control group. But fingolimod patients showed no B- or T-cell responses.
Dr. Achiron concluded that patients on ocrelizumab should wait at least 9 months following the last dose before receiving COVID vaccination, and that patients taking fingolimod should consider a switch to a different medication.
But she pointed out that, despite the lack of humoral cellular responses in the fingolimod group, in this study there does not seem to have been an increase in COVID infection in patients taking fingolimod in a large registry study.
“This leads us to the idea that maybe lymphopenia is not the only story, and maybe innate immunity is playing a role. We still don’t really know the answer for that.”
Dr. Achiron said she was also surprised to see that even untreated and healthy subjects did not develop complete B-cell and T-cell responses after double COVID vaccination. And similar results have been seen in patients who have recovered from natural COVID infection, where the B-cell response is “not 100%,” she added.
“This points to the suggestion that everyone might need a third vaccination, MS patients or not,” she concluded.
A version of this article first appeared on Medscape.com.
The results also show a reduced response to COVID vaccination in some patients on fingolimod.
The data come from a new series of vaccinated patients with MS from Madrid, which was presented at the annual meeting of the European Committee for Treatment and Research in Multiple Sclerosis (ECTRIMS).
Presenting the data, Celia Oreja-Guevara, MD, Hospital Clínico San Carlos, Madrid, concluded that “currently approved COVID-19 vaccines appear safe in MS patients and are effective in most patients. However, vaccine strategy in patients treated with anti-CD20 and S1P inhibitors [such as fingolimod] need further study.”
“We showed that patients on ocrelizumab or rituximab had a very low or no antibody response to COVID vaccination,” she added. “However, some previous studies have shown some T-cell response to vaccination in these patients, and we are looking at that now.”
Assessing postvaccination antibody response
For the current study, the researchers analyzed the antibody response to COVID-19 vaccination at week 3, week 6, and month 3 after the first dose in 165 patients with MS and 200 healthy controls.
Of the patients with MS, 120 received both doses of mRNA vaccine and 42 received the AstraZeneca vaccine. The mean age of the MS patients was 45 years and 46 years in the healthy controls.
Adverse events were similar in the two groups, and no increase in relapse activity was seen in the patients with MS.
Mean antibody titers were slightly lower in the patients with MS versus the healthy controls. At 3 weeks, mean titers were 7,910 AU/mL in the patients with MS and 9,397 in the healthy controls. At 6 weeks, mean levels were 16,347 AU/mL in the patients with MS and 18,120 in the healthy controls.
Patients with MS treated with interferon-beta, glatiramer acetate, teriflunomide, dimethyl fumarate, cladribine, and natalizumab who received mRNA vaccines developed a similar postvaccination humoral response as the healthy controls at each of 3, 6, and 12 weeks after the first dose.
Patients with MS receiving the AstraZeneca vaccine mounted a lower humoral response than those receiving the mRNA vaccine, but this same effect was also seen in the healthy controls.
However, patients on the anti-CD20 drugs ocrelizumab or rituximab showed a lower humoral response to COVID vaccination. Only 3 of 20 patients who had been treated with ocrelizumab developed antibodies, but these patients had longer washout periods (at least 6 months) between receiving ocrelizumab and the COVID vaccine. All six patients treated with rituximab had no antibody response to the COVID vaccination.
Dr. Oreja-Guevara suggested that ocrelizumab-treated patients may have a worse outcome after COVID-19 infection. “In the first wave of infection in Madrid, we recorded five patients on ocrelizumab with COVID-19, four of whom were hospitalized,” she noted.
“In patients on ocrelizumab we need to try and have a long interval between giving this drug and giving the COVID vaccine. The longer the washout period, the more antibodies are seen,” she said.
She noted that two patients in the study received the COVID vaccine 1 year after ocrelizumab administration and had a normal humoral response, similar to the healthy controls.
The new anti-CD20 drug, ofatumumab, did not seem to affect the COVID vaccine antibody response as much as ocrelizumab or rituximab. In the current study, four of five patients treated with ofatumumab had an antibody response.
Dr. Oreja-Guevara suggested that this was probably because the depletion of B cells is not so strong with ofatumumab. “This drug is dosed every 4 weeks and it doesn’t deplete all the B cells and they are replaced quite quickly.”
Fingolimod is another MS drug that seems to affect the antibody response to COVID-19 vaccination.
Dr. Oreja-Guevara described the response to COVID vaccination in patients on fingolimod as “very variable.” Of 16 patients treated with fingolimod, 4 failed to develop a humoral response, 7 had a low antibody response, and 5 had a similar response to that seen in the healthy controls (three of these patients had also had a previous COVID-19 infection). The response to vaccination in fingolimod-treated patients did not appear to be related to lymphopenia.
Cellular response also impaired with fingolimod
These data are consistent with those from another cohort from Israel reported previously.
In that study, which was published earlier in 2021, a team led by Anat Achiron, MD, Sheba Medical Center, Tel Aviv, analyzed humoral immunity in 125 patients with MS 1 month after the second dose of the Pfizer COVID vaccine. A group of healthy people similarly vaccinated served as control.
Results showed that protective humoral immunity occurred in 97.9% of the control group after vaccination, compared with 100% in untreated patients and 100% in patients treated with cladribine but in just 22.7% of those treated with ocrelizumab and only 3.8% of those taking fingolimod.
For ocrelizumab-treated patients, the failure to mount appropriate IgG immune response was regardless of the absolute lymphocyte counts that were in the normal range or to the time interval from the last ocrelizumab treatment dose that ranged from 3.1 to 8.9 months, “suggesting the need to postpone the next dosing to enable an effective postvaccination humoral response,” the authors said.
They noted that the majority of the fingolimod-treated patients in the study had a low lymphocyte count (<1,000 cells/mm3), which may be the cause for failing to mount an immune response. But even in the small group of fingolimod-treated MS patients with an absolute lymphocyte count above 1,000 cells/mm3, no humoral response was detected.
At the ECTRIMS meeting, Dr. Achiron presented further results from this study on memory B-cell and T-cell responses to the COVID vaccine in these patients.
The results showed that COVID-specific B- and T-cell responses were only present in about half of healthy subjects, untreated patients with MS, and those treated with cladribine.
While the B-cell response was almost completely impaired in the ocrelizumab-treated patients, the T-cell response was present to the same extent as in the control group. But fingolimod patients showed no B- or T-cell responses.
Dr. Achiron concluded that patients on ocrelizumab should wait at least 9 months following the last dose before receiving COVID vaccination, and that patients taking fingolimod should consider a switch to a different medication.
But she pointed out that, despite the lack of humoral cellular responses in the fingolimod group, in this study there does not seem to have been an increase in COVID infection in patients taking fingolimod in a large registry study.
“This leads us to the idea that maybe lymphopenia is not the only story, and maybe innate immunity is playing a role. We still don’t really know the answer for that.”
Dr. Achiron said she was also surprised to see that even untreated and healthy subjects did not develop complete B-cell and T-cell responses after double COVID vaccination. And similar results have been seen in patients who have recovered from natural COVID infection, where the B-cell response is “not 100%,” she added.
“This points to the suggestion that everyone might need a third vaccination, MS patients or not,” she concluded.
A version of this article first appeared on Medscape.com.
The results also show a reduced response to COVID vaccination in some patients on fingolimod.
The data come from a new series of vaccinated patients with MS from Madrid, which was presented at the annual meeting of the European Committee for Treatment and Research in Multiple Sclerosis (ECTRIMS).
Presenting the data, Celia Oreja-Guevara, MD, Hospital Clínico San Carlos, Madrid, concluded that “currently approved COVID-19 vaccines appear safe in MS patients and are effective in most patients. However, vaccine strategy in patients treated with anti-CD20 and S1P inhibitors [such as fingolimod] need further study.”
“We showed that patients on ocrelizumab or rituximab had a very low or no antibody response to COVID vaccination,” she added. “However, some previous studies have shown some T-cell response to vaccination in these patients, and we are looking at that now.”
Assessing postvaccination antibody response
For the current study, the researchers analyzed the antibody response to COVID-19 vaccination at week 3, week 6, and month 3 after the first dose in 165 patients with MS and 200 healthy controls.
Of the patients with MS, 120 received both doses of mRNA vaccine and 42 received the AstraZeneca vaccine. The mean age of the MS patients was 45 years and 46 years in the healthy controls.
Adverse events were similar in the two groups, and no increase in relapse activity was seen in the patients with MS.
Mean antibody titers were slightly lower in the patients with MS versus the healthy controls. At 3 weeks, mean titers were 7,910 AU/mL in the patients with MS and 9,397 in the healthy controls. At 6 weeks, mean levels were 16,347 AU/mL in the patients with MS and 18,120 in the healthy controls.
Patients with MS treated with interferon-beta, glatiramer acetate, teriflunomide, dimethyl fumarate, cladribine, and natalizumab who received mRNA vaccines developed a similar postvaccination humoral response as the healthy controls at each of 3, 6, and 12 weeks after the first dose.
Patients with MS receiving the AstraZeneca vaccine mounted a lower humoral response than those receiving the mRNA vaccine, but this same effect was also seen in the healthy controls.
However, patients on the anti-CD20 drugs ocrelizumab or rituximab showed a lower humoral response to COVID vaccination. Only 3 of 20 patients who had been treated with ocrelizumab developed antibodies, but these patients had longer washout periods (at least 6 months) between receiving ocrelizumab and the COVID vaccine. All six patients treated with rituximab had no antibody response to the COVID vaccination.
Dr. Oreja-Guevara suggested that ocrelizumab-treated patients may have a worse outcome after COVID-19 infection. “In the first wave of infection in Madrid, we recorded five patients on ocrelizumab with COVID-19, four of whom were hospitalized,” she noted.
“In patients on ocrelizumab we need to try and have a long interval between giving this drug and giving the COVID vaccine. The longer the washout period, the more antibodies are seen,” she said.
She noted that two patients in the study received the COVID vaccine 1 year after ocrelizumab administration and had a normal humoral response, similar to the healthy controls.
The new anti-CD20 drug, ofatumumab, did not seem to affect the COVID vaccine antibody response as much as ocrelizumab or rituximab. In the current study, four of five patients treated with ofatumumab had an antibody response.
Dr. Oreja-Guevara suggested that this was probably because the depletion of B cells is not so strong with ofatumumab. “This drug is dosed every 4 weeks and it doesn’t deplete all the B cells and they are replaced quite quickly.”
Fingolimod is another MS drug that seems to affect the antibody response to COVID-19 vaccination.
Dr. Oreja-Guevara described the response to COVID vaccination in patients on fingolimod as “very variable.” Of 16 patients treated with fingolimod, 4 failed to develop a humoral response, 7 had a low antibody response, and 5 had a similar response to that seen in the healthy controls (three of these patients had also had a previous COVID-19 infection). The response to vaccination in fingolimod-treated patients did not appear to be related to lymphopenia.
Cellular response also impaired with fingolimod
These data are consistent with those from another cohort from Israel reported previously.
In that study, which was published earlier in 2021, a team led by Anat Achiron, MD, Sheba Medical Center, Tel Aviv, analyzed humoral immunity in 125 patients with MS 1 month after the second dose of the Pfizer COVID vaccine. A group of healthy people similarly vaccinated served as control.
Results showed that protective humoral immunity occurred in 97.9% of the control group after vaccination, compared with 100% in untreated patients and 100% in patients treated with cladribine but in just 22.7% of those treated with ocrelizumab and only 3.8% of those taking fingolimod.
For ocrelizumab-treated patients, the failure to mount appropriate IgG immune response was regardless of the absolute lymphocyte counts that were in the normal range or to the time interval from the last ocrelizumab treatment dose that ranged from 3.1 to 8.9 months, “suggesting the need to postpone the next dosing to enable an effective postvaccination humoral response,” the authors said.
They noted that the majority of the fingolimod-treated patients in the study had a low lymphocyte count (<1,000 cells/mm3), which may be the cause for failing to mount an immune response. But even in the small group of fingolimod-treated MS patients with an absolute lymphocyte count above 1,000 cells/mm3, no humoral response was detected.
At the ECTRIMS meeting, Dr. Achiron presented further results from this study on memory B-cell and T-cell responses to the COVID vaccine in these patients.
The results showed that COVID-specific B- and T-cell responses were only present in about half of healthy subjects, untreated patients with MS, and those treated with cladribine.
While the B-cell response was almost completely impaired in the ocrelizumab-treated patients, the T-cell response was present to the same extent as in the control group. But fingolimod patients showed no B- or T-cell responses.
Dr. Achiron concluded that patients on ocrelizumab should wait at least 9 months following the last dose before receiving COVID vaccination, and that patients taking fingolimod should consider a switch to a different medication.
But she pointed out that, despite the lack of humoral cellular responses in the fingolimod group, in this study there does not seem to have been an increase in COVID infection in patients taking fingolimod in a large registry study.
“This leads us to the idea that maybe lymphopenia is not the only story, and maybe innate immunity is playing a role. We still don’t really know the answer for that.”
Dr. Achiron said she was also surprised to see that even untreated and healthy subjects did not develop complete B-cell and T-cell responses after double COVID vaccination. And similar results have been seen in patients who have recovered from natural COVID infection, where the B-cell response is “not 100%,” she added.
“This points to the suggestion that everyone might need a third vaccination, MS patients or not,” she concluded.
A version of this article first appeared on Medscape.com.
FROM ECTRIMS 2021
New safety data regarding COVID vaccines
from the French National Agency for the Safety of Medicines and Health Products (ANSM).
The rare condition — more common in men than in women — is characterized by the sudden onset of severe pain in the shoulder, followed by arm paralysis. Its etiopathogenesis is not well understood, but vaccines, in particular the flu vaccine, have been implicated in some cases, the report states.
Six serious cases of the syndrome related to the Comirnaty (Pfizer) vaccine were reported by healthcare professionals and vaccinated individuals or their family and friends since the start of the monitoring program. Four of these cases occurred from September 3 to 16.
All six cases involved patients 19 to 69 years of age — two women and four men — who developed symptoms in the 50 days after vaccination. Half were reported after the first dose and half after the second dose. Four of the patients are currently recovering; the outcomes of the other two are unknown.
In the case of the Spikevax vaccine (Moderna), two cases of Parsonage-Turner syndrome were reported after vaccination (plus one that occurred after 50 days, which is currently being managed). The onset of symptoms in these two men — one in his early 30s and one in his early 60s — occurred less than 18 days after vaccination. One occurred after the first dose and one after the second dose. This timing indicates a possible link between the syndrome and the vaccine. Both men are currently in recovery.
This signal of mRNA vaccines is now “officially recognized,” according to the Pfizer and Moderna reports.
It is also considered a “potential signal” in the Vaxzevria (AstraZeneca) pharmacovigilance report, released October 8, which describes eight cases of Parsonage-Turner syndrome after vaccination.
Safety profile of mRNA COVID vaccines in youth
Between June 15, when children 12 years and older became eligible for vaccination, and August 26, there were 591 reports of potential adverse events — out of 6 million Pfizer doses administered — in 12- to 18-year-old children.
Of the 591 cases, 35.2% were deemed serious. The majority of these were cases of reactogenicity, malaise, or postvaccine discomfort (25%), followed by instances of myocarditis and pericarditis (15.9% and 7.2%, respectively). In eight of 10 cases, one of the first symptom reported was chest pain.
Myocarditis occurred in 39.4% of people after the first injection (mean time to onset, 13 days) and 54.5% after the second (mean time to onset, 4 days). Recorded progress was favorable in nearly nine of 10 cases.
Pericarditis occurred in 53.3% of people after the first injection (mean time to onset, 13 days), and 40.0% after the second (mean time to onset, 4 days).
Three cases of multisystem inflammatory syndrome in children (MISC) were reported after monitoring ended.
For this age group, “all reported events will continue to be monitored, especially serious events and multisystem inflammatory syndrome in children,” report authors conclude.
Data for adverse events after the Moderna vaccine remain limited, but the report stipulates that “the adverse events reported in 12- to 18-year-olds who received an injection do not display any particular pattern, compared with those reported in older subjects, with the exception of a roughly 100-fold lower incidence of reported adverse effects in the 12- to 17-year age group.”
No safety warnings for pregnant women
The pharmacovigilance report — which covered the period from December 27, 2020 to September 9, 2021 — “raises no safety warnings for pregnant or nursing women with any of the COVID-19 vaccines.” In addition, two recent studies — one published in JAMA and one in the New England Journal of Medicine — have shown no link between spontaneous miscarriage and mRNA vaccines.
“Moreover, it should be stressed that current data from the international literature consistently show that maternal SARS COV-2 infection increases the risk for fetal, maternal, and neonatal complications, and that this risk may increase with the arrival of the Alpha and Delta variants,” they write. “It is therefore important to reiterate the current recommendations to vaccinate all pregnant women, regardless of the stage of pregnancy.”
Some adverse effects, such as thromboembolic effects, in utero death, HELLP (hemolysis, elevated liver enzymes, and low platelets) syndrome, and uterine contractions, will continue to be monitored.
Questions regarding menstrual disorders
As for gynecological disorders reported after vaccination, questions still remain. “In most of the reported cases, it is difficult to accurately determine whether the vaccine played a role in the occurrence of menstrual/genital bleeding,” the authors of the pharmacovigilance monitoring report state.
“Nonetheless, these cases warrant attention,” they add, and further discussions with the French National Association of Obstetricians and Gynecologists and the French Society of Endocrinology are needed in regard to these potential safety signals.
A version of this article first appeared on Medscape.com.
from the French National Agency for the Safety of Medicines and Health Products (ANSM).
The rare condition — more common in men than in women — is characterized by the sudden onset of severe pain in the shoulder, followed by arm paralysis. Its etiopathogenesis is not well understood, but vaccines, in particular the flu vaccine, have been implicated in some cases, the report states.
Six serious cases of the syndrome related to the Comirnaty (Pfizer) vaccine were reported by healthcare professionals and vaccinated individuals or their family and friends since the start of the monitoring program. Four of these cases occurred from September 3 to 16.
All six cases involved patients 19 to 69 years of age — two women and four men — who developed symptoms in the 50 days after vaccination. Half were reported after the first dose and half after the second dose. Four of the patients are currently recovering; the outcomes of the other two are unknown.
In the case of the Spikevax vaccine (Moderna), two cases of Parsonage-Turner syndrome were reported after vaccination (plus one that occurred after 50 days, which is currently being managed). The onset of symptoms in these two men — one in his early 30s and one in his early 60s — occurred less than 18 days after vaccination. One occurred after the first dose and one after the second dose. This timing indicates a possible link between the syndrome and the vaccine. Both men are currently in recovery.
This signal of mRNA vaccines is now “officially recognized,” according to the Pfizer and Moderna reports.
It is also considered a “potential signal” in the Vaxzevria (AstraZeneca) pharmacovigilance report, released October 8, which describes eight cases of Parsonage-Turner syndrome after vaccination.
Safety profile of mRNA COVID vaccines in youth
Between June 15, when children 12 years and older became eligible for vaccination, and August 26, there were 591 reports of potential adverse events — out of 6 million Pfizer doses administered — in 12- to 18-year-old children.
Of the 591 cases, 35.2% were deemed serious. The majority of these were cases of reactogenicity, malaise, or postvaccine discomfort (25%), followed by instances of myocarditis and pericarditis (15.9% and 7.2%, respectively). In eight of 10 cases, one of the first symptom reported was chest pain.
Myocarditis occurred in 39.4% of people after the first injection (mean time to onset, 13 days) and 54.5% after the second (mean time to onset, 4 days). Recorded progress was favorable in nearly nine of 10 cases.
Pericarditis occurred in 53.3% of people after the first injection (mean time to onset, 13 days), and 40.0% after the second (mean time to onset, 4 days).
Three cases of multisystem inflammatory syndrome in children (MISC) were reported after monitoring ended.
For this age group, “all reported events will continue to be monitored, especially serious events and multisystem inflammatory syndrome in children,” report authors conclude.
Data for adverse events after the Moderna vaccine remain limited, but the report stipulates that “the adverse events reported in 12- to 18-year-olds who received an injection do not display any particular pattern, compared with those reported in older subjects, with the exception of a roughly 100-fold lower incidence of reported adverse effects in the 12- to 17-year age group.”
No safety warnings for pregnant women
The pharmacovigilance report — which covered the period from December 27, 2020 to September 9, 2021 — “raises no safety warnings for pregnant or nursing women with any of the COVID-19 vaccines.” In addition, two recent studies — one published in JAMA and one in the New England Journal of Medicine — have shown no link between spontaneous miscarriage and mRNA vaccines.
“Moreover, it should be stressed that current data from the international literature consistently show that maternal SARS COV-2 infection increases the risk for fetal, maternal, and neonatal complications, and that this risk may increase with the arrival of the Alpha and Delta variants,” they write. “It is therefore important to reiterate the current recommendations to vaccinate all pregnant women, regardless of the stage of pregnancy.”
Some adverse effects, such as thromboembolic effects, in utero death, HELLP (hemolysis, elevated liver enzymes, and low platelets) syndrome, and uterine contractions, will continue to be monitored.
Questions regarding menstrual disorders
As for gynecological disorders reported after vaccination, questions still remain. “In most of the reported cases, it is difficult to accurately determine whether the vaccine played a role in the occurrence of menstrual/genital bleeding,” the authors of the pharmacovigilance monitoring report state.
“Nonetheless, these cases warrant attention,” they add, and further discussions with the French National Association of Obstetricians and Gynecologists and the French Society of Endocrinology are needed in regard to these potential safety signals.
A version of this article first appeared on Medscape.com.
from the French National Agency for the Safety of Medicines and Health Products (ANSM).
The rare condition — more common in men than in women — is characterized by the sudden onset of severe pain in the shoulder, followed by arm paralysis. Its etiopathogenesis is not well understood, but vaccines, in particular the flu vaccine, have been implicated in some cases, the report states.
Six serious cases of the syndrome related to the Comirnaty (Pfizer) vaccine were reported by healthcare professionals and vaccinated individuals or their family and friends since the start of the monitoring program. Four of these cases occurred from September 3 to 16.
All six cases involved patients 19 to 69 years of age — two women and four men — who developed symptoms in the 50 days after vaccination. Half were reported after the first dose and half after the second dose. Four of the patients are currently recovering; the outcomes of the other two are unknown.
In the case of the Spikevax vaccine (Moderna), two cases of Parsonage-Turner syndrome were reported after vaccination (plus one that occurred after 50 days, which is currently being managed). The onset of symptoms in these two men — one in his early 30s and one in his early 60s — occurred less than 18 days after vaccination. One occurred after the first dose and one after the second dose. This timing indicates a possible link between the syndrome and the vaccine. Both men are currently in recovery.
This signal of mRNA vaccines is now “officially recognized,” according to the Pfizer and Moderna reports.
It is also considered a “potential signal” in the Vaxzevria (AstraZeneca) pharmacovigilance report, released October 8, which describes eight cases of Parsonage-Turner syndrome after vaccination.
Safety profile of mRNA COVID vaccines in youth
Between June 15, when children 12 years and older became eligible for vaccination, and August 26, there were 591 reports of potential adverse events — out of 6 million Pfizer doses administered — in 12- to 18-year-old children.
Of the 591 cases, 35.2% were deemed serious. The majority of these were cases of reactogenicity, malaise, or postvaccine discomfort (25%), followed by instances of myocarditis and pericarditis (15.9% and 7.2%, respectively). In eight of 10 cases, one of the first symptom reported was chest pain.
Myocarditis occurred in 39.4% of people after the first injection (mean time to onset, 13 days) and 54.5% after the second (mean time to onset, 4 days). Recorded progress was favorable in nearly nine of 10 cases.
Pericarditis occurred in 53.3% of people after the first injection (mean time to onset, 13 days), and 40.0% after the second (mean time to onset, 4 days).
Three cases of multisystem inflammatory syndrome in children (MISC) were reported after monitoring ended.
For this age group, “all reported events will continue to be monitored, especially serious events and multisystem inflammatory syndrome in children,” report authors conclude.
Data for adverse events after the Moderna vaccine remain limited, but the report stipulates that “the adverse events reported in 12- to 18-year-olds who received an injection do not display any particular pattern, compared with those reported in older subjects, with the exception of a roughly 100-fold lower incidence of reported adverse effects in the 12- to 17-year age group.”
No safety warnings for pregnant women
The pharmacovigilance report — which covered the period from December 27, 2020 to September 9, 2021 — “raises no safety warnings for pregnant or nursing women with any of the COVID-19 vaccines.” In addition, two recent studies — one published in JAMA and one in the New England Journal of Medicine — have shown no link between spontaneous miscarriage and mRNA vaccines.
“Moreover, it should be stressed that current data from the international literature consistently show that maternal SARS COV-2 infection increases the risk for fetal, maternal, and neonatal complications, and that this risk may increase with the arrival of the Alpha and Delta variants,” they write. “It is therefore important to reiterate the current recommendations to vaccinate all pregnant women, regardless of the stage of pregnancy.”
Some adverse effects, such as thromboembolic effects, in utero death, HELLP (hemolysis, elevated liver enzymes, and low platelets) syndrome, and uterine contractions, will continue to be monitored.
Questions regarding menstrual disorders
As for gynecological disorders reported after vaccination, questions still remain. “In most of the reported cases, it is difficult to accurately determine whether the vaccine played a role in the occurrence of menstrual/genital bleeding,” the authors of the pharmacovigilance monitoring report state.
“Nonetheless, these cases warrant attention,” they add, and further discussions with the French National Association of Obstetricians and Gynecologists and the French Society of Endocrinology are needed in regard to these potential safety signals.
A version of this article first appeared on Medscape.com.
‘Fascinating’ link between Alzheimer’s and COVID-19
The findings could lead to new treatment targets to slow progression and severity of both diseases.
Investigators found that a single genetic variant in the oligoadenylate synthetase 1 (OAS1) gene increases the risk for AD and that related variants in the same gene increase the likelihood of severe COVID-19 outcomes.
“These findings may allow us to identify new drug targets to slow progression of both diseases and reduce their severity,” Dervis Salih, PhD, senior research associate, UK Dementia Research Institute, University College London, said in an interview.
“Our work also suggests new approaches to treat both diseases with the same drugs,” Dr. Salih added.
The study was published online Oct. 7 in Brain.
Shared genetic network
The OAS1 gene is expressed in microglia, a type of immune cell that makes up around 10% of all cells in the brain.
In earlier work, investigators found evidence suggesting a link between the OAS1 gene and AD, but the function of the gene in microglia was unknown.
To further investigate the gene’s link to AD, they sequenced genetic data from 2,547 people – half with AD, and half without.
The genotyping analysis confirmed that the single-nucleotide polymorphism (SNP) rs1131454 within OAS1 is significantly associated with AD.
Given that the same OAS1 locus has recently been linked with severe COVID-19 outcomes, the researchers investigated four variants on the OAS1 gene.
Results indicate that SNPs within OAS1 associated with AD also show linkage to SNP variants associated with critical illness in COVID-19.
The rs1131454 (risk allele A) and rs4766676 (risk allele T) are associated with AD, and rs10735079 (risk allele A) and rs6489867 (risk allele T) are associated with critical illness with COVID-19, the investigators reported. All of these risk alleles dampen expression of OAS1.
“This study also provides strong new evidence that interferon signaling by the innate immune system plays a substantial role in the progression of Alzheimer’s,” said Dr. Salih.
“Identifying this shared genetic network in innate immune cells will allow us with future work to identify new biomarkers to track disease progression and also predict disease risk better for both disorders,” he added.
‘Fascinating’ link
In a statement from the UK nonprofit organization, Science Media Center, Kenneth Baillie, MBChB, with the University of Edinburgh, said this study builds on a discovery he and his colleagues made last year that OAS1 variants are associated with severe COVID-19.
“In the ISARIC4C study, we recently found that this is probably due to a change in the way cell membranes detect viruses, but this mechanism doesn’t explain the fascinating association with Alzheimer’s disease reported in this new work,” Dr. Baillie said.
“It is often the case that the same gene can have different roles in different parts of the body. Importantly, it doesn’t mean that having COVID-19 has any effect on your risk of Alzheimer’s,” he added.
Also weighing in on the new study, Jonathan Schott, MD, professor of neurology, University College London, noted that dementia is the “main preexisting health condition associated with COVID-19 mortality, accounting for about one in four deaths from COVID-19 between March and June 2020.
“While some of this excessive mortality may relate to people with dementia being overrepresented in care homes, which were particularly hard hit by the pandemic, or due to general increased vulnerability to infections, there have been questions as to whether there are common factors that might increase susceptibility both to developing dementia and to dying from COVID-19,” Dr. Schott explained.
This “elegant paper” provides evidence for the latter, “suggesting a common genetic mechanism both for Alzheimer’s disease and for severe COVID-19 infection,” Dr. Schott said.
“The identification of a genetic risk factor and elucidation of inflammatory pathways through which it may increase risk has important implications for our understanding of both diseases, with potential implications for novel treatments,” he added.
The study was funded by the UK Dementia Research Institute. The authors have disclosed no relevant financial relationships. Dr. Schott serves as chief medical officer for Alzheimer’s Research UK and is clinical adviser to the UK Dementia Research Institute. Dr. Baillie has disclosed no relevant financial relationships.
A version of this article first appeared on Medscape.com.
The findings could lead to new treatment targets to slow progression and severity of both diseases.
Investigators found that a single genetic variant in the oligoadenylate synthetase 1 (OAS1) gene increases the risk for AD and that related variants in the same gene increase the likelihood of severe COVID-19 outcomes.
“These findings may allow us to identify new drug targets to slow progression of both diseases and reduce their severity,” Dervis Salih, PhD, senior research associate, UK Dementia Research Institute, University College London, said in an interview.
“Our work also suggests new approaches to treat both diseases with the same drugs,” Dr. Salih added.
The study was published online Oct. 7 in Brain.
Shared genetic network
The OAS1 gene is expressed in microglia, a type of immune cell that makes up around 10% of all cells in the brain.
In earlier work, investigators found evidence suggesting a link between the OAS1 gene and AD, but the function of the gene in microglia was unknown.
To further investigate the gene’s link to AD, they sequenced genetic data from 2,547 people – half with AD, and half without.
The genotyping analysis confirmed that the single-nucleotide polymorphism (SNP) rs1131454 within OAS1 is significantly associated with AD.
Given that the same OAS1 locus has recently been linked with severe COVID-19 outcomes, the researchers investigated four variants on the OAS1 gene.
Results indicate that SNPs within OAS1 associated with AD also show linkage to SNP variants associated with critical illness in COVID-19.
The rs1131454 (risk allele A) and rs4766676 (risk allele T) are associated with AD, and rs10735079 (risk allele A) and rs6489867 (risk allele T) are associated with critical illness with COVID-19, the investigators reported. All of these risk alleles dampen expression of OAS1.
“This study also provides strong new evidence that interferon signaling by the innate immune system plays a substantial role in the progression of Alzheimer’s,” said Dr. Salih.
“Identifying this shared genetic network in innate immune cells will allow us with future work to identify new biomarkers to track disease progression and also predict disease risk better for both disorders,” he added.
‘Fascinating’ link
In a statement from the UK nonprofit organization, Science Media Center, Kenneth Baillie, MBChB, with the University of Edinburgh, said this study builds on a discovery he and his colleagues made last year that OAS1 variants are associated with severe COVID-19.
“In the ISARIC4C study, we recently found that this is probably due to a change in the way cell membranes detect viruses, but this mechanism doesn’t explain the fascinating association with Alzheimer’s disease reported in this new work,” Dr. Baillie said.
“It is often the case that the same gene can have different roles in different parts of the body. Importantly, it doesn’t mean that having COVID-19 has any effect on your risk of Alzheimer’s,” he added.
Also weighing in on the new study, Jonathan Schott, MD, professor of neurology, University College London, noted that dementia is the “main preexisting health condition associated with COVID-19 mortality, accounting for about one in four deaths from COVID-19 between March and June 2020.
“While some of this excessive mortality may relate to people with dementia being overrepresented in care homes, which were particularly hard hit by the pandemic, or due to general increased vulnerability to infections, there have been questions as to whether there are common factors that might increase susceptibility both to developing dementia and to dying from COVID-19,” Dr. Schott explained.
This “elegant paper” provides evidence for the latter, “suggesting a common genetic mechanism both for Alzheimer’s disease and for severe COVID-19 infection,” Dr. Schott said.
“The identification of a genetic risk factor and elucidation of inflammatory pathways through which it may increase risk has important implications for our understanding of both diseases, with potential implications for novel treatments,” he added.
The study was funded by the UK Dementia Research Institute. The authors have disclosed no relevant financial relationships. Dr. Schott serves as chief medical officer for Alzheimer’s Research UK and is clinical adviser to the UK Dementia Research Institute. Dr. Baillie has disclosed no relevant financial relationships.
A version of this article first appeared on Medscape.com.
The findings could lead to new treatment targets to slow progression and severity of both diseases.
Investigators found that a single genetic variant in the oligoadenylate synthetase 1 (OAS1) gene increases the risk for AD and that related variants in the same gene increase the likelihood of severe COVID-19 outcomes.
“These findings may allow us to identify new drug targets to slow progression of both diseases and reduce their severity,” Dervis Salih, PhD, senior research associate, UK Dementia Research Institute, University College London, said in an interview.
“Our work also suggests new approaches to treat both diseases with the same drugs,” Dr. Salih added.
The study was published online Oct. 7 in Brain.
Shared genetic network
The OAS1 gene is expressed in microglia, a type of immune cell that makes up around 10% of all cells in the brain.
In earlier work, investigators found evidence suggesting a link between the OAS1 gene and AD, but the function of the gene in microglia was unknown.
To further investigate the gene’s link to AD, they sequenced genetic data from 2,547 people – half with AD, and half without.
The genotyping analysis confirmed that the single-nucleotide polymorphism (SNP) rs1131454 within OAS1 is significantly associated with AD.
Given that the same OAS1 locus has recently been linked with severe COVID-19 outcomes, the researchers investigated four variants on the OAS1 gene.
Results indicate that SNPs within OAS1 associated with AD also show linkage to SNP variants associated with critical illness in COVID-19.
The rs1131454 (risk allele A) and rs4766676 (risk allele T) are associated with AD, and rs10735079 (risk allele A) and rs6489867 (risk allele T) are associated with critical illness with COVID-19, the investigators reported. All of these risk alleles dampen expression of OAS1.
“This study also provides strong new evidence that interferon signaling by the innate immune system plays a substantial role in the progression of Alzheimer’s,” said Dr. Salih.
“Identifying this shared genetic network in innate immune cells will allow us with future work to identify new biomarkers to track disease progression and also predict disease risk better for both disorders,” he added.
‘Fascinating’ link
In a statement from the UK nonprofit organization, Science Media Center, Kenneth Baillie, MBChB, with the University of Edinburgh, said this study builds on a discovery he and his colleagues made last year that OAS1 variants are associated with severe COVID-19.
“In the ISARIC4C study, we recently found that this is probably due to a change in the way cell membranes detect viruses, but this mechanism doesn’t explain the fascinating association with Alzheimer’s disease reported in this new work,” Dr. Baillie said.
“It is often the case that the same gene can have different roles in different parts of the body. Importantly, it doesn’t mean that having COVID-19 has any effect on your risk of Alzheimer’s,” he added.
Also weighing in on the new study, Jonathan Schott, MD, professor of neurology, University College London, noted that dementia is the “main preexisting health condition associated with COVID-19 mortality, accounting for about one in four deaths from COVID-19 between March and June 2020.
“While some of this excessive mortality may relate to people with dementia being overrepresented in care homes, which were particularly hard hit by the pandemic, or due to general increased vulnerability to infections, there have been questions as to whether there are common factors that might increase susceptibility both to developing dementia and to dying from COVID-19,” Dr. Schott explained.
This “elegant paper” provides evidence for the latter, “suggesting a common genetic mechanism both for Alzheimer’s disease and for severe COVID-19 infection,” Dr. Schott said.
“The identification of a genetic risk factor and elucidation of inflammatory pathways through which it may increase risk has important implications for our understanding of both diseases, with potential implications for novel treatments,” he added.
The study was funded by the UK Dementia Research Institute. The authors have disclosed no relevant financial relationships. Dr. Schott serves as chief medical officer for Alzheimer’s Research UK and is clinical adviser to the UK Dementia Research Institute. Dr. Baillie has disclosed no relevant financial relationships.
A version of this article first appeared on Medscape.com.
Stay tuned for CSI: Olive oil
Cracking down on food fraud
How do you know the olive oil in your pantry is from Greece? Or that the avocados on your toast are from Mexico? The label, right? Well, maybe not. False claims of origin are a huge problem in the food industry, costing over $30 billion in economic damage annually.
Fear not, citizens, because botanists are on the job, and they’ve found a cheaper and more efficient way to expose that non-Greek olive oil.
How? Florian Cueni, PhD, of the University of Basel, Switzerland, and associates developed a new model to simulate oxygen isotope ratios in plants from a specific region, based on the temperature, precipitation, growing season information, and humidity data. Previously, botanists had to collect reference data from the claimed origin country and from other regions to validate where the product actually came from.
“With minor adjustments to the parameters, our model can be used to determine all plant products,” said senior investigator Ansgar Kahmen. This can open up the door for even more plant forensics, including drug confiscations and illegal timber logging, with information that will hold up in court.
Why pay Greek-olive prices for olives from California?
Fear leads to anger, anger leads to unhelpful online reviews
And reading angry online reviews leads to hate and suffering. We may have co-opted Master Yoda’s wise words ever so slightly, but anyone who’s done any shopping online (so everyone) knows that the review section of any product can be downright villainous. Do these reviews affect what we buy?
The angry online product review was the subject of a recent study published in MIS Quarterly. In a series of experiments, participants were shown a series of realistic online reviews with varying amounts of anger but with similar amounts of information. After reading the reviews, participants rated helpfulness, their personal opinion of the product/retailer, and whether or not they would buy the product.
Participants overwhelmingly rated calmly written reviews as more helpful than angrily written ones. One would expect, then, that those unhelpful angry reviews would have little effect on the participant’s view or willingness to buy a product, but the study investigators found the opposite. Reading angry reviews made the participants more likely to reject the product, even though they didn’t think the angry review was useful. And when you think about it, it does make sense. Anger means drama, and we can’t resist a juicy bit of drama.
So while we should all aspire to be Yoda and rise above anger and hatred, in reality we seem to be channeling Emperor Palpatine. We let the hate flow through us, and in our anger, we ignore perfectly good products. On the plus side, now we can shoot lightning out of our hands, so that’s pretty cool.
Health care is heading to the hall of fame
We couldn’t be happier here at LOTME because it’s that time of year again.
No, we’re not talking about Healthcare Security and Safety Week or National Metric Week, although those are both kind of important. Hmm, maybe we should talk about health care security or the metric system. After all, in this country, medicine is one of the metric system’s biggest customers. And who doesn’t love picograms? They’re the unit-of-measurement equivalent of a koala.
So we’re doing the metric system, then? Nah.
We’re excited because the 2022 inductees to the National Inventors Hall of Fame were just announced, and, as usual, the world of health care is well represented.
First up is the surprisingly relevant (thanks to the party guest that won’t leave, SARS-CoV-2) pair of Katalin Karikó, PhD, and Drew Weissman, MD, who worked together in the early 2000s to modify mRNA “so it could avoid immediate immune detection, remain active longer and efficiently instruct cells to create antigens to protect against severe disease.” Their discoveries eventually led to the use of modified mRNA in the COVID-19 vaccines.
The second, albeit posthumous, physician-inductee is Patricia Bath, MD, who was the first Black female physician to receive a U.S. patent for a medical invention. The laserphaco device and technique to remove cataracts “performed all steps of cataract removal: making the incision, destroying the lens, and vacuuming out the fractured pieces.”
Two other inductees have somewhat tenuous connections to medical care. Lonnie Johnson invented the Super Soaker, a powerful squirt gun that has been criticized by psychologists for encouraging violence, and Carl Benz invented the automobile, which sort of means he invented the ambulance, so there you go.
The induction ceremony takes place on May 5, 2022, in Washington, DC. If you’re attending the black-tie dinner at The Anthem, let us know and we’ll split an Uber. It’s our only night to be fancy.
Cracking down on food fraud
How do you know the olive oil in your pantry is from Greece? Or that the avocados on your toast are from Mexico? The label, right? Well, maybe not. False claims of origin are a huge problem in the food industry, costing over $30 billion in economic damage annually.
Fear not, citizens, because botanists are on the job, and they’ve found a cheaper and more efficient way to expose that non-Greek olive oil.
How? Florian Cueni, PhD, of the University of Basel, Switzerland, and associates developed a new model to simulate oxygen isotope ratios in plants from a specific region, based on the temperature, precipitation, growing season information, and humidity data. Previously, botanists had to collect reference data from the claimed origin country and from other regions to validate where the product actually came from.
“With minor adjustments to the parameters, our model can be used to determine all plant products,” said senior investigator Ansgar Kahmen. This can open up the door for even more plant forensics, including drug confiscations and illegal timber logging, with information that will hold up in court.
Why pay Greek-olive prices for olives from California?
Fear leads to anger, anger leads to unhelpful online reviews
And reading angry online reviews leads to hate and suffering. We may have co-opted Master Yoda’s wise words ever so slightly, but anyone who’s done any shopping online (so everyone) knows that the review section of any product can be downright villainous. Do these reviews affect what we buy?
The angry online product review was the subject of a recent study published in MIS Quarterly. In a series of experiments, participants were shown a series of realistic online reviews with varying amounts of anger but with similar amounts of information. After reading the reviews, participants rated helpfulness, their personal opinion of the product/retailer, and whether or not they would buy the product.
Participants overwhelmingly rated calmly written reviews as more helpful than angrily written ones. One would expect, then, that those unhelpful angry reviews would have little effect on the participant’s view or willingness to buy a product, but the study investigators found the opposite. Reading angry reviews made the participants more likely to reject the product, even though they didn’t think the angry review was useful. And when you think about it, it does make sense. Anger means drama, and we can’t resist a juicy bit of drama.
So while we should all aspire to be Yoda and rise above anger and hatred, in reality we seem to be channeling Emperor Palpatine. We let the hate flow through us, and in our anger, we ignore perfectly good products. On the plus side, now we can shoot lightning out of our hands, so that’s pretty cool.
Health care is heading to the hall of fame
We couldn’t be happier here at LOTME because it’s that time of year again.
No, we’re not talking about Healthcare Security and Safety Week or National Metric Week, although those are both kind of important. Hmm, maybe we should talk about health care security or the metric system. After all, in this country, medicine is one of the metric system’s biggest customers. And who doesn’t love picograms? They’re the unit-of-measurement equivalent of a koala.
So we’re doing the metric system, then? Nah.
We’re excited because the 2022 inductees to the National Inventors Hall of Fame were just announced, and, as usual, the world of health care is well represented.
First up is the surprisingly relevant (thanks to the party guest that won’t leave, SARS-CoV-2) pair of Katalin Karikó, PhD, and Drew Weissman, MD, who worked together in the early 2000s to modify mRNA “so it could avoid immediate immune detection, remain active longer and efficiently instruct cells to create antigens to protect against severe disease.” Their discoveries eventually led to the use of modified mRNA in the COVID-19 vaccines.
The second, albeit posthumous, physician-inductee is Patricia Bath, MD, who was the first Black female physician to receive a U.S. patent for a medical invention. The laserphaco device and technique to remove cataracts “performed all steps of cataract removal: making the incision, destroying the lens, and vacuuming out the fractured pieces.”
Two other inductees have somewhat tenuous connections to medical care. Lonnie Johnson invented the Super Soaker, a powerful squirt gun that has been criticized by psychologists for encouraging violence, and Carl Benz invented the automobile, which sort of means he invented the ambulance, so there you go.
The induction ceremony takes place on May 5, 2022, in Washington, DC. If you’re attending the black-tie dinner at The Anthem, let us know and we’ll split an Uber. It’s our only night to be fancy.
Cracking down on food fraud
How do you know the olive oil in your pantry is from Greece? Or that the avocados on your toast are from Mexico? The label, right? Well, maybe not. False claims of origin are a huge problem in the food industry, costing over $30 billion in economic damage annually.
Fear not, citizens, because botanists are on the job, and they’ve found a cheaper and more efficient way to expose that non-Greek olive oil.
How? Florian Cueni, PhD, of the University of Basel, Switzerland, and associates developed a new model to simulate oxygen isotope ratios in plants from a specific region, based on the temperature, precipitation, growing season information, and humidity data. Previously, botanists had to collect reference data from the claimed origin country and from other regions to validate where the product actually came from.
“With minor adjustments to the parameters, our model can be used to determine all plant products,” said senior investigator Ansgar Kahmen. This can open up the door for even more plant forensics, including drug confiscations and illegal timber logging, with information that will hold up in court.
Why pay Greek-olive prices for olives from California?
Fear leads to anger, anger leads to unhelpful online reviews
And reading angry online reviews leads to hate and suffering. We may have co-opted Master Yoda’s wise words ever so slightly, but anyone who’s done any shopping online (so everyone) knows that the review section of any product can be downright villainous. Do these reviews affect what we buy?
The angry online product review was the subject of a recent study published in MIS Quarterly. In a series of experiments, participants were shown a series of realistic online reviews with varying amounts of anger but with similar amounts of information. After reading the reviews, participants rated helpfulness, their personal opinion of the product/retailer, and whether or not they would buy the product.
Participants overwhelmingly rated calmly written reviews as more helpful than angrily written ones. One would expect, then, that those unhelpful angry reviews would have little effect on the participant’s view or willingness to buy a product, but the study investigators found the opposite. Reading angry reviews made the participants more likely to reject the product, even though they didn’t think the angry review was useful. And when you think about it, it does make sense. Anger means drama, and we can’t resist a juicy bit of drama.
So while we should all aspire to be Yoda and rise above anger and hatred, in reality we seem to be channeling Emperor Palpatine. We let the hate flow through us, and in our anger, we ignore perfectly good products. On the plus side, now we can shoot lightning out of our hands, so that’s pretty cool.
Health care is heading to the hall of fame
We couldn’t be happier here at LOTME because it’s that time of year again.
No, we’re not talking about Healthcare Security and Safety Week or National Metric Week, although those are both kind of important. Hmm, maybe we should talk about health care security or the metric system. After all, in this country, medicine is one of the metric system’s biggest customers. And who doesn’t love picograms? They’re the unit-of-measurement equivalent of a koala.
So we’re doing the metric system, then? Nah.
We’re excited because the 2022 inductees to the National Inventors Hall of Fame were just announced, and, as usual, the world of health care is well represented.
First up is the surprisingly relevant (thanks to the party guest that won’t leave, SARS-CoV-2) pair of Katalin Karikó, PhD, and Drew Weissman, MD, who worked together in the early 2000s to modify mRNA “so it could avoid immediate immune detection, remain active longer and efficiently instruct cells to create antigens to protect against severe disease.” Their discoveries eventually led to the use of modified mRNA in the COVID-19 vaccines.
The second, albeit posthumous, physician-inductee is Patricia Bath, MD, who was the first Black female physician to receive a U.S. patent for a medical invention. The laserphaco device and technique to remove cataracts “performed all steps of cataract removal: making the incision, destroying the lens, and vacuuming out the fractured pieces.”
Two other inductees have somewhat tenuous connections to medical care. Lonnie Johnson invented the Super Soaker, a powerful squirt gun that has been criticized by psychologists for encouraging violence, and Carl Benz invented the automobile, which sort of means he invented the ambulance, so there you go.
The induction ceremony takes place on May 5, 2022, in Washington, DC. If you’re attending the black-tie dinner at The Anthem, let us know and we’ll split an Uber. It’s our only night to be fancy.