Clinical Neurology News

PHILADELPHIA – Monthly or quarterly treatment with fremanezumab provides significant and clinically meaningful reductions in migraine days at 4 weeks, compared with placebo, in patients with inadequate responses to as many as four classes of preventive medications for migraine, according to research presented at the annual meeting of the American Headache Society. Fremanezumab may be an effective treatment for a population that otherwise is difficult to treat, said the researchers.

Fremanezumab is a fully humanized monoclonal antibody that selectively targets calcitonin gene-related peptide (CGRP). Previous trials have supported the treatment’s efficacy for the preventive treatment of episodic and chronic migraine in adults. Egilius L. H. Spierings, MD, PhD, a clinical professor of neurology at Tufts Medical Center in Boston and the founder, medical director, and principal investigator at MedVadis Research in Watertown, Massachusetts, and colleagues conducted the phase 3 FOCUS study to examine fremanezumab’s efficacy at preventing migraine in adults with chronic or episodic migraine and inadequate response to two to four classes of migraine preventive medications.

The investigators randomized patients in this multinational, double-blind study to one of three treatment arms. In the first arm, participants received monthly subcutaneous doses of fremanezumab. Patients with chronic migraine in this arm received 675 mg during month 1 and 225 mg during months 2 and 3. Patients with episodic migraine received 225 mg each month. In the second arm, participants received quarterly treatment with fremanezumab (i.e., 675 mg during month 1, followed by placebo during months 2 and 3). In the third arm, participants received matched monthly placebo. The treatment period lasted for 12 weeks.

Dr. Spierings and colleagues created logistic regression models to compare the proportions of responders, defined as patients who achieved 50% or greater and 75% or greater reduction in mean monthly migraine days, during the 4- and 12-week periods after the first dose of study drug. They used a logistic regression model to analyze the proportions of patients who achieved 50% or greater reduction in mean monthly migraine days during the first 4 weeks and sustained this level of response throughout the 12-week period. The study’s secondary endpoints were 50% or greater reductions in migraine days at weeks 4 and 12.

The investigators randomized 837 patients. In all, 278 participants received placebo, 283 received monthly fremanezumab, and 276 received quarterly fremanezumab. At baseline, the mean number of migraine days was 14.3 in the placebo arm, 14.1 in the monthly fremanezumab arm, and 14.1 in the quarterly fremanezumab arm. The proportions of patients who failed to respond to 2, 3, and 4 classes of preventive medications, respectively, were 51%, 29%, and 19% in the placebo group; 47%, 35%, and 18% in the monthly fremanezumab group; and 51%, 31%, and 18% in the quarterly fremanezumab group.

Overall, approximately 37% of patients receiving fremanezumab achieved 50% or greater reductions in migraine days within 4 weeks of the first dose, compared with 10% of patients who received placebo. Approximately 20% of patients receiving fremanezumab had sustained 50% or greater reductions in migraine days from 4 weeks throughout the 12-week treatment period, compared with 3% of controls. Higher proportions of patients also achieved 75% or greater reductions at 4 weeks and during 12 weeks after the first dose with fremanezumab, compared with placebo.

Dr. Spierings is a member of the Teva Pharmaceuticals speakers bureau and has received research grants from the company. His coinvestigators are all employees of Teva, which manufactures fremanezumab.

egreb@mdedge.com

SOURCE: Spierings ELH et al. AHS 2019. Abstract 631663.

PHILADELPHIA – Monthly or quarterly treatment with fremanezumab provides significant and clinically meaningful reductions in migraine days at 4 weeks, compared with placebo, in patients with inadequate responses to as many as four classes of preventive medications for migraine, according to research presented at the annual meeting of the American Headache Society. Fremanezumab may be an effective treatment for a population that otherwise is difficult to treat, said the researchers.

Fremanezumab is a fully humanized monoclonal antibody that selectively targets calcitonin gene-related peptide (CGRP). Previous trials have supported the treatment’s efficacy for the preventive treatment of episodic and chronic migraine in adults. Egilius L. H. Spierings, MD, PhD, a clinical professor of neurology at Tufts Medical Center in Boston and the founder, medical director, and principal investigator at MedVadis Research in Watertown, Massachusetts, and colleagues conducted the phase 3 FOCUS study to examine fremanezumab’s efficacy at preventing migraine in adults with chronic or episodic migraine and inadequate response to two to four classes of migraine preventive medications.

The investigators randomized patients in this multinational, double-blind study to one of three treatment arms. In the first arm, participants received monthly subcutaneous doses of fremanezumab. Patients with chronic migraine in this arm received 675 mg during month 1 and 225 mg during months 2 and 3. Patients with episodic migraine received 225 mg each month. In the second arm, participants received quarterly treatment with fremanezumab (i.e., 675 mg during month 1, followed by placebo during months 2 and 3). In the third arm, participants received matched monthly placebo. The treatment period lasted for 12 weeks.

Dr. Spierings and colleagues created logistic regression models to compare the proportions of responders, defined as patients who achieved 50% or greater and 75% or greater reduction in mean monthly migraine days, during the 4- and 12-week periods after the first dose of study drug. They used a logistic regression model to analyze the proportions of patients who achieved 50% or greater reduction in mean monthly migraine days during the first 4 weeks and sustained this level of response throughout the 12-week period. The study’s secondary endpoints were 50% or greater reductions in migraine days at weeks 4 and 12.

The investigators randomized 837 patients. In all, 278 participants received placebo, 283 received monthly fremanezumab, and 276 received quarterly fremanezumab. At baseline, the mean number of migraine days was 14.3 in the placebo arm, 14.1 in the monthly fremanezumab arm, and 14.1 in the quarterly fremanezumab arm. The proportions of patients who failed to respond to 2, 3, and 4 classes of preventive medications, respectively, were 51%, 29%, and 19% in the placebo group; 47%, 35%, and 18% in the monthly fremanezumab group; and 51%, 31%, and 18% in the quarterly fremanezumab group.

Overall, approximately 37% of patients receiving fremanezumab achieved 50% or greater reductions in migraine days within 4 weeks of the first dose, compared with 10% of patients who received placebo. Approximately 20% of patients receiving fremanezumab had sustained 50% or greater reductions in migraine days from 4 weeks throughout the 12-week treatment period, compared with 3% of controls. Higher proportions of patients also achieved 75% or greater reductions at 4 weeks and during 12 weeks after the first dose with fremanezumab, compared with placebo.

Dr. Spierings is a member of the Teva Pharmaceuticals speakers bureau and has received research grants from the company. His coinvestigators are all employees of Teva, which manufactures fremanezumab.

egreb@mdedge.com

SOURCE: Spierings ELH et al. AHS 2019. Abstract 631663.

PHILADELPHIA – Monthly or quarterly treatment with fremanezumab provides significant and clinically meaningful reductions in migraine days at 4 weeks, compared with placebo, in patients with inadequate responses to as many as four classes of preventive medications for migraine, according to research presented at the annual meeting of the American Headache Society. Fremanezumab may be an effective treatment for a population that otherwise is difficult to treat, said the researchers.

Fremanezumab is a fully humanized monoclonal antibody that selectively targets calcitonin gene-related peptide (CGRP). Previous trials have supported the treatment’s efficacy for the preventive treatment of episodic and chronic migraine in adults. Egilius L. H. Spierings, MD, PhD, a clinical professor of neurology at Tufts Medical Center in Boston and the founder, medical director, and principal investigator at MedVadis Research in Watertown, Massachusetts, and colleagues conducted the phase 3 FOCUS study to examine fremanezumab’s efficacy at preventing migraine in adults with chronic or episodic migraine and inadequate response to two to four classes of migraine preventive medications.

The investigators randomized patients in this multinational, double-blind study to one of three treatment arms. In the first arm, participants received monthly subcutaneous doses of fremanezumab. Patients with chronic migraine in this arm received 675 mg during month 1 and 225 mg during months 2 and 3. Patients with episodic migraine received 225 mg each month. In the second arm, participants received quarterly treatment with fremanezumab (i.e., 675 mg during month 1, followed by placebo during months 2 and 3). In the third arm, participants received matched monthly placebo. The treatment period lasted for 12 weeks.

Dr. Spierings and colleagues created logistic regression models to compare the proportions of responders, defined as patients who achieved 50% or greater and 75% or greater reduction in mean monthly migraine days, during the 4- and 12-week periods after the first dose of study drug. They used a logistic regression model to analyze the proportions of patients who achieved 50% or greater reduction in mean monthly migraine days during the first 4 weeks and sustained this level of response throughout the 12-week period. The study’s secondary endpoints were 50% or greater reductions in migraine days at weeks 4 and 12.

The investigators randomized 837 patients. In all, 278 participants received placebo, 283 received monthly fremanezumab, and 276 received quarterly fremanezumab. At baseline, the mean number of migraine days was 14.3 in the placebo arm, 14.1 in the monthly fremanezumab arm, and 14.1 in the quarterly fremanezumab arm. The proportions of patients who failed to respond to 2, 3, and 4 classes of preventive medications, respectively, were 51%, 29%, and 19% in the placebo group; 47%, 35%, and 18% in the monthly fremanezumab group; and 51%, 31%, and 18% in the quarterly fremanezumab group.

Overall, approximately 37% of patients receiving fremanezumab achieved 50% or greater reductions in migraine days within 4 weeks of the first dose, compared with 10% of patients who received placebo. Approximately 20% of patients receiving fremanezumab had sustained 50% or greater reductions in migraine days from 4 weeks throughout the 12-week treatment period, compared with 3% of controls. Higher proportions of patients also achieved 75% or greater reductions at 4 weeks and during 12 weeks after the first dose with fremanezumab, compared with placebo.

Dr. Spierings is a member of the Teva Pharmaceuticals speakers bureau and has received research grants from the company. His coinvestigators are all employees of Teva, which manufactures fremanezumab.

egreb@mdedge.com

SOURCE: Spierings ELH et al. AHS 2019. Abstract 631663.

PHILADELPHIA – The age at which adolescent girls experience thelarche and menarche is associated with the prevalence of migraine during later adolescence, according to research presented at the annual meeting of the American Headache Society. The results suggest that earlier exposure to estrogen increases the risk for migraine in adolescent girls, said Vincent Martin, MD, director of the Headache and Facial Pain Center at the University of Cincinnati Gardner Neuroscience Institute.

Previous studies observed an association between earlier onset of menarche and greater prevalence of migraine in adolescent girls, but no investigators had examined the relationship between earlier stages of pubertal development, such as thelarche and pubarche, and migraine.

Dr. Martin and colleagues included participants in the Breast Cancer and Environment Research Program puberty cohort in their study. Physicians examined the girls every 6 to 12 months from the time that they were aged 6-8 years to the time of late adolescence. During the last examination, participants responded to a validated questionnaire to determine whether they met International Classification of Headache Disorders–3 criteria for a diagnosis of migraine. Dr. Martin and colleagues performed logistic regression to examine whether age at thelarche, pubarche, or menarche predicted migraine.

Of 761 girls included in this study, 85 (11.2%) received a diagnosis of migraine. The mean age at which the questionnaire was administered was 15.6 years. After adjusting the data for potential confounders, the researchers found that an earlier age of onset of thelarche and menarche was associated with a higher prevalence of migraine. A 1-year decrease in the age of onset of thelarche or menarche was associated with a 32.8% or 33.8% increase in the odds of migraine headache, respectively. Pubarche was not associated with migraine.

Dr. Martin had no relevant disclosures.

egreb@mdedge.com

PHILADELPHIA – The age at which adolescent girls experience thelarche and menarche is associated with the prevalence of migraine during later adolescence, according to research presented at the annual meeting of the American Headache Society. The results suggest that earlier exposure to estrogen increases the risk for migraine in adolescent girls, said Vincent Martin, MD, director of the Headache and Facial Pain Center at the University of Cincinnati Gardner Neuroscience Institute.

Previous studies observed an association between earlier onset of menarche and greater prevalence of migraine in adolescent girls, but no investigators had examined the relationship between earlier stages of pubertal development, such as thelarche and pubarche, and migraine.

Dr. Martin and colleagues included participants in the Breast Cancer and Environment Research Program puberty cohort in their study. Physicians examined the girls every 6 to 12 months from the time that they were aged 6-8 years to the time of late adolescence. During the last examination, participants responded to a validated questionnaire to determine whether they met International Classification of Headache Disorders–3 criteria for a diagnosis of migraine. Dr. Martin and colleagues performed logistic regression to examine whether age at thelarche, pubarche, or menarche predicted migraine.

Of 761 girls included in this study, 85 (11.2%) received a diagnosis of migraine. The mean age at which the questionnaire was administered was 15.6 years. After adjusting the data for potential confounders, the researchers found that an earlier age of onset of thelarche and menarche was associated with a higher prevalence of migraine. A 1-year decrease in the age of onset of thelarche or menarche was associated with a 32.8% or 33.8% increase in the odds of migraine headache, respectively. Pubarche was not associated with migraine.

Dr. Martin had no relevant disclosures.

egreb@mdedge.com

PHILADELPHIA – The age at which adolescent girls experience thelarche and menarche is associated with the prevalence of migraine during later adolescence, according to research presented at the annual meeting of the American Headache Society. The results suggest that earlier exposure to estrogen increases the risk for migraine in adolescent girls, said Vincent Martin, MD, director of the Headache and Facial Pain Center at the University of Cincinnati Gardner Neuroscience Institute.

Previous studies observed an association between earlier onset of menarche and greater prevalence of migraine in adolescent girls, but no investigators had examined the relationship between earlier stages of pubertal development, such as thelarche and pubarche, and migraine.

Dr. Martin and colleagues included participants in the Breast Cancer and Environment Research Program puberty cohort in their study. Physicians examined the girls every 6 to 12 months from the time that they were aged 6-8 years to the time of late adolescence. During the last examination, participants responded to a validated questionnaire to determine whether they met International Classification of Headache Disorders–3 criteria for a diagnosis of migraine. Dr. Martin and colleagues performed logistic regression to examine whether age at thelarche, pubarche, or menarche predicted migraine.

Of 761 girls included in this study, 85 (11.2%) received a diagnosis of migraine. The mean age at which the questionnaire was administered was 15.6 years. After adjusting the data for potential confounders, the researchers found that an earlier age of onset of thelarche and menarche was associated with a higher prevalence of migraine. A 1-year decrease in the age of onset of thelarche or menarche was associated with a 32.8% or 33.8% increase in the odds of migraine headache, respectively. Pubarche was not associated with migraine.

Dr. Martin had no relevant disclosures.

egreb@mdedge.com

Early nerve transfer surgery is safe and can provide significant functional improvement to patients with cervical spinal cord injury and tetraplegia, according to research published online July 4 ahead of print in the Lancet. Combining nerve transfer with tendon transfer may maximize the functional benefit of surgery.

The loss of upper extremity function after cervical spinal cord injury can reduce independence and social and vocational engagement. People with tetraplegia rank improvement in hand function as their most important goal. Tendon transfers have been the traditional method of restoring function, but interest in nerve transfers has been increasing with the publication of successful results. Nerve transfers can reanimate several muscles at once and require a smaller incision and shorter immobilization, compared with tendon transfers.
 

Injury had occurred less than 18 months previously

Natasha van Zyl, MBBS, a plastic and reconstructive surgeon at Austin Health in Melbourne, and colleagues conducted a prospective case series to examine the clinical and functional outcomes of nerve transfer surgery for the reanimation of upper limb function in patients with tetraplegia. The investigators also sought to compare these outcomes with published outcomes for tendon transfer surgery.

Between April 14, 2014, and Nov. 22, 2018, Dr. van Zyl and colleagues recruited consecutive patients of any age with early cervical spinal cord injury of motor level C5 and below. Injury was required to have occurred fewer than 18 months before enrollment. Eligible participants had been referred to a single center for upper extremity reanimation and were considered candidates for nerve transfer.

Every participant underwent single or multiple nerve transfers in one or both upper limbs, and some participants also underwent tendon transfers. The goal of surgery was the restoration of elbow extension, grasp, pinch, and hand opening. An independent assessor evaluated participants at baseline and at 12 months and 24 months after surgery. The primary outcome measures were the action research arm test (ARAT), the grasp release test (GRT), and the spinal cord independence measure (SCIM).
 

Grasp function improved significantly

Dr. van Zyl and colleagues recruited 16 participants with traumatic spinal cord injury who underwent 59 nerve transfers. Ten participants also underwent tendon transfers. The population’s mean age at time of injury was 27.3 years. Three patients were female. Motor vehicle accidents were the most common cause of injury (31%). Follow-up data at 24 months were unavailable for three patients.

Participants’ median ARAT total score significantly improved from 16.5 at baseline to 34.0 at 24 months. Median GRT total score significantly improved from 35.0 at baseline to 125.2 at 24 months. The population’s mean total SCIM score and mobility in the room and toilet SCIM score improved by more than the minimal detectable change and the minimal clinically important difference. The mean self-care SCIM score improved by more than the minimal detectable change between baseline and 24 months.

The researchers observed six adverse events related to the surgery, but none had sustained functional consequences. No patients had an increase in musculoskeletal or neuropathic pain. Four of the 50 nerve transfers with 24-month follow-up failed.
 

A novel technique

“This project is the first to comprehensively examine outcomes for early, multiple nerve transfer surgery in the upper limbs of people with tetraplegia following traumatic spinal cord injury and is the largest prospective series of nerve transfers reported in this population to date,” said Dr. van Zyl and colleagues. Study limitations included the small sample size, the high variability of spinal cord injury patterns, and the potential for the multiple procedures that each participant underwent to confound data analysis.

Future research could explore whether nerve transfers are beneficial at more than 24 months after spinal cord injury, wrote the authors. In addition, it is unclear whether function and strength continue to improve beyond 24 months after surgery.

The study was funded by the Institute for Safety, Compensation, and Recovery Research in Australia. The authors had no competing interests.

egreb@mdedge.com

SOURCE: van Zyl N et al. Lancet. 2019 Jul 4. doi: 10.1016/S0140-6736(19)31143-2.

Early nerve transfer surgery is safe and can provide significant functional improvement to patients with cervical spinal cord injury and tetraplegia, according to research published online July 4 ahead of print in the Lancet. Combining nerve transfer with tendon transfer may maximize the functional benefit of surgery.

The loss of upper extremity function after cervical spinal cord injury can reduce independence and social and vocational engagement. People with tetraplegia rank improvement in hand function as their most important goal. Tendon transfers have been the traditional method of restoring function, but interest in nerve transfers has been increasing with the publication of successful results. Nerve transfers can reanimate several muscles at once and require a smaller incision and shorter immobilization, compared with tendon transfers.
 

Injury had occurred less than 18 months previously

Natasha van Zyl, MBBS, a plastic and reconstructive surgeon at Austin Health in Melbourne, and colleagues conducted a prospective case series to examine the clinical and functional outcomes of nerve transfer surgery for the reanimation of upper limb function in patients with tetraplegia. The investigators also sought to compare these outcomes with published outcomes for tendon transfer surgery.

Between April 14, 2014, and Nov. 22, 2018, Dr. van Zyl and colleagues recruited consecutive patients of any age with early cervical spinal cord injury of motor level C5 and below. Injury was required to have occurred fewer than 18 months before enrollment. Eligible participants had been referred to a single center for upper extremity reanimation and were considered candidates for nerve transfer.

Every participant underwent single or multiple nerve transfers in one or both upper limbs, and some participants also underwent tendon transfers. The goal of surgery was the restoration of elbow extension, grasp, pinch, and hand opening. An independent assessor evaluated participants at baseline and at 12 months and 24 months after surgery. The primary outcome measures were the action research arm test (ARAT), the grasp release test (GRT), and the spinal cord independence measure (SCIM).
 

Grasp function improved significantly

Dr. van Zyl and colleagues recruited 16 participants with traumatic spinal cord injury who underwent 59 nerve transfers. Ten participants also underwent tendon transfers. The population’s mean age at time of injury was 27.3 years. Three patients were female. Motor vehicle accidents were the most common cause of injury (31%). Follow-up data at 24 months were unavailable for three patients.

Participants’ median ARAT total score significantly improved from 16.5 at baseline to 34.0 at 24 months. Median GRT total score significantly improved from 35.0 at baseline to 125.2 at 24 months. The population’s mean total SCIM score and mobility in the room and toilet SCIM score improved by more than the minimal detectable change and the minimal clinically important difference. The mean self-care SCIM score improved by more than the minimal detectable change between baseline and 24 months.

The researchers observed six adverse events related to the surgery, but none had sustained functional consequences. No patients had an increase in musculoskeletal or neuropathic pain. Four of the 50 nerve transfers with 24-month follow-up failed.
 

A novel technique

“This project is the first to comprehensively examine outcomes for early, multiple nerve transfer surgery in the upper limbs of people with tetraplegia following traumatic spinal cord injury and is the largest prospective series of nerve transfers reported in this population to date,” said Dr. van Zyl and colleagues. Study limitations included the small sample size, the high variability of spinal cord injury patterns, and the potential for the multiple procedures that each participant underwent to confound data analysis.

Future research could explore whether nerve transfers are beneficial at more than 24 months after spinal cord injury, wrote the authors. In addition, it is unclear whether function and strength continue to improve beyond 24 months after surgery.

The study was funded by the Institute for Safety, Compensation, and Recovery Research in Australia. The authors had no competing interests.

egreb@mdedge.com

SOURCE: van Zyl N et al. Lancet. 2019 Jul 4. doi: 10.1016/S0140-6736(19)31143-2.

Early nerve transfer surgery is safe and can provide significant functional improvement to patients with cervical spinal cord injury and tetraplegia, according to research published online July 4 ahead of print in the Lancet. Combining nerve transfer with tendon transfer may maximize the functional benefit of surgery.

The loss of upper extremity function after cervical spinal cord injury can reduce independence and social and vocational engagement. People with tetraplegia rank improvement in hand function as their most important goal. Tendon transfers have been the traditional method of restoring function, but interest in nerve transfers has been increasing with the publication of successful results. Nerve transfers can reanimate several muscles at once and require a smaller incision and shorter immobilization, compared with tendon transfers.
 

Injury had occurred less than 18 months previously

Natasha van Zyl, MBBS, a plastic and reconstructive surgeon at Austin Health in Melbourne, and colleagues conducted a prospective case series to examine the clinical and functional outcomes of nerve transfer surgery for the reanimation of upper limb function in patients with tetraplegia. The investigators also sought to compare these outcomes with published outcomes for tendon transfer surgery.

Between April 14, 2014, and Nov. 22, 2018, Dr. van Zyl and colleagues recruited consecutive patients of any age with early cervical spinal cord injury of motor level C5 and below. Injury was required to have occurred fewer than 18 months before enrollment. Eligible participants had been referred to a single center for upper extremity reanimation and were considered candidates for nerve transfer.

Every participant underwent single or multiple nerve transfers in one or both upper limbs, and some participants also underwent tendon transfers. The goal of surgery was the restoration of elbow extension, grasp, pinch, and hand opening. An independent assessor evaluated participants at baseline and at 12 months and 24 months after surgery. The primary outcome measures were the action research arm test (ARAT), the grasp release test (GRT), and the spinal cord independence measure (SCIM).
 

Grasp function improved significantly

Dr. van Zyl and colleagues recruited 16 participants with traumatic spinal cord injury who underwent 59 nerve transfers. Ten participants also underwent tendon transfers. The population’s mean age at time of injury was 27.3 years. Three patients were female. Motor vehicle accidents were the most common cause of injury (31%). Follow-up data at 24 months were unavailable for three patients.

Participants’ median ARAT total score significantly improved from 16.5 at baseline to 34.0 at 24 months. Median GRT total score significantly improved from 35.0 at baseline to 125.2 at 24 months. The population’s mean total SCIM score and mobility in the room and toilet SCIM score improved by more than the minimal detectable change and the minimal clinically important difference. The mean self-care SCIM score improved by more than the minimal detectable change between baseline and 24 months.

The researchers observed six adverse events related to the surgery, but none had sustained functional consequences. No patients had an increase in musculoskeletal or neuropathic pain. Four of the 50 nerve transfers with 24-month follow-up failed.
 

A novel technique

“This project is the first to comprehensively examine outcomes for early, multiple nerve transfer surgery in the upper limbs of people with tetraplegia following traumatic spinal cord injury and is the largest prospective series of nerve transfers reported in this population to date,” said Dr. van Zyl and colleagues. Study limitations included the small sample size, the high variability of spinal cord injury patterns, and the potential for the multiple procedures that each participant underwent to confound data analysis.

Future research could explore whether nerve transfers are beneficial at more than 24 months after spinal cord injury, wrote the authors. In addition, it is unclear whether function and strength continue to improve beyond 24 months after surgery.

The study was funded by the Institute for Safety, Compensation, and Recovery Research in Australia. The authors had no competing interests.

egreb@mdedge.com

SOURCE: van Zyl N et al. Lancet. 2019 Jul 4. doi: 10.1016/S0140-6736(19)31143-2.

PHILADELPHIA – The more days per month a person reported experiencing migraine headaches the greater their prevalence of various comorbidities associated with migraine headaches, including insomnia, depression, anxiety, and gastric ulcer disease, according to results from a survey of more than 92,000 U.S. residents.

Mitchel L. Zoler/MDedge News

“Increasing monthly headache day [MHD] frequency was associated with an increased risk of other health conditions in people with migraine,” Richard B. Lipton, MD, and his associates reported in a poster at the annual meeting of the American Headache Society. “The findings may be due to direct causality, reverse causality, shared risk factors, or detection bias.”

Additional analysis of the association with gastric ulcer disease (GUD) showed that it also linked with the number of days per month when a person with migraine used an NSAID. Migraineurs who self-reported having GUD averaged 10.5 days a month using an NSAID, compared with an average NSAID usage of just over 6 days a month among migraineurs without GUD, Dr. Lipton, a professor and vice-chair of neurology at Albert Einstein College of Medicine, New York, reported in a separate poster at the meeting.

The Migraine in America Symptoms and Treatment (MAST) study enrolled more than 90,000 U.S. residents starting in 2016. Using a validated diagnostic screening tool, the MAST researchers identified 15,133 of these people as having at least one day with a migraine headache during the 3 months prior to the survey and 77,453 who reported no migraine history (Headache. 2018 Oct;58[9]: 1408-26). The people with migraine averaged 43 years old, compared with an average of 52 years for those without migraine; 73% of the migraineurs were women.

Analysis of the prevalence of various self-reported, physician-diagnosed comorbidities showed a strong correlation between the relative odds of having a comorbidity and the self-reported number of MHDs. For example, the odds ratio for having insomnia, compared with the people without migraine, was nearly 200% among people reporting 1-4 MHDs, more than 300% higher among those reporting 5-9 MHDs, 500% higher with MHDs of 10-14, and nearly 700% higher among people reporting 20 or more MHDs. The researchers saw roughly similar patterns of rising comorbidity prevalence with higher numbers of MHDs for depression, anxiety, and GUD. The prevalence of a history of stroke or transient ischemic attack also increased with increasing numbers of MHDs but less steeply than for the other comorbidities. And while the prevalence of peripheral artery disease and epilepsy was consistently more than 100% greater among the migraineurs, compared with those with no recent migraine history, the prevalence of each of these two comorbidities showed no clear pattern of increasing prevalence as MHDs increased.

The analysis looked specifically at the relationship between GUD and NSAID use among people reporting migraine. Overall, the migraineurs had a greater than 200% increased prevalence of GUD than those without migraine. The odds ratio for GUD among migraineurs with 1-4 MHDs was 2.6, compared with those without migraine, and the odds ratio steadily rose with increasing MHDs to a peak of 490% higher among those who averaged 21 or more MHDs.

This link between the number of MHDs and prevalence of GUD may have some relationship to oral NSAID use, as overall NSAID use was higher among people with recent migraines than in those without migraines. However, the number of days per month of oral NSAID use appeared to plateau at an average of about 19 days once people reported having at least 10 MHDs, the researchers said. Even when people reported having more than twice as many MHDs their NSAID use remained at an average of about 19 days per month.

MAST was sponsored by Dr. Reddy’s Laboratories. Dr. Lipton had been a consultant to Dr. Reddy’s and to several other companies.

mzoler@mdedge.com

SOURCE: Lipton RB et al. Headache. 2019 June;59[S1]:1-208, P54.

PHILADELPHIA – The more days per month a person reported experiencing migraine headaches the greater their prevalence of various comorbidities associated with migraine headaches, including insomnia, depression, anxiety, and gastric ulcer disease, according to results from a survey of more than 92,000 U.S. residents.

Mitchel L. Zoler/MDedge News

“Increasing monthly headache day [MHD] frequency was associated with an increased risk of other health conditions in people with migraine,” Richard B. Lipton, MD, and his associates reported in a poster at the annual meeting of the American Headache Society. “The findings may be due to direct causality, reverse causality, shared risk factors, or detection bias.”

Additional analysis of the association with gastric ulcer disease (GUD) showed that it also linked with the number of days per month when a person with migraine used an NSAID. Migraineurs who self-reported having GUD averaged 10.5 days a month using an NSAID, compared with an average NSAID usage of just over 6 days a month among migraineurs without GUD, Dr. Lipton, a professor and vice-chair of neurology at Albert Einstein College of Medicine, New York, reported in a separate poster at the meeting.

The Migraine in America Symptoms and Treatment (MAST) study enrolled more than 90,000 U.S. residents starting in 2016. Using a validated diagnostic screening tool, the MAST researchers identified 15,133 of these people as having at least one day with a migraine headache during the 3 months prior to the survey and 77,453 who reported no migraine history (Headache. 2018 Oct;58[9]: 1408-26). The people with migraine averaged 43 years old, compared with an average of 52 years for those without migraine; 73% of the migraineurs were women.

Analysis of the prevalence of various self-reported, physician-diagnosed comorbidities showed a strong correlation between the relative odds of having a comorbidity and the self-reported number of MHDs. For example, the odds ratio for having insomnia, compared with the people without migraine, was nearly 200% among people reporting 1-4 MHDs, more than 300% higher among those reporting 5-9 MHDs, 500% higher with MHDs of 10-14, and nearly 700% higher among people reporting 20 or more MHDs. The researchers saw roughly similar patterns of rising comorbidity prevalence with higher numbers of MHDs for depression, anxiety, and GUD. The prevalence of a history of stroke or transient ischemic attack also increased with increasing numbers of MHDs but less steeply than for the other comorbidities. And while the prevalence of peripheral artery disease and epilepsy was consistently more than 100% greater among the migraineurs, compared with those with no recent migraine history, the prevalence of each of these two comorbidities showed no clear pattern of increasing prevalence as MHDs increased.

The analysis looked specifically at the relationship between GUD and NSAID use among people reporting migraine. Overall, the migraineurs had a greater than 200% increased prevalence of GUD than those without migraine. The odds ratio for GUD among migraineurs with 1-4 MHDs was 2.6, compared with those without migraine, and the odds ratio steadily rose with increasing MHDs to a peak of 490% higher among those who averaged 21 or more MHDs.

This link between the number of MHDs and prevalence of GUD may have some relationship to oral NSAID use, as overall NSAID use was higher among people with recent migraines than in those without migraines. However, the number of days per month of oral NSAID use appeared to plateau at an average of about 19 days once people reported having at least 10 MHDs, the researchers said. Even when people reported having more than twice as many MHDs their NSAID use remained at an average of about 19 days per month.

MAST was sponsored by Dr. Reddy’s Laboratories. Dr. Lipton had been a consultant to Dr. Reddy’s and to several other companies.

mzoler@mdedge.com

SOURCE: Lipton RB et al. Headache. 2019 June;59[S1]:1-208, P54.

PHILADELPHIA – The more days per month a person reported experiencing migraine headaches the greater their prevalence of various comorbidities associated with migraine headaches, including insomnia, depression, anxiety, and gastric ulcer disease, according to results from a survey of more than 92,000 U.S. residents.

Mitchel L. Zoler/MDedge News

“Increasing monthly headache day [MHD] frequency was associated with an increased risk of other health conditions in people with migraine,” Richard B. Lipton, MD, and his associates reported in a poster at the annual meeting of the American Headache Society. “The findings may be due to direct causality, reverse causality, shared risk factors, or detection bias.”

Additional analysis of the association with gastric ulcer disease (GUD) showed that it also linked with the number of days per month when a person with migraine used an NSAID. Migraineurs who self-reported having GUD averaged 10.5 days a month using an NSAID, compared with an average NSAID usage of just over 6 days a month among migraineurs without GUD, Dr. Lipton, a professor and vice-chair of neurology at Albert Einstein College of Medicine, New York, reported in a separate poster at the meeting.

The Migraine in America Symptoms and Treatment (MAST) study enrolled more than 90,000 U.S. residents starting in 2016. Using a validated diagnostic screening tool, the MAST researchers identified 15,133 of these people as having at least one day with a migraine headache during the 3 months prior to the survey and 77,453 who reported no migraine history (Headache. 2018 Oct;58[9]: 1408-26). The people with migraine averaged 43 years old, compared with an average of 52 years for those without migraine; 73% of the migraineurs were women.

Analysis of the prevalence of various self-reported, physician-diagnosed comorbidities showed a strong correlation between the relative odds of having a comorbidity and the self-reported number of MHDs. For example, the odds ratio for having insomnia, compared with the people without migraine, was nearly 200% among people reporting 1-4 MHDs, more than 300% higher among those reporting 5-9 MHDs, 500% higher with MHDs of 10-14, and nearly 700% higher among people reporting 20 or more MHDs. The researchers saw roughly similar patterns of rising comorbidity prevalence with higher numbers of MHDs for depression, anxiety, and GUD. The prevalence of a history of stroke or transient ischemic attack also increased with increasing numbers of MHDs but less steeply than for the other comorbidities. And while the prevalence of peripheral artery disease and epilepsy was consistently more than 100% greater among the migraineurs, compared with those with no recent migraine history, the prevalence of each of these two comorbidities showed no clear pattern of increasing prevalence as MHDs increased.

The analysis looked specifically at the relationship between GUD and NSAID use among people reporting migraine. Overall, the migraineurs had a greater than 200% increased prevalence of GUD than those without migraine. The odds ratio for GUD among migraineurs with 1-4 MHDs was 2.6, compared with those without migraine, and the odds ratio steadily rose with increasing MHDs to a peak of 490% higher among those who averaged 21 or more MHDs.

This link between the number of MHDs and prevalence of GUD may have some relationship to oral NSAID use, as overall NSAID use was higher among people with recent migraines than in those without migraines. However, the number of days per month of oral NSAID use appeared to plateau at an average of about 19 days once people reported having at least 10 MHDs, the researchers said. Even when people reported having more than twice as many MHDs their NSAID use remained at an average of about 19 days per month.

MAST was sponsored by Dr. Reddy’s Laboratories. Dr. Lipton had been a consultant to Dr. Reddy’s and to several other companies.

mzoler@mdedge.com

SOURCE: Lipton RB et al. Headache. 2019 June;59[S1]:1-208, P54.

A third of medical malpractice cases associated with patient death or permanent disability result from diagnostic errors by health providers, an analysis finds.

Lead investigator David E. Newman-Toker, MD, PhD, of Johns Hopkins University, Baltimore, and colleagues reviewed malpractice claims during 2006-2015 from medical liability insurer CRICO’s Comparative Benchmarking System database, which represents 30% of all malpractice claims in the United States.

Investigators sought to identify diseases accounting for the majority of serious diagnosis-related harms associated with the claims. Of 55,377 closed claims, researchers identified 11,592 diagnostic error cases, of which 7,379 resulted in high-severity harm.

Of the high-severity claims, 34% stemmed from inaccurate or delayed diagnosis (Diagnosis 2019 Jul 11. doi. org/10.1515/dx-2019-0019).

The majority of diagnostic mistakes (74%) causing the most severe harm were attributable to cancer (38%), vascular events (23%), and infection (14%). These cases resulted in nearly $2 billion in malpractice payouts over a 10-year period, investigators found.

Clinical judgment factors were the primary reason behind the alleged errors, specifically: failure or delay in ordering a diagnostic test, narrow diagnostic focus with failure to establish a differential diagnosis, failure to appreciate and reconcile relevant symptoms or test results, and failure or delay in obtaining consultation or referral and misinterpretation of diagnostic studies.

“Diagnostic errors are the most common, the most catastrophic, and the most costly of medical errors,” Dr. Newman-Toker said at a press conference July 11. “We know that this is a major problem, at an individual, personal level, but also at a societal level and something we really have to take action toward fixing.”

This study breaks new ground by drilling into the major diseases most commonly associated with diagnostic errors, Dr. Newman-Toker said. In the cancer category, the most common cancers linked to severe harm were lung, breast, colorectal, prostate, and melanoma. In the vascular category, the most common conditions were stroke; myocardial infarction; venous thromboembolism; aortic aneurysm and dissection; and arterial thromboembolism. In the area of infection, sepsis; meningitis and encephalitis; spinal abscess; pneumonia; and endocarditis were the most common infections identified.

The findings provide a starting point to make improvements in the area of medical errors, said Dr. Newman-Toker, president of the Society to Improve Diagnosis in Medicine, an organization that aims to improve diagnosis and eliminate harm from diagnostic error.

“Although diagnostic errors happen everywhere, across all of medicine in every discipline with every disease, we might be able to take a big chunk out of this problem if we save a lot of lives and prevent a lot disability and if we focus some energy on tackling these problems,” he said. “It at least gives us a starting place and a roadmap for how to move the ball forward in this regard.”

The Society to Improve Diagnosis in Medicine has called on Congress to invest more funding into research to address diagnostic errors. Society CEO and cofounder Paul L. Epner noted that the 2019 House appropriations bill proposes not less than $4 million for diagnostic safety and quality research, which is up from $2 million last year.

“It’s a small step, but in the right direction,” Mr. Epner said. “[However,] the federal investment in research remains trivially small in relation to the public burden. That’s why we urge Congress to commit to research funding levels proportionate to the societal cost, in both human lives and in dollars.”

agallegos@mdedge.com
 

A third of medical malpractice cases associated with patient death or permanent disability result from diagnostic errors by health providers, an analysis finds.

Lead investigator David E. Newman-Toker, MD, PhD, of Johns Hopkins University, Baltimore, and colleagues reviewed malpractice claims during 2006-2015 from medical liability insurer CRICO’s Comparative Benchmarking System database, which represents 30% of all malpractice claims in the United States.

Investigators sought to identify diseases accounting for the majority of serious diagnosis-related harms associated with the claims. Of 55,377 closed claims, researchers identified 11,592 diagnostic error cases, of which 7,379 resulted in high-severity harm.

Of the high-severity claims, 34% stemmed from inaccurate or delayed diagnosis (Diagnosis 2019 Jul 11. doi. org/10.1515/dx-2019-0019).

The majority of diagnostic mistakes (74%) causing the most severe harm were attributable to cancer (38%), vascular events (23%), and infection (14%). These cases resulted in nearly $2 billion in malpractice payouts over a 10-year period, investigators found.

Clinical judgment factors were the primary reason behind the alleged errors, specifically: failure or delay in ordering a diagnostic test, narrow diagnostic focus with failure to establish a differential diagnosis, failure to appreciate and reconcile relevant symptoms or test results, and failure or delay in obtaining consultation or referral and misinterpretation of diagnostic studies.

“Diagnostic errors are the most common, the most catastrophic, and the most costly of medical errors,” Dr. Newman-Toker said at a press conference July 11. “We know that this is a major problem, at an individual, personal level, but also at a societal level and something we really have to take action toward fixing.”

This study breaks new ground by drilling into the major diseases most commonly associated with diagnostic errors, Dr. Newman-Toker said. In the cancer category, the most common cancers linked to severe harm were lung, breast, colorectal, prostate, and melanoma. In the vascular category, the most common conditions were stroke; myocardial infarction; venous thromboembolism; aortic aneurysm and dissection; and arterial thromboembolism. In the area of infection, sepsis; meningitis and encephalitis; spinal abscess; pneumonia; and endocarditis were the most common infections identified.

The findings provide a starting point to make improvements in the area of medical errors, said Dr. Newman-Toker, president of the Society to Improve Diagnosis in Medicine, an organization that aims to improve diagnosis and eliminate harm from diagnostic error.

“Although diagnostic errors happen everywhere, across all of medicine in every discipline with every disease, we might be able to take a big chunk out of this problem if we save a lot of lives and prevent a lot disability and if we focus some energy on tackling these problems,” he said. “It at least gives us a starting place and a roadmap for how to move the ball forward in this regard.”

The Society to Improve Diagnosis in Medicine has called on Congress to invest more funding into research to address diagnostic errors. Society CEO and cofounder Paul L. Epner noted that the 2019 House appropriations bill proposes not less than $4 million for diagnostic safety and quality research, which is up from $2 million last year.

“It’s a small step, but in the right direction,” Mr. Epner said. “[However,] the federal investment in research remains trivially small in relation to the public burden. That’s why we urge Congress to commit to research funding levels proportionate to the societal cost, in both human lives and in dollars.”

agallegos@mdedge.com
 

A third of medical malpractice cases associated with patient death or permanent disability result from diagnostic errors by health providers, an analysis finds.

Lead investigator David E. Newman-Toker, MD, PhD, of Johns Hopkins University, Baltimore, and colleagues reviewed malpractice claims during 2006-2015 from medical liability insurer CRICO’s Comparative Benchmarking System database, which represents 30% of all malpractice claims in the United States.

Investigators sought to identify diseases accounting for the majority of serious diagnosis-related harms associated with the claims. Of 55,377 closed claims, researchers identified 11,592 diagnostic error cases, of which 7,379 resulted in high-severity harm.

Of the high-severity claims, 34% stemmed from inaccurate or delayed diagnosis (Diagnosis 2019 Jul 11. doi. org/10.1515/dx-2019-0019).

The majority of diagnostic mistakes (74%) causing the most severe harm were attributable to cancer (38%), vascular events (23%), and infection (14%). These cases resulted in nearly $2 billion in malpractice payouts over a 10-year period, investigators found.

Clinical judgment factors were the primary reason behind the alleged errors, specifically: failure or delay in ordering a diagnostic test, narrow diagnostic focus with failure to establish a differential diagnosis, failure to appreciate and reconcile relevant symptoms or test results, and failure or delay in obtaining consultation or referral and misinterpretation of diagnostic studies.

“Diagnostic errors are the most common, the most catastrophic, and the most costly of medical errors,” Dr. Newman-Toker said at a press conference July 11. “We know that this is a major problem, at an individual, personal level, but also at a societal level and something we really have to take action toward fixing.”

This study breaks new ground by drilling into the major diseases most commonly associated with diagnostic errors, Dr. Newman-Toker said. In the cancer category, the most common cancers linked to severe harm were lung, breast, colorectal, prostate, and melanoma. In the vascular category, the most common conditions were stroke; myocardial infarction; venous thromboembolism; aortic aneurysm and dissection; and arterial thromboembolism. In the area of infection, sepsis; meningitis and encephalitis; spinal abscess; pneumonia; and endocarditis were the most common infections identified.

The findings provide a starting point to make improvements in the area of medical errors, said Dr. Newman-Toker, president of the Society to Improve Diagnosis in Medicine, an organization that aims to improve diagnosis and eliminate harm from diagnostic error.

“Although diagnostic errors happen everywhere, across all of medicine in every discipline with every disease, we might be able to take a big chunk out of this problem if we save a lot of lives and prevent a lot disability and if we focus some energy on tackling these problems,” he said. “It at least gives us a starting place and a roadmap for how to move the ball forward in this regard.”

The Society to Improve Diagnosis in Medicine has called on Congress to invest more funding into research to address diagnostic errors. Society CEO and cofounder Paul L. Epner noted that the 2019 House appropriations bill proposes not less than $4 million for diagnostic safety and quality research, which is up from $2 million last year.

“It’s a small step, but in the right direction,” Mr. Epner said. “[However,] the federal investment in research remains trivially small in relation to the public burden. That’s why we urge Congress to commit to research funding levels proportionate to the societal cost, in both human lives and in dollars.”

agallegos@mdedge.com
 

Risks of osteoporosis and osteoarthritis, but not that for inflammatory musculoskeletal diseases, are high among adults with cerebral palsy (CP), compared with adults without the disorder, according to a study published in Bone.

eranicle/Thinkstock

Neil E. O’Connell, PhD, of Brunel University London, and colleagues assessed the risks of osteoporosis, osteoarthritis, and inflammatory musculoskeletal diseases in a population-based cohort study that used data collected by the U.K. Clinical Practice Research Datalink during 1987-2015. The study included 1,705 patients with CP and 5,115 patients matched for age, sex, and general practices; data on smoking status and alcohol consumption for many of the patients also were gathered.

After adjustment for smoking status, alcohol consumption, and mean yearly general practice visits, investigators found evidence of significantly increased risk for osteoarthritis (hazard ratio, 1.54; 95% confidence interval, 1.17-2.02; P = .002) and osteoporosis (HR, 6.19; 95% CI, 3.37-11.39; P less than .001); they did not see increased risk for inflammatory musculoskeletal diseases (HR, 0.89; 95% CI, 0.45-1.75; P = .731).

One limitation of the study is the risk for residual confounding given the investigators could not account for mobility status or physical activity. Other limitations include potential incompleteness of diagnostic code lists, how identification of cases is depending on quality of original recording in the database, and that data regarding smoking status and alcohol consumption were missing for a substantial proportion of patients.

“Despite previous studies identifying a high prevalence of joint pain and functional deterioration among people with CP, there is a dearth of literature on the burden of musculoskeletal disorders in this population,” they wrote. “Further research is required into effective management of these conditions in adults with CP.”

This study was supported by an interdisciplinary award from Brunel University London’s Research Catalyst Fund. The authors declared no competing interests.

cpalmer@mdedge.com

SOURCE: O’Connell NE et al. Bone. 2019 Aug;125:30-5.

Risks of osteoporosis and osteoarthritis, but not that for inflammatory musculoskeletal diseases, are high among adults with cerebral palsy (CP), compared with adults without the disorder, according to a study published in Bone.

eranicle/Thinkstock

Neil E. O’Connell, PhD, of Brunel University London, and colleagues assessed the risks of osteoporosis, osteoarthritis, and inflammatory musculoskeletal diseases in a population-based cohort study that used data collected by the U.K. Clinical Practice Research Datalink during 1987-2015. The study included 1,705 patients with CP and 5,115 patients matched for age, sex, and general practices; data on smoking status and alcohol consumption for many of the patients also were gathered.

After adjustment for smoking status, alcohol consumption, and mean yearly general practice visits, investigators found evidence of significantly increased risk for osteoarthritis (hazard ratio, 1.54; 95% confidence interval, 1.17-2.02; P = .002) and osteoporosis (HR, 6.19; 95% CI, 3.37-11.39; P less than .001); they did not see increased risk for inflammatory musculoskeletal diseases (HR, 0.89; 95% CI, 0.45-1.75; P = .731).

One limitation of the study is the risk for residual confounding given the investigators could not account for mobility status or physical activity. Other limitations include potential incompleteness of diagnostic code lists, how identification of cases is depending on quality of original recording in the database, and that data regarding smoking status and alcohol consumption were missing for a substantial proportion of patients.

“Despite previous studies identifying a high prevalence of joint pain and functional deterioration among people with CP, there is a dearth of literature on the burden of musculoskeletal disorders in this population,” they wrote. “Further research is required into effective management of these conditions in adults with CP.”

This study was supported by an interdisciplinary award from Brunel University London’s Research Catalyst Fund. The authors declared no competing interests.

cpalmer@mdedge.com

SOURCE: O’Connell NE et al. Bone. 2019 Aug;125:30-5.

Risks of osteoporosis and osteoarthritis, but not that for inflammatory musculoskeletal diseases, are high among adults with cerebral palsy (CP), compared with adults without the disorder, according to a study published in Bone.

eranicle/Thinkstock

Neil E. O’Connell, PhD, of Brunel University London, and colleagues assessed the risks of osteoporosis, osteoarthritis, and inflammatory musculoskeletal diseases in a population-based cohort study that used data collected by the U.K. Clinical Practice Research Datalink during 1987-2015. The study included 1,705 patients with CP and 5,115 patients matched for age, sex, and general practices; data on smoking status and alcohol consumption for many of the patients also were gathered.

After adjustment for smoking status, alcohol consumption, and mean yearly general practice visits, investigators found evidence of significantly increased risk for osteoarthritis (hazard ratio, 1.54; 95% confidence interval, 1.17-2.02; P = .002) and osteoporosis (HR, 6.19; 95% CI, 3.37-11.39; P less than .001); they did not see increased risk for inflammatory musculoskeletal diseases (HR, 0.89; 95% CI, 0.45-1.75; P = .731).

One limitation of the study is the risk for residual confounding given the investigators could not account for mobility status or physical activity. Other limitations include potential incompleteness of diagnostic code lists, how identification of cases is depending on quality of original recording in the database, and that data regarding smoking status and alcohol consumption were missing for a substantial proportion of patients.

“Despite previous studies identifying a high prevalence of joint pain and functional deterioration among people with CP, there is a dearth of literature on the burden of musculoskeletal disorders in this population,” they wrote. “Further research is required into effective management of these conditions in adults with CP.”

This study was supported by an interdisciplinary award from Brunel University London’s Research Catalyst Fund. The authors declared no competing interests.

cpalmer@mdedge.com

SOURCE: O’Connell NE et al. Bone. 2019 Aug;125:30-5.

Appellate judges appeared to doubt that the Affordable Care Act should survive without the law’s signature insurance mandate during oral arguments on July 9, in a highly watched legal battle that may upend the health care law.

During the 2-hour hearing, a three-judge panel for the 5th U.S. Circuit Court of Appeals peppered attorneys with questions about whether Congress intended the ACA to function without the individual mandate, and the panel seemed doubtful the law can stand if the regulation is parsed, according to an audio transcript of the arguments. As written, the individual mandate required that all Americans have insurance or pay a tax penalty. However, budget legislation in 2017 zeroed out the penalties associated with the mandate, rendering it unenforceable.

Appeals Judge Kurt Engelhardt, a President Trump appointee, asked defense attorney Samuel Siegel why Congress failed to add a clause in the original law that would have allowed ACA components to be severed if such sectioning was acceptable.

“Congress could have included a severability clause when it adopted the ACA in 2010. Couldn’t it have done so?” Judge Engelhardt asked during oral arguments. “It seems like it did the opposite, where it said, ‘This is a complete overhaul,’ and it set forth a bunch of factual findings. Couldn’t Congress have said, ‘Oh by the way, we think all of these provisions are such excellent ideas and helpful to the public that if any go by the wayside, then we would want the remainder to continue to apply’?”

Congress’s silence on the severing of the ACA does not create a presumption against parsing of the law, argued Mr. Siegel, who is representing the Democratic states suing to retain the ACA in Texas v. United States. He emphasized that in 2017, when Congress terminated the individual mandate penalty, it chose not to repeal preexisting protections or other important reforms instituted by the ACA.

“With that action, your Honor, Congress expressed its views that the individual marketplace and indeed the entire Affordable Care Act can operate without an enforceable individual mandate,” Mr. Siegel said. “We think that’s all this court needs to know to resolve the severability question.”

However, Appellate Judge Jennifer Elrod, a President George W. Bush appointee to the court, questioned whether legislators zeroed out the mandate penalty because they knew the law could not survive without the core provision. She surmised that Congress might have assumed, “Aha, this is the silver bullet that’s going to undo Obamacare.”

Kyle Hawkins, an attorney representing the Republican-led plaintiff states, meanwhile, argued the text of the ACA clearly declares the individual mandate essential to the law and to the goals that Congress intended to achieve.

“The Obama administration thought of that as an inseverable clause,” Mr. Hawkins argued. “The district court directly synthesized those considerations ... and it reached the correct conclusion: The individual mandate is unconstitutional and it is inseverable from the remainder of the law.”

Texas v. United States stems from a legal challenge by a group of 18 Republican state attorneys general and two individuals in 2018 who argue the ACA should be declared unconstitutional. The plaintiffs say that, because budget legislation in 2017 effectively eliminated the penalty associated with the mandate, the requirement itself is invalid. Without the mandate, the entire law must fall, the plaintiffs contend. The Department of Justice declined to fully defend the law, so 16 Democratic state attorneys general intervened. In December 2018, a district court declared the entire ACA to be invalid, a decision immediately appealed to the 5th U.S. Circuit Court of Appeals by the Democratic attorneys general.

The Trump administration initially agreed that the mandate was unconstitutional and should be parsed. Attorneys for the administration said, if the mandate is found unconstitutional, the court should also consider finding two other provisions – the guaranteed issue and community rating requirements – of the ACA invalid. At the time, the Trump administration said the remainder of the ACA can stand without the three linked provisions. The administration later shifted its stance and asserted that much of the ACA should fall because provisions of the law cannot be severed. However, the DOJ expressed support in keeping some provision intact, such as certain criminal statutes that prevent health care fraud.

Most recently, the DOJ has indicated that, if the ACA is struck down or severed, the decision should only apply in the 18 plaintiff states and not to the entire nation. The fickle position of the Trump administration was questioned during the Court of Appeals hearing with judges asking DOJ attorney August Flentje to clarify why a final ruling should not apply nationwide.

“A lot of this stuff would need to get sorted out,” Mr. Flentje responded. “And it’s complicated. How it applies in the states and which parts can’t be applied at all because they would injure the states ... that raises a lot of complicated issues which I think [will be determined after] a final resolution.”

By their line of questioning, the appellate panel appeared to lean toward the plaintiffs’ position more so than toward the defendants’, said Katie Keith, an attorney and health law analyst who writes about Texas v. United States for the Health Affairs Blog.

“At least two of the three judges – the only two that were asking questions – seem very inclined to at, a minimum, strike down the individual mandate itself,” Ms. Keith said in an interview. “The conventional wisdom had been that this court would overturn the lower court’s decision, and I think folks are walking away, myself included, from oral arguments feeling less certain that that’s going to happen.”

Robert Henneke, general counsel for the American Future at the Texas Public Policy Foundation, said that plaintiffs “had a good day in court” and that the defendants’ arguments seemed to “hit a thud with the judges.” Mr. Henneke represents two individual plaintiffs from Texas in the lawsuit.

“Obamacare is still unconstitutional, and the three-judge panel seemed to agree with the trial court that the entirety of the law should be struck down,” Mr. Henneke said in a press conference after oral arguments. “The court really seemed skeptical with the arguments of the other side. We had the chance to tell the story of my clients and how they continue to be hurt by the Affordable Care Act.

Whichever way the Court of Appeals rules, the losing party is expected to appeal to the U.S. Supreme Court, Ms. Keith said. If justices accept the case, a decision could arrive in the summer of 2020, which would coincide with the presidential election. Another options is for the appellate court to send the case back to the lower court for further review, particularly to clear up the DOJ’s murky position, Ms. Keith said.

“They might send it back to [the lower court] and say there’s some questions here about what’s severable,” she said. “The DOJ sort of struggled to explain what they’re talking about. So they could remand the case back to Judge [Reed Charles] O’Connor to say, ‘Figure this out. Work with the parties.’ That’s an option.”

A decision by the Court of Appeals is expected in the next two months.

agallegos@mdedge.com

Appellate judges appeared to doubt that the Affordable Care Act should survive without the law’s signature insurance mandate during oral arguments on July 9, in a highly watched legal battle that may upend the health care law.

During the 2-hour hearing, a three-judge panel for the 5th U.S. Circuit Court of Appeals peppered attorneys with questions about whether Congress intended the ACA to function without the individual mandate, and the panel seemed doubtful the law can stand if the regulation is parsed, according to an audio transcript of the arguments. As written, the individual mandate required that all Americans have insurance or pay a tax penalty. However, budget legislation in 2017 zeroed out the penalties associated with the mandate, rendering it unenforceable.

Appeals Judge Kurt Engelhardt, a President Trump appointee, asked defense attorney Samuel Siegel why Congress failed to add a clause in the original law that would have allowed ACA components to be severed if such sectioning was acceptable.

“Congress could have included a severability clause when it adopted the ACA in 2010. Couldn’t it have done so?” Judge Engelhardt asked during oral arguments. “It seems like it did the opposite, where it said, ‘This is a complete overhaul,’ and it set forth a bunch of factual findings. Couldn’t Congress have said, ‘Oh by the way, we think all of these provisions are such excellent ideas and helpful to the public that if any go by the wayside, then we would want the remainder to continue to apply’?”

Congress’s silence on the severing of the ACA does not create a presumption against parsing of the law, argued Mr. Siegel, who is representing the Democratic states suing to retain the ACA in Texas v. United States. He emphasized that in 2017, when Congress terminated the individual mandate penalty, it chose not to repeal preexisting protections or other important reforms instituted by the ACA.

“With that action, your Honor, Congress expressed its views that the individual marketplace and indeed the entire Affordable Care Act can operate without an enforceable individual mandate,” Mr. Siegel said. “We think that’s all this court needs to know to resolve the severability question.”

However, Appellate Judge Jennifer Elrod, a President George W. Bush appointee to the court, questioned whether legislators zeroed out the mandate penalty because they knew the law could not survive without the core provision. She surmised that Congress might have assumed, “Aha, this is the silver bullet that’s going to undo Obamacare.”

Kyle Hawkins, an attorney representing the Republican-led plaintiff states, meanwhile, argued the text of the ACA clearly declares the individual mandate essential to the law and to the goals that Congress intended to achieve.

“The Obama administration thought of that as an inseverable clause,” Mr. Hawkins argued. “The district court directly synthesized those considerations ... and it reached the correct conclusion: The individual mandate is unconstitutional and it is inseverable from the remainder of the law.”

Texas v. United States stems from a legal challenge by a group of 18 Republican state attorneys general and two individuals in 2018 who argue the ACA should be declared unconstitutional. The plaintiffs say that, because budget legislation in 2017 effectively eliminated the penalty associated with the mandate, the requirement itself is invalid. Without the mandate, the entire law must fall, the plaintiffs contend. The Department of Justice declined to fully defend the law, so 16 Democratic state attorneys general intervened. In December 2018, a district court declared the entire ACA to be invalid, a decision immediately appealed to the 5th U.S. Circuit Court of Appeals by the Democratic attorneys general.

The Trump administration initially agreed that the mandate was unconstitutional and should be parsed. Attorneys for the administration said, if the mandate is found unconstitutional, the court should also consider finding two other provisions – the guaranteed issue and community rating requirements – of the ACA invalid. At the time, the Trump administration said the remainder of the ACA can stand without the three linked provisions. The administration later shifted its stance and asserted that much of the ACA should fall because provisions of the law cannot be severed. However, the DOJ expressed support in keeping some provision intact, such as certain criminal statutes that prevent health care fraud.

Most recently, the DOJ has indicated that, if the ACA is struck down or severed, the decision should only apply in the 18 plaintiff states and not to the entire nation. The fickle position of the Trump administration was questioned during the Court of Appeals hearing with judges asking DOJ attorney August Flentje to clarify why a final ruling should not apply nationwide.

“A lot of this stuff would need to get sorted out,” Mr. Flentje responded. “And it’s complicated. How it applies in the states and which parts can’t be applied at all because they would injure the states ... that raises a lot of complicated issues which I think [will be determined after] a final resolution.”

By their line of questioning, the appellate panel appeared to lean toward the plaintiffs’ position more so than toward the defendants’, said Katie Keith, an attorney and health law analyst who writes about Texas v. United States for the Health Affairs Blog.

“At least two of the three judges – the only two that were asking questions – seem very inclined to at, a minimum, strike down the individual mandate itself,” Ms. Keith said in an interview. “The conventional wisdom had been that this court would overturn the lower court’s decision, and I think folks are walking away, myself included, from oral arguments feeling less certain that that’s going to happen.”

Robert Henneke, general counsel for the American Future at the Texas Public Policy Foundation, said that plaintiffs “had a good day in court” and that the defendants’ arguments seemed to “hit a thud with the judges.” Mr. Henneke represents two individual plaintiffs from Texas in the lawsuit.

“Obamacare is still unconstitutional, and the three-judge panel seemed to agree with the trial court that the entirety of the law should be struck down,” Mr. Henneke said in a press conference after oral arguments. “The court really seemed skeptical with the arguments of the other side. We had the chance to tell the story of my clients and how they continue to be hurt by the Affordable Care Act.

Whichever way the Court of Appeals rules, the losing party is expected to appeal to the U.S. Supreme Court, Ms. Keith said. If justices accept the case, a decision could arrive in the summer of 2020, which would coincide with the presidential election. Another options is for the appellate court to send the case back to the lower court for further review, particularly to clear up the DOJ’s murky position, Ms. Keith said.

“They might send it back to [the lower court] and say there’s some questions here about what’s severable,” she said. “The DOJ sort of struggled to explain what they’re talking about. So they could remand the case back to Judge [Reed Charles] O’Connor to say, ‘Figure this out. Work with the parties.’ That’s an option.”

A decision by the Court of Appeals is expected in the next two months.

agallegos@mdedge.com

Appellate judges appeared to doubt that the Affordable Care Act should survive without the law’s signature insurance mandate during oral arguments on July 9, in a highly watched legal battle that may upend the health care law.

During the 2-hour hearing, a three-judge panel for the 5th U.S. Circuit Court of Appeals peppered attorneys with questions about whether Congress intended the ACA to function without the individual mandate, and the panel seemed doubtful the law can stand if the regulation is parsed, according to an audio transcript of the arguments. As written, the individual mandate required that all Americans have insurance or pay a tax penalty. However, budget legislation in 2017 zeroed out the penalties associated with the mandate, rendering it unenforceable.

Appeals Judge Kurt Engelhardt, a President Trump appointee, asked defense attorney Samuel Siegel why Congress failed to add a clause in the original law that would have allowed ACA components to be severed if such sectioning was acceptable.

“Congress could have included a severability clause when it adopted the ACA in 2010. Couldn’t it have done so?” Judge Engelhardt asked during oral arguments. “It seems like it did the opposite, where it said, ‘This is a complete overhaul,’ and it set forth a bunch of factual findings. Couldn’t Congress have said, ‘Oh by the way, we think all of these provisions are such excellent ideas and helpful to the public that if any go by the wayside, then we would want the remainder to continue to apply’?”

Congress’s silence on the severing of the ACA does not create a presumption against parsing of the law, argued Mr. Siegel, who is representing the Democratic states suing to retain the ACA in Texas v. United States. He emphasized that in 2017, when Congress terminated the individual mandate penalty, it chose not to repeal preexisting protections or other important reforms instituted by the ACA.

“With that action, your Honor, Congress expressed its views that the individual marketplace and indeed the entire Affordable Care Act can operate without an enforceable individual mandate,” Mr. Siegel said. “We think that’s all this court needs to know to resolve the severability question.”

However, Appellate Judge Jennifer Elrod, a President George W. Bush appointee to the court, questioned whether legislators zeroed out the mandate penalty because they knew the law could not survive without the core provision. She surmised that Congress might have assumed, “Aha, this is the silver bullet that’s going to undo Obamacare.”

Kyle Hawkins, an attorney representing the Republican-led plaintiff states, meanwhile, argued the text of the ACA clearly declares the individual mandate essential to the law and to the goals that Congress intended to achieve.

“The Obama administration thought of that as an inseverable clause,” Mr. Hawkins argued. “The district court directly synthesized those considerations ... and it reached the correct conclusion: The individual mandate is unconstitutional and it is inseverable from the remainder of the law.”

Texas v. United States stems from a legal challenge by a group of 18 Republican state attorneys general and two individuals in 2018 who argue the ACA should be declared unconstitutional. The plaintiffs say that, because budget legislation in 2017 effectively eliminated the penalty associated with the mandate, the requirement itself is invalid. Without the mandate, the entire law must fall, the plaintiffs contend. The Department of Justice declined to fully defend the law, so 16 Democratic state attorneys general intervened. In December 2018, a district court declared the entire ACA to be invalid, a decision immediately appealed to the 5th U.S. Circuit Court of Appeals by the Democratic attorneys general.

The Trump administration initially agreed that the mandate was unconstitutional and should be parsed. Attorneys for the administration said, if the mandate is found unconstitutional, the court should also consider finding two other provisions – the guaranteed issue and community rating requirements – of the ACA invalid. At the time, the Trump administration said the remainder of the ACA can stand without the three linked provisions. The administration later shifted its stance and asserted that much of the ACA should fall because provisions of the law cannot be severed. However, the DOJ expressed support in keeping some provision intact, such as certain criminal statutes that prevent health care fraud.

Most recently, the DOJ has indicated that, if the ACA is struck down or severed, the decision should only apply in the 18 plaintiff states and not to the entire nation. The fickle position of the Trump administration was questioned during the Court of Appeals hearing with judges asking DOJ attorney August Flentje to clarify why a final ruling should not apply nationwide.

“A lot of this stuff would need to get sorted out,” Mr. Flentje responded. “And it’s complicated. How it applies in the states and which parts can’t be applied at all because they would injure the states ... that raises a lot of complicated issues which I think [will be determined after] a final resolution.”

By their line of questioning, the appellate panel appeared to lean toward the plaintiffs’ position more so than toward the defendants’, said Katie Keith, an attorney and health law analyst who writes about Texas v. United States for the Health Affairs Blog.

“At least two of the three judges – the only two that were asking questions – seem very inclined to at, a minimum, strike down the individual mandate itself,” Ms. Keith said in an interview. “The conventional wisdom had been that this court would overturn the lower court’s decision, and I think folks are walking away, myself included, from oral arguments feeling less certain that that’s going to happen.”

Robert Henneke, general counsel for the American Future at the Texas Public Policy Foundation, said that plaintiffs “had a good day in court” and that the defendants’ arguments seemed to “hit a thud with the judges.” Mr. Henneke represents two individual plaintiffs from Texas in the lawsuit.

“Obamacare is still unconstitutional, and the three-judge panel seemed to agree with the trial court that the entirety of the law should be struck down,” Mr. Henneke said in a press conference after oral arguments. “The court really seemed skeptical with the arguments of the other side. We had the chance to tell the story of my clients and how they continue to be hurt by the Affordable Care Act.

Whichever way the Court of Appeals rules, the losing party is expected to appeal to the U.S. Supreme Court, Ms. Keith said. If justices accept the case, a decision could arrive in the summer of 2020, which would coincide with the presidential election. Another options is for the appellate court to send the case back to the lower court for further review, particularly to clear up the DOJ’s murky position, Ms. Keith said.

“They might send it back to [the lower court] and say there’s some questions here about what’s severable,” she said. “The DOJ sort of struggled to explain what they’re talking about. So they could remand the case back to Judge [Reed Charles] O’Connor to say, ‘Figure this out. Work with the parties.’ That’s an option.”

A decision by the Court of Appeals is expected in the next two months.

agallegos@mdedge.com

Children exposed to opioids via maternal use during pregnancy were at increased risk of perinatal and postnatal physical and neurodevelopmental disabilities, according to data from more than 8,000 children.

Antonio_Diaz/Thinkstock

Previous studies have shown the increased risk of a range of health problems associated with maternal opioid use, including neonatal abstinence syndrome (NAS), but data on the long-term consequences of in utero opioid exposure are limited, wrote Romuladus E. Azuine, DrPH, MPH, of the U.S. Department of Health and Human Services, Rockville, Md., and colleagues.

In a study published in JAMA Network Open, the researchers reviewed data from 8,509 mother/newborn pairs in the Boston Birth Cohort, a database that included a large urban, low-income, multiethnic population of women who had singleton births at the Boston Medical Center starting in 1998.

A total of 454 infants (5%) experienced prenatal opioid exposure. Mothers were interviewed 48-72 hours after delivery about sociodemographic factors, drug use, smoking, and alcohol use.

The risk of small for gestational age and preterm birth were significantly higher in babies exposed to opioids (OR 1.87 and OR 1.49, respectively), compared with unexposed newborns.

Children’s developmental outcomes were collected starting in 2003 based on electronic medical records. A total of 3,153 mother-newborn pairs were enrolled in a postnatal follow-up study. For preschoolers, prenatal opioid exposure was associated with increased risk of lack of expected physiological development and conduct disorder/emotional disturbance (OR 1.80 and OR 2.13, respectively), compared with unexposed children. School-aged children with prenatal opioid exposure had an increased risk of ADHD (OR 2.55).

The incidence of NAS in the study population was at least 24 per 1,000 hospital births starting in 2004, and peaked at 61 per 1,000 hospital births in 2008, but remained higher than 32 per 1,000 through 2016.

The study findings were limited by several factors including potential misclassification of opioid exposure, confounding from other pregnancy exposures, loss of many participants to follow-up, and a lack of generalizability, but the results support the need for additional research, and show that the prevalence of NAS was approximately 10 times the national average in a subset of low-income, urban, minority women, the researchers said.

“However, the effect of opioids is still difficult to disentangle from effects of other childhood exposures. Policy and programmatic efforts to prevent NAS and mitigate its health consequences require more comprehensive longitudinal and intergenerational research,” they concluded.

The study findings contribute to and support the evidence of poor neurodevelopmental and emotional/behavioral outcomes for children with prenatal exposure to opioids or a history of NAS, Susan Brogly, PhD, MSc, noted in an accompanying editorial. Other studies have shown increased risks for visual impairments including strabismus, reduced visual acuity, and delayed visual maturation.

Dr. Brogly, of Queen’s University, Kingston Health Science Center, Ontario, nonetheless noted that a child’s home environment may modify the impact of prenatal opioid exposure or NAS, as evidence has shown that children with in utero heroin exposure have improved outcomes in healthy home environments.

Although the mechanism for how opioid exposure affects development remains uncertain, she suggested that future research should address “interventions to improve health outcomes in this rapidly growing population of children, regardless of the causal mechanism of impairment.”

Dr. Brogly noted that most of the opioid-using mothers in the study by Azuine et al. were unmarried, non-Hispanic white, and multiparous, and had histories of other substance abuse. She emphasized the need for supportive communities for women at risk of opioid use, who also are more likely to have unstable housing situations and histories of sexual and physical abuse.

“The risks of poor pregnancy and child outcomes in cases of maternal opioid exposure are not because of prenatal opioid exposure alone; ongoing difficult social and environmental circumstances have an important role,” and future interventions should address these circumstances to improve long-term health of high-risk women and their children, she emphasized.

The Boston Birth Cohort study is supported in part by grants from the National Institutes of Health and the U.S. Department of Health and Human Services. None of the authors had financial conflicts to disclose.

Dr. Brogly disclosed grants from the Eunice Kennedy Shriver National Institute of Child Health and Human Development outside the submitted work.

SOURCE: Azuine RE et al. JAMA Network Open. 2019 Jun 28. doi: 10.1001/jamanetworkopen.2019.6405; Brogly S. JAMA Network Open. 2019 Jun 28. doi:10.1001/jamanetworkopen.2019.6428.

Children exposed to opioids via maternal use during pregnancy were at increased risk of perinatal and postnatal physical and neurodevelopmental disabilities, according to data from more than 8,000 children.

Antonio_Diaz/Thinkstock

Previous studies have shown the increased risk of a range of health problems associated with maternal opioid use, including neonatal abstinence syndrome (NAS), but data on the long-term consequences of in utero opioid exposure are limited, wrote Romuladus E. Azuine, DrPH, MPH, of the U.S. Department of Health and Human Services, Rockville, Md., and colleagues.

In a study published in JAMA Network Open, the researchers reviewed data from 8,509 mother/newborn pairs in the Boston Birth Cohort, a database that included a large urban, low-income, multiethnic population of women who had singleton births at the Boston Medical Center starting in 1998.

A total of 454 infants (5%) experienced prenatal opioid exposure. Mothers were interviewed 48-72 hours after delivery about sociodemographic factors, drug use, smoking, and alcohol use.

The risk of small for gestational age and preterm birth were significantly higher in babies exposed to opioids (OR 1.87 and OR 1.49, respectively), compared with unexposed newborns.

Children’s developmental outcomes were collected starting in 2003 based on electronic medical records. A total of 3,153 mother-newborn pairs were enrolled in a postnatal follow-up study. For preschoolers, prenatal opioid exposure was associated with increased risk of lack of expected physiological development and conduct disorder/emotional disturbance (OR 1.80 and OR 2.13, respectively), compared with unexposed children. School-aged children with prenatal opioid exposure had an increased risk of ADHD (OR 2.55).

The incidence of NAS in the study population was at least 24 per 1,000 hospital births starting in 2004, and peaked at 61 per 1,000 hospital births in 2008, but remained higher than 32 per 1,000 through 2016.

The study findings were limited by several factors including potential misclassification of opioid exposure, confounding from other pregnancy exposures, loss of many participants to follow-up, and a lack of generalizability, but the results support the need for additional research, and show that the prevalence of NAS was approximately 10 times the national average in a subset of low-income, urban, minority women, the researchers said.

“However, the effect of opioids is still difficult to disentangle from effects of other childhood exposures. Policy and programmatic efforts to prevent NAS and mitigate its health consequences require more comprehensive longitudinal and intergenerational research,” they concluded.

The study findings contribute to and support the evidence of poor neurodevelopmental and emotional/behavioral outcomes for children with prenatal exposure to opioids or a history of NAS, Susan Brogly, PhD, MSc, noted in an accompanying editorial. Other studies have shown increased risks for visual impairments including strabismus, reduced visual acuity, and delayed visual maturation.

Dr. Brogly, of Queen’s University, Kingston Health Science Center, Ontario, nonetheless noted that a child’s home environment may modify the impact of prenatal opioid exposure or NAS, as evidence has shown that children with in utero heroin exposure have improved outcomes in healthy home environments.

Although the mechanism for how opioid exposure affects development remains uncertain, she suggested that future research should address “interventions to improve health outcomes in this rapidly growing population of children, regardless of the causal mechanism of impairment.”

Dr. Brogly noted that most of the opioid-using mothers in the study by Azuine et al. were unmarried, non-Hispanic white, and multiparous, and had histories of other substance abuse. She emphasized the need for supportive communities for women at risk of opioid use, who also are more likely to have unstable housing situations and histories of sexual and physical abuse.

“The risks of poor pregnancy and child outcomes in cases of maternal opioid exposure are not because of prenatal opioid exposure alone; ongoing difficult social and environmental circumstances have an important role,” and future interventions should address these circumstances to improve long-term health of high-risk women and their children, she emphasized.

The Boston Birth Cohort study is supported in part by grants from the National Institutes of Health and the U.S. Department of Health and Human Services. None of the authors had financial conflicts to disclose.

Dr. Brogly disclosed grants from the Eunice Kennedy Shriver National Institute of Child Health and Human Development outside the submitted work.

SOURCE: Azuine RE et al. JAMA Network Open. 2019 Jun 28. doi: 10.1001/jamanetworkopen.2019.6405; Brogly S. JAMA Network Open. 2019 Jun 28. doi:10.1001/jamanetworkopen.2019.6428.

Children exposed to opioids via maternal use during pregnancy were at increased risk of perinatal and postnatal physical and neurodevelopmental disabilities, according to data from more than 8,000 children.

Antonio_Diaz/Thinkstock

Previous studies have shown the increased risk of a range of health problems associated with maternal opioid use, including neonatal abstinence syndrome (NAS), but data on the long-term consequences of in utero opioid exposure are limited, wrote Romuladus E. Azuine, DrPH, MPH, of the U.S. Department of Health and Human Services, Rockville, Md., and colleagues.

In a study published in JAMA Network Open, the researchers reviewed data from 8,509 mother/newborn pairs in the Boston Birth Cohort, a database that included a large urban, low-income, multiethnic population of women who had singleton births at the Boston Medical Center starting in 1998.

A total of 454 infants (5%) experienced prenatal opioid exposure. Mothers were interviewed 48-72 hours after delivery about sociodemographic factors, drug use, smoking, and alcohol use.

The risk of small for gestational age and preterm birth were significantly higher in babies exposed to opioids (OR 1.87 and OR 1.49, respectively), compared with unexposed newborns.

Children’s developmental outcomes were collected starting in 2003 based on electronic medical records. A total of 3,153 mother-newborn pairs were enrolled in a postnatal follow-up study. For preschoolers, prenatal opioid exposure was associated with increased risk of lack of expected physiological development and conduct disorder/emotional disturbance (OR 1.80 and OR 2.13, respectively), compared with unexposed children. School-aged children with prenatal opioid exposure had an increased risk of ADHD (OR 2.55).

The incidence of NAS in the study population was at least 24 per 1,000 hospital births starting in 2004, and peaked at 61 per 1,000 hospital births in 2008, but remained higher than 32 per 1,000 through 2016.

The study findings were limited by several factors including potential misclassification of opioid exposure, confounding from other pregnancy exposures, loss of many participants to follow-up, and a lack of generalizability, but the results support the need for additional research, and show that the prevalence of NAS was approximately 10 times the national average in a subset of low-income, urban, minority women, the researchers said.

“However, the effect of opioids is still difficult to disentangle from effects of other childhood exposures. Policy and programmatic efforts to prevent NAS and mitigate its health consequences require more comprehensive longitudinal and intergenerational research,” they concluded.

The study findings contribute to and support the evidence of poor neurodevelopmental and emotional/behavioral outcomes for children with prenatal exposure to opioids or a history of NAS, Susan Brogly, PhD, MSc, noted in an accompanying editorial. Other studies have shown increased risks for visual impairments including strabismus, reduced visual acuity, and delayed visual maturation.

Dr. Brogly, of Queen’s University, Kingston Health Science Center, Ontario, nonetheless noted that a child’s home environment may modify the impact of prenatal opioid exposure or NAS, as evidence has shown that children with in utero heroin exposure have improved outcomes in healthy home environments.

Although the mechanism for how opioid exposure affects development remains uncertain, she suggested that future research should address “interventions to improve health outcomes in this rapidly growing population of children, regardless of the causal mechanism of impairment.”

Dr. Brogly noted that most of the opioid-using mothers in the study by Azuine et al. were unmarried, non-Hispanic white, and multiparous, and had histories of other substance abuse. She emphasized the need for supportive communities for women at risk of opioid use, who also are more likely to have unstable housing situations and histories of sexual and physical abuse.

“The risks of poor pregnancy and child outcomes in cases of maternal opioid exposure are not because of prenatal opioid exposure alone; ongoing difficult social and environmental circumstances have an important role,” and future interventions should address these circumstances to improve long-term health of high-risk women and their children, she emphasized.

The Boston Birth Cohort study is supported in part by grants from the National Institutes of Health and the U.S. Department of Health and Human Services. None of the authors had financial conflicts to disclose.

Dr. Brogly disclosed grants from the Eunice Kennedy Shriver National Institute of Child Health and Human Development outside the submitted work.

SOURCE: Azuine RE et al. JAMA Network Open. 2019 Jun 28. doi: 10.1001/jamanetworkopen.2019.6405; Brogly S. JAMA Network Open. 2019 Jun 28. doi:10.1001/jamanetworkopen.2019.6428.

SEATTLE – In patients with multiple sclerosis (MS), black holes are associated with worse cognitive function, including processing speed and visuospatial memory, according to an investigation presented at the annual meeting of the Consortium of Multiple Sclerosis Centers. Black holes are not associated with physical function, however. Evaluating black holes as part of routine clinical practice could be a quick method for screening people with MS for referral to a comprehensive cognitive assessment, said the authors.

Black holes (also known as T1-hypointense lesions) can be used as a marker of axonal loss and neuronal tissue destruction in patients with MS. Loss of axons and destruction of neuronal tissue contribute to cognitive and physical disability, but the literature contains few data about whether black holes correlate with cognitive and physical outcomes in MS.

Serkan Özakbas, MD, professor of neurology at Dokuz Eylül University in Izmir, Turkey, and colleagues examined 226 patients with MS to investigate this potential correlation. The population’s median Expanded Disability Status Scale score was 1.5. The researchers categorized participants into two groups according whether they had at least one black hole or not. They assessed patients’ cognitive function by administering the Brief International Cognitive Assessment for MS (BICAMS), which comprises the Symbol Digit Modalities Test (SDMT), California Verbal Learning Test II (CVLT-II), and the Brief Visuospatial Memory Test–Revised (BVMTR). They evaluated participants’ physical function using the Timed 25-Foot Walk (T25FW), Nine-Hole Peg Test (9HPT), 6-Minute Walk Test (6MWT), Timed Up and Go (TUG), and 12-Item MS Walking Scale (MSWS-12).

In all, 116 (43.6%) participants had at least one black hole, and 150 (56.4%) had no black hole. Dr. Özakbas and colleagues found no significant difference between patients with and without black holes on the T25FW, 9HPT, 6MWT, TUG, MSWS-12, and CVLT-II. Patients without a black hole, however, had significantly higher SDMT (49.0 vs 42.9) and BVMTR (26.3 vs 23.3) scores, compared with those with at least one black hole.

“This study suggests that presence of black holes is related to cognitive function, but not to physical function,” the researchers concluded.

The investigators had no disclosures and conducted their study without financial support.
 

egreb@mdedge.com

SOURCE: Özakbas S et al. CMSC 2019, Abstract IMG02.

SEATTLE – In patients with multiple sclerosis (MS), black holes are associated with worse cognitive function, including processing speed and visuospatial memory, according to an investigation presented at the annual meeting of the Consortium of Multiple Sclerosis Centers. Black holes are not associated with physical function, however. Evaluating black holes as part of routine clinical practice could be a quick method for screening people with MS for referral to a comprehensive cognitive assessment, said the authors.

Black holes (also known as T1-hypointense lesions) can be used as a marker of axonal loss and neuronal tissue destruction in patients with MS. Loss of axons and destruction of neuronal tissue contribute to cognitive and physical disability, but the literature contains few data about whether black holes correlate with cognitive and physical outcomes in MS.

Serkan Özakbas, MD, professor of neurology at Dokuz Eylül University in Izmir, Turkey, and colleagues examined 226 patients with MS to investigate this potential correlation. The population’s median Expanded Disability Status Scale score was 1.5. The researchers categorized participants into two groups according whether they had at least one black hole or not. They assessed patients’ cognitive function by administering the Brief International Cognitive Assessment for MS (BICAMS), which comprises the Symbol Digit Modalities Test (SDMT), California Verbal Learning Test II (CVLT-II), and the Brief Visuospatial Memory Test–Revised (BVMTR). They evaluated participants’ physical function using the Timed 25-Foot Walk (T25FW), Nine-Hole Peg Test (9HPT), 6-Minute Walk Test (6MWT), Timed Up and Go (TUG), and 12-Item MS Walking Scale (MSWS-12).

In all, 116 (43.6%) participants had at least one black hole, and 150 (56.4%) had no black hole. Dr. Özakbas and colleagues found no significant difference between patients with and without black holes on the T25FW, 9HPT, 6MWT, TUG, MSWS-12, and CVLT-II. Patients without a black hole, however, had significantly higher SDMT (49.0 vs 42.9) and BVMTR (26.3 vs 23.3) scores, compared with those with at least one black hole.

“This study suggests that presence of black holes is related to cognitive function, but not to physical function,” the researchers concluded.

The investigators had no disclosures and conducted their study without financial support.
 

egreb@mdedge.com

SOURCE: Özakbas S et al. CMSC 2019, Abstract IMG02.

SEATTLE – In patients with multiple sclerosis (MS), black holes are associated with worse cognitive function, including processing speed and visuospatial memory, according to an investigation presented at the annual meeting of the Consortium of Multiple Sclerosis Centers. Black holes are not associated with physical function, however. Evaluating black holes as part of routine clinical practice could be a quick method for screening people with MS for referral to a comprehensive cognitive assessment, said the authors.

Black holes (also known as T1-hypointense lesions) can be used as a marker of axonal loss and neuronal tissue destruction in patients with MS. Loss of axons and destruction of neuronal tissue contribute to cognitive and physical disability, but the literature contains few data about whether black holes correlate with cognitive and physical outcomes in MS.

Serkan Özakbas, MD, professor of neurology at Dokuz Eylül University in Izmir, Turkey, and colleagues examined 226 patients with MS to investigate this potential correlation. The population’s median Expanded Disability Status Scale score was 1.5. The researchers categorized participants into two groups according whether they had at least one black hole or not. They assessed patients’ cognitive function by administering the Brief International Cognitive Assessment for MS (BICAMS), which comprises the Symbol Digit Modalities Test (SDMT), California Verbal Learning Test II (CVLT-II), and the Brief Visuospatial Memory Test–Revised (BVMTR). They evaluated participants’ physical function using the Timed 25-Foot Walk (T25FW), Nine-Hole Peg Test (9HPT), 6-Minute Walk Test (6MWT), Timed Up and Go (TUG), and 12-Item MS Walking Scale (MSWS-12).

In all, 116 (43.6%) participants had at least one black hole, and 150 (56.4%) had no black hole. Dr. Özakbas and colleagues found no significant difference between patients with and without black holes on the T25FW, 9HPT, 6MWT, TUG, MSWS-12, and CVLT-II. Patients without a black hole, however, had significantly higher SDMT (49.0 vs 42.9) and BVMTR (26.3 vs 23.3) scores, compared with those with at least one black hole.

“This study suggests that presence of black holes is related to cognitive function, but not to physical function,” the researchers concluded.

The investigators had no disclosures and conducted their study without financial support.
 

egreb@mdedge.com

SOURCE: Özakbas S et al. CMSC 2019, Abstract IMG02.

The Department of Health & Human Services lacks the authority to require drug manufacturers to disclose the list price of drugs in television advertising, a district court judge has ruled.

©Mathier/thinkstockphotos.com

“The court finds that HHS lacks the statutory authority under the Social Security Act to adopt the [Wholesale Acquisition Cost] Disclosure Rule,” Judge Amit P. Mehta of the U.S. District Court for the District of Columbia, said in his July 8 ruling.

“Neither the [Social Security] Act’s text, structure, nor context evince an intent by Congress to empower HHS to issue a rule that compels drug manufacturers to disclose list prices. The rule is therefore invalid,” according to the ruling.

The ruling stems from a case brought against HHS by Merck & Co. Inc., Eli Lilly and Company, and Amgen Inc., along with the National Association of Advertisers Inc., in response to the May 8 final rule that required pharmaceutical manufacturers to include the wholesale acquisition cost (WAC) if above $35, in all television advertising. The final rule also required a disclaimer that if a person had health insurance that covers drugs, “your cost may be different.”

In addition to not having authority, the court took exception to the HHS issuing the rule through the Centers for Medicare & Medicaid Services.

“It has adopted a rule that regulates the conduct of market actors that are not direct participants in the Medicare or Medicaid programs,” the ruling states. “Pharmaceutical manufacturers are not health care providers, private plan carriers, or beneficiaries – each of whom plays a direct role in the public health insurance programs. They do not receive payment for their products from CMS. Their pricing decisions, of course, affect the cost of pharmaceutical benefits offered under the Medicare and Medicaid programs. But those decisions impact the program costs in an indirect way.”

The American Medical Association expressed disappointment that the final rule is not moving forward.

“The AMA supported the Trump Administration’s effort to require pricing information in direct-to-consumer television advertising of prescription drugs,” AMA President Patrice Harris, MD, said in a statement. “Last year, the AMA called for regulations requiring the ads to include the manufacturer’s list price of those drugs, and we have supported similar legislative efforts.”

Dr. Harris noted that having the list price would provide a vital piece of information when patients and their physicians are discussing treatment options, as it would “help patients have a more complete picture when faced with prescription drug ads. While current ads outline the potential benefits and side effects, a crucial factor for patients – the drug’s price – is not included. Patients, especially those who pay a drug’s list price or whose cost-sharing is based on the list price, would benefit by having another tool in their toolbox as they work with their physicians to determine their prescription drug regimens.”

Likewise, AARP also expressed disappointment in the decision, calling it “a step backward in the battle against skyrocketing drug prices and providing more information to consumers. Americans should be trusted to evaluate drug price information and discuss any concerns with their health care providers.”

Judge Mehta noted in his ruling that “the court does not question HHS’ motives in adopting the WAC Disclosure Rule. ... That policy very well could be an effective tool in halting the rising cost of prescription drugs. But no matter how vexing the problem of spiraling drug costs may be, HHS cannot do more than what Congress has authorized. The responsibility rests with Congress to act in the first instance.”

gtwachtman@mdedge.com

The Department of Health & Human Services lacks the authority to require drug manufacturers to disclose the list price of drugs in television advertising, a district court judge has ruled.

©Mathier/thinkstockphotos.com

“The court finds that HHS lacks the statutory authority under the Social Security Act to adopt the [Wholesale Acquisition Cost] Disclosure Rule,” Judge Amit P. Mehta of the U.S. District Court for the District of Columbia, said in his July 8 ruling.

“Neither the [Social Security] Act’s text, structure, nor context evince an intent by Congress to empower HHS to issue a rule that compels drug manufacturers to disclose list prices. The rule is therefore invalid,” according to the ruling.

The ruling stems from a case brought against HHS by Merck & Co. Inc., Eli Lilly and Company, and Amgen Inc., along with the National Association of Advertisers Inc., in response to the May 8 final rule that required pharmaceutical manufacturers to include the wholesale acquisition cost (WAC) if above $35, in all television advertising. The final rule also required a disclaimer that if a person had health insurance that covers drugs, “your cost may be different.”

In addition to not having authority, the court took exception to the HHS issuing the rule through the Centers for Medicare & Medicaid Services.

“It has adopted a rule that regulates the conduct of market actors that are not direct participants in the Medicare or Medicaid programs,” the ruling states. “Pharmaceutical manufacturers are not health care providers, private plan carriers, or beneficiaries – each of whom plays a direct role in the public health insurance programs. They do not receive payment for their products from CMS. Their pricing decisions, of course, affect the cost of pharmaceutical benefits offered under the Medicare and Medicaid programs. But those decisions impact the program costs in an indirect way.”

The American Medical Association expressed disappointment that the final rule is not moving forward.

“The AMA supported the Trump Administration’s effort to require pricing information in direct-to-consumer television advertising of prescription drugs,” AMA President Patrice Harris, MD, said in a statement. “Last year, the AMA called for regulations requiring the ads to include the manufacturer’s list price of those drugs, and we have supported similar legislative efforts.”

Dr. Harris noted that having the list price would provide a vital piece of information when patients and their physicians are discussing treatment options, as it would “help patients have a more complete picture when faced with prescription drug ads. While current ads outline the potential benefits and side effects, a crucial factor for patients – the drug’s price – is not included. Patients, especially those who pay a drug’s list price or whose cost-sharing is based on the list price, would benefit by having another tool in their toolbox as they work with their physicians to determine their prescription drug regimens.”

Likewise, AARP also expressed disappointment in the decision, calling it “a step backward in the battle against skyrocketing drug prices and providing more information to consumers. Americans should be trusted to evaluate drug price information and discuss any concerns with their health care providers.”

Judge Mehta noted in his ruling that “the court does not question HHS’ motives in adopting the WAC Disclosure Rule. ... That policy very well could be an effective tool in halting the rising cost of prescription drugs. But no matter how vexing the problem of spiraling drug costs may be, HHS cannot do more than what Congress has authorized. The responsibility rests with Congress to act in the first instance.”

gtwachtman@mdedge.com

The Department of Health & Human Services lacks the authority to require drug manufacturers to disclose the list price of drugs in television advertising, a district court judge has ruled.

©Mathier/thinkstockphotos.com

“The court finds that HHS lacks the statutory authority under the Social Security Act to adopt the [Wholesale Acquisition Cost] Disclosure Rule,” Judge Amit P. Mehta of the U.S. District Court for the District of Columbia, said in his July 8 ruling.

“Neither the [Social Security] Act’s text, structure, nor context evince an intent by Congress to empower HHS to issue a rule that compels drug manufacturers to disclose list prices. The rule is therefore invalid,” according to the ruling.

The ruling stems from a case brought against HHS by Merck & Co. Inc., Eli Lilly and Company, and Amgen Inc., along with the National Association of Advertisers Inc., in response to the May 8 final rule that required pharmaceutical manufacturers to include the wholesale acquisition cost (WAC) if above $35, in all television advertising. The final rule also required a disclaimer that if a person had health insurance that covers drugs, “your cost may be different.”

In addition to not having authority, the court took exception to the HHS issuing the rule through the Centers for Medicare & Medicaid Services.

“It has adopted a rule that regulates the conduct of market actors that are not direct participants in the Medicare or Medicaid programs,” the ruling states. “Pharmaceutical manufacturers are not health care providers, private plan carriers, or beneficiaries – each of whom plays a direct role in the public health insurance programs. They do not receive payment for their products from CMS. Their pricing decisions, of course, affect the cost of pharmaceutical benefits offered under the Medicare and Medicaid programs. But those decisions impact the program costs in an indirect way.”

The American Medical Association expressed disappointment that the final rule is not moving forward.

“The AMA supported the Trump Administration’s effort to require pricing information in direct-to-consumer television advertising of prescription drugs,” AMA President Patrice Harris, MD, said in a statement. “Last year, the AMA called for regulations requiring the ads to include the manufacturer’s list price of those drugs, and we have supported similar legislative efforts.”

Dr. Harris noted that having the list price would provide a vital piece of information when patients and their physicians are discussing treatment options, as it would “help patients have a more complete picture when faced with prescription drug ads. While current ads outline the potential benefits and side effects, a crucial factor for patients – the drug’s price – is not included. Patients, especially those who pay a drug’s list price or whose cost-sharing is based on the list price, would benefit by having another tool in their toolbox as they work with their physicians to determine their prescription drug regimens.”

Likewise, AARP also expressed disappointment in the decision, calling it “a step backward in the battle against skyrocketing drug prices and providing more information to consumers. Americans should be trusted to evaluate drug price information and discuss any concerns with their health care providers.”

Judge Mehta noted in his ruling that “the court does not question HHS’ motives in adopting the WAC Disclosure Rule. ... That policy very well could be an effective tool in halting the rising cost of prescription drugs. But no matter how vexing the problem of spiraling drug costs may be, HHS cannot do more than what Congress has authorized. The responsibility rests with Congress to act in the first instance.”

gtwachtman@mdedge.com