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Lucas Franki is an associate editor for MDedge News, and has been with the company since 2014. He has a BA in English from Penn State University and is an Eagle Scout.
FDA approves multiple ambrisentan generics for patients with PAH
The Food and Drug Administration has approved multiple generics for ambrisentan (Letairis) tablets, as well as their associated risk evaluation and mitigation strategies (REMS), for patients with pulmonary arterial hypertension.
A total of four generics were approved, licensed to Mylan Pharmaceuticals, Sun Pharma Global, Watson Laboratories, and Zydus Pharmaceuticals. All four were approved at 5-mg and 10-mg doses. According to the label, the most common adverse events associated with ambrisentan include peripheral edema, nasal congestion, sinusitis, and flushing.
In addition to the generics, the FDA also approved two shared system REMS programs for ambrisentan. The first, Ambrisentan REMS, includes the brand sponsor and three abbreviated new drug applications. The FDA also approved two shared system REMS programs for ambrisentan. The first, Ambrisentan REMS, is composed of the brand sponsor and three abbreviated new drug applications. The second, PS-Ambrisentan REMS, is a parallel system and currently is constituted by one abbreviated new drug application.
“With the approval of these first generics ... patients will now have access to additional products (brand-name and generic) and additional types of pharmacies to fill their prescriptions,” the FDA said.
Find the full press release on the FDA website.
The Food and Drug Administration has approved multiple generics for ambrisentan (Letairis) tablets, as well as their associated risk evaluation and mitigation strategies (REMS), for patients with pulmonary arterial hypertension.
A total of four generics were approved, licensed to Mylan Pharmaceuticals, Sun Pharma Global, Watson Laboratories, and Zydus Pharmaceuticals. All four were approved at 5-mg and 10-mg doses. According to the label, the most common adverse events associated with ambrisentan include peripheral edema, nasal congestion, sinusitis, and flushing.
In addition to the generics, the FDA also approved two shared system REMS programs for ambrisentan. The first, Ambrisentan REMS, includes the brand sponsor and three abbreviated new drug applications. The FDA also approved two shared system REMS programs for ambrisentan. The first, Ambrisentan REMS, is composed of the brand sponsor and three abbreviated new drug applications. The second, PS-Ambrisentan REMS, is a parallel system and currently is constituted by one abbreviated new drug application.
“With the approval of these first generics ... patients will now have access to additional products (brand-name and generic) and additional types of pharmacies to fill their prescriptions,” the FDA said.
Find the full press release on the FDA website.
The Food and Drug Administration has approved multiple generics for ambrisentan (Letairis) tablets, as well as their associated risk evaluation and mitigation strategies (REMS), for patients with pulmonary arterial hypertension.
A total of four generics were approved, licensed to Mylan Pharmaceuticals, Sun Pharma Global, Watson Laboratories, and Zydus Pharmaceuticals. All four were approved at 5-mg and 10-mg doses. According to the label, the most common adverse events associated with ambrisentan include peripheral edema, nasal congestion, sinusitis, and flushing.
In addition to the generics, the FDA also approved two shared system REMS programs for ambrisentan. The first, Ambrisentan REMS, includes the brand sponsor and three abbreviated new drug applications. The FDA also approved two shared system REMS programs for ambrisentan. The first, Ambrisentan REMS, is composed of the brand sponsor and three abbreviated new drug applications. The second, PS-Ambrisentan REMS, is a parallel system and currently is constituted by one abbreviated new drug application.
“With the approval of these first generics ... patients will now have access to additional products (brand-name and generic) and additional types of pharmacies to fill their prescriptions,” the FDA said.
Find the full press release on the FDA website.
FDA approves Mavenclad for treatment of relapsing MS
including relapsing/remitting and active secondary progressive disease.
The drug’s manufacturer, EMD Serono, said in a press release that cladribine is the first short-course oral therapy for such patients, and its use is generally recommended for patients who have had an inadequate response to, or are unable to tolerate, an alternate drug indicated for the treatment of MS. Cladribine is not recommended for use in patients with clinically isolated syndrome.
The agency’s decision is based on results from a clinical trial of 1,326 patients with relapsing MS who had experienced at least one relapse in the previous 12 months. Patients who received cladribine had significantly fewer relapses than did those who received placebo; the progression of disability was also significantly reduced in the cladribine group, compared with placebo, according to the FDA’s announcement.
The most common adverse events associated with cladribine include upper respiratory tract infections, headache, and decreased lymphocyte counts. In addition, the medication must be dispensed with a patient medication guide because the label includes a boxed warning for increased risk of malignancy and fetal harm. Other warnings include a risk for decreased lymphocyte count, hematologic toxicity and bone marrow suppression, and graft-versus-host-disease.
“We are committed to supporting the development of safe and effective treatments for patients with multiple sclerosis. The approval of Mavenclad represents an additional option for patients who have tried another treatment without success,” Billy Dunn, MD, director of the division of neurology products in the FDA’s Center for Drug Evaluation and Research, said in the announcement.
The approved dose of cladribine is 3.5 mg/kg body weight over 2 years, administered as one treatment course of 1.75 mg/kg per year, each consisting of 2 treatment weeks. Additional courses of cladribine are not to be administered because retreatment with cladribine during years 3 and 4 may further increase the risk of malignancy. The safety and efficacy of reinitiating cladribine more than 2 years after completing two treatment courses has not been studied, according to EMD Serono.
Cladribine is approved in more than 50 other countries and was approved for use in the European Union in August 2017.
including relapsing/remitting and active secondary progressive disease.
The drug’s manufacturer, EMD Serono, said in a press release that cladribine is the first short-course oral therapy for such patients, and its use is generally recommended for patients who have had an inadequate response to, or are unable to tolerate, an alternate drug indicated for the treatment of MS. Cladribine is not recommended for use in patients with clinically isolated syndrome.
The agency’s decision is based on results from a clinical trial of 1,326 patients with relapsing MS who had experienced at least one relapse in the previous 12 months. Patients who received cladribine had significantly fewer relapses than did those who received placebo; the progression of disability was also significantly reduced in the cladribine group, compared with placebo, according to the FDA’s announcement.
The most common adverse events associated with cladribine include upper respiratory tract infections, headache, and decreased lymphocyte counts. In addition, the medication must be dispensed with a patient medication guide because the label includes a boxed warning for increased risk of malignancy and fetal harm. Other warnings include a risk for decreased lymphocyte count, hematologic toxicity and bone marrow suppression, and graft-versus-host-disease.
“We are committed to supporting the development of safe and effective treatments for patients with multiple sclerosis. The approval of Mavenclad represents an additional option for patients who have tried another treatment without success,” Billy Dunn, MD, director of the division of neurology products in the FDA’s Center for Drug Evaluation and Research, said in the announcement.
The approved dose of cladribine is 3.5 mg/kg body weight over 2 years, administered as one treatment course of 1.75 mg/kg per year, each consisting of 2 treatment weeks. Additional courses of cladribine are not to be administered because retreatment with cladribine during years 3 and 4 may further increase the risk of malignancy. The safety and efficacy of reinitiating cladribine more than 2 years after completing two treatment courses has not been studied, according to EMD Serono.
Cladribine is approved in more than 50 other countries and was approved for use in the European Union in August 2017.
including relapsing/remitting and active secondary progressive disease.
The drug’s manufacturer, EMD Serono, said in a press release that cladribine is the first short-course oral therapy for such patients, and its use is generally recommended for patients who have had an inadequate response to, or are unable to tolerate, an alternate drug indicated for the treatment of MS. Cladribine is not recommended for use in patients with clinically isolated syndrome.
The agency’s decision is based on results from a clinical trial of 1,326 patients with relapsing MS who had experienced at least one relapse in the previous 12 months. Patients who received cladribine had significantly fewer relapses than did those who received placebo; the progression of disability was also significantly reduced in the cladribine group, compared with placebo, according to the FDA’s announcement.
The most common adverse events associated with cladribine include upper respiratory tract infections, headache, and decreased lymphocyte counts. In addition, the medication must be dispensed with a patient medication guide because the label includes a boxed warning for increased risk of malignancy and fetal harm. Other warnings include a risk for decreased lymphocyte count, hematologic toxicity and bone marrow suppression, and graft-versus-host-disease.
“We are committed to supporting the development of safe and effective treatments for patients with multiple sclerosis. The approval of Mavenclad represents an additional option for patients who have tried another treatment without success,” Billy Dunn, MD, director of the division of neurology products in the FDA’s Center for Drug Evaluation and Research, said in the announcement.
The approved dose of cladribine is 3.5 mg/kg body weight over 2 years, administered as one treatment course of 1.75 mg/kg per year, each consisting of 2 treatment weeks. Additional courses of cladribine are not to be administered because retreatment with cladribine during years 3 and 4 may further increase the risk of malignancy. The safety and efficacy of reinitiating cladribine more than 2 years after completing two treatment courses has not been studied, according to EMD Serono.
Cladribine is approved in more than 50 other countries and was approved for use in the European Union in August 2017.
Scales assessing pediatric OCD possess little symptom overlap
There is considerable heterogeneity among symptoms included in various freely available, self-reported scales assessing obsessive-compulsive disorder in pediatric populations, according to Rachel Visontay and her associates at the University of New South Wales, Sydney.
They reviewed seven scales that exclusively assessed obsessive-compulsive disorder (OCD) and measured both obsessive and compulsive components in their study, published in the Journal of Obsessive-Compulsive and Related Disorders. The scales are:
- Children’s Florida Obsessive Compulsive Inventory.
- Children’s Yale-Brown Obsessive Compulsive Scale Symptom Checklist.
- Leyton Obsessional Inventory–Child Version.
- Children’s Obsessional Compulsive Inventory–Revised–Self Report.
- Obsessive Compulsive Inventory–Child Version.
- OCD Family Functioning Scale.
- Short OCD Screener.
A total of 54 umbrella symptoms were included over all seven scales: 32 obsessions, 21 compulsion, and 1 other symptom (Give poor class presentations despite planning). Half of these symptoms were unique to one scale but were more commonly obsessions (18 of 32) than compulsions (8 of 21). No obsession symptom appeared on more than five of the seven scales, but two compulsion symptoms (cleaning and checking compulsion) did appear on all scales.
The mean overlap between scales after Jaccard analysis was 0.14 for obsessions and 0.39 for compulsions, indicating very weak and weak overlap, respectively. The correlation between number of included symptoms and mean overlap was 0.43 for obsessions, indicating that scale length did play a role in determining overlap, but was –0.09 for compulsions, indicating no relationship between scale length and symptom overlap.
“While youth OCD scales generally measure the same broader construct, they might have different scopes within that construct, or may be more or less comprehensive than one another. As such, low content overlap does not necessarily mean a scale is ‘worse’ than one with higher overlap,” the investigators wrote. “However, researchers and
The study authors reported no conflicts of interest. The study was funded by a University of New South Wales Medicine, Neuroscience, Mental Health and Addiction Theme and SPHERE Mindgardens Clinical Academic Group collaborative research seed funding grant.
There is considerable heterogeneity among symptoms included in various freely available, self-reported scales assessing obsessive-compulsive disorder in pediatric populations, according to Rachel Visontay and her associates at the University of New South Wales, Sydney.
They reviewed seven scales that exclusively assessed obsessive-compulsive disorder (OCD) and measured both obsessive and compulsive components in their study, published in the Journal of Obsessive-Compulsive and Related Disorders. The scales are:
- Children’s Florida Obsessive Compulsive Inventory.
- Children’s Yale-Brown Obsessive Compulsive Scale Symptom Checklist.
- Leyton Obsessional Inventory–Child Version.
- Children’s Obsessional Compulsive Inventory–Revised–Self Report.
- Obsessive Compulsive Inventory–Child Version.
- OCD Family Functioning Scale.
- Short OCD Screener.
A total of 54 umbrella symptoms were included over all seven scales: 32 obsessions, 21 compulsion, and 1 other symptom (Give poor class presentations despite planning). Half of these symptoms were unique to one scale but were more commonly obsessions (18 of 32) than compulsions (8 of 21). No obsession symptom appeared on more than five of the seven scales, but two compulsion symptoms (cleaning and checking compulsion) did appear on all scales.
The mean overlap between scales after Jaccard analysis was 0.14 for obsessions and 0.39 for compulsions, indicating very weak and weak overlap, respectively. The correlation between number of included symptoms and mean overlap was 0.43 for obsessions, indicating that scale length did play a role in determining overlap, but was –0.09 for compulsions, indicating no relationship between scale length and symptom overlap.
“While youth OCD scales generally measure the same broader construct, they might have different scopes within that construct, or may be more or less comprehensive than one another. As such, low content overlap does not necessarily mean a scale is ‘worse’ than one with higher overlap,” the investigators wrote. “However, researchers and
The study authors reported no conflicts of interest. The study was funded by a University of New South Wales Medicine, Neuroscience, Mental Health and Addiction Theme and SPHERE Mindgardens Clinical Academic Group collaborative research seed funding grant.
There is considerable heterogeneity among symptoms included in various freely available, self-reported scales assessing obsessive-compulsive disorder in pediatric populations, according to Rachel Visontay and her associates at the University of New South Wales, Sydney.
They reviewed seven scales that exclusively assessed obsessive-compulsive disorder (OCD) and measured both obsessive and compulsive components in their study, published in the Journal of Obsessive-Compulsive and Related Disorders. The scales are:
- Children’s Florida Obsessive Compulsive Inventory.
- Children’s Yale-Brown Obsessive Compulsive Scale Symptom Checklist.
- Leyton Obsessional Inventory–Child Version.
- Children’s Obsessional Compulsive Inventory–Revised–Self Report.
- Obsessive Compulsive Inventory–Child Version.
- OCD Family Functioning Scale.
- Short OCD Screener.
A total of 54 umbrella symptoms were included over all seven scales: 32 obsessions, 21 compulsion, and 1 other symptom (Give poor class presentations despite planning). Half of these symptoms were unique to one scale but were more commonly obsessions (18 of 32) than compulsions (8 of 21). No obsession symptom appeared on more than five of the seven scales, but two compulsion symptoms (cleaning and checking compulsion) did appear on all scales.
The mean overlap between scales after Jaccard analysis was 0.14 for obsessions and 0.39 for compulsions, indicating very weak and weak overlap, respectively. The correlation between number of included symptoms and mean overlap was 0.43 for obsessions, indicating that scale length did play a role in determining overlap, but was –0.09 for compulsions, indicating no relationship between scale length and symptom overlap.
“While youth OCD scales generally measure the same broader construct, they might have different scopes within that construct, or may be more or less comprehensive than one another. As such, low content overlap does not necessarily mean a scale is ‘worse’ than one with higher overlap,” the investigators wrote. “However, researchers and
The study authors reported no conflicts of interest. The study was funded by a University of New South Wales Medicine, Neuroscience, Mental Health and Addiction Theme and SPHERE Mindgardens Clinical Academic Group collaborative research seed funding grant.
FROM THE JOURNAL OF OBSESSIVE-COMPULSIVE AND RELATED DISORDERS
Artesunate to become first-line malaria treatment in U.S.
Starting April 1, 2019, intravenous artesunate will become the first-line treatment for malaria in the United States, following the discontinuation of quinidine, the only Food and Drug Administration–approved intravenous drug for severe malaria treatment.
Although artesunate is not approved or commercially available in the United States, it is recommended by the World Health Organization. The Centers for Disease Control and Prevention have made the drug available through an expanded use investigational new drug protocol, an FDA regulatory mechanism. Clinicians can obtain the medication through the CDC’s Malaria Hotline (770-488-7788); artesunate will be stocked at 10 quarantine stations and will be released to hospitals free of charge, according to a CDC announcement.
Clinical trials have illustrated that intravenous artesunate is safe, well tolerated, and can be administered even to infants, children, and pregnant women in the second and third trimester.
About 1,700 cases of malaria are reported in the United States per year, 300 of which are classified as severe. The CDC believes the supply of artesunate obtained will be sufficient to treat all cases of severe malaria in the country, according to a CDC press release.
Starting April 1, 2019, intravenous artesunate will become the first-line treatment for malaria in the United States, following the discontinuation of quinidine, the only Food and Drug Administration–approved intravenous drug for severe malaria treatment.
Although artesunate is not approved or commercially available in the United States, it is recommended by the World Health Organization. The Centers for Disease Control and Prevention have made the drug available through an expanded use investigational new drug protocol, an FDA regulatory mechanism. Clinicians can obtain the medication through the CDC’s Malaria Hotline (770-488-7788); artesunate will be stocked at 10 quarantine stations and will be released to hospitals free of charge, according to a CDC announcement.
Clinical trials have illustrated that intravenous artesunate is safe, well tolerated, and can be administered even to infants, children, and pregnant women in the second and third trimester.
About 1,700 cases of malaria are reported in the United States per year, 300 of which are classified as severe. The CDC believes the supply of artesunate obtained will be sufficient to treat all cases of severe malaria in the country, according to a CDC press release.
Starting April 1, 2019, intravenous artesunate will become the first-line treatment for malaria in the United States, following the discontinuation of quinidine, the only Food and Drug Administration–approved intravenous drug for severe malaria treatment.
Although artesunate is not approved or commercially available in the United States, it is recommended by the World Health Organization. The Centers for Disease Control and Prevention have made the drug available through an expanded use investigational new drug protocol, an FDA regulatory mechanism. Clinicians can obtain the medication through the CDC’s Malaria Hotline (770-488-7788); artesunate will be stocked at 10 quarantine stations and will be released to hospitals free of charge, according to a CDC announcement.
Clinical trials have illustrated that intravenous artesunate is safe, well tolerated, and can be administered even to infants, children, and pregnant women in the second and third trimester.
About 1,700 cases of malaria are reported in the United States per year, 300 of which are classified as severe. The CDC believes the supply of artesunate obtained will be sufficient to treat all cases of severe malaria in the country, according to a CDC press release.
FDA approves Jatenzo for treatment of male hypogonadism
The Food and Drug Administration has approved testosterone undecanoate (Jatenzo), an oral capsule for the treatment of male hypogonadism caused by certain conditions, such as genetic disorders or tumors that have damaged the pituitary gland.
The approval is based on results from a 4-month clinical trial involving 166 men with hypogonadism. Patients received 237 mg testosterone undecanoate twice a day initially, a dosage that was adjusted downward or upward to a maximum of 396 mg twice a day, based on testosterone levels. At the end of the trial, 87% of men had achieved testosterone levels within the normal range.
The label for testosterone undecanoate contains a warning that the drug can cause an increase in blood pressure, raising the risk of heart attack, stroke, and cardiovascular death. Other common adverse events associated with testosterone undecanoate include headache, an increase in hematocrit, a decrease in HDL cholesterol, and nausea.
“[The] oral route of administration provides an important addition to current treatment options available for men with certain hypogonadal conditions who, until now, have most commonly been treated with testosterone products that are applied to the skin or injected,” said Hylton V. Joffe, MD, MMSc, director of the division of bone, reproductive, and urologic products at the FDA’s Center for Drug Evaluation and Research, in the press release.
Testosterone undecanoate is not approved to treat age-related hypogonadism, even in cases in which men have symptoms caused by low testosterone. The drug’s benefits do not outweigh its risks in those cases, the agency noted.
Find the full press release on the FDA website.
lfranki@mdedge.com
The Food and Drug Administration has approved testosterone undecanoate (Jatenzo), an oral capsule for the treatment of male hypogonadism caused by certain conditions, such as genetic disorders or tumors that have damaged the pituitary gland.
The approval is based on results from a 4-month clinical trial involving 166 men with hypogonadism. Patients received 237 mg testosterone undecanoate twice a day initially, a dosage that was adjusted downward or upward to a maximum of 396 mg twice a day, based on testosterone levels. At the end of the trial, 87% of men had achieved testosterone levels within the normal range.
The label for testosterone undecanoate contains a warning that the drug can cause an increase in blood pressure, raising the risk of heart attack, stroke, and cardiovascular death. Other common adverse events associated with testosterone undecanoate include headache, an increase in hematocrit, a decrease in HDL cholesterol, and nausea.
“[The] oral route of administration provides an important addition to current treatment options available for men with certain hypogonadal conditions who, until now, have most commonly been treated with testosterone products that are applied to the skin or injected,” said Hylton V. Joffe, MD, MMSc, director of the division of bone, reproductive, and urologic products at the FDA’s Center for Drug Evaluation and Research, in the press release.
Testosterone undecanoate is not approved to treat age-related hypogonadism, even in cases in which men have symptoms caused by low testosterone. The drug’s benefits do not outweigh its risks in those cases, the agency noted.
Find the full press release on the FDA website.
lfranki@mdedge.com
The Food and Drug Administration has approved testosterone undecanoate (Jatenzo), an oral capsule for the treatment of male hypogonadism caused by certain conditions, such as genetic disorders or tumors that have damaged the pituitary gland.
The approval is based on results from a 4-month clinical trial involving 166 men with hypogonadism. Patients received 237 mg testosterone undecanoate twice a day initially, a dosage that was adjusted downward or upward to a maximum of 396 mg twice a day, based on testosterone levels. At the end of the trial, 87% of men had achieved testosterone levels within the normal range.
The label for testosterone undecanoate contains a warning that the drug can cause an increase in blood pressure, raising the risk of heart attack, stroke, and cardiovascular death. Other common adverse events associated with testosterone undecanoate include headache, an increase in hematocrit, a decrease in HDL cholesterol, and nausea.
“[The] oral route of administration provides an important addition to current treatment options available for men with certain hypogonadal conditions who, until now, have most commonly been treated with testosterone products that are applied to the skin or injected,” said Hylton V. Joffe, MD, MMSc, director of the division of bone, reproductive, and urologic products at the FDA’s Center for Drug Evaluation and Research, in the press release.
Testosterone undecanoate is not approved to treat age-related hypogonadism, even in cases in which men have symptoms caused by low testosterone. The drug’s benefits do not outweigh its risks in those cases, the agency noted.
Find the full press release on the FDA website.
lfranki@mdedge.com
Pathogenic ball pits, zombie bacteria, and OTC beer
It’s the pits
Physical therapists sometimes use therapeutic ball pits to provide stimulation to pediatric patients with sensory impairments. However, anyone who’s ever been to a fast food joint or a Chuck E. Cheeses in the last 30 years knows that ball pits are not as innocent as they seem – instead of being simply a joyous sunken hole of fun, they are a prime breeding ground for all sorts of bacteria. And adhesive bandages. Why are there always bandages??
Researchers recently took a deep, disgusting dive into the underworld of clinical ball pits, which do not seem to be regulated by any governing body. There are no clinical guidelines from the Ball Pit Association of America on how or when to clean these cesspools of spheres. In fact, there’s no Ball Pit Association of America at all! Shocking.
Unsurprisingly (for any parent or person older than 14), the ball pits sampled were teeming with human and zoonotic-associated microorganisms. Researchers found that “bacterial colonization was found to be as high as thousands of cells per ball” (gag), exposing children to a lot of opportunity for infections. In case the diapers and bandages swimming in the McDonald’s ball pit didn’t turn you off them, this certainly should.
Zom-bacteria are coming
Special edition: Zombie Bacteria vs. The World. Recent research reveals that one type of bacteria, Bacillus subtilis, enters an oligotrophic state when nutrient starved, in which they are not fully dormant but verrrrrry slowly continue to grow and divide. Much like zombies verrrrry slowly continue to walk and eat flesh.
This research fundamentally changes the way we look at bacteria’s ability to survive. Previously, all bacteria were thought to go into a state of complete dormancy within a protective endospore. It appears that the zombie-like bacteria can awaken more easily from their oligotrophic state than bacteria using an endospore, which may shed light on how bacteria can escape antibiotic treatments. As if superbugs weren’t enough to deal with already.
An OTC beer keeps the doctor away
There’s plenty of evidence that a beer or two every now and again is good for your health. But the owner of the Seery Athlone Brewing Company in Addison, Ill., may have taken things too far.
While the reason of its closure just a few months after its grand opening in December 2018 is technically still a mystery, we feel fairly safe in speculating that it had something to do with the fact that brewery owner James Stephen was making his beer at the same location as his main business – a pharmaceutical company engaging in testing of over-the-counter drugs.
In fact, the Food and Drug Administration sent Mr. Stephen a letter in August 2018 warning him that, among numerous other transgressions, fermenting beer literally 10 feet away from where drugs were being tested is a health hazard, for both the beer and the drugs. The FDA ordered the brewery shut down, but the intrepid Mr. Stephen soldiered on, to obviously limited success.
Our advice to Mr. Stephen? Go all in with the pharmaceutical theme. Who wouldn’t want to drink an ibuprofen IPA, ranitidine red ale, loratadine lambic, pseudoephedrine porter, or diphenhydramine doppelbock? You’ll make millions!
A seat in the oval office
No, not that seat, and not the Oval Office. This is LOTME, after all, not Politico. The “seat” we’re talking about is a cardiovascular monitoring system, and “oval office” is just a euphemism for a toilet.
Here’s the deal: A company called Heart Health Intelligence (See? Intelligence is involved, so clearly we’re not talking about politics) has developed a toilet seat equipped “with an integrated electrocardiogram, ballistocardiogram , and photoplethysmogram … capable of clinical-grade measurements of systolic and diastolic blood pressure, stroke volume, and peripheral blood oxygenation.” Wait, ballistocardiogram? That sounds like something from that show House; it sounds too cool to pass up: “Chase, you idiot, why didn’t you do that ballistocardiogram I ordered?”
The idea is to prevent expensive readmissions by keeping track of patients with heart failure after they leave the hospital in a way that fits into their daily routine and ensures adherence.
It would cost about $200,000 to provide 150 heart failure patients with the toilet seats when they left the hospital, the company estimated, but the penalties from the Centers for Medicare & Medicaid Services for readmitting 150 patients come to $500,000 a year. Thus saving money by flushing it down the toilet.
So it looks like we were talking about politics after all. An intelligent toilet seat is like the Oval Office because, in both cases, the buck stops here.
It’s the pits
Physical therapists sometimes use therapeutic ball pits to provide stimulation to pediatric patients with sensory impairments. However, anyone who’s ever been to a fast food joint or a Chuck E. Cheeses in the last 30 years knows that ball pits are not as innocent as they seem – instead of being simply a joyous sunken hole of fun, they are a prime breeding ground for all sorts of bacteria. And adhesive bandages. Why are there always bandages??
Researchers recently took a deep, disgusting dive into the underworld of clinical ball pits, which do not seem to be regulated by any governing body. There are no clinical guidelines from the Ball Pit Association of America on how or when to clean these cesspools of spheres. In fact, there’s no Ball Pit Association of America at all! Shocking.
Unsurprisingly (for any parent or person older than 14), the ball pits sampled were teeming with human and zoonotic-associated microorganisms. Researchers found that “bacterial colonization was found to be as high as thousands of cells per ball” (gag), exposing children to a lot of opportunity for infections. In case the diapers and bandages swimming in the McDonald’s ball pit didn’t turn you off them, this certainly should.
Zom-bacteria are coming
Special edition: Zombie Bacteria vs. The World. Recent research reveals that one type of bacteria, Bacillus subtilis, enters an oligotrophic state when nutrient starved, in which they are not fully dormant but verrrrrry slowly continue to grow and divide. Much like zombies verrrrry slowly continue to walk and eat flesh.
This research fundamentally changes the way we look at bacteria’s ability to survive. Previously, all bacteria were thought to go into a state of complete dormancy within a protective endospore. It appears that the zombie-like bacteria can awaken more easily from their oligotrophic state than bacteria using an endospore, which may shed light on how bacteria can escape antibiotic treatments. As if superbugs weren’t enough to deal with already.
An OTC beer keeps the doctor away
There’s plenty of evidence that a beer or two every now and again is good for your health. But the owner of the Seery Athlone Brewing Company in Addison, Ill., may have taken things too far.
While the reason of its closure just a few months after its grand opening in December 2018 is technically still a mystery, we feel fairly safe in speculating that it had something to do with the fact that brewery owner James Stephen was making his beer at the same location as his main business – a pharmaceutical company engaging in testing of over-the-counter drugs.
In fact, the Food and Drug Administration sent Mr. Stephen a letter in August 2018 warning him that, among numerous other transgressions, fermenting beer literally 10 feet away from where drugs were being tested is a health hazard, for both the beer and the drugs. The FDA ordered the brewery shut down, but the intrepid Mr. Stephen soldiered on, to obviously limited success.
Our advice to Mr. Stephen? Go all in with the pharmaceutical theme. Who wouldn’t want to drink an ibuprofen IPA, ranitidine red ale, loratadine lambic, pseudoephedrine porter, or diphenhydramine doppelbock? You’ll make millions!
A seat in the oval office
No, not that seat, and not the Oval Office. This is LOTME, after all, not Politico. The “seat” we’re talking about is a cardiovascular monitoring system, and “oval office” is just a euphemism for a toilet.
Here’s the deal: A company called Heart Health Intelligence (See? Intelligence is involved, so clearly we’re not talking about politics) has developed a toilet seat equipped “with an integrated electrocardiogram, ballistocardiogram , and photoplethysmogram … capable of clinical-grade measurements of systolic and diastolic blood pressure, stroke volume, and peripheral blood oxygenation.” Wait, ballistocardiogram? That sounds like something from that show House; it sounds too cool to pass up: “Chase, you idiot, why didn’t you do that ballistocardiogram I ordered?”
The idea is to prevent expensive readmissions by keeping track of patients with heart failure after they leave the hospital in a way that fits into their daily routine and ensures adherence.
It would cost about $200,000 to provide 150 heart failure patients with the toilet seats when they left the hospital, the company estimated, but the penalties from the Centers for Medicare & Medicaid Services for readmitting 150 patients come to $500,000 a year. Thus saving money by flushing it down the toilet.
So it looks like we were talking about politics after all. An intelligent toilet seat is like the Oval Office because, in both cases, the buck stops here.
It’s the pits
Physical therapists sometimes use therapeutic ball pits to provide stimulation to pediatric patients with sensory impairments. However, anyone who’s ever been to a fast food joint or a Chuck E. Cheeses in the last 30 years knows that ball pits are not as innocent as they seem – instead of being simply a joyous sunken hole of fun, they are a prime breeding ground for all sorts of bacteria. And adhesive bandages. Why are there always bandages??
Researchers recently took a deep, disgusting dive into the underworld of clinical ball pits, which do not seem to be regulated by any governing body. There are no clinical guidelines from the Ball Pit Association of America on how or when to clean these cesspools of spheres. In fact, there’s no Ball Pit Association of America at all! Shocking.
Unsurprisingly (for any parent or person older than 14), the ball pits sampled were teeming with human and zoonotic-associated microorganisms. Researchers found that “bacterial colonization was found to be as high as thousands of cells per ball” (gag), exposing children to a lot of opportunity for infections. In case the diapers and bandages swimming in the McDonald’s ball pit didn’t turn you off them, this certainly should.
Zom-bacteria are coming
Special edition: Zombie Bacteria vs. The World. Recent research reveals that one type of bacteria, Bacillus subtilis, enters an oligotrophic state when nutrient starved, in which they are not fully dormant but verrrrrry slowly continue to grow and divide. Much like zombies verrrrry slowly continue to walk and eat flesh.
This research fundamentally changes the way we look at bacteria’s ability to survive. Previously, all bacteria were thought to go into a state of complete dormancy within a protective endospore. It appears that the zombie-like bacteria can awaken more easily from their oligotrophic state than bacteria using an endospore, which may shed light on how bacteria can escape antibiotic treatments. As if superbugs weren’t enough to deal with already.
An OTC beer keeps the doctor away
There’s plenty of evidence that a beer or two every now and again is good for your health. But the owner of the Seery Athlone Brewing Company in Addison, Ill., may have taken things too far.
While the reason of its closure just a few months after its grand opening in December 2018 is technically still a mystery, we feel fairly safe in speculating that it had something to do with the fact that brewery owner James Stephen was making his beer at the same location as his main business – a pharmaceutical company engaging in testing of over-the-counter drugs.
In fact, the Food and Drug Administration sent Mr. Stephen a letter in August 2018 warning him that, among numerous other transgressions, fermenting beer literally 10 feet away from where drugs were being tested is a health hazard, for both the beer and the drugs. The FDA ordered the brewery shut down, but the intrepid Mr. Stephen soldiered on, to obviously limited success.
Our advice to Mr. Stephen? Go all in with the pharmaceutical theme. Who wouldn’t want to drink an ibuprofen IPA, ranitidine red ale, loratadine lambic, pseudoephedrine porter, or diphenhydramine doppelbock? You’ll make millions!
A seat in the oval office
No, not that seat, and not the Oval Office. This is LOTME, after all, not Politico. The “seat” we’re talking about is a cardiovascular monitoring system, and “oval office” is just a euphemism for a toilet.
Here’s the deal: A company called Heart Health Intelligence (See? Intelligence is involved, so clearly we’re not talking about politics) has developed a toilet seat equipped “with an integrated electrocardiogram, ballistocardiogram , and photoplethysmogram … capable of clinical-grade measurements of systolic and diastolic blood pressure, stroke volume, and peripheral blood oxygenation.” Wait, ballistocardiogram? That sounds like something from that show House; it sounds too cool to pass up: “Chase, you idiot, why didn’t you do that ballistocardiogram I ordered?”
The idea is to prevent expensive readmissions by keeping track of patients with heart failure after they leave the hospital in a way that fits into their daily routine and ensures adherence.
It would cost about $200,000 to provide 150 heart failure patients with the toilet seats when they left the hospital, the company estimated, but the penalties from the Centers for Medicare & Medicaid Services for readmitting 150 patients come to $500,000 a year. Thus saving money by flushing it down the toilet.
So it looks like we were talking about politics after all. An intelligent toilet seat is like the Oval Office because, in both cases, the buck stops here.
FDA approves solriamfetol for daytime sleepiness treatment
The. It is the first dopamine and norepinephrine reuptake inhibitor approved to treat those conditions.
Approval was based on results from TONES (Treatment of Obstructive Sleep Apnea and Narcolepsy Excessive Sleepiness), a phase 3 study that combined four randomized, placebo-controlled trials assessing solriamfetol at various doses, compared with a placebo. After 12 weeks, 68%-74% of patients taking solriamfetol at 75 mg and 78%-90% of those taking solriamfetol at 150 mg reported improvement as assessed by the Patient Global Impression of Change scale.
Solriamfetol is approved at 75 mg and 150 mg for patients with narcolepsy and at 37.5 mg, 75 mg, and 150 mg for patients with obstructive sleep apnea. The most common adverse events associated with solriamfetol are headache, nausea, decreased appetite, and anxiety.
“Excessive daytime sleepiness can negatively impact the daily lives of people living with narcolepsy or obstructive sleep apnea at work, at home, or in daily activities. With this approval, a new, daytime medicine that can provide sustained wakefulness throughout the day will be available for patients,” Bruce Cozadd, chairman and CEO of Jazz Pharmaceuticals, said in the press release.
Find the full press release on the Jazz Pharmaceuticals website.
The. It is the first dopamine and norepinephrine reuptake inhibitor approved to treat those conditions.
Approval was based on results from TONES (Treatment of Obstructive Sleep Apnea and Narcolepsy Excessive Sleepiness), a phase 3 study that combined four randomized, placebo-controlled trials assessing solriamfetol at various doses, compared with a placebo. After 12 weeks, 68%-74% of patients taking solriamfetol at 75 mg and 78%-90% of those taking solriamfetol at 150 mg reported improvement as assessed by the Patient Global Impression of Change scale.
Solriamfetol is approved at 75 mg and 150 mg for patients with narcolepsy and at 37.5 mg, 75 mg, and 150 mg for patients with obstructive sleep apnea. The most common adverse events associated with solriamfetol are headache, nausea, decreased appetite, and anxiety.
“Excessive daytime sleepiness can negatively impact the daily lives of people living with narcolepsy or obstructive sleep apnea at work, at home, or in daily activities. With this approval, a new, daytime medicine that can provide sustained wakefulness throughout the day will be available for patients,” Bruce Cozadd, chairman and CEO of Jazz Pharmaceuticals, said in the press release.
Find the full press release on the Jazz Pharmaceuticals website.
The. It is the first dopamine and norepinephrine reuptake inhibitor approved to treat those conditions.
Approval was based on results from TONES (Treatment of Obstructive Sleep Apnea and Narcolepsy Excessive Sleepiness), a phase 3 study that combined four randomized, placebo-controlled trials assessing solriamfetol at various doses, compared with a placebo. After 12 weeks, 68%-74% of patients taking solriamfetol at 75 mg and 78%-90% of those taking solriamfetol at 150 mg reported improvement as assessed by the Patient Global Impression of Change scale.
Solriamfetol is approved at 75 mg and 150 mg for patients with narcolepsy and at 37.5 mg, 75 mg, and 150 mg for patients with obstructive sleep apnea. The most common adverse events associated with solriamfetol are headache, nausea, decreased appetite, and anxiety.
“Excessive daytime sleepiness can negatively impact the daily lives of people living with narcolepsy or obstructive sleep apnea at work, at home, or in daily activities. With this approval, a new, daytime medicine that can provide sustained wakefulness throughout the day will be available for patients,” Bruce Cozadd, chairman and CEO of Jazz Pharmaceuticals, said in the press release.
Find the full press release on the Jazz Pharmaceuticals website.
Patients with OCD/hoarding differ from those with OCD/nonhoarding
More autism spectrum disorder symptoms identified as distinguishing factor
Hoarding symptoms are frequently present in patients with obsessive-compulsive disorder (OCD), and significant differences can be found between them and patients with OCD and no hoarding symptoms, a study of 407 patients shows.
The study also identified links to autism spectrum disorder (ASD) among patients with OCD/hoarding symptoms. “The most relevant outcome of this study was the association between persons with OCD/hoarding and the increased severity of autism symptoms,” wrote Yentl E. Boerema of the Amsterdam Public Health Research Institute, and associates. The study was published in the Journal of Affective Disorders.
To conduct the study, the investigators used cross-sectional baseline data from the Netherlands Obsessive Compulsive Disorder Association (NOCDA) study. Participants in the NOCDA sample were aged 18-79 years with current or remitted DSM-IV-TR criteria for OCD. Hoarding symptoms were determined via the adapted version of the Yale-Brown Obsessive Compulsive Scale. A total of 58 patients were found to have both OCD/hoarding symptoms, compared with 349 who did not, the investigators reported.
OCD/hoarding was associated with earlier age of onset (P less than .05) and more severe OCD symptoms (P less than .001), as well as higher scores on all OCD subtypes. It was associated with living without a partner (P less than .05), being less conscientious (P less than .05), and severity of autism symptoms (P less than .001). The investigators speculated that ASD factors might “be responsible for hoarding behavior, including (a) having intense or focused interests, which can lead to collecting of items, and/or (b) having a lack of seeking shared enjoyment, interests, and activity with other people.”
Meanwhile, the investigators found that coexisting OCD/hoarding was not associated with childhood trauma, posttraumatic stress disorder or attention-deficit/hyperactivity disorder – inattentive type or hyperactive type.
“Clinical implications of our findings are to have the treatment follow a more intensive and structured course (i.e., avoid surprises),” having more attention for affective education, and making more use of visual illustrations, the investigators said. “Taken together, this knowledge provides a better understanding of persons with OCD/hoarding and has the potential to improve treatment.”
The study authors reported no conflicts of interest.
More autism spectrum disorder symptoms identified as distinguishing factor
More autism spectrum disorder symptoms identified as distinguishing factor
Hoarding symptoms are frequently present in patients with obsessive-compulsive disorder (OCD), and significant differences can be found between them and patients with OCD and no hoarding symptoms, a study of 407 patients shows.
The study also identified links to autism spectrum disorder (ASD) among patients with OCD/hoarding symptoms. “The most relevant outcome of this study was the association between persons with OCD/hoarding and the increased severity of autism symptoms,” wrote Yentl E. Boerema of the Amsterdam Public Health Research Institute, and associates. The study was published in the Journal of Affective Disorders.
To conduct the study, the investigators used cross-sectional baseline data from the Netherlands Obsessive Compulsive Disorder Association (NOCDA) study. Participants in the NOCDA sample were aged 18-79 years with current or remitted DSM-IV-TR criteria for OCD. Hoarding symptoms were determined via the adapted version of the Yale-Brown Obsessive Compulsive Scale. A total of 58 patients were found to have both OCD/hoarding symptoms, compared with 349 who did not, the investigators reported.
OCD/hoarding was associated with earlier age of onset (P less than .05) and more severe OCD symptoms (P less than .001), as well as higher scores on all OCD subtypes. It was associated with living without a partner (P less than .05), being less conscientious (P less than .05), and severity of autism symptoms (P less than .001). The investigators speculated that ASD factors might “be responsible for hoarding behavior, including (a) having intense or focused interests, which can lead to collecting of items, and/or (b) having a lack of seeking shared enjoyment, interests, and activity with other people.”
Meanwhile, the investigators found that coexisting OCD/hoarding was not associated with childhood trauma, posttraumatic stress disorder or attention-deficit/hyperactivity disorder – inattentive type or hyperactive type.
“Clinical implications of our findings are to have the treatment follow a more intensive and structured course (i.e., avoid surprises),” having more attention for affective education, and making more use of visual illustrations, the investigators said. “Taken together, this knowledge provides a better understanding of persons with OCD/hoarding and has the potential to improve treatment.”
The study authors reported no conflicts of interest.
Hoarding symptoms are frequently present in patients with obsessive-compulsive disorder (OCD), and significant differences can be found between them and patients with OCD and no hoarding symptoms, a study of 407 patients shows.
The study also identified links to autism spectrum disorder (ASD) among patients with OCD/hoarding symptoms. “The most relevant outcome of this study was the association between persons with OCD/hoarding and the increased severity of autism symptoms,” wrote Yentl E. Boerema of the Amsterdam Public Health Research Institute, and associates. The study was published in the Journal of Affective Disorders.
To conduct the study, the investigators used cross-sectional baseline data from the Netherlands Obsessive Compulsive Disorder Association (NOCDA) study. Participants in the NOCDA sample were aged 18-79 years with current or remitted DSM-IV-TR criteria for OCD. Hoarding symptoms were determined via the adapted version of the Yale-Brown Obsessive Compulsive Scale. A total of 58 patients were found to have both OCD/hoarding symptoms, compared with 349 who did not, the investigators reported.
OCD/hoarding was associated with earlier age of onset (P less than .05) and more severe OCD symptoms (P less than .001), as well as higher scores on all OCD subtypes. It was associated with living without a partner (P less than .05), being less conscientious (P less than .05), and severity of autism symptoms (P less than .001). The investigators speculated that ASD factors might “be responsible for hoarding behavior, including (a) having intense or focused interests, which can lead to collecting of items, and/or (b) having a lack of seeking shared enjoyment, interests, and activity with other people.”
Meanwhile, the investigators found that coexisting OCD/hoarding was not associated with childhood trauma, posttraumatic stress disorder or attention-deficit/hyperactivity disorder – inattentive type or hyperactive type.
“Clinical implications of our findings are to have the treatment follow a more intensive and structured course (i.e., avoid surprises),” having more attention for affective education, and making more use of visual illustrations, the investigators said. “Taken together, this knowledge provides a better understanding of persons with OCD/hoarding and has the potential to improve treatment.”
The study authors reported no conflicts of interest.
FROM THE JOURNAL OF AFFECTIVE DISORDERS
Biogen, Eisai discontinue aducanumab Alzheimer’s trials
Biogen and Eisai have announced that they are discontinuing the ENGAGE and EMERGE trials, which were designed to test the efficacy and safety of aducanumab in patients with mild cognitive impairment caused by Alzheimer’s disease and mild Alzheimer’s disease dementia.
The phase 3, multicenter, randomized, double-blind, placebo-controlled, parallel-group trials were canceled not because of safety concerns but because of a futility analysis conducted by an independent data monitoring committee that indicated the drug would not meet the trials’ primary endpoint, which was the slowing of cognitive and functional impairment as measured by changes in Clinical Dementia Rating–Sum of Boxes score, compared with placebo.
In addition to ENGAGE and EMERGE, the phase 2 EVOLVE safety study and the long-term extension of the phase 1b PRIME study have also been canceled. Data from the ENGAGE and EMERGE trials will be presented at future medical meetings.
Aducanumab is a human monoclonal antibody derived from B cells collected from healthy elderly subjects with no cognitive decline or those with unusually slow cognitive decline through Neurimmune’s technology platform called Reverse Translational Medicine. It was granted Fast Track designation by the Food and Drug Administration.
“This disappointing news confirms the complexity of treating Alzheimer’s disease and the need to further advance knowledge in neuroscience. We are incredibly grateful to all the Alzheimer’s disease patients, their families, and the investigators who participated in the trials and contributed greatly to this research,” Michel Vounatsos, CEO at Biogen, said in a press release.
Biogen and Eisai have announced that they are discontinuing the ENGAGE and EMERGE trials, which were designed to test the efficacy and safety of aducanumab in patients with mild cognitive impairment caused by Alzheimer’s disease and mild Alzheimer’s disease dementia.
The phase 3, multicenter, randomized, double-blind, placebo-controlled, parallel-group trials were canceled not because of safety concerns but because of a futility analysis conducted by an independent data monitoring committee that indicated the drug would not meet the trials’ primary endpoint, which was the slowing of cognitive and functional impairment as measured by changes in Clinical Dementia Rating–Sum of Boxes score, compared with placebo.
In addition to ENGAGE and EMERGE, the phase 2 EVOLVE safety study and the long-term extension of the phase 1b PRIME study have also been canceled. Data from the ENGAGE and EMERGE trials will be presented at future medical meetings.
Aducanumab is a human monoclonal antibody derived from B cells collected from healthy elderly subjects with no cognitive decline or those with unusually slow cognitive decline through Neurimmune’s technology platform called Reverse Translational Medicine. It was granted Fast Track designation by the Food and Drug Administration.
“This disappointing news confirms the complexity of treating Alzheimer’s disease and the need to further advance knowledge in neuroscience. We are incredibly grateful to all the Alzheimer’s disease patients, their families, and the investigators who participated in the trials and contributed greatly to this research,” Michel Vounatsos, CEO at Biogen, said in a press release.
Biogen and Eisai have announced that they are discontinuing the ENGAGE and EMERGE trials, which were designed to test the efficacy and safety of aducanumab in patients with mild cognitive impairment caused by Alzheimer’s disease and mild Alzheimer’s disease dementia.
The phase 3, multicenter, randomized, double-blind, placebo-controlled, parallel-group trials were canceled not because of safety concerns but because of a futility analysis conducted by an independent data monitoring committee that indicated the drug would not meet the trials’ primary endpoint, which was the slowing of cognitive and functional impairment as measured by changes in Clinical Dementia Rating–Sum of Boxes score, compared with placebo.
In addition to ENGAGE and EMERGE, the phase 2 EVOLVE safety study and the long-term extension of the phase 1b PRIME study have also been canceled. Data from the ENGAGE and EMERGE trials will be presented at future medical meetings.
Aducanumab is a human monoclonal antibody derived from B cells collected from healthy elderly subjects with no cognitive decline or those with unusually slow cognitive decline through Neurimmune’s technology platform called Reverse Translational Medicine. It was granted Fast Track designation by the Food and Drug Administration.
“This disappointing news confirms the complexity of treating Alzheimer’s disease and the need to further advance knowledge in neuroscience. We are incredibly grateful to all the Alzheimer’s disease patients, their families, and the investigators who participated in the trials and contributed greatly to this research,” Michel Vounatsos, CEO at Biogen, said in a press release.
Sleepless democracy, space herpes, and the F-bomb diet
Sleep: the key to democracy?
You might need to lie down for this one. Insufficient sleep could be affecting the very institutions and behaviors that keep society from crumbling.
Lack of sleep is proven to affect “private” behaviors, like working, but a new study has shown that exhaustion also has consequences on a national scale. Sleeping less negatively affects the “social behaviors that hold society and democracy together,” according to the study’s authors.
Willingness to vote, donate to charities, and sign petitions decreased in sleep-deprived participants. Although that last one is iffy – is anyone really willing to sign a petition, regardless of sleep intake? One thing to glean from this study is, if you’re holding a clipboard, let the most tired-looking people keep walking.
Perhaps we should start a petition to make the day before Election Day a national napping holiday.
I hear you knocking, but you can’t come in
LOTME takes you to the ends of the earth for this edition of Bacteria vs. the World. Let’s go to our correspondent, Danielle Kang, on the International Space Station.
Hi, this is Briny Baird in Berlin, Germany. The space station’s extreme environment weakens astronauts’ immune systems, but it has the opposite effect on bacteria, as Elisabeth Grohmann, PhD, of Beuth University of Applied Sciences explains.
“The bacteria [astronauts] carry become hardier – developing thick protective coatings and resistance to antibiotics – and more vigorous, multiplying and metabolizing faster.”
This is, as scientists put it, bad. To prevent an on-board bacterial bacchanal, Dr. Grohmann and her associates covered a vital piece of ISS equipment, the toilet door, with a new coating containing “silver and ruthenium, conditioned by a vitamin derivative.” After 19 months in space, the coated section of the door had 80% fewer bacteria on it than an uncoated control surface.
With long-term missions to Mars being considered, it should be safer for astronauts and their toilet doors to … go where no one has gone before. Back to the studio.
The F-bomb diet
You might think vulgarities and Homo sapiens have been an inseparable pair since the first human bashed her thumb while chipping stones into spearheads to add meat to her diet. You’d probably be right – except for blue-tinged language built on the consonant foundations of the letters F and V.
New linguistics research finds that those $#%*! letters, like truckers and Marine gunnery sergeants, are relatively modern developments. As humans moved away from finger-harming hunting and gathering and toward finger-harming farming, they developed a taste for softer foods. And their speech picked up “labiodentals” such as F and V – which are sounds made when we touch our lower lips to our upper teeth. Half the world’s languages are now riddled with soft-food profanities, er, labiodentals.
Next on the linguists’ research list: Does the paleo diet lead to the dropping of fewer F-bombs?
Herpes! In space!
Viruses can never let bacteria have all the fun. Where there’s an immune system weakened by radiation and microgravity, rest assured, our old friend the herpes virus will be waiting for us.
Yes, it looks like frequent bathroom trips won’t be the only issue future Dr. McCoys will be treating. According to a study published in Frontiers in Microbiology, four of the eight herpes viruses were discovered in the saliva and urine of more than half of the hundred or so astronauts who had samples analyzed during spaceflight.
The good news is that only six astronauts actually had symptoms emerge, all of which were minor. The bad news is that the strength, frequency, and duration of viral shedding through urine and saliva increased as more time was spent in space. Also, only one of the herpes varieties found has a vaccine. The rest will just have to be treated as symptoms emerge.
We’ll just hope Captain Kirk doesn’t come down with a case of mononucleosis while fighting the Klingons. Damn it, Jim, I’m a doctor, not a miracle worker!

Sleep: the key to democracy?
You might need to lie down for this one. Insufficient sleep could be affecting the very institutions and behaviors that keep society from crumbling.
Lack of sleep is proven to affect “private” behaviors, like working, but a new study has shown that exhaustion also has consequences on a national scale. Sleeping less negatively affects the “social behaviors that hold society and democracy together,” according to the study’s authors.
Willingness to vote, donate to charities, and sign petitions decreased in sleep-deprived participants. Although that last one is iffy – is anyone really willing to sign a petition, regardless of sleep intake? One thing to glean from this study is, if you’re holding a clipboard, let the most tired-looking people keep walking.
Perhaps we should start a petition to make the day before Election Day a national napping holiday.
I hear you knocking, but you can’t come in
LOTME takes you to the ends of the earth for this edition of Bacteria vs. the World. Let’s go to our correspondent, Danielle Kang, on the International Space Station.
Hi, this is Briny Baird in Berlin, Germany. The space station’s extreme environment weakens astronauts’ immune systems, but it has the opposite effect on bacteria, as Elisabeth Grohmann, PhD, of Beuth University of Applied Sciences explains.
“The bacteria [astronauts] carry become hardier – developing thick protective coatings and resistance to antibiotics – and more vigorous, multiplying and metabolizing faster.”
This is, as scientists put it, bad. To prevent an on-board bacterial bacchanal, Dr. Grohmann and her associates covered a vital piece of ISS equipment, the toilet door, with a new coating containing “silver and ruthenium, conditioned by a vitamin derivative.” After 19 months in space, the coated section of the door had 80% fewer bacteria on it than an uncoated control surface.
With long-term missions to Mars being considered, it should be safer for astronauts and their toilet doors to … go where no one has gone before. Back to the studio.
The F-bomb diet
You might think vulgarities and Homo sapiens have been an inseparable pair since the first human bashed her thumb while chipping stones into spearheads to add meat to her diet. You’d probably be right – except for blue-tinged language built on the consonant foundations of the letters F and V.
New linguistics research finds that those $#%*! letters, like truckers and Marine gunnery sergeants, are relatively modern developments. As humans moved away from finger-harming hunting and gathering and toward finger-harming farming, they developed a taste for softer foods. And their speech picked up “labiodentals” such as F and V – which are sounds made when we touch our lower lips to our upper teeth. Half the world’s languages are now riddled with soft-food profanities, er, labiodentals.
Next on the linguists’ research list: Does the paleo diet lead to the dropping of fewer F-bombs?
Herpes! In space!
Viruses can never let bacteria have all the fun. Where there’s an immune system weakened by radiation and microgravity, rest assured, our old friend the herpes virus will be waiting for us.
Yes, it looks like frequent bathroom trips won’t be the only issue future Dr. McCoys will be treating. According to a study published in Frontiers in Microbiology, four of the eight herpes viruses were discovered in the saliva and urine of more than half of the hundred or so astronauts who had samples analyzed during spaceflight.
The good news is that only six astronauts actually had symptoms emerge, all of which were minor. The bad news is that the strength, frequency, and duration of viral shedding through urine and saliva increased as more time was spent in space. Also, only one of the herpes varieties found has a vaccine. The rest will just have to be treated as symptoms emerge.
We’ll just hope Captain Kirk doesn’t come down with a case of mononucleosis while fighting the Klingons. Damn it, Jim, I’m a doctor, not a miracle worker!

Sleep: the key to democracy?
You might need to lie down for this one. Insufficient sleep could be affecting the very institutions and behaviors that keep society from crumbling.
Lack of sleep is proven to affect “private” behaviors, like working, but a new study has shown that exhaustion also has consequences on a national scale. Sleeping less negatively affects the “social behaviors that hold society and democracy together,” according to the study’s authors.
Willingness to vote, donate to charities, and sign petitions decreased in sleep-deprived participants. Although that last one is iffy – is anyone really willing to sign a petition, regardless of sleep intake? One thing to glean from this study is, if you’re holding a clipboard, let the most tired-looking people keep walking.
Perhaps we should start a petition to make the day before Election Day a national napping holiday.
I hear you knocking, but you can’t come in
LOTME takes you to the ends of the earth for this edition of Bacteria vs. the World. Let’s go to our correspondent, Danielle Kang, on the International Space Station.
Hi, this is Briny Baird in Berlin, Germany. The space station’s extreme environment weakens astronauts’ immune systems, but it has the opposite effect on bacteria, as Elisabeth Grohmann, PhD, of Beuth University of Applied Sciences explains.
“The bacteria [astronauts] carry become hardier – developing thick protective coatings and resistance to antibiotics – and more vigorous, multiplying and metabolizing faster.”
This is, as scientists put it, bad. To prevent an on-board bacterial bacchanal, Dr. Grohmann and her associates covered a vital piece of ISS equipment, the toilet door, with a new coating containing “silver and ruthenium, conditioned by a vitamin derivative.” After 19 months in space, the coated section of the door had 80% fewer bacteria on it than an uncoated control surface.
With long-term missions to Mars being considered, it should be safer for astronauts and their toilet doors to … go where no one has gone before. Back to the studio.
The F-bomb diet
You might think vulgarities and Homo sapiens have been an inseparable pair since the first human bashed her thumb while chipping stones into spearheads to add meat to her diet. You’d probably be right – except for blue-tinged language built on the consonant foundations of the letters F and V.
New linguistics research finds that those $#%*! letters, like truckers and Marine gunnery sergeants, are relatively modern developments. As humans moved away from finger-harming hunting and gathering and toward finger-harming farming, they developed a taste for softer foods. And their speech picked up “labiodentals” such as F and V – which are sounds made when we touch our lower lips to our upper teeth. Half the world’s languages are now riddled with soft-food profanities, er, labiodentals.
Next on the linguists’ research list: Does the paleo diet lead to the dropping of fewer F-bombs?
Herpes! In space!
Viruses can never let bacteria have all the fun. Where there’s an immune system weakened by radiation and microgravity, rest assured, our old friend the herpes virus will be waiting for us.
Yes, it looks like frequent bathroom trips won’t be the only issue future Dr. McCoys will be treating. According to a study published in Frontiers in Microbiology, four of the eight herpes viruses were discovered in the saliva and urine of more than half of the hundred or so astronauts who had samples analyzed during spaceflight.
The good news is that only six astronauts actually had symptoms emerge, all of which were minor. The bad news is that the strength, frequency, and duration of viral shedding through urine and saliva increased as more time was spent in space. Also, only one of the herpes varieties found has a vaccine. The rest will just have to be treated as symptoms emerge.
We’ll just hope Captain Kirk doesn’t come down with a case of mononucleosis while fighting the Klingons. Damn it, Jim, I’m a doctor, not a miracle worker!









