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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 Givlaari for treatment of acute hepatic porphyria
The Food and Drug Administration has approved givosiran (Givlaari) for the treatment of adult patients with acute hepatic porphyria, a genetic disorder that causes buildup of porphyrin molecules.
“This buildup can cause acute attacks, known as porphyria attacks, which can lead to severe pain and paralysis, respiratory failure, seizures, and mental status changes. These attacks occur suddenly and can produce permanent neurological damage and death. Prior to today’s approval, treatment options have only provided partial relief from the intense unremitting pain that characterizes these attacks,” Richard Pazdur, MD, director of the FDA’s Oncology Center of Excellence, said in a statement.
Approval for givosiran is based on results from a clinical trial of 94 patients with acute hepatic porphyria. Patients who received givosiran experienced 70% fewer porphyria attacks that required hospitalization, urgent health care visits, or home intravenous hemin injections compared with patients who received a placebo.
The most common adverse events associated with givosiran were nausea and injection site reactions. Patients receiving the medication should be monitored for anaphylactic reaction and renal function, and liver function should be tested before and periodically during treatment.
“The drug approved today can treat this disease by helping to reduce the number of attacks that disrupt the lives of patients,” said Dr. Pazdur, acting director of the Office of Oncologic Diseases in the FDA’s Center for Drug Evaluation and Research.
The Food and Drug Administration has approved givosiran (Givlaari) for the treatment of adult patients with acute hepatic porphyria, a genetic disorder that causes buildup of porphyrin molecules.
“This buildup can cause acute attacks, known as porphyria attacks, which can lead to severe pain and paralysis, respiratory failure, seizures, and mental status changes. These attacks occur suddenly and can produce permanent neurological damage and death. Prior to today’s approval, treatment options have only provided partial relief from the intense unremitting pain that characterizes these attacks,” Richard Pazdur, MD, director of the FDA’s Oncology Center of Excellence, said in a statement.
Approval for givosiran is based on results from a clinical trial of 94 patients with acute hepatic porphyria. Patients who received givosiran experienced 70% fewer porphyria attacks that required hospitalization, urgent health care visits, or home intravenous hemin injections compared with patients who received a placebo.
The most common adverse events associated with givosiran were nausea and injection site reactions. Patients receiving the medication should be monitored for anaphylactic reaction and renal function, and liver function should be tested before and periodically during treatment.
“The drug approved today can treat this disease by helping to reduce the number of attacks that disrupt the lives of patients,” said Dr. Pazdur, acting director of the Office of Oncologic Diseases in the FDA’s Center for Drug Evaluation and Research.
The Food and Drug Administration has approved givosiran (Givlaari) for the treatment of adult patients with acute hepatic porphyria, a genetic disorder that causes buildup of porphyrin molecules.
“This buildup can cause acute attacks, known as porphyria attacks, which can lead to severe pain and paralysis, respiratory failure, seizures, and mental status changes. These attacks occur suddenly and can produce permanent neurological damage and death. Prior to today’s approval, treatment options have only provided partial relief from the intense unremitting pain that characterizes these attacks,” Richard Pazdur, MD, director of the FDA’s Oncology Center of Excellence, said in a statement.
Approval for givosiran is based on results from a clinical trial of 94 patients with acute hepatic porphyria. Patients who received givosiran experienced 70% fewer porphyria attacks that required hospitalization, urgent health care visits, or home intravenous hemin injections compared with patients who received a placebo.
The most common adverse events associated with givosiran were nausea and injection site reactions. Patients receiving the medication should be monitored for anaphylactic reaction and renal function, and liver function should be tested before and periodically during treatment.
“The drug approved today can treat this disease by helping to reduce the number of attacks that disrupt the lives of patients,” said Dr. Pazdur, acting director of the Office of Oncologic Diseases in the FDA’s Center for Drug Evaluation and Research.
Grading Dr. Google and treating malaria by the bowlful
Google: A hypochondriac’s dream
Thanks to Google, we have basically free and unlimited access to a huge amount of information right at our fingertips. So when you’re laid up at home with a cold that seems to be taking a turn for the worse, it’s only natural to pull out your phone and ask Google all about your strange new symptoms. After all, the doctor’s office is so far away, and it costs money and time, and who even wants to deal with doctors anyway?
According to a survey commissioned by LetsGetChecked, you’d hardly be alone in turning to Dr. Google. Although 51% of the 2,000 survey respondents consulted a doctor as their first choice for medical help, 65% admitted that they use Google to self-diagnose, 26% have no primary care physician, and about 60% actively avoid doctor’s offices.
So, for the two-thirds of Americans who made an appointment with the good internet doctor, how did things turn out? Not well. About three-quarters reported worrying more afterward, and 43% of all survey respondents managed to convince themselves that they had contracted a serious illness. And the information they looked up? It was wrong more than 60% of the time.
As it turns out, a trained medical professional is actually better than a search engine. Now all we need to do is make accessing health care cheaper, more convenient, and easier to understand. No problem, right?
Better the second time around?
“What’s this stuff?”
“Recycled water. Supposed to taste just like regular water.”
“Did you drink it?”
“I’m not gonna drink it. You drink it.”
“I’m not gonna drink it.”
“Let’s get Mikey!”
“He won’t drink it. He hates everything.”
This time, the kids were right. Mikey did hate the recycled wastewater, or to be more accurate, he was disgusted by it. Like most people, he supports the idea of water conservation but is too disgusted by the source of recycled water to drink it, according to investigators at the University of California, Riverside.
In three separate experiments, volunteers were shown videos about water. One was about water conservation, another was about the urban myth that crocodiles live in New York City sewers, and the third was an educational video demonstrating that recycled wastewater is contaminant free.
In the first experiment, half of the subjects watched the conservation video and half watched the NYC sewer video. Afterward, nearly all participants in each group said no thanks to recycling. In the second experiment, subjects from the two video-watching groups were all shown the third video on recycled water’s purity. That led to a small but insubstantial increase in willingness to use recycled water.
In the third experiment, each of three groups watched one of the videos. Afterward, all subjects were asked to sign a petition supporting conservation and were offered a bottle of water labeled “SMARTdrop – Pure Recycled Water.” About two-thirds of each group signed the petition and took the bottle despite the investigators’ expectation that the group watching the water purity video would have greater acceptance.
Messaging involving water scarcity and conservation alone may not be enough in this case. Instead, the researchers urged “a focus on the more visceral roadblock of disgust.”
Maybe, or maybe not. For now, let’s get back to Mikey and company.
“Don’t tell the kids it’s the recycled wastewater you’ve been trying to get them to drink. You’re the only one who has to know.”
Chicken soup for the malarial soul
A nice hot cup of soup: The refuge of concerned parents who managed to resist looking at Google and decided that their child’s cold wasn’t actually stage IV lung cancer. It’s good, and it’s good for you. But just how good for you? Could the healing powers of soup be harnessed to treat something like, say, malaria?
The research, published in Archives of Disease in Childhood, has perhaps the most adorable setup of any study our cold, stony hearts at LOTME world headquarters have ever seen. The researchers went to a London primary school and asked a group of students to bring in homemade soup for testing and analysis. The students obliged, bringing in dozens of unique soups, of which 56 were tested for 72 hours against the deadliest malaria species, Plasmodium falciparum.
Not every soup was effective, but extracts from five broths were able to halt growth of sexually immature parasites by more than 50%, two of which were about as effective as dihydroartemisinin, a leading antimalarial drug. In addition, four other broths were more than 50% effective at blocking sexual maturation.
The researchers noted that they haven’t analyzed the ingredients of the soups yet and that the utility of soup in combating malaria will depend on a number of factors; regardless, we hope those kids got some serious extra credit. Curing malaria is way more impressive than knowing that mitochondria are the powerhouse of the cell.
Google: A hypochondriac’s dream
Thanks to Google, we have basically free and unlimited access to a huge amount of information right at our fingertips. So when you’re laid up at home with a cold that seems to be taking a turn for the worse, it’s only natural to pull out your phone and ask Google all about your strange new symptoms. After all, the doctor’s office is so far away, and it costs money and time, and who even wants to deal with doctors anyway?
According to a survey commissioned by LetsGetChecked, you’d hardly be alone in turning to Dr. Google. Although 51% of the 2,000 survey respondents consulted a doctor as their first choice for medical help, 65% admitted that they use Google to self-diagnose, 26% have no primary care physician, and about 60% actively avoid doctor’s offices.
So, for the two-thirds of Americans who made an appointment with the good internet doctor, how did things turn out? Not well. About three-quarters reported worrying more afterward, and 43% of all survey respondents managed to convince themselves that they had contracted a serious illness. And the information they looked up? It was wrong more than 60% of the time.
As it turns out, a trained medical professional is actually better than a search engine. Now all we need to do is make accessing health care cheaper, more convenient, and easier to understand. No problem, right?
Better the second time around?
“What’s this stuff?”
“Recycled water. Supposed to taste just like regular water.”
“Did you drink it?”
“I’m not gonna drink it. You drink it.”
“I’m not gonna drink it.”
“Let’s get Mikey!”
“He won’t drink it. He hates everything.”
This time, the kids were right. Mikey did hate the recycled wastewater, or to be more accurate, he was disgusted by it. Like most people, he supports the idea of water conservation but is too disgusted by the source of recycled water to drink it, according to investigators at the University of California, Riverside.
In three separate experiments, volunteers were shown videos about water. One was about water conservation, another was about the urban myth that crocodiles live in New York City sewers, and the third was an educational video demonstrating that recycled wastewater is contaminant free.
In the first experiment, half of the subjects watched the conservation video and half watched the NYC sewer video. Afterward, nearly all participants in each group said no thanks to recycling. In the second experiment, subjects from the two video-watching groups were all shown the third video on recycled water’s purity. That led to a small but insubstantial increase in willingness to use recycled water.
In the third experiment, each of three groups watched one of the videos. Afterward, all subjects were asked to sign a petition supporting conservation and were offered a bottle of water labeled “SMARTdrop – Pure Recycled Water.” About two-thirds of each group signed the petition and took the bottle despite the investigators’ expectation that the group watching the water purity video would have greater acceptance.
Messaging involving water scarcity and conservation alone may not be enough in this case. Instead, the researchers urged “a focus on the more visceral roadblock of disgust.”
Maybe, or maybe not. For now, let’s get back to Mikey and company.
“Don’t tell the kids it’s the recycled wastewater you’ve been trying to get them to drink. You’re the only one who has to know.”
Chicken soup for the malarial soul
A nice hot cup of soup: The refuge of concerned parents who managed to resist looking at Google and decided that their child’s cold wasn’t actually stage IV lung cancer. It’s good, and it’s good for you. But just how good for you? Could the healing powers of soup be harnessed to treat something like, say, malaria?
The research, published in Archives of Disease in Childhood, has perhaps the most adorable setup of any study our cold, stony hearts at LOTME world headquarters have ever seen. The researchers went to a London primary school and asked a group of students to bring in homemade soup for testing and analysis. The students obliged, bringing in dozens of unique soups, of which 56 were tested for 72 hours against the deadliest malaria species, Plasmodium falciparum.
Not every soup was effective, but extracts from five broths were able to halt growth of sexually immature parasites by more than 50%, two of which were about as effective as dihydroartemisinin, a leading antimalarial drug. In addition, four other broths were more than 50% effective at blocking sexual maturation.
The researchers noted that they haven’t analyzed the ingredients of the soups yet and that the utility of soup in combating malaria will depend on a number of factors; regardless, we hope those kids got some serious extra credit. Curing malaria is way more impressive than knowing that mitochondria are the powerhouse of the cell.
Google: A hypochondriac’s dream
Thanks to Google, we have basically free and unlimited access to a huge amount of information right at our fingertips. So when you’re laid up at home with a cold that seems to be taking a turn for the worse, it’s only natural to pull out your phone and ask Google all about your strange new symptoms. After all, the doctor’s office is so far away, and it costs money and time, and who even wants to deal with doctors anyway?
According to a survey commissioned by LetsGetChecked, you’d hardly be alone in turning to Dr. Google. Although 51% of the 2,000 survey respondents consulted a doctor as their first choice for medical help, 65% admitted that they use Google to self-diagnose, 26% have no primary care physician, and about 60% actively avoid doctor’s offices.
So, for the two-thirds of Americans who made an appointment with the good internet doctor, how did things turn out? Not well. About three-quarters reported worrying more afterward, and 43% of all survey respondents managed to convince themselves that they had contracted a serious illness. And the information they looked up? It was wrong more than 60% of the time.
As it turns out, a trained medical professional is actually better than a search engine. Now all we need to do is make accessing health care cheaper, more convenient, and easier to understand. No problem, right?
Better the second time around?
“What’s this stuff?”
“Recycled water. Supposed to taste just like regular water.”
“Did you drink it?”
“I’m not gonna drink it. You drink it.”
“I’m not gonna drink it.”
“Let’s get Mikey!”
“He won’t drink it. He hates everything.”
This time, the kids were right. Mikey did hate the recycled wastewater, or to be more accurate, he was disgusted by it. Like most people, he supports the idea of water conservation but is too disgusted by the source of recycled water to drink it, according to investigators at the University of California, Riverside.
In three separate experiments, volunteers were shown videos about water. One was about water conservation, another was about the urban myth that crocodiles live in New York City sewers, and the third was an educational video demonstrating that recycled wastewater is contaminant free.
In the first experiment, half of the subjects watched the conservation video and half watched the NYC sewer video. Afterward, nearly all participants in each group said no thanks to recycling. In the second experiment, subjects from the two video-watching groups were all shown the third video on recycled water’s purity. That led to a small but insubstantial increase in willingness to use recycled water.
In the third experiment, each of three groups watched one of the videos. Afterward, all subjects were asked to sign a petition supporting conservation and were offered a bottle of water labeled “SMARTdrop – Pure Recycled Water.” About two-thirds of each group signed the petition and took the bottle despite the investigators’ expectation that the group watching the water purity video would have greater acceptance.
Messaging involving water scarcity and conservation alone may not be enough in this case. Instead, the researchers urged “a focus on the more visceral roadblock of disgust.”
Maybe, or maybe not. For now, let’s get back to Mikey and company.
“Don’t tell the kids it’s the recycled wastewater you’ve been trying to get them to drink. You’re the only one who has to know.”
Chicken soup for the malarial soul
A nice hot cup of soup: The refuge of concerned parents who managed to resist looking at Google and decided that their child’s cold wasn’t actually stage IV lung cancer. It’s good, and it’s good for you. But just how good for you? Could the healing powers of soup be harnessed to treat something like, say, malaria?
The research, published in Archives of Disease in Childhood, has perhaps the most adorable setup of any study our cold, stony hearts at LOTME world headquarters have ever seen. The researchers went to a London primary school and asked a group of students to bring in homemade soup for testing and analysis. The students obliged, bringing in dozens of unique soups, of which 56 were tested for 72 hours against the deadliest malaria species, Plasmodium falciparum.
Not every soup was effective, but extracts from five broths were able to halt growth of sexually immature parasites by more than 50%, two of which were about as effective as dihydroartemisinin, a leading antimalarial drug. In addition, four other broths were more than 50% effective at blocking sexual maturation.
The researchers noted that they haven’t analyzed the ingredients of the soups yet and that the utility of soup in combating malaria will depend on a number of factors; regardless, we hope those kids got some serious extra credit. Curing malaria is way more impressive than knowing that mitochondria are the powerhouse of the cell.
FDA announces approval of fifth adalimumab biosimilar, Abrilada
The Food and Drug Administration has cleared adalimumab-afzb (Abrilada) as the fifth approved Humira biosimilar and the 25th approved biosimilar drug overall, the agency said in a Nov. 15 announcement.
According to a press release from Pfizer, approval for Abrilada was based on review of a comprehensive data package demonstrating biosimilarity of the drug to the reference product. This included data from a clinical comparative study, which found no clinically meaningful difference between Abrilada and the reference in terms of efficacy, safety, and immunogenicity in patients with moderate to severe rheumatoid arthritis (RA). In addition to RA, Abrilada is indicated for juvenile idiopathic arthritis, psoriatic arthritis, ankylosing spondylitis, adult Crohn’s disease, ulcerative colitis, and plaque psoriasis.
Common adverse events in adalimumab clinical trials included infection, injection-site reactions, headache, and rash.
Pfizer said that it “is working to make Abrilada available to U.S. patients as soon as feasible based on the terms of our agreement with AbbVie [the manufacturer of Humira]. Our current plans are to launch in 2023.”
The Food and Drug Administration has cleared adalimumab-afzb (Abrilada) as the fifth approved Humira biosimilar and the 25th approved biosimilar drug overall, the agency said in a Nov. 15 announcement.
According to a press release from Pfizer, approval for Abrilada was based on review of a comprehensive data package demonstrating biosimilarity of the drug to the reference product. This included data from a clinical comparative study, which found no clinically meaningful difference between Abrilada and the reference in terms of efficacy, safety, and immunogenicity in patients with moderate to severe rheumatoid arthritis (RA). In addition to RA, Abrilada is indicated for juvenile idiopathic arthritis, psoriatic arthritis, ankylosing spondylitis, adult Crohn’s disease, ulcerative colitis, and plaque psoriasis.
Common adverse events in adalimumab clinical trials included infection, injection-site reactions, headache, and rash.
Pfizer said that it “is working to make Abrilada available to U.S. patients as soon as feasible based on the terms of our agreement with AbbVie [the manufacturer of Humira]. Our current plans are to launch in 2023.”
The Food and Drug Administration has cleared adalimumab-afzb (Abrilada) as the fifth approved Humira biosimilar and the 25th approved biosimilar drug overall, the agency said in a Nov. 15 announcement.
According to a press release from Pfizer, approval for Abrilada was based on review of a comprehensive data package demonstrating biosimilarity of the drug to the reference product. This included data from a clinical comparative study, which found no clinically meaningful difference between Abrilada and the reference in terms of efficacy, safety, and immunogenicity in patients with moderate to severe rheumatoid arthritis (RA). In addition to RA, Abrilada is indicated for juvenile idiopathic arthritis, psoriatic arthritis, ankylosing spondylitis, adult Crohn’s disease, ulcerative colitis, and plaque psoriasis.
Common adverse events in adalimumab clinical trials included infection, injection-site reactions, headache, and rash.
Pfizer said that it “is working to make Abrilada available to U.S. patients as soon as feasible based on the terms of our agreement with AbbVie [the manufacturer of Humira]. Our current plans are to launch in 2023.”
FDA approves Pentax duodenoscope with sterile, disposable elevator
The Food and Drug Administration has cleared the Pentax Medical Video ED34-i10T2 model duodenoscope for marketing in the United States, the first approved duodenoscope with a sterile, disposable elevator component.
Previous communication from the FDA has recommended to both health care facilities and duodenoscope manufacturers to transition to duodenoscopes with disposable components. Disposable designs reduce or eliminate the need for reprocessing certain components, a major source of between-patient duodenoscope contamination, the FDA said.
FDA approval for the Pentax device is based on a review through the premarket clearance pathway, and the manufacturer submitted evidence that the device is substantially equivalent to previous devices. Potential risks of using the Pentax duodenoscope include burns, electric shock, perforation, infection, and bleeding.
“Duodenoscopes with a disposable elevator component represent another major step toward lowering the risk of infection among patients who undergo procedures with these devices,” said Jeff Shuren, MD, JD, director of the FDA’s Center for Devices and Radiological Health. “Improving the safety of duodenoscopes is a top priority for the FDA since such devices remain critical to life-saving care for many patients in the U.S.”
Find the full press release on the FDA website.
The Food and Drug Administration has cleared the Pentax Medical Video ED34-i10T2 model duodenoscope for marketing in the United States, the first approved duodenoscope with a sterile, disposable elevator component.
Previous communication from the FDA has recommended to both health care facilities and duodenoscope manufacturers to transition to duodenoscopes with disposable components. Disposable designs reduce or eliminate the need for reprocessing certain components, a major source of between-patient duodenoscope contamination, the FDA said.
FDA approval for the Pentax device is based on a review through the premarket clearance pathway, and the manufacturer submitted evidence that the device is substantially equivalent to previous devices. Potential risks of using the Pentax duodenoscope include burns, electric shock, perforation, infection, and bleeding.
“Duodenoscopes with a disposable elevator component represent another major step toward lowering the risk of infection among patients who undergo procedures with these devices,” said Jeff Shuren, MD, JD, director of the FDA’s Center for Devices and Radiological Health. “Improving the safety of duodenoscopes is a top priority for the FDA since such devices remain critical to life-saving care for many patients in the U.S.”
Find the full press release on the FDA website.
The Food and Drug Administration has cleared the Pentax Medical Video ED34-i10T2 model duodenoscope for marketing in the United States, the first approved duodenoscope with a sterile, disposable elevator component.
Previous communication from the FDA has recommended to both health care facilities and duodenoscope manufacturers to transition to duodenoscopes with disposable components. Disposable designs reduce or eliminate the need for reprocessing certain components, a major source of between-patient duodenoscope contamination, the FDA said.
FDA approval for the Pentax device is based on a review through the premarket clearance pathway, and the manufacturer submitted evidence that the device is substantially equivalent to previous devices. Potential risks of using the Pentax duodenoscope include burns, electric shock, perforation, infection, and bleeding.
“Duodenoscopes with a disposable elevator component represent another major step toward lowering the risk of infection among patients who undergo procedures with these devices,” said Jeff Shuren, MD, JD, director of the FDA’s Center for Devices and Radiological Health. “Improving the safety of duodenoscopes is a top priority for the FDA since such devices remain critical to life-saving care for many patients in the U.S.”
Find the full press release on the FDA website.
FDA approves Brukinsa for relapsed, refractory MCL
The Food and Drug Administration has approved zanubrutinib (Brukinsa) for the treatment of mantle cell lymphoma (MCL) in adult patients who have received at least one prior therapy.
The approval is based on results from two separate studies; in a global phase 1/2 trial, patients with relapsed or refractory MCL who received zanubrutinib had an overall response rate of 84%, with 22% experiencing a complete response and 62% experiencing partial response. Median duration of response was 18.5 months. The ORR in the second study – a multicenter phase 2 trial – was also 84%, but with 59% experiencing a complete response and 24% experiencing partial response; duration of response was 19.5 months.
The most common adverse events reported during the trials were decreased neutrophil count, decreased platelet count, upper respiratory tract infection, decreased white blood cell count, decreased hemoglobin, rash, bruising, diarrhea, cough, musculoskeletal pain, pneumonia, urinary tract infection, hematuria, fatigue, constipation, and hemorrhage. The most common serious adverse events were pneumonia and hemorrhage.
Of the 118 patients with MCL treated with zanubrutinib over the two trials, 8 had to be discontinued because of adverse events.
The recommended dose of zanubrutinib is 320 mg, taken orally 160 mg twice daily or 320 mg once daily, with or without food.
“BTK [Bruton kinase] inhibition is an established mode of treatment for patients with MCL, but many patients treated with previously approved BTK inhibitors do not fully respond to BTK therapy or are forced to discontinue treatment early due to side effects. Today we have a new option for our adult patients who have received one prior systemic or targeted therapy and are living with MCL,” Luhua (Michael) Wang, MD, clinical trial investigator and professor in the department of lymphoma and myeloma at the University of Texas MD Anderson Cancer Center, Houston, said in a statement.
The Food and Drug Administration has approved zanubrutinib (Brukinsa) for the treatment of mantle cell lymphoma (MCL) in adult patients who have received at least one prior therapy.
The approval is based on results from two separate studies; in a global phase 1/2 trial, patients with relapsed or refractory MCL who received zanubrutinib had an overall response rate of 84%, with 22% experiencing a complete response and 62% experiencing partial response. Median duration of response was 18.5 months. The ORR in the second study – a multicenter phase 2 trial – was also 84%, but with 59% experiencing a complete response and 24% experiencing partial response; duration of response was 19.5 months.
The most common adverse events reported during the trials were decreased neutrophil count, decreased platelet count, upper respiratory tract infection, decreased white blood cell count, decreased hemoglobin, rash, bruising, diarrhea, cough, musculoskeletal pain, pneumonia, urinary tract infection, hematuria, fatigue, constipation, and hemorrhage. The most common serious adverse events were pneumonia and hemorrhage.
Of the 118 patients with MCL treated with zanubrutinib over the two trials, 8 had to be discontinued because of adverse events.
The recommended dose of zanubrutinib is 320 mg, taken orally 160 mg twice daily or 320 mg once daily, with or without food.
“BTK [Bruton kinase] inhibition is an established mode of treatment for patients with MCL, but many patients treated with previously approved BTK inhibitors do not fully respond to BTK therapy or are forced to discontinue treatment early due to side effects. Today we have a new option for our adult patients who have received one prior systemic or targeted therapy and are living with MCL,” Luhua (Michael) Wang, MD, clinical trial investigator and professor in the department of lymphoma and myeloma at the University of Texas MD Anderson Cancer Center, Houston, said in a statement.
The Food and Drug Administration has approved zanubrutinib (Brukinsa) for the treatment of mantle cell lymphoma (MCL) in adult patients who have received at least one prior therapy.
The approval is based on results from two separate studies; in a global phase 1/2 trial, patients with relapsed or refractory MCL who received zanubrutinib had an overall response rate of 84%, with 22% experiencing a complete response and 62% experiencing partial response. Median duration of response was 18.5 months. The ORR in the second study – a multicenter phase 2 trial – was also 84%, but with 59% experiencing a complete response and 24% experiencing partial response; duration of response was 19.5 months.
The most common adverse events reported during the trials were decreased neutrophil count, decreased platelet count, upper respiratory tract infection, decreased white blood cell count, decreased hemoglobin, rash, bruising, diarrhea, cough, musculoskeletal pain, pneumonia, urinary tract infection, hematuria, fatigue, constipation, and hemorrhage. The most common serious adverse events were pneumonia and hemorrhage.
Of the 118 patients with MCL treated with zanubrutinib over the two trials, 8 had to be discontinued because of adverse events.
The recommended dose of zanubrutinib is 320 mg, taken orally 160 mg twice daily or 320 mg once daily, with or without food.
“BTK [Bruton kinase] inhibition is an established mode of treatment for patients with MCL, but many patients treated with previously approved BTK inhibitors do not fully respond to BTK therapy or are forced to discontinue treatment early due to side effects. Today we have a new option for our adult patients who have received one prior systemic or targeted therapy and are living with MCL,” Luhua (Michael) Wang, MD, clinical trial investigator and professor in the department of lymphoma and myeloma at the University of Texas MD Anderson Cancer Center, Houston, said in a statement.
Spray-painted bandages and pharma sings ‘Dough Canada!’
He’s not quite dead yet!
In 2015, Benjamin Schreiber, an Iowa man convicted of murder and sentenced to life in prison without parole, developed a case of septic poisoning because of large, untreated kidney stones. While at the hospital, his heart stopped several times, requiring resuscitation. After being stabilized, he underwent surgery to remove the kidney stones and was then released back to his prison cell.
Fast forward to 2018. Mr. Schreiber filed for relief from his conviction, arguing that, because he technically died, his life sentence had been served and he should be released. While the logic is impeccable, an Iowa district court didn’t buy it, noting that the fact that Mr. Schreiber was able to submit a petition for his release “confirms the petitioner’s current status as living.”
Sadly for Mr. Schreiber, the Iowa Court of Appeals agreed with the lower court’s decision. In a wonderfully pithy summation of the case, Judge Amanda Potterfield wrote: “Schreiber is either still alive, in which case he must remain in prison, or he is actually dead, in which case this appeal is moot.”
While the Livin’ on the MDedge team is glad that a convicted murderer will not be released back into the public, we salute his devotion to the art of technicality. The judges may not have been convinced, but you’re dead to us, Mr. Schreiber.
Breaking news: Drug companies gouge consumers
Canada. It’s home to many things: Trees, glaciers, beavers, and several people. But we Americans also know it as the home of cheap drugs. It may be borderline illegal, but that’s never stopped America from taking things that don’t belong to us before.
You’d think then that it’d be great being sick in Canada. But it turns out that many of those poor, desperate souls living in the frozen tundra of the north are actually overpaying for drugs just like the rest of us, according to research published in the Canadian Medical Association Journal.
It all comes down to those strange items called drug discount cards. They’re coupons offered by brand-name drug manufacturers to keep patients from switching to cheap generics.
Sounds great, right? Well, while a few patients saw savings, the average cost to patients with public insurance increased by 1.3% over generics. And if you were unfortunate enough to have private insurance, you’d be paying 46% more using the cards rather than generics. In some instances, patients were paying a whole $10 more for a prescription of the name brand, compared with the generic. And we thought Tim Hortons was our northern neighbor’s only company making a lot of dough. Ten loonies more per Rx ain’t Timbits.
So, Canada, how does it feel to have your health care made fun of? U-S-A! U-S-A! Now, if you’ll excuse us, we’re off to pay $1,000 a pill to cure us some hepatitis C. That’s some real red-blooded American price gouging right there.
This looks like a job for vacuum science
The LOTME staff, of course, scans a veritable buffet of sources to come up with the tasty tidbits we present each week to our deliciously wonderful and highly scrumptious readers each week.
One of our favorite sauces … umm, we mean sources, and the home of a tantalizing medical morsel (can you tell it’s almost lunch time?), is the Journal of Vacuum Science and Technology B. That’s B, not A. Anyone, at least anyone who’s serious about vacuum science, will tell you that the Journal of Vacuum Science and Technology A is pretty much a bottomless pit of trolling, political bickering, and popular nonsense. But B, now that’s a different story.
B is where we meet the EStAD (electrostatic and air driven) device. EStAD is a portable device that may someday offer physicians and first responders a way to treat wounds in rural areas where immediate care may not be available, the investigators said.
EStAD, using a process called electrospinning along with a confined electric field, works like a can of spray paint to deposit a fiber mat, which could be a bandage or a drug, onto a wound.
The device is still under development, but the research team reports that it has been successfully tested on a porcine skin incision and a gloved human hand.
The next step in EStAD development is to bring it to Washington, where the investigators will see if spray-on bandages can stand up to the hot air coming out of politicians’ mouths. We’re hoping that they sell tickets.
He’s not quite dead yet!
In 2015, Benjamin Schreiber, an Iowa man convicted of murder and sentenced to life in prison without parole, developed a case of septic poisoning because of large, untreated kidney stones. While at the hospital, his heart stopped several times, requiring resuscitation. After being stabilized, he underwent surgery to remove the kidney stones and was then released back to his prison cell.
Fast forward to 2018. Mr. Schreiber filed for relief from his conviction, arguing that, because he technically died, his life sentence had been served and he should be released. While the logic is impeccable, an Iowa district court didn’t buy it, noting that the fact that Mr. Schreiber was able to submit a petition for his release “confirms the petitioner’s current status as living.”
Sadly for Mr. Schreiber, the Iowa Court of Appeals agreed with the lower court’s decision. In a wonderfully pithy summation of the case, Judge Amanda Potterfield wrote: “Schreiber is either still alive, in which case he must remain in prison, or he is actually dead, in which case this appeal is moot.”
While the Livin’ on the MDedge team is glad that a convicted murderer will not be released back into the public, we salute his devotion to the art of technicality. The judges may not have been convinced, but you’re dead to us, Mr. Schreiber.
Breaking news: Drug companies gouge consumers
Canada. It’s home to many things: Trees, glaciers, beavers, and several people. But we Americans also know it as the home of cheap drugs. It may be borderline illegal, but that’s never stopped America from taking things that don’t belong to us before.
You’d think then that it’d be great being sick in Canada. But it turns out that many of those poor, desperate souls living in the frozen tundra of the north are actually overpaying for drugs just like the rest of us, according to research published in the Canadian Medical Association Journal.
It all comes down to those strange items called drug discount cards. They’re coupons offered by brand-name drug manufacturers to keep patients from switching to cheap generics.
Sounds great, right? Well, while a few patients saw savings, the average cost to patients with public insurance increased by 1.3% over generics. And if you were unfortunate enough to have private insurance, you’d be paying 46% more using the cards rather than generics. In some instances, patients were paying a whole $10 more for a prescription of the name brand, compared with the generic. And we thought Tim Hortons was our northern neighbor’s only company making a lot of dough. Ten loonies more per Rx ain’t Timbits.
So, Canada, how does it feel to have your health care made fun of? U-S-A! U-S-A! Now, if you’ll excuse us, we’re off to pay $1,000 a pill to cure us some hepatitis C. That’s some real red-blooded American price gouging right there.
This looks like a job for vacuum science
The LOTME staff, of course, scans a veritable buffet of sources to come up with the tasty tidbits we present each week to our deliciously wonderful and highly scrumptious readers each week.
One of our favorite sauces … umm, we mean sources, and the home of a tantalizing medical morsel (can you tell it’s almost lunch time?), is the Journal of Vacuum Science and Technology B. That’s B, not A. Anyone, at least anyone who’s serious about vacuum science, will tell you that the Journal of Vacuum Science and Technology A is pretty much a bottomless pit of trolling, political bickering, and popular nonsense. But B, now that’s a different story.
B is where we meet the EStAD (electrostatic and air driven) device. EStAD is a portable device that may someday offer physicians and first responders a way to treat wounds in rural areas where immediate care may not be available, the investigators said.
EStAD, using a process called electrospinning along with a confined electric field, works like a can of spray paint to deposit a fiber mat, which could be a bandage or a drug, onto a wound.
The device is still under development, but the research team reports that it has been successfully tested on a porcine skin incision and a gloved human hand.
The next step in EStAD development is to bring it to Washington, where the investigators will see if spray-on bandages can stand up to the hot air coming out of politicians’ mouths. We’re hoping that they sell tickets.
He’s not quite dead yet!
In 2015, Benjamin Schreiber, an Iowa man convicted of murder and sentenced to life in prison without parole, developed a case of septic poisoning because of large, untreated kidney stones. While at the hospital, his heart stopped several times, requiring resuscitation. After being stabilized, he underwent surgery to remove the kidney stones and was then released back to his prison cell.
Fast forward to 2018. Mr. Schreiber filed for relief from his conviction, arguing that, because he technically died, his life sentence had been served and he should be released. While the logic is impeccable, an Iowa district court didn’t buy it, noting that the fact that Mr. Schreiber was able to submit a petition for his release “confirms the petitioner’s current status as living.”
Sadly for Mr. Schreiber, the Iowa Court of Appeals agreed with the lower court’s decision. In a wonderfully pithy summation of the case, Judge Amanda Potterfield wrote: “Schreiber is either still alive, in which case he must remain in prison, or he is actually dead, in which case this appeal is moot.”
While the Livin’ on the MDedge team is glad that a convicted murderer will not be released back into the public, we salute his devotion to the art of technicality. The judges may not have been convinced, but you’re dead to us, Mr. Schreiber.
Breaking news: Drug companies gouge consumers
Canada. It’s home to many things: Trees, glaciers, beavers, and several people. But we Americans also know it as the home of cheap drugs. It may be borderline illegal, but that’s never stopped America from taking things that don’t belong to us before.
You’d think then that it’d be great being sick in Canada. But it turns out that many of those poor, desperate souls living in the frozen tundra of the north are actually overpaying for drugs just like the rest of us, according to research published in the Canadian Medical Association Journal.
It all comes down to those strange items called drug discount cards. They’re coupons offered by brand-name drug manufacturers to keep patients from switching to cheap generics.
Sounds great, right? Well, while a few patients saw savings, the average cost to patients with public insurance increased by 1.3% over generics. And if you were unfortunate enough to have private insurance, you’d be paying 46% more using the cards rather than generics. In some instances, patients were paying a whole $10 more for a prescription of the name brand, compared with the generic. And we thought Tim Hortons was our northern neighbor’s only company making a lot of dough. Ten loonies more per Rx ain’t Timbits.
So, Canada, how does it feel to have your health care made fun of? U-S-A! U-S-A! Now, if you’ll excuse us, we’re off to pay $1,000 a pill to cure us some hepatitis C. That’s some real red-blooded American price gouging right there.
This looks like a job for vacuum science
The LOTME staff, of course, scans a veritable buffet of sources to come up with the tasty tidbits we present each week to our deliciously wonderful and highly scrumptious readers each week.
One of our favorite sauces … umm, we mean sources, and the home of a tantalizing medical morsel (can you tell it’s almost lunch time?), is the Journal of Vacuum Science and Technology B. That’s B, not A. Anyone, at least anyone who’s serious about vacuum science, will tell you that the Journal of Vacuum Science and Technology A is pretty much a bottomless pit of trolling, political bickering, and popular nonsense. But B, now that’s a different story.
B is where we meet the EStAD (electrostatic and air driven) device. EStAD is a portable device that may someday offer physicians and first responders a way to treat wounds in rural areas where immediate care may not be available, the investigators said.
EStAD, using a process called electrospinning along with a confined electric field, works like a can of spray paint to deposit a fiber mat, which could be a bandage or a drug, onto a wound.
The device is still under development, but the research team reports that it has been successfully tested on a porcine skin incision and a gloved human hand.
The next step in EStAD development is to bring it to Washington, where the investigators will see if spray-on bandages can stand up to the hot air coming out of politicians’ mouths. We’re hoping that they sell tickets.
Amneal Pharma issues recall for ranitidine products
Amneal Pharmaceuticals has announced a voluntary recall for both ranitidine tablets and ranitidine syrup because of potential N-nitrosodimethylamine (NDMA) levels above Food and Drug Administration–allowed cutoffs, according to an FDA MedWatch alert.
NDMA, a probable human carcinogen, has been found in several different ranitidine products since an initial FDA announcement in September 2019. Ranitidine, a histamine2 receptor blocker, is indicated for multiple conditions, including treatment and prevention of ulcers of the stomach and intestines and treatment of gastroesophageal reflux disease.
The affected ranitidine products being recalled by Amneal include 60-, 100-, 180-, 500-, and 1,000-count 150-mg tablets; 30-, 100-, 250-, and 1,000-count 300-mg tablets, and a 15-mg/mL syrup. The manufacturer has not received any reports of adverse events confirmed to be directly related to the recall.
Consumers should contact their physicians or health care providers if they have experienced any problems that may be related to the use of this drug product, the FDA said. Adverse reactions or quality problems can be reported to Amneal Drug Safety by phone at 1-877-835-5472.
Amneal Pharmaceuticals has announced a voluntary recall for both ranitidine tablets and ranitidine syrup because of potential N-nitrosodimethylamine (NDMA) levels above Food and Drug Administration–allowed cutoffs, according to an FDA MedWatch alert.
NDMA, a probable human carcinogen, has been found in several different ranitidine products since an initial FDA announcement in September 2019. Ranitidine, a histamine2 receptor blocker, is indicated for multiple conditions, including treatment and prevention of ulcers of the stomach and intestines and treatment of gastroesophageal reflux disease.
The affected ranitidine products being recalled by Amneal include 60-, 100-, 180-, 500-, and 1,000-count 150-mg tablets; 30-, 100-, 250-, and 1,000-count 300-mg tablets, and a 15-mg/mL syrup. The manufacturer has not received any reports of adverse events confirmed to be directly related to the recall.
Consumers should contact their physicians or health care providers if they have experienced any problems that may be related to the use of this drug product, the FDA said. Adverse reactions or quality problems can be reported to Amneal Drug Safety by phone at 1-877-835-5472.
Amneal Pharmaceuticals has announced a voluntary recall for both ranitidine tablets and ranitidine syrup because of potential N-nitrosodimethylamine (NDMA) levels above Food and Drug Administration–allowed cutoffs, according to an FDA MedWatch alert.
NDMA, a probable human carcinogen, has been found in several different ranitidine products since an initial FDA announcement in September 2019. Ranitidine, a histamine2 receptor blocker, is indicated for multiple conditions, including treatment and prevention of ulcers of the stomach and intestines and treatment of gastroesophageal reflux disease.
The affected ranitidine products being recalled by Amneal include 60-, 100-, 180-, 500-, and 1,000-count 150-mg tablets; 30-, 100-, 250-, and 1,000-count 300-mg tablets, and a 15-mg/mL syrup. The manufacturer has not received any reports of adverse events confirmed to be directly related to the recall.
Consumers should contact their physicians or health care providers if they have experienced any problems that may be related to the use of this drug product, the FDA said. Adverse reactions or quality problems can be reported to Amneal Drug Safety by phone at 1-877-835-5472.
Sleep vs. Netflix, and grape juice BPAP
Sleep vs. Netflix: the eternal struggle
Ladies and gentlemen, welcome to Livin’ on the MDedge World Championship Boxing! Tonight, we bring you a classic match-up in the endless battle for your valuable time.
In the red corner, weighing in at a muscular 8 hours, is the defending champion: a good night’s sleep! And now for the challenger in the blue corner, coming in at a strong “just one more episode, I promise,” it’s binge watching!
Oh, sleep opens the match strong: According to a survey from the American Academy of Sleep Medicine, U.S. adults rank sleep as their second-most important priority, with only family beating it out. My goodness, that is a strong opening offensive.
But wait, binge watching is countering! According to the very same survey, 88% of Americans have admitted that they’d lost sleep because they’d stayed up late to watch extra episodes of a TV show or streaming series, a rate that rises to 95% in people aged 18-44 years. Oh dear, sleep looks like it’s in trouble.
Hang on, what’s binge watching doing? It’s unleashing a quick barrage of attacks: 72% of men aged 18-34 reported delaying sleep for video games, two-thirds of U.S. adults reported losing sleep to read a book, and nearly 60% of adults delayed sleep to watch sports. We feel slightly conflicted about our metaphor choice now.
And with a final haymaker from “guess I’ll watch ‘The Office’ for a sixth time,” binge watching has defeated the defending champion! Be sure to tune in next week, when alcohol takes on common sense. A true fight for the ages there.
Lead us not into temptation
Can anyone resist the temptation of binge watching? Can no one swim against the sleep-depriving, show-streaming current? Is resistance to an “Orange Is the New Black” bender futile?
University of Wyoming researchers say there’s hope. Those who would sleep svelte and sound in a world of streaming services and Krispy Kreme must plan ahead to tame temptation.
Proactive temptation management begins long before those chocolate iced glazed with sprinkles appear at the nurses’ station. Planning your response ahead of time increases the odds that the first episode of “Stranger Things” is also the evening’s last episode.
Using psychology’s human lab mice – undergraduate students – the researchers tested five temptation-proofing self-control strategies.
The first strategy: situation selection. If “Game of Thrones” is on in the den, avoid the room as if it were an unmucked House Lannister horse stall. Second: situation modification. Is your spouse hotboxing GoT on an iPad next to you in the bed? Politely suggest that GoT is even better when viewed on the living room sofa.
The third strategy: distraction. Enjoy the wholesome snap of a Finn Crisp while your coworkers destroy those Krispy Kremes like Daenerys leveling King’s Landing. Fourth: reappraisal. Tell yourself that season 2 of “Ozark” can’t surpass season 1, and will simply swindle you of your precious time. And fifth, the Nancy-Reagan, temptation-resistance classic: response inhibition. When offered the narcotic that is “Breaking Bad,” just say no!
Which temptation strategies worked best?
Planning ahead with one through four led fewer Cowboy State undergrads into temptation.
As for responding in the moment? Well, the Krispy Kremes would’ve never lasted past season 2 of “The Great British Baking Show.”
Stuck between a tongue and a hard place
There once was a 7-year-old boy who loved grape juice. He loved grape juice so much that he didn’t want to waste any after drinking a bottle of the stuff.
To get every last drop, he tried to use his tongue to lick the inside of a grape juice bottle. One particular bottle, however, was evil and had other plans. It grabbed his tongue and wouldn’t let go, even after his mother tried to help him.
She took him to the great healing wizards at Auf der Bult Children’s Hospital in Hannover, Germany – which is quite surprising, because they live in New Jersey. [Just kidding, they’re from Hannover – just checking to see if you’re paying attention.]
When their magic wands didn’t work, doctors at the hospital mildly sedated the boy with midazolam and esketamine and then advanced a 70-mm plastic button cannula between the neck of the bottle and his tongue, hoping to release the presumed vacuum. No such luck.
It was at that point that the greatest of all the wizards, Dr. Christoph Eich, a pediatric anesthesiologist at the hospital, remembered having a similar problem with a particularly villainous bottle of “grape juice” during his magical training days some 20 years earlier.
The solution then, he discovered, was to connect the cannula to a syringe and inject air into the bottle to produce positive pressure and force out the foreign object.
Dr. Eich’s reinvention of BPAP (bottle positive airway pressure) worked on the child, who, once the purple discoloration of his tongue faded after 3 days, was none the worse for wear and lived happily ever after.
We’re just wondering if the good doctor told the child’s mother that the original situation involved a bottle of wine that couldn’t be opened because no one had a corkscrew. Well, maybe she reads the European Journal of Anaesthesiology.
Sleep vs. Netflix: the eternal struggle
Ladies and gentlemen, welcome to Livin’ on the MDedge World Championship Boxing! Tonight, we bring you a classic match-up in the endless battle for your valuable time.
In the red corner, weighing in at a muscular 8 hours, is the defending champion: a good night’s sleep! And now for the challenger in the blue corner, coming in at a strong “just one more episode, I promise,” it’s binge watching!
Oh, sleep opens the match strong: According to a survey from the American Academy of Sleep Medicine, U.S. adults rank sleep as their second-most important priority, with only family beating it out. My goodness, that is a strong opening offensive.
But wait, binge watching is countering! According to the very same survey, 88% of Americans have admitted that they’d lost sleep because they’d stayed up late to watch extra episodes of a TV show or streaming series, a rate that rises to 95% in people aged 18-44 years. Oh dear, sleep looks like it’s in trouble.
Hang on, what’s binge watching doing? It’s unleashing a quick barrage of attacks: 72% of men aged 18-34 reported delaying sleep for video games, two-thirds of U.S. adults reported losing sleep to read a book, and nearly 60% of adults delayed sleep to watch sports. We feel slightly conflicted about our metaphor choice now.
And with a final haymaker from “guess I’ll watch ‘The Office’ for a sixth time,” binge watching has defeated the defending champion! Be sure to tune in next week, when alcohol takes on common sense. A true fight for the ages there.
Lead us not into temptation
Can anyone resist the temptation of binge watching? Can no one swim against the sleep-depriving, show-streaming current? Is resistance to an “Orange Is the New Black” bender futile?
University of Wyoming researchers say there’s hope. Those who would sleep svelte and sound in a world of streaming services and Krispy Kreme must plan ahead to tame temptation.
Proactive temptation management begins long before those chocolate iced glazed with sprinkles appear at the nurses’ station. Planning your response ahead of time increases the odds that the first episode of “Stranger Things” is also the evening’s last episode.
Using psychology’s human lab mice – undergraduate students – the researchers tested five temptation-proofing self-control strategies.
The first strategy: situation selection. If “Game of Thrones” is on in the den, avoid the room as if it were an unmucked House Lannister horse stall. Second: situation modification. Is your spouse hotboxing GoT on an iPad next to you in the bed? Politely suggest that GoT is even better when viewed on the living room sofa.
The third strategy: distraction. Enjoy the wholesome snap of a Finn Crisp while your coworkers destroy those Krispy Kremes like Daenerys leveling King’s Landing. Fourth: reappraisal. Tell yourself that season 2 of “Ozark” can’t surpass season 1, and will simply swindle you of your precious time. And fifth, the Nancy-Reagan, temptation-resistance classic: response inhibition. When offered the narcotic that is “Breaking Bad,” just say no!
Which temptation strategies worked best?
Planning ahead with one through four led fewer Cowboy State undergrads into temptation.
As for responding in the moment? Well, the Krispy Kremes would’ve never lasted past season 2 of “The Great British Baking Show.”
Stuck between a tongue and a hard place
There once was a 7-year-old boy who loved grape juice. He loved grape juice so much that he didn’t want to waste any after drinking a bottle of the stuff.
To get every last drop, he tried to use his tongue to lick the inside of a grape juice bottle. One particular bottle, however, was evil and had other plans. It grabbed his tongue and wouldn’t let go, even after his mother tried to help him.
She took him to the great healing wizards at Auf der Bult Children’s Hospital in Hannover, Germany – which is quite surprising, because they live in New Jersey. [Just kidding, they’re from Hannover – just checking to see if you’re paying attention.]
When their magic wands didn’t work, doctors at the hospital mildly sedated the boy with midazolam and esketamine and then advanced a 70-mm plastic button cannula between the neck of the bottle and his tongue, hoping to release the presumed vacuum. No such luck.
It was at that point that the greatest of all the wizards, Dr. Christoph Eich, a pediatric anesthesiologist at the hospital, remembered having a similar problem with a particularly villainous bottle of “grape juice” during his magical training days some 20 years earlier.
The solution then, he discovered, was to connect the cannula to a syringe and inject air into the bottle to produce positive pressure and force out the foreign object.
Dr. Eich’s reinvention of BPAP (bottle positive airway pressure) worked on the child, who, once the purple discoloration of his tongue faded after 3 days, was none the worse for wear and lived happily ever after.
We’re just wondering if the good doctor told the child’s mother that the original situation involved a bottle of wine that couldn’t be opened because no one had a corkscrew. Well, maybe she reads the European Journal of Anaesthesiology.
Sleep vs. Netflix: the eternal struggle
Ladies and gentlemen, welcome to Livin’ on the MDedge World Championship Boxing! Tonight, we bring you a classic match-up in the endless battle for your valuable time.
In the red corner, weighing in at a muscular 8 hours, is the defending champion: a good night’s sleep! And now for the challenger in the blue corner, coming in at a strong “just one more episode, I promise,” it’s binge watching!
Oh, sleep opens the match strong: According to a survey from the American Academy of Sleep Medicine, U.S. adults rank sleep as their second-most important priority, with only family beating it out. My goodness, that is a strong opening offensive.
But wait, binge watching is countering! According to the very same survey, 88% of Americans have admitted that they’d lost sleep because they’d stayed up late to watch extra episodes of a TV show or streaming series, a rate that rises to 95% in people aged 18-44 years. Oh dear, sleep looks like it’s in trouble.
Hang on, what’s binge watching doing? It’s unleashing a quick barrage of attacks: 72% of men aged 18-34 reported delaying sleep for video games, two-thirds of U.S. adults reported losing sleep to read a book, and nearly 60% of adults delayed sleep to watch sports. We feel slightly conflicted about our metaphor choice now.
And with a final haymaker from “guess I’ll watch ‘The Office’ for a sixth time,” binge watching has defeated the defending champion! Be sure to tune in next week, when alcohol takes on common sense. A true fight for the ages there.
Lead us not into temptation
Can anyone resist the temptation of binge watching? Can no one swim against the sleep-depriving, show-streaming current? Is resistance to an “Orange Is the New Black” bender futile?
University of Wyoming researchers say there’s hope. Those who would sleep svelte and sound in a world of streaming services and Krispy Kreme must plan ahead to tame temptation.
Proactive temptation management begins long before those chocolate iced glazed with sprinkles appear at the nurses’ station. Planning your response ahead of time increases the odds that the first episode of “Stranger Things” is also the evening’s last episode.
Using psychology’s human lab mice – undergraduate students – the researchers tested five temptation-proofing self-control strategies.
The first strategy: situation selection. If “Game of Thrones” is on in the den, avoid the room as if it were an unmucked House Lannister horse stall. Second: situation modification. Is your spouse hotboxing GoT on an iPad next to you in the bed? Politely suggest that GoT is even better when viewed on the living room sofa.
The third strategy: distraction. Enjoy the wholesome snap of a Finn Crisp while your coworkers destroy those Krispy Kremes like Daenerys leveling King’s Landing. Fourth: reappraisal. Tell yourself that season 2 of “Ozark” can’t surpass season 1, and will simply swindle you of your precious time. And fifth, the Nancy-Reagan, temptation-resistance classic: response inhibition. When offered the narcotic that is “Breaking Bad,” just say no!
Which temptation strategies worked best?
Planning ahead with one through four led fewer Cowboy State undergrads into temptation.
As for responding in the moment? Well, the Krispy Kremes would’ve never lasted past season 2 of “The Great British Baking Show.”
Stuck between a tongue and a hard place
There once was a 7-year-old boy who loved grape juice. He loved grape juice so much that he didn’t want to waste any after drinking a bottle of the stuff.
To get every last drop, he tried to use his tongue to lick the inside of a grape juice bottle. One particular bottle, however, was evil and had other plans. It grabbed his tongue and wouldn’t let go, even after his mother tried to help him.
She took him to the great healing wizards at Auf der Bult Children’s Hospital in Hannover, Germany – which is quite surprising, because they live in New Jersey. [Just kidding, they’re from Hannover – just checking to see if you’re paying attention.]
When their magic wands didn’t work, doctors at the hospital mildly sedated the boy with midazolam and esketamine and then advanced a 70-mm plastic button cannula between the neck of the bottle and his tongue, hoping to release the presumed vacuum. No such luck.
It was at that point that the greatest of all the wizards, Dr. Christoph Eich, a pediatric anesthesiologist at the hospital, remembered having a similar problem with a particularly villainous bottle of “grape juice” during his magical training days some 20 years earlier.
The solution then, he discovered, was to connect the cannula to a syringe and inject air into the bottle to produce positive pressure and force out the foreign object.
Dr. Eich’s reinvention of BPAP (bottle positive airway pressure) worked on the child, who, once the purple discoloration of his tongue faded after 3 days, was none the worse for wear and lived happily ever after.
We’re just wondering if the good doctor told the child’s mother that the original situation involved a bottle of wine that couldn’t be opened because no one had a corkscrew. Well, maybe she reads the European Journal of Anaesthesiology.
FDA approves Ziextenzo for neutropenia-related infection reduction
The Food and Drug Administration has approved the biosimilar Ziextenzo (pegfilgrastim-bmez) to reduce the incidence of infection in patients with nonmyeloid cancer receiving suppressive anticancer drugs that are associated with febrile neutropenia.
More than 60,000 cancer patients are hospitalized in the United States each year with evidence of neutropenia, resulting in more than 4,000 deaths, according to Ziextenzo maker Sandoz, a Novartis division.
The FDA approval was based on analytical, preclinical, and clinical research, including data from a three-way pharmacokinetics and pharmacodynamics study that compared pegfilgrastim-bmez with the reference drug pegfilgrastim (Neulasta) from the United States and the European Union. Pharmacokinetic and pharmacodynamic similarity were shown between pegfilgrastim-bmez with the reference drugs, and there were no clinically significant differences in safety or immunogenicity.
The most common adverse events associated with pegfilgrastim-bmez are bone pain and pain in the extremities, according to the label.
The Food and Drug Administration has approved the biosimilar Ziextenzo (pegfilgrastim-bmez) to reduce the incidence of infection in patients with nonmyeloid cancer receiving suppressive anticancer drugs that are associated with febrile neutropenia.
More than 60,000 cancer patients are hospitalized in the United States each year with evidence of neutropenia, resulting in more than 4,000 deaths, according to Ziextenzo maker Sandoz, a Novartis division.
The FDA approval was based on analytical, preclinical, and clinical research, including data from a three-way pharmacokinetics and pharmacodynamics study that compared pegfilgrastim-bmez with the reference drug pegfilgrastim (Neulasta) from the United States and the European Union. Pharmacokinetic and pharmacodynamic similarity were shown between pegfilgrastim-bmez with the reference drugs, and there were no clinically significant differences in safety or immunogenicity.
The most common adverse events associated with pegfilgrastim-bmez are bone pain and pain in the extremities, according to the label.
The Food and Drug Administration has approved the biosimilar Ziextenzo (pegfilgrastim-bmez) to reduce the incidence of infection in patients with nonmyeloid cancer receiving suppressive anticancer drugs that are associated with febrile neutropenia.
More than 60,000 cancer patients are hospitalized in the United States each year with evidence of neutropenia, resulting in more than 4,000 deaths, according to Ziextenzo maker Sandoz, a Novartis division.
The FDA approval was based on analytical, preclinical, and clinical research, including data from a three-way pharmacokinetics and pharmacodynamics study that compared pegfilgrastim-bmez with the reference drug pegfilgrastim (Neulasta) from the United States and the European Union. Pharmacokinetic and pharmacodynamic similarity were shown between pegfilgrastim-bmez with the reference drugs, and there were no clinically significant differences in safety or immunogenicity.
The most common adverse events associated with pegfilgrastim-bmez are bone pain and pain in the extremities, according to the label.
Requests for crowd diagnoses of STDs common on social media
Requests for crowd diagnosis of sexually transmitted diseases were frequent on a social media website, new research found.
The social media website Reddit, which currently has 330 million monthly active users, is home to more than 230 health-related subreddits, including r/STD, a forum that allows users to publicly share “stories, concerns, and questions” about “anything and everything STD related,” Alicia L. Nobles, PhD, of the department of medicine at the University of California, San Diego, and associates wrote in a research letter published in JAMA.
Dr. Noble and associates conducted an analysis of all posts published to r/STD from the subreddit’s inception during November 2010–February 2019, a total of 16,979 posts. Three coauthors independently coded each post, recording whether or not a post requested a crowd diagnosis, and if so, whether that request was made to obtain a second opinion after a visit to a health care professional.
About 58% of posts requested a crowd diagnosis, 31% of which included an image of the physical signs. One-fifth of the requests for a crowd diagnosis were seeking a second opinion after a previous diagnosis by a health care professional. Nearly 90% of all crowd-diagnosis requests received at least one reply (mean responses, 1.7), with a median response time of 3.04 hours. About 80% of requests were answered in less than 1 day.
While crowd diagnoses do seem to be popular and have the benefits of anonymity, rapid response, and multiple opinions, the accuracy of crowd diagnoses is unknown given the limited information responders operate with and the potential lack of responder medical training, the study authors noted. Misdiagnosis could allow further disease transmission, and third parties viewing posts could incorrectly self-diagnose their own condition.
“Health care professionals could partner with social media outlets to promote the potential benefits of crowd diagnosis while suppressing potential harms, for example by having trained professionals respond to posts to better diagnose and make referrals to health care centers,” Dr. Nobles and associates concluded.
One coauthor reported receiving personal fees from Bloomberg and Good Analytics, and another reported receiving grants from the National Institutes of Health; no other disclosures were reported.
SOURCE: Nobles AL et al. JAMA. 2019 Nov 5;322(17):1712-3.
Requests for crowd diagnosis of sexually transmitted diseases were frequent on a social media website, new research found.
The social media website Reddit, which currently has 330 million monthly active users, is home to more than 230 health-related subreddits, including r/STD, a forum that allows users to publicly share “stories, concerns, and questions” about “anything and everything STD related,” Alicia L. Nobles, PhD, of the department of medicine at the University of California, San Diego, and associates wrote in a research letter published in JAMA.
Dr. Noble and associates conducted an analysis of all posts published to r/STD from the subreddit’s inception during November 2010–February 2019, a total of 16,979 posts. Three coauthors independently coded each post, recording whether or not a post requested a crowd diagnosis, and if so, whether that request was made to obtain a second opinion after a visit to a health care professional.
About 58% of posts requested a crowd diagnosis, 31% of which included an image of the physical signs. One-fifth of the requests for a crowd diagnosis were seeking a second opinion after a previous diagnosis by a health care professional. Nearly 90% of all crowd-diagnosis requests received at least one reply (mean responses, 1.7), with a median response time of 3.04 hours. About 80% of requests were answered in less than 1 day.
While crowd diagnoses do seem to be popular and have the benefits of anonymity, rapid response, and multiple opinions, the accuracy of crowd diagnoses is unknown given the limited information responders operate with and the potential lack of responder medical training, the study authors noted. Misdiagnosis could allow further disease transmission, and third parties viewing posts could incorrectly self-diagnose their own condition.
“Health care professionals could partner with social media outlets to promote the potential benefits of crowd diagnosis while suppressing potential harms, for example by having trained professionals respond to posts to better diagnose and make referrals to health care centers,” Dr. Nobles and associates concluded.
One coauthor reported receiving personal fees from Bloomberg and Good Analytics, and another reported receiving grants from the National Institutes of Health; no other disclosures were reported.
SOURCE: Nobles AL et al. JAMA. 2019 Nov 5;322(17):1712-3.
Requests for crowd diagnosis of sexually transmitted diseases were frequent on a social media website, new research found.
The social media website Reddit, which currently has 330 million monthly active users, is home to more than 230 health-related subreddits, including r/STD, a forum that allows users to publicly share “stories, concerns, and questions” about “anything and everything STD related,” Alicia L. Nobles, PhD, of the department of medicine at the University of California, San Diego, and associates wrote in a research letter published in JAMA.
Dr. Noble and associates conducted an analysis of all posts published to r/STD from the subreddit’s inception during November 2010–February 2019, a total of 16,979 posts. Three coauthors independently coded each post, recording whether or not a post requested a crowd diagnosis, and if so, whether that request was made to obtain a second opinion after a visit to a health care professional.
About 58% of posts requested a crowd diagnosis, 31% of which included an image of the physical signs. One-fifth of the requests for a crowd diagnosis were seeking a second opinion after a previous diagnosis by a health care professional. Nearly 90% of all crowd-diagnosis requests received at least one reply (mean responses, 1.7), with a median response time of 3.04 hours. About 80% of requests were answered in less than 1 day.
While crowd diagnoses do seem to be popular and have the benefits of anonymity, rapid response, and multiple opinions, the accuracy of crowd diagnoses is unknown given the limited information responders operate with and the potential lack of responder medical training, the study authors noted. Misdiagnosis could allow further disease transmission, and third parties viewing posts could incorrectly self-diagnose their own condition.
“Health care professionals could partner with social media outlets to promote the potential benefits of crowd diagnosis while suppressing potential harms, for example by having trained professionals respond to posts to better diagnose and make referrals to health care centers,” Dr. Nobles and associates concluded.
One coauthor reported receiving personal fees from Bloomberg and Good Analytics, and another reported receiving grants from the National Institutes of Health; no other disclosures were reported.
SOURCE: Nobles AL et al. JAMA. 2019 Nov 5;322(17):1712-3.
FROM JAMA
Key clinical point: Crowd-diagnosis requests of STDs are popular on a social media–based health forum.
Major finding: Nearly 60% of r/STD posts were a request for diagnosis, 87% of which received a reply (mean responses, 1.7; mean response time, 3.0 hours).
Study details: A review of 16,979 posts on the subreddit r/STD.
Disclosures: One coauthor reported receiving personal fees from Bloomberg and Good Analytics, and another reported receiving grants from the National Institutes of Health; no other disclosures were reported.Source: Nobles AL et al. JAMA. 2019 Nov 5;322(17):1712-3.