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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 advises stopping SGLT2 inhibitor treatment prior to surgery
The new changes affect canagliflozin, dapagliflozin, empagliflozin, and ertugliflozin, and were made because surgery may put patients being treated with SGLT2 inhibitors at a higher risk of ketoacidosis. Canagliflozin, dapagliflozin, and empagliflozin should be discontinued 3 days before scheduled surgery, and ertugliflozin should be stopped at least 4 days before, the agency noted in a press release. Blood glucose should be monitored after drug discontinuation and appropriately managed before surgery.
“The SGLT2 inhibitor may be restarted once the patient’s oral intake is back to baseline and any other risk factors for ketoacidosis are resolved,” the agency added.
SGLT2 inhibitors lower blood sugar by causing the kidney to remove sugar from the body through urine. Side effects for the drugs vary, but include urinary tract infections and genital mycotic infection. Patients with severe renal impairment or end-stage renal disease, who are on dialysis treatment, or who have a known hypersensitivity to the medication should not take SGLT2 inhibitors, the FDA said.
The new changes affect canagliflozin, dapagliflozin, empagliflozin, and ertugliflozin, and were made because surgery may put patients being treated with SGLT2 inhibitors at a higher risk of ketoacidosis. Canagliflozin, dapagliflozin, and empagliflozin should be discontinued 3 days before scheduled surgery, and ertugliflozin should be stopped at least 4 days before, the agency noted in a press release. Blood glucose should be monitored after drug discontinuation and appropriately managed before surgery.
“The SGLT2 inhibitor may be restarted once the patient’s oral intake is back to baseline and any other risk factors for ketoacidosis are resolved,” the agency added.
SGLT2 inhibitors lower blood sugar by causing the kidney to remove sugar from the body through urine. Side effects for the drugs vary, but include urinary tract infections and genital mycotic infection. Patients with severe renal impairment or end-stage renal disease, who are on dialysis treatment, or who have a known hypersensitivity to the medication should not take SGLT2 inhibitors, the FDA said.
The new changes affect canagliflozin, dapagliflozin, empagliflozin, and ertugliflozin, and were made because surgery may put patients being treated with SGLT2 inhibitors at a higher risk of ketoacidosis. Canagliflozin, dapagliflozin, and empagliflozin should be discontinued 3 days before scheduled surgery, and ertugliflozin should be stopped at least 4 days before, the agency noted in a press release. Blood glucose should be monitored after drug discontinuation and appropriately managed before surgery.
“The SGLT2 inhibitor may be restarted once the patient’s oral intake is back to baseline and any other risk factors for ketoacidosis are resolved,” the agency added.
SGLT2 inhibitors lower blood sugar by causing the kidney to remove sugar from the body through urine. Side effects for the drugs vary, but include urinary tract infections and genital mycotic infection. Patients with severe renal impairment or end-stage renal disease, who are on dialysis treatment, or who have a known hypersensitivity to the medication should not take SGLT2 inhibitors, the FDA said.
Nearly half of STI events go without HIV testing
according to Danielle Petsis, MPH, of the Children’s Hospital of Philadelphia, and associates.
In a study published in Pediatrics, the investigators conducted a retrospective analysis of 1,816 acute STI events from 1,313 patients aged 13-24 years admitted between July 2014 and Dec. 2017 at two urban health care clinics. The most common STIs in the analysis were Chlamydia, gonorrhea, trichomoniasis, and syphilis; the mean age at diagnosis was 17 years, 71% of episodes occurred in females, and 97% occurred in African American patients.
Of the 1,816 events, HIV testing was completed within 90 days of the STI diagnosis for only 55%; there was 1 confirmed HIV diagnosis among the completed tests. When HIV testing did occur, in 38% of cases it was completed concurrently with STI testing or HIV testing was performed in 35% of the 872 follow-up cases. Of the 815 events where HIV testing was not performed, 27% had a test ordered by the provider but not completed by the patient; the patient leaving the laboratory before the test could be performed was the most common reason for test noncompletion (67%), followed by not showing up at all (18%) and errors in the medical record or laboratory (5%); the remaining patients gave as reasons for test noncompletion: declining an HIV test, a closed lab, or no reason.
Logistic regression showed that participants who were female and those with a previous history of STIs had significantly lower adjusted odds of HIV test completion, compared with males and those with no previous history of STIs, respectively, the investigators said. In addition, having insurance and having a family planning visit were associated with decreased odds of HIV testing, compared with not having insurance or a family planning visit.
“As we enter the fourth decade of the HIV epidemic, it remains clear that missed opportunities for diagnosis have the potential to delay HIV diagnosis and linkage to antiretroviral therapy or PrEP and prevention services, thus increasing the population risk of HIV transmission. Our data underscore the need for improved HIV testing education for providers of all levels of training and the need for public health agencies to clearly communicate the need for testing at the time of STI infection to reduce the number of missed opportunities for testing,” Ms. Petsis and colleagues concluded.
The study was supported by the National Institutes of Mental Health and the Children’s Hospital of Philadelphia Research Institute K-Readiness Award. One coauthor reported receiving funding from Bayer Healthcare, the Templeton Foundation, the National Institutes of Health, and Janssen Biotech. She also serves on expert advisory boards for Mylan Pharmaceuticals and Merck. The other authors have no relevant financial disclosures.
SOURCE: Wood S et al. Pediatrics. 2020 Mar 16. doi: 10.1542/peds.2019-2265.
according to Danielle Petsis, MPH, of the Children’s Hospital of Philadelphia, and associates.
In a study published in Pediatrics, the investigators conducted a retrospective analysis of 1,816 acute STI events from 1,313 patients aged 13-24 years admitted between July 2014 and Dec. 2017 at two urban health care clinics. The most common STIs in the analysis were Chlamydia, gonorrhea, trichomoniasis, and syphilis; the mean age at diagnosis was 17 years, 71% of episodes occurred in females, and 97% occurred in African American patients.
Of the 1,816 events, HIV testing was completed within 90 days of the STI diagnosis for only 55%; there was 1 confirmed HIV diagnosis among the completed tests. When HIV testing did occur, in 38% of cases it was completed concurrently with STI testing or HIV testing was performed in 35% of the 872 follow-up cases. Of the 815 events where HIV testing was not performed, 27% had a test ordered by the provider but not completed by the patient; the patient leaving the laboratory before the test could be performed was the most common reason for test noncompletion (67%), followed by not showing up at all (18%) and errors in the medical record or laboratory (5%); the remaining patients gave as reasons for test noncompletion: declining an HIV test, a closed lab, or no reason.
Logistic regression showed that participants who were female and those with a previous history of STIs had significantly lower adjusted odds of HIV test completion, compared with males and those with no previous history of STIs, respectively, the investigators said. In addition, having insurance and having a family planning visit were associated with decreased odds of HIV testing, compared with not having insurance or a family planning visit.
“As we enter the fourth decade of the HIV epidemic, it remains clear that missed opportunities for diagnosis have the potential to delay HIV diagnosis and linkage to antiretroviral therapy or PrEP and prevention services, thus increasing the population risk of HIV transmission. Our data underscore the need for improved HIV testing education for providers of all levels of training and the need for public health agencies to clearly communicate the need for testing at the time of STI infection to reduce the number of missed opportunities for testing,” Ms. Petsis and colleagues concluded.
The study was supported by the National Institutes of Mental Health and the Children’s Hospital of Philadelphia Research Institute K-Readiness Award. One coauthor reported receiving funding from Bayer Healthcare, the Templeton Foundation, the National Institutes of Health, and Janssen Biotech. She also serves on expert advisory boards for Mylan Pharmaceuticals and Merck. The other authors have no relevant financial disclosures.
SOURCE: Wood S et al. Pediatrics. 2020 Mar 16. doi: 10.1542/peds.2019-2265.
according to Danielle Petsis, MPH, of the Children’s Hospital of Philadelphia, and associates.
In a study published in Pediatrics, the investigators conducted a retrospective analysis of 1,816 acute STI events from 1,313 patients aged 13-24 years admitted between July 2014 and Dec. 2017 at two urban health care clinics. The most common STIs in the analysis were Chlamydia, gonorrhea, trichomoniasis, and syphilis; the mean age at diagnosis was 17 years, 71% of episodes occurred in females, and 97% occurred in African American patients.
Of the 1,816 events, HIV testing was completed within 90 days of the STI diagnosis for only 55%; there was 1 confirmed HIV diagnosis among the completed tests. When HIV testing did occur, in 38% of cases it was completed concurrently with STI testing or HIV testing was performed in 35% of the 872 follow-up cases. Of the 815 events where HIV testing was not performed, 27% had a test ordered by the provider but not completed by the patient; the patient leaving the laboratory before the test could be performed was the most common reason for test noncompletion (67%), followed by not showing up at all (18%) and errors in the medical record or laboratory (5%); the remaining patients gave as reasons for test noncompletion: declining an HIV test, a closed lab, or no reason.
Logistic regression showed that participants who were female and those with a previous history of STIs had significantly lower adjusted odds of HIV test completion, compared with males and those with no previous history of STIs, respectively, the investigators said. In addition, having insurance and having a family planning visit were associated with decreased odds of HIV testing, compared with not having insurance or a family planning visit.
“As we enter the fourth decade of the HIV epidemic, it remains clear that missed opportunities for diagnosis have the potential to delay HIV diagnosis and linkage to antiretroviral therapy or PrEP and prevention services, thus increasing the population risk of HIV transmission. Our data underscore the need for improved HIV testing education for providers of all levels of training and the need for public health agencies to clearly communicate the need for testing at the time of STI infection to reduce the number of missed opportunities for testing,” Ms. Petsis and colleagues concluded.
The study was supported by the National Institutes of Mental Health and the Children’s Hospital of Philadelphia Research Institute K-Readiness Award. One coauthor reported receiving funding from Bayer Healthcare, the Templeton Foundation, the National Institutes of Health, and Janssen Biotech. She also serves on expert advisory boards for Mylan Pharmaceuticals and Merck. The other authors have no relevant financial disclosures.
SOURCE: Wood S et al. Pediatrics. 2020 Mar 16. doi: 10.1542/peds.2019-2265.
FROM PEDIATRICS
FDA warns of serious infection risk after FMT
The Food and Drug Administration has issued a Safety Alert warning of the potential risk of serious, life-threatening infection in patients who receive fecal microbiota transplant for Clostridioides difficile infection.
The FDA has received six reports of infection associated with fecal microbiota transplant from a stool bank company based in the United States: Two patients had enteropathogenic Escherichia coli (EPEC) infection, and four had shiga toxin–producing E. coli (STEC). The two EPEC infections came from two separate donors, but the four STEC infections came from a single donor, according to the FDA.
In addition, two patients died after receiving fecal microbiota transplant from the donor associated with the STEC infections. These patients died before any of the STEC infections were reported to the FDA; as their stool was not tested for STEC, it is unclear whether it contributed to their deaths.
The use of fecal microbiota transplant is still investigational, and as such, patients should be made aware by health care providers of the risks, which include the potential for transmission of pathogenic bacteria and the resultant adverse events, the FDA said in the press release.
The Food and Drug Administration has issued a Safety Alert warning of the potential risk of serious, life-threatening infection in patients who receive fecal microbiota transplant for Clostridioides difficile infection.
The FDA has received six reports of infection associated with fecal microbiota transplant from a stool bank company based in the United States: Two patients had enteropathogenic Escherichia coli (EPEC) infection, and four had shiga toxin–producing E. coli (STEC). The two EPEC infections came from two separate donors, but the four STEC infections came from a single donor, according to the FDA.
In addition, two patients died after receiving fecal microbiota transplant from the donor associated with the STEC infections. These patients died before any of the STEC infections were reported to the FDA; as their stool was not tested for STEC, it is unclear whether it contributed to their deaths.
The use of fecal microbiota transplant is still investigational, and as such, patients should be made aware by health care providers of the risks, which include the potential for transmission of pathogenic bacteria and the resultant adverse events, the FDA said in the press release.
The Food and Drug Administration has issued a Safety Alert warning of the potential risk of serious, life-threatening infection in patients who receive fecal microbiota transplant for Clostridioides difficile infection.
The FDA has received six reports of infection associated with fecal microbiota transplant from a stool bank company based in the United States: Two patients had enteropathogenic Escherichia coli (EPEC) infection, and four had shiga toxin–producing E. coli (STEC). The two EPEC infections came from two separate donors, but the four STEC infections came from a single donor, according to the FDA.
In addition, two patients died after receiving fecal microbiota transplant from the donor associated with the STEC infections. These patients died before any of the STEC infections were reported to the FDA; as their stool was not tested for STEC, it is unclear whether it contributed to their deaths.
The use of fecal microbiota transplant is still investigational, and as such, patients should be made aware by health care providers of the risks, which include the potential for transmission of pathogenic bacteria and the resultant adverse events, the FDA said in the press release.
Dermatologists best at finding work satisfaction in the office
, according to Medscape’s 2020 Lifestyle, Happiness, and Burnout Report.
About 41% of dermatologists reported being very happy at work, making their specialty the only one to break the 40% barrier. While dermatologists weren’t the happiest outside of work – that honor went to rheumatologists – dermatology was only 4 percentage points behind (60% vs. 56%).
Perhaps unsurprisingly, the percentage of dermatologists who were burned out was lower than that of physicians overall (36% vs. 41%). The biggest factors leading to burnout in dermatologists were an overabundance of bureaucratic tasks (58%), increased time devoted to EHRs (38%), and compliance with government regulations (35%).
Dermatologists dealt with burnout through a variety of ways, with the most common being exercise (44%), talk with family/friends (44%), and isolation from others (40%). In addition, dermatologists took slightly more vacation time than did physicians overall, with 51% of dermatologists taking 3-4 weeks of vacation, compared with 44% for physicians overall.
About 16% of dermatologists have contemplated suicide; however, none reported attempting suicide, and 72% of dermatologists have never felt suicidal. Most dermatologists also plan to deal with burnout or depression on their own, with only 31% reporting that they are currently seeking professional help, planning to seek help, or are not currently looking but have been treated in the past.
The Medscape survey was conducted from June 25 to Sept. 19, 2019, and involved 15,181 physicians.
, according to Medscape’s 2020 Lifestyle, Happiness, and Burnout Report.
About 41% of dermatologists reported being very happy at work, making their specialty the only one to break the 40% barrier. While dermatologists weren’t the happiest outside of work – that honor went to rheumatologists – dermatology was only 4 percentage points behind (60% vs. 56%).
Perhaps unsurprisingly, the percentage of dermatologists who were burned out was lower than that of physicians overall (36% vs. 41%). The biggest factors leading to burnout in dermatologists were an overabundance of bureaucratic tasks (58%), increased time devoted to EHRs (38%), and compliance with government regulations (35%).
Dermatologists dealt with burnout through a variety of ways, with the most common being exercise (44%), talk with family/friends (44%), and isolation from others (40%). In addition, dermatologists took slightly more vacation time than did physicians overall, with 51% of dermatologists taking 3-4 weeks of vacation, compared with 44% for physicians overall.
About 16% of dermatologists have contemplated suicide; however, none reported attempting suicide, and 72% of dermatologists have never felt suicidal. Most dermatologists also plan to deal with burnout or depression on their own, with only 31% reporting that they are currently seeking professional help, planning to seek help, or are not currently looking but have been treated in the past.
The Medscape survey was conducted from June 25 to Sept. 19, 2019, and involved 15,181 physicians.
, according to Medscape’s 2020 Lifestyle, Happiness, and Burnout Report.
About 41% of dermatologists reported being very happy at work, making their specialty the only one to break the 40% barrier. While dermatologists weren’t the happiest outside of work – that honor went to rheumatologists – dermatology was only 4 percentage points behind (60% vs. 56%).
Perhaps unsurprisingly, the percentage of dermatologists who were burned out was lower than that of physicians overall (36% vs. 41%). The biggest factors leading to burnout in dermatologists were an overabundance of bureaucratic tasks (58%), increased time devoted to EHRs (38%), and compliance with government regulations (35%).
Dermatologists dealt with burnout through a variety of ways, with the most common being exercise (44%), talk with family/friends (44%), and isolation from others (40%). In addition, dermatologists took slightly more vacation time than did physicians overall, with 51% of dermatologists taking 3-4 weeks of vacation, compared with 44% for physicians overall.
About 16% of dermatologists have contemplated suicide; however, none reported attempting suicide, and 72% of dermatologists have never felt suicidal. Most dermatologists also plan to deal with burnout or depression on their own, with only 31% reporting that they are currently seeking professional help, planning to seek help, or are not currently looking but have been treated in the past.
The Medscape survey was conducted from June 25 to Sept. 19, 2019, and involved 15,181 physicians.
Australian apocalypse essentials and bacterial evolution stoppers
Irony 1, Council on Foreign Relations 0
It’s not a great time to be a business owner right now. People everywhere are feeling nervous, thanks to our old friend COVID-19, and it can be difficult to actually sell things when half the population is staying indoors hoarding toilet paper.
So if you are a business owner, you’re probably thinking: “Gee, it sure would be nice to meet up with my fellow business owners to come up with a plan on how to operate in a world dealing with a potential pandemic.” Right?
That’s the idea behind the Council on Foreign Relations’ roundtable discussion called “Doing Business Under Coronavirus,” scheduled for March 13, 2020, in New York. Or at least, it was the idea, because the conference has been canceled. And you’ll never guess why.
Okay, it was coronavirus. Uh, you probably did guess that. We’re not entirely sure what that means for business owners, but come on, there’s no need to worry, at least the infectious disease physicians had their meeting this past weekend ... oh wait. Hmm, maybe it’s time to start searching Amazon for some toilet paper.
Wipe away coronavirus fear
People now have smartphones to read the news while on the toilet, but at one point or another, having a newspaper to read in the john was probably pretty essential to combat boredom. Our friends down under, however, seem to have found another essential way to use a newspaper in the bathroom.
The coronavirus is slowly making its way around the world, and in Australia, people are stocking up on toilet paper. Toilet paper companies are working extra hard to keep a steady supply of toilet paper in supermarkets. A newspaper has tried to help by adding extra pages to its newspapers that could potentially be used as toilet paper. This seems like a good time to swap out your smartphone for one of these newspapers as it would not be wise to use your smartphone for toilet paper.
No one is sure why everyone in Australia is in a frenzy over toilet paper since it’s not a very big necessity in a large coronavirus outbreak. Are Aussies preparing to hide out in their homes just in case those affected by coronavirus turn into zombies, thus creating a zombie apocalypse? In that case, yeah, toilet paper, among other things, is probably essential.
Resistance meets resistance
As our planet moves from zombie apocalypse to coronapocalypse, even the business news has gone full COVID-19. So, it would be pointless for us to cover any other topic, right?
Well, welcome to the Bureau of Missing the Point. Ladies and gentleman, we give you [drum roll, please] bacteria.
That’s right, we said bacteria. In a world ruled by coronavirus, LOTME dares to bring you the latest edition of Bacteria vs. the World.
This week, we’re talking antibiotic resistance. The problem is that bacteria have the ability to pick up DNA from their surroundings to create resistance. That ability, known as competence, could be considered a form of evolution, and scientists are trying to stop it.
Investigators at the University of Groningen in the Netherlands and the Swiss University of Lausanne “developed a high-throughput assay to simultaneously test cells for competence and growth,” lead investigator Arnau Domenech, PhD, said in a written statement. Of the 1,366 approved drugs that they tested against Streptococcus pneumoniae, 46 blocked bacterial competence.
“When cells are under growth stress, for instance in the presence of antibiotics, they try to find a solution and become resistant to these drugs,” Dr. Domenech explained. “Importantly, we did not observe resistance to the drugs found here as they do not cause growth stress.”
The drug concentrations used to block competence may be too high to be safe for humans, but the results suggest that competence blockers are, indeed, anti-evolution drugs. As we go bacteria to the future, it seems, the ghost of Charles Darwin is working for the humans. Thanks, Chuck.
Oh, one more thing … CORONAVIRUS!
Irony 1, Council on Foreign Relations 0
It’s not a great time to be a business owner right now. People everywhere are feeling nervous, thanks to our old friend COVID-19, and it can be difficult to actually sell things when half the population is staying indoors hoarding toilet paper.
So if you are a business owner, you’re probably thinking: “Gee, it sure would be nice to meet up with my fellow business owners to come up with a plan on how to operate in a world dealing with a potential pandemic.” Right?
That’s the idea behind the Council on Foreign Relations’ roundtable discussion called “Doing Business Under Coronavirus,” scheduled for March 13, 2020, in New York. Or at least, it was the idea, because the conference has been canceled. And you’ll never guess why.
Okay, it was coronavirus. Uh, you probably did guess that. We’re not entirely sure what that means for business owners, but come on, there’s no need to worry, at least the infectious disease physicians had their meeting this past weekend ... oh wait. Hmm, maybe it’s time to start searching Amazon for some toilet paper.
Wipe away coronavirus fear
People now have smartphones to read the news while on the toilet, but at one point or another, having a newspaper to read in the john was probably pretty essential to combat boredom. Our friends down under, however, seem to have found another essential way to use a newspaper in the bathroom.
The coronavirus is slowly making its way around the world, and in Australia, people are stocking up on toilet paper. Toilet paper companies are working extra hard to keep a steady supply of toilet paper in supermarkets. A newspaper has tried to help by adding extra pages to its newspapers that could potentially be used as toilet paper. This seems like a good time to swap out your smartphone for one of these newspapers as it would not be wise to use your smartphone for toilet paper.
No one is sure why everyone in Australia is in a frenzy over toilet paper since it’s not a very big necessity in a large coronavirus outbreak. Are Aussies preparing to hide out in their homes just in case those affected by coronavirus turn into zombies, thus creating a zombie apocalypse? In that case, yeah, toilet paper, among other things, is probably essential.
Resistance meets resistance
As our planet moves from zombie apocalypse to coronapocalypse, even the business news has gone full COVID-19. So, it would be pointless for us to cover any other topic, right?
Well, welcome to the Bureau of Missing the Point. Ladies and gentleman, we give you [drum roll, please] bacteria.
That’s right, we said bacteria. In a world ruled by coronavirus, LOTME dares to bring you the latest edition of Bacteria vs. the World.
This week, we’re talking antibiotic resistance. The problem is that bacteria have the ability to pick up DNA from their surroundings to create resistance. That ability, known as competence, could be considered a form of evolution, and scientists are trying to stop it.
Investigators at the University of Groningen in the Netherlands and the Swiss University of Lausanne “developed a high-throughput assay to simultaneously test cells for competence and growth,” lead investigator Arnau Domenech, PhD, said in a written statement. Of the 1,366 approved drugs that they tested against Streptococcus pneumoniae, 46 blocked bacterial competence.
“When cells are under growth stress, for instance in the presence of antibiotics, they try to find a solution and become resistant to these drugs,” Dr. Domenech explained. “Importantly, we did not observe resistance to the drugs found here as they do not cause growth stress.”
The drug concentrations used to block competence may be too high to be safe for humans, but the results suggest that competence blockers are, indeed, anti-evolution drugs. As we go bacteria to the future, it seems, the ghost of Charles Darwin is working for the humans. Thanks, Chuck.
Oh, one more thing … CORONAVIRUS!
Irony 1, Council on Foreign Relations 0
It’s not a great time to be a business owner right now. People everywhere are feeling nervous, thanks to our old friend COVID-19, and it can be difficult to actually sell things when half the population is staying indoors hoarding toilet paper.
So if you are a business owner, you’re probably thinking: “Gee, it sure would be nice to meet up with my fellow business owners to come up with a plan on how to operate in a world dealing with a potential pandemic.” Right?
That’s the idea behind the Council on Foreign Relations’ roundtable discussion called “Doing Business Under Coronavirus,” scheduled for March 13, 2020, in New York. Or at least, it was the idea, because the conference has been canceled. And you’ll never guess why.
Okay, it was coronavirus. Uh, you probably did guess that. We’re not entirely sure what that means for business owners, but come on, there’s no need to worry, at least the infectious disease physicians had their meeting this past weekend ... oh wait. Hmm, maybe it’s time to start searching Amazon for some toilet paper.
Wipe away coronavirus fear
People now have smartphones to read the news while on the toilet, but at one point or another, having a newspaper to read in the john was probably pretty essential to combat boredom. Our friends down under, however, seem to have found another essential way to use a newspaper in the bathroom.
The coronavirus is slowly making its way around the world, and in Australia, people are stocking up on toilet paper. Toilet paper companies are working extra hard to keep a steady supply of toilet paper in supermarkets. A newspaper has tried to help by adding extra pages to its newspapers that could potentially be used as toilet paper. This seems like a good time to swap out your smartphone for one of these newspapers as it would not be wise to use your smartphone for toilet paper.
No one is sure why everyone in Australia is in a frenzy over toilet paper since it’s not a very big necessity in a large coronavirus outbreak. Are Aussies preparing to hide out in their homes just in case those affected by coronavirus turn into zombies, thus creating a zombie apocalypse? In that case, yeah, toilet paper, among other things, is probably essential.
Resistance meets resistance
As our planet moves from zombie apocalypse to coronapocalypse, even the business news has gone full COVID-19. So, it would be pointless for us to cover any other topic, right?
Well, welcome to the Bureau of Missing the Point. Ladies and gentleman, we give you [drum roll, please] bacteria.
That’s right, we said bacteria. In a world ruled by coronavirus, LOTME dares to bring you the latest edition of Bacteria vs. the World.
This week, we’re talking antibiotic resistance. The problem is that bacteria have the ability to pick up DNA from their surroundings to create resistance. That ability, known as competence, could be considered a form of evolution, and scientists are trying to stop it.
Investigators at the University of Groningen in the Netherlands and the Swiss University of Lausanne “developed a high-throughput assay to simultaneously test cells for competence and growth,” lead investigator Arnau Domenech, PhD, said in a written statement. Of the 1,366 approved drugs that they tested against Streptococcus pneumoniae, 46 blocked bacterial competence.
“When cells are under growth stress, for instance in the presence of antibiotics, they try to find a solution and become resistant to these drugs,” Dr. Domenech explained. “Importantly, we did not observe resistance to the drugs found here as they do not cause growth stress.”
The drug concentrations used to block competence may be too high to be safe for humans, but the results suggest that competence blockers are, indeed, anti-evolution drugs. As we go bacteria to the future, it seems, the ghost of Charles Darwin is working for the humans. Thanks, Chuck.
Oh, one more thing … CORONAVIRUS!
Fezolinetant safe, effective for menopausal vasomotor symptoms
The selective neurokinin 3 receptor antagonist Graeme L. Fraser, PhD, of Ogeda, a subsidiary of Astellas Pharma, and associates reported in Menopause.
The investigators conducted a randomized, double-blind, placebo-controlled, dose-ranging, parallel-group study between July 19, 2017, and Sept. 19, 2018, in 287 women who completed the full 12-week trial. The women were aged between 41 and 65 years, were menopausal, and had moderate to severe vasomotor symptoms (VMS) with an incidence of at least 50 episodes per week. The majority of the women were white, 25% were black, 1% were Asian, and 1% were “other.”
The reduction in VMS episodes in patients who received fezolinetant ranged from 1.9 to 3.5 episodes per day at week 4 and from 1.8 to 2.6 per day at week 12. The mean difference from placebo in VMS severity score was –0.4 to –1 at week 4 and was –0.2 to –0.6 at week 12. At least a 50% reduction in VMS frequency at week 12 was achieved by 81%-95% of patients who received fezolinetant, compared with 59% of those who received placebo.
Treatment-emergent adverse events were generally mild to moderate, with the most common events including nausea, diarrhea, fatigue, urinary tract infection, upper respiratory tract infections, sinusitis, headache, and cough. Of the five severe adverse events reported, only two were considered related to treatment – cholelithiasis and drug-induced liver injury. A total of 21 patients discontinued because of adverse events.
“Further evaluation of fezolinetant in larger and longer phase 3 trials of women with VMS associated with menopause is warranted to more fully characterize its efficacy and safety profile,” Dr. Fraser and colleagues concluded.
The study was funded by Astellas Pharma. The investigators reported numerous conflicts of interest with pharmaceutical companies.
SOURCE: Fraser GL et al. Menopause. 2020 Feb 24. doi: 10.1097/GME.0000000000001510.
The selective neurokinin 3 receptor antagonist Graeme L. Fraser, PhD, of Ogeda, a subsidiary of Astellas Pharma, and associates reported in Menopause.
The investigators conducted a randomized, double-blind, placebo-controlled, dose-ranging, parallel-group study between July 19, 2017, and Sept. 19, 2018, in 287 women who completed the full 12-week trial. The women were aged between 41 and 65 years, were menopausal, and had moderate to severe vasomotor symptoms (VMS) with an incidence of at least 50 episodes per week. The majority of the women were white, 25% were black, 1% were Asian, and 1% were “other.”
The reduction in VMS episodes in patients who received fezolinetant ranged from 1.9 to 3.5 episodes per day at week 4 and from 1.8 to 2.6 per day at week 12. The mean difference from placebo in VMS severity score was –0.4 to –1 at week 4 and was –0.2 to –0.6 at week 12. At least a 50% reduction in VMS frequency at week 12 was achieved by 81%-95% of patients who received fezolinetant, compared with 59% of those who received placebo.
Treatment-emergent adverse events were generally mild to moderate, with the most common events including nausea, diarrhea, fatigue, urinary tract infection, upper respiratory tract infections, sinusitis, headache, and cough. Of the five severe adverse events reported, only two were considered related to treatment – cholelithiasis and drug-induced liver injury. A total of 21 patients discontinued because of adverse events.
“Further evaluation of fezolinetant in larger and longer phase 3 trials of women with VMS associated with menopause is warranted to more fully characterize its efficacy and safety profile,” Dr. Fraser and colleagues concluded.
The study was funded by Astellas Pharma. The investigators reported numerous conflicts of interest with pharmaceutical companies.
SOURCE: Fraser GL et al. Menopause. 2020 Feb 24. doi: 10.1097/GME.0000000000001510.
The selective neurokinin 3 receptor antagonist Graeme L. Fraser, PhD, of Ogeda, a subsidiary of Astellas Pharma, and associates reported in Menopause.
The investigators conducted a randomized, double-blind, placebo-controlled, dose-ranging, parallel-group study between July 19, 2017, and Sept. 19, 2018, in 287 women who completed the full 12-week trial. The women were aged between 41 and 65 years, were menopausal, and had moderate to severe vasomotor symptoms (VMS) with an incidence of at least 50 episodes per week. The majority of the women were white, 25% were black, 1% were Asian, and 1% were “other.”
The reduction in VMS episodes in patients who received fezolinetant ranged from 1.9 to 3.5 episodes per day at week 4 and from 1.8 to 2.6 per day at week 12. The mean difference from placebo in VMS severity score was –0.4 to –1 at week 4 and was –0.2 to –0.6 at week 12. At least a 50% reduction in VMS frequency at week 12 was achieved by 81%-95% of patients who received fezolinetant, compared with 59% of those who received placebo.
Treatment-emergent adverse events were generally mild to moderate, with the most common events including nausea, diarrhea, fatigue, urinary tract infection, upper respiratory tract infections, sinusitis, headache, and cough. Of the five severe adverse events reported, only two were considered related to treatment – cholelithiasis and drug-induced liver injury. A total of 21 patients discontinued because of adverse events.
“Further evaluation of fezolinetant in larger and longer phase 3 trials of women with VMS associated with menopause is warranted to more fully characterize its efficacy and safety profile,” Dr. Fraser and colleagues concluded.
The study was funded by Astellas Pharma. The investigators reported numerous conflicts of interest with pharmaceutical companies.
SOURCE: Fraser GL et al. Menopause. 2020 Feb 24. doi: 10.1097/GME.0000000000001510.
FROM MENOPAUSE
FDA issues stronger warning on neuropsychiatric event risk linked to montelukast
The Food and Drug Administration has issued , a prescription drug for asthma and allergy.
The new boxed warning advises health care providers to avoid prescribing montelukast for patients with mild symptoms, particularly those with allergic rhinitis, the FDA said in a press release. The drug was first approved in 1998, and the product labeling was updated in 2008 to include information about neuropsychiatric adverse events reported with usage of montelukast.
While the Sentinel study, along with other observational studies, did not find an increased risk of mental health side effects with montelukast treatment, compared with inhaled corticosteroids, those studies had limitations that may have affected results, the FDA said in the Drug Safety Communication. However, the FDA has continued to receive reports of neuropsychiatric events – including agitation, depression, sleeping problems, and suicidal thoughts and actions – in patients receiving the medication.
“The incidence of neuropsychiatric events associated with montelukast is unknown, but some reports are serious, and many patients and health care professionals are not fully aware of these risks,” Sally Seymour, MD, director of the division of pulmonary, allergy and rheumatology products in the FDA’s Center for Drug Evaluation and Research, said in the press release. “There are many other safe and effective medications to treat allergies with extensive history of use and safety, such that many products are available over the counter without a prescription.”
In addition to the boxed warning, the FDA now requires a new medication guide to be given to patients with each montelukast prescription, the FDA said.
The Food and Drug Administration has issued , a prescription drug for asthma and allergy.
The new boxed warning advises health care providers to avoid prescribing montelukast for patients with mild symptoms, particularly those with allergic rhinitis, the FDA said in a press release. The drug was first approved in 1998, and the product labeling was updated in 2008 to include information about neuropsychiatric adverse events reported with usage of montelukast.
While the Sentinel study, along with other observational studies, did not find an increased risk of mental health side effects with montelukast treatment, compared with inhaled corticosteroids, those studies had limitations that may have affected results, the FDA said in the Drug Safety Communication. However, the FDA has continued to receive reports of neuropsychiatric events – including agitation, depression, sleeping problems, and suicidal thoughts and actions – in patients receiving the medication.
“The incidence of neuropsychiatric events associated with montelukast is unknown, but some reports are serious, and many patients and health care professionals are not fully aware of these risks,” Sally Seymour, MD, director of the division of pulmonary, allergy and rheumatology products in the FDA’s Center for Drug Evaluation and Research, said in the press release. “There are many other safe and effective medications to treat allergies with extensive history of use and safety, such that many products are available over the counter without a prescription.”
In addition to the boxed warning, the FDA now requires a new medication guide to be given to patients with each montelukast prescription, the FDA said.
The Food and Drug Administration has issued , a prescription drug for asthma and allergy.
The new boxed warning advises health care providers to avoid prescribing montelukast for patients with mild symptoms, particularly those with allergic rhinitis, the FDA said in a press release. The drug was first approved in 1998, and the product labeling was updated in 2008 to include information about neuropsychiatric adverse events reported with usage of montelukast.
While the Sentinel study, along with other observational studies, did not find an increased risk of mental health side effects with montelukast treatment, compared with inhaled corticosteroids, those studies had limitations that may have affected results, the FDA said in the Drug Safety Communication. However, the FDA has continued to receive reports of neuropsychiatric events – including agitation, depression, sleeping problems, and suicidal thoughts and actions – in patients receiving the medication.
“The incidence of neuropsychiatric events associated with montelukast is unknown, but some reports are serious, and many patients and health care professionals are not fully aware of these risks,” Sally Seymour, MD, director of the division of pulmonary, allergy and rheumatology products in the FDA’s Center for Drug Evaluation and Research, said in the press release. “There are many other safe and effective medications to treat allergies with extensive history of use and safety, such that many products are available over the counter without a prescription.”
In addition to the boxed warning, the FDA now requires a new medication guide to be given to patients with each montelukast prescription, the FDA said.
COVID-19’s hairy conspiracy, and a Kardashian Kolonoscopy
Coronavirus conspiracy gets hairy
It was inevitable, of course. The government’s response to COVID-19 and the novel coronavirus has become an issue, and the increased scrutiny has now turned up a conspiracy.
This particular plot, recently uncovered by the Twitterverse and reported by Newsweek, is being perpetuated by the CDC against the American patriots who make up the bearded wings of the Men-ocratic and Republi-man parties.
Our story begins on Nov. 2, 2017, when the National Institute for Occupational Safety and Health posted “To Beard or not to Beard? That’s a good Question!” on its science blog, which was aimed at “workers who wear tight-fitting respirators.” Like the N95 face mask. More than 2 years before the coronavirus was “discovered” in China. Hmmm, interesting.
The NIOSH post claimed that beards, sideburns, and some mustaches “will interfere with respirators that rely on a tight facepiece seal to achieve maximum protection.” The agency further alleged that “research tells us that the presence of facial hair under the sealing surface causes 20 to 1,000 times more leakage, compared to clean-shaven individuals.” As if research ever proved anything.
The post’s pièce de résistance, however, was an infograph illustrating 36 types of facial hairstyles and whether they worked with a face mask/respirator. Did you know that beard styles such as the chin curtain, French fork, Garibaldi, and Hulihee get a thumbs down? Did you know there are beard styles called the chin curtain, French fork, Garibaldi, and Hulihee? [What? No ZZ Top beard?]
Most mustaches are okay, though, and therein lies the proof of a conspiracy. Among the approved mustache styles is the toothbrush. You’ll find it on the bottom row of the graph, third from the left. Notice anything?
It’s a Hitler mustache! The CDC put its seal of approval on a Hitler mustache!
Thus, by the transfollicular property of the High Castle corollary to the Boys from Brazil theorem, a government conspiracy must exist.
The coronavirus will now proceed to take over the world. Have a nice day.
Keeping up with the Kolonoscopies
Imagine owing your life to the Kardashians. It’s a bit tough to swallow, but a man from Ohio owes Kim and her Krew a life debt.
Gary Paine was just passing the time, watching some daytime “Keeping Up With the Kardashians” television in the doctor’s waiting room while his wife was getting a colonoscopy. We’ve all been there – we in the Bureau of LOTME have watched more waiting-room “Judge Judy” than we care to admit.
And just like us, Gary said he was getting bored while watching the Kardashians’ TV travails. Although he felt relatively healthy, he decided to distract himself the best way he knew how: making his own colonoscopy appointment. Anything’s better than getting sucked into an 8-hour Kardashian marathon, right?
During Gary’s Kim K–inspired colonoscopy, it was discovered that he had an irregularity in his heart. Eventually, doctors found two severely blocked arteries. Paine underwent immediate, lifesaving quadruple-bypass surgery.
He now urges people to be aware that checkups are essential, whether you’re showing symptoms of poor health or not.
Which leads us to wonder: Do Kris Jenner and her clan know they’re now officially more painful than a colonoscopy appointment?
(Crosswalks) Don’t stop me now
There’s always that one guy. You’re stuck in a long line behind a big slow tractor trailer going 10 under the speed limit, and there’s a flashy BMW practically living inside your trunk. A brief passing zone approaches, but there’s no point ... oh, of course they swerve around and cut you off, what did they even gain from doing that?
Point is, people who drive expensive cars have a bit of a reputation for being less than courteous behind the wheel, and thanks to a study published in the Journal of Transport & Health, there’s some science to back that up.
A group of four presumably well-paid volunteers were sent out to crosswalks and crossed in front of cars to see how many would yield. Results were less than encouraging: Only 28% of 461 cars yielded. The only factor that significantly predicted whether or not a car would yield was how expensive it was; for every $1,000 increase in the value of the car, the driver was 3% less likely to stop.
It’s not looking good for owners of expensive cars, especially when even the study authors suggest that these drivers were displaying increased entitlement and narcissism through their lack of yielding behavior.
Our suggestion? Clearly rich people are sick and need intensive psychotherapy, and the offending vehicles should be removed and redistributed to the rest of us. We wouldn’t mind a nice slightly used Corvette, in red preferably. Nope, no ulterior motive here.
Coronavirus conspiracy gets hairy
It was inevitable, of course. The government’s response to COVID-19 and the novel coronavirus has become an issue, and the increased scrutiny has now turned up a conspiracy.
This particular plot, recently uncovered by the Twitterverse and reported by Newsweek, is being perpetuated by the CDC against the American patriots who make up the bearded wings of the Men-ocratic and Republi-man parties.
Our story begins on Nov. 2, 2017, when the National Institute for Occupational Safety and Health posted “To Beard or not to Beard? That’s a good Question!” on its science blog, which was aimed at “workers who wear tight-fitting respirators.” Like the N95 face mask. More than 2 years before the coronavirus was “discovered” in China. Hmmm, interesting.
The NIOSH post claimed that beards, sideburns, and some mustaches “will interfere with respirators that rely on a tight facepiece seal to achieve maximum protection.” The agency further alleged that “research tells us that the presence of facial hair under the sealing surface causes 20 to 1,000 times more leakage, compared to clean-shaven individuals.” As if research ever proved anything.
The post’s pièce de résistance, however, was an infograph illustrating 36 types of facial hairstyles and whether they worked with a face mask/respirator. Did you know that beard styles such as the chin curtain, French fork, Garibaldi, and Hulihee get a thumbs down? Did you know there are beard styles called the chin curtain, French fork, Garibaldi, and Hulihee? [What? No ZZ Top beard?]
Most mustaches are okay, though, and therein lies the proof of a conspiracy. Among the approved mustache styles is the toothbrush. You’ll find it on the bottom row of the graph, third from the left. Notice anything?
It’s a Hitler mustache! The CDC put its seal of approval on a Hitler mustache!
Thus, by the transfollicular property of the High Castle corollary to the Boys from Brazil theorem, a government conspiracy must exist.
The coronavirus will now proceed to take over the world. Have a nice day.
Keeping up with the Kolonoscopies
Imagine owing your life to the Kardashians. It’s a bit tough to swallow, but a man from Ohio owes Kim and her Krew a life debt.
Gary Paine was just passing the time, watching some daytime “Keeping Up With the Kardashians” television in the doctor’s waiting room while his wife was getting a colonoscopy. We’ve all been there – we in the Bureau of LOTME have watched more waiting-room “Judge Judy” than we care to admit.
And just like us, Gary said he was getting bored while watching the Kardashians’ TV travails. Although he felt relatively healthy, he decided to distract himself the best way he knew how: making his own colonoscopy appointment. Anything’s better than getting sucked into an 8-hour Kardashian marathon, right?
During Gary’s Kim K–inspired colonoscopy, it was discovered that he had an irregularity in his heart. Eventually, doctors found two severely blocked arteries. Paine underwent immediate, lifesaving quadruple-bypass surgery.
He now urges people to be aware that checkups are essential, whether you’re showing symptoms of poor health or not.
Which leads us to wonder: Do Kris Jenner and her clan know they’re now officially more painful than a colonoscopy appointment?
(Crosswalks) Don’t stop me now
There’s always that one guy. You’re stuck in a long line behind a big slow tractor trailer going 10 under the speed limit, and there’s a flashy BMW practically living inside your trunk. A brief passing zone approaches, but there’s no point ... oh, of course they swerve around and cut you off, what did they even gain from doing that?
Point is, people who drive expensive cars have a bit of a reputation for being less than courteous behind the wheel, and thanks to a study published in the Journal of Transport & Health, there’s some science to back that up.
A group of four presumably well-paid volunteers were sent out to crosswalks and crossed in front of cars to see how many would yield. Results were less than encouraging: Only 28% of 461 cars yielded. The only factor that significantly predicted whether or not a car would yield was how expensive it was; for every $1,000 increase in the value of the car, the driver was 3% less likely to stop.
It’s not looking good for owners of expensive cars, especially when even the study authors suggest that these drivers were displaying increased entitlement and narcissism through their lack of yielding behavior.
Our suggestion? Clearly rich people are sick and need intensive psychotherapy, and the offending vehicles should be removed and redistributed to the rest of us. We wouldn’t mind a nice slightly used Corvette, in red preferably. Nope, no ulterior motive here.
Coronavirus conspiracy gets hairy
It was inevitable, of course. The government’s response to COVID-19 and the novel coronavirus has become an issue, and the increased scrutiny has now turned up a conspiracy.
This particular plot, recently uncovered by the Twitterverse and reported by Newsweek, is being perpetuated by the CDC against the American patriots who make up the bearded wings of the Men-ocratic and Republi-man parties.
Our story begins on Nov. 2, 2017, when the National Institute for Occupational Safety and Health posted “To Beard or not to Beard? That’s a good Question!” on its science blog, which was aimed at “workers who wear tight-fitting respirators.” Like the N95 face mask. More than 2 years before the coronavirus was “discovered” in China. Hmmm, interesting.
The NIOSH post claimed that beards, sideburns, and some mustaches “will interfere with respirators that rely on a tight facepiece seal to achieve maximum protection.” The agency further alleged that “research tells us that the presence of facial hair under the sealing surface causes 20 to 1,000 times more leakage, compared to clean-shaven individuals.” As if research ever proved anything.
The post’s pièce de résistance, however, was an infograph illustrating 36 types of facial hairstyles and whether they worked with a face mask/respirator. Did you know that beard styles such as the chin curtain, French fork, Garibaldi, and Hulihee get a thumbs down? Did you know there are beard styles called the chin curtain, French fork, Garibaldi, and Hulihee? [What? No ZZ Top beard?]
Most mustaches are okay, though, and therein lies the proof of a conspiracy. Among the approved mustache styles is the toothbrush. You’ll find it on the bottom row of the graph, third from the left. Notice anything?
It’s a Hitler mustache! The CDC put its seal of approval on a Hitler mustache!
Thus, by the transfollicular property of the High Castle corollary to the Boys from Brazil theorem, a government conspiracy must exist.
The coronavirus will now proceed to take over the world. Have a nice day.
Keeping up with the Kolonoscopies
Imagine owing your life to the Kardashians. It’s a bit tough to swallow, but a man from Ohio owes Kim and her Krew a life debt.
Gary Paine was just passing the time, watching some daytime “Keeping Up With the Kardashians” television in the doctor’s waiting room while his wife was getting a colonoscopy. We’ve all been there – we in the Bureau of LOTME have watched more waiting-room “Judge Judy” than we care to admit.
And just like us, Gary said he was getting bored while watching the Kardashians’ TV travails. Although he felt relatively healthy, he decided to distract himself the best way he knew how: making his own colonoscopy appointment. Anything’s better than getting sucked into an 8-hour Kardashian marathon, right?
During Gary’s Kim K–inspired colonoscopy, it was discovered that he had an irregularity in his heart. Eventually, doctors found two severely blocked arteries. Paine underwent immediate, lifesaving quadruple-bypass surgery.
He now urges people to be aware that checkups are essential, whether you’re showing symptoms of poor health or not.
Which leads us to wonder: Do Kris Jenner and her clan know they’re now officially more painful than a colonoscopy appointment?
(Crosswalks) Don’t stop me now
There’s always that one guy. You’re stuck in a long line behind a big slow tractor trailer going 10 under the speed limit, and there’s a flashy BMW practically living inside your trunk. A brief passing zone approaches, but there’s no point ... oh, of course they swerve around and cut you off, what did they even gain from doing that?
Point is, people who drive expensive cars have a bit of a reputation for being less than courteous behind the wheel, and thanks to a study published in the Journal of Transport & Health, there’s some science to back that up.
A group of four presumably well-paid volunteers were sent out to crosswalks and crossed in front of cars to see how many would yield. Results were less than encouraging: Only 28% of 461 cars yielded. The only factor that significantly predicted whether or not a car would yield was how expensive it was; for every $1,000 increase in the value of the car, the driver was 3% less likely to stop.
It’s not looking good for owners of expensive cars, especially when even the study authors suggest that these drivers were displaying increased entitlement and narcissism through their lack of yielding behavior.
Our suggestion? Clearly rich people are sick and need intensive psychotherapy, and the offending vehicles should be removed and redistributed to the rest of us. We wouldn’t mind a nice slightly used Corvette, in red preferably. Nope, no ulterior motive here.
FDA rules to ban ESDs for self-injurious, aggressive behavior
The Food and Drug Administration has banned all electrical stimulation devices used for self-injurious or aggressive behavior because of an unreasonable risk of illness or injury. This marks only the third time the FDA has banned a medical device since it gained the authority to do so.
Electrical stimulation devices (ESDs) administer electric shocks through electrodes attached to the skin during self-injurious or aggressive behavior in an attempt to condition the patient to stop engaging in that behavior, according to the FDA press release. Current evidence indicates that use of these devices can lead to worsening of underlying symptoms, depression, anxiety, PTSD, pain, burns, and tissue damage; in contrast, evidence supporting their use is weak. In addition, many patients exposed to ESDs have intellectual or developmental disabilities and might not be able to adequately communicate their level of pain.
“Since ESDs were first marketed more than 20 years ago, we have gained a better understanding of the danger these devices present to public health. Through advancements in medical science, there are now more treatment options available to reduce or stop self-injurious or aggressive behavior, thus avoiding the substantial risk ESDs present,” William H. Maisel, MD, MPH, director of the Office of Product Evaluation and Quality in the FDA’s Center for Devices and Radiological Health, said in the release.
The ruling follows a 2016 proposal to ban ESDs from the marketplace; the proposed rule received more than 1,500 comments from stakeholders, such as parents of people with intellectual and developmental disabilities, state agencies and their sister public-private organizations, the affected manufacturer and residential facility, some of the facility’s employees, and parents of individual residents, as well as from state and federal legislators and advocacy groups. Nearly all supported the ban.
The rule will go into effect 30 days after publication of the rule in the Federal Register, and compliance is required within 180 days.
The Food and Drug Administration has banned all electrical stimulation devices used for self-injurious or aggressive behavior because of an unreasonable risk of illness or injury. This marks only the third time the FDA has banned a medical device since it gained the authority to do so.
Electrical stimulation devices (ESDs) administer electric shocks through electrodes attached to the skin during self-injurious or aggressive behavior in an attempt to condition the patient to stop engaging in that behavior, according to the FDA press release. Current evidence indicates that use of these devices can lead to worsening of underlying symptoms, depression, anxiety, PTSD, pain, burns, and tissue damage; in contrast, evidence supporting their use is weak. In addition, many patients exposed to ESDs have intellectual or developmental disabilities and might not be able to adequately communicate their level of pain.
“Since ESDs were first marketed more than 20 years ago, we have gained a better understanding of the danger these devices present to public health. Through advancements in medical science, there are now more treatment options available to reduce or stop self-injurious or aggressive behavior, thus avoiding the substantial risk ESDs present,” William H. Maisel, MD, MPH, director of the Office of Product Evaluation and Quality in the FDA’s Center for Devices and Radiological Health, said in the release.
The ruling follows a 2016 proposal to ban ESDs from the marketplace; the proposed rule received more than 1,500 comments from stakeholders, such as parents of people with intellectual and developmental disabilities, state agencies and their sister public-private organizations, the affected manufacturer and residential facility, some of the facility’s employees, and parents of individual residents, as well as from state and federal legislators and advocacy groups. Nearly all supported the ban.
The rule will go into effect 30 days after publication of the rule in the Federal Register, and compliance is required within 180 days.
The Food and Drug Administration has banned all electrical stimulation devices used for self-injurious or aggressive behavior because of an unreasonable risk of illness or injury. This marks only the third time the FDA has banned a medical device since it gained the authority to do so.
Electrical stimulation devices (ESDs) administer electric shocks through electrodes attached to the skin during self-injurious or aggressive behavior in an attempt to condition the patient to stop engaging in that behavior, according to the FDA press release. Current evidence indicates that use of these devices can lead to worsening of underlying symptoms, depression, anxiety, PTSD, pain, burns, and tissue damage; in contrast, evidence supporting their use is weak. In addition, many patients exposed to ESDs have intellectual or developmental disabilities and might not be able to adequately communicate their level of pain.
“Since ESDs were first marketed more than 20 years ago, we have gained a better understanding of the danger these devices present to public health. Through advancements in medical science, there are now more treatment options available to reduce or stop self-injurious or aggressive behavior, thus avoiding the substantial risk ESDs present,” William H. Maisel, MD, MPH, director of the Office of Product Evaluation and Quality in the FDA’s Center for Devices and Radiological Health, said in the release.
The ruling follows a 2016 proposal to ban ESDs from the marketplace; the proposed rule received more than 1,500 comments from stakeholders, such as parents of people with intellectual and developmental disabilities, state agencies and their sister public-private organizations, the affected manufacturer and residential facility, some of the facility’s employees, and parents of individual residents, as well as from state and federal legislators and advocacy groups. Nearly all supported the ban.
The rule will go into effect 30 days after publication of the rule in the Federal Register, and compliance is required within 180 days.
Among all physicians, internists near bottom for workplace happiness
Physicians in internal medicine struggle to find happiness both in and outside the workplace, according to Medscape’s 2020 Lifestyle, Happiness, and Burnout Report.
Only 22% of internists reported that they were very happy at work, with only neurologists reporting a worse at-work happiness rate, according to the Medscape report.
The news wasn’t much better when it came to happiness outside the office, as only 48% of internists reported they were very happy. Once again, neurologists had the lowest happiness rate outside the office, at 44%.
The rate of burnout among internists, at 43%, was similar to that of physicians overall at 41%; 14% of internists reported that they were both burned out and depressed. The most common contributing factors to burnout for internists were having too many bureaucratic tasks (62%), receiving a lack of respect from colleagues (34%), and spending too many hours at work (33%).
Internists dealt with burnout by isolating themselves from others (47%), talking with family/friends (45%), and exercising (41%). In addition, only 41% of internists took 3-4 weeks’ vacation, less than the 44% for physicians overall, and 43% took less than 3 weeks of vacation.
About 14% of internists said that they’d contemplated suicide, and 1% reported that they’d attempted it; 80% said they’d never thought about suicide. Only 16% said that they were seeking or planning to seek professional help for symptoms of burnout or depression, and 64% said they weren’t planning on seeking help and had never done so in the past.
The Medscape survey was conducted from June 25 to Sept. 19, 2019, and involved 15,181 physicians.
Physicians in internal medicine struggle to find happiness both in and outside the workplace, according to Medscape’s 2020 Lifestyle, Happiness, and Burnout Report.
Only 22% of internists reported that they were very happy at work, with only neurologists reporting a worse at-work happiness rate, according to the Medscape report.
The news wasn’t much better when it came to happiness outside the office, as only 48% of internists reported they were very happy. Once again, neurologists had the lowest happiness rate outside the office, at 44%.
The rate of burnout among internists, at 43%, was similar to that of physicians overall at 41%; 14% of internists reported that they were both burned out and depressed. The most common contributing factors to burnout for internists were having too many bureaucratic tasks (62%), receiving a lack of respect from colleagues (34%), and spending too many hours at work (33%).
Internists dealt with burnout by isolating themselves from others (47%), talking with family/friends (45%), and exercising (41%). In addition, only 41% of internists took 3-4 weeks’ vacation, less than the 44% for physicians overall, and 43% took less than 3 weeks of vacation.
About 14% of internists said that they’d contemplated suicide, and 1% reported that they’d attempted it; 80% said they’d never thought about suicide. Only 16% said that they were seeking or planning to seek professional help for symptoms of burnout or depression, and 64% said they weren’t planning on seeking help and had never done so in the past.
The Medscape survey was conducted from June 25 to Sept. 19, 2019, and involved 15,181 physicians.
Physicians in internal medicine struggle to find happiness both in and outside the workplace, according to Medscape’s 2020 Lifestyle, Happiness, and Burnout Report.
Only 22% of internists reported that they were very happy at work, with only neurologists reporting a worse at-work happiness rate, according to the Medscape report.
The news wasn’t much better when it came to happiness outside the office, as only 48% of internists reported they were very happy. Once again, neurologists had the lowest happiness rate outside the office, at 44%.
The rate of burnout among internists, at 43%, was similar to that of physicians overall at 41%; 14% of internists reported that they were both burned out and depressed. The most common contributing factors to burnout for internists were having too many bureaucratic tasks (62%), receiving a lack of respect from colleagues (34%), and spending too many hours at work (33%).
Internists dealt with burnout by isolating themselves from others (47%), talking with family/friends (45%), and exercising (41%). In addition, only 41% of internists took 3-4 weeks’ vacation, less than the 44% for physicians overall, and 43% took less than 3 weeks of vacation.
About 14% of internists said that they’d contemplated suicide, and 1% reported that they’d attempted it; 80% said they’d never thought about suicide. Only 16% said that they were seeking or planning to seek professional help for symptoms of burnout or depression, and 64% said they weren’t planning on seeking help and had never done so in the past.
The Medscape survey was conducted from June 25 to Sept. 19, 2019, and involved 15,181 physicians.