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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 authorizes first COVID-19 test kit with home collection option
a reissue of the emergency use authorization allowing for testing of samples self-collected by patients at home with the Pixel by LabCorp COVID-19 RT-PCR Test.
The reissued authorization allows for testing of a sample taken from the nose by way of a self-collection kit that contains nasal swabs and saline, according to the FDA press release. After self-swabbing, users should send the samples in an insulated package to a LabCorp laboratory for testing. LabCorp intends to make the Pixel test available to consumers in most states, accessible through doctors’ orders.
The Pixel test includes a specific Q-tip–style cotton swab for patients to use to collect their samples, the FDA noted. Because of concerns with sterility and cross-reactivity caused by inherent genetic material in cotton swabs, generic cotton swabs should not be used as a substitute. The FDA will work with test developers to determine if generic cotton swabs can be used safely and effectively with other tests.
“Throughout this pandemic we have been facilitating test development to ensure patients’ access to accurate diagnostics, which includes supporting the development of reliable and accurate at-home sample collection options. ... [The FDA] worked with LabCorp to ensure the data demonstrated from at-home patient sample collection is as safe and accurate as sample collection at a doctor’s office, hospital, or other testing site. With this action, there is now a convenient and reliable option for patient sample collection from the comfort and safety of their home,” FDA Commissioner Stephen M. Hahn, MD, said in the press release.
a reissue of the emergency use authorization allowing for testing of samples self-collected by patients at home with the Pixel by LabCorp COVID-19 RT-PCR Test.
The reissued authorization allows for testing of a sample taken from the nose by way of a self-collection kit that contains nasal swabs and saline, according to the FDA press release. After self-swabbing, users should send the samples in an insulated package to a LabCorp laboratory for testing. LabCorp intends to make the Pixel test available to consumers in most states, accessible through doctors’ orders.
The Pixel test includes a specific Q-tip–style cotton swab for patients to use to collect their samples, the FDA noted. Because of concerns with sterility and cross-reactivity caused by inherent genetic material in cotton swabs, generic cotton swabs should not be used as a substitute. The FDA will work with test developers to determine if generic cotton swabs can be used safely and effectively with other tests.
“Throughout this pandemic we have been facilitating test development to ensure patients’ access to accurate diagnostics, which includes supporting the development of reliable and accurate at-home sample collection options. ... [The FDA] worked with LabCorp to ensure the data demonstrated from at-home patient sample collection is as safe and accurate as sample collection at a doctor’s office, hospital, or other testing site. With this action, there is now a convenient and reliable option for patient sample collection from the comfort and safety of their home,” FDA Commissioner Stephen M. Hahn, MD, said in the press release.
a reissue of the emergency use authorization allowing for testing of samples self-collected by patients at home with the Pixel by LabCorp COVID-19 RT-PCR Test.
The reissued authorization allows for testing of a sample taken from the nose by way of a self-collection kit that contains nasal swabs and saline, according to the FDA press release. After self-swabbing, users should send the samples in an insulated package to a LabCorp laboratory for testing. LabCorp intends to make the Pixel test available to consumers in most states, accessible through doctors’ orders.
The Pixel test includes a specific Q-tip–style cotton swab for patients to use to collect their samples, the FDA noted. Because of concerns with sterility and cross-reactivity caused by inherent genetic material in cotton swabs, generic cotton swabs should not be used as a substitute. The FDA will work with test developers to determine if generic cotton swabs can be used safely and effectively with other tests.
“Throughout this pandemic we have been facilitating test development to ensure patients’ access to accurate diagnostics, which includes supporting the development of reliable and accurate at-home sample collection options. ... [The FDA] worked with LabCorp to ensure the data demonstrated from at-home patient sample collection is as safe and accurate as sample collection at a doctor’s office, hospital, or other testing site. With this action, there is now a convenient and reliable option for patient sample collection from the comfort and safety of their home,” FDA Commissioner Stephen M. Hahn, MD, said in the press release.
COPD, smoking independently associated with developing depression
People with chronic obstructive pulmonary disorder (COPD) and those who smoke are at an increased risk of developing depression, results of a population-based cohort study of more than 3 million patients show.
Using data from the Veterans Affairs Corporate Data Warehouse, Natalie B. Riblet, MD, MPH, and colleagues conducted the study on 3,284,496 patients who accessed VA health care during 2004-2014 and had a negative depression screen. About 95% of this population was male, 83.4% were white, and the average age was 61.3 years. Just under 40,000 people were patients with COPD, reported Dr. Riblet, of the Veterans Affairs Medical Center in White River Junction, Vt., and the Geisel School of Medicine at Dartmouth, Hanover, N.H. The study was published in General Hospital Psychiatry.
The investigators found that current, former, and never smokers were split fairly evenly at 32.1%, 32.4%, and 30.3% of the total study population, respectively. Of those with COPD, 53.6% were current smokers, 27% were former smokers, and 11.6% were never smokers.
The odds of developing depression in a year were 2.3%, 1.5%, and 1.4% in current, former, and never smokers without COPD, respectively; for those with COPD, the odds were 2.9%, 2.2%, and 2% for current, former, and never smokers, respectively. Overall, the odds ratio of patients with COPD developing depression, compared with those without COPD, was 1.57 (95% confidence interval, 1.54-1.61). Current smokers also were at an increased risk, compared with never smokers (OR, 1.83; 95% CI, 1.81-1.85), though the effect was somewhat mitigated after adjusting for confounders (OR, 1.56; 95% CI, 1.55-1.58).
as this may guide the development and implementation of new treatments for depression in the COPD population,” the investigators concluded. “If COPD-related depression is due, at least in part, to adverse physiological effects related to chronic hypoxia, these patients may require new or more tailored interventions.”
No disclosures or conflicts of interest were reported.
SOURCE: Riblet NB et al. Gen Hosp Psychiatry. 2020 May-Jun;64:72-9.
People with chronic obstructive pulmonary disorder (COPD) and those who smoke are at an increased risk of developing depression, results of a population-based cohort study of more than 3 million patients show.
Using data from the Veterans Affairs Corporate Data Warehouse, Natalie B. Riblet, MD, MPH, and colleagues conducted the study on 3,284,496 patients who accessed VA health care during 2004-2014 and had a negative depression screen. About 95% of this population was male, 83.4% were white, and the average age was 61.3 years. Just under 40,000 people were patients with COPD, reported Dr. Riblet, of the Veterans Affairs Medical Center in White River Junction, Vt., and the Geisel School of Medicine at Dartmouth, Hanover, N.H. The study was published in General Hospital Psychiatry.
The investigators found that current, former, and never smokers were split fairly evenly at 32.1%, 32.4%, and 30.3% of the total study population, respectively. Of those with COPD, 53.6% were current smokers, 27% were former smokers, and 11.6% were never smokers.
The odds of developing depression in a year were 2.3%, 1.5%, and 1.4% in current, former, and never smokers without COPD, respectively; for those with COPD, the odds were 2.9%, 2.2%, and 2% for current, former, and never smokers, respectively. Overall, the odds ratio of patients with COPD developing depression, compared with those without COPD, was 1.57 (95% confidence interval, 1.54-1.61). Current smokers also were at an increased risk, compared with never smokers (OR, 1.83; 95% CI, 1.81-1.85), though the effect was somewhat mitigated after adjusting for confounders (OR, 1.56; 95% CI, 1.55-1.58).
as this may guide the development and implementation of new treatments for depression in the COPD population,” the investigators concluded. “If COPD-related depression is due, at least in part, to adverse physiological effects related to chronic hypoxia, these patients may require new or more tailored interventions.”
No disclosures or conflicts of interest were reported.
SOURCE: Riblet NB et al. Gen Hosp Psychiatry. 2020 May-Jun;64:72-9.
People with chronic obstructive pulmonary disorder (COPD) and those who smoke are at an increased risk of developing depression, results of a population-based cohort study of more than 3 million patients show.
Using data from the Veterans Affairs Corporate Data Warehouse, Natalie B. Riblet, MD, MPH, and colleagues conducted the study on 3,284,496 patients who accessed VA health care during 2004-2014 and had a negative depression screen. About 95% of this population was male, 83.4% were white, and the average age was 61.3 years. Just under 40,000 people were patients with COPD, reported Dr. Riblet, of the Veterans Affairs Medical Center in White River Junction, Vt., and the Geisel School of Medicine at Dartmouth, Hanover, N.H. The study was published in General Hospital Psychiatry.
The investigators found that current, former, and never smokers were split fairly evenly at 32.1%, 32.4%, and 30.3% of the total study population, respectively. Of those with COPD, 53.6% were current smokers, 27% were former smokers, and 11.6% were never smokers.
The odds of developing depression in a year were 2.3%, 1.5%, and 1.4% in current, former, and never smokers without COPD, respectively; for those with COPD, the odds were 2.9%, 2.2%, and 2% for current, former, and never smokers, respectively. Overall, the odds ratio of patients with COPD developing depression, compared with those without COPD, was 1.57 (95% confidence interval, 1.54-1.61). Current smokers also were at an increased risk, compared with never smokers (OR, 1.83; 95% CI, 1.81-1.85), though the effect was somewhat mitigated after adjusting for confounders (OR, 1.56; 95% CI, 1.55-1.58).
as this may guide the development and implementation of new treatments for depression in the COPD population,” the investigators concluded. “If COPD-related depression is due, at least in part, to adverse physiological effects related to chronic hypoxia, these patients may require new or more tailored interventions.”
No disclosures or conflicts of interest were reported.
SOURCE: Riblet NB et al. Gen Hosp Psychiatry. 2020 May-Jun;64:72-9.
FROM GENERAL HOSPITAL PSYCHIATRY
FDA approves Koselugo for pediatric neurofibromatosis treatment
The Food and Drug Administration has approved selumetinib (Koselugo) for the treatment of pediatric patients aged 2 years and older with type 1 neurofibromatosis (NF1) with symptomatic, inoperable plexiform neurofibromas.
FDA approval was based on results from the phase 2 SPRINT Stratum 1 trial, in which 50 patients with NF1 received selumetinib as twice-daily oral monotherapy. Of this group, 33 (66%) patients had a partial response of at least a 20% reduction in tumor volume. There were no complete responses, according to a press release.
The most common adverse events were vomiting, rash, abdominal pain, diarrhea, nausea, dry skin, fatigue, musculoskeletal pain, pyrexia, rash acneiform, stomatitis, headache, paronychia, and pruritus. Dose interruptions, dose reductions, and permanent drug discontinuation occurred in 80%, 24%, and 12% of patients, respectively.
Serious adverse reactions included cardiomyopathy, ocular toxicity, gastrointestinal toxicity, increased creatinine phosphokinase, and increased vitamin E levels and risk of bleeding, according to the press release.
“Previously, there were no medicines approved for this disease. This approval has the potential to change how symptomatic, inoperable NF1 plexiform neurofibromas are treated and provides new hope to these patients,” Roy Baynes, MD, PhD, senior vice president, head of global clinical development, and chief medical officer of Merck Research Laboratories, said in the press release.
The Food and Drug Administration has approved selumetinib (Koselugo) for the treatment of pediatric patients aged 2 years and older with type 1 neurofibromatosis (NF1) with symptomatic, inoperable plexiform neurofibromas.
FDA approval was based on results from the phase 2 SPRINT Stratum 1 trial, in which 50 patients with NF1 received selumetinib as twice-daily oral monotherapy. Of this group, 33 (66%) patients had a partial response of at least a 20% reduction in tumor volume. There were no complete responses, according to a press release.
The most common adverse events were vomiting, rash, abdominal pain, diarrhea, nausea, dry skin, fatigue, musculoskeletal pain, pyrexia, rash acneiform, stomatitis, headache, paronychia, and pruritus. Dose interruptions, dose reductions, and permanent drug discontinuation occurred in 80%, 24%, and 12% of patients, respectively.
Serious adverse reactions included cardiomyopathy, ocular toxicity, gastrointestinal toxicity, increased creatinine phosphokinase, and increased vitamin E levels and risk of bleeding, according to the press release.
“Previously, there were no medicines approved for this disease. This approval has the potential to change how symptomatic, inoperable NF1 plexiform neurofibromas are treated and provides new hope to these patients,” Roy Baynes, MD, PhD, senior vice president, head of global clinical development, and chief medical officer of Merck Research Laboratories, said in the press release.
The Food and Drug Administration has approved selumetinib (Koselugo) for the treatment of pediatric patients aged 2 years and older with type 1 neurofibromatosis (NF1) with symptomatic, inoperable plexiform neurofibromas.
FDA approval was based on results from the phase 2 SPRINT Stratum 1 trial, in which 50 patients with NF1 received selumetinib as twice-daily oral monotherapy. Of this group, 33 (66%) patients had a partial response of at least a 20% reduction in tumor volume. There were no complete responses, according to a press release.
The most common adverse events were vomiting, rash, abdominal pain, diarrhea, nausea, dry skin, fatigue, musculoskeletal pain, pyrexia, rash acneiform, stomatitis, headache, paronychia, and pruritus. Dose interruptions, dose reductions, and permanent drug discontinuation occurred in 80%, 24%, and 12% of patients, respectively.
Serious adverse reactions included cardiomyopathy, ocular toxicity, gastrointestinal toxicity, increased creatinine phosphokinase, and increased vitamin E levels and risk of bleeding, according to the press release.
“Previously, there were no medicines approved for this disease. This approval has the potential to change how symptomatic, inoperable NF1 plexiform neurofibromas are treated and provides new hope to these patients,” Roy Baynes, MD, PhD, senior vice president, head of global clinical development, and chief medical officer of Merck Research Laboratories, said in the press release.
SARS-CoV-2 escapes cotton, surgical masks of infected
June 9, 2020 — Editor’s note: The study on which this news story is based has been retracted by the journal. The retraction notice can be found here.
according to Seongman Bae, MD, of the University of Ulsan College of Medicine in Seoul, South Korea, and associates.
The report was published in Annals of Internal Medicine.
Because the COVID-19 pandemic has caused a shortage of N95 and surgical masks, cotton masks have gained interest as a substitute, as surgical masks have been shown to effectively filter influenza virus, the researchers wrote. However, the size of and concentrations of SARS-CoV-2 in aerosols generated during coughing are unknown.
To compare the effectiveness of cotton and surgical masks, a group of patients infected with SARS-CoV-2 coughed into petri dishes while wearing no mask, a surgical mask, and a cotton mask. The mask surfaces were swabbed afterward to assess viral positivity on the mask itself.
The median nasopharyngeal and saliva viral load was 5.66 log copies/mL and 4.00 log copies/mL, respectively. The median viral loads after coughing was 2.56 log copies/mL without a mask, 2.42 log copies/mL with a surgical mask, and 1.85 log copies/mL with a cotton mask. All outer surfaces of the mask were positive for SARS-CoV-2, while most inner surfaces were negative.
The investigators acknowledged that the test did not include N95 masks and does not reflect the actual infection transmission, and that they didn’t know whether cotton or surgical masks shorten the travel distance of droplets while coughing.
“Further study is needed to recommend whether face masks decrease transmission of virus from asymptomatic individuals or those with suspected COVID-19 who are not coughing,” they added.
The study was funded by a grant from the government-wide R&D Fund Project for Infectious Disease Research. The investigators reported that they had no conflicts of interest.
SOURCE: Bae S et al. Ann Intern Med. 2020 Apr 6. doi: 10.7326/M20-1342.
Correction, 4/9/20: The headline of an earlier version of this article misstated a finding of this study. Whether cotton and surgical masks can block transmission was not investigated.
June 9, 2020 — Editor’s note: The study on which this news story is based has been retracted by the journal. The retraction notice can be found here.
according to Seongman Bae, MD, of the University of Ulsan College of Medicine in Seoul, South Korea, and associates.
The report was published in Annals of Internal Medicine.
Because the COVID-19 pandemic has caused a shortage of N95 and surgical masks, cotton masks have gained interest as a substitute, as surgical masks have been shown to effectively filter influenza virus, the researchers wrote. However, the size of and concentrations of SARS-CoV-2 in aerosols generated during coughing are unknown.
To compare the effectiveness of cotton and surgical masks, a group of patients infected with SARS-CoV-2 coughed into petri dishes while wearing no mask, a surgical mask, and a cotton mask. The mask surfaces were swabbed afterward to assess viral positivity on the mask itself.
The median nasopharyngeal and saliva viral load was 5.66 log copies/mL and 4.00 log copies/mL, respectively. The median viral loads after coughing was 2.56 log copies/mL without a mask, 2.42 log copies/mL with a surgical mask, and 1.85 log copies/mL with a cotton mask. All outer surfaces of the mask were positive for SARS-CoV-2, while most inner surfaces were negative.
The investigators acknowledged that the test did not include N95 masks and does not reflect the actual infection transmission, and that they didn’t know whether cotton or surgical masks shorten the travel distance of droplets while coughing.
“Further study is needed to recommend whether face masks decrease transmission of virus from asymptomatic individuals or those with suspected COVID-19 who are not coughing,” they added.
The study was funded by a grant from the government-wide R&D Fund Project for Infectious Disease Research. The investigators reported that they had no conflicts of interest.
SOURCE: Bae S et al. Ann Intern Med. 2020 Apr 6. doi: 10.7326/M20-1342.
Correction, 4/9/20: The headline of an earlier version of this article misstated a finding of this study. Whether cotton and surgical masks can block transmission was not investigated.
June 9, 2020 — Editor’s note: The study on which this news story is based has been retracted by the journal. The retraction notice can be found here.
according to Seongman Bae, MD, of the University of Ulsan College of Medicine in Seoul, South Korea, and associates.
The report was published in Annals of Internal Medicine.
Because the COVID-19 pandemic has caused a shortage of N95 and surgical masks, cotton masks have gained interest as a substitute, as surgical masks have been shown to effectively filter influenza virus, the researchers wrote. However, the size of and concentrations of SARS-CoV-2 in aerosols generated during coughing are unknown.
To compare the effectiveness of cotton and surgical masks, a group of patients infected with SARS-CoV-2 coughed into petri dishes while wearing no mask, a surgical mask, and a cotton mask. The mask surfaces were swabbed afterward to assess viral positivity on the mask itself.
The median nasopharyngeal and saliva viral load was 5.66 log copies/mL and 4.00 log copies/mL, respectively. The median viral loads after coughing was 2.56 log copies/mL without a mask, 2.42 log copies/mL with a surgical mask, and 1.85 log copies/mL with a cotton mask. All outer surfaces of the mask were positive for SARS-CoV-2, while most inner surfaces were negative.
The investigators acknowledged that the test did not include N95 masks and does not reflect the actual infection transmission, and that they didn’t know whether cotton or surgical masks shorten the travel distance of droplets while coughing.
“Further study is needed to recommend whether face masks decrease transmission of virus from asymptomatic individuals or those with suspected COVID-19 who are not coughing,” they added.
The study was funded by a grant from the government-wide R&D Fund Project for Infectious Disease Research. The investigators reported that they had no conflicts of interest.
SOURCE: Bae S et al. Ann Intern Med. 2020 Apr 6. doi: 10.7326/M20-1342.
Correction, 4/9/20: The headline of an earlier version of this article misstated a finding of this study. Whether cotton and surgical masks can block transmission was not investigated.
FROM ANNALS OF INTERNAL MEDICINE
FDA removes pregnancy category C warning from certain MS medications
The FDA based the decision on data from more than 1,000 real-world pregnancies, including pregnancies from a large epidemiologic study and published studies over several decades, which found no connection between use of interferon-beta products during early pregnancy and an increased risk of major birth defects, according to the FDA.
As a result, the labels for both medications will no longer have the pregnancy category C designation; however, patients should continue to notify their health care provider if they are pregnant or plan to become pregnant.
The FDA decision to remove the warning follows a similar decision by the European Medicines Agency last year.
“Many women with MS are diagnosed during their childbearing years. With this important update for Plegridy and Avonex, healthcare providers have more data to inform appropriate treatment paths for patients who may be pregnant or planning for pregnancy,” said Bernd Kieseier, MD, MHBA, executive director and head of global MS at Worldwide Medical, Biogen, in a press release.
The FDA based the decision on data from more than 1,000 real-world pregnancies, including pregnancies from a large epidemiologic study and published studies over several decades, which found no connection between use of interferon-beta products during early pregnancy and an increased risk of major birth defects, according to the FDA.
As a result, the labels for both medications will no longer have the pregnancy category C designation; however, patients should continue to notify their health care provider if they are pregnant or plan to become pregnant.
The FDA decision to remove the warning follows a similar decision by the European Medicines Agency last year.
“Many women with MS are diagnosed during their childbearing years. With this important update for Plegridy and Avonex, healthcare providers have more data to inform appropriate treatment paths for patients who may be pregnant or planning for pregnancy,” said Bernd Kieseier, MD, MHBA, executive director and head of global MS at Worldwide Medical, Biogen, in a press release.
The FDA based the decision on data from more than 1,000 real-world pregnancies, including pregnancies from a large epidemiologic study and published studies over several decades, which found no connection between use of interferon-beta products during early pregnancy and an increased risk of major birth defects, according to the FDA.
As a result, the labels for both medications will no longer have the pregnancy category C designation; however, patients should continue to notify their health care provider if they are pregnant or plan to become pregnant.
The FDA decision to remove the warning follows a similar decision by the European Medicines Agency last year.
“Many women with MS are diagnosed during their childbearing years. With this important update for Plegridy and Avonex, healthcare providers have more data to inform appropriate treatment paths for patients who may be pregnant or planning for pregnancy,” said Bernd Kieseier, MD, MHBA, executive director and head of global MS at Worldwide Medical, Biogen, in a press release.
FDA issues EUA allowing hydroxychloroquine sulfate, chloroquine phosphate treatment in COVID-19
The Food and Drug Administration issued an Emergency Use Authorization on March 28, 2020, allowing for the usage of hydroxychloroquine sulfate and chloroquine phosphate products in certain hospitalized patients with COVID-19.
The products, currently stored by the Strategic National Stockpile, will be distributed by the SNS to states so that doctors may prescribe the drugs to adolescent and adult patients hospitalized with COVID-19 in the absence of appropriate or feasible clinical trials. The SNS will work with the Federal Emergency Management Agency to ship the products to states.
According to the Emergency Use Authorization, fact sheets will be provided to health care providers and patients with important information about hydroxychloroquine sulfate and chloroquine phosphate, including the risks of using them to treat COVID-19.
The Food and Drug Administration issued an Emergency Use Authorization on March 28, 2020, allowing for the usage of hydroxychloroquine sulfate and chloroquine phosphate products in certain hospitalized patients with COVID-19.
The products, currently stored by the Strategic National Stockpile, will be distributed by the SNS to states so that doctors may prescribe the drugs to adolescent and adult patients hospitalized with COVID-19 in the absence of appropriate or feasible clinical trials. The SNS will work with the Federal Emergency Management Agency to ship the products to states.
According to the Emergency Use Authorization, fact sheets will be provided to health care providers and patients with important information about hydroxychloroquine sulfate and chloroquine phosphate, including the risks of using them to treat COVID-19.
The Food and Drug Administration issued an Emergency Use Authorization on March 28, 2020, allowing for the usage of hydroxychloroquine sulfate and chloroquine phosphate products in certain hospitalized patients with COVID-19.
The products, currently stored by the Strategic National Stockpile, will be distributed by the SNS to states so that doctors may prescribe the drugs to adolescent and adult patients hospitalized with COVID-19 in the absence of appropriate or feasible clinical trials. The SNS will work with the Federal Emergency Management Agency to ship the products to states.
According to the Emergency Use Authorization, fact sheets will be provided to health care providers and patients with important information about hydroxychloroquine sulfate and chloroquine phosphate, including the risks of using them to treat COVID-19.
Dapagliflozin trial in CKD halted because of high efficacy
AstraZeneca has announced that the phase 3 DAPA-CKD trial for dapagliflozin (Farxiga) in patients with chronic kidney disease has been halted early because of overwhelming efficacy of the drug, at the recommendation of an independent data monitoring committee.
DAPA-CKD is an international, multicenter, randomized, double-blinded trial in 4,245 patients with stage 2-4 chronic kidney disease. Patients received either 10 mg of the dapagliflozin once-daily or a placebo. The primary composite endpoint is worsening of renal function, defined as a composite of an estimated glomerular filtration rate decline of at least 50%, onset of end-stage kidney disease, and death from cardiovascular or renal cause.
The decision to stop the trial came after a routine assessment of efficacy and safety that showed dapagliflozin’s benefits significantly earlier than expected. AstraZeneca will initiate closure of the study, and results will be published and submitted for presentation at a forthcoming medical meeting.
Dapagliflozin is a sodium-glucose transporter 2 inhibitor currently indicated for the treatment type 2 diabetes patients with inadequately controlled type 2 diabetes and for reduction of the risk of hospitalization for heart failure. In August 2019, the drug was granted Fast Track status by the Food and Drug Administration for the treatment of chronic kidney disease. In January 2020, the agency also granted Fast Track status for the reduction of risk of cardiovascular death or worsening of heart failure in adult patients, regardless of diabetes status, with heart failure with reduced ejection fraction.
“Chronic kidney disease patients have limited treatment options, particularly those without type-2 diabetes. We are very pleased the data monitoring committee concluded that patients experienced overwhelming benefit. Farxiga has the potential to change the management of chronic kidney disease for patients around the world,” Mene Pangalos, executive vice president of BioPharmaceuticals R&D, said in the press release.
AstraZeneca has announced that the phase 3 DAPA-CKD trial for dapagliflozin (Farxiga) in patients with chronic kidney disease has been halted early because of overwhelming efficacy of the drug, at the recommendation of an independent data monitoring committee.
DAPA-CKD is an international, multicenter, randomized, double-blinded trial in 4,245 patients with stage 2-4 chronic kidney disease. Patients received either 10 mg of the dapagliflozin once-daily or a placebo. The primary composite endpoint is worsening of renal function, defined as a composite of an estimated glomerular filtration rate decline of at least 50%, onset of end-stage kidney disease, and death from cardiovascular or renal cause.
The decision to stop the trial came after a routine assessment of efficacy and safety that showed dapagliflozin’s benefits significantly earlier than expected. AstraZeneca will initiate closure of the study, and results will be published and submitted for presentation at a forthcoming medical meeting.
Dapagliflozin is a sodium-glucose transporter 2 inhibitor currently indicated for the treatment type 2 diabetes patients with inadequately controlled type 2 diabetes and for reduction of the risk of hospitalization for heart failure. In August 2019, the drug was granted Fast Track status by the Food and Drug Administration for the treatment of chronic kidney disease. In January 2020, the agency also granted Fast Track status for the reduction of risk of cardiovascular death or worsening of heart failure in adult patients, regardless of diabetes status, with heart failure with reduced ejection fraction.
“Chronic kidney disease patients have limited treatment options, particularly those without type-2 diabetes. We are very pleased the data monitoring committee concluded that patients experienced overwhelming benefit. Farxiga has the potential to change the management of chronic kidney disease for patients around the world,” Mene Pangalos, executive vice president of BioPharmaceuticals R&D, said in the press release.
AstraZeneca has announced that the phase 3 DAPA-CKD trial for dapagliflozin (Farxiga) in patients with chronic kidney disease has been halted early because of overwhelming efficacy of the drug, at the recommendation of an independent data monitoring committee.
DAPA-CKD is an international, multicenter, randomized, double-blinded trial in 4,245 patients with stage 2-4 chronic kidney disease. Patients received either 10 mg of the dapagliflozin once-daily or a placebo. The primary composite endpoint is worsening of renal function, defined as a composite of an estimated glomerular filtration rate decline of at least 50%, onset of end-stage kidney disease, and death from cardiovascular or renal cause.
The decision to stop the trial came after a routine assessment of efficacy and safety that showed dapagliflozin’s benefits significantly earlier than expected. AstraZeneca will initiate closure of the study, and results will be published and submitted for presentation at a forthcoming medical meeting.
Dapagliflozin is a sodium-glucose transporter 2 inhibitor currently indicated for the treatment type 2 diabetes patients with inadequately controlled type 2 diabetes and for reduction of the risk of hospitalization for heart failure. In August 2019, the drug was granted Fast Track status by the Food and Drug Administration for the treatment of chronic kidney disease. In January 2020, the agency also granted Fast Track status for the reduction of risk of cardiovascular death or worsening of heart failure in adult patients, regardless of diabetes status, with heart failure with reduced ejection fraction.
“Chronic kidney disease patients have limited treatment options, particularly those without type-2 diabetes. We are very pleased the data monitoring committee concluded that patients experienced overwhelming benefit. Farxiga has the potential to change the management of chronic kidney disease for patients around the world,” Mene Pangalos, executive vice president of BioPharmaceuticals R&D, said in the press release.
Despite strict controls, some infants born to mothers with COVID-19 appear infected
Despite implementation of strict infection control and prevention procedures in a hospital in Wuhan, China, according to Lingkong Zeng, MD, of the department of neonatology at Wuhan Children’s Hospital, and associates.
Thirty-three neonates born to mothers with COVID-19 were included in the study, published as a research letter in JAMA Pediatrics. Of this group, three neonates (9%) were confirmed to be infected with the novel coronavirus 2019 at 2 and 4 days of life through nasopharyngeal and anal swabs.
Of the three infected neonates, two were born at 40 weeks’ gestation and the third was born at 31 weeks. The two full-term infants had mild symptoms such as lethargy and fever and were negative for the virus at 6 days of life. The preterm infant had somewhat worse symptoms, but the investigators acknowledged that “the most seriously ill neonate may have been symptomatic from prematurity, asphyxia, and sepsis, rather than [the novel coronavirus 2019] infection.” They added that outcomes for all three neonates were favorable, consistent with past research.
“Because strict infection control and prevention procedures were implemented during the delivery, it is likely that the sources of [novel coronavirus 2019] in the neonates’ upper respiratory tracts or anuses were maternal in origin,” Dr. Zeng and associates surmised.
While previous studies have shown no evidence of COVID-19 transmission between mothers and neonates, and all samples, including amniotic fluid, cord blood, and breast milk, were negative for the novel coronavirus 2019, “vertical maternal-fetal transmission cannot be ruled out in the current cohort. Therefore, it is crucial to screen pregnant women and implement strict infection control measures, quarantine of infected mothers, and close monitoring of neonates at risk of COVID-19,” the investigators concluded.
The study authors reported that they had no conflicts of interest.
SOURCE: Zeng L et al. JAMA Pediatrics. 2020 Mar 26. doi: 10.1001/jamapediatrics.2020.0878.
Despite implementation of strict infection control and prevention procedures in a hospital in Wuhan, China, according to Lingkong Zeng, MD, of the department of neonatology at Wuhan Children’s Hospital, and associates.
Thirty-three neonates born to mothers with COVID-19 were included in the study, published as a research letter in JAMA Pediatrics. Of this group, three neonates (9%) were confirmed to be infected with the novel coronavirus 2019 at 2 and 4 days of life through nasopharyngeal and anal swabs.
Of the three infected neonates, two were born at 40 weeks’ gestation and the third was born at 31 weeks. The two full-term infants had mild symptoms such as lethargy and fever and were negative for the virus at 6 days of life. The preterm infant had somewhat worse symptoms, but the investigators acknowledged that “the most seriously ill neonate may have been symptomatic from prematurity, asphyxia, and sepsis, rather than [the novel coronavirus 2019] infection.” They added that outcomes for all three neonates were favorable, consistent with past research.
“Because strict infection control and prevention procedures were implemented during the delivery, it is likely that the sources of [novel coronavirus 2019] in the neonates’ upper respiratory tracts or anuses were maternal in origin,” Dr. Zeng and associates surmised.
While previous studies have shown no evidence of COVID-19 transmission between mothers and neonates, and all samples, including amniotic fluid, cord blood, and breast milk, were negative for the novel coronavirus 2019, “vertical maternal-fetal transmission cannot be ruled out in the current cohort. Therefore, it is crucial to screen pregnant women and implement strict infection control measures, quarantine of infected mothers, and close monitoring of neonates at risk of COVID-19,” the investigators concluded.
The study authors reported that they had no conflicts of interest.
SOURCE: Zeng L et al. JAMA Pediatrics. 2020 Mar 26. doi: 10.1001/jamapediatrics.2020.0878.
Despite implementation of strict infection control and prevention procedures in a hospital in Wuhan, China, according to Lingkong Zeng, MD, of the department of neonatology at Wuhan Children’s Hospital, and associates.
Thirty-three neonates born to mothers with COVID-19 were included in the study, published as a research letter in JAMA Pediatrics. Of this group, three neonates (9%) were confirmed to be infected with the novel coronavirus 2019 at 2 and 4 days of life through nasopharyngeal and anal swabs.
Of the three infected neonates, two were born at 40 weeks’ gestation and the third was born at 31 weeks. The two full-term infants had mild symptoms such as lethargy and fever and were negative for the virus at 6 days of life. The preterm infant had somewhat worse symptoms, but the investigators acknowledged that “the most seriously ill neonate may have been symptomatic from prematurity, asphyxia, and sepsis, rather than [the novel coronavirus 2019] infection.” They added that outcomes for all three neonates were favorable, consistent with past research.
“Because strict infection control and prevention procedures were implemented during the delivery, it is likely that the sources of [novel coronavirus 2019] in the neonates’ upper respiratory tracts or anuses were maternal in origin,” Dr. Zeng and associates surmised.
While previous studies have shown no evidence of COVID-19 transmission between mothers and neonates, and all samples, including amniotic fluid, cord blood, and breast milk, were negative for the novel coronavirus 2019, “vertical maternal-fetal transmission cannot be ruled out in the current cohort. Therefore, it is crucial to screen pregnant women and implement strict infection control measures, quarantine of infected mothers, and close monitoring of neonates at risk of COVID-19,” the investigators concluded.
The study authors reported that they had no conflicts of interest.
SOURCE: Zeng L et al. JAMA Pediatrics. 2020 Mar 26. doi: 10.1001/jamapediatrics.2020.0878.
FROM JAMA PEDIATRICS
FDA issues warning on fecal transplant transmission of SARS-CoV-2
and that additional safety procedures may be required.
The risk of SARS-CoV-2 transmission through fecal microbiota transplant is unknown, but “several recent studies have documented the presence of SARS-CoV-2 ribonucleic acid (RNA) and/or SARS-CoV-2 virus in stool of infected individuals,” the FDA said in the press release. The testing of nasopharyngeal specimens from stool donors may not be available, and the availability and sensitivity of direct testing of stool for SARS-CoV-2 is currently unknown.
Because of the risk of serious adverse events, the FDA has issued several recommendations for any medically necessary usage of fecal microbiota transplantation involving stool samples donated after Dec. 1, 2019.
- Donor screening with questions directed at identifying those currently or recently infected with SARS-CoV-2.
- Testing donors and/or donor stool for SARS-CoV-2, as feasible.
- Development of criteria for exclusion of donors and donor stool based on screening and testing.
- Informed consent that includes information about the potential for transmission of SARS-CoV-2 via fecal microbiota transplantation, including transplantation prepared from stool from donors who are asymptomatic for COVID-19.
“As the scientific community learns more about SARS-CoV-2 and COVID-19, FDA will provide further information as warranted,” the agency said.
and that additional safety procedures may be required.
The risk of SARS-CoV-2 transmission through fecal microbiota transplant is unknown, but “several recent studies have documented the presence of SARS-CoV-2 ribonucleic acid (RNA) and/or SARS-CoV-2 virus in stool of infected individuals,” the FDA said in the press release. The testing of nasopharyngeal specimens from stool donors may not be available, and the availability and sensitivity of direct testing of stool for SARS-CoV-2 is currently unknown.
Because of the risk of serious adverse events, the FDA has issued several recommendations for any medically necessary usage of fecal microbiota transplantation involving stool samples donated after Dec. 1, 2019.
- Donor screening with questions directed at identifying those currently or recently infected with SARS-CoV-2.
- Testing donors and/or donor stool for SARS-CoV-2, as feasible.
- Development of criteria for exclusion of donors and donor stool based on screening and testing.
- Informed consent that includes information about the potential for transmission of SARS-CoV-2 via fecal microbiota transplantation, including transplantation prepared from stool from donors who are asymptomatic for COVID-19.
“As the scientific community learns more about SARS-CoV-2 and COVID-19, FDA will provide further information as warranted,” the agency said.
and that additional safety procedures may be required.
The risk of SARS-CoV-2 transmission through fecal microbiota transplant is unknown, but “several recent studies have documented the presence of SARS-CoV-2 ribonucleic acid (RNA) and/or SARS-CoV-2 virus in stool of infected individuals,” the FDA said in the press release. The testing of nasopharyngeal specimens from stool donors may not be available, and the availability and sensitivity of direct testing of stool for SARS-CoV-2 is currently unknown.
Because of the risk of serious adverse events, the FDA has issued several recommendations for any medically necessary usage of fecal microbiota transplantation involving stool samples donated after Dec. 1, 2019.
- Donor screening with questions directed at identifying those currently or recently infected with SARS-CoV-2.
- Testing donors and/or donor stool for SARS-CoV-2, as feasible.
- Development of criteria for exclusion of donors and donor stool based on screening and testing.
- Informed consent that includes information about the potential for transmission of SARS-CoV-2 via fecal microbiota transplantation, including transplantation prepared from stool from donors who are asymptomatic for COVID-19.
“As the scientific community learns more about SARS-CoV-2 and COVID-19, FDA will provide further information as warranted,” the agency said.
Earthworm lollipops and Monty Python peer review
So you think you can pandemic?
What’s that? You say you’ve got an idea for the next great pandemic? Well, if your pandemic is going to beat coronavirus/COVID-19, it’s going to have to top this:
Sex: Porn star Lola Taylor (real name, Iyubov Bushueva) is currently in COVID-related isolation in Moscow and has offered to “have sex with the first scientist who finds a cure for coronavirus,” the Daily Star reported.
Sensible terrorists: “Islamic State has adopted a safety-first approach to the coronavirus pandemic and advised its members not to travel to Europe,” Politico reported. The terrorist group’s latest newsletter recommends that followers “stay away from the land of the epidemic” for the time being.
Drugs: Michigan is doing its part to keep the cannabis flowing. The state is temporarily lifting its ban against curbside pickup at marijuana stores as a way to limit exposure to coronavirus. “There has been an increase of customers who are stockpiling both medical and recreational cannabis, and sales are definitely up, just like other essentials,” Michigan Cannabis Industry Association Director Robin Schneider told mLive.com.
Sewage gridlock: Please don’t feed the fatbergs. That’s the message from the United Kingdom’s largest water and sewage authority. Thames Water is warning customers that flushing paper towels and wet wipes will add to the nonbiodegradable sewage blobs known as fatbergs, the Guardian reported. Thames Water’s position: “The only things that should be flushed are the 3 P’s: poo, pee and (toilet) paper,” the Guardian said.
Airship hospitals: China built two hospitals in response to the coronavirus epidemic, but can either of them fly? No. Science writer Bill Gourgey suggests that it’s time to revisit an idea proposed 100 years ago during a tuberculosis epidemic. Airships equipped as hospitals “could offer all of the resources – staff and equipment – to extract, quarantine, and treat patients. And a fleet could deliver at scale,” he wrote on OneZero.
The Governator: His royal Arnold-ness, along with this his pony Whiskey and donkey Lulu, has taken to Twitter to try to convince folks to stay inside and eat carrots together. Happily, Mr. Schwarzenegger did not go all Terminator when Whiskey tried to bite Lulu, instead offering a gentle, “You’ve got to get along.”
If your pandemic doesn’t have all of this, then you’re just not trying hard enough.
Earthworm Surprise
If you watched the Rugrats as a kid – or if your kids did, nonmillennials – you may remember how Phil and Lil used to eat bugs and worms whenever they played outside. We used to think it was gross, but now we think it may be time to follow their lead.
A Latvian scientist has unearthed (sorry) ways to make bread, muffins, lollipops, and so on using earthworms, claiming that earthworms are full of protein. Next time your children are crying for candy or sweets, why not hand them an earthworm lollipop to appease them? You’ll be making sure they’re getting their daily dose of protein!
The scientist, Ilga Gedrovica of the Latvian University of Life Science and Technologies, reported that earthworms not only contain just as much protein as meat, but they are also cheaper to produce. She also explained that, when dried, earthworms contain about three times more protein than meat.
Research is now underway to determine the safety of eating earthworms, fried or otherwise.
Just think: In a post–COVID-19 future, instead of a steak dinner, we could be making earthworm casseroles! Which, of course, kids won’t eat. Not because of the earthworms, of course. But because, ewwww, casseroles.
It’s ... Monty Python’s Flying Study!
It’s one of life’s most haunting questions, asked by one of our best philosophers: What is the velocity of an unladen swallow?
Sadly, Nathaniel Dominy and Erin Butler of Dartmouth University did not tackle this conundrum, but they did address another issue raised by Monty Python: Just how silly are the walks displayed by the Ministry of Silly Walks?
As you might expect, the minister himself is a masterclass of inefficiency, moving with 6.7 times more variability than someone walking in a nonhumorous fashion. Mr. Pudey, the man applying for the government grant to develop his own silly walk, is noticeably more efficient, merely displaying a rate of variability 3.3 times that of a normal walk. However, the researchers agreed with the minister that Mr. Pudey was well deserving of a government grant.
While we feel answering that question alone was worth a study, the researchers did have a larger point to make: comparing the bureaucratic inefficiency of the Ministry of Silly Walks to today’s peer-review process within the health field, particularly when researchers seek funding.
Grants take months to be approved and often involve researchers flying back and forth. A streamlined process could save huge amounts of both time and money, they noted.
The LOTME team would like to salute these two researchers for their excellent choice of metaphor, and hope they use Monty Python to make further points about health care. The swallow problem is just begging to be made into a metaphor.
So you think you can pandemic?
What’s that? You say you’ve got an idea for the next great pandemic? Well, if your pandemic is going to beat coronavirus/COVID-19, it’s going to have to top this:
Sex: Porn star Lola Taylor (real name, Iyubov Bushueva) is currently in COVID-related isolation in Moscow and has offered to “have sex with the first scientist who finds a cure for coronavirus,” the Daily Star reported.
Sensible terrorists: “Islamic State has adopted a safety-first approach to the coronavirus pandemic and advised its members not to travel to Europe,” Politico reported. The terrorist group’s latest newsletter recommends that followers “stay away from the land of the epidemic” for the time being.
Drugs: Michigan is doing its part to keep the cannabis flowing. The state is temporarily lifting its ban against curbside pickup at marijuana stores as a way to limit exposure to coronavirus. “There has been an increase of customers who are stockpiling both medical and recreational cannabis, and sales are definitely up, just like other essentials,” Michigan Cannabis Industry Association Director Robin Schneider told mLive.com.
Sewage gridlock: Please don’t feed the fatbergs. That’s the message from the United Kingdom’s largest water and sewage authority. Thames Water is warning customers that flushing paper towels and wet wipes will add to the nonbiodegradable sewage blobs known as fatbergs, the Guardian reported. Thames Water’s position: “The only things that should be flushed are the 3 P’s: poo, pee and (toilet) paper,” the Guardian said.
Airship hospitals: China built two hospitals in response to the coronavirus epidemic, but can either of them fly? No. Science writer Bill Gourgey suggests that it’s time to revisit an idea proposed 100 years ago during a tuberculosis epidemic. Airships equipped as hospitals “could offer all of the resources – staff and equipment – to extract, quarantine, and treat patients. And a fleet could deliver at scale,” he wrote on OneZero.
The Governator: His royal Arnold-ness, along with this his pony Whiskey and donkey Lulu, has taken to Twitter to try to convince folks to stay inside and eat carrots together. Happily, Mr. Schwarzenegger did not go all Terminator when Whiskey tried to bite Lulu, instead offering a gentle, “You’ve got to get along.”
If your pandemic doesn’t have all of this, then you’re just not trying hard enough.
Earthworm Surprise
If you watched the Rugrats as a kid – or if your kids did, nonmillennials – you may remember how Phil and Lil used to eat bugs and worms whenever they played outside. We used to think it was gross, but now we think it may be time to follow their lead.
A Latvian scientist has unearthed (sorry) ways to make bread, muffins, lollipops, and so on using earthworms, claiming that earthworms are full of protein. Next time your children are crying for candy or sweets, why not hand them an earthworm lollipop to appease them? You’ll be making sure they’re getting their daily dose of protein!
The scientist, Ilga Gedrovica of the Latvian University of Life Science and Technologies, reported that earthworms not only contain just as much protein as meat, but they are also cheaper to produce. She also explained that, when dried, earthworms contain about three times more protein than meat.
Research is now underway to determine the safety of eating earthworms, fried or otherwise.
Just think: In a post–COVID-19 future, instead of a steak dinner, we could be making earthworm casseroles! Which, of course, kids won’t eat. Not because of the earthworms, of course. But because, ewwww, casseroles.
It’s ... Monty Python’s Flying Study!
It’s one of life’s most haunting questions, asked by one of our best philosophers: What is the velocity of an unladen swallow?
Sadly, Nathaniel Dominy and Erin Butler of Dartmouth University did not tackle this conundrum, but they did address another issue raised by Monty Python: Just how silly are the walks displayed by the Ministry of Silly Walks?
As you might expect, the minister himself is a masterclass of inefficiency, moving with 6.7 times more variability than someone walking in a nonhumorous fashion. Mr. Pudey, the man applying for the government grant to develop his own silly walk, is noticeably more efficient, merely displaying a rate of variability 3.3 times that of a normal walk. However, the researchers agreed with the minister that Mr. Pudey was well deserving of a government grant.
While we feel answering that question alone was worth a study, the researchers did have a larger point to make: comparing the bureaucratic inefficiency of the Ministry of Silly Walks to today’s peer-review process within the health field, particularly when researchers seek funding.
Grants take months to be approved and often involve researchers flying back and forth. A streamlined process could save huge amounts of both time and money, they noted.
The LOTME team would like to salute these two researchers for their excellent choice of metaphor, and hope they use Monty Python to make further points about health care. The swallow problem is just begging to be made into a metaphor.
So you think you can pandemic?
What’s that? You say you’ve got an idea for the next great pandemic? Well, if your pandemic is going to beat coronavirus/COVID-19, it’s going to have to top this:
Sex: Porn star Lola Taylor (real name, Iyubov Bushueva) is currently in COVID-related isolation in Moscow and has offered to “have sex with the first scientist who finds a cure for coronavirus,” the Daily Star reported.
Sensible terrorists: “Islamic State has adopted a safety-first approach to the coronavirus pandemic and advised its members not to travel to Europe,” Politico reported. The terrorist group’s latest newsletter recommends that followers “stay away from the land of the epidemic” for the time being.
Drugs: Michigan is doing its part to keep the cannabis flowing. The state is temporarily lifting its ban against curbside pickup at marijuana stores as a way to limit exposure to coronavirus. “There has been an increase of customers who are stockpiling both medical and recreational cannabis, and sales are definitely up, just like other essentials,” Michigan Cannabis Industry Association Director Robin Schneider told mLive.com.
Sewage gridlock: Please don’t feed the fatbergs. That’s the message from the United Kingdom’s largest water and sewage authority. Thames Water is warning customers that flushing paper towels and wet wipes will add to the nonbiodegradable sewage blobs known as fatbergs, the Guardian reported. Thames Water’s position: “The only things that should be flushed are the 3 P’s: poo, pee and (toilet) paper,” the Guardian said.
Airship hospitals: China built two hospitals in response to the coronavirus epidemic, but can either of them fly? No. Science writer Bill Gourgey suggests that it’s time to revisit an idea proposed 100 years ago during a tuberculosis epidemic. Airships equipped as hospitals “could offer all of the resources – staff and equipment – to extract, quarantine, and treat patients. And a fleet could deliver at scale,” he wrote on OneZero.
The Governator: His royal Arnold-ness, along with this his pony Whiskey and donkey Lulu, has taken to Twitter to try to convince folks to stay inside and eat carrots together. Happily, Mr. Schwarzenegger did not go all Terminator when Whiskey tried to bite Lulu, instead offering a gentle, “You’ve got to get along.”
If your pandemic doesn’t have all of this, then you’re just not trying hard enough.
Earthworm Surprise
If you watched the Rugrats as a kid – or if your kids did, nonmillennials – you may remember how Phil and Lil used to eat bugs and worms whenever they played outside. We used to think it was gross, but now we think it may be time to follow their lead.
A Latvian scientist has unearthed (sorry) ways to make bread, muffins, lollipops, and so on using earthworms, claiming that earthworms are full of protein. Next time your children are crying for candy or sweets, why not hand them an earthworm lollipop to appease them? You’ll be making sure they’re getting their daily dose of protein!
The scientist, Ilga Gedrovica of the Latvian University of Life Science and Technologies, reported that earthworms not only contain just as much protein as meat, but they are also cheaper to produce. She also explained that, when dried, earthworms contain about three times more protein than meat.
Research is now underway to determine the safety of eating earthworms, fried or otherwise.
Just think: In a post–COVID-19 future, instead of a steak dinner, we could be making earthworm casseroles! Which, of course, kids won’t eat. Not because of the earthworms, of course. But because, ewwww, casseroles.
It’s ... Monty Python’s Flying Study!
It’s one of life’s most haunting questions, asked by one of our best philosophers: What is the velocity of an unladen swallow?
Sadly, Nathaniel Dominy and Erin Butler of Dartmouth University did not tackle this conundrum, but they did address another issue raised by Monty Python: Just how silly are the walks displayed by the Ministry of Silly Walks?
As you might expect, the minister himself is a masterclass of inefficiency, moving with 6.7 times more variability than someone walking in a nonhumorous fashion. Mr. Pudey, the man applying for the government grant to develop his own silly walk, is noticeably more efficient, merely displaying a rate of variability 3.3 times that of a normal walk. However, the researchers agreed with the minister that Mr. Pudey was well deserving of a government grant.
While we feel answering that question alone was worth a study, the researchers did have a larger point to make: comparing the bureaucratic inefficiency of the Ministry of Silly Walks to today’s peer-review process within the health field, particularly when researchers seek funding.
Grants take months to be approved and often involve researchers flying back and forth. A streamlined process could save huge amounts of both time and money, they noted.
The LOTME team would like to salute these two researchers for their excellent choice of metaphor, and hope they use Monty Python to make further points about health care. The swallow problem is just begging to be made into a metaphor.