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Lucas Franki is an associate editor for MDedge News, and has been with the company since 2014. He has a BA in English from Penn State University and is an Eagle Scout.
FDA approves Baqsimi nasal powder for emergency hypoglycemia treatment
in patients aged 4 years and older.
Injectable glucagon has been approved in the United States for several decades.
The safety and efficacy of the Baqsimi powder was assessed in two studies with adults with diabetes and one with pediatric patients. In all three studies, a single dose of Baqsimi was compared with a single dose of glucagon injection, and Baqsimi adequately raised blood sugar levels in response to insulin-induced hypoglycemia.
The most common adverse events associated with Baqsimi include nausea, vomiting, headache, upper respiratory tract irritation, watery eyes, redness of eyes, and itchiness. The safety profile is similar to that of injectable glucagon, with the addition of nasal- and eye-related symptoms because of the method of delivery.
“There are many products on the market for those who need insulin, but until now, people suffering from a severe hypoglycemic episode had to be treated with a glucagon injection that first had to be mixed in a several-step process. This new way to administer glucagon may simplify the process, which can be critical during an episode, especially since the patient may have lost consciousness or may be having a seizure. In those situations, we want the process to treat the suffering person to be as simple as possible,” Janet Woodcock, MD, director of the FDA’s Center for Drug Evaluation and Research, said in the press release.
Find the full press release on the FDA website.
in patients aged 4 years and older.
Injectable glucagon has been approved in the United States for several decades.
The safety and efficacy of the Baqsimi powder was assessed in two studies with adults with diabetes and one with pediatric patients. In all three studies, a single dose of Baqsimi was compared with a single dose of glucagon injection, and Baqsimi adequately raised blood sugar levels in response to insulin-induced hypoglycemia.
The most common adverse events associated with Baqsimi include nausea, vomiting, headache, upper respiratory tract irritation, watery eyes, redness of eyes, and itchiness. The safety profile is similar to that of injectable glucagon, with the addition of nasal- and eye-related symptoms because of the method of delivery.
“There are many products on the market for those who need insulin, but until now, people suffering from a severe hypoglycemic episode had to be treated with a glucagon injection that first had to be mixed in a several-step process. This new way to administer glucagon may simplify the process, which can be critical during an episode, especially since the patient may have lost consciousness or may be having a seizure. In those situations, we want the process to treat the suffering person to be as simple as possible,” Janet Woodcock, MD, director of the FDA’s Center for Drug Evaluation and Research, said in the press release.
Find the full press release on the FDA website.
in patients aged 4 years and older.
Injectable glucagon has been approved in the United States for several decades.
The safety and efficacy of the Baqsimi powder was assessed in two studies with adults with diabetes and one with pediatric patients. In all three studies, a single dose of Baqsimi was compared with a single dose of glucagon injection, and Baqsimi adequately raised blood sugar levels in response to insulin-induced hypoglycemia.
The most common adverse events associated with Baqsimi include nausea, vomiting, headache, upper respiratory tract irritation, watery eyes, redness of eyes, and itchiness. The safety profile is similar to that of injectable glucagon, with the addition of nasal- and eye-related symptoms because of the method of delivery.
“There are many products on the market for those who need insulin, but until now, people suffering from a severe hypoglycemic episode had to be treated with a glucagon injection that first had to be mixed in a several-step process. This new way to administer glucagon may simplify the process, which can be critical during an episode, especially since the patient may have lost consciousness or may be having a seizure. In those situations, we want the process to treat the suffering person to be as simple as possible,” Janet Woodcock, MD, director of the FDA’s Center for Drug Evaluation and Research, said in the press release.
Find the full press release on the FDA website.
Robust microbiota, cat dominance, and a nice Martian red
Aesop’s infant fecal microbiotas
There once was a city baby who visited his Amish country cousin. (Actually, this study involved two groups of five babies each; but for our purposes, one child will do.)
Amish baby served a simple meal, and the two relations talked of an odd experience they had shared.
City baby said that one day, a group of scientists from The Ohio State University visited his home in Wooster, where he had no known contact with livestock. The scientists asked if they could have some of city baby’s poop so they could examine his microbiome. Amish baby said that scientists also had visited her rural home, where the family raised goats and pigs, and asked for some of her poop.
Amish baby said that there was “an abundance of beneficial bacteria” in her gut, as the researchers had put it, that wasn’t found in city baby’s gut. The reason, the scientists told Amish baby, was her “exposure to the livestock and the fact that the Amish tend to live a relatively less-sanitized lifestyle than most other Americans.”
City baby frowned and pulled out his smartphone. After some quick Googling, he found a written statement from the study’s co-lead author, Zhongtang Yu of Ohio State’s Food Innovation Center: “Good hygiene is important, but from the perspective of our immune systems, a sanitized environment robs our immune systems of the opportunity to be educated by microbes. Too clean is not necessarily a good thing.”
City baby became a little sad, so Amish baby tried to comfort him. But then his Uber showed up, and he had to go home.
The Red (wine) Planet
The first astronauts who make the long voyage to Mars will face many health challenges. The hostility of space itself. Years of isolation cooped up inside a tiny metal can. Potentially lethal doses of radiation.
Comparatively speaking, the degrading effects of the Red Planet’s lighter gravity on the human body seem almost trivial. But the weakening of both bone and muscle is a serious problem; luckily, it’s a problem that seems to have a solution. Just bring some wine along.
Specifically, red wine.
According to a study undertaken by researchers in Boston, resveratrol – a chemical found in red wine with anti-inflammatory, antioxidant, and antidiabetic effects – may stave off the musculoskeletal degradation effects of lighter gravity.
Rats placed in an environment simulating Mars’s lighter gravity that received resveratrol had significantly greater limb grip force, muscle weight, myofiber size, and muscle composition protection than did rats placed in Mars-like gravity that did not receive the chemical.
While some muscle atrophy did occur, the results were definitely impressive, and the researchers noted that a greater dose may further improve results.
We eagerly await the first fateful words when the first Mars expedition touches down: “Tranquility Base here, the commander’s gotten into the wine cellar again. Give us a few minutes to sober him up.”
The purrrrfect pet
There’s more than one way to pet a cat, but what’s the very best way? Cats are notoriously fickle – one second they could be enjoying a nice back rub and the next, you’ve been eviscerated. How do you avoid this fate when you’re just trying to bond with Mittens? Science has your answer.
A surprising amount of studies are done on domestic cats (surprising to this dog lover, anyway). Unlike man’s best friend, domestic cats display only a slight genetic divergence from their ancestors, which means they still have strong wildcat instincts. That’s right, your precious Snowball knows she’s actually a lion. It might be best not to dissuade her of this notion.
Cats vary widely in whether they like being touched or not. Many cats simply tolerate their humans in order to receive food – although a tolerant cat is not always a happy cat. The best way to pet your cat is to let them be in control. A study on the human-cat relationship found that the most successful interactions happened when the cat initiated. Basically, just wait until your cat pets you. As any cat parent will tell you, they don’t own a cat – the cat owns them.
Aesop’s infant fecal microbiotas
There once was a city baby who visited his Amish country cousin. (Actually, this study involved two groups of five babies each; but for our purposes, one child will do.)
Amish baby served a simple meal, and the two relations talked of an odd experience they had shared.
City baby said that one day, a group of scientists from The Ohio State University visited his home in Wooster, where he had no known contact with livestock. The scientists asked if they could have some of city baby’s poop so they could examine his microbiome. Amish baby said that scientists also had visited her rural home, where the family raised goats and pigs, and asked for some of her poop.
Amish baby said that there was “an abundance of beneficial bacteria” in her gut, as the researchers had put it, that wasn’t found in city baby’s gut. The reason, the scientists told Amish baby, was her “exposure to the livestock and the fact that the Amish tend to live a relatively less-sanitized lifestyle than most other Americans.”
City baby frowned and pulled out his smartphone. After some quick Googling, he found a written statement from the study’s co-lead author, Zhongtang Yu of Ohio State’s Food Innovation Center: “Good hygiene is important, but from the perspective of our immune systems, a sanitized environment robs our immune systems of the opportunity to be educated by microbes. Too clean is not necessarily a good thing.”
City baby became a little sad, so Amish baby tried to comfort him. But then his Uber showed up, and he had to go home.
The Red (wine) Planet
The first astronauts who make the long voyage to Mars will face many health challenges. The hostility of space itself. Years of isolation cooped up inside a tiny metal can. Potentially lethal doses of radiation.
Comparatively speaking, the degrading effects of the Red Planet’s lighter gravity on the human body seem almost trivial. But the weakening of both bone and muscle is a serious problem; luckily, it’s a problem that seems to have a solution. Just bring some wine along.
Specifically, red wine.
According to a study undertaken by researchers in Boston, resveratrol – a chemical found in red wine with anti-inflammatory, antioxidant, and antidiabetic effects – may stave off the musculoskeletal degradation effects of lighter gravity.
Rats placed in an environment simulating Mars’s lighter gravity that received resveratrol had significantly greater limb grip force, muscle weight, myofiber size, and muscle composition protection than did rats placed in Mars-like gravity that did not receive the chemical.
While some muscle atrophy did occur, the results were definitely impressive, and the researchers noted that a greater dose may further improve results.
We eagerly await the first fateful words when the first Mars expedition touches down: “Tranquility Base here, the commander’s gotten into the wine cellar again. Give us a few minutes to sober him up.”
The purrrrfect pet
There’s more than one way to pet a cat, but what’s the very best way? Cats are notoriously fickle – one second they could be enjoying a nice back rub and the next, you’ve been eviscerated. How do you avoid this fate when you’re just trying to bond with Mittens? Science has your answer.
A surprising amount of studies are done on domestic cats (surprising to this dog lover, anyway). Unlike man’s best friend, domestic cats display only a slight genetic divergence from their ancestors, which means they still have strong wildcat instincts. That’s right, your precious Snowball knows she’s actually a lion. It might be best not to dissuade her of this notion.
Cats vary widely in whether they like being touched or not. Many cats simply tolerate their humans in order to receive food – although a tolerant cat is not always a happy cat. The best way to pet your cat is to let them be in control. A study on the human-cat relationship found that the most successful interactions happened when the cat initiated. Basically, just wait until your cat pets you. As any cat parent will tell you, they don’t own a cat – the cat owns them.
Aesop’s infant fecal microbiotas
There once was a city baby who visited his Amish country cousin. (Actually, this study involved two groups of five babies each; but for our purposes, one child will do.)
Amish baby served a simple meal, and the two relations talked of an odd experience they had shared.
City baby said that one day, a group of scientists from The Ohio State University visited his home in Wooster, where he had no known contact with livestock. The scientists asked if they could have some of city baby’s poop so they could examine his microbiome. Amish baby said that scientists also had visited her rural home, where the family raised goats and pigs, and asked for some of her poop.
Amish baby said that there was “an abundance of beneficial bacteria” in her gut, as the researchers had put it, that wasn’t found in city baby’s gut. The reason, the scientists told Amish baby, was her “exposure to the livestock and the fact that the Amish tend to live a relatively less-sanitized lifestyle than most other Americans.”
City baby frowned and pulled out his smartphone. After some quick Googling, he found a written statement from the study’s co-lead author, Zhongtang Yu of Ohio State’s Food Innovation Center: “Good hygiene is important, but from the perspective of our immune systems, a sanitized environment robs our immune systems of the opportunity to be educated by microbes. Too clean is not necessarily a good thing.”
City baby became a little sad, so Amish baby tried to comfort him. But then his Uber showed up, and he had to go home.
The Red (wine) Planet
The first astronauts who make the long voyage to Mars will face many health challenges. The hostility of space itself. Years of isolation cooped up inside a tiny metal can. Potentially lethal doses of radiation.
Comparatively speaking, the degrading effects of the Red Planet’s lighter gravity on the human body seem almost trivial. But the weakening of both bone and muscle is a serious problem; luckily, it’s a problem that seems to have a solution. Just bring some wine along.
Specifically, red wine.
According to a study undertaken by researchers in Boston, resveratrol – a chemical found in red wine with anti-inflammatory, antioxidant, and antidiabetic effects – may stave off the musculoskeletal degradation effects of lighter gravity.
Rats placed in an environment simulating Mars’s lighter gravity that received resveratrol had significantly greater limb grip force, muscle weight, myofiber size, and muscle composition protection than did rats placed in Mars-like gravity that did not receive the chemical.
While some muscle atrophy did occur, the results were definitely impressive, and the researchers noted that a greater dose may further improve results.
We eagerly await the first fateful words when the first Mars expedition touches down: “Tranquility Base here, the commander’s gotten into the wine cellar again. Give us a few minutes to sober him up.”
The purrrrfect pet
There’s more than one way to pet a cat, but what’s the very best way? Cats are notoriously fickle – one second they could be enjoying a nice back rub and the next, you’ve been eviscerated. How do you avoid this fate when you’re just trying to bond with Mittens? Science has your answer.
A surprising amount of studies are done on domestic cats (surprising to this dog lover, anyway). Unlike man’s best friend, domestic cats display only a slight genetic divergence from their ancestors, which means they still have strong wildcat instincts. That’s right, your precious Snowball knows she’s actually a lion. It might be best not to dissuade her of this notion.
Cats vary widely in whether they like being touched or not. Many cats simply tolerate their humans in order to receive food – although a tolerant cat is not always a happy cat. The best way to pet your cat is to let them be in control. A study on the human-cat relationship found that the most successful interactions happened when the cat initiated. Basically, just wait until your cat pets you. As any cat parent will tell you, they don’t own a cat – the cat owns them.
FDA approves Otezla for treatment of Behçet’s-associated oral ulcers
The Food and Drug Administration has expanded the indication for apremilast (Otezla) to include the treatment of oral ulcers associated with Behçet’s disease in adults, according to an announcement from the manufacturer, Celgene.
FDA approval was based on results of the randomized, placebo-controlled, double-blind, phase 3 RELIEF trial, in which 207 patients with Behçet’s disease with active ulcers underwent treatment for 12 weeks with 30 mg apremilast or placebo. When measured on a visual analog scale, the reduction in pain from oral ulcers after 12 weeks in patients receiving apremilast was 42.7 points, compared with 18.7 points in the placebo group. Just over 50% of apremilast patients achieved complete response by week 12, compared with 22.3% in the placebo group.
The most common adverse events associated with apremilast during RELIEF were diarrhea, nausea, headache, and upper respiratory infection. This was consistent with apremilast’s known safety profile.
Apremilast is also indicated for treatment of patients with moderate to severe plaque psoriasis who are candidates for phototherapy or systemic therapy, and for patients with active psoriatic arthritis.
“Oral ulcers are a recurring and debilitating manifestation that affects nearly everyone living with Behçet’s disease and have an important negative impact on the quality of life for these patients. In the clinical trial, Otezla demonstrated improvements in measures of oral ulcers at week 12. Otezla has the potential to be a needed treatment option for U.S. patients and their physicians, who previously had limited options available,” Yusuf Yazici, MD, clinical associate professor in the department of medicine at New York University, said in the announcement.
The Food and Drug Administration has expanded the indication for apremilast (Otezla) to include the treatment of oral ulcers associated with Behçet’s disease in adults, according to an announcement from the manufacturer, Celgene.
FDA approval was based on results of the randomized, placebo-controlled, double-blind, phase 3 RELIEF trial, in which 207 patients with Behçet’s disease with active ulcers underwent treatment for 12 weeks with 30 mg apremilast or placebo. When measured on a visual analog scale, the reduction in pain from oral ulcers after 12 weeks in patients receiving apremilast was 42.7 points, compared with 18.7 points in the placebo group. Just over 50% of apremilast patients achieved complete response by week 12, compared with 22.3% in the placebo group.
The most common adverse events associated with apremilast during RELIEF were diarrhea, nausea, headache, and upper respiratory infection. This was consistent with apremilast’s known safety profile.
Apremilast is also indicated for treatment of patients with moderate to severe plaque psoriasis who are candidates for phototherapy or systemic therapy, and for patients with active psoriatic arthritis.
“Oral ulcers are a recurring and debilitating manifestation that affects nearly everyone living with Behçet’s disease and have an important negative impact on the quality of life for these patients. In the clinical trial, Otezla demonstrated improvements in measures of oral ulcers at week 12. Otezla has the potential to be a needed treatment option for U.S. patients and their physicians, who previously had limited options available,” Yusuf Yazici, MD, clinical associate professor in the department of medicine at New York University, said in the announcement.
The Food and Drug Administration has expanded the indication for apremilast (Otezla) to include the treatment of oral ulcers associated with Behçet’s disease in adults, according to an announcement from the manufacturer, Celgene.
FDA approval was based on results of the randomized, placebo-controlled, double-blind, phase 3 RELIEF trial, in which 207 patients with Behçet’s disease with active ulcers underwent treatment for 12 weeks with 30 mg apremilast or placebo. When measured on a visual analog scale, the reduction in pain from oral ulcers after 12 weeks in patients receiving apremilast was 42.7 points, compared with 18.7 points in the placebo group. Just over 50% of apremilast patients achieved complete response by week 12, compared with 22.3% in the placebo group.
The most common adverse events associated with apremilast during RELIEF were diarrhea, nausea, headache, and upper respiratory infection. This was consistent with apremilast’s known safety profile.
Apremilast is also indicated for treatment of patients with moderate to severe plaque psoriasis who are candidates for phototherapy or systemic therapy, and for patients with active psoriatic arthritis.
“Oral ulcers are a recurring and debilitating manifestation that affects nearly everyone living with Behçet’s disease and have an important negative impact on the quality of life for these patients. In the clinical trial, Otezla demonstrated improvements in measures of oral ulcers at week 12. Otezla has the potential to be a needed treatment option for U.S. patients and their physicians, who previously had limited options available,” Yusuf Yazici, MD, clinical associate professor in the department of medicine at New York University, said in the announcement.
USPSTF updates, reaffirms recommendation for HBV screening in pregnant women
The according to task force member Douglas K. Owens, MD, of the Veterans Affairs Palo Alto (Calif.) Health Care System and other members of the task force.
The recommendation statement, published in JAMA, was based on an evidence report and systematic review also published in JAMA. In that review, two studies of fair quality were identified; one included 155,081 infants born to HBV-positive women identified for case management through the national Perinatal Hepatitis B Prevention Program from 1994 to 2008, and the other included 4,446 infants born in a large, regional health care organization in the United States between 1997 and 2010. In both, low rates of perinatal transmission were reported for those periods – between 0.5% and 1.9% – with the rate falling over time.
In the 2009 recommendation, the USPSTF found adequate evidence that serologic testing for hepatitis B surface antigen accurately identifies HBV infection, and that interventions were effective in preventing perinatal transmission. That recommendation has been reaffirmed in the current update, with HBV screening receiving a grade of A, which is the strongest the USPSTF offers.
In a related editorial, Neil S. Silverman, MD, of the Center for Fetal Medicine and Women’s Ultrasound in Los Angeles noted several improvements in maternal HBV therapy since the publication of the original 2009 recommendation, including maternal HBV-targeted antiviral therapy during pregnancy as an adjunct to neonatal immunoprophylaxis and the ability to refer women for chronic treatment of their HBV disease to prevent long-term infection complications. The task forces also noted that HBV screening of all pregnant women is mandated by law in 26 states.
One member of the task force reported receiving grants and/or personal fees from Healthwise, another member reported receiving personal fees from UpToDate; a third reported participating in the American Association for the Study of Liver Diseases’ Hepatitis B Guidance and Hepatitis B Systematic Review Group. The evidence and review study was funded by the Agency for Healthcare Research and Quality. Dr. Silverman reported no disclosures.
SOURCes: Owens DK et al. JAMA. 2019 Jul 23. doi: 10.1001/jama.2019.9365; Henderson JT et al. JAMA. 2019 Jul 23;32(4):360-2; Silverman NS. JAMA. 2019 Jul 23;32(4):312-14.
The according to task force member Douglas K. Owens, MD, of the Veterans Affairs Palo Alto (Calif.) Health Care System and other members of the task force.
The recommendation statement, published in JAMA, was based on an evidence report and systematic review also published in JAMA. In that review, two studies of fair quality were identified; one included 155,081 infants born to HBV-positive women identified for case management through the national Perinatal Hepatitis B Prevention Program from 1994 to 2008, and the other included 4,446 infants born in a large, regional health care organization in the United States between 1997 and 2010. In both, low rates of perinatal transmission were reported for those periods – between 0.5% and 1.9% – with the rate falling over time.
In the 2009 recommendation, the USPSTF found adequate evidence that serologic testing for hepatitis B surface antigen accurately identifies HBV infection, and that interventions were effective in preventing perinatal transmission. That recommendation has been reaffirmed in the current update, with HBV screening receiving a grade of A, which is the strongest the USPSTF offers.
In a related editorial, Neil S. Silverman, MD, of the Center for Fetal Medicine and Women’s Ultrasound in Los Angeles noted several improvements in maternal HBV therapy since the publication of the original 2009 recommendation, including maternal HBV-targeted antiviral therapy during pregnancy as an adjunct to neonatal immunoprophylaxis and the ability to refer women for chronic treatment of their HBV disease to prevent long-term infection complications. The task forces also noted that HBV screening of all pregnant women is mandated by law in 26 states.
One member of the task force reported receiving grants and/or personal fees from Healthwise, another member reported receiving personal fees from UpToDate; a third reported participating in the American Association for the Study of Liver Diseases’ Hepatitis B Guidance and Hepatitis B Systematic Review Group. The evidence and review study was funded by the Agency for Healthcare Research and Quality. Dr. Silverman reported no disclosures.
SOURCes: Owens DK et al. JAMA. 2019 Jul 23. doi: 10.1001/jama.2019.9365; Henderson JT et al. JAMA. 2019 Jul 23;32(4):360-2; Silverman NS. JAMA. 2019 Jul 23;32(4):312-14.
The according to task force member Douglas K. Owens, MD, of the Veterans Affairs Palo Alto (Calif.) Health Care System and other members of the task force.
The recommendation statement, published in JAMA, was based on an evidence report and systematic review also published in JAMA. In that review, two studies of fair quality were identified; one included 155,081 infants born to HBV-positive women identified for case management through the national Perinatal Hepatitis B Prevention Program from 1994 to 2008, and the other included 4,446 infants born in a large, regional health care organization in the United States between 1997 and 2010. In both, low rates of perinatal transmission were reported for those periods – between 0.5% and 1.9% – with the rate falling over time.
In the 2009 recommendation, the USPSTF found adequate evidence that serologic testing for hepatitis B surface antigen accurately identifies HBV infection, and that interventions were effective in preventing perinatal transmission. That recommendation has been reaffirmed in the current update, with HBV screening receiving a grade of A, which is the strongest the USPSTF offers.
In a related editorial, Neil S. Silverman, MD, of the Center for Fetal Medicine and Women’s Ultrasound in Los Angeles noted several improvements in maternal HBV therapy since the publication of the original 2009 recommendation, including maternal HBV-targeted antiviral therapy during pregnancy as an adjunct to neonatal immunoprophylaxis and the ability to refer women for chronic treatment of their HBV disease to prevent long-term infection complications. The task forces also noted that HBV screening of all pregnant women is mandated by law in 26 states.
One member of the task force reported receiving grants and/or personal fees from Healthwise, another member reported receiving personal fees from UpToDate; a third reported participating in the American Association for the Study of Liver Diseases’ Hepatitis B Guidance and Hepatitis B Systematic Review Group. The evidence and review study was funded by the Agency for Healthcare Research and Quality. Dr. Silverman reported no disclosures.
SOURCes: Owens DK et al. JAMA. 2019 Jul 23. doi: 10.1001/jama.2019.9365; Henderson JT et al. JAMA. 2019 Jul 23;32(4):360-2; Silverman NS. JAMA. 2019 Jul 23;32(4):312-14.
FROM JAMA
FDA approves first generics of pregabalin
The generics were approved to manage neuropathic pain associated with diabetic peripheral neuropathy, postherpetic neuralgia, and fibromyalgia, as well as neuropathic pain associated with spinal cord injury, and as an adjunctive therapy for the treatment of partial-onset seizures in patients aged 17 years and older. Approvals were granted to Alembic Pharmaceuticals, Alkem Laboratories, Amneal Pharmaceuticals, Dr. Reddy’s Laboratories, InvaGen Pharmaceuticals, MSN Laboratories, Rising Pharmaceuticals, Sciegen Pharmaceuticals, and Teva Pharmaceuticals.
The most common adverse events associated with pregabalin include dizziness, somnolence, dry mouth, swelling, blurred vision, weight gain, and abnormal thinking. Pregabalin must be dispensed with a patient Medication Guide containing a guide to the drug’s uses and risks. Angioedema, hypersensitivity reactions, increased seizure frequency, increased suicidal behavior, and peripheral edema are all possible.
“Today’s approval of the first generics for pregabalin, a widely used medication, is another example of the FDA’s long-standing commitment to advance patient access to lower-cost, high-quality generic medicines,” Janet Woodcock, MD, director of the FDA’s Center for Drug Evaluation and Research, said in a press release.
The generics were approved to manage neuropathic pain associated with diabetic peripheral neuropathy, postherpetic neuralgia, and fibromyalgia, as well as neuropathic pain associated with spinal cord injury, and as an adjunctive therapy for the treatment of partial-onset seizures in patients aged 17 years and older. Approvals were granted to Alembic Pharmaceuticals, Alkem Laboratories, Amneal Pharmaceuticals, Dr. Reddy’s Laboratories, InvaGen Pharmaceuticals, MSN Laboratories, Rising Pharmaceuticals, Sciegen Pharmaceuticals, and Teva Pharmaceuticals.
The most common adverse events associated with pregabalin include dizziness, somnolence, dry mouth, swelling, blurred vision, weight gain, and abnormal thinking. Pregabalin must be dispensed with a patient Medication Guide containing a guide to the drug’s uses and risks. Angioedema, hypersensitivity reactions, increased seizure frequency, increased suicidal behavior, and peripheral edema are all possible.
“Today’s approval of the first generics for pregabalin, a widely used medication, is another example of the FDA’s long-standing commitment to advance patient access to lower-cost, high-quality generic medicines,” Janet Woodcock, MD, director of the FDA’s Center for Drug Evaluation and Research, said in a press release.
The generics were approved to manage neuropathic pain associated with diabetic peripheral neuropathy, postherpetic neuralgia, and fibromyalgia, as well as neuropathic pain associated with spinal cord injury, and as an adjunctive therapy for the treatment of partial-onset seizures in patients aged 17 years and older. Approvals were granted to Alembic Pharmaceuticals, Alkem Laboratories, Amneal Pharmaceuticals, Dr. Reddy’s Laboratories, InvaGen Pharmaceuticals, MSN Laboratories, Rising Pharmaceuticals, Sciegen Pharmaceuticals, and Teva Pharmaceuticals.
The most common adverse events associated with pregabalin include dizziness, somnolence, dry mouth, swelling, blurred vision, weight gain, and abnormal thinking. Pregabalin must be dispensed with a patient Medication Guide containing a guide to the drug’s uses and risks. Angioedema, hypersensitivity reactions, increased seizure frequency, increased suicidal behavior, and peripheral edema are all possible.
“Today’s approval of the first generics for pregabalin, a widely used medication, is another example of the FDA’s long-standing commitment to advance patient access to lower-cost, high-quality generic medicines,” Janet Woodcock, MD, director of the FDA’s Center for Drug Evaluation and Research, said in a press release.
Collagen powder deemed noninferior to primary closure for punch-biopsy healing
Collagen powder may be noninferior to primary closure for healing punch biopsy–induced wounds and possibly leads to improved early cosmetic outcomes and accelerated wound maturation, according to Azam Qureshi of the University of Maryland, Baltimore, and associates.
In a small pilot study published in Journal of Drugs in Dermatology, eight volunteers (mean age, 37 years) received a 4-mm punch biopsy on each thigh. One wound was managed with primary closure, the other with daily application of collagen powder. The wounds were biopsied at 4 weeks for histopathologic analysis, and the study subjects rated pain, itch, and treatment preferences at 1, 2, 4, 6, and 12 weeks.
The size of wounds treated with collagen was reduced by 28.95% at 1 week, 55.76% at 2 weeks, and 95.94% at 4 weeks; six of the eight collagen-treated wounds were completely healed at 4 weeks. Wound size was reduced by 75.71% 1 week after the second biopsy, much faster than the initial healing. In addition to collagen, one patient required hyfrecation for hemostasis, which did not affect results; three of the eight subjects rated the collagen treatment as “annoying,” but no one rated it as “difficult,” and patients generally regarded collagen treatment as more time consuming.
The histopathologic analysis showed epidermal reepithelialization in collagen-treated wounds and wounds managed with primary closure, with more organized granulation tissue in the collagen-treated wounds. Similar pain and itch ratings were reported between wound types, and both patients and blinded dermatologists observing the study preferred the appearance of collagen-treated wounds.
“Future research elucidating the optimal duration of collagen therapy is needed, as less than 4 weeks may be sufficient. Shortened treatment courses would decrease the cost and effort required by patients. Future studies should also investigate the efficacy of collagen powder in healing larger wounds and in comparison to healing by secondary intention,” the investigators wrote.
CPN Biosciences funded the study. No authors had relevant financial disclosures.
SOURCE: Qureshi A et al. J Drug Dermatol. 2019;18(7):667-73
Collagen powder may be noninferior to primary closure for healing punch biopsy–induced wounds and possibly leads to improved early cosmetic outcomes and accelerated wound maturation, according to Azam Qureshi of the University of Maryland, Baltimore, and associates.
In a small pilot study published in Journal of Drugs in Dermatology, eight volunteers (mean age, 37 years) received a 4-mm punch biopsy on each thigh. One wound was managed with primary closure, the other with daily application of collagen powder. The wounds were biopsied at 4 weeks for histopathologic analysis, and the study subjects rated pain, itch, and treatment preferences at 1, 2, 4, 6, and 12 weeks.
The size of wounds treated with collagen was reduced by 28.95% at 1 week, 55.76% at 2 weeks, and 95.94% at 4 weeks; six of the eight collagen-treated wounds were completely healed at 4 weeks. Wound size was reduced by 75.71% 1 week after the second biopsy, much faster than the initial healing. In addition to collagen, one patient required hyfrecation for hemostasis, which did not affect results; three of the eight subjects rated the collagen treatment as “annoying,” but no one rated it as “difficult,” and patients generally regarded collagen treatment as more time consuming.
The histopathologic analysis showed epidermal reepithelialization in collagen-treated wounds and wounds managed with primary closure, with more organized granulation tissue in the collagen-treated wounds. Similar pain and itch ratings were reported between wound types, and both patients and blinded dermatologists observing the study preferred the appearance of collagen-treated wounds.
“Future research elucidating the optimal duration of collagen therapy is needed, as less than 4 weeks may be sufficient. Shortened treatment courses would decrease the cost and effort required by patients. Future studies should also investigate the efficacy of collagen powder in healing larger wounds and in comparison to healing by secondary intention,” the investigators wrote.
CPN Biosciences funded the study. No authors had relevant financial disclosures.
SOURCE: Qureshi A et al. J Drug Dermatol. 2019;18(7):667-73
Collagen powder may be noninferior to primary closure for healing punch biopsy–induced wounds and possibly leads to improved early cosmetic outcomes and accelerated wound maturation, according to Azam Qureshi of the University of Maryland, Baltimore, and associates.
In a small pilot study published in Journal of Drugs in Dermatology, eight volunteers (mean age, 37 years) received a 4-mm punch biopsy on each thigh. One wound was managed with primary closure, the other with daily application of collagen powder. The wounds were biopsied at 4 weeks for histopathologic analysis, and the study subjects rated pain, itch, and treatment preferences at 1, 2, 4, 6, and 12 weeks.
The size of wounds treated with collagen was reduced by 28.95% at 1 week, 55.76% at 2 weeks, and 95.94% at 4 weeks; six of the eight collagen-treated wounds were completely healed at 4 weeks. Wound size was reduced by 75.71% 1 week after the second biopsy, much faster than the initial healing. In addition to collagen, one patient required hyfrecation for hemostasis, which did not affect results; three of the eight subjects rated the collagen treatment as “annoying,” but no one rated it as “difficult,” and patients generally regarded collagen treatment as more time consuming.
The histopathologic analysis showed epidermal reepithelialization in collagen-treated wounds and wounds managed with primary closure, with more organized granulation tissue in the collagen-treated wounds. Similar pain and itch ratings were reported between wound types, and both patients and blinded dermatologists observing the study preferred the appearance of collagen-treated wounds.
“Future research elucidating the optimal duration of collagen therapy is needed, as less than 4 weeks may be sufficient. Shortened treatment courses would decrease the cost and effort required by patients. Future studies should also investigate the efficacy of collagen powder in healing larger wounds and in comparison to healing by secondary intention,” the investigators wrote.
CPN Biosciences funded the study. No authors had relevant financial disclosures.
SOURCE: Qureshi A et al. J Drug Dermatol. 2019;18(7):667-73
FROM JOURNAL OF DRUGS IN DERMATOLOGY
New oral polio vaccine is noninferior to currently licensed vaccine
according to Khalequ Zaman, MBBS, PhD, of the International Center for Diarrheal Disease Research in Dhaka, Bangladesh, and associates.
In the first part of the observer-blind, randomized, controlled study, 40 patients aged 5-6 years received either the new vaccine (BBio bOPV) or the licensed vaccine (SII bOPV). In the second part, 1,080 patients aged 6-8 weeks received either BBio bOPV or SII bOPV at age 6, 10, and 14 weeks. Blood samples were taken to assess neutralizing antibody responses against poliovirus types 1 and 3, and safety also was assessed.
In the first part of the study, 12 adverse events were reported, none of which were serious and none of which were related to the vaccines. All participants demonstrated seroprotective titers against both poliovirus types 1 month after vaccination.
In the second part, more than 96% of infants demonstrated seroprotection and seroconversion against both poliovirus types. Geometric mean titers were equivalent in both groups. A total of 387 participants had at least one adverse event, and 18 serious adverse events were reported. None of these were related to the vaccines.
“The BBio bOPV has been proven safe and immunogenic in the target infant population in Bangladesh. As the use of bOPV is expected to be continued until at least 2022, availability of new bOPV bulk manufacturer will be helpful in securing adequate supplies of bOPV for global demand in the polio endgame strategy,” the investigators concluded.
The study was funded by Bilthoven Biologicals. Four coauthors are employed by Bilthoven, manufacturer of the study vaccine; two others are employed by the Serum Institute of India, which provided the control vaccine.
SOURCE: Zaman K et al. Vaccine. 2019 Jun 22. doi: 10.1016/j.vaccine.2019.06.048.
according to Khalequ Zaman, MBBS, PhD, of the International Center for Diarrheal Disease Research in Dhaka, Bangladesh, and associates.
In the first part of the observer-blind, randomized, controlled study, 40 patients aged 5-6 years received either the new vaccine (BBio bOPV) or the licensed vaccine (SII bOPV). In the second part, 1,080 patients aged 6-8 weeks received either BBio bOPV or SII bOPV at age 6, 10, and 14 weeks. Blood samples were taken to assess neutralizing antibody responses against poliovirus types 1 and 3, and safety also was assessed.
In the first part of the study, 12 adverse events were reported, none of which were serious and none of which were related to the vaccines. All participants demonstrated seroprotective titers against both poliovirus types 1 month after vaccination.
In the second part, more than 96% of infants demonstrated seroprotection and seroconversion against both poliovirus types. Geometric mean titers were equivalent in both groups. A total of 387 participants had at least one adverse event, and 18 serious adverse events were reported. None of these were related to the vaccines.
“The BBio bOPV has been proven safe and immunogenic in the target infant population in Bangladesh. As the use of bOPV is expected to be continued until at least 2022, availability of new bOPV bulk manufacturer will be helpful in securing adequate supplies of bOPV for global demand in the polio endgame strategy,” the investigators concluded.
The study was funded by Bilthoven Biologicals. Four coauthors are employed by Bilthoven, manufacturer of the study vaccine; two others are employed by the Serum Institute of India, which provided the control vaccine.
SOURCE: Zaman K et al. Vaccine. 2019 Jun 22. doi: 10.1016/j.vaccine.2019.06.048.
according to Khalequ Zaman, MBBS, PhD, of the International Center for Diarrheal Disease Research in Dhaka, Bangladesh, and associates.
In the first part of the observer-blind, randomized, controlled study, 40 patients aged 5-6 years received either the new vaccine (BBio bOPV) or the licensed vaccine (SII bOPV). In the second part, 1,080 patients aged 6-8 weeks received either BBio bOPV or SII bOPV at age 6, 10, and 14 weeks. Blood samples were taken to assess neutralizing antibody responses against poliovirus types 1 and 3, and safety also was assessed.
In the first part of the study, 12 adverse events were reported, none of which were serious and none of which were related to the vaccines. All participants demonstrated seroprotective titers against both poliovirus types 1 month after vaccination.
In the second part, more than 96% of infants demonstrated seroprotection and seroconversion against both poliovirus types. Geometric mean titers were equivalent in both groups. A total of 387 participants had at least one adverse event, and 18 serious adverse events were reported. None of these were related to the vaccines.
“The BBio bOPV has been proven safe and immunogenic in the target infant population in Bangladesh. As the use of bOPV is expected to be continued until at least 2022, availability of new bOPV bulk manufacturer will be helpful in securing adequate supplies of bOPV for global demand in the polio endgame strategy,” the investigators concluded.
The study was funded by Bilthoven Biologicals. Four coauthors are employed by Bilthoven, manufacturer of the study vaccine; two others are employed by the Serum Institute of India, which provided the control vaccine.
SOURCE: Zaman K et al. Vaccine. 2019 Jun 22. doi: 10.1016/j.vaccine.2019.06.048.
FROM VACCINE
Weaponized ticks, pothead parents, and spider smoothies
Spider smoothie, anyone?
Eating spiders, grasshoppers, and cicadas – does that idea BUG you? Plenty of people around the world chomp down on insects as part of a balanced diet. But here in the United States, there’s definitely still an “ick” factor – as in, “ick, that thing has far too many legs to put in my mouth.”
These creepy crawlers, however, could be the key to a healthier lifestyle. Scientists have been recently looking at insects as a source of protein and antioxidants, among other health buzzwords.
Researchers from the University of Teremo in Italy took a look at commercially available insects (ever heard that phrase before?) and found that certain bugs, such as crickets, silkworms, caterpillars, and cicadas, displayed two or three times as much antioxidant activity as orange juice and olive oil. Perhaps you’d like a nice glass of cicada juice to go with your morning cereal?
Barclays also recently predicted that the insect protein market could be worth as much as $8 billion in the next decade, because of several factors. The earth’s population is rising, and people need new sources of food. We know bugs are plentiful – just go outside in the summer and stand with your mouth open, and you’ve got a three-course meal in 5 minutes.
We can also thank the teens: Barclays stated that Gen Z is the “most health-aware and environmentally conscious” generation yet, and therefore are all aboard the bug-eating train.
So, are you ready to start making eggs with a side of fried crickets? Perhaps a nice plant-based burger topped with cicada crumbles? Just make sure to stay away from the zombie ones.
Mom, put the joint down!
Way to harsh my mellow. You might think that smoking a little Mary Jane would chill parents out a bit. Turns out, that’s not the case.
A study from Ohio State University examined California parents, their substance use, and their disciplinarian styles. This is one of the first studies to look at how substance use relates to parenting, and the news is not good for the kids.
If you’re thinking about getting your parents into pot, think again. Parents who used marijuana in the past year tended to discipline their children more than parents who hadn’t used. Researchers also found similar trends with parents who used alcohol in the past.
Kids, if you’ve got a no-smoking, no-drinking square of a parent, be happy. It might save you a few groundings.
The true power of the dark side
When people go the grocery store, the produce department is – for many people – a big waste of space. It’s something to be skipped over. Who wants to buy fruits or vegetables anyway? Sure, they’re healthy, but they’re totally gross.
Turns out, there may be a way to get even your stubborn Uncle Joe, who probably thinks the food pyramid is a communist plot, to buy veggies. The key is a little black dress.
Okay, we’re not literally talking about sticking pineapples or broccoli in actual black dresses. But according to a study published in Food Quality and Preference, placing various types of produce against a black background made them more attractive to consumers over white or shades of gray. Even the lowly carrot, rated least attractive by the study participants when placed in front of every other color, got a big boost when placed on a black background. Something about black just brought out its natural shine.
So, next time you go through the produce department and it looks like it’s been designed by a teenager going through a particularly rough Goth phase, now you’ll know why.
The Lyme disease truth is out there
The setting is Rocky Mountain Laboratories in Hamilton, Mont. A man and a woman, both wearing dark suits, are standing in a large, poorly lit room full of file cabinets. Each is holding a flashlight.
Sculder: Explain to me again, Mully, why we couldn’t just ask to see these files?
Mully: C’mon, Sculder. My very secret and very reliable source said that Dr. Willy Burgdorfer, the scientist who discovered Lyme disease and worked in this lab, was actually a bioweapons specialist. My source said that Burgdorfer and “other bioweapons specialists stuffed ticks with pathogens to cause severe disability, disease – even death – to potential enemies.” If we had asked to see the records, they would have been destroyed by operatives of the shadow government.
Sculder: Where did you find this secret and reliable source, Mully?
Mully: I read his press release.
Sculder: Did the press release say anything about releases of diseased ticks, either accidental or by design?
Mully: Not until I ran it past a Navajo code talker.
Sculder stares at him blankly for several seconds.
Mully: Okay, okay. There’s this congressman, Rep. Chris Smith from New Jersey. The House of Representatives just approved his amendment to the 2020 National Defense Authorization Act. The amendment “directs the Inspector General of the Department of Defense to investigate the possible involvement of DOD biowarfare labs in the weaponization of Lyme disease in ticks and other insects from 1950 to 1975.” Honestly, it does.
Sculder turns around and quickly walks away. Mully follows her.
Mully: It could’ve happened! What if it’s another in the long line of government conspiracies that were too crazy to be true? Like Roswell. Or birtherism. Or New Coke. I suppose you’re going to tell me that Elvis and J. Edgar Hoover didn’t help NASA fake the moon landings?
Spider smoothie, anyone?
Eating spiders, grasshoppers, and cicadas – does that idea BUG you? Plenty of people around the world chomp down on insects as part of a balanced diet. But here in the United States, there’s definitely still an “ick” factor – as in, “ick, that thing has far too many legs to put in my mouth.”
These creepy crawlers, however, could be the key to a healthier lifestyle. Scientists have been recently looking at insects as a source of protein and antioxidants, among other health buzzwords.
Researchers from the University of Teremo in Italy took a look at commercially available insects (ever heard that phrase before?) and found that certain bugs, such as crickets, silkworms, caterpillars, and cicadas, displayed two or three times as much antioxidant activity as orange juice and olive oil. Perhaps you’d like a nice glass of cicada juice to go with your morning cereal?
Barclays also recently predicted that the insect protein market could be worth as much as $8 billion in the next decade, because of several factors. The earth’s population is rising, and people need new sources of food. We know bugs are plentiful – just go outside in the summer and stand with your mouth open, and you’ve got a three-course meal in 5 minutes.
We can also thank the teens: Barclays stated that Gen Z is the “most health-aware and environmentally conscious” generation yet, and therefore are all aboard the bug-eating train.
So, are you ready to start making eggs with a side of fried crickets? Perhaps a nice plant-based burger topped with cicada crumbles? Just make sure to stay away from the zombie ones.
Mom, put the joint down!
Way to harsh my mellow. You might think that smoking a little Mary Jane would chill parents out a bit. Turns out, that’s not the case.
A study from Ohio State University examined California parents, their substance use, and their disciplinarian styles. This is one of the first studies to look at how substance use relates to parenting, and the news is not good for the kids.
If you’re thinking about getting your parents into pot, think again. Parents who used marijuana in the past year tended to discipline their children more than parents who hadn’t used. Researchers also found similar trends with parents who used alcohol in the past.
Kids, if you’ve got a no-smoking, no-drinking square of a parent, be happy. It might save you a few groundings.
The true power of the dark side
When people go the grocery store, the produce department is – for many people – a big waste of space. It’s something to be skipped over. Who wants to buy fruits or vegetables anyway? Sure, they’re healthy, but they’re totally gross.
Turns out, there may be a way to get even your stubborn Uncle Joe, who probably thinks the food pyramid is a communist plot, to buy veggies. The key is a little black dress.
Okay, we’re not literally talking about sticking pineapples or broccoli in actual black dresses. But according to a study published in Food Quality and Preference, placing various types of produce against a black background made them more attractive to consumers over white or shades of gray. Even the lowly carrot, rated least attractive by the study participants when placed in front of every other color, got a big boost when placed on a black background. Something about black just brought out its natural shine.
So, next time you go through the produce department and it looks like it’s been designed by a teenager going through a particularly rough Goth phase, now you’ll know why.
The Lyme disease truth is out there
The setting is Rocky Mountain Laboratories in Hamilton, Mont. A man and a woman, both wearing dark suits, are standing in a large, poorly lit room full of file cabinets. Each is holding a flashlight.
Sculder: Explain to me again, Mully, why we couldn’t just ask to see these files?
Mully: C’mon, Sculder. My very secret and very reliable source said that Dr. Willy Burgdorfer, the scientist who discovered Lyme disease and worked in this lab, was actually a bioweapons specialist. My source said that Burgdorfer and “other bioweapons specialists stuffed ticks with pathogens to cause severe disability, disease – even death – to potential enemies.” If we had asked to see the records, they would have been destroyed by operatives of the shadow government.
Sculder: Where did you find this secret and reliable source, Mully?
Mully: I read his press release.
Sculder: Did the press release say anything about releases of diseased ticks, either accidental or by design?
Mully: Not until I ran it past a Navajo code talker.
Sculder stares at him blankly for several seconds.
Mully: Okay, okay. There’s this congressman, Rep. Chris Smith from New Jersey. The House of Representatives just approved his amendment to the 2020 National Defense Authorization Act. The amendment “directs the Inspector General of the Department of Defense to investigate the possible involvement of DOD biowarfare labs in the weaponization of Lyme disease in ticks and other insects from 1950 to 1975.” Honestly, it does.
Sculder turns around and quickly walks away. Mully follows her.
Mully: It could’ve happened! What if it’s another in the long line of government conspiracies that were too crazy to be true? Like Roswell. Or birtherism. Or New Coke. I suppose you’re going to tell me that Elvis and J. Edgar Hoover didn’t help NASA fake the moon landings?
Spider smoothie, anyone?
Eating spiders, grasshoppers, and cicadas – does that idea BUG you? Plenty of people around the world chomp down on insects as part of a balanced diet. But here in the United States, there’s definitely still an “ick” factor – as in, “ick, that thing has far too many legs to put in my mouth.”
These creepy crawlers, however, could be the key to a healthier lifestyle. Scientists have been recently looking at insects as a source of protein and antioxidants, among other health buzzwords.
Researchers from the University of Teremo in Italy took a look at commercially available insects (ever heard that phrase before?) and found that certain bugs, such as crickets, silkworms, caterpillars, and cicadas, displayed two or three times as much antioxidant activity as orange juice and olive oil. Perhaps you’d like a nice glass of cicada juice to go with your morning cereal?
Barclays also recently predicted that the insect protein market could be worth as much as $8 billion in the next decade, because of several factors. The earth’s population is rising, and people need new sources of food. We know bugs are plentiful – just go outside in the summer and stand with your mouth open, and you’ve got a three-course meal in 5 minutes.
We can also thank the teens: Barclays stated that Gen Z is the “most health-aware and environmentally conscious” generation yet, and therefore are all aboard the bug-eating train.
So, are you ready to start making eggs with a side of fried crickets? Perhaps a nice plant-based burger topped with cicada crumbles? Just make sure to stay away from the zombie ones.
Mom, put the joint down!
Way to harsh my mellow. You might think that smoking a little Mary Jane would chill parents out a bit. Turns out, that’s not the case.
A study from Ohio State University examined California parents, their substance use, and their disciplinarian styles. This is one of the first studies to look at how substance use relates to parenting, and the news is not good for the kids.
If you’re thinking about getting your parents into pot, think again. Parents who used marijuana in the past year tended to discipline their children more than parents who hadn’t used. Researchers also found similar trends with parents who used alcohol in the past.
Kids, if you’ve got a no-smoking, no-drinking square of a parent, be happy. It might save you a few groundings.
The true power of the dark side
When people go the grocery store, the produce department is – for many people – a big waste of space. It’s something to be skipped over. Who wants to buy fruits or vegetables anyway? Sure, they’re healthy, but they’re totally gross.
Turns out, there may be a way to get even your stubborn Uncle Joe, who probably thinks the food pyramid is a communist plot, to buy veggies. The key is a little black dress.
Okay, we’re not literally talking about sticking pineapples or broccoli in actual black dresses. But according to a study published in Food Quality and Preference, placing various types of produce against a black background made them more attractive to consumers over white or shades of gray. Even the lowly carrot, rated least attractive by the study participants when placed in front of every other color, got a big boost when placed on a black background. Something about black just brought out its natural shine.
So, next time you go through the produce department and it looks like it’s been designed by a teenager going through a particularly rough Goth phase, now you’ll know why.
The Lyme disease truth is out there
The setting is Rocky Mountain Laboratories in Hamilton, Mont. A man and a woman, both wearing dark suits, are standing in a large, poorly lit room full of file cabinets. Each is holding a flashlight.
Sculder: Explain to me again, Mully, why we couldn’t just ask to see these files?
Mully: C’mon, Sculder. My very secret and very reliable source said that Dr. Willy Burgdorfer, the scientist who discovered Lyme disease and worked in this lab, was actually a bioweapons specialist. My source said that Burgdorfer and “other bioweapons specialists stuffed ticks with pathogens to cause severe disability, disease – even death – to potential enemies.” If we had asked to see the records, they would have been destroyed by operatives of the shadow government.
Sculder: Where did you find this secret and reliable source, Mully?
Mully: I read his press release.
Sculder: Did the press release say anything about releases of diseased ticks, either accidental or by design?
Mully: Not until I ran it past a Navajo code talker.
Sculder stares at him blankly for several seconds.
Mully: Okay, okay. There’s this congressman, Rep. Chris Smith from New Jersey. The House of Representatives just approved his amendment to the 2020 National Defense Authorization Act. The amendment “directs the Inspector General of the Department of Defense to investigate the possible involvement of DOD biowarfare labs in the weaponization of Lyme disease in ticks and other insects from 1950 to 1975.” Honestly, it does.
Sculder turns around and quickly walks away. Mully follows her.
Mully: It could’ve happened! What if it’s another in the long line of government conspiracies that were too crazy to be true? Like Roswell. Or birtherism. Or New Coke. I suppose you’re going to tell me that Elvis and J. Edgar Hoover didn’t help NASA fake the moon landings?
FDA approves Recarbrio for cUTI, cIAI treatment in adults
The Recarbrio is a three-drug combo injection containing imipenem/cilastatin, an antibiotic previously approved by the FDA, and relebactam, a beta-lactamase inhibitor.
The efficacy of Recarbrio was supported by data on the efficacy of imipenem/cilastatin in the treatment of cUTI and cIAI and by in vitro studies and animal models of infection with treatment by relebactam. The safety was assessed in a pair of clinical studies, one that assessed cUTI patients and another that assessed cIAI patients.
The most common adverse events reported were nausea, diarrhea, headache, fever, and increased liver enzymes. Treatment with Recarbrio is not recommended in patients taking ganciclovir, valproic acid, or divalproex sodium because there is an increased risk of seizures, according to the FDA.
“The FDA remains focused on facilitating the development of safe and effective new antibacterial drugs to give patients more options to fight serious infections. It is important that the use of Recarbrio be reserved for situations when there are limited or no alternative antibacterial drugs for treating a patient’s infection,” Ed Cox, MD, MPH, director for the Office of Antimicrobial Products in FDA’s Center for Drug Evaluation and Research, said in the press release.
Find the full press release on the FDA website.
The Recarbrio is a three-drug combo injection containing imipenem/cilastatin, an antibiotic previously approved by the FDA, and relebactam, a beta-lactamase inhibitor.
The efficacy of Recarbrio was supported by data on the efficacy of imipenem/cilastatin in the treatment of cUTI and cIAI and by in vitro studies and animal models of infection with treatment by relebactam. The safety was assessed in a pair of clinical studies, one that assessed cUTI patients and another that assessed cIAI patients.
The most common adverse events reported were nausea, diarrhea, headache, fever, and increased liver enzymes. Treatment with Recarbrio is not recommended in patients taking ganciclovir, valproic acid, or divalproex sodium because there is an increased risk of seizures, according to the FDA.
“The FDA remains focused on facilitating the development of safe and effective new antibacterial drugs to give patients more options to fight serious infections. It is important that the use of Recarbrio be reserved for situations when there are limited or no alternative antibacterial drugs for treating a patient’s infection,” Ed Cox, MD, MPH, director for the Office of Antimicrobial Products in FDA’s Center for Drug Evaluation and Research, said in the press release.
Find the full press release on the FDA website.
The Recarbrio is a three-drug combo injection containing imipenem/cilastatin, an antibiotic previously approved by the FDA, and relebactam, a beta-lactamase inhibitor.
The efficacy of Recarbrio was supported by data on the efficacy of imipenem/cilastatin in the treatment of cUTI and cIAI and by in vitro studies and animal models of infection with treatment by relebactam. The safety was assessed in a pair of clinical studies, one that assessed cUTI patients and another that assessed cIAI patients.
The most common adverse events reported were nausea, diarrhea, headache, fever, and increased liver enzymes. Treatment with Recarbrio is not recommended in patients taking ganciclovir, valproic acid, or divalproex sodium because there is an increased risk of seizures, according to the FDA.
“The FDA remains focused on facilitating the development of safe and effective new antibacterial drugs to give patients more options to fight serious infections. It is important that the use of Recarbrio be reserved for situations when there are limited or no alternative antibacterial drugs for treating a patient’s infection,” Ed Cox, MD, MPH, director for the Office of Antimicrobial Products in FDA’s Center for Drug Evaluation and Research, said in the press release.
Find the full press release on the FDA website.
Little association found between in utero H1N1 vaccine and 5-year health outcomes
according to Laura K. Walsh of the University of Ottawa and associates.
The investigators conducted a population-based retrospective cohort study from November 2009 to October 2010 of all live births within the province of Ontario. Of the 104,249 eligible live births reported to the Ontario birth registry, 31,295 were exposed to the H1N1 vaccine in utero. After adjustment, there were no significant differences in the women who did and did not receive vaccines during pregnancy, according to the study, published in the BMJ.
After a median follow-up of 5 years, 14% of children received an asthma diagnosis, with a median age at diagnosis of 1.8 years. Children were more likely to receive an asthma diagnosis if their mothers had a preexisting condition or if they were born preterm. At follow-up, 34% of children had at least one upper respiratory tract infection. Sensory disorder, neoplasm, and pediatric complex chronic condition were rare, each occurring in less than 1% of the study cohort (BMJ. 2019 Jul 10. doi: 10.1136/bmj.l4151).
No significant association was found between prenatal exposure to the H1N1 vaccine and upper or lower respiratory infections, otitis media, all infections, neoplasms, sensory disorders, rates of urgent and inpatient health services use, pediatric complex chronic conditions, or mortality. A weak but significant association was observed for asthma (adjusted hazard ratio, 1.05; 95% confidence interval, 1.02-1.09), and a weak inverse association was found for gastrointestinal infections (adjusted incidence rate ratio, 0.94; 95% CI, 0.91-0.98).
“Although we observed a small, but statistically significant, increase in pediatric asthma and a reduction in gastrointestinal infections, we are not aware of any biologic mechanisms to explain these findings. Future studies in different settings and with different influenza vaccine formulations will be important for developing the evidence base on longer-term pediatric outcomes following influenza vaccination during pregnancy,” the investigators concluded.
The study was funded by grants from the Canadian Institutes of Health Research and the Institute for Clinical Evaluative Sciences.
according to Laura K. Walsh of the University of Ottawa and associates.
The investigators conducted a population-based retrospective cohort study from November 2009 to October 2010 of all live births within the province of Ontario. Of the 104,249 eligible live births reported to the Ontario birth registry, 31,295 were exposed to the H1N1 vaccine in utero. After adjustment, there were no significant differences in the women who did and did not receive vaccines during pregnancy, according to the study, published in the BMJ.
After a median follow-up of 5 years, 14% of children received an asthma diagnosis, with a median age at diagnosis of 1.8 years. Children were more likely to receive an asthma diagnosis if their mothers had a preexisting condition or if they were born preterm. At follow-up, 34% of children had at least one upper respiratory tract infection. Sensory disorder, neoplasm, and pediatric complex chronic condition were rare, each occurring in less than 1% of the study cohort (BMJ. 2019 Jul 10. doi: 10.1136/bmj.l4151).
No significant association was found between prenatal exposure to the H1N1 vaccine and upper or lower respiratory infections, otitis media, all infections, neoplasms, sensory disorders, rates of urgent and inpatient health services use, pediatric complex chronic conditions, or mortality. A weak but significant association was observed for asthma (adjusted hazard ratio, 1.05; 95% confidence interval, 1.02-1.09), and a weak inverse association was found for gastrointestinal infections (adjusted incidence rate ratio, 0.94; 95% CI, 0.91-0.98).
“Although we observed a small, but statistically significant, increase in pediatric asthma and a reduction in gastrointestinal infections, we are not aware of any biologic mechanisms to explain these findings. Future studies in different settings and with different influenza vaccine formulations will be important for developing the evidence base on longer-term pediatric outcomes following influenza vaccination during pregnancy,” the investigators concluded.
The study was funded by grants from the Canadian Institutes of Health Research and the Institute for Clinical Evaluative Sciences.
according to Laura K. Walsh of the University of Ottawa and associates.
The investigators conducted a population-based retrospective cohort study from November 2009 to October 2010 of all live births within the province of Ontario. Of the 104,249 eligible live births reported to the Ontario birth registry, 31,295 were exposed to the H1N1 vaccine in utero. After adjustment, there were no significant differences in the women who did and did not receive vaccines during pregnancy, according to the study, published in the BMJ.
After a median follow-up of 5 years, 14% of children received an asthma diagnosis, with a median age at diagnosis of 1.8 years. Children were more likely to receive an asthma diagnosis if their mothers had a preexisting condition or if they were born preterm. At follow-up, 34% of children had at least one upper respiratory tract infection. Sensory disorder, neoplasm, and pediatric complex chronic condition were rare, each occurring in less than 1% of the study cohort (BMJ. 2019 Jul 10. doi: 10.1136/bmj.l4151).
No significant association was found between prenatal exposure to the H1N1 vaccine and upper or lower respiratory infections, otitis media, all infections, neoplasms, sensory disorders, rates of urgent and inpatient health services use, pediatric complex chronic conditions, or mortality. A weak but significant association was observed for asthma (adjusted hazard ratio, 1.05; 95% confidence interval, 1.02-1.09), and a weak inverse association was found for gastrointestinal infections (adjusted incidence rate ratio, 0.94; 95% CI, 0.91-0.98).
“Although we observed a small, but statistically significant, increase in pediatric asthma and a reduction in gastrointestinal infections, we are not aware of any biologic mechanisms to explain these findings. Future studies in different settings and with different influenza vaccine formulations will be important for developing the evidence base on longer-term pediatric outcomes following influenza vaccination during pregnancy,” the investigators concluded.
The study was funded by grants from the Canadian Institutes of Health Research and the Institute for Clinical Evaluative Sciences.
FROM THE BMJ